This non-provisional patent application is a continuation-in-part application, filed 3/28/2012 under the designation "Tissue Thickness Compensator compliance of documents" in accordance with the 35 u.s.c. 120 specification, entitled U.S. patent application serial No. 13/433,129, the entire disclosure of which is hereby incorporated by reference.
Detailed Description
The applicant of the present application also owns the following identified U.S. patent applications, each of which is hereby incorporated by reference in their respective entireties:
U.S. patent application Ser. No. 12/894,311 (nowU.S. patent publication 2012/0080496) entitled "SURGICAL INSTRUMENTS WITH RECONFIGURABLE SHAFT SEGMENTS";
U.S. patent application Ser. No. 12/894,340 entitled "SURGICAL STAPLE CARTRIDGES SUPPORTING NON-LINEARLY ARRANGED STAPLES AND SURGICAL STAPLING INSTRUMENTS WITH COMMON STAPLE-FORMING POCKETS" (nowU.S. patent publication 2012/0080482);
U.S. patent application Ser. No. 12/894,327 entitled "JAW CLOSURE ARRANGEMENTS FOR SURGICAL INSTRUMENTS" (nowU.S. patent publication 2012/0080499);
U.S. patent application Ser. No. 12/894,351 entitled "SURGICAL CUTTING AND FASTENING INSTRUMENTS WITH SEPARATE AND DISTINCT FASTENER DEPLOYMENT AND TISSUE CUTTING SYSTEMS" (nowU.S. patent publication 2012/0080502);
U.S. patent application Ser. No. 12/894,338 (nowU.S. patent publication 2012/0080481) entitled "IMPLANTABLE FASTENER CARTRIDGE HAVING A NON-UNIFORM ARRANGEMENT";
U.S. patent application Ser. No. 12/894,369 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING A SUPPORT RETAINER" (nowU.S. patent publication 2012/0080344);
U.S. patent application Ser. No. 12/894,312 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING MULTIPLE LAYERS" (nowU.S. patent publication 2012/0080479);
U.S. patent application serial No. 12/894,377 entitled "SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE" (nowU.S. patent publication 2012/0080334);
U.S. patent application Ser. No. 12/894,339 entitled "SURGICAL STAPLING INSTRUMENT WITH COMPACT ARTICULATION CONTROL ARRANGEMENT" (nowU.S. patent publication 2012/0080500);
U.S. patent application Ser. No. 12/894,360 entitled "SURGICAL STAPLING INSTRUMENT WITH A VARIABLE STAPLE FORMING SYSTEM" (nowU.S. patent publication 2012/0080484);
U.S. patent application Ser. No. 12/894,322 (nowU.S. patent publication 2012/0080501), entitled "SURGICAL STAPLING INSTRUMENT WITH INTERCHANGEABLE STAPLE CARTRIDGE ARRANGEMENTS";
U.S. patent application Ser. No. 12/894,350 entitled "SURGICAL STAPLE CARTRIDGES WITH DETACHABLE SUPPORT STRUCTURES AND SURGICAL STAPLING INSTRUMENTS WITH SYSTEMS FOR PREVENTING ACTION MOTIONS WHEN A CARTRIDGE IS NOT PRESENT" (nowU.S. patent publication 2012/0080478);
U.S. patent application Ser. No. 12/894,383 entitled "IMPLANTABLE FASTENER CARTRIDGE COMPRISING BIOABSORBABLE LAYERS" (nowU.S. patent publication 2012/0080345);
U.S. patent application serial No. 12/894,389 entitled "compact FASTENER CARTRIDGE" (nowU.S. patent publication 2012/0080335);
U.S. patent application serial No. 12/894,345 entitled "FASTENERS SUPPORTED BY A FASTENER CARTRIDGE SUPPORT" (nowU.S. patent publication 2012/0080483);
U.S. patent application serial No. 12/894,306 entitled "COLLAPSIBLE FASTENER CARTRIDGE" (nowU.S. patent publication 2012/0080332);
U.S. patent application Ser. No. 12/894,318 entitled "FASTENER SYSTEM composition A PLURALITY OF CONNECTED RETENTION MATRIX ELEMENTS" (nowU.S. patent publication 2012/0080480);
U.S. patent application Ser. No. 12/894,330 entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND AN ALIGNMENT MATRIX" (nowU.S. patent publication 2012/0080503);
U.S. patent application Ser. No. 12/894,361 entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (nowU.S. patent publication 2012/0080333);
U.S. patent application Ser. No. 12/894,367 entitled "FASTENING INSTRUMENT FOR DEPLOYING A FASTENER SYSTEM COMPRISING A RETENTION MATRIX" (nowU.S. patent publication 2012/0080485);
U.S. patent application Ser. No. 12/894,388 entitled "FASTENER SYSTEM COMPRISING A RETENTION MATRIX AND A COVER" (nowU.S. patent publication 2012/0080487);
U.S. patent application Ser. No. 12/894,376 entitled "FASTENER SYSTEM COMPRISING A PLURALITY OF FASTENER CARTRIDGES" (nowU.S. patent publication 2012/0080486);
U.S. patent application Ser. No. 13/097,865 entitled "SURGICAL STAPLER ANVIL COMPRISING A PLURALITY OF FORMING POCKETS" (nowU.S. patent publication 2012/0080488);
U.S. patent application Ser. No. 13/097,936 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER" (nowU.S. patent publication 2012/0080339);
U.S. patent application Ser. No. 13/097,954 entitled "STAPLE CARTRIDGE COMPRISING A VARIABLE THICKNESS COMPRESSIBLE PORTION" (nowU.S. patent publication 2012/0080340);
U.S. patent application Ser. No. 13/097,856 entitled "STAPLE CARTRIDGE COMPRISING STAPLES POSITIONED WITHIN A COMPRESSIBLE PORTION THEREOF" (nowU.S. patent publication 2012/0080336);
U.S. patent application Ser. No. 13/097,928 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING DEACABLE PORTIONS" (nowU.S. patent publication 2012/0080490);
U.S. patent application Ser. No. 13/097,891 entitled "TISSUE THICKNESS COMPENSATOR FOR A SURGICAL STAPLER COMPRISING AN ADJUSTABLE ANVIL" (nowU.S. patent publication 2012/0080489);
U.S. patent application Ser. No. 13/097,948 (nowU.S. patent publication 2012/0083836), entitled "STAPLE CARTRIDGE COMPRISING AN ADJUSTABLE DISTAL PORTION";
U.S. patent application serial No. 13/097,907 entitled "compact STAPLE CARTRIDGE asset" (nowU.S. patent publication 2012/0080338);
U.S. patent application Ser. No. 13/097,861 entitled "TISSUE THICKNESS COMPENSATOR COMPATINING PORTIONS HAVING DIFFERENT PROPERTIES" (nowU.S. patent publication 2012/0080337);
U.S. patent application Ser. No. 13/097,869 (nowU.S. patent publication 2012/0160721), entitled "STAPLE CARTRIDGE LOADING ASSEMBLY";
U.S. patent application Ser. No. 13/097,917 entitled "COMPRESSIBLE STAPLE CARTRIDGE COMPRISING ALIGNMENT MEMBERS" (nowU.S. patent publication 2012/0083834);
U.S. patent application Ser. No. 13/097,873 entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (nowU.S. patent publication 2012/0083833);
U.S. patent application Ser. No. 13/097,938 entitled "STAPLE CARTRIDGE composite curable resin compositions" (nowU.S. patent publication 2012/0080491);
U.S. patent application Ser. No. 13/097,924 entitled "STAPLE CARTRIDGE COMPRISING A TISSUE THICKNESS COMPENSATOR" (nowU.S. patent publication 2012/0083835);
U.S. patent application Ser. No. 13/242,029 entitled "SURGICAL STAPLER WITH FLOATING ANVIL" (nowU.S. patent publication 2012/0080493);
U.S. patent application Ser. No. 13/242,066 (nowU.S. patent publication 2012/0080498), entitled "CURVED END EFFECTOR FOR A STAPLING INSTRUMENTS";
U.S. patent application Ser. No. 13/242,086 entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK";
U.S. patent application serial No. 13/241,912 entitled "STAPLE CARTRIDGE INCLUDING COLLAPSIBLE DECK ARRANGEMENT";
U.S. patent application Ser. No. 13/241,922 entitled "SURGICAL STAPLER WITH STATIONARY STAPLE DRIVERS";
U.S. patent application Ser. No. 13/241,637 (nowU.S. patent publication 2012/0074201) entitled "SURGICAL INSTRUMENT WITH TRIGGER ASSEMBLY FOR GENERATING MULTIPLE ACTION MOTIONS";
U.S. patent application Ser. No. 13/241,629 (nowU.S. patent publication 2012/0074200), entitled "SURGICAL INSTRUMENT WITH SELECTIVELY ARTICULATABLE END EFFECTOR";
U.S. patent application Ser. No. 13/433,096 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF CAPSULES" (nowU.S. patent publication 2012/0241496);
U.S. patent application Ser. No. 13/433,103 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF LAYERS" (nowU.S. patent publication 2012/0241498);
U.S. patent application Ser. No. 13/433,098 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR" (nowU.S. patent publication 2012/0241491);
U.S. patent application Ser. No. 13/433,102 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A RESERVOIR" (nowU.S. patent publication 2012/0241497);
U.S. patent application Ser. No. 13/433,114 entitled "RETAINER ASSEMBLY INCLUDING A TISSUE THICKNESS COMPENSATOR" (nowU.S. patent publication 2012/0241499);
U.S. patent application Ser. No. 12/433,136 entitled "TISSUE THICKNESS COMPENSATOR COMPISING AT LEAST ONE MEDICAMENT" (nowU.S. patent publication 2012/0241492);
U.S. patent application Ser. No. 13/433,141 entitled "TISSUE THICKNESS COMPENSATOR COMPATINING CONTROLLED RELEASE AND EXPANSION" (nowU.S. patent publication 2012/0241493);
U.S. patent application Ser. No. 13/433,144 (nowU.S. patent publication 2012/0241500), entitled "TISSUE THICKNESS COMPENSATOR COMPISING FIBERS TO PRODUCE A RESILIENT LOAD";
U.S. patent application Ser. No. 13/433,148 entitled "TISSUE THICKNESS COMPENSATOR COMPISING STRUCTURE TO PRODUCE A RESILIENT LOAD" (nowU.S. patent publication 2012/0241501);
U.S. patent application Ser. No. 13/433,155 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING RESILINT MEMBERS" (nowU.S. patent publication 2012/0241502);
U.S. patent application Ser. No. 13/433,163 entitled "METHOD FOR FORMING TISSUE THICKNESS COMPENSATOR ARRANGEMENTS FOR SURGICAL STAPLERS" (nowU.S. patent publication 2012/0248169);
U.S. patent application Ser. No. 13/433,167 entitled "TISSUE THICKNESS COMPENSATORS" (nowU.S. patent publication 2012/0241503);
U.S. patent application Ser. No. 13/433,175 entitled "laminated TISSUE THICKNESS COMPENSATOR" (nowU.S. patent publication 2012/0253298);
U.S. patent application Ser. No. 13/433,179 entitled "TISSUE THICKNESS COMPENSATORS FOR CIRCULAR SURGICAL STAPLERS" (nowU.S. patent publication 2012/0241505);
U.S. patent application Ser. No. 13/433,115 entitled "TISSUE THICKNESS COMPENSATOR COMPLEMENTING CAPSULES DEFINING A LOW PRESSURE ENVIRONMENT";
U.S. patent application Ser. No. 13/433,118 entitled "TISSUE THICKNESS COMPENSATOR COMPRISED OF A PLURALITY OF MATERIALS";
U.S. patent application Ser. No. 13/433,135 entitled "Movable Membrane FOR USE WITH A TISSUE THICKNESS COMPENSATOR";
U.S. patent application Ser. No. 13/433,140 entitled "TISSUE THICKNESS COMPENSATOR AND METHOD FOR MAKING THE SAME";
U.S. patent application Ser. No. 13/433,147 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING CHANNELS";
U.S. patent application Ser. No. 13/433,126 entitled "TISSUE THICKNESS COMPENSATOR COMPISING TISSUE INGROWTH FEATURES";
U.S. patent application Ser. No. 13/433,132 entitled "DEVICES AND METHODS FOR ATTACHING titanium catalyst TO minor catalyst insertion systems"; and
U.S. patent application Ser. No. 13/433,129 entitled "TISSUE THICKNESS COMPENSATOR COMPRISING A PLURALITY OF MEDICAMENTS".
The applicant of the present application also owns the following identified U.S. patent applications, each of which is hereby incorporated by reference in their respective entireties:
U.S. patent application Ser. No. 11/216,562 (now U.S. Pat. No. 7,669,746) entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS";
U.S. patent application Ser. No. 11/714,049 entitled "SURGICAL STAPLING DEVICE WITH ANVIL HAVING STAPLE FORMING POCKETS OF VARYING DEPTHS" (now U.S. patent publication 2007/0194082);
U.S. patent application Ser. No. 11/711,979 (now U.S. Pat. No. 8,317,070) entitled "SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS";
U.S. patent application serial No. 11/711,975 entitled "SURGICAL STAPLING DEVICE WITH STAPLE DRIVERS OF DIFFERENT HEIGHT" (now U.S. patent publication 2007/0194079);
U.S. patent application Ser. No. 11/711,977 entitled "SURGICAL STAPLING DEVICE WITH STAPLE DRIVER THAT SUPPORTS MULTIPLE WIRE DIAMETER STAPLES" (now U.S. Pat. No. 7,673,781);
U.S. patent application Ser. No. 11/712,315 (now U.S. Pat. No. 7,500,979) entitled "SURGICAL STAPLING DEVICE WITH MULTIPLE STACKED ACTUATOR WEDGE CAMS FOR DRIVING STAPLE DRIVERS";
U.S. patent application Ser. No. 12/038,939 (now U.S. Pat. No. 7,934,630) entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS";
U.S. patent application Ser. No. 13/020,263 entitled "SURGICAL STAPLING SYSTEMS THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS" (now U.S. patent publication 2011/0147434);
U.S. patent application Ser. No. 13/118,278 (now U.S. patent publication 2011/0290851), entitled "ROBOTIC-CONTROLLED SURGICAL STAPLING DEVICES THAT PRODUCE FORMED STAPLES HAVING DIFFERENT LENGTHS";
U.S. patent application Ser. No. 13/369,629 entitled "ROBOTIC-CONTROLLED CABLE-BASED SURGICAL END EFFECTORS" (nowU.S. patent publication 2012/0138660);
U.S. patent application Ser. No. 12/695,359 entitled "SURGICAL STAPLING DEVICES FOR FORMING STAPLES WITH DIFFERENT FORMED HEIGHTS" (nowU.S. patent publication 2010/0127042); and
U.S. patent application Ser. No. 13/072,923 (now U.S. patent publication 2011/0174863), entitled "STAPLE CARTRIDGES FOR FORMING STAPLES HAVING DIFFERING FORMED STAPLE HEIGHTS".
The applicant of the present application also owns the following identified U.S. patent applications filed on the same day as the present application and each of which is herein incorporated by reference in its respective entirety:
U.S. patent application Ser. No. _______________ entitled "SURGICAL STAPLING CARTRIDGE WITH LAYER RETENTION FEATURES" (attorney docket number END7104USCIP1/110606CIP 1);
U.S. patent application Ser. No. _______________ entitled "ADHESIVE FILM LAMINATE" (attorney docket number END6843USCIP19/100528CP 19);
U.S. patent application Ser. No. _______________ entitled "ACTUATOR FOR RELEASING A TISSUE THICKNESS COMPENSATOR FROM A FASTENER CARTRIDGE" (attorney docket number END6848USCIP2/100533CIP 2);
U.S. patent application Ser. No. _______________ entitled "RELEABLE TISSUE THICKNESS COMPENSATOR AND FASTENER CARTRIDGE HAVING THE SAME" (attorney docket number END6848USCIP3/100533CIP 3);
U.S. patent application Ser. No. _______________ entitled "FASTENER CARTRIDGE COMPRISING A RELEABLE TISSUE THICKNESS COMPENSATOR" (attorney docket number END6848USCIP4/100533CIP 4);
U.S. patent application Ser. No. _______________ entitled "FASTENER CARTRIDGE COMPRISING A CUTTING MEMBER FOR RELEASING A TISSUE THICKNESS COMPENSATOR" (attorney docket number END6848USCIP5/100533CIP 5);
U.S. patent application Ser. No. _______________ entitled "FASTENER CARTRIDGE COMPRISING A RELEASABLE ATTACHED TISSUE THICKNESS COMPENSATOR" (attorney docket number END6848USCIP6/100533CIP 6);
U.S. patent application Ser. No. _______________ entitled "STAPLE CARTRIDGE COMPRISING A RELEASBECODECOVER" (attorney docket number END7201 USNP/120294);
U.S. patent application Ser. No. _______________ entitled "ANVIL LAYER ATTACHED TO A PROXIMAL END OF AN END EFFECTOR" (attorney docket number END7102USCIP2/110604CIP 2);
U.S. patent application Ser. No. _______________ entitled "LAYER compring DEPLOYABLE ATTACHMENT MEMBERS" (attorney docket number END7102USCIP3/110604CIP 3);
U.S. patent application Ser. No. _______________ entitled "LAYER ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES" (attorney docket number END6232USCIP1/070348CIP 1);
U.S. patent application Ser. No. _______________ entitled "IMPLANTABLE ARRANGEMENTS FOR SURGICAL STAPLE CARTRIDGES" (attorney docket number END6232USCIP2/070348CIP 2);
U.S. patent application Ser. No. _______________ entitled "MULTIPLE THICKNESESS IMPLANTABLE LAYERS FOR SURGICAL STAPLING DEVICES" (attorney docket number END6840USCIP2/100525CIP 2);
U.S. patent application Ser. No. _______________ entitled "RELEABLE LAYER OF MATERIAL AND SURGICAL END EFFECTOR HAVING THE SAME" (attorney docket number END6232USCIP3/070348CIP 3);
U.S. patent application Ser. No. _______________ entitled "ACTUATOR FOR RELEASING A LAYER OF MATERIAL FROM A SURGICAL END EFFECTOR" (attorney docket number END6232USCIP4/070348CIP 4); and
U.S. patent application Ser. No. _______________ entitled "STAPLE CARTRIDGE COMPRISING A RELEASABLE PORTION" (attorney docket number END7200 USNP/120302).
Certain exemplary embodiments will now be described to provide an overall understanding of the structure, function, principles of manufacture, and uses of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the various embodiments of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
Reference throughout this specification to "various embodiments," "some embodiments," "one embodiment," or "an embodiment," etc., means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in various embodiments," "in some embodiments," "in one embodiment," or "in an embodiment," or the like, throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics shown or described in connection with one embodiment may be combined, in whole or in part, with the features, structures, or characteristics of one or more other embodiments, without limitation. Such modifications and variations are intended to be included within the scope of the present invention.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion away from the clinician. It will be further appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein with respect to the drawings. However, surgical instruments are capable of use in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Various exemplary devices and methods for performing laparoscopic and minimally invasive surgical procedures are provided. However, one of ordinary skill in the art will readily appreciate that the various methods and devices disclosed herein may be used in a number of surgical procedures and applications, including, for example, in conjunction with open surgery. With continued reference to the present detailed description, those of ordinary skill in the art will further appreciate that the various instruments disclosed herein may be inserted into the body in any manner, such as through a natural orifice, through an incision or puncture formed in tissue, and the like. The working portion or end effector portion of the instrument can be inserted directly into a patient or can be inserted through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument can be advanced.
In fig. 1 and 2, a surgical stapling and severinginstrument 8010 can include ananvil 8014 that can be repeatedly opened and closed about its pivotal attachment to anelongate staple channel 8016. Thestaple applying assembly 8012 can comprise ananvil 8014 and achannel 8016, wherein theassembly 8012 can be attached proximally to anelongate shaft 8018 that forms an implementportion 8022. When thestaple applying assembly 8012 is closed, or at least substantially closed, the implementportion 8022 can present a sufficiently small cross-section that is suitable for insertion of thestaple applying assembly 8012 through a trocar. In various embodiments, theassembly 8012 can be manipulated by ahandle 8020 connected to theshaft 8018. Thehandle 8020 can include user controls such as aknob 8030 that rotates theelongate shaft 8018 andstaple applying assembly 8012 about the longitudinal axis of theshaft 8018. Theclosure trigger 8026, which can be depressed to close thestaple applying assembly 8012, can pivot in front of thepistol grip 8036 about a closure trigger pin 8152 (fig. 3) engaged laterally across thehandle housing 8154. In various embodiments, when theclosure trigger 8026 is clamped, theclosure release button 8038 can be presented outwardly on thehandle 8020 such that therelease button 8038 can be depressed to release theclosure trigger 8026 and open thestaple applying assembly 8012, as described in more detail below. Afiring trigger 8034, which can be pivoted before theclosure trigger 8026, can cause thestaple applying assembly 8012 to simultaneously sever and staple tissue clamped therein. In various circumstances, as described in more detail below, multiple firing strokes can be employed using thefiring trigger 8034 to reduce the amount of force required to be applied by the surgeon's hand per stroke. In certain embodiments, thehandle 8020 can include a rotatableright indicator wheel 8040 and/or a left indicator wheel 8041 (fig. 3) that can indicate firing progress. For example, full firing travel may require three full firing strokes of thefiring trigger 8034, and thus theindicator wheels 8040 and 8041 may each rotate up to one-third of a revolution per stroke of thefiring trigger 8034. As described in more detail below, the manualfiring release lever 8042 can allow the firing system to retract before full firing travel is complete, if desired, and further, the firingrelease lever 8042 can allow a surgeon or other clinician to retract the firing system if the firing system jams and/or fails.
Referring to fig. 1 and 3, theelongate shaft 8018 can comprise an outer structure that includes a longitudinallyreciprocating closure tube 8024 that pivots theanvil 8014 toward its closed position in response to proximal depression of aclosure trigger 8026 of thehandle 8020. Theelongate channel 8018 may be connected to thehandle 8020 by a frame 8028 (fig. 3) inside theclosure tube 8024. Theframe 8028 is rotatably coupled to thehandle 8020 such that rotation of the knob 8030 (fig. 1) can rotate the implementportion 8022. With particular reference to fig. 3, theknob 8030 may be constructed from two half-shells that may include one or moreinward projections 8031 that may extend through one or moreelongated side openings 8070 in theclosure tube 8024 and engage theframe 8028. Thus, theknob 8030 and theframe 8028 may be rotated together or simultaneously, such that the rotational position of theknob 8030 determines the rotational position of the implementportion 8022. In various embodiments, the longitudinal length of thelonger opening 8070 is long enough to enable theclosure tube 8024 to undergo longitudinal closing and opening motions. With respect to generating the closing motion of theclosure tube 8024, referring primarily to fig. 3 and 5, anupper portion 8160 of theclosure trigger 8026 can push a closure yoke 8162 (fig. 4) forward via aclosure link 8164. Theclosure link 8164 is pivotally attached at its distal end to theclosure yoke 8162 by aclosure yoke pin 8166 and pivotally attached at its proximal end by aclosure link pin 8168. In various embodiments, theclosure trigger 8026 can be urged to the open position by a closure trigger tension spring 8246 that is proximally connected to theupper portion 8160 of theclosure trigger 8026 and thehandle housing 8154 formed by the right and lefthalf shells 8156, 8158. The tension applied by the tension spring 8246 can be overcome by the closing force applied to theclosure trigger 8026 in order to advance theyoke 8162,closure link 8164, andclosure tube 8024 distally.
When theclosure trigger 8026 is actuated or depressed as described above, theclosure release button 8038 can be positioned to enable a surgeon or other clinician to depress theclosure release button 8038, and enable theclosure trigger 8026 and the rest of the surgical instrument to return to an unactuated state, if desired. In various embodiments, theclosure release button 8038 can be connected to apivoting locking arm 8172 by a centraltransverse pivot 8173, such that motion can be transferred between therelease button 8038 and thelocking arm 8172. Referring again to fig. 3, thecompression spring 8174 can bias theclosure release button 8038 proximally, i.e., clockwise about the centraltransverse pivot 8173 as viewed from the right, and theupper portion 8160 of theclosure trigger 8026 can include aproximal crest 8170 having anaft recess 8171. When theclosure trigger 8026 is depressed, the pivotinglocking arm 8172 can ride over theproximal crest 8170, and when theclosure trigger 8026 reaches its fully depressed position, it will be appreciated that therear notch 8171 resides beneath the pivotinglocking arm 8172, which drops into therear notch 8171 and locks therear notch 8171 under the urging of thecompression spring 8174. At this point, manual depression of theclosure release button 8038 rotates the pivotinglocking arm 8172 upward and out of therear notch 8171, thereby unlocking theclosure trigger 8026 and allowing theclosure trigger 8026 to return to its undamped position.
Once theclosure trigger 8026 is clamped proximally as described above, thefiring trigger 8034 can be pulled toward thepistol grip 8036 to advance thefiring bar 8032 distally from thehandle 8020. In various embodiments, thefiring trigger 8034 can pivot about afiring trigger pin 8202 that traverses through and engages the right and lefthalf shells 8156, 8158 of thehandle 8020. When thefiring trigger 8034 is actuated, it can advance the linkedtransmission firing mechanism 8150. The linkedtransmission firing mechanism 8150 can be urged to a retracted, unfired position by aspring 8184 that is 1) attached to thepistol grip 8036 of thehandle 8020, and 2) attached to one of the links of the linkedtransmission firing mechanism 8150, for example, as described in more detail below.Spring 8184 may include anon-moving tip 8186 connected tohousing 8154, and a movingtip 8188 connected to a proximal end 8190 of asteel band 8192. A distally disposedtip 8194 of thesteel band 8192 may be attached to anattachment feature 8195 on aforward link 8196a of the plurality of links 8196 a-8196 d, the plurality of links 8196 a-8196 d forming a linkedrack 8200. The linkedrack 8200 can be flexible such that it can be easily retracted into thepistol grip 8036 and minimize the length of thehandle 8020, creating a straight, rigid rack assembly that can transfer significant firing forces to and/or through thefiring bar 8032. As described in more detail below, thefiring trigger 8034 can be engaged with thefirst link 8196a during a first actuation of thefiring trigger 8034, engaged with thesecond link 8196b during a second actuation of thefiring trigger 8034, engaged with thethird link 8196c during a third actuation of thefiring trigger 8034, and engaged with thefourth link 8196d during a fourth actuation of thefiring trigger 8034, wherein each actuation of thefiring trigger 8034 can advance the linkedrack 8200 distally an incremental amount. In various embodiments, in addition to the above, multiple strokes of thefiring trigger 8034 can rotate the right and leftindicator wheels 8040, 8041 to indicate the distance the linkedrack 8200 has advanced.
Referring now to fig. 3 and 5, ananti-backup mechanism 8250 can prevent the combined tension/compression spring 8184 from retracting the linkedrack 8200 between firing strokes. In various embodiments, acoupling slide tube 8131 abuts thefirst link 8196a and connects to thefiring bar 8032 to transfer the firing motion. Thefiring rod 8032 extends proximally out of the proximal end of theframe 8028 and through the through-hole 8408 of theanti-backup plate 8266. The throughhole 8408 is sized to slidingly receive thefiring bar 8032 when vertically aligned with thefiring bar 8032 and to allow thefiring bar 8032 to jam in the through hole when tilted. Alower tab attachment 8271 extends proximally from a lower lip of the proximal end of theframe 8028, extending through an aperture 8269 on a lower edge of theanti-backup plate 8266. Thislower tab attachment 8271 pulls a lower portion of theanti-backup plate 8266 adjacent to theframe 8028 such that theanti-backup plate 8266 is vertical when thefiring rod 8032 is advanced distally and theanti-backup plate 8266 enables the top to tip back to a restrained state when thefiring rod 8032 attempts to retract. Theanti-backup compression spring 8264 is distally constrained by the proximal end of theframe 8028 and proximally abuts a top portion of theanti-backup plate 8266, biasing theanti-backup plate 8266 to a locked state. Ananti-backup cam tube 8268 slidingly surrounds thecoupling slide tube 8131 against a spring bias and abuts theanti-backup plate 8266. A proximally projectinganti-backup yoke 8256 attached to theanti-backup cam tube 8268 extends beyond theclosure yoke 8162.
Referring to FIG. 3, a linkage triggeredautomatic retraction mechanism 8289 is incorporated into the surgical stapling and severinginstrument 8010 to retract the knife at the end of the full firing travel. To this end, thedistal link 8196d includes atang 8290, thetang 8290 protruding upward when thedistal link 8196d is advanced into a rack channel 8291 (fig. 3) formed in theclosure yoke 8162. Thetang 8290 is aligned to activate the bottomproximal cam 8292 on the anti-backup release lever 8248 (FIG. 6). Referring specifically to fig. 6, structure formed in the right and lefthalf shells 8156, 8158 constrains movement of theanti-backup release lever 8248. Apin receptacle 8296 and acircular pin 8293, formed respectively between the right and lefthalf shells 8156, 8158, are received through a longitudinallyelongated hole 8294, thehole 8294 being formed in theanti-backup release lever 8248 distal to the bottomproximal cam 8292, allowing longitudinal translation as well as rotation about thecircular pin 8293. In theright half shell 8156, the proximally open channel includes a proximal horizontal portion in communication with an upwardly and distally angled portion that receives the rightwardaft pin 8297 near the proximal end of theanti-backup release lever 8248, imparting an upward rotation when theanti-backup release lever 8248 reaches its translating distal-most portion. Once theanti-backup release lever 8248 is assembled, a blocking structure formed in theright half shell 8156 proximal to theanti-backup release lever 8248 prevents theanti-backup release lever 8248 from moving proximally to retain the rightwardaft pin 8297 in the proximally open channel as described above.
In addition to the above, referring now to fig. 3 and 7, thedistal end 8254 of theanti-backup release lever 8248 is thus urged distally and downwardly with therightward front pin 8298 falling into the distally open steppedstructure 8299 formed in theright half shell 8156, this engagement being achieved by securing a compression spring 8300 (fig. 3) to theleftward hook 8301 on theanti-backup release lever 8248 between therightward front pin 8298 and the longitudinallyelongated hole 8294. The other end of thecompression spring 8300 is attached to a hook 8302 (fig. 6) formed in theright half shell 8156 at a position closer and lower immediately above theclosure yoke 8266. Thecompression spring 8300 thus pulls thedistal end 8254 of theanti-backup release lever 8248 downward and rearward, locking therightward front pin 8298 into the distallyopen step structure 8299 as it is advanced distally. Thus, once released, referring to FIG. 7, theanti-backup release lever 8248 remains forward, vertically holding theanti-backup plate 8266, thereby enabling the linkedrack 8200 to retract. When theclosure yoke 8266 is subsequently retracted upon release of theend effector 8012, the upwardly projectingreset tang 8303 on theclosure yoke 8266 contacts the bottom distal cam 8305 of theanti-backup release lever 8248, lifting therightward front pin 8298 from the distallyopen step structure 8299 such that theanti-backup compression spring 8264 can urge theanti-backup cam tube 8268 and theanti-backup release lever 8248 proximally to their retracted positions (fig. 6).
In various embodiments, referring to fig. 1-3, thefiring trigger 8034 can be operably engaged to the linkedrack 8200 in any suitable manner. With specific reference to fig. 2 and 3, thefiring trigger 8034 pivots about afiring trigger pin 8202 connected to thehousing 8154. As thefiring trigger 8034 is depressed toward thepistol grip 8036, anupper portion 8204 of thefiring trigger 8034 moves distally about afiring trigger pin 8202, stretching a proximally placed firing trigger tension spring 8206 (fig. 3), whichtension spring 8206 is proximally connected between theupper portion 8204 of thefiring trigger 8034 and thehousing 8154. During each firing trigger depression, anupper portion 8204 of thefiring trigger 8034 engages the linkedrack 8200 via a spring-biasedside pawl mechanism 8210. When the firing trigger is released, the side pawl mechanism is disengaged from the linkedrack 8200 and the firing trigger can return to an undepressed, i.e., unfired, position. In use, the angled right side track formed by the proximally and rightwardly facingramps 8284 in each of the links 8196 a-8196 d is engaged by theside pawl assembly 8285. Specifically, the pawl slide 8270 (fig. 3 and 4) has left and rightlower guides 8272 that slide in left and right tracks 8274 (fig. 3) and 8275, respectively, formed in aclosure yoke 8266 below therack channel 8291 and in a closure yoke guide rail 8276 that is parallel to therack channel 8291 and attached to arack channel cover 8277 that closes a rightward opening portion of therack channel 8291 in theclosure yoke 8266, the rightward opening portion being distal in the direction of travel of thepawl slide 8270. In fig. 3-5, acompression spring 8278 is attached between ahook 8279 located on the closure yoke rail 8276 at a top proximal location and a hook 8280 located on the distal right side of thepawl slide 8270, which causes thepawl slide 8270 to be pulled proximally into contact with theupper portion 8204 of thefiring trigger 8034.
Referring specifically to fig. 3, thepawl block 8318 is positioned on thepawl slide 8270 to pivot about a verticalrear pin 8320, therear pin 8320 passing through thepawl block 8318 and a left proximal corner of thepawl slide 8270. A kick-out block recess 8322 is formed on a distal portion of the top surface of thepawl block 8318 to receive a kick-out block 8324 pivotally secured therein by a vertical pin 8326, the bottom tip of which vertical pin 8326 extends into apawl spring recess 8328 on the top surface of thepawl slide 8270. A pawl spring 8330 in thepawl spring recess 8328 extends to the right of the vertical front pin 8326 forcing thepawl block 8318 to rotate counterclockwise when viewed from above into engagement with the angledright track 8282. A small coil spring 8332 in the kick-out block recess 8322 forces the kick-out block 8324 to rotate clockwise when viewed from above, causing its proximal end to be forced into contact with acontoured lip 8334 formed in theclosure yoke 8266 above therack channel 8291. As shown in fig. 5, the greater mechanical advantage of the pawl spring 8330 over the small coil spring 8332 means that thepawl block 8318 is susceptible to engagement with the kick-out block 8324 rotating clockwise. In FIG. 3, when thefiring trigger 8034 is fully depressed and begins to be released, the kick-out block 8324 encounters a ridge 8336 in the contouredlip 8334 as thepawl slide 8270 retracts, forcing the kick-out block 8324 to rotate clockwise when viewed from above, kicking thepawl block 8318 out of engagement with the linkedrack 8200. The shape of the kick-out block recess 8322 stops clockwise rotation of the kick-out block 8324 to an orientation perpendicular to the contouredlip 8334, maintaining the disengagement during full retraction to eliminate ratcheting noise.
In fig. 3, 4, 8, and 12, the surgical stapling and severinginstrument 8010 can include amanual retraction mechanism 8500 that provides for manual release of the firing mechanism, manual retraction, and in one version (fig. 13-15) also performs automatic retraction at the end of full firing travel. Referring now to fig. 3 and 8, specifically, aforward idler gear 8220 is engaged with the toothed leftupper surface 8222 of the linkedrack 8200, with theforward idler gear 8220 also engaging anaft idler gear 8230 having a smaller right-side ratchet gear 8231. The forward 8220 and aft 8230 idler gears are rotatably connected to thehandle housing 8154 on forward 8232 and aft 8234 idler shafts, respectively. Each end of theaft idler shaft 8232 extends through the respective right and lefthalf shells 8156, 8158 and is attached to the left andright indicator wheels 8040,8041, and theindicator wheels 8040,8041 and aftidler gear 8230 rotate together as theaft idler shaft 8234 is free to rotate in thehandle housing 8154 and is splined to theaft idler gear 8230. The gear relationship between the linkedrack 8200, theforward idler gear 8220, and theaft idler gear 8230 can be advantageously selected such that the toothedupper surface 8222 has tooth dimensions of suitable strength and such that theaft idler gear 8230 does not rotate more than one revolution during the full firing travel of the linkedtransmission firing mechanism 8150. Thegear mechanism 8502, in addition to visually indicating the firing stroke or progress, may also be used to manually retract the knife. In various embodiments, the smaller right-side ratchet gear 8231 of theaft idler gear 8230 extends into thehub 8506 of themanual retraction lever 8042, specifically, in alignment with a vertical, longitudinally aligned slot 8508 (fig. 8) bisecting thehub 8506. The transverse through-hole 8510 of thehub 8506 communicates with theupper recess 8512. Thefront portion 8514 is shaped to receive a proximally directedlocking pawl 8516, whichlocking pawl 8516 pivots about a rightwardtransverse pin 8518 formed in the distal end of theupper recess 8512. Therear portion 8520 is shaped to receive an L-shapedspring tab 8522, whichspring tab 8522 forces the lockingpawl 8516 downward into engagement with the rightsmaller ratchet gear 8231. A blocking structure 8524 (fig. 6) protrudes from theright half shell 8156 into theupper recess 8512; when themanual retraction lever 8042 is down (fig. 10), the blockingstructure 8524 prevents the lockingpawl 8516 from engaging the smaller rightside ratchet gear 8231. A coil spring 8525 (fig. 3) forces themanual retraction lever 8042 downward.
In use, as depicted in fig. 9 and 10, the combined tension/compression spring 8184 can be disconnected from the distally positioned linked rack. In fig. 11 and 12, when themanual retraction lever 8042 is raised, the lockingpawl 8516 rotates clockwise and is no longer stopped by the blockingstructure 8524 and engages the smaller right-side ratchet gear 8231, rotating theaft idler gear 8230 clockwise when viewed from the left. Thus, theforward idler gear 8220 responds counterclockwise, retracting the linkedrack 8200. Further, a rightwardcurved ridge 8510 protrudes from thehub 8506, sized to contact and move theanti-backup release lever 8248 distally, releasing theanti-backup mechanism 8250 upon rotation of themanual retraction lever 8042.
In fig. 13-15, anautomatic retraction mechanism 8600 of a surgical stapling and severing instrument may incorporate automatic retraction into aforward idler gear 8220a having teeth 8602 at the end of a full firing stroke; thefront idler gear 8220a moves within acircular groove 8604 in thecam 8606 until encountering an obstruction after nearly a full rotation corresponding to three firing strokes. In such circumstances, therightward ridge 8610 rotates upward into contact with thebottom cam groove 8612 to move theanti-backup release lever 8248a distally. Referring specifically to fig. 13, theanti-backup release lever 8248a includes adistal end 8254 that operates as previously described. Thecircular pin 8293 andpin socket 8296 formed between the right and lefthalf shells 8156, 8158 are received through a generallyrectangular aperture 8294a formed in theanti-backup release lever 8248a behind thebottom cam 8192, allowing longitudinal translation and downward locking movement of thedistal end 8254 of theanti-backup release lever 8248 a. In theright half shell 8156, a horizontal proximally open channel receives a rightward rear pin near the proximal end of theanti-backup release lever 8248 a.
In operation, prior to firing in fig. 13 and 14, the linkedrack 8200 and theanti-backup cam tube 8268 are in a retracted position, locking theanti-backup mechanism 8250 as theanti-backup compression spring 8264 tilts theanti-backup plate 8266 proximally. Theautomatic retraction mechanism 8600 is in an initial state with theanti-backup release lever 8248a retracted and thelink 8196a in contact with thefront idler gear 8220 a. Tooth 8602 is in the six o' clock position and the full travel ofcircular groove 8604 is counterclockwise, withrightward ridge 8610 just adjacent tooth 8602. After one firing stroke, the linkedrack 8200 has moved adistal link 8196b upward into contact with theforward idler gear 8220 a. The tooth 8602 has advanced one-third of a turn through thecircular groove 8604 of the fixedcam 8606. After the second firing stroke, the linked rack has moved yet anotherlink 8196c upward into contact with theforward idler gear 8220 a. The tooth 8602 has advanced two thirds of a turn through thecircular groove 8604 of the fixedcam 8606. After the third firing stroke, the linkedrack 8200 has moved yet anotherdistal link 8196d upward into contact with theforward idler gear 8220 a. The teeth 8602 have advanced all the way around thecircular groove 8604 into contact with the above-mentioned obstruction, thereby initiating counterclockwise rotation (when viewed from the right) of thecam 8606, which in turn brings the rightward ridge into contact with theanti-backup release lever 8248 a. In fig. 15, theanti-backup release lever 8248a has moved distally in response thereto, locking therightward front pin 8298 into the distally open steppedstructure 8299 and releasing theanti-backup mechanism 8250. A similar surgical stapling instrument is disclosed in U.S. patent 7,083,075, published 2006, 8/1, the entire disclosure of which is incorporated herein by reference.
Referring to fig. 16, thestaple applying assembly 9012 of thesurgical stapling instrument 9010 performs the following functions: clamping on the tissue, driving the staples and severing the tissue by two distinct motions transmitted longitudinally down theshaft 9016 relative to theshaft carrier 9070. Theshaft bracket 9070 is attached proximally to a handle of the surgical stapling instrument and is coupled to the handle for rotation about a longitudinal axis. An exemplary multi-stroke handle for a SURGICAL STAPLING AND severing INSTRUMENT is described in more detail in co-pending AND commonly owned U.S. patent application Ser. No. 10/374,026 entitled "SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTISTROKE FIRING POSITION INDICATOR AND RETRACTION MECHANISM", the disclosure of which is hereby incorporated by reference in its entirety. Other applications consistent with the present invention may incorporate a single-shot stroke, such as described in co-pending and commonly owned U.S. patent application serial No. 10/441,632, entitled "SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS," the disclosure of which is hereby incorporated by reference in its entirety.
Referring specifically to fig. 17, the distal end of theshaft housing 9070 is attached to thestaple channel 9018. Theanvil 9022 has aproximal pivot end 9072 that is pivotally received within theproximal end 9074 of thestaple channel 9018 just distal of its junction with theshaft carrier 9070. As theanvil 9022 pivots downward, theanvil 9022 moves thetissue contacting surface 9028 and the formingpockets 9026 toward the opposing staple cartridge as described in further detail below. Thepivot end 9072 of theanvil 9022 includes aclosure feature 9076 adjacent to its pivotal attachment to thestaple channel 9018, but distal to its pivotal attachment to thestaple channel 9018. Thus, the closure tube 9078 (the distal end of which includes the horseshoe-shapedaperture 9080 that engages the closure feature 9076) selectively imparts an opening motion to theanvil 9022 during proximal longitudinal movement and a closing motion to theanvil 9022 during distal longitudinal movement, theclosure tube 9078 sliding over theshaft housing 9070 in response to the closure trigger, similar to that described above. Theshaft carriage 9070 facilitates and guides the firing motion from the handle through the longitudinally reciprocating two-blade knife and firingbar 9090. In particular, theshaft housing 9070 includes a longitudinalfiring bar slot 9092 that receives a proximal portion of a two-piece knife and firingbar 9090, in particular a laminate taperedfiring bar 9094. It should be appreciated that the laminated taperedfiring bar 9094 may be replaced by a solid firing bar and/or any other suitable material.
TheE-beam 9102 is the distal portion of the two-piece knife and firingbar 9090, which facilitates separate closure and firing, as well as spacing theanvil 9022 from theelongate staple channel 9018 during firing. With particular reference to fig. 17 and 19, in addition to any attachment process such as brazing or adhesives, the two-piece knife and firingbar 9090 is also formed with a femalevertical attachment hole 9104 formed proximally in theE-beam 9102, whichattachment hole 9104 receives a correspondingmale attachment member 9106 distally presented by the laminated taperedfiring bar 9094, such that each portion is formed of a selected material and method suitable for its different function (e.g., strength, flexibility, friction). TheE-beam 9102 may be advantageously formed from a material having suitable material properties. Such material is used to form a pair oftop pins 9110, a pair ofmiddle pins 9112, and a bottom pin orfoot 9114, and can achieve asharp cutting edge 9116. In addition, the proximally projecting integrally formedtop guide 9118 andmiddle guide 9120 that cradle each vertical end of thecutting edge 9116 also defines atissue staging area 9122 that helps guide tissue to thesharp cutting edge 9116 prior to severing the tissue. Theintermediate guide 9120 also serves to engage and fire thestaple applying assembly 9012 through a steppedcentral member 9124 that abuts a wedge sled 9126 (fig. 20) to effect staple formation by thestaple applying assembly 9012, as described in greater detail below. Integrally molding these features (e.g., thetop pins 9110, themiddle pins 9112, and the bottom legs 9114) with theE-beam 9102 facilitates manufacturing the desired structure with tighter tolerances relative to each other than if it were assembled from multiple parts, thereby ensuring that the desired operation is achieved during firing and/or during effective interaction with the various lockout features of thestaple applying assembly 9012.
In fig. 21 and 22, thestaple applying assembly 9012 is shown in an open state with the E-beam 9102 fully retracted. During assembly, thelower leg 9114 of theE-beam 9102 drops through awidened hole 9130 in thestaple channel 9018, and theE-beam 9102 is then advanced, causing theE-beam 9102 to slide distally along alower track 9132 formed in thestaple channel 9018. In particular, thelower track 9132 includes anarrow slot 9133 that opens into a widenedslot 9134 on the lower surface of thestaple channel 9018 to form an inverted T-shape in transverse cross-section, as particularly depicted in fig. 109322 and 23; thenarrow slot 9133 communicates with awidened hole 9130. Once the components proximally coupled to the laminated taperedfiring bar 9094 are assembled, they no longer allow thelower leg 9114 to travel proximally to the widenedhole 9130, allowing disengagement therefrom. Referring to fig. 24, laminating the taperedfiring bar 9094 facilitates insertion of thestaple applying assembly 9012 through a trocar. Specifically, when theE-beam 9102 is fully retracted, the more distaldownward projection 9136 lifts theE-beam 9102. This is achieved by thedownward projection 9136 being displaced at a point where theprojection 9136 is ejected upward over the proximal edge of the widenedhole 9130 in thestaple channel 9018. Referring now to fig. 25, the laminated taperedfiring bar 9094 also enhances the operation of certain lockout features that may be incorporated into thestaple channel 9018 by including a more proximalupward projection 9138. The more proximalupward projection 9138 is urged downward by thecarriage 9070 during the initial portion of the firing stroke. In particular, thetransverse rod 9140 is defined between a pair ofsquare holes 9142 in the pedestal 9070 (fig. 17). Theclamp spring 9144 surrounding thetransverse rod 9140 forces a portion of the laminated taperedfiring bar 9094 to protrude distally from the longitudinalfiring bar slot 9092 downward, ensuring that certain advantageous lockout features are engaged when appropriate. When theupward projection 9138 contacts theclamp spring 9144, the urging force is more pronounced or limited to only that portion of the firing stroke.
In fig. 21 and 22, theE-beam 9102 is retracted with itstop pin 9110 positioned within theanvil pocket 9150 near the pivot proximal end of theanvil 9022. A downwardly opening vertical anvil slot 9152 (fig. 16) widens laterally in theanvil 9022 into an anvilinner track 9154, which track 9154 captures thetop pins 9110 of theE-beam 9102 as it advances distally during firing, as depicted in fig. 24 and 25, thereby positively separating theanvil 9022 from thestaple channel 9018. Thus, when theE-beam 9102 is retracted, the surgeon can repeatedly open and close thestaple applying assembly 9012 until satisfactory placement and orientation of the tissue captured therein to be stapled and severed, and theE-beam 9102 facilitates proper positioning of the tissue even with a reduced diameter and a correspondingly reduced stiffness of thestaple applying assembly 9012. In fig. 16, 17, 20, 21, 23, and 29, thestaple applying assembly 9012 is shown with analternative staple cartridge 9020 that includes awedge sled 9126. A plurality of longitudinally aligned and parallel downwardly opening wedge slots 9202 (fig. 23) receiverespective wedges 9204 integral withwedge sled 9126. In fig. 23-25, thewedge sled 9126 thus lifts the plurality ofstaple drivers 9206 upwardly, which can slide vertically within the staple driver recesses 9208. In this exemplary version, eachstaple driver 9206 includes two vertical prongs, each translating upward into a respective staple hole 9210 orcavity 9024 to force a staple 9023 up against the vertical prong and deform the staple 9023 against the staple forming surface 9214 (fig. 25) of theanvil 9022. A central firing recess 9216 (fig. 17) defined within thestaple cartridge 9020 adjacent thestaple channel 9018 allows passage of the bottom horizontal portion 9218 (fig. 20) of thewedge sled 9126 as well as themiddle pin 9112 of theE-beam 9102. Specifically, a staple cartridge tray 9220 (fig. 17 and 23) is attached to and underlies the polymericstaple cartridge body 9222; the polymericstaple cartridge body 9222 has staple driver recesses 9208, staple holes 9210, and acentral firing recess 9216 formed therein. When thestaple 9023 is thus formed on either side, thesharp cutting edge 9116 enters avertical channel 9230 that passes through the longitudinal axis of thestaple cartridge 9020 except for only the distal-most end of the vertical channel.
Firing thestaple applying assembly 9012 begins as depicted in fig. 25. In fig. 25, the two-blade knife and firingbar 9090 are pulled proximally until thedownward projections 9136 jack themiddle guide 9120 on the E-beam 9102 up and rearward, whereby anew staple cartridge 9020 can be inserted into thestaple channel 9018 when theanvil 9022 is opened, as depicted in fig. 16 and 21. In fig. 26, the two-bladed knife and firingbar 9090 has been advanced distally a small distance, and thedownward projection 9136 may drop into the widenedhole 9130 of thelower track 9132 as theclamp spring 9144 acts on theupward projection 9138 of the laminated taperedfiring bar 9094. Themiddle guide 9120 prevents further downward rotation due to resting on the steppedcentral member 9124 of thewedge sled 9126, thereby retaining themiddle pin 9112 of the E-beam within thecentral firing recess 9216. In fig. 27, the two knife and firingbar 9090 has been distally fired advancing thewedge sled 9126 to form thestaples 9023 while severingtissue 9242 clamped between theanvil 9022 and thestaple cartridge 9020 with thesharp cutting edge 9116. Subsequently, in fig. 28, the two-blade knife and firingbar 9090 is retracted, leaving the distally positionedwedge sled 9126. In fig. 29, themiddle pin 9112 is allowed to translate downward into alockout recess 9240 formed in the staple channel 9018 (see also fig. 22 and 25). Thus, when the wedge sled 9126 (not shown in fig. 29) is not positioned proximally (i.e., thestaple cartridge 9020 is missing or thestaple cartridge 9020 is depleted), the operator will receive a tactile indication if themiddle pin 9112 encounters the distal edge of thelockout recess 9240. A similar surgical stapling instrument is disclosed in U.S. patent 7,380,696, published 3/6/2008, the entire disclosure of which is incorporated herein by reference.
