# Patent

## Title
Surgical staple assembly with hemostatic feature

## Abstract

A surgical instrument includes a handle portion, a shaft housing a firing bar, an end effector comprising an anvil, a lower jaw, and a stapling and severing assembly responsive to a longitudinal closing motion produced by the handle portion and the shaft. The lower jaw is configured to receive a removable cartridge. The cartridge includes a housing, a plurality of staples disposed in the housing, a deck disposed over the plurality of staples, and a fastener insert tip including a plurality of hooks. The deck defines apertures, with each aperture being substantially disposed over each staple. The instrument includes a fastener insert including hooks, and the fastener insert is removably received in the anvil. A buttress is attached to one or both of the anvil and the cartridge via the hooks.

## Background
BACKGROUND
In some settings, endoscopic surgical instruments may be preferred over traditional open surgical devices since a smaller incision may reduce the post-operative recovery time and complications. Consequently, some endoscopic surgical instruments may be suitable for placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors may engage tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, stapler, clip applier, access device, drug/gene therapy delivery device, and energy delivery device using ultrasound, RF, laser, etc.). Endoscopic surgical instruments may include a shaft between the end effector and a handle portion, which is manipulated by the clinician. Such a shaft may enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within the patient. Positioning of an end effector may be further facilitated through inclusion of one or more articulation joints or features, enabling the end effector to be selectively articulated or otherwise deflected relative to the longitudinal axis of the shaft.
Examples of endoscopic surgical instruments include surgical staplers. Some such staplers are operable to clamp down on layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the tissue layers. Merely exemplary surgical staplers are disclosed in; U.S. Pat. No. 4,805,823, entitled “Pocket Configuration for Internal Organ Staplers,” issued Feb. 21, 1989; U.S. Pat. No. 5,415,334, entitled “Surgical Stapler and Staple Cartridge,” issued May 16, 1995; U.S. Pat. No. 5,465,895, entitled “Surgical Stapler Instrument,” issued Nov. 14, 1995; U.S. Pat. No. 5,597,107, entitled “Surgical Stapler Instrument,” issued Jan. 28, 1997; U.S. Pat. No. 5,632,432, entitled “Surgical Instrument,” issued May 27, 1997; U.S. Pat. No. 5,673,840, entitled “Surgical Instrument,” issued Oct. 7, 1997; U.S. Pat. No. 5,704,534, entitled “Articulation Assembly for Surgical Instruments,” issued Jan. 6, 1998; U.S. Pat. No. 5,814,055, entitled “Surgical Clamping Mechanism,” issued Sep. 29, 1998; U.S. Pat. No. 6,964,363, entitled “Surgical Stapling Instrument having Articulation Joint Support Plates for Supporting a Firing Bar,” issued Nov. 15, 2005; U.S. Pat. No. 6,978,921, entitled “Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism,” issued Dec. 27, 2005; U.S. Pat. No. 6,988,649, entitled “Surgical Stapling Instrument Having a Spent Cartridge Lockout,” issued Jan. 24, 2006; U.S. Pat. No. 7,000,818, entitled “Surgical Stapling Instrument Having Separate Distinct Closing and Firing Systems,” issued Feb. 21, 2006; U.S. Pat. No. 7,111,769, entitled “Surgical Instrument Incorporating an Articulation Mechanism having Rotation about the Longitudinal Axis,” issued Sep. 26, 2006; U.S. Pat. No. 7,143,923, entitled “Surgical Stapling Instrument Having a Firing Lockout for an Unclosed Anvil,” issued Dec. 5, 2006; U.S. Pat. No. 7,303,108, entitled “Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack,” issued Dec. 4, 2007; U.S. Pat. No. 7,367,485, entitled “Surgical Stapling Instrument Incorporating a Multistroke Firing Mechanism Having a Rotary Transmission,” issued May 6, 2008; U.S. Pat. No. 7,380,695, entitled “Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing,” issued Jun. 3, 2008; U.S. Pat. No. 7,380,696, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism,” issued Jun. 3, 2008; U.S. Pat. No. 7,404,508, entitled “Surgical Stapling and Cutting Device,” issued Jul. 29, 2008; U.S. Pat. No. 7,434,715, entitled “Surgical Stapling Instrument having Multistroke Firing with Opening Lockout,” issued Oct. 14, 2008; U.S. Pat. No. 7,721,930, entitled “Disposable Cartridge with Adhesive for Use with a Stapling Device,” issued May 25, 2010; and U.S. Pat. No. 7,455,208, entitled “Surgical Instrument with Articulating Shaft with Rigid Firing Bar Supports,” issued Nov. 25, 2008. The disclosure of each of the above-cited U.S. Patents is incorporated by reference herein. While the surgical staplers referred to above are described as being used in endoscopic procedures, it should be understood that such surgical staplers may also be used in open procedures and/or other non-endoscopic procedures.
While various kinds of surgical stapling instruments and associated components have been made and used, it is believed that no one prior to the inventor(s) has made or used the invention described in the appended claims.



BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.
FIG. 1A depicts a perspective view of an articulating surgical instrument with an end effector in a nonarticulated position;
FIG. 1B depicts a perspective view of the surgical instrument of FIG. 1A with an end effector in an articulated position;
FIG. 2 depicts a perspective view of an opened end effector of the surgical instrument of FIGS. 1A-1B;
FIG. 3A depicts a side cross-sectional view of the end effector of FIG. 2, taken along line 3-3 of FIG. 2, with the firing bar in a proximal position;
FIG. 3B depicts a side cross-sectional view of the end effector of FIG. 2, taken along line 3-3 of FIG. 2, but showing the firing bar in a distal position;
FIG. 4 depicts an end cross-sectional view of the end effector of FIG. 2, taken along line 4-4 of FIG. 2;
FIG. 5 depicts an exploded perspective view of the end effector of FIG. 2;
FIG. 6 depicts a perspective view of the end effector of FIG. 2, positioned at tissue and having been actuated once in the tissue;
FIG. 7 depicts a perspective, fragmentary view of a version of the anvil of the end effector of FIG. 2, and a fastener insert configured for receipt within an opening of the anvil;
FIG. 8 depicts a perspective, fragmentary view of a version of a cartridge of the end effector of FIG. 2;
FIG. 9 depicts a partial, side elevation view of a version of the end effector of FIG. 2 including the anvil of FIG. 7 and the cartridge of FIG. 8, and a buttress attached to the end effector; and
FIG. 10 depicts a perspective view of an end effector with an attached buttress, the end effector positioned at and actuated within the tissue to release a tissue repair composition from the buttress onto the tissue.



