Surgical adjunct comprising polyurethane foam

Abstract

The disclosed technology includes a surgical adjunct comprising a polyurethane foam. The volume ratio of the polyurethane foam to the total volume of the surgical adjunct may range from about 0.125 to about 0.325. The glass transition temperature of the surgical adjunct may be from about 0 DEG C to about 40 DEG C.

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 / 484,807, 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, ducts, shunts, or other objects or body portions involved in a particular surgical procedure. These openings can be naturally occurring, such as passageways in blood vessels or internal organs like the stomach, or they can be formed during the surgical procedure by the surgeon, 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 user-operable, others of which can be operated 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. 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 an example of the present invention, a surgical adjunct comprising a polyurethane material is provided. A volume ratio of the polyurethane material to a total volume of the surgical adjunct is in a range of about 0.125 to about 0.325. The surgical adjunct has a glass transition temperature of about 0°C to about 40°C.

[0006] According to an example of the present invention, a method of manufacturing a surgical adjunct is provided. The method includes selectively adding a plasticizer to a polyurethane material to generate the surgical adjunct. The surgical adjunct has a glass transition temperature of about 0°C to about 40°C.

[0007] According to an example of the invention, a surgical appendage comprising a polyurethane material is provided. The glass transition temperature of the surgical appendage 604 is from about 0°C to about 40°C.

[0008] According to an example of the present invention, a surgical stapler assembly is provided, comprising a cartridge having a length of about 80 mm to about 90 mm and a width of about 8.9 mm to about 14 mm. The surgical stapler assembly also includes a surgical appendage disposed on the cartridge. The surgical appendage comprises a polyurethane material and a plasticizer added to the polyurethane material, the volume ratio of the polyurethane material to the total volume of the surgical appendage 604 being in the range of about 0.125 to about 0.325. The glass transition temperature T of the surgical appendage is... g The temperature is from about 0°C to about 40°C. The surgical appendage has a length of about 40 mm to about 80 mm, a width of about 8 mm to about 12 mm, and a height of about 2.5 mm to about 3.5 mm. Attached Figure Description

[0009] The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which: Figure 1 A perspective view of an exemplary embodiment of a conventional surgical suturing and cutting instrument.

[0010] Figure 2A To and Figure 1 A top view of a staple cartridge used in conjunction with surgical suturing and cutting instruments; Figure 2B for Figure 2A Side view of the staple cartridge; Figure 3 It can be set to Figure 2A A side view of the staple cartridge of the surgical cartridge assembly in an unfired (pre-deployed) configuration with staples in the cartridge. Figure 4 for Figure 1 A perspective view of the scalpel and firing pin (“E-beam”) of a surgical suturing and cutting instrument; Figure 5 for Figure 1 A perspective view of the wedge-shaped slide of the staple cartridge for surgical suturing and cutting instruments; Figure 6A A longitudinal cross-sectional view of an exemplary embodiment of a surgical cartridge assembly having compressible non-fibrous appendages attached to the top surface or platform surface of the staple cartridge; Figure 6B This is a longitudinal cross-sectional view of a surgical end effector having an anvil that can be pivotally connected to an elongated channel and Figure 6A The surgical compartment assembly is set within and connected to a narrow channel, and the figure shows the anvil in a closed position with no tissue between the anvil and the appendage; Figure 6C Perspective view of an exemplary surgical end effector having a channel and a surgical cartridge having a sled and a driver; Figure 6D Perspective view of an exemplary sled for an exemplary surgical cartridge; Figure 6E Perspective view of an exemplary single driver for an exemplary surgical cartridge; Figure 6F Front view of an exemplary single driver of Figure 6E Figure 6G Perspective view of an exemplary dual driver for an exemplary surgical cartridge; Figure 6H Front view of an exemplary dual driver of Figure 6G Figure 6I Cross-sectional view of an exemplary cartridge in an exemplary end effector; Figure 7 Partial schematic view of an adjunct of Figures 6A-6B in a tissue deployment condition; Figure 8A Perspective view of an exemplary cartridge assembly; Figure 8B Side view of an exemplary adjunct for a cartridge assembly; Figure 8C Top view of an exemplary adjunct for a cartridge assembly; Figure 8D Front view of an exemplary adjunct for a cartridge assembly; Figure 8E Diagram showing an enlarged portion of an exemplary adjunct having a porous structure; Figure 9A Side view of an exemplary adjunct compressed into a dog bone profile; Figure 9B Front view of Figure 9A

[0011] Figure 10A Perspective view of an exemplary cartridge platform having three tiers; Figure 10B Perspective view of an enlarged front portion of an exemplary cartridge platform of Figure 10A Perspective view of an enlarged rear portion of an exemplary cartridge platform of Figure 10C Figure 10A Perspective view of an enlarged front portion of an exemplary cartridge platform of Figure 10D Top view of an enlarged front portion of an exemplary cartridge platform of Figure 10A Figure 11A ​​​​​A perspective view of an exemplary warehouse platform with two levels; Figure 11B for Figure 11A An enlarged perspective view of the front portion of an exemplary warehouse platform; Figure 11C for Figure 11A An enlarged perspective view of the rear portion of an exemplary warehouse platform; Figure 11D for Figure 10A A top view of the enlarged front portion of an exemplary warehouse platform; Figure 12A This is a top perspective view of an exemplary accessory after use; Figure 12B A side view of an exemplary accessory after use; Figure 13 To illustrate the glass transition temperature T of an exemplary accessory g The curve graph; and Figure 14 A flowchart illustrating an exemplary method for manufacturing an accessory. Detailed Implementation

[0012] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements are labeled identically across different drawings. The drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example rather than limitation. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including those currently believed to be the best mode for carrying out the invention.

