# Patent

## Title
Surgical stapling apparatus including releasable buttress

## Abstract

A staple cartridge for use with a surgical stapling apparatus includes a cartridge body, a plurality of staples disposed within the cartridge body, a tissue contacting surface on the cartridge body defining staple retaining slots dimensioned to releasably retain a staple, and a buttress material including at least one weld joining the buttress material to the tissue contacting surface of the cartridge body. The at least one weld is positioned to at least partially overlie a staple retaining slot.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 14/523,998, filed Oct. 27, 2014, which is a continuation of U.S. patent application Ser. No. 14/075,087, filed Nov. 8, 2013, now U.S. Pat. No. 8,870,050, which is a continuation of U.S. patent application Ser. No. 13/289,197, filed Nov. 4, 2011, now U.S. Pat. No. 8,584,920, and the disclosures of each of the above-identified applications are hereby incorporated by reference in their entirety.


BACKGROUND
1. Technical Field
The present disclosure relates to surgical stapling apparatus including surgical buttresses which can be releasably attached to the surgical stapling apparatus, and in particular, to surgical stapling apparatus having surgical buttresses including at least one weld joining the buttress to the surgical stapling apparatus over an ejection path of a leg of a staple such that the buttress is released upon firing of the surgical stapling apparatus.
2. Background of Related Art
Surgical stapling apparatus are employed by surgeons to sequentially or simultaneously apply one or more rows of fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together. Such apparatus generally include a pair of jaws or finger-like structures between which the body tissue to be joined is placed. When the stapling apparatus is actuated, or “fired”, longitudinally moving firing bars contact staple drive members in one of the jaws. The staple drive members push the surgical staples through the body tissue and into an anvil in the opposite jaw which forms the staples. If tissue is to be removed or separated, a knife blade can be provided in the jaws of the apparatus to cut the tissue between the lines of staples.
A number of surgical stapling apparatus rely on a knife blade cutting of some portion of the buttress to affect buttress release. These methods typically employ a secondary material or mounting structure in addition to the buttress material (e.g., sutures) to provide attachment of the buttress to the surgical stapling apparatus. Typically, firing forces are increased with each material that must be transected by the knife blade in order to release the buttress.
It would be desirable to provide a buttress that may be releasably secured to a surgical stapling apparatus without the need for a secondary material or mounting structure, and without the need for a knife blade to cut the buttress and/or secondary material or mounting structure to release the buttress from the surgical stapling apparatus, thereby resulting in the use of fewer materials and lower firing forces.
SUMMARY
According to an aspect of the present disclosure, a staple cartridge for use with a surgical stapling apparatus includes a cartridge body, a plurality of staples disposed within the cartridge body, a tissue contacting surface on the cartridge body defining staple retaining slots dimensioned to releasably retain staples, and a buttress material including at least one weld joining the buttress material to the tissue contacting surface. The at least one weld is positioned to at least partially overlie a staple retaining slot.
In embodiments, the at least one weld is dimensioned to extend at least partially over an ejection path of a leg of staple disposed in the staple retaining slot.
The buttress material may include a plurality of welds positioned at least partially over the staple retaining slots of the tissue contacting surface. In embodiments, the buttress material includes a plurality of welds positioned at least partially over a portion of all of the staple retaining slots of the tissue contacting surface. The plurality of welds may be distributed in a pattern over the tissue contacting surface.
The buttress material may be porous, non-porous, or combinations thereof. In embodiments, the buttress material is porous. In other embodiments, a portion of the buttress material, including the at least one weld, is non-porous.
The staple retaining slots may linearly extend along a length of the tissue contacting surface. Alternatively, the staple retaining slots may be in an annular or curved configuration. In embodiments, the tissue contacting surface includes at least two rows of staple retaining slots. The at least two row of staple retaining slots may be positioned in one of a linear configuration and an annular configuration. The buttress material may include a plurality of welds overlying at least one row of the staple retaining slots of the tissue contacting surface.
According to another aspect of the present disclosure, a surgical stapling apparatus including a releasable buttress material includes a cartridge assembly including a plurality of staples and a tissue contacting surface defining staple retaining slots, an anvil assembly including a tissue contacting surface defining staple pockets for forming staples expelled from the staple retaining slots of the cartridge assembly, and a buttress material including at least one weld joining the buttress material to the tissue contacting surface of the cartridge assembly. The at least one weld is positioned to at least partially overlie a staple retaining slot of the cartridge assembly.
In embodiments, the at least one weld is dimensioned to extend at least partially over an ejection path of a leg of a staple disposed in the staple retaining slot.
The buttress material may include a plurality of welds positioned at least partially over the staple retaining slots of the cartridge assembly. In embodiments, the buttress material includes a plurality of welds positioned at least partially over a portion of all of the staple retaining slots of the cartridge assembly. The plurality of welds may be distributed in a pattern over the tissue contacting surface of the cartridge assembly.
A buttress material may also be attached to the tissue contacting surface of the anvil assembly. The buttress material of the anvil assembly may be the same as, or different from, the buttress material of the cartridge assembly.
The buttress material may be porous, non-porous, or combinations thereof. In embodiments, the buttress material is porous. In other embodiments, a portion of the buttress material, including the at least one weld, is non-porous.
In embodiments, the cartridge assembly is associated with a first jaw and the anvil assembly is associated with a second jaw. The first and second jaws are selectively movable relative to one another from a first spaced apart position to a second position wherein the first and second jaws cooperate to grasp tissue therebetween. In such embodiments, the staple retaining slots and the staple pockets may linearly extend along a length of the cartridge assembly and the anvil assembly, respectively. The tissue contacting surfaces of the cartridge assembly and the anvil assembly may also include at least two rows of staple retaining slots and staple pockets, respectively. The buttress material of the cartridge assembly may include a plurality of welds overlying at least one row of the staple retaining slots of the cartridge assembly.
In embodiments, the cartridge assembly may be associated with a body portion of the surgical stapling apparatus and the anvil assembly includes a shaft removably mountable to the body portion, the anvil assembly being movable toward and away from the body portion. In such embodiments, the buttress material may include a plurality of welds in an annular configuration. The cartridge assembly and the anvil assembly may also include at least two annular rows of staple retaining slots and staple pockets. The buttress material of the cartridge assembly may include a plurality of welds overlying at least one row of the staple retaining slots of the cartridge assembly.



