# Patent

## Title
Circular stapler and staple line reinforcement material

## Abstract

A surgical stapling instrument comprises a staple cartridge assembly having a plurality of rows of staple receiving slots, an anvil assembly having an anvil member defining a plurality of rows of staple forming recesses, the staple cartridge assembly, the anvil assembly, or both, having one or more attachment members; and a staple line reinforcement material attached to the attachment members by ultrasonic welding. The staple line reinforcement material can be attached to an anvil assembly utilizing a retainer.

## Background
BACKGROUND
1. Technical field
The present application relates to surgical stapling and staple line reinforcement materials. In particular, the staple line reinforcement material is attached to one or both tissue contacting surfaces of a surgical stapler utilizing a retainer.
2. Background
The use of staple line reinforcement materials, or buttresses, in conjunction with staplers is known. U.S. Pat. No. 5,542,594 to McKean et al., the disclosure of which is hereby incorporated by reference herein, discloses a surgical stapling apparatus with a biocompatible surgical fabric attached to the apparatus. The surgical fabric and staples are attached to body tissue by the stapling apparatus. Pins or clips secure the fabric to surfaces of the stapling apparatus.
U.S. Pat. No. 7,128,748 discloses a circular stapler and buttress. The buttress material is positioned on the staple cartridge of the stapler and on the anvil component of the stapler. The anvil buttress material has a cylindrical raised center portion adapted to fit the central recessed aperture of the anvil and the staple cartridge buttress has a cylindrical raised center portion adapted to fit a central recessed aperture in the cartridge component of the stapler.
U.S. Pat. No. 6,503,257 discloses an adhesive used to releasably attach a buttress material to clamping members of a stapler. The buttress material is releasably attached by the adhesive material.
There is a need for a staple line reinforcement material or buttress material attachment that does not complicate assembly or manufacturing, does not interfere with the operation of the surgical instrument, and securely attaches the material while allowing the material to be reliably released when desired.
SUMMARY
In an aspect of the present disclosure, a surgical stapling instrument comprises a staple cartridge assembly having a plurality of rows of staple receiving slots, an anvil assembly having an anvil member defining a plurality of rows of staple forming recesses. The staple cartridge assembly, the anvil assembly, or both, has one or more attachment members. A staple line reinforcement material is attached to the attachment members by ultrasonic welding.
In certain embodiments, the staple line reinforcement material defines perforations adjacent the attachment members. Such perforations can be useful to facilitate release of the buttress from the surgical stapling apparatus. In certain embodiments, the surgical stapling instrument is a circular stapler. The plurality of rows of staple receiving slots can be circular rows. Such staplers are useful in intestinal anastomosis procedures and other surgical procedures. The plurality of rows of staple forming recesses can be circular rows.
In certain embodiments, the one or more attachment members are formed on the anvil member by molding plastic. The one or more attachment members can be disposed on the anvil member; the anvil member is made of metal, whereas the attachment members can made from plastic.
In certain embodiments, the one or more attachment members are disposed on the staple cartridge assembly outwardly of the rows of staple receiving slots. The staple line reinforcement material can be attached to the one or more attachment members and define perforations adjacent the one or more attachment members. In this way, the staple line reinforcement material lifts away from the staple cartridge assembly, separating at the perforations. A margin of material remains on the staple cartridge assembly.
In another arrangement, the one or more attachment members are disposed on the anvil assembly outwardly of the rows of staple forming recesses. The staple line reinforcement material is attached to the one or more attachment members and defines perforations adjacent the one or more attachment members.
The anvil assembly may include a hub attached to the anvil member. The anvil assembly may include a shaft and further comprising a tubular body portion, the staple cartridge assembly being mountable in the tubular body portion; the tubular body portion has a rod, the shaft of the anvil assembly being attachable to the shaft. The surgical stapling instrument, in certain embodiments, comprises a handle assembly.
In another aspect of the present disclosure, a surgical stapling instrument comprises a staple cartridge assembly having a plurality of rows of staple receiving slots, an anvil assembly having a shaft and an anvil member; the anvil member defines a plurality of rows of staple forming recesses. A retainer is engaged to the shaft, and a staple line reinforcement material attached to the anvil assembly by the retainer.
The surgical stapling instrument can be a circular stapler. The plurality of rows of staple receiving slots can be circular rows, whereas the plurality of rows of staple forming recesses would be circular rows.
In certain embodiments, the retainer is circular in shape and has a central aperture for receiving the shaft. The retainer may be frictionally engaged with the shaft. For example, the retainer is formed of a material that has a coefficient of friction with the shaft, the coefficient of friction being selected so as to retain the retainer and the staple line reinforcement material on the shaft.
In certain embodiments, the retainer is secured to the shaft utilizing a fastener. Alternatively, the retainer is secured to the shaft utilizing a snap-fit relationship between the retainer and the anvil assembly. The retainer, the shaft, or both, may be texturized in such a way so as to improve the frictional engagement of those parts. For example, the surface of the shaft is mechanically treated, or the shaft, the retainer, or both, have a coating that increases friction between the shaft and the retainer.
The anvil assembly may include a hub attached to the anvil member. In certain embodiments, the surgical stapling instrument has a tubular body portion, the staple cartridge assembly being mountable in the tubular body portion; the tubular body portion has a rod, the shaft of the anvil assembly being attachable to the shaft. In certain embodiments, the surgical stapling instrument has a handle assembly.



