Modified surgical adjunct and stapling assembly

Abstract

The disclosed technology includes a surgical adjunct that includes a polyurethane foam and a film disposed on at least one surface of the polyurethane foam. The volume ratio of the polyurethane foam to the total volume of the surgical adjunct 604 is in the range of about 0.125 to about 0.325.

Description

Cross Reference to Related Applications

[0001] This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 522,660, filed June 22, 2023, and U.S. Non-Provisional Patent Application No. 18 / 485,047, filed October 11, 2023, the entire contents of which are incorporated herein by reference in their entirety. TECHNICAL FIELD

[0002] The present invention relates generally to compressible surgical adjuncts, cartridges, cartridge assemblies, and methods of manufacturing the adjuncts and cartridge assemblies. BACKGROUND

[0003] Surgical staplers are used in surgical procedures to close openings in tissue, blood vessels, conduits, shunts, or other objects or body parts involved in a particular procedure. These openings can be naturally occurring, such as passageways in blood vessels or internal organs like the stomach, or they can be created by the surgeon during the surgical procedure, such as by puncturing tissue or blood vessels to create a bypass or anastomosis, or by cutting tissue during a stapling procedure.

[0004] Most staplers have a handle with an elongate shaft, some of which are directly manipulatable by a user, others of which can be manipulated by a user via a robotic interface, that extends from the handle and has a pair of movable opposing jaws formed on an end thereof for holding and forming staples therebetween. The staples are typically housed in a staple cartridge, which can house multiple rows of staples and is typically disposed in one of the two jaws for ejection of the staples to the surgical site. During use, the jaws are positioned such that the object to be stapled is disposed between the jaws, and the staples are ejected and formed when the jaws are closed and the device is actuated. Some staplers include a knife configured to travel between the rows of staples in the staple cartridge to longitudinally cut and / or open the stapled tissue between the rows of staples. SUMMARY

[0005] According to one example of the present invention, there is provided a surgical adjunct comprising a polyurethane foam and a film disposed on at least one surface of the polyurethane foam. The volume ratio of the polyurethane foam to the total volume of the surgical adjunct is in the range of about 0.125 to about 0.325.

[0006] According to one example of the present application, a stapling assembly is provided. The stapling assembly can include a deck of a cartridge including at least one post extending away from the deck. The at least one post can include a first diameter at a top of the at least one post that is greater than a second diameter at a bottom of the at least one post. The cartridge can include a first film disposed on the deck and at least partially around the at least one post with a gap between the top of the at least one post and the film. The cartridge can further include a surgical adjunct disposed on the first film and at least partially around the at least one post. The surgical adjunct can include a polyurethane foam, wherein a volume ratio of the polyurethane foam to a total volume of the surgical adjunct is in a range of about 0.125 to about 0.325.

[0007] According to one example of the present application, a stapling assembly is provided. The stapling assembly includes a deck and a surgical adjunct disposed on the deck. The surgical adjunct can include a polyurethane foam, wherein a volume ratio of the polyurethane foam to a total volume of the surgical adjunct is in a range of about 0.125 to about 0.325. BRIEF DESCRIPTION OF DRAWINGS

[0008] The present application will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: Figure 1 Perspective view of one exemplary embodiment of a conventional surgical stapling and severing instrument.

[0009] Figure 2A Top view of a staple cartridge for use with the surgical stapling and severing instrument of Figure 1 Figure 2B Side view of the staple cartridge of Figure 2A Figure 3 Side view of a staple that can be disposed within a staple cartridge of the surgical cartridge assembly of Figure 2A Figure 4 Perspective view of the knife and firing bar ("E-beam") of the surgical stapling and severing instrument of Figure 1 Figure 5 Perspective view of the wedge sled of the staple cartridge of the surgical stapling and severing instrument of Figure 1 Longitudinal cross-sectional view of an exemplary embodiment of a surgical cartridge assembly having a compressible non-fibrous adjunct attached to a top surface or deck surface of a staple cartridge. Figure 6A Longitudinal cross-sectional view of a surgical end effector having an anvil pivotably coupled to an elongate channel and Figure 6B Figure 6A ​​​​​a surgical cartridge assembly disposed within and coupled to the elongate channel, the illustration showing the anvil in a closed position with no tissue between the anvil and the adjunct; Figure 6C a perspective view of an exemplary surgical end effector having a channel and a surgical cartridge having a sled and a driver; Figure 7 a partial schematic view of an adjunct in a tissue-deployed condition; Figures 6A-6B Figure 8A a perspective view of an exemplary cartridge assembly; Figure 8B a side view of an exemplary adjunct for a cartridge assembly; Figure 8C a top view of an exemplary adjunct for a cartridge assembly; Figure 8D a front view of an exemplary adjunct for a cartridge assembly; Figure 8E a diagram illustrating an enlarged portion of an exemplary adjunct having a porous structure; Figure 9A a side view of an exemplary surgical adjunct having a film; Figure 9B a side view of an exemplary surgical adjunct having a film; Figure 9C an exemplary cartridge assembly is shown including a surgical adjunct having a film; Figure 10A an exemplary cartridge assembly is shown having posts and an adhesive film for attaching a surgical adjunct; Figure 10B an exemplary cartridge assembly is shown having posts and an adhesive film for attaching a surgical adjunct; Figure 10C an exemplary cartridge assembly is shown having posts, an adhesive film, and a surgical adjunct; Figure 10D a top view showing an exemplary post, staple slot, and perforated film surrounding the staple slot; Figure 10E a top view showing an exemplary staple surrounded by a film; Figure 11A a flowchart showing an exemplary method for attaching a film to a polyurethane foam; Figure 11B a flowchart showing an exemplary method of disposing a film on a polyurethane foam; Figure 11C a flowchart showing an exemplary method for attaching a surgical adjunct to a cartridge using a film and a post; and Figure 12 ​A graph showing the glass transition temperature Tg of an exemplary adjunct. DETAILED DESCRIPTION

[0010] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are identified with like references. The detailed description and drawings provide examples of preferred embodiments of the application. The description is not limiting on the scope of the application. The description provides examples of specific embodiments of the application, and the description is not limiting on the scope of the application. The description will clearly enable one of ordinary skill in the art to prepare and use the application, and the description describes several embodiments, adaptations, variations, alternatives, and uses of the application, including what is presently believed to be the best way to implement the application. However, the description is not intended to limit the scope of the application to these specific embodiments.

[0011] As used herein, the term "about" or "approximately," with reference to any numerical or range of values, indicates that suitable dimensional tolerances are permitted which allow the parts or components to perform their intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values ±10% of the recited value, for example, "about 90%" can refer to a range of values of 81% to 99%.

[0012] Surgical stapling assemblies are provided, as well as methods of manufacturing and using the same. Generally, the surgical stapling assemblies can include a cartridge having staples disposed therein and an adjunct configured to be releasably held on the cartridge. As discussed herein, a variety of adjuncts can be configured to compensate for variations in tissue properties, such as variations in tissue thickness, and / or to promote tissue ingrowth when the adjunct is stapled to tissue.

