Modified surgical aids and staple fastening assemblies

Abstract

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

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 / 485,047, filed on 11 October 2023, under Section 119 of the U.S. Patent Act, the entire contents of which are incorporated herein by reference in full.

[0002] (Field of invention) The present invention generally relates to compressible surgical aids, cartridges, cartridge assemblies, and methods for manufacturing 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 by puncturing tissue or blood vessels, or by incising tissue during stapling.

[0004] Most staplers have a handle (some directly operated by the user, others via a robotic interface), and a slender shaft extends from the handle, with a pair of movable opposing jaws formed at one end, between which staples are held and formed. Staples are typically housed in a staple cartridge, which can hold multiple rows of staples and is often located within one of the two jaws for the release of 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 close and the device is activated, the staples are released and formed. Some staplers include a knife, which is configured to move between rows of staples in the staple cartridge, and between the stapled rows, to longitudinally incise and / or open the stapled tissue. [Overview of the Initiative] [Means for solving the problem]

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

[0006] According to an example of the present invention, a stapled assembly is provided. The stapled assembly may include a deck of cartridges including at least one post extending away from the deck. The at least one post may include a first diameter at the top of the at least one post that is larger than a second diameter at the bottom of the at least one post. The cartridge may include a first film disposed on the deck and at least partially surrounding the at least one post with a gap between the top of the at least one post and the film. The cartridge may also include a surgical aid disposed on the first film and at least partially surrounding the at least one post. The surgical aid may include a polyurethane foam, the volume ratio of the polyurethane foam to the total volume of the surgical aid being in the range of about 0.125 to about 0.325.

[0007] According to an example of the present invention, a stapled assembly is provided. The stapled assembly includes a deck and surgical aids disposed on the deck. The surgical aids may include a polyurethane foam, the volume ratio of the polyurethane foam to the total volume of the surgical aids being in the range of about 0.125 to about 0.325. [Brief explanation of the drawing]

[0008] The present invention will be better understood from the following detailed description 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-deployed) 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-beam") of a 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] This is a longitudinal cross-sectional view of a surgical end effector having an anvil pivotably connected to an elongated channel, and a surgical cartridge assembly (Figure 6A) positioned within and connected to the elongated channel, showing the anvil in a closed position with no tissue between it and the auxiliary material. [Figure 6C] This is a perspective view of an exemplary surgical end effector having a channel and a surgical cartridge having threads and a driver. [Figure 7] These are schematic diagrams showing the auxiliary materials in Figures 6A and 6B, illustrating the organizational deployment. [Figure 8A] Objective perspective of a cartridge assembly [Figure 8B] This is a side view of an exemplary auxiliary component for a cartridge assembly. [Figure 8C] This is a top view of an exemplary auxiliary material for a cartridge assembly. [Figure 8D] This is a front view of an exemplary auxiliary component for a cartridge assembly. [Figure 8E] This figure shows an enlarged portion of an exemplary auxiliary material having a porous structure. [Figure 9A] This is a side view of an exemplary surgical aid having a film. [Figure 9B] This is a side view of an exemplary surgical aid having a film. [Figure 9C] An exemplary cartridge assembly including a surgical aid with a film is shown. [Figure 10A]An exemplary cartridge assembly having posts and an adhesive film for attaching a surgical aid is shown. [Figure 10B] An exemplary cartridge assembly having posts and an adhesive film for attaching a surgical aid is shown. [Figure 10C] An exemplary cartridge assembly having posts, an adhesive film, and a surgical aid is shown. [Figure 10D] It is a top view showing an exemplary stake, staple slot, and perforated film surrounding the staple slot. [Figure 10E] It is a top view showing an exemplary staple surrounded by a film. [Figure 11A] It is a flowchart showing an exemplary method for attaching a film to a polyurethane foam. [Figure 11B] It is a flowchart showing an exemplary method for placing a film on a polyurethane foam. [Figure 11C] It is a flowchart showing an exemplary method for attaching a surgical aid to a cartridge using a film and posts. [Figure 12] It is a graph showing the glass transition temperature Tg of an exemplary aid.

Best Mode for Carrying Out the Invention

[0009] The following detailed description should be read with reference to the drawings, and like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the present invention. The detailed description is illustrative, not limiting, and exemplifies the principles of the present invention. This specification enables those skilled in the art to make and use the present invention and describes some embodiments, adaptations, variations, alternatives, and uses of the present invention, including what is currently considered to be the best mode for carrying out the present invention.

[0010] 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%.

[0011] Surgical staple assemblies, as well as methods for manufacturing and using the same, are provided. Generally, a surgical staple assemblies may include a staple cartridge in which staples are disposed, and auxiliary materials 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 ingraftment when the auxiliary materials are stapled to the tissue.

[0012] Exemplary staple fastening assemblies, as described herein and shown in the drawings, may include various features to facilitate the application of surgical staples. However, those skilled in the art will understand that staple fastening assemblies may include only some of these features, and / or various other features known in the art. The staple fastening assemblies described herein are intended to represent specific exemplary examples only. Furthermore, while auxiliary materials are described in relation to surgical staple cartridge assemblies, auxiliary materials can be used in relation to the reloading of staples that are not cartridge bases or any type of surgical instrument.

