CN109069154B - Surgical stapler/cutter and extension buttress - Google Patents

Abstract

The present invention relates to a surgical stapler for stapling and resecting tissue comprising a surgical buttress at least partially disposed on a tissue-facing surface of at least one of the cartridge or the anvil, the buttress having a width substantially greater than a width of the tissue-facing surface. The buttress comprises a first portion positioned over the deployable staples or over the staple forming pockets and at least one flap portion not positioned over the deployable staples or over the staple forming pockets; the flap portion is folded or wrapped upon itself and is configured to be deployable and wrappable about the resected tissue. The invention also relates to methods of using such stapler assembly devices.

Description

Surgical stapler/cutter and extension buttress

Technical Field

The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or engaged by surgical staples, and more particularly to surgical instruments and methods designed for applying buttress material to enhance properties of repaired or engaged tissue at a target surgical site.

Background

Over the years, the medical field has utilized various techniques in an attempt to join or bond bodily tissues together. Historically, suturing is an acceptable technique for rejoining several tissues and closing a wound. Suturing is accomplished with surgical needles and sutures, where the intended function of the suture is to hold the edges of the wound or tissue against each other to hold them to each other during the healing process. Staples are used in place of sutures when joining or anastomosing various body structures (e.g., bowel). Surgical stapling devices for applying staples are typically designed to simultaneously cut and seal an elongated section of patient tissue.

Linear or circular surgical stapling devices are used by surgeons to sequentially or simultaneously apply one or more lines of surgical fasteners (e.g., staples) to body tissue for joining sections of body tissue together and/or for creating anastomoses. Linear surgical stapling devices typically include a pair of jaws or fingers between which body tissue to be engaged is placed. When the surgical stapling device is actuated, the firing bar moves longitudinally and contacts the staple driving member in one of the jaws, and the surgical staples are pushed through the body tissue and advanced to and against the anvil in the opposing jaw, thereby crimping the staples closed. A blade may be provided to cut between rows/lines of staples.

A number of surgical staplers are known for open and endoscopic procedures. Some such staplers are operable to clamp 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 layers of tissue. Surgical staplers, for exemplary purposes only, are disclosed in the following U.S. patents: U.S. Pat. No.4,805,823 entitled "Pocket Configuration for Internal Organ formers" published on 21/2/1989; U.S. Pat. No.5,415,334 entitled "Surgical Stapler and Staple Cartidge" published 5, 16.1995; U.S. Pat. No.5,465,895, entitled "Surgical Standard Instrument" published 11/14 in 1995; U.S. patent No.5,597,107 entitled "scientific Stapler Instrument" published on 28.1.1997; U.S. patent No.5,632,432 entitled "scientific Instrument" published 27/5/1997; U.S. Pat. No.5,673,840, entitled "Surgical Instrument", published 10/7/1997; U.S. Pat. No.5,704,534 entitled "insulation Assembly for scientific Instruments" published on 6.1.1998; U.S. Pat. No.5,814,055 entitled "scientific Clamping Mechanism" published on 29.9.1998; U.S. Pat. No.6,978,921 entitled "Surgical stabilizing Instrument Incorporating an E-Beam fastening Mechanism" published at 27.12.2005; U.S. Pat. No.7,000,818 entitled "Surgical stabilizing Instrument cutting and dispensing and fastening Systems" published on 21.2.2006; U.S. Pat. No.7,143,923 entitled "Surgical stabilizing Instrument bathing A Firing Lookout for an Unlocked animal" published on 5.12.2006; U.S. Pat. No.7,303,108 entitled "scientific sampling Instrument Incorporating a Multi-Stroke Firing Mechanism with a Flexible Rack" published on 12, 4.2007; U.S. Pat. No.7,367,485 entitled "scientific sampling Instrument incorporation a Multi-Stroke Firing Mechanism Transmission" published 6.5.2008; U.S. Pat. No.7,380,695 entitled "scientific sampling Instrument Single Loockout Mechanism for prediction of training" published 3.6.2008; U.S. Pat. No.7,380,696 entitled "engineering scientific sampling Instrument Incorporating a Two-Piece E-Beam fastening Mechanism" published on 3.6.2008; U.S. patent No.7,404,508 entitled "scientific labeling and Cutting Device" published 29.7.2008; U.S. Pat. No.7,434,715 entitled "Surgical stabilizing Instrument reading with Opening Lockout" published 10.14.2008; U.S. Pat. No.7,721,930 entitled "Disposable card with Adhesive for Use with a splicing Device" published on 25.5.2010; U.S. Pat. No.8,408,439 entitled "scientific sampling Instrument with An annular End Effect" published on 2.4.2013; U.S. Pat. No.8,453,914 entitled "Motor-Driven scientific Current Instrument with Electric Actuator directive Control Assembly" published on 6, 4.2013. The disclosure of each of the above-referenced U.S. patents is incorporated herein by reference.

Although many of 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. By way of example only, a surgical stapler can be inserted through a thoracotomy and thereby positioned between a patient's ribs to access one or more organs in thoracic surgery that does not use a trocar as a conduit for the stapler. These procedures may include the use of a stapler to cut and close blood vessels leading to the lungs. For example, prior to removal of the organ from the chest cavity, blood vessels leading to the organ may be severed and closed by a stapler. Surgical staplers may be used in a variety of other situations and procedures. An example of a Surgical stapler that may be particularly suitable or used by thoracotomy is disclosed in U.S. patent No.9,186,142, entitled "Surgical Instrument End Effector apparatus Drive with Pinion and operating Racks," the disclosure of which is incorporated herein by reference in its entirety.

Many supports and tissue thickness compensators that are placed over and sutured to tissue are known in the art. Reference is made to U.S. Pat. No.8,657,176 "Tissue thickness compensator for a preliminary stage"; U.S. Pat. No.8,746,535 "Tissue thickness compensator comprising removable ports"; U.S. Pat. No.8,864,009 "Tissue thickness compensator for a preliminary stapler comprising an adjustable angular anvil"; U.S. Pat. No.9,113,865 "Staple Tridge composing a layer"; U.S. Pat. No.9,168,038 "Staple card comprising a tissue thickness compensator"; U.S. Pat. No.9,198,662 "Tissue thickness compensator having improved visibility"; U.S. Pat. No.9,220,501 "Tissue thickness generators"; U.S. Pat. No.9,241,714 "Tissue thickness compensator and method for damping the same"; U.S. Pat. No.8,308,042 "Structure for attachment of button materials to animals and cards of scientific tags"; U.S. Pat. No.9,113,873 "removable button material coverage systems for use with a protective marking device".

U.S. patent publication No.2014/0239047 "ADHERENCE CONCEPTS FOR NON-WOVEN ABSORBABLE FELT BUTTRESSES" discloses a surgical stapling apparatus comprising: a housing; a handle supported by the housing; an elongate body extending distally from the housing; a tool assembly at the distal end of the elongate body, the tool assembly comprising: a cartridge assembly comprising a staple cartridge having a tissue-facing surface, a plurality of staple-retaining pockets, and a knife channel formed in the tissue-facing surface thereof; a plurality of surgical fasteners each loaded one in a staple retaining pocket; and an anvil assembly in juxtaposed relation to the cartridge assembly, the anvil assembly including an anvil having a tissue-facing surface defining a plurality of staple forming pockets and pockets therein, at least one of the cartridge assembly or the anvil assembly being movable relative to the other of the cartridge assembly and the anvil assembly; and a surgical buttress attached to the tissue-facing surface of at least one of the cartridge assembly or the anvil assembly, the surgical buttress conforming to the tissue-facing surface such that the surgical buttress is locally deformed into the knife channel of the cartridge retaining pocket and cartridge assembly or the knife channel of the staple forming pocket and anvil assembly, the surgical buttress attached to the anvil assembly thereby increasing the contact area between the surgical buttress and the tissue-facing surface.

U.S. patent publication No.2013/0062391, "SURGICAL INSTRUMENT WITH FLUID FILLABLE BUTTRESS," discloses an apparatus comprising: (a) a surgical cutter comprising a distal end and a proximal end, wherein the proximal end comprises a handle, wherein the distal end comprises an anvil and a lower jaw, wherein the anvil and the lower jaw are configured to clamp tissue, wherein the surgical cutter is configured to sever tissue clamped by the anvil and the lower jaw; and (b) a liquid-filled buttress, wherein the buttress is configured to be placed between the anvil and the lower jaw, wherein the buttress comprises a compressed portion and a pressure portion, wherein the compressed portion is clamped by the anvil and the lower jaw, the compressed portion being configured to be squeezed by the distal end of the surgical cutter, wherein the pressure portion is configured to be pressurized by the liquid in response to the clamping on the compressed portion, wherein the buttress is configured to be severed and stapled by the surgical cutter substantially simultaneously with the surgical cutter severing tissue, wherein upon severing the buttress, the pressure portion is configured to force the liquid through the compressed portion.