In various embodiments, turning now to fig. 30-38, asurgical instrument 12000 can include ahandle 12010, ashaft 12020 extending from thehandle 12010, and anend effector 12040 configured to be removably attached to theshaft 12020, as described in more detail further below. Thehandle 12010 may include atrigger 12014, which trigger 12014 may be actuated to: 1) closing theend effector 12040, and 2) advancing the firingmember 12043 distally through theend effector 12040. Although not shown in fig. 30-38, thehandle 12010 can include any suitable drive train configured to transmit rotational motion of thetrigger 12014 and convert the rotational motion into linear motion of the firingmember 12023 extending through theshaft 12010. In use, thetrigger 12014 can be actuated toward thepistol grip 12012 of thehandle 12010 to advance the firingmember 12023 distally along thelongitudinal axis 12039 within theshaft 12020, and when theshaft firing member 12023 is operably coupled with the endeffector firing member 12043, as described in more detail further below, distal motion of theshaft firing member 12023 can be transferred to the endeffector firing member 12043. As the endeffector firing member 12043 is advanced distally, the endeffector firing member 12043 is configured to engage afirst jaw 12040a including an anvil and/or asecond jaw 12040b including a staple cartridge channel and move at least one of thefirst jaw 12040a and thesecond jaw 12040b toward the other jaw. In addition to the above, referring primarily to fig. 30-32, theend effector 12040 may be assembled to theshaft 12010 in a direction transverse to thelongitudinal axis 12039. For example, theend effector 12040 may be assembled to theshaft 12010, e.g., in a direction perpendicular to thelongitudinal axis 12039. In such instances, theend effector 12040 can be moved toward theshaft 12010 such that theframe 12041 of theend effector 12040 engages and is connected to theframe 12021, and such that theproximal end 12044 of the firingmember 12043 engages and is connected to thedistal end 12024 of the firingmember 12023. Theshaft carrier 12021 can include achannel 12022 defined therein, which can be configured to slidably receive ashaft firing member 12023 and define alongitudinal axis 12039. To align theend effector frame 12041 with theshaft mount 12021, in various embodiments, theproximal end 12045 of theend effector frame 12041 and thedistal end 12025 of theshaft mount 12021 can include cooperating dovetail features that, for example, enable theend effector 12040 to be oriented relative to theshaft 12020. The shaft mounts 12021 can also include mountingholes 12026 defined therein, which mountingholes 12026 can be configured to receive mountingtabs 12046 extending from theend effector frame 12041. Due to the mounting features 12026 and 12046, and/or the cooperating dovetail features of theends 12025 and 12045, theend effector 12040 can be securely mounted to theshaft 12020 in all circumstances. In various embodiments, thesurgical instrument 12000 can further comprise alock collar 12030, which lockcollar 12030 can be configured to lock theend effector 12040 to theshaft 12020. Referring now primarily to fig. 34-36, thelock collar 12030 can be moved between an unlocked position (fig. 34 and 35) and a locked position (fig. 36). When thelock collar 12030 is in its unlocked position (see fig. 34), theend effector 12040 can be assembled to theshaft 12020. Once theend effector 12040 has been engaged with theshaft 12020, thelock collar 12030 can be slid over the interconnection between theend effector 12040 and theshaft 12020 to lock theend effector 12040 in place. More specifically, in at least one embodiment, thelock collar 12030 can define aninner bore 12031, and theinner bore 12031 can be configured to closely receive the outer periphery of theend effector 12040 and theshaft 12020. In certain embodiments, thesurgical instrument 12000 can include a spring or biasing member configured to bias thelock collar 12030 into its locked position. In such embodiments, the clinician may pull thelock collar 12030 proximally against the biasing force of the spring and then release thelock collar 12030, allowing the spring to return thelock collar 12030 to its locked position.
Referring again to fig. 30-38, and primarily to fig. 32 and 33, thesurgical instrument 12000 can include anarticulation joint 12050. In various embodiments, the articulation joint 12050 can be configured to allow a distal portion of theend effector 12040 to pivot about an axis defined by thearticulation joint 12050. In this embodiment, theend effector 12040 can include a proximal portion fixedly mounted to theshaft 12020 and a distal portion rotatable relative to the proximal portion about thearticulation joint 12050. In certain embodiments, thesurgical instrument 12000 can comprise a lock configured to engage and disengage a distal portion of theend effector 12040. For example, theend effector 12040 can include an endeffector lock portion 12047, which endeffector lock portion 12047 can be pushed distally to lock a distal portion of theend effector 12040 into place, and/or can be pulled proximally to unlock a distal portion of theend effector 12040. Thesurgical instrument 12000 can further include alock actuator 12060 adjacent to thehandle 12010, for example, thelock actuator 12060 can be pulled proximally to pull the endeffector lock portion 12047 proximally. In such embodiments, thelock actuator 12060 can be operably coupled with alock portion 12027 extending through ashaft 12020, theshaft 12020 being operably coupled, or can be operably coupled, to the endeffector lock portion 12047. In at least one such embodiment, theproximal end 12048 of the endeffector lock portion 12047 can be assembled to thedistal end 12028 of thelock portion 12027 when theend effector 12040 is assembled to theshaft 12020. In at least one such embodiment, the endeffector lock portion 12047 can be assembled to thelock portion 12027 at the same time the endeffector firing member 12043 is assembled to theshaft firing member 12023.
In various embodiments, as described above, a staple cartridge can comprise a cartridge body comprising a plurality of staple cavities defined therein. The cartridge body can comprise a deck and a top deck surface, wherein each staple cavity can define an opening in the deck surface. As also described above, staples can be positioned within each staple cavity such that the staples are stored within the cartridge body until they are ejected from the cartridge body. In various embodiments, the staples can be loaded within the cartridge body before being ejected from the cartridge body such that the staples do not protrude above the deck surface. In such embodiments, the likelihood of staples being damaged and/or prematurely contacting the target tissue may be reduced when the staples are positioned below the deck surface. In various circumstances, the staples can be moved between an unfired position, wherein the staples do not protrude from the cartridge body, and a fired position; in the fired position, the staples have been exposed from the cartridge body and can contact an anvil positioned opposite the staple cartridge. In various embodiments, the anvil and/or staple forming pockets defined within the anvil can be positioned a predetermined distance above the deck surface such that the staples are deformed to a predetermined formed height when deployed from the cartridge body. In some instances, the thickness of the tissue captured between the anvil and the staple cartridge can vary. Thus, thicker tissue may be captured within some staples, while thinner tissue may be captured within some other staples. In either case, the clamping pressure or force applied by the staples to the tissue may vary from staple to staple, for example, or may vary between staples at one end of a row of staples and staples at the other end of the row of staples. In some instances, the gap between the anvil and the staple cartridge deck may be controlled such that the staples exert a certain minimum clamping pressure within each staple. In some such situations, however, significant variations in the clamping pressure within different staples may still exist.
In use, in addition to the above, and referring primarily to fig. 39, for example, an anvil (such as anvil 10060) can be moved to a closed position opposite thestaple cartridge 10000. As described in greater detail below, theanvil 10060 can position tissue against thetissue thickness compensator 10020 and, in various embodiments, press thetissue thickness compensator 10020 against thedeck surface 10011 of thesupport portion 10010, for example. Once theanvil 10060 has been properly positioned, thestaples 10030 can be deployed, which is also illustrated in fig. 39. In various embodiments, as described above, thestaple firing sled 10050 can be moved from theproximal end 10001 toward thedistal end 10002 of thestaple cartridge 10000, as shown in fig. 40. As thesled 10050 is advanced, thesled 10050 can contact thestaple drivers 10040 and lift thestaple drivers 10040 upwardly within thestaple cavities 10012. In at least one embodiment, thesled 10050 and thestaple drivers 10040 can each comprise one or more ramps or inclined surfaces that can cooperate to move thestaple drivers 10040 upwardly from their unfired positions. In at least one such embodiment, eachstaple driver 10040 can comprise at least one ramped surface, and thesled 10050 can comprise one or more ramped surfaces such that the sled ramped surfaces can slide under the driver ramped surfaces as thesled 10050 is advanced distally within the staple cartridge. As thestaple drivers 10040 are lifted upwardly within theirrespective staple cavities 10012, thestaple drivers 10040 can lift thestaples 10030 upwardly such that thestaples 10030 can be exposed from theirstaple cavities 10012 through openings in the staple deck 10011 (fig. 41). In an exemplary firing sequence, thesled 10050 can contact thefirst staples 10030 and begin lifting thefirst staples 10030 upward. As thesled 10050 is advanced farther laterally, thesled 10050 can begin to liftadditional staples 10030, and any other subsequent staples, in a sequential order. Thesled 10050 can drive thestaples 10030 upward such that thelegs 10032 of the staples, which are in contact with the opposing anvil, are deformed to a desired shape and ejected from thesupport portion 10010. In various circumstances, as part of the firing sequence, thesled 10050 can simultaneously move a plurality of staples upward.
Referring to fig. 49-54, each staple 10030 can be deformed such that acompressed area 10039 is defined therein. For example, each staple 10030 can comprise abase 10031 and one ormore legs 10032 extending from thebase 10031. As these legs deform, thebase 10031 can cooperate to define an area in which tissue T andtissue thickness compensator 10020 can be captured. Within thecompression region 10039, thetissue thickness compensator 10020 can apply pressure to the tissue T and, in some instances, assume different compressed heights depending on the thickness of the tissue T. In some instances, thetissue thickness compensator 10020 can resiliently fill gaps, i.e., free spaces, within thecompression regions 10039 defined by thestaples 10030.
As described above and referring to fig. 41, thestaple legs 10032 of thestaples 10030 can extend above thedeck surface 10011 of thesupport portion 10010 when thestaples 10030 are in their unfired positions. In various embodiments, the tips of thestaple legs 10032, or any other portion of thestaple legs 10032, may not protrude through the top tissue-contactingsurface 10021 of thetissue thickness compensator 10020 when thestaples 10030 are in their unfired position. As thestaples 10030 are moved from their unfired positions to their fired positions, the tips of the staple legs can protrude through the tissue contacting surface. In various embodiments, the tips of thestaple legs 10032 can comprise sharp tips that can cut into and penetrate thetissue thickness compensator 10020. In certain embodiments, thetissue thickness compensator 10020 can comprise a plurality of apertures which can be configured to receive thestaple legs 10032 and allow thestaple legs 10032 to slide relative to thetissue thickness compensator 10020. In certain embodiments, thesupport portion 10010 can further comprise a plurality of guides 10013 (fig. 41) extending from theplatform surface 10011. Theguides 10013 can be positioned adjacent to the staple cavity openings in thedeck surface 10011 such that thestaple legs 10032 can be at least partially supported by theguides 10013. In certain embodiments, theguide 10013 can be positioned at the proximal and/or distal ends of the staple cavity opening. In various embodiments, afirst guide 10013 can be positioned at a first end of each staple cavity opening and asecond guide 10013 can be positioned at a second end of each staple cavity opening such that eachfirst guide 10013 can support a firststaple leg 10032 of astaple 10030 and eachsecond guide 10013 can support a secondstaple leg 10032 of astaple 10030. In at least one embodiment, referring to fig. 41, eachguide 10013 can, for example, comprise a channel or slot, such aschannel 10016, in which thestaple legs 10032 can be slidably received. In various embodiments, eachguide 10013 can comprise cleats, protrusions, and/or spikes that can extend from thedeck surface 10011 and into thetissue thickness compensator 10020. In at least one embodiment, as described in greater detail below, cleats, protrusions, and/or spikes can reduce relative movement between thetissue thickness compensator 10020 and thesupport portion 10010. In certain embodiments, the tips of thestaple legs 10032 can be positioned in theguides 10013 and can not extend above the top surface of theguides 10013 when thestaples 10030 are in their unfired positions. In at least such embodiments, theguides 10013 can define a guide height and thestaples 10030 can not extend above the guide height when thestaples 10030 are in their unfired positions.
In various embodiments, a tissue thickness compensator (such as tissue thickness compensator 10020) can be constructed from a single sheet of material, for example. In at least one embodiment, the tissue thickness compensator can comprise a continuous sheet of material that can cover the entiretop deck surface 10011 of thesupport portion 10010, or less than theentire deck surface 10011. In certain embodiments, the sheet of material can cover the staple cavity openings in thesupport portion 10010, while in other embodiments, the sheet of material can include openings that can be aligned, or at least partially aligned, with the staple cavity openings. In various embodiments, the tissue thickness compensator can be constructed from multiple layers of material. In some embodiments, the tissue thickness compensator can comprise a compressible core and a wrap surrounding the compressible core.
In various embodiments, the tissue thickness compensator can comprise a wrap for releasably retaining the compressible core to thesupport portion 10010. In at least one such embodiment, the staple cartridge can further comprise a retainer clip, which can be configured to inhibit the wrap and compressible core from prematurely separating from thesupport portion 10010. In certain embodiments, as described above, the tissue thickness compensator can be removably attached to thesupport portion 10010 bystaples 10030. More specifically, as also described above, when thestaples 10030 are in their unfired positions, the legs of thestaples 10030 can extend into thetissue thickness compensator 10020, thereby releasably retaining thetissue thickness compensator 10020 to thesupport portion 10010. In at least one embodiment, the legs of thestaples 10030 can be in contact with the sidewalls of theirrespective staple cavities 10012 wherein, due to the friction between thestaple legs 10032 and the sidewalls, thestaples 10030 and thetissue thickness compensator 10020 can be held in place until thestaples 10030 are deployed from thestaple cartridge 10000. When thestaples 10030 are deployed, thetissue thickness compensator 10020 can be captured within thestaples 10030 and retained against the stapled tissue T. When the anvil is subsequently moved to the open position to release the tissue T, thesupport portion 10010 can be moved away from thetissue thickness compensator 10020 which has been secured to the tissue. In certain embodiments, thetissue thickness compensator 10020 can be removably retained to thesupport portion 10010 using an adhesive. In at least one embodiment, a two-part adhesive may be used. In at least one embodiment, wherein a first portion of the adhesive can be placed on theplatform surface 10011 and a second portion of the adhesive can be placed on thetissue thickness compensator 10020 such that when thetissue thickness compensator 10020 is placed against theplatform surface 10011, the first portion can contact the second portion to activate the adhesive and detachably bond thetissue thickness compensator 10020 to thesupport portion 10010. In various embodiments, the tissue thickness compensator can be detachably retained to the support portion of the staple cartridge using any other suitable method.
In various embodiments, in addition to the above, thesled 10050 can be advanced from the proximal end to the distal end to fully deploy all of thestaples 10030 contained within thestaple cartridge 10000. In at least one embodiment, referring now to fig. 44, thesled 10050 can be advanced distally within a longitudinal cavity within thesupport portion 10010 by a firing member orknife bar 10052 of a surgical stapler. In use, astaple cartridge 10000 can be inserted into a staple cartridge channel in a jaw of a surgical stapler and the firingmember 10052 can be advanced into contact with thesled 10050, as illustrated in fig. 44. As thesled 10050 is advanced distally by the firingmember 10052, thesled 10050 can contact the proximal-most staple driver ordrivers 10040 and fire (i.e., eject) thestaples 10030 from thecartridge body 10010 as described above. As shown in fig. 44, the firingmember 10052 can further comprise acutting edge 10053 that can be advanced distally through a knife slot in thesupport portion 10010 when thestaples 10030 are fired. In various embodiments, the respective knife slot can extend through an anvil positioned opposite thestaple cartridge 10000 such that, in at least one embodiment, thecutting edge 10053 can extend between the anvil and thesupport portion 10010 and incise the tissue and the tissue thickness compensator positioned between the anvil and thesupport portion 10010. In various circumstances, thesled 10050 can be advanced distally by the firingmember 10052 until thesled 10050 reaches the distal end of thestaple cartridge 10000. At this point, the firingmember 10052 can be retracted proximally. In some embodiments, thesled 10050 can be retracted proximally with the firingmember 10052, but in various embodiments, thesled 10050 can remain in thedistal end 10002 of thestaple cartridge 10000 as the firingmember 10052 is retracted. Once the firingmember 10052 has been sufficiently retracted, the anvil can be reopened, at which point thetissue thickness compensator 10020 can be separated from thesupport portion 10010 and the remaining non-implanted portion (including the support portion 10010) of the spentstaple cartridge 10000 can be removed from the staple cartridge channel.
After the depletedstaple cartridge 10000 is removed from the staple cartridge channel, anew staple cartridge 10000 or any other suitable staple cartridge may be inserted into the staple cartridge channel in addition to the above. In various embodiments, in addition to the above, the staple cartridge channel, the firingmember 10052, and/or thestaple cartridge 10000 can comprise cooperating features that can prevent the firingmember 10052 from being advanced distally again when a new unfiredstaple cartridge 10000 has not yet been positioned in thestaple cartridge channel 10070. More specifically, when the firingmember 10052 is advanced into contact with thesled 10050, and when thesled 10050 is in its proximal, unfired position, a support nose of the firingmember 10052 can be positioned on and/or over a support ledge on thesled 10050 such that the firingmember 10052 is held in a position sufficiently upward to prevent a lock orbeam 10054 extending from the firingmember 10052 from falling into a lock recess defined within the cartridge channel. Since thelock 10054 will not fall into the lock recess under such circumstances, thelock 10054 may not abut the distal side wall of the lock recess as the firingmember 10052 is advanced. As the firingmember 10052 pushes thesled 10050 distally, the firingmember 10052 can be supported in its upward fired position due to the support nose resting against the support flange. When the firingmember 10052 is retracted relative to thesled 10050 as described above, the firingmember 10052 can fall from its upward position as the support nose no longer rests against the support ledge of thesled 10050. In at least one such embodiment, the surgical stapler can comprise a spring and/or any other suitable biasing element that can be configured to bias the firingmember 10052 to its downward position. Once the firingmember 10052 has been fully retracted, it cannot be advanced distally through the spentstaple cartridge 10000 again. More specifically, when thesled 10050 is left at the distal end of thestaple cartridge 10000 at this point in the operating sequence, the firingmember 10052 cannot be held in its upper position by thesled 10050. Thus, as discussed above, if the firingmember 10052 is advanced again without replacing the staple cartridge, thelock beam 10054 will contact theside walls 10057 of the lock recess, which will prevent the firingmember 10052 from being advanced again distally into thestaple cartridge 10000. In other words, once the spentstaple cartridge 10000 has been replaced with a new staple cartridge, the firingmember 10052 can be retained in its upper position and the firingmember 10052 allowed to advance distally again due to the proximally positionedsled 10050 of the new staple cartridge.
As described above, thesled 10050 can be configured to move thestaple drivers 10040 between a first, unfired position and a second, fired position in order to eject thestaples 10030 from thesupport portion 10010. In various embodiments, thestaple drivers 10040 can be loaded within thestaple cavities 10012 after thestaples 10030 have been ejected from thesupport portion 10010. In certain embodiments, thesupport portion 10010 can comprise one or more retention features that can be configured to prevent thestaple drivers 10040 from ejecting or falling out of thestaple cavities 10012. In various other embodiments, thesled 10050 can be configured to eject thestaple drivers 10040 from thesupport portion 10010 with thestaples 10030. In at least one such embodiment, thestaple drivers 10040 can be comprised of a bioabsorbable material and/or a biocompatible material, such as polyetherimide, for example. In certain embodiments, the staple drivers can be attached to thestaples 10030. In at least one such embodiment, the staple drivers can be molded over and/or around the base of each staple 10030 such that the staple drivers are integrally formed with the staples. U.S. patent application Ser. No. 11/541,123 entitled "SURGICAL STAPLES HAVING COMPOSITABLE OR CRUSHABLE MEMBERS FOR SECURING TISSUE THEREIN AND STAPLING INSTRUMENTS FOR DEPLOYING THE SAME" filed on 29.9.2006 is hereby incorporated by reference in its entirety.
In various instances, in addition to the above, the compressible tissue thickness compensator can move, twist, and/or deflect relative to the underlying rigid support portion of the staple cartridge. In various embodiments, the support portion and/or any other suitable portion of the staple cartridge can include one or more features configured to limit relative movement between the tissue thickness compensator and the support portion. As described above, at least a portion of thestaples 10030 can extend above thedeck surface 10011 of thesupport portion 10010 wherein, in certain instances, lateral forces applied to the tissue thickness compensator can be resisted by, for example, thestaples 10030 and/or thecleats 10013 extending from thesupport portion 10010. In various circumstances, thestaples 10030 can tilt and/or bend within thestaple cavities 10012 as they resist lateral movement of the tissue thickness compensator, wherein in various embodiments, thestaple cavities 10012 and thestaples 10030 can be sized and configured to maintain relative alignment between thelegs 10032 of thestaples 10030 and the forming pockets in the opposinganvil 10060 such that thestaples 10000 are properly formed during the staple forming process. In various embodiments, thestaples 10030 and/orcleats 10013 can be configured to prevent, or at least limit, lateral distortion within thetissue thickness compensator 10020. In at least one such embodiment, thestaples 10030 and/orcleats 10013, for example, can be configured to reinforce or restrict lateral and/or longitudinal movement of a first surface or tissue-contacting surface of the tissue thickness compensator relative to a second, bottom surface. In various embodiments, the staple cartridge and/or the staple cartridge channel in which the staple cartridge is positioned can comprise at least one distortion minimizing member that can extend upwardly to limit lateral and/or longitudinal movement or distortion of the tissue thickness compensator. As described above, the wrap at least partially surrounding the tissue thickness compensator can also prevent, or at least limit, lateral and/or longitudinal movement or twisting of the tissue thickness compensator.
In various embodiments, a staple cartridge can comprise a plurality of staple cavities, each staple cavity containing a staple positioned therein, wherein the staple cavities can be arranged in a plurality of rows, and wherein an anvil positioned opposite the staple cartridge can comprise a plurality of staple forming pockets corresponding to the staple cavities in the staple cartridge. In other words, the anvil can comprise a plurality of rows of forming pockets, wherein each forming pocket can be positioned opposite a staple cavity in the staple cartridge. In various embodiments, each forming pocket can comprise two forming cups configured to receive thestaple legs 10032 of astaple 10030, wherein each forming cup is configured to receive astaple leg 10032 and form or crimp thestaple leg 10032, e.g., toward the otherstaple leg 10032. In various circumstances, thestaple legs 10032 can fail or not properly enter the forming cups and, as a result, thestaple legs 10032 can become deformed during the firing sequence. In various embodiments described herein, the anvil can include an array or grid of forming pockets each configured to receive and form staple legs. In at least one such embodiment, the array of forming pockets can include a number of forming pockets that exceeds the number of staples contained within the staple cartridge. In at least one embodiment, a staple cartridge can comprise, for example, six longitudinal rows of staple cavities, wherein the anvil can comprise six rows of forming pockets aligned with the six rows of staple cavities, and further wherein the forming pockets are positioned intermediate the rows of forming pockets. For example, on one side of the anvil, the anvil can comprise a first row of forming pockets positionable over a first row of staple cavities, a second row of forming pockets positionable over a second row of staple cavities adjacent to the first row of staple cavities, and a row of forming pockets positioned intermediate the first row of forming pockets and the second row of forming pockets.
In various embodiments, as described above, for example, the anvil can be moved from an open position to a closed position in order to compress tissue against a tissue thickness compensator (such as tissue thickness compensator 10020) of the staple cartridge. In various instances, the tissue thickness compensator can be positioned adjacent to the support portion of the staple cartridge prior to positioning the tissue thickness compensator relative to the tissue. In certain embodiments, thetissue thickness compensator 10020 can be in a position that: in this position, thetissue thickness compensator 10020 abuts the support portion 10018 before the anvil is moved to its closed position. In certain other embodiments, thetissue thickness compensator 10020 can be in a position that: in this position, a gap exists between thetissue thickness compensator 10020 and the support portion 10018. In at least one such embodiment, the anvil can displace the tissue and thetissue thickness compensator 10020 downward until thetissue thickness compensator 10020 abuts the support portion 10018, at which point the anvil can be moved to its closed position and create compression within the tissue. If the surgeon does not feel satisfactory with respect to the positioning of the tissue between the anvil and the staple cartridge, the anvil may be opened, the position of the anvil and staple cartridge adjusted, and then the anvil closed again. As the staple cartridge can be so positioned and repositioned relative to the tissue, in various circumstances, for example, the distal end of thetissue thickness compensator 10020 can be separated from thesupport portion 10010. In some such circumstances, the distal end of thetissue thickness compensator 10020 can contact tissue and peel away from thesupport portion 10010 or roll up relative to thesupport portion 10010. In various embodiments, as described in greater detail below, the staple cartridge can include one or more features configured to releasably retain the tissue thickness compensator to an underlying support portion of the staple cartridge.
In various embodiments, referring now to fig. 55, thestaple cartridge 10300 can comprise asupport portion 10310, atissue thickness compensator 10320 supported by thesupport portion 10310, and adistal end 10302 comprising anose 10303, thenose 10303 configured to releasably retain thedistal end 10325 of thetissue thickness compensator 10320 in place. In at least one embodiment, thenose 10303 can include aslot 10305 configured to receive thedistal end 10325 of thetissue thickness compensator 10320. In various embodiments, thedistal end 10325 can be compressed or wedged within theslot 10305 such that thedistal end 10325 can be held in place when thestaple cartridge 10300 is positioned relative to tissue. In at least one such embodiment, theslots 10305 can be oriented in a direction parallel, or at least substantially parallel, to the platform surface 10311 of thesupport portion 10310. In various embodiments, theslot 10305 can be horizontal relative to the platform surface 10311. In various other embodiments, referring now to fig. 56, thestaple cartridge 10400 can comprise a support portion, atissue thickness compensator 10420 supported by the support portion, and adistal end 10402 comprising anose 10403, thenose 10403 configured to releasably hold adistal end 10425 of thetissue thickness compensator 10420 in place. In at least one embodiment, thedistal end 10425 can include a protrusion extending therefrom, and thenose 10403 can include avertical slot 10405 configured to receive the protrusion of thedistal end 10425. In various embodiments, thedistal end 10425 and/or the projections extending therefrom can be compressed or wedged within theslot 10405 such that thedistal end 10425 can be held in place when thestaple cartridge 10400 is positioned relative to the tissue. In certain embodiments, for example, thetissue thickness compensator 10420 can comprise a slot (such as slot 10429) that can be configured to receive at least a portion of thenose 10403 therein. In at least one embodiment, theslots 10405 can be oriented in a direction perpendicular, or at least substantially perpendicular, to the platform surface 10411 of the support portion. In various embodiments, referring now to fig. 57, astaple cartridge 10500 can comprise a support portion, atissue thickness compensator 10520 supported by the support portion, and adistal end 10502 comprising a nose configured to releasably hold thedistal end 10525 of thetissue thickness compensator 10520 in place. In at least one embodiment, the nose can include avertical slot 10505 configured to receive thedistal end 10525 of thetissue thickness compensator 10520. In various embodiments, thedistal end 10525 can be compressed or wedged within theslot 10505 such that thedistal end 10525 can be held in place when thestaple cartridge 10500 is positioned relative to tissue.
In various embodiments, referring again to fig. 55, thetissue thickness compensator 10320 can comprise atop surface 10324, thetop surface 10324 can be positioned above thetop surface 10304 of thenose 10303. Fig. 44 illustrates another exemplary embodiment in which a top surface of a tissue thickness compensator is positioned over the nose of a staple cartridge, wherein, for example, thetop surface 10721 of thetissue thickness compensator 10720 is positioned over thetop surface 10004 of thenose 10003. In use, referring again to fig. 55, tissue can slide over thetop surface 10304 of thenose 10303 and, in some instances, the tissue can contact thedistal end 10325 of thetissue thickness compensator 10320 and a force can be applied to thetissue thickness compensator 10320, thereby facilitating thetissue thickness compensator 10320 to peel away from thesupport portion 10310. In the embodiments described herein, this peel force can be resisted by the portion of thedistal end 10325 wedged within thenose 10303. In any event, once the tissue has been properly positioned relative to thestaple cartridge 13000, the anvil can be rotated to a closed position to compress the tissue and thetissue thickness compensator 10320 against thesupport portion 10310. In at least one such embodiment, the anvil can be rotated to a position that: in this position, the anvil contacts thetop surface 10304 of thenose 10303, thus preventing further rotation of the anvil. In various circumstances, because thetop surface 10324 of thetissue thickness compensator 10320 is being positioned above thetop surface 10304 of thenose 10303, thetop surface 10324 can be pushed downward toward thesupport portion 10310 as the anvil is being closed, and in some cases, for example, thetop surface 10324 can be pushed below thetop surface 10304 of thenose 10303. As described herein, after the staples contained within thestaple cartridge 10300 have been deployed and thetissue thickness compensator 10320 has been incised, thesupport portion 10310 and thenose 10303 can be moved away from thetissue thickness compensator 10320 such that thedistal end 10325 of thetissue thickness compensator 10320 can slide out of theslot 10305.
As described above, an anvil (such as the anvil 10060), for example, can be rotated to a closed position in which theanvil 10060 contacts atop nose surface 10004 of a staple cartridge (such as the staple cartridge 10000). The amount by which the tissue thickness compensator (such as tissue thickness compensator 10020) is compressed once the anvil has reached its closed position will depend on, among other things, the uncompressed thickness or height of the tissue thickness compensator, and the thickness of the tissue. Referring now to fig. 42 and 43, thetissue thickness compensator 10920 can comprise a top surface that is flush, or at least substantially flush, with thetop surface 10004 of thenose 10003. In such embodiments, the top surface of thetissue thickness compensator 10920 can be urged below thetop surface 10004 of thenose 10003. Referring now to fig. 47 and 48, a tissue thickness compensator (such as tissue thickness compensator 10820) can comprise, for example, atop surface 10821. Thetop surface 10821 is positioned below thetop nose surface 10004 prior to thetissue thickness compensator 10820 being compressed by the tissue T and theanvil 10060. In the case of relatively thin tissue T, as shown in fig. 45 and 46, thetissue thickness compensator 10920 may undergo relatively little compression. Referring now to fig. 47 and 48, when the tissue T is relatively thick, thetissue thickness compensator 10820 can undergo greater compression. In the case of tissue T having both thinner and thicker portions, as shown in fig. 47 and 48, for example, thetissue thickness compensator 10820 may be compressed a greater amount when it is positioned under thicker tissue T and a lesser amount when it is positioned under thinner tissue T. In this manner, the tissue thickness compensator can compensate for different tissue thicknesses, as described above.
In various embodiments, referring now to fig. 58 and 59, the surgical stapling instrument can comprise 1) acartridge channel 16670 configured to receive astaple cartridge 16600, and 2) an anvil 16660 pivotably coupled to thecartridge channel 16670. Thestaple cartridge 16600 can include asupport portion 16610 and atissue thickness compensator 16620, wherein adistal end 16625 of thetissue thickness compensator 16620 can be releasably retained to thesupport portion 16610 by anose 16603 at thedistal end 16602 of thestaple cartridge 16600. In at least one embodiment, thenose 16603 can include a slot 16605 and can be constructed from a flexible material. In use, referring primarily to fig. 58, thenose 16603 can be flexed downward to enlarge the opening of the slot 16605. In certain embodiments, thenose 16603 can include a notch orcutout 16606, which can be configured to enable downward deflection of thenose 16603. Regardless, in various circumstances, the enlarged opening of the slot 16605 can facilitate insertion of thedistal end 16625 of thetissue thickness compensator 16620 into the slot 16605. Once thetissue thickness compensator 16620 has been properly positioned, thenose 16603 can be released. Because of the resiliency of the material comprising thenose 16603, thenose 16603 can return, or at least substantially return, to its undeflected state and trap thedistal end 16625 of thetissue thickness compensator 16620 against theplatform surface 16611, as shown in fig. 59. In use, similar to the above, thedistal end 16625 can be pulled out of the slot 16605 as thesupport portion 16610 is moved away from the stapled tissue. In various circumstances, theflexible nose 16603 can be configured to deflect when thetissue thickness compensator 16620 is separated from thesupport portion 16610. In various embodiments, referring again to fig. 59, thetissue thickness compensator 16620 can comprise atop surface 16621 that is aligned, or at least substantially aligned, with atop surface 16604 of thenose 16603.
In various embodiments, referring now to fig. 60-61, a staple cartridge (such as staple cartridge 11400) can comprise, for example, atissue thickness compensator 11420 removably attached to asupport portion 11410. In at least one embodiment, thestaple cartridge 11400 can include one ormore retainer bars 11413 configured to retain the longitudinal sides of thetissue thickness compensator 11420 to thedeck surface 11411. In at least one such embodiment, eachretainer bar 11413 can include opposingarms 11418 that can define achannel 11416 therebetween. In such embodiments, one of thearms 11418 can be configured to extend over thetissue thickness compensator 11420 and theother arm 11418 can be configured to extend under alip 11419 extending from thesupport portion 11410. Referring primarily to FIG. 60, thechannel 11416 of eachretainer rod 11413 may be sized and configured to apply a compressive force to the longitudinal sides of thetissue thickness compensator 11420 prior to use of thestaple cartridge 11400. During use, referring primarily to fig. 61, astaple cartridge 11400 can be positioned within the staple cartridge channel, and once thestaple cartridge 11400 has been properly positioned, an anvil (such as anvil 11460), for example, can be moved to a position where it can compress thetissue thickness compensator 11420. Similar to the above, when thetissue thickness compensator 11420 is compressed, it may expand laterally or outwardly, thus separating theretainer rod 11413 from thestaple cartridge 11400. In certain other embodiments, closing theanvil 11460 may not separate theretainer rod 11413 from the staple cartridge, or may not completely separate theretainer rod 11413 from the staple cartridge. In at least one such embodiment, advancing the firing bar through thestaple cartridge 11400 as described above can deploy thestaples 10030 from thesupport portion 11410 while pressing theanvil 11460 and thestaple cartridge 11400 closer together to apply a compressive force to thetissue thickness compensator 11420 sufficient to laterally expand thetissue thickness compensator 11420 and separate theretainer bar 11413 from thestaple cartridge 11400. Once theretainer rod 11413 has been separated from thestaple cartridge 11400, thesupport portion 11410 can be moved away from the implantedtissue thickness compensator 11420 and removed from the surgical site.
In various embodiments, in addition to the above, the staple cartridge can comprise a plurality of fasteners configured to releasably retain the tissue thickness compensator to the support portion of the staple cartridge. In certain embodiments, for example, the support portion may include a plurality of apertures defined in the platform surface. Wherein the fastener is extendable through the tissue thickness compensator and releasably retainable in the aperture of the support portion. In use, the fastener may be progressively released from the supporting portion as the staples are progressively ejected from the supporting portion. In at least one such embodiment, the fastener can be implanted with the tissue thickness compensator, and in at least one embodiment, for example, the fastener can be constructed of at least one bioabsorbable material. In some embodiments, the fastener can be detached from the support portion after the tissue thickness compensator has been implanted and when the support portion is moved at least partially away from the implanted tissue thickness compensator. In various embodiments, referring now to fig. 130-131, a staple cartridge (such as staple cartridge 11600) can include, for example, atissue thickness compensator 11620 releasably mounted to asupport portion 11610 by a plurality offasteners 11613. Eachfastener 11613 can include afirst end portion 11618 embedded within and/or engaged with thetissue thickness compensator 11620, asecond end portion 11618 engaged with thesupport portion 11610, and aconnector 11616 connecting thefirst end portion 11618 to thesecond end portion 11618. In various embodiments, thefastener 11613 may extend through aknife slot 11615 defined in thesupport portion 11610. In use, the firingmember 10052 can move the knife edge through theknife slot 11615 in thesupport portion 11610 and incise thefasteners 11613 in order to release thetissue thickness compensator 11620 from thesupport portion 11610. In at least one such embodiment, the firingbar 10052 can be advanced from a proximal end of thestaple cartridge 11600 to a distal end of thestaple cartridge 11600 in order to 1) advance thesled 10050 distally and incrementally fire thestaples 10030 as described above; 2) progressively incising thefastener 11613 and/or breaking thefastener 11613 to progressively release thetissue thickness compensator 11620 from thesupport portion 11610. In certain embodiments, similar to the above, thetissue thickness compensator 11620 can include a plurality of separable sections. These multiple separable sections can each be retained to thesupport portion 11610 by one ormore fasteners 11613, for example. If the firingmember 10052 comes to rest intermediate the proximal and distal ends of thestaple cartridge 11600, as illustrated in fig. 130, thefasteners 11613 can help retain the unimplanted portion of thetissue thickness compensator 11620 to thesupport portion 11610 after theanvil 11660 is opened and thesupport portion 11610 is moved away from the tissue T, as illustrated in fig. 131. In various embodiments, in addition to the above, thecutting edge 10053 of the firingmember 10052 can be configured to incise thefastener 11613 and/or sever thefastener 11613.
In various embodiments, referring now to fig. 132, a staple cartridge can comprise, for example, a tissue thickness compensator (such as tissue thickness compensator 15120), which can comprise a plurality of portions having different thicknesses. In at least one embodiment, thetissue thickness compensator 15120 can include a first orinner portion 15122a that can have a first thickness, a second orintermediate portion 15122b extending from thefirst portion 15122a that can each have a second thickness, and a third orouter portion 15122c extending from thesecond portion 15122b that can each have a third thickness. In at least one such embodiment, for example, the third thickness may be thicker than the second thickness, and the second thickness may be thicker than the first thickness. However, in various other embodiments, any suitable thickness may be used. In various embodiments, the portions 15122 a-15122 c of thetissue thickness compensator 15120 can include steps having different thicknesses. In at least one embodiment, similar to the above, a staple cartridge can comprise a plurality ofrows 10030 of staples and a plurality of staple drivers having different heights that can deform thestaples 10030 to different formed heights. Also similar to the above, the staple cartridge can comprise afirst staple driver 15140a, whichfirst staple driver 15140a can drive thestaples 10030 supported thereon to a first formed height; asecond staple driver 15140b, thesecond staple driver 15140b can drive thestaples 10030 supported thereon to a second formed height; and a thirdstaple driver 15140c, thethird staple driver 15140c can drive thestaples 10030 supported thereon to a third formed height. In the staple cartridge, for example, the first forming height can be shorter than the second forming height, which can be shorter than the third forming height. In various embodiments, as shown in fig. 132, each staple 10030 can comprise the same or substantially the same unformed, or unfired, height. In certain other embodiments, referring now to fig. 133, thefirst driver 15140a, thesecond driver 15140b, and/or thethird driver 15140c can support staples having different unformed heights. In at least one such embodiment, thefirst staple drivers 15140a can supportstaples 15130a having a first unformed height, thesecond staple drivers 15140b can supportstaples 15130b having a second unformed height, and thethird staple drivers 15140c can supportstaples 15130c having a third unformed height. Wherein, for example, the first unformed height can be shorter than the second unformed height, which can be shorter than the third unformed height. In various embodiments, referring again to fig. 133, the tips of thepegs 15130a, 15130b, and/or 15130c can lie in, or at least substantially lie in, the same plane, while in other embodiments, the tips of thepegs 15130a, 15130b, and/or 15130c can not lie in the same plane.
In certain embodiments, referring now to fig. 154, a staple cartridge can comprise atissue thickness compensator 15220 having a plurality of portions with different thicknesses. Thetissue thickness compensator 15220 can be implanted against tissue T bystaples 15130a, 15130b and 15130c as described above. In at least one embodiment, referring now to fig. 155, thepegs 15130a, 15130b, and/or 15130c can be deformed to different formed heights. Wherein thefirst staples 15130a can be formed to a first formed height, thesecond staples 15130b can be formed to a second formed height, and thethird staples 15130c can be formed to a third formed height, and wherein, for example, the first formed height can be shorter than the second formed height, and the second formed height can be shorter than the third formed height. Other embodiments are contemplated in which thestaples 15130a, 15130b, 15130c may be formed to any suitable formed height and/or any relative formed height.
As described above and with reference to fig. 134, a staple cartridge (such as staple cartridge 10000), for example, can comprise asupport portion 10010 and atissue thickness compensator 10020. Wherein a plurality ofstaples 10030 can be at least partially stored in thesupport portion 10010 and can extend into thetissue thickness compensator 10020 when thestaples 10030 are in their unfired positions. In various embodiments, the tips of thestaples 10030 do not protrude from thetissue thickness compensator 10020 when thestaples 10030 are in their unfired position. As thestaple drivers 10040 move thestaples 10030 from their unfired positions to their fired positions as described above, the tips of thestaples 10030 can penetrate thetissue thickness compensator 10020 and/or penetrate the upper layer orskin 10022. In certain alternative embodiments, the tips of thestaples 10030 can protrude through the top surface of thetissue thickness compensator 10020 and/or theskin 10022 when thestaples 10030 are in their unfired position. In either case, as thestaples 10030 extend upwardly out of thesupport portion 10010 prior to being deployed, thestaples 10030 can also tilt and/or deflect relative to the support portion as described above.
In various embodiments, referring now to fig. 140, a staple cartridge can comprise atissue thickness compensator 13620, and a skin ortop layer 13621, for example. In at least one such embodiment, for example, one or more pledgets orretainers 13622 can be embedded in theskin 13621. In certain embodiments, eachretainer 13622 can comprise one ormore apertures 13629 defined therein which can be configured to receive thestaple legs 13032 of thestaples 13030 therein when thestaples 13030 are in their unfired positions, as shown in fig. 140. In use, in addition to the above, as thestaples 13030 are moved from their unfired positions to their fired positions, thestaple legs 10032 can slide through theapertures 13629 until, for example, thebases 13031 of thestaples 13030 contact thetissue thickness compensator 13620 and compress at least a portion of thetissue thickness compensator 13620 against a bottom surface of thepledget 13622. In various embodiments, referring now to fig. 135, for example, a staple cartridge can comprise atissue thickness compensator 13120, and a skin ortop layer 13122. In at least one such embodiment, thetissue thickness compensator 13120 can comprise tapered lugs, protrusions, and/orprotuberances 13128 that can extend upwardly from atop surface 13121 of thetissue thickness compensator 13120, for example. Theprojections 13128 can be configured to receive and enclose the tips of thestaple legs 13032 of thestaples 13030 when thestaples 13030 are in their unfired positions, as shown in fig. 135. Thetop layer 13122 may also include tapered lugs, tabs, and/orprotrusions 13129 that may be aligned, or at least substantially aligned, with thetabs 13128. In use, thestaple legs 10032 can penetrate theprotrusions 13128 and 13129 and emerge from thetissue thickness compensator 13120. In various embodiments, referring now to fig. 139, a staple cartridge can comprise atissue thickness compensator 13520, and a skin ortop layer 13522, for example. In at least one such embodiment, theskin 13522 can include tapered lugs, protrusions, and/orprotrusions 13529 that can extend upwardly from thetop surface 13521 of thetissue thickness compensator 13520, for example. Similar to the above, theprojections 13529 can be configured to receive and enclose the top ends of thestaple legs 13032 of thestaples 13030 when thestaples 13030 are in their unfired positions, as illustrated in fig. 139. In use, thestaple legs 10032 can penetrate theprotrusions 13529 and emerge from theskin 13522.
In various embodiments, referring now to fig. 136, a staple cartridge can comprise atissue thickness compensator 13220, and a skin ortop layer 13222, for example. In at least one such embodiment, for example, thetissue thickness compensator 13220 can comprise tapered dimples and/orgrooves 13128 that can extend down into thetop surface 13221 of thetissue thickness compensator 13220. In various embodiments, the tips of thestaple legs 13032 can extend through theflutes 13128 when thestaples 13030 are in their unfired positions, as shown in fig. 136. In at least one embodiment, thetop layer 13222 can further include tapered dimples and/orrecesses 13229 that can be aligned, or at least substantially aligned, with therecesses 13228. In various embodiments, referring now to fig. 137, a staple cartridge can comprise atissue thickness compensator 13320, and a skin ortop layer 13322, for example. In at least one such embodiment, theskin 13320 can include athick portion 13329 that can extend down into thetop surface 13321 of thetissue thickness compensator 13320. In various circumstances, thethick portions 13329 can be configured to receive at least a portion of thestaple legs 13032 of thestaples 13030 therein when thestaples 13030 are in their unfired positions, as illustrated in fig. 137. In such embodiments, thethick portions 13329 can hold thestaple legs 13032 in position such that thestaple legs 13032 are aligned, or at least substantially aligned, with the staple forming pockets of the anvil positioned opposite thetissue thickness compensator 13320. In various embodiments, referring now to fig. 138, for example, a staple cartridge can include atissue thickness compensator 13420, and a skin ortop layer 13422. In at least one such embodiment, theskin 13422 can include athick portion 13429 that can extend upwardly from thetop surface 13421 of thetissue thickness compensator 13420. In various circumstances, thethick portions 13429 can be configured to receive at least a portion of thestaple legs 13032 of thestaples 13030 therein when thestaples 13030 are in their unfired positions, as illustrated in fig. 138. In such embodiments, thethick portions 13429 can hold thestaple legs 13032 in position such that thestaple legs 13032 are aligned, or at least substantially aligned, with the staple forming pockets of the anvil positioned opposite thetissue thickness compensator 13420.
In various embodiments, referring now to fig. 141 and 142, for example, a staple cartridge can includetissue thickness compensators 13720 and, and a skin ortop layer 13721. In at least one such embodiment, for example, thetissue thickness compensator 13720 can comprise pyramidal and/or stepped lugs, protrusions, and/orprotrusions 13728 that can extend upwardly from thetop surface 13721 of thetissue thickness compensator 13720. Theprojections 13728 can be configured to receive and envelop the tips of thestaple legs 13032 of thestaples 13030 when thestaples 13030 are in their unfired positions, as shown in fig. 142. Similarly,top layer 13721 may include pyramid-shaped and/or stepped lugs, protrusions, and/orprotrusions 13729 that may be aligned, or at least substantially aligned, withprotrusions 13728. In various embodiments,skin 13721 can further include one ormore teeth 13727 extending upwardly fromtabs 13729, which can be configured to engage tissue positioned againsttop layer 13721 and prevent, or at least limit, relative lateral and/or longitudinal movement between the tissue,top layer 13721, and/or the tips ofstaple legs 13032. In use, as thestaples 13030 are moved from their unfired positions to their fired positions, thestaple legs 13032 can penetrate theprojections 13728 and 13729 and emerge from thetissue thickness compensator 13720. In various embodiments, referring now to fig. 143 and 144, for example, a staple cartridge can comprise atissue thickness compensator 13820, and a skin ortop layer 13821. In at least one such embodiment, for example, thetissue thickness compensator 13820 can comprise pyramidal and/or stepped lugs, projections, and/orprotrusions 13828 that can extend upwardly from thetop surface 13821 of thetissue thickness compensator 13820. Theprojections 13828 can be configured to receive and enclose the tips of thestaple legs 13032 of thestaples 13030 when thestaples 13030 are in their unfired positions, as illustrated in fig. 144. Similarly,top layer 13821 may include pyramidal and/or stepped lugs, projections, and/orprotrusions 13829 that may be aligned, or at least substantially aligned, withprojections 13828. In various embodiments,top layer 13821 may further include one ormore teeth 13827 extending downwardly intotissue thickness compensator 13820, for example, which may be configured to prevent or at least limit relative lateral and/or longitudinal movement betweentop layer 13821 andtissue thickness compensator 13820. In use, as thestaples 13030 are moved from their unfired position to their fired position, thestaple legs 10032 can penetrate theprojections 13828 and 13829 and emerge from thetissue thickness compensator 13820.
In various embodiments, referring now to fig. 145, for example, a staple cartridge can comprise a tissue thickness compensator (such as tissue thickness compensator 13920) which can compriseridges 13923 andvalleys 13924 defined therein, and in at least one embodiment,valleys 13924 can be defined between theridges 13923. In various embodiments, eachridge 13923 may have the same height, substantially the same height, or a different height. Similarly, eachvalley 13924 may include the same depth, substantially the same depth, or a different depth. In various embodiments, a plurality ofstaples 13030 can be at least partially stored in thetissue thickness compensator 13920 such that the tips of thestaples 13030 can be positioned within theridges 13923. In at least one such embodiment, for example, thestaple legs 13032 of thestaples 13030 can not protrude from thetissue thickness compensator 13920 and/or a skin ortop layer 13921 attached to thetissue thickness compensator 13920 when thestaples 13030 are stored in their unfired positions. In various embodiments, theridges 13923 and/orvalleys 13924 may extend laterally across the staple cartridge. In at least one such embodiment, a staple cartridge can comprise a longitudinal knife slot. Wherein theridges 13923 andvalleys 13924 may extend in a direction transverse and/or perpendicular to the knife slot. In various circumstances, theridges 13923 can be configured to retain the tips of thestaple legs 13032 in position until thestaples 13030 are moved from their unfired positions to their fired positions. In various embodiments, referring now to fig. 146, the tissue thickness compensator and/or the skin covering the tissue thickness compensator can comprise longitudinal ridges and/or valleys. In at least one such embodiment, for example, the tissue thickness compensator can comprise a top surface defined byridges 14023 andvalleys 14024, wherein thevalleys 14024 can be defined between theridges 14023. In various embodiments, the tissue thickness compensator can comprise askin 14021, whichskin 14021 can comprise a plurality ofapertures 14029 defined therein, each of which can be configured to receive astaple leg 13032. In certain embodiments,apertures 14029 can be defined inridges 14023 wherein the tips ofstaple legs 13032 can be positioned belowapex 14028 ofridge 14029, positioned flush withapex 14028, and/or positioned aboveapex 14028. In certain embodiments, in addition to or in lieu of the above, anaperture 14029 may be defined in avalley 14024, for example. In certain embodiments, for example, each aperture may be surrounded or at least partially surrounded by embossing, which may enhance the skin and/or tissue thickness compensator surrounding the aperture. In any event, in addition to the above, for example, theskin 14021 can be attached to the tissue thickness compensator in any suitable manner, including using at least one adhesive.