The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.
DETAILED DESCRIPTION
The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
I. Exemplary Surgical Stapler
FIGS. 1-6 depict an exemplary surgical stapling and severing instrument (10) that is sized for insertion, in a nonarticulated state as depicted in FIG. 1A, through a trocar cannula passageway to a surgical site in a patient for performing a surgical procedure. Surgical stapling and severing instrument (10) includes handle portion (20) connected to implement portion (22), the latter further comprising shaft (23) distally terminating in an articulation mechanism (11) and a distally attached end effector (12). Once articulation mechanism (11) and end effector (12) are inserted through the cannula passageway of a trocar, articulation mechanism (11) may be remotely articulated, as depicted in FIG. 1B, by articulation control (13). Thereby, end effector (12) may reach behind an organ or approach tissue from a desired angle or for other reasons. It should be understood that terms such as “proximal” and “distal” are used herein with reference to a clinician gripping handle portion (20) of instrument (10). Thus, end effector (12) is distal with respect to the more proximal handle portion (20). It will be further appreciated that for convenience and clarity, spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
End effector (12) of the present example includes a lower jaw (16) and a pivotable anvil (18). Handle portion (20) includes pistol grip (24) toward which closure trigger (26) is pivotally drawn by the clinician to cause clamping, or closing, of the anvil (18) toward lower jaw (16) of end effector (12). Such closing of anvil (18) is provided through an outmost closure sleeve (32), which longitudinally translates relative to handle portion (20) in response to pivoting of closure trigger (26) relative to pistol grip (24). A distal closure ring (33) of closure sleeve (32) is indirectly supported by frame (34) of implement portion (22). At articulation mechanism (11), a proximal closure tube (35) of closure sleeve (32) communicates with the distal closure ring (33). Frame (34) is flexibly attached to lower jaw (16) via articulation mechanism (11), enabling articulation in a single plane. Frame (34) also longitudinally slidingly supports a firing drive member (not shown) that extends through shaft (23) and communicates a firing motion from firing trigger (28) to firing bar (14). Firing trigger (28) is farther outboard of closure trigger (26) and is pivotally drawn by the clinician to cause the stapling and severing of clamped tissue in end effector (12), as will be described in greater detail below. Thereafter, release button (30) is depressed to release the tissue from end effector (12).
FIGS. 2-5 depict end effector (12) employing an E-beam firing bar (14) to perform a number of functions. As best seen in FIGS. 3A-3B, firing bar (14) includes a transversely oriented upper pin (38), a firing bar cap (44), a transversely oriented middle pin (46), and a distally presented cutting edge (48). Upper pin (38) is positioned and translatable within an anvil pocket (40) of anvil (18). Firing bar cap (44) slidably engages a lower surface of lower jaw (16) by having firing bar (14) extend through channel slot (45) (shown in FIG. 3B) that is formed through lower jaw (16). Middle pin (46) slidingly engages a top surface of lower jaw (16), cooperating with firing bar cap (44). Thereby, firing bar (14) affirmatively spaces end effector (12) during firing, overcoming pinching that may occur between anvil (18) and lower jaw (16) with a minimal amount of clamped tissue and overcoming staple malformation with an excessive amount of clamped tissue.
FIG. 2 shows firing bar (14) proximally positioned and anvil (18) pivoted to an open position, allowing an unspent staple cartridge (37) to be removably installed into a channel of lower jaw (16). As best seen in FIGS. 4-5, staple cartridge (37) of this example includes a cartridge body (70), which presents an upper deck (72) and is coupled with a lower cartridge tray (74). As best seen in FIG. 2, a vertical slot (49) is formed through part of staple cartridge (37). As also best seen in FIG. 2, three rows of staple apertures (51) are formed through upper deck (72) on one side of vertical slot (49), with another set of three rows of staple apertures (51) being formed through upper deck (72) on the other side of vertical slot (49). Referring back to FIGS. 3-5, a wedge sled (41) and a plurality of staple drivers (43) are captured between cartridge body (70) and tray (74), with wedge sled (41) being located proximal to staple drivers (43). Wedge sled (41) is movable longitudinally within staple cartridge (37); while staple drivers (43) are movable vertically within staple cartridge (37). Staples (47) are also positioned within cartridge body (70), above corresponding staple drivers (43). In particular, each staple (47) is driven vertically within cartridge body (70) by a staple driver (43) to drive staple (47) out through an associated staple aperture (51). As best seen in FIGS. 3A-3B and 5, wedge sled (41) presents inclined cam surfaces that urge staple drivers (43) upwardly as wedge sled (41) is driven distally through staple cartridge (37).
