US20150157318A1 - Variable compression surgical fastener cartridge - Google Patents

Abstract

A non-reloadable surgical fastener cartridge is provided. The non-reloadable surgical fastener cartridge includes a cartridge body that includes a tissue contacting surface that includes a plurality of fastener retention slots. A plurality of surgical fasteners is disposed in the plurality of fastener retention slots. Each surgical fastener includes first and second legs of different lengths. A plurality of pushers is operably associated with the plurality of surgical fasteners. One or more of the pushers is configured such that, upon formation of a corresponding surgical fastener, a first area defined by the first leg is smaller than a second area defined by the second leg. The non-reloadable surgical fastener cartridge also includes an actuation mechanism operably associated with the plurality of pushers.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 12/427,794, filed Apr. 22, 2009, which claims priority to U.S. Provisional Patent Application Ser. No. 61/051,923 filed May 9, 2008, the contents of which is incorporated herein by reference in its entirety.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to surgical fastener applying apparatus. More particularly, the present disclosure relates to a surgical fastener cartridge that includes a plurality of surgical fasteners configured so as to have areas of different sizes, depending on the location of the tissue with respect to the cartridge, and potentially to apply different compressive forces to tissue, and methods of manufacturing and using the same.
• 2. Background of the Related Art
• Commercially available surgical fastening apparatus are well known in the art, some of which are specifically adapted for use in various surgical procedures including, but not limited to, anastomosis. U.S. Pat. Nos. 5,915,616; 6,202,914; 5,865,361; and 5,964,394 each describe one or more suitable apparatus which may be employed while performing one of these procedures.
• In general, a surgical fastening apparatus will include an anvil that is approximated relative to a fastener cartridge during use. The anvil includes depressions that are aligned with, and/or are in registration with slots defined in the cartridge, through which the fasteners will emerge. To effectuate formation, the fasteners emerge from the cartridge and are driven against the anvil. The fastener cartridge typically has one or more rows of fasteners disposed alongside a longitudinal slot that is configured to accommodate a knife, or other such cutting element, such that tissue can be simultaneously cut and joined together. Depending upon the particular surgical fastening apparatus, the rows of fasteners may be arranged in a linear or non-linear, e.g. circular, semi-circular, or otherwise arcuate configuration.
• Various types of surgical fasteners are well known in the art, including but not limited to unitary fasteners and two-part fasteners. Unitary fasteners have a pre-formed configuration and a formed configuration. Unitary fasteners generally include a pair of legs adapted to penetrate tissue and connected by a backspan from which they extend. In use, subsequent to formation, certain types of unitary fasteners have a “B” shaped configuration. Typically, the two-part fastener includes legs that are barbed and connected by a backspan which are engaged and locked into a separate retainer piece that is usually located in the anvil. In use, the two-part fastener is pressed into the tissue so that the barbs penetrate the tissue and emerge from the other side where they are then locked into the retainer piece. The retainers prevent the two-part fastener from dislodging from the tissue. The two-part fasteners are not intended to be unlocked or removable. They are generally made of a bioabsorbable material.
• A common concern in each of these procedures is hemostasis, or the rate at which bleeding of the target tissue is stopped. It is commonly known that by increasing the amount of pressure applied to a wound, the flow of blood can be limited, thereby decreasing the time necessary to achieve hemostasis. To this end, conventional surgical fastening apparatus generally apply two or more rows of fasteners about the cut-line to compress the surrounding tissue in an effort to stop any bleeding and to join the cut tissue together. Each of the fasteners will generally apply a compressive force to the tissue sufficient to effectuate hemostasis, however, if too much pressure is applied, this can result in a needless reduction in blood flow to the tissue surrounding the cut-line. Accordingly, the joining of tissue together in this manner may result in an elevated level of necrosis, a slower rate of healing, and/or a greater convalescence.
• Consequently, it would be advantageous to provide a surgical fastening apparatus capable of limiting the flow of blood in the tissue immediately adjacent the cut tissue to effectuate hemostasis and wound closure, while maximizing blood flow in the surrounding tissue to facilitate healing. It may also be desirable to cut and staple across tissue that varies in thickness. It would therefore be advantageous to provide staples which could better accommodate these resulting different tissue thicknesses.
SUMMARY
• The present disclosure provides a surgical fastener cartridge. The surgical fastener cartridge includes a cartridge body that includes a tissue contacting surface. The tissue contacting surface includes a plurality of fastener retention slots. In embodiments, each of the plurality of fastener retention slots are angled forming inner and outer ends with respect to the slot. The cartridge body includes a plurality of surgical fasteners disposed in the plurality of fastener retention slots; each of the surgical fasteners having a first leg and a second leg. In embodiments, the first leg of the surgical fastener includes a length that is shorter than a length of the second leg of the surgical fasteners. In embodiments, the first and second legs of the surgical fastener are connected by a backspan that defines an angle with respect to the tissue contacting surface. The cartridge body includes a plurality of pushers operably associated with the plurality of surgical fasteners; each pusher configured for ejecting an associated surgical fastener towards a depression in an anvil. One or more of the pushers may be configured such that, upon formation of a corresponding surgical fastener, a first area defined by the first leg is smaller than a second area defined by the second leg. In embodiments, each of the formed surgical fasteners includes a first loop defining the first area and a second loop defining the second area. In embodiments, one or more of the surgical fasteners includes a recess in the backspan thereof, prior to formation. An actuation mechanism may be operably associated with the plurality of pushers.
