US20140236228A1 - Surgical stapler - Google Patents

Abstract

An anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples. The anvil head is mounted to the anvil shaft and the anvil shaft has a longitudinal axis and first and second spaced apart elongated projections attached to the anvil shaft and extending therefrom. The projections are configured and dimensioned to retain a purse string suture.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a divisional of U.S. patent application Ser. No. 12/637,841, filed Dec. 15, 2009, which claims the benefit of, and priority to, U.S. Provisional Patent Application Ser. No. 61/142,660, filed Jan. 6, 2009, now expired, the entire content of each of the above-identified applications being incorporated in their entireties by reference herein.
BACKGROUND
• 1. Technical Field
• The present disclosure relates to a surgical stapling device and more particularly to a surgical stapling device suitable for treatment of internal hemorrhoids.
• 2. Background of Related Art
• Anastomosis is the surgical joining of separate hollow organ sections. In known circular anastomosis procedures, two ends of organ sections are joined by means of a stapling device which drives a circular array of staples through each organ section and simultaneously cores any tissue interior of the driven circular array of staples to free a tubular passage. Examples of such devices are described in U.S. Pat. Nos. 7,234,624, 6,945,444, 6,053,390, 5,588,579, 5,119,983, 4,646,745, 4,576,167, 4,473,077.
• Typically the circular stapling device has an elongated shaft having a handle portion at a proximal end and a staple cartridge at a distal end. An anvil assembly including an anvil rod with an attached anvil head is mounted to the distal end of the device. The anvil is approximated to clamp tissue between the staple holding component and the anvil. The clamped tissue is stapled by actuation of the handle portion to drive circular arrays of staples through the tissue and into anvil depressions on the anvil head to form the staples. An annular knife is advanced with the handle actuation to core tissue inboard of the staple array.
• Surgical stapling devices for performing circular anastomosis have also been used to treat hemorrhoids in the rectum. Hemorrhoids are masses of tissue in the anus containing enlarged blood vessels. Internal hemorrhoids are inside the anal canal; external hemorrhoids lie outside the anal canal. Hemorrhoidectomy is a surgical procedure in which the hemorrhoids are removed. Stapled hemorrhoidopexy is a surgical procedure in which a stapling device is used to remove tissue just above the hemorrhoids in order to pull the hemorrhoids back up inside the rectum and reduce the symptoms. The staples interrupt the blood flow of the superior hemorrhoidal arterial branches, cutting off the blood supply, thus causing the hemorrhoids to shrink. This is used for treatment of internal hemorrhoids.
• During the use of a circular stapling device for hemorrhoid treatment, the anvil head and the staple holding component of the device are inserted through and into the rectum with the anvil head and the stapling holding component in an open or unapproximated position. Thereafter, a purse string suture is used to pull the internal hemorrhoidal tissue and/or mucosal tissue toward the anvil rod. Next, the anvil head and the staple holding component are approximated to clamp the hemorrhoidal tissue and/or mucosal tissue between the anvil head and the staple holding component. The stapling device is fired to remove the hemorrhoidal tissue and/or mucosal tissue and staple the cut tissue.
• It would be advantageous to provide a device with an option to adjust the amount of tissue for purse stringing to enhance control over the amount of tissue removed.
SUMMARY
• The present disclosure provides an anvil assembly comprising an anvil shaft and an anvil bead. The anvil head has anvil depressions for forming surgical staples and is mounted to the anvil shaft. The anvil shaft has a longitudinal axis and first and second spaced apart elongated projections attached to the anvil shaft and extending therefrom, the projections configured and dimensioned to retain a purse string suture.
• In a preferred embodiment, the projections are positioned at an acute angle with respect to the longitudinal axis of the anvil shall, preferably angling away from the anvil head toward a proximal end of the anvil shall. In one embodiment, the plurality of projections are substantially equidistantly axially spaced. In one embodiment, the projections comprise a plurality of elongated pins.