[0013] The use of absorbable staple-fastening aids or other damping implants (e.g., ligament anchoring surgery, tendon repair) requires a balance between the mechanical strength of the implant / aid and its chemical properties (e.g., absorbability) and deployment requirements. The strength required to hold staples, sutures, screws, etc., may conflict with the requirements for endoscopic deployment (e.g., compression through a trocar). As the strength of the implant increases, the force required to compress the implant for insertion increases. This may exceed the limitations of endoscopic instruments (e.g., surgical staple-fastening and cutting devices 100) that require compromises on implant performance. This can be mitigated by phase-change materials (e.g., water swelling, transition from glass to rubber), but this further limits the applicable chemical properties given the need for absorbable implants or aids.

[0014] A simple way to improve the strength required to hold the stapes, sutures, screws, etc., without compromising the bulk mechanical properties of the implant is to include a lining material or film. Given the potential need to increase mechanical strength, the lining material may be a different material from the surgical adjuvant or implant. The lining material may be incorporated in situ into the surgical adjuvant or implant, or it may be bonded to it.

[0015] An example of bonding during processing is fusion welding, which is commonly used to join thermoplastic materials. In this process, the combination of temperature, pressure, and time is controlled so that the thermoplastic materials diffuse with each other. This process is less likely to be used between thermoplastic and thermosetting materials because the thermoplastic material flows around the geometric features on the thermosetting material, forming a mechanical bond.

[0016] Staple fastening aids or damping implants are likely to be composed of either thermoplastic or thermosetting materials. In the case of thermoplastic materials, the material may flow during processing, limiting its ability to maintain the desired shape through heat treatment. Conversely, incorporating backing material with thermosetting resins is limited during heat treatment because the materials do not flow and do not form a close bonding interface.

[0017] In the case of fusion welding of absorbent materials (e.g., polyurethane foam), another limited concern is the possibility of degradation during processing. Many absorbent materials, especially those with rapid absorption rates, are thermally unstable and therefore may lose their mechanical properties and produce decomposition products during processing.

[0018] Therefore, there are limitations related to adhesion, which is limited to (i) the use of thermally unstable materials, (ii) the inability to spatially adjust adhesive properties, and (iii) the mechanical encapsulation required for thermosetting / thermoplastic resin combinations. Consequently, incorporating lining materials into surgical adjuvants or damping implants is inefficient. Therefore, alternative methods and materials are discussed herein.

[0019] In addition, the film used to attach surgical aids to the staple cartridge deck can be mechanically attached to the cartridge deck together with the surgical aids to prevent premature release of the surgical aids from the staple cartridge deck.

[0020] In addition, the surgical aid itself may be designed or fabricated to include a gradient or double gradient in the bore diameter to help maintain both the compressive and tensile properties required to create a hemostatic seal, and to have sufficient strength to allow the surgeon to grasp and manipulate the tail of the cushion. Such forms mimic the shapes of bone or other naturally occurring materials.

[0021] 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 mounted at its proximal end on an elongated shaft 108 that forms a mounting portion 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 mounting portion 110 can present a sufficiently small cross-section 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.

[0022] In various cases, 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) substantially crossing 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 is presented on the outside of the handle 112, and 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.

[0023] In some examples, 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 be any combination of these. A manual firing release lever 126 allows the firing system to be retracted before completing its full movement for firing, if desired, and further allows a surgeon or other clinician to retract the firing system if it becomes immobile and / or malfunctions.

[0024] Further details relating to the surgical stapling and cutting device 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, the surgical stapling and cutting device does 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 incorporated herein by reference in their entirety.

[0025] As further shown in Figure 1, the staple cartridge 200 can be used with the apparatus 100. During 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 example, 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 nearly parallel to the longitudinal axis (LS) of the elongated shaft 108. Furthermore, the staple cartridge 200 is defined by two opposing walls 210a, 210b and includes a longitudinal slot 210 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 in other examples the longitudinal slot 210 may be omitted.

[0026] The illustrated staple cartridge 200 includes defined staple cavities 212, 214, each 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 to be removably placed inside. In this illustrated example, 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. For 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 separated by approximately 0.158 inches.

[0027] 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-deployed, unformed) configuration in Figure 3. The illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of the crown 302. In this example, the crown 302 extends linearly, and the staple legs 304 have the same unformed height. Furthermore, before the staple 300 is deployed, the staple crown 302 may be supported by a staple driver positioned within the staple cartridge 200, and at the same time, the staple legs 304 may be at least partially housed within the staple cavities 212 and 214. Furthermore, when the staple 300 is in the un-launched position, the staple legs 304 may extend beyond an upper surface such as the upper surface 206 of the staple cartridge 200. In certain cases, as shown in Figure 3, the tip 306 of the staple leg 304 may be pointed and sharp so as to be able to cut and penetrate tissue.

[0028] During use, the staple 300 can deform 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 in 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.

