Surgical adjuvants containing polyurethane foam

Abstract

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

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 522,660, filed on 22 June 2023, and U.S. Non-Provisional Patent Application No. 18 / 484,807, filed on 11 October 2023, under Section 119 of the U.S. Patent Act, which are incorporated herein in their entirety by reference.

[0002] (Field of invention) The present invention relates, as a whole, to compressible surgical aids, cartridges, cartridge assemblies, and methods for manufacturing the aids and cartridge assemblies. [Background technology]

[0003] Surgical staplers are used in surgical procedures to close openings in tissues, blood vessels, conduits, shunts, or other objects or body parts related to a particular procedure. Openings may be naturally occurring, such as passages within blood vessels or viscera like the stomach, or they may be created by a surgeon during a surgical procedure, such as by forming a bypass or anastomosis through tissue or vascular puncture, or by tissue incision during stapling.

[0004] Most staplers have a handle (some of which are directly user-operable, others via a robotic interface), an elongated shaft extending from the handle, and having a pair of movable opposing jaws formed at its end, the pair of movable opposing jaws used to hold and form staples between them. Staples are typically housed in a staple cartridge, which can hold multiple rows of staples and is often positioned within one of the two jaws for releasing staples to the surgical site. During use, the jaws are positioned so that the object to be stapled is placed between them, and when the jaws are closed and the device is activated, the staples are released and formed. Some staplers include a knife configured to move between rows of staples in the staple cartridge and, between the stapled rows, longitudinally incise and / or open the stapled tissue. [Overview of the project] [Means for solving the problem]

[0005] According to one embodiment of the present invention, a surgical aid containing a polyurethane material is provided. The volume ratio of the polyurethane material to the total volume of the surgical aid is in the range of about 0.125 to about 0.325. The glass transition temperature of the surgical aid is about 0°C to about 40°C.

[0006] According to one embodiment of the present invention, a method for producing a surgical aid is provided. This method comprises selectively adding a plasticizer to a polyurethane material to produce a surgical aid. The surgical aid has a glass transition temperature of about 0°C to about 40°C.

[0007] According to one embodiment of the present invention, a surgical aid comprising a polyurethane material is provided. The glass transition temperature of the surgical aid 604 is approximately 0°C to approximately 40°C.

[0008] According to one embodiment of the present invention, a surgical staple cartridge 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 staple cartridge assembly also comprises a surgical auxiliary material disposed on the cartridge. The surgical auxiliary material comprises a polyurethane material comprising a volume ratio of polyurethane material to the total volume of the surgical auxiliary material 604 in the range of about 0.125 to about 0.325, and a plasticizer added to the polyurethane material. Glass transition T of the surgical auxiliary material g The temperature ranges from approximately 0°C to 40°C. The surgical aids have a length of approximately 40mm to 80mm, a width of approximately 8mm to 12mm, and a height of approximately 2.5mm to 3.5mm. [Brief explanation of the drawing]

[0009] The present invention will be more fully understood by reading the following embodiments in conjunction with the accompanying drawings. [Figure 1] This is a perspective view of an exemplary embodiment of a conventional surgical staple fastening and cutting instrument. [Figure 2A] Figure 1 is a top view of a staple cartridge for use with surgical staple fastening and cutting instruments. [Figure 2B] Figure 2A is a side view of the staple cartridge. [Figure 3] Figure 2A is a side view of a staple in an unfired (pre-deployment) configuration, which may be placed inside the staple cartridge of the surgical cartridge assembly. [Figure 4] Figure 1 is a perspective view of the knife and launching bar ("E-shaped beam section") of the surgical staple fastening and cutting instrument. [Figure 5] Figure 1 is a perspective view of the wedge thread of the staple cartridge for a surgical staple fastening and cutting instrument. [Figure 6A] This is a longitudinal cross-sectional view of an exemplary surgical cartridge assembly having a compressible, non-fibrous auxiliary material attached to the top or deck surface of a staple cartridge. [Figure 6B]A longitudinal cross-sectional view of a surgical end effector having an anvil pivotally connected to an elongate channel and a surgical cartridge assembly of FIG. 6A disposed within and connected to the elongate channel, showing the anvil in a closed position with no tissue between the anvil and the bolster. [Figure 6C] A perspective view of an exemplary surgical end effector having a channel and a surgical cartridge having threads and a driver. [Figure 6D] A perspective view of an exemplary thread for an exemplary surgical cartridge. [Figure 6E] A perspective view of an exemplary single driver for an exemplary surgical cartridge. [Figure 6F] A front view of the exemplary single driver of FIG. 6E. [Figure 6G] A perspective view of an exemplary double driver for an exemplary surgical cartridge. [Figure 6H] A front view of the exemplary double driver of FIG. 6G. [Figure 6I] A cross-sectional view of an exemplary cartridge within an exemplary end effector. [Figure 7] A partial schematic view showing the bolster of FIGS. 6A - 6B in a tissue deployed state. [Figure 8A] A perspective view of an exemplary cartridge assembly. [Figure 8B] A side view of an exemplary bolster for a cartridge assembly. <0oooo090> [Figure 8C] A top view of an exemplary bolster for a cartridge assembly. [Figure 8D] A front view of an exemplary bolster for a cartridge assembly. [Figure 8E] A view showing an enlarged portion of an exemplary bolster having a porous structure. [Figure 9A] A side view of an exemplary bolster compressed in a dog bone shape. [Figure 9B] A front view of FIG. 9A. [Figure 10A]A perspective view of an exemplary cartridge deck with three levels. [Figure 10B] Figure 10A is an illustrative perspective view of the enlarged front portion of a cartridge deck. [Figure 10C] Figure 10A is an illustrative perspective view of the enlarged rear portion of a cartridge deck. [Figure 10D] Figure 10A is an illustrated top view of the enlarged front portion of a cartridge deck. [Figure 11A] A perspective view of an exemplary cartridge deck having two levels. [Figure 11B] Figure 11A is an illustrative perspective view of the enlarged front portion of a cartridge deck. [Figure 11C] Figure 11A is an illustrative perspective view of the enlarged rear portion of a cartridge deck. [Figure 11D] Figure 10A is an illustrated top view of the enlarged front portion of a cartridge deck. [Figure 12A] This is an overhead perspective view of an example of an auxiliary material after use. [Figure 12B] This is a side view of an example of an auxiliary material after use. [Figure 13] This is a graph showing the glass transition temperature (Tg) of an exemplary auxiliary material. [Figure 14] This flowchart shows an exemplary method for preparing auxiliary materials. [Modes for carrying out the invention]

[0010] The following detailed description should be read in reference to the drawings, where similar elements in different drawings are numbered identically. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative of the principles of the invention, not limiting, but illustrating them as examples. This specification describes several embodiments, adaptations, modifications, alternatives, and uses of the invention, including those that are currently considered to be the best modes for carrying out the invention, which will make it obvious to those skilled in the art how to make and use the invention.

[0011] Where used herein, the terms “about” or “approximately” for any number or range indicate a preferred dimensional tolerance that enables some or all of the components to function for the intended purposes described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±10% of the enumerated values. For example, “about 90%” may refer to a range of values ​​between 81% and 99%.