BRIEF DESCRIPTION OF THE DRAWINGS
Embodiments of the presently disclosed surgical stapling apparatus and surgical buttress are described herein with reference to the accompanying drawings, wherein:
FIG. 1 is a perspective view of an illustrative embodiment of a surgical stapling apparatus including a surgical buttress in accordance with an embodiment of the present disclosure;
FIG. 2A is a perspective view, with parts separated, of a staple cartridge of the surgical stapling apparatus and of the surgical buttress of FIG. 1;
FIG. 2B is an enlarged area of detail depicted in FIG. 2A;
FIGS. 3A and 3B are perspective views of a staple cartridge of the surgical stapling apparatus and of a surgical buttress in accordance with other embodiments of the present disclosure;
FIGS. 4A and 4B are cross-sectional views of a staple cartridge of the surgical stapling apparatus and a surgical buttress in a pre-welded (FIG. 4A) and a post-welded (FIG. 4B) configuration in accordance with an exemplary process of forming the welds in accordance with an embodiment of the present disclosure;
FIG. 5 is a schematic view illustrating another exemplary process of forming the welds in accordance with another embodiment of the present disclosure;
FIG. 6 is a perspective view of a distal end of the surgical stapling apparatus of FIG. 1, shown in use positioned about a tissue section;
FIG. 7A is a cross-sectional view taken along line 7A-7A of FIG. 6;
FIG. 7B is an enlarged area of detail depicted in FIG. 7A;
FIG. 8 is a perspective view of the stapled and divided tissue section of FIG. 6;
FIG. 9A is a perspective view of an illustrative embodiment of a surgical stapling apparatus in accordance with another embodiment of the present disclosure;
FIG. 9B is a cross-sectional view of the surgical stapling apparatus of FIG. 9A;
FIG. 10A is a perspective view of an illustrative embodiment of the staple cartridge of the surgical stapling apparatus of FIG. 9A including a surgical buttress in accordance with an embodiment of the present disclosure;
FIG. 10B is an enlarged area of detail depicted in FIG. 10A;
FIG. 11 is perspective view of an intestinal area of a patient, illustrating a method of positioning the anvil rod and staple cartridge of the surgical stapling apparatus of FIGS. 9A, 9B, and 10 within the intestinal area;
FIG. 12 is a schematic perspective view of the intestinal area of FIG. 11, illustrating the anvil rod mounted to the surgical stapling apparatus;
FIG. 13 is a perspective view of an anvil assembly including a polymeric insert in accordance with an embodiment of the present disclosure;
FIG. 14 is a perspective view of another illustrative embodiment of a surgical stapling apparatus for use with a surgical buttress of the present disclosure; and
FIG. 15 is a perspective view of yet another illustrative embodiment of a surgical stapling apparatus for use with a surgical buttress of the present disclosure.