[0029] In some examples, all staples placed within the staple cartridge 200 may have the same unfired (pre-deployed, unformed) configuration. In other examples, the staples may include at least two groups of staples, each having a different unfired (pre-deployed, unformed) configuration, such as differing in height and / or shape from one another.

[0030] 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.

[0031] 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 may 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 402 located in the distal portion of the launch assembly 400 can launch staples from the staple cartridge. During launch, the E-shaped 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-shaped beam 402 includes a pair of upper pins 404, a pair of intermediate pins 406 which may follow a portion 504 of the wedge thread 500, and a lower pin or foot 408. The E-shaped beam 402 may also include a sharp cutting edge 410 configured to cut captured tissue as the firing assembly 400 advances distally, and thus toward the distal end of the staple cartridge. In addition, integrally formed, proximal projecting upper guides 412 and intermediate guides 414, flanking each vertical end of the cutting edge 410, may further define a tissue staging area 416 to assist in guiding tissue to the sharp cutting edge 410 before cutting the tissue. The intermediate guides 414 may also function to engage with and fire staples in the staple cartridge by abutting a stepped central member 506 of the wedge thread 500, which results in staple formation by the end effector 106.

[0032] During use, the anvil 102 in Figure 1 moves to the closed position by pressing down the closing trigger in Figure 1, allowing the E-shaped beam 402 in Figure 4 to advance. The anvil 102 can position the tissue relative to at least the upper surface 206 of the staple cartridge 200 in Figures 2A-2B. Once the anvil is properly positioned, the staples 300 in Figure 3, which are located within the staple cartridge, can be deployed.

[0033] 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 the staple driver upward within the staple cavities 212, 214. In at least one example, the thread and staple driver may each include one or more inclined or beveled surfaces, which can work together to move the staple driver upward from its unfired position. Once the staple driver is lifted upward within its respective staple cavity, the staple advances 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.

[0034] As described above, the stapling device can be used in combination with a compressible auxiliary material. Although 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 staple cartridge as described. Furthermore, those skilled in the art will understand that the staple cartridge does not need to be replaceable.

[0035] 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 cases, 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 and / or along the row of staples.

[0036] Therefore, to avoid the need to consider staple height when stapling tissue during surgery, various examples of auxiliary materials are provided that can be configured to compensate for the varying thicknesses of tissue captured within the fired (deployed) staples. That is, the auxiliary materials described herein can also be used in combination with the auxiliary material to provide sufficient tissue compression within and between fired staples, while enabling the use of sets of staples of the same or similar height when stapling tissues of varying thicknesses (e.g., from thin to thick tissues). Thus, the auxiliary materials described herein can maintain suitable compression for thin or thick tissues that are stapled, thereby minimizing leakage and / or tearing of tissue at the staple site. In addition, the exemplary auxiliary materials described herein may be configured to be essentially completely absorbed by the body over a period of 100 to 300 days, depending on the implantation site and the health of the tissue.

[0037] Alternatively or in addition, the implantable material may be configured to promote tissue endografting. In various cases, 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, endografting of blood vessels, particularly leukocytes, into and / or around the implantable material may combat infection in and around the implantable material and adjacent tissue. Tissue endografting may also facilitate the acceptance of foreign bodies (e.g., implantable materials and staples) by the patient's body and 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.

[0038] 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 staples deform 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.

[0039] How to staple tissue Figures 6A and 6B show exemplary examples of a staple fastening assembly 600 including a staple cartridge 200 and an auxiliary material 604. For simplification, the auxiliary material 604 is shown in its entirety in Figures 6A and 6B, and various configurations of the auxiliary material are 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 unfold within the structure. The staples 300 can have any preferred unformed (pre-unfolded) height.

[0040] In the illustrated example, the auxiliary material 604 may be fitted to 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 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 below and are described in U.S. Patent Application Publication No. 2016 / 0106427, which is incorporated herein by reference in its entirety.

[0041] Figure 6B shows a staple fastening assembly 600 positioned within and connected to an elongated channel 610 of a surgical end effector 106. 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. Anvil 102 is shown in the closed position in Figure 6B, and the interstitial gap T created between the staple cartridge 602 and 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 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 approximately constant across the end effector 106 (e.g., in the y-direction) (e.g., constant within manufacturing tolerances). In other examples, the microstructure compression surface of the anvil includes 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 interstitial gap T G1 It can fluctuate.

[0042] The auxiliary material 604 is compressible and can be compressed to various heights to compensate for different tissue thicknesses captured within the deployed staple. 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 placed 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 formed configuration).

[0043] As shown in Figure 6C, the staple cartridge 200 includes a thread 614 and a plurality of drivers 612, the plurality of drivers 612 configured to drive one or more staples upward and 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) (see Figure 7) between the anvil 104 and the fired staple 300a. The cartridge 200 may include a first row 613a of a single driver 612a corresponding to driving staples 300 located in the third rows 212c, 214c 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).

[0044] Referring to Figure 6C, one or more single drivers 612a may have a height SDH of approximately 0.044 inches to approximately 0.074 inches, for example, 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, for example, 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, for example 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 launched staple 300a having a crush height CH of approximately 0.08 inches to approximately 0.12 inches, for example approximately 0.97 inches or approximately 0.1 inches.