[0013] As used herein, the term “about” or “approximately” for any numerical value or range indicates appropriate dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of values ​​within ±10% of the enumerated values; for example, “about 90%” could refer to a range of values ​​from 81% to 99%.

[0014] Surgical suture assemblies and methods for manufacturing and using them are provided. Generally, a surgical suture assembly may include a cartridge having staples disposed therein and appendages configured to be releasably held on the cartridge. As discussed herein, various appendages may be configured to compensate for variations in tissue properties (such as variations in tissue thickness) and / or promote inward tissue growth when the appendage is sutured to the tissue.

[0015] Exemplary stapling assemblies can include various features to facilitate application of surgical staples, as described herein and shown in the drawings. However, those skilled in the art will appreciate that 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 staple cartridge assemblies, the adjuncts can be used in connection with staple reloaders that are not based on staple cartridges or any type of surgical instrument.

[0016] Figure 1 An exemplary surgical stapling and severing device 100 adapted for use with an implantable adjunct 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 is movable between an open position (as shown) and a closed position in which the anvil 102 is positioned adjacent 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 from the open position toward the elongated channel in Figure 1 The tool portion 110 can present a sufficiently small cross-section adapted for insertion of 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

[0017] 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 rotates the elongated shaft 108 and the end effector 106 about a longitudinal axis (Ls) of the elongated shaft 108, and an articulation control 115 that can articulate the end effector 106 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.

[0018] ​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.

[0019] 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.

[0020] As Figure 1 As 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. 2A-2C, has a proximal end 202a and a distal end 202b, with a longitudinal cartridge axis (LC) extending between the proximal end and the distal end. Thus, when the staple cartridge 200 is inserted into the elongate channel 104 (FIG. 1), Figure 1 ) the longitudinal axis (LC) is substantially or approximately parallel to the longitudinal axis (LS) 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 below in Figure 4 the firing assembly 400 in FIG. 4, as discussed further below. 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.

[0021] The illustrated staple cartridge 200 includes staple cavities 212, 214 defined therein, each staple cavity 212, 214 being configured to removably receive at least a portion of a staple (not shown). The number, shape, and position of the staple cavities can vary and can depend at least on the size and shape (e.g., orifice shape) of the staple removably disposed therein. In this illustrated example, the staple cavities are arranged in two sets of three longitudinal rows, wherein the first set of staple cavities 212 is positioned on a first side of the longitudinal slot 210, and the second set 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 set of rows, the staple cavities 212a, 214a of the first longitudinal row extend along the longitudinal slot 210, the staple cavities 212b, 214b of the second row extend along the staple cavities 212a, 214a of the first row, and the staple cavities 212c, 214c of the third row extend along the staple cavities 212b, 214b of the second row. Each row can be approximately parallel, and the nail cavities constituting the rows can be approximately parallel in orientation to the longitudinal slot 210. For example... Figure 2A As shown, each nail cavity 212, 214 may 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. In addition, at least two adjacent cavities 212, 214 are spaced apart by about 0.158 inches.

[0022] The nails releasably stored in the nail cavities 212, 214 can have various configurations. An exemplary nail 300, which can be releasably stored in each of the nail cavities 212, 214, is shown in its unfired (pre-deployed, unformed) configuration. Figure 3 The illustrated nail 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 nail legs 304 have the same unformed height. Furthermore, before the nail 300 is deployed, the nail crown 302 may be supported by a nail driver positioned within the nail cartridge 200, and simultaneously, the nail legs 304 may be at least partially accommodated within nail cavities 212, 214. Additionally, when the nail 300 is in its unfired position, the nail legs 304 may extend beyond the top surface of the nail cartridge 200, such as the top surface 206. In some cases, such as... Figure 3 As shown, the end 306 of the pin leg 304 can be sharp and pointed, which can cut into and penetrate tissue.

[0023] In use, the nail 300 can deform from an unfired position to a fired position, causing the nail legs 304 to move through the nail cavities 212, 214, penetrate the tissue positioned between the anvil 102 and the nail cartridge 200, and contact the anvil 102. As the nail legs 304 deform against the anvil 102, each nail leg 304 can capture a portion of the tissue within each nail 300 and apply compressive force to that tissue. Additionally, each nail leg 304 can deform downwards toward the crown 302 of the nail 300 to form a nail retention area in which tissue can be captured. In various cases, the nail retention area can be defined between the inner surface of the deformed leg and the inner surface of the crown of the nail. For example, the size of the nail retention area can depend on several factors, such as the length of the leg, the diameter of the leg, the width of the crown, and / or the degree of leg deformation.

[0024] In some examples, all nails disposed within the nail magazine 200 may have the same unfired (pre-deployed, unshaped) configuration. In other examples, the nails may include at least two sets of nails, each with a different unfired (pre-deployed, unshaped) configuration, for example, varying in height and / or shape relative to each other.