[0013] Exemplary stapling assemblies can include various features to facilitate the application of surgical staples, as described herein and shown in the drawings. However, those skilled in the art will appreciate that the stapling assemblies can include only some of these features and / or they can include a number of other features known in the art. The stapling assemblies described herein are merely intended to represent certain exemplary examples. Moreover, while the adjuncts are described in connection with surgical cartridge assemblies, the adjuncts can be used in connection with staple reloaders that are not based on a cartridge or any type of surgical instrument.

[0014] The use of absorbable suture adjuncts or other dampening implants (e.g., ligament anchor surgery, tendon repair) requires a balance between the mechanical strength, chemical properties (e.g., absorbable), and deployment requirements of the implant / adjunct. Maintaining the strength of the staple, suture, screw, etc. can conflict with the requirements of endoscopic deployment (e.g., compression through a trocar). As the strength of the implant is increased, increased force is required to compress the implant for insertion. This can exceed the limits of the endoscopic instrument (e.g., surgical stapling and severing device 100) that requires a trade-off in implant performance. While this can be mitigated by a phase change material (e.g., water swelling, glass to rubber transition), further limiting the applicable chemistry is the requirement to have an absorbable implant or adjunct.

[0015] A simple method for increasing strength that includes a backing material or film that requires the retention of the stirrup, suture, screw, etc. without compromising the overall mechanical properties of the implant. The backing material can be a different material than the surgical adjunct or implant given the potential need for increased mechanical strength. The backing material can be bonded or adhered to the surgical adjunct or implant in situ.

[0016] An example of adhesion during processing can include fusion welding that is commonly used to bond thermoplastic materials. In this process, the combination of temperature, pressure, and time are controlled to cause the thermoplastics to diffuse into each other. This process can be used to a lesser extent between thermoplastics and thermosets where the thermoplastic flows around the geometric features on the thermoset and forms a mechanical bond.

[0017] The suture adjunct or dampening implant will likely be constructed of a thermoplastic or thermoset material. In the case of a thermoplastic material, there are limitations in maintaining the desired shape through heat processing as the material can flow during processing. Conversely, the bonding of a backing material to a thermoset material is limited during heat processing as the material does not flow and form a tight bond interface.

[0018] In the case of absorbable materials (e.g., polyurethane foam), another limiting case of fusion welding is the potential degradation during processing. Many absorbable materials, particularly the faster absorbing materials, are thermally unstable and thus can lose mechanical properties, generate degradation species, etc. during processing.

[0019] Thus, there are limitations associated with (i) utilizing thermally unstable materials, (ii) not being able to spatially tune the adhesive properties, and (iii) for thermoset / thermoplastic combinations, adhesion is limited to mechanical encapsulation. Thus, the bonding of a backing material to a surgical adjunct or dampening implant is inefficient. Thus, alternative methods and materials are discussed herein.

[0020] Additionally, the film used to attach the surgical adjunct to the staple cartridge platform can be mechanically attached to the cartridge platform along with the surgical adjunct to prevent early release of the surgical adjunct from the staple cartridge platform.

[0021] Additionally, the surgical adjunct itself can be designed or manufactured to include a gradient or bi- gradient of pore size in order to help maintain both the compressive properties and tensile properties required to create a hemostatic seal and also be strong enough to allow the surgeon to grasp and manipulate the tail of the bolster. This morphology would mimic that of bone or other materials found in nature.

[0022] Figure 1 An exemplary surgical stapling and severing device 100 suitable for use with implantable adjuncts is illustrated. The illustrated surgical stapling and severing device 100 includes an end effector 106 having an anvil 102 pivotably coupled to an end of an elongated channel 104. Thus, the staple applying assembly 106 can be moved between an open position (as shown) and a closed position in which the anvil 102 is positioned adjacent to the elongated channel 104 to engage tissue therebetween. The end effector 106 can be attached at its proximal end to an elongated shaft 108 forming a tool portion 110. When the end effector 106 is closed or at least substantially closed (e.g., the anvil 102 is moved toward the elongated channel from the open position in Figure 1 The tool portion 110 can present a sufficiently small cross-section suitable for inserting the end effector 106 through a trocar when the end effector 106 is closed or at least substantially closed. While the device 100 is configured to staple and sever tissue, surgical devices configured to staple but not sever tissue are also contemplated herein. Figure 1

[0023] In various instances, the end effector 106 can be manipulated by a handle 112 connected to the elongated shaft 108. The handle 112 can include user controls such as a rotation knob 114 that causes the elongated shaft 108 and end effector 106 to rotate about a longitudinal axis (Ls) of the elongated shaft 108, and an articulation control 115 that can cause the end effector 106 to articulate about an articulation axis (T A ) that is substantially transverse to the longitudinal axis (Ls) of the elongated shaft 108. Additional controls include a closure trigger 116 that can be pivoted relative to a pistol grip 118 to close the end effector 106. For example, when the closure trigger 116 is clamped, a closure release button 120 can be present outwardly on the handle 112 such that the closure release button 120 can be depressed to unclamp the closure trigger 116 and open the end effector 106. The handle 112 can also take the form of an interface for connection to a surgical robot.

[0024] ​In some examples, the firing trigger 122, which can be pivoted relative to the closure trigger 116, can cause the end effector 106 to simultaneously cut and staple tissue clamped therein. The firing trigger 122 can be powered, require force from the user to engage, or some combination thereof. If desired, a manual firing release lever 126 can allow the firing system to be retracted before the full firing stroke is complete, and, in addition, the firing release lever 126 can allow the surgeon or other clinician to retract the firing system in the event the firing system jams and / or fails.

[0025] Additional details regarding the surgical stapling and severing device 100 and other surgical stapling and severing devices suitable for use with the present disclosure are described, for example, in U.S. Patent No. 9,332,984 and U.S. Patent Publication No. 2009 / 0090763, the disclosures of which are incorporated by reference herein in their entireties. Additionally, the surgical stapling and severing device need not include a handle, but rather can have a housing configured to be coupled to a surgical robot, for example, as described in U.S. Patent Application No. 2019 / 0059889, the disclosure of which is incorporated by reference herein in its entirety.

[0026] As Figure 1 Further shown, the staple cartridge 200 can be used with the instrument 100. In use, the staple cartridge 200 is placed within and coupled to the elongate channel 104. While the staple cartridge 200 can have various configurations, in this illustrated example, the staple cartridge 200 comprises a deck 204 that is configured to support a plurality of staples 206 therein. As will be discussed in further detail below, the deck 204 can be configured to support the plurality of staples 206 in a plurality of staple cavities 208 defined therein. Figures 2A-2B The staple cartridge 200, shown in further detail in FIGS. 1A-1C, has a proximal end 202a and a distal end 202b with a longitudinal cartridge axis (LC) extending therebetween. Thus, when the staple cartridge 200 is inserted into the elongate channel 104 Figure 1 ) of the elongate shaft 108. Additionally, the staple cartridge 200 includes a longitudinal slot 210 defined by two opposing walls 210a, 210b and configured to receive at least a portion of a firing member of a firing assembly, as will be discussed in further detail below with respect to the firing assembly 400 in FIGS. 2A-2C. As shown, the longitudinal slot 210 extends from the proximal end 202a toward the distal end 202b of the staple cartridge 200. It is also contemplated herein that in other examples, the longitudinal slot 210 can be omitted. Figure 4