DETAILED DESCRIPTION OF THE EMBODIMENTS
Various exemplary embodiments of the present disclosure are discussed herein below in terms of buttresses for use with surgical stapling apparatus. The buttresses described herein may be used in sealing a wound by approximating the edges of wound tissue between a staple cartridge and an anvil of a surgical stapling apparatus which contains at least one buttress. The at least one buttress is joined to the surgical stapling apparatus by at least one weld positioned at least partially within and/or across an ejection path of a staple. Firing of the surgical stapling apparatus forces the legs of at least one staple to pass through the opening on the staple cartridge, the at least one weld and the buttress, the tissue, and the openings on the anvil to secure the buttress to the tissue, to secure the adjoining tissue to one another, and to seal the tissue. The firing force of the staple impacts the weld and applies a force thereto that weakens or breaks the bond created by the weld between the buttress and the tissue contacting surface of the surgical stapling apparatus, releasing the buttress therefrom. Thus, the present disclosure describes surgical buttresses, surgical stapling apparatus supporting said surgical buttresses, and methods and mechanisms for using the same.
It should be understood that a variety of surgical stapling apparatus may be utilized with a surgical buttress of the present disclosure. For example, linear stapler configurations may be utilized, such as, for example those including Duet TRSTM reloads and staplers with Tri-StapleTM technology, available through Covidien, which maintain a principal place of business at 555 Long Wharf Drive, North Haven, Conn. 06511, and transverse anastomosis staplers, such as, for example, EEATM, CEEATM, GIATM, EndoGIATM, and TATM, also available through Covidien. It should also be appreciated that the principles of the present disclosure are equally applicable to surgical staplers having alternate configurations, such as, for example, end-to-end anastomosis staplers having a circular cartridge and anvil (see, e.g., commonly owned U.S. Pat. No. 5,915,616, entitled “Surgical Fastener Applying Apparatus,” the entire content of which is incorporated herein by this reference); laparoscopic staplers (see, e.g., commonly owned U.S. Pat. Nos. 6,330,965 and 6,241,139, each entitled “Surgical Stapling Apparatus,” the entire contents of each of which being incorporated herein by this reference); and transverse anastomosis staplers (see, e.g., commonly owned U.S. Pat. Nos. 5,964,394 and 7,334,717, each entitled “Surgical Fastener Applying Apparatus”, the entire contents of each of which being incorporated herein by this reference).
Embodiments of the presently disclosed surgical buttress and surgical stapling apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the following discussion, the terms “proximal” and “trailing” may be employed interchangeably, and should be understood as referring to the portion of a structure that is closer to a clinician during proper use. The terms “distal” and “leading” may also be employed interchangeably, and should be understood as referring to the portion of a structure that is further from the clinician during proper use. As used herein, the term “patient” should be understood as referring to a human subject or other animal, and the term “clinician” should be understood as referring to a doctor, nurse, or other care provider and may include support personnel.
Referring now to FIG. 1, there is disclosed an exemplary surgical stapling apparatus or surgical stapler 10 for use in stapling tissue and applying a buttress material or surgical buttress to the tissue. Surgical stapling apparatus 10 generally includes a handle 12 having an elongate tubular member 14 extending distally from handle 12. A jaw assembly 16 is mounted on a distal end 18 of elongate tubular member 14. Jaw assembly 16 includes a staple clinching anvil jaw member 20 and a receiving jaw member 22 configured to receive a staple cartridge 32 (see FIG. 2A). Jaw assembly 16 may be permanently affixed to elongate tubular member 14 or may be detachable and thus replaceable with a new jaw assembly 16. Staple clinching anvil jaw member 20 is movably mounted on distal end 18 of jaw assembly 16 and is movable between an open position spaced apart from staple cartridge jaw member 22 to a closed position substantially adjacent staple cartridge jaw member 22.
Surgical stapling apparatus 10 further includes a trigger 33, as seen in FIG. 1, movably mounted on handle 12. Actuation of trigger 33 initially operates to move anvil jaw member 20 from the open to the closed position relative to staple cartridge jaw member 22 and subsequently actuates surgical stapling apparatus 10 to apply lines of staples to tissue. In order to properly orient jaw assembly 16 relative to the tissue to be stapled, surgical stapling apparatus 10 is additionally provided with a rotation knob 34 mounted on handle 12. Rotation of rotation knob 34 relative to handle 12 rotates elongate tubular member 14 and jaw assembly 16 relative to handle 12 so as to properly orient jaw assembly 16 relative to the tissue to be stapled.
A driver 36, as seen in FIGS. 6 and 7A, is provided to move anvil jaw member 20 between the open and closed positions relative to staple cartridge jaw member 22. Driver 36 moves through a longitudinal slot 38 (FIG. 1) formed in anvil jaw member 20. A knife 30 with knife blade 31 is associated with driver 36 to cut tissue captured between anvil jaw member 20 and staple cartridge jaw member 22 as driver 36 passes through slot 38.
Reference may be made to commonly owned U.S. Pat. Nos. 5,915,616, 6,330,965, and 6,241,139, referenced above, for a detailed discussion of the construction and operation of surgical stapling apparatus 10.
Staple clinching anvil jaw member 20 and/or staple cartridge jaw member 22 may be provided with a surgical buttress 24. It should be understood that a surgical buttress 24 may be associated with the staple cartridge jaw member 22, the anvil jaw member 20, and/or the staple cartridge 32. Surgical buttress 24 is provided to reinforce and seal the lines of staples applied to tissue by surgical stapling apparatus 10. Surgical buttress 24 may be configured into any shape, size, or dimension suitable to fit any surgical stapling, fastening, or firing apparatus.
Surgical buttress 24 is fabricated from a biocompatible material which is a bioabsorbable or non-absorbable, natural or synthetic material. It should of course be understood that any combination of natural, synthetic, bioabsorbable, and non-bioabsorbable materials may be used to form the surgical buttress.
The surgical buttress 24 may be porous, non-porous, or combinations thereof. It is also envisioned that surgical buttress 24 described herein may contain a plurality of layers in which any combination of non-porous and porous layers may be configured as discussed further below. For example, surgical buttress may be formed to include multiple non-porous layers and porous layers that are stacked in an alternating manner. In another example, surgical buttress may be formed in a “sandwich-like” manner wherein the outer layers of the surgical buttress include porous layers and the inner layers are non-porous layers. It is further envisioned that non-porous and porous layers may be positioned in any order relative to the tissue contacting surfaces of the staple cartridge jaw member and the anvil jaw member. Examples of multilayered surgical buttresses are disclosed in U.S. Patent Application Publication No. 2009/0001122 filed Jun. 27, 2007, entitled “Buttress and Surgical Stapling Apparatus,” the entire disclosure of which is incorporated by reference herein.