[0025] Re-reference Figures 2A-2B The staple cartridge 200 extends from a top surface or platform surface 206 to a bottom surface 208, wherein the top surface 206 is configured to face the tissue, and the bottom surface 208 is configured to face the channel. Therefore, when the staple cartridge 200 is inserted into the elongated channel 104, as... Figure 1 As shown, the top surface 206 faces the anvil 102, and the bottom surface 208 (which is obscured) faces the elongated channel 104.

[0026] refer to Figure 4 and Figure 5 Firing components such as firing component 400 can be used with surgical suture and cutting devices (such as...) Figure 1 The firing assembly 400 is used in conjunction with the device 100 in the middle. The firing assembly 400 may be configured to advance a wedge-shaped slide 500 having a wedge 502, which is configured to deploy the nail from the nail cartridge 200 to the anvil (such as...). Figure 1 The anvil 102 and the staple cartridge (such as 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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 fired 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 the body over a period of 100 to 300 days depending on the location of implantation and the health of the tissue.

[0032] 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.

[0033] 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 as 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.

[0034] Method of suturing tissue Figures 6A-6B An exemplary example of a stapling assembly 600 is illustrated that includes 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 in greater detail. 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 that are configured to be deployed into tissue. The staples 300 can have any suitable unformed (pre-deployment) height.

[0035] 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.

[0036] 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 thereto (and thus relative to the staple cartridge 200) between open and closed positions. The anvil 102 is shown in the closed position in Figure 6B and a tissue gap T G1 is illustrated formed 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.

[0037] The appendage 604 is compressible to allow for varying heights of compression, thereby compensating for differences in tissue thickness trapped within the deployed staple. 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 have 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).

[0038] like Figure 6C As shown, the staple cartridge 200 includes a slider 614 and a plurality of actuators 612 configured to respond to user pressure. Figure 1 The firing trigger 122 shown drives one or more pins in an upward direction to deploy the pins. 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, forcing one or more actuators 612a, 612b upward along with one or more corresponding pins 300 to form the firing pin 300a and to deposit material such as tissue (T) (see Figure 7) captured between the anvil 104 and the firing staples 300a. The cartridge 200 can include a first row 613a of single drivers 612a corresponding to driving the staples 300 positioned in the third row staple cavities 214c, 212c, and a second row 613b of double drivers 612b corresponding to driving the staples 300 positioned in the first and third rows of staple cavities 212a, 214b and 212a, 212b (see FIGS. 6A and 6B for staple cavities). Figure 2A ].

[0039] Referring to Figures 6C-6I , the one or more single drivers 612a can 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. The one or more double drivers 612b can 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. The sled 614 can have at least a first rail 614a corresponding to the single drivers 612a positioned in the first row 613a and a second rail 614b corresponding to the double drivers 612b positioned in the second row 613b. The first rail 614a can have a rail height SRH of about 0.164 inches or about 0.167 inches and engages the single drivers 612a. The second rail 614b can have a 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 the double drivers 612b. Once the staples 300 are deployed, they form a firing staple 300a having a crush height CH of about 0.08 inches to about 0.12 inches, such as about 0.97 inches or about 0.1 inches.

[0040] Referring to Figure 6I , the saddle 624a of the single drivers 612a can be spaced apart from the cartridge deck 206 a distance SDSD of about -0.010 inches to about -0.031 inches, such as -0.021 inches or about -0.017 inches when the single drivers 612a are fully engaged with the sled 614. The saddle 624b of the double drivers 612b can be spaced apart from the cartridge deck 206 a distance DDSD of about -0.022 inches to about -0.042 inches, such as about -0.032 inches or about -0.036 inches when the double drivers 612b are fully engaged with the sled 614.

[0041] Referring to Figures 6D-6IOne or more single actuators 612a may have a rigging 622a that may have a ramp position SDL extending from the proximal edge 615a of the single actuator 612a for about 0.056 inches to about 0.066 inches, such as about 0.061 inches. The rigging 622a may have a height SRH of about 0.035 inches to about 0.055 inches, such as about 0.45 inches or about 0.43 inches. One or more dual actuators 612b may have a rigging 622b that may have a ramp position DDL extending from the proximal edge 615b of the dual actuator 612b for about 0.094 inches to about 0.114 inches, such as about 0.104 inches. The rigging 622b may have a height of about 0.039 inches to about 0.060 inches, such as about 0.050 inches or about 0.048 inches. The single actuator 612a may have a ramp angle SDRA of about 24 degrees to about 34 degrees, such as about 29 degrees. The dual actuator 612b may have a ramp angle DDRA of about 22 degrees to about 30 degrees, such as about 26 degrees. The first guide rail 614a of the slider 614 may have a ramp angle SRA of about 22 degrees to about 32 degrees, such as about 26.9 degrees. The second guide rail 614b of the slider 614 may have a ramp angle SRA of about 20 degrees to about 30 degrees, such as about 24.1 degrees to about 24.5 degrees.