[0027] ​The illustrated staple cartridge 200 includes staple cavities 212, 214 defined therein, wherein each staple cavity 212, 214 is configured to removably receive at least a portion of a staple (not shown). The number, shape, and location of the staple cavities can vary and can depend at least on the size and shape (e.g., a mouth-like shape) of the staples removably disposed therein. In this illustrated example, the staple cavities are arranged in two groups of three longitudinally arranged rows, wherein a first group of staple cavities 212 is positioned on a first side of the longitudinal slot 210 and a second group of staple cavities 214 is positioned on a second side of the longitudinal slot 210. On each side of the longitudinal slot 210, and thus for each group of rows, the staple cavities 212a, 214a of a first longitudinal row extend along the longitudinal slot 210, the staple cavities 212b, 214b of a second row extend along the staple cavities 212a, 214a of the first row, and the staple cavities 212c, 214c of a third row extend along the staple cavities 212b, 214b of the second row. Each row can be substantially parallel, and the staple cavities making up a row can be oriented substantially parallel to the longitudinal slot 210. As Figure 2A illustrated, each staple cavity 212, 214 can include a maximum length SL of about 0.122 inches to about 0.124 inches and a maximum width SW of about 0.023 inches to about 0.027 inches. Further, the centers of at least two adjacent cavities 212, 214 are spaced apart by about 0.158 inches.

[0028] The staples removably stored in the staple cavities 212, 214 can have various configurations. An exemplary staple 300 that can be removably stored in each of the staple cavities 212, 214 is illustrated in its un-fired (pre-deployed, unformed) configuration in Figure 3 The illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of the crown 302. In this example, the crown 302 extends in a linear direction, and the staple legs 304 have the same unformed height. Additionally, prior to deployment of the staple 300, the staple crown 302 can be supported by a staple driver positioned within the staple cartridge 200, and simultaneously, the staple legs 304 can be at least partially housed within the staple cavities 212, 214. Additionally, when the staple 300 is in its unfired position, the staple legs 304 can extend beyond a top surface of the staple cartridge 200, such as the top surface 206. In certain instances, as Figure 3 illustrated, the tips 306 of the staple legs 304 can be sharp and pointed, which tips can cut into and penetrate tissue.

[0029] In use, the staples 300 can be deformed from an unfired position to a fired position such that the staple legs 304 move through the staple cavities 212, 214, penetrate tissue positioned between the anvil 102 and the staple cartridge 200, and contact the anvil 102. As the staple legs 304 are deformed against the anvil 102, the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply a compressive force to the tissue. Additionally, the legs 304 of each staple 300 can be deformed downward toward the crown 302 of the staple 300 to form a staple trap region in which tissue can be captured. In various instances, the staple trap region can be defined between the inner surfaces of the deformed legs and the inner surface of the crown of the staple. For example, the size of the staple trap region can depend on several factors, such as the length of the legs, the diameter of the legs, the width of the crown, and / or the degree of leg deformation.

[0030] In some examples, all of the staples disposed within the staple cartridge 200 can have the same unfired (pre-deployed, unformed) configuration. In other examples, the staples can include at least two groups of staples each having a different unfired (pre-deployed, unformed) configuration, e.g., varying in height and / or shape relative to one another, etc.

[0031] Referring back to Figures 2A-2B , the staple cartridge 200 extends from a top or deck surface 206, which is configured as a tissue-facing surface, to a bottom surface 208, which is configured as a channel-facing surface. Thus, when the staple cartridge 200 is inserted into the elongate channel 104, as shown in Figure 1 , the top surface 206 faces the anvil 102 and the bottom surface 208 (obscured) faces the elongate channel 104.

[0032] Referring to Figure 4 and Figure 5 , a firing assembly, such as the firing assembly 400, can be used with a surgical stapling and severing device, such as the device 100 in Figure 1 . The firing assembly 400 can be configured to advance a wedge sled 500 having a wedge 502 configured to deploy staples from a staple cartridge 200 to be captured between an anvil, such as the anvil 102 in Figure 1 , and the staple cartridge, such as the staple cartridge 200 in Figure 1The staples are located within the tissue between the staple cartridge 200. Furthermore, an E-beam 402 at the distal portion of the firing assembly 400 can fire staples from the staple cartridge. During firing, the E-beam 402 can also pivot the anvil toward the staple cartridge, and thus move the end effector from an open position to a closed position. The illustrated E-beam 402 includes a pair of top pins 404, a pair of intermediate pins 406 that follow a portion 504 of the wedge-shaped slide 500, and a bottom pin or foot 408. The E-beam 402 may also include a sharp cutting edge 410 configured to cut the captured tissue as the firing assembly 400 advances distally, and thus toward the distal end of the staple cartridge. Furthermore, integrally formed, proximal-projecting top guides 412 and intermediate guides 414 supporting each vertical end of the cutting edge 410 further define a tissue accumulation area 416, thereby facilitating the guidance of tissue to the sharp cutting edge 410 before cutting the tissue. The intermediate guide 414 can also be used to engage and fire nails in the nail magazine via a stepped central member 506 adjacent to the wedge-shaped slider 500, which influences nail formation via the end actuator 106.

[0033] During use, by pressing Figure 1 Closed trigger in the middle to advance Figure 4 E-shaped beam 402 in the middle, Figure 1 The anvil 102 can be moved to a closed position. The anvil 102 can hold the tissue against. Figures 2A-2B At least the top surface 206 of the staple cartridge 200 is positioned. Once the anvil has been properly positioned, Figure 3 The 300 nails set in the nail pod can then be deployed.

[0034] To deploy nails from the nail repository, as discussed above, Figure 5 The slider 500 can move from the proximal end toward the distal end of the cartridge body, and therefore toward the distal end of the staple cartridge. When Figure 4 When the firing assembly 400 is advanced, the slider can contact and lift the staple driver within the staple cartridge upward within the staple cavities 212, 214. In at least one example, the slider and the staple driver may each include one or more ramps or inclined surfaces that cooperate to move the staple driver upward from its unfired position. As the staple drivers are lifted upward within their respective staple cavities, the staples are advanced upward, causing them to emerge from their cavities and penetrate into the tissue. In various cases, as part of a firing sequence, the slider can simultaneously move several staples upward.

[0035] As discussed above, the stapling devices can be used in combination with compressible adjuncts. Those skilled in the art will understand that while adjuncts are illustrated and described below, the adjuncts disclosed herein can be used with other surgical instruments and need not be coupled to a staple cartridge as described. Further, those skilled in the art will also understand that the staple cartridge need not be replaceable.

[0036] As discussed above, for some surgical staplers, a surgeon often needs to select an appropriate staple having an appropriate staple height for the tissue to be stapled. For example, a surgeon will utilize long staples for thick tissue and short staples for thin tissue. However, in some instances, the tissue being stapled does not have a consistent thickness and, therefore, the staple cannot achieve the desired firing configuration for each portion of the tissue being stapled (e.g., thick and thin portions of tissue). The inconsistent thickness of the tissue can also result in undesirable leakage and / or tearing of the tissue at the staple site when using staples having the same or substantially greater height, particularly when the staple site is exposed to intra-tissue pressure at the staple site and / or along the staple line.