[0012] Surgical staple fastening assemblies, as well as methods for manufacturing and using the same, are provided. Generally, a surgical staple fastening assembly may include a staple cartridge in which staples are disposed internally, and an auxiliary material configured to be releasably held on the staple cartridge. As discussed herein, the various auxiliary materials provided may be configured to compensate for changes in tissue properties, such as changes in tissue thickness, and / or to promote tissue endografting when the auxiliary material is stapled to the tissue.

[0013] An exemplary staple fastening assembly, as described herein and shown in the drawings, may include various features to facilitate the application of surgical staples. However, it will be understood by those skilled in the art that a staple fastening assembly may include only some of these features, and / or may include various other features known in the art. The staple fastening assemblies described herein are intended to represent specific exemplary embodiments only. Furthermore, although auxiliary materials are described in relation to surgical staple cartridge assemblies, auxiliary materials may be used in relation to the reloading of staples that are not cartridge bases or any type of surgical instrument.

[0014] Figure 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable auxiliary materials. The illustrated surgical stapling and cutting device 100 includes an end effector 106 having an anvil 102 pivotally connected to an elongated channel 104. As a result, the stapling application assembly 106 can move between an open position, as shown in Figure 1, and a closed position in which the anvil 102 is positioned adjacent to the elongated channel 104 and engages tissue between them. The end effector 106 can be attached at its proximal end to an elongated shaft 108 that forms an implement 110. When the end effector 106 is closed, or at least substantially closed (for example, when the anvil 102 moves from the open position in Figure 1 toward the elongated channel), the implement 110 can present a cross-section small enough to be suitable for inserting the end effector 106 through a trocar. Device 100 is configured to staple and cut tissue, but surgical devices configured to staple tissue but not cut it are also contemplated herein.

[0015] In various situations, the end effector 106 can be operated by a handle 112 connected to an elongated shaft 108. The handle 112 includes a user control unit such as a rotary knob 114 that rotates the elongated shaft 108 and the end effector 106 around the longitudinal axis (Ls) of the elongated shaft 108, and an articulated axis (T) which is substantially transverse to the longitudinal axis (Ls) of the elongated shaft 108. A The system may include an articulation control unit 115 that can articulate the end effector 106 around the pistol grip 118. Further control units may include a closing trigger 116 that can pivot relative to the pistol grip 118 to close the end effector 106. For example, when the closing trigger 116 is clamped, a closing release button 120 may be provided on the outside of the handle 112, so that pressing the closing release button 120 releases the clamp on the closing trigger 116 and opens the end effector 106. The handle 112 may also take the form of an interface for connection to a surgical robot.

[0016] In some embodiments, the firing trigger 122 can pivot relative to the closing trigger 116, thereby allowing the end effector 106 to simultaneously cut and staple the tissue clamped inside it. The firing trigger 122 may be powered, require user force to engage, or any combination thereof. A manual firing release lever 126 allows the firing system to be retracted if necessary before the firing system completes its movement for firing, and further, the firing release lever 126 allows a surgeon or other clinician to retract the firing system if it becomes stuck and / or malfunctions.

[0017] Further details regarding surgical stapling and cutting devices 100 and other surgical stapling and cutting devices suitable for use with the present disclosure are described, for example, in U.S. Patent No. 9,332,984 and U.S. Patent Application Publication No. 2009 / 0090763, which are incorporated herein by reference in their entirety. Furthermore, surgical stapling and cutting devices do not need to include a handle and instead may have a housing configured to be coupled to a surgical robot, as described, for example, in U.S. Patent Application Publication No. 2019 / 0059889, which are also incorporated herein by reference in their entirety.

[0018] As further shown in Figure 1, the staple cartridge 200 can be used with the apparatus 100. When in use, the staple cartridge 200 is positioned and connected within the elongated channel 104. The staple cartridge 200 can have various configurations, but in this illustrated embodiment, the staple cartridge 200 shown in detail in Figures 2A and 2B has a proximal end 202a and a distal end 202b, with the longitudinal axis (LC) of the cartridge extending between the proximal end 202a and the distal end 202b. As a result, when the staple cartridge 200 is inserted into the elongated channel 104 (Figure 1), the longitudinal axis (LC) is substantially or approximately parallel to the longitudinal axis (LS) of the elongated shaft 108. Furthermore, 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 launching member of a launching assembly, such as the launching assembly 400 in Figure 4, as will be discussed further below. As shown, the longitudinal slot 210 extends from the proximal end 202a to the distal end 202b of the staple cartridge 200. It is also intended herein that the longitudinal slot 210 may be omitted in other embodiments.

[0019] The illustrated staple cartridge 200 includes defined staple cavities 212, 214, each of which is configured to removably accommodate at least a portion of staples (not shown). The number, shape, and position of the staple cavities can vary and depend at least on the size and shape (e.g., mouth-like shape) of the staples removably disposed inside. In this illustrated embodiment, the staple cavities are arranged in two sets of three longitudinal rows, with the staple cavities 212 of the first set located on the first side of the longitudinal slot 210, and the staple cavities 214 of the second set located on the second side of the longitudinal slot 210. On each side of the longitudinal slot 210, and therefore for each set of rows, the first longitudinal row of staple cavities 212a, 214a extends along the longitudinal slot 210, the second row of staple cavities 212b, 214b extends along the first row of staple cavities 212a, 214a, and the third row of staple cavities 212c, 214c extends along the second row of staple cavities 212b, 214b. Each row may be substantially parallel, and the staple cavities constituting the row may be oriented substantially parallel to the longitudinal slot 210. As shown in Figure 2A, each staple 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. Furthermore, at least the centers of the two adjacent cavities 212 and 214 are spaced approximately 0.158 inches apart.

[0020] The staples, which are releasably stored within the staple cavities 212 and 214, can have various configurations. An exemplary staple 300, which can be releasably stored in each of the staple cavities 212 and 214, is shown in its un-launched (pre-deployment, 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 linearly, and the staple legs 304 have the same unformed height. Furthermore, before the staple 300 is deployed, the staple crown 302 can be supported by a staple driver positioned within the staple cartridge 200, and at the same time, the staple legs 304 can be at least partially housed within the staple cavities 212 and 214. Furthermore, the staple leg 304 can extend beyond the upper surface, such as the upper surface 206 of the staple cartridge 200, when the staple 300 is in the non-firing position. In certain circumstances, as shown in Figure 3, the tip 306 of the staple leg 304 can be sharp and pointed, capable of cutting and penetrating tissue.

[0021] During use, the staple 300 can be deformed from an unfired position to a firing 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 deform relative to the anvil 102, the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply compressive force to the tissue. Furthermore, the legs 304 of each staple 300 can deform downward toward the crown 302 of the staple 300 to form a staple capture region into which tissue can be captured. In various cases, the staple capture region may be defined between the inner surface of the deformed leg and the inner surface of the crown of the staple. The size of the staple capture region may 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.

[0022] In some embodiments, all staples arranged within the staple cartridge 200 may have the same unfired (pre-deployed, unformed) configuration. In other embodiments, the staples may include at least two groups of staples, each having different unfired (pre-deployed, unformed) configurations, such as differing in height and / or shape from one another.