In various embodiments, referring now to fig. 148, for example, a disposable loading unit 15900 can comprise ananvil 15960 and astaple cartridge channel 15970, wherein thestaple cartridge channel 15970 can be rotated relative to theanvil 15960. In at least one such embodiment, theanvil 15960 may not be able to rotate. In certain embodiments, tissue can be positioned between theanvil 15960 and thestaple cartridge channel 15970, and then thestaple cartridge channel 15970 can be rotated toward the tissue to clamp the tissue against the anvil. In at least one such embodiment, the disposable loading unit 15900 can further comprise atissue thickness compensator 15920 which can be configured to contact tissue.
In various embodiments, referring now to fig. 149-151, thedisposable loading unit 12900 can comprise a loading assembly comprising abottom portion 12922 that can be removably attached to thesupport portion 12610, atop portion 12990 that can be removably attached to theanvil 12560, and a flexible joint 12991 that connects thebottom portion 12922 and thetop portion 12990. Similar to the above, alongitudinal retention rail 12825 can extend downwardly from thebottom portion 12922 into theknife slot 12615 defined in thesupport portion 12610 such that thebottom portion 12922 can be releasably retained to thesupport portion 12610. Similarly, alongitudinal retention rail 12995 can extend upwardly from thetop portion 12990 into a knife slot defined in theanvil 12560 such that thetop portion 12990 can be releasably retained to theanvil 12560. As shown in fig. 150 and 151, thetissue thickness compensator 12620 can be mounted to thebottom portion 12922 of the loading assembly wherein, to position thetissue thickness compensator 12620 relative to thesupport portion 12610, the clinician can flex thetop portion 12990 and thebottom portion 12922 toward one another, position the loading assembly between theanvil 12560 and thesupport portion 12610, and then release the flexed loading assembly such that the loading assembly can resiliently expand and bias thetop portion 12990 against theanvil 12560 and thebottom portion 12922 against thesupport portion 12610.
In various embodiments, referring now to fig. 152, for example, a staple cartridge (such as staple cartridge 14900) can include asupport portion 14910 in addition to atissue thickness compensator 14920 positioned against thesupport portion 14910. Similar to the above, for example, thesupport portion 14910 can include staple drivers that can be lifted upward away by the staple deployment sled in order to lift away a staple (such as staple 10030). The staples are positioned at least partially within thesupport portion 14910 toward an anvil, such as, for example, theanvil 10060 positioned opposite thestaple cartridge 14900. In certain embodiments, for example, thesupport portion 14910 may include six rows of staple cavities, such as two outer rows of staple cavities, two inner rows of staple cavities, and two intermediate rows of staple cavities positioned intermediate the inner and outer rows. Wherein theanvil 10060 can comprise six rows of formingpockets 10062 that are aligned, or at least substantially aligned, with the staple cavities. In various embodiments, the inside row of staple cavities may includestaple drivers 14940a positioned therein, the middle row of staple cavities may includestaple drivers 14940b positioned therein, and the outside row of staple cavities may includestaple drivers 14940c positioned therein. Wherein each ofstaple drivers 14940a can comprise ashelf 14949a configured to support astaple 10030, each ofstaple drivers 14940b can comprise ashelf 14949b configured to support astaple 10030, and each ofstaple drivers 14940c can comprise ashelf 14949c configured to support astaple 10030. In the unfired position of the staple drivers, i.e., when the staple drivers 14940 a-14940 c are seated on driver supports 14926 that extend below thesupport portion 14910, theshelf 14949a of thestaple drivers 14940a may be positioned closer to theanvil 10060 than theshelf 14949b of thestaple drivers 14940b and theshelf 14949c of thestaple drivers 14940 c. In such a position, a first forming distance can be defined betweenbracket 14949a and formingpocket 10062 positioned abovebracket 14949 a; a second forming distance can be defined betweenbracket 14949b and formingpocket 10062 positioned abovebracket 14949 b; a third forming distance can be defined betweensupport 14949c and formingpocket 10062 positioned abovesupport 14949 c. Wherein in various embodiments, for example, the first forming distance can be shorter than the second forming distance, and the second forming distance can be shorter than the third forming distance. As the staple drivers 14940 a-14940 c are moved from their unfired position (fig. 152) to their fired position, each staple driver 14940 a-14940 c can be moved upward toward theanvil 10060 an equal, or at least substantially equal, distance by the staple deployment sled such that afirst driver 14940a drives itsrespective staple 10030 to a first forming height, asecond driver 14940b drives itsrespective staple 10030 to a second forming height, and athird driver 14940c drives itsrespective staple 10030 to a third forming height. Wherein, for example, the first forming height may be shorter than the second forming height, and the second forming height may be shorter than the third forming height. Various other embodiments are contemplated in whichfirst staple driver 14940a is displaced upward a first distance,second staple driver 14940b is displaced upward a second distance, and thirdstaple driver 14940c is displaced upward a third distance. Wherein one or more of the first distance, the second distance, and the third distance may be different.
In various embodiments, referring again to fig. 152, thedeck surface 14911 of thesupport portion 14910 can vary in height relative to the tissue-contactingsurface 10061 of theanvil 10060. In certain embodiments, this height variation can occur in the lateral direction, and in at least one embodiment, for example, the height ofplateau surface 14911 surrounding the medial row of staple cavities can be higher than the height ofplateau surface 14911 surrounding the lateral row of staple cavities. In various embodiments, thebottom surface 14922 of thetissue thickness compensator 14920 is configured to be parallel, or at least substantially parallel, to thedeck surface 14911 of thesupport portion 14910. In addition to the above, thetissue thickness compensator 14920 may also vary in thickness. Wherein in at least one embodiment, the top ortissue contacting surface 14921 of thetissue thickness compensator 14920 can be sloped inwardly from its outer, i.e., lateral, edge. In at least one such embodiment, as a result of the above, for example, thetissue thickness compensator 14920 can be thinner in the areas positioned over the medial row of staple cavities and thicker in the areas positioned over the lateral row of staple cavities. In various embodiments, referring now to fig. 153, the platform surface of thesupport portion 15010 may comprise a stepped platform surface, for example. Wherein, for example, the highest step of the stepped surface may surround the inside row of staple cavities and the lowest step of the stepped surface may surround the outside row of staple cavities. In at least one such embodiment, a step having an intermediate height can surround the intermediate row of staple cavities. In certain embodiments, for example, a tissue thickness compensator (such as tissue thickness compensator 15020) may include a bottom surface that may be parallel to and contiguous with a deck surface of thesupport portion 15010. In at least one embodiment, for example, the top surface ortissue contacting surface 15021 of the tissue thickness compensator can comprise an arcuate, parabolic, and/or curved surface, which in at least one such embodiment can extend from a first lateral side of thetissue thickness compensator 15020 to a second lateral side of thetissue thickness compensator 15020, e.g., with the apex aligned with, or at least substantially aligned with, the center of thestaple cartridge 15000.
In various embodiments, in addition to the above, thestaple firing sled 10050 of thestaple cartridge 10000 can be moved from the proximal end of thestaple cartridge 10000 toward thedistal end 10002 of the staple cartridge by a firing member (as shown elsewhere), as shown in fig. 161 and 162. As thesled 10050 is advanced, thesled 10050 can contact thestaple drivers 10040 and lift thestaple drivers 10040 upwardly within thestaple cavities 10012 defined in thecartridge body 10010 of thestaple cartridge 10000. In at least one embodiment, thesled 10050 and thestaple drivers 10040 can each comprise one or more ramps or inclined surfaces that can cooperate to move thestaple drivers 10040, and the staples supported thereon, upwardly from their unfired positions. Thestaple cartridge 10000 can further comprise atray 10027, which can, for example, at least partially surround the bottom of thecartridge body 10010 and at least partially house thestaple drivers 10040 disposed within thecartridge body 10010. Thecartridge body 10010 can further comprise alongitudinal slot 10016 defined therein, thelongitudinal slot 10016 being configured to at least partially receive a firing member as the firing member passes through thestaple cartridge 10000.
Turning now to fig. 163, the staples contained within thestaple cartridge body 10010 can be fired sequentially between theproximal end 10001 and thedistal end 10002 of thestaple cartridge 10000. In various embodiments, for example, thestaple cartridge 10000 can comprisestaple drivers 10040a, 10040b, and 10040c, which can fire staples in a predetermined manner. For example, thestaple cartridge 10000 can comprise aproximal driver 10040c positioned on a first side of thelongitudinal slot 10016 and a secondproximal driver 10040c positioned on a second, opposite side of thelongitudinal slot 10016. Eachdriver 10040c is configured to fire two staples, i.e., the two most proximal staples, simultaneously. Such staples are positioned in staple cavities labeled 10012 c. In fact, of the two staple cavities labeled 10012c on each side of thelongitudinal slot 10016,such staple cavities 10012c can comprise a distal staple cavity labeled 10013c and a proximal staple cavity labeled 10014 c. The reader will appreciate that thestaple cavities 10013c are positioned in a different row of staples than thestaple cavities 10014 c. In fact, thestaple cavities 10013c and 10014c can be located in two innermost staple rows, with the third outermost staple row having no staples to be fired by thedriver 10040 c. In addition, thestaple cartridge 10000 can comprise anintermediate driver 10040b positioned on a first side of thelongitudinal slot 10016 and a secondintermediate driver 10040b positioned on a second, opposite side of thelongitudinal slot 10016. Eachdriver 10040b is configured to fire three staples simultaneously. Such staples are positioned in staple cavities labeled 10012 b. In fact, of the three staple cavities labeled 10012b on each side of thelongitudinal slot 10016,such staple cavities 10012b can comprise a distal staple cavity labeled 10013b, an intermediate staple cavity labeled 10014b, and a distal staple cavity labeled 10015 b. The reader will appreciate that the threestaple cavities 10013b, 10014b, and 10015b are all positioned in different rows of staples. In addition, thestaple cartridge 10000 can comprise adistal driver 10040a positioned on a first side of the longitudinal slot 10015 and a seconddistal driver 10040a positioned on a second, opposite side of the longitudinal slot 10015. Eachdriver 10040a is configured to fire four staples simultaneously. Such staples are positioned in staple cavities labeled 10012 a. In fact, of the four staple cavities labeled 10012a on each side of thelongitudinal slot 10016, suchstaple cavities 10012a can include two distal staple cavities labeled 10013a, an intermediate staple cavity labeled 10014a, and a distal staple cavity labeled 10015 a. The reader will appreciate that thestaple cavities 10013a, 10014a, and 10015a are all positioned in an array that extends across all three rows of staples on one side of thelongitudinal slot 10016. In fact, the distal-most staples positioned within the distal-moststaple cavities 10013a located within thecartridge body 10010 are positioned in the inner and outer rows of staples and extend distally relative to the distal-moststaple cavities 10014a in the intermediate row of staple cavities positioned between the inner and outer rows of staple cavities. While only a fewstaple drivers 10040a, 10040b, and 10040c are discussed above, thestaple cartridge 10000 can comprise any suitable number of staple drivers for ejecting the staples from the staple cavities. Such staple drivers may eject two, three, four, and/or more staples simultaneously. Referring specifically to fig. 18, a staple cartridge can comprise one or morestaple drivers 41040a, e.g., configured to support two staples thereon, one or morestaple drivers 41040b, e.g., configured to support three staples thereon, and/or one or morestaple drivers 41040c, e.g., configured to support four staples thereon. In various embodiments, the last or distal-most staple driver housed within the staple cartridge can comprisestaple drivers 41040c, whichdrivers 41040c can comprise twodistal support legs 41041c configured to retain the last staple in the staple line. For example, drivers 41040 a-41040 c support staples in six staple lines, anddriver 41040c supports the last staples in the four staple lines of those staple lines. Such staples can be aligned along an axis perpendicular to the cutting path (which extends along the longitudinal axis), or at least substantially aligned. Because such staples have the above-described arrangement, they can provide a variety of hemostatic benefits. The last of the two other staple lines may be supported by thesupport 41041 b.
In various embodiments, a staple cartridge for a surgical stapler can include, for example, a layer, such as a tissue thickness compensator and/or a buttress material, disposed on a staple deck of the staple cartridge. In use, the layer and patient tissue can be captured by the staples as they are fired. The layer may then be separated from the surgical stapler, and may remain in the patient when the stapler is removed from the patient. In certain embodiments, the distal end of the layer can be attached to the staple cartridge to stabilize the layer relative to the staple cartridge when the staple cartridge and the layer are being positioned relative to the patient tissue.
In certain embodiments in which the distal end of the layer is attached to the staple cartridge, the staple cartridge can include a distally disposed cutting blade that cuts away the distal end of the layer that is attached to the staple cartridge. Fig. 81A-83 illustrate thestaple cartridge assembly 2300, whichstaple cartridge assembly 2300 includes astaple cartridge 2330 and adistal cutting blade 2324 disposed in adistal chamber 2332 of thestaple cartridge 2330. As described in more detail below, thedistal cutting blade 2324 may be moved from an undeployed position to a deployed position within thedistal chamber 2332. In the deployed position, cuttingblade 2324 extends out ofdistal chamber 2332 to severdistal end 2316 oflayer 2306 disposed on the staple cartridge.
Referring to fig. 82 and 83, in various embodiments,distal portion 2316 oflayer 2306 can be attached tostaple cartridge 2300 by being captured betweenstaple cartridge 2300 andpanel 2310, whichpanel 2310 extends proximally fromnose 2308 ofstaple cartridge assembly 2300. In some embodiments,layer 2306 may be captured by compression betweenstaple cartridge 2330 andpanel 2310. In other words, the gap betweenstaple cartridge 2330 andpanel 2310 may be less than the thickness ofdistal portion 2316 oflayer 2306 positioned in the gap such thatdistal portion 2316 is compressed betweenstaple cartridge 2330 andpanel 2310. In certain embodiments, referring to fig. 82 and 83,distal portion 2316 oflayer 2306 may include one ormore apertures 2320. One ormore pegs 2318 may extend frompanel 2308 and throughapertures 2320 to capturedistal portions 2316 oflayers 2306. In certain embodiments, for example,distal portion 2316 oflayer 2306 may be attached tostaple cartridge 2330 by adhesive, welding, and/or heat staking.
Adistal cutting blade 2324 that seversdistal portion 2316 oflayer 2306 from the rest oflayer 2306 may be disposed indistal chamber 2332 ofstaple cartridge 2330. Thedistal cavity 2332 anddistal cutting blade 2324 may be positioned such that thedistal cutting blade 2324 may sever thedistal portion 2316 oflayer 2306 at a location that is more proximal relative to the location at which thedistal portion 2316 is attached to thestaple cartridge 2330. For example, referring to fig. 82 and 83, thedistal cutting blade 2324 may sever thedistal portion 2316 of thelayer 2306 at a more proximal location relative to thepegs 2318 andholes 2320 that attach thedistal portion 2316 to thestaple cartridge 2330. Thus, whendistal cutting blade 2324 seversdistal portion 2316 oflayer 2306, the remainder oflayer 2306 can be released from the staple cartridge.
Thedistal cutting blade 2324 may include acam 2322, thecam 2322 being configured to push thedistal cutting blade 2324 out of thedistal chamber 2332.Cam 2322 may engage a rail and/orchannel 2334 indistal chamber 2332, which rail and/orchannel 2334 may limit movement ofcam 2322 anddistal cutting blade 2324 to a particular direction asblade 2324 extends out ofdistal chamber 2332. The rails and/orchannels 2334 are shown in fig. 82 and 83 as being perpendicular to thestaple deck 2302 ofstaple cartridge 2330. In this arrangement, thedistal cutting blade 2324 may extend from thedistal chamber 2332 in a direction perpendicular to thestaple deck 2302 of thestaple cartridge 2330 as it moves from the undeployed position (shown in fig. 82) to the deployed position (shown in fig. 83). In various embodiments, the rails and/orchannels 2334 can be arranged at any suitable angle relative to thestaple deck 2302 of thestaple cartridge 2330. For example, the rails and/orchannels 2334 can be arranged at a 30 ° angle relative to thestaple deck 2302 of thestaple cartridge 2330 such that thedistal cutting blade 2324 partially extends out of thedistal cavity 2322 in a distal direction at a 30 ° angle relative to thestaple deck 2302 of thestaple cartridge 2330.
To deploy the distal cutting blade, thecam 2322 may be pushed by the firingmember 2326. For example, the firingmember 2326 may be disposed in a slot (such as knife slot 2304) in thestaple cartridge 2330. The firingmember 2326 can includecam surfaces 2328 and 2329 that can be engaged with thecam 2322 to displace thecam 2322 and thedistal cutting blade 2324 toward thelayer 2306. The firingmember 2326 can be moved distally relative to thecam 2322 and thedistal cutting blade 2324 from an unactuated position to an actuated position to deploy thecutting blade 2324 and sever thedistal portion 2316 of thelayer 2306. Fig. 82 illustrates the firingmember 2326 in an unactuated position in which the cam surfaces 2328 and 2329 have not yet engaged thecams 2322. In various embodiments, one or both of the cam surfaces 2328 and 2329 of the firingmember 2326 may contact the cam when the firingmember 2326 is in the unactuated position, so long as thedistal cutting blade 2324 is not pushed out of thedistal chamber 2332. As the firingmember 2326 is moved distally to the actuated position shown in fig. 83, thecam surface 2328 of the firingmember 2326 engages thecam 2322 to incrementally push thecam 2322 and thedistal cutting blade 2324 to the deployed position such that thedistal cutting blade 2324 severs thedistal portion 2316 of thelayer 2306.
As described above,cam 2322 may engage a rail and/orchannel 2334 indistal chamber 2332. In addition, the rails and/orchannels 2334 can be disposed at an angle relative to thestaple deck 2302 of thestaple cartridge 2330. In various embodiments, the rails and/orchannels 2334 can be arranged at an angle such that thecams 2322 andblades 2324 move distally when thedistal cutting blade 2324 is deployed from thedistal chamber 2332. In various circumstances, arranging the rails at such an angle may reduce the amount of force required to actuate the firingmember 2326 by: the components of the motion of thecam 2322 and theblade 2324 are aligned along the longitudinal axis along which thefiring member 2326 moves. Arranging the rails at such an angle may also reduce the likelihood of adhesions occurring betweencam 2322 and firingmember 2326 and/or betweencam 2322 and rails and/orchannel 2324 indistal chamber 2332.
In various embodiments, the firingmember 2326 can be moved distally from the unactuated position to the actuated position by thecutting blade 2312 and/or thestaple driver 2340. In various embodiments, the firingmember 2326 can be integral with thetissue cutting blade 2312 and/or thestaple drivers 2340 such that the firingmember 2326 travels with thetissue cutting blade 2312 and/or thestaple drivers 2340 along the longitudinal axis of thestaple cartridge 2330 through thestaple cartridge 2330. In various other embodiments, the firingmember 2326 can be separate from thetissue cutting blade 2312 and/or thestaple driver 2340. In such embodiments, thetissue cutting blade 2312 and/or thestaple driver 2340 can push thefiring member 2326 through thestaple cartridge 2330. Alternatively, in such embodiments where the firingmember 2326 is separate from thetissue cutting blade 2312 and/or thestaple drivers 2340, the firingmember 2326 may be positioned at the distal end of thestaple cartridge 2330 with the firingmember 2326 in the unactuated position, as shown in fig. 82. When thecutting blade 2312 and/orstaple driver 2340 reaches the distal end of thestaple cartridge 2330, thecutting blade 2312 and/orstaple driver 2340 may travel through thestaple cartridge 2330, subsequently pushing the firingmember 2326 to the actuated position, as shown in fig. 83. In all of these embodiments, movement of thetissue cutting blade 2312 and/or thestaple driver 2340 in a direction along the longitudinal axis of thestaple cartridge 2330 can deploy thedistal cutting blade 2324 in a different direction than the tissue cutting blade and/or thestaple driver 2340.
In various embodiments, thedistal cutting blade 2324 is not deployed to sever thedistal portion 2316 of thelayer 2306 until the firing stroke of thetissue cutting blade 2312 and/orstaple driver 2340 has been completed or nearly completed. In such embodiments,distal portion 2316 oflayer 2306 can remain attached tostaple cartridge 2330, thereby stabilizinglayer 2306 relative tostaple cartridge 2330 until most or even all of the staples have been fired bystaple drivers 2340 and/or until the patient tissue andlayer 2306 have been severed bytissue cutting blade 2312. In various other embodiments, thedistal cutting blade 2324 can be deployed to sever thedistal portion 2316 of thelayer 2306 before thetissue cutting blade 2312 and/orstaple driver 2340 begin their firing strokes. For example, the firingmember 2326 can be moved from the unactuated position shown in fig. 82 to the actuated position shown in fig. 83 by a first actuation of a firing trigger of the surgical stapler. Subsequent actuations of the firing trigger may move thetissue cutting blade 2312 and/or thestaple drivers 2340. Thus,distal portion 2316 oflayer 2306 can be separated fromstaple cartridge 2330 beforetissue cutting blade 2312 severs patient tissue and/or beforestaple capture layer 2306 and patient tissue. As another example, the firingmember 2326 can be actuated by a first trigger of the surgical instrument, and thetissue cutting blade 2312 and/or thestaple driver 2340 can be actuated by a second trigger.
As described above,nose 2308 ofstaple cartridge assembly 2300 may includepanel 2310, whichpanel 2310 extends proximally fromnose 2308 and at least partially coversdistal portion 2316 ofcartridge 2306.Panel 2310 can include an inwardly facingsurface 2309, which inwardly facingsurface 2309 can face adistal portion 2316 oflayer 2306. In certain embodiments, the inward-facingsurface 2309 of thepanel 2310 may support thedistal portion 2316 of thelayer 2306 as thedistal cutting blade 2324 severs thedistal portion 2316. In various circumstances, as thedistal cutting blade 2324 is deployed, thedistal cutting blade 2324 may eventually come into contact with the inwardly facingsurface 2309, thereby completely severing thedistal portion 2316 of thelayer 2306 from the remainder of thelayer 2306.
Thefaceplate 2310 may also protect patient tissue from thedistal cutting blade 2324. In various circumstances, unaffected patient tissue that is not severed by thetissue cutting blade 2312 and/or stapled by staples from thestaple cartridge 2330 may pass over the outward facingsurface 2311 of theface plate 2310. In such cases, thefaceplate 2310 may protect the unaffected tissue from thedistal cutting blade 2324. For example, as shown in fig. 83, theface plate 2310 may be positioned between thedistal cutting blade 2324 extending out of thedistal chamber 2332 and patient tissue proximate theoutward surface 2311 of theface plate 2310 such that these patient tissue is not exposed to thedistal cutting blade 2324.
Referring now to fig. 77-79, thestaple cartridge 20000 can comprise acartridge body 20010 and atissue thickness compensator 20020 releasably attached to thecartridge body 20010. Thestaple cartridge 20000 can include any suitable arrangement of staples, staple cavities, and/or staple drivers. The staple drivers, after being fired by the sled or firing member, pass distally through thestaple cartridge 20000 to capture at least a portion of thetissue thickness compensator 20020 and at least a portion of the patient tissue within the staples, as described elsewhere herein. For the sake of brevity, the reader is not repeated herein with respect to the staples, staple cavities, and staple drivers. Referring now primarily to fig. 77 and 77A, thestaple cartridge 20000 can include asled 20060 that is distally advanced by a firingmember 20050. At some point during distal advancement of the firingmember 20050 andsled 20060, thesled 20060 can be configured to enable release of thetissue thickness compensator 20020 from thecartridge body 20010, as shown in fig. 78 and 79, for example. For example, thedistal end 20022 of thetissue thickness compensator 20020 can be releasably retained to the distal end of thecartridge body 20010 by theflexible jaws 20013 and the retainingpin 20072, wherein thesled 20060 can overcome the retaining action of the retainingpin 20072 or be withdrawn therefrom. Theflexible jaws 20013 can be configured to securely hold thetissue thickness compensator 20020 against thedeck 20015 of thecartridge body 20010. In such cases, theflexible clamp 20013 can provide sufficient clamping force to thetissue thickness compensator 20020 to hold thetissue thickness compensator 20020 in place. The retaining pins 20072 can also securely retain thetissue thickness compensator 20020 to thecartridge body 20010. For example, referring to fig. 77 and 77A, thedistal end 20022 of thetissue thickness compensator 20020 can include anaperture 20023 defined therein, theaperture 20023 can be configured to receive a retainingpin 20072, and the retainingpin 20072 can prevent thetissue thickness compensator 20020 from slipping out from between theclamp 20013 and thecartridge deck 20015 due to the interaction between the retainingpin 20072 and the side wall of theaperture 20023. Further, theretention pin 20072 and theclip 20013 can cooperate to limit movement of thetissue thickness compensator 20020, and in various circumstances, the top of theretention pin 20072 can abut theclip 20013 or can be positioned immediately adjacent to the clip.
In use, in addition to the above, the position of the retainingpin 20072 can be lowered as theslider 20060 is withdrawn, as shown in fig. 78 and 79. More specifically, theretention pin 20072 may extend from thecam 20070. Wherein thecams 20070 can be seated or seated on resilient members, springs 20012, extending from adisc 20011 attached to thecartridge body 20010; and when theslider 20060 engages thecam 20070, theslider 20060 may push thecam 20070 and the retainingpin 20072 downward, thereby compressing thespring 20012. Thecartridge body 20010 can include aguide 20018 defined therein which limits the movement of thecams 20070 along a substantially vertical path, i.e., a path perpendicular to thecartridge platform 20015. In various embodiments,sled 20060 can comprise acamming actuator 20062 that extends distally relative to staple driver lift-off surface 20063. Once the position of thepin 20072 has been sufficiently lowered, thetissue thickness compensator 20020 can slide relative to thecartridge deck 20015 and out of thejaws 20013. In each case, thepin 20072 can be lowered a sufficient amount, but still protrude at least partially from thecartridge deck 20015. In other instances, thepin 20072 can be lowered below thecartridge deck 20015. In either case, thecam actuator 20062 and staple driver ofsled 20060 being lifted offsurface 20063 enables theretention pin 20072 to be lowered sufficiently while the last or most distal staple is fired bysled 20060. In other instances, thecam actuator 20062 and staple driver lift-off surface 20063 ofsled 20060 can be configured to enable theretention pin 20072 to descend sufficiently before the last or most distal staple is fired bysled 20060. In still other instances,cam actuator 20062 and staple driver lift-off surface 20063 ofsled 20060 can enableretention pin 20072 to descend sufficiently after the last or most distal staple is fired bysled 20060. Althoughcam 20070 is described herein as having oneretention pin 20072, a plurality of retention pins 20072 can extend fromcam 20070, each of which can releasably retain atissue thickness compensator 20020 tocartridge body 20010. Thus, thetissue thickness compensator 20020 can include a suitable number ofapertures 20023 that can receive the retaining pins 20072.
Referring now to fig. 80 and 81, for example, thestaple cartridge 21000 can comprise acartridge body 21010, atissue thickness compensator 21020 releasably secured to thecartridge body 21010, and asled 21060 configured to release thetissue thickness compensator 21020 from thecartridge body 21010. Similar to that described above, thesled 21060 can include staple driver lift-offsurfaces 21063. The staple driver lift-off surface 21063 is configured to lift the staple drivers and staples supported thereon toward an anvil positioned opposite thetissue thickness compensator 21020. Also similar to the above, theslider 21060 may also include acam actuator 21062. The cam actuators 21062 can act on thejaws 21013 such that thejaws 21013 no longer hold thedistal end 21022 of thetissue thickness compensator 21020 to thedeck surface 21015 of thecartridge body 21010. More specifically, thejaws 21013 can comprisecams 21072 that extend downwardly into thecartridge body 21010. Wherein thecam 21072 can be engaged by thecam actuator 21062 as thesled 21060 is advanced distally through thestaple cartridge 21000. When thecam actuator 21062 engages thecam 21072, thecam actuator 21062 can lift thecam 21072 upward and flex thejaws 21013 away from thedistal end 21022 of thetissue thickness compensator 21020, as shown in fig. 81. At this point, thecartridge body 21010 can be moved away from thetissue thickness compensator 21020. In other words, thetissue thickness compensator 21020 has been implanted into the patient's tissue by one or more staples prior to being released from thecartridge body 21010. In such a case, after thetissue thickness compensator 21020 is released, thecartridge body 21010 can be moved away from the implantedtissue thickness compensator 21020 and removed from the surgical site.
In addition to the foregoing, thecam actuators 21062 and staple driver lift-offsurfaces 21063 of thesled 21060 can cause thecams 20072 to rise sufficiently to sufficiently reduce the clamping force applied by thejaws 21013 while the last or most distal staple is fired by thesled 20060. In other instances, thecam actuators 21062 and staple driver lift-offsurfaces 21063 of thesled 21060 can be configured such that thecams 21072 are sufficiently elevated to reduce the clamping force applied by thejaws 21013 prior to the firing of the last or most distal staple by thesled 21060. In still other instances, thecam actuators 21062 and staple driver lift-offsurfaces 21063 of thesled 21060 can cause thecams 20072 to rise sufficiently after the last or distal-most staple is fired by thesled 21060 to sufficiently reduce the clamping force applied by thejaws 21013. While thejaws 21013 are described herein as having onecam 21072 extending therefrom, a plurality ofcams 21072 can extend from thejaws 21013 that are each capable of lifting off thejaws 21013 to release thetissue thickness compensator 20020 from thecartridge body 20010.
In addition to the above, a sled or firing member passing through the staple cartridge can release the tissue thickness compensator from the cartridge body at or near the end of the distal movement of the sled, and/or at the end of the firing stroke of the firing member. In other words, the tissue thickness compensator can be released from the cartridge body at the same time as all or substantially all of the staples are fired from the staple cartridge. In various other embodiments, the tissue thickness compensator can be released from the cartridge body at the same time as or prior to the firing of the first, and most proximal, staple from the staple cartridge. One such exemplary embodiment is depicted in fig. 90-92, which illustrate astaple cartridge 22000. Similar to the above, thestaple cartridge 22000 can comprise acartridge body 22010, and atissue thickness compensator 22020 releasably secured to thecartridge body 22010. While thestaple cartridge 22000 can also include a staple firing sled as described above, the sled may not release thetissue thickness compensator 22020; conversely, thestaple cartridge 22000 can further comprise anactuator 22011, which actuator 22011 can be advanced distally by the firing member at the beginning of the firing stroke of the firing member. Various other embodiments disclosed herein disclose devices for distally advancing an actuator. For the sake of brevity, however, these other embodiments related to this embodiment will not be described in detail herein. In any case, theactuator 22011 can include acam support 22012 extending therefrom, thecam support 22012 being configured to support thecam 22070 when theactuator 22011 is in its unactuated position, as shown in fig. 90. In addition,staple cartridge 22000 can further comprise a biasing member, i.e.,spring 22074. The biasing member,spring 22074, is capable of holding or biasing thecam 22070 against thecam support 22012, again when theactuator 22011 is in its unactuated position shown in fig. 90. When thecam 22070 is in such a position, aretention pin 22072 extending from thecam 22070 can engage ahole 22023 defined in thedistal end 22022 of thetissue thickness compensator 22020 and extend through thehole 22023 such that theretention pin 22072, and/or theretention pin 22072 in cooperation with ajaw 22013 extending from thecartridge body 22010, can retain thetissue thickness compensator 22020 in place similar to that described above.
When theactuator 22011 is advanced distally by the firing member, referring now to fig. 91, thecam support 22012 may be advanced distally such that thecam support 22012 may no longer support thecam 22070. In such instances, thespring 22074 can bias thecam 22070 downward such that theretention pin 22072 is biased out of engagement with thetissue thickness compensator 22020, or at least partially out of engagement with thetissue thickness compensator 22020. In at least one instance, thespring 22074 can bias thecam 22070 downward such that theretention pin 22072 is positioned below thedeck 22015 of thestaple cartridge 22010. In any event, distal advancement of theactuator 22011 can cause thetissue thickness compensator 22020 to be released from thecartridge body 22010. In other words, thejaws 22013 can provide a clamping force to thetissue thickness compensator 22020 despite the lowering of the position of theretention pin 22072, thereby maintaining thetissue thickness compensator 22020 against thestaple deck 22015; however, once a sufficient relative force is applied between thetissue thickness compensator 22020 and thecartridge body 22010, thetissue thickness compensator 22020 can be slid out from under thejaws 22013. In addition to the above, release of thetissue thickness compensator 22020 from thecartridge body 22010 can occur prior to, concurrently with, and/or immediately after the firing of the proximal-most staples from thestaple cartridge 22000. In such instances, premature release of thetissue thickness compensator 22020 allows thetissue thickness compensator 22020 to be released from thecartridge body 22010 even if, for example, thestaple cartridge 22000 is only partially fired.
Referring now to fig. 84-87, theend effector assembly 5000 can include first andsecond jaws 5002 shown elsewhere. In various embodiments, thesecond jaw 5002 can comprise a cartridge assembly. The cartridge assembly includes afastener cartridge body 5050, and atissue thickness compensator 5058 releasably secured to thefastener cartridge body 5050. Referring primarily to fig. 84, thefastener cartridge body 5050 can have acartridge deck 5052 andfastener cavities 5054 defined in thecartridge deck 5052. Additionally, thesecond jaw 5002 can include fasteners (such as surgical staples), for example, that can be removably positioned in thefastener cavities 5054. For example, such fasteners can be ejectably positioned in eachfastener cavity 5054 of thecartridge body 5050. In certain embodiments, thecartridge body 5050 can comprise aslot 5056, whichslot 5056 can extend from theproximal portion 5004 of thesecond jaw 5002 toward thedistal portion 5006 of thesecond jaw 5002. In various embodiments, thefiring assembly 5030 can translate along theslot 5056 of thecartridge body 5050. For example, thefiring assembly 5030 can translate within theslot 5056 during a firing stroke and can eject fasteners from thefastener cavities 5054 during the firing stroke.
Referring primarily to fig. 84, 86, and 87, thefiring assembly 5030 can include a firing bar (fig. 84), acutting edge 5036, acrossbar 5038, and legs 5044 (fig. 86 and 87). Thecutting edge 5036 can cut tissue and/or cut thetissue thickness compensator 5058 as thefiring assembly 5030 is fired through thesecond jaw 5002 during a firing stroke. For example, thecrossbar 5038 can hold the first jaw relative to thecartridge body 5050 and thefeet 5044 can hold thefiring assembly 5030 relative to thecartridge body 5050. In various embodiments, thecrossbar 5038 andfeet 5044 can, for example, hold thecutting element 5036 perpendicular to theplatform 5052 of thefastener cartridge 5050. Referring primarily to fig. 29A and 29B, thefiring assembly 5030 can engage thesled 5034 in thecartridge body 5050 during the firing stroke. Thefiring assembly 5030 can push thesled 5034 distally, e.g., during a firing stroke, thereby ejecting fasteners from thefastener cavities 5054.
Referring primarily to fig. 84, thetissue thickness compensator 5058 can be releasably secured to thecartridge body 5050 by at least oneconnector 5080a,5080 b. In certain embodiments, a plurality ofconnectors 5080a,5080b can secure thetissue thickness compensator 5058 to thecartridge body 5050. For example, theproximal connector 5080a can secure thetissue thickness compensator 5058 to thecartridge body 5050 at theproximal portion 5004 of thesecond jaw 5002, and thedistal connector 5080b can secure thetissue thickness compensator 5058 to thecartridge body 5050 at thedistal portion 5006 of thesecond jaw 5002. In certain embodiments, additional connectors can secure thetissue thickness compensator 5058 to thecartridge body 5050. In such embodiments, for example, additional connectors can be spaced along at least a portion of the length of thecartridge body 5050 and can be positioned between theproximal connector 5080a and thedistal connector 5080 b.
Still referring primarily to fig. 84, theconnectors 5080a and 5080b can retain thetissue thickness compensator 5058 relative to thecartridge body 5050. When theconnectors 5080a and 5080b are cracked, cut, displaced, or otherwise rendered ineffective, thetissue thickness compensator 5058 can be released from thecartridge body 5050. In certain embodiments, thefiring assembly 5030 can overcome theconnectors 5080a and 5080b as it translates along theslot 5056 in thefastener cartridge 5050 during the firing stroke. During this firing stroke, thefiring assembly 5030 can not only cut tissue clamped between the first jaw and thesecond jaw 5002, but can also move fasteners from thefastener cavities 5054 into the clamped tissue. In various embodiments, thefiring assembly 5030 can push the sled 5034 (fig. 86 and 87) distally during the firing stroke. Theslide 5034 can have a camming surface orramp 5042 that can engage a driver in thefastener cavity 5054. When theramp 5042 engages the driver, the ramp may push the driver toward theplatform 5052 to eject the fastener from thefastener cavity 5054. In addition, thefiring assembly 5030 can cut thetissue thickness compensator 5058 and theconnectors 5080a,5080b during the firing stroke.
Referring primarily to FIG. 84, thecutting edge 5036 of thefiring assembly 5030 can cut theproximal connector 5080a, such as at or shortly after the beginning of the firing stroke, and can cut thedistal connector 5080b, such as at or near the end of the firing stroke. In certain embodiments, the sled 5034 (fig. 86 and 87) can eject the fasteners from thefastener cavities 5054 after thecutting edge 5036 cuts theproximal connector 5080a and before thecutting edge 5036 cuts thedistal connector 5080 b. In such embodiments, if thefiring assembly 5030 does not complete the firing stroke, thecutting edge 5036 of thefiring assembly 5030 can stop before reaching thedistal connector 5080b, while thetissue thickness compensator 5058 can remain secured to thecartridge body 5050 at thedistal portion 5006 of thesecond jaw 5002. In certain embodiments, thetissue thickness compensator 5058 can remain secured to thecartridge body 5050 until the operator cuts or otherwise overcomes thedistal connector 5080 b. For example, the operator may overcomedistal connector 5080b by introducing additional surgical instruments and/or steps during the surgical procedure.
Still referring to fig. 84-87, in various embodiments, thesecond jaw 5002 can overcome theconnectors 5080a and 5080b at the beginning of or shortly after the firing stroke. In other words, the element of thesecond jaw 5002 can overcome theproximal connector 5080a, thedistal connector 5080b, and any additional connectors between the two connectors at the beginning or shortly after the beginning of the firing stroke. For example, thesecond jaw 5002 and/or the cartridge assembly can include anactuator 5010 that can overcome thedistal connector 5080b prior to ejection of the fastener from the fastener cavity. Theactuator 5010 can overcome thedistal connector 5080b and thetissue thickness compensator 5358 can be released from thecartridge body 5050 even if the firing stroke ends prematurely, that is, for example, thefiring assembly 5030 before reaching thedistal portion 5006 of thesecond jaw 5002. In various embodiments, theactuator 5010 can include a bottom side 5016 (fig. 85A-85C) and sidewalls 5018 (fig. 84 and 85D). Theside walls 5018 can extend from thebottom side 5016 and extend around at least a portion of thecartridge body 5050. Thebottom side 5016 and/or theside walls 5018 can extend past or around fasteners positioned in thefastener cavities 5054. In addition, theactuator 5010 can be movably retained relative to thecartridge body 5050. For example, theactuator 5010 can be moved from a pre-actuation position (fig. 85A) to an actuation position (fig. 85B and 85D). In certain embodiments, theside walls 5018 of theactuator 5010 can engage slots in thecartridge body 5050 such that theactuator 5010 moves within the slots to slide relative to thecartridge body 5050. As theactuator 5010 moves relative to thecartridge body 5050, theactuator 5010 can slide relative to the fasteners positioned in thefastener cavities 5054 of thecartridge body 5050. For example, theactuator 5010 can slide past and/or around fasteners in thefastener cavities 5054.
Referring primarily to fig. 85A-85C, theactuator 5010 can include aslot 5012, theslot 5012 can extend from theproximal portion 5004 toward thedistal portion 5006 of thesecond jaw 5002. Theslots 5012 in theactuator 5010 can correspond to and/or be aligned with the slots 5056 (fig. 84) in thecartridge body 5050, for example. In addition, thefiring assembly 5030, when translated along theslot 5056 in thecartridge body 5050 and/or within theslot 5056 during the firing stroke, can also translate along theslot 5012 in theactuator 5010 and/or within theslot 5012. In various embodiments, thefiring assembly 5030 can engage theactuator 5010 to move theactuator 5010 distally at or shortly after the beginning of the firing stroke. In such embodiments, thefiring assembly 5030 can actuate theactuator 5010 at theproximal portion 5004 of thesecond jaw 5002. For example, when theactuator 5010 is actuated and moved distally, the distal end of theactuator 5010 can cut or otherwise overcome thedistal connector 5080 b. In other words, proximal actuation of theactuator 5010 can effect distal release of thetissue thickness compensator 5058 from thecartridge body 5050. In various embodiments, theactuator 5010 can only be distally displaced to overcome thedistal connector 5080 b. In at least one embodiment, theactuator 5010 can be displaced, for example, by about 1mm before overcoming thedistal connector 5080 b. In certain embodiments, theactuator 5010 can be displaced, for example, by about 0.5mm to about 5mm before overcoming thedistal connector 5080 b.
Referring primarily to fig. 85A and 85B, theactuator 5010 can move from a pre-actuated position (fig. 85A) to an actuated position (fig. 85B) as thefiring assembly 5030 moves between the unfired position and the partially fired position during a firing stroke. In various embodiments, theactuator 5010 can include a release stop, such as adetent tab 5022, for example. The travel of the firing element relative to theactuator 5010 can be halted by encountering thedetent tab 5022. In other words, thedetent tab 5022 can temporarily stop the travel of thefiring assembly 5030 relative to theactuator 5010. For example, as theactuator 5010 is moved from the pre-actuated position to the actuated position, thedetent tabs 5022 can engage thesled 5034 and/or thefiring assembly 5030 to retain thefiring assembly 5030 relative to theactuator 5010 such that theactuator 5010 and thefiring assembly 5030 move together. For example, referring primarily to fig. 86 and 87, theunderside 5016 of theactuator 5010 can includedetent tabs 5022 and thesled 5034 can include a groove orchannel 5040. In various embodiments, thegroove 5040 can receive thetab 5022 when thesled 5034 is positioned in theproximal portion 5004 of thesecond jaw 5002. For example, thegrooves 5040 can be aligned with thetabs 5022 when thefiring assembly 5030 is moved from an unfired position to a fired position, such that the actuator is correspondingly pushed from a pre-actuated position (fig. 85A) to an actuated position (fig. 85B). In various embodiments, at least onetab 5022 can be positioned on either side of a slot 5012 (fig. 85A-85C) in theactuator 5010, and eachtab 5022 can engage asled 5034.
Referring primarily to fig. 85A, as thefiring assembly 5030 andsled 5034 translate along the slot 5056 (fig. 84) during the firing stroke, thesled 5034 can engage thedetent tab 5022. For example, thedetent tab 5022 can engage thesled 5034 at the beginning of or shortly after the firing stroke. In certain embodiments, thedetent tab 5022 can be located near the proximal end of theactuator 5010, and the sled 4034 can engage thedetent tab 5022 at the beginning of the firing stroke. When thefiring bar 5032 is moved distally and thedetent tab 5022 engages with thegroove 5040 in the sled 5034 (fig. 86 and 87), theactuator 5010 can be driven distally and/or displaced distally. In certain embodiments, referring primarily to fig. 85B, theactuator 5010 can be moved distally, for example, until it reaches ahard stop 5060 defined in thecartridge body 5050. Ahard stop 5060 can be located, for example, at thedistal portion 5006 of thesecond jaw 5002 and can prevent further distal movement of theactuator 5010. In various embodiments, theactuator 5010 can abut thehard stop 5060 before thefiring assembly 5030 ejects fasteners from the fastener cavities 5054 (fig. 84) of thecartridge body 5050. In some embodiments, theactuator 5010 does not abut thehard stop 5060 until thefiring assembly 5030 ejects the at least one fastener from thefastener cavity 5054, and/or until thefiring assembly 5030 has ejected the at least one fastener from thefastener cavity 5054.
Referring primarily to fig. 85D, as theactuator 5010 is pushed distally by thesled 5034 and/or thefiring assembly 5030, theactuator 5010 can cut thedistal connector 5080b or otherwise overcome thedistal connector 5080b to release thetissue thickness compensation 5058 from thecartridge body 5050 at thedistal portion 5006 of thesecond jaw 5002. In certain embodiments, theactuator 5010 can include anotch 5024 for receiving and securing thedistal connector 5080 b. Thenotch 5024 can secure thedistal connector 5080b as theactuator 5010 is displaced distally toward thehard stop 5060. In addition, theactuator 5010 can, for example, include acutting edge 5020 along thenotch 5024. In certain embodiments, theactuator 5010, when moving toward thehard stop 5060, can push thedistal connector 5080b between thehard stop 5060 and thecutting edge 5020 of theactuator 5010. In various embodiments, thecutting edge 5020 can cut thedistal connector 5080b as thecutting edge 5020 is pushed into and/or towards thehard stop 5060. In such embodiments, at the beginning or shortly after the beginning of the firing stroke, and prior to the firing of fasteners from the fastener cavities 5054 (fig. 84), thedistal connector 5080b may be cut by thecutting edge 5020 of theactuator 5010. In some embodiments, thecutting edge 5020 can cut thedistal connector 5080b when thefiring assembly 5030 ejects the at least one fastener from thefastener cavity 5054 and/or after thefiring assembly 5030 has ejected the at least one fastener from thefastener cavity 5054. In various embodiments, theactuator 5010 can overcome thedistal connector 5080b without cutting thedistal connector 5080 b. For example, theactuator 5010 can separate or stretch thedistal connector 5080b such that thedistal connector 5080b no longer secures thetissue thickness compensator 5058 relative to thecartridge body 5050.
In various embodiments, theproximal connector 5080a can be cut by a proximal cutting edge of theactuator 5010. Similarly, additional connectors disposed along the length of thecartridge body 5050 can be cut or otherwise overcome by theactuator 5010 at the beginning or shortly after the beginning of the firing stroke. Additionally or alternatively, thecutting edge 5036 of thefiring assembly 5030 can cut theproximal connector 5080a and/or additional connector, or can otherwise overcome theproximal connector 5080a and/or additional connector. For example, thecutting edge 5036 of thefiring assembly 5030 can cut theproximal connector 5080a and thecutting edge 5020 of theactuator 5010 can cut thedistal connector 5080b prior to the ejection of fasteners from the fastener cavities 5054 (fig. 84) of thecartridge body 5050.
Referring primarily to FIG. 87, thesled 5034 and/or firingassembly 5030 can overcome the interference of thedetent tab 5022 in theactuator 5010. Thefiring assembly 5030 and thesled 5034 can move relative to theactuator 5010 when thesled 5034 and/or thefiring assembly 5030 overcome the interference of thedetent tabs 5022. For example, thefiring assembly 5030 can push thesled 5034 distally to move theactuator 5010 distally until thehard stop 5060 prevents further distal movement of the actuator 5010 (fig. 85A, 85C, and 85D). Still referring to fig. 87, when further distal movement of theactuator 5010 is prevented, thefiring assembly 5030 can push thesled 5034 with sufficient force to deform, deflect, and/or disengage thedetent tabs 5022 from thegrooves 5040 in thesled 5034. For example, eachtab 5022 can comprise a cantilever arm that can flex downward out of engagement with thechannel 5040 upon application of a sufficient longitudinal force to thesled 5034. Thefiring assembly 5030 and thesled 5034 can move relative to theactuator 5010 as thefiring assembly 5030 pushes thesled 5034 out of engagement with thedetent tabs 5022. In various embodiments, thedetent tab 5022 can be sufficiently rigid to break to withstand the force exerted by thefiring assembly 5030 as theactuator 5010 shifts distally toward thehard stop 5060; and when theactuator 5010 reaches thehard stop 5060, thepawl tab 5022 can be flexible enough to deflect without requiring excessive force by the motor and/or the operator. In various circumstances, thedetent tabs 5022 can allow thefiring bar 5032 to pass through thecartridge body 5050 after the force applied to thedetent tabs 5022 has exceeded a predetermined force.
Referring now to fig. 29A and 29B, theend effector assembly 5100 may include a first jaw (as shown elsewhere) and asecond jaw 5102. In various embodiments, thesecond jaw 5102 and/or fastener cartridge assembly positionable therein can include anactuator 5110. Theactuator 5110 can slide or displace, for example, relative to a fastener cartridge body of a fastener cartridge assembly, such as the fastener cartridge body 5050 (fig. 84). Additionally, in certain embodiments, theactuator 5110 can comprise abottom wall 5116 andside walls 5118 which can be positioned at least partially about thecartridge body 5050. When the fixedactuator 5110 is positioned relative to thecartridge body 5050, thebottom wall 5116 and/or theside walls 5118 can extend past or around the fasteners positioned in the fastener cavities 5054 (fig. 84). In various embodiments, theactuator 5110 can include aslot 5112, theslot 5112 extending along at least a portion of thebottom wall 5116. In addition, theside wall 5118 can comprise alip 5122 and/or alip 5124 which can be configured to slidably engage thecartridge body 5050. For example, thelip 5122 can extend around thecartridge body 5050 and into a slit in the deck 5052 (fig. 84) of thecartridge body 5050. In addition, thelips 5124 can extend into the slits, for example, along the sides of thecartridge body 5050. In various embodiments, thelip 5122,5124 can slide within the slot as theactuator 5110 is moved relative to thecartridge body 5050. In such embodiments, the lip can, for example, constrain and/or define relative motion between theactuator 5110 and thecartridge body 5050. As theactuator 5110 moves relative to thecartridge body 5050, theactuator 5110 can slide relative to the fasteners positioned in thefastener cavities 5054 of thecartridge body 5050. For example, theactuator 5110 can slide past or around a fastener in thefastener cavity 5054.