[0037] Accordingly, various examples of adjuncts are provided that can be configured to compensate for different thicknesses of tissue captured within a fired (deployed) staple to avoid the need to consider staple height when stapling tissue during a surgical procedure. That is, the adjuncts described herein can allow a set of staples having the same or similar height to be used to staple tissue having varying thicknesses (e.g., from thin to thick tissue), while also combining with the adjunct to provide sufficient compression of the tissue within and between the staples. Accordingly, the adjuncts described herein can maintain proper compression of thin or thick tissue stapled to the adjunct, thereby minimizing leakage and / or tearing of the tissue at the staple site. Further, the example adjuncts described herein can be configured to be substantially completely absorbed in vivo over a period of 100 to 300 days depending on the implant location and tissue health.

[0038] Alternatively or additionally, the adjuncts can be configured to promote tissue ingrowth. In various instances, it is desirable to promote tissue ingrowth into the implanted adjunct to promote healing of the treated tissue (e.g., stapled tissue and / or incised tissue) and / or to accelerate recovery of the patient. More particularly, tissue ingrowth into the implanted adjunct can reduce the incidence, extent, and / or duration of inflammation at the surgical site. Tissue ingrowth into and / or around the implanted adjunct can control the spread of infection, for example, at the surgical site. Vascularization, particularly white blood cells, ingrowth into and / or around the implanted adjunct can combat infection in and / or around the implanted adjunct and adjacent tissue. Tissue ingrowth can also promote acceptance of the foreign body (e.g., the implanted adjunct and staples) by the patient’s body and can reduce the likelihood that the patient’s body will reject the foreign body. Rejection of the foreign body can result in infection and / or inflammation at the surgical site.

[0039] Generally, the adjuncts provided herein are designed and positioned at the top of a staple cartridge, such as staple cartridge 200. When the staples are fired (deployed) from the cartridge, the staples penetrate the adjunct and into tissue. As the legs of the staples are deformed against an anvil positioned opposite the staple cartridge, the deformed legs capture a portion of the adjunct and a portion of the tissue within each staple. That is, at least a portion of the adjunct becomes positioned between the tissue and the fired staples when the staples are fired into the tissue. While the adjuncts described herein can be configured to attach to a staple cartridge, it is also contemplated herein that the adjuncts can be configured to cooperate with other instrument components, such as the anvil of a surgical stapler. Those of ordinary skill in the art will appreciate that the adjuncts provided herein can be used with replaceable cartridges or staple reloaders that are not cartridge-based.

[0040] Method of suturing tissue Figures 6A-6B An exemplary example of a stapling assembly 600 is illustrated, including a staple cartridge 200 and an adjunct 604. For simplicity, the adjunct 604 is generally illustrated and described in Figures 6A-6B various configurations below. As shown, the adjunct 604 is positioned against the staple cartridge 200. While partially obscured in Figures 6A-6B the staple cartridge 200 includes staples 300 configured to be deployed into tissue. The staples 300 can have any suitable unformed (pre-deployment) height.

[0041] In the illustrated example, the adjunct 604 can cooperate with at least a portion of the top surface or deck surface 206 of the staple cartridge 602. In some examples, the top surface 206 of the staple cartridge 200 can include one or more surface features that can be configured to engage the adjunct 604 to avoid unwanted movement of the adjunct 604 relative to the staple cartridge 200 and / or to prevent premature release of the adjunct 604 from the staple cartridge 200. Exemplary surface features are further described below and in U.S. Patent Publication No. 2016 / 0106427, which is incorporated herein by reference in its entirety.

[0042] Figure 6B A stapling assembly 600 is shown placed within and coupled to the elongate channel 610 of the surgical end effector 106. The anvil 102 is pivotally coupled to the elongate channel 610 and is thus movable relative to the elongate channel 610 (and thus relative to the staple cartridge 200) between an open position and a closed position. The anvil 102 is shown in the closed position in Figure 6B and a tissue gap T G1 is illustrated between the staple cartridge 602 and the anvil 612. More specifically, the tissue gap T G1The distance between the tissue compression surface 102a of the anvil 102 (e.g., the tissue engagement surface between the pin-forming recesses in the anvil) and the tissue contact surface 604a of the appendage 604 is defined. In this illustrative example, both the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the appendage 604 are planar or substantially planar (e.g., planar within manufacturing tolerances). Therefore, when the anvil 102 is in the closed position, as... Figure 6B As shown, when no tissue is present, the tissue gap T G1 They are typically uniform (e.g., nominally identical within manufacturing tolerances). In other words, the interstitial space T G1 The trans-end actuator 106 (e.g., in the y-direction) is typically constant (e.g., constant within manufacturing tolerances). In other examples, the tissue compression surface of the anvil may include a stepped surface with longitudinal steps between adjacent longitudinal portions, thus creating a stepped profile (e.g., in the y-direction). In such examples, the tissue gap T G1 It can change.

[0043] The appendage 604 is compressible to allow for varying heights of compression, thereby compensating for differences in tissue thickness trapped within the deployed staples. The appendage 604 has an uncompressed (undeformed) or pre-deployed height and is configured to deform to one of a plurality of compressed (deformed) or deployed heights. For example, the appendage 604 may have a firing height greater than that of the staple 300 disposed within the staple cartridge 200 (e.g., Figure 7 The uncompressed height (H) of the firing pin 300a. That is, the appendage 604 may be in an undeformed state, wherein the maximum height of the appendage 604 is greater than the maximum height of the firing pin (e.g., a pin in a shaped configuration).

[0044] like Figure 6C As shown, the staple cartridge 200 includes a slider 614 and a plurality of actuators 612 configured to drive one or more staples in an upward direction upon user press. Figure 1 The firing trigger 122 is shown to deploy the pin. Once the firing trigger 122 is pressed, the slider 614 moves toward the distal end 616 of the end effector 106, thereby contacting one or more actuators 612a, 612b at a time, thereby forcing one or more actuators 612a, 612b upward along with one or more corresponding pins 300 upward to form the firing pin 300a and capture material, such as tissue (T) between the anvil 104 and the firing pin 300a (see See Figure 7The compartment 200 may include a first row 613a of a single actuator 612a corresponding to the drive pins 300 positioned in the third row of pin cavities 212a, 214b, and a first row 613a corresponding to the drive pins 300 positioned in the first row of pin cavities 212a, 214b and the third row 212a, 212b (see...). Figure 2A The second row 613b of the dual actuator 612b corresponding to the drive nail 300 in the nail cavity.

[0045] refer to Figure 6C One or more single actuators 612a may have a height SDH of about 0.044 inches to about 0.074 inches, such as about 0.050 inches to about 0.068 inches, about 0.054 inches, or about 0.06 inches. One or more dual actuators 612b may have a height DDH of about 0.044 inches to about 0.074 inches, such as about 0.050 inches to about 0.068 inches, about 0.054 inches, or about 0.06 inches. Slider 614 may have at least a first guide rail 614a corresponding to the single actuators 612a positioned in the first row 613a and a second guide rail 614b corresponding to the dual actuators 612b positioned in the second row 613b. The first guide rail 614a may have a guide rail height SRH of about 0.164 inches or about 0.167 inches and engages with the single actuator 612a. The second guide rail 614b may have a guide rail height DRH of about 0.140 inches to about 0.162 inches (such as about 0.149 inches or about 0.152 inches) and engages with the dual actuator 612b. Once the pins 300 are deployed, they form a firing pin 300a with a compression height CH of about 0.08 inches to about 0.12 inches (such as about 0.97 inches or about 0.1 inches).