[0042] During use, once the surgical suture and cutting device (such as...) Figure 1 The device 100 is guided to the surgical site, and the tissue is positioned between the anvil 102 and the suture assembly 600, such that the anvil 102 is positioned adjacent to a first side of the tissue, and the suture assembly 600 is positioned adjacent to a second side of the tissue (e.g., the tissue may be positioned against the tissue contact surface 604a of the appendage 604). Once the tissue is positioned between the anvil 102 and the suture assembly 600, the surgical stapler can be actuated, for example as discussed above, to clamp the tissue between the anvil 102 and the suture assembly 600 (e.g., between the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the appendage 604), and staples are deployed from the cartridge through the appendage and into the tissue to suture and attach the appendage to the tissue.

[0043] like Figure 7 As shown, when the pin 300 is fired, a portion of the tissue (T) and appendage 604 is captured by the fired (formed) pin 300a. As discussed above, each of the firing pins 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.

[0044] 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 from about 0.035 inches to about 0.046 inches. The adjunct 604 has a length L of from about 40 mm to about 80 mm, such as from about 60 mm to about 65 mm, from about 66.04 mm to about 66.3 mm, from about 45 mm to about 55 mm, or from about 51.12 mm to about 51.38 mm. The adjunct 604 has a width W of from about 8 mm to about 12 mm, such as from about 9.75 mm to about 10.25 mm, or from about 10.025 mm to about 10.035 mm. The adjunct 604 can also have a thickness or height TH of from about 2.5 mm to about 3.5 mm, such as from about 2.85 mm to about 3.15 mm, or from about 2.95 mm to about 3.05 mm.

[0045] The cartridge 200 has a height CH of from about 6.3 mm to about 8.1 mm, a width CW of from about 8.9 mm to about 14 mm, and a length CL of from about 80 mm to about 90 mm, such as about 86.7 mm.

[0046] Referring to Figures 8B-8D The adjunct 604 has an underside 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 from 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 proximate the vertical portion 818a. The angled portion 818b has a slope VA of from about 30 degrees to about 60 degrees, such as about 45 degrees, measured from the tissue-contacting surface 604a.

[0047] 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.

[0048] 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.

[0049] Referring back to Figure 8A The 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 cartridge 200.

[0050] As previously mentioned, the adjunct 604 is compressible. Figure 9A and Figure 9B The dog bone shape and dimensions of the adjunct 604 are shown as it is subjected to a compressibility test to determine its material properties. As shown, the adjunct 604 has a compressed length CPL of about 9.45 mm to about 9.61 mm, such as about 9.53 mm. The adjunct 604 has a compressed thickness CT of about 3.15 mm to about 3.21 mm, such as about 3.18 mm. The adjunct 604 has a dog bone radius DBR of about 12.62 mm to about 12.78 mm, such as about 12.7 degrees. The adjunct 604 has a dog bone height DBH of about 6.35 mm to about 12.71 mm, such as about 9.53 mm. The adjunct 604 has a dog bone length DBL of about 40 mm to about 80 mm, such as about 63.5 mm. The adjunct has a dog bone width DBW of about 2.5 mm to about 3.5 mm, such as about 3.03 mm.

[0051] Figures 10A-10DAn exemplary staple cartridge 1000 having a deck 1012 is illustrated that has three tiers such that the adjunct 604 can expand around various protrusions and depressions to increase the contact surface area between the adjunct 604 and the staple cartridge 1000 to increase the adhesion and alignment between the staple cartridge 1000 and the adjunct 604. The staple cartridge 1000 is similar to the staple cartridge 200, but has more exemplary details of the deck 1012 shown. Specifically, the staple cartridge 1000 can comprise a proximal end 1001a and a distal end 1001b having an atraumatic shape. The staple cartridge 1000 can comprise one or more raised flanges 1004, such as two raised flanges 104, aligned with the longitudinal edges of the deck 1012. The staple cartridge 1000 can comprise a plurality of staple cavities 1014 positioned and aligned in a first row 1022a, a second row 1022b, and a third row 100c on each side of the cartridge slot 1006. In each row, at least two adjacent staple cavities 1014 are separated by a raised surface 1018 or a combined raised surface of the deck 1012 that conforms to the end of the staple cavities 1014. The combined raised surface 1018 substantially combines the raised surface corresponding to the proximal end of the adjacent staple cavities 1014 with the distal end of the staple cavities 1014. Further, the staple cavities 1014 positioned at the distal end 1001b and the proximal end 1001a of the first row 1022a, the second row 1022b, and the third row 100c comprise raised surfaces 1020b, 1020a that are approximately half the size of the combined raised surface 1018 between the staple cavities 1014. The cartridge deck 1012 can further comprise a plurality of lowered surfaces 1016. At least two triangular lower surfaces 1016 can be located at the lateral sides of the staple cavities 1014 in the second row 1022b, wherein the apex of the triangle points toward the combined raised surface 1018 located in the adjacent rows 1022a, 1022c of staple cavities 1014. At least one triangular lower surface 1018 located at the lateral side of the third row 1022c away from the slot 1006 can have an apex of the triangle pointing toward the combined raised surface 1018 located in the adjacent row 1022b. Further, the staple cartridge 1000 can comprise a triangular end lower surface 1016a positioned between the distal end 1001b of the cartridge 1000 and the second row 1022b of staple cavities 1014, wherein the apex is aligned with the second row 1022b and points toward the proximal end 1001a of the staple cartridge 1000. As illustrated, the cartridge 1000 can not comprise any lowered surfaces directly adjacent to the staple cavities 1014 of the first row 1022a.