Still referring to fig. 29A and 29B, theactuator 5110 can include a release stop, such as adetent 5114, for example, at theproximal portion 5104 of thesecond jaw 5102. Referring primarily to fig. 29A, thedetent 5114 can comprise adetent arm 5120, thedetent arm 5120 can be configured to operably retain theslider 5134 of the cartridge body 5050 (fig. 84). For example, theslider 5134 can include agroove 5144 and thedetent arm 5120 can engage thegroove 5144 to retain theslider 5134 relative to theactuator 5110. In various embodiments, thedetent 5114 can have a plurality ofdetent arms 5120, thedetent arms 5120 can be retained in thegroove 5144 of theslider 5134. Thedetent arm 5120 can extend, for example, from opposite sides of theactuator 5110, and theslider 5134 can be positioned, for example, intermediate thedetent arm 5120. In certain embodiments, when thedetent arm 5120 is retained in the groove 5144 (fig. 29A) of thesled 5134, thefiring assembly 5030 can push against thesled 5134 and can distally displace theactuator 5110. Thedetent arm 5120 can be sufficiently rigid to retain thesled 5134 relative to theactuator 5110 when theactuator 5110 is pushed distally by thefiring assembly 5030. Theactuator 5110 can then, for example, abut a hard stop, such as hard stop 5060 (fig. 84-85B, and 85D), which can prevent further distal movement of theactuator 5110.
Referring primarily to fig. 29B, when theactuator 5010 abuts the hard stop 5060 (fig. 84-85B, and 85D), thefiring assembly 5030 can push thesled 5134 through thedetent 5114. In other words, thefiring assembly 5030 can cause thesled 5134 to overcome thedetent arm 5120. In such embodiments, thedetent arm 5120 can be flexible enough to flex out of engagement with thegroove 5144 of thesled 5134 and can allow thefiring assembly 5030 to pass between thedetent arms 5120 along theslot 5112 in theactuator 5110. Similar to theactuator 5010, theactuator 5110 can include a blade that can cut or otherwise overcome a distal connector, similar to thedistal connector 5080b (fig. 84 and 85D), for example, when theactuator 5110 is distally displaced by thefiring assembly 5030. Thefiring assembly 5030 and thesled 5134 can then translate, e.g., along theslot 5112, and can eject the fasteners from thefastener cavities 5054 of the cartridge body. In various embodiments, theactuator 5110 can overcome the distal connector and/or additional connector before the fasteners are fired from thefastener cartridge 5050. In certain embodiments, theactuator 5110 can overcome the distal connector and/or additional connectors before the fasteners are fired from thefastener cartridge 5050.
Referring now to fig. 87A and 87B,end effector assembly 5200 may include a first jaw (as shown elsewhere) and asecond jaw 5202. In various embodiments, thesecond jaw 5202 and/or the fastener cartridge assembly can, for example, comprise anactuator 5210, which actuator 5210 can be slid relative to a fastener cartridge body, such as the fastener cartridge body 5050 (fig. 84). Additionally, in certain embodiments, theactuator 5210 can comprise abottom wall 5216 and a side wall. The sidewalls can be positioned, for example, at least partially around thecartridge body 5050. Theactuator 5210 can comprise aslot 5212, theslot 5212 extending along at least a portion of thebottom wall 5216. Additionally, theactuator 5210 can be movably retained relative to thecartridge body 5050. As theactuator 5210 is moved relative to thecartridge body 5050, theactuator 5210 can be moved relative to the fasteners positioned in thefastener cavities 5054 of thecartridge body 5050. For example, theactuator 5210 can be slid past or around a fastener positioned in thefastener cavity 5054.
In various embodiments, thefiring assembly 5030 can translate along theslot 5212 and/or within theslot 5212 during the firing stroke. Similar to theactuators 5010 and 5110, theactuator 5210 can comprise arelease stop 5214. In various embodiments, therelease stop 5214 can comprise afrangible portion 5220, which can be, for example, a bridge across theslot 5212. Referring primarily to fig. 87A, thefiring assembly 5030 can abut therelease stop 5214 to push theactuator 5210 distally. Theactuator 5210 can then abut a hard stop, such as hard stop 5060 (fig. 84-85B, and 85D), which can prevent further distal movement of theactuator 5210. Referring primarily to fig. 87B, when thefiring assembly 5030 reaches thehard stop 5060, thefrangible portion 5220 of therelease stop 5214 can be broken and thefiring assembly 5030 can continue to move distally along theslot 5212 during the firing stroke. Thefrangible portion 5220 can be sufficiently rigid to withstand the force exerted by thefiring assembly 5030 as theactuator 5210 is displaced distally toward the hard stop 5060 (FIG. 85D); and may be sufficiently frangible to break when theactuator 5210 reaches thehard stop 5060 without requiring excessive force by the motor and/or operator. In various embodiments, theactuator 5210 can overcome thedistal connector 5080b and/or additional connectors before the fasteners are fired from thefastener cartridge 5050. In certain embodiments, theactuator 5210 can overcome the distal connector and/or additional connector only after the at least one fastener is fired from the fastener cavity, and/or after the at least one fastener has been fired from the fastener cavity.
Referring now to fig. 88 and 89, theend effector assembly 5300 can include a first jaw (shown elsewhere) and asecond jaw 5302. In various embodiments, thesecond jaw 5302 can comprise acartridge body 5350, and atissue thickness compensator 5358 releasably secured to thecartridge body 5350. Similar to thesecond jaw 5002, thesecond jaw 5302 can comprise fasteners, such as surgical staples, for example, that can be removably positioned in the fastener cavities of thecartridge body 5350. For example, a fastener can be positioned in each fastener cavity in an ejectable manner. In certain embodiments, thecartridge body 5350 can comprise a slot 5356 (fig. 88), whichslot 5356 can extend from theproximal portion 5304 toward thedistal portion 5306 of thesecond jaw 5302. In various embodiments, thefiring assembly 5030 can translate along theslot 5356 of thecartridge body 5350. Thefiring assembly 5030 can translate within the slot of thefastener cartridge 5350, e.g., during a firing stroke, and can eject fasteners from the fastener cavities, e.g., during a firing stroke. Thefiring assembly 5030 can engage the sled 5334 (fig. 89) in thecartridge body 5350, e.g., during a firing stroke, and can push the sled 5334 distally, e.g., during a firing stroke. In addition, thefiring assembly 5030 and/or theactuator 5310 can release thetissue thickness compensator 5358 from thecartridge body 5350 during the firing stroke.
Still referring to fig. 88 and 89, thetissue thickness compensator 5358 can comprise abody 5360, aproximal mount 5362 extending from thebody 5360, and adistal mount 5364 extending from thebody 5360. Referring primarily to fig. 89, for example, thepin 5366 can extend through theproximal mount 5362 into theopening 5356a in thecartridge body 5350 such that thepin 5366 releasably retains thetissue thickness compensator 5358 relative to thecartridge body 5350 at theproximal portion 5304 of thesecond jaw 5302. Thepin 5366 can be friction fit and/or snap fit into theopening 5356a, for example. In certain embodiments, thepin 5366 can be retained in the opening 5456a, for example, using one or more adhesives. In some embodiments, at least a portion of thecartridge body 5350 and/or thepins 5366 can be welded together, for example. In various embodiments, thetissue thickness compensator 5358 can comprise a plurality ofproximal mounts 5362 which can be releasably secured to thecartridge body 5350 on either or both sides of a slot 5356 (fig. 88) in thecartridge body 5350. In certain embodiments, thedistal mount 5364 can be fixed to thecartridge body 5350, e.g., at thedistal portion 5306 of thesecond jaw 5302. Thedistal mounts 5364 can be secured to thecartridge body 5350, for example, via at least one adhesive between thedistal mounts 5364 and thecartridge body 5350. Additionally or alternatively, thedistal mount 5364 can be secured to thecartridge body 5350, e.g., by at least one pin and/or additional fasteners.
Referring primarily to fig. 89,actuator 5310 can be looped ondistal mount 5364 and can extend to slide 5334 insecond jaw 5302. In various embodiments, theactuator 5310 can comprise, for example, a cable or cord configured to extend through thecartridge body 5350 and/or through achannel 5346 defined in thesecond jaw 5302 and/or the slide 5334. In various embodiments, distal movement of the slide 5334 can pull theactuator 5310 to penetrate thedistal mount 5364 of thetissue thickness compensator 5358. For example, theactuator 5310 can have afirst end 5316 fixed to a slide 5334, asecond end 5318 fixed within thecartridge body 5350, and aring 5320 located between the first andsecond ends 5316 and 5318. Thering 5320 can, for example, loop around thedistal mount 5364. In various embodiments, thering 5320 can be wrapped around thedistal mount 5364 between the portion of thedistal mount 5364 that is fixed to thecartridge body 5350 and thebody 5360 of thetissue thickness compensator 5358. In certain embodiments, thesecond end 5318 can be fixedly secured in thecartridge body 5350 such that theloop 5320 is tightened around thedistal mount 5364 as thefirst end 5316 moves. In various embodiments, thesecond jaw 5302 and/or thecartridge body 5350 can comprise a button, a pin, and/or a caster, such as the first button 5312 and thesecond button 5314, for example. Theactuator 5310 may, for example, wrap around a first button 5312 and asecond button 5314. The position ofbutton 5312,5314 and the orientation ofactuator 5310 aboutbutton 5312,5314 allowsring 5320 ofactuator 5310 to tighten arounddistal mount 5364 as sled 5334 and firing assembly 5330 move distally during a firing stroke. Additionally, as thering 5320 is tightened around thedistal mount 5364, thering 5320 can penetrate thedistal mount 5364 to release thebody 5360 of thetissue thickness compensator 5358 from thecartridge body 5350 at thedistal portion 5306 of thesecond jaw 5302. Thus, in view of the above, thedistal mount 5364 can be disengaged from the cartridge body during the beginning of the firing stroke.
In various embodiments, thepins 5366 that secure theproximal mounts 5362 of thetissue thickness compensator 5358 to thecartridge body 5350 can be released from theopenings 5356 of thecartridge body 5350 when thedistal mounts 5364 of thetissue thickness compensator 5358 are released from thecartridge body 5350. For example, at the beginning of the firing stroke or shortly thereafter, thepin 5366 can be released from theopening 5356. Thepin 5366 can be sheared and/or severed by thecutting edge 5036 of thefiring assembly 5030, for example, and/or can be pushed out of and/or driven out of theopening 5356 by a component of thefiring assembly 5030. In such embodiments, after both the proximal anddistal mounts 5362, 5364 are released from thecartridge body 5350, thetissue thickness compensator 5358 can be released from thecartridge body 5350 at the beginning of the firing stroke or shortly thereafter. In other words, theactuator 5310 can release thetissue thickness compensator 5358 from thecartridge body 5350 before thefiring assembly 5030 and/or the sled 5334 eject the fasteners from the fastener cavities in thecartridge body 5350. In some embodiments, thefiring assembly 5030 and/or the sled 5334 can eject at least one fastener from the fastener cavity before and/or while theactuator 5310 releases thetissue thickness compensator 5358 from thecartridge body 5350.
The fastener cartridge assembly can comprise a cartridge body comprising a slot and a plurality of fastener cavities. The fastener cartridge assembly may also include a plurality of fasteners, wherein each fastener is removably positioned in a fastener cavity. The fastener cartridge assembly can further comprise a firing element movable along the slot, a tissue thickness compensator releasably secured to the cartridge body, and a mount, wherein the mount secures the tissue thickness compensator to the cartridge body, and wherein the mount is positioned distal to a fastener of the plurality of fasteners. The fastener cartridge assembly can further comprise a cable positioned between the firing element and the mount, wherein the cable is configured to disconnect the mount when the firing element is moved distally along the slot. The tissue thickness compensator can be released from the cartridge body when the cable breaks the mount. The cable breaks the mount prior to removing the fastener from the fastener cavity. The fastener cartridge assembly may also include a channel, wherein the cable extends through the channel.
Referring now to fig. 93A-93D, anend effector assembly 5600 can include a first jaw (as shown elsewhere) and asecond jaw 5602. In various embodiments, thesecond jaw 5602 can include afastener cartridge body 5650, and atissue thickness compensator 5658 releasably secured to thesecond jaw 5602 and/or thefastener cartridge body 5650. In certain embodiments, thefastener cartridge body 5650, as well as atissue thickness compensator 5658 releasably secured to thefastener cartridge body 5650, can comprise a fastener cartridge assembly. Referring primarily to fig. 93A, thecartridge body 5650 can have acartridge deck 5652, andfastener cavities 5654 defined in thecartridge deck 5652. Additionally, thesecond jaw 5602 can include a fastener (such as a surgical staple), for example, that can be removably positioned in thefastener cavity 5654. For example, a single fastener can be ejectably positioned in eachfastener cavity 5654 of thecartridge body 5650. Still referring primarily to fig. 93A, thecartridge body 5650 can compriseridges 5648 extending from acartridge deck 5652. Theridge 5648 may, for example, extend around at least a portion of thefastener cavity 5654. In various embodiments, when the fastener is positioned in thefastener cavity 5654, the tip of the fastener may protrude from thefastener cavity 5654. In such embodiments, aridge 5648 positioned at least partially around thefastener cavity 5654 can support and/or guide the tip of the fastener as the fastener is ejected from thefastener cavity 5654. In certain embodiments, still referring to fig. 93A, thecartridge body 5650 can comprise aslot 5656 that can extend from theproximal portion 5604 of thesecond jaw 5602 toward thedistal portion 5606 of thesecond jaw 5602. In various embodiments, thefiring assembly 5630 can be translated along theslot 5656 of thecartridge body 5650. For example, thefiring assembly 5630 can translate along theslot 5656 during a firing stroke and can eject fasteners from thefastener cavities 5654 during the firing stroke.
Still referring to fig. 93A-93D, thefiring assembly 5630 can include afiring bar 5632, acutting edge 5636, across bar 5638, andlegs 5644. Thecutting edge 5636 can cut tissue and/or cut thetissue thickness compensator 5658 as thefiring assembly 5630 is fired through thesecond jaw 5602 during a firing stroke. Thecross bar 5638 can engage a slot in the first jaw anvil to retain thefiring assembly 5630 relative to the first jaw; and thelegs 5644 can engage a slot in thesecond jaw 5602, such as aslot 5656 in thecartridge body 5650, for example, to retain the first jaw relative to thecartridge body 5650. In various embodiments, thecross bar 5638 and/or thelegs 5644 can, for example, maintain thecutting edge 5636 of the firing assembly 6530 perpendicular to thedeck 5652 of thefastener cartridge 5650. Referring primarily to fig. 93A and 93D, thefiring assembly 5630 can engage thesled 5634 in thecartridge body 5650 during a firing stroke. Thefiring assembly 5630 can push thesled 5634 distally, e.g., during a firing stroke, to eject fasteners from thefastener cavities 5654. In various embodiments, theslider 5634 can have a cam surface or ramp 5642 that can engage a driver and/or fastener in thefastener cavity 5654, for example. When the ramp 5642 engages the driver, the ramp 5642 may push the driver toward theplatform 5652 to eject the corresponding fastener from thefastener cavity 5654. Additionally, in various embodiments, thefiring assembly 5630 can cut thetissue thickness compensator 5658 during the firing stroke.
Referring primarily to fig. 93A and 93B, thetissue thickness compensator 5658 can comprise a cartridge contact surface 5662 (fig. 93A) and a tissue contact surface 5664 (fig. 93B). Thecartridge contact surface 5662 can be positioned against thecartridge deck 5652, such as when thetissue thickness compensator 5658 is secured to the cartridge body 5650 (fig. 93B). Additionally, thetissue contact surface 5664 can be positioned against tissue, for example, when tissue is grasped between the first andsecond jaws 5602. Referring primarily to fig. 93A, thetissue thickness compensator 5658 can include a mountingmember 5660. In various embodiments, the mountingmember 5660 can be, for example, a rectangular or triangular tab that can extend from thetissue thickness compensator 5658. Additionally, the mountingmember 5660 can be an incised portion of thetissue thickness compensator 5658 that leaves aspace 5666 in thetissue thickness compensator 5658 that corresponds to the shape of the mountingmember 5660. When thetissue thickness compensator 5658 is positioned relative to thecartridge body 5650, themounts 5660 can, for example, be aligned with theslots 5656 of thecartridge body 5650. Additionally, themounts 5660 can extend into theslots 5656 when thecartridge contact surface 5662 of thetissue thickness compensator 5658 is positioned adjacent thedeck 5652 of thecartridge body 5650. In various embodiments, themounts 5660 can be friction fit into theslots 5656 when thetissue thickness compensator 5658 is secured to thecartridge body 5650. The mountingmembers 5660 can retain at least a portion of thetissue thickness compensator 5658 relative to thecartridge body 5650. For example, when themount 5660 is friction fit to theslot 5656, thecartridge contact surface 5662 can be positioned against thedeck 5652 of thecartridge body 5650.
In various embodiments, thetissue thickness compensator 5658 can comprise a plurality ofmounts 5660 that can be aligned with theslots 5656 of thecartridge body 5650. For example, at least onemount 5660 can be positioned in theproximal portion 5604 of thesecond jaw 5602, and at least onemount 5660 can be positioned in thedistal portion 5606 of thesecond jaw 5602. In various embodiments, the mountingmembers 5660 can be spaced along at least a portion of the length of thetissue thickness compensator 5658. For example, theslot 5656 can be a longitudinal slot extending from theproximal portion 5604 of thesecond jaw 5602 to thedistal portion 5606 of thesecond jaw 5602. The mountingmembers 5660 can, for example, be friction fit into thelongitudinal slots 5656 and can secure thetissue thickness compensator 5658 to thecartridge body 5650.
Referring primarily to fig. 93A and 93D, theslider 5634 can include atongue 5640, whichtongue 5640 can project from theslider 5634 toward thedistal portion 5606 of thesecond jaw 5602. As thefiring assembly 5630 pushes thesled 5634 during the firing stroke, thetongues 5640 can move along theslots 5656 in thecartridge body 5650. Referring primarily to fig. 93D, thetongue 5640 can be moved along theslot 5656 adjacent thecartridge contact surface 5664 of thetissue thickness compensator 5658. Additionally, thetongue 5640 is movable against a mountingmember 5660 positioned in theslot 5656. In various embodiments, themount 5660 can be deflectable. When thetongue 5640 pushes against the mountingelement 5660, thetongue 5640 can deflect the mountingelement 5660 into alignment, or at least substantial alignment, with the body of thetissue thickness compensator 5658. For example, as thetongues 5640 move within thecartridge body 5650, themounts 5660 can sequentially deflect intocorresponding spaces 5666 defined in thetissue thickness compensator 5658. As themounts 5660 deflect away from theslots 5656, thetissue thickness compensator 5658 can no longer be secured to thecartridge body 5650 and/or released from thecartridge body 5650. In various embodiments, thesled 5634 and/or another element of thefiring assembly 5630 can deflect themount 5660 away from theslot 5656 such that thetissue thickness compensator 5658 is no longer secured to thecartridge body 5650 and/or released from thecartridge body 5650.
Referring now to fig. 94, similar to theend effector assembly 5600, theend effector assembly 5700 can include a first jaw (as shown elsewhere) and asecond jaw 5702. In various embodiments, thesecond jaw 5702 can comprise afastener cartridge body 5750, and atissue thickness compensator 5758 that is releasably secured to thecartridge body 5750 and/or thesecond jaw 5702. In certain embodiments, thefastener cartridge body 5750 and thetissue thickness compensator 5758, which is releasably secured to thecartridge body 5750, can comprise, for example, a fastener cartridge assembly. Similar to thecartridge body 5650, thecartridge body 5750 can have acartridge deck 5752,fastener cavities 5754 defined in thecartridge deck 5752 for retaining fasteners,ridges 5748 at least partially surrounding thefastener cavities 5754, and/or slots 5756 extending from aproximal portion 5704 of thesecond jaw 5702 toward adistal portion 5706 of thesecond jaw 5702. In various embodiments, thecartridge body 5750 can comprisebridges 5780 that traverse the slots 5756 or extend across the slots 5756. Thebridge 5780 may be, for example, a frangible and/or separable bridge. In certain embodiments,bridge 5780 may be a thin breakable portion, for example, and may be an absorbable material in solid form, such as PGA, PCL, PGA/PCL, PLA/PCL, and/or TMC. Thebridge 5780 can have ahole 5782, and thehole 5782 can extend at least partially through thebridge 5780.
Still referring to fig. 94, in various embodiments, thefiring assembly 5630 can be translatable along the slot 5756 of thecartridge body 5750. For example, thefiring assembly 5630 can translate along the slot 5756 during a firing stroke and can eject fasteners from thefastener cavities 5754 during the firing stroke. Thefiring assembly 5630 can include afiring bar 5632, acutting edge 5636, a cross-bar 5638, and afoot 5644. Thecutting edge 5636 can cut the tissue and/or thetissue thickness compensator 5758 as thefiring assembly 5630 is fired through thesecond jaw 5702 during a firing stroke. Thecrossbar 5638 can engage a slot in the first jaw anvil to retain the first jaw relative to thecartridge body 5750, and thelegs 5644 can engage a slot in the second jaw 5702 (such as the slot 5756 in the cartridge body 5750), for example, to retain thefiring assembly 5630 relative to thesecond jaw 5702. In various embodiments, the cross-bar 5638 and/or thelegs 5644 can, for example, hold thecutting edge 5636 perpendicular to theplatform 5752 of thefastener cartridge 5750.
Still referring to fig. 94, thetissue thickness compensator 5758 can comprise acartridge contacting surface 5762 and a tissue contacting surface. Thecartridge contact surface 5762 can be positioned against thecartridge platform 5752, for example, when thetissue thickness compensator 5758 is secured to thecartridge body 5750 and/or thesecond jaw 5702. Additionally, the tissue contacting surface can be positioned against tissue, for example, when tissue is clamped between the first andsecond jaws 5702. In various embodiments, thetissue thickness compensator 5758 can comprise a mountingmember 5760. The mountingmember 5760 can be, for example, a protrusion, pin, tab, and/or post that can extend from thecartridge contacting surface 5762 of thetissue thickness compensator 5758. Themounts 5760 can be aligned, or at least substantially aligned, with theapertures 5782 of thebridges 5780, such as when thetissue thickness compensator 5758 is positioned relative to thecartridge body 5750. Additionally, themounts 5760 can extend at least partially into theapertures 5782 when thecartridge contact surface 5762 of thetissue thickness compensator 5758 is positioned adjacent thedeck 5752 of thecartridge body 5750. In various embodiments, themounts 5760 can be friction fit into theapertures 5782 when thetissue thickness compensator 5758 is secured to thecartridge body 5750. Themounts 5760 can retain and/or secure thetissue thickness compensator 5758 relative to thecartridge body 5750 and/or thesecond jaw 5702. For example, thecartridge contact surface 5762 can be positioned against thedeck 5752 of thecartridge body 5750 when themounts 5760 are friction fit into theapertures 5782 of thebridges 5780.
In various embodiments, thefastener cartridge 5750 can comprise a plurality ofbridges 5780 that extend across the slots 5756 of thecartridge body 5750. Thebridges 5780 can be spaced apart, for example, along at least a portion of the length of the slots 5756. For example, the slot 5756 can be a longitudinal slot extending from aproximal portion 5704 of thesecond jaw 5702 to adistal portion 5706 of thesecond jaw 5702. Additionally, in various embodiments, thetissue thickness compensator 5758 can comprise a plurality ofmounts 5760 that can be aligned with thebridges 5780 of thecartridge body 5750. For example, when thetissue thickness compensator 5758 is positioned relative to thecartridge body 5750, the at least onemount 5760 can be positioned in theproximal portion 5704 of thesecond jaw 5702 and the at least onemount 5760 can be positioned in thedistal portion 5706 of thesecond jaw 5702. In various embodiments, themounts 5760 can be spaced along at least a portion of the length of thetissue thickness compensator 5758. Themounts 5760 can, for example, be friction fit into the slots 5756 and can secure thetissue thickness compensator 5758 to thecartridge body 5750 and/or thesecond jaw 5702.
Still referring to fig. 94, as thefiring assembly 5630 moves along the slot 5756 during the firing stroke, thecutting edge 5636 of thefiring assembly 5630 can cut thetissue thickness compensator 5758 and/or the tissue clamped between the first andsecond jaws 5702 of theend effector assembly 5700. Additionally, thefiring assembly 5630 can disengage thebridge 5780 as thefiring assembly 5630 moves through the slot 5756. For example, as firingassembly 5630 moves through slot 5756, cuttingedge 5636 of firingassembly 5630 can breakbridge 5780, or cut the bridge. In various embodiments, thecutting edge 5636 can cut eachbridge 5780 in succession as thefiring assembly 5630 moves within the slot 5756 during the firing stroke. Once thebridge 5780 has been cut by thecutting edge 5636 or ruptured by thecutting edge 5636, thetissue thickness compensator 5758 can no longer be secured to thecartridge body 5750 and/or released from thecartridge body 5750. In certain embodiments, thecutting edge 5636 can rupture, or cut, themount 5760 aligned therewith during the firing stroke. In various embodiments, another element of the sled and/or firingassembly 5630 can rupture thebridges 5780 or cut thebridges 5780 to release thetissue thickness compensator 5758 from thecartridge body 5750.
Referring now to fig. 95 and 96, similar to theend effector assembly 5600, theend effector assembly 5800 can include a first jaw (as shown elsewhere) and asecond jaw 5802. In various embodiments, thesecond jaw 5802 can comprise afastener cartridge body 5850, and atissue thickness compensator 5858 releasably secured to thecartridge body 5850 and/or thesecond jaw 5802. In certain embodiments, thefastener cartridge body 5850, as well as atissue thickness compensator 5858 releasably secured to thefastener cartridge body 5850, can comprise a fastener cartridge assembly. Similar to thecartridge body 5650, thecartridge body 5850 can have acartridge deck 5852,fastener cavities 5854 defined in thecartridge deck 5852 that are configured to receive fasteners,ridges 5848 positioned about at least a portion of thefastener cavities 5854, and/orslots 5856 that can extend from aproximal portion 5804 of thesecond jaw 5802 toward adistal portion 5806 of thesecond jaw 5802. In various embodiments, thecartridge body 5850 can comprisebridges 5880 that traverse theslots 5856 or extend at least partially across theslots 5856. Thebridges 5880 may be, for example, frangible and/or separable bridges. In certain embodiments, thebridge 5880 can include afirst leg 5884 and asecond leg 5886. Referring primarily to fig. 96, afirst leg 5884 can extend into theslot 5856, e.g., from a first side of thecartridge body 5850, and asecond leg 5886 can extend into theslot 5856, e.g., from a second side of thecartridge body 5850. Thefirst leg 5884 and thesecond leg 5886 may be oriented at an angle relative to an axis of theslot 5856, and thefirst leg 5884 may be oriented at approximately 90 degrees relative to thesecond leg 5886, for example. In certain embodiments, thefirst leg 5884 and/or thesecond leg 5886 are capable of deflecting. In various embodiments, thebridge 5880 can include a gap between thefirst leg 5884 and thesecond leg 5886, for example.
Still referring to fig. 95 and 96, in various embodiments, thefiring assembly 5630 can translate along theslot 5856 of thecartridge body 5850. For example, thefiring assembly 5630 can translate along theslot 5856 during a firing stroke and can eject fasteners from thefastener cavities 5854 during the firing stroke. Thefiring assembly 5630 can include afiring bar 5632, acutting edge 5636, a cross-bar 5638, and afoot 5644. Thecutting edge 5636 can cut tissue and/or thetissue thickness compensator 5858 as thefiring assembly 5630 is fired through thesecond jaw 5802 during a firing stroke. Thecrossbar 5638 can engage a slot in the first jaw anvil to hold the first jaw relative to thecartridge body 5850, and thelegs 5644 can engage a slot in the second jaw 5802 (such as aslot 5856 in the cartridge body 5850), for example, to hold thefiring assembly 5630 relative to thesecond jaw 5802. In various embodiments, the cross-bar 5638 and/or thelegs 5644 can, for example, hold thecutting edge 5636 perpendicular to theplatform 5852 of thefastener cartridge 5850.
Still referring to fig. 95 and 96, thetissue thickness compensator 5858 can comprise acartridge contacting surface 5862 and a tissue contacting surface. Thecartridge contact surface 5862 can be positioned against thecartridge platform 5852, for example, when thetissue thickness compensator 5858 is secured to thecartridge body 5850 and/or thesecond jaw 5802. Additionally, the tissue contacting surface can be positioned against tissue, for example, when tissue is clamped between the first andsecond jaws 5802. In various embodiments, thetissue thickness compensator 5858 can comprise amount 5860. Similar to themount 5760, themount 5860 can be, for example, a protrusion, pin, tab, and/or post that can extend from thecartridge contacting surface 5862 of thetissue thickness compensator 5858. Themounts 5860 can be aligned with the gaps between thelegs 5884 and 5886 of thebridge 5880, such as when thetissue thickness compensator 5858 is positioned relative to thecartridge body 5850. Additionally, when the cartridge-contactingsurface 5862 of thetissue thickness compensator 5858 is positioned adjacent to thedeck 5852 of thecartridge body 5850, themounts 5860 can be secured by thelegs 5884 and 5886 of thebridge 5880. In various embodiments, themounts 5860 can frictionally fit into the gaps between thelegs 5884 and 5886 when thetissue thickness compensator 5858 is secured to thecartridge body 5850. The engagement of the mounts with the bridges in thesecond jaw 5802 can retain atissue thickness compensator 5858 relative to thecartridge body 5850. For example, once themounts 5860 are frictionally engaged between thelegs 5884 and 5886 of thebridges 5880, thecartridge contact surface 5862 can be secured against thedeck 5852 of thecartridge body 5850.
In various embodiments, referring primarily to fig. 95, afastener cartridge 5850 can comprise a plurality ofbridges 5880 that extend acrossslots 5856 of thecartridge body 5850.Bridges 5880 may be spaced apart, for example, along at least a portion of the length ofslot 5856. For example, theslot 5856 can be a longitudinal slot extending from aproximal portion 5804 of thesecond jaw 5802 to adistal portion 5806 of thesecond jaw 5802. Additionally, in various embodiments, thetissue thickness compensator 5858 can comprise a plurality ofmounts 5860 that can be aligned with thebridges 5880 of thecartridge body 5850. For example, when thetissue thickness compensator 5858 is positioned relative to thecartridge body 5850 and/or thesecond jaw 5802, the at least onemount 5860 can be positioned in aproximal portion 5804 of thesecond jaw 5802, and the at least onemount 5860 can be positioned in adistal portion 5806 of thesecond jaw 5802. In various embodiments, themounts 5860 can be spaced apart along at least a portion of the length of thetissue thickness compensator 5858. Themounts 5860 can, for example, friction fit into thebridges 5880 and can secure thetissue thickness compensator 5858 to thecartridge body 5850.
Still referring to fig. 95 and 96, as thefiring assembly 5630 moves along theslot 5856 during the firing stroke, thecutting edge 5636 of thefiring assembly 5630 can cut thetissue thickness compensator 5858 and/or the tissue clamped between the first andsecond jaws 5802 of theend effector assembly 5800. Additionally, as thefiring assembly 5630 moves through theslot 5856, thebridge 5880 can be disengaged. For example, as firingassembly 5630 moves throughslot 5856, cuttingedge 5636 of firingassembly 5630 can deflectlegs 5884 and 5886 ofbridge 5880 and/or separate the legs of the bridge. In various embodiments, as firingassembly 5630 moves withinslot 5856 during a firing stroke, cuttingedge 5636 can successively deflectlegs 5884 and 5886 of eachbridge 5880 to separate eachbridge 5880. Once thelegs 5884 and 5886 of thebridge 5880 are deflected by thecutting edge 5636, thebridge 5880 can release the correspondingmounts 5860 of thetissue thickness compensator 5858. After eachmount 5860 is released from eachbridge 5880 along the length of thecartridge body 5850, thetissue thickness compensator 5858 can no longer be secured to and/or released from thecartridge body 5850. In certain embodiments, thecutting edge 5636 can cut, or rupture, themount 5860 aligned therewith during the firing stroke. In various embodiments, another element of the sled and/or firingassembly 5630 can separate thebridges 5880 to release thetissue thickness compensator 5858 from thecartridge body 5850.
Referring now to fig. 97-100, similar to theend effector assembly 5600, theend effector assembly 5900 can include a first, anvil 5910 (fig. 99 and 100) and asecond jaw 5902. In various embodiments, thesecond jaw 5902 can comprise afastener cartridge body 5950, and atissue thickness compensator 5958 releasably secured to thefastener cartridge body 5950 and/or thesecond jaw 5902. In certain embodiments, thefastener cartridge body 5950, as well as thetissue thickness compensator 5958 releasably secured to thecartridge body 5950, can comprise, for example, a fastener cartridge assembly. Referring primarily to fig. 98, thefastener cartridge body 5950 can have acartridge deck 5952 and fastener cavities defined in thecartridge deck 5962. The mountingcavity 5948 and/or thefastener cavity 5954 may be defined in thecartridge deck 5952, for example. In various embodiments, the mountingcavity 5948 and thefastener cavity 5954 may have the same or similar structures and/or geometries. Thesecond jaw 5902 may, for example, include a fastener (such as a surgical staple) that is removably positionable in thefastener cavity 5954. In certain embodiments, thecartridge body 5950 can comprise aslot 5956, theslot 5956 can extend from theproximal portion 5904 of thesecond jaw 5902 toward thedistal portion 5906 of thesecond jaw 5902.
Still referring to fig. 97-100, in various embodiments, thefiring assembly 5630 can translate along theslot 5956 of thecartridge body 5950 during a firing stroke and can eject fasteners from thefastener cavities 5954 during the firing stroke. Thecutting edge 5636 can cut tissue and/or thetissue thickness compensator 5958 as thefiring assembly 5630 is fired through theend effector assembly 5900 during a firing stroke. Thecross bar 5638 can engage a slot 5912 (fig. 99 and 100) in theanvil 5910 to maintain the first jaw relative to thecartridge body 5950, and thelegs 5644 can engage a slot in thesecond jaw 5902, such as theslot 5956 in thecartridge body 5950, for example, to maintain thefiring assembly 5630 relative to thesecond jaw 5902. In various embodiments, the cross-bar 5638 and/or thefeet 5644 can, for example, hold thecutting edge 5636 perpendicular to theplatform 5952 of thefastener cartridge 5950.
Still referring to fig. 97-100, thetissue thickness compensator 5958 can include a cartridge contacting surface 5962 (fig. 97) and a tissue contacting surface 5964 (fig. 98 and 99). Thecartridge contact surface 5962 can be positioned against thecartridge deck 5952, such as when thetissue thickness compensator 5958 is secured to thecartridge body 5950 and/or thesecond jaw 5902. Additionally, thetissue contacting surface 5964 may be positioned against tissue, such as when tissue is clamped between theanvil 5910 and thesecond jaw 5902. In various embodiments, thetissue thickness compensator 5958 can include amount 5960. Similar to themounts 5760 and/or mounts 5860, themounts 5960 can be, for example, protrusions, pins, tabs, and/or posts that can extend from thecartridge contacting surface 5962 of thetissue thickness compensator 5958. In certain embodiments, thetissue thickness compensator 5958 can, for example, comprise agroove 5970 that can be adjacent to the mountingmember 5960. Thegroove 5970 may be vertically aligned with themount 5970, for example. Referring primarily to fig. 99, agroove 5970 can be defined in thetissue contacting surface 5964 of thetissue thickness compensator 5958 and can extend toward the mountingmember 5960. In various embodiments, a flap of thetissue thickness compensator 5958 can be positioned between thegroove 5970 and themount 5960, for example.
Themounts 5960 can align with the mountingcavities 5948 in thecartridge deck 5952, such as when thetissue thickness compensator 5958 is positioned relative to thecartridge body 5950. Additionally, themount 5960 can be positioned in the mountingcavity 5948 when thecartridge contact surface 5962 of thetissue thickness compensator 5958 is positioned adjacent thedeck 5952 of thecartridge body 5950. In various embodiments, themounts 5960 can be friction fit into the mountingcavity 5948 when thetissue thickness compensator 5958 is secured to thecartridge body 5950. Themounts 5960 and mountingcavities 5948, which are frictionally engaged together, can retain at least a portion of thetissue thickness compensator 5958 relative to thecartridge body 5950. For example, thecartridge contact surface 5962 can be secured against theplatform 5952 of thecartridge body 5950 when themount 5960 is friction fit into the mountingcavity 5948.
Referring primarily to fig. 97 and 98, thefastener cartridge 5950 can include a plurality of mountingcavities 5948 defined in thecartridge deck 5952. In certain embodiments, corresponding mountingcavities 5948 may be defined in thecartridge platform 5952 on either side of theslot 5956. A first mountingcavity 5948 can, for example, be defined at a first longitudinal side of thecartridge body 5950, and a corresponding second mountingcavity 5948 can, for example, be defined at a second longitudinal side of thecartridge body 5950. For example, a first pair of corresponding mountingcavities 5948 can be positioned in theproximal portion 5904 of thesecond jaw 5902 and/or a second pair of corresponding mountingcavities 5948 can be positioned in thedistal portion 5906 of thesecond jaw 5902. In various embodiments,fastener cavities 5954 may be positioned between respective pairs of mountingcavities 5948, that is, closer to slot 5956; and can be positioned between the pair of mountingcavities 5948 at theproximal portion 5904 of thesecond jaw 5902 and the pair of mountingcavities 5948 at thedistal portion 5906 of thesecond jaw 5902, that is, in an intermediate portion of thecartridge body 5950. Additionally, in various embodiments, thetissue thickness compensator 5958 can comprise a plurality ofmounts 5960 which can be aligned with the mountingcavity 5948 of thecartridge body 5950. For example, at least onemount 5960 may be positioned in theproximal portion 5904 of thesecond jaw 5902; and at least onemount 5960 may be positioned in thedistal portion 5906 of thesecond jaw 5902. In various embodiments, a pair ofmounts 5960 can be positioned in theproximal portion 5904 of thesecond jaw 5902; and a pair ofmounts 5960 may be positioned in thedistal portion 5906 of thesecond jaw 5902. Themount 5960 can, for example, be friction fit into the mountingcavity 5948, and can secure at least a portion of thetissue thickness compensator 5958 to thecartridge body 5950.
Referring primarily to fig. 99 and 100, themount 5960 may be removed from the mountingcavity 5948 during the firing stroke. In various embodiments, adriver 5920 movably positioned in the mountingcavity 5948 can eject themount 5960 from the mountingcavity 5948 during a firing stroke. For example, adriver 5920 may be positioned in each mountingcavity 5948. During the firing stroke, elements of thefiring assembly 5630 and/or sled in thesecond jaw 5902 can be engaged with thedriver 5920, for example, to move thedriver 5920 toward thecartridge deck 5952 and/or toward thetissue thickness compensator 5958. Thedriver 5920, when moved, can, for example, urge themount 5960 positioned in the mountingcavity 5948 toward theplatform 5952 and/or thetissue thickness compensator 5958. In various embodiments, agroove 5970 defined in thetissue thickness compensator 5958 corresponding to the pushed outmount 5960 can receive the pushed outmount 5960. For example, thedriver 5920 can push themount 5960 into thegroove 5970. The mountingmember 5960 may, for example, be squeezed into thegroove 5970, deformed into the groove, and/or compressed into thegroove 5970. Once themounts 5960 are removed from the mountingcavity 5960 and pushed into thecorresponding grooves 5970 during the firing stroke, thetissue thickness compensator 5958 can no longer be secured to thecartridge body 5950 and/or released from thecartridge body 5950.
In various embodiments, referring now to fig. 62-66, thestaple cartridge 13000 can comprise acartridge body 1310, atissue thickness compensator 13020, and a plurality of cockable connectors configured to releasably retain thetissue thickness compensator 13020 to thecartridge body 13010, as described in further detail below. Thecartridge body 13010 can comprise aproximal end 13011, adistal end 13012, and adeck 13015, thedeck 13015 being configured to support atissue thickness compensator 13020 thereon. Thecartridge body 13010 can comprise one or moreproximal stops 13013 extending therefrom which can be configured to block, or prevent, thetissue thickness compensator 13020 from moving proximally. Similarly, thecartridge body 13010 can comprise one or moredistal stops 13014, which can be configured to block, or prevent, thetissue thickness compensator 13020 from moving distally. Referring primarily to fig. 63, thecartridge body 13010 can further comprise a plurality ofstaple cavities 13016 defined therein. In various embodiments, thestaple cartridge 13000 can comprise a plurality ofconnectors 13030 and 13040 that are configured to releasably retain thetissue thickness compensator 13020 to thecartridge body 13010. For example, eachconnector 13030 can comprise a plurality of lumen plugs 13031 positionable in thestaple cavities 13016, and a connectingrod 13032 extending between the lumen plugs 13031 and over thetissue thickness compensator 13020. In at least one embodiment, the cavity plugs 13031 can fit snugly within thestaple cavities 13016. In certain embodiments, thelumen plug 13031 can be press-fit and/or snap-fit into thestaple lumen 13016. For example, eachconnector 13040 can comprise alumen plug 13031 and ahead 13042 extending therefrom, wherein thehead 13042 can extend at least partially over thetissue thickness compensator 13020. Referring again to fig. 63, thetissue thickness compensator 13020 can comprise, for example: a set ofproximal recesses 13023 defined in theproximal end 13021 of thetissue thickness compensator 13020, the proximal recesses configured to receive lumen plugs 13031 extending from theproximal connector 13030;intermediate recesses 13024, eachintermediate recess 13024 being configured to receive alumen plug 13031 extending from anintermediate connector 13040; and a set ofdistal notches 13025 defined in thedistal end 13022 of thetissue thickness compensator 13020 that are configured to receive lumen plugs 13031 extending from thedistal connector 13030.
In use, a sled or firing member can be advanced distally through thestaple cartridge 13000 to eject the staples positioned within thestaple cavities 13016. In various embodiments, thestaple cavities 13016 in which the staples are positioned can be unplugged from the cavity plugs 13031. In some embodiments, the staple cavities in which the cavity plugs 13031 are positioned may not have staples positioned therein. Although not shown, in some embodiments, the staple cavities can include fasteners and cavity plugs 13031 positioned therein. Referring again to fig. 65 and 66, thestaple cartridge 13000 can, for example, further comprise a plurality ofstaple drivers 13050,such staple drivers 13050 supporting the staples in their unfired positions. For example, as the firing member is advanced distally through the staple cartridge, thestaple drivers 13050 and staples can be lifted upwardly (i.e., toward thedeck 13015 of thecartridge body 13010 and toward an anvil positioned opposite the tissue thickness compensator 13020). Similarly, at least some of thestaple drivers 13050 can contact the cavity plugs 13031 positioned in some of thestaple cavities 13016 and lift those cavity plugs 13031 upwardly toward the anvil. As the staples are lifted upwardly by thestaple drivers 13050, the staple legs of the staples can pass through thetissue thickness compensator 13020, through the tissue positioned between thetissue thickness compensator 13020 and the anvil, and contact the anvil positioned on the opposite side of the tissue. Thestaple drivers 13050 can then drive the staples against the anvil, thereby deforming the staples to capture thetissue thickness compensator 13020 and tissue therein. When thecavity stopper 13031 is lifted upward by thestaple drivers 13050, the anvil can prevent thecavity stopper 13031 from moving upward. In such cases, referring primarily to fig. 63, thelumen plug 13031 may deform, deflect, and/or break. In certain embodiments, thecavity plug 13031 can, for example, comprise one or more notches that can cause thecavity plug 13031 to deform, deflect, and/or break at a particular location therein. In various circumstances, theentire cavity plug 13031, or at least substantially theentire cavity plug 13031, can be ejected from thestaple cavities 13016 upon actuation of thestaple drivers 13050. At this point, theconnectors 13030 and/or 13040 can no longer connect thetissue thickness compensator 13020 to thecartridge body 13010, and as a result, thecartridge body 13010 can be moved away from thetissue thickness compensator 13020 that has been implanted against the tissue.
In use, in addition to the above, the firing member can be advanced from theproximal end 13011 of thestaple cartridge 13000 toward thedistal end 13012 of thestaple cartridge 13000. Thecartridge body 13010 can comprise alongitudinal slot 13019, thelongitudinal slot 13019 being configured to slidably receive at least a portion of a firing member therein. The firing member, when advanced distally, can eject some of thestaples 13016 positioned proximally and subsequently fire theproximal-most connector 13030. Firing of theproximal-most connector 13030 can release theproximal end 13021 of thetissue thickness compensator 13020 from thecartridge body 13010. In other embodiments, the firing member may fire the proximal-most connector prior to firing any staples. In any event, the firing member can be advanced further distally to eject the staples from thestaple cavities 13016 and then re-fire theintermediate connector 13040. At this point, only thedistal-most connector 13030 that holds thetissue thickness compensator 13020 to thecartridge body 13010 can remain. Once the firing member has fired thedistal-most connector 13030, thetissue thickness compensator 13020 can no longer be attached to thecartridge body 13010. The firing sequence described above describes the full or complete firing of the staple cartridge. Other situations may also occur in which the staples contained in the staple cartridge are not fully fired. In such instances, some of the connectors that hold thetissue thickness compensator 13020 to thecartridge body 13010 can be unfired. Upon completion of the partial use of thestaple cartridge 13000, the anvil can be opened and thecartridge body 13010 pulled away from the partially implantedtissue thickness compensator 13020. In such instances, the unfired connectors are configured to slide out of thestaple cavities 13016 even if they have not been fired at all times. In any event, for example, theconnectors 13030 and 13040 can be constructed of any suitable biocompatible and/or bioabsorbable material.
In addition to the above, the firing member can, for example, comprise a cutting portion (such as a knife) that can be configured to transect thetissue thickness compensator 13020 with tissue as the firing member is advanced distally through thestaple cartridge 13000. In such a case, the cutting portion is also configured to transect the connectingrod 13032 of theconnector 13030.
In various embodiments, referring now to fig. 101 and 102, astaple cartridge 10800 including asupport portion 10810 and atissue thickness compensator 10820 can be loaded into a staple cartridge channel, e.g., using astaple cartridge applicator 10880. Similar to the above, thestaple cartridge applicator 10880 can also be configured to position the uppertissue thickness compensator 10890 relative to an anvil (such as the anvil 10060), for example, such that theanvil 10060 can contact and engage thetissue thickness compensator 10890 when theanvil 10060 is closed. In at least one embodiment, thetissue thickness compensator 10890 can comprise a plurality ofretention legs 10895 extending from thetop surface 10891 of thetissue thickness compensator 10890 configured to engage theanvil 10060 and releasably retain thetissue thickness compensator 10890 thereto. In at least one such embodiment, thelegs 10895 can be arranged in a longitudinal row, wherein eachleg 10895 can include at least one foot configured to enter and engage theknife slot 10065 defined in theanvil 10060. In some embodiments, some of thelegs 10895 may extend in one direction, while other legs may extend in another direction. In at least one embodiment, some of the feet may extend in opposite directions.
In any event, once theanvil 10060 has been engaged with thetissue thickness compensator 10890, referring now to fig. 102 and 103, theanvil 10060 can be reopened and the clinician can then move thecartridge applicator 10880 away from thetissue thickness compensators 10820 and 10890. Then, referring to fig. 104, an uppertissue thickness compensator 10890 can be positioned on a first side of the target tissue, and a tissue thickness compensator 10820 (which can include a lower tissue thickness compensator) can be positioned on a second side of the tissue. After thetissue thickness compensators 10820 and 10890 have been properly positioned, referring now to fig. 105, for example, a knife edge (such as knife edge 10053) of a firing member can be advanced through the target tissue and tissue thickness compensator described above.
In various embodiments, referring now to fig. 106, a staple cartridge applicator, such asapplicator 12280, for example, can comprise atissue thickness compensator 12290 detachably mounted thereto, which can be inserted into the staple cartridge channel similar to that described above (as shown in fig. 106A) and engaged with theanvil 10060 when theanvil 10060 is moved to the closed position. Theapplicator 12280 can include ahandle 10084 for positioning thetissue thickness compensator 12290 relative to the staple cartridge. In addition, theapplicator 10084 can comprise a plurality oflegs 10081 that can secure thetissue thickness compensator 12290 to the staple cartridge. In at least one such embodiment, thetissue thickness compensator 12290 can comprise a plurality ofretention members 12295 extending upwardly from atop surface 12291 thereof. Wherein eachretention member 12295 can comprise a plurality offlexible legs 12296 configured to be insertable into theknife slots 10065 in theanvil 10060. Referring primarily to fig. 107 and 108, theflexible legs 12296 of eachretention member 12295 can be separated by agap 12298 such that theflexible legs 12296 can flex inwardly when inserted into theknife slot 10065, and thelegs 12296 can then spring back outwardly once the enlarged foot of thelegs 12296 has passed through theknife slot 10065. In various embodiments, the enlarged feet of theflexible legs 12296 can flex behind opposingretention lips 12297 defined in theanvil 10060, and thetissue thickness compensator 12290 can be retained to theanvil 10060 due to the interaction of thelegs 12296 andlips 12297. Thestaple cartridge applicator 12280 can then be moved away from thetissue thickness compensator 12290, as shown in 106B. In use, once thetissue thickness compensator 12290 has been implanted against tissue, such as by staples deployed from thestaple cartridge 10000, theanvil 10060 can be reopened and thelegs 12296 of theretention members 12995 can flex inwardly as theanvil 10060 is moved away from the implantedtissue thickness compensator 12290 such that the legs can be pulled out of theknife slot 10065.
As outlined above, the end effector assembly may comprise a staple cartridge, an anvil, and at least one piece of buttress material positioned intermediate the staple cartridge and the anvil. In at least one embodiment, referring now to fig. 109-111, a piece of buttress material, such as buttressmaterial 336, is configured to be snap-fit onto at least one ofstaple cartridge 322 and/or an anvil (not shown) to releasably retain the piece of buttress material within the end-effector. Referring to fig. 110 and 111,staple cartridge 322 can comprisefirst sidewall 302 andsecond sidewall 304, wherein at least one offirst sidewall 302 andsecond sidewall 304 can compriselip 306 extending outwardly therefrom. In various embodiments, the buttressmaterial 336 can include a first edge orside 308, a second edge orside 310, and at least onelip 312 extending at least partially along the length of the first andsecond edges 308, 310. In at least one embodiment, referring to FIG. 111,lip 312 is configured to engagelip 306 in a snap-fit manner to releasably retain buttressmaterial 336 tostaple cartridge 322.