[0046] like Figure 7 As shown, when the pin 300 is fired, tissue (T) and a portion of appendage 604 are captured by the firing (forming) pin 300a. As discussed above, each firing pin 300a defines a retention area therein for accommodating the captured appendage 604 and tissue (T). The retention area defined by the firing pin 300a is at least partially limited by the height (H) of the firing pin 300a.

[0047] Figure 8AA perspective view of a staple cartridge assembly 600 having an adjunct 604 and a staple cartridge 200 is illustrated. The adjunct 604 has a tissue-contacting surface 604a, a proximal end 604a, and a distal end 604b. The adjunct 604 can include a slot / slit 808 that separates or partially separates two parallel portions of the adjunct 604. In one example, the adjunct 604 can include a slot 808 that separates the two parallel portions of the adjunct 604, while in another example, the adjunct 604 can include a slit 808 that separates the two parallel portions of the adjunct 604 and one or more bridges (e.g., five bridges) 802 that connect the two parallel portions of the adjunct 604. The at least one bridge has a length in the longitudinal direction of about 0.035 inches to about 0.046 inches. The adjunct 604 has a length L of about 40 mm to about 80 mm, such as about 60 mm to about 65 mm, about 66.04 mm to about 66.3 mm, about 45 mm to about 55 mm, or about 51.12 mm to about 51.38 mm. The adjunct 604 has a width W of about 8 mm to about 12 mm, such as about 9.75 mm to about 10.25 mm, or about 10.025 mm to about 10.035 mm. The adjunct 604 can also have a thickness or height TH of about 2.5 mm to about 3.5 mm, such as about 2.85 mm to about 3.15 mm, or about 2.95 mm to about 3.05 mm.

[0048] The cartridge 200 has a height CH of about 6.3 mm to about 8.1 mm, a width CW of about 8.9 mm to about 14 mm, and a length CL of about 80 mm to about 90 mm, such as about 86.7 mm.

[0049] Referring to Figures 8B-8D The adjunct 604 has a lower surface 604d and can have a distal chamfered portion 818, a proximal chamfered portion 820, and a central portion 822. The distal chamfered portion 818 has a vertical portion 818a having a height CPH of about 0.009 inches to about 0.029 inches, such as about 0.019 inches. The distal chamfered portion 818 can have an angled portion 818b proximal to the vertical portion 818a. The angled portion 818b has a slope VA of about 30 degrees to about 60 degrees, such as about 45 degrees, measured from the tissue-contacting surface 604a.

[0050] Referring to Figure 8CThe distal chamfered portion 818 and the central portion 822 have a combined length DL of about 2.25 inches to about 2.45 inches, such as about 2.35 inches. The proximal chamfered portion 820 has an angled portion 820b having a length DCL of about 0.1 inches to about 0.3 inches. In addition, the proximal chamfered portion 820 has a horizontal portion 820a and an angled portion 820n. The horizontal portion 820a can have a width CW of about 0.27 inches to about 0.29 inches, such as about 0.28 inches.

[0051] In some examples, the adjunct 604 includes one or more slits 808 having two or more bridges 802 spaced apart by a bridge length BL of about 0.035 inches to about 0.045 inches, such as about 0.04 inches.

[0052] Referring back to Figure 8A The staple cartridge 200 can include one or more raised flanges 804 along one or more sides of the adjunct 602 to help align the adjunct 604 on the deck of the staple cartridge 200.

[0053] The surgical adjunct 604 can have one or more of the properties described below to enable the adjunct to be flexible when in the body, but to remain in a particular positioning attached to the cartridge when outside the body. For example, a polyurethane can be used to create the adjunct 604 that is flexible when entering the body, but "sets up" to its final mechanical properties as the plasticizer is absorbed in the body. In some examples, a plasticizer can be added to the polyurethane foam to lower its glass transition temperature to within the ranges described below and to comply with other listed properties. Regardless, the adjunct 604 having one or more of the following properties consistently forms a hemostatic or near-hemostatic seal on tissue.

[0054] The surgical adjunct 604 can include a polyurethane foam with or without a plasticizer, where the glass transition temperature of the surgical adjunct 604 is about 0 °C to about 40 °C (e.g., about 19.4 °C), such as about 7.5 °C to about 22.5 °C or about 12.5 °C to about 17.5 °C. The glass transition temperature of the adjunct 604 is obtained by using a standard differential scanning calorimetry (DSC) system. Using the DSC system shown with its output, the adjunct 604 is equilibrated at about -40 °C, heated at about 40 °C / min to about 120 °C, isothermally held for about 1 minute, cooled at about 40 °C / min to about -40 °C, isothermally held for about 1 minute, and then heated at about 10 °C / min to about 120 °C, where the glass transition temperature Tg is the midpoint of the transition from the glassy state to the rubbery state. Figure 12 Using the DSC system shown with its output, the adjunct 604 is equilibrated at about -40 °C, heated at about 40 °C / min to about 120 °C, isothermally held for about 1 minute, cooled at about 40 °C / min to about -40 °C, isothermally held for about 1 minute, and then heated at about 10 °C / min to about 120 °C, where the glass transition temperature Tg is the midpoint of the transition from the glassy state to the rubbery state. g is measured and recorded by the DSC system.

[0055] The surgical adjunct 604 can include a volume ratio of polyurethane foam to the total volume of the adjunct 604 of about 0.125 to about 0.325, such as about 0.175 to about 0.225 or about 0.19 to about 0.21. The total volume can include air (from the pores of the foam) or other materials in addition to the foam structure.

[0056] The plasticizer can include one or more of a low molecular weight diol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, triacetin, glyceryl behenate, caproic acid, capric acid, octadecanoic acid, borate ester, and a fatty acid. In some examples, the plasticizer includes one or more fatty acids.

[0057] Referring to Figure 8E , the adjunct 604 can have pores 832 having a median pore size of about 0.025 mm 3 to about 0.300 mm 3 such as about 0.022 mm 3 In some examples, the adjunct 604 can have one or more struts 834 between the pores 832 that provide support and strength to the adjunct 604. In particular, the adjunct 604 can include a plurality of struts 834 having a median strut thickness ST of about 0.025 mm to about 0.300 mm, such as about 0.08 mm.

[0058] In some examples, the adjunct 604 includes a polydioxanone (PDO) film disposed on one or more surfaces of the polyurethane foam. In some examples, the PDO film is adhered to at least the base or coronal side of the adjunct 604. In some examples, the PDO film has a thickness of about 20 pm to about 100 pm, such as about 40 pm.

[0059] The adjunct 604 can have a compressive strength of about 30 kPa to about 70 kPa, such as about 30 kPa to about 60 kPa (e.g., about 42 kPa), about 30 kPa to about 50 kPa, about 32.5 kPa to about 37.5 kPa. To test the compressive strength, the adjunct 604 is placed in a humid heat environment of about 37°C, compressed to a first height, then compressed to a second height that is shorter than the first height, and then released back to the first height, at which point the compressive strength of the adjunct is measured.