BRIEF DESCRIPTION OF THE DRAWINGS
An embodiment or embodiments of the presently disclosed surgical instrument and staple line reinforcement material is disclosed with reference to the drawings, wherein:
FIG. 1 is a perspective view of an embodiment of the present disclosure showing including a circular stapling instrument;
FIG. 2 is perspective view of the circular stapling instrument of FIG. 1 with the anvil assembly detached;
FIG. 3 is a perspective view of the circular stapling instrument of FIGS. 1 and 2 with the anvil assembly attached;
FIG. 4 is a perspective view of a circular stapling instrument anvil assembly, staple line reinforcement material, and retainer, with parts separated, according to the embodiment of FIGS. 1 through 3;
FIG. 5 is an elevation view of a staple line reinforcement material retainer assembly according to the embodiment of FIGS. 1 through 4;
FIG. 6 is a staple line reinforcement material retainer assembly according to a further embodiment of the present disclosure;
FIG. 7 is a plan view of a prior art circular stapling instrument anvil member;
FIG. 8 is a plan view of a circular stapling instrument anvil member according to a further embodiment of the present disclosure;
FIG. 9 is a detail of FIG. 7 showing attachment tabs;
FIG. 10 is a plan view of a ring having attachment member tabs in accordance with a further embodiment of the present disclosure;
FIG. 11 is a partial perspective view of a circular stapling instrument body portion and cartridge assembly in accordance with another embodiment;
FIG. 12 is a plan view of a ring having attachment member tabs in accordance with the embodiment of FIG. 11;
FIG. 13 is a perspective view of a staple line reinforcement material in accordance with a further embodiment of the present disclosure;
FIG. 14 is perspective view of a linear surgical stapling instrument according to another embodiment of the present disclosure;
FIG. 15 is a perspective view of a staple cartridge assembly in accordance with the embodiment of FIG. 14;
FIG. 16 is a perspective view of an anvil member in accordance with the embodiment of FIGS. 14 through 15;
FIG. 17 is a perspective view of a staple line reinforcement material in accordance with the embodiment of FIGS. 14 through 16;
FIG. 18 is a plan view of a ring or frame having attachment member tabs in accordance with the embodiment of FIGS. 14 through 17;
FIG. 19 is a perspective view of a staple line reinforcement material in accordance with an embodiment of the present disclosure; and
FIG. 20 is a perspective view of a staple line reinforcement material in accordance with a further embodiment of the present disclosure.