[0045] 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, as described above, to contain the captured auxiliary material 604 and tissue (T). The capture area defined by the fired staple 300a is at least partially limited by the height (H) of the fired staple 300a.

[0046] 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 604a, 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, such as approximately 2.85 mm to approximately 3.15 mm, or approximately 2.95 mm to approximately 3.05 mm.

[0047] 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.

[0048] 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 approximately 0.009 inches to approximately 0.029 inches, such as approximately 0.019 inches. The distal chamfered portion 818 may have an inclined portion 818b proximal to the vertical portion 818a. The inclined portion 818b has a slope VA of approximately 30 degrees to approximately 60 degrees, for example, approximately 45 degrees, measured from the tissue contact surface 604a.

[0049] Referring to Figure 8C, the distal chamfered portion 818 and the central portion 822 have a total 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 inclined portion 820b with a length DCL of approximately 0.1 inches to approximately 0.3 inches. The proximal chamfered portion 820 also 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.

[0050] In some examples, the auxiliary material 604 includes one or more slits 808 having two or more bridges 802 spaced apart by a bridge length BL of approximately 0.035 inches to approximately 0.045 inches, for example, approximately 0.04 inches.

[0051] 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 onto the deck of the staple cartridge 200.

[0052] Surgical adjuvants 604 may have one or more of the properties described below to enable them 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 adjuvant 604 that is flexible when in vivo but "set" to its final mechanical properties once a plasticizer is absorbed in vivo. In some examples, 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 adjuvant 604 having one or more of the properties described below consistently produces hemostasis or near-hemostatic seal on tissue.

[0053] The surgical aid 604 may include a polyurethane foam with or without a plasticizer. The glass transition temperature of the surgical aid 604 is about 0°C to about 40°C (e.g., about 19.4°C), for example, 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 aid 604 is obtained by using a standard differential scanning calorimetry (DSC) system. Using a DSC system having its output shown in FIG. 12, the aid 604 is equilibrated at about -40°C, heated to about 120°C at about 40°C / min, held isothermally for about 1 minute, cooled to about -40°C at about 40°C / min, held isothermally for about 1 minute, and then heated to about 120°C at about 10°C / min, and the glass transition temperature T g is measured and recorded by the DSC system.

[0054] The surgical aid 604 may include a volume ratio of polyurethane foam to the total volume of the aid 604 of about 0.125 to about 0.325, such as about 0.175 to about 0.225 or about 0.19 to about 0.21. The total volume may include air (from the pores of the foam) or other materials other than the foam structure.

[0055] 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, borate esters, and fatty acids. In some examples, the plasticizer includes one or more fatty acids.

[0056] Referring to FIG. 8E, the aid 604 may have pores 832 with a median pore diameter of about 0.025 mm 3 [[ID=十六]]such as about 0.022 mm 3 ~ 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.

[0057] In some examples, the auxiliary material 604 includes a polydioxanone (PDO) film placed on one or more surfaces of the polyurethane foam. In some examples, the PDO film is bonded to at least the bottom or crown side of the auxiliary material 604. In some examples, the PDO film has a thickness of about 20 μm to about 100 μm, for example, about 40 μm.

[0058] The auxiliary material 604 may have compressive strengths ranging from approximately 30 kPa to approximately 70 kPa, such as approximately 30 kPa to approximately 60 kPa (e.g., approximately 42 kPa), approximately 30 kPa to approximately 50 kPa, and approximately 32.5 kPa to approximately 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 once the compressive strength of the auxiliary material was measured.

[0059] In some examples, the auxiliary material 604 may have a tensile strength of 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 examples, the auxiliary material 604 may have a tensile strength of approximately 110 kPa to approximately 150 kPa.

[0060] Referring to Figure 9A, the surgical aid 604 may include a bioabsorbable material 902 (e.g., a bioabsorbable foam such as polyurethane foam) and a film 904 having a film thickness FT disposed on the absorbable material. This film thickness FT of film 904 may range from about 0.0003 inches to about 0.010 inches. For example, the film may be a skin made from the same material as the bioabsorbable material 902 and may have a film thickness FT in the range of about 0.001 inches to about 0.010 inches. In other cases, the film 904 may be a substantially continuous surface on the staple crown side of the bioabsorbable material 902 to help guide the staple 300 during firing and may have a film thickness in the range of about 0.00039 inches to about 0.0039 inches (e.g., about 0.00046 inches to about 0.020 inches). If the film 904 is formed from the same material as the bioabsorbable material 902 (e.g., polyurethane or polyurethane foam), it may contain pores with diameters ranging from about 0.0005 inches to about 0.005 inches. In some examples, if the film 904 contains the same bioabsorbable material (e.g., polyurethane), the film 904 may have a higher density than the bioabsorbable material 902. If the film 904 contains other materials, the film thickness FT may range from about 0.001 inches to about 0.003 inches. For example, film 904 may contain polydioxanone (PDO), poly(delta-gluconolactone) (PGL-1), poly(glycolide / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and epsilon-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglutinin 370 (PG-370), polyglutinin 185 (PG-185), or a combination thereof.