• In embodiments, the tissue contacting surface includes a slot configured to accommodate longitudinal movement of a cutting element.
• In embodiments, the surgical fastener has portions with different diameters.
• In embodiments, a top surface of the one or more pushers is sloped.
• In embodiments, the backspan of the surgical fastener follows substantially the same contour as the top surface the at least one pusher.
• The present disclosure also provides surgical fastener cartridge that includes a cartridge body that includes a tissue contacting surface. The tissue contacting surface includes a plurality of fastener retention slots and a knife slot configured to accommodate longitudinal movement of a cutting element. In embodiments, each of the plurality of fastener retention slots may be angled forming inner and outer ends with respect to the knife slot. The cartridge body includes a plurality of surgical fasteners that are disposed in the plurality of fastener retention slots; each surgical fastener having a first end that is closer to the knife slot than a second end. In embodiments, the surgical fastener includes a first leg at the first end and a second leg at the second end. The first leg may include a length that is shorter than a length of the second leg. In embodiments, the first and second leg of each of the surgical fasteners is connected by a backspan that defines an angle with respect to the tissue contacting surface. In embodiments, one or more of the surgical fasteners may include a recess in the backspan thereof, prior to formation. The cartridge body includes a plurality of pushers operably associated with the plurality of surgical fasteners; each pusher configured to eject an associated surgical fastener towards a depression in an anvil. One or more of the pushers includes a corresponding surgical fastener and the one or more pushers may be configured such that, upon formation, the first end of the corresponding surgical fastener is smaller in height than the second end of the corresponding surgical fastener. In embodiments, each of the formed surgical fasteners includes a first loop and a second loop. An actuation mechanism may be operably associated with the plurality of pushers.
• In embodiments, the surgical fastener has portions with different diameters.
• In embodiments, a top surface of the one or more pushers is sloped.
• In embodiments, the backspan of the surgical fastener follows substantially the same contour as the top surface the at least one pusher.
• The present disclosure additionally provides a surgical fastener applying apparatus. The surgical fastener applying apparatus includes a handle assembly, an elongated shaft extending distally from the handle assembly; and an operative tool adapted to couple to the shaft. The operative tool includes a pair of opposed jaws pivotally coupled to one another and respectively including an anvil member and a non-reloadable surgical fastener cartridge that are approximated relative to one another during use. In certain embodiments, the non-reloadable surgical fastener cartridge includes a cartridge body that includes a tissue contacting surface. The tissue contacting surface includes a plurality of fastener retention slots. In embodiments, each of the plurality of fastener retention slots are angled forming inner and outer ends with respect to the slot. The cartridge body includes a plurality of surgical fasteners disposed in the plurality of fastener retention slots; each of the surgical fasteners having a first leg and a second leg. In embodiments, the first leg of the surgical fastener includes a length that is shorter than a length of the second leg of the surgical fasteners. In embodiments, the first and second legs of the surgical fastener are connected by a backspan that defines an angle with respect to the tissue contacting surface. The cartridge body includes a plurality of pushers operably associated with the plurality of surgical fasteners; each pusher configured for ejecting an associated surgical fastener towards a depression in an anvil. One or more of the pushers may be configured such that, upon formation of a corresponding surgical fastener, a first area defined by the first leg is smaller than a second area defined by the second leg. In embodiments, each of the formed surgical fasteners includes a first loop defining the first area and a second loop defining the second area. In embodiments, one or more of the surgical fasteners includes a recess in the backspan thereof, prior to formation. An actuation mechanism may be operably associated with the plurality of pushers.
• In embodiments, the tissue contacting surface includes a slot configured to accommodate longitudinal movement of a cutting element.
• In embodiments, the surgical fastener has portions with different diameters.
• In embodiments, a top surface of the one or more pushers is sloped.
• In embodiments, the backspan of the surgical fastener follows substantially the same contour as the top surface the at least one pusher.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
• FIG. 1 illustrates a surgical fastener applying apparatus for use with a surgical fastener cartridge that employs surgical fasteners in accordance with an embodiment of the present disclosure;
• FIG. 2 illustrates another type of surgical fastener device that employs an alternate embodiment of a surgical fastener cartridge in accordance with the present disclosure;
• FIG. 3 illustrates another type of surgical fastener instrument that employs an alternate embodiment of surgical fastener cartridge in accordance with the present disclosure;
• FIG. 4A is an enlarged top perspective view of the surgical fastener cartridge configured for use with the surgical fastener applying apparatus shown inFIG. 1;
• FIG. 4B is a partially exploded view of an alternate embodiment of a surgical fastener loading unit configured for use with the surgical fastener applying apparatus depicted inFIG. 3;