Some non-limiting examples of materials from which non-porous and/or porous layers of surgical buttress 24 may be made include, but are not limited to, poly(lactic acid), poly (glycolic acid), poly (hydroxybutyrate), poly (phosphazine), polyesters, polyethylene glycols, polyethylene oxides, polyacrylamides, polyhydroxyethylmethylacrylate, polyvinylpyrrolidone, polyvinyl alcohols, polyacrylic acid, polyacetate, polycaprolactone, polypropylene, aliphatic polyesters, glycerols, poly(amino acids), copoly (ether-esters), polyalkylene oxalates, polyamides, poly (iminocarbonates), polyalkylene oxalates, polyoxaesters, polyorthoesters, polyphosphazenes and copolymers, block copolymers, homopolymers, blends, and combinations thereof.
In embodiments, natural biological polymers are used in forming a non-porous and/or porous layer of the surgical buttress. Suitable natural biological polymers include, but are not limited to, collagen, gelatin, fibrin, fibrinogen, elastin, keratin, albumin, hydroxyethyl cellulose, cellulose, oxidized cellulose, hydroxypropyl cellulose, carboxyethyl cellulose, carboxymethyl cellulose, chitan, chitosan, and combinations thereof. In addition, the natural biological polymers may be combined with any of the other polymeric materials described herein to produce a non-porous layer of the surgical buttress.
In embodiments, amorphous polymers, e.g., thermoplastics, are utilized to form the surgical buttress of the present disclosure. Amorphous polymers melt gradually over a range of temperatures and include, for example, acrylonitrile-butadiene-styrene, acrylic, butadiene-styrene, polycarbonate, polyetherimide, polythalamide, polystyrene, polysulfone, polyvinyl chloride, and styrene-acrylonitrile copolymer. In embodiments, semi-crystalline materials such as nylon, polyethylene, and polypropylene, may be utilized alone or in combination with other materials to form a surgical buttress.
The use of non-porous layer(s) in the surgical buttress may enhance the ability of the surgical buttress to resist tears and perforations during the manufacturing, shipping, handling, and stapling processes. Also, the use of a non-porous layer in the surgical buttress may retard or prevent tissue ingrowth from surrounding tissues thereby acting as an adhesion barrier and preventing the formation of unwanted scar tissue. Thus, in embodiments, the non-porous layer(s) of the surgical buttress may possess anti-adhesion properties.
A non-porous layer of the surgical buttress may be formed using techniques within the purview of those skilled in the art, such as casting, molding, and the like.
Any of the porous layers of the surgical buttress may have openings or pores over at least a portion of a surface thereof. As described in more detail below, suitable materials for forming a porous layer include, but are not limited to, fibrous structures (e.g., knitted structures, woven structures, non-woven structures, etc.) and/or foams (e.g., open or closed cell foams). In embodiments, the pores may be in sufficient number and size so as to interconnect across the entire thickness of the porous layer. Woven fabrics, kitted fabrics, and open cell foam are illustrative examples of structures in which the pores can be in sufficient number and size so as to interconnect across the entire thickness of the porous layer. In embodiments, the pores may not interconnect across the entire thickness of the porous layer, but rather may be present at a portion thereof. Thus, in some embodiments, pores may be located on a portion of the porous layer, with other portions of the porous layer having a non-porous texture. Those skilled in the art reading the present disclosure will envision a variety of pore distribution patterns and configurations for the porous layer. Closed cell foam or fused non-woven materials are illustrative examples of structures in which the pores may not interconnect across the entire thickness of the porous layer.
Where a porous layer of the surgical buttress is fibrous, the fibers may be filaments or threads suitable for knitting or weaving or may be staple fibers, such as those frequently used for preparing non-woven materials. Suitable techniques for making fibrous structures are within the purview of those skilled in the art.
Where a porous layer of the surgical buttress is a foam, the porous layer may be formed using any method suitable to forming a foam or sponge including, but not limited to the lyophilization or freeze-drying of a composition. Suitable techniques for making foams are within the purview of those skilled in the art.
The origin and types of collagens that may be used to form the porous layer are the same as those indicated above for the non-porous layer. However, the oxidized or non-oxidized collagen may be lyophilized, freeze-dried, or emulsified in the presence of a volume of air to create a foam and then freeze-dried, to form a porous compress.
In embodiments, a porous layer of the surgical buttress may be made from denatured collagen or collagen which has at least partially lost its helical structure through heating or any other method. The term “denatured collagen” means collagen which has lost its helical structure. The collagen used for the porous layer as described herein may be native collagen or atellocollagen. The collagen may have been previously chemically modified by oxidation, methylation, succinylation, ethylation, or any other known process.
The porous layer(s) may enhance the ability of the surgical buttress to absorb fluid, reduce bleeding, and seal the wound. Also, the porous layer(s) may allow for tissue ingrowth to fix the surgical buttress in place.
As illustrated in the current embodiment and shown in FIG. 2A, the surgical buttress 24 is releasably attached to the staple cartridge 32 and/or the anvil jaw member 20 by welds 40 that bond the surgical buttress 24 to the inwardly facing or tissue contacting surface 23 of the staple cartridge 32 and/or the anvil jaw member 20, as discussed in detail below.
A buttress retention system 26 may also be incorporated into the staple cartridge 32 to aid in releasably securing the surgical buttress 24 to the staple cartridge 32. It is envisioned that buttress retention system 26 may additionally or alternatively be incorporated into anvil jaw member 20 such that a surgical buttress 24 may be releasably secured to anvil jaw member 20. Buttress retention system 26 may include means for attaching the surgical buttress 24 to the staple cartridge 32 and/or anvil jaw member 20, such as by pin 28 located on the staple cartridge 32 that is designed to releasably attach surgical buttress 24 to staple cartridge 32 via at least one hole 24a formed in the surgical buttress 24 that is shaped and designed to frictionally fit onto the pin 28. Other mechanical and/or chemical attachment means are within the purview of those skilled in the art and include, for example, the use of adhesives, sealants, glues, pins, tacks, tabs, clamps, channels, straps, protrusions, and combinations thereof.
As illustrated in FIG. 2B, in conjunction with FIG. 2A, the welds 40 releasably attach the staple cartridge 32 and/or the anvil jaw member 20 in a manner which allows the surgical buttress 24 to be removed or released from the staple cartridge 32 and/or the anvil jaw member 20 upon penetration of the surgical buttress 24 by a surgical staple 50 (see FIG. 7A) or other fastening device. Accordingly, welds 40 are positioned at least partially over a staple pocket 52 (shown in phantom), as will be discussed in greater detail below.
The surgical buttress 24 may include a plurality of welds 40 attaching the surgical buttress 24 to the surgical stapling apparatus 10. As illustrated in FIG. 2A, welds 40 are positioned at least partially over a portion of all of the staple retaining slots 52 of the tissue contacting surface 23 of the staple cartridge 32.