U.S. patent No.6,325,810 "FOAM buttons FOR stable tissue appling APPARATUS" discloses an APPARATUS FOR tissue hemostasis or pulmonary stasis comprising a staple cartridge containing a plurality of surgical staples arranged in two spaced lines having an upper surface with openings through which the staples can be ejected, the upper surface having a compliant bioabsorbable open-cell FOAM releasably attached thereto, wherein the open-cell FOAM has at least one substantially sealed surface in contact with the upper surface of the cartridge.

Post-operative leakage and delayed healing of the sutured tissue seal, particularly where the edges of the tissue are cut and sutured, can lead to morbidity and mortality. Even when pre-loaded with a buttress, existing staplers expose the edge of the excised tissue, resulting in potential blood and/or body fluid leakage, infection, and adhesion. There is a need to improve the healing of resected and stapled tissue to improve the viability of the tissue engaged by the staples.

Disclosure of Invention

The present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or engaged by surgical staples, and more particularly to surgical instruments and methods designed for applying a therapeutic material to enhance properties of repaired or engaged tissue at a target surgical site.

In one embodiment, the present invention is directed to a surgical stapler for engaging and resecting tissue, the surgical stapler comprising: a body, a shaft assembly, and an end effector, wherein the end effector comprises: a lower jaw configured to receive a staple cartridge; an anvil pivotable toward and away from the lower jaw; and a translatable knife member; a disposable cartridge mounted in the lower jaw, the cartridge housing a plurality of deployable staples arranged in an array separated by a tissue resection channel through which the knife member can translate; the anvil has a plurality of staple forming pockets aligned with the deployable staples; a surgical buttress at least partially disposed on a tissue-facing surface of at least one of the cartridge or the anvil, said buttress having a width substantially greater than a width of said tissue-facing surface; the buttress includes a first portion positioned over the deployable staples or staple forming pockets and at least one flap portion not positioned over the deployable staples or staple forming pockets; the flap portion is folded or wrapped upon itself and is configured to be deployable and wrappable about the resected tissue.

In another embodiment, the present invention is directed to a method of joining tissue using a surgical stapler, the method comprising the steps of: inserting a staple cartridge into the lower jaw; capturing tissue between the anvil and the staple cartridge; translating the knife member distally from a proximal position to a distal position; substantially simultaneously cutting the captured tissue to form a resected tissue edge and driving a plurality of staples of a staple cartridge through the captured tissue, substantially simultaneously attaching the first portion of the buttress to a first tissue surface with the staples and cutting the buttress in half without attaching the flap portion to the tissue with the staples; removing the surgical stapler from contact with tissue, leaving the buttress attached to a first tissue surface; deploying at least one of the flap portions and wrapping the at least one flap portion around the resected tissue edge, and optionally contacting the at least one flap portion with a second tissue surface opposite the first tissue surface.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention.

FIG. 1 depicts a perspective view of an exemplary articulating surgical stapling instrument;

FIG. 2 depicts a side elevational view of the instrument of FIG. 1;

FIG. 3 depicts a perspective view of the end effector of the instrument of FIG. 1 with the end effector in a closed configuration;

FIG. 4 depicts a perspective view of the end effector of FIG. 3 with the end effector in an open configuration;

FIG. 5 depicts an exploded perspective view of the end effector of FIG. 3;

FIG. 6 depicts a cross-sectional end view of the end effector of FIG. 3 taken along line 6-6 of FIG. 4;

FIG. 7 depicts a perspective view of an exemplary cartridge that can be incorporated into the end effector of FIG. 3;

FIG. 8 illustrates an exploded perspective view of an alternative exemplary surgical stapling instrument;

FIG. 9 illustrates a perspective view of an exemplary cartridge having a buttress in a flat deployed configuration placed on top of a tissue-facing surface of the cartridge;

FIG. 10 illustrates a perspective view of an exemplary anvil having buttresses in a flat deployed configuration placed on top of a tissue-facing surface of the anvil;

FIG. 11 shows a schematic top view of an exemplary cartridge having a buttress in a flat deployed configuration placed on top of a tissue-facing surface of the cartridge;

FIGS. 12-17 show simplified cross-sectional views of a cartridge having a buttress disposed on a tissue-facing surface with flaps folded or rolled;

FIG. 18 illustrates a schematic top view of an exemplary cartridge having channels in a tissue-facing surface for storing support tabs;

FIG. 19 shows a simplified cross-sectional view of a cartridge with a buttress disposed on a tissue-facing surface with fins stored in channels;

FIGS. 20-22 illustrate cross-sectional views of an exemplary cartridge within an end effector showing a buttress schematically mounted thereon with flaps folded;

FIG. 23 shows a simplified cross-sectional view of tissue positioned prior to stapling and severing between an anvil and cartridge mounted in an end effector;

FIG. 24 shows the view of FIG. 23 after resection and suturing;

FIGS. 25-28 show schematic cross-sectional views of the tissue and buttress after stapling and removal of the surgical stapler, showing deployment and wrapping of the flaps around the resected surface and the opposing tissue surface;

FIGS. 29A-F show schematic cross-sectional views of embodiments of single and multi-layered supports on a cartridge;

FIGS. 30A-E show schematic cross-sectional views of tissue and two layers of buttress after stapling and removal of a surgical stapler, showing deployment and wrapping of flaps around the resected surface and the opposing tissue surface;

FIGS. 31 and 32 show simplified cross-sectional views of a cartridge having two layers of buttress disposed on a tissue-facing surface with flaps folded;

fig. 33-35 illustrate several configurations of the buttress positioned on the anvil;

36A-D show schematic top views of a support with peripheral flaps and a support with central flaps, with the flaps shown in flat plan view and also in folded view;

figures 37 to 39 show schematic cross-sectional views of a cartridge having a support with a central fin;

FIGS. 40 and 41 show schematic cross-sectional views of an anvil having a buttress with a center tab;

FIG. 42 shows a simplified cross-sectional view of tissue positioned between an anvil and cartridge mounted in an end effector with a buttress having a center flap after resection and stapling;

43A-C show schematic cross-sectional views of tissue and buttress with a central flap after stapling and removal of the surgical stapler, showing the deployment and wrapping of the flap around the resected surface and the opposing tissue surface;

44A-C show simplified cross-sectional views of a cartridge having two layers of buttress disposed on a tissue-facing surface with flaps folded; and is

Fig. 45A and 45B show schematic top views of a support with peripheral flaps and a support with central flaps, wherein the flaps have holes or apertures and are shown in flat plan view.

Detailed Description

The following description of certain examples of the invention should not be used to limit the scope of the 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 given 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 description are to be regarded as illustrative in nature and not as restrictive.

Surgical procedures often involve joining two or more layers of tissue together, and optionally simultaneously sectioning a portion of the tissue along a suture. A typical surgical stapling instrument, such as a surgical linear stapling instrument, has a staple containing member and an opposing anvil member between which at least two tissue layers to be joined are compressed prior to delivery of staples from the staple containing member, whereby the staples penetrate the two tissue layers and bend, deform, or close against the opposing anvil member. For linear surgical staplers, a disposable staple cartridge is the component that contains the staples, the cartridge typically being mounted in a jaw of the device, such as a lower jaw adapted to hold the cartridge, and the opposite or upper jaw being the anvil component. The staple cartridge has a slot disposed between adjacent, parallel rows of staples and extending substantially the entire length of the rows of staples. The stapler includes a firing member for the staples and a cutting device movable along the slot.

Referring now to FIGS. 1-6, there is shown a SURGICAL stapling instrument or stapler, the drawings being taken from U.S. patent publication No.2015/0374373A1 "METHOD OF USING LOCKOUT FEATURES FOR SURGICAL STAPLER CARTRIDGE," which is incorporated herein by reference in its entirety.

Fig. 1 illustrates an exemplary surgical stapling and severing instrument (10) that includes a handle assembly (20), a shaft assembly (30), and an end effector (40). The distal portions of the end effector (40) and shaft assembly (30) are sized for insertion through the trocar cannula into a surgical site of a patient in the unarticulated state shown in fig. 1 for performing a surgical procedure. By way of example only, such a trocar may be inserted into a patient's abdomen from between the patient's two ribs or elsewhere. In some cases, the instrument (10) is used without the presence of a trocar. For example, the end effector (40) and distal portion of the shaft assembly (30) may be inserted directly through a thoracotomy or other type of incision. It should be understood that terms such as "proximal" and "distal" are used herein with respect to a clinician gripping a handle assembly (20) of an instrument (10). Thus, the end effector (40) is distal with respect to the more proximal handle assembly (20). It will also be appreciated that for convenience and clarity, spatial terms such as "vertical" and "horizontal" may be used herein in connection with the illustrations. However, surgical instruments are capable of use in many orientations and positions, and these terms are not intended to be limiting and absolute.

As shown in fig. 1-2, the handle assembly (20) of the present example includes a pistol grip (22), a closure trigger (24), and a firing trigger (26). Each trigger (24,26) is selectively pivotable toward and away from the pistol grip portion (22). The handle assembly (20) further includes an anvil release button (25), a firing beam reverse switch (27), and a removable battery pack (28). The handle assembly (20) may have a variety of other components, features, and operability in addition to or in place of any of those described above.