With end effector (12) closed as depicted in FIG. 3A, firing bar (14) is advanced in engagement with anvil (18) by having upper pin (38) enter a longitudinal anvil slot (42). A pusher block (80) is located at the distal end of firing bar (14), and is configured to engage wedge sled (41) such that wedge sled (41) is pushed distally by pusher block (80) as firing bar (14) is advanced distally through staple cartridge (37). During such firing, cutting edge (48) of firing bar (14) enters vertical slot (49) of staple cartridge (37), severing tissue clamped between staple cartridge (37) and anvil (18). As shown in FIGS. 3A-3B, middle pin (46) and pusher block (80) together actuate staple cartridge (37) by entering into slot (49) within staple cartridge (37), driving wedge sled (41) into upward camming contact with staple drivers (43) that in turn drive staples (47) out through staple apertures (51) and into forming contact with staple forming pockets (53) on the inner surface of anvil (18). FIG. 3B depicts firing bar (14) fully distally translated after completing severing and stapling tissue.
FIG. 6 shows end effector (12) having been actuated through a single stroke through tissue (90). Cutting edge (48) has cut through tissue (90), while staple drivers (43) have driven three alternating rows of staples (47) through the tissue (90) on each side of the cut line produced by cutting edge (48). Staples (47) are all oriented substantially parallel to the cut line in this example, though it should be understood that staples (47) may be positioned at any suitable orientations. In the present example, end effector (12) is withdrawn from the trocar after the first stroke is complete, spent staple cartridge (37) is replaced with a new staple cartridge, and end effector (12) is then again inserted through the trocar to reach the stapling site for further cutting and stapling. This process may be repeated until the desired amount of cuts and staples (47) have been provided. Anvil (18) may need to be closed to facilitate insertion and withdrawal through the trocar; and anvil (18) may need to be opened to facilitate replacement of staple cartridge (37).
It should be understood that cutting edge (48) may sever tissue substantially contemporaneously with staples (47) being driven through tissue during each actuation stroke. In the present example, cutting edge (48) just slightly lags behind driving of staples (47), such that a staple (47) is driven through the tissue just before cutting edge (48) passes through the same region of tissue, though it should be understood that this order may be reversed or that cutting edge (48) may be directly synchronized with adjacent staples. While FIG. 6 shows end effector (12) being actuated in two layers (92, 94) of tissue (90), it should be understood that end effector (12) may be actuated through a single layer of tissue (90) or more than two layers (92, 94) of tissue. It should also be understood that the formation and positioning of staples (47) adjacent to the cut line produced by cutting edge (48) may substantially seal the tissue at the cut line, thereby reducing or preventing bleeding and/or leaking of other bodily fluids at the cut line. Various suitable settings and procedures in which instrument (10) may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.
It should be understood that instrument (10) may be configured and operable in accordance with any of the teachings of U.S. Pat. No. 4,805,823; U.S. Pat. No. 5,415,334; U.S. Pat. No. 5,465,895; U.S. Pat. No. 5,597,107; U.S. Pat. No. 5,632,432; U.S. Pat. No. 5,673,840; U.S. Pat. No. 5,704,534; U.S. Pat. No. 5,814,055; U.S. Pat. No. 6,978,921; U.S. Pat. No. 7,000,818; U.S. Pat. No. 7,143,923; U.S. Pat. No. 7,303,108; U.S. Pat. No. 7,367,485; U.S. Pat. No. 7,380,695; U.S. Pat. No. 7,380,696; U.S. Pat. No. 7,404,508; U.S. Pat. No. 7,434,715; and/or U.S. Pat. No. 7,721,930.
As noted above, the disclosures of each of those patents are incorporated by reference herein. Additional exemplary modifications that may be provided for instrument (10) will be described in greater detail below. Various suitable ways in which the below teachings may be incorporated into instrument (10) will be apparent to those of ordinary skill in the art. Similarly, various suitable ways in which the below teachings may be combined with various teachings of the patents cited herein will be apparent to those of ordinary skill in the art. It should also be understood that the below teachings are not limited to instrument (10) or devices taught in the patents cited herein. The below teachings may be readily applied to various other kinds of instruments, including instruments that would not be classified as surgical staplers. Various other suitable devices and settings in which the below teachings may be applied will be apparent to those of ordinary skill in the art in view of the teachings herein.
II. Exemplary Alternative Anvil and Cartridge with Buttress