• FIG. 5A is a partial cross-sectional view of the surgical fastener cartridge depicted inFIG. 4B with the surgical fastener shown subsequent to formation;
• FIG. 5B is an enlarged view of the area of detail represented by5B depicted inFIG. 5A;
• FIG. 6 is a side perspective view of a surgical fastener configured for use with the cartridge depicted inFIG. 4A prior to formation;
• FIGS. 7A-7E illustrate alternate embodiments of surgical fasteners according to the present disclosure;
• FIG. 8 is a side cross-sectional view of the surgical fastener depicted inFIG. 6 shown subsequent to formation and within adjacent tissue segments;
• FIG. 9 is a side perspective view of a pusher configuration depicted inFIG. 4B;
• FIG. 10 illustrates the surgical fastener depicted inFIG. 6 being shown prior to and subsequent to formation (in phantom);
• FIG. 11 is partial cross-sectional view taken along the line segment “11-11” ofFIG. 4A illustrating the surgical fastener cartridge loaded with the surgical fasteners depicted inFIG. 6; and
• FIG. 12 illustrates another type of surgical fastener device that may employ an alternate embodiment of surgical fastener cartridge in accordance with the present disclosure.
DETAILED DESCRIPTION OF EMBODIMENTS
• Various embodiments of the presently disclosed surgical fastener cartridge will now be described in detail with reference to the drawings wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal” will refer to the end of the surgical fastener cartridge that is closer to the operator during use, while the term “distal” will refer to the end of the fastener cartridge that is farther from the operator, as is traditional and conventional in the art. In addition, the term “surgical fastener” should be understood to include any structure formed of a biocompatible material that is suitable for the intended purpose of joining tissue together, including but not being limited to surgical staples, clips, and the like.
• The present disclosure provides a surgical fastener cartridge adapted to house a plurality of surgical fasteners configured so as to have areas of different sizes, depending on the location of the tissue with respect to the cartridge, and potentially to apply different compressive forces to tissue, such that a hemostatic effect may be achieved. To this end, certain embodiments have surgical fasteners each of which includes two legs each configured to provide a different compression force to stapled tissue when formed.
• With reference toFIG. 1, a surgicalfastener applying apparatus1000 that employs asurgical fastener cartridge100 is illustrated. Surgicalfastener applying apparatus1000 is used to sequentially apply a plurality of surgical fasteners to a patient's tissue.Surgical fastener apparatus1000 may be configured for use, subsequent sterilization and reuse, or may be configured for single use. Surgicalfastener applying apparatus1000 includes a handle ortrigger1002, anelongated shaft1004 extending distally therefrom, and anoperative tool1006 coupled to adistal end1008 of theelongated shaft1004. In general,operative tool1006 is adapted to clamp, sequentially fasten together, and sever adjacent tissue segments along a cut-line, orlongitudinal slot122.Operative tool1006 includes a pair ofopposed jaws1012,1010 pivotally coupled to one another and respectively including ananvil member1014 andcartridge100 that are approximated relative to one another during use. Theanvil1014 includes ananvil plate90 having depressions91 (seeFIG. 5A) that are aligned with, and/or are in registration with fastener retention slots126 (FIG. 4A) defined in thecartridge100, through which thefasteners130 will emerge, to be driven against anvil plate90 (seeFIGS. 5A and 5B). For a more detailed discussion of the approximation and firing of surgicalfastener applying apparatus1000, reference is made to commonly owned U.S. Pat. Nos. 7,258,262 and 5,865,361 currently assigned to Tyco Healthcare Group LP, the entire contents of which are hereby incorporated herein by reference. Theoperative tool1006 and/orcartridge100 may be a removable and/or replaceable loading unit for theapparatus1000.
• While surgicalfastener applying apparatus1000 is depicted as an apparatus suitable for use in laparoscopic procedures for performing surgical anastomotic fastening of tissue, those skilled in the art will appreciate thatcartridge100 may be adapted for use with any surgical fastening instrument. For example,cartridge100 may be adapted for use with an end-to-end anastomosis device2000, as seen inFIG. 2, and/or asurgical stapling instrument3000, as seen inFIG. 3, for use during an open gastro-intestinal anastomotic stapling procedure, or, for example, any of the surgical fastener applying apparatus discussed in U.S. Pat. Nos. 6,045,560; 5,964,394; 5,894,979; 5,878,937; 5,915,616; 5,836,503; 5,865,361; 5,862,972; 5,817,109; 5,797,538; and 5,782,396, which are each hereby incorporated by reference herein in their entirety. The cartridge in certain embodiments is removable and replaceable with another loaded cartridge. In other embodiments, theoperative tool1006 is removable and replaceable.
• For the purposes of brevity, the structural and operational features ofcartridge100 will be described in terms of use with the surgicalfastener applying apparatus1000.
• With reference toFIGS. 4A and 4B, and initially with reference toFIG.4A cartridge100 is shown.Cartridge100 extends along a longitudinal axis “A-A” and includes acartridge body112 with a pair ofopposed side walls114,116, abottom wall118, and atissue contacting surface120. Thetissue contacting surface120 includes alongitudinal slot122 that is configured to accommodate longitudinal movement of aknife bar601, or other suitable cutting element, such that stapled tissue may be severed along a cut-line. Thetissue contacting surface120 includes a plurality offastener retention slots126 arranged into a plurality ofrows128 that extend substantially the length of thecartridge100. As shown inFIG. 4A, thefastener retention slots126 are arranged intorows128 that are spaced laterally from thelongitudinal slot122.Retention slots126 are configured such that deployment of thesurgical fastener130 and subsequent formation thereof, provides a formed surgical fastener with an end that is closer to the cut-line and an end that is farther from the cut-line, orlongitudinal slot122. To this end,retention slots126 are angled with respect tolongitudinal slot122, as best seen inFIG. 4A, such that inner (closest to the longitudinal slot) and outer ends (farthest to the longitudinal slot)128_Aand128_B, respectively, are formed. While thecartridge100 is depicted as including pairs ofrows128, it is within the purview of the present disclosure to have more or fewer rows of thefastener retention slots126 disposed oncartridge100. Additionally,rows128 may be annular, as opposed to linear, and spaced radially from the cutting element; such is the case when the fastening cartridge is employed with the surgical fastening device depicted inFIG. 2. In addition, theretention slots126 could be aligned with a longitudinal axis of the fastening cartridge.