[0023] Referring again to Figures 2A and 2B, the staple cartridge 200 extends from the top or deck surface 206 to the bottom surface 208, with the top surface 206 configured as the surface facing the tissue and the bottom surface 208 configured as the surface facing the channel. As a result, as shown in Figure 1, when the staple cartridge 200 is inserted into the elongated channel 104, the top surface 206 faces the anvil 102 and the bottom surface 208 (which is obscured) faces the elongated channel 104.

[0024] Referring to Figures 4 and 5, a launch assembly, such as launch assembly 400, can be used in conjunction with a surgical stapling and cutting device, such as device 100 in Figure 1. The launch assembly 400 can be configured to advance a wedge thread 500, which has a wedge 502 configured to deploy staples from a staple cartridge 200, into tissue trapped between an anvil, such as an anvil 102 in Figure 1, and a staple cartridge, such as the staple cartridge 200 in Figure 1. Furthermore, an E-shaped beam section 402 at the distal portion of the launch assembly 400 may launch staples from the staple cartridge. During launch, the E-shaped beam section 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-shaped beam section 402 includes a pair of upper pins 404, a pair of intermediate pins 406 which may be along a portion 504 of the wedge thread 500, and a lower pin or foot 408. The E-shaped beam section 402 may also include a sharp cutting edge 410 configured to cut captured tissue as the launch assembly 400 advances distally, and thus toward the distal end of the staple cartridge. Furthermore, integrally molded upper guides 412 and intermediate guides 414, which bracket each vertical end of the cutting edge 410 and project proximally, may further define a tissue staging area 416 that assists in guiding tissue toward the sharp cutting edge 410 before cutting the tissue. The intermediate guides 414 may also function to engage with and launch staples in the staple cartridge by abutting a stepped central member 506 of the wedge thread 500, which enables staple forming by the end effector 106.

[0025] During use, the anvil 102 in Figure 1 is moved to the closed position by pressing down the closing trigger in Figure 1, which advances the E-shaped beam section 402 in Figure 4. The anvil 102 can position the tissue relative to at least the upper surface 206 of the staple cartridge 200 in Figures 2A and 2B. Once the anvil is properly positioned, the staples 300 in Figure 3, which are arranged inside the staple cartridge, can be deployed.

[0026] To deploy staples from the staple cartridge, as described above, the thread 500 in Figure 5 can be moved from the proximal end to the distal end of the cartridge body, and therefore from the proximal end to the distal end of the staple cartridge. As the firing assembly 400 in Figure 4 advances, the thread can contact the staple driver in the staple cartridge and lift it upward within the staple cavities 212, 214. In at least one example, the thread and staple driver may each include one or more inclined surfaces, i.e., beveled surfaces, which work together to move the staple driver upward from its unfired position. Once the staple driver is lifted upward within each staple cavity, the staples advance upward, exiting the staple cavity and penetrating into the tissue. In various cases, the thread may move several staples upward simultaneously as part of the firing sequence.

[0027] As described above, the stapling device can be used in combination with a compressible auxiliary material. While such auxiliary materials are shown and described below, those skilled in the art will understand that the auxiliary materials disclosed herein can be used with other surgical instruments and do not need to be connected to a stapling cartridge as described. Furthermore, those skilled in the art will understand that the stapling cartridge does not need to be replaceable.

[0028] As mentioned above, with some surgical staplers, surgeons are often required to select the appropriate staple with the appropriate staple height for the tissue being stapled. For example, surgeons use tall staples for thick tissue and short staples for thin tissue. However, in some situations, the stapled tissue does not have a consistent thickness, and therefore the staple cannot achieve the desired post-launch configuration for all parts of the stapled tissue (e.g., parts of thick tissue and parts of thin tissue). If staples of the same or substantially higher height are used due to the inconsistent thickness of the tissue, undesirable leakage and / or tearing of the tissue may occur at the staple site, especially if the staple site is exposed to internal pressure at that site and / or along the row of staples.

[0029] Therefore, to avoid the need to consider staple height when stapling tissue during surgery, various embodiments of auxiliary materials are provided that can be configured to compensate for the varying thicknesses of tissue captured within fired (deployed) staples. That is, the auxiliary materials described herein can also, in combination with the auxiliary material, provide appropriate tissue compression within and between fired staples, while enabling the use of sets of staples of the same or similar height when stapling tissue of varying thicknesses (e.g., from thin to thick tissue). Thus, the auxiliary materials described herein can maintain suitable compression for thin or thick tissue being stapled, thereby minimizing leakage and / or tearing of tissue at the staple site. Furthermore, the exemplary auxiliary materials described herein may be configured to be absorbed into the body over a period of 100 to 300 days, depending on the implantation site and the health of the tissue.

[0030] Alternatively or in addition, the implantable material may be configured to promote tissue endografting. In various situations, it is desirable to promote tissue endografting into the implantable material in order to promote the healing of the tissue being treated (e.g., stapled and / or incised tissue) and / or to accelerate the patient's recovery. More specifically, tissue endografting into the implantable material may reduce the incidence, severity, and / or duration of inflammation at the surgical site. Tissue endografting into and / or around the implantable material may, for example, control the spread of infection at the surgical site. For example, vascular, particularly leukocyte, endografting into and / or around the implantable material may combat infection in and around the implantable material and adjacent tissue. Tissue endografting may also assist the patient's body in accepting foreign bodies (e.g., implantable materials and staples) and may reduce the likelihood of the patient's body rejecting foreign bodies. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0031] Generally, the auxiliary materials provided herein are designed and positioned on top of a staple cartridge, such as a staple cartridge 200. When a staple is fired (deployed) from the cartridge, the staple penetrates the auxiliary material and enters the tissue. When the legs of the staple are deformed upon contact with an anvil positioned on the opposite side of the staple cartridge, the deformed legs capture a portion of the auxiliary material and a portion of the tissue within each staple. That is, when a staple is fired into the tissue, at least a portion of the auxiliary material is positioned between the tissue and the fired staple. While the auxiliary materials described herein may be configured to be attached to a staple cartridge, it is also intended herein that the auxiliary materials may be configured to mate with components of other instruments, such as an anvil for a surgical stapler. Those skilled in the art will understand that the auxiliary materials provided herein may be used for reloading staples that are not replaceable cartridges or cartridge-based.

[0032] How to staple tissue Figures 6A and 6B show exemplary embodiments of a staple fastening assembly 600 including a staple cartridge 200 and an auxiliary material 604. For simplicity, the auxiliary material 604 is schematically shown in Figures 6A and 6B, and various configurations of the auxiliary material will be described in more detail below. As shown, the auxiliary material 604 is positioned relative to the staple cartridge 200. Although partially obscured in Figures 6A and 6B, the staple cartridge 200 includes staples 300 configured to be deployed within the structure. The staples 300 may have any preferred unformed (pre-deployment) height.

[0033] In the illustrated embodiments, the auxiliary material 604 can be fitted to at least a portion of the top surface or deck surface 206 of the staple cartridge 602. In some embodiments, the top surface 206 of the staple cartridge 200 may include one or more surface features that engage with the auxiliary material 604 and / or prevent premature release of the auxiliary material 604 from the staple cartridge 200. Exemplary surface features are described further later in U.S. Patent Application Publication No. 2016 / 0106427, which is incorporated herein by reference in whole.