In addition to the above, referring to FIG. 111, buttressmaterial 336 can include asurface 316, thesurface 316 being configured to be positioned adjacent to thedeck 328 ofstaple cartridge 322 or against thedeck 328 ofstaple cartridge 322. In at least one embodiment, the side edges 308 and 310 can include sidewalls that can extend in a direction perpendicular or transverse to the opposingsurface 316. In such embodiments,lip 312 may extend from these sidewalls such thatlip 312 may interlock withlip 306 behindlip 306 ofstaple cartridge 322. In various embodiments,lip 312 of buttressmaterial 336 can disengage fromlip 306 ofstaple cartridge 322 when staples are deployed fromstaple cartridge 322. More specifically, as the staples are deployed, the staples may come into contact with buttressmaterial 336, apply an upward force to buttressmaterial 336, and separate buttress material 336 fromstaple cartridge 322. Thus, advantageously, buttressmaterial 336 can be automatically detached fromstaple cartridge 322 when the staples are deployed fromstaple cartridge 322 and/or when the end effector is opened, as described above.
In various embodiments, referring to fig. 110 and 111, a piece of buttress material can include at least one member extending therefrom that can be configured to releasably retain the buttress material to one of the staple cartridge and/or the anvil. In at least one embodiment,member 318 can extend fromsupport material 336 in a direction perpendicular or transverse to surface 316. In various embodiments, themember 318 can engage one of thestaple cavities 320 and/or anvil pockets in a friction or press fit manner to releasably retain the piece of buttress material to one of the staple cartridge and the anvil. Similar to the above, in various embodiments, staples deployed fromstaple cavities 320 can apply an upward force to buttressmaterial 336 andseparate member 318 fromstaple cavities 320. In various embodiments, staples can piercemember 318 and/or buttressmaterial 336 to secure the buttress material to tissue, as outlined above.
As shown in fig. 110, a piece of buttress material can include more than one member (i.e., tab) extending therefrom for retaining the piece of buttress material to one of the staple cartridge and the anvil. In various embodiments, referring now to fig. 112 and 113, more than one member 318 'may extend from the sheet of buttress material 336', for example. In at least one embodiment, the member 318 'can be press-fit into the staple cavities 320' of the staple cartridge 322 'and/or the anvil pockets of the anvil (not shown) such that the member 318' frictionally retains the piece of buttress material into the staple cartridge and/or the anvil, as outlined above. As described in greater detail herein, in addition to the staple cavities of the staple cartridge and the anvil pockets of the anvil for receiving projections (or retention members) extending from a piece of buttress material, the staple cartridge and/or anvil can include slots or apertures therein.
In certain embodiments, as described in greater detail below, the support portion can include retention features configured to gradually release the tissue thickness compensator from the support portion as the staples are progressively fired from the staple cartridge. Referring now to fig. 114, a staple cartridge, such as staple cartridge 11200, for example, can comprise asupport portion 11210, thesupport portion 11210 comprising aretention feature 11213 that can be configured to releasably retain a tissue thickness compensator 11220 (fig. 115) thereto. In various embodiments, aretention feature 11213 can be positioned, for example, at a distal end of eachstaple cavity 11212, wherein eachretention feature 11213 can comprise aguide channel 11216 defined therein that is configured to slidably receive thestaple legs 10032 of astaple 10030. In such embodiments, both thestaple legs 10032 and the retention features 11213 can be configured to releasably retain thetissue thickness compensator 11220 to thesupport portion 11210.
In use, referring now to fig. 115, thestaple drivers 10040 contained within thesupport portion 11210 can be driven upwardly by thesled 10050 as described above. Wherein thestaple drivers 10040 can be configured to contact the retention features 11213, at least partially detach the retention features 11213 from thesupport portion 11210, and displace the retention features 11213 outwardly and away from thestaples 10030 andstaple cavities 11212. Upon separation and/or outward displacement of theretention feature 11213 from thesupport portion 11210, theretention feature 11213 may no longer be able to retain thetissue thickness compensator 11220 to thesupport portion 11210, and thus, thetissue thickness compensator 11220 may be released from thesupport portion 11210. Similar to the above, thetissue thickness compensator 11220 can be gradually released from thesupport portion 11210 as thestaples 10030 are gradually ejected from the staple cartridge toward an anvil (such as the anvil 11260), for example. In various embodiments, thestaple drivers 10040 can be in contact with the retention features 11213, such as when the top surface of thestaple drivers 10040 is coplanar, or at least substantially coplanar, with thedeck surface 11211 of thesupport portion 11210. In such embodiments, thetissue thickness compensator 11220 can be released from thesupport portion 11210 while and/or before thestaples 10030 are being formed into their fully formed or fully fired configuration.
In at least one such embodiment, referring primarily to fig. 116, thedrivers 10040 can be overdriven such that they are pushed over thedeck surface 11211 to fully form thestaples 10030, and thedrivers 10040, during the overdriven, can cause the retention features 11213 to break away from thesupport portion 11210. In various embodiments, referring again to fig. 115, the retention features 11213 can extend over or overhang the staple cavities before separating or displacing outward from thestaple cavities 11212 such that thedrivers 10040 can come into contact with the retention features 11213 just as they reach thedeck surface 11211. In any event, once thetissue thickness compensator 11220 has been released from thesupport portion 11210, referring now to fig. 116, thesupport portion 11210 can be moved away from the implantedtissue thickness compensator 11220.
Referring now to fig. 117, afastener cartridge assembly 6002 for use with an end effector assembly can comprise acartridge body 6050, and atissue thickness compensator 6058 releasably secured to thecartridge body 6050. Similar to thecartridge body 5650, for example, thecartridge body 6050 can comprise aslot 6056 configured to guide advancement of the firing assembly and/orfastener cavities 6054 configured to removably retain fasteners in thecartridge body 6050. In various embodiments, thecartridge body 6050 can compriseprojections 6048, such as posts, mounts, tabs, and/or ridges, for example. When thetissue thickness compensator 6058 is positioned relative to the cartridge deck, theprojections 6048 can extend from the cartridge deck of thecartridge body 6050 and into thetissue thickness compensator 6058. In various embodiments, thecartridge body 6050 can comprise a plurality ofprojections 6048 extending from the cartridge deck. Theprojections 6048 can be positioned along the length of thecartridge body 6050, for example, and can be positioned betweenadjacent fastener cavities 6054, for example.
Still referring to fig. 117, in various embodiments, thetissue thickness compensator 6058 can be thermoformed around theprojections 6048 of thetissue thickness compensator 6058. For example, thetissue thickness compensator 6058 can be positioned relative to the cartridge deck of thecartridge body 6050. Once positioned, thetissue thickness compensator 6058 can be heated to a sufficiently high temperature to cause thetissue thickness compensator 6058 to deform to conform to the shape of the cartridge platform including the shape of theprojections 6048 extending therefrom. Thetissue thickness compensator 6058 can be, for example, locally heated, and can be, for example, heated to approximately and/or near the glass transition temperature of the material comprising thetissue thickness compensator 6058. The tissue thickness compensator can be heated, for example, to about 90 ℃ to about 120 ℃. In certain embodiments, the tissue thickness compensator can be heated, for example, to about 75 ℃ to about 150 ℃. Once thetissue thickness compensator 6058 has deformed and conformed around theprotrusion 6048, the heat source can be removed or relieved from providing heat, and thetissue thickness compensator 6058 can cool. Thetissue thickness compensator 6058 can be subjected to the elevated temperature for about 2 seconds to about 5 seconds, for example, to sufficiently deform it around theprojections 6048. In other cases, thetissue thickness compensator 6058 can be subjected to an elevated temperature, for example, for about 1 second to about 10 seconds, to sufficiently deform it around theprojections 6048. Thetissue thickness compensator 6058, upon cooling, can, for example, contract closer to theprojections 6048 and/or more tightly around theprojections 6048. In various embodiments, the thermoformedtissue thickness compensator 6058 can prevent and/or limit lateral displacement and/or buckling of thetissue thickness compensator 6058 along the length of thecartridge body 6050 and between thefastener cavities 6054.
Additionally or alternatively, thetissue thickness compensator 6058 can be thermoformed around at least a portion of a fastener removably positioned in thefastener cavity 6054. For example, thetissue thickness compensator 6058 can be thermoformed around the legs of the staples that extend above the cartridge deck. Still referring to fig. 117, in various embodiments, thefastener cartridge assembly 6002 can comprise a cover orhousing 6060 that surrounds at least a portion of thecartridge body 6050. Thehousing 6060 can extend, for example, around the bottom, sides, and/or deck of thecartridge body 6050. Thehousing 6060 can be secured to thecartridge body 6050, for example, by pins 6062. Additionally, in various embodiments, thehousing 6060 may comprise a metallic material, such as stainless steel 300 series, stainless steel 400 series, titanium, and/or medical grade aluminum, for example. Themetal housing 6060 can, for example, facilitate heat transfer in thecartridge body 6050 and/or theprojections 6048 to improve the thermoforming effect.
Referring now to fig. 118, afastener cartridge assembly 6102 for use with the end effector assembly can comprise acartridge body 6150, and atissue thickness compensator 6158 releasably secured to thecartridge body 6050. Similar to thecartridge body 5650, thecartridge body 6150 can comprise aslot 6156, e.g., configured to guide advancement of the firing assembly, andfastener cavities 6154, e.g., configured to removably retain fasteners in thecartridge body 6150. Thecartridge body 6150 can also include ridges 6146 (similar to the ridges 5648) extending from thecartridge deck 6152. Theridge 6146 can, for example, extend around at least a portion of thefastener cavity 6154. In various embodiments, the tip of the fastener can protrude from thefastener cavity 6148 when the fastener is positioned in thefastener cavity 6154. In such embodiments, theridge 6146 positioned at least partially around thefastener cavity 6154 can support and/or guide the tip of the fastener as it is ejected from thefastener cavity 6154. In various embodiments, thecartridge body 6150 can comprise a plurality ofridges 6146 at least partially encircling thefastener cavities 6154. For example, theridge 6146 can extend at least around the proximal end and/or the distal end of eachfastener lumen 6154.
Still referring to fig. 118, in various embodiments, thefastener cartridge assembly 6102 can comprise a cover orhousing 6160 positioned around at least a portion of thecartridge body 6150 and similar tohousing 6060, for example. Thehousing 6160 can extend, for example, around the bottom and/or sides of thecartridge body 6150 and can be secured to thecartridge body 6150, for example, by pins 6162. In various embodiments, thehousing 6160 can include aprojection 6148, such as a post, mount, tab, and/or ridge, for example. Theprojections 6148 can extend beyond thecartridge deck 6152 of thecartridge body 6150. In various embodiments, theprojections 6148 can extend into thetissue thickness compensator 6158 when thetissue thickness compensator 6158 is positioned relative to the cartridge deck. In various embodiments, thehousing 6160 can include a plurality ofprojections 6148 extending therefrom. Theprojections 6148 can be positioned, for example, along the length of thehousing 6160 and can be positioned, for example, around the perimeter of thecartridge body 6150.
Similar to thetissue thickness compensator 6058, thetissue thickness compensator 6158 can be thermoformed around theprojections 6148 of thehousing 6160. In various embodiments, thetissue thickness compensator 6158 can be wider than thehousing 6160 such that a portion of thetissue thickness compensator 6158 extends beyond the perimeter of thecartridge body 6150. In such embodiments, thetissue thickness compensator 6158 can be, for example, thermoformed toprotrusions 6148 around the perimeter of thecartridge body 6150. Additionally or alternatively, thetissue thickness compensator 6158 can be thermoformed, for example, to theridge 6146 and/or staple legs extending from thefastener lumen 6154. In various embodiments, thehousing 6160 may, for example, comprise a metallic material, such as stainless steel 300 series, stainless steel 400 series, titanium, and/or medical grade aluminum, to facilitate heat transfer and improve thermoforming.
Referring now to fig. 119 and 120, theend effector assembly 6200 can comprise a first oranvil 6210 and asecond jaw 6202. Thesecond jaw 6202 can comprise acartridge body 6250, and atissue thickness compensator 6258 releasably secured to thecartridge body 6250. Similar to thecartridge body 5650, thecartridge body 6250 can, for example, comprisefastener cavities 6254 and fasteners (such as surgical staples) that can be removably positioned in thefastener cavities 6254. In various embodiments, asurgical staple 6290 can be positioned on thedriver 6220 in thefastener cavity 6254. Referring primarily to fig. 119, a portion of thestaples 6290 can be positioned in thefastener cavities 6254 when thedriver 6220 is in the pre-fired position. In various embodiments,staple 6290 can comprise abase 6292, andlegs 6294a and 6294b extending frombase 6292. Thefirst leg 6294a may, for example, extend from a first end of thebase 6292 and thesecond leg 6294b may, for example, extend from a second end of thebase 6292. In various embodiments, when thedriver 6220 is in a pre-fired position and thestaples 6290 are in a preformed configuration, thebase portions 6292 of thestaples 6290 can be positioned in thefastener cavities 6254 and thelegs 6294a and 6294b of thestaples 6290 can extend from thefastener cavities 6254 into thetissue thickness compensator 6258.
In various embodiments, referring still to fig. 119 and 120, eachstaple leg 6294a,6294b can comprise a barb betweenbase 6292 andtip 6299a of eachstaple leg 6294a,6294 b. The barbs may be, for example, sharp and/or pointed projections, such as spikes. In various embodiments, the wire diameter of the staple may be, for example, about 0.0069 inches, about 0.0079 inches, and/or about 0.0089 inches. The wire diameter of the barbs may be, for example, about 0.001 inches. In some cases, the barbs may be, for example, between about 0.0005 inches and about 0.003 inches. In certain embodiments, firstlower barb 6296a may be positioned onfirst leg 6294a and secondlower barb 6296b may be positioned onsecond leg 6294 b.Lower barbs 6296a,6296b may be positioned betweenbase 6292 andtips 6299a,6299b oflegs 6294a,6294 b. In addition, firstupper barb 6298a may be positioned onfirst leg 6294a and secondupper barb 6298b may be positioned onsecond leg 6294 b.Upper barbs 6298a,6298b may be positioned onrespective legs 6294a,6294b betweenlower barbs 6296a,6296b andtips 6299a,6299 b. At least onebarb 6296a,6296b,6298a,6298b of a staple 6290 can be positioned in atissue thickness compensator 6258 when thedriver 6220 is in the pre-fired position and thestaples 6290 are in the pre-formed configuration. In such embodiments, thebarbs 6296a,6296b,6298a,6298b can, for example, grasp and/or hold thetissue thickness compensator 6258 relative to thecartridge body 6250.Barbs 6296a,6296b,6298a,6298b embedded intissue thickness compensator 6258 can, for example, prevent and/or limit lateral movement of thetissue thickness compensator 6258 relative to the cartridge deck, and/or can, for example, prevent lifting of thetissue thickness compensator 6258 away from the cartridge deck. Additionally or alternatively, in various embodiments, barbs may be positioned attips 6299a,6299b oflegs 6294a, 6294b.
Referring primarily to fig. 120, as thedriver 6220 moves to the fired position, thestaples 6290 can be removed and/or ejected from thefastener cavities 6254. Additionally, thetissue thickness compensator 6258 and the tissue T can be clamped between theanvil 6210 and thecartridge body 6250 of theend effector assembly 6200. Thestaple forming pockets 6214 in theanvil 6210 can, for example, form thestaples 6290 into a B-shape. Additionally, at least onebarb 6296a,6296b,6298a,6298b of staple 6290 can, for example, engage tissue grasped instaple 6290.Barbs 6296a,6296b,6298a,6298b can grasp and/or hold tissue T captured withinstaples 6290.
Referring now to fig. 121-124, afastener 6390 may be releasably retained in afastener cavity 6350 by a lock driver 6320 (fig. 123 and 124) used with an end effector assembly. In various embodiments,fastener 6390 may include abase 6392, andlegs 6394a and 6294b extending frombase 6392. Thefirst leg 6394a may extend from a first end of thebase 6392, for example, and thesecond leg 6394b may extend from a second end of thebase 6392, for example. In certain embodiments, thelock driver 6320 may be configured to releasably retain thebase 6392 of thefastener 6390. In various embodiments, thelock driver 6320 may include alatch 6340, where thelatch 6340 may be configured to releasably hook and/or retain thebase 6392. Thelatch 6340 may be flexible, for example, and may flex, for example, to release thebase 6392 of thefastener 6390. In various embodiments, thelock driver 6320 and/or thelock 6340 may be constructed of a plastic, such as polyetherimide, with or without a glass filler, for example, such that thelock 6340 is sufficiently elastically and/or plastically deformable.
Referring primarily to fig. 123 and 124, thelock drivers 6320 are movably positioned infastener cavities 6354 defined in thecartridge deck 6352 of thecartridge body 6350. Thelock driver 6320 is movable in the fastener cavity from a locked position (fig. 123) to an unlocked position (fig. 124). A sled and/or driver in thecartridge body 6350 can engage thelock driver 6320 during the firing stroke to move thelock driver 6320 from the locked position to the unlocked position. In various embodiments, thefastener 6390 may be secured to thelock driver 6320 when thelock driver 6320 is in the locked position and may be released from thelock driver 6320 when thelock driver 6320 is moved to the unlocked position. When thelock driver 6320 is moved from the locked position to the unlocked position, thefastener 6390 may be ejected from thefastener cavity 6354. A key 6353 adjacent to thefastener cavity 6354 may, for example, allow thefastener 6390 to be released from thelock driver 6320. The key 6353 may be, for example, a lip extending inward from at least a portion of the edge of thefastener cavity 6354. In various embodiments, thekeys 6353 may have cam surfaces 6355. After thelock driver 6320 is moved from the locked position to the unlocked position, thelip 6344 of thelatch 6340 may abut thecam surface 6355 of the key 6353. In such embodiments, when thecatch 6340 moves against thecam surface 6355, thecam surface 6355 may flex thecatch 6340, causing thehook 6342 to release thebase 6392 of thefastener 6390. In various embodiments, thehook 6342 may be rotated upward to release thebase 6392. For example, thehook 6342 may be rotated upward such that its opening is directed upward toward thetissue thickness compensator 6358, and such that thebase 6392 may be moved upward through this opening and ultimately away from thelock driver 6320.
Still referring to fig. 123 and 124, thetissue thickness compensator 6358 can be releasably secured to thecartridge deck 6352 of thecartridge body 6350. When thelock driver 6320 is in the locked position (fig. 123), thestaple legs 6394a and 6394b may extend from thefastener cavity 6354 into thetissue thickness compensator 6358. Thestaple legs 6394a and 6394b can retain thetissue thickness compensator 6358 relative to thecartridge platform 6352, for example, and can prevent and/or limit lateral movement of thetissue thickness compensator 6358 relative to thecartridge platform 6352, for example. Additionally, when thelock drivers 6320 are moved to the unlocked position and thefasteners 6390 are ejected from the fastener cavities 6354 (fig. 124), thelatches 6340 can release thebases 6392 of thefasteners 6390 such that thefasteners 6390 can be disengaged from thelock drivers 6320 and thecartridge body 6350. When thefasteners 6390 removably positioned in thefastener cavities 6354 are ejected from theirrespective fastener cavities 6354 and out of engagement with thecartridge body 6350, the tissue thickness compensator 6858 can no longer be secured to thecartridge body 6350 and/or released from thecartridge body 6350.
Referring now to fig. 125-129, theend effector assembly 6400 may include a first jaw and/or anvil 6410 (fig. 127-129), and asecond jaw 6402. Thesecond jaw 6402 can comprise afastener cartridge body 6450, and atissue thickness compensator 6458 releasably secured to thesecond jaw 6402 and/or thetissue thickness compensator 6458. In certain embodiments, thefastener cartridge body 6450 and thetissue thickness compensator 6458, which is releasably secured to thecartridge body 6450, can comprise, for example, a fastener cartridge assembly. In various embodiments, thecartridge body 6450 can comprise acartridge platform 6452 and aslot 6456 extending through at least a portion of thecartridge body 6450. The cavity may be defined in thecartridge deck 6452 and into thecartridge body 6450. For example,fastener cavities 6454 can be defined in thecartridge platform 6452 and can receivefasteners 6490 therein (fig. 126A-129). Thefastener 6490 may be removably positioned in thefastener cavity 6454. For example, asingle fastener 6490 may be removably positioned in eachfastener cavity 6454 and may be ejected from thefastener cavity 6454 during the firing stroke. Additionally, alock cavity 6448 can be defined in thecartridge platform 6452 and can receive thelock 6440 therein. For example, asingle lock 6440 may be movably positioned in eachlock cavity 6448 and may move from a locked position (fig. 127 and 128) to an unlocked position (fig. 129) during the firing stroke.
Referring primarily to fig. 126, thelock 6440 may include abase 6444 and ahook 6442, which may be movably positioned relative to thebase 6444. For example, thehook 6442 may move within a hole formed through at least a portion of thebase 6444. Thehook 6442 may, for example, receive and/or retain theconnector 6480. Thehooks 6442 may be constructed of, for example, Liquid Crystal Polymer (LCP), nylon, polyetherimide, polycarbonate, and/or ABS. Theconnector 6480 may be a suture, for example. In certain embodiments, the connector may be comprised of, for example, a PDS, PGA/PCL, PLLA/PCL, TMC/PCL, PGA, and/or PCL. In various embodiments, thehook 6442 may constrain theconnector 6480 after being embedded or partially embedded in thebase 6444. Theconnector 6480 may be held between thehook 6442 and thebase 6444, for example. When thehook 6442 is lifted off or partially lifted off of thebase 6444, theconnector 6480 may, for example, no longer be bound by thehook 6442 and may, for example, move out of engagement with thelock 6440. In various embodiments, theconnector 6480 can slide out of engagement with thelock 6440 after thehook 6442 is at least partially lifted off thebase 6444.
Referring primarily to fig. 126A, aconnector 6480 may extend from thetissue thickness compensator 6458. Thetissue thickness compensator 6458 can be, for example, friction fit with theconnector 6480, and/or thermoformed with theconnector 6480. In various embodiments, theconnector 6480 may be passed through thehook 6442 of thelock 6440 when thelock 6440 is in the unlocked position. Thetissue thickness compensator 6458 can be moved into position relative to thecartridge body 6450 as theconnector 6480 is passed through thehooks 6442. For example, thetissue thickness compensator 6458 can be positioned on thecartridge deck 6452 of thecartridge body 6450. Referring primarily to fig. 127, once thetissue thickness compensator 6458 is positioned relative to thecartridge body 6450, thelock 6440 can be moved from the unlocked position to the locked position. For example, thehooks 6442 of thelock 6440 may be embedded or partially embedded in thebase 6444 such that thelock 6440 encloses theconnector 6480 and/or constrains theconnector 6480. In various embodiments, thelock 6440 and/ordriver 6420 may, for example, comprise a spring that may bias thelock 6440 to an unlocked position. When thelock 6440 is in the locked position, thetissue thickness compensator 6458 can be secured to thecartridge body 6450, for example, by engagement of a connector with the lock.
Referring primarily to fig. 128 and 129, the keys can move along at least a portion of thecartridge body 6450 during the firing stroke. The key may be, for example, a component of thesled 6434 and/or firing assembly. In various embodiments, thesled 6434 can engage with drivers in cavities in thecartridge body 6450 during the firing stroke. Theslide 6434 can push the driver toward thecartridge deck 6452 and/or toward thetissue thickness compensator 6458 to eject the fastener from thefastener cavity 6454 and/or move thelock 6440 from the locked position to the unlocked position. Referring primarily to fig. 128, thesled 6434 may engage with thedriver 6420 in thelock cavity 6448 during the firing stroke. Theslide 6434 can move thedriver 6420 toward thecartridge platform 6452 and/or toward thetissue thickness compensator 6458. Additionally, referring primarily to fig. 129, thedriver 6420 may move thelock 6440 from a locked position to an unlocked position. For example, thedriver 6420 may push thehook 6442 out of thebase 6444. When thehook 6442 is lifted off thebase 6444, the connector can no longer be bound by thelock 6440. In such embodiments, thetissue thickness compensator 6458 can be unsecured to thecartridge body 6450 and/or released from thecartridge body 6450, for example.
Referring now to fig. 67, thetissue thickness compensator 17050 can comprise, for example, afirst portion 17052, and asecond portion 17054 extending opposite thefirst portion 17052. Thetissue thickness compensator 17050 may form part of a staple cartridge assembly. In some cases, atissue thickness compensator 17050 can be attached to a cartridge body on the staple cartridge assembly. In some instances, thetissue thickness compensator 17050 can be assembled to an anvil of a surgical stapling instrument. In any case, thefirst portion 17052 of thetissue thickness compensator 17050 can be compressible. In use, thefirst portion 17052 can be captured within a staple ejected from a staple cartridge and can apply a compressive force to tissue also captured within the staple. Thesecond portion 17054 of thetissue thickness compensator 17050 can extend through thefirst portion 17052, wherein thesecond portion 17054 can include aproximal end 17053 and adistal end 17055 extending from thefirst portion 17052. As described in more detail below, thesecond portion 17054 may be less flexible than thefirst portion 17052 and/or more rigid than thefirst portion 17052. Referring now to fig. 68, astaple cartridge assembly 17000 can comprise acartridge body 17010 comprising a plurality of staple cavities defined therein and a plurality of staples at least partially stored within the staple cavities. As shown in fig. 68, atissue thickness compensator 17050 can be mounted to thecartridge body 17010.
Thestaple cartridge assembly 17000 can comprise a proximal mount 17060 configured to releasably retain aproximal end 17053 of thesecond portion 17054 to thecartridge body 17010 and adistal mount 17070 configured to releasably retain adistal end 17055 of thesecond portion 17054 to thesecond portion 17054. The proximal mount 17060 can comprise a single component, or more than one component. As shown in fig. 68, the proximal mount 17060 can comprise afirst mount portion 17060a and asecond mount portion 17060b configured to at least partially capture thesecond portion 17054 and retain thesecond portion 17054 against thecartridge body 17010. Turning now to fig. 69, eachmount portion 17060a and 17060b can comprise a key 17062, whichkey 17062 can be releasably secured within akeyway 17012 defined in thecartridge body 17010. Each key 17062 and eachkeyway 17012 may be sized such that the sidewalls of thekeyways 17012 apply a retaining force to thekeys 17062, thereby resisting removal of thekeys 17062 from thekeyways 17012. In various instances, the key 17062 can be releasably press-fit and/or snap-fit within thekeyway 17012. In at least one instance, the key 17062 can, for example, include anenlarged end 17063 that can be releasably clamped between the sidewalls of thekeyway 17012. As shown in fig. 68 and 69, eachmount portion 17060a and 17060b can include awindow 17064 configured to at least partially receive theproximal end 17053 of thesecond portion 17054. In such instances, the sidewalls of thewindow 17064 can be configured to engage thetissue thickness compensator 17030 and press thetissue thickness compensator 17030 against thedeck 17014 of thecartridge body 17010. Further, at least a portion of thesecond portion 17054 can be housed within themount portions 17060a and 17060 b.
Referring again to fig. 68 and 69, similar to the above, thedistal mount 17070 can include awindow 17074, whichwindow 17074 can be sized and configured to receive at least a portion of thedistal end 17055 of thesecond portion 17054. Also similar to the above, the sidewalls of thewindow 17074 can be configured to engage thetissue thickness compensator 17030 and press thetissue thickness compensator 17030 against thedeck 17014 of thecartridge body 17010. Further, at least a portion of thesecond portion 17054 can be housed within themount portion 17070. Thedistal mount portion 17070 can comprise one ormore pins 17072 extending therefrom that can be releasably secured within one or more pin holes 17011 defined in thecartridge body 17010. Eachpin 17070 and each pin aperture 17011 may be sized and configured such that the sidewalls of the pin apertures 17011 apply a retaining force to thepins 17072, thereby resisting removal of thepins 17072 from the pin apertures 17011. In various circumstances, eachpin 17072 can be releasably press-fit and/or snap-fit within the pin aperture 17011.
To assemble thestaple cartridge 17000, in at least one instance, thetissue thickness compensator 17030 can first be positioned against thedeck 17014 of thecartridge body 17010, and the proximal anddistal mounts 17060, 17070 can be assembled to thecartridge body 17010. The proximal anddistal mounts 17060, 17070 are assembled to thecartridge body 17010 to capture or trap thetissue thickness compensator 17050 against thecartridge body 17010 as described above. The proximal anddistal mounts 17060, 17070 can be configured to capture and releasably retain an end of thesecond portion 17074 to thecartridge body 17010, as also described above. In certain instances, the proximal mount 17060 and/or thedistal mount 17070 can be configured to capture at least a portion of thefirst portion 17052 therein. While fig. 67-69 depict atissue thickness compensator 17050 comprising only two portions, various alternative forms of tissue thickness compensators comprising more than two portions are also contemplated. For example, the tissue thickness compensator can include a compressiblefirst portion 17052, and two or more rigidsecond portions 17054 extending therethrough. Further, for example, the tissue thickness compensator can comprise two or more compressible portions arranged in any suitable arrangement, such as in two or more layers.
Once thestaple cartridge 17000 is assembled, it can be assembled to a surgical stapler. In at least one instance,staple cartridge 17000 can be removably retained using a channel defined in an end effector of a surgical stapler, andstaple cartridge 17000 can subsequently be inserted into a surgical site within a patient. The proximal mount 17060 and/or thedistal mount 17070 can be configured to retain thetissue thickness compensator 17050 to thecartridge body 17010 as thestaple cartridge 17000 is inserted into and/or manipulated within a surgical site. Thesecond portion 17054 of thetissue thickness compensator 17050 can make thetissue thickness compensator 17050 sufficiently rigid such that thetissue thickness compensator 17050 does not become separated from thecartridge body 17010 until one or more of the proximal mounts 17060 and/or thedistal mounts 17070 are severed and/or separated from thecartridge body 17010, as described in more detail below. Since thesecond portion 17054 is rigid, in each case, the properties of thefirst portion 17052 of thetissue thickness compensator 17050 are selected primarily or exclusively to provide thetissue thickness compensator 17050 with desired tissue compensation characteristics. In use, thesecond portion 17054 of thetissue thickness compensator 17050 can resist relative movement between theproximal end 17053 and thedistal end 17055, and in various instances, resist movement of theproximal end 17053 and thedistal end 17055 toward each other.
In various circumstances, once thestaple cartridge 17000 has been properly positioned, the firingmember 17030 can be advanced through thestaple cartridge 17000 to deploy staples removably positioned in thestaple cartridge 17000. Thestaple cartridge 17000 can include amoveable member 17034, whichmoveable member 17034 can be advanced from a proximal end of thestaple cartridge 17000 toward a distal end of thestaple cartridge 17000 by a firingmember 17030. In addition to the above, themovable member 17034 can be configured to lift staples removably stored within thecartridge body 17010 between an unfired position and a fired position. The firingmember 17030 can, for example, further comprise a cutting portion (such as a knife 17032) that can be configured to transect tissue being stapled as the firingmember 17030 is advanced distally through thestaple cartridge 17000. Theknife 17032 can also be configured to transect thetissue thickness compensator 17050 as the firingmember 17030 is advanced distally through thestaple cartridge 17000. Referring primarily to fig. 67 and 68, theproximal end 17053 of thesecond portion 17054 may be severed by aknife 17032. In at least one such embodiment, thetissue thickness compensator 17050 can be at least partially severed, or completely severed, along a longitudinal axis defined at least in part by thenotch 17057 defined in thesecond portion 17054. As shown in fig. 68, thenotches 17057 can be aligned, or at least substantially aligned, with thelongitudinal knife slot 17015 extending through thecartridge body 17010. Once theknife 17032 at least partially transects theproximal end 17053 of thesecond portion 17054, thesecond portion 17054 can be at least partially released, or released, from theproximal mounts 17060a,17060 b. In such instances, thetissue thickness compensator 17050 can become separated from thecartridge body 17010. For example, the firingmember 17030 can be advanced at least partially or fully through thestaple cartridge 17000 to at least partially or fully implant thetissue thickness compensator 17050 into tissue, and as thetissue thickness compensator 17050, and particularly thesecond portion 17054, is at least partially transected, thetissue thickness compensator 17050 can be flexible enough to slide out of theproximal mount portions 17060a,17060b and thedistal mount 17070. In use, in various circumstances, after the firingmember 17030 has been at least partially fired and thetissue thickness compensator 17050 has been at least partially implanted, the firingmember 17030 can be retracted to its proximal or starting position wherein thecartridge body 17010 can then be pulled away from the implantedtissue thickness compensator 17050. For example, if thecartridge body 17010 is pulled away from thetissue thickness compensator 17050 along a longitudinal axis, thetissue thickness compensator 17050, e.g., at least partially transected, can be longitudinally flexed and the proximal and distal ends of thetissue thickness compensator 17050 can be moved toward one another.
70-72, thetissue thickness compensator 17150 can include acompressible portion 17152, and amount portion 17154 extending through thecompressible portion 17152 and/or from thecompressible portion 17152. Thecompressible portion 17152 can include aproximal end 17153, theproximal end 17153 can have a thickness that is less than a thickness of thebody portion 17156 of thetissue thickness compensator 17150. In at least one such embodiment, theproximal end 17153 may, for example, include a tapered portion. Referring again to fig. 70-72, a staple cartridge assembly (such as staple cartridge 17100), for example, can comprise aproximal mount 17160 that is configured to releasably secure amount portion 17154 of thetissue thickness compensator 17150 to thecartridge body 17010. Theproximal mount 17160 can comprise one ormore locks 17162 extending therefrom which locks 17162 can be received within one or more keyholes 10112 defined in thecartridge body 17110. In at least one such embodiment, eachlock 17162 can include a leg and a foot extending from the leg, wherein the leg can be configured to flex laterally whenlock 17162 is inserted intokeyhole 17112 and then spring back, or at least substantially spring back, to its unflexed configuration, thereby enabling the foot to releasably engage or move behind thekeyhole 17112 side wall. Similar to the above, theproximal mount 17160 can further include alumen 17164, thelumen 17164 being configured to receive theproximal mount portion 17154 of thetissue thickness compensator 17150. Thelumen 17164 can be configured to press theproximal mount portion 17154 toward the deck of thecartridge body 17110 and hold the proximal end of thetissue thickness compensator 17150 in place. In various circumstances, a firing member, such as the firingmember 17030, for example, can be configured to incise theproximal mount 17160 as the firingmember 17030 advances to incise thetissue thickness compensator 17150. In at least one such instance, cutting into theproximal mount 17160 can release thetissue thickness compensator 17150 from thecartridge body 17110. Referring again to the embodiment depicted in fig. 68, for example, the firingmember 17030 can be configured to pass through a slot defined between theproximal mount portions 17060a and 17060b, and in at least some instances, to pass through theproximal mount portions 17060a,17060b without cutting therein.
In addition to the above, referring now to fig. 73-76, a proximal mount for releasably retaining a tissue thickness compensator to the cartridge body can comprise a first portion 17260a and asecond portion 17260b which, upon assembly to the cartridge body, can define a longitudinal gap orslot 17267 which can be sized to allow the firingmember 17030 to pass between the first portion 17260a and thesecond portion 17260 b. Similar to the above, each of the first andsecond portions 17260a, 17260b can include acavity 17264 configured to at least partially receive and hold in place a tissue thickness compensator. Also similar to the above, each of the first andsecond portions 17260a, 17260b can comprise alock 17262 extending therefrom, thelock 17262 can be configured to be engaged with the cartridge body.
As described above, the staple cartridge assembly can comprise a proximal mount or attachment portion and a distal mount or attachment portion, wherein the proximal mount or attachment portion is configured to retain a proximal end of the tissue thickness compensator to a proximal end of the cartridge body and the distal mount or attachment portion is configured to retain a distal end of the tissue thickness compensator to a distal end of the cartridge body. In certain other embodiments, the cartridge assembly may employ only at least one proximal mount or at least one distal mount for retaining the tissue thickness compensator to the cartridge body. Turning now to fig. 147, the cartridge assembly 17300 can comprise a cartridge body 17310 and a tissue thickness compensator 17350, wherein a distal end of the tissue thickness compensator 17350 can comprise a distal end 17355 configured to be releasably mountable to the cartridge body 17310. In at least one such embodiment, the distal end of the cartridge body 17310 can comprise a lock aperture 17011, the lock aperture 17011 being configured to receive and attach at least one distal mount to the cartridge body 17310. The reader will appreciate that, at least with respect to this embodiment, the cartridge assembly 17300 does not additionally include a proximal mount for mounting the proximal end of the tissue thickness compensator 17350 to the cartridge body 17310. In various instances, the distal end 17355 can be integrally formed with the body portion 17356 of the tissue thickness compensator 17350, or alternatively, can be attached to the body portion 17356.
In various embodiments, referring now to fig. 156 and 157, a staple cartridge assembly, such as astaple cartridge 10400, for example, can comprise acartridge body 10410 comprising a distal end ornose 10419 which can be configured to releasably hold atissue thickness compensator 10450 in place. Similar to the above, thetissue thickness compensator 10450 can comprise afirst portion 10452 mounted to asecond portion 10454, wherein thesecond portion 10454 can comprise adistal end 10455 configured to be releasably retained by thenose 10419. In various circumstances, thenose 10419 and theplatform 10414 of thecartridge body 10410 can define aslot 10418 therebetween, theslot 10418 being configured to receive thedistal end 10455.Nose 10419 may be constructed of an elastic material that may be sized and configured to biasnose 10419 into engagement withdistal end 10455. In use, referring to fig. 157, after thetissue thickness compensator 10450 has been at least partially implanted, thenose 10419 can be sufficiently flexible to allow thetissue thickness compensator 10450 to slide out from under thenose 10419 as thecartridge body 10410 is moved away from thetissue thickness compensator 10450. Turning now to fig. 158, in addition to the above,first layer 10452 may be constructed of a compressible foam and may be mounted tosecond layer 10454. In various instances, thefirst layer 10452 can be mounted to thesecond layer 10454 with one or more adhesives. Thefirst layer 10452 is mounted to thesecond layer 10454 such that thedistal end 10455 and thenotch 10457 defined in thedistal end 10455 remain exposed. Additionally, thefirst layer 10452 is mounted to thesecond layer 10454 such that thefirst layer 10452 is laterally centered with respect to a longitudinalcentral axis 10459 defined by thesecond layer 10454.
As described above, the cartridge module can include a movable firing member at least partially stored therein, which can be configured to lift staples stored within the cartridge module between an unfired position and a fired position. Turning now to fig. 159 and 160, thestaple cartridge assembly 10500 can comprise acartridge body 10510, atissue thickness compensator 10550, and a movable firing member orsled 10034 slidably stored therein. Thesled 10034 can comprise one ormore ramps 10035 defined thereon that can be configured, in use, to lift staples upwardly from their unfired position to a fired position. Prior to use, thesled 10034 can be releasably locked in place. In at least one such embodiment, thetissue thickness compensator 10550 can be configured to releasably retain thesled 10034 in a proximal position prior to distal advancement of thesled 10034 to eject staples from thestaple cartridge assembly 10500 and cut into thetissue thickness compensator 10550. Thetissue thickness compensator 10550 can include one or more tabs ordetent devices 10557 extending therefrom, the tabs ordetent devices 10557 can be configured to releasably engage thesled 10034. For example, thesled 10034 can comprise one ormore grooves 10037 in which thedetent devices 10557 can be positioned 10037 until thesled 10034 is exerted with sufficient force to cause thesled 10034 to overcome the retention force exerted thereon by thedetent devices 10557. In use, thedetent 10557 can be configured to hold thesled 10034 in place until a longitudinal firing force applied to thesled 10034 in a distal direction exceeds a threshold force, wherein when the firing force exceeds the threshold force, thesled 10034 can slide distally and thedetent 10557 can flex or deform sufficiently to enable thesled 10034 to slide therethrough. In at least one embodiment, thedetent 10557 can be positioned proximal of the staple cavities defined in thecartridge body 10510 and/or proximal of the staples stored within thecartridge body 10510 such that thesled 10034 can be releasably retained in an unfired position proximal of the staples. Once thesled 10034 has been advanced distally, thesled 10034 can be advanced toward the staples.
In addition to the above, referring again to fig. 159 and 160, thecartridge body 10510 can comprise one ormore retention slots 10517, whichretention slots 10517 can be configured to receive at least a portion of thedetent 10557. More specifically, at least in the illustrated embodiment, when thesled 10034 is in its proximal, unfired position, aretention slot 10517 defined on one side of thecartridge body 10510 can be aligned with arecess 10037 defined on a corresponding side of thesled 10034 such that thedetent 10557 can be synchronously positioned within the alignedretention slot 10517 andrecess 10037. In at least one such embodiment, the side walls of theretention slots 10517 defined in thecartridge body 10510 can support thedetent devices 10557 and at least inhibit thedetent devices 10557 from prematurely disengaging from therecesses 10037. As described above, thesled 10034 can be advanced distally such that thegroove 10037 is no longer aligned with thedetent 10557; however, at least in the illustrated embodiment, thepawl 10557 can remain aligned with theretention slot 10517 and/or positioned within theretention slot 10517 after theslider 10034 has been at least partially advanced. Referring primarily to fig. 159, a first arrangement comprising thedetent device 10557, thesled groove 10037, and thecartridge retention slot 10517 can be disposed on a first side of thesled 10034, comprising asecond detent device 10557, and a second arrangement of thesecond sled groove 10037 and the secondcartridge retention slot 10517 can be disposed on a second or opposite side of thesled 10034.
Certain embodiments of staple cartridges may, for example, comprise a pliable layer (such as a tissue thickness compensator and/or buttress material) on a staple deck, wherein the staples may be arranged such that the tips of the unfired staples extend into the layer. In certain other embodiments, the pliable layer may constitute a compressible and/or squeezable staple cartridge that is implantable in the patient and deforms and/or compresses when captured in the staple. The flexible layer and/or the implantable staple cartridge can also, for example, deform and/or compress if a surgeon, nurse, technician, or other user(s) inadvertently presses a thumb or other finger against the flexible layer or the implantable staple cartridge. Such deformation and/or compression renders the staple cartridge unusable.
A retainer is typically fitted in the staple cartridge, which may assist the user in smoothly loading the staple cartridge into the surgical stapler. The retainer may also cover the staple deck and any pliable layer, thereby preventing a user from inadvertently compressing, squeezing, and/or deforming the pliable layer. However, users sometimes prematurely remove the staple cartridge holder before the staple cartridge is not fully installed into the end effector of the surgical stapler. In the event of premature removal of the cartridge holder, the flexible layer may be damaged by the user.
Fig. 164-167 illustrate an embodiment of aretainer 10000 that is attachable to thestaple cartridge 10010. Referring to fig. 166 and 167, thestaple cartridge 10010 can comprise a pliable layer 10020 (such as a tissue thickness compensator and/or buttress material) disposed on acartridge deck 10011 thereof. As shown in fig. 167, thestaples 10030 can extend from thestaple cartridge 10010 into the exposedflexible layer 10020. If theretainer 10000 is removed prematurely, a user can inadvertently press thepliable layer 10020 while pushing thestaple cartridge 10010 into the staple cartridge channel of the end effector, thereby compressing thelayer 10020 and/or deforming thelayer 10020.
168-173 illustrate an embodiment of aretainer 2600 that may be locked to thestaple cartridge 2650 and cannot be unlocked and removed from thestaple cartridge 2650 until thestaple cartridge 2650 is fully inserted into thestaple cartridge channel 2670 of the end effector. As best shown in fig. 168, theproximal end portion 2604 of theretainer 2600 can includemovable cam portions 2616, themovable cam portions 2616 havinglocking tabs 2626 extending therefrom. The lockingtabs 2626 extend into slots 2652 (such as knife slots) of thestaple cartridge 2650 and engage theslots 2652. The lockingtabs 2626 are engaged within theslots 2652 to releasably hold theretainer 2600 and thestaple cartridge 2650 together. As described in greater detail below, after thecam portions 2616 of theretainer 2616 engage the keys in thestaple cartridge channel 2670, causing thecam portions 2616 to flex inwardly toward one another, the locking tabs are only disengaged from theslots 2652, thereby allowing theretainer 2600 to be released and removed from thestaple cartridge 2650. Further, in various embodiments, thecam portions 2616 may only engage the keys if thestaple cartridge 2650 is properly seated in thestaple cartridge channel 2670.
As described above, in certain embodiments, theproximal end portion 2604 of theholder 2600 can includecam portions 2616, eachcam portion 2616 being attached to thebody 2606 of theholder 2600 by aneck 2624. Thecam portions 2616 may be separated from each other by agap 2622. Thecam portion 2616 may flex inwardly in the direction of arrow I (shown in fig. 172) when subjected to an inward compressive force and, in addition, may flex resiliently outwardly about theneck 2624 in the direction of arrow O (shown in fig. 170). Alocking tab 2626 may extend from eachcam portion 2618. As described in greater detail below, when thelocking tabs 2626 are disposed on thestaple cartridge 2650, they can extend into slots 2652 (such as knife slots) of thestaple cartridge 2650 and releasably engage theslots 2652. Referring primarily to fig. 170 and 171, the cam portions can be biased in an outwardly flexed position such thatlips 2628 extending from the lockingtabs 2626 can engageridges 2654 inslots 2652 of thestaple cartridge 2650. Thecam portions 2616, when biased in the outwardly flexed position, can push thelips 2628 of thelocking tabs 2626 into engagement with theridges 2654 in theslots 2652 such that theretainer 2600 is locked onto thestaple cartridge 2650 in the absence of an inward compressive force from the keys of thestaple cartridge channel 2670.
Referring primarily to fig. 170-173, in various embodiments, the splines of thestaple cartridge channel 2670 can comprise interior walls of thestaple cartridge channel 2670 that provide an increasing inward compressive force to thecam portions 2616, thereby enabling thecam portions 2616 to flex inward in the direction of arrow I (shown in fig. 172) as theretainer 2600 andstaple cartridge 2650 are inserted into thestaple cartridge channel 2670. For example, thestaple cartridge channel 2670 can include a firstinner wall 2672 defining a first width that can accommodate thecam portions 2616 in the outwardly flexed, biased position. Thestaple cartridge channel 2670 can include a secondinner wall 2676 defining a second width that can accommodate thecam portions 2616 in the inwardly flexed position as shown in FIG. 172. Thestaple cartridge channel 2670 can include an intermediateinner wall 2674 positioned intermediate the firstinner wall 2672 and the secondinner wall 2676, the intermediateinner wall 2674 can transition from a first width to a second width. In use, thestaple cartridge 2650 andretainer 2600 are moved in a proximal direction relative to and toward thestaple cartridge channel 2670 for insertion into thestaple cartridge channel 2670 as indicated by arrow P in fig. 170 and 172. Referring primarily to fig. 170 and 171, as thestaple cartridge 2650 andretainer 2600 are moved toward thestaple cartridge channel 2670, the rounded ends 2620 andoutward surfaces 2618 of thecam portions 2616 may engage thefirst wall 2672 of thestaple cartridge channel 2670. As described above, in certain embodiments, thefirst wall 2672 defines a width that accommodates thecam portion 2616 in the outwardly deflected biased position. In various other embodiments, thefirst wall 2672 defines a width that accommodates thecam portion 2616 in an inwardly deflected position, wherein the inwardly deflected position is sufficient enough that thelips 2628 of thelocking tabs 2626 do not disengage from theridges 2654 of thestaple cartridge 2650 and unlock theretainer 2600 from thestaple cartridge 2650. Referring now to fig. 172 and 173, as thestaple cartridge 2650 andretainer 2600 continue to move proximally in the direction of arrow P toward thestaple cartridge channel 2670, therounded end 2620 andoutward surface 2618 engage theintermediate wall 2674 and then thesecond wall 2676.Intermediate wall 2674 andsecond wall 2676 may provide an incremental force that gradually flexescam portion 2616 inward. Eventually, thecam portions 2616 will flex inward an amount such that thelips 2628 of thelocking tabs 2626 can disengage from theridges 2654 in theslots 2652 of thestaple cartridge 2650. Once the lockingtabs 2626 are disengaged from theridges 2654, theretainer 2600 is unlocked from thestaple cartridge 2650 such that theretainer 2600 can be removed from thestaple cartridge 2650. In various embodiments, thecam portions 2616 flex inwardly such that thelocking tabs 2626 only disengage from theridges 2654 when thestaple cartridge 2650 is fully inserted into thestaple cartridge channel 2670.
In certain embodiments, a lockable retainer, such asretainer 2600 described above in connection with fig. 168-173, can also prevent a particular sized staple cartridge from being inserted into an end effector intended for use with a different particular sized staple cartridge. For example, thestaple cartridge 2650 can comprise adatum surface 2632, and thedatum surface 2632 can engage adatum surface 2674 of thestaple cartridge channel 2670. The first predetermined distance from thedatum surface 2632 of thestaple cartridge 2650 to thecam portion 2616 may correspond to a second predetermined distance between thedatum surface 2674 of thestaple cartridge channel 2670 and thewalls 2672,2674 and 2676 of thestaple cartridge channel 2670 that include the keys. The first and second predetermined distances for a particular sized retainer, staple cartridge, and staple cartridge channel intended for use with a particular sized staple cartridge may be different than the first and second predetermined distances for another differently sized retainer, staple cartridge, and staple cartridge channel. In other words, the first and second predetermined distances for each size of staple cartridge, retainer, and staple cartridge channel may be different than the first and second predetermined distances for other sizes of staple cartridges, retainers, and staple cartridge channels. Thus, attempts to insert the staple cartridge and retainer into an improperly sized staple cartridge channel may result in the cam portions of the retainer failing to engage the walls of the staple cartridge channel and/or the datum surface of the staple cartridge failing to engage the datum surface of the staple cartridge channel. For example, thestaple cartridge 2650 andretainer 2600 can be arranged such that thecam portions 2616 can only engage thesecond wall 2676 of thestaple cartridge channel 2670 when inserted into a correspondingly sized staple cartridge channel such that thelocking tabs 2626 disengage from theslots 2652 in thestaple cartridge 2650 when thedatum surfaces 2632 and 2674 engage one another. For example, if thestaple cartridge 2650 andretainer 2600 are too short relative to thestaple cartridge channel 2670, thecam portions 2616 may not reach thesecond wall 2676, thereby causing thelocking tabs 2626 to disengage from theslots 2552 in thestaple cartridge 2650 when thereference surfaces 2632 and 2674 are engaged. Thus, theretainer 2600 will not unlock and cannot be removed from thestaple cartridge 2650. Conversely, if thestaple cartridge 2650 andretainer 2600 are too long relative to thestaple cartridge channel 2670, for example, thecam portions 2616 engaging thesecond wall 2676 of thestaple cartridge channel 2670 may interfere with the engagement of thereference surfaces 2632 of thestaple cartridge 2650 with thereference surfaces 2674 of thestaple cartridge channel 2670, respectively. Thus, thestaple cartridge 2650 will not be fully seated in thestaple cartridge channel 2670.