[0060] In some examples, the adjunct 604 can have a tensile strength of about 30 kPa to about 90 kPa, such as about 45 kPa to about 85 kPa or about 55 kPa to about 75 kPa. In some examples, the adjunct 604 will have a tensile strength of about 110 kPa to about 150 kPa.

[0061] Referring to Figure 9AThe surgical appendage 604 may include a bioabsorbable material 902 (e.g., a bioabsorbable foam, such as polyurethane foam) and a membrane 904 having a membrane thickness FT disposed on the absorbable material. The membrane thickness FT of the membrane 904 may range from about 0.0003 inches to about 0.010 inches. For example, the membrane may be an epidermis made of the same material as the bioabsorbable material 902 and may include a membrane thickness FT ranging from about 0.001 inches to about 0.010 inches. In other instances, the membrane 904 may be a large continuous surface on the crown side of the bioabsorbable material 902 to aid in guiding the nail 300 upon firing and may have a membrane thickness ranging from about 0.00039 inches to about 0.0039 inches (e.g., about 0.00046 inches to about 0.020 inches). When formed from the same material as bioabsorbable material 902 (e.g., polyurethane or polyurethane foam), the membrane 904 may include pores having a diameter ranging from about 0.0005 inches to about 0.005 inches. In some examples, when membrane 904 comprises the same bioabsorbable material (e.g., polyurethane), membrane 904 may have a higher density than bioabsorbable material 902. When membrane 904 comprises other materials, the membrane thickness FT may range from about 0.001 inches to about 0.003 inches. For example, membrane 904 may include polydioxane (PDO), poly(δ-gluconolactone) (PGL-1), poly(glycolic acid / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and ε-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polylactic-co-glycolic acid 370 (PG-370), polylactic-co-glycolic acid 185 (PG-185), or combinations thereof.

[0062] refer to Figure 9B The surgical appendage 604 may include a bioabsorbable material 902 and a membrane 904 disposed on the bioabsorbable material 902, wherein an adhesive 906 is disposed between the membrane 904 and the bioabsorbable material 902. (Reference) Figure 9C The surgical appendage 604 may include a bioabsorbable material 902 disposed on the staple cartridge 200, wherein an adhesive 906 is disposed between the bioabsorbable material 902 and the cartridge 200. Additionally, a membrane 904 is disposed on the surface of the bioabsorbable material 902. In some examples, the adhesive may include polyvinylpyrrolidone. In some examples, the adhesive 906 is bioabsorbable.

[0063] refer to Figure 10A, the surgical adjunct 604 can include a dual gradient with respect to its pore size. For example, the surgical adjunct 604 can include a pore 832 having a small diameter (e.g., in a range of about 100 pm to about 0.4 mm, such as about 0.15 mm to about 0.25 mm) adjacent to a first end and a second end opposite the first end. Moving from the first end or the second end of the surgical adjunct 604 to the center, the diameter of the pore 832 continues to increase to a large diameter size (e.g., about 0.4 mm to about 1 mm, such as about 0.5 mm to about 0.6 mm). Referring to Figure 10B , the surgical adjunct 604 can include two bioabsorbable materials 1002a, 1002b each having a single gradient for pore size. The two bioabsorbable materials 1002a, 1002b can be combined together to form a dual gradient. In Figure 10A and Figure 10B both, the surgical adjunct can include a strut 834 that can have a greater thickness near the larger pores than the thickness near the smaller pores.

[0064] Referring to Figure 10A , the stapling assembly 600 can include a cartridge 200 including a deck 206 and at least one post 1104a extending away from the deck. The stapling assembly includes a film 904 disposed on the deck 206. The at least one post 1104a can be heated to form a post 1104b having a top 1106 and a bottom 1108, as shown in Figure 10B . As shown in Figure 10C , a bioabsorbable material 902 can be disposed on the film 904 and within a gap 1110 between the top 1006 of the at least one post 1104b and the film 904. As the top 1106 can have a diameter PDT that is greater than a diameter PDB of the bottom 1108, the bioabsorbable material 902 can be mechanically locked in place or attached to the stapling assembly 600.

[0065] Figure 10D A top view of an example stapling assembly 600 is shown. As shown, the posts 1104 can be disposed between staple slots 1112 of the cartridge 200. Further, the film 904 can include perforations 1114 at least partially surrounding or covering the staple slots 1112 and the posts 1104 to allow the film to support Figure 10E the staples 300 shown.

[0066] Referring to Figure 11A , the method 1200 involves adding a film to a bioabsorbable material, such as a polyurethane foam. The method includes providing 1202 a polyurethane foam, and attaching 1204 a film to the polyurethane foam via a volatile solvent (e.g., solvent welding), a reactive adhesive, or direct deposition.

[0067] Solvent welding can be used to add a film to a bioabsorbable material. For example, solvents such as ethyl acetate, dichloromethane, acetone can be used. Using this process eliminates the need for heat treatment and eliminates the need for spatial arrangement of the bonding components with the film.

[0068] A reactive adhesive can be used to add a film to a bioabsorbable material. Some reactive adhesives can include polyurethanes, epoxies, acrylates, and the like. The reactive adhesive can be deposited directly onto the adjunct and / or the film. This can be patterned with both surface area and mass to modulate the adhesive strength along and across the bioabsorbable material. This application can be used in cases where the selective release of the film is designed to minimize the overall bioabsorbable material (e.g., only the film is in contact with the staple, the rest is in contact with the endoscopic instrument). In addition to the application process, chemical properties can be used to modulate the adhesive properties. Inkjet printing, direct deposition, thermal spray, cold dynamic spray, cold spray, electro spray, ultrasonic spray, dip coating, screen printing, and spin coating can be used to apply the reactive adhesive. Using an adhesive is beneficial because two thermoset materials (the film and the bioabsorbable material) can be bonded without the need for material flow. Using a reactive adhesive can eliminate the need for heat treatment, eliminate the need for arranging bonding points between the film and the bioabsorbable material, and allow for modulating the adhesive force across the surgical adjunct to create a selective release feature when needed.

[0069] Direct deposition can be used to apply a film directly to a bioabsorbable material. The film itself can be distributed in a solution or consist of a reactive mixture that is subsequently applied to the bioabsorbable material. Direct deposition methods for adding a film to a bioabsorbable material can include stereolithography, photolithography, holographic printing, inkjet printing, directional deposition, thermal spray, cold dynamic spray, cold spray, electro spray, ultrasonic spray, dip coating, screen printing, and spin coating. Reactive mixtures for these processes can include polyurethanes, epoxies. Photo-curable formulations can also be used. These can include photo-initiators, solvents, inhibitors, photo-curable oligomers or monomers, light absorbers, and mixtures thereof. Advantages of directly applying a film include the ability to conformally apply the film, spatial control of the film, the ability to easily apply the film, and flexibility in rate, thickness, etc. when applying the film for different uses.

[0070] Referring to Figure 11B Method 1225 involves adding or forming a film in situ while forming a polyurethane foam. Method 1225 includes providing 1226 a polyurethane foam precursor cured to its gel point to form a partially cured polyurethane foam 902, disposing or forming a film 904 on at least a portion of one surface of the partially cured polyurethane foam, and finally curing 1230 the partially cured polyurethane foam with the film to form a surgical adjunct 604.