[0034] Figure 6B shows a staple fastening assembly 600 positioned within and connected to the elongated channel 610 of the surgical end effector 106. The anvil 102 is pivotally connected to the elongated channel 610 and is therefore movable between an open position and a closed position relative to the elongated channel 610, and thus to the staple cartridge 200. The anvil 102 is shown in the closed position in Figure 6B, and the interstitial gap T formed between the staple cartridge 602 and the anvil 612 is visible. G1 This shows that. More specifically, the interstitial space T G1The intercellular gap T is defined by the distance between the microstructure compression surface 102a of the anvil 102 (e.g., the microstructure engagement surface between staple-forming pockets in the anvil) and the microstructure contact surface 604a of the auxiliary material 604. In this illustrated example, both the microstructure compression surface 102a of the anvil 102 and the microstructure contact surface 604a of the auxiliary material 604 are planar or substantially planar (e.g., planar within manufacturing tolerances). As a result, when the anvil 102 is in the closed position, the intercellular gap T is defined as shown in Figure 6B. G1 When no tissue is present within it, it is generally uniform (for example, nominally identical within manufacturing tolerances). In other words, the inter-tissue gap T G1 The interstitial gap T is substantially constant across the end effector 106 (e.g., in the y-direction) (e.g., constant within manufacturing tolerances). In other embodiments, the microstructure compression surface of the anvil includes a stepped surface having longitudinal steps between adjacent longitudinal portions, and thus a stepped profile can be formed (e.g., in the y-direction). In such examples, the interstitial gap T G1 It can fluctuate.

[0035] The auxiliary material 604 is compressible, and can be compressed to various heights to compensate for the different tissue thicknesses captured within the deployed staples. The auxiliary material 604 has an uncompressed (undeformed) or pre-deployment height and is configured to deform to one of several compressed (deformed) or deployed heights. For example, the auxiliary material 604 may have an uncompressed height that is higher than the post-launch height of the staple 300 deployed in the staple cartridge 200 (e.g., the height (H) of the launched staple 300a in Figure 7). That is, the auxiliary material 604 may have an undeformed state in which the maximum height of the auxiliary material 604 is higher than the maximum height of the launched staple (e.g., the staple in the molded configuration).

[0036] As shown in Figure 6C, the staple cartridge 200 includes a thread 614 and a plurality of drivers 612 configured to drive one or more staples upward to deploy the staples when the user presses the firing trigger 122 shown in Figure 1. When the firing trigger 122 is pressed, the thread 614 moves toward the distal end 616 of the end effector 106, contacting one or more drivers 612a, 612b at a time, pushing one or more drivers 612a, 612b upward together with one or more corresponding staples 300 to form a fired staple 300a, trapping material such as tissue (T) between the anvil 104 and the fired staple 300a (see Figure 7). The cartridge 200 may include a first row 613a of a single driver 612a corresponding to driving staples 300 located in the third rows 214c, 212c of the staple cavity, and a second row 613b of a dual driver 612b corresponding to driving staples 300 located in the first rows 212a, 214b and the third rows 212a, 212b of the staple cavity (see Figure 2A for the staple cavity).

[0037] Referring to Figures 6C to 6I, one or more single drivers 612a may have a height SDH of approximately 0.044 inches to approximately 0.074 inches, such as approximately 0.050 inches to approximately 0.068 inches, approximately 0.054 inches, or approximately 0.06 inches. One or more dual drivers 612b may have a height DDH of approximately 0.044 inches to approximately 0.074 inches, such as approximately 0.050 inches to approximately 0.068 inches, approximately 0.054 inches, or approximately 0.06 inches. The thread 614 may have at least a first rail 614a corresponding to a single driver 612a located in a first column 613a, and a second rail 614b corresponding to a dual driver 612b located in a second column 613b. The first rail 614a may have a rail height SRH of approximately 0.164 inches or approximately 0.167 inches and engages with a single driver 612a. The second rail 614b may have a rail height DRH of approximately 0.140 inches to approximately 0.162 inches, such as approximately 0.149 inches or approximately 0.152 inches, and engages with a double driver 612b. When the staple 300 is deployed, the staple 300 forms a fired staple 300a having a crush height CH of approximately 0.08 inches to approximately 0.12 inches, such as approximately 0.97 inches or approximately 0.1 inches.

[0038] Referring to Figure 6I, the saddle 624a of a single driver 612a can be spaced about -0.010 inches to about -0.031 inches, for example -0.021 inches or about -0.017 inches, by a distance of SDSD from the cartridge deck 206 when the single driver 612a is fully engaged with the thread 614. The saddle 624b of a dual driver 612b can be spaced about DDSD, for example -0.032 inches or about -0.036 inches, by a distance of about -0.022 inches to about -0.042 inches from the cartridge deck 206 when the dual driver 612b is fully engaged with the thread 614.

[0039] Referring to Figures 6D to 6I, one or more single drivers 612a may have a rigger 622a having an inclined position SDL extending about 0.056 inches to about 0.066 inches, such as about 0.061 inches from the proximal edge 615a of the single driver 612a. The rigger 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 drivers 612b may have a rigger 622b having an inclined position DDL extending about 0.094 inches to about 0.114 inches, such as about 0.104 inches from the proximal edge 615b of the dual driver 612b. The rigger 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. A single driver 612a may have an inclination angle SDRA of approximately 24 to 34 degrees, such as approximately 29 degrees. A dual driver 612b may have an inclination angle DDRA of approximately 22 to 30 degrees, such as approximately 26 degrees. The first rail 614a of the thread 614 may have an inclination angle SRA of approximately 22 to 32 degrees, such as approximately 26.9 degrees. The second rail 614b of the thread 614 may have an inclination angle SRA of approximately 20 to 30 degrees, such as approximately 24.1 to 24.5 degrees.

[0040] When used, a surgical stapling and cutting device such as device 100 in Figure 1 is directed toward the surgical site, and the tissue is positioned between the anvil 102 and the stapling assembly 600 so that the anvil 102 is positioned adjacent to a first side of the tissue and the stapling assembly 600 is positioned adjacent to a second side of the tissue (for example, the tissue can be positioned relative to the tissue contact surface 604a of the auxiliary material 604). Once the tissue is positioned between the anvil 102 and the stapling assembly 600, the surgical stapler is operated, for example as described above, thereby clamping the tissue between the anvil 102 and the stapling assembly 600 (for example, between the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the auxiliary material 604), deploying staples from the cartridge through the auxiliary material into the tissue, and stapling and attaching the auxiliary material to the tissue.

[0041] As shown in Figure 7, when the staple 300 is fired, a portion of the tissue (T) and auxiliary material 604 is captured by the fired (formed) staple 300a. Each fired staple 300a defines a capture area within itself to accommodate the captured auxiliary material 604 and tissue (T), as described above. The capture area defined by the fired staple 300a is at least partially limited by the height (H) of the fired staple 300a.