As seen in FIG. 2B, in an embodiment, surgical buttress 24 may be secured to the tissue contacting surface 23 of staple cartridge 32 by welds 40 wherein a pair of welds 40A, 40B are provided for, or associated with, each staple retaining slot 52. In particular, a first weld 40A may secure surgical buttress 24 to the tissue contacting surface 23 of the staple cartridge 32 at a location near a distal end of staple retaining slot 52 wherein at least a portion of first weld 40A extends across a distal portion of staple retaining slot 52 such that at least a portion (e.g., a staple leg) of a surgical staple 50 (FIG. 7A), disposed within staple retaining slot 52, will at least impact or penetrate the first weld 40A and facilitate the release of first weld 40A from the tissue contacting surface 23 of staple cartridge 32 upon a firing of surgical stapling apparatus 10.
Similarly, as seen in FIG. 2B, a second weld 40B may secure surgical buttress 24 to the tissue contacting surface 23 of the staple cartridge 32 at a location near a proximal end of staple retaining slot 52 wherein at least a portion of second weld 40B extends across a proximal portion of staple retaining slot 52 such that at least a portion (e.g., a staple leg) of surgical staple 50, disposed within staple retaining slot 52, will at least impact or penetrate the second weld 40B and facilitate the release of second weld 40B from the tissue contacting surface 23 of staple cartridge 32 upon a firing of surgical stapling apparatus 10.
As can be appreciated from the foregoing description, in embodiments, first and second welds 40A, 40B are aligned with an ejection path of the legs of surgical staple 50. While a pair of welds 40A, 40B have been shown associated with each staple retaining slot 52, it is contemplated that a single weld may be associated with each staple retaining slot 52 or that fewer than all the staple retaining slots 52 will have a weld 40 associated therewith.
Additionally, it is contemplated that weld(s) 40 may be disposed at any location along the length of staple retaining slot 52.
In embodiments, it is contemplated that the welds 40 may be distributed in a systematic or random pattern. Other configurations are also envisioned, such as those shown in FIGS. 3A and 3B. As illustrated in FIG. 3A, welds 40 are positioned around the perimeter of the surgical buttress 24. FIG. 3B illustrates welds 40 spaced about the surgical buttress 24 to facilitate passage of surgical stapling apparatus 10 into the body of a patient without risk of tearing or wrinkling of the surgical buttress 24 as surgical stapling apparatus 10 is inserted into and manipulated within the body of a patient. It is envisioned that the number of welds, weld size, and weld spacing can be varied to optimize the attachment of the surgical buttress to the surgical stapling apparatus, as well as to minimize the detachment force required during firing.
With reference now to FIGS. 4A and 4B, an ultrasonic welding assembly 1000, or the like, is illustrated for attaching a surgical buttress 24 to a staple cartridge 32. The staple cartridge 32 and surgical buttress 24 are placed within a channel 1022 of base 1020 of welding assembly 1000. Welding assembly 1000 includes an ultrasonic device 1010 operably connected to a generator (not shown) for ultrasonically vibrating a die 1012 extending from ultrasonic device 1010. Die 1012 defines a patterned surface 1014 including projections 1016 for forming the individual welds 40 on the surgical buttress 24. Projections 1016 provide small contact surfaces so that the energy delivered by ultrasonic device 1010 is concentrated over a small area. The projections 1016 may be any shape, such as, for example, rectangular, triangular, circular, oval, and other polygons and irregular shapes and combinations thereof.
In one embodiment, welding assembly 1000 is operatively mounted on a press assembly (not shown) for approximating die 1012 of welding assembly 1000 towards and away from base 1020. Alternatively, welding assembly 1000 may be securely mounted relative to base 1020 and base 1020 may be raised and lowered to approximate base 1020 towards and away from die 1012. The downward pressure exerted on the surgical buttress 24 by the patterned die 1012, indicated by the arrows in FIG. 4B, and the ultrasonic vibration of die 1012 causes the portions of the surgical buttress 24 and staple cartridge 32 that are in contact with each other to locally heat, and in some instances, begin to melt thereby fusing/bonding the surgical buttress 24 to the staple cartridge 32 by welds 40.
FIG. 5 illustrates another ultrasonic welding assembly 2000 that may be utilized to attach the surgical buttress 24 to the staple cartridge 32. Ultrasonic welding assembly 2000 includes a horn 2010 and an anvil 2020. Anvil 2020 is shaped as a cylindrical drum having raised projections 2022 for structuring the size and distribution of the welds 40.
The staple cartridge 32 and surgical buttress 24 are passed over anvil 2020 and mechanically worked by moving horn 2010 up and down via driving means 2012 into portions of buttress material 24 lying on projections 2022 with a frequency that lies within the ultrasonic range. Heat is generated in the worked areas of the surgical buttress 24 causing the surgical buttress 24 to melt and fuse/bond with the staple cartridge 32. Alternatively, the amount of heat generated may be higher to affect heating and melting of both the surgical buttress 24 and staple cartridge 32.
Any combination of steps as described above may be utilized to fuse/bond the surgical buttress 24 to the staple cartridge 32. Larger areas of the surgical buttress 24 may be sonically welded by providing additional horns or larger horns to the welding device 2000 or by using an anvil 2020 with larger projections, or, in embodiments, a flat anvil.
In embodiments, the staple cartridge 32 and surgical buttress 24 may be fabricated from the same material, or from materials with similar melting temperatures to achieve welds 40. Alternatively, different combinations of compatible materials for staple cartridge 32 and surgical buttress 24 may be utilized to form welds 40.
As illustrated in FIG. 6, during use of surgical stapling apparatus 10, the anvil jaw member 20 and the staple cartridge jaw member 22 including a staple cartridge 32, which has been loaded with a surgical buttress 24 such as by an ultrasonic welding process as described above, are positioned on either side of the surgical site where adjacent layers of tissue “T” are to be fastened to one another.
As best shown in FIG. 7A, staple cartridge 32 includes surgical staples 50 positioned within individual staple pockets 52. Staples 50 are of a conventional type and include a backspan 54 having a pair of legs 56 and 58 extending from backspan 54. Legs 56 and 58 terminate in tissue penetrating tips 60 and 62, respectively. Pushers 64 are located within staple pockets 52 and are positioned between staples 50 and the path of a drive bar 66.
Surgical stapling apparatus 10 is initially actuated by movement of trigger 33 relative to handle 12 (FIG. 1) causing driver 36 to move in the direction of arrow “A” (FIG. 6), and against sloped edge 21 of anvil jaw member 20 thereby causing anvil jaw member 20 to be moved to the closed position relative to staple cartridge jaw member 22. As drive bar 66 advances distally within staple cartridge 32, drive bar 66 urges pushers 64 upwardly against backspan 54 of staples 50 driving legs 56 and 58 of staples 50 (which are aligned with respective welds 40 as detailed in FIG. 7B) through at least a portion of the welds 40, the surgical buttress 24, tissue “T”, and towards staple forming pockets 68 in anvil jaw member 20. Tissue penetrating tips 60 and 62 of staple legs 56 and 58 are bent within staple forming pockets 68 in anvil jaw member 20 with backspan 54 securing surgical buttress 24 against tissue “T”. The force of the staples 50 being fired breaks the bonds between the surgical buttress 24 and the staple cartridge 32, thereby releasing the surgical buttress 24 from the staple cartridge 32 of the surgical stapling apparatus 10.
Upon full actuation of surgical stapling apparatus 10, a knife 30 associated with surgical stapling apparatus 10 and carried by driver 36 may be utilized to cut tissue “T”, as well as surgical buttress 24 between the rows of now formed staples 50. Upon movement of anvil jaw member 20 to the open position spaced apart from staple cartridge jaw member 22, surgical buttress 24 finishes pulling away from anvil jaw member 20 and staple cartridge 32 of staple cartridge jaw member 22.