Theretainer 2600 includes not only lockingtabs 2626 extending from thecam portion 2616, but also a pair ofproximal tabs 2612 disposed near theproximal end 2602 of theretainer 2600 and a pair ofdistal tabs 2610 disposed near thedistal end 2604 of theretainer 2600. The proximal anddistal tabs 2608, 2610 can extend from thebody 2606 and can engage thestaple cartridge 2650 and releasably retain thestaple cartridge 2650. In certain embodiments, the proximal anddistal tabs 2612, 2610 can engage thestaple cartridge 2650 and hold thestaple cartridge 2650 until thestaple cartridge 2650 is fully seated in thestaple cartridge channel 2670. In other words, the proximal and/ordistal tabs 2612, 2610 can act as another type of lock that prevents theretainer 2600 from being removed from thestaple cartridge 2650 before thestaple cartridge 2650 is fully seated in thestaple cartridge channel 2670.
Referring primarily to fig. 168, eachproximal tab 2612 can include aproximal lip 2614, and eachdistal tab 2610 can include adistal lip 2610. Eachproximal lip 2614 can include an inwardly facing angledsurface 2615, and eachdistal lip 2610 can include an inwardly facing angledsurface 2611. The proximal anddistal lips 2614, 2610 can engage lateral sides of thestaple cartridge 2650 and releasably retain the lateral sides of thestaple cartridge 2650. Upon insertion of thestaple cartridge 2650 andretainer 2600 into thestaple cartridge channel 2670, the inwardly facingangled surfaces 2611 and 2615 may engageedges 2672 and 2678 of thestaple cartridge channel 2670. Theedges 2672 and 2678 of thestaple cartridge channel 2670 can flex the proximal and/ordistal tabs 2612 and 2610 outward, thereby disengaging the proximal anddistal lips 2614 and 2610 from the lateral sides of thestaple cartridge 2650. When the proximal anddistal lips 2614, 2610 are disengaged from the lateral sides of thestaple cartridge 2650, theretainer 2600 can be released and removed from thestaple cartridge 2650.
Referring to fig. 174-180, for example, theend effector 12 of the surgical instrument can be configured to receive anend effector insert 28010. In various embodiments, theend effector insert 28010 may comprise acompensator body 28012 and at least oneclamp 28014a,28014 b. In various embodiments, theend effector insert 28010 may, for example, comprise aproximal clamp 28014b at a proximal end of thecompensator body 28012, and adistal clamp 28014a at a distal end of thecompensator body 28012. Referring primarily to fig. 177, adistal clamp 28014a can be secured to theanvil 25060 of theend effector 12 at or near the distal end of theanvil 25060. For example, thedistal clamp 28014a can be substantially aligned with thelongitudinal slot 25062 of theanvil 25060 and/or can be partially positioned within thelongitudinal slot 25062 of theanvil 25060. Referring primarily to fig. 178, theproximal clamp 28014b can be secured to a staple cartridge 25000 (fig. 179) in thelower jaw 25070 of theend effector 12. Theproximal clamp 28014b can be secured to thestaple cartridge 25000 at or near the proximal end of thestaple cartridge 25000. For example, theproximal clamp 28014b can be substantially aligned with thelongitudinal slot 25004 in thestaple cartridge 25000 and/or can be positioned within thelongitudinal slot 25004 in thestaple cartridge 25000.
Referring now to fig. 179 and 180, theend effector insert 28010 may be inserted into theend effector 12 of the surgical instrument. In various embodiments, at least a portion of the end effector insert 28010 (e.g., thecompensator body 28012, thedistal clamp 28014a, and/or theproximal clamp 28014b) can be, for example, deformable and/or resilient. When theend effector insert 28010 is inserted into theend effector 12, thedistal clamp 28014a and/or theproximal clamp 28014b can bend or flex. Onceclamps 28014a and 28014b are flexed, for example, clamps 28014a and 28014b may, for example, have a tendency to return to their original, undeformed configuration and may develop a spring back or restoring force. In various embodiments, theend effector insert 28010 may apply a spring load to theend effector 12 when theend effector insert 28010 is positioned within theend effector 12. In some embodiments, theend effector insert 28010 may be solid or substantially solid such that an operator can grasp theinsert 28010 when inserting theend effector insert 28010 andstaple cartridge 25000 into theend effector 12.
In some embodiments, theend effector insert 28010 may be removed from theend effector 12 after a cutting and/or fastening operation of theend effector 12. In other embodiments, theend effector insert 28010 may remain positioned in theend effector 12 during the cutting and/or firing operation. For example, theend effector insert 28010 can be transected by the cuttingelement 25052 as staples are fired from staple cavities 25002 (fig. 178) in thestaple cartridge 25000. In various embodiments, theend effector insert 28010 can comprise a tissue thickness compensating material similar to at least one of the tissue thickness compensators described herein. For example, theend effector insert 28010 may comprise a polymeric composition, such as a bioabsorbable, biocompatible elastomeric polymer. Theend effector insert 28010 may also comprise a bioabsorbable polymer, such as lyophilized polysaccharide, glycoprotein, elastin, proteoglycan, gelatin, collagen, and/or Oxidized Regenerated Cellulose (ORC). In some embodiments,end effector insert 28010 may contain at least one therapeutic agent, such as a pharmaceutically active agent or drug.
Still referring to fig. 174-180, theend effector insert 28010 can be releasably attached to theend effector 12 and/or to theanvil 25060 and/or to thestaple cartridge 25000 of theend effector 12. Theproximal clamp 28014b can be releasably secured to the staple cartridge 25000 (fig. 178), for example, and thedistal clamp 28014a can be releasably secured to the anvil 25060 (fig. 177), for example. In various embodiments, theproximal clamp 28014b can be aligned with theslot 25004 of thestaple cartridge 25000 and/or can be retained within theslot 25004. Additionally, in certain embodiments, thedistal clamp 28014a can be aligned with theslot 25062 of theanvil 25060 and/or can be retained within theslot 25062. Referring primarily to FIG. 179, in certain embodiments, theproximal clamp 28014b can be releasably secured to thestaple cartridge 25000 prior to positioning thestaple cartridge 25000 in the lower jaw 25070 (FIG. 179). For example, as thestaple cartridge 25000 and attachedend effector insert 28010 are moved toward and/or into theend effector 12 and/orlower jaw 25070, thedistal clamp 28014a can be moved into alignment with theslot 25062 in theanvil 25060. In various embodiments, thedistal clamp 28014a can be configured to releasably engage theanvil 25060 when thestaple cartridge 25000 andend effector insert 28010 are positioned in the end effector 12 (fig. 180). Thedistal clamp 28014a can, for example, be slid into theslot 25062 of theanvil 25060. In various embodiments, theproximal clamp 28014b is positioned relative to thestaple cartridge 25000 prior to or simultaneously with positioning thedistal clamp 28014a relative to theanvil 25060.
When theend effector insert 28010 is releasably secured within theend effector 12, e.g., by the proximal anddistal clamps 28014b and 28014a as described herein, theend effector insert 28010 may remain taut in theend effector 12. In other words, aproximal clamp 28014b that is fixed relative to astaple cartridge 25000 in thelower jaw 25070 can apply a pulling force to adistal clamp 28014a that is fixed relative to theanvil 25060, e.g., along theend effector insert 28010. In various embodiments, tension between theproximal clamp 28014b and thedistal clamp 28014a can help retain theend effector insert 28010 in theend effector 12.
In various embodiments, when thestaple cartridge 25000 andend effector insert 28010 are positioned in theend effector 12, theproximal clamp 28014b can be positioned intermediate the unfired sled 25056 (fig. 178) and thestaple cartridge 25000. For example, an unfired sled 25056 can be proximal to the proximal clamp 28013 b. In certain embodiments, the sled 25056 can move distally past theproximal clip 28014b, e.g., during a firing stroke, and can deflect theproximal clip 28014 b. In various embodiments, upon deflection of theproximal clamp 28014b by sled 25056 during a firing stroke, theproximal clamp 28014b can be released from theslot 25004 in thestaple cartridge 25000. In certain embodiments, elements of the sled 25056 and/or firing bar 25050 (as shown elsewhere) can release theproximal clamp 28014b from thestaple cartridge 25000. Additionally, upon release of theproximal clamp 28014b from thestaple cartridge 25000, the tension in theend effector insert 28010 can be at least partially relieved. In the absence of a pulling force applied to thedistal clamp 28014a, thedistal clamp 28014a can be released from theanvil 25060. Thus, theend effector insert 28010 may be released from theend effector 12 and may, for example, remain in the tissue of the patient after theend effector 12 is removed from the patient.
In certain embodiments, an anvil-attachable layer, such as a tissue thickness compensator and/or a proximal end of a buttress material, for example, can be releasably attached to the proximal end of the staple cartridge for alignment with and attachment to an anvil of an end effector insertable into the staple cartridge. Generally, the anvil-attachable layer can be disposed relative to a side of the staple cartridge facing the anvil. For example, an anvil-attachable layer can be disposed on a staple deck of a staple cartridge and/or can be disposed on a staple deck layer. The proximal end of the anvil-attachable layer may be attached to the proximal end of the staple cartridge, or to the proximal end of the staple platform layer. Upon insertion of the staple cartridge into the end effector of the surgical stapler, the anvil of the surgical stapler can be closed against the anvil-attachable layer, thereby attaching the anvil-attachable layer to the anvil. When the anvil is reopened, the anvil-attachable layer, which is currently attached to the anvil, may be moved away from the staple cartridge with the anvil. In various instances, the attachment layer, when moved with the anvil, may pivot about a proximal end attached to the staple cartridge and/or staple cartridge layer. In various other instances, the attachment layer, when moved with the anvil, may have its proximal end detached from the staple cartridge. At this point, the surgical stapler with the anvil-attachable layer attached to the anvil can cut and staple patient tissue. An anvil-attachable layer may also be cut by the surgical stapler and captured by the staples. After the anvil-attachable layer and the patient tissue are captured by the staples, the surgical stapler can be removed from the patient. In various embodiments in which the anvil-attachable layer remains attached to the staple cartridge, the surgical stapler can be pulled away from the layer, thereby breaking the attachment between the layer and the staple cartridge.
Fig. 181 and 182 illustrate an embodiment of astaple cartridge assembly 2400 that includes an anvil-attachable layer 2414. The anvil-attachable layer 2414 may, for example, comprise a tissue thickness compensator and/or a buttress material. Theproximal end 2416 of the anvil-attachable layer 2414 can be attached to theproximal end 2418 of thecartridge body 2402. In various embodiments, thestaple cartridge assembly 2400 may include astaple cartridge layer 2412, such as a tissue thickness compensator and/or buttress material, for example, disposed on a staple deck of thestaple cartridge body 2402. Thecartridge pan 2404 can, for example, at least partially surround thestaple cartridge body 2402 and can be constructed of a metallic material. Thecartridge body 2402 may include asurface 2406 at aproximal end 2418 thereof and agroove 2408 defined in thesurface 2406. Referring to fig. 181, to attach the anvil-attachable layer 2414 to thestaple cartridge body 2402, theproximal end portion 2416 of the anvil-attachable layer 2414 can be positioned over thechannel 2408. Next, as shown in fig. 182, for example, thetabs 2410 extending from thecartridge tray 2404 can be deformed such that they extend into thechannels 2408, and theproximal end portions 2416 of the anvil-attachable layer 2414 are captured in thechannels 2408 between the side walls of the channels and thetabs 2410. Thetab 2410 may also capture the anvil-attachable layer 2414, for example, between the bottom of thegroove 2408 and thetab 2410.
In use, thecartridge assembly 2400 shown in FIG. 182 can be inserted into a cartridge channel of an end effector of a surgical stapler. Next, the anvil of the end effector may be closed against the anvil-attachable layer 2414. The anvil-attachable layer 2414 is disposed within thecartridge body 2402 such that when thecartridge assembly 2400 is inserted into thecartridge channel 2400 and the anvil is subsequently closed, the anvil-attachable layer 2414 is properly aligned with the anvil. In various embodiments, the anvil-facingsurface 2415 of the anvil-attachable layer 2414 can comprise an adhesive configured to adhere to the anvil surface and/or one or more attachment features that engage the anvil to attach the anvil-attachable layer 2414 to the anvil. For example, the anvil-facingsurface 2415 can include one or more protrusions extending therefrom that can engage the knife slots of the anvil. After the anvil-attachable layer 2414 has been attached to the anvil, the anvil can be returned to the open position with the anvil-attachable layer 2414 attached thereto. The portion of the anvil-attachable layer 2414 attached to the anvil can pivot about theproximal end 2416 of thelayer 2414 attached to thecartridge body 2402 to enable thelayer 2414 to move with the anvil. At this point, the surgical stapler can include acartridge layer 2412 aligned over thecartridge body 2402, and an anvil-attachable layer 2414 attached to and aligned with the anvil.
When thestaple cartridge layer 2412 is aligned with thestaple cartridge body 2402 and the anvil-attachable layer 2414 has been attached to and aligned with the anvil, the surgical stapler can be ready to cut and staple patient tissue. Thestaple cartridge body 2402 andstaple cartridge layer 2412 may be positioned on one side of the patient tissue, and the anvil andanvil attachable layer 2414 may be positioned on the opposite side of the patient tissue. The attachment of the anvil-attachable layer 2414 to the anvil andcartridge body 2402 may stabilize the anvil-attachable layer 2414 relative to the anvil when positioning the stapler against the patient tissue. When the surgical stapler is properly positioned relative to the patient's tissue, the anvil can be closed, capturing the tissue between thecartridge body 2402 andcartridge layer 2412 on one side of the tissue and the anvil andanvil attachable layer 2414 on a second, opposite side of the tissue.
After the anvil is closed, the surgical stapler can be fired with the patient tissue captured between thecartridge body 2402 andcartridge layer 2412 on one side of the tissue and the anvil andanvil attachable layer 2414 on the other side of the tissue. For example, staple drivers can be advanced in a distal direction throughstaple driver slots 2422 in thestaple cartridge body 2402 to fire and form the staples stored in the staple cartridge. The fired and formed staples can capture thestaple cartridge layer 2412, the anvil-attachable layer 2414, and patient tissue therebetween. Additionally, a cutting blade can be advanced in a distal direction through theknife slot 2420 in thecartridge body 2402 and the knife slot in the anvil. The cutting blade, when advanced, can sever thecartridge layer 2412, the anvil-attachable layer 2414, and patient tissue therebetween. In various embodiments, the staple drivers and cutting blades can be advanced simultaneously. In various circumstances, the staple drivers can direct the cutting blade such that the staples are fired and formed prior to severing the patient tissue, thestaple cartridge layer 2412, and theanvil attachable layer 2414.
After the cartridge layer, the anvil-attachable layer 2414, and the patient tissue therebetween are captured by the staples and cut by the cutting blade, the anvil can be opened again. When the anvil is reopened, the anvil-attachable layer 2414, now attached to thestaple cartridge layer 2412 and the patient's tissue by the staples, can be separated from the anvil. For example, upon opening the anvil and/or upon removal of the surgical stapler from the patient, thelayer 2414, which may be attached due to the anvil, may be held in place by the staples and the patient tissue such that thelayer 2414 may be pulled away from, for example, the adhesive and/or attachment features that hold it to the anvil. Further, theproximal end 2416 of the anvil-attachable layer 2414 may be pulled away from thecartridge body 2402, thereby separating from theproximal end 2416 of thecartridge body 2402. For example, in various circumstances, the portion of theproximal end 2416 of the anvil-attachable layer 2414 captured between thechannel 2408 in thecartridge body 2402 and thetab 2410 of thecartridge tray 2404 can be pulled out from between thetab 2410 and thechannel 2408. In various other instances, the anvil-attachable layer 2414 can be torn from the portion thereof captured between thegroove 2408 and thetab 2410 of thecartridge tray 2404. For example, the portion of the anvil-attachable layer 2414 captured between thegroove 2408 and thetab 2410 can be trapped by thetab 2410 pressing in that portion of thelayer 2414, which can reduce the force required to tear the remainder of thelayer 2414 and/or define a location where thelayer 2414 is torn. For example, thetabs 2410 that extend into the anvil-attachable layer 2414 may, for example, be partially scored, cut, and/or perforated into thelayer 2414. After thecartridge layer 2412 is separated from thecartridge body 2402 and the anvil-attachable layer 2414 is separated from thecartridge body 2402 and the anvil, the surgical stapler is removed from the patient, but the implantedlayers 2412 and 2414 remain in the patient. For example, layers 2412 and 2414 may be stapled with rows of staples and/or may be compressed by different staples to different thicknesses in order to apply at least a minimum amount of compression to the patient tissue captured by the staples.
Still referring to fig. 181 and 182, in various embodiments, the anvil-attachable layer 2414 can be detached from thestaple cartridge body 2402 after being attached to the anvil and the anvil reopened. As described above, after thecartridge assembly 2400 is inserted into the cartridge channel and the anvil is pressed closed against the anvil-attachable layer 2414, thelayer 2414 may be attached to the anvil using an adhesive and/or attachment features on its anvil-facingsurface 2415. Upon reopening the anvil, the anvil-attachable layer 2414 can move with the anvil away from thestaple cartridge body 2402. In various circumstances, moving the anvil-attachable layer 2414 and the anvil together away from thestaple cartridge body 2402 can pull the portion of thelayer 2414 captured between thetabs 2410 of thecartridge tray 2404 and thegrooves 2408 in thecartridge body 2402 out from between thetabs 2410 and thegrooves 2408, such that theproximal end 2416 of thelayer 2414 will also move with the anvil.
Fig. 183 and 184 illustrate anotherembodiment 2450 of a staple cartridge assembly, whichstaple cartridge assembly 2450 comprises an anvil-attachable layer 2464 that is attachable to acartridge body 2452. In this embodiment, theproximal end 2466 of the anvil-attachable layer 2464 is attached to thesurface 2472 on anattachment portion 2470 that can extend from thesurface 2456 of thecartridge body 2452. Theproximal end 2466 of the anvil-attachable layer 2464 can be attached to thesurface 2472, for example, with an adhesive, ultrasonic welding, thermal welding, and/or thermal riveting. In various embodiments,staple cartridge assembly 2450 can comprise astaple cartridge layer 2462 disposed on astaple cartridge body 2462. In such embodiments, theattachment portion 2470 can extend from thesurface 2456 of thecartridge body 2452 such that thesurface 2472 is substantially flush with the anvil-facingsurface 2467 of thestaple cartridge layer 2462. Thus, the anvil-attachable layer 2464 can be substantially flat on the anvil-facingsurface 2467 andsurface 2472 of thecartridge layer 2462. In various instances, similar to the embodiment described above in connection with fig. 181 and 182, after insertion of thestaple cartridge assembly 2450 into the staple cartridge channel of the end effector, the anvil of the end effector can be closed such that the anvil is in contact with the anvil-facingside 2465 of the anvil-attachable layer 2464. Adhesive and/or attachment features on the anvil-facingside 2465 of anvil-attachable layer 2464 can attach anvil-attachable layer 2464 to the anvil. Next, the anvil is opened again, at which point the anvil-attachable layer 2464 can be pivoted aboutproximal end 2466 attached tosurface 2472. Similar to the embodiment described above in connection with fig. 181 and 182, thestaple cartridge layer 2462, the anvil-attachable layer 2464, and the patient's tissue therebetween can be cut and stapled together. Next, the anvil of the surgical stapler is reopened and/or removed from the patient, anvil-attachable layer 2464 can be separated from the anvil, andcartridge layer 2462 can be separated fromcartridge body 2452. Additionally,proximal end 2466 of anvil-attachable layer 2464 can be separated from the adhesive and/or other attachment features attached tosurface 2472, such that anvil-attachable layer 2464 can be implanted within a patient.
Still referring to fig. 183 and 184, in various embodiments, when the anvil is opened again after the anvil-attachable layer 2464 is attached to the anvil, theproximal portion 2466 of the anvil-attachable layer 2464 can be separated from thesurface 2472. For example, theproximal end 2466 of the anvil-attachable layer 2464 can also be attached to the anvil. As the anvil and attached anvil-attachable layer 2464 move in a direction away fromcartridge body 2452 and/orcartridge layer 2462,proximal end 2466 oflayer 2464 can be pulled up fromsurface 2472 and separated fromsurface 2472. In such embodiments, the anvil-attachable layer 2464 can be separated from the staple cartridge prior to thestaple cartridge layer 2462, the anvil-attachable layer 2464, and patient tissue therebetween being cut and stapled.
Fig. 185 and 186 illustrate another embodiment of astaple cartridge assembly 2500, whichstaple cartridge assembly 2500 comprises astaple cartridge layer 2506 and an anvil-attachable layer 2510. In the embodiment illustrated in fig. 185 and 186, the anvil-attachable layer 2510 is attached to thecartridge layer 2506 rather than thecartridge body 2502. For example, thestaple cartridge layer 2506 and the anvil-attachable layer 2510 can each comprise a tissue thickness compensator and/or a buttress material. The anvil-attachable layer 2510 can include a firstproximal tab portion 2512 that extends from aproximal end 2508 of thelayer 2510. The firstproximal tab portion 2512 can be attached to aproximal end surface 2516 of thecartridge layer 2506. For example, the firstproximal tab portion 2512 can be glued, welded, and/or overmolded onto theproximal end surface 2516 of thecartridge layer 2506. In certain embodiments, the anvil-attachable layer 2510 can include a secondproximal tab portion 2514 extending from the firstproximal tab portion 2512. The secondproximal tab portion 2514 can be attached to thebottom surface 2518 of thecartridge layer 2506, for example, using glue, welding, and/or overmolding.
Similar to the embodiment described above in connection with fig. 181-184, upon insertion of thestaple cartridge assembly 2500 into the staple cartridge channel of the surgical stapler end effector, an anvil-facingsurface 2511 of the anvil-attachable layer 2510 may be attached to the anvil by adhesive and/or attachment features as the anvil of the end effector is closed upon the anvil-attachable layer 2510. Upon reopening the anvil, the anvil-attachable layer 2510 can move with the anvil away from thecartridge layer 2506 and thecartridge body 2502. In various circumstances, the anvil-attachable layer 2510 can pivot about thefirst tab portion 2512 when the anvil is reopened. After the anvil-attachable layer 2510 is attached to the anvil, the end effector can be closed on the patient's tissue such that thecartridge body 2502 andcartridge layer 2506 are positioned on a first side of the patient's tissue and the anvil and anvil-attachable layer 2510 is positioned on a second, opposite side of the patient's tissue. As described above in connection with fig. 181 and 182, the cutting blade can be advanced through theknife slots 2520 in thecartridge body 2502 and the staple drivers can be advanced through thestaple driver slots 2422 in thecartridge body 2502. Referring primarily to fig. 185, in certain embodiments, the first andsecond tab portions 2512, 2514 of the anvil-attachable layer may be aligned with theknife slot 2512. The cutting blade may cut the first andsecond tab portions 2512 and 2514 as the cutting blade advances through theblade slot 2520. In various circumstances, first andsecond tab portions 2512 and 2514 can be separated from thecartridge layer 2506 by severing the first andsecond tab portions 2512 and 2514 with a cutting blade. After the cutting blade and staple drivers have been advanced, thecartridge layer 2506, the anvil-attachable layer 2510, and the patient tissue therebetween have been cut and stapled, the anvil can be reopened such that the anvil-attachable layer 2510 separates from the anvil and thecartridge layer 2506 separates from thecartridge body 2502. As described above, the anvil-attachable layer 2510 in the embodiment of fig. 185 and 186 is attached to thestaple cartridge layer 2506 and not to thestaple cartridge body 2502. Accordingly, no action needs to be taken to separate the anvil-attachable layer 2510 from thecartridge body 2502. Further, the first and/orsecond tab portions 2512, 2514 of the anvil-attachable layer 2510 can remain attached to thecartridge layer 2506 because both layers are captured by the staples and implantable within the patient. For example, if the cutting blade does not separate the first andsecond tab portions 2512 and 2514 from thecartridge layer 2506, thecartridge layer 2506 and anvil-attachable layer 2510 will be attached to each other within the patient's body by the first andsecond tab portions 2512 and 2514, as well as the formed staples.
Still referring to fig. 185 and 186, in various embodiments, after thestaple cartridge assembly 2500 has been inserted into the staple cartridge channel and the anvil-attachable layer 2510 has been attached to the anvil, the first andsecond tab portions 2512 and 2514 can be separated from thestaple cartridge layer 2506 when the anvil is reopened and the anvil and anvil-attachable layer 2510 are moved away from thestaple cartridge layer 2506. For example, the anvil and anvil-attachable layer 2510 attached thereto can pull first andsecond tab portions 2512 and 2514 away from thecartridge layer 2506, thereby separating first andsecond tab portions 2512 and 2514 from thecartridge layer 2506.
Fig. 187 and 188 illustrate anotherembodiment 2550 of an anvil-attachable layer for use with a surgical stapler. As explained below, theproximal end portion 2554 of the anvil-attachable layer 2550 can be attached to a proximal end portion of a staple cartridge for insertion into and alignment with and attachment to an anvil of a surgical stapler. At the beginning of the stroke of the cutting blade, thebody 2552 of the anvil-attachable layer 2550 can be separated from the staple cartridge by the cutting blade of the surgical stapler. For example, thecutting blade 2570 shown in fig. 188 can separate the anvil-attachable layer 2550 from the staple cartridge prior to cutting any patient tissue and prior to any portion of thebody 2552 of the anvil-attachable layer 2550 being captured by the staples.
Referring primarily to fig. 187, the anvil-attachable layer 2550 can comprise abody 2552 and aproximal end portion 2554. Theproximal end portion 2554 includes anattachment feature 2556 that is attachable to the proximal end portion of the staple cartridge. For example, the attachment features 2556 may include adhesives, welds, and/or heat staking points. The attachment features 2556 can also, for example, include portions that are captured between the slots of the staple cartridge and the tabs of the cartridge tray, as described above in connection with fig. 181 and 182. An anvil-attachable layer 2550 can be attached to and aligned with the staple cartridge, the staple cavities of such staple cartridge being aligned with thebody 2552 oflayer 2550. In other words, as the staples are fired from the staple cartridge, the staples will capture thebody 2552 of the anvil-attachable layer 2550. Similar to the embodiment described above in connection with fig. 181-186, a staple cartridge assembly comprising an anvil-attachable layer 2550 attached to a staple cartridge can be inserted into a staple cartridge channel of a surgical stapler end effector. The anvil of the end effector can then be closed on the anvil-facingsurface 2553 of the anvil-attachable layer 2550. The anvil-facingsurface 2553 can comprise an adhesive and/or attachment features that releasably attach the anvil-attachable layer 2550 to the anvil when the anvil is pressed closed against the anvil-facingsurface 2553. Next, the anvil is opened again, at which point the anvil-attachable layer 2550 can be pivoted with the anvil about the attachment features 2556. Similar to the embodiments described above in connection with fig. 181-186, a staple cartridge can, for example, comprise a layer of staple cartridges, such as a tissue thickness compensator and/or a buttress material.
The anvil-attachable layer 2550 can comprise a firstlateral side 2566 and a secondlateral side 2568. The firstlateral side 2566 and the secondlateral side 2568 can define amidline 2564 therebetween. In certain embodiments, the anvil-attachable layer 2550 can be attached to and aligned with the anvil of the end effector such that themidline 2564 is aligned with the knife slot in the anvil and the knife slot in the staple cartridge. Thebody 2552 of the anvil-attachable layer 2550 can comprise afirst lateral slit 2558 positioned near the proximal end and extending from a firstlateral side 2566 and through themidline 2564. Thebody 2552 of the anvil-attachable layer 2550 can further comprise asecond lateral slit 2560, thesecond lateral slit 2560 being positioned proximally relative to thefirst lateral slit 2558 and extending from the secondlateral side 2568 and through themidline 2564. Thefirst lateral slit 2558 and thesecond lateral slit 2560 can define a connectingportion 2562 therebetween, which connectingportion 2562 can connect thebody 2552 of the anvil-attachable layer 2550 to theproximal end portion 2554 of thelayer 2550.
Referring primarily to fig. 188, after the anvil-attachable layer 2550 is releasably attached to the anvil of the end effector, the end effector can be closed on the patient tissue with the anvil and anvil-attachable layer 2550 on one side of the tissue and the staple cartridge and/or staple cartridge layer on the opposite side of the tissue. Next, thecutting blade 2570 can be advanced through a knife slot in the staple cartridge (such asknife slot 2418 shown in fig. 181-185) and a knife slot in the anvil, for example. Amidline 2564 of the anvil-attachable layer 2550 can be aligned with the knife slot such that thecutting blade 2570 progressively cuts the anvil-attachable layer 2550 along the midline. As thecutting blade 2570 is advanced through the anvil-attachable layer 2550 in the distal direction indicated by arrow D, itscutting edge 2572 first cuts theproximal end portion 2554 of thatlayer 2550 and then severs the connectingportion 2562, thereby separating thebody 2552 of thelayer 2550 from theproximal end portion 2554 of thelayer 2550. Thecutting blade 2570 eventually severs thebody 2552 of the anvil-attachable layer 2550. After thecutting blade 2570 is advanced through the anvil-attachable layer 2550, thelayer 2550 is divided into four pieces. Thebody 2552 of the anvil-attachable layer 2550 is separated from theproximal portion 2554 of thelayer 2550. Further, thebody 2552 of the anvil-attachable layer 2550 is divided into two pieces, 2580 and 2582; theproximal portion 2554 of the anvil-attachable layer 2550 is divided into two pieces, 2586 and 2588.
In various circumstances, a surgeon using a surgical stapler may not fully fire the stapler. For example, referring to FIG. 188, the surgeon may only advance thecutting blade 2570 and staple driver to a position half of thebody 2552 of the anvil-attachable layer 2550. Continuing with the example, at the beginning of the cutting stroke of thecutting blade 2570, thebody 2552 of the anvil-attachable layer 2550 is released from the staple cartridge as theblade 2570 severs the connectingportion 2560 of thelayer 2550. Thecutting blade 2570 then continues to advance along thecenterline 2564 to a position where thebody 2552 of the anvil-attachable layer 2550 is about half way along the length. During the above process, the staple drivers will also advance, firing and forming the staples in half of thebody 2552 of thelayer 2550 and the patient tissue that are severed by thecutting blade 2570. The other half of thebody 2552 of the anvil-attachable layer 2550 is uncut and not captured by the staples. Thecutting blade 2570 and staple driver can then be retracted and the anvil reopened. When the anvil is reopened, the portion of thebody 2552 of the anvil-attachable layer 2550 that was captured by the staples and attached to the patient tissue can be separated from the anvil. As described above, the connectingportion 2560 connecting thebody 2552 of the anvil-attachable layer 2550 to theproximal end portion 2554 can be severed before any staples are fired and thecutting blade 2570 severs any patient tissue or any portion of thebody 2552 of thelayer 2550. Thus, thebody 2552 oflayer 2550 has been released from the staple cartridge. As the surgical stapler is removed from the patient, the portion of thebody 2552 of the anvil-attachable layer 2550 that is captured by the patient's tissue can pull the remainder of thebody 2552 away from the anvil. As described in this example, the anvil-attachable layer 2550 can accommodate incomplete firing of the surgical stapler because the connectingportion 2560 of the anvil-attachable layer 2550 can be cut by thecutting blade 2570 before any staples from the staple cartridge are fired and formed in thebody 2552 of thelayer 2550.
The embodiments described in connection with fig. 181-186 can also accommodate incomplete firing of the surgical stapler. In each case, the anvil-attachable layer need not be separated from the staple cartridge with the cutting blade of the surgical stapler. In the embodiments described in connection with fig. 181-184, after partial firing of the surgical instrument, the anvil-attachable layer can be pulled away from attachment with the staple cartridge body. In the embodiments described in connection with fig. 185 and 186, the anvil-attachable layer is attached to the cartridge deck and not to the staple cartridge. As described above, the cartridge layer and the anvil-attachable layer are implanted simultaneously within the patient. Thus, whether the surgical instrument is fully fired is not relevant to separating the layers to which the anvil may be attached in the embodiment described in connection with fig. 181-186.
In various circumstances, the surgeon can use a second surgical instrument to separate the anvil-attachable layers described above in connection with fig. 181-184. For example, in various circumstances, if a surgeon is using the surgical stapler on delicate tissue (such as lung tissue), he may wish to avoid pulling the tissue hard to pull the surgical stapler away from the anvil-attachable layer. In such cases, the surgeon may introduce another surgical instrument, such as a grasping tool, to hold the stapled patient tissue and the anvil-attachable layer stationary while removing the surgical stapler from the patient. In the various embodiments of anvil-attachable layers described above in connection with fig. 185-188, the surgeon may no longer need to introduce a second surgical tool to separate the anvil-attachable layers from the surgical stapler. Referring again to the embodiment described in connection with fig. 185 and 186, an anvil-attachable layer 2510 is attached to acartridge layer 2506, which is also implanted in the patient. The anvil-attachable layer is not attached to a staple cartridge in the surgical stapler. Thus, when the stapler is removed from the patient, there is no need to pull or pull the patient tissue hard to separate the anvil-attachable layer from the staple cartridge. Referring again to the embodiment described in connection with fig. 187 and 188, at the beginning of the stroke of thecutting blade 2570, thebody 2552 of the anvil-attachable layer 2550 is mechanically separated from the surgical stapler by the cutting blade. Likewise, there is also no attachment between thebody 2552 of the anvil-attachable layer 2550 and the staple cartridge of the surgical stapler in preparation for removal of the surgical stapler from the patient after the patient tissue has been cut and stapled with the surgical stapler. Thus, thebody 2552 of the anvil-attachable layer 2550 can be separated from the staple cartridge without having to pull or pull on the patient's tissue when the stapler is removed from the patient.
Referring primarily to fig. 189-190, acompensator 27120 for asleeve 27110 can include amain body 27122 with alongitudinal protrusion 27124 extending along at least a portion of themain body 27122. Thelongitudinal protrusion 27124 can, for example, define a longitudinal path along the midline of thebody 27122. In various embodiments, when thesleeve 27110 is positioned on the anvil, thelongitudinal protrusion 27124 may be received by a longitudinal slot in the anvil. Referring primarily to fig. 191, thelongitudinal protrusion 27124 may include rounded protrusions. For example, the cross-section of thelongitudinal protrusion 27124 may form an arc and/or a partial circle. In other embodiments, thelongitudinal protrusion 27124 may include angled and/or stepped protrusions. Thecompensator 27120 can also, for example, include anedge 27126, whichedge 27126 can be straight, curved, fluted, undulating, and/or zigzagged. In various embodiments, theedges 27126 may includegaps 27128, whichgaps 27128 are configured to receive latch extensions extending from the anvil when the assembledsleeve 27110 is positioned on the anvil.
As outlined herein, a layer such as a tissue thickness compensator, for example, can be implanted in tissue by one or more fasteners ejected by the staple cartridge. In addition, as outlined herein, in various instances, the entire staple line can capture at least a portion of the layer into tissue. For example, the proximal-most staple in the staple line may capture at least a portion of the layer therein, while the distal-most staple in the staple line may also capture at least a portion of the layer therein. In some cases, a proximal portion of the layer can extend proximally relative to a proximal-most staple in the staple line, and/or a distal portion of the layer can extend distally relative to a distal-most staple in the staple line. In use, a series of layers may be implanted. In at least one such case, the layers may be implanted sequentially along the cut line. In some cases, layers may be implanted such that one layer partially overlaps another layer. For example, the distal end of the first implant layer may overlap the proximal end of the second implant layer. Likewise, the distal end of the second implant layer may overlap the proximal end of the third implant layer, and so on. Thus, some fasteners may capture a portion of two or more layers therein. Capturing two or more layers within a staple can increase the pressure applied to the captured tissue within the staple and/or increase tissue stiffness, particularly when several adjacent staples have captured more than one layer. Referring now to fig. 192-194, as described in greater detail below, thetissue thickness compensator 11050 can include aproximal end 11053 and adistal end 11055, wherein theproximal end 11053 and/or thedistal end 11055 can include one or more strain relief portions that can reduce the rigidity of thetissue thickness compensator 11050 and the rigidity of the tissue being stapled.
Referring again to fig. 192-194, thedistal end 11055 of thetissue thickness compensator 11050 can include one ormore slots 11058 defined therein. Theslots 11058 may, for example, include cuts and/or notches defined in thetissue thickness compensator 11050. Theslots 11058 may define projections ortabs 11056, which projections ortabs 11056 may be configured to be at least partially movable and/or deflectable relative to each other and/or a body portion of thetissue thickness compensator 11050. In other words, theslots 11058 may locally relieve strain in thetissue thickness compensator 11050 and the tissue below it. In some instances, thetabs 11056 of the firsttissue thickness compensator 11050 can overlap theproximal end 11053 of the secondtissue thickness compensator 11050. In various circumstances,slots 11058 can allow first and secondtissue thickness compensators 11050, 11050 to pivot relative to one another. In some cases, referring primarily to fig. 194, thetabs 11056 of the firsttissue thickness compensator 11050 can overlap thetabs 11056 of the secondtissue thickness compensator 11050. In various circumstances, theslots 11058 in the overlapping twodistal ends 11055 can also reduce rigidity within the underlying tissue. While the illustrated embodiment of thetissue thickness compensator 11050 includes an arrangement oftabs 11057 andslots 11058 on only one end thereof, the tissue thickness compensator can include an arrangement oftabs 11057 andslots 11058 on both ends thereof, for example.
In certain embodiments, in addition to the above, eachtab 11056 may include a tapered profile. For example, eachtab 11056 may include a base attached to the body of thetissue thickness compensator 11050 and having a base width and a free end opposite thereto having an end width, wherein the base width may be wider than the end width. In certain embodiments, the end width may be wider than the base width. Referring primarily to fig. 194, theend 11055 may include a plurality oftabs 11056 having different configurations. For example, thetabs 11056 may have different lengths. As shown in fig. 194, for example, the endmost tab 10056a can have a first length, the second tab 10056b can have a second length that is longer than the first length, the third tab 10056c can have a third length that is longer than the second length, the fourth tab 10056d can have a fourth length that is longer than the third length, the fifth tab 10056e can have a fifth length that is longer than the fourth length, and the sixth tab 10056f can have a sixth length that is longer than the fifth length. In such embodiments, the tab 10056 can become shorter closer to the distal end of thetissue thickness compensator 10050. In other embodiments, the tab 10056 lengths can be arranged in any other suitable arrangement.
In various instances, in addition to the above, the layer can include an edge defining a perimeter of the layer. In some cases, the edges may be straight, substantially straight, linear, and/or substantially linear. In some such cases, the layer edges may be in intimate contact and/or otherwise affect the surrounding tissue. Additionally, in some such cases, the edges may be rigid and may rigidly support tissue. In fact, some portions of the tissue adjacent to other portions of the tissue rigidly supported by the layer may be unsupported by the layer without a transition therebetween. Referring again to fig. 192-194, the perimeter of thetissue thickness compensator 11050 can include a contoured configuration that can provide an area of graduated stiffness to underlying tissue. The perimeter of thetissue thickness compensator 11050 can include a plurality of notches orgrooves 11059 defined therein, which notches orgrooves 11059 can definetabs 11057. Similar to the above, thetabs 11057 may extend from the body of thetissue thickness compensator 11050 and may be movable relative to the body. Also similar to the above, eachtab 11057 may include a base end attached to the body of thetissue thickness compensator 11050 and a free end that is movable relative to the base end. In some cases, the free end of thetab 11057 can have a width that is narrower than the width of the base end of thetab 11057, while in other cases, the free end of thetab 11057 can have a width that is wider than the width of the base end of thetab 11057. Thetabs 11057 may include any suitable configuration, such as a semi-circular configuration, or an at least partially arcuate configuration, for example. In view of the above, tissue underlying the body portion of thetissue thickness compensator 11050 and/or tissue secured to the body portion of the tissue thickness compensator can be rigidly supported by the body portion, tissue underlying thetabs 11057 and/or tissue secured to the tabs are less rigidly supported by thetabs 11057, and tissue adjacent to but not underlying thetabs 11057 can be unsupported by thetissue thickness compensator 11050.
Referring now to fig. 195 and 196, thestaple cartridge assembly 11100 can comprise acartridge body 11110 and atissue thickness compensator 11150 attached to thecartridge body 11110. Thestaple cartridge assembly 11100 can further comprise one ormore attachment members 11160, theattachment members 11160 can be configured to releasably retain thetissue thickness compensator 11150 on thecartridge body 11110. In at least one instance, each attachment member can comprise a strap that extends around thecartridge body 11110 and thetissue thickness compensator 11150. In use, in addition to the above, the firingmember 10030 can be advanced through thestaple cartridge 11100 to incise thetissue thickness compensator 11150, subsequently fire the staples at least partially stored within thecartridge body 11110, and sever theattachment member 11160. Thetissue thickness compensator 11150 can comprise a first orproximal end 11157, and a second ordistal end 11155. Thedistal end 11155 can include anelongated protrusion 11156, theprotrusion 11156 extending from abody portion 11153 of thetissue thickness compensator 11150. As shown in fig. 195, theelongated projection 11156 can extend distally relative to thedistal-most attachment member 11160. In at least the illustrated embodiment, thecartridge body 11110 can comprise adeck 11113 within which the staple cavities of thecartridge body 11110 can be defined. In various circumstances, thebody 11153 of thetissue thickness compensator 11150 can be configured and arranged such that it covers thedeck 11113 and staple cavities defined in thecartridge body 11110. In at least some instances, as also shown in fig. 195, theelongated projections 11156 can extend distally from thedeck 11113 and distally relative to a staple cavity defined within thedeck 11113.
In use, in addition to the above, thetissue thickness compensator 11150 can be secured to tissue as described herein and can provide tissue thickness compensating properties. Similar to the above, the tissue underlying thetissue thickness compensator 11150 can be rigidly supported by thetissue thickness compensator 11150 and the staples securing the tissue, while the tissue surrounding thetissue thickness compensator 11150 can be unsupported by thetissue thickness compensator 11150 and can be flexible. In such cases, an undesirable degree of strain may occur in the tissue between the unsupported, flexible tissue and the rigidly supported tissue below the tissue thickness compensator 11150 (i.e., the transitional tissue). Such strain may negatively impact the transitional tissue. For example, when securing a tissue thickness compensator to, for example, lung tissue, the tissue immediately surrounding the tissue thickness compensator (i.e., the peripheral tissue) may in some cases tear, particularly the peripheral tissue adjacent to and/or surrounding the distal end of the tissue thickness compensator (i.e., the end peripheral tissue). However, thedistal protrusion 11156 of thetissue thickness compensator 11150 can support end periphery tissue. In other words, thedistal protrusion 11156 can provide transitional support to the end periphery tissue. Such transitional support may be less than that provided by the body of thetissue thickness compensator 11150 and may mitigate strain changes between unsupported tissue and sufficiently supported tissue beneath thetissue thickness compensator 11150. In various circumstances, thedistal protrusion 11156 can provide an enlarged region in which force can be transferred between unstitched tissue and stapled tissue. Thedistal projection 11156 can be configured to flex and move with the unsupported tissue and thetissue thickness compensator 11150. In various circumstances, thedistal projection 11156 can move relative to the body portion of thetissue thickness compensator 11150 and/or the unsupported tissue.
Referring again to fig. 195 and 196, thetissue thickness compensator 11150 can further comprise anotch 11157 defined in aproximal end 11153 thereof. Thenotch 11157 may be defined between two distally extendingprojections 11158. Therecess 11157 may have any suitable shape, such as a parabolic shape, for example. Similar to the above, thedistally extending protrusion 11158 may provide transitional support to the proximal end perimeter tissue. Such transitional support may be less than the support provided by the body of thetissue thickness compensator 11150 and may mitigate strain changes between unsupported tissue and sufficiently supported tissue below thetissue thickness compensator 11150. In various instances, theproximal tab 11158 can provide an enlarged area in which force can be transferred between unstitched tissue and sutured tissue. Theproximal tab 11158 can be configured to flex and move with the unsupported tissue and thetissue thickness compensator 11150. In various circumstances, the twoproximal tabs 11158 can move relative to the body portion of thetissue thickness compensator 11150, each other, and/or the unsupported tissue. Various alternative embodiments of more than two projections extending from the proximal end and/or the distal end of the tissue thickness compensator are also contemplated.
As shown in fig. 196, two or moretissue thickness compensators 11150 may be implanted in an end-to-end fashion along a path. In such cases, thedistal end 11155 of the firsttissue thickness compensator 11150 can overlap theproximal end 11153 of the secondtissue thickness compensator 11150. Similarly, thedistal end 11155 of the secondtissue thickness compensator 11150 can overlap theproximal end 11153 of the thirdtissue thickness compensator 11150. In various circumstances, thedistal protrusion 11156 of the firsttissue thickness compensator 11150 can be aligned, or at least substantially aligned, with therecess 11157 of the secondtissue thickness compensator 11150. Additionally, in various embodiments, thedistal protrusion 11156 and theproximal recess 11158 may be sized and configured such that they have substantially the same size and/or shape. In various instances, thedistal protrusion 11156 can be configured to be positioned within theproximal recess 11157 of an adjacenttissue thickness compensator 11150.
Turning now to fig. 293 and 294, an end effector of a surgical stapling instrument can comprise a first jaw comprising acartridge channel 11390 configured to receive astaple cartridge 11300 therein and a second jaw comprising ananvil 11391. Similar to the above, thestaple cartridge 11300 can comprise acartridge body 11310 and atissue thickness compensator 11350. Thestaple cartridge 11300 can further comprise atissue abutment member 11355 attached thereto. In various circumstances, the tissue abutment member 13555 can be removably attached to thecartridge body 11310. In addition to, or in the alternative to, being removably attached to thecartridge body 11310, thetissue abutment member 11355 can also be attached to thetissue thickness compensator 11350. In at least one such embodiment, thetissue abutment member 11355 can be releasably secured to thetissue thickness compensator 11350. In use, similar to the above, fasteners can be deployed from thecartridge body 11310 to secure thetissue thickness compensator 11350 to tissue T captured between thetissue thickness compensator 11350 and theanvil 11391. In various circumstances, the fastener may not penetrate thetissue abutment member 11355. In certain other instances, the fastener can penetrate thetissue abutment member 11355 and capture at least a portion of thetissue abutment member 11355 therein and secure thetissue abutment member 11355 to the tissue T. In either case, similar to the above, at least a portion of thetissue abutment member 11355 can be configured to provide transitional support between unsupported tissue and tissue rigidly supported by the fastener below thetissue thickness compensator 11350. Thetissue abutment member 11355 may, for example, have any suitable shape, such as a tongue. In at least one embodiment, thetissue abutment member 11355 can include one ormore notches 11358 that can define atab 11356 therebetween. Once thetissue thickness compensator 11350 is positioned against and secured to the tissue T, thetissue abutment member 11355 can be configured to flex relative to thetissue thickness compensator 11350 and provide support to the tissue adjacent the distal end of thetissue thickness compensator 11350. In various instances, for example, thetissue abutment member 11355 can flex relative to thetissue thickness compensator 11350, and in addition, thetabs 11356 can flex relative to each other, the body of thetissue abutment member 11355, and/or thetissue thickness compensator 11350.
Referring again to fig. 293 and 294, at least a portion of thetissue abutment member 11355 can overlap thetissue thickness compensator 11350. In various instances, the portion of thetissue abutment member 11355 can be attached to thetissue thickness compensator 11350, for example, by one or more adhesives. In certain instances, at least a portion of thetissue abutment member 11355 can overlap one or more staple cavities defined in thecartridge body 11310 such that staples ejected from these staple cavities can capture at least a portion of thetissue abutment member 11355 therein and secure thetissue abutment member 11355 to tissue. At least a portion of thetissue abutment member 11355 can overlap thenose portion 11311 of thecartridge body 11310. In various instances, this portion of thetissue abutment member 11355 can be attached to thenose 11311, for example, by one or more adhesives. In other cases, this portion of thetissue abutment member 11355 may not be attached to thenose 11311. Referring primarily to fig. 294, at least a portion of thetissue abutment member 11355 can overlap a distal portion 11312 of thenose 11311. In various circumstances, this portion of thetissue abutment member 11355 can be unattached to the distal portion 11312 of thenose 11311. In at least some instances, a gap may be defined between thetissue abutment members 11355. At least a portion of thetissue abutment member 11355 can extend freely from thenose portion 11311 of thecartridge body 11310. In such embodiments, thetissue abutment member 11355 can comprise a cantilever.
In use, in addition to the above, thestaple cartridge 11300 can be positioned on a first side of the tissue T and theanvil 11391 can be positioned on a second side. Theanvil 11391 can then be pivoted toward thestaple cartridge 11300 about apivot axis 11392 defined in theshaft 11393 of the surgical stapling instrument. Once theanvil 11391 andstaple cartridge 11300 have been properly positioned, the staples contained within thecartridge body 11310 can be ejected therefrom, penetrate thetissue thickness compensator 11350, and secure thetissue thickness compensator 11350 to the tissue T. Thereafter, theanvil 11391 can be opened and the end effector can be moved away from the tissue T. In such instances, thecartridge body 11310 can be pulled away from thetissue thickness compensator 11350, thereby leaving thetissue thickness compensator 11350 behind in the tissue T. At the same time, thetissue abutment member 11355 can be detached from thestaple cartridge 11300 along with thetissue thickness compensator 11350. The significance of attaching thetissue abutment member 11355 to thetissue thickness compensator 11350 is that thetissue thickness compensator 11350 can hold thetissue abutment member 11355 against the tissue. In various instances, thetissue abutment member 11355 can be biased against the tissue T by thetissue thickness compensator 11350. For example, thetissue abutment member 11355 can flexibly support underlying tissue T and distribute pressure, stress, and/or strain of the tissue over a larger area as the tissue moves, stretches, and/or flexes.