[0042] Figure 8A shows a perspective view of a staple cartridge assembly 600 having an auxiliary material 604 and a staple cartridge 200. The auxiliary material 604 has a tissue contact surface 604a, a proximal end 604c, and a distal end 604b. The auxiliary material 604 may include a slot / slit 808 that separates or partially separates two parallel portions of the auxiliary material 604. In one example, the auxiliary material 604 may include a slot 808 that separates two parallel portions of the auxiliary material 604, while in another example, the auxiliary material 604 may include a slit 808 that separates two parallel portions of the auxiliary material 604, and one or more bridges (e.g., five bridges) 802 that connect the two parallel portions of the auxiliary material 604. At least one bridge has a longitudinal length of about 0.035 inches to about 0.046 inches. The auxiliary material 604 has a length L of approximately 40 mm to approximately 80 mm, such as approximately 60 mm to approximately 65 mm, approximately 66.04 mm to approximately 66.3 mm, approximately 45 mm to approximately 55 mm, or approximately 51.12 mm to approximately 51.38 mm. The auxiliary material 604 has a width W of approximately 8 mm to approximately 12 mm, such as approximately 9.75 mm to approximately 10.25 mm or approximately 10.025 mm to approximately 10.035 mm. The auxiliary material 604 may also have a thickness or height TH of approximately 2.5 mm to approximately 3.5 mm, for example, approximately 2.85 mm to approximately 3.15 mm, or approximately 2.95 mm to approximately 3.05 mm.

[0043] Cartridge 200 has a height CH of approximately 6.3 mm to approximately 8.1 mm, a width CW of approximately 8.9 mm to approximately 14 mm, and a length CL of approximately 80 mm to approximately 90 mm, for example, approximately 86.7 mm.

[0044] Referring to Figures 8B to 8D, the auxiliary material 604 has a lower surface 604d and may 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 may have an angled portion 818b proximal to the vertical portion 818a. The angled portion 818b has an inclination VA of about 30 degrees to about 60 degrees (e.g., about 45 degrees), measured from the tissue contact surface 604a.

[0045] Referring to Figure 8C, the distal chamfered portion 818 and the central portion 822 have a combined length DL of approximately 2.25 inches to approximately 2.45 inches, for example, approximately 2.35 inches. The proximal chamfered portion 820 has an angled portion 820b having a length DCL of approximately 0.1 inches to approximately 0.3 inches. Furthermore, the proximal chamfered portion 820 has a horizontal portion 820a and an inclined portion 820n. The horizontal portion 820a may have a width CW of approximately 0.27 inches to approximately 0.29 inches, for example, approximately 0.28 inches.

[0046] In some embodiments, the auxiliary member 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, for example, about 0.04 inches.

[0047] Referring again to Figure 8A, the staple cartridge 200 may include one or more raised ledges 804 along one or more sides of the auxiliary material 602 to help align the auxiliary material 604 on the deck of the staple cartridge 200.

[0048] As mentioned above, the auxiliary material 604 is compressible. Figures 9A and 9B show the dogbone shape and dimensions that the auxiliary material 604 takes when subjected to compressibility testing to determine its material properties. As shown in the figures, the auxiliary material 604 has a compressive length CPL of approximately 9.45 mm to approximately 9.61 mm, for example, approximately 9.53 mm. The auxiliary material 604 has a compressive thickness CT of approximately 3.15 mm to approximately 3.21 mm, for example, approximately 3.18 mm. The auxiliary material 604 has a dogbone radius DBR of approximately 12.62 mm to approximately 12.78 mm, for example, approximately 12.7 degrees. The auxiliary material 604 has a dogbone height DBH of approximately 6.35 mm to approximately 12.71 mm, for example, approximately 9.53 mm. The auxiliary material 604 has a dogbone length DBL of approximately 40 mm to approximately 80 mm, for example, approximately 63.5 mm. The support material has a dogbone width (DBW) of approximately 2.5 mm to 3.5 mm, for example, approximately 3.03 mm.

[0049] Figures 10A to 10D show an exemplary staple cartridge 1000 having a deck 1012 with three levels, thereby allowing the auxiliary material 604 to extend around various protrusions and recesses to increase the contact surface area between the auxiliary material 604 and the staple cartridge 1000, thereby increasing adhesion and alignment between the staple cartridge 1000 and the auxiliary material 604. The staple cartridge 1000 is similar to the staple cartridge 200 but has more exemplary details showing the deck 1012. In particular, the staple cartridge 1000 may include a distal end 1001b and a proximal end 1001a having a non-traumatic shape. The staple cartridge 1000 may include one or more raised ledges 1004 (e.g., two raised ledges 104) that align with the longitudinal edge of the deck 1012. The staple cartridge 1000 may include a plurality of aligned staple cavities 1014 positioned 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 combined raised surface of the deck 1012 that fits the ends of the staple cavities 1014. This combined raised surface 1018 essentially combines the raised surface corresponding to the proximal end of the adjacent staple cavity 1014 with the distal end of the staple cavity 1014. Furthermore, staple cavities 1014 located at the distal ends 1001b and proximal ends 1001a of the first row 1022a, the second row 1022b, and the third row 100c include raised surfaces 1020b, 1018a, which are approximately half the size of the combined raised surfaces 1020 between the staple cavities 1014. The cartridge deck 1012 may also include a plurality of lowered surfaces 1016. At least two triangular lower surfaces 1016 may be located on the sides of the staple cavity 1014 located in the second row 1022b, with the vertices of the triangles pointing to the combined raised surfaces 1018 located in the adjacent rows 1022a, 1022c of the staple cavity 1014.At least one triangular underface 1018 located on the side of the third row 1022c distal to slot 1006 may have a triangular vertex pointing to a combined raised surface 1018 located in the adjacent row 1022b. Furthermore, the staple cartridge 1000 may include a triangular end underface 1016a located between the distal end 1001b of the cartridge 1000 and the second row 1022b of the staple cavity 1014, the vertex of which is aligned with the second row 1022b and points toward the proximal end 1001a of the staple cartridge 1000. As shown, the cartridge 1000 does not have to include any descending surface directly adjacent to the staple cavity 1014 of the first row 1022a.

[0050] Figures 11A–11D show an exemplary staple cartridge 1100 similar to the exemplary staple cartridge 1000 in Figures 10A–10D, with several notable differences, including having a flat deck 1112 without raised surfaces adjacent to the staple cavity 1114. The deck 1112 may include multiple lowered surfaces 1116, 1116a that are positioned and molded similarly to the lowered surfaces 1016, 1016a of the exemplary cartridge 1000. Furthermore, the deck 1112 may include an additional lowered surface 1116 positioned adjacent to the staple cavity 1114 of the first row 1122a on the side closest to the slot 1106. Thus, each staple cavity 1114 of the first row 1122a, second row 1122b, and third row 1122c may have at least one adjacent lower surface 1016 that is triangular in shape.

[0051] Both staple cartridges 1000 and 1100 allow for staples 300 with a pre-formed height of approximately 0.179 inches, which is higher than that of previous equipment, along with a deck height of approximately 0.060 inches, which is lower than that of previous equipment.

[0052] Figures 12A and 12B show a top and side view of the auxiliary material 604 after the staples have been fired. As can be seen from the figures, the auxiliary material 604 may be split into two after firing, and the adhesive 1232 (see Figures 6A and 6B) that adheres the auxiliary material 604 to the cartridge 200 may, together with the auxiliary material 604, form ridges 604e, 604f and corresponding ridges 1232a within the auxiliary material. This means that the auxiliary material 604 can be adapted to different heights and compressions depending on the application. The auxiliary material can be attached to the cartridge 200 using approximately 100 mg to approximately 120 mg of adhesive or buttress adhesive material.