DETAILED DESCRIPTION
An embodiment or embodiments of the presently disclosed stapling instrument, retainer, and staple line reinforcement material will now be described in detail with reference to the drawings. Like numerals in the drawings designate identical or corresponding elements in each of the several views. As is common in the art, the term “proximal” refers to that part or component that is closer to the user of the instrument while the term “distal” refers to that part or component that is farther from the user of the instrument.
FIG. 1 illustrates a circular surgical stapling instrument which is generally designated as 10. Surgical stapling instrument 10 includes a handle assembly 12 having at least one pivotable actuating handle 14 and a rotatable actuator 18. A tubular body portion 20 extends from the handle assembly 12. The tubular body portion 20, which generally has a circular cross-sectional shape, may have a straight or a curved shape along its length and may be flexible or relatively rigid. Cross-sectional shapes other that circular are contemplated, so that the tubular body portion 20 can have a polygonal, elliptical, semi-circular, ovoid, or other shape. The body portion 20 terminates in a staple cartridge assembly 22 which includes a distally facing tissue contacting surface defining one or more rows 37 of staple receiving slots 36. Each staple receiving slot has a staple (not shown) disposed therein. Typically, a pair of circular rows 37 of staple receiving slots 36 is provided, although other shapes, such as annular, are contemplated. An anvil assembly 30 is positioned distally of the staple cartridge assembly 22, which includes an anvil member 26 and an anvil shaft 28 operatively associated therewith. The anvil assembly has a proximally facing tissue contacting surface that defines staple forming recesses 27 that correspond to the circular rows of staple receiving slots. The tubular body portion 20 has a corresponding rod or shaft 40 centrally located with respect to the staple cartridge assembly 22. The shaft 28 of the anvil assembly is removably connectable to the rod or shaft 40 of the tubular body portion 20. The anvil shaft defines a longitudinal axis “x”.
The staple cartridge assembly 22 is connectable to the distal end of tubular body portion 20 or may be configured to concentrically fit within the distal end of tubular body portion 20. Typically, staple cartridge assembly 22 includes a staple pusher (not shown) with a distal portion defining two concentric rings of peripherally spaced fingers (not shown), each one of which is received within a respective staple receiving slot 36. Typically, a knife (not shown) having a cutting edge is disposed within the staple cartridge assembly 22. The knife edge is circular and disposed radially inward of the rows of staples. The knife is mounted so that as the staple pusher is advanced axially in the direction of the anvil assembly, the knife is also advanced axially. Alternatively, the knife may be separately actuated. The staple pusher is advanced in the distal direction to drive staples from the staple receiving slots 36 against the anvil member so that the staple forming recesses 27 form the staples in a closed shape. The knife is advanced and driven toward the anvil assembly 30 to cut tissue. U.S. Pat. No. 5,915,616 to Viola et al., the entire content of which is hereby incorporated herein by reference, discloses a circular stapling instrument. Although a circular stapling instrument is shown in FIG. 1, the stapling device may be arranged to deploy staples in a semi-circular, linear, or other desired shape. Although discussed with reference to intestinal tissue, devices according to the present disclosure can be arranged to join and/or treat other tissues in other procedures.
The anvil member 26 may or may not be pivotable about the anvil shaft 28 from a first, initial position in which a plane defined by the tissue contact surface 52 of the anvil member 26 is substantially perpendicular to the longitudinal axis of the anvil shaft 28 to a second position, tilted with respect to the longitudinal axis “x”. The second position is desirably a reduced profile position in which anvil member 26 defines an angle with respect to the longitudinal axis “x”. Alternately, the anvil member 26 is rigidly attached to the anvil shaft 28.
The anvil shaft 28 is dimensioned to releasably engage an anvil retainer (not shown) on the rod or shaft 40 of a circular surgical stapling instrument, such as the surgical stapling instrument 10. One such surgical stapling device having an anvil retainer and with which anvil assembly 30 may be used is disclosed in U.S. provisional patent application Ser. No. 60/281,259, filed Apr. 3, 2001, (“the '259 application”) which is hereby incorporated by reference herein, in its entirety. The anvil retainer functions to align anvil assembly 30 with the body portion 20 (FIG. 1) of the surgical stapling instrument 10 during movement of the anvil assembly 30 from a positioned spaced from the staple cartridge assembly 22 of the surgical stapling device to an approximated position in close alignment with the staple cartridge assembly 22.
The circular stapling instrument can be used to form an anastomosis between sections of intestinal tissue. As shown in FIGS. 2 and 3, the anvil assembly 30 is detached from the rod or shaft 40 of the tubular body portion 20 and a section of tubular body vessel, such as a section of intestine, is secured to the anvil assembly 30, typically by tying a suture “P” around the shaft 28 of the anvil assembly 30. Another section of tubular tissue is secured to the tubular body portion 20 by tying a suture around the shaft 40. See FIG. 2. The shaft 28 is then connected to the shaft 40. The actuator 18 is rotated to withdraw the shafts 28, 40 thereby approximating the anvil assembly 30 with the staple cartridge assembly 22. To fire the staples, the actuating handles 14 are squeezed, which advances the staple pusher and the knife (not shown). The staples pass through each section of tubular tissue and are formed against the anvil so that the sections of tubular tissue are joined to one another. The knife cuts the tissue radially inward of the rows of staples, and the sutured material is removed with the circular stapling device.