As shown in fig. 1-3, the shaft assembly (30) of the present example includes an outer closure tube (32), an articulation section (34), and a closure ring (36) that is further coupled to an end effector (40). A closure tube (32) extends along the length of the shaft assembly (30). A closure ring (36) is positioned distal to the articulation section (34). The closure tube (32) and closure ring (36) are configured to longitudinally translate relative to the handle assembly (20). Longitudinal translation of the closure tube (32) is transmitted to the closure ring (36) via the articulation section (34).

The articulation section (34) is operable to laterally deflect the closure ring (36) and the end effector (40) laterally away from the Longitudinal Axis (LA) of the shaft assembly (30) at a desired angle (a). Thus, the end effector (40) may reach behind an organ or proximate tissue from a desired angle or for other reasons. In some versions, the articulation section (34) is configured to deflect the end effector (40) along a single plane. In some other versions, the articulation section (34) is configured to deflect the end effector along more than one plane. In this example, articulation is controlled by an articulation control knob (35) located at the proximal end of the shaft assembly (30). The knob 35 is rotatable about an axis perpendicular to a Longitudinal Axis (LA) of the shaft assembly (30). In response to rotation of the knob (35), the closure ring (36) and the end effector (40) pivot about an axis perpendicular to the Longitudinal Axis (LA) of the shaft assembly (30). By way of example only, clockwise rotation of the knob (35) may cause corresponding clockwise pivoting of the closure ring (36) and end effector (40) at the articulation section (34). The articulation section (34) is configured to transmit a longitudinal translation of the closure tube (32) to the closure ring (36) regardless of whether the articulation section (34) is in a straight configuration or an articulated configuration.

As shown in fig. 1-2, the shaft assembly (30) of the present example further includes a knob (31). The knob (31) is operable to rotate the entire shaft assembly (30) and end effector (40) relative to the handle assembly (20) about a Longitudinal Axis (LA) of the shaft assembly (30). In some versions, the knob (31) is operable to selectively lock the angular positioning of the shaft assembly (30) and end effector (40) relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30). For example, the knob (31) may be translatable between a first longitudinal position in which the shaft assembly (30) and end effector (40) are rotatable relative to the handle assembly (20) about a Longitudinal Axis (LA) of the shaft assembly (30); in the second longitudinal position, the shaft assembly (30) and the end effector (40) are not rotatable relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30). Of course, the shaft assembly (30) may have a variety of other components, features, and operability in addition to or in place of any of those described above.

As also shown in fig. 1-3, the end effector (40) of the present example includes a lower jaw (50) and a pivotable anvil (60). The anvil (60) includes a pair of integral outwardly extending pins (66) disposed in corresponding curved slots (54) of the lower jaw (50). The pin (66) and slot (54) are shown in fig. 5. The anvil (60) is pivotable toward and away from the lower jaw (50) between an open position (shown in fig. 2 and 4) and a closed position (shown in fig. 1, 3). As seen in fig. 5, the lower jaw (50) of the present example defines a channel (52) configured to receive a staple cartridge (70). A staple cartridge (70) may be inserted into the channel (52), the end effector (40) may be actuated, and then the staple cartridge (70) may be removed and replaced with another staple cartridge (70). The lower jaw (50) thus releasably holds the staple cartridge (70) in alignment with the anvil (60) for actuating the end effector (40).

As seen in fig. 4-7, the staple cartridge (70) of the present example includes a cartridge body (71) and a tray (76) secured to the underside of the cartridge body (71). The upper side of the cartridge body (71) presents a platform (73) against which the tissue can be compressed when the anvil (60) is in the closed position. The cartridge body (71) further defines a longitudinally extending channel (72) and a plurality of staple pockets (74). A staple (77) is positioned in each staple pocket (74). A staple driver (75) is also positioned in each staple pocket (74) below the respective staple (77) and above the tray (76). The staple drivers (75) are operable to translate upwardly in the staple pockets (74) to thereby drive the staples (77) upwardly through the staple pockets (74) and into engagement with the anvil (60). The staple drivers (75) are driven upwardly by a wedge sled 78 that is captured between the cartridge body (71) and the tray 76 and translates longitudinally through the cartridge body (71). The wedge sled (78) includes a pair of obliquely angled cam surfaces (79) configured to engage the staple drivers (75) and thereby drive the staple drivers (75) upward as the wedge sled (78) translates longitudinally through the cartridge (70).

It should be appreciated that the configuration of the staple cartridge (70) may be altered in a number of ways. For example, the staple cartridge (70) of the present example includes two longitudinally extending rows of staple pockets (74) located on one side of the channel (72); and another set of two longitudinally extending rows of staple pockets (74) located on the other side of the channel (72). However, in some other versions, staple cartridge (70) includes three, one, or some other number of staple pockets (74) on each side of channel (72).

As seen in fig. 4, the anvil (60) of the present example includes a longitudinally extending channel (62) and a plurality of staple forming pockets (64). The channel (62) is configured to align with a channel (72) of a staple cartridge (70) when the anvil (60) is in the closed position. Each staple forming pocket (64) is positioned to overlie a corresponding staple pocket 74 of the staple cartridge (70) when the anvil (60) is in the closed position. The staple forming pockets (64) are configured to deform the legs of the staples (77) as the staples (77) are driven through tissue and into the anvil (60). In particular, the staple forming pockets (64) are configured to bend the legs of the staples (77) to secure the formed staples (77) in tissue.

In the present example, the knife member (80) is configured to translate through the end effector (40). As shown in fig. 5, the knife member (80) is secured to the distal end of the firing beam (82). As can be seen in fig. 4 and 6, the knife member (80) is positioned in the channel (62) of the anvil (60) and the channel (72) of the staple cartridge (70). The knife member (80) includes a distally presented cutting edge (84) configured to cut tissue compressed between the anvil (60) and the deck (73) of the staple cartridge (70) as the knife member (80) is translated distally through the end effector (40).

In some versions, the end effector (40) includes a lockout feature configured to prevent the knife member (80) from being advanced distally through the end effector (40) when the staple cartridge (70) is not inserted in the lower jaw (50). Additionally or alternatively, the end effector (40) can include a lockout feature configured to prevent the knife member (80) from being advanced distally through the end effector (40) when a staple cartridge (70) that has been actuated once (e.g., with all staples (77) deployed therefrom) is inserted into the lower jaw (50). Alternatively, the end effector (40) may simply omit such lockout features.

In the present example, the anvil (60) is driven toward the lower jaw (50) by pushing the closure ring (36) distally relative to the end effector (40). In response to distal translation of the closure ring (36) relative to the end effector (40), the closure ring (36) cooperates with the anvil (60) via a camming action to drive the anvil (60) toward the lower jaw (50). Similarly, in response to proximal translation of the closure ring (36) relative to the end effector (40), the closure ring (36) may cooperate with the anvil (60) to open the anvil (60) away from the lower jaw (50).

As noted above, the handle assembly (20) includes a pistol grip (22) and a closure trigger (24). As also noted above, in response to distal advancement of the closure ring (36), the anvil (60) closes toward the lower jaw (50). In this example, the closure trigger (24) may pivot toward the pistol grip (22) to drive the closure tube (32) and closure ring (36) distally. Various suitable components that may be used to translate the pivotal movement of the closure trigger (24) toward the pistol grip (22) into distal translation of the closure tube (32) and closure ring (36) relative to the handle assembly (20) will be apparent to those of ordinary skill in the art in view of the teachings herein. When the closure trigger (24) reaches a fully pivoted state such that the anvil (60) is in a fully closed position relative to the lower jaw (50), a locking feature in the handle assembly (20) locks the position of the trigger (24) and closure tube (32), thereby locking the anvil (60) in the fully closed position relative to the lower jaw (50). These locking features are released by actuating an anvil release button (25). The anvil release button (25) is configured and positioned to be actuatable by a thumb of an operator grasping the pistol grip (22). In other words, the operator may grasp the pistol grip (22) with one hand, actuate the closure trigger (24) with one or more fingers of the same hand, and then actuate the anvil release button (25) with the thumb of the same hand, without releasing the grasp of the pistol grip (22) with the same hand. Other suitable features may be used to actuate the anvil (60).

Referring now to FIG. 8, an alternative exemplary Surgical stapling instrument or linear stapler device is shown, which is suitable for use in U.S. Pat. No.5,275,323, "Surgical stapler", and which patent application publication is incorporated herein by reference in its entirety. As seen in fig. 8, the surgical stapler 11 includes an upper member 300, a firing device 400, a lower member 500, and a staple cartridge 600.

The staple cartridge 600 fits within the lower member 500. Specifically, a front portion of staple cartridge 600 fits into lower jaw channel 540. More specifically, parallel sidewalls 610 of staple cartridge 600 fit within lower jaw channel 540. The rear portion of staple cartridge 600 has a breakable cross-member 660. Such a breakable cross member 660 is placed on top of the cartridge lockout 470 of the firing device 400. At the same time, two legs 650 in the rearwardly extending surface 620 secure the staple cartridge 600 to the lower member 500.