• In another aspect, the present disclosure provides an anvil assembly comprising an anvil shaft and an anvil head, the anvil head having anvil depressions for forming surgical staples. The anvil head is mounted to the anvil shaft. The anvil shaft has a longitudinal axis and first and second spaced apart cutouts formed therein, the cutouts progressively narrowing in width in a direction toward an opposite wall of the anvil shaft and configured and dimensioned to cinch a purse siring suture positioned therein.
• In one embodiment, the cutouts are substantially equidistantly spaced. Preferably, the cutouts curve inwardly and are directed toward a distal end of the anvil shaft such that they form projecting regions angling toward a proximal end of the anvil shaft.
• The present disclosure also provides in another aspect a surgical stapler comprising a handle assembly, an elongated body portion extending distally from the handle assembly, and a head portion disposed adjacent a distal end of the elongated body portion and including an anvil assembly and a shell assembly. The anvil assembly is movable in relation to the shell assembly between spaced and approximated positions and has an anvil head and a plurality of elongated projections for receiving a purse string suture. The projections extend at an angle with respect to a longitudinal axis of the anvil shaft such that longitudinal axis of the projections are angled with respect to the longitudinal axis of the anvil shaft.
• In one embodiment, the anvil assembly includes an anvil shaft extending proximally of the anvil head and removably mountable to an anvil retainer of the stapler. In one embodiment, the projections are integral with the anvil shaft and formed by angled cuts in the anvil shaft, the cuts preferably angling toward a distal end of the anvil shaft. In one embodiment, the cuts have a first dimension and a second dimension closer to a center of the anvil shaft smaller than the first dimension. In this embodiment, the dimension of the cuts can progressively decrease toward the longitudinal axis of the shaft to form cinch regions for the suture. In other embodiments, the projections are attached to the anvil shaft and comprise a plurality of pins substantially equidistantly longitudinally spaced.
BRIEF DESCRIPTION OF THE DRAWINGS
• Various embodiments of the present disclosure are described hereinbelow with reference to the drawings, wherein:
• FIG. 1 is a perspective view of a first embodiment of the surgical stapler of the present disclosure;
• FIG. 1A is a longitudinal cross-sectional view of the surgical stapler ofFIG. 1;
• FIG. 1B is a cross-sectional view of the anvil retainer of the stapler ofFIG. 1;
• FIG. 1C is a side view of the connector of the stapler ofFIG. 1;
• FIGS. 1D and 1E are cross-sectional views of portions of the shell assembly ofFIG. 1;
• FIGS. 2 and 3 are close up perspective and side views, respectively, of the anvil assembly and shell assembly ofFIG. 1;
• FIG. 3A is a cross-sectional view of an alternate embodiment of the anvil head;
• FIG. 4 is a side view of an alternate embodiment of the anvil assembly for use with the surgical stapler ofFIG. 1;
• FIG. 5 is a top view of a portion of the anvil shaft ofFIG. 4;
• FIG. 6 is an exploded view of an alternate embodiment of the anvil assembly of the present disclosure;
• FIG. 7 is a perspective view of the anvil assembly ofFIG. 6;
• FIG. 8 is a perspective view of an alternate embodiment of the anvil assembly of the present disclosure;
• FIG. 9 is a side view illustrating placement of the purse string suture in an anvil assembly of the present disclosure; and
• FIG. 10 is a side view illustrating placement of the purse string suture in an anvil assembly of the present disclosure.
DETAILED DESCRIPTION OF EMBODIMENTS
• The presently disclosed surgical stapler will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. Throughout this description, the term “proximal” will refer to the portion of the stapler closer to the operator and the term “distal” will refer to the portion of the instrument further from the operator. The presently disclosed stapler is particularly suited for surgical procedures for the treatment of colon prolapse and hemorrhoids, although it can be used for other procedures.
• FIGS. 1 and 1A illustrate one embodiment of the presently disclosedhemorrhoid stapler10. Briefly,surgical stapler10 includes ahandle assembly12, a central body orelongated portion14 and adistal head portion15.Head portion15 includes ananvil assembly18 and ashell assembly20. Except where otherwise noted, the components ofstapler10 are generally formed from thermoplastics including polycarbonates, and metals including stainless steel and aluminum. The particular material selected to form a particular component will depend upon the strength requirements of the particular component. For example, the anvil may be formed from a metal such as stainless steel, whereas portions ofhandle assembly12 may be formed from thermoplastic such as a polycarbonate. Alternately, other materials having the requisite strength requirements which are suitable for surgical use may be used to form the components ofstapler10.