[0061] Referring to Figure 9B, the surgical aid 604 may include a bioabsorbable material 902 and a film 904 placed on the bioabsorbable material 902, with an adhesive 906 placed between the film 940 and the bioabsorbable material 902. Referring to Figure 9C, the surgical aid 604 may include a bioabsorbable material 902 placed on a staple cartridge 200, with an adhesive 906 placed between the bioabsorbable material 902 and the cartridge 200. Furthermore, the film 904 is placed on the surface of the bioabsorbable material 902. In some examples, the adhesive may include polyvinylpyrrolidone. In some examples, the adhesive 906 is bioabsorbable.

[0062] Referring to Figure 10A, the surgical aid 604 may include a double gradient with respect to its pore diameter. For example, the surgical aid 604 may include holes 832 having a small diameter (e.g., in the range of about 100 μm to about 0.4 mm, such as about 0.15 mm to about 0.25 mm) adjacent to a first end and a second end opposite the first end. Moving from the first or second end to the center of the surgical aid 604, the diameter of the holes 832 continues to increase to a larger diameter size (e.g., about 0.4 mm to about 1 mm, such as about 0.5 mm to about 0.6 mm). Referring to Figure 10B, the surgical aid 604 may include two bioabsorbable materials 1002a, 1002b, each having a single gradient of pore diameter. These two bioabsorbable materials 1002a, 1002b may be joined together to form a double gradient. In both Figure 10A and Figure 10B, the surgical aid may include a support 834 whose thickness may increase closer to the larger hole than to the smaller hole.

[0063] Referring to Figure 10A, the stapled assembly 600 may include a cartridge 200 comprising a deck 206 and at least one post 1104a extending away from the deck. The stapled assembly includes a film 904 placed on the deck 206. At least one post 1104a may be heated to form a post 1104b having an upper part 1106 and a bottom part 1108, as shown in Figure 10B. As shown in Figure 10C, the bioabsorbable material 902 may be placed on the film 904 and in the gap 1110 between the upper part 1006 of the at least one post 1104b and the film 904. The upper part 1106 may have a diameter PDT larger than the diameter PDB of the bottom part 1108, so that the bioabsorbable material 902 can be mechanically locked in place or attached to the stapled assembly 600.

[0064] Figure 10D shows a top view of an exemplary stable assembly 600. As shown, the post 1104 may be positioned between the staple slots 1112 of the cartridge 200. In addition, the film 904 may include perforations 1114 that at least partially surround or cover the staple slots 1112 and the post 1104, allowing the film to support the staples 300 shown in Figure 10E.

[0065] Referring to Figure 11A, Method 1200 relates to adding a film to a bioabsorbable material such as a polyurethane foam. This method comprises providing a polyurethane foam 1202 and attaching a film to the polyurethane foam 1204 via a volatile solvent (e.g., solvent welding), a reactive adhesive, or direct deposition.

[0066] Solvent welding can be used to add a film to a bioabsorbable material. For example, solvents such as ethyl acetate, dichloromethane, and acetone can be used. This process eliminates the need for heat treatment and the spatial arrangement of the bond between the film and the material.

[0067] Reactive adhesives can be used to add films to bioabsorbable materials. Some reactive adhesives may include polyurethane, epoxy, and acrylate. The reactive adhesive can be deposited directly onto the auxiliary material and / or film. It can be patterned along and across the bioabsorbable material so that both surface area and mass modulate the adhesive strength. Such applications may be useful when selective release of the film is designed to minimize the overall bioabsorbable material (e.g., only the film contacts the staples, while the rest remains with the endoscopic instrument). In addition to the application process, chemical properties can be used to adjust the adhesive properties. Reactive adhesives may be applied using inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, dip coating, screen printing, and spin coating. The use of adhesives is beneficial because it allows for the bonding of two thermosetting materials (film and bioabsorbable material) without the need for material flow. By using reactive adhesives, the need for heat treatment can be eliminated, the need to place bonding points between the film and the bioabsorbable material can be eliminated, and if necessary, the adhesive strength across surgical adjuvants can be adjusted to create selective release features.

[0068] Direct deposition can be used to directly apply a film to a bioabsorbable material. The film itself may be dispersed in a solution or consist of a reactive mixture that is later applied to the bioabsorbable material. Direct deposition methods for adding a film to a bioabsorbable material may include stereolithography, lithography, holographic printing, injection printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, dip coating, screen printing, and spin coating. Reactive mixtures for these processes may include polyurethanes and epoxys. Photocurable formulations can also be used. These may include photoinitiators, solvents, inhibitors, photocurable oligomers or monomers, light absorbers, and mixtures thereof. Advantages of direct film application include the ability to conformally apply the film, spatial control of the film, ease of application, and flexibility in applying the film in terms of speed, thickness, etc., for different applications.

[0069] Referring to Figure 11B, Method 1225 relates to adding or forming a film when forming a polyurethane foam, or in situ. Method 1225 includes providing a polyurethane foam precursor cured to its gelling point 1226 to form a partially cured polyurethane foam 902, placing or forming a film 904 on at least a portion of one surface of the partially cured polyurethane foam, and finally curing the partially cured polyurethane foam together with the film 1230 to form a surgical aid 604.