[0071] When using a thermoset material (e.g., a polyurethane foam) for a surgical adjunct, there is the possibility of incorporating the material during the adjunct manufacturing process. A film can be applied to the adjunct before the curing and / or specific stoichiometric imbalance is complete. For optimal results, the addition of the film should be done after the gel point of the thermoset material to ensure that the film does not constrain adjunct formation. After the film is applied, the curing process should resume to allow for chemical bonding between the thermoset material and the film. This is especially true in the case of polyurethane-based adjuncts when free hydroxyl groups are present. The chemical bond will provide a strength profile that can exceed any adhesive interaction between the film and the thermoset material. Advantages of using this method include, eliminating heat treatment, potential covalent attachment between the film and the thermoset material, and eliminating the need for a separate adhesive.

[0072] Additionally, the film, such as PDO, can be overmolded on the bioabsorbable material.

[0073] Referring to Figure 11C Method 1250 illustrates a method of attaching a film 904 and a bioabsorbable material 902 to a cartridge platform. Method 1250 can include providing 1252 a cartridge platform 206 having at least one post 1104, disposing 1254 a film on the platform and at least partially around the at least one post 1104, applying 1256 heat to the at least one post 1104 to form a top portion 1106 having a first diameter and a bottom portion 1108 having a second diameter, such that the top portion 1106 of the at least one post 1104 at least partially overlaps with the film 904. Method 1250 further includes disposing 1258 a surgical adjunct on the film 904 to at least partially surround the at least one post 1104.

[0074] Those skilled in the art will appreciate that the above embodiments have been presented by way of example and that the application is not limited to the details above. Rather, the scope of the application includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

[0075] In some examples, the disclosed devices (e.g., end effectors, surgical adjuncts, and / or staple cartridges) and methods involving one or more disclosed devices can involve one or more of the following clauses: Clause 1 : A surgical adjunct 604, comprising: a polyurethane foam 902 comprising a volume ratio of the polyurethane foam 902 to a total volume of the surgical adjunct 604 in a range of about 0.125 to about 0.325; and a film 904 disposed on at least one surface of the polyurethane foam.

[0076] Clause 2: The surgical adjunct 604 of Clause 1, wherein the film 904 comprises a polyurethane having a higher density than the polyurethane foam.

[0077] Clause 3: The surgical adjunct 604 of Clause 1, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.010 inches and has a pore size of about 0.0005 inches to about 0.005 inches.

[0078] Clause 4: The surgical adjunct 604 of Clause 1, wherein the film 904 is laminated on the at least one surface of the polyurethane foam 902 and comprises an absorbable material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconate lactone) (PGL-1), poly(glycolide / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and epsilon-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglycolic acid 370 (PG-370), polyglycolic acid 185 (PG-185), or combinations thereof.

[0079] Clause 5: The surgical adjunct 604 of Clause 4, wherein the absorbable material comprises polyglycolic acid 370 or polyglycolic acid 185.

[0080] Clause 6: The surgical adjunct 604 of Clause 4, wherein the absorbable material comprises poly(glycolide / l-lactide).

[0081] Clause 7: The surgical adjunct 604 of Clause 4, wherein the film 904 has a thickness FT of about 0.0003 inches to about 0.003 inches.

[0082] Clause 8: The surgical adjunct 604 of Clause 1, wherein the film 904 is attached to the at least one surface of the polyurethane foam 902 with an adhesive 906.

[0083] Clause 9: The surgical adjunct 604 of Clause 8, wherein the adhesive 906 comprises polyvinylpyrrolidone.

[0084] Clause 10: The surgical adjunct 604 of Clause 1, wherein the surgical adjunct 604 is attached to a platform with a bioabsorbable adhesive.

[0085] Clause 11: A method for manufacturing the surgical adjunct 604 of clause 1, the method comprising: providing a polyurethane foam 902; disposing at least one volatile solvent on at least a portion of at least one surface of the polyurethane foam; disposing a film 904 on the at least one volatile solvent 906; dissolving at least a portion of the polyurethane foam and the film 904 with the at least one volatile solvent to bond the polyurethane foam and the film.

[0086] Clause 12: A method for manufacturing the surgical adjunct 604 of clause 1, the method comprising: providing a polyurethane foam 902; disposing a reactive adhesive on at least a portion of a film 904, at least a portion of the polyurethane foam, or both; and disposing the film on at least polyurethane foam 902 such that the reactive adhesive is sandwiched between the polyurethane foam and the film 904.

[0087] Clause 13: The method of clause 12, wherein disposing the reactive adhesive comprises applying the adhesive via at least one application process selected from the group consisting of: inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electro-spraying, ultrasonic spraying, dip coating, screen printing, spin coating, or combinations thereof.

[0088] Clause 14: A method for manufacturing the surgical adjunct 604 of clause 1, the method comprising: providing a polyurethane foam precursor cured to its gel point to form a partially cured polyurethane foam; disposing a film 904 on the partially cured polyurethane foam on at least a portion of one surface; and final curing the partially cured polyurethane foam with the film to form the surgical adjunct 604.

[0089] Clause 15: A method for manufacturing the surgical adjunct 604 of clause 1, the method comprising: providing a polyurethane foam 902; applying a film to the polyurethane foam 902 via a direct deposition method to produce the surgical adjunct 904.

[0090] Clause 16: The method of clause 15, wherein the direct deposition method comprises at least one process selected from the group consisting of: stereolithography, photolithography, holographic printing, inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electro-spraying, ultrasonic spraying, dip coating, screen printing, spin coating, or combinations thereof.

[0091] Clause 17: A cartridge for surgical stapling, the cartridge comprising: a deck 206 comprising at least one post 1104 extending away from the deck 206, wherein the at least one post has a first diameter PDT at a top 1106 of the at least one post 1104 that is greater than a second diameter PDB at a bottom 1108 of the at least one post 1104; a first film 904 disposed on the deck 206 and at least partially around the at least one post, wherein there is a gap 1110 between the top 1106 of the at least one post and the film; and a surgical adjunct 604 disposed on the first film 904 and at least partially around the at least one post 1104, the surgical adjunct 604 comprising a polyurethane foam 902, wherein a volume ratio of the polyurethane foam 902 to a total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.

[0092] Clause 18: The cartridge of Clause 17, wherein the first film 904 comprises a perforation pattern at least partially around or covering one or more staple slots 1112.

[0093] Clause 19: The cartridge of Clause 17, further comprising a second film 904 disposed on the polyurethane foam, wherein the first film 904 has a first melting point that is lower than a second melting point of the polyurethane foam 902.

[0094] Clause 20: A method of manufacturing the cartridge of Clause 17, the method comprising: providing a deck 206 with at least one post; disposing a film 904 on the deck and at least partially around the at least one post 1104; applying heat to the at least one post 1104 to form a top 1106 having a first diameter PDT and a bottom 1108 having a second diameter PDB, such that the top of the at least one post at least partially overlaps with the film 904; and disposing a surgical adjunct 604 on the film to at least partially around the at least one post 1104.