According to the present disclosure, a surgical stapling instrument has a staple line reinforcement material retained thereon. In certain embodiments, the anvil head 42 has an inner recess 53 that is generally annular and may include a cut ring for receiving the knife. As shown in FIG. 4, a staple line reinforcement material 50 has a central aperture 51 for receiving the anvil shaft 28 and is dimensioned so that the staple line reinforcement material overlies the staple forming recesses 27 of the anvil member 26 when the staple line reinforcement material is placed on the shaft 28. A small amount of excess material may lie over the outside edge of the anvil member. A retainer 60, which may be shaped as a washer with a central aperture 61, has an outside diameter slightly less than the inside diameter of the knife so that the retainer does not interfere with cutting. The inside diameter is dimensioned to receive the anvil shaft and be frictionally retained on the shaft. FIG. 5 shows the staple line reinforcement material retainer assembly 66. When the staple line reinforcement material is placed on the anvil shaft 28 and the retainer 60 is then placed on the anvil shaft 28 over the staple line reinforcement material, the frictional engagement between the retainer 60 and the shaft keep the staple line reinforcement material in place during use. The retainer 60 may be formed of a material that has a desired coefficient of friction with the shaft, which is normally metal, such as stainless steel.
In another embodiment, the retainer is secured to the anvil assembly utilizing a fastener (such as a screw or bolt), a clip, a detent, or by a snap-fit relationship between the retainer and the anvil assembly. In a further alternative, the retainer 60, the shaft 28, or both, may be texturized 69, 29, respectively in such a way so as to improve the frictional engagement of those parts. This can include mechanically treating the surfaces of the shaft and/or retainer, or can include coatings.
During use, the rotatable actuator 18 is manipulated to approximate the anvil assembly 30 toward the staple cartridge assembly 22 and clamp tissue therebetween. When the pivotable actuating handle 14 is moved, the knife and/or pusher will be moved in a direction toward the anvil assembly to fire the staples and cut tissue. The staple line reinforcement material retainer assembly 66 is arranged so that the retainer 60 lies inwardly of the knife. The retainer retains the staple line reinforcement material 50 against the tissue contacting surface 52 of the anvil member 26. The knife will cut the tissue and the staple line reinforcement material, making the retainer easy to remove with the circular stapling instrument 10.
In another embodiment of the present disclosure, a circular stapling instrument as discussed above in connection with FIGS. 1 through 3 has an anvil assembly 130 with an anvil member 126 attached to an anvil head 142. The anvil assembly 130 further includes an anvil shaft 128 attachable to the rod or shaft 40. A typical prior art anvil member 125 is shown in FIG. 7 and has two rows of staple forming recesses 127 formed in the tissue contact surface 152 of the anvil member 125. An anvil member 126 according to an embodiment of the present disclosure is shown in FIG. 8. Attachment members 132, which may be formed as tabs, are attached to the anvil member 126 so that the attachment members 132 are generally flush with the tissue contact surface 152. Recessed or protruding attachment members are also contemplated. In this way, the anvil member 126 can be formed from a material that is useful for defining staple forming recesses therein and for forming staples. Thus, typically the anvil member is formed from a metal such as stainless steel. The attachment members 132 are formed from a material that is useful for attachment to a staple line reinforcement material. The staple line reinforcement material 50 is attached to the attachment members utilizing adhesives, ultrasonic or other kinds of welding, or other methods. The attachment member or members 132 may be formed of a variety of polymeric materials, such as the polymeric materials from which the staple line reinforcement material is made. In one example, recesses are formed in the anvil member, as by grinding, drilling, machining, etc. A polymeric material is overmolded on the anvil member so that attachment members of the polymeric material are disposed in the recesses. In a further embodiment, a plastic frame or ring 141 having tabs extending inwardly (see FIG. 10) is attached to the anvil member, either before or after the assembly of the anvil member 126 with the anvil head 142. The tabs are snapped into place in preformed recesses in the anvil member. Alternately, the frame or ring 141 is attached to the anvil member so that the tab or tabs are disposed adjacent the tissue contact surface 152 but outside of the staple forming recesses 127. In another embodiment, the plastic ring may be used, without tabs, so that the staple line reinforcement material is attached at the ring.
One or more attachment members 132 may be used and they may have a variety of shapes. The tabs shown in FIG. 9 are generally trapezoidal in shape and are disposed between the staple forming recesses of the anvil member as shown in FIG. 8. The attachment members/tabs do not interfere with the formation of the staples in the staple receiving recesses.