FIGS. 7-10 show an exemplary alternative end effector (121) that includes an anvil (99) and a cartridge (101), either of which may be coupled with an exemplary buttress (142). End effector (121) is similar to end effector (12) described above except as set forth below. Anvil (99) is similar to anvil (18) described above except as set forth below. Further, cartridge (101) is similar to cartridge (101) described above except as set forth below. Thus, anvil (99) and cartridge (101) may be actuated using instrument (10), in a manner similar to that described above with respect to actuation of anvil (18) and cartridge (37).
A. Exemplary Anvil Fastener Insert
FIG. 7 shows anvil (99) configured for receipt of a fastener insert (100) in the direction of arrow (A). Particularly, anvil (99) includes an opening (102) at the distal end (103) of an anvil slot (42). Opening (102) is configured to receive and retain fastener insert (100). Opening (102) includes a top portion (104) and a bottom portion (106), which is disposed below and narrower in width than top portion (104). Top portion (104) is defined by an internal top surface (108) of anvil (99), opposite ledge surfaces (110), and first internal sidewalls (112) positioned therebetween. Bottom portion (106) is defined by second internal sidewalls (114) projecting from and disposed below ledge surfaces (110), and rear wall (116) disposed between second internal sidewalls (114).
Fastener insert (100) includes a top surface (118), a distal wall (120), and a proximal wall (122). Proximal wall (122) is first received into opening (102) in the direction of arrow (A). Both distal wall (120) and proximal wall (122) include oppositely positioned upper portions and lower portions. First longitudinal walls (124) are positioned between upper portions of distal wall (120) and proximal wall (122). Second longitudinal walls (126) are positioned between lower portions of distal wall (120) and proximal wall (122). Transverse walls (128) are positioned between ends of first and second longitudinal walls (124, 126) to define an area of demarcation between upper portions and lower portions of distal wall (120) and proximal wall (122). Bottom surface (130) is disposed between lower ends of second longitudinal walls (126) and is separated from top surface (118) by distal wall (120) and proximal wall (122). Hooks (132) project downwardly from bottom surface (130) in a direction substantially perpendicular to bottom surface (130).
Fastener insert (100) may comprise a molded, unitary piece inserted into opening (102) at a manufacturing site, a surgical site, or elsewhere. When fastener insert (100) is received within opening (102), top surface (118) of fastener insert (100) is configured to abut internal top surface (108) of opening (102). First longitudinal walls (124) of fastener insert (100) are configured to be slidingly received for abutment against first internal sidewalls (112) of top portion (104) of opening (102). Transverse walls (128) of fastener insert (100) are configured to be slidingly received for abutment against ledge surfaces (110) of top portion (104) of opening (102). Concurrently, second longitudinal walls (126) of fastener insert (100) are configured to be slidingly received to abut against second internal sidewalls (114) of bottom portion (106) until proximal wall (122) of fastener insert (100) abuts against rear wall (116) of opening (102).
When fastener insert (100) is received within opening (102), as described above, hooks (132) are atraumatically positioned such that in use, described further below, they may hook to loop-type formations in an attached buttress (142) without causing trauma to the tissue to which the buttress material will be deposited upon. In particular, hooks (132), and hooks (140, 148) described below, will connect only to the small fibers forming the loop-type formations within an attached buttress (142) and not to any clamped tissue (90).
B. Exemplary Cartridge for Lower Jaw
FIG. 8 shows a version of removable cartridge (101) manufactured with fastener insert (134) such that fastener insert (134) is molded as a tip to distal end (136) of removable cartridge (101) prior to use at a surgical site. Fastener insert (134) includes top surface (138) to face towards anvil (99) when cartridge (101) is received within lower jaw (16). Hooks (140) project from top surface (138) of fastener insert (134) in a direction substantially perpendicular to top surface (138). Similar to hooks (132), hooks (140) connect to the small fibers forming the loop-type formations within an attached buttress (142) and not to any tissue (90) clamped by end effector (121).
C. Exemplary End Effector and Buttress Assembly
As shown in FIG. 9, buttress (142) of the present example includes an anvil portion (144) and a cartridge portion (146) to respectively attach to anvil (99) and cartridge (101). Anvil portion (144) and cartridge portion (146) may alternatively form two separate buttresses rather than single buttress (142). With single buttress (142), cartridge (101) may additionally include hooks (148) at a proximal portion of cartridge (101) to provide additional mechanical attachment of buttress (142) to end effector (121). Similar to hooks (132, 140), hooks (148) connect to the small fibers forming the loop-type formations within an attached buttress (142) and not to any clamped tissue (90). FIG. 9 shows buttress (142) attached to both anvil (99) and cartridge (101). Alternatively, buttress (142) may attach to only one of anvil (99) or cartridge (101).