In fig. 8, the upper part 300 has a rear upper handle portion 310 and a front upper jaw portion or anvil 320. Likewise, lower member 500 includes a rear movable lower handle portion 510 and a front lower jaw portion 530. The embodiment of the surgical stapler illustrated in FIG. 8 incorporates a firing device 400, a leaf spring 570, and a staple cartridge 600 into a lower member 500. However, these elements may be placed in the upper member 300 instead of the lower member 500.

The lower handle portion 510 shown in fig. 8 is movable, more particularly pivotable, between two locking positions. In the first locked position, the movable lower handle portion 510 is positioned at an oblique angle to the lower jaw portion 530. During the first locked position, C-shaped member 520 of lower handle 510 is disengaged from fixed locking pin 330. The upper and lower members 300 and 500 may be separated before or after the stapler 11 is operated at the first locking position, respectively. On the other hand, in the second locked position, the C-shaped member 520 of the movable lower handle 510 locks the upper and lower components 300 and 500 together. In the second, locked position, the movable lower handle portion 510 is parallel to the lower jaw portion 520. This second locked position occurs by engaging the static locking pin 330 with the C-shaped member 520. Such movable handle section designs may be located on upper handle section 310 or lower handle sections and 510, respectively.

The firing knob 590 activates the firing device 400. The firing device 400 also includes a top assembly 700 and also includes a cutting device, such as a knife blade assembly 440. Cutting surface 450 is included in blade assembly 440. Although FIG. 8 shows a blade assembly, tissue may be cut in many ways other than by a blade or razor.

The firing knob 590 may be manually pushed toward the staple cartridge 600 when the knife-blade assembly 440 is aligned with the slot 640. Pushing the firing knob 590 moves the knife blade assembly 440 forward toward the staple cartridge 600. The blade cutting surface 450 is then moved through the slot 640 of the staple cartridge 600 while the staples are advanced from the staple cartridge 600 through the longitudinal slots 630. In some staple cartridge 600 embodiments, a knife blade assembly is incorporated into the staple cartridge 600.

Other versions and modifications of the surgical staplers 10, 11 are known to those skilled in the art, all of which include a staple cartridge 70 or 600 having a plurality of staple pockets 74 or longitudinal slots 630 (staples not shown in FIG. 8) that receive staples 77, wherein the staple pockets 74 or longitudinal slots 630 are generally arranged in one or more rows on either side of the longitudinally extending channel 72 or slot 640. There are typically at least two and often at least three rows of staple pockets 74 or longitudinal slots 630 on each side of the longitudinally extending channel 72 or slot 640, with the staple pockets 74 or longitudinal slots 630 in each row typically being staggered or offset relative to the pockets or slots in adjacent rows to improve sealing and prevent leakage along the suture.

In the following description, the descriptors and reference numbers associated with fig. 1-7 will be used to maintain consistency, it being understood that alternative structures such as those shown in fig. 8 may also be used. Accordingly, when referring to a staple cartridge, reference numeral 70 of fig. 1-7 will be used with the understanding that the present disclosure is also applicable to the staple cartridge 600 of fig. 8.

Referring now to fig. 9 and 10, in accordance with the present invention, a buttress 100 or 100a is provided comprising an absorbable or non-absorbable substantially flat and flexible material, such as a fabric, cloth, knit, felt, nonwoven, foam, mesh, or the like, which is disposed at least partially on the tissue-facing surface 170 of the cartridge 70 or on the tissue-facing surface 160 of the anvil 60 prior to stapling. For clarity, a translucent support 100 or 100a is shown, but it may also be opaque. In some embodiments, buttress 100 or 100a is substantially wider than the width of tissue-facing surface 170 of cartridge 70 or tissue-facing surface 160 of anvil 60, wherein the excess width of buttress 100 or 100a includes peripheral flap 110 or 110 a. Buttress 100 or 100a at least partially covers staple pocket 74 and preferably completely covers staple pocket 74.

Referring to fig. 11, a simplified top view of the cartridge 70 presents two rows of staple pockets 74 on each side of the channel 72 and buttresses 100 (shown translucent for clarity) disposed on the tissue-facing surface 170 with a substantially symmetrical arrangement of buttresses 100 on the top and surrounding channel 72 with the peripheral tabs 110 extending symmetrically on both sides of the cartridge 70. The peripheral flap 110 is schematically indicated by an arrow showing the width of the peripheral flap 110 and shows a portion of the collapsible support 100 after deployment of the staples.

Referring to fig. 12, a simplified front cross-sectional view of the cartridge 70 presents two rows of staple pockets 74 on each side of the channel 72 and a buttress 100 disposed on a tissue-facing surface 170, with the peripheral flaps 110 folded back at least once onto the buttress 100, without the peripheral flaps 110 being over any staple pockets 74, thereby preventing stapling of the peripheral flaps 110 as staples (not shown for simplicity) are deployed from the staple pockets 74. The perimeter flaps 110 are shown folded back twice onto the support 100 and onto themselves. Referring to fig. 13, the peripheral flap 110 is shown folded back four times to be stored on the support 100 and on itself, or folded into an accordion-like shape. Any number of folds may be utilized to achieve the necessary width to support the peripheral flaps. Referring to fig. 14, 15, 16, the peripheral flaps 110 are shown wound upon themselves to be stored in a roll positioned below or above the tissue-facing surface 170, or at about the level of the tissue-facing surface 170. Referring to fig. 17, the peripheral flaps 110 are shown stored in a curved position alongside the cartridge body 71.

Referring to fig. 18 and 19, one embodiment of a cartridge 70 is shown having a longitudinal cavity or channel or depression 172 formed in the tissue-facing surface 170 of the cartridge 70 and extending parallel to the channel 72 on both sides of the channel 72 on the periphery of the tissue-facing surface 170 with a row 74 of staple pockets between the longitudinal cavity or channel 172 and the channel 72. Fig. 18 does not show the support 100 for simplicity, but in fig. 19 it can be seen that the peripheral flaps 110 of the support 100 are fitted into the cavities or grooves 172.

Referring now to fig. 20-22, and similar to fig. 6, there is shown a cross-sectional end view of the end effector of fig. 3 taken along line 6-6 of fig. 4, wherein the knife member 80 assembly is not shown for simplicity, and the buttress 100 with peripheral tabs 110 is schematically illustrated. Fig. 20 shows an embodiment similar to that of fig. 15 or 17. Fig. 21 shows an embodiment similar to fig. 12 or fig. 13. Fig. 22 shows an embodiment similar to fig. 19.

In all embodiments, peripheral flaps 110 are stored outside of staple cartridge 74 to prevent stapling peripheral flaps 110 during staple deployment. The peripheral tab 110 is stored distally of the channel 72 on the periphery of the cartridge 70 and opposite the channel 72 with the staple pockets 74 located between the peripheral tab 110 and the channel 72.

The peripheral flap 110 is stored by wrapping itself in one or more passes before deployment/folding over the tissue-resected edge; folded in one or more layers into an accordion-like shape, folded in one or more layers onto the cartridge 70, or similarly packaged for later deployment.

Referring to FIG. 23, a simplified cross-sectional view of the layers of tissue to be excised and the layers of stapled tissue T1 and T2 compressed between the lower jaw 50 with cartridge 70 and anvil 60 is presented. The cartridge 70 is shown with the buttress 100 disposed over the cartridge 70 and in contact with the tissue T2 with the peripheral tabs 110 fitting into the channels 172, as shown in the embodiment of fig. 19. It will be apparent that any other arrangement of peripheral tabs 110 outside of the staple pockets 74 may be utilized. The arrangement in fig. 23 corresponds to a position immediately prior to deploying staples 77 (not shown in fig. 23) and driving staples 77 through tissue T1 and T2 into anvil 60, and also corresponds to a position prior to knife member 80 (not shown in fig. 23) translating through channel 72 and excising stapled tissue T1 and T2.

Referring to FIG. 24, a simplified cross-sectional view of the location of staples 77 after deployment and removal of tissue layers T1 and T2 is presented. Buttress 100 is stapled to tissues T1 and T2 by staples 77 and is cut in half by the action of knife member 80 (not shown in fig. 23) as knife member 80 resects/cuts the tissue.

Referring to FIG. 25, a simplified cross-sectional view of a position after opening stapler 10, i.e., separation of lower jaw 50 from anvil 60 after stapling and removal of stapler 10, is presented. Buttress 100 remains attached to stapled and excised tissues T1 and T2 by staples 77. The support 100 with the peripheral flap 110 has been separated from the cartridge 70 with the peripheral flap 110 moved from its storage position within the channel 172. For simplicity, only one side of the excised tissue layers T1 and T2 is shown. Tissue layers T1 and T2 have formed exposed cut edge 120.