• With reference toFIG. 4B, each of thefastener retention slots126 is configured to receive one of a plurality ofsurgical fasteners130 therein such that thesurgical fasteners130 are deployed in rows on opposite sides of the cut-line, orlongitudinal slot122 created in the tissue during fastening, seeFIG. 11 for example.Pushers150 are operatively associated and aligned withfastener retention slots126 and are sequentially contacted by one or more cam wedges644 (four cam wedges are shown) of anactuation sled600 asactuation sled600 is driven distally throughcartridge100 by an axial drive assembly which includesknife bar601 and an abutment surface which engages thecentral support wedge645 ofactuation sled600. Axial drive assembly, among other things, transmits the longitudinal drive forces exerted by a control rod (not shown) disposed inelongated shaft1004 to theactuation sled600 disposed such that theactuation sled600 engages therespective pushers150.Pushers150 interact with the plurality ofsurgical fasteners130 housed withinstaple cartridge100 to sequentially eject thesurgical fasteners130 therefrom (FIG. 4B). An example of a drive assembly is disclosed in commonly owned U.S. Pat. No. 7,258,262, the contents of which are hereby incorporated by reference in its entirety.
• In order to move the anvil member between the open and closed positions,surgical stapling instrument1000 includes a trigger or handle1002 pivotally mounted to the handle assembly.Handle1002 controls the linear movement of a control rod (not shown) which is mounted within theelongated tubular member1004. The control rod operates to move theknife bar601 distally to initially move the anvil member and/or slot101 between the open and closed positions. The knife bar also acts to move the sled (not shown) distally through the staple cartridge18 to eject staples. The knife bar desirably includes a knife blade to cut tissue as the knife bar translates through the staple cartridge18, but the knife bar may be configured as a series of cam bars and a separate knife.
• Although surgical stapling instrument12 is shown with a singlemovable handle1002 which accomplishes both jaw closure and firing of staples, it is further contemplated that the present buttress release mechanism can also be used with surgical stapling instruments of the type which utilize a clamping mechanism to close the jaws which is separate from the firing mechanism. See, for example, U.S. Pat. No. 5,476,206, the contents of which are expressly incorporated herein by reference.
• In operation, prior to firingstapling apparatus1000,actuation sled600 is in a proximal-most position. At such a time,knife bar601 is disposed adjacent a proximal end ofcartridge100 and proximal to thesled600. Theknife bar601 of the axial drive assembly has an upper member that engages aslot92 disposed within theanvil member90 and a lower member that engages theslot101 that supports the cartridge100 (seeFIG. 11). Theoperative tool1006 is first actuated to clamp onto tissue.Movable handle1002 of the handle assembly advances the control rod distally. The control rod advances the knife bar so that the upper and lower members of the knife bar engage theanvil member90 andslot101 respectively to approximate theanvil member90 andcartridge100 with one another. With tissue clamped betweenanvil member90 andcartridge100, the fasteners are fired from the apparatus into the tissue. Thehandle1002 is again operated to further advance the knife bar. Accordingly, a drive bar drivesactuation sled600 distally throughcartridge100. During its distal translation, the angled leading surfaces ofcam wedges644 sequentiallycontact pushers150, urging them in a direction perpendicular to the direction of movement of actuation sled600 (FIG. 5A), toward the anvil. As a result,pushers150 pushsurgical fasteners130 from their individual slots, driving eachsurgical fastener150 into a respective formingdepression91 of anvil plate90 (FIG. 5B). The forming depressions are configured to form the surgical fasteners into the desired shape. Sequential firing of the staples continues untilactuation sled600 is advanced to the distal end ofcartridge100, at which time, all of the staples once housed withincartridge100 will have been ejected. A more detailed description of the interaction betweenactuation sled600 andpushers150 will be described below.
• With reference now to FIGS.6 and7A-7D,cartridge100 may loaded with one or more varieties of surgical fastener, represented generally assurgical fastener130.Surgical fastener130 includes twolegs132, afirst leg132_Aand asecond leg132_Beach having different lengths and connected by abackspan134 extending therebetween. In the embodiment shown,backspan134 is at an angle with respect to both oflegs132 and follows substantially the same contour as atop surface152 ofpusher150, seeFIG. 10 for example.Backspan134 may be slanted at any angle with respect to each oflegs132_A,132_Bandtop surface152 ofpusher150. The thickness of thebackspan134 and thelegs132 may be varied to fasten adjacent tissue segments “T₁”, “T₂” of varying thickness (seeFIG. 8). In certain embodiments, the backspan of the surgical fastener has a recess defined therein, prior to formation. The recess generally reduces the interior space or area of the formed surgical fastener, seeFIG. 7E for example.