In use, as shown in FIG. 9, buttress (142) may attach to anvil (99) via hooks (132) described above with respect to fastener insert (100). Buttress (142) is attached at an opposite end to hooks (140) of fastener insert (136) described above with respect to cartridge (101). Buttress (142) is also attached to hooks (148) at proximal portion (150) intermediate to respective proximal ends (152, 154) of anvil (99) and cartridge (101). The attachment between buttress (142) and hooks (132, 140, 148) is a hook and loop type of attachment or fastening. That is, hooks (132, 140, 148) fasten to loop-type formations in the material comprising buttress (142). Other types of fastening apparent to those of ordinary skill in the art in view of the teachings herein are within the scope of this disclosure.
Hooks (132, 140, 148) act as retention features to retain buttress (142) securely against anvil (99) and cartridge (101) when firing bar (14) drives through buttress (142) to release portions of buttress (142) onto tissue (90), as described below. When staples (47) are driven toward anvil (99) and through buttress (142), staples (47) will provide sufficient force to remove a substantial amount of buttress (142) from end effector (121) and substantially, evenly distribute the removed amount of buttress material about a severed and stapled area of tissue (90). Without the retention aspect provided by hooks (132, 140, 148), the removed amount of material might otherwise be less evenly distributed. Further, unremoved buttress material on one side of end effector (12), such as the side of anvil (99), might have a greater likelihood of sticking to the unremoved buttress material from the other side, such as the side of cartridge (101), if force is not provided via hooks (132, 140, 148) to retain the buttress material to the respective sides of end effector (121) before end effector (121) is clamped onto tissue (90).
Firing bar (14) may be fired through anvil slot (42), as described above, to slice through buttress (142) and release material from buttress (142) onto tissue (90) when anvil (99) clamps layers (92, 94) of tissue (90) together with lower jaw (161) of end effector (121). Simultaneously, as described above, staples (47) from cartridge (101) may be driven upwards toward staples pockets on anvil (99) and through buttress (142) to be formed into staples attaching to and securing layers (92, 94) of tissue (90) to one another to prevent additional loss of blood from the severing and stapling of tissue (90).
Thus, when surgical staple (47) is driven into tissue (90) by a surgical instrument, such as by instrument (10) in the manner disclosed above, surgical staple (47) will compress, connect, and retain such tissue as shown in FIG. 10. Material from buttress (142) will contact the compressed tissue and release onto the tissue to assist with tissue repair by reducing the amount of bleeding at the surgical site. Buttress (142) may be composed of a material including, for example, a hemostatic agent to assist to coagulate blood and reduce bleeding at the severed and/or stapled surgical site along tissue (90). In addition or in the alternative, buttress (142) may comprise a biodegradable polymer operable to assist with tissue repair as described below. Also in addition or in the alternative, material from buttress (142) may provide reinforcement to the integrity of the mechanical attachment of tissue (90) by staples (47). Surgical staple (47) may comprise a material selected from iron, nickel titanium alloy, stainless steel, and/or titanium. Of course, any other suitable materials may be used.
D. Exemplary Buttress
Buttress (142) may comprise a fibrous pad, a foam (e.g., open or closed cell), a matrix, a mesh, or another structure, in accordance with the teachings of, by way of example, U.S. Patent App. Pub. No. 2009/0120994, entitled “Surgical Fastening Device with Initiator Impregnation of a Matrix or Buttress to Improve Adhesive Application”, published May 14, 2009, now U.S. Pat. No. 7,708,180, issued May 4, 2010, the disclosure of which is incorporated by reference herein. The material may include porosities that induce a wicking feature to drawing adhesive into the material and ensure the openings remain clear of the adhesive, allowing tissue growth through the openings after application to tissue. Other suitable structures that may be used to form buttress (142) will be apparent to those of ordinary skill in the art in view of the teachings herein.
The material forming buttress (142) may comprise, for example, adjunct or hemostatic agents such as fibrin or thrombin that assist to coagulate blood and reduce the amount of bleeding at the surgical site. The hemostatic abilities of such adjuncts may also contribute to the use of such adjuncts as adhesives and sealants. The agents may assist to coagulate blood at a surgical site which allows tissue surrounding such blood to stick together and may prevent leaks along the stapled tissue site, for example.