• Handleassembly12 includes astationary handle22, a firingtrigger24, anapproximation knob26, anindicator assembly28, and alockout mechanism30.Approximation knob26 functions to retract and advance adrive screw32 to advance or retractanvil assembly18 in relation toshell assembly20. Firingtrigger24 functions to advance apusher link34 to actuate a pusher to eject staples fromshell assembly20. Each of the components ofhandle assembly12 identified above are substantially as described in U.S. Pat. No. 7,303,106 (“'106 patent”) entitled “Surgical Stapling Device With Visual Indicator” which issued on Dec. 4, 2007. The '106 patent is incorporated herein by reference in its entirety. Accordingly, these components and assemblies will not be described in detail herein.
• Referring toFIGS. 1A-1C, ananvil retainer36 is secured to a distal end ofdrive screw32 by aconnector38.Anvil retainer36 includes abody40 defining anelongated bore42. Aproximal end40aofbody40 includes alongitudinal slot44 and a pair oftransverse throughbores46. Adistal end40bofbody40 includes three segmentedflexible arms48. Each of thearms48 has aninner retention surface50 which will be described in further detail below.
• Connector38 includes acentral body52 having aproximal extension54 and adistal extension56.Proximal extension54 is dimensioned to be received within a slot (not shown) formed in the distal end ofdrive screw32.Extension54 and the distal end ofdrive screw32 each define a transverse throughbore for receiving a pin, rivet, screw or the like39A for fixedly securingconnector38 to drivescrew32.Distal extension56 is dimensioned to be received withinslot44 ofbody40 ofanvil retainer36.Extension56 includes a pair of spaced throughbores which align withthroughbores46 ofanvil retainer36 and are dimensioned to receive pins, screws, rivets or the like39B to fixedly secureanvil retainer36 toconnector38. Although pins, screws, rivets or the like are specifically disclosed for securingconnector38 to drivescrew32 andanvil retainer36, other known fastening techniques are envisioned, e.g., welding, crimping, and interlocking structure. In an alternate embodiment, the connector and anvil retainer can be replaced with a single part, e.g. an elongated anvil retainer, having an extended length to function similarly to the extended length resulting from the provision ofconnector38.
• Referring toFIGS. 2 and 3,anvil assembly18 includes an anvil shaft orcenter rod64 and ananvil head66.Anvil shaft64 includes a tapered proximalblunt end64a(FIG. 1A) and an opposite distal end for mounting toanvil post68 ofanvil head66. A pin72 (or alternatively a screw, rivet or the like) mounts theanvil post68 toanvil shaft64. It should be appreciated, thatanvil post68 can be pivotally mounted toanvil shaft64 so that the anvil can move between an operative non-tilted position to a tilted position. This is described in detail in U.S. Pat. No. 7,303,106, the entire contents of which are incorporated herein by reference. Alternatively, the anvil can be fixedly (non-pivotably) mounted to theanvil shaft64. This is shown for example in the embodiment ofFIGS. 6 and 7 described below.
• Anvil shaft64 includes a stepped surface orring74 which is configured to engage retention surfaces50 (FIG. 1B) offlexible arms48 to releasablysecure anvil shaft64 toanvil retainer36. An orientation groove or grooves is provided in anvil shall64 beneathsplines76 to effect proper alignment ofsplines76 aboutshaft64 to facilitate proper alignment ofanvil assembly18 andshell assembly20 whenanvil assembly18 is retracted (approximated) towardsshell assembly26.
• Anvil shaft64 can haveover-molded splines76, or alternatively, the anvil shaft can have machined splines.
• Anvil shaft64 has a series of longitudinally spaced projections in the form ofpins78 as shown. Thepins78 provide for a purse-string attachment location. Although the projections are shown in the form of pins, other outwardly extending elongated structure for retaining purse string suture is also contemplated. As shown, five pins are provided, although a fewer or greater number of pins are also contemplated.