[0070] When using thermosetting materials (e.g., polyurethane foam) as surgical adjuvants, the material may be incorporated during the manufacturing process of the adjuvant. The film may be applied to the adjuvant before curing and / or completion of certain stoichiometric imbalances. For best results, the addition of the film should be completed after the gelation point of the thermosetting material to ensure that the film does not inhibit the formation of the adjuvant. After the film is applied, the curing process should be restarted to allow for chemical bonding between the thermosetting material and the film. This is especially true in the case of polyurethane-based adjuvants where free hydroxyl groups are present. The chemical bonding provides a strength profile that can overcome any adhesive interactions between the film and the thermosetting material. Advantages of using this method include the elimination of heat treatment, potential covalent bonding between the film and the thermosetting material, and the elimination of the need for a separate adhesive.

[0071] Furthermore, films such as PDO may be overmolded onto bioabsorbable materials.

[0072] Referring to Figure 11C, a method 1250 for mounting the film 904 and the bioabsorbable material 902 to a cartridge deck is shown. Method 1250 may include providing a cartridge deck 206 having at least one post 1104 1252, arranging the film on the deck so as to at least partially surround the at least one post 1104 1254, and applying heat to the at least one post 1104 to form an upper part 1106 having a first diameter and a bottom part 1108 having a second diameter such that the upper part 1106 of the at least one post 1104 at least partially overlaps the film 904 1256. Method 1250 also includes arranging a surgical aid on the film 904 so as to at least partially surround the at least one post 1104 1258.

[0073] 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.

[0074] In some cases, the disclosed devices (e.g., end effectors, surgical aids, and / or staple cartridges), and methods involving one or more of the disclosed devices, may be subject to one or more of the following provisions.

[0075] Clause 1: Surgical aid 604 comprising: a polyurethane foam 902, wherein the volume ratio of the polyurethane foam 902 to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.325; and a film 904 disposed on at least one surface of the polyurethane foam.

[0076] Clause 2: The surgical adjuvant 604 according to Clause 1, wherein the film 904 contains polyurethane having a higher density than the polyurethane foam.

[0077] Clause 3: The surgical aid 604 described in Clause 1, wherein the film 904 has a thickness FT of approximately 0.0003 inches to approximately 0.010 inches and a hole diameter of approximately 0.0005 inches to approximately 0.005 inches.

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

[0079] Clause 5: Surgical adjuvant 604 as described in Clause 4, wherein the absorbable material comprises polyglutin 370 or polyglutin 185.

[0080] Clause 6: Surgical adjuvant 604 as described in Clause 4, wherein the absorbent material comprises poly(glycolide / l-lactide).

[0081] Clause 7: The surgical aid 604 described in Clause 4, wherein film 904 has a thickness FT of approximately 0.0003 inches to approximately 0.003 inches.

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

[0083] Clause 9: Surgical adjuvant 604 as described in Clause 8, wherein the adhesive 906 contains polyvinylpyrrolidone.

[0084] Clause 10: The surgical aid 604 as described in Clause 1, wherein the surgical aid 604 is attached to the deck with a bioabsorbable adhesive.

[0085] Clause 11: A method for producing the surgical aid 604 described in Clause 1, comprising: providing a polyurethane foam 902; placing at least one volatile solvent on at least a portion of at least one surface of the polyurethane foam; placing a film 904 on at least one volatile solvent 906; and dissolving at least a portion of the polyurethane foam and the film 904 in at least one volatile solvent in order to bond the polyurethane foam and the film.

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

[0087] Clause 13: The method according to Clause 12, wherein the placement of the reactive adhesive is comprising applying the adhesive via at least one application process selected from the group consisting of inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, dip coating, screen printing, spin coating, or a combination thereof.

[0088] Clause 14: A method for producing the surgical aid 604 described in Clause 1, comprising: providing a polyurethane foam precursor cured to its gelation point to form a partially cured polyurethane foam; placing a film 904 on the partially cured polyurethane foam on at least a portion of one of its surfaces; and finally curing the partially cured polyurethane foam together with the film to form the surgical aid 604.

[0089] Clause 15: A method for producing the surgical aid 604 described in Clause 1, comprising providing a polyurethane foam 902 and applying a film to the polyurethane foam 902 by direct deposition to produce the surgical aid 904.

[0090] Clause 16: The method according to Clause 15, wherein the direct deposition method comprises at least one process selected from the group consisting of stereolithography, lithography, holographic printing, inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, dip coating, screen printing, spin coating, or a combination thereof.

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

[0092] Clause 18: The cartridge according to Clause 17, wherein the first film 904 includes a perforation pattern that at least partially surrounds or covers one or more staple slots 1112.

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

[0094] Clause 20. A method for manufacturing the cartridge described in Clause 17, comprising: providing a deck 206 having at least one post; arranging a film 904 on the deck so as to at least partially surround at least one post 1104; applying heat to at least one post 1104 to form an upper portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB such that the upper portion of at least one post at least partially overlaps with the film 904; and arranging a surgical aid 604 on the film so as to at least partially surround at least one post 1104.