Adjuncts or reagents may further include but are not limited to medical fluid and/or buttress components such as platelet poor plasma (PPP), platelet rich plasma (PRP), starch, chitosan, alginate, fibrin, polysaccharide, cellulose, collagen, bovine collagen, gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid), agarose, amylose, hyaluronan, polyhydroxybutyrate (PHB), hyaluronic acid, poly(vinyl pyrrolidone) (PVP), poly(vinyl alcohol) (PVA), polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers, VICRYL® (Ethicon, Inc., Somerville, N.J.), MONOCRYL material, PANACRYL (Ethicon, Inc., Somerville, N.J.), and/or any other material suitable to be mixed with biological material and introduced to a wound or defect site, including combinations of materials. Additional exemplary materials include natural or genetically engineered absorbable polymers or synthetic absorbable polymers, or mixtures thereof. Examples of natural or genetically engineered absorbable polymers are proteins, polysaccharides and combinations thereof. Proteins include, prothrombin, thrombin, fibrinogen, fibrin, fibronectin, heparinase, Factor X/Xa, Factor VII/VIIa, Factor IX/IXa, Factor XI/XIa, Factor XII/XIIa, tissue factor, batroxobin, ancrod, ecarin, von Willebrand Factor, collagen, elastin, albumin, gelatin, platelet surface glycoproteins, vasopressin, vasopressin analogs, epinephrine, selectin, procoagulant venom, plasminogen activator inhibitor, platelet activating agents, synthetic peptides having hemostatic activity, and/or combinations thereof. Polysaccharides include, without limitation, cellulose, alkyl cellulose, e.g. methylcellulose, alkylhydroxyalkyl cellulose, hydroxyalkyl cellulose, cellulose sulfate, salts of carboxymethyl cellulose, carboxymethyl cellulose, carboxyethyl cellulose, chitin, carboxymethyl chitin, hyaluronic acid, salts of hyaluronic acid, alginate, alginic acid, propylene glycol alginate, glycogen, dextran, dextran sulfate, curdlan, pectin, pullulan, xanthan, chondroitin, chondroitin sulfates, carboxymethyl dextran, carboxymethyl chitosan, chitosan, heparin, heparin sulfate, heparan, heparan sulfate, dermatan sulfate, keratan sulfate, carrageenans, chitosan, starch, amylose, amylopectin, poly-N-glucosamine, polymannuronic acid, polyglucuronic acid polyguluronic acid, and derivatives of any of the above. Examples of synthetic absorbable polymers are aliphatic polyester polymers, copolymers, and/or combinations thereof. The aliphatic polyesters are typically synthesized in a ring opening polymerization of monomers including, but not limited to, lactic acid, lactide (including L-, D-, meso and D, L mixtures), glycolic acid, glycolide, ε-caprolactone, p-dioxanone (1,4-dioxan-2-one), and trimethylene carbonate (1,3-dioxan-2-one).
In some versions, buttress (142) may comprise a biocompatible carrier to contain a medical fluid. Suitable carriers may include, for example, a physiological buffer solution, a flowable gel solution, saline, and water. In the case of gel solutions, the tissue repair composition may be in a flowable gel form prior to delivery at the target site, or may form a gel and remain in place after delivery at the target site. Flowable gel solutions may comprise one or more gelling materials with or without added water, saline, or a physiological buffer solution. Suitable gelling materials include biological and synthetic materials. Exemplary gelling materials include proteins, polysaccharides, polynucleotides, and other materials such as alginate, cross-linked alginate, poly(N-isopropylacrylamide), poly(oxyalkylene), copolymers of poly(ethylene oxide)-poly(propylene oxide), poly(vinyl alcohol), polyacrylate, or monostearoyl glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, and combinations of any of the foregoing.
FIG. 10 shows an example of using end effector (12) to apply exemplary buttress (142) described herein onto tissue (90) to deposit portions of buttress (142) as a tissue repair composition onto tissue (90). After such an application as described above, buttress (142) deposited on tissue (90) may substantially surround and/or coat onto staples (47) that secure layers (92, 94) of tissue (90).
It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. that are described herein. The following-described teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those of ordinary skill in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
Versions of the devices described above may have application in conventional medical treatments and procedures conducted by a medical professional, as well as application in robotic-assisted medical treatments and procedures.
Versions of described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
By way of example only, versions described herein may be sterilized before and/or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.
Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