• Thepins78 extend radially outwardly from theanvil shaft64 and are positioned at an angle to a longitudinal axis of the anvil shaft. That is, a longitudinal axis of the pins is angled with respect to a longitudinal axis of theanvil shaft64. In a preferred embodiment, the angle of the pins with respect to the longitudinal axis is between about 30 degrees and about 60 degrees, although other angles are also contemplated as long as they are sufficient to capture the suture. Thepins78 preferably angle toward the proximal end of the anvil shall64 to help retain the suture therebetween, but can alternatively be angled in other directions. Also, although shown as straight, the projections can be curved and/or have multiple angles. The pins can be pressed, machined or attached by other techniques to theanvil shaft64. The projections, e.g. pins, can be formed integrally/monolithically with the anvil shaft or separate components attached to the shaft.
• The pins are configured to receive a purse-string suture therebetween, thereby creating a catch or capturing region to retain the suture between twoadjacent pins78. The series ofpins78 enables the user to decide the amount of tissue desired for purse stringing, e.g. placing the suture between the twoproximal pins78a,78bwould enable additional tissue to be taken and presented for stapling compared to distal pins.
• It should be appreciated that the suture can also be retained by wrapping around the individual pin or pins78 instead of placement between two adjacent pins.
• Although the pins are shown as substantially identical, the size and configuration of the pins can vary along the length of theanvil shaft64. Also, although shown substantially equidistantly axially spaced, the distance between adjacent pins can vary.
• In the illustrated embodiment, the anvil shaft is of circular cross-section with the pins extending radially from the circumferential surface of the anvil shaft.
• In the alternate embodiment ofFIGS. 4 and 5, a different structure is disclosed for capturing and retaining the purse string suture. Except for the suture retaining structure, the anvil assembly and shell assembly are identical to that described with respect to the embodiment ofFIG. 1. Theanvil shaft164 is mown table to the surgical staplers disclosed herein. For brevity, the description of these identical components will not be repeated.
• Turning to the structure for receiving the purse string suture ofFIGS. 4 and 5, theanvil shaft164 has a series ofcutouts178 forming cinch spots to grasp the suture. As shown, each of thecutouts178 is arcuate and cut in a direction toward adistal end165 of theanvil shaft164. This angled cut forms a plurality of projecting surfaces or projections extending toward aproximal end167 of theanvil shaft164. Thecutouts178 narrow in dimension as they extend toward an opposing wall of the shaft, such thatinner region180 is narrower thanouter region181. Theinner regions180 preferably narrow to a dimension smaller than an outer dimension of the purse string suture so the suture is cinched within theinner region180 when placed through thecutout178. As with thepins78 described above, the user can select the amount of tissue desired by selecting theappropriate cutout178 in which to cinch the suture, e.g. the more proximal the cutout, the more tissue to be taken and presented for stapling (theproximalmost cutouts178aproviding the most tissue). Although five cutouts are shown, a fewer or greater number of cutouts are also contemplated. The cutouts are also shown as extending to a depth approximately up to the central longitudinal axis of the shaft; cutouts of different depths are also contemplated. Also, although the cutouts as shown are substantially identical, the configuration of the cutouts can vary along theanvil shaft164. Also, although shown equidistantly axially spaced, the spacing between thecutouts178 can be varied. The remaining components, e.g. anvil head, are identical to the embodiment ofFIG. 1.
• As discussed above, anvil retainer36 (FIG. 1B) defines anelongated bore42 which is dimensioned to receiveanvil shaft64 such that steppedsurface74 ofshaft64 engagesretention surface50 to releasablysecure anvil assembly18 toanvil retainer36. In one embodiment,anvil shaft64 is of a length to protrude from the anus when properly positioned during a surgical procedure to treat colon prolapse. By protruding from the anus, the interface between theanvil shaft64 andanvil retainer36 is exposed and visible for attachment. For example, in one embodiment,shaft64 extends outwardly from a face86 (FIG. 2) of anvil head66 a distance greater than about three inches, and for example extends outwardly fromface86 of anvil head66 a distance of about 3.55 inches. In another embodiment, the shaft extends outwardly a distance of greater than about live inches, and for example extends about 5.234 inches.