[0095] Clause 21 : A stapling assembly 600 for surgical stapling, the stapling assembly comprising: a deck 206; and a surgical adjunct 604 disposed on the deck 604 and comprising a polyurethane foam 902, wherein a volume ratio of the polyurethane foam 902 to a total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.

[0096] Clause 22: The stapling assembly of Clause 21, wherein the surgical adjunct 604 comprises a film 904 disposed on at least one surface of the polyurethane foam 902.

[0097] Clause 23: The stitching assembly according to Clause 22, wherein the membrane 904 comprises polyurethane 902 having a higher density than the polyurethane foam 902.

[0098] Clause 24: The suture assembly according to Clause 22, wherein the membrane 904 has a thickness FT of about 0.0003 inches to about 0.010 inches and has a pore size of about 0.0005 inches to about 0.005 inches.

[0099] Clause 25: The suture assembly according to Clause 22, wherein the membrane 904 is laminated on at least one surface of the polyurethane foam and comprises an absorbable material selected from the group consisting of: polydioxane (PDO), poly(δ-gluconolactone) (PGL-1), poly(glycolic acid / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide-ε-caprolactone copolymer (PGCL), glycolide-l-lactide copolymer, urethane, polycaprolactone (PCL), polylactic-co-glycolic acid 370 (PG-370), polylactic-co-glycolic acid 185 (PG-185), or combinations thereof.

[0100] Clause 26: The suture assembly according to Clause 25, wherein the membrane 904 has a thickness FT of about 0.0003 inches to about 0.003 inches.

[0101] Clause 27: The stitching assembly according to Clause 25 or 26, wherein the membrane 904 is attached to at least one surface of the polyurethane foam using an adhesive.

[0102] Clause 28: The suture assembly according to Clause 21, wherein the absorbable material comprises polylactic-co-glycolic acid 370.

[0103] Clause 29: The suture assembly according to Clause 21, wherein the surgical appendage 604 further includes an additional polyurethane foam 902 attached to the polyurethane foam 902, wherein the polyurethane foam has a first density gradient and the additional polyurethane foam 902 has a second density gradient substantially opposite to the first density gradient.

[0104] Clause 30: The stapling assembly of Clause 21, wherein: the platform 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having a top 1106 with a first diameter PDT and a bottom 1108 with a second diameter PDB that is less than the first diameter PDT, the membrane 904 disposed on the surface and at least partially around the at least one post 1104 with a gap 1110 between the top 1106 of the at least one post 904 and the membrane 904; and the surgical adjunct 604 disposed on the membrane 1104 and at least partially around the at least one post.

[0105] Clause 31 : The stapling assembly of Clause 30, wherein the membrane 904 comprises a perforation pattern around one or more staple slots 1112.

[0106] Clause 32: A method for manufacturing a surgical instrument 200, the method comprising: providing a polyurethane foam 902 comprising a volume ratio of the polyurethane foam 902 to a total volume of the surgical adjunct 604 in a range of about 0.125 to about 0.325; and disposing or forming a membrane 904 on the polyurethane foam 902.

[0107] Clause 33: The method of Clause 32, the method comprising: disposing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902; disposing the membrane 904 on the at least one volatile solvent 906; and utilizing the at least one volatile solvent to dissolve at least a portion of the polyurethane foam 902 and the membrane 904 to bond the polyurethane foam 902 and the membrane 904.

[0108] Clause 34. The method of Clause 32, the method comprising: providing the polyurethane foam 902; disposing a reactive adhesive 906 on at least a portion of the membrane 904, at least a portion of the polyurethane foam 902, or both; and disposing the membrane on at least the polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the membrane 904.

[0109] Clause 35: The method of clause 32, comprising: providing a cartridge 200 comprising a platform having at least one post extending from the platform; disposing the film 904 on the platform and at least partially around the at least one post 1104; applying heat to the at least one post 1104 to form a top portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB, such that the top portion of the at least one post at least partially overlaps with the film 904; and disposing a surgical appendage 604 on the film 904 to at least partially surround the at least one post 1104.

Claims

1. A stapling assembly 600, comprising: a platform 206; and a surgical adjunct 604 disposed on the platform 206 and comprising a polyurethane foam 902, wherein a volume ratio of the polyurethane foam 902 to a total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.

325.

2. The stapling assembly of claim 1, wherein, The surgical adjunct 604 comprises a film 904 disposed on at least one surface of the polyurethane foam 902.

3. The stapling assembly of claim 2, wherein, The film 904 comprises a polyurethane 902 having a higher density than the polyurethane foam 902.

4. The stapling assembly of claim 2, wherein, The film 904 has a thickness FT of about 0.0003 inches to about 0.010 inches and has a pore size of about 0.0005 inches to about 0.005 inches.

5. The stapling assembly of claim 2, wherein, The film 904 is laminated on the at least one surface of the polyurethane foam and comprises an absorbable material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconate lactone) (PGL-1), poly(glycolide / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and epsilon-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglycolic acid 370 (PG-370), polyglycolic acid 185 (PG-185), or combinations thereof.

6. The stapling assembly of claim 5, wherein, The film 904 has a thickness FT of about 0.0003 inches to about 0.003 inches.

7. The stapling assembly of claim 5 or 6, wherein, The film 904 is attached to the at least one surface of the polyurethane foam with an adhesive.

8. The stapling assembly of claim 5, wherein, The absorbable material comprises polyglycolic acid 370.

9. The stapling assembly of claim 1, wherein, The surgical adjunct 604 further comprises an additional polyurethane foam 902 attached to the polyurethane foam 902, wherein the polyurethane foam has a first density gradient and the additional polyurethane foam 902 has a second density gradient that is generally opposite the first density gradient.

10. The stapling assembly of claim 1, wherein: The platform 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having a top 1106 with a first diameter PDT and a bottom 1108 with a second diameter PDB that is less than the first diameter PDT, The film 904 is disposed on the surface and at least partially around the at least one post 1104, having a gap 1110 between the top 1106 of the at least one post 1104 and the film 904; and The surgical adjunct 604 is disposed on film 904 and at least partially around the at least one post.

11. The stapling assembly of claim 10, wherein, The film 904 comprises a perforated pattern around one or more staple slots 1112.

12. A method for manufacturing a surgical tool 200, comprising: providing a polyurethane foam 902 comprising a volume ratio of the polyurethane foam 902 to a total volume of a surgical adjunct 604 is in a range of about 0.125 to about 0.325; and disposing or forming a film 904 on the polyurethane foam 902.

13. The method of claim 12, comprising: disposing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902; disposing the film 904 on the at least one volatile solvent 906; and using the at least one volatile solvent to dissolve at least a portion of the polyurethane foam 902 and the film 904 to bond the polyurethane foam 902 and the film 904.

14. The method of claim 12, comprising: providing the polyurethane foam 902; disposing a reactive adhesive 906 on at least a portion of the film 904, at least a portion of the polyurethane foam 902, or both; and disposing the film on at least the polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the film 904.

15. The method of claim 12, comprising: providing a cartridge 200 comprising a platform having at least one post extending therefrom; disposing the film 904 on the platform and at least partially around the at least one post 1104; applying heat to the at least one post 1104 to form a top portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB such that the top portion of the at least one post at least partially overlaps the film 904; and disposing the surgical adjunct 604 on the film 904 to at least partially surround the at least one post 1104. ​

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