The peripheral flap 110 is then unfolded and flipped over from its folded storage position or folded back and wrapped around the cut-away edge 120 as schematically indicated by the arrow in fig. 25, resulting in the position of the peripheral flap 110 shown in fig. 26A. It can be seen that the peripheral flaps 110 begin to fold at the stitched area of the buttress 100, i.e., at the row of staples 77 furthest from the edge 120.

Peripheral flap 110 covers tissue T2, edge 120, and the sutured areas of the buttress on at least a portion of tissue T1. Advantageously, the peripheral flap 110 of the support 100 covers the cut-away edge 120, which will help stop bleeding and tissue sealing, improve healing, and prevent adhesions. Buttress 100 brings tissue T2 into contact with one surface of the buttress and brings edge 120 and tissue T1 into contact with the opposite surface of buttress 100. In some embodiments, such as the embodiment shown in fig. 26, the peripheral flap 110 covers and extends beyond the sutured area of tissue T1. In some embodiments, such as the embodiment shown in fig. 27, the peripheral flap 110 covers only a small portion of the tissue T1 and does not cover the suture region of the tissue T1.

Peripheral flap 110 brings tissue edge 120 and opposing tissue T1 into contact with the side of buttress 100 not in contact with tissue T1, in other words, with the side of buttress 100 opposite the side of the buttress in contact with tissue T1.

The surgeon operates the peripheral flap 110 using any available tool (such as a surgical grasper) or manually.

The description of the above operation is provided with respect to the embodiment of fig. 19, 22, however, it should be understood that a similar sequence of operation and location will result for other embodiments of the invention, i.e., other arrangements of peripheral tabs 110 deposited on anvil 60 or on cartridge 70.

The above description is provided primarily with reference to engaging and cutting two tissue layers T1 and T2. However, the same procedure and construction method is applicable for joining more than two tissue layers, or for cutting and closing one tissue layer. Referring to fig. 26B, a position similar to fig. 26A is presented except that only one tissue layer, labeled T, has been excised and stapled with surfaces S1 and S2 in fig. 26B, where surface S2 corresponds to tissue T2 and surface S1 corresponds to tissue T1.

In some embodiments, an optional securing device is provided for securing peripheral flap 110 on rim 120 and/or on tissue T1. In a more preferred embodiment, peripheral flap 110 has means for securing to at least tissue T1.

Referring to fig. 27, in one embodiment, an adhesive coating or layer 130 is provided on the side of buttress 100 facing away from tissue T2, with at least adhesive layer 130a on the perimeter of peripheral flap 110 in contact with tissue T1. Optionally, an adhesive layer 130b may also be present on the area of the peripheral flap 110 that is in contact with the edge 120. Optionally, an adhesive layer 130c may also be present on the area of the peripheral flap 110 that is in contact with the stitched area of the buttress 100. Optionally, all sides of buttress 100 facing away from tissue T2 may be covered by an adhesive layer (not shown).

When the peripheral flap 110 is folded over the resected edge and brought into contact with the tissue T1, the peripheral flap 110 is secured to the tissue edge 120 and/or the tissue T1 by the action of the adhesive layer 130. Many biocompatible tissue adhesives and sealants are known and available that can be activated by moisture, blood, and/or by contact with wet tissue. Such biocompatible binders include, for example, fibrin glue, various cross-linking agents, alone or in combination with additional agents such as proteins, and are known to the skilled person.

U.S. Pat. No.6,458,147 "Compositions, systems, and methods for restraining or controlling a sheet or fluid leakage in body tissue" discloses biocompatible and biodegradable hydrogel compounds for preventing the flow of blood or fluid from body tissue. The compound preferably comprises an albumin-containing protein mixed with a polymer comprising poly (ethylene) glycol (PEG), and most preferably, a multi-arm PEG polymer.

U.S. patent publication No.2006/0062768, "Biocompatible hydrogel composition," discloses a Biocompatible synthetic electrophilic component mixed with a nucleophilic component. The electrophilic component can include functionalized electrophilic poly (anhydride ester) materials. The nucleophilic material may comprise a protein. These components may pass through a crosslinking reaction when exposed to moisture.

U.S. patent publication No.2011/0104280, "round sample systems, devices, and methods using biocompatable synthetic hydrogel compositions," discloses mixing a multi-armed poly (ethylene glycol) (PEG) succinimidyl glutaric acid with a biocompatible synthetic nucleophilic polymer component that is substantially free of albumin and other biomolecules, which contains, for example, a polypeptide moiety having at least twenty active surface lysines per 5000M/W, which may also be blended with multi-armed poly (ethylene glycol) (PEG) amine.

U.S. patent publication No.2014/0369991a1 "Formulations for Wound Therapy" discloses Formulations comprising a dry powder fibrin sealant comprising a mixture of fibrinogen and/or thrombin for treating wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention.

The patents and patent applications cited above are incorporated herein by reference.

In one embodiment, the binder is formed from a dry protein such as albumin and a cross-linking agent. An example of a cross-linking agent is 4-arm polyethylene glycol succinimidyl glutarate (also known as PEG-SG4, succinimidyl PEG NHS, tetra-functional poly (ethylene glycol) succinimidyl glutarate). The protein and cross-linking agent are disposed on the peripheral flap 110 or impregnated into the peripheral flap 110, thereby forming an adhesive layer 130a, 130b, 130c or on all sides of the buttress 100 facing away from tissue T2 when exposed to moisture or blood. The adhesive is activated upon exposure to moisture or blood, causing the peripheral flap 110 to adhere to the rim 120 and/or the tissue T1.

In one embodiment, the adhesive forms a fibrin glue from the dried precursor, such as fibrinogen and thrombin, disposed on or impregnated into the peripheral flap 110, thereby forming an adhesive layer 130a, 130b, 130c or on all sides of the buttress 100 facing away from tissue T2 when exposed to moisture or blood. Upon contact with moisture, fibrin forms, causing the peripheral flap 110 to adhere to the rim 120 and/or tissue T1.

According to one embodiment shown in fig. 28, one or more microanchor(s), such as barbed pins 135, are provided on peripheral flap 110 in a region on the periphery of peripheral flap 110 that is in contact with tissue T1 and corresponds to region 130a in fig. 27.

According to one embodiment, peripheral flap 110 is made of a material that is self-adhering to wet tissue surfaces (such as dry collagen foam, ORC sheets, PEG-SG coated bioabsorbable sheets, fibrinogen and/or thrombin coated sheets), natural or natural synthetic composite materials (such as gelatin, chitosan, and the like, and combinations thereof). Other materials may be utilized.

According to another embodiment, the peripheral flap 110 is coated with a moisture-activating composition, such as a mucoadhesive composition, that has high adhesion to wet tissue.

Referring now to fig. 29A, a schematic cross-sectional view of buttress 100 is presented, which is disposed over cartridge 70 in an expanded and straightened configuration. The width of the central stitched portion or area of buttress 100 to be stitched by the staples (not shown) in staple pockets 74 is represented by arrow "CSP" and indicates the central stitched portion of buttress 100. The width of the peripheral flap 110 of the support 100 located on the periphery of the support 100 (the peripheral flap 110 is not sewn) is indicated by the arrow "PF" and indicates the peripheral flap width. During suturing and resection, the buttress 100 is cut in half along the channel 72, and the entire width PF of the peripheral flap 110 may be folded back and wrapped around the resected tissue (not shown). The width PF of the perimeter flap 110 is defined as the area of the buttress 100 distal to the channel 72 that is not stitched and can be folded over the stitched portion of the buttress.

The width of the central stitched portion of buttress 100, 100a is configured such that it covers the stitched area or covers the staple pocket 74 or staple forming pocket 64. In some embodiments, the width of the central stitched portion of buttress 100, 100a is about 0.5 to about 1.0 times the width of tissue-facing surface 170 or 160, such as 0.7, 0.8, 0.9, 1.0 times the width of tissue-facing surface 170 or 160.

The width of the peripheral flaps 110, 110a is configured such that the peripheral flaps can be folded back and wrapped around the resected tissue edge 120. In some embodiments, the width of each peripheral flap is at least equal to or greater than half the width of the tissue-facing surface 170 or 160, such as 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.5, 2 times the width of the tissue-facing surface 170 or 160.

Still referring to fig. 29A, in one embodiment, buttress 100 comprises a single layer of material of uniform thickness. In an alternative embodiment, referring now to fig. 29B-F, buttress 100 includes multiple layers of non-uniform thickness material or a single layer of non-uniform thickness material.

Referring to fig. 29B, in one embodiment, the buttress 100 comprises a bi-layer construction in which the peripheral flaps 110 face the cartridge 70 and are adapted to wrap around the edges of the tissue, while the second layer 111 (optionally less flexible and optionally thicker material) of the buttress 100 is optimized for tissue support and/or staple line reinforcement, adapted to remain opposite the tissue T2. Fig. 30A shows the embodiment of fig. 29B after stapling and resection with the peripheral flap 110 wrapped around the tissue and positioned over the tissue T1 with the second layer 111 remaining in contact with the tissue T2 after stapling. Advantageously, tissue support and/or staple line reinforcement is provided by layer 111, and at the same time the resected edges 120 are covered by the peripheral flap 110. Thus, only the flexible peripheral flap 110 disposed directly facing the cartridge 70 is folded back over the cut-away edge; the second layer 111 serves to reinforce the stapled tissue.