It may be desirable to attach a staple line reinforcement material 50 adjacent the staple cartridge assembly 22. As shown in FIG. 11, the staple cartridge assembly 22 has a central recess 24 through which the rod or shaft 40 (which has been omitted for clarity) passes. An attachment member or attachment members 232, which may be formed as tabs, are attached to the tissue contact surface 25 of the cartridge assembly 22. The attachment members 232 may be formed so that they are generally flush with the tissue contact surface 25, but recessed or protruding attachment members are contemplated. The attachment member or members are formed from a material useful for attachment to the staple line reinforcement material. The staple line reinforcement material 50 is attached to the attachment members utilizing adhesives, ultrasonic or other kinds of welding, or other methods. The attachment members 232 may be formed from a variety of polymeric materials, such as the polymeric materials from which the staple line reinforcement material is made. In one example, recesses are formed in the staple cartridge tissue contact surface 25 and a polymeric material is overmolded on the staple cartridge in the recesses. In this way, the material of the staple cartridge can be different from the material for attaching the staple line reinforcement material. In other embodiment, a plastic frame or ring 241 (FIG. 11) having tabs extending inwardly is attached to the staple cartridge so there the tabs are snapped into place in preformed recesses. Alternately, the frame or ring 241 is attached to the cartridge assembly or to the body portion 20 so that the tab or tabs are disposed on the tissue contact surface 25 but lie outwardly of the staple slots 36. In another embodiment, the plastic ring may be used, without tabs, so that the staple line reinforcement material is attached at the ring.
Alternately, the material of the staple cartridge 23, which is normally plastic, can be selected so as to be useful for attaching the staple line reinforcement material by adhesives, ultrasonic or other kinds of welding, or other methods. In certain embodiments, the anvil assembly 130 includes a cut ring disposed in the recess 153. The cut ring can be formed with tabs extending proximally toward the tissue contact surface 152 so as to be accessible for attachment to the staple line reinforcement material.
In the embodiments discussed in connection with FIGS. 6 through 12, the staple line reinforcement material 50 can be dimensioned to have an inner diameter that is smaller than the diameter of the knife of the circular stapling instrument. When the knife is actuated, a portion of the staple line reinforcement material is removed. This may tend to increase the firing forces for the circular stapling instrument. Alternately, the staple line reinforcement material 50 can be dimensioned to have an inner diameter that is larger than the diameter of the knife of the circular stapling instrument so that the knife does not cut the staple line reinforcement material. When the staple firing is actuated, the staples hit the staple line reinforcement material, passing through the staple line reinforcement material. The staples that impact near the weld or other attachment points apply enough force to substantially break the connection between the staple line reinforcement material and the attachment member or attachment members. The staple line reinforcement material is thereby released. Alternately, the gentle manipulation of the circular stapling instrument can be relied upon to gently separate the staple line reinforcement material from the attachment points.
In another embodiment of the present disclosure, a surgical stapling instrument and staple line reinforcement material according to FIGS. 1 through 3 and 6 through 12 has a staple line reinforcement material 50a attached to an attachment member or attachment members 132 disposed at the tissue contacting surface 52 of the anvil assembly and/or disposed at the tissue contact surface 25 of the staple cartridge assembly 22. The attachment member or members 132 are formed from a material that is useful for attaching the staple line reinforcement material 50a. The staple line reinforcement material 50a is attached to the attachment member or attachment members 132 permanently, so that the material 50 is not intended to be releasable when the staples are fired or the instrument is manipulated in removing the instrument from the surgical site. The staple line reinforcement material includes perforations 68, or areas of weakness, adjacent the attachment member or members. See FIG. 19. The inner diameter of the staple line reinforcement material 50a is larger than the diameter of the knife. Desirably, the attachment member or attachment members 132 lie outwardly of the staple forming recesses 27 of the anvil assembly 30 and/or outwardly of the staple receiving slots 36 of the staple cartridge assembly 22. The perforations 68 are disposed inwardly of the attachment member or members 132, but outwardly of the knife. In use, the anvil assembly will be approximated with the staple cartridge assembly to clamp tissue, and the staples will be fired and the knife deployed. Upon removal of the stapling instrument, the staple line reinforcement material 50a will separate from the anvil assembly and/or cartridge assembly at the perforations. A margin of material will remain with the anvil assembly and/or cartridge assembly.
In another embodiment, the staple line reinforcement material 50a has an inner diameter that is smaller than the diameter of the knife so that a portion of the staple line reinforcement material 50a is severed removed by the knife.
In another embodiment of the present disclosure a linear stapling instrument is used with a staple line reinforcement material on the anvil, the cartridge assembly, or both. The linear stapling instrument 300 has stapler jaws 310, 320. See FIG. 14. The stapler jaw 310 is a staple cartridge assembly having one or more rows 337 of staple receiving slots 336. Each staple receiving slot has a staple (not shown) disposed therein. Typically, three linear rows 337 of staple receiving slots 336 are provided on either side of a channel 339. The other jaw is an anvil assembly 320 positioned in opposition to the staple cartridge assembly 310 and pivotably mounted so that the anvil assembly and staple cartridge assembly can be approximated to clamp tissue therebetween. The anvil assembly includes an anvil member 326 defining a plurality of staple forming recesses 331 that correspond to the linear rows 337 so that the stapling instrument forms linear staple lines. The stapling jaws 310, 320 are disposed at a distal end of an endoscopic shaft 340. A handle assembly 301 includes a pivotable handle 303 that drives movement of a drive member through the staple cartridge assembly 310. The drive member (not shown) passes through the channel 339 and pushes a sled or camming bar through the staple cartridge to drive staple pushers, and the staples, through the slots 336 toward the staple forming recesses of the anvil member 326. Certain embodiments of such a surgical instrument is disclosed in U.S. Pat. No. 6,241,139 to Milliman et al., the disclosure of which is hereby incorporated by reference herein, in its entirety.