[0053] Surgical adjuvants 604 may have one or more of the properties described below to enable the adjuvants to be flexible when in vivo but to remain in a specific position attached to a cartridge when outside the body. For example, polyurethane may function to create an adjuvants 604 that is flexible when in vivo but "set" to its final mechanical properties once a plasticizer is absorbed in vivo. In some embodiments, a plasticizer may be added to a polyurethane foam to lower its glass transition temperature to the range described below and conform to other enumerated properties. In any case, an adjuvants 604 having one or more of the properties described below consistently produce hemostasis or near-hemostatic seals on tissue.

[0054] The surgical augment 604 may comprise a polyurethane foam with or without a plasticizer, and the glass transition temperature of the surgical augment 604 is approximately 0°C to approximately 40°C (e.g., approximately 19.4°C), e.g., approximately 7.5°C to approximately 22.5°C or approximately 12.5°C to approximately 17.5°C. The glass transition temperature of the augment 604 is obtained by using a standard differential scanning calorimetry (DSC) system. Using a DSC system having the output shown in Figure 13, the augment 604 is equilibrated at approximately -40°C, heated to approximately 120°C at approximately 40°C / min, held isothermally for approximately 1 minute, cooled to approximately -40°C at approximately 40°C / min, held isothermally for approximately 1 minute, and then heated to approximately 120°C at approximately 10°C / min to obtain the glass transition temperature T g The values ​​were measured and recorded using a DSC system.

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

[0056] The plasticizer may include one or more of low molecular weight glycols, polyethylene glycols, polyvinyl pyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, boric acid esters, and fatty acids. In some embodiments, the plasticizer includes one or more fatty acids.

[0057] Referring to FIG. 8E, the aid 604 may have pores 832 having a median pore size, such as about 0.022 mm 3 such as about 0.025 mm 3 to about 0.300 mm 3 In some examples, the aid 604 may have one or more struts 834 between the pores 832 that provide support and strength to the aid 604. Specifically, the aid 604 may 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 embodiments, the aid 604 includes a polydioxanone (PDO) film disposed on one or more surfaces of the polyurethane foam. In some embodiments, the PDO film is adhered to at least the bottom or crown side of the aid 604. In some embodiments, the PDO film has a thickness of about 20 μm to about 100 μm, such as about 40 μm.

[0059] Generally, the auxiliary material 604 can have a compressive strength of approximately 30 kPa to 70 kPa, such as approximately 30 kPa to 60 kPa (e.g., approximately 42 kPa), approximately 30 kPa to 50 kPa, and approximately 32.5 kPa to 37.5 kPa. To test the compressive strength, the auxiliary material 604 was placed in a humid, warm environment at approximately 37°C, compressed to a first height, then compressed to a second height lower than the first height, and then released back to the first height when the compressive strength of the auxiliary material was measured.

[0060] In some embodiments, the foam (e.g., polyurethane foam) portion of the auxiliary material 604 may have a (peak) tensile strength of approximately 50 kPa to approximately 150 kPa or approximately 30 kPa to approximately 90 kPa, such as approximately 45 kPa to approximately 85 kPa or approximately 55 kPa to approximately 75 kPa. In some embodiments, the foam (e.g., polyurethane foam) of the auxiliary material 604 has a (peak) tensile strength of approximately 110 kPa to approximately 150 kPa. The tensile strength is measured on the auxiliary material 604 having a dogbone configuration illustrated and described with respect to Figures 9A and 9B. Specifically, the tensile strength of the auxiliary material 604 is measured after immersion in water at a temperature of approximately 37°C for less than 1 minute, followed by a tensile strength test.

[0061] Referring to Figure 14, the surgical aid 604 may be prepared by using Method 1400, which includes selectively adding a plasticizer to a polyurethane foam (Step 1402) to produce the surgical aid 604 described throughout. The plasticizer can plasticize the polyurethane foam to lower the glass transition temperature of the foam and / or reduce the mechanical strength of the polyurethane foam, either by bulk swelling in solution or by direct deposition on or within the surgical aid. In some embodiments, Method 1400 may optionally include: preparing a partially sealed foam by bonding at least one surface of a polyurethane foam (e.g., the bottom or crown surface) with a PDO film (optional step 1404); subjecting the partially sealed polyurethane foam to a temperature of about 105°C to about 115°C for about 24 minutes (optional step 1406); subjecting the partially sealed foam to a pressure of about 5 kN (optional step 1408); allowing the partially sealed foam to stand for at least 30 seconds (e.g., about 60 seconds) (optional step 1410); and subjecting the partially sealed foam to a temperature of about 35°C to about 45°C for about 24 minutes (optional step 1412). Step 1408 may be performed concurrently with steps 1406, 1410, and 1412. In some embodiments, the surgical aid 604 is manufactured without plasticizer, and the polyurethane foam is produced such that it has a specific ratio of air to polyurethane for a given volume, due to the size and amount of pores.

[0062] As those skilled in the art will understand, the embodiments described above are by illustrative reference only, and the present invention is not limited to those specifically illustrated and described herein. Rather, the scope of the present invention includes both combinations and partial combinations thereof of the various features described herein, as well as variations and modifications thereof not disclosed in the prior art, which will be conceivable to those skilled in the art by reading the above description.

[0063] In some embodiments, the disclosed devices (e.g., end effectors, surgical aids, and / or staple cartridges), and methods involving one or more of the disclosed devices, may include one or more of the following provisions:

[0064] Clause 1: Surgical adjuvant 604 comprising a polyurethane foam, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of about 0.125 to about 0.325, and the glass transition temperature of the surgical adjuvant 604 is about 0°C to about 40°C.

[0065] Clause 2: The volume ratio of polyurethane foam to the total volume of the surgical adjuvant 604 as described in Clause 1 is approximately 0.175 to approximately 0.225.

[0066] Clause 3: The volume ratio of polyurethane foam to the total volume of the surgical adjuvant 604 as described in Clause 1 is approximately 0.19 to approximately 0.21.

[0067] Clause 4: The glass transition temperature of the surgical adjuvant 604 described in Clause 1 is approximately 7.5°C to approximately 22.5°C.

[0068] Clause 5: The glass transition temperature of surgical aid 604 is approximately 12.5°C to approximately 17.5°C, as described in Clause 1 of the surgical aid 604.

[0069] Clause 6: The median pore size of surgical adjuvant 604 is approximately 0.025 to 0.300 mm. 3 Surgical aid 604 as described in Article 1.

[0070] Clause 7: The surgical adjuvant 604 according to Clause 1, further comprising a polydioxanone (PDO) film disposed on at least one surface of a polyurethane foam.

[0071] Clause 8: The PDO film is a surgical adjuvant 604 as described in Clause 7, having a thickness of approximately 20 μm to approximately 100 μm.

[0072] Clause 9: Surgical adjuvant 604 as described in Clause 1, further comprising a plasticizer added to the polyurethane foam.