Referring to fig. 29C, in one embodiment, the buttress 100 comprises a double-layer construction in which the peripheral flaps 110 face the cartridge 70 and are adapted to wrap around the edges of tissue, while the second layer 112 (optionally less flexible and optionally thicker material) of the buttress 100 is optimized for staple line reinforcement and/or tissue thickness compensation and is adapted to be stapled and held against tissue T2. Fig. 30B shows the embodiment of fig. 29C after stapling and resection with the peripheral flap 110 wrapped around the tissue and positioned over the tissue T1 with the second layer 112 remaining in contact with the tissue T2 after stapling. Advantageously, staple line reinforcement and/or tissue thickness compensation is provided by layer 112 while the resected edge 120 is covered by the peripheral flap 110. Thus, only the flexible peripheral flap 110 disposed directly facing the cartridge 70 is folded back over the cut-away edge; the second layer 112 serves to reinforce the sutured tissue. The width of second layer 112 is as shown, at least wide enough to cover the stitch area, i.e., the area between the outermost rows of staple pockets 74. Alternatively (not shown), the second layer 112 has a width equal to or slightly wider than the width of the cartridge 70.

Referring to fig. 29D, in one embodiment, the buttress 100 comprises a bi-layer construction having a second layer 113 of the buttress 100 facing the cartridge 70 and optimized for staple line reinforcement and/or tissue thickness compensation, adapted to be stapled and held against tissue T2. A second layer 113 is positioned between the cartridge 70 and the peripheral flap 110, which is adapted to wrap around the tissue edges. Fig. 30C shows the embodiment of fig. 29D after stapling and resection with the peripheral flap 110 wrapped around the tissue and positioned over the tissue T1 with the second layer 112 remaining in contact with the tissue T2 after stapling. Advantageously, staple line reinforcement and/or tissue thickness compensation is provided by layer 112 while simultaneously covering the resected edge 120 by the peripheral flap 110. Thus, only the flexible peripheral flap 110 is folded back over the cut-away edge; the second layer 112 serves to reinforce the stapled tissue. The width of the second layer 113, as shown, is substantially equal to the width of the bin 70. Alternatively (not shown), the width of the second layer 113 is at least wide enough to cover the stitch area, i.e., the area between the outermost rows of staple pockets 74.

Referring to fig. 29E, in one embodiment, buttress 100 comprises a construction made of the same material and has a central thicker region 114 optimized for staple line reinforcement and/or tissue thickness compensation that is adapted to be stapled and held against tissue T2. The peripheral flaps 110 positioned on either side of the central thicker region 114 are adapted to wrap around the tissue edges. Fig. 30D shows the embodiment of fig. 29E after stapling and resection with the peripheral flap 110 wrapped around the tissue and positioned over the tissue T1 with the central thicker region 114 remaining in contact with the tissue T2 after stapling. Advantageously, staple line reinforcement and/or tissue thickness compensation is provided by region 114 and simultaneously the resected edge 120 is covered by the peripheral flap 110. The width of the central thicker region 114, as shown, is substantially equal to the width of the cartridge 70. Alternatively (not shown), the width of the central thicker region 114 is at least wide enough to cover the stitch area, i.e., the area between the outermost rows of staple pockets 74.

Referring to fig. 29F, in one embodiment, buttress 100 includes a construct having a central thicker region 115 made of a first material optimized for staple line reinforcement and/or tissue thickness compensation, adapted to be stapled and held against tissue T2. The peripheral flaps 110 positioned on either side of the central thicker region 115 are made of a second material joined to the first material and are adapted to wrap around the tissue edges. Fig. 30E shows the embodiment of fig. 30E after stapling and resection with the peripheral flap 110 wrapped around the tissue and positioned over the tissue T1 with the central thicker region 115 remaining in contact with the tissue T2 after stapling. Advantageously, staple line reinforcement and/or tissue thickness compensation is provided by the region 115 and at the same time the resected edge 120 is covered by the peripheral flap 110. The width of the central thicker region 115 is substantially equal to the width of the bin 70, as shown. Alternatively (not shown), the width of the central thicker region 115 is at least wide enough to cover the stitch area, i.e., the area between the outermost rows of staple pockets 74.

Referring to FIG. 31, a simplified elevational cross-sectional view of an embodiment of the cartridge 70 is presented with two rows of staple pockets 74 on each side of the channel 72 and the buttress 100 of the embodiment shown in FIG. 29C is disposed on a tissue-facing surface 170 with the peripheral flaps 110 folded over onto the buttress 100 and onto itself. The buttress 100 comprises a double-layer construction with the peripheral flaps 110 facing the cartridge 70 and adapted to wrap around the tissue edges, while the second layer 112 (optionally less flexible) of the buttress 100 is optimized for staple line reinforcement and/or tissue thickness compensation.

Referring to fig. 32, a simplified elevational cross-sectional view of an embodiment of the cartridge 70 having longitudinal grooves 172 is shown. The buttress 100 of the embodiment shown in fig. 29C is disposed on the tissue-facing surface 170 with the peripheral flaps 110 fitting into the channels 172. Buttress 100 comprises a double-layer construction in which peripheral flap 110 is adapted to wrap around the tissue edges, while a second layer 112 (optionally less flexible) of buttress 100 is optimized for staple line reinforcement and/or tissue thickness compensation.

In certain embodiments, a buttress 100a supported on the anvil 60 is provided.

Referring to fig. 33, in addition to the buttress 100 supported on the cartridge 70 described above, a simplified cross-sectional view of the anvil 60 is shown, wherein in one embodiment, a buttress 100d is supported on the anvil 60. In this embodiment, the buttress 100d has no flaps and has a width substantially the same as the width of the anvil 60. The buttress 100d has an adhesive 140 disposed on a side of the buttress 100d facing the anvil 60 and staple forming pockets 64. Adhesive 140 may be used to adhesively secure the peripheral flap 110 of buttress 100 to buttress 100d when both buttress 100d and buttress 100 are deployed onto stapled tissue T1 and T2.

Referring to fig. 34, a simplified cross-sectional view of the anvil 60 is shown wherein in one embodiment, a buttress 100a is supported on the anvil 60 in place of or in addition to the buttress 100 supported on the cartridge 70 described above. In this embodiment, the buttress 100a has a peripheral flap 110a that wraps around the anvil 60 prior to deployment.

Referring to fig. 35, a simplified cross-sectional view of the anvil 60 is shown, wherein in one embodiment, a buttress 100a is supported on the anvil 60 in place of or in addition to the buttress 100 supported on the cartridge 70 described above. In this embodiment, the buttress 100a has peripheral tabs 110a that fit into longitudinal cavities or channels 172a formed in the anvil 60 and extend parallel to the channel 62 on both sides of the channel 62 on the periphery of the anvil 60 as shown, with rows of staple forming pockets 64 located between the longitudinal cavities or channels 172a and the channel 62.

In operation, buttress 100a is sutured to tissue T1 and T2 and, as knife member 80 resects/cuts tissue, it is cut in half by the action of knife member 80. After stapling and removal of stapler 10, buttress 100a remains attached to stapled and excised tissues T1 and T2 with peripheral flap 110a detached from anvil 60. The peripheral flap 110a is then unfolded and flipped over from its folded storage position or folded back and wrapped around the cut-away edge.

The above description has focused primarily on the peripheral flaps 110, 110a of the buttresses 100 and 100a, which are positioned on the periphery of the buttresses 100 or 100a and the peripheral central stitched portion CSP of the buttresses, with the peripheral flaps stored distally of the longitudinally extending channels 72 or 62, on the periphery of the tissue facing surface 170 of the cartridge 70 or the tissue facing surface 160 of the anvil 60.

In an alternative embodiment of the invention described below, the Central Flap (CF)105 or 105a portion of buttress 100 or 100a is positioned proximal to channel 72, i.e., between channel 72 and staple pocket row 74 or channel 62 and staple forming pocket row 62.

Referring to fig. 36A and 36B, for purposes of comparison, a schematic top view of a support 100 or 100a having peripheral flaps 110, 110a is shown. Fig. 36A shows buttress 100, 100a in a flat, unencapsulated/unwrapped view prior to suturing and resection, with peripheral flap 110 or 110a forming a peripheral portion of buttress 100 or 100a, and also schematically showing resection line 720 and suture line 740.

Fig. 36B shows a schematic top view of buttress 100 or 100a in a wrapped/wrapped configuration prior to suturing and resecting, with supporting perimeter flap 110 or 110a folded and tucked in the perimeter region outside of suture 740 and distal to resection line 720. The fold 106 of the peripheral flap 110, 110a is schematically shown.