The resulting tissue “T”, divided and stapled closed with staples 50, is illustrated in FIG. 8. Specifically, surgical buttress 24 is secured against tissue “T” by backspans 54 of staples 50. Thus, surgical buttress 24 is stapled to tissue “T” thereby sealing and reinforcing the staple lines created by staples 50.
Referring now to FIGS. 9A and 9B, an annular surgical stapling apparatus 110, for use with a surgical buttress 124 of the present disclosure, is shown. Surgical stapling apparatus 110 includes a handle assembly 112 having at least one pivotable actuating handle member 133, and an advancing member 135. Extending from handle member 112, there is provided a tubular body portion 114 which may be constructed so as to have a curved shape along its length. Body portion 114 terminates in a staple cartridge assembly 132 which includes a pair of annular arrays of staple receiving slots 152 having a staple 150 disposed in each one of staple receiving slots 152. Positioned distally of staple cartridge assembly 132 there is provided an anvil assembly 120 including an anvil member 121 and a shaft 123 operatively associated therewith for removably connecting anvil assembly 120 to a distal end portion of stapling apparatus 110.
Staple cartridge assembly 132 may be fixedly connected to the distal end of tubular body portion 114 or may be configured to concentrically fit within the distal end of tubular body portion 114. Staple cartridge assembly 132 includes a staple pusher 164 including a proximal portion having a generally frusto-conical shape and 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 152.
A knife 130, substantially in the form of an open cup with the rim thereof defining a knife blade 131, is disposed within staple cartridge assembly 132 and mounted to a distal surface of a staple pusher 164. The knife 130 is disposed radially inward of the pair of annular arrays of staples 150. Accordingly, in use, as the staple pusher 164 is advanced, the knife 130 is also advanced axially outward.
As seen in FIG. 10A, a surgical buttress 124 is releasably attached to the staple cartridge 132 by welds 140 that bond the surgical buttress 124 thereto. It is envisioned that the surgical buttress 124 may be additionally or alternatively attached to the anvil assembly 120. Surgical buttress 124 is provided in an annular configuration and includes an aperture 125 to receive shaft 123 of anvil assembly 120 therethrough. As illustrated, the welds 140 are in an annular configuration such that they at least partially overlay and extend across the staple retaining slots 152.
As shown in FIG. 10B, surgical buttress 124 may be secured to the staple cartridge 32 by welds 140 wherein a pair of welds 140A, 140B are provided for, or associated with, each staple retaining slot 152 (FIG. 9A). In particular, a first weld 140A may secure surgical buttress 124 to the staple cartridge 132 such that at least a portion of first weld 140A extends across a portion of a staple retaining slot 152. In such a configuration, at least a portion (e.g., a staple leg) of a surgical staple (not shown) disposed within staple retaining slot 152, will at least impact or penetrate the first weld 140A and facilitate the release of first weld 140A from the staple cartridge 132 upon a firing of surgical stapling apparatus 110. Similarly, a second weld 140B may secure surgical buttress 124 to the staple cartridge 132 such that at least a portion of second weld 140B extends across the staple retaining slot 152.
It is envisioned that other configurations may be utilized to retain the surgical buttress 124 to the staple cartridge 132, such as providing the welds 140 in either the inner or outer annular row of staple retaining slots 152, or alternating the welds 140 between the staple retaining slots 152, among other arrangements within the purview of those skilled in the art.
Surgical stapling apparatus 110 and detachable anvil assembly 120 are used in an anastomosis procedure to effect joining of intestinal sections 50 and 52. The anastomosis procedure is typically performed using minimally invasive surgical techniques including laparoscopic means and instrumentation. At the point in the procedure shown in FIG. 11, a diseased intestinal section has been previously removed, anvil assembly 120 has been applied to the operative site either through a surgical incision or transanally and positioned within intestinal section 52, and tubular body portion 114 of surgical stapling apparatus 110 has been inserted transanally into intestinal section 50. Intestinal sections 50 and 52 are also shown temporarily secured about their respective components (e.g., shaft 123 of anvil assembly 120, and the distal end of tubular body portion 114) by conventional means such as a purse string suture “P”, as illustrated in FIG. 12.
Thereafter, the clinician maneuvers anvil assembly 120 until the proximal end of shaft 123 is inserted into the distal end of tubular body portion 114 of surgical stapling apparatus 110, wherein the mounting structure (not shown) within the distal end of tubular body portion 114 engages shaft 123 to effect the mounting. Anvil assembly 120 and tubular body portion 114 are then approximated to approximate intestinal sections 50, 52. Surgical stapling apparatus 110 is then fired. The force of the staples (not shown) being fired breaks the bonds between the surgical buttress 124 and the staple cartridge 132 created by welds 140 thereby releasing the surgical buttress 124 from the staple cartridge 132, and effecting stapling of intestinal sections 50, 52 to one another. A knife (not shown) cuts the portion of tissue and surgical buttress 124 disposed radially inward of the knife, to complete the anastomosis. In embodiments in which the surgical buttress 124 is disposed radially outward of the knife, only tissue is transected by the knife blade.
Referring now to FIG. 13, anvil assembly 120 is illustrated including a polymeric insert 170. Typically the anvil assembly 120 is formed from a metal, such as stainless steel, and thus, a polymeric insert 170 may be utilized for attachment of a surgical buttress (not shown) thereto. Anvil head 121 includes a plurality of staple forming pockets 168 extending radially around an outer periphery of the tissue contacting surface 127 of the anvil head 121 for receiving and deforming staples (not shown). A cut ring 129 is disposed radially inward of the staple forming pockets 168 such that the knife blade (not shown) abuts and/or penetrates the cut ring 129 during firing of the surgical stapling apparatus to enhance cutting of tissue. Typically, cut ring 129 is formed from a soft material, e.g., polyethylene, to allow some degree of knife penetration into the cut ring 129.
Polymeric insert 170 may be fabricated from the same material as the surgical buttress, or alternatively, from a material compatible with the surgical buttress. The polymeric insert 170 may be attached to the tissue contacting surface 127 of the anvil head 121 utilizing methods within the purview of those skilled in the art, such as by utilizing adhesives or overmolding the polymeric insert 170 over the tissue contacting surface 127 of the anvil head 121. A surgical buttress is attached to the polymeric insert 170 by welds that bond the surgical buttress to thereto, such that the welds at least partially overlay and extend across the staple forming pockets 168 along an ejection path of a staple as described above. In some embodiments, such as embodiments including a surgical buttress associated with the cartridge assembly, a surgical buttress may be attached to a portion of cut ring 129 (e.g., by welding) such that release of the surgical buttress associated with the cartridge assembly is provided by firing of the staples and release of the surgical buttress associated with the anvil assembly is accomplished by knife blade cutting.