• Thelegs132 and thebackspan134 may define a cross-section having any suitable geometric configuration, including but not limited to rectangular, oval, square, triangular, and trapezoidal. Thelegs132 and thebackspan134 may exhibit the same geometrical configuration such that the cross-sectional configuration of thesurgical fastener130 is substantially uniform, or, alternatively, thelegs132 and thebackspan134 may exhibit different geometrical configurations, e.g., thelegs132 may exhibit a rectangular cross-section and the backspan34 may exhibit an oval cross-section, as shown inFIGS. 7A-7D.Backspan134 and/orlegs132 may be formed by any suitable means known in the art including but not limited to welding, braising, coining, casting, overmolding and so on. Additionally,backspan134 and/orlegs132 may be treated by way of annealing, cold working, heat treating, and so on. This may provide increased burst strength to the surgical fastener. Moreover, backspan may include different configurations of blocking and/or retainer material, tube, sleeve, collar, and/or grommet.
• As seen inFIG. 6, prior to the formation ofsurgical fastener130,legs132 extend from thebackspan134 such that they are substantially parallel. Alternatively, thelegs132 may converge or diverge from the backspan. The present disclosure contemplates that thesurgical fastener130 may also be configured as a directionally biased staple, such as those described in commonly owned U.S. patent application Ser. No. 11/253,493, filed Oct. 17, 2005, the entire contents of which are incorporated by reference herein.
• Each of thelegs132 terminates in apenetrating end136 that is configured to penetrate tissue (tissue segments “T₁”, “T₂” for example) and/or other suitable material (blocking and/or retainer material for example). The penetrating ends136 oflegs132 can be tapered to facilitate the penetration of tissue segments “T₁”, “T₂”, or alternatively, the penetrating ends136 may not include a taper. In various embodiments, penetrating ends136 may define a conical or flat surface, as described in co-pending U.S. patent application Ser. No. 11/444,761, filed Apr. 13, 2003, the entire contents of which are incorporated by reference herein. In embodiments, one or both oflegs132 may be barbed. Havinglegs132 configured in such a manner may facilitate maintaining thesurgical fastener130 in a fixed position within the tissue and/or blocking material. In certain embodiments, each oflegs132 has different lengths. More particularly, theleg132 closer to the cut-line, or longitudinal slot122 (e.g., leg132_A) will have a shorter length than theleg132 farther from the cut-line, or longitudinal slot122 (e.g., leg132_B). A more detailed description of thelegs132 will be described below.
• Turning now toFIG. 8,surgical fastener130 is shown subsequent to formation.Surgical fastener130 is configured to provide a compression force to stapled tissue occupied therein. To this end,legs132_Aand132_Bcooperate withbackspan134 to maintain adjacent tissue segments or layers “T₁”, “T₂” in approximation and apply respective compressive forces “F₁” and “F₂” thereto. The respective compressive forces “F₁” and “F₂” applies pressure to the tissue segments “T₁”, “T₂”, thereby restricting the flow of blood through the tissue surrounding thesurgical fastener130 and facilitating hemostasis. The amount of pressure that is applied to the tissue segments “T₁”, “T₂” is limited such that the flow of blood through the tissue is not completely restricted. When formed,surgical fastener130 is generally “B” shaped having a first loop at a first end of the surgical fastener with an overall height “H_L1” and a respective tissue compression space or area Tc₁, and a second loop at a second end of the surgical fastener with an overall height “H_L2” and a respective tissue compression space Tc₂(each tissue compression space or area measured from the outermost surface of the backspan134 to the outermost curve of the legs132).
• With reference toFIGS. 9 and 10, an initially with reference toFIG. 9,pusher150 is shown. As noted above,cartridge100 is configured such that theleg132 of thesurgical fastener130 deployed closer to the cut-line orslot122 provides a greater compression force to the stapled tissue than theleg132 of thesurgical fastener130 deployed farther from the cut line,longitudinal slot122. To this end,pusher150 is configured such that aportion150aof thepusher150 driving theleg132 of thesurgical fasteners130 closer to the cut-line orlongitudinal slot122 has greater height than aportion150bof thepusher150 driving theleg132 of the surgical fasteners farther from the cut-line or slot122 (seeFIG. 10, for example).
• Pusher150 includes abase154 and twosidewalls156,158 extending in a generally orthogonal direction therefrom.Pusher150 may include structure similar to conventional pushers known in the art. Whilebase154 is shown having a generally linear configuration, it is within the purview of the present disclosure forbase154, or portion thereof, to be curved or angled. Havingbase154 curved or angled may facilitate operative interaction betweensled600 andpusher150.Base154 ofpusher150 may have any suitable width “W”.Sidewall156 supports correspondingleg portion132_Aand has a height “H₁”, whilesidewall158 supports correspondingleg portion132_Band has a height “H₂(seeFIG. 10). Height “H₁” ofsidewall156 being greater than height “H₂” ofsidewall158. As noted above,pusher150 includes atop surface152.Top surface152 is oblique or slanted and extends fromsidewall156 tosidewall158. Havingpusher150 configured in such a manner facilitates forming ofsurgical fastener130 againstdepressions91 ofanvil plate90.Top surface154 may extend from thesidewalls156,158 at any suitable angle “α” (FIG. 9). More particularly, angle “α” may be equal to, less than, and/or greater than the angle or slant that backspan134 extends with respect to each oflegs132_A,132_B.Pusher150 also includes front andrear walls160,162, respectively. In further embodiments, thetop surface152 may be stepped, with two or more generally horizontal surfaces.
• Those skilled in the art will appreciate that several variations of the above described pusher configurations may be employed to achieve the same or similar result. For example, instead of havingsidewalls156,158 with different heights, sidewalls156,158, may have similar heights and include any number of intents, detents, slits, slots, or other suitable structure configured to raise or lower a corresponding leg of a surgical fastener. Part of the pusher may comprise a collapsible or compressible material to correspond to a portion of a fastener having a larger compressive space.