[0052] Figures 11A-11D An exemplary staple cartridge 1000 having a deck 1012 is illustrated that has three tiers such that the adjunct 604 can expand around various protrusions and depressions to increase the contact surface area between the adjunct 604 and the staple cartridge 1000 to increase the adhesion and alignment between the staple cartridge 1000 and the adjunct 604. The staple cartridge 1000 is similar to the staple cartridge 200, but has more exemplary details of the deck 1012 shown. Specifically, the staple cartridge 1000 can comprise a proximal end 1001a and a distal end 1001b having an atraumatic shape. The staple cartridge 1000 can comprise one or more raised flanges 1004, such as two raised flanges 104, aligned with the longitudinal edges of the deck 1012. The staple cartridge 1000 can comprise a plurality of staple cavities 1014 positioned and aligned in a first row 1022a, a second row 1022b, and a third row 100c on each side of the cartridge slot 1006. In each row, at least two adjacent staple cavities 1014 are separated by a raised surface 1018 or a combined raised surface of the deck 1012 that conforms to the end of the staple cavities 1014. The combined raised surface 1018 substantially combines the raised surface corresponding to the proximal end of the adjacent staple cavities 1014 with the distal end of the staple cavities 1014. Further, the staple cavities 1014 positioned at the distal end 1001b and the proximal end 1001a of the first row 1022a, the second row 1022b, and the third row 100c comprise raised surfaces 1020b, 1020a that are approximately half the size of the combined raised surface 1018 between the staple cavities 1014. The cartridge deck 1012 can further comprise a plurality of lowered surfaces 1016. At least two triangular lower surfaces 1016 can be located at the lateral sides of the staple cavities 1014 in the second row 1022b, wherein the apex of the triangle points toward the combined raised surface 1018 located in the adjacent rows 1022a, 1022c of staple cavities 1014. At least one triangular lower surface 1018 located at the lateral side of the third row 1022c away from the slot 1006 can have an apex of the triangle pointing toward the combined raised surface 1018 located in the adjacent row 1022b. Further, the staple cartridge 1000 can comprise a triangular end lower surface 1016a positioned between the distal end 1001b of the cartridge 1000 and the second row 1022b of staple cavities 1014, wherein the apex is aligned with the second row 1022b and points toward the proximal end 1001a of the staple cartridge 1000. As illustrated, the cartridge 1000 can not comprise any lowered surfaces directly adjacent to the staple cavities 1014 of the first row 1022a. Figures 10A-10DThe example staple cartridge 1100 of the example staple cartridge 1000, with some notable differences, such as having a flat deck 1112 without raised surfaces adjacent the staple cavities 1114. The deck 1112 can include a plurality of lowered surfaces 1116, 1116a that are positioned and shaped similar to the lowered surfaces 1016, 1016a of the example cartridge 1000. In addition, the deck 1112 can include an additional lowered surface 1116 positioned adjacent the staple cavities 1114 of the first row 1122a on the side closest to the slot 1106. Thus, each staple cavity 1114 of the first row 1122a, the second row 1122b, and the third row 1122c can have at least one adjacent lower surface 1016 that is triangular in shape.

[0053] Both the staple cartridges 1000 and 1100 allow the staples 300 to have a preformed height of about 0.179 inches, which is greater than previous devices, where the deck height is about 0.060 inches, which is shorter than previous devices.

[0054] Figure 12A and Figure 12B Top and side views of the adjunct 604 after the staples have been fired are shown. As can be seen, the adjunct 604 can split into two after firing and adhere the adjunct 604 to the cartridge 200 (see Figure 6A and Figure 6B The adhesive 1232 of the adjunct 604 can form nubs 604e, 604f and corresponding nubs 1232a in the adjunct along with the adjunct 604. This means that the adjunct 604 is able to adapt to different heights and compressions depending on the application. The adjunct can be attached to the cartridge 200 with about 100 mg to about 120 mg of adhesive or buttress adhesive material.

[0055] 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 position 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" 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 below and to comply with other listed properties. Regardless, the adjunct 604 with one or more of the following properties consistently creates a hemostatic or near hemostatic seal on tissue.

[0056] 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 whose output is shown in Figure 13 about -40 °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 T g is measured and recorded by the DSC system.

[0057] The volume ratio of the polyurethane foam of the surgical adjunct 604 to the total volume of the adjunct 604 can be 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.

[0058] The plasticizer can include one or more of a low molecular weight diol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, triacetin, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate ester, and a fatty acid. In some examples, the plasticizer contains one or more fatty acids.

[0059] Referring to Figure 8E , the adjunct 604 can have pores 832 with 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.

[0060] 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 µm to about 100 µm such as about 40 µm.

[0061] 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.

[0062] In some examples, the foam (e.g., polyurethane foam) portion of the adjunct 604 can have a (peak) tensile strength of about 50 kPa to about 150 kPa or 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 foam (e.g., polyurethane foam) of the adjunct 604 will have a (peak) tensile strength of about 110 kPa to about 150 kPa. In having a ratio of air to polyurethane for a given volume due to the size and amount of pores. Figure 9A and Figure 9B The tensile strength is measured on the adjunct 604 of the dog bone configuration shown and described. Specifically, the tensile strength of the adjunct 604 is measured after submerging the adjunct 604 in water at a temperature of about 37°C for less than one minute and then conducting the tensile strength test.