Referring again to fig. 293 and 294, the end effector of the surgical instrument can comprise a tissue abutment member, such as, for example,tissue abutment member 11395 attached toanvil 11391. In various instances,tissue abutment member 11395 may be identical, or at least substantially identical, totissue abutment member 11355. In at least one instance, thetissue abutment member 11395 can includenotches 11398 defined between tabs 11396. In use, thetissue abutment member 11395 can be attached to theanvil 11391, such as with one or more adhesives, wherein thetissue abutment member 11395 can be positioned against the tissue T when theanvil 11391 is positioned relative to the tissue T and subsequently closed. Upon reopening theanvil 11391 after the staples are fired from the staple cartridge, thetissue abutment member 11395 may separate from theanvil 11391 and remain attached to the tissue T. In various circumstances, at least a portion of thetissue abutment member 11395 can be captured within the staples ejected from thecartridge body 11310, for example. In at least some such instances, thetissue abutment member 11395 can at least partially overlap with, or extend over, the staple cavities defined in theanvil 11391. In some cases, one or more adhesives (such as activatable adhesives) may be located on the tissue contacting surface oftissue abutment member 11395, for example, such thattissue abutment member 11395 adheres to tissue T. In any event, referring primarily to fig. 294,tissue abutment member 11355 and/ortissue abutment member 11395 can be used to flexibly support tissue T. In embodiments utilizing bothtissue abutment member 11355 andtissue abutment member 11395,tissue abutment members 11355 and 11395 can be comprised of the same material, or different materials.Tissue abutment members 11355 and 11395 may have the same shape and configuration, or different shapes and configurations.Tissue abutment members 11355 and 11395 may also have the same thickness or different thicknesses. Such characteristics of thetissue abutment members 11355 and 11395 may be selected so as to provide a desired support profile (profile) for tissue positioned therebetween. For example, such characteristics can be selected such that one of thetissue thickness compensators 11355 and 11395 is more rigid than the other. At the same time, these characteristics can be selected such that one of thetissue thickness compensators 11355 and 11395 is more flexible than the other.
In various instances, the tissue thickness compensator can comprise a plurality of layers. For example, the tissue thickness compensator can comprise a first layer and a second layer. Such layers may be composed of the same material or different materials. Some layers may be configured to provide different characteristics to the tissue thickness compensator. For example, the tissue thickness compensator can comprise a compressible first layer that provides tissue thickness compensation properties, and a more rigid second layer that can support the first layer. Referring primarily to fig. 197 and 198, atissue thickness compensator 11250 can comprise afirst layer 11251 and asecond layer 11252. Thesecond layer 11252 is compressible and can provide tissue thickness compensation properties. Thefirst layer 11251 can be rigid and can support thesecond layer 11252. Thesecond layer 11252 can be positioned against thecartridge body 11210 and/or attached to thecartridge body 11210, for example. In certain instances, thefirst layer 11251 can comprise alongitudinal channel 11253 extending along its length, whichlongitudinal channel 11253 can be sized and configured to be releasably retained in alongitudinal knife slot 11215 defined in thecartridge body 11210. In various instances, thesecond layer 11252 can be secured to thefirst layer 11251 and held in place by thefirst layer 11251.
Referring again to fig. 197 and 198, thecompensator 11250 can comprise a plurality of layers. Additionally, the outer perimeter 11218 of thesecond layer 11252 can extend at least partially beyond theouter perimeter 11220 of thefirst layer 11251. Further, thefirst layer 11251 and thesecond layer 11252 can include different degrees of stiffness. For example, thesecond layer 11252 may be softer than thefirst layer 11251. Such an arrangement may providetissue thickness compensator 11250 with a sufficiently rigid inner region comprised offirst layer 11251 andsecond layer 11252 that may be adapted to provide sufficient support tostaples 11260 and a sufficiently flexible outer region comprised ofsecond layer 11252 that may be adapted to provide sufficient flexibility to alleviate the burden placed on tissue T, for example, during and/or after tissue T andtissue thickness compensator 11250 are captured bystaples 11260. Thefirst layer 11251 and thesecond layer 11252 can be joined together, for example, by an adhesive. Other attachment means for attaching thefirst layer 11251 to thesecond layer 11252 are also contemplated within the scope of the present disclosure.
In addition to the above,first layer 11251 can include aninterior portion 11254 and anexterior portion 11256 at least partially surroundinginterior portion 11254, whereinexterior portion 11256 can be more flexible thaninterior portion 11254. For example, theouter portion 11254 may include a plurality ofslits 11210, theslits 11210 may increase the flexibility of theouter portion 11254. Further, as described above, thesecond layer 11252 may be configured to be more flexible than thefirst layer 11251. This arrangement can provide thetissue thickness compensator 11250 with three regions of different stiffness, including a first inner region, a middle region, and a third, outer region. The first interior region, which is comprised of theinterior portion 11254 of thefirst layer 11251, has the greatest rigidity; an intermediate region having an intermediate level of rigidity, the intermediate region being formed by anouter portion 11256 of thefirst layer 11251 and thesecond layer 11252; the third region has the least rigidity and is composed of only thesecond layer 11252.
Thesecond layer 11252 of thetissue thickness compensator 11250 can have a fabric structure that can include a plurality of fibers that can be woven into the fabric structure. The fabric structure may provide thesecond layer 11252 with sufficient flexibility to reduce the burden imposed on the tissue T, for example, during and/or after the tissue T andtissue thickness compensator 11250 are captured bystaples 11260. Further, outer periphery 11218 may be comprised of fibers that may provide an atraumatic tissue contacting surface to minimize the burden placed on tissue T as described above. The fabric structure and fibers may be constructed of biocompatible materials. Furthermore, the above-described textile structures and/or fibers may be constructed, for example, from bioabsorbable materials such as PLLA, PGA, PCL, and/or combinations thereof.
Referring to fig. 199-201, the staple cartridge channel can be configured to receive astaple cartridge 1060, wherein thestaple cartridge 1060 can comprise acartridge body 1062, acartridge deck 1064, and supports 1065. In addition, a tissue thickness compensator (e.g., tissue thickness compensator 1100) can be removably positioned against thecartridge deck 1064 or adjacent thecartridge deck 1064, as shown in fig. 199.
Referring again to fig. 199-201, the tissue thickness compensator can be absorbed by tissue after implantation in a patient. This absorption process may initially break down the tissue thickness compensator into smaller pieces that include rough edges that can adversely affect the surrounding tissue T. To mitigate these adverse effects, thetissue thickness compensator 1100 can be at least partially assembled from a plurality ofpieces 1140, each of which has an atraumatic outer periphery and can be bonded together to form a single structure, as shown in fig. 201. The manner in which thetabs 1140 are joined to form thetissue thickness compensator 1100 is such that the absorption process first breaks thetissue thickness compensator 1100 intoseveral tabs 1140, thereby minimizing the possibility of rough edges. For example, thepanels 1140 may have a circular profile and may be thermally bonded together to form thetissue thickness compensator 1100. Other contours of thetabs 1140 and other ways of joining thetabs 1140 together are also contemplated within the scope of the present disclosure. In one example, thesheets 1140 are joined together by an adhesive 1143 (see fig. 200). The adhesive 1143 is absorbed by the tissue more quickly than thesheets 1140, so that thesheets 1140 can be separated from each other at an initial stage of the absorption process. As shown in fig. 200, the plurality ofsheets 1140 may be arranged in a stacked array wherein an end portion of onesheet 1140 may overlap an end portion of anothersheet 1140 such that the two end portions of the plurality ofsheets 1140 may be releasably attached to one another, such as by an adhesive. In some cases, the plurality ofsheets 1140 may be arranged in another stacked array, wherein one of thesheets 1140 may be positioned over the plurality ofsheets 1140 and releasably attached to theseveral sheets 1140, as shown in fig. 201.
Referring to fig. 202-204, as described above, the tissue thickness compensator is capable of being absorbed by tissue after implantation in a patient, and the absorption process may initially break the tissue thickness compensator up into random small pieces. As mentioned above, by starting with a patch having an atraumatic outer edge, guidance of the absorption process may be achieved to produce a patch having an atraumatic outer edge. Another method may include modifying the tissue thickness compensator in the following manner: it can be split into smaller pieces with an atraumatic periphery at the initial stage of the absorption process. For example, as shown in fig. 202, thetissue thickness compensator 1200 can, for example, comprise a pattern, such as pattern 1212, which can be molded or engraved into thetissue thickness compensator 1200 to create, for example, a plurality ofrounded portions 1210. Theportion 1210 can be defined by reducing the thickness of thetissue thickness compensator 1200 along theperimeter 1214 of thecircular portion 1210, as shown in the cross-sectional view 202A. Thus, those portions of thetissue thickness compensator 1200 along theperimeter 1214 of thecircular portion 1210 may be more quickly absorbed by tissue, which may cause thecircular portions 1210 to separate from each other during the initial stages of the absorption process. Other patterns including portions having other geometries and atraumatic outer perimeters are also contemplated within the scope of the present disclosure. For example, as shown in fig. 203, the tissue thickness compensator 1200 'can have apattern 1216, thepattern 1216 including a plurality ofportions 1218, the contours of which can extend longitudinally in an undulating curve along the length of the tissue thickness compensator 1200'. In another example, as shown in fig. 204, thetissue thickness compensator 1200 "can comprise apattern 1220, and thepattern 1220 can comprise a plurality of hexagonal shapedportions 1222.
Referring to fig. 205, as described above, a tissue thickness compensator, such astissue thickness compensator 1250, can be captured, for example, along tissue T by staples, such asstaples 1002, and can be configured to break down into several atraumatic pieces, such aspieces 1226, at an initial stage of the absorption process, for example, after being implanted in a patient. Once separated, thepieces 1226 may move and/or slide relative to each other, which may affect the surrounding tissue T. To minimize relative movement between thepieces 1226, the firedstaples 1002 can be spatially arranged onto thetissue thickness compensator 1250 such that thestaples 1002 can capturemultiple pieces 1226, as shown in fig. 205. Such an arrangement may also help thetissue thickness compensator 1250 to remain a substantially unitary structure even if the plurality ofsheets 1226 are separated from one another during the initial stages of the absorption process. Thus,tissue thickness compensator 1250 can continue to provide support to tissue T captured bystaples 1002 afterpieces 1226 are separated from one another during the initial stages of the absorption process.
In addition to the above, referring now to fig. 206, yet another method may be employed to guide the absorption process of the tissue thickness compensator to produce a sheet having an atraumatic outer edge. For example, as shown in fig. 206, a tissue thickness compensator, such astissue thickness compensator 1300, can include a plurality ofslits 1310, theslits 1310 being strategically positioned to enhance the flexibility of thetissue thickness compensator 1300 as described above. In addition, theslits 1310 may partially divide thetissue thickness compensator 1300 into a plurality ofportions 1312 that may be separated from each other at an initial stage of the absorption process. Theslits 1312 can reduce the width of thetissue thickness compensator 1300 along theouter perimeter 1314 of theportion 1312, as shown in fig. 206. The reduction in width may result inportions 1312 being absorbed faster alongouter perimeter 1314, which may causetissue thickness compensator 1300 to break down intoseparate portions 1312 at an initial stage of the absorption process.
Referring to fig. 207A and 207B, an end effector of a surgical stapling instrument can comprise a first jaw and a second jaw, wherein at least one of the first jaw and the second jaw can be configured to move relative to the other jaw. In certain embodiments, the end effector can comprise a first jaw with astaple cartridge channel 1010, and a second jaw with an anvil 1012 (fig. 207B), wherein theanvil 1012 can pivot toward thestaple cartridge channel 1010 and/or away from thestaple cartridge channel 1010, for example. Thestaple cartridge channel 1010 can be configured to receive astaple cartridge 1020, thestaple cartridge 1020, for example, can be removably retained within thestaple cartridge channel 1010. Other embodiments may include staple cartridges that are not easily removable from thestaple cartridge channel 1010. Thestaple cartridge 1020 can comprise acartridge body 1022, acartridge deck 1024, and alayer 1000, wherein thelayer 1000 can be removably positioned against or adjacent to thecartridge deck 1024, as shown in fig. 207A.
Similar to the other embodiments described herein, referring again to fig. 207A and 207B, thecartridge body 1022 can comprise a plurality ofstaple cavities 1026 andstaples 1002 positioned within eachstaple cavity 1026. Also similar to the other embodiments described herein, thestaples 1002 can be supported bystaple drivers 1028 positioned within thecartridge body 1022. Wherein the sled and/or firing member can be advanced through thestaple cartridge 1020, for example, to lift thestaple drivers 1028 upwardly within thestaple cavities 1026 and eject thestaples 1002 from thestaple cavities 1026, as illustrated in fig. 207B. Asstaples 1002 are ejected fromstaple cavities 1026, tissue T and/orlayer 1000 can be captured bystaples 1002, as shown in fig. 207B.
Layer 1000 may be constructed of a biocompatible material. Additionally,layer 1000 can be constructed of, for example, a bioabsorbable material such as PLLA, PGA, PCL, and/or combinations thereof. In at least one embodiment, thelayer 1000 can include a tissue thickness compensator that can include internal compression features designed to compensate for the thickness of the tissue T as thelayer 1000 and the tissue T are captured by thestaples 1002 as described above.
Referring again to fig. 207B, thelayer 1000 can include atissue contacting surface 1003, and thetissue contacting surface 1003 can be configured to reduce slippage between thelayer 1000 and tissue T positioned against thelayer 1000. The pressure applied against the tissue T in contact with thetissue contacting surface 1003 may depend in part on the contact area between the tissue T and thetissue contacting surface 1003. Since this pressure is inversely proportional to the area, reducing the contact area may result in higher pressure against the tissue T and, in turn, may result in better slip protection. Thetissue contacting surface 1003 may include a plurality ofcleats 1030, thecleats 1030 comprising a smaller contact area, wherein thecleats 1030 may reduce slippage between thelayer 1000 and tissue T positioned against thelayer 1000.Layer 1000 withcleats 1030 may be formed, for example, by compression molding techniques. Alternatively, thelayer 1000 can be fabricated and thecleats 1030 formed on thetissue contacting surface 1003, for example, by laser and/or chemical etching techniques that can create a plurality of protruding structures. In addition,cleats 1030 may include micro-scale and/or nano-scale structures formed ontissue contacting surface 1003 using, for example, photolithographic techniques. Photolithography techniques can generally use a pre-fabricated photomask as a master from which the final pattern of micro-and/or nano-scale cleats can be obtained. Other techniques for forming micro-scale and/or nano-scale cleats 1030 are also contemplated within the scope of the present disclosure, and these techniques may be employed to produce the desiredcleats 1030. In one example, thecleats 1030 can be fabricated using electron beam lithography.
Referring now to fig. 207C-224,cleats 1030 may include a plurality of shapes. For example, as shown in fig. 207C, thetissue contacting surface 1003 can includecylindrical cleats 1038, and thesecylindrical cleats 1038 can include square and/or rectangular bases and generally perpendicular sides that extend generally away from thetissue contacting surface 1003. Additionally, thecylindrical cleats 1038 may terminate in a generally narrower top portion ortip 1040, as shown in cross-section 208. In addition,tissue contacting surface 1003 can include conical cleats 1032 (as shown in fig. 218), pyramidal cleats 1034 (as shown in fig. 219), and/or dome-shaped cleats 1042 (as shown in fig. 211). Pyramid-shapedcleats 1034 may include square and/or triangular bases, as well as sloped sides that may extend generally away from tissue-contactingsurface 1003 and terminate at atop portion 1036, as shown in cross-section in fig. 220.
Thecleats 1030 may be spatially arranged in a predetermined pattern or array on thetissue contacting surface 1003. For example,cleats 1030 may be arranged ontissue contacting surface 1003 in a plurality of rows that extend longitudinally along the length ofsurface 1003 in space and parallel to one another. Thecleats 1030 may also be arranged in a spatial loop. For example,cleats 1030 may be arranged in concentric circles. Alternatively,cleats 1030 may be randomly positioned ontissue contacting surface 1003.
In addition to the above, thetissue contacting surface 1003 can havecleats 1030 that include multiple shapes, multiple heights, and/or multiple spatial arrangements to avoid the aforementioned slippage to varying degrees along various regions of thetissue contacting surface 1003. For example, a greater degree of slippage avoidance may be desired at and/or around the region of thetissue contacting surface 1003 where thestaples 1002 are configured to penetrate and capture the tissue T.
Referring to fig. 209, 210, and 215-217,layer 1000 can includelinear protrusions 1044, which can be disposed ontissue contacting surface 1003.Linear protrusions 1044 may extend longitudinally. For example,linear protrusions 1044 may extend parallel to each other along the length oflayer 1000, as shown in fig. 209. Alternatively,linear protrusions 1044 may extend along the width oflayer 1000, as shown in fig. 215. In addition, longitudinal and transverselinear protrusions 1044 may form a cross-shaped path. For example, as shown in fig. 217, afirst pattern 1046 oflinear protrusions 1044 may extend parallel to a first direction ontissue contacting surface 1003, and asecond pattern 1048 oflinear protrusions 1044 may extend parallel to a second direction ontissue contacting surface 1003, wherein the first direction may be perpendicular or substantially perpendicular to the second direction. Further,linear protrusions 1044 may have substantially uniform cross-sectional areas as shown in section area 210. Alternatively,linear protrusions 1044 may have different cross-sectional areas (not shown). In some cases, thefirst pattern 1046 and thesecond pattern 1048 may be continuous or discontinuous.
In addition to the above,layer 1000 may include non-linear protrusions, which may be provided ontissue contacting surface 1003 alone or in combination withlinear protrusions 1044. In addition, in combination withcleats 1030,linear protrusions 1044 and/or non-linear protrusions may be provided ontissue contacting surface 1003 to avoid slippage within desired limits.
Referring to fig. 213 and 214,layer 1000 can include a plurality ofrecesses 1050 that can be etched intotissue contacting surface 1003, as shown in fig. 223. Thedepression 1050 may comprise a substantially uniform socket shape, as shown in fig. 224. Alternatively, therecesses 1050 may include different depths, which may avoid slippage to varying degrees along various regions of thetissue contacting surface 1003. In general, deeper individual depressions can make the regions in which they are located softer and make such regions more susceptible to disintegration. Further, as described above in connection withcleats 1030, recesses 1050 may comprise a variety of shapes and/or spatial arrangements. Additionally,layer 1000 may include a combination ofindentations 1050 andcleats 1030 spatially disposed ontissue contacting surface 1003. In some cases,cleats 1030 andrecesses 1050 may be arranged in an alternating pattern.
Referring again to fig. 223 and 244,layer 1000 may includelinear depressions 1052 similar to linear protrusions 1044 (described above), which may, for example, extend longitudinally along the length oflayer 1000 and parallel to one another as shown in fig. 223. Furthermore,layer 1000 may comprise a combination oflinear depressions 1052 andlinear protrusions 1044 spatially arranged ontissue contacting surface 1003, e.g., in an alternating pattern. Further, referring now to fig. 221 and 222, the combinations oflinear depressions 1052 andlinear protrusions 1044 may be arranged in acorrugated pattern 1054, as shown in fig. 221.
Referring now to fig. 244-246, a tissue thickness compensator, such ascompensator 22320, for example, can comprise a plurality offirst cavities 22322a and a plurality ofsecond cavities 22322b, thefirst cavities 22322a and thesecond cavities 22322b can be aligned withstaple forming pockets 22062a and 22062b, respectively. Referring primarily to fig. 245,staple forming pockets 22062a and 22062b can be defined in separate stepped surfaces on theanvil 22060. More specifically, for example,staple forming pockets 22062a can be defined in afirst surface 22069a of theanvil 22060 andstaple forming pockets 22062b can be defined in asecond surface 22069b of theanvil 22060, wherein thefirst surface 22069a can be positioned offset, or higher, relative to thesecond surface 22069 b. Thefirst cavity 22322a of thetissue thickness compensator 22320 can be larger than thesecond cavity 22322b, wherein in at least one such embodiment, thefirst cavity 22322a can extend higher than thesecond cavity 22322 b. In view of the above, thefirst cavities 22322a can extend upwardly into the firststaple forming pockets 22062a while thesecond cavities 22322b can extend upwardly into the secondstaple forming pockets 22062 b. Thefirst cavity 22322a and/or thesecond cavity 22322b can be configured to contain a drug.
In addition to the above, thefirst cavities 22322a can be arranged in certain rows and thesecond cavities 22322b can be arranged in different rows. Thefirst cavities 22322a and/or thesecond cavities 22322b can be configured to fit snugly within thestaple forming pockets 22062a and/or 22062b, respectively. Further, thetissue thickness compensator 22320 can be assembled to theanvil 22060 such that thesecond layer 22327 of thecompensator 22320 is positioned against thesecond surface 22069b of theanvil 22060. Referring now to fig. 247 and 248, thecompensator 22320 can be positioned adjacent to theanvil 22060 such that thecompensator 22320 can abut theanvil 22060 when theanvil 22060 is displaced toward thestaple cartridge 22000 compressing the tissue T therebetween.
Referring now to fig. 224A and 224B, similar to the above, thelayer 1000 can also be positioned adjacent to theanvil 1012 such that thelayer 1000 can abut theanvil 1012 when theanvil 1012 is displaced toward thestaple cartridge 1020 compressing the tissue T therebetween. Also similar to the above, thelayer 1000 can be captured by thestaples 1002 after thestaples 1002 are ejected from thestaple cavities 1026 by thestaple drivers 1028. Specifically, as shown in fig. 224A and 224B, thestaple 1002 can include abase 1060, afirst deformable member 1062, and asecond deformable member 1064. Thefirst deformable member 1062 includes afirst apex 1063 and thesecond deformable member 1064 includes asecond apex 1065, the second apex 1065 together with the first apex 1063 can penetrate thelayer 1000 to their correspondingstaple forming pockets 1066 and 1068 as thestaple 1002 is driven out of thestaple cavity 1026 by thestaple driver 1028. In addition, thetips 1063 and 1065 can each re-penetrate thelayer 1000 as thetips 1063 and 1065 are directed in a return path away from thestaple forming pockets 1066 and 1068, respectively.
Referring again to fig. 224A,layer 1000 may include a plurality ofportions 1070 that may include a reduced thickness relative to the remainder oflayer 1000. For example, as shown in fig. 224A,layer 1000 may include a substantially uniform thickness "a" andportion 1070 may include a thickness that is less than thickness "a". In addition, thelayer 1000 can be aligned with thestaple cartridge 1020 such that, once thestaples 1002 are fired, thetips 1063 and 1065 of thestaples 1002 can penetrate the tissue T and the entire thickness "a" of thelayer 1000 as thetips 1063 and 1065 of thedeformable members 1062 and 1064 travel toward therespective pockets 1066 and 1068, and can penetrate this reduced thickness of theportion 1070 as it is directed out of thestaple forming pockets 1066 and 1068, respectively. The reduced thickness ofportion 1070 may facilitate re-penetration oftips 1063 and 1065 frompockets 1066 and 1068, respectively, into tissue T on the return path oftips 1063 and 1065.
Referring now to fig. 224B,layer 1000 can include a plurality ofprotrusions 1080, which can include an increased thickness relative to the remainder oflayer 1000. For example, as shown in fig. 224B,layer 1000 can include a substantially uniform thickness "a" andprotrusions 1080 can include a thickness "a + B" that is greater than thickness "a". Thelayer 1000 can be aligned with thestaple cartridge 1020 such that once thestaples 1002 are fired, thetips 1063 and 1065 of thestaples 1002 can penetrate the tissue T and the thickness "a" of thelayer 1000 as thetips 1063 and 1065 of thedeformable members 1062 and 1064 travel toward therespective pockets 1066 and 1068. Additionally,tips 1063 and 1065 ofstaples 1002 may penetrate through thickness "a" oflayer 1000 as they are directed out ofrecesses 1066 and 1068, respectively, thereby wrapping or substantially wrappingdeformable members 1062 and 1064 at least partially aroundprotrusions 1080. In other words, tissue T andprotrusions 1080 can be captured between each ofdeformable members 1062 and 1064 andbase 1060 ofstaple 1002. In addition to the above, theprotrusions 1080 can be arranged in rows and can be configured to fit snugly within the staple forming pockets of theanvil 1020. For example, as shown in fig. 224B, theprotrusions 1080 can have a curved profile configured to matingly engagestaple forming pockets 1066 and 1068.
As described above, certain embodiments of the surgical stapler can include a layer disposed on an anvil surface of the end effector, such as a buttress material and/or a tissue thickness compensator. The layer may be susceptible to movement and/or misalignment. For example, if the surgeon drags the layer across the tissue as the surgical stapler is positioned prior to stapling the tissue, the layer will move relative to the anvil. In certain embodiments, the layer can include releasable retention features for attaching it to the anvil such that the layer is retained in alignment with the anvil until the surgical stapler is fired. In certain embodiments, the releasable retention feature may be implanted in the patient.
In certain embodiments, referring now to fig. 225-227, an anvil-attachable layer 33420 (such as a buttress material and/or a tissue thickness compensator) may comprise ahousing 33426, acavity 33424 defined in thehousing 33426, and acore 33425 positioned within thecavity 33424. In at least one such embodiment, for example, thehousing 33426 can comprise a film body formed from a continuous extrusion, and thecore 33425 can comprise a fibrous drug core (such as an ORC). In at least one embodiment, thehousing 33426 can comprise one or moreflexible legs 33423 that can be configured to extend into aknife slot 22063 defined in theanvil 22060 and releasably retain the anvil-attachable layer 33420 to theanvil 22060.
In certain other embodiments, referring to fig. 244-248, an anvil-attachable layer 22320 (such as a buttress material and/or a tissue thickness compensator) can be attached to theanvil 22060. In at least one embodiment, the anvil-attachable layer 22320 can comprisecavities 22322a and/orcavities 22322b that can be configured to fit snugly within thestaple forming pockets 22062a and/or 22062b, respectively. The snug fit may releasably retain the anvil-attachable layer 22320 relative to theanvil 22060. In certain embodiments, the anvil-attachable layer 22320 can be assembled to theanvil 22060 such that thesecond layer 22327 of the anvil-attachable layer 22320 is positioned against thesecond surface 22069b of theanvil 22060. In certain other embodiments, referring now to fig. 247 and 248, the anvil-attachable layer 22320 can be positioned adjacent to theanvil 22060 such that the anvil-attachable layer 22320 can abut theanvil 22060 when theanvil 22060 is displaced toward thestaple cartridge 22000 compressing the tissue T therebetween.
Referring to fig. 228-234, the retainer can be used to align and attach the anvil-attachable layer to the anvil of the end effector. Referring primarily to fig. 229 and 230, the anvil-attachable layer 2030 can include abody 2034 and aprotrusion 2036 extending from thebody 2034. Referring to fig. 231-234, theprotrusion 2036 can be engaged with aslot 2048, such as a knife slot, in theend effector anvil 2042. In some embodiments,protrusions 2036 may be wider thanslots 2048, such thatprotrusions 2036 are compressed when inserted intoslots 2048. In certain embodiments, theprotrusion 2036 can be deformed such that it bulges outward and presses against a surface of theslot 2048. The compressive force between theprotrusions 2036 and theslots 2048 can provide a retention force that secures the anvil-attachable layer 2030 relative to theanvil 2042.
Anvil-attachable layer 2030 is releasably attachable toholder 2000. Theretainer 2000 can align the anvil-attachable layer 2030 with theanvil 2042 and attach the anvil-attachable layer 2030 to theanvil 2042. Embodiments of theretainer 2000 may include acover 2006 andtabs 2008 and 2010 extending from the cover 2006 (tabs 2010 are shown in fig. 228-230). As shown in fig. 229 and 230, the tabs are configured to engage thestaple cartridge 2020 and releasably retain thestaple cartridge 2020 to theretainer 2000. The retainer can further include agrip portion 2002 extending from thecover 2006, and a user can insert theretainer 2000, thestaple cartridge 2020, and the anvil-attachable layer 2030 into thestaple cartridge channel 2040 of the end effector by gripping thegrip portion 2002.
Holder 2000 may also includetabs 2014 extending fromcover 2006. In certain embodiments, theretainer 2000 can include twotabs 2014, onetab 2014 extending from each lateral side of thecover 2006. As best seen in fig. 228, eachtab 2014 may include an inwardly facinggroove 2016 and an inwardly facing angledsurface 2018. Referring to fig. 229 and 230, lateral edges of the anvil-attachable layer 2030 can engage withgrooves 2016 intabs 2014. In various embodiments, the anvil-attachable layer 2030 and thecover 2006 of theretainer 2000 can define a gap therebetween when the anvil-attachable layer 2030 is engaged in theslot 2016 of theretainer 2000. The anvil-attachable layer 2030 may be arranged on theholder 2000 such that theprotrusions 2036 of thelayer 2030 extend away from theholder 2000. As best seen in fig. 228 and 231,retainer 2000 may further include a raisedridge 2022 extending fromcover 2006. As can be clearly seen in fig. 231, raisedridges 2022 ofretainer 2000 may be aligned withprotrusions 2036 of anvil-attachable layer 2030.
In use, a surgeon, nurse, clinician or other user may insert thestaple cartridge 2020 into thestaple cartridge channel 2040 of the end effector, close the anvil onto the retainer to release and attach the anvil-attachable layer to the anvil, and then remove the retainer from the end effector. Referring primarily to fig. 231-234, a user may grasp the retainer 2000 (by grasping the grasping portion 2002) and insert thestaple cartridge 2020 into thestaple cartridge channel 2040 of the end effector. Upon insertion of thestaple cartridge 2020 into thestaple cartridge channel 2040 of the end effector, thetabs 2008 of theretainer 2000 may be engaged with thestaple cartridge channel 2040. Fig. 231 shows thestaple cartridge 2020 loaded into thestaple cartridge channel 2040 with theretainer 2000 andanvil attachable layer 2030 positioned on top of thestaple cartridge 2020. Fig. 231 also shows that theanvil 2042 of the end effector is positioned over the anvil-attachable layer 2030 and theretainer 2000. Referring now to fig. 232, theanvil 2042 may be moved toward theretainer 2000 and the anvil-attachable layer 2030. As theanvil 2042 is moved, asurface 2044 of theanvil 2042 may come into contact with thebody 2034 of the anvil-attachable layer 2030. Further, a slot 2046 (such as a knife slot) of theanvil 2042 may engage with aridge 2036 of the anvil-attachable layer 2030. Additionally, as theanvil 2042 is moved toward thestaple cartridge 2020,lateral edges 2050 of theanvil 2042 may engage the inwardly facingangled surfaces 2018 of thefilm retention tabs 2014, pushing thetabs 2014 outwardly such that the inwardly facingchannels 2016 may move away from the lateral edges of the anvil-attachable layer 2030.
Continued movement of theanvil 2042 toward the anvil-attachable layer 2030 may push the anvil-attachable layer 2030 toward thecover 2006 of theholder 2000. Additionally, as theanvil 2042 continues to move toward thestaple cartridge 2020, the raisedridges 2022 of theretainer 2000 will support theprotrusions 2036 of theanvil attachable layer 2034 as theprotrusions 2036 engage theslots 2046 of theanvil 2042. As described above, the raisedridge 2022 of theretainer 2000 can deform theprotrusions 2036 of the anvil-attachable layer 2030 such that the outer dimensions of theprotrusions 2036 of the anvil-attachable layer 2030 extend outward. In other words, as theprotrusions 2036 of the anvil-attachable layer 2030 enter theslots 2046 of theanvil 2042, the raisedridges 2022 of theretainer 2000 can press into the anvil-attachable layer 2030 under theprotrusions 2036, causing theprotrusions 2036 to bulge and/or expand into theslots 2046 of theanvil 2042. The expandedprotrusions 2036 in contact with theslots 2046 can retain theridges 2036 of the anvil-attachable layer 2030 within theslots 2046. Theslot 2046 can include alip 2048, and thelip 2048 can capture at least a portion of theprotrusion 2036, more securely retaining theprotrusion 2036 within theslot 2046 of theanvil 2042.
Referring now to fig. 233, as theanvil 2042 is moved away from theretainer 2000, theanvil 2042 carries the anvil-attachable layer 2030 therewith away from theretainer 2000. As shown in fig. 234, after theanvil 2042 and anvil-attachable layer 2030 are moved away from theretainer 2000, theretainer 2000 can be removed from the end effector leaving the anvil-attachable layer 2030 andstaple cartridge 2020 in place.
Referring again to fig. 229 and 230, in certain embodiments, theproximal end 2032 of the anvil-attachable layer 2030 may be attached to thestaple cartridge 2020. For example, the anvil-attachable layer 2030 may be attached to thestaple cartridge 2020 using an adhesive, spot welding, and/or heat staking. In various embodiments, the anvil-attachable layer 2030 is attached to theanvil 2042 and, upon reopening theanvil 2042, the anvil-attachable layer 2030 may be separated from thestaple cartridge 2020. In various other embodiments, the anvil-attachable layer 2030 may remain attached to thestaple cartridge 2020 until the staples in the staple cartridge are fired and the attendant anvil-attachable layer 2030 is captured within the fired staples.
Fig. 235 shows an anvil-attachable layer 2030 separate fromretainer 2000. Fig. 236 and 237 illustrate other embodiments of anvil attachable layers. Fig. 236 illustrates an anvil-attachable layer embodiment 2060 comprising amain body 2064 anddiscrete protrusions 2062 extending therefrom. Fig. 237 illustrates another anvil-attachable layer embodiment 2070 comprising abody 2074 anddiscrete protrusions 2072 extending therefrom. For example, eachdiscrete protrusion 2072 can comprise apeg 2073 extending from the body of the anvil-attachable layer 2070 and acap 2075 extending from thepeg 2073. In certain embodiments, thecap 2075 may have a larger dimension than thepeg 2073 such that when theprojection 2072 is inserted into theslot 2046, the cap may extend over thelateral edge 2048 in theslot 2046 of theanvil 2042.
Referring now to fig. 238-243, various embodiments of the anvil-attachable layer can include one or more deployable attachment features that can be formed in the body of the anvil-attachable layer. Fig. 238-240 illustrate an anvil-attachable layer 2080 embodiment, such anvil-attachable layer 2080 including abody 2082 and a series of deployable attachment features 2084 formed in thebody 2082. Eachdeployable attachment feature 2084 can be formed in thebody 2082 by forming ahole 2085 in thebody 2082. Eachdeployable attachment feature 2084 can include alongitudinal portion 2086 attached to thebody 2082, and atransverse portion 2088 attached to thelongitudinal portion 2086. In various embodiments,longitudinal portion 2086 may be attached tobody 2082 by ahinge 2087.Apertures 2085 and hinges 2087 surrounding eachdeployable attachment feature 2084 may allow deployable attachment features 2084 to move between an undeployed configuration and a deployed configuration, as described in more detail below. In various other embodiments,hinge 2087 may not be present. In such embodiments, the deployable attachment features 2084 can be bent, for example, about thelongitudinal portion 2086, to move between an undeployed configuration and a deployed configuration.
Fig. 238 shows deployable attachment features 2084 in an undeployed configuration, wherein eachdeployable attachment feature 2084 lies substantially in the plane of abody 2082 of alayer 2084 attachable by a defined anvil. Fig. 239 shows deployable attachment features 2084 in a deployed configuration, where eachdeployable attachment feature 2084 extends out of a plane defined by abody 2082 of an anvil-attachable layer 2080. For example,deployable attachment feature 2084 may rotate abouthinge 2087 to extend out of the plane defined bybody 2082. As shown in fig. 240, the deployable attachment features 2084 can be deployed into theslots 2046 of theanvil 2042. The deployable attachment features 2084, when deployed, can extend withlongitudinal portions 2086 intoslots 2046 of theanvil 2042 andlateral portions 2088 can extend further into theslots 2046. In various circumstances, alateral portion 2088 of thedeployable attachment feature 2084 can engage with alip 2048 in theslot 2046 to provide a stronger retention force between the anvil-attachable layer 2080 and theanvil 2042. Further, engagement of alateral portion 2088 of thedeployable attachment feature 2084 with alip 2048 in aslot 2046 may prevent thedeployable attachment feature 2084 from returning to an undeployed position. In certain embodiments, thelongitudinal portion 2086 of eachdeployable attachment feature 2084 may be shorter than thenarrow portion 2047 of theslot 2046. In such embodiments, tension may be applied tolongitudinal portion 2086 astransverse portion 2088 engageslip 2048 inslot 2046. Tension in thelateral portion 2088 may hold thebody 2082 of the anvil-attachable layer 2080 tight against theanvil 2042.
Thebody 2082 and the deployable attachment features 2084 can be formed from a single body. Anaperture 2085 may then be formed in thebody 2082, for example, by cutting anaperture 2085 in thebody 2082. Theholes 2085 may be cut with a punch tool, a cutting blade, a laser, or any other suitable device. In various other embodiments, the anvil-attachable layer 2080 and theaperture 2085 can be formed in a mold. In certain embodiments, theaperture 2085 can include a gap between thebody 2082 and the deployable attachment features 2084. In certain other embodiments, theaperture 2085 does not provide clearance between thebody 2082 and the deployable attachment features 2084. In various embodiments, for example, anvil-attachable layer 2080 interposed betweenbody 2082 andlongitudinal portion 2086 may be thinned or scored, thereby forminghinge 2087. In various other embodiments, the hinge can be formed without changing the thickness between thebody 2082 and thelongitudinal portion 2086 of thedeployable attachment feature 2084.
Fig. 238-240, which have been described above, illustrate an anvil-attachable layer 2080 embodiment in which deployable attachment features 2084 all include arounded lateral portion 2088. Thetransverse portion 2088 may have other suitable shapes including, but not limited to, triangular, elliptical, and polygonal. For example, fig. 241-243 illustrate an anvil-attachable layer 2090 embodiment, where deployable attachment features 2094 each include atransverse portion 2098 having a rectangular cross-section. Eachdeployable attachment feature 2094 may be attached to themain body 2092 by ahinge 2097.
In certain embodiments, the body of the anvil-attachable layer and the deployable attachment features may comprise flexible and/or resilient materials. For example, referring again to fig. 238-240, thebody 2082 and deployable attachment features 2084 of the anvil-attachable layer 2080 can comprise a flexible and/or elastic material. As another example, referring to fig. 241-243, thebody 2092 of the anvil-attachable layer 2090 and thedeployable attachment feature 2094 may comprise a flexible and/or elastic material. Referring to the anvil-attachable layer 2080 of fig. 238-240, as eachdeployable attachment feature 2084 is deployed into a slot 2046 (such as a knife slot) of theanvil 2042, thelateral portion 2088 can flex and/or deform to pass through thenarrow portion 2047 of theslot 2046. Then, aslateral portion 2088 extends pastlip 2048 ofslot 2046 and intowide portion 2049 ofslot 2046,lateral portion 2088 may resume an undeflected and/or undeformed shape. During the return oflateral portion 2088 to the undeflected and/or undeformed shape,lateral portion 2088 may extend laterally intowide portion 2049 ofslot 2046. After thelateral portion 2088 extends laterally into thewide portion 2049 of theslot 2046, thenarrow portion 2047 of theslot 2046 can provide an interference fit that inhibits thelateral portion 2088 from being easily pulled out of theslot 2046. In other words, to pull thetransverse portion 2088 out of theslot 2046, thetransverse portion 2088 must again flex and/or deform appropriately to pass through thenarrow portion 2047 of theslot 2046. In various embodiments,transverse portion 2088 and/ornarrow portion 2047 ofslot 2046 may be sized such that: the pulling force required to pull thedeployable attachment feature 2084 out of the slot may be large enough so that the anvil-attachable layer 2080 is not displaced from theanvil 2042 when theanvil 2042 is positioned relative to the patient tissue. However, after anvil-attachable layer 2080 is captured by the staples, the pulling force may be small enough such that anvil-attachable layer 2080 may be pulled away from the anvil.
In various embodiments, a cutting blade of a surgical stapler can sever a deployable attachment feature of an anvil-attachable layer. Referring to fig. 240, the cutting blade may travel through theslot 2046 of theanvil 2042. The cutting blade may generally cut eachdeployable attachment feature 2084 in half. Upon removal of the anvil-attachable layer 2080 from theanvil 2042 after firing of the staples, it is easy to pull half of eachdeployable attachment feature 2084 out of theslot 2046.
For anvil-attachable layers that include deployable attachment features, such as the anvil-attachable layers disclosed in fig. 238-243, a retainer may be used to align the anvil-attachable layer with the anvil and deploy the deployable attachment features into the slots of the anvil. Fig. 251-254 illustrate aretainer 19700 that can first mount thestaple cartridge 19690 into thestaple cartridge channel 19740 and then squeeze the anvil-attachable layer 2056 toward theanvil 19720. Theretainer 19700 includes afirst portion 2052 and asecond portion 2054, wherein thefirst portion 2052 is movable relative to thesecond portion 2054 in the directions indicated by arrows Q and S (shown in fig. 253 and 254, respectively).First portion 2052 may include a cam that includes anti-lobes 19646 and 19647, andlobes 19642 and 19643. The second portion can includecam protrusions 19614 and 19616 that engage the cam of thefirst portion 2052. As seen in fig. 251 and 252, when theretainer 19700 is inserted into the end effector, thecam protrusions 19614 and 19616 engage the reverse lobes 16646 and 16647 of the cams of thefirst portion 2052. Referring now to fig. 253 and 254, after a staple cartridge is seated in thestaple cartridge channel 19740 of the end effector, thefirst portion 2052 can be moved in the direction of arrow Q relative to thesecond portion 2054. Movement of thefirst portion 2052 in the direction of arrow Q causes thecam protrusions 19614 and 19616 to engage thecam lobes 19642 and 19643 of thefirst portion 2052. Thelobes 19642 and 19643 push thecam protrusions 19614 and 19616 apart, pushing the anvil-attachable layer 2056 into contact with theanvil 19720.
Referring now to fig. 255-258, in certain embodiments, the retainer can mount a staple cartridge into the staple cartridge channel, dispose the anvil-attachable layer on the anvil, and deploy the deployable attachment features of the anvil-attachable layer into an engaged configuration with the anvil. Referring to fig. 256 and 257,retainer 2110 embodiments may include agrip portion 2112, acartridge facing portion 2114, and ananvil facing portion 2118. The cartridge-facingportion 2114 and the anvil-facingportion 2118 may be spaced apart by abuttress 2116 and may be disposed at an angle relative to one another. As can be best seen in fig. 258, thecartridge facing portion 2114 and theanvil facing portion 2118 can be disposed at an angle similar to the angle between thecartridge channel 2160 and theanvil 2150 when theanvil 2150 is in the fully open position. Cartridge-facingportion 2114 can include afirst clamp 2124 and asecond clamp 2126 extending from cartridge-facingportion 2114. Thefirst clamp 2114 can be engaged with thestaple cartridge 2140 to releasably retain thestaple cartridge 2140 to theholder 2110, as shown in FIG. 255. Thesecond clamp 2126 can engage thestaple cartridge channel 2160 of the end effector such that theretainer 2110 can be releasably retained to thestaple cartridge channel 2160. Anvil-facingportion 2118 may include aclamp 2120 that holds an anvil-attachable layer, such as anvil-attachable layer 2080 shown in fig. 238-240, relative toanvil surface 2118. The anvil-facingportion 2118 can further includediscrete protrusions 2122 that are positioned relative to the location of the deployable attachment features 2084 on the anvil-attachable layer 2080. As shown in fig. 255, when the anvil-attachable layer 2080 is loaded onto the anvil-facingportion 2118 of theretainer 2110, the anvil-attachable layer 2080 may first rest on top of thediscrete protrusions 2122.
Referring to fig. 258, in certain embodiments, the anvil-attachable layer 2080 can be in contact with theanvil 2150 upon insertion of theretainer 2110 into the end effector and upon seating of thestaple cartridge 2140 in thestaple cartridge channel 2160. Once the anvil-attachable layer 2080 is in contact with theanvil 2150, theretainer 2110 andstaple cartridge 2140 may continue to move relative to theanvil 2150 until thestaple cartridge 2140 is fully seated within thestaple cartridge channel 2160. In such embodiments, the anvil-facingportion 2118 ofretainer 2110 can be moved toward anvil-attachable layer 2080 and pushed against anvil-attachable layer 2080 such thatdiscrete protrusions 2122 extending from the anvil-facingportion 2118 ofretainer 2110 can push deployable attachment features 2084 inlayer 2080 upward to a deployed configuration as described above in connection with fig. 238-243. In various embodiments, eachdiscrete protrusion 2122 of theretainer 2110 facing theanvil portion 2118 can include anangled face 2123, which angledface 2123 can engage with thedeployable attachment feature 2084. As theretainer 2110 continues to move relative to theanvil 2150 and the anvil-attachable layer 2080, theinclined surface 2123 may progressively engage with thedeployable attachment feature 2084 until thedeployable attachment feature 2084 is rotating about thehinge 2087 and is deployed into theslot 2152 of theanvil 2150. As shown in fig. 258, theinclined surface 2123 of thediscrete protrusions 2122 can simultaneously support thelongitudinal portion 2086 and thelateral portion 2088 of each deployable attachment feature such that both thelongitudinal portion 2086 and thelateral portion 2088 are deployed into theslot 2152 of theanvil 2150.
In certain other embodiments, thestaple cartridge 2140 may be fully seated in thestaple cartridge channel 2160 using theretainer 2110 without contacting theanvil attachable layer 2080 with theanvil 2150. In such embodiments, after thestaple cartridge 2140 is fully seated in thestaple cartridge channel 2160, theanvil 2150 can be moved from the fully open position toward the closed position such that theanvil 2150 is in contact with the anvil-attachable layer 2080 and thediscrete protrusions 2122 deploy the deployable attachment features 2084 into theslots 2052 of theanvil 2050.
Fig. 259-262 illustrate anotherretainer embodiment 2170.Retainer 2170 can include a staplecartridge facing portion 2174 and ananvil facing portion 2178 that are spaced apart bysupports 2190 and arranged at an angle relative to each other. The staplecartridge facing portion 2174 can engage thestaple cartridge 2140 and releasably retain thestaple cartridge 2140. The staplecartridge facing portion 2174 may also engage and releasably retain thestaple cartridge channel 2160 of the end effector. Anvil-facingportion 2178 may have an anvil-attachable layer disposed thereon, such as anvil-attachable layer 2080 described above in connection with fig. 238-240. As shown in more detail in fig. 261 and 262, anvil-facingportion 2178 may include anaperture 2182 that may be aligned with adeployable attachment feature 2084 of an anvil-attachable layer 2080 disposed on anvil-facingportion 2178. Eachaperture 2182 may include acam 2202 disposed therein. Eachcam 2202 may be attached by aflexible member 2204 to an anvil-facingportion 2178 such that thecam 2202 may be rotated about theflexible member 2204 out of thehole 2182 and into contact with adeployable attachment feature 2084. Eachcam 2202 can include acurved surface 2203 that can progressively deploy adeployable attachment feature 2084 into aslot 2152 in ananvil 2150. Referring to fig. 261, as thecam 2202 begins to move out of theaperture 2182 and into contact with thedeployable attachment feature 2084, thecurved surface 2203 of thecam 2202 first comes into contact with thelateral portion 2088 of thedeployable attachment feature 2084, causing thelateral portion 2088 to deploy into theslot 2152 of theanvil 2150. Referring now to fig. 262, as thecam 2202 continues to move out of theaperture 2182, thecurved surface 2203 of thecam 2202 may come into contact with thelongitudinal portion 2086 of thedeployable attachment feature 2086, causing thelongitudinal portion 2086 to deploy into theslot 2152 of theanvil 2150.
Thesupport 2190 between the staplecartridge facing portion 2174 and theanvil facing portion 2178 may include a fixedportion 2194 and amovable portion 2196. Themovable portion 2196 can be operably coupled to thebutton 2192, and a user depressing thebutton 2192 moves themovable portion 2196 relative to the fixedportion 2194. Themovable portion 2196 of thesupport 2190 may include a series ofcam surfaces 2206 that may engage thecam portion 2202 to push thecam portion 2202 out of thehole 2182. As themovable portion 2196 moves proximally relative to the fixedportion 2194, thecam surface 2206 may allow thecam 2202 to move out of thehole 2182 as described above and into contact with the deployable attachment features 2084 of the anvil-attachable layer 2080.
In certain embodiments, themovable portion 2196 of thesupport 2190 can be biased in a distal position relative to the fixedportion 2194, as shown in fig. 259. For example, a spring or the like may be disposed between the fixedportion 2194 and themovable portion 2196. The spring may bias themovable portion 2196 of thesupport 2190 in a distal position relative to the fixedportion 2194. In various embodiments, the biasing force may be sufficiently large such that the force required to seat thestaple cartridge 2140 in thestaple cartridge channel 2160 will not overcome the biasing force. Thus, the deployable attachment features 2084 are less likely to be deployed by thecams 2202 in the event that thebutton 2192 is inadvertently applied with the force required to fully seat thestaple cartridge 2140 in thestaple cartridge channel 2160.
In various embodiments in which the anvil-attachable layer is releasably retained to the surgical stapler anvil, the anvil-attachable layer can include additional features that stabilize patient tissue relative to the anvil-attachable layer and the anvil. Referring now to fig. 249 and 250, anvil-attachable layers 22320a and 22320b are shown positioned between theanvil 22060 and the patient tissue T. Embodiments of anvil-attachable layers 22320a and 22320b may includeprotrusions 2078 extending from the body on a side facing the patient tissue T. Theprotrusions 2078 can push or pierce the tissue T, thereby providing a grip between the tissue T and the anvil-attachable layers 22320a and 22320 b. This grip may prevent tissue from sliding relative to the anvil-attachable layers 22320a and 22320 b.