• As noted, in certain embodiments, thelegs132 supported by sidewalls156 (e.g., legs132_A), and thus closest to the cut-line orlongitudinal slot122, are shorter and as a result are intended to form a smaller loop. In operation, whencam wedges644 contact and drivepushers150, the correspondinglegs132_Aofsurgical fasteners130 forms a loop, or other generally closed shape, when it is urged against theanvil plate90, thereby restricting the flow of blood through the tissue surrounding thesurgical fastener130 and facilitating hemostasis. As also noted, the legs supported by sidewalls158 (e.g., legs132_B), and thus farther from the cut-line, are longer and as a result are intended to form a larger loop, or generally closed shape. In operation, whencam wedges644 contact and drivepushers150, the correspondinglegs132_Bofsurgical fasteners130 forms a larger loop when thesurgical fastener130 is urged against theanvil plate90, thereby allowing some blood to flow through the tissue surrounding thesurgical fastener130 and facilitating healing, as best seen inFIG. 5B.
• With reference again toFIG. 10 formation ofsurgical fastener130 will be described. In the following description,cam wedges644 ofsled600 are configured to provide the driving force forpushers150 andsurgical fasteners130. As shown,surgical fastener130 has a diameter “D₁” and includeslegs132_Aand132_Bthat have respective lengths “L₁” and “L₂”.Legs132_Aand132_Eare substantially similar to each other. The overall heights of thelegs132_A,132_Ein the unformed condition (measured from the penetratingtip136 of the legs to the outermost surface of the backspan134) are shown withleg132_Abeing shorter thanleg132_B.Surgical fasteners130_Aare shown in their initial and formed conditions (in phantom). Thebackspan134 cooperates with each of132_Aand132_Eof thesurgical fastener130 to form two respective tissue compressive spaces140₁,140₂(FIG. 10).Sidewalls156 and158 are configured to supportrespective legs132_A,132_B. As noted, the legs of the surgical fasteners formed farther from the cut-line, or slot122 provide a loop with a larger tissue compression zone140₂and the legs of the surgical fasteners formed closer to the cut-line, orlongitudinal slot122 provide a loop with a smaller tissue compression zone140_k, seeFIGS. 5A and 5B for example. Thus, becauseleg132_Bhas a length “L₂” that is greater thanleg132_Aand is supported by asidewall158 with a height “H₂” that is smaller thansidewall156, a larger loop is formed when urged against a respective anvil portion. The resultant compression space or zone140₂facilitates hemostatsis. However, because blood flow is not completely restricted through tissue compression space140₂, unnecessary necrosis of the stapled tissue may be prevented and/or impeded. Conversely, becauseleg132_Ahas a length “L₁” that is less thanleg132_Band is supported by asidewall136 with a height “H₁” that is larger thansidewall132_B, a smaller loop is formed when urged against a respective anvil portion. The resultant compression space or zone140₁further facilitates hemostatsis. Here, because blood flow is substantially restricted through tissue compression space140₁, this results in facilitating and effectuating hemostatsis.
• The respective dimensions ofsidewalls156 and158 andlegs132_A,132_B, may be altered, which, in turn, may alter the respective dimensions of the compressive spaces140₁and140₂occupied by stapled tissue segments “T₁”, “T₂” when the respectivesurgical fasteners130_Aare in their formed conditions. By altering the respective dimensions ofsidewalls156 and158, and/orlegs132_A,132_B, any desired level of hemostasis and blood flow in the stapled tissue segments “T₁”, “T₂” may be effectuated. Other various attributes of the tissue (e.g., thickness or the presence of scar tissue) may increase or diminish the level of hemostasis and blood flow in the stapled tissue segments. In further embodiments, the fasteners may have a smaller compression space adjacent the lateral sides of the cartridge and a larger compression space adjacent thelongitudinal slot122. In other embodiments, the heights of the pushers, length of the legs, or both, differ to form a fastener with compressive spaces that differ in size.
• FIG. 11 illustrates thesurgical fasteners130 includinglegs132_Aand132_B, andrespective pushers150 havingsidewalls156 and158 loaded within thecartridge body112 shown inFIGS. 1 and 4. Thesurgical fasteners130 andrespective pushers150 are arranged to define a pair ofrows128 offastener retention slots126 formed in thetop wall120. The pair ofrows128 are each spaced laterally from thelongitudinal slot122, on opposite sides thereof, and include inner andouter ends128_Aand128_B, respectively, such that thesurgical fasteners130 will be deployed on opposite sides of the cut-line, orlongitudinal slot122 created in the tissue upon fastening. That is, thelegs132_Aof thefasteners130, which are driven bycam wedges644 and are supported bysidewall156, provide a greater compressive force as there is a shorter distance between the inner surface of the backspan and the curve of the formed legs, and in the illustrated embodiment are provided closer to the cut line, orlongitudinal slot122. Thelegs132_Boffasteners130, which are also driven bycam wedges644 and are supported bysidewall158, provide a lesser compressive force as there is a greater distance between the inner surface of the backspan and the curve of the formed legs, and in the illustrated embodiment are provided farther from the cut line, orslot122. It should be appreciated, however, that the fasteners can be placed in rows that are configured differently than the foregoing. For example, two or more rows are on either side of theslot122, with the outer rows having compressive spaces that differ after forming, or having standard fasteners and/or some combination thereof.
• In further embodiments, the shape of the cartridge or anvil or both applies a compression force to the tissue that varies depending on the location with respect to the cartridge and anvil. In certain embodiments, the cartridge or anvil or both are configured to apply a compression force to the tissue that corresponds to the compressive space or area of the fastener at that location.
• In certain embodiments, a staple having legs of approximately the same length are formed using pushers configured aspusher150 so that one leg of the staple is crimped more than the other.