The surgical buttress of the present disclosure may be adapted for use with other surgical stapling apparatus in accordance with the present disclosure, such as the surgical stapling apparatus shown and described in U.S. Pat. No. 7,334,717, entitled “Surgical Fastener Applying Apparatus,” the entire content of which is incorporated herein by reference. As illustrated in FIG. 14, surgical stapling apparatus 210 includes an anvil receiving section 220 and a cartridge receiving section 222. A surgical buttress (not shown) may be welded to at least one of an anvil 221 coupled to the anvil receiving section 220, a staple cartridge 232 coupled to the cartridge receiving section 222, or both, as discussed above. The anvil receiving section 220 and the cartridge receiving section 222 are pivotally connected via handles 212, 213 for approximation during use. Following approximation of the anvil receiving section 220 and the cartridge receiving section 222, the surgical stapling apparatus 210 is fired by driving a firing slide 236 distally through the advancement of a firing lever 233. Distal movement of the firing slide 233 causes a plurality of cam bars to engage camming surfaces that interact with a plurality of pushers to expel a plurality of surgical staples (not shown) from the cartridge receiving section 222. The force of the staples being fired breaks the bonds between the surgical buttress and the staple cartridge, for example, created by welds between the surgical buttress and the staple cartridge, thereby releasing the surgical buttress from the staple cartridge. The staples are positioned on either side of a track which guides a knife (not shown) during longitudinal movement to thereby sever tissue along a cut-line.
The surgical buttress of the present disclosure may also be adapted for use with a transverse surgical stapling apparatus 310, as illustrated in FIG. 15. An exemplary transverse surgical stapling apparatus is shown and described in U.S. Pat. No. 5,964,394, entitled “Surgical Fastener Applying Device,” the entire content of which is incorporated herein by reference. The surgical stapling apparatus 310 includes an approximation lever 333, a movable handle 312, an elongated portion 314 that extends distally from the handle 312, and an arm 322 that extends from a distal end 315 of the elongated portion 314. The surgical stapling apparatus 310 further includes an anvil 321 that is orthogonally affixed to the arm 322, and a cartridge receiver 320 that is operatively coupled to the distal end 315 of the elongated portion 314 for retention of a staple cartridge 332. A surgical buttress (not shown) may be welded to at least one of the anvil 321, staple cartridge 332, or both as discussed above.
In embodiments, at least one bioactive agent may be combined with a surgical buttress of the present disclosure. The at least one bioactive agent may be disposed on a surface of the surgical buttress and/or impregnated therein. In these embodiments, the surgical buttress can also serve as a vehicle for delivery of the bioactive agent. The term “bioactive agent”, as used herein, is used in its broadest sense and includes any substance or mixture of substances that have clinical use. Consequently, bioactive agents may or may not have pharmacological activity per se, e.g., a dye, or fragrance. Alternatively a bioactive agent could be any agent which provides a therapeutic or prophylactic effect, a compound that affects or participates in tissue growth, cell growth, cell differentiation, an anti-adhesive compound, a compound that may be able to invoke a biological action such as an immune response, or could play any other role in one or more biological processes. It is envisioned that the bioactive agent may be applied to the surgical buttress in any suitable form of matter, e.g., films, powders, liquids, gels and the like.
Examples of classes of bioactive agents which may be utilized in accordance with the present disclosure include anti-adhesives, antimicrobials, analgesics, antipyretics, anesthetics, antiepileptics, antihistamines, anti-inflammatories, cardiovascular drugs, diagnostic agents, sympathomimetics, cholinomimetics, antimuscarinics, antispasmodics, hormones, growth factors, muscle relaxants, adrenergic neuron blockers, antineoplastics, immunogenic agents, immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids, lipopolysaccharides, polysaccharides, and enzymes. It is also intended that combinations of bioactive agents may be used.
Other bioactive agents which may be included as a bioactive agent in the surgical buttress of the present disclosure include: local anesthetics; non-steroidal antifertility agents; parasympathomimetic agents; psychotherapeutic agents; tranquilizers; decongestants; sedative hypnotics; steroids; sulfonamides; sympathomimetic agents; vaccines; vitamins; antimalarials; anti-migraine agents; anti-parkinson agents such as L-dopa; anti-spasmodics; anticholinergic agents (e.g. oxybutynin); antitussives; bronchodilators; cardiovascular agents such as coronary vasodilators and nitroglycerin; alkaloids; analgesics; narcotics such as codeine, dihydrocodeinone, meperidine, morphine and the like; non-narcotics such as salicylates, aspirin, acetaminophen, d-propoxyphene and the like; opioid receptor antagonists, such as naltrexone and naloxone; anti-cancer agents; anti-convulsants; anti-emetics; antihistamines; anti-inflammatory agents such as hormonal agents, hydrocortisone, prednisolone, prednisone, non-hormonal agents, allopurinol, indomethacin, phenylbutazone and the like; prostaglandins and cytotoxic drugs; estrogens; antibacterials; antibiotics; anti-fungals; anti-virals; anticoagulants; anticonvulsants; antidepressants; antihistamines; and immunological agents.
Other examples of suitable bioactive agents which may be included include viruses and cells, peptides, polypeptides and proteins, analogs, muteins, and active fragments thereof, such as immunoglobulins, antibodies, cytokines (e.g. lymphokines, monokines, chemokines), blood clotting factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4, IL-6), interferons (β-IFN, (α-IFN and γ-IFN), erythropoietin, nucleases, tumor necrosis factor, colony stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor agents and tumor suppressors, blood proteins, gonadotropins (e.g., FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth hormone), vaccines (e.g., tumoral, bacterial and viral antigens); somatostatin; antigens; blood coagulation factors; growth factors (e.g., nerve growth factor, insulin-like growth factor); protein inhibitors, protein antagonists, and protein agonists; nucleic acids, such as antisense molecules, DNA and RNA; oligonucleotides; polynucleotides; and ribozymes.
In embodiments, a reinforcement member may be positioned within or over a surgical buttress. In embodiments utilizing a multilayered surgical buttress, one or more reinforcement members may be positioned between, within, or at an external surface of a layer of the surgical buttress as are disclosed, for example, in U.S. Patent Application Publication No. 2009/0001122, reference above.
Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying figures are non-limiting exemplary embodiments, and that the description, disclosure, and figures should be construed merely exemplary of particular embodiments. It is to be understood, therefore, that the present disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, it is envisioned that the elements and features illustrated or described in connection with one exemplary embodiment may be combined with the elements and features of another exemplary embodiment without departing from the scope of the present disclosure, and that such modifications and variations are also intended to be included within the scope of the present disclosure. Accordingly, the subject matter of the present disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