• Anvil head66 is shown with a low distal profile, however, other shapes are contemplated such as the bulbous, smoothly contouredanvil266 illustrated inFIG. 3A.Bulbous portion296 facilitates insertion ofhead266 through a purse string suture. Theanvil head266 can be attached to the anvil shafts disclosed herein. Cuttingring292 is shown attached toanvil head266.
• The bulbous anvil head can be used with anvils pivotally attached to an anvil shaft viaanvil post270. Alternatively, the bulbous anvil head can be non-pivotably attached to the anvil shaft such asanvil head366,466, shown inFIGS. 7 and 8, respectively. In the embodiment ofFIGS. 6 and 7,bulbous anvil head366 has ananvil post368 which receivesproximal end365 of anvil shaft orcenter rod364 thereover. A pin372 (or other fastening or attachment structure) extends though opening367 and369 ofanvil shaft364 andanvil post368, respectively, to fixedly (non-pivotably) secure theanvil shaft364 toanvil head assembly366.Anvil373 containing annular rows of anvil depressions is secured toanvil head366. Cuttingring375 is positioned in a recess ofanvil373. In all other respects, theanvil assembly318 is identical to the anvil assembly ofFIG. 1 and has, e.g. angledprojections378 for reception of purse string sutures, splines376, etc. A markingring380 adjacent the proximalmost suture receiving structure can also be provided as shown in the embodiment ofFIG. 6, as well as in the other embodiments disclosed herein, to indicate to the user that a proximalmost pin or cutout is being utilized which present the largest amount of tissue for stapling.
• A bulbous anvil head can also be used in a non-pivoting anvil assembly such as illustrated inFIG. 8. Theanvil assembly418 ofFIG. 8 is identical to theanvil assembly165 ofFIG. 4, except that the anvil head is non-pivotally attached toanvil shaft464, abulbous head466 is provided, and amarking ring480 is provided onanvil shaft464 adjacent theproximalmost cutout478aof the series ofcutouts478 forming projections.
• It should be appreciated that the anvil heads of the embodiments ofFIGS. 1 and 4, respectively, can be used with anvil assemblies wherein the anvil heads non-pivotably mounted to the anvil shafts, such as the embodiments ofFIGS. 7 and 8.
• Referring toFIGS. 1A,1D and1E,shell assembly20 is secured to the distal end ofcentral body portion14 in a manner substantially similar to that described in the '106 patent incorporated herein by reference.Shell assembly20 includes a shell or housing98, a pusher back100, acylindrical knife102, and a staple guide housing one or more rows of staples (not shown). Vent holes29 (FIG. 1) are provided inshell assembly20.
• Shell98 includes anouter housing portion106 and aninner guide portion108 havinggrooves110 for mating withsplines76 onanvil shaft64.Outer housing portion106 defines athroughbore112 having a distalcylindrical section114, a centralconical section116 and a proximal smaller diametercylindrical section118. A plurality ofopenings120 are formed inconical section116.Openings116 are dimensioned to permit fluid and tissue passage during operation ofstapler10. A pair of diametrically opposedflexible engagement members122 are formed on proximalcylindrical section118 of shell98.Engagement members122 are positioned to be received in openings formed on a distal end ofbody portion14 to secure shell98 tobody portion14.