• In one particular embodiment, therows128, are comprised solely ofsurgical fasteners130 such that the flow of blood through the tissue immediately surrounding the cut-line, orslot122 is substantially restricted by formedlegs132_Aofsurgical fasteners130, whereas the flow of blood through the tissue surrounding areas away from the cut-line, orslot122 is less restricted by formedlegs132_Bofsurgical fasteners130. Accordingly, the flow of blood is minimized in the tissue immediately adjacent the cut-line, orlongitudinal slot122 and is increased gradually as the lateral distance from the cut-line is also increased. It should be appreciated that some of the fasteners incartridge100 can have different configurations, e.g., the diameters of the fasteners could be varied to accommodate tissue of different thicknesses and to control tissue compression by the fasteners. In addition, the formed configuration of the fasteners can be varied to vary the tissue compression applied by the fasteners. For example, the backspan of thefastener130_Amay be dimpled or crimped to decrease the compression space of the formed fastener.
• From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications can also be made to the present disclosure without departing from the scope of the same. For example, the surgical fasteners described herein above may be formed from a variety of surgically acceptable materials including titanium, plastics, bio-absorbable materials, etc. Additionally, any of the aforementioned surgical fasteners may be treated, chemically or otherwise, prior to being loaded intocartridge100.
• It is also contemplated that thebackspan134 of thesurgical fastener130 may include one or more pockets (seeFIG. 7C, for example) that are positioned to engage (i.e., receive or bend) thelegs132 during formation of thesurgical fastener130 and configured to redirect thelegs132 such that they are coiled toward thebackspan134, as discussed in commonly owned U.S. patent application Ser. No. 11/444,664, filed Jun. 1, 2006, the entire contents of which are incorporated by reference herein.
• It is contemplated that in addition to varying the respective heights and lengths of thepusher150 andsurgical fastener130, the thickness of thebackspan134 and thelegs132_Aand132_Bmay also be varied such that one leg of thesurgical fastener130 provides a greater compression force to stapled tissue occupied therein than the other leg of thesurgical fastener130. For example, in the embodiment ofFIGS. 6 and 8, the backspan and legs are shown having a uniform diameter. It should be appreciated that the diameter of the legs and backspan, or portions thereof, can vary within the fastener. Examples of varying backspan sizes are shown inFIGS. 7A-7B. In the embodiment ofFIG. 7A, the backspan is enlarged with respect to the legs and is anintegral element234 in which thefastener legs232 are embedded. InFIG. 7C, the backspan is334 is integral with thefastener legs332. In the embodiments ofFIGS. 7B and 7D, a separate backspan material is attached to thefastener430,530, respectively, withbackspan434 ofFIG. 7B including acylindrical collar435 encircling thebackspan portion431 of thefastener430 and thebackspan534 offastener530 ofFIG. 7D encompassing thebackspan portion531 of the fastener and a portion of thefastener legs532. In the embodiment ofFIG. 7E, a surgical fastener730_Ais shown in its formed condition. The surgical fastener730_Aincludes recesses, humps or mounds738_Aformed in the backspan734_A. Recesses extend inwardly from the backspan734_acurving towards the penetrating ends736 of thelegs732 and defining a recess, hump or mound of a first height “H₁”. The backspan material ofFIGS. 7B and 7D can be composed of any suitable material, by way of example, a resilient form, elastomer, or molder plastic can be used. Varying the thickness or height of these backspans or backspan materials can vary the compression force of the formed staple by varying the distance between the curved legs and inner portion of the backspan. This variation can be provided in addition to the varying gap distances of the cam wedges to accommodate varying tissue thicknesses.FIG. 7B illustrates this varying backspan by showing in phantom a collar of larger diameter (D2 compared to D1) to decrease the compression area. Other backspan shapes and attachments to achieve the various compression forces are also contemplated.
• The surgical fastener applying apparatus according to certain embodiments of the present disclosure includes a plurality of cam bars for interacting with the pushers to deploy the surgical fasteners. For example, the apparatus disclosed in U.S. Pat. No. 5,318,221, the disclosure of which is hereby incorporated by reference herein, in its entirety, has a cam bar adapter that holds a plurality of cam bars and a knife. A slot is advanced through operation of the handle of the apparatus, which drives the cam bars and knife forward. A clamp tube that surrounds the proximal end of the anvil is advanced to clamp the anvil and cartridge together. In another example, the apparatus disclosed in U.S. Pat. No. 5,782,396, the disclosure of which is hereby incorporated by reference herein, in its entirety, has an actuation sled. An elongated drive beam is advanced distally through operation of the handle of the apparatus, driving the actuation sled forward. The distal end of the drive beam engages the anvil and the slot that supports the cartridge as the drive beam travels distally, to deploy the staples and clamp the anvil and cartridge together. The surgical fastener applying apparatus shown in U.S. Pat. No. 7,070,083 employs a pusher bar incorporating a plurality of pushers that are advanced substantially simultaneously to deploy the fasteners against an anvil. One or more of the pushers may incorporate a deflectable portion, in certain embodiments of the present disclosure.
• Thesurgical fastening cartridge100 may also be employed with a surgical fastener applying apparatus4000 (FIG. 12).Apparatus4000 has a drive bar that advances distally that is typically used to simultaneously deploy a plurality of surgical fasteners (surgical fasteners130 for example) into a target section of tissue (not explicitly shown). Here, a scalpel or other such cutting element may be used to remove the target section of tissue. Further details regarding the use and function of surgicalfastener applying apparatus4000 may be obtained through reference to U.S. Pat. No. 7,070,083 the entire contents of which having been previously incorporated by reference herein. In an alternate embodiment, theapparatus4000 could include a cutting element as in the other cartridges disclosed herein.
• Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, the above description, disclosure, and figures should not be construed as limiting, but merely as exemplary of various embodiments.