[0063] Referring to Figure 14 The surgical adjunct 604 can be manufactured by using the method 1400, which includes selectively (step 1402) adding a plasticizer to a polyurethane foam to generate the surgical adjunct 604 described throughout. The plasticizer can be placed onto or within the surgical adjunct via bulk swelling in solution or via direct deposition to plasticize the polyurethane foam in order to lower the foam glass transition temperature and / or reduce the mechanical strength of the polyurethane foam. In some examples, the method 1400 can optionally include adhering (optional step 1404) at least one side (e.g., the bottom or crown side) of the polyurethane foam with a PDO film to create an at least partially sealed foam, subjecting (optional step 1406) the partially sealed polyurethane foam to a temperature of about 105°C to about 115°C for about 24 minutes, subjecting (optional step 1408) the partially sealed foam to a pressure of about 5 kN, allowing the partially sealed foam to rest (optional step 1410) for at least thirty seconds (e.g., about 60 seconds), and subjecting (optional step 1412) the partially sealed foam to a temperature of about 35°C to about 45°C for about 24 minutes. Step 1408 can be performed simultaneously with steps 1406, 1410, and 1412. In some examples, the surgical adjunct 604 is created without a plasticizer and the polyurethane foam is generated to have a certain ratio of air to polyurethane for a given volume due to the size and amount of pores.

[0064] Those skilled in the art will understand that the embodiments described above are cited by way of example, and that the present application is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present application includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which would occur to persons of ordinary skill in the art upon reading the foregoing description and which are not disclosed in the prior art. The disclosure in all parts of this application for patent shall be considered intact in all countries throughout the world which have patent laws compatible with the patent law of the United States.

[0065] 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 in a volume ratio to a total volume of the surgical adjunct 604 in a range of about 0.125 to about 0.325, wherein a glass transition temperature of the surgical adjunct 604 is about 0°C to about 40°C.

[0066] Clause 2: The surgical adjunct 604 of Clause 1, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjunct is about 0.175 to about 0.225.

[0067] Clause 3: The surgical adjunct 604 of Clause 1, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjunct is about 0.19 to about 0.21.

[0068] Clause 4: The surgical adjunct 604 of Clause 1, wherein the glass transition temperature of the surgical adjunct is about 7.5°C to about 22.5°C.

[0069] Clause 5: The surgical adjunct 604 of Clause 1, wherein the glass transition temperature of the surgical adjunct 604 is about 12.5°C to about 17.5°C.

[0070] Clause 6: The surgical adjunct 604 of Clause 1, wherein a median pore size of the surgical adjunct 604 is about 0.025 mm 3 to about 0.300 mm 3 .

[0071] Clause 7: The surgical adjunct 604 of Clause 1, further comprising a polydioxanone (PDO) film disposed on at least one surface of the polyurethane foam.

[0072] Clause 8: The surgical adjunct 604 of Clause 7, wherein the PDO film has a thickness of about 20 pm to about 100 pm.

[0073] Clause 9: The surgical adjunct 604 of claim 1, further comprising a plasticizer added to the polyurethane foam.

[0074] Clause 10: The surgical adjunct 604 of clause 9, wherein the plasticizer contains at least one 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.

[0075] Clause 11: The surgical adjunct 604 of clause 9, wherein the plasticizer contains at least one fatty acid.

[0076] Clause 12: The surgical adjunct 604 of claim 1, wherein the surgical adjunct 604 has a compressive strength of about 30 kPa to about 70 kPa.

[0077] Clause 13: The surgical adjunct 604 of clause 12, wherein the compressive strength is about 30 kPa to about 60 kPa.

[0078] Clause 14: The surgical adjunct 604 of claim 1, wherein the surgical adjunct 604 has a peak tensile strength of about 50 kPa to about 150 kPa.

[0079] Clause 15: The surgical adjunct 604 of claim 1, wherein the surgical adjunct 604 has a length of about 40 mm to about 80 mm, a width of about 8 mm to about 12 mm, and a height of about 2.5 mm to about 3.5 mm.

[0080] Clause 16: The surgical adjunct 604 of clause 15, wherein the surgical adjunct 604 has a distal end chamfer 604b and a proximal end chamfer 604c, wherein the distal end chamfer includes a vertical portion extending from a bottom of the surgical adjunct 604 having a height of about 0.009 inches to about 0.029 inches, wherein the distal end chamfer includes an angled portion extending from the vertical portion to a top surface 604a of the surgical adjunct having a slope of about 30 degrees to about 60 degrees relative to the top surface, wherein the proximal end chamfer includes a proximal end having a width of about 0.27 inches to about 0.29 inches, wherein the proximal end chamfer 604c includes first and second angled side extensions extending away from the distal end of the surgical adjunct to the proximal end of the proximal end chamfer 604c, each having a length of about 0.01 inches to about 0.40 inches when measured horizontally.

[0081] Clause 17: The surgical adjunct 604 of clause 1, further comprising a plurality of struts having a median strut thickness of about 0.025 mm to about 0.300 mm.

[0082] Clause 18: A method of manufacturing a surgical adjunct 604, the method comprising: selectively adding a plasticizer to a polyurethane foam to generate the surgical adjunct 604, wherein the surgical adjunct 604 has a glass transition temperature of about 0 °C to about 40 °C.