[0073] Clause 10: Surgical adjuvant 604 as described in Clause 9, comprising at least one of the following plasticizers: low molecular weight glycol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate esters, and fatty acids.

[0074] Clause 11: The plasticizer comprises at least one fatty acid, as described in the surgical adjuvant 604 of Clause 9.

[0075] Clause 12: The surgical aid 604 described in Clause 1, having a compressive strength of approximately 30 kPa to approximately 70 kPa.

[0076] Clause 13: The compressive strength is approximately 30 to approximately 60 kPa, for surgical adjuvants 604 as described in Clause 12.

[0077] Clause 14: Surgical aid 604 as described in Clause 1, having a peak tensile strength of approximately 50 to approximately 150 kPa.

[0078] Clause 15: The surgical aid 604 described in Clause 1, having a length of approximately 40 mm to approximately 80 mm, a width of approximately 8 mm to approximately 12 mm, and a height of approximately 2.5 mm to approximately 3.5 mm.

[0079] Clause 16: The surgical aid 604 has a distal chamfered portion 604b and a proximal chamfered portion 604c, the distal chamfered portion having a vertical portion extending from the bottom of the surgical aid 604, the vertical portion having a height of approximately 0.009 inches to approximately 0.029 inches, the distal chamfered portion having an angled portion extending from the vertical portion to the upper surface 604a of the surgical aid, the angled portion having an inclination of approximately 30 degrees to approximately 60 degrees with respect to the upper surface, the proximal chamfered portion, The surgical aid 604 according to Clause 15, having a proximal end having a width of approximately 0.27 inches to approximately 0.29 inches, the proximal end chamfered portion 604c comprising a first angled lateral extension and a second angled lateral extension extending away from the distal end of the surgical aid to the proximal end of the proximal end chamfered portion 604c, each having a length of approximately 0.01 inches to approximately 0.40 inches when measured horizontally.

[0080] Clause 17: Surgical aid 604 as described in Clause 1, further comprising a plurality of supports having a central support thickness of approximately 0.025 mm to approximately 0.300 mm.

[0081] Clause 18: A method for producing a surgical aid 604, comprising selectively adding a plasticizer to a polyurethane foam to produce a surgical aid 604, wherein the surgical aid 604 has a glass transition temperature of about 0°C to about 40°C.

[0082] Clause 19: The method according to Clause 18, wherein selective addition of a plasticizer comprises either immersing a polyurethane foam in a solution containing a plasticizer or adding a plasticizer to at least a portion of at least one surface of a polyurethane foam via direct deposition, wherein the volume ratio of the polyurethane foam to the total volume of the surgical adjuvant 604 is in the range of about 0.125 to about 0.325.

[0083] Clause 20: The method according to Clause 18, further comprising laminating a polyurethane foam with a polydioxanone (PDO) film by bonding one side of the polyurethane foam to a PDO film, 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 5kN, leaving the partially sealed foam for at least 30 seconds, and subjecting the partially sealed foam to a temperature of about 35°C to about 45°C, in order to create a partially sealed foam.

[0084] Clause 21: Surgical adjuvant 604 comprising polyurethane foam, wherein the glass transition temperature of surgical adjuvant 604 is approximately 0°C to approximately 40°C.

[0085] Clause 22: The volume ratio of polyurethane foam to the total volume of the surgical aid 604 as described in Clause 21, wherein the volume ratio of polyurethane foam to the total volume of the surgical aid 604 is in the range of approximately 0.125 to approximately 0.325.

[0086] Clause 23: The volume ratio of polyurethane foam to the total volume of the surgical adjuvant 604 as described in Clause 21 is approximately 0.175 to approximately 0.225.

[0087] Clause 24: The volume ratio of polyurethane foam to the total volume of surgical adjuvant 604 is approximately 0.19 to approximately 0.21, as described in Clause 21.

[0088] Clause 25: The glass transition temperature of the surgical adjuvant 604 is approximately 7.5°C to approximately 22.5°C, as specified in any one of Clauses 21 to 24.

[0089] Clause 26: Surgical adjuvant 604 according to any one of Clauses 21 to 24, further comprising a plasticizer added to a polyurethane foam, wherein the glass transition temperature of surgical adjuvant 604 is approximately 12.5°C to approximately 17.5°C.

[0090] Clause 27: The median pore size of surgical adjuvant 604 shall be approximately 0.025 to approximately 0.300 mm. 3Surgical adjuvants 604 as described in any one of clauses 21 to 26.

[0091] Clause 28: Surgical adjuvant 604 according to any one of Clauses 21 to 27, further comprising a polydioxanone (PDO) film disposed on at least one surface of a polyurethane foam.

[0092] Clause 29: The PDO film is a surgical adjuvant 604 as described in Clause 28, having a thickness of approximately 20 μm to approximately 100 μm.

[0093] Clause 30: Surgical adjuvant 604 as described in Clause 26, comprising at least one of the following plasticizers: low molecular weight glycol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate esters, and fatty acids.

[0094] Clause 31: The plasticizer comprises at least one fatty acid, as described in the surgical adjuvant 604 of Clause 26.

[0095] Clause 32: Surgical aid 604 having a compressive strength of approximately 30 to approximately 70 kPa, according to any one of Clauses 21 to 31.

[0096] Clause 33: Surgical aid 604 having a compressive strength of approximately 30 to approximately 50 kPa, according to any one of Clauses 21 to 31.

[0097] Clause 34: Surgical aid 604 as described in any one of Clauses 21 to 33, having a peak tensile strength of approximately 50 to approximately 150 kPa.

[0098] Clause 35: Surgical aid 604 as described in any one of Clauses 21 to 33, having a peak tensile strength of approximately 45 to approximately 85 kPa.

[0099] Clause 36: Surgical aid 604 as described in any one of Clauses 21 to 35, having a length of approximately 40 mm to approximately 80 mm, a width of approximately 8 mm to approximately 12 mm, and a height of approximately 2.5 mm to approximately 3.5 mm.

[0100] Clause 37: Surgical aid 604 as described in any one of Clauses 21 to 35, having a length of approximately 60 mm to approximately 70 mm or approximately 45 mm to approximately 55 mm, a width of approximately 9.75 mm to approximately 10.25 mm, and a height of approximately 2.85 mm to approximately 3.15 mm.

[0101] Clause 38: Surgical aid 604 as described in any one of Clauses 21 to 35, having a length of approximately 66.04 mm to approximately 66.3 mm or approximately 21.12 mm to approximately 51.38 mm, a width of approximately 10.025 mm to approximately 10.035 mm, and a height of approximately 2.95 mm to approximately 3.05 mm.

[0102] Clause 39: A surgical staple 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, and a surgical auxiliary material 604 disposed on the cartridge 200, comprising polyurethane foam in a volume ratio of polyurethane foam to the total volume of the surgical auxiliary material 604 in the range of about 0.125 to about 0.325, wherein the glass transition T of the surgical auxiliary material 604 g A surgical staple cartridge assembly 106 comprises a surgical auxiliary material 604 having a temperature of approximately 0°C to approximately 40°C, and the surgical auxiliary material 604 having a length of approximately 40 mm to approximately 80 mm, a width of approximately 8 mm to approximately 12 mm, and a height of approximately 2.5 mm to approximately 3.5 mm.