To attach the staple line reinforcement material to the jaw or jaws 310, 330, attachment members are formed on or in the cartridge assembly 310 and/or anvil assembly 330. Typically the anvil member 326 is formed from a metal such as stainless steel. The attachment members 332 are formed from a material that is useful for attachment to a staple line reinforcement material. The staple line reinforcement material 350 is attached to the attachment members 332 utilizing adhesives, ultrasonic or other kinds of welding, or other methods. The attachment member or members 332 may be formed of a variety of polymeric materials, such as the polymeric materials from which the staple line reinforcement material is made. In one example, recesses are formed in the anvil member, as by grinding, drilling, machining, etc. A polymeric material is overmolded on the anvil member so that attachment members of the polymeric material are disposed in the recesses. In one embodiment, the attachment members 332 include a first distal attachment member 332a, a second distal attachment member 332b, a first proximal attachment member 332c, and a second proximal attachment member 332d, so that there are one or more attachment members at each of the distal and proximal ends of the anvil member. See FIG. 16.
In a further embodiment, a plastic frame or ring 341 having tabs 342 extending inwardly (see FIG. 18) is attached to the anvil member, either before or after the assembly of the anvil member 326 in the anvil assembly. The tabs are snapped into place in preformed recesses in the anvil member. Alternately, the frame or ring 341 is attached to the anvil member so that the tab or tabs are disposed adjacent the tissue contact surface 352 but outside of the staple forming recesses 327. In another embodiment, the plastic frame or ring may be used, without tabs, so that the staple line reinforcement material is attached at the ring.
It may be desirable to attach a staple line reinforcement material to the tissue contact surface 311 of the cartridge assembly 310. Attachment members 334 are provided for the staple cartridge assembly and are formed from a material that is useful for attachment to a staple line reinforcement material. The staple line reinforcement material 350 is attached to the attachment members 334 utilizing adhesives, ultrasonic or other kinds of welding, or other methods. The attachment member or members 334 may be formed of a variety of polymeric materials, such as the polymeric materials from which the staple line reinforcement material is made. The attachment member or members 334 can be made by providing recesses in the tissue contact surface 311 of the cartridge assembly 310, and overmolding. Alternately, a plastic frame or ring, like that shown in FIG. 18 may or may not include tabs and provides a surface at which to attach the staple line reinforcement material using adhesives, ultrasonic or other welding, and other methods. Alternatively, the material of the staple cartridge can be selected so as to be useful for attaching the staple line reinforcement material.
In another embodiment of the present disclosure, a surgical stapling instrument and staple line reinforcement material according to FIGS. 14 through 18 has a staple line reinforcement material 350A attached to an attachment member or attachment members 332 disposed at the tissue contacting surface of the anvil assembly 320 and/or attachment member or members 334 disposed at the tissue contact surface of the staple cartridge assembly 310. The attachment member or members 332, 334 are formed from a material that is useful for attaching the staple line reinforcement material 350A. The staple line reinforcement material 350A is attached to the attachment member or attachment members 332, 334 permanently, so that the material 350A is not intended to be releasable when the staples are fired or the instrument is manipulated in removing the instrument from the surgical site. The staple line reinforcement material includes perforations 368, or areas of weakness, adjacent the attachment member or members 332, 334. See FIG. 20. Desirably, the attachment member or attachment members 332, 334 lie outwardly of the rows 337 of staple forming recesses 331 of the anvil assembly 30 and/or outwardly of the rows 337 of the staple receiving slots 336 of the staple cartridge assembly 310. The perforations are disposed inwardly of the attachment member or members 332, 334, but outwardly of the rows 337 staple forming recesses 331 of the anvil assembly 30 and/or outwardly of the rows 337 of the staple receiving slots 336. In use, the anvil assembly will be approximated with the staple cartridge assembly to clamp tissue, and the staples will be fired and the knife deployed. Upon removal of the stapling instrument, the staple line reinforcement material 350A will separate from the anvil assembly and/or cartridge assembly at the perforations. A margin of staple line reinforcement material remains with the surgical stapling instrument.
It is contemplated that the staple line reinforcement materials discussed above may be fabricated from or include a surgical grade, biocompatible, non-absorbable material and may comprise a mesh. For example, the staple line reinforcement material may be fabricated from “TEFLON”, which is a registered trademark owned by DuPont de Nemours & Co. It is further contemplated that body portion 102 may be fabricated from a biocompatible polymeric foam, felt, polytetrafluoroethylene (ePTFE), gelatin, fabric or the like, or any other biocompatible material.