[0083] Clause 19: The method of clause 18, wherein selectively adding the plasticizer comprises soaking the polyurethane foam in a solution comprising the plasticizer or adding the plasticizer on at least a portion of at least one surface of the polyurethane foam via direct deposition, and wherein a volume ratio of the polyurethane foam to a total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.

[0084] Clause 20: The method of clause 18, further comprising: laminating the polyurethane foam with a polydioxanone (PDO) film by adhering one side of the polyurethane foam with a PDO film to create a partially sealed foam; subjecting the partially sealed foam to a temperature of about 105 °C to about 115 °C; subjecting the partially sealed foam to a pressure of about 5 kN; allowing the partially sealed foam to rest for at least thirty seconds; and subjecting the partially sealed foam to a temperature of about 35 °C to about 45 °C.

[0085] Clause 21 : A surgical adjunct 604, comprising: a polyurethane foam, and wherein a glass transition temperature of the surgical adjunct 604 is about 0 °C to about 40 °C.

[0086] Clause 22: The surgical adjunct 604 of clause 21, wherein a volume ratio of the polyurethane foam to the total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.325.

[0087] Clause 23: The surgical adjunct 604 of clause 21, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjunct is about 0.175 to about 0.225.

[0088] Clause 24: The surgical adjunct 604 of clause 21, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjunct 604 is about 0.19 to about 0.21.

[0089] Clause 25: The surgical adjunct 604 of any one of clauses 21-24, wherein the glass transition temperature of the surgical adjunct is about 7.5 °C to about 22.5 °C.

[0090] Clause 26: The surgical adjunct 604 of any one of clauses 21-24, further comprising a plasticizer added to the polyurethane foam, wherein the glass transition temperature of the surgical adjunct 604 is about 12.5 °C to about 17.5 °C.

[0091] Clause 27: The surgical adjunct 604 of any one of clauses 21-26, wherein the median pore size of the surgical adjunct 604 is about 0.025 mm 3 to about 0.300 mm 3 .

[0092] Clause 28: The surgical adjunct 604 of any one of clauses 21-27, further comprising a polydioxanone (PDO) film disposed on at least one surface of the polyurethane foam.

[0093] Clause 29: The surgical adjunct 604 of clause 28, wherein the PDO film has a thickness of about 20 pm to about 100 pm.

[0094] Clause 30: The surgical adjunct 604 of clause 26, wherein the plasticizer contains at least one of a low molecular weight diol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, caproic acid, capric acid, octadecanoic acid, borate ester, and a fatty acid.

[0095] Clause 31: The surgical adjunct 604 of clause 26, wherein the plasticizer contains at least one fatty acid.

[0096] Clause 32: The surgical adjunct 604 of any one of clauses 21-31, wherein the surgical adjunct 604 has a compressive strength of about 30 kPa to about 70 kPa.

[0097] Clause 33: The surgical adjunct 604 of any one of clauses 21-31, wherein the surgical adjunct 604 has a compressive strength of about 30 kPa to about 50 kPa.

[0098] Clause 34: The surgical adjunct 604 of any one of clauses 21-33, wherein the surgical adjunct 604 has a peak tensile strength of about 50 kPa to about 150 kPa.

[0099] Clause 35: The surgical adjunct 604 of any one of clauses 21-33, wherein the surgical adjunct 604 has a peak tensile strength of about 45 kPa to about 85 kPa.

[0100] Clause 36: The surgical adjunct 604 of any one of clauses 21-35, wherein the surgical adjunct 604 has a length of about 40 mm to about 80 mm, a width of about 8 mm to about 12 mm, and a height of about 2.5 mm to about 3.5 mm.

[0101] Clause 37: The surgical adjunct 604 of any one of clauses 21-35, wherein the surgical adjunct 604 has a length of about 60 mm to about 70 mm or about 45 mm to about 55 mm, a width of about 9.75 mm to about 10.25 mm, and a height of about 2.85 mm to about 3.15 mm.

[0102] Clause 38: The surgical adjunct 604 of any one of clauses 21-35, wherein the surgical adjunct 604 has a length of about 66.04 mm to about 66.3 mm or about 21.12 mm to about 51.38 mm, a width of about 10.025 mm to about 10.035 mm, and a height of about 2.95 mm to about 3.05 mm.

[0103] Clause 39: A surgical cartridge assembly 106 comprising: a cartridge 200 having a length of about 80 mm to about 90 mm and a width of about 8.9 mm to about 14 mm; a surgical adjunct 604 disposed on the cartridge 200, the surgical adjunct comprising: a polyurethane foam having a volume ratio to a total volume of the surgical adjunct 604 in a range of about 0.125 to about 0.325, wherein the surgical adjunct 604 has a glass transition temperature T g of about 0 °C to about 40 °C, and wherein the surgical adjunct 604 has a length of about 40 mm to about 80 mm, a width of about 8 mm to about 12 mm, and a height of about 2.5 mm to about 3.5 mm.

[0104] Clause 40: The surgical cartridge assembly 106 of clause 39, wherein the surgical adjunct 604 further comprises a plasticizer added to the polyurethane foam.