[0103] Clause 40: Surgical auxiliary material 604 further comprises a plasticizer added to a polyurethane foam, as described in Clause 39, for the surgical cartridge assembly 106.

[0104] Clause 41: The surgical cartridge assembly 106 according to Clause 39 or 40, comprising a set of at least two 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, an orifice 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.

[0105] Clause 42: The surgical cartridge assembly 106 as described in Clause 39, wherein at least the centers of two adjacent staple cavities 212 in column 212a are spaced about 0.158 inches apart.

[0106] Clause 43: The surgical cartridge assembly 106 according to Clause 38, comprising two parallel parts 806a, 806b separated by a slot 808, the surgical auxiliary material 604.

[0107] Clause 44: The surgical cartridge assembly 106 according to Clause 38, comprising: surgical auxiliary material 604, two parallel portions 806a, 806b separated by at least one slit 808; and at least one bridge 802 connecting the two parallel portions 806a, 806b across at least one slit 808.

[0108] Clause 45: At least one bridge 802 having a length of approximately 0.035 inches to approximately 0.046 inches, a surgical cartridge assembly 106 as described in Clause 44.

[0109] Clause 46. A surgical cartridge assembly 106 according to any one of Clauses 39 to 45, wherein an adhesive is disposed between the surgical aid 604 and the cartridge 200 and is configured to bond the surgical aid to the cartridge.

[0110] Clause 47: The surgical cartridge assembly 106 as described in Clause 46, further comprising approximately 100 mg to approximately 120 mg of adhesive between the cartridge 200 and the surgical adjuvant 604.

[0111] Clause 48: A surgical cartridge assembly 106 according to any one of Clauses 39 to 47, comprising a deck 206 configured to align surgical aids 604, with at least one raised surface 804 along the side and / or distal side of the cartridge 200, and a non-traumatic molded distal end DC.

[0112] Clause 49: A surgical cartridge assembly 106 according to any one of Clauses 39 to 47, comprising a substantially flat deck 206, for cartridge 200.

[0113] Clause 50: A surgical cartridge assembly 106 according to any one of Clauses 39 to 48, wherein the cartridge 200 comprises a plurality of raised surfaces located at the distal and proximal ends of each staple cavity 212, 214, the raised surface corresponding to the distal end of the staple cavity 212, 214 forming a raised surface when combined with the raised surface corresponding to the proximal end of the adjacent staple cavity 212, 214.

[0114] Clause 51: A surgical cartridge assembly 106 according to any one of Clauses 39 to 50, wherein the cartridge 200 has multiple descending surfaces lower than the deck 206, and at least one descending surface is positioned along at least one side of the staple cavities 212, 214.

[0115] [Implementation Method] (1) Surgical auxiliary material 604, Contains polyurethane foam, The glass transition temperature of the surgical aid 604 is approximately 0°C to approximately 40°C, and The volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of approximately 0.125 to approximately 0.325. (2) The surgical aid 604 according to Embodiment 1, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid is about 0.175 to about 0.225. (3) The surgical aid 604 according to Embodiment 1, wherein the volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is about 0.19 to about 0.21. (4) The surgical auxiliary material 604 according to any one of Embodiments 1 to 2, wherein the glass transition temperature of the surgical auxiliary material is approximately 7.5°C to approximately 22.5°C. (5) The surgical auxiliary material 604 according to any one of embodiments 1 to 2, wherein the glass transition temperature of the surgical auxiliary material 604 is approximately 12.5°C to approximately 17.5°C.

[0116] (6) The median pore size of the surgical aid 604 is approximately 0.025 to approximately 0.300 mm. 3 A surgical aid 604 according to any of embodiments 1 to 5. (7) The surgical aid 604 according to any one of embodiments 1 to 6, further comprising a polydioxanone (PDO) film disposed on at least one surface of the polyurethane foam. (8) The surgical aid 604 according to Embodiment 7, wherein the PDO film has a thickness of about 20 μm to about 100 μm. (9) A surgical aid 604 according to any one of embodiments 1 to 8, further comprising a plasticizer added to the polyurethane foam. (10) The surgical adjuvant 604 according to Embodiment 9, wherein the plasticizer comprises a low molecular weight glycol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate ester, fatty acid, or a combination thereof.

[0117] (11) The surgical adjuvant 604 according to Embodiment 9, wherein the plasticizer comprises at least one fatty acid. (12) The surgical aid 604 according to any one of embodiments 1 to 11, wherein the surgical aid 604 has a compressive strength of about 30 to about 70 kPa. (13) The surgical aid 604 according to any one of embodiments 1 to 11, wherein the surgical aid 604 has a compressive strength of about 30 to about 50 kPa. (14) The surgical aid 604 according to any one of embodiments 1 to 13, wherein the surgical aid 604 has a peak tensile strength of about 50 to about 150 kPa. (15) The surgical aid 604 according to any one of embodiments 1 to 13, wherein the surgical aid 604 has a peak tensile strength of about 45 to about 85 kPa.

Claims

1. Surgical aid 604, Contains polyurethane foam, The glass transition temperature of the surgical auxiliary material 604 is approximately 0°C to approximately 40°C, and The volume ratio of the polyurethane foam to the total volume of the surgical aid 604 is in the range of approximately 0.125 to approximately 0.

325.

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

225.

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

21.

4. The surgical auxiliary material 604 according to any one of claims 1 to 2, wherein the glass transition temperature of the surgical auxiliary material is approximately 7.5°C to approximately 22.5°C.

5. The surgical auxiliary material 604 according to any one of claims 1 to 2, wherein the glass transition temperature of the surgical auxiliary material 604 is about 12.5°C to about 17.5°C.

6. The median pore size of the surgical aid 604 is approximately 0.025 to approximately 0.300 mm. ３ The surgical aid 604 according to any one of claims 1 to 2.

7. The surgical aid 604 according to any one of claims 1 to 2, further comprising a polydioxanone (PDO) film disposed on at least one surface of the polyurethane foam.

8. The PDO film has a thickness of approximately 20 μm to approximately 100 μm, and is a surgical aid 604 according to claim 7.

9. A surgical aid 604 according to any one of claims 1 to 2, further comprising a plasticizer added to the polyurethane foam.

10. The surgical adjuvant 604 according to claim 9, wherein the plasticizer comprises low molecular weight glycol, polyethylene glycol, polyvinylpyrrolidone, dibutyl sebacate, glyceryl triacetate, glyceryl behenate, hexanoic acid, decanoic acid, octadecanoic acid, borate ester, fatty acid, or a combination thereof.

11. The surgical aid 604 according to claim 9, wherein the plasticizer comprises at least one fatty acid.

12. The surgical aid 604 according to any one of claims 1 to 2, wherein the surgical aid 604 has a compressive strength of about 30 to about 70 kPa.

13. The surgical aid 604 according to any one of claims 1 to 2, wherein the surgical aid 604 has a compressive strength of about 30 to about 50 kPa.

14. The surgical aid 604 according to any one of claims 1 to 2, wherein the surgical aid 604 has a peak tensile strength of about 50 to about 150 kPa.

15. The surgical aid 604 according to any one of claims 1 to 2, wherein the surgical aid 604 has a peak tensile strength of about 45 to about 85 kPa.

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