Non-absorbable materials used for staple line reinforcement material include, and are not limited to, those that are fabricated from such polymers as polyethylene, polypropylene, nylon, polyethylene terephthalate, polytetrafluoroethylene, polyvinylidene fluoride, and the like. Further non-absorbable materials include and are not limited to stainless steel, titanium and the like.
In one embodiment, the staple line reinforcement material may be fabricated from a bio-absorbable material. In other embodiments, the staple line reinforcement material has at least one portion that is absorbable and at least one portion that is not absorbable. Bio-absorbable materials used for staple line reinforcement material include, and are not limited to, those fabricated from homopolymers, copolymers or blends obtained from one or more monomers selected from the group consisting of glycolide, glycolic acid, lactide, lactic acid, p-dioxanone, α-caprolactone and trimethylene carbonate. Other bio-absorbable materials include and are not limited to, for example, Polyglycolic Acid (PGA) and Polylactic Acid (PLA). In one embodiment, the staple line reinforcement material may be fabricated from bio-absorbable felt, gelatin or any other bio-absorbable materials.
The staple line reinforcement material can incorporate a wound treatment material “W”, which includes and is not limited to one or a combination of adhesives, hemostats, sealants, coagulants, astringents, and medicaments. Other surgically biocompatible wound treatment materials “W” which may be employed in or applied by surgical instruments, including surgical staplers, include adhesives whose function is to attach or hold organs, tissues or structures; sealants to prevent fluid leakage; hemostats to halt or prevent bleeding; coagulants, astringents (e.g., sulfates of aluminum) and medicaments. Examples of adhesives which can be employed include protein derived, aldehyde-based adhesive materials, for example, the commercially available albumin/glutaraldehyde materials sold under the trade designation BioGlueTM by Cryolife, Inc., and cyanoacrylate-based materials sold under the trade designations IndermilTM and Derma BondTM by Tyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively. Examples of sealants, which can be employed, include fibrin sealants and collagen-based and synthetic polymer-based tissue sealants. Examples of commercially available sealants are synthetic polyethylene glycol-based, hydrogel materials sold under the trade designation CoSealTM by Cohesion Technologies and Baxter International, Inc. Examples of hemostat materials, which can be employed, include fibrin-based, collagen-based, oxidized regenerated cellulose-based and gelatin-based topical hemostats. Examples of commercially available hemostat materials are fibrinogen-thrombin combination materials sold under the trade designations CoStasisTM by Tyco Healthcare Group, LP, and TisseelTM sold by Baxter International, Inc. The W can include medicaments. Medicaments may include one or more medically and/or surgically useful substances such as drugs, enzymes, growth factors, peptides, proteins, dyes, diagnostic agents or hemostasis agents, monoclonal antibodies, or any other pharmaceutical used in the prevention of stenosis.
The staple line reinforcement material may include a single layer including a homogeneous array of bio-absorbable or non-absorbable materials or a heterogeneous array of bio-absorbable and/or non-absorbable materials. The staple line reinforcement material may include a layered body portion having at least two layers as indicated by first layer, film or wafer and second layer, film or wafer. In this embodiment, each layer may include a homogeneous or heterogeneous array of bio-absorbable and/or non-absorbable materials.
In certain preferred embodiments, the staple line reinforcement material is a non-woven fabric. The non-woven fabric can be formed utilizing a melt blown process, including the following steps. The polymer resin is melt extruded. A melt pump meters out the molten polymer to a die head having an array of holes. By way of example, the holes have a diameter of between about 0.175 and about 0.25 millimeters. The polymer is forced through the array of holes in the die. Polymer fibers exit the die and are forced onto a conveyor belt. A stream of blowing hot air can be used to force the polymer fibers onto the conveyor. Suction through the conveyor belt surface can be used to compact the fibers against the belt and against each other, as the fibers cool. Additional compression may be applied to the fibers, such as by using a calendaring roll, which may include heating or cooling. The non-woven fabric may then be annealed. For example, isometric tension or other uniform compression can be used to drive crystallization and remove the monomer. The polymer is desirably a bioabsorbable or non-bioabsorbable polymer, such as a glycolide lactide copolymer (the material utilized in PolysorbTM sutures), a termpolymer composed of glycolide, trimethylene carbonate and dioxanone (the material utilized in BiosynTM sutures), a polymer of glycolide, caprolactone, trimethylene carbonate, and lactide (the material utilized in CaprosynTM sutures), and a glycolide trimethylene carbonate copolymer (the material utilized in MaxonTM sutures).
In certain embodiments, the non-woven fabric is porous. For example, the non-woven fabric can have a porousity of between about 50% and about 90%. The fiber diameter may be between about 5 and about 100 μm. The fabric thickness may be between about 150 and about 400 μm.
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, the surgical stapling instrument need not apply staples but rather may apply two part fasteners as is known in the art. Further, the length of the linear row of staples or fasteners, or the length or diameter of a circular row of staples or fasteners, may be modified to meet the requirements of a particular surgical procedure. 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 thereto.