Referring to fig. 36C, 36D, an embodiment of the present invention is shown wherein the Central Flap (CF)105 or 105a forms the central portion of the buttress 100 or 100a, while the Peripheral Stitched Portions (PSP) of the buttress 100 or 100a are located on the periphery of the buttress 100 or 100 a. Fig. 36C, 36D also schematically present a resection line 720 and a suture line 740.

Fig. 36C shows a schematic top view of the support 100 or 100a in an unloaded/unwound view. Fig. 37D shows a schematic top view of the buttress 100 or 100a in a stowed/wrapped configuration prior to suturing and resection, with the supporting central flap 105 or 105a folded and stowed in the area between the resection line 720 and the suture 740. The fold 106 of the central flap 105 or 105a is schematically shown.

Fig. 37 shows a schematic cross-sectional view of cartridge 70 with buttress 100, with central tab 105 folded and fitted into a groove 172 located proximal to channel 72 on both sides of channel 72, i.e., the central tab is between channel 72 and staple pocket row 74.

Fig. 38 shows an alternative embodiment in which the groove 172 opens on one side to the channel 72.

Fig. 39 shows an alternative embodiment in which buttress 100 is pre-cut into two halves that are positioned on either side of channel 72.

Similarly, the embodiment shown in fig. 40-41, as applicable to the anvil 60 and buttress 100a, presents a schematic cross-sectional view of the anvil 60 with the buttress 100a, with the central tab 105a of the buttress 100a positioned proximal of the channel 62, i.e., between the channel 62 and the row of staple forming pockets 64. The central flap 105a of these embodiments is formed in the central portion of the support 100 a.

Fig. 40 shows the central flap 105a folded and fitted into a groove 172a located on either side of the channel 62 proximal to the channel 62, i.e. between the channel 62 and the row of staple forming pockets 64.

Fig. 41 illustrates an alternative embodiment in which the channel 172a is completely cut through the anvil 60 and is a longitudinally open channel, beginning with the tissue-facing surface 160 and ending on the side of the anvil 60 opposite the tissue-facing side 160, with the center tab 105a partially exposed on the side of the anvil 60 opposite the tissue-facing side of the anvil 60. Not shown is an alternative embodiment similar to that of fig. 39, in which buttress 100a is pre-cut in two halves positioned on either side of channel 62.

In operation, the embodiment with the central flap 105, 105A of fig. 36C, 36D and 37-41 operates in a similar manner to the embodiment with the peripheral flap 110, 110a, such that when the staples are deployed and the tissue T or tissue layers T1 and T2 are cut, the buttress 100, 110a is sutured to the tissue and is cut in half by the action of the knife member. The buttress 100, 100a remains attached to the stapled and excised tissue and detached from the cartridge 70 or anvil 60 with the center flap 105 and/or 105a moved from the stored position within the channel 172, 172 a. The center flap 105 and/or 105a is then unfolded from the folded storage position and wrapped around the edge of the excised tissue. Unlike the embodiment in which the peripheral flaps 110 or 110a are positioned on the periphery of the buttress 100 or 100a, the central flaps 105 and 105a need not be flipped or folded back, but rather can be wrapped directly around the tissue edge 120.

Referring now to FIG. 42, a simplified cross-sectional view of a location after staples 77 are deployed and tissue T is resected is presented. As shown, one tissue layer T, but several layers as presented above, such as tissues T1 and T2, may be sutured. Buttress 100 is shown stapled to tissue T by staples 77 and, as knife member 80 resects/cuts tissue, it is cut in half by the action of knife member 80 (not shown in fig. 42).

Referring to FIG. 43A, a simplified cross-sectional view of a position after opening stapler 10, i.e., separation of lower jaw 50 from anvil 60 after stapling and removal of stapler 10, is presented. Buttress 100 remains attached to stapled and excised tissue T by staples 77. The support 100 with the central flap 105 has been separated from the cartridge 70 with the central flap 105 being moved from its stored position within the channel 172. For simplicity, only one side of the excised tissue T is shown. Tissue T has formed an exposed resection edge 120.

The center flap 105 is then unfolded from its folded storage position and wrapped around the cut-away edge 120, as schematically illustrated by the arrow in fig. 43B, resulting in the position of the center flap 105 shown in fig. 43C. As can be seen, the central flap 105 covers at least a portion of the tissue edge 120 and the tissue surface S1, which is opposite the tissue surface S2. The peripheral sutured portions PSP of the buttress 100 are sutured to the tissue surface S2, and the central flap 105 wraps around the tissue T starting from surface S2, over the tissue edge 120, and covers at least a portion of the tissue surface S1, which will help to stop bleeding and tissue seal, improve healing, prevent adhesions.

The above description of operation also applies to other embodiments of the invention which employ a central flap 105, 105a for the anvil 60 mounted buttress 100a, when the knife member 80 is cutting/severing tissue, the buttress 100a is stapled to tissue T1 and T2 or a single layer of tissue T and is severed in half by the action of the knife member 80. After stapling and removal of stapler 10, buttress 100a remains attached to stapled and excised tissues T1 and T2 with central flap 105a detached from anvil 60. The central flap 105a is then unfolded from its folded storage position and wrapped around the cut-away edge 120.

Unlike the embodiment with peripheral flaps 110, 110a, the central flap 105, 105a brings the tissue edge 120 and the opposite tissue side S1 into contact with the same side of the buttress 100 that is in contact with the tissue T, in other words, the side of the buttress 100 is in contact with the tissue T surface S2.

Similar to the embodiment with peripheral flaps 110, 110a, the embodiment with central flaps 105, 105a may be provided with optional fixation means for fixation on the rim 120 and/or on the tissue surface S1. In some embodiments, an adhesive coating or layer is provided on the support side facing the tissue T surface S2, wherein at least the adhesive layer is disposed on the central panel 105, 105 a.

When the central flap 105, 105a is wrapped around the resected tissue edge 120 and brought into contact with the tissue surface S1, the flap may be secured to the tissue edge 120 and/or surface S1 by the action of adhesives, microanchmers (such as barbed pins), moisture-activated compositions that are highly adhesive to wet tissue, and the like.

The width of the peripheral stitched part PSP of the buttress 100 comprises two peripheral portions of the buttress 100, 100a separated by two central flaps 105, 105 a. The width of the PSP is configured to ensure that there is a portion of buttress 100, 100a covering the stapling area or covering suture 740 or covering staple cartridge 74 or staple forming pocket 64.

In some embodiments, the width of the peripheral stitched portion PSP of buttress 100 comprises from about half the width of tissue-facing surface 170 or 160 to about 0.9 times the width of tissue-facing surface 170 or 160, such as 0.6, 0.7, 0.8 times the width of the tissue-facing surface.

The width of the central panel 105, 105a is configured such that the central panel can wrap around the resected tissue edge 120. In some embodiments, the width of each central panel 105, 105a is at least equal to or greater than the thickness of tissue T or the combined thickness of tissue T1 and T2, such as 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4.5, 4, 4.5, 5, 8, 10, 15 times the tissue thickness, most preferably 2 to 5 times the tissue thickness.

Similar to the embodiments with peripheral flaps 110, 110a, embodiments with central flaps 105, 105a may have supports 100, 100a that include a single layer of uniform thickness material, or multiple layers of non-uniform thickness material or a single layer of non-uniform thickness material.

Referring to fig. 44A, a schematic cross-sectional view of a cartridge 70 having a buttress 100 with a central flap 105, an additional layer 112 disposed on top of the buttress 100, distal to a surface 170, wherein the layer 112 may optionally be less flexible and/or thicker than the material of the central flap 105 is shown. The layer 112 may be configured for tissue support and/or staple line reinforcement and is configured to remain opposite the tissue T surface S2. Layer 112 may be integrated into support 100.

Referring to fig. 44B, a schematic cross-sectional view of the cartridge 70 with the buttress 100 having the central fin 105 is shown with the additional layer 113 disposed between the buttress 100 and the surface 170 of the cartridge 70. Layer 113 may optionally be less flexible and/or thicker than the material of the central panel 105. Layer 113 may be configured for tissue support and/or staple line reinforcement, and may be integrated into buttress 100.

Referring to fig. 44C, a schematic cross-sectional view of the cartridge 70 is shown with the buttress 100 having a central flap 105, the buttress 100 being shown with a thicker peripheral stitched portion 114 or PSP, and a thinner central flap 105. Portion 114 may optionally be less flexible and/or thicker than the material of central panel 105. Portion 114 can be configured for tissue support and/or staple line reinforcement, and is integrated into buttress 100.

The layers 112, 113, 114 may be made of the same material as the support 100, or of different materials.

In operation, only the flexible center flap is unfolded from the storage position and wrapped over the cut-out edge 120 after sewing/cutting; the layers 112, 113, 114 serve to reinforce the stapled tissue and are not folded or wrapped over the tissue edge 120.

The width of the layers 112, 113, 114 may be substantially equal to the width of the bin 70. Alternatively, the width of layers 112, 113, 114 is at least wide enough to cover the stitch area, i.e., the area between the outermost rows of staple pockets 74.