Claims (18)

1. (canceled)

2. A surgical fastener cartridge comprising:

a cartridge body including a tissue contacting surface, the tissue contacting surface including a fastener retention slot;

a surgical fastener disposed in the fastener retention slot, the surgical fastener having a first leg and a second leg;

a pusher operably associated with the surgical fastener, the pusher configured for urging the surgical fastener through the fastener retention slot, the pusher having a first sidewall, a second sidewall, and a top surface, the first sidewall having a height larger than a height of the second sidewall such that, upon formation of the surgical fastener, a first area defined by the first leg is less than a second area defined by the second leg, the top surface of the pusher defining an acute angle with respect to the tissue contacting surface; and

an actuation mechanism operably associated with the pusher.

3. The surgical fastener cartridge ofclaim 2, wherein the pusher is configured to urge the surgical fastener towards a depression in an anvil.

4. The surgical fastener cartridge ofclaim 2, wherein the first leg has a first length and the second leg has a second length, the first length different from the second length.

5. The surgical fastener ofclaim 4, wherein the first length is less than the second length.

6. The surgical fastener cartridge ofclaim 2, wherein the tissue contacting surface includes a slot configured to accommodate longitudinal movement of a cutting element.

7. The surgical fastener cartridge ofclaim 6, wherein the fastener retention slot is angled forming inner and outer ends with respect to the slot.

8. The surgical fastener cartridge ofclaim 2, wherein the formed surgical fastener includes a first loop defining the first area and a second loop defining the second area.

9. The surgical fastener cartridge ofclaim 2, wherein the first and second legs of the surgical fastener are connected by a backspan that defines an angle with respect to the tissue contacting surface.

10. A surgical fastener applying apparatus comprising:

a handle assembly;

an elongated shaft extending distally from the handle assembly; and

an operative tool attachable to the shaft, the operative tool including:

an anvil pivotably coupled to a cartridge, the anvil and the cartridge configured to move between an approximated relationship and a spaced apart relationship, the cartridge includes a cartridge body with a tissue contacting surface, the tissue contacting surface including a fastener retention slot;

a surgical fastener disposed in the fastener retention slot, the surgical fastener having a first leg and a second leg;

a pusher operably associated with the surgical fastener, the pusher configured for ejecting the surgical fastener towards a depression in the anvil, the pusher having a first sidewall, a second sidewall, and a top surface, the first sidewall having a height larger than a height of the second sidewall such that, upon formation of the surgical fastener, a first area defined by the first leg is smaller than a second area defined by the second leg, the top surface of the pusher being sloped; and

an actuation mechanism operably associated with the pusher.

11. The surgical fastener applying apparatus ofclaim 10, wherein the first leg of has a first length and the second leg has a second length that is different from the first length.

12. The surgical fastener applying apparatus ofclaim 11, wherein the first length is less than the second length.

13. The surgical fastener applying apparatus ofclaim 10, wherein the tissue contacting surface includes a slot configured to accommodate longitudinal movement of a cutting element.

14. The surgical fastener applying apparatus ofclaim 13, wherein the fastener retention slot is angled forming inner and outer ends with respect to the slot.

15. The surgical fastener applying apparatus ofclaim 10, wherein the formed surgical fastener includes a first loop defining the first area and a second loop defining the second area.

16. The surgical fastener applying apparatus ofclaim 10, wherein the first and second legs of the surgical fastener are connected by a backspan that defines an angle with respect to the tissue contacting surface.

17. The surgical fastener applying apparatus ofclaim 10, wherein the slope of the top surface of the pusher defines an angle with respect to the tissue contacting surface.

18. The surgical fastener applying apparatus ofclaim 16, wherein the backspan of the surgical fastener follows substantially the same contour as the top surface the pusher.

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