## Claims

1. A surgical instrument apparatus comprising:
(a) a handle portion;
(b) a shaft housing a firing bar;
(c) an end effector comprising an anvil, a lower jaw, and a stapling and severing assembly responsive to distal motion of the firing bar;
(d) a removable cartridge, wherein the lower jaw is configured to receive the cartridge when the end effector is in an open position, the cartridge comprising:
(i) a housing,
(ii) a plurality of staples disposed in the housing, and
(iii) a deck disposed over the plurality of staples, the deck defining a plurality of apertures, each aperture substantially disposed over each staple; and

(e) a removable fastener insert comprising a plurality of fasteners, wherein the fastener insert is configured for receipt in the anvil, wherein the plurality of fasteners are atraumatic and configured to attach to a biocompatible material without extending through the biocompatible material, wherein the plurality of fasteners attach to a side of the biocompatible material facing the anvil.

2. The apparatus of claim 1, wherein the biocompatible material is selected from a group consisting of at least one of the following materials: epsilon-caprolactone glycolide, bovine pericardium, polylactic acid, polyglycolic acid, polyglactin, polydioxanone, polyglyconate, whey protein, cellulose gum, starch, gelatin, silk, nylon, polypropylene, braided polyester, polybutester, polyethylene, and polyetheretherketones.

3. The apparatus of claim 1, wherein the biocompatible material comprises one of fibrin or thrombin.

4. The apparatus of claim 1, wherein the biocompatible material comprises at least one of a hemostatic agent, a sealant, or an adhesive.

5. The apparatus of claim 1, wherein the fasteners comprise a plurality of hooks.

6. The apparatus of claim 5, wherein the hooks are configured to attach to loop formations in a biocompatible material to retain the biocompatible material to the anvil.

7. The apparatus of claim 1, wherein the cartridge comprises a fastener insert at a distal end, the fastener insert comprising fasteners.

8. The apparatus of claim 7, wherein the fasteners are configured to attach to a biocompatible material to retain the biocompatible material to the cartridge.

9. The apparatus of claim 7, wherein the fasteners comprise hooks that are configured to attach to loop formations in a biocompatible material to retain the material to the cartridge.

10. The apparatus of claim 1, wherein a proximal end of the cartridge comprises fasteners.

11. The apparatus of claim 10, wherein the fasteners comprise hooks that are configured to attach to loop formations in a biocompatible material to retain the biocompatible material to the cartridge.

12. The apparatus of claim 1, wherein the fasteners comprise hooks.

13. The apparatus of claim 1, wherein the biocompatible material comprises a buttress, and wherein the buttress comprises one of fibrin or thrombin.

14. A surgical instrument comprising:
(a) a handle portion and a shaft, the shaft housing a firing bar;
(b) a stapling and severing assembly responsive to distal motion of the firing bar,
(c) an end effector connected to the handle portion, the end effector comprising an anvil and a lower jaw, the anvil defining an opening, the lower jaw being configured to receive a cartridge when the end effector is in an open position;
(d) a plurality of staples disposed in a housing of the cartridge, the anvil configured to form the staples in response to distal motion of the firing bar when the end effector is in a closed position;
(e) a deck disposed over the plurality of staples, the deck defining a plurality of apertures, each aperture being substantially disposed over each staple; and
(f) a fastener insert comprising a plurality of hooks configured for receipt within the opening in the anvil, wherein the hooks are configured to attach to loop formations in a biocompatible material to retain the biocompatible material to the anvil;
wherein the firing bar is operable to move between the anvil and the cartridge to sever the biocompatible material; and
wherein the staples are operable to be driven towards the anvil and through the biocompatible material in response to distal motion of the firing bar.

15. A surgical instrument apparatus comprising:
(a) a handle portion;
(b) a shaft housing a firing bar;
(c) an end effector comprising an anvil, a lower jaw, and a stapling and severing assembly responsive to distal motion of the firing bar, wherein the anvil comprises a distal end, wherein the distal end of the anvil comprises an opening;
(d) a removable cartridge, wherein the lower jaw is configured to receive the cartridge when the end effector is in an open position, the cartridge comprising:
(i) a housing,
(ii) a plurality of staples disposed in the housing,
(iii) a deck disposed over the plurality of staples, the deck defining a plurality of apertures, each aperture substantially disposed over each staple, and
(iv) a plurality of fasteners located at the proximal end of the cartridge; and

(e) a removable fastener insert comprising a plurality of fasteners, wherein the fastener insert is configured for receipt in the opening of the distal end of the anvil.