[0105] Clause 41 : The surgical cartridge assembly 106 of Clause 39 or 40, wherein the cartridge 200 comprises at least two sets of substantially parallel staple cavities 212, 214 spaced apart by a longitudinal slot 210, each staple cavity 212, 214 having: an orientation substantially parallel to the longitudinal slot 210; a mouth-like shape; a maximum length of about 0.122 inches to about 0.124 inches; and a maximum width of about 0.023 inches to about 0.027 inches.

[0106] Clause 42: The surgical cartridge assembly 106 of Clause 39, wherein at least the centers of two adjacent staple cavities 212 in a row 212a are spaced apart by about 0.158 inches.

[0107] Clause 43: The surgical cartridge assembly 106 of Clause 38, wherein the surgical adjunct 604 comprises two parallel portions 806a, 806b separated by a slot 808.

[0108] Clause 44: The surgical cartridge assembly 106 of Clause 38, wherein the surgical adjunct 604 comprises two parallel portions 806a, 806b separated by at least one slit 808, at least one bridge 802 connecting the two parallel portions 806a, 806b across the at least one slit 808.

[0109] Clause 45: The surgical cartridge assembly 106 of Clause 44, wherein the at least one bridge 802 has a length of about 0.035 inches to about 0.046 inches.

[0110] Clause 46. The surgical cartridge assembly 106 of any of Clauses 39 to 45, wherein an adhesive is disposed between the surgical adjunct 604 and the cartridge 200 and is configured to adhere the surgical adjunct to the cartridge.

[0111] Clause 47: The surgical cartridge assembly 106 of Clause 46, further comprising about 100 mg to about 120 mg of adhesive between the cartridge 200 and the surgical adjunct 604.

[0112] Clause 48: The surgical cartridge assembly 106 of any of Clauses 39 to 47, wherein the cartridge 200 comprises a platform 206 comprising at least one raised surface 804 along a lateral side and / or a distal side of the cartridge 200 and is configured to align the surgical adjunct 604; and an atraumatic contoured distal end DC.

[0113] Clause 49: The surgical cartridge assembly 106 of any of Clauses 39 to 47, wherein the cartridge 200 comprises a substantially flat platform 206.

[0114] Clause 50: The surgical cartridge assembly 106 of any of clauses 39-48, wherein the cartridge 200 comprises a plurality of raised surfaces positioned at each distal and proximal end of each staple cavity 212, 214, and wherein a raised surface corresponding to a distal end of a staple cavity 212, 214 forms a combined raised surface with a raised surface corresponding to a proximal end of an adjacent staple cavity 212, 214.

[0115] Clause 51 : The surgical cartridge assembly 106 of any of clauses 39-50, wherein the cartridge 200 comprises a plurality of lowered surfaces below the deck 206, and wherein at least one lowered surface is positioned along at least one lateral side of a staple cavity 212, 214.

Claims

1. A surgical adjunct 604 comprising: a polyurethane foam, wherein a glass transition temperature of the surgical adjunct 604 is in a range of about 0 °C to about 40 °C, and wherein a volume ratio of the polyurethane foam to a total volume of the surgical adjunct 604 is in a range of about 0.125 to about 0.

325.

2. The surgical adjunct 604 of Claim 1, wherein, the volume ratio of the polyurethane foam to the total volume of the surgical adjunct is about 0.175 to about 0.

225.

3. The surgical adjunct 604 of Claim 1, wherein, the volume ratio of the polyurethane foam to the total volume of the surgical adjunct 604 is about 0.19 to about 0.

21.

4. The surgical adjunct 604 of any one of claims 1-2, wherein, the glass transition temperature of the surgical adjunct is about 7.5 °C to about 22.5 °C.

5. The surgical adjunct 604 of any one of Claims 1-2, wherein, the glass transition temperature of the surgical adjunct 604 is about 12.5 °C to about 17.5 °C.

6. The surgical adjunct 604 of any one of Claims 1-5, wherein, The median pore size of the surgical adjunct 604 is about 0.025 mm 3 to about 0.300 mm 3 .

7. The surgical adjunct 604 of any one of claims 1 to 6, further comprising a polydioxanone (PDO) film disposed on at least one surface of the polyurethane foam.

8. The surgical adjunct 604 of Claim 7, wherein, the PDO film has a thickness of about 20 pm to about 100 pm.

9. The surgical adjunct 604 of any one of claims 1 to 8, further comprising a plasticizer added to the polyurethane foam.

10. The surgical adjunct 604 of Claim 9, wherein, the plasticizer contains a low molecular weight diol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, caproic acid, capric acid, octadecanoic acid, borate ester, a fatty acid, or a combination thereof.

11. The surgical adjunct 604 of Claim 9, wherein, the plasticizer contains at least one fatty acid.

12. The surgical adjunct 604 of any one of Claims 1-11, wherein, the surgical adjunct 604 has a compressive strength of about 30 kPa to about 70 kPa.

13. The surgical adjunct 604 of any one of Claims 1-11, wherein, the surgical adjunct 604 has a compressive strength of about 30 kPa to about 50 kPa.

14. The surgical adjunct 604 of any one of Claims 1-13, wherein, the surgical adjunct 604 has a peak tensile strength of about 50 kPa to about 150 kPa.

15. The surgical adjunct 604 of any one of Claims 1-13, wherein, the surgical adjunct 604 has a peak tensile strength of about 45 kPa to about 85 kPa.

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