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

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

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

[0098] Clause 24: A staple fastening assembly as described in Clause 22, wherein the film 904 has a thickness of approximately 0.0003 inches to approximately 0.010 inches and a hole diameter of approximately 0.0005 inches to approximately 0.005 inches.

[0099] Clause 25: The stapled assembly according to Clause 22, wherein film 904 is laminated on at least one surface of a polyurethane foam and comprises an absorbent material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconolactone) (PGL-1), poly(glycolide / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and epsilon-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglutin 370 (PG-370), polyglutin 185 (PG-185), or a combination thereof.

[0100] Clause 26: A staple fastening assembly as described in Clause 25, wherein the film 904 has a thickness of approximately 0.0003 inches to approximately 0.003 inches FT.

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

[0102] Clause 28: The staple fastening assembly described in Clause 21, wherein the absorbent material comprises polyglactin 370.

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

[0104] Clause 30: The stapled assembly according to Clause 21, wherein the deck 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having an upper part 1106 having a first diameter PDT and a bottom part 1108 having a second diameter PDB smaller than the first diameter PDT, the film 904 is placed on the surface and at least partially surrounds the at least one post 1104 with a gap 1110 between the upper part 1106 of the at least one post 1104 and the film 904, and the surgical aid 604 is placed on the film 904 and at least partially surrounds the at least one post.

[0105] Clause 31: The staple fastening assembly according to Clause 30, wherein the film 904 has a perforation pattern surrounding one or more staple slots 1112.

[0106] Clause 32: A method for producing a surgical tool 200, comprising providing a foam 902 such that the volume ratio of the polyurethane foam 902 to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.325, and arranging or forming a film 904 on the polyurethane foam 902.

[0107] Clause 33: The method according to Clause 32, comprising: placing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902; placing a film 904 on the at least one volatile solvent 906; and dissolving at least a portion of the polyurethane foam 902 and the film 904 in at least one volatile solvent to bond the polyurethane foam 902 and the film 904.

[0108] The method according to Clause 34, comprising providing a polyurethane foam 902, arranging a reactive adhesive 906 on at least a portion of the film 904, at least a portion of the polyurethane foam 902, or both, and arranging the film on at least the polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the film 904.

[0109] Clause 35: The method according to Clause 32, comprising providing a cartridge 200 having a deck, wherein at least one post extends from the deck; arranging a film 904 on the deck, at least partially surrounding at least one post 1104; heating at least one post 1104 to form an upper portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB, such that the upper portion of at least one post at least partially overlaps with the film 904; and arranging a surgical aid 604 on the film 904, at least partially surrounding at least one post 1104.

[0110] [Implementation Method] (1) Staple fastening assembly 600, Deck 206 and, A staple fastening assembly 600 comprising a surgical support 604 disposed on the deck 206 and comprising a polyurethane foam 902, wherein the volume ratio of the polyurethane foam 902 to the total volume of the surgical support 604 is in the range of about 0.125 to about 0.325. (2) The staple fastening assembly according to Embodiment 1, wherein the surgical aid 604 comprises a film 904 disposed on at least one surface of the polyurethane foam 902. (3) The staple fastening assembly according to Embodiment 2, wherein the film 904 includes polyurethane 902 having a higher density than the polyurethane foam 902. (4) The staple fastening assembly according to Embodiment 2, wherein the film 904 has a thickness FT of about 7.62 μm to about 254 μm (about 0.0003 inches to about 0.010 inches) and a hole diameter of about 12.7 μm to about 127 μm (about 0.0005 inches to about 0.005 inches). (5) The staple fastening assembly according to Embodiment 2, wherein the film 904 is laminated on the at least one surface of the polyurethane foam and comprises an absorbent material selected from the group consisting of polydioxanone (PDO), poly(delta-gluconolactone) (PGL-1), poly(glycolide / l-lactide) (PGL-2), polyglycolic acid (PGA), glycolide and epsilon-caprolactone copolymer (PGCL), glycolide and l-lactide copolymer, urethane, polycaprolactone (PCL), polyglutin 370 (PG-370), polyglutin 185 (PG-185), or a combination thereof.

[0111] (6) The staple fastening assembly according to Embodiment 5, wherein the film 904 has a thickness FT of about 7.62 μm to about 76.2 μm (about 0.0003 inches to about 0.003 inches). (7) The staple fastening assembly according to embodiment 5 or 6, wherein the film 904 is attached to the at least one surface of the polyurethane foam using an adhesive. (8) The staple fastening assembly according to Embodiment 5, wherein the absorbent material comprises polyglutin 370. (9) The staple fastening assembly according to Embodiment 1, wherein the surgical support material 604 further comprises an additional polyurethane foam 902 attached to the polyurethane foam 902, the polyurethane foam having a first density gradient, and the additional polyurethane foam 902 having a second density gradient substantially opposite to the first density gradient. (10) The deck 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having an upper part 1106 having a first diameter PDT and a bottom part 1108 having a second diameter PDB smaller than the first diameter PDT, The film 904 is placed on the surface and surrounds at least one post 1104 at least partially, with a gap 1110 between the upper part 1106 of the at least one post 1104 and the film 904. The staple fastening assembly according to Embodiment 1, wherein the surgical support material 604 is placed on the film 904 and at least partially surrounds the at least one post.