In one embodiment, buttress 100 is deployed over cartridge 70 and buttress 100a is deployed over anvil 60 with peripheral flaps 110 and 110a and/or central flaps 105 and 105a wrapped/folded over the resected edges (from one surface of the tissue and the other opposing surface of the tissue in an overlapping configuration and secured to each other by velcro, adhesive, or any other securing mechanism).

In one embodiment, buttress 100 or 100a includes both central flaps 105, 105a and peripheral flaps 110, 110 a. After suturing and resection, the peripheral flap 110 or 110a and the central flap 105 or 105a are wrapped/folded over the resected edge from the same tissue surface and in an overlapping configuration.

In certain embodiments, peripheral flaps 110 and 110a and/or central flaps 105 and 105a are shape memory materials that unfold to cover edge 120 and the opposing tissue surface when exposed to moisture. The mechanism of deployment is, for example, a double-layer flap (not shown) having a high coefficient of contraction when exposed to moisture of the flap layer facing away from the tissue T2 and/or a high coefficient of expansion when exposed to moisture of the layer of the peripheral flap 110 facing the tissue T2. The contraction and/or expansion upon absorption of moisture will cause the flap to automatically unfold and wrap around the edge 120 and the opposing tissue T1.

The buttress 100, 100a and/or the wings 110, 110a, 105a may optionally be coated or impregnated with a biomedical agent, such as an agent to promote healing and prevent inflammation and infection. The biomedically used agents then enter the surrounding environment over time ranging from a few hours to a few days to a few weeks, such as 12 hours, 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 12 weeks, wherein such drug release is referred to as sustained release of the biomedically used agents.

By a biomedically used agent or therapeutic substance is meant any medically useful substance or combination of substances that improves tissue viability, including drugs, enzymes, growth factors, peptides, proteins, nutrients, excipients, antimicrobials, and any other injectable agent. Of particular interest are hemostatic agents, such as thrombin and/or fibrinogen. Other examples of therapeutic agents are autologous cells.

The buttress 100, 100a and/or the wings 110, 110a, 105a are preferably made of any suitable biocompatible material or composite material in the form of a nonwoven, felt, knit, woven, molded sheet, or the like. The buttress 100, 100a and/or the tab 110, 110a, 105a of the present invention may be made of any biodegradable and/or non-biodegradable material, including polymers useful in surgical procedures. The term "biodegradable" is defined to include both bioabsorbable and bioresorbable materials. The materials include natural, synthetic, bioabsorbable, and/or non-absorbable materials, and combinations thereof. Naturally biodegradable polymers that may be used to form the buttress 100, 100a and/or the flap 110, 110a, 105a include natural materials or derivatives: polysaccharides such as chitosan, cellulose, collagen, gelatin, alone or in combination with biomaterials and/or synthetic polymers. Examples of cellulose derivatives include carboxymethyl cellulose, oxidized regenerated cellulose, and the like, and combinations thereof. Synthetic biodegradable polymers that can be used to form medical devices include various known bioerodible/bioresorbable polymers such as poly (lactide-co-polyglycolide), and more typically polymers and copolymers made from glycolide, lactide, epsilon-caprolactone, trimethylene carbonate, p-dioxanone, and the like, and combinations thereof. Non-degradable materials may include polyethylene, polypropylene, polytetrafluoroethylene; nylon and the like.

The thickness of the support 100 is from about 0.05mm to about 3mm, more preferably from 0.1mm to 2mm, such as 0.2, 0.5, 0.8, 1.0, 1.5 mm.

The width of the buttress 100 including the fins is at least 1.3 times the width of the tissue-facing surface 170 of the cartridge 70, more preferably at least 1.5, 2, 3 times the width of the tissue-facing surface 170 of the cartridge 70. In some embodiments, the width of the buttress 100 including the fins 110 is 15mm to 60mm, such as 20, 25, 30, 35, 40 mm.

In some embodiments, the width of each flap is equal to or greater than 0.5 times the width of the tissue-facing surface 160, 170, such as 0.75, 1, 1.5, 2 times the width of the tissue-facing surface 160, 170.

In some embodiments, the width of each flap is greater than the distance between channel 72 and the most distal row of staple pockets 74 and the sum of the thicknesses of the stapled tissue T1 and T2, such as 5mm, 10mm, 15mm, 20mm, 30mm greater.

The length of the buttress 100, 100a is about 0.5 to about 1.3 times the length of the tissue-facing surface 170 or 160, such as 0.75, 1.0, 1.2 times the length of the tissue-facing surface 170 or 160. In some embodiments, the length of buttress 100, 100a is equal to or greater than the length of the stitched region or the length of staple line 740 by 5-20%.

The above description applies to the joining and resection of two or more layers of tissue T1 and T2 or a single layer of tissue T. However, the same procedure and construction method is applicable to joining more than two tissue layers, or to resecting and closing one tissue layer, such as pleural or lung tissue, liver tissue, kidney tissue, etc. As disclosed with reference to fig. 26B, 42, 43, only one tissue layer, labeled T, having surfaces S1 and S2 may be cut and sutured, with surface S2 corresponding to tissue T2 of fig. 23-28, 30 and surface S1 corresponding to tissue T1 of fig. 23-28, 30.

Referring now to fig. 45, in some embodiments, the tab portion has a plurality of holes or apertures 118. Advantageously, the holes or apertures may provide better tissue healing.

As shown in FIG. 45A, the peripheral flap 110 or 110a has an aperture 118 or hole 118. As shown in fig. 45B, the center flap 105 or 105a has an opening 118.

While the invention has been described above with reference to specific embodiments thereof, it is apparent that many changes, modifications, and variations can be made without departing from the inventive concept disclosed herein. Accordingly, it is intended to embrace all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims (19)

1. A surgical stapler for stapling and resecting at least a section of tissue, comprising:

a body, a shaft assembly, and an end effector, wherein the end effector comprises: a lower jaw configured to receive a staple cartridge; an anvil pivotable toward and away from the lower jaw; and a translatable knife member;

a disposable cartridge mounted in the lower jaw, the disposable cartridge housing a plurality of deployable staples arranged in an array separated by a tissue resection channel through which the knife member is translatable;

the anvil has a plurality of staple forming pockets aligned with the deployable staples;

a surgical buttress at least partially disposed on a tissue-facing surface of at least one of the disposable cartridge or the anvil,

the width of the buttress is substantially greater than the width of the tissue-facing surface;

the buttress comprises a first portion positioned over the deployable staples or over the staple forming pockets and at least one flap portion not positioned over the deployable staples or over the staple forming pockets;

The flap portion is folded or wrapped upon itself and is deployable and wrappable around the excised tissue;

wherein the flap portions each have a width greater than a width of the tissue-facing surface.

2. The surgical stapler of claim 1, wherein the buttress comprises two tab portions.

3. The surgical stapler of claim 2, wherein the flap portion is configured to have a width sufficient to wrap around the resected tissue.

4. The surgical stapler of claim 2, wherein the buttress is substantially rectangular.

5. The surgical stapler of claim 2, wherein the flap portion is perforated.

6. The surgical stapler of claim 2, wherein the buttress is at least partially bioresorbable or at least partially soluble.

7. The surgical stapler of claim 2, wherein the buttress comprises a releasable medically-useful medicament.

8. The surgical stapler of claim 3, wherein said flap portions are stored in a groove formed in said tissue facing surface of at least one of said disposable cartridge or said anvil.

9. The surgical stapler of claim 3, wherein said flap portions are foldably stored on said tissue facing surface of at least one of said disposable cartridge or said anvil.

10. The surgical stapler of claim 3, wherein said flap portion is rolled out of said tissue facing surface stored in at least one of said disposable cartridge or said anvil.

11. The surgical stapler of claim 3, wherein the buttress comprises at least two layers.

12. The surgical stapler of claim 1, wherein the first portion comprises two layers and the flap portion comprises one layer.

13. The surgical stapler of claim 1, wherein the first portion has a higher thickness and the flap portion has a lower thickness.

14. The surgical stapler of claim 1, wherein the flap portion comprises an attachment device.

15. The surgical stapler of claim 14, wherein the attachment means comprises a layer of adhesive or at least one barbed pin.

16. The surgical stapler of claim 3, wherein said flap portions are located on a periphery of said buttress and surround said first portion, said flap portions each having a width greater than half a width of said tissue-facing surface.

17. The surgical stapler of claim 8, wherein said groove is positioned on a periphery of said disposable cartridge or said anvil and distal to said tissue resection channel.

18. The surgical stapler of claim 3, wherein said flap portion is located in a center of said buttress and said first portion comprises two portions surrounding said flap portion, each of said flap portions having a width greater than a thickness of tissue or greater than half a width of said tissue-facing surface.

19. The surgical stapler of claim 8, wherein the groove is positioned proximal to the tissue resection channel and between the tissue resection channel and a deployable row of staples or staple forming pockets.

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