In various embodiments, the retention feature can be separable from the anvil-attachable layer after the surgical stapler mounted with the anvil-attachable layer has been fired. In such embodiments, the retention features described above may be attached to one or more tethers. The tether may be attached to the surgical stapler, or another object outside the patient's body, such that after firing of the stapler, the retention features can be removed from the patient by pulling on the tether.
In various embodiments, the tissue thickness compensator can comprise a polymer composition. The polymer composition may comprise one or more synthetic polymers and/or one or more non-synthetic polymers. The synthetic polymer may comprise a synthetic absorbable polymer and/or a synthetic non-absorbable polymer. In various embodiments, the polymer composition can comprise, for example, a biocompatible foam. Such biocompatible foam may include, for example, porous open cell foam and/or porous closed cell foam. This biocompatible foam may have a uniform pore morphology, or may have a gradient pore morphology (i.e., small pores gradually increasing in size to large pores throughout the foam thickness in one direction). In various embodiments, the polymeric composition can comprise one or more of a porous scaffold, a porous matrix, a gel matrix, a hydrogel matrix, a solution matrix, a filamentous matrix, a tubular matrix, a composite matrix, a membrane matrix, a biostable polymer, and a biodegradable polymer, and combinations thereof. For example, the tissue thickness compensator may comprise a foam reinforced by a filamentous matrix, or may comprise a foam with an additional hydrogel layer that stretches in the presence of bodily fluids to provide further compression on the tissue. In various embodiments, the tissue thickness compensator can also be comprised of a material and/or a coating on the second or third layer that stretches in the presence of bodily fluids to provide further compression on the tissue. Such layers may be hydrogels, for example, which may be synthetic and/or naturally derived materials, and may be biodurable and/or biodegradable materials. In certain embodiments, the tissue thickness compensator may be reinforced with, for example, a fibrous nonwoven or a fibrous mesh type element that can provide additional flexibility, stiffness, and/or strength. In various embodiments, the tissue thickness compensator has a porous morphology that exhibits a gradient structure, such as, for example, small pores on one surface and larger pores on the other surface. Such a morphology may be more desirable for tissue in-growth or hemostatic behavior. Furthermore, the gradient may also be combined with a varying bio-absorption profile. A short-term absorption profile may be more suitable for achieving hemostasis, while a long-term absorption profile may achieve better tissue healing without leakage.
Examples of non-synthetic polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, and Oxidized Regenerated Cellulose (ORC). Examples of synthetic absorbable polymers include, but are not limited to, poly (lactic acid) (PLA), poly (L-lactic acid) (PLLA), Polycaprolactone (PCL), polyglycolic acid (PGA), poly (trimethylene carbonate) (TMC), polyethylene terephthalate (PET), Polyhydroxyalkanoate (PHA), copolymers of glycolide and epsilon-caprolactone (PGCL), copolymers of glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), polydioxanone, poly (orthoesters), polyanhydrides, polysaccharides, poly (ester-amides), tyrosine-based polyarylates, tyrosine-based polyiminocarbonates, tyrosine-based polycarbonates, poly (D, L-lactide-urethanes), poly (B-hydroxybutyric acid), poly (E-caprolactone), polyethylene glycol (PEG), poly [ di (carboxyphenoxy) phosphazene ], (N-methyl-co-phosphazene), Poly (amino acids), pseudo-poly (amino acids), absorbable polyurethanes, and combinations thereof.
In various embodiments, the polymeric composition can comprise, for example, from about 50% to about 90% by weight of the polymeric composition of PLLA, and from about 50% to about 10% by weight of the polymeric composition of PCL. In at least one embodiment, the polymeric composition may comprise, for example, about 70% by weight PLLA, and about 30% by weight PCL. In various embodiments, the polymeric composition can comprise, for example, from about 55% to about 85% by weight of the polymeric composition of PGA, and from 15% to 45% by weight of the polymeric composition of PCL. In at least one embodiment, the polymer composition can comprise, for example, about 65% by weight PGA, and about 35% by weight PCL. In various embodiments, the polymer composition can comprise, for example, from about 90% to about 95% by weight of the polymer composition of PGA, and from about 5% to about 10% by weight of the polymer composition of PLA.
In various embodiments, the synthetic absorbable polymer may comprise a bioabsorbable biocompatible elastomeric copolymer. Suitable bioabsorbable biocompatible elastomeric copolymers include, but are not limited to, copolymers of epsilon-caprolactone and glycolide (the mole ratio of epsilon-caprolactone to glycolide is preferably from about 30:70 to about 70:30, preferably from 35:65 to about 65:35, and more preferably from 45:55 to 35: 65); elastomeric copolymers of epsilon-caprolactone and lactide (including L-lactide, D-lactide, blends thereof or lactic acid copolymers) (the mole ratio of epsilon-caprolactone to lactide is preferably from about 35:65 to about 65:35, and more preferably from 45:55 to 30: 70); elastomeric copolymers of p-dioxanone (1, 4-dioxan-2-one) and lactide (including L-lactide, D-lactide, and lactic acid) (the molar ratio of p-dioxanone to lactide is preferably from about 40:60 to about 60: 40); elastomeric copolymers of epsilon-caprolactone and p-dioxanone (the mole ratio of epsilon-caprolactone to p-dioxanone is preferably from about 30:70 to about 70: 30); an elastomeric copolymer of p-dioxanone and trimethylene carbonate (the molar ratio of p-dioxanone to trimethylene carbonate is preferably from about 30:70 to about 70: 30); elastomeric copolymers of trimethylene carbonate and glycolide (preferably in a mole ratio of trimethylene carbonate to glycolide of from about 30:70 to about 70: 30); elastomeric copolymers of trimethylene carbonate and lactide (including L-lactide, D-lactide, blends thereof or lactic acid copolymers) (the molar ratio of trimethylene carbonate to lactide is preferably from about 30:70 to about 70: 30); and blends thereof. In one embodiment, the elastomeric copolymer is a copolymer of glycolide and epsilon-caprolactone. In another embodiment, the elastomeric copolymer is a copolymer of lactide and epsilon-caprolactone.
The disclosures of U.S. Pat. No. 5,468,253, entitled "ELASTOMERIC MEDICAL DEVICE", published at 21.11.1995 and U.S. Pat. No. 6,325,810, entitled "FOAM BUTTRESS FOR STAPLING APPATUS", published at 4.12.2001, are hereby incorporated by reference in their entireties.
In various embodiments, the synthetic absorbable polymer may include, for example, one or more of 90/10 poly (glycolide-L-lactide) copolymer commercially available from Ethicon, inc. under the trade name VICRYL 910, polyglycolide commercially available from American Cyanamid co. under the trade name DEXON, polydioxanone commercially available from Ethicon, inc. under the trade name PDS, poly (glycolide-trimethylene carbonate) random block copolymer commercially available from American Cyanamid co. under the trade name MAXON, 75/25 poly (glycolide-epsilon-caprolactone) copolymer commercially available from Ethicon under the trade name MONOCRYL 25.
Examples of synthetic non-absorbable polymers include, but are not limited to, polyurethane foams, polypropylene (PP), Polyethylene (PE), polycarbonate, polyamides such as nylon, polyvinyl chloride (PVC), polymethyl methacrylate (PMMA), Polystyrene (PS), polyester, Polyetheretherketone (PEEK), Polytetrafluoroethylene (PTFE), Polychlorotrifluoroethylene (PTFCE), polyvinyl fluoride (PVF), Fluorinated Ethylene Propylene (FEP), polyacetal, polysulfone, and combinations thereof. Synthetic non-absorbable polymers may include, but are not limited to, elastomeric foams and porous elastomers such as silicone, polyisoprene, and rubber. In various embodiments, the synthetic polymer may comprise expanded polytetrafluoroethylene (ePTFE) commercially available from W.L.Gore & Associates, Inc. under the trade name GORE-TEX Soft Tissue Patch, and copolyether ester polyurethane foam commercially available from Polyganics under the trade name NASPORE.
The polymer composition of the tissue thickness compensator can be characterized by, for example, percent porosity, pore size, and/or hardness. In various embodiments, the polymer composition can have a percent porosity of, for example, from about 30% to about 99% by volume. In certain embodiments, the polymer composition can have a percent porosity of, for example, about 60% to about 98% by volume. In various embodiments, the polymer composition can have a percent porosity of, for example, about 85% to about 97% by volume. In at least one embodiment, the polymeric composition may comprise, for example, about 70% by weight PLLA and about 30% by weight PCL, and may have, for example, about 90% porosity by volume. In at least one such embodiment, therefore, the polymer composition will comprise about 10% copolymer by volume. In at least one embodiment, the polymer composition may comprise, for example, about 65% by weight PGA and about 35% by weight PCL, and may have, for example, a percent porosity of about 93% to about 95% by volume. In various embodiments, the polymer composition can have a porosity of greater than 85% by volume. The polymer composition can have a pore size of, for example, about 5 microns to about 2000 microns. In various embodiments, the polymer composition can have a pore size of, for example, between about 10 microns to about 100 microns. In at least one such embodiment, the polymeric composition can comprise, for example, a copolymer of PGA and PCL. In certain embodiments, the polymer composition can have a pore size of, for example, between about 100 microns to about 1000 microns. In at least one such embodiment, the polymeric composition can comprise, for example, a copolymer of PLLA and PCL. According to certain aspects, the hardness of a polymer composition may be expressed in terms of shore hardness, which may be defined as the resistance of a material to permanent indentation as measured by a durometer (such as shore durometer). To evaluate the Durometer value of a given material, the material was pressed with a Durometer pin according to ASTM procedure D2240-00, entitled "Standard Test Method for Rubber Property-Durometer Hardness" (which is incorporated herein by reference in its entirety). The durometer indenter foot may be pressed into the material for a sufficient period of time (e.g., 15 seconds), with the reading then being taken on a suitable scale. Depending on the type of scale used, when the indenter foot has fully penetrated the material, a reading of 0 can be obtained; and when the indenter foot did not penetrate the material, a reading of 100 was obtained. The readings are dimensionless. In various embodiments, hardness can be determined according to ASTM D2240-00 using any suitable scale, such as a class A and/or OO class scale. In various embodiments, the polymer composition of the tissue thickness compensator can have a shore a hardness value of, for example, about 4A to about 16A, which is about 45OO to about 65OO in the shore OO range. In at least one such embodiment, the polymeric composition can comprise, for example, a PLLA/PCL copolymer or a PGA/PCL copolymer. In various embodiments, the polymer composition of the tissue thickness compensator can have a shore a hardness value of less than 15A. In various embodiments, the polymer composition of the tissue thickness compensator can have a shore a hardness value of less than 10A. In various embodiments, the polymer composition of the tissue thickness compensator can have a shore a hardness value of less than 5A. In certain embodiments, the polymeric material may have a shore OO composition value of, for example, about 35OO to about 75 OO.
In various embodiments, the polymer composition can have at least two of the above identified properties. In various embodiments, the polymer composition can have at least three of the above identified properties. The polymer composition can have, for example, a porosity of 85% to 97% by volume, a pore size of 5 microns to 2000 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO. In at least one embodiment, for example, the polymeric composition can comprise 70% by weight of the polymeric composition of PLLA and 30% by weight of the polymeric composition of PCL, and have a porosity of 90% by volume, a pore size of 100 microns to 1000 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO. In at least one embodiment, for example, the polymeric composition can comprise 65% by weight of the polymeric composition of PGA and 35% by weight of the polymeric composition of PCL, and have a porosity of 93% to 95% by volume, a pore size of 10 microns to 100 microns, and a shore a hardness value of 4A to 16A, and a shore OO hardness value of 45OO to 65 OO.
In various embodiments, the tissue thickness compensator can be releasably attached to the staple cartridge and/or anvil using a flowable attachment portion. Such flowable attachment portions can be operably associated with a staple cartridge and/or an anvil. In various embodiments, a flowable attachment portion can be disposed between the tissue thickness compensator and the staple cartridge and/or anvil. In various embodiments, at least a portion of the outer surface of the tissue thickness compensator can comprise a flowable attachment portion. In various embodiments, the adhesive laminate may include a tissue thickness compensator and a flowable attachment portion. The adhesive laminate can include a base layer including a tissue thickness compensator and an adhesive layer on at least a portion of a surface of the base layer, the adhesive layer including a flowable attachment portion. The adhesive laminate can include a tissue contacting surface including a tissue thickness compensator and an opposing surface including a flowable attachment portion. The adhesive laminate can be releasably attachable to the staple cartridge and/or anvil.
In various embodiments, the flowable attachment portion can comprise a flowable polymeric composition, such as a pressure sensitive adhesive ("PSA"), for example. An effective amount of a pressure sensitive adhesive capable of providing sufficient cohesive strength to produce the desired adhesive characteristics to adhere to the staple cartridge and/or anvil may be applied to the tissue thickness compensator. The pressure sensitive adhesive may have one or more of the following properties: (1) strong and durable tack; (2) the adhesive can be adhered by slightly pressing the fingers; (3) sufficient ability to remain on an adherend; (4) sufficient cohesive strength to be removed thoroughly from the adherend. In various embodiments, the flowable attachment portion can flow when pressure, heat, and/or stress is applied to the flowable attachment portion. Such pressure and/or stress may be applied directly, for example by hand and/or by a device (such as a mechanical device), and accordingly may be a manual process and/or an automated process.
In various embodiments, the flowable attachment portion may respond to temperature changes and/or pressure changes. In various embodiments, the flowable attachment portion can flow from the first position to the second position when heat and/or pressure is applied to the flowable attachment portion. In various embodiments, the flowable attachment portion is flowable at body temperature (37 ℃) and/or room temperature (25 ℃). In various embodiments, the flowable attachment portion is flowable at body temperature (37 ℃) but not at room temperature (25 ℃). In various embodiments, the flowable attachment portion can be responsive to temperature changes such that the flowable attachment portion is in a first position when the tissue thickness compensator is at a first temperature and the flowable attachment portion is in a second position when the tissue thickness compensator is at a second temperature. In various embodiments, the second temperature may be higher than the first temperature. In various embodiments, the first temperature may be room temperature and the second temperature is body temperature. In various embodiments, the flowable attachment portion can be responsive to pressure changes such that the flowable attachment portion is in a first position when the tissue thickness compensator is subjected to a first pressure and the flowable attachment portion is in a second position when the tissue thickness compensator is subjected to a second pressure. In various embodiments, the second pressure may be greater than the first pressure. In various embodiments, the first pressure may be atmospheric pressure and the second pressure may be finger pressure. In various embodiments, the flowable attachment portion can flow from a first position when at room temperature and/or atmospheric pressure to a second position when at body temperature and/or finger pressure. In various embodiments, the flowable attachment portion may flow from a first (unstressed) position to a second position when pressure and/or stress is applied to the flowable attachment portion.
In various embodiments, the flowable attachment portion can flow into a void in the staple cartridge and/or anvil. In various embodiments, when heat and/or pressure is applied to the flowable attachment portion, the flowable attachment portion can flow and extend over at least a portion of a surface of the staple cartridge and/or anvil that is free of the flowable attachment portion and/or fill at least a portion of a void (such as, for example, a slot and/or staple cavity) in the staple cartridge and/or anvil. In various embodiments, the flowable attachment portion can flow in vivo to fill at least a portion of a void in the staple cartridge and/or anvil. In various embodiments, the flowable attachment portion is flowable such that the flowable attachment portion comprises a shape complementary to at least a portion of a void in the staple cartridge and/or anvil. In various embodiments, the flowable polymeric composition can flow to fill at least a portion of the slots and/or staple cavities in the anvil. In various embodiments, the flowable attachment portion can flow into the void and take the shape of the void when pressure is applied to the flowable attachment portion. Without wishing to be bound by any particular theory, it is believed that filling at least a portion of the void in the staple cartridge and/or anvil with a flowable attachment portion may increase the strength of attachment of the tissue thickness compensator to the staple cartridge and/or anvil.
In various embodiments, a flowable attachment portion, such as a pressure sensitive adhesive, may respond to temperature changes and/or pressure changes to move between a first position and/or first profile and a second position and/or second profile. In various embodiments, the flowable attachment portion can have a first position spaced from the staple cartridge and/or the anvil. In various embodiments, the flowable attachment portion can be configured to infiltrate and/or fill at least a portion of a void in the staple cartridge and/or anvil when the flowable attachment portion is in the second position. As described herein, the flowable attachment portion can be in the shape of the void such that when the flowable attachment portion is specified to be in the second profile, the flowable attachment portion includes a profile that is complementary to the void. In various embodiments, the first position and/or first profile can be spaced from the staple cartridge and/or anvil and the second position and/or second profile can be in contact with the staple cartridge and/or anvil. In various embodiments, the first position and/or first profile may comprise a neutral (original) profile when at room temperature and/or atmospheric pressure, and the second position and/or second profile may comprise a profile that is complementary to a void in the staple cartridge and/or anvil when at body temperature and/or finger pressure. The flowable attachment portion can be contoured to achieve a shape and/or size complementary to a void in the staple cartridge and/or anvil.
In various embodiments, methods of bonding a tissue thickness compensator to a substrate (e.g., a staple cartridge and/or an anvil) can generally comprise: providing a tissue thickness compensator, applying a flowable attachment portion (such as a pressure sensitive adhesive), for example, to at least a portion of a surface of the tissue thickness compensator, and contacting the flowable attachment portion with a substrate. In various embodiments, a method of bonding a tissue thickness compensator to a substrate can comprise applying pressure to at least one of the tissue thickness compensator and the substrate. The flowable attachment portion can flow from a first location on the outer surface of the tissue thickness compensator to a second location that also includes the outer surface and/or the inner surface of the base. The flowable attachment portion can be in contact with the substrate, adhering the tissue thickness compensator to the substrate. In various embodiments, the flowable attachment portion can adhere the tissue thickness compensator to the substrate. In various embodiments, the flowable attachment portion can flow into at least one void in the substrate, such as a slot and/or staple cavity. In various embodiments, the flowable attachment portion can fill at least a portion of at least one void in the substrate when in the second position.
In various embodiments, methods of attaching a tissue thickness compensator to a substrate (e.g., a staple cartridge and/or an anvil) can generally comprise: the method includes applying at least one discrete bead and/or discrete strip of a flowable polymeric composition (such as a pressure sensitive adhesive) to a surface of a tissue thickness compensator, contacting the substrate with the at least one discrete bead and/or discrete strip of the flowable polymeric composition, and pressing the substrate and the at least one discrete bead and/or discrete strip of the flowable polymeric composition against the at least one discrete bead and/or discrete strip of another flowable polymeric composition to releasably attach the tissue thickness compensator to the substrate. In various embodiments, the method of attaching the tissue thickness compensator to the substrate can comprise applying at least one discrete bead and/or discrete strip of the flowable polymeric composition to the substrate at a desired location of the substrate on the tissue thickness compensator perimeter and/or central axis. In various embodiments, a method of attaching a tissue thickness compensator to a substrate can comprise applying at least one discrete bead and/or discrete strip of a flowable polymeric composition to the tissue thickness compensator in a longitudinal direction and/or a transverse direction.
In various embodiments, the method of attaching the tissue thickness compensator to the substrate can comprise applying at least one discrete bead and/or discrete strip of the flowable polymeric composition in a pattern and/or amount pre-selected based at least in part on the desired coating amount on the tissue thickness compensator. The pattern and amount of flowable polymer composition applied can be selected to withstand the stresses (e.g., shear stresses) associated with manipulation of the medical device by a clinician. The pattern and amount of application of the flowable polymer composition is preferably selected to balance the amounts on the flowable polymer composition in view of the clinician's ease of handling and/or preservation of the flowable polymer composition. Additionally, the composition of the flowable polymer composition can be considered in selecting the pattern and amount of application of the flowable polymer composition.
In various embodiments, the flowable attachment portion can partially affix the tissue thickness compensator to the staple cartridge and/or the anvil, and/or can fully affix the tissue thickness compensator to the staple cartridge and/or the anvil. A fully attached tissue thickness compensator can comprise a complete layer of a flowable polymer composition (such as, for example, a pressure sensitive adhesive) between the tissue thickness compensator and the substrate. In other words, a fully attached tissue thickness compensator can be a tissue thickness compensator without any portion of the tissue thickness compensator being uncoated with the flowable polymer composition. The partially attached tissue thickness compensator can comprise an effective amount of a flowable polymer composition between the tissue thickness compensator and the substrate, including at least a portion of the tissue thickness compensator being free of the flowable polymer composition. A partially attached tissue thickness compensator can impart a greater shear stress to the flowable polymer composition than a fully attached tissue thickness compensator. Thus, the shear properties of the flowable polymeric composition and/or the pattern and amount of the flowable polymeric composition can be selected to withstand manipulation of the medical device by a clinician in a desired manner.
In various embodiments, the flowable polymeric composition can be applied to the tissue thickness compensator in one of a continuous pattern and a discontinuous pattern. In various embodiments, the continuous pattern of flowable polymeric composition can comprise discrete bands of flowable polymeric composition applied to at least a portion of the tissue thickness compensator. In various embodiments, the continuous pattern of flowable polymer composition can comprise continuous beads of flowable polymer composition disposed longitudinally along at least a portion of a central axis of the tissue thickness compensator and/or disposed along at least a portion of a perimeter of the tissue thickness compensator. The flowable polymeric composition may be applied to the substrate in a variety of other patterns and configurations, such as a cruciform pattern or other diagonal pattern, in a continuous sheet or layer, or in any other design that achieves the desired adhesive properties. In various embodiments, a continuous pattern of flowable polymer composition can be applied along the inner and/or outer perimeter of the tissue thickness compensator. In various embodiments, a continuous pattern of the flowable polymeric composition can be applied along the inner perimeter of the tissue thickness compensator such that upon attachment of the tissue thickness compensator to the substrate, the flowable polymeric composition is positioned along the central longitudinal axis of the substrate. In various embodiments, a continuous pattern of the flowable polymer composition can be applied along the inner perimeter of the tissue thickness compensator such that upon attachment of the tissue thickness compensator to the substrate, the flowable polymer composition aligns with at least one void (such as a slot and/or staple cavity) in the substrate. In various embodiments, a continuous pattern of the flowable polymer composition can be applied along the outer periphery of the tissue thickness compensator such that upon attaching the tissue thickness compensator to the substrate, the flowable polymer composition is positioned along the outer periphery of the substrate. In various embodiments, the flowable polymer composition is applied to the tissue thickness compensator such that the inner portion and/or the peripheral boundary of the substrate is free of the flowable polymer composition.
In various embodiments, the discontinuous pattern of flowable polymeric composition may comprise a plurality of discrete beads and/or discrete stripes of flowable polymeric composition spaced apart from each other on the substrate. In various embodiments, at least a portion of the plurality of beads and/or ribbons of flowable polymeric composition may be pressed together when pressure and/or stress is applied. In various embodiments, a plurality of beads and/or ribbons of the flowable polymer composition that are pressed together can form a continuous pattern of the flowable polymer composition. In various embodiments, the partially attached tissue thickness compensator can comprise a plurality of discrete beads and/or discrete strips of the flowable polymeric composition spaced apart from one another on a surface thereof such that at least a portion of the surface of the tissue thickness compensator is free space free of the flowable polymeric composition when subjected to pressure. Such free space may include portions of the tissue thickness compensator where no beads and/or strips of the flowable polymer composition contact each other, and/or portions of the tissue thickness compensator where no beads and/or strips of the flowable polymer composition are applied. In various embodiments, the free space may be an interior portion and/or a perimeter boundary of the substrate.
In various embodiments, a method of attaching a tissue thickness compensator to a substrate can comprise applying at least one discrete strip of a flowable polymeric composition onto the tissue thickness compensator. In various embodiments, the discrete strips of flowable polymeric composition can extend along a portion of the central longitudinal axis of the tissue thickness compensator. In at least one embodiment, discrete bands of flowable polymeric composition can be applied along a portion of the tissue thickness compensator that is aligned with at least one void (such as a slot and/or staple cavity) in the substrate. In various embodiments, a method of attaching a tissue thickness compensator to a substrate can comprise applying a plurality of parallel discrete strips of a flowable polymeric composition onto the tissue thickness compensator. In various embodiments, two discrete strips of flowable polymeric composition can extend longitudinally along opposite side edges of the tissue thickness compensator. In at least one embodiment, for example, each of two discrete strips of flowable polymeric composition can be applied along a portion of the tissue thickness compensator that is aligned with at least one void (such as a slot and/or staple cavity) in the substrate. In various embodiments, the distance between the strips and/or between the side edges can be preselected such that upon attachment of the tissue thickness compensator to the substrate, the flowable polymeric composition can flow into at least one void in the substrate (such as at least one staple cavity of an anvil).
In various embodiments, the distance between the plurality of parallel discrete strips of flowable polymeric composition and/or the distance between the side edges can be preselected to enable the tissue thickness compensator to be fully adhered to the substrate, or partially adhered to the substrate. In various embodiments, the width of the strip may be at least 1mm, for example. In various embodiments, the width of the strip may be, for example, between about 0.5mm and about 1.5 mm. In various embodiments, the width of the strip may be, for example, between about 1.0mm and about 1.25 mm. In various embodiments, the gap width between the adhesive stripes and/or between the side edges may be, for example, at least 1 mm. In various embodiments, the distance between the strips and/or between the side edges can be preselected to partially adhere the tissue thickness compensator to the substrate, with the ratio of adhesive to adhesive-free space being preselected based on the intended application amount on the tissue thickness compensator. In various embodiments, the ratio of adhesive to adhesive-free space may be 1:10 to 10:1, such as 1:1, 1:2, 1:3, 1:4, 1:5, and 2: 3.
In various embodiments, for example, it may be desirable to: the minimum value at which the pressure sensitive adhesive can flow is 0.25 mm. In various embodiments, for example, the pressure sensitive adhesive substrate can comprise a thickness between about 1.25mm and about 1.50 mm. In certain embodiments, for example, the pressure sensitive adhesive substrate may comprise a thickness between about 0.5mm and about 0.75 mm.
As described herein, in various embodiments, the flowable attachment portion can comprise a flowable polymeric composition. The flowable polymer composition may include a pressure sensitive adhesive. The flowable attachment portion may comprise a pressure sensitive adhesive laminate. In various embodiments, the flowable attachment portion can include an adhesive laminate including a tissue thickness compensator and a flowable polymer composition. The polymer composition may comprise one or more synthetic polymers and/or one or more natural polymers. The polymer composition may be bioabsorbable, biocompatible, and/or biodegradable. Examples of natural polymers include, but are not limited to, lyophilized polysaccharides, glycoproteins, elastin, proteoglycans, gelatin, collagen, fibrin, fibronectin, fibrinogen, elastin, serum albumin, hemoglobin, ovalbumin, Oxidized Regenerated Cellulose (ORC), and combinations thereof. Examples of polysaccharides include, but are not limited to, hyaluronic acid, chondroitin sulfate, hydroxyethyl starch, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, chitin/chitosan, agarose, alginate, and combinations thereof. Examples of synthetic polymers include, but are not limited to, poly (lactic acid) (PLA), poly (L-lactic acid) (PLLA), Polycaprolactone (PCL), polyglycolic acid (PGA), poly (glycolic acid), poly (hydroxybutyric acid), poly (phosphazene), polyester, poly (trimethylene carbonate) (TMC), polyethylene terephthalate (PET), Polyhydroxyalkanoates (PHA), copolymers of glycolide and epsilon-caprolactone (PGCL), copolymers of glycolide and trimethylene carbonate, poly (glycerol sebacate) (PGS), polydioxanone, poly (orthoesters), polyanhydrides, polyacrylamides, polysaccharides, poly (ester-amides), tyrosine-based polyarylates, tyrosine-based polyiminocarbonates, tyrosine-based polycarbonates, poly (D, L-lactide-urethane), poly (B-hydroxybutyric acid), Poly (E-caprolactone), polyethylene glycol (PEG), polyethylene oxide, poly [ di (carboxyphenoxy) phosphazene ], poly (amino acids), pseudo poly (amino acids), absorbable polyurethanes, polyhydroxyethylmethacrylate, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylic acid, polyacetate, polycaprolactone, polypropylene, nylon, and combinations thereof.
In various embodiments, the flowable polymer composition can comprise a copolymer of epsilon-caprolactone and glycolide (PCL/PGA). In various embodiments, the flowable polymeric composition can comprise, for example, from about 50% to about 90% by weight of the polymeric composition of PGA, and from about 50% to about 10% by weight of the polymeric composition of PCL. In various embodiments, the flowable polymeric composition can comprise, for example, from about 50% to about 75% by weight of the polymeric composition of PGA, and from about 50% to about 25% by weight of the polymeric composition of PCL. In various embodiments, the flowable polymeric composition can comprise, for example, from about 50% to about 60% by weight of the polymeric composition of PGA, and from about 50% to about 40% by weight of the polymeric composition of PCL. In at least one embodiment, the flowable polymeric composition can comprise, for example, about 70% by weight of the polymeric composition of PGA, and about 30% by weight of the polymeric composition of PCL. In at least one embodiment, the flowable polymeric composition can comprise, for example, about 64% by weight of the polymeric composition of PGA, and about 36% by weight of the polymeric composition of PCL.
In various embodiments, the flowable polymer composition can comprise a copolymer of epsilon-caprolactone and lactide (including L-lactide, D-lactide, blends thereof, and lactic acid copolymers). In various embodiments, the flowable polymer composition can include a molar ratio of PCL to PGA of from 30:70 to 70:30 (such as, for example, 35:65 to 65:35, 45:55 to 35:65, and 50: 50). In various embodiments, the amount of epsilon-caprolactone may be 30 to 45 mole percent with the balance being glycolide, such as, for example, an amount of epsilon-caprolactone of 35 to 40 mole percent with the balance being glycolide. In various embodiments, the pressure sensitive adhesive may comprise 36:64 (moles/mole) of the poly (e-caprolactone-co-glycolide) copolymer. In various embodiments, the flowable polymer composition can comprise a copolymer of dioxanone (1, 4-dioxan-2-one) and lactide (including L-lactide, D-lactide, and lactic acid). In various embodiments, the flowable polymer composition can comprise p-dioxanone and lactide in a molar ratio of 40:60 to 60: 40. In various embodiments, the flowable polymer composition can comprise a copolymer of epsilon-caprolactone and para-dioxanone. In various embodiments, the flowable polymer composition can comprise epsilon-caprolactone and para-dioxanone in a molar ratio of 30:70 to 70: 30.
In various embodiments, the tissue thickness compensator and the flowable attachment portion can comprise the same polymeric composition, or different polymeric compositions. In various embodiments, the tissue thickness compensator and the flowable attachment portion can comprise the same bioabsorbable material, such as a copolymer of epsilon-caprolactone and glycolide (PCL/PGA). In various embodiments, the tissue thickness compensator and the flowable attachment portion can differ in at least one feature selected from the group consisting of: material composition, modulus, elongation, intrinsic viscosity, crystallinity, and bioabsorbability. In various embodiments, the tissue thickness compensator and the flowable attachment portion can comprise the same copolymer that differs in at least one characteristic selected from the group consisting of: material composition, modulus, elongation, intrinsic viscosity, crystallinity, and bioabsorbability. For example, both the tissue thickness compensator and the flowable attachment portion can comprise a PCL/PGA copolymer that differs in the weight percent of epsilon-caprolactone to glycolide and/or the molar ratio of epsilon-caprolactone to glycolide. In at least one embodiment, the tissue thickness compensator can comprise about 50% by weight of the polymeric composition of PGA and about 50% by weight of the polymeric composition of PCL, and the flowable attachment portion can comprise about 64% by weight of the polymeric composition of PGA and about 36% by weight of the polymeric composition of PCL. In at least one embodiment, the tissue thickness compensator can comprise a PCL/PGA copolymer having a mole ratio of epsilon-caprolactone to glycolide of 50:50, and the flowable attachment portion can comprise a PCL/PGA copolymer having a mole ratio of epsilon-caprolactone to glycolide of 36: 64.
In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator (each by weight of the polymer composition) may differ by at least 1 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 5 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 10 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 15 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 1 to 15 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 10 to 15 weight percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 14 weight percent. In various embodiments, as described above, the concentration of epsilon-caprolactone in the pressure sensitive adhesive may be different than the concentration of epsilon-caprolactone in the tissue thickness compensator such that the concentration of epsilon-caprolactone in the pressure sensitive adhesive may be greater or less than the concentration of epsilon-caprolactone in the tissue thickness compensator.
In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 1 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 5 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 10 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 15 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 20 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by 1 to 20 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive may differ from the concentration of polyglycolic acid in the tissue thickness compensator by 15 to 20 weight percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive may differ from the concentration of polyglycolic acid in the tissue thickness compensator by 16 weight percent. In various embodiments, as described above, the concentration of polyglycolic acid in the pressure sensitive adhesive may be different than the concentration of polyglycolic acid in the tissue thickness compensator such that the concentration of polyglycolic acid in the pressure sensitive adhesive may be greater than or less than the concentration of polyglycolic acid in the tissue thickness compensator.
In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 1 mole percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 5 mole percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 10 mole percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by at least 15 mole percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 1 to 15 mole percent. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 10 mole% to 15 mole%. In various embodiments, the concentration of epsilon-caprolactone in the pressure sensitive adhesive and the concentration of epsilon-caprolactone in the tissue thickness compensator can differ by 14 mole percent. In various embodiments, as described above, the concentration of epsilon-caprolactone in the pressure sensitive adhesive may be different than the concentration of epsilon-caprolactone in the tissue thickness compensator such that the concentration of epsilon-caprolactone in the pressure sensitive adhesive may be greater or less than the concentration of epsilon-caprolactone in the tissue thickness compensator.
In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 1 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 5 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 10 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 15 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive and the concentration of polyglycolic acid in the tissue thickness compensator can differ by at least 20 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive can differ from the concentration of polyglycolic acid in the tissue thickness compensator by 1 to 20 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive may differ from the concentration of polyglycolic acid in the tissue thickness compensator by 15 to 20 mole percent. In various embodiments, the concentration of polyglycolic acid in the pressure sensitive adhesive may differ from the concentration of polyglycolic acid in the tissue thickness compensator by 16 mole percent. In various embodiments, as described above, the concentration of polyglycolic acid in the pressure sensitive adhesive may be different than the concentration of polyglycolic acid in the tissue thickness compensator such that the concentration of polyglycolic acid in the pressure sensitive adhesive may be greater than or less than the concentration of polyglycolic acid in the tissue thickness compensator.
In various embodiments, the flowable polymeric composition may include additional optional components to further improve the processability and/or mechanical properties of the composition, as well as other properties such as tack, light aging resistance, oxygen aging resistance, heat aging resistance, and visual appearance. Such optional components may include other copolymers that the flowable polymer composition may include to achieve desired properties, such as enhanced adhesion or compatibility with the substrate. In various embodiments, such additional optional components may include, but are not limited to, other polymers or copolymers, fillers, crosslinkers, tackifiers, plasticizers, pigments, dyes, antioxidants, colorants, and stabilizers. In various embodiments, the flowable polymeric composition may comprise an amount of tackifier in an amount of at least 0.1 weight percent, at least 2 weight percent, or at least 5 weight percent and up to 10 weight percent, 25 weight percent, or 50 weight percent, based on the total weight of the polymeric composition. In various embodiments, the flowable polymer composition can include an amount of plasticizer of at least 0.1 weight percent, at least 2 weight percent, or at least 5 weight percent and up to 10 weight percent, 25 weight percent, or 50 weight percent, based on the total weight of the polymer composition.
In various embodiments, the flowable attachment portion can include a flowable (plastically deformable) polymer composition. In various embodiments, the flowable polymeric composition is generally tacky at room temperature (e.g., 20 ℃ to 25 ℃) and can be releasably adhered to a variety of substrates by application of only moderate pressure thereto (e.g., finger pressure) to form a bond attached to the substrate. In various embodiments, the flowable polymer composition is a solid at up to 40 ℃, up to 45 ℃, up to 50 ℃, up to 55 ℃, and/or up to 60 ℃. In various embodiments, the flowable polymer composition melts, but does not degrade, above 40 ℃, above 45 ℃, above 50 ℃, above 55 ℃, above 60 ℃, and/or above 120 ℃. In various embodiments, the flowable polymer composition can be melted without degradation up to 600 ℃, up to 500 ℃, up to 400 ℃, up to 300 ℃, up to 240 ℃, and/or up to 180 ℃. In various embodiments, the flowable polymer composition can melt without degradation at a temperature in the range of 40.1 ℃ to 600 ℃, in the range of 120 ℃ to 240 ℃, and/or at a temperature of 180 ℃.
In various embodiments, the flowable polymer composition can be characterized by: a0.1 g/dL solution of the composition in hexafluoroisopropanol has an intrinsic viscosity at 25 ℃ of 0.6 to 4.0g/dL, 0.8 to 3.2g/dL, 1.0 to 2.4g/dL, and/or 1.6 g/dL. In various embodiments, the flowable polymer composition may not contain a gel.
In various embodiments, the flowable polymer composition can have one or more of the following characteristics: a percent crystallinity of less than about 25%, less than about 15%, and from 15% to 25%; a percent elongation of greater than about 200, greater than about 500, and from about 200 to about 500; the modulus is less than about 40,000psi, less than about 20,000, and from about 20,000psi to about 40,000 psi.
In various embodiments, the flowable attachment portion can comprise one of a strip, a ribbon, a roll of tape, a sheet, and a membrane attached to a surface and/or edge of the tissue thickness compensator. In various embodiments, the flowable attachment portion can comprise a pressure sensitive tape comprising an adhesive and a backing. In various embodiments, the backing may comprise one of a flexible backing material and a non-flexible backing material. Examples of flexible backing materials include, but are not limited to, plastic films such as polypropylene, polyethylene, polyvinyl chloride, polyester (polyethylene terephthalate), polycarbonate, polymethyl methacrylate (PMMA), cellulose acetate, cellulose triacetate, and ethyl cellulose. A foam backing may be used. Examples of non-flexible backing materials include, but are not limited to, metals, metallized polymer films, indium tin oxide coated glass and polyester, PMMA plates, polycarbonate plates, glass or ceramic sheets. In various embodiments, the pressure sensitive adhesive tape may include a release liner. In various embodiments, the pressure sensitive adhesive tape may be applied by removing the release liner to expose the adhesive.
In various embodiments, the flowable attachment portion can be applied to the tissue thickness compensator using conventional coating techniques such as roll coating, flow coating, dip coating, spin coating, spray coating, knife coating, and extrusion coating. In various embodiments, the flowable attachment portion can have an initial thickness of about 1.25mm to about 1.50mm, for example. In some embodiments, the flowable attachment portion can have an initial thickness of about 0.5mm to about 0.75mm, for example. In various embodiments, the flowable attachment portion can have a final thickness of, for example, at least 0.25mm when pressure is applied thereto.
In various embodiments, referring to fig. 263, theflowable attachment portion 30000 can comprise a continuous strip longitudinally centered along a portion of the central axis of thetissue thickness compensator 30010. The width of the strip may be, for example, at least 1 mm. The width of the strip may be, for example, between about 0.5mm and about 1.5 mm. The width of the strip may be, for example, between about 1.0mm and about 1.25 mm. The first position of theflowable attachment portion 30000 can be spaced apart from theanvil 30020, and the first profile of theflowable attachment portion 30000 can comprise a neutral (original) profile. As shown in fig. 264, theflowable attachment portion 30000 can be aligned with a void 30025 (e.g., such as a centrally disposed slot) in theanvil 30020. As shown in fig. 265, when pressure is applied to theflowable attachment portion 30000 up to a threshold level, theflowable attachment portion 30000 can flow into theslot 30025 to securely engage theanvil 30020. Theflowable attachment portion 30000 can fill at least a portion of theslot 30025 such that theflowable attachment portion 30000 can assume the shape of theslot 30025. The second position of theflowable attachment portion 30000 can be in contact with theanvil 30020, and the second profile of theflowable attachment portion 30000 can include a profile complementary to theslot 30025. Theflowable attachment portion 30000 can releasably attach thetissue thickness compensator 30010 to theanvil 30020.
In various embodiments, referring to fig. 266, theflowable attachment portion 30000 can comprise two continuous strips disposed longitudinally along a portion of thetissue thickness compensator 30010 and parallel to each other. The width of the strip may be, for example, at least 1 mm. The width of the strip may be, for example, between about 0.5mm and about 1.5 mm. The width of the strip may be, for example, between about 1.0mm and about 1.25 mm. Two separate strips may be spaced apart from the central axis and the side edges of thetissue thickness compensator 30010. The width of the gap between each strip may for example be at least 1mm and the width of the gap between each strip and the side edges may for example be at least 1 mm. The ratio of adhesive to adhesive free space may be, for example, between about 1:4 and about 1: 2. The ratio of adhesive to adhesive-free space may be, for example, at least 1: 10. In each case, the ratio of adhesive to adhesive-free space may be 0. In some cases, a constant layer may be desired across the entire surface. The first position of theflowable attachment portion 30000 can be spaced apart from theanvil 30020, and the first profile of theflowable attachment portion 30000 can comprise a neutral (original) profile. As shown in fig. 267, theflowable attachment portion 30000 can be aligned with thestaple cavity 30030, for example. As shown in fig. 268, when pressure (such as finger pressure) is applied to theflowable attachment portion 30000 up to a threshold level, theflowable attachment portion 30000 can flow into thestaple cavity 30030, which in turn forms a secure engagement with theanvil 30020. Theflowable attachment portion 30000 can fill at least a portion of thestaple cavity 30030 such that theflowable attachment portion 30000 can take the shape of thestaple cavity 30030. At least a portion of thestaple cavity 30030 can be free of theflowable attachment portion 30000. The second position of theflowable attachment portion 30000 can be in contact with theanvil 30020, and the second profile of theflowable attachment portion 30000 can comprise a profile complementary to thestaple cavity 30030. Theflowable attachment portion 30000 can releasably attach thetissue thickness compensator 30000 to theanvil 30020.
In various embodiments, referring now to fig. 269-273, astaple cartridge 30100 including asupport portion 30102 and atissue thickness compensator 30110 can be loaded into a staple cartridge channel, for example, using astaple cartridge applicator 30140. In various embodiments, thestaple cartridge applicator 30140, in addition to being capable of positioning thestaple cartridge 30100 within a staple cartridge channel, can be further configured to position the uppertissue thickness compensator 30110 relative to theanvil 30120. Thestaple cartridge applicator 30140 can include lockarms 30141 that can be releasably engaged with lock tabs that extend from thesupport portion 30102 of thestaple cartridge 30100 such that thestaple cartridge applicator 30140 can be held in place over thetissue thickness compensator 30110 of thestaple cartridge 30100. In various embodiments, the uppertissue thickness compensator 30110 is removably attachable to thecartridge applicator 30140 such that theanvil 30120 of the surgical instrument can be closed on theapplicator 30140, engaged with thetissue thickness compensator 30110, and thetissue thickness compensator 30110 separated from thecartridge applicator 30140. In various embodiments, thetissue thickness compensator 30110 and/or theanvil 30120 can comprise one or more retention features that can be configured to releasably retain thetissue thickness compensator 30110 to the anvil. In various embodiments, the retention features may include adhesive patches and/oradhesive tabs 30112.
In various embodiments, the adhesive sheet and/or adhesive tab may be integrally formed with a portion of thetissue thickness compensator 30110. In various embodiments, thetissue thickness compensator 30110 can include at least oneadhesive tab 30112 along its edges. Theadhesive tab 30112 may include arelease liner 30113. Referring to fig. 271, theanvil 30120 can be moved to a closed position to engage thetissue thickness compensator 30110. Therelease liner 30113 can then be removed to expose the adhesive surface of theadhesive tab 30112. Next, referring to fig. 272 and 273, a first end of theadhesive tab 30112 can be secured to the anvil and a second end of theadhesive tab 30112 can be secured to the anvil to releasably attach thetissue thickness compensator 30110 to the anvil. Theadhesive tab 30112 can be pulled distally to separate thetissue thickness compensator 30110 from thestaple cartridge applicator 30140. Upon completion of the above-described operations, the anvil andstaple cartridge 30100 can be positioned relative to the tissue to be stapled and/or incised. Next, the clinician can pull on theadhesive tab 30112 to separate thetissue thickness compensator 30110 from the anvil.
Referring to fig. 284-288, in various embodiments, thetissue thickness compensator 30210 can include at least oneadhesive tab 30212 along its distal edge. Theadhesive tab 30212 may include arelease liner 30213. As described herein, thestaple cartridge applicator 30240 can be configured to position the uppertissue thickness compensator 30210 relative to theanvil 30220. Therelease liner 30213 may be removed to expose the adhesive surface of theadhesive tab 30212. Theadhesive tab 30212 may be flipped over and secured to theanvil 30220 such that thetissue thickness compensator 30210 is releasably attached to theanvil 30220. Theadhesive tab 30212 may then be pulled distally to separate thetissue thickness compensator 30210 from thestaple cartridge applicator 30240. Theanvil 30220 and thestaple cartridge 30200 can then be positioned relative to the tissue to be stapled and/or incised. Referring to fig. 289-290, in use, a staple deployment sled can be advanced distally through the staple cartridge by the firing member, which in turn can advance aknife edge 30211 through thetissue thickness compensator 30210 to cut into at least a portion of theadhesive tab 30212 and gradually separate thetissue thickness compensator 30210 from theanvil 30220. The clinician may pull the remainder of theadhesive tab 30212 away from theanvil 30220 prior to reloading anew staple cartridge 30200.
In various embodiments, the adhesive sheet and/or adhesive tab may be separate from the tissue thickness compensator. Referring to fig. 274-276, in at least one embodiment, an adhesive tab 30312 (see also fig. 288 and 292) can be disposed between thestaple cartridge 30300 and thetissue thickness compensator 30310. Thetissue thickness compensator 30310 can include anotch 30311 that is sized and configured to cooperate with theadhesive tab 30312 to releasably retain thetissue thickness compensator 30310 to theanvil 30320. A first end of theadhesive tab 30312 may be secured to thetissue thickness compensator 30310 adjacent to thenotch 30311, and a second end of theadhesive tab 30312 may be secured to theanvil 30320. As shown in fig. 277, theadhesive tab 30312 does not engage thenotch 30311. Thereafter, theanvil 30320 andstaple cartridge 30300 can be positioned relative to the tissue T to be stapled and/or incised.
As noted above, in use, a staple deployment sled can be advanced distally through the staple cartridge by the firing member to eject the staples from the staple cartridge as outlined above. As the staples deform, each staple can capture a portion of the tissue thickness compensator against the tissue top surface. At the same time, the firing member can advance the knife blade through thetissue thickness compensator 30310, wherein in at least one embodiment the knife blade can advance through thetissue thickness compensator 30310 to move thetissue thickness compensator 30310 distally and align theadhesive tab 30312 with thenotch 30311 as shown in fig. 277-279 so that the knife blade cuts into thetissue thickness compensator 30310 and separates thetissue thickness compensator 30310 from theanvil 30320. In various embodiments, the non-notchedtissue thickness compensator 30310 can move downward, as shown in fig. 280 and 281, to disengage theadhesive tabs 30312 and separate thetissue thickness compensator 30310 from theanvil 30320 as the staples are moved from their unfired positions to their fired positions by the staple drivers as described above. After the staples have been deployed, theanvil 30320 can be opened again and moved away from the implantedtissue thickness compensator 30310, as shown in fig. 283. By comparing fig. 282 and 283, the reader will appreciate that thetissue thickness compensator 30310 may be secured to the tissue T and incised by the cutting member as described above.
In various embodiments, the flowable attachment portion can be applied by removing the first release liner from the first adhesive tab, thereby exposing the flowable attachment portion (e.g., comprising a pressure sensitive adhesive). The first adhesive tab may then be rolled or otherwise pressed onto the outer surface of the substrate. The second release liner can then be removed from the second adhesive tab, exposing the pressure sensitive adhesive. The second adhesive tab may be pressed onto the outer surface of the substrate and/or the first adhesive tab at this time. Once the pressure sensitive adhesive is applied to the tissue thickness compensator, it is placed in contact with the staple cartridge and/or anvil. The pressure sensitive adhesive may secure the tissue thickness compensator to the substrate.
The various embodiments described herein are described in the context of staples that are removably stored within a staple cartridge for use with a surgical stapling instrument. In some cases, a staple may include a wire that deforms when it contacts an anvil of a surgical stapler. Such wires may be constructed, for example, from metal (such as stainless steel) and/or any other suitable material. Such embodiments and the teachings thereof are applicable to embodiments that include fasteners that are removably stored within a fastener cartridge for use with any suitable fastening instrument.
Various embodiments described herein are described in the context of a tissue thickness compensator attached to and/or used with a staple cartridge and/or a fastener cartridge. Such tissue thickness compensators may be used to compensate for variations in tissue thickness from one end of the staple cartridge to the other, or to compensate for variations in tissue thickness captured within one staple or fastener as compared to the thickness of tissue captured within another staple or fastener. Such tissue thickness compensators may also be used to compensate for variations in tissue thickness from one side of the staple cartridge to the other. Such embodiments and their teachings are applicable to embodiments that include one or more layers of material attached to and/or used with a staple cartridge and/or fastener cartridge. Such a layer of material may comprise a buttress material.
The various embodiments described herein are described in the context of a linear end effector and/or linear fastener cartridge. Such embodiments and their teachings can be applied to non-linear end effectors and/or non-linear fastener cartridges, such as rounded and/or contoured end effectors. For example, various end effectors, including non-linear end effectors, are disclosed in U.S. patent application serial No. 13/036,647 (now U.S. patent application publication 2011/0226837), entitled "SURGICAL STAPLING INSTRUMENT," filed 28/2.2011, which is hereby incorporated by reference in its entirety. Additionally, U.S. patent application serial No. 12/893,461 (now U.S.patent application publication 2012/0074198), entitled "STAPLE CARTRIDGE," filed 9, 29, 2012, is hereby incorporated by reference in its entirety. U.S. patent application Ser. No. 12/031,873 (now U.S. Pat. No. 7,980,443), entitled "END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT", filed on 15.2.2008, is also hereby incorporated by reference in its entirety.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. Thus, where necessary, the disclosure explicitly set forth herein may supersede any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein is only incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
While this invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.