## Claims

1. A method of assembling a surgical stapling instrument, the method comprising the steps of:
providing a staple cartridge assembly having a tissue contacting surface including a plurality of rows of staple receiving slots,
providing an anvil assembly having an anvil member with a tissue contacting surface defining a plurality of rows of staple forming recesses, the staple cartridge assembly, the anvil assembly, or both, having one or more attachment members attached to the tissue contacting surface of the staple cartridge assembly, the anvil assembly, or both;
providing staple line reinforcement material;
securing the staple line reinforcement material to the attachment members by ultrasonic welding, wherein the ultrasonic welding is between the staple line reinforcement material and the attachment members.

2. The method according to claim 1, further comprising the step of releasably attaching the staple line reinforcement material to the attachment members by ultrasonic welding.

3. The method according to claim 1, further comprising the step of providing staple line reinforcement material that defines perforations adjacent the attachment members.

4. The method according to claim 1, wherein the step of providing a staple cartridge assembly includes the step of providing a staple cartridge assembly having a plurality of rows arranged in circular rows.

5. The method according to claim 4, wherein the step of providing an anvil assembly includes the step or providing an anvil assembly having a plurality of rows of staple forming recesses arranged in circular rows.

6. The method according to claim 1, further comprising the step of forming the one or more attachment members on the anvil member by molding plastic.

7. The method according to claim 1, further comprising the steps of:
providing a metal anvil member;
providing plastic attachment members; and
disposing the one or more attachment members on the anvil member.

8. The method according to claim 5, further comprising the step of disposing the one or more attachment members on the staple cartridge assembly at a location outwardly of the rows of staple receiving slots.

9. The method according to claim 8, further comprising the steps of:
attaching the staple line reinforcement material to the one or more attachment members; and
defining perforations adjacent the one or more attachment members.

10. The method according to claim 5, further comprising the step of disposing the one or more attachment members on the anvil assembly at a location outwardly of the rows of staple forming recesses.

11. The method according to claim 10, further comprising the steps of:
attaching the staple line reinforcement material to the one or more attachment members; and
defining perforations adjacent the one or more attachment members.

12. The method according to claim 1, further comprising the steps of:
providing an anvil assembly including, a shaft;
providing a tubular body portion including a rod;
mounting the staple cartridge assembly in the tubular body portion by attaching the shaft of the anvil assembly to the rod of the tubular body portion.

13. The method according to claim 1, further comprising the step of disposing the attachment members between adjacent staple forming recesses of the anvil member.

14. The method according to claim 1, further comprising the step of disposing the attachment members flush with the tissue contacting surface of the anvil member.

15. The method according to claim 1, further comprising the step of forming the attachment members from a polymeric material.