[0112] (11) The staple fastening assembly according to embodiment 10, wherein the film 904 has a perforation pattern surrounding one or more staple slots 1112. (12) A method for preparing a surgical tool 200, To provide a polyurethane foam 902 in which the volume ratio of the polyurethane foam 902 to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.325. A method comprising arranging or forming a film 904 on the polyurethane foam 902. (13) Distributing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902, Placing the film 904 on the at least one volatile solvent 906, The method according to Embodiment 12, comprising dissolving at least a portion of the polyurethane foam 902 and the film 904 in at least one volatile solvent to bond the polyurethane foam 902 and the film 904. (14) To provide the polyurethane foam 902, The reactive adhesive 906 is placed on at least a portion of the film 904, at least a portion of the polyurethane foam 902, or both thereof. The method according to Embodiment 12, comprising arranging the film on at least the polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the film 904. (15) To provide a cartridge 200 having a deck, wherein at least one post extends from the deck, The film 904 is placed on the deck and at least partially surrounds the at least one post 1104, Heat is applied to at least one post 1104 to form an upper portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB, such that the upper portion of the at least one post at least partially overlaps the film 904. The method according to Embodiment 12, comprising arranging the surgical aid 604 on the film 904 so as to at least partially surround the at least one post 1104.

Claims

1. Staple fastening assembly 600, Deck 206 and, A staple fastening assembly 600 comprising a surgical support 604 disposed on the deck 206 and comprising a polyurethane foam 902, wherein the volume ratio of the polyurethane foam 902 to the total volume of the surgical support 604 is in the range of about 0.125 to about 0.

325.

2. The staple fastening assembly according to claim 1, wherein the surgical aid 604 comprises a film 904 disposed on at least one surface of the polyurethane foam 902.

3. The staple fastening assembly according to claim 2, wherein the film 904 includes polyurethane 902 having a higher density than the polyurethane foam 902.

4. The staple fastening assembly according to claim 2, wherein the film 904 has a thickness FT of about 7.62 μm to about 254 μm (about 0.0003 inches to about 0.010 inches) and a hole diameter of about 12.7 μm to about 127 μm (about 0.0005 inches to about 0.005 inches).

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

6. The staple fastening assembly according to claim 5, wherein the film 904 has a thickness FT of about 7.62 μm to about 76.2 μm (about 0.0003 inches to about 0.003 inches).

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

8. The staple fastening assembly according to claim 5, wherein the absorbent material comprises polyglutin 370.

9. The stapling assembly according to claim 1, wherein the surgical support material 604 further comprises an additional polyurethane foam 902 attached to the polyurethane foam 902, the polyurethane foam having a first density gradient, and the additional polyurethane foam 902 having a second density gradient substantially opposite to the first density gradient.

10. The deck 206 comprises a surface and at least one post 1104 extending away from the surface, the at least one post 1104 having an upper portion 1106 having a first diameter PDT and a lower portion 1108 having a second diameter PDB smaller than the first diameter PDT. The film 904 is placed on the surface and surrounds at least one post 1104 at least partially, with a gap 1110 between the upper part 1106 of the at least one post 1104 and the film 904. The staple fastening assembly according to claim 1, wherein the surgical support material 604 is placed on the film 904 and at least partially surrounds the at least one post.

11. The staple fastening assembly according to claim 10, wherein the film 904 has a perforation pattern surrounding one or more staple slots 1112.

12. A method for fabricating a surgical tool 200, To provide a polyurethane foam 902 in which the volume ratio of the polyurethane foam 902 to the total volume of the surgical aid 604 is in the range of about 0.125 to about 0.

325. A method comprising arranging or forming a film 904 on the polyurethane foam 902.

13. Distributing at least one volatile solvent 906 on at least a portion of at least one surface of the polyurethane foam 902, Placing the film 904 on the at least one volatile solvent 906, The method according to claim 12, comprising dissolving at least a portion of the polyurethane foam 902 and the film 904 in at least one volatile solvent to bond the polyurethane foam 902 and the film 904.

14. To provide the aforementioned polyurethane foam 902, The reactive adhesive 906 is placed on at least a portion of the film 904, at least a portion of the polyurethane foam 902, or both thereof. The method according to claim 12, comprising arranging the film on at least the polyurethane foam 902 such that the reactive adhesive 906 is sandwiched between the polyurethane foam 902 and the film 904.

15. To provide a cartridge 200 having a deck, wherein at least one post extends from the deck, The film 904 is placed on the deck and surrounds at least one post 1104 in part, Heat is applied to the at least one post 1104 to form an upper portion 1106 having a first diameter PDT and a bottom portion 1108 having a second diameter PDB, such that the upper portion of the at least one post at least partially overlaps the film 904. The method according to claim 12, comprising arranging the surgical aid 604 on the film 904 such that it at least partially surrounds the at least one post 1104.

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