## Claims

1. A staple cartridge for use with a surgical stapling apparatus, the staple cartridge comprising:
a cartridge body;
a plurality of staples disposed within the cartridge body, each staple including a crown and at least one leg depending from the crown;
a tissue contacting surface of the cartridge body defining staple retaining slots, each staple retaining slot having a first end and a second end; and
a buttress material secured to the cartridge body by a plurality of welds joining the buttress material to the tissue contacting surface,
the plurality of welds being in registration with at least the first end and second end of a portion of the staple retaining slots of the tissue contacting surface such that the at least one leg of the staple impacts at least one of the plurality of welds when the staple is ejected from the staple retaining slot.

2. The staple cartridge of claim 1, wherein the staple retaining slots include a first staple retaining slot; and
the buttress material being secured by a first weld and a second weld of the plurality of welds, the first weld being in registration with the first end of the first staple retaining slot, and the second weld being in registration with the second end of the first staple retaining slot.

3. The staple cartridge of claim 2, wherein the staple includes a pair of legs, the pair of legs impacting the first and second welds when the staple is ejected from the first staple retaining slot.

4. The staple cartridge of claim 1, wherein the plurality of welds is in registration with at least the first end and second end of each staple retaining slot of the tissue contacting surface.

5. The staple cartridge of claim 1, wherein the plurality of welds are distributed in a pattern over the tissue contacting surface.

6. The staple cartridge of claim 1, wherein the buttress material is porous.

7. The staple cartridge of claim 1, wherein a portion of the buttress material is non-porous.

8. The staple cartridge of claim 1, wherein the plurality of welds is a portion of the buttress material.

9. The staple cartridge of claim 1, wherein the staple retaining slots are arranged in an annular configuration.

10. The staple cartridge of claim 1, wherein the tissue contacting surface includes at least two rows of staple retaining slots.

11. The staple cartridge of claim 10, wherein the at least two rows of staple retaining slots are positioned in one of a linear configuration and an annular configuration.

12. A staple cartridge for use with a surgical stapling apparatus, the staple cartridge comprising:
a cartridge body having a tissue contacting surface defining staple retaining slots, each staple retaining slot having a first end and second end; and
a buttress material secured to the cartridge body by a plurality of welds joining the buttress material to the tissue contacting surface, the plurality of welds being in registration with at least the first end and the second end of a portion of the staple retaining slots.

13. The staple cartridge of claim 12, wherein the staple retaining slots include a first staple retaining slot; and
the buttress material being secured by a first weld and a second weld of the plurality of welds, the first weld being in registration with the first end of the first staple retaining slot, and the second weld being in registration with the second end of the first staple retaining slot.

14. The staple cartridge of claim 12, wherein the plurality of welds are in registration with at least the first end and the second end of each staple retaining slot of the tissue contacting surface.

15. The staple cartridge of claim 12, wherein the plurality of welds are distributed in a pattern over the tissue contacting surface.

16. The staple cartridge of claim 12, including a plurality of staples disposed within the cartridge body, wherein at least one of the plurality of staples impact at least one of the plurality of welds when the plurality of staples are ejected from the staple retaining slots.

17. The staple cartridge of claim 12, wherein the buttress material is porous.

18. The staple cartridge of claim 12, wherein a portion of the buttress material is non-porous.

19. The staple cartridge of claim 12, wherein the staple retaining slots are arranged in an annular configuration.

20. The staple cartridge of claim 12, wherein the tissue contacting surface includes at least two rows of staple retaining slots.

21. The staple cartridge of claim 20, wherein the at least two rows of staple retaining slots are positioned in one of a linear configuration and an annular configuration.