• Pusher back100 includes acentral throughbore124 which is slidably positioned aboutinner guide portion108 of shell98. Pusher back100 includes a distalcylindrical section126 which is slidably positioned within distalcylindrical section114 of shell98, a centralconical section128 and a proximal smaller diametercylindrical section130. The proximal end of pusher back100 includesmembers132 which are configured to lockingly engage with a pusher link ofstapler10 as described in the '106 patent incorporated by reference herein. Pusher back100 also defines areceptacle133 for receiving excised tissue.Receptacle133 is preferably configured to have a depth of substantially within the range of approximately 0.275 cm (approximately 0.75 inches) to approximately 0.70 cm (approximately 2.0 inches). For example, in one embodiment, the receptacle215 is configured to define a depth of approximately 0.52 cm (approximately 1.33 inches)
• The distal end of pusher back100 includes apusher134.Pusher134 includes a multiplicity of distally extendingfingers136 dimensioned to be slidably received within slots (not shown) formed in staple guide104 to eject staples (not shown) therefrom.Cylindrical knife102 is retained within the central throughbore of pusher back100 to fixedlysecure knife102 in relation topusher134.Knife102 may be retained within pusher back100 using adhesives, crimping, pins, friction, etc. The distal end ofknife102 includes a circular cutting edge.
• Therigid bushing140 is supported in the proximal end ofinner guide portion108 of shell98.Bushing140 defines a throughbore dimensioned to slidably receiveanvil retainer36 andanvil shaft64 ofanvil assembly18.Bushing140 provides lateral support forflexible arms48 ofanvil retainer36 when theanvil assembly18 has been approximated to prevent disengagement ofanvil assembly18 fromanvil retainer36. In the unapproximated position,flexible arms48 are positioned externally ofbushing140 to permit flexing of the arms for removal ofanvil assembly18 fromretainer36.
• As discussed above,stapler10 is particularly suitable for use in surgical procedures for treating colon prolapse. During such procedure, an access port can be inserted into the anus to facilitate access to the prolapsed colon. Next, a purse string suture S1 is placed into, above or in the vicinity of the colon prolapse and theanvil assembly318 is inserted through the access port into the anus and rectum. Thereafter, the purse string suture S1 is placed between (or alternately wrapped around) selected adjacent pins378 (or pins78) as shown inFIG. 9.Pins378 are longitudinally spaced alongshaft364 such that the amount of tissue drawn into the shell assembly can be controlled by properly selecting the two pins378 (or78) to which the purse string suture is inserted between. A greater amount of tissue will be drawn into shell assembly by capturing and retaining the purse siring suture between the twoproximalmost pins378a,378b,The suture ends are tightened and pulled toward the user, therefore pulling the tissue proximally. The surgeon can then visualize the tissue to be stapled, i.e. the tissue donut to be removed. The stapling instrument,e.g. instrument10 ofFIG. 1, is inserted through the port and attached to the anvil assembly, with the elongated anvil shaft and elongated instrument shaft providing increased visibility.Anvil assembly318 and theshell assembly20 are then approximated viaknob26 to draw the prolapsed colon intoshell assembly20.
• Whensurgical stapler10 is fully approximated, firingtrigger24 can be actuated or fired in a manner described in the '106 patent to staple, sever and allow removal of a portion of the prolapsed colon. Thereafter, the stapler is at least partially unapproximated and removed from the anus with the excised tissue contained withinreceptacle133 of pusher back100 withinshell assembly20. In the embodiments where a tilting anvil is used, after the firing step and sufficient movement of the anvil away from theshell assembly20, the anvil will tilt (not shown) to its inoperative position to facilitate-removal.
• FIG. 10 illustrates a purse string suture S1 placed within acutout478 of anvil shaft474 ofanvil assembly418 ofFIG. 8.FIG. 10 also illustrates theshell assembly20 containing the staples with the procedural steps similar to that described above with reference toFIG. 9.
• It will be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

Claims (4)

1-17. (canceled)

18. A method of performing a surgical procedure comprising: securing a suture to a section of target tissue of a patient; inserting an anvil assembly of a surgical staple applying apparatus into the patient; selecting an amount of the target tissue to be resected by securing the suture to one of a series of cutouts formed in an anvil shaft of the anvil assembly; connecting the anvil assembly to a body of the surgical staple applying apparatus; approximating the anvil assembly and a shell assembly of the surgical staple applying apparatus; and firing the surgical staple applying apparatus.

19. The method ofclaim 18, wherein approximating the anvil assembly and the shell assembly includes drawing the target tissue into the body of the surgical staple applying apparatus.

20. The method ofclaim 19, wherein firing the surgical staple applying apparatus includes advancing a knife member to sever the target tissue.

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