System and method for attaching auxiliary materials to surgical staple cartridges using biocompatible adhesive.

Abstract

The disclosed technology includes a method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive. The method may include depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive. The biocompatible adhesive may have components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 63 / 522,660, filed Jun. 22, 2023, and U.S. Patent Application No. 18 / 485,117, filed Oct. 11, 2023, the entire disclosures of which are hereby incorporated by reference in their entirety.

[0002] (Field of the Invention) The present invention generally relates to systems and methods for attaching a reinforcement to a surgical staple cartridge using a biocompatible adhesive.

Background Art

[0003] Surgical staplers are used in surgical procedures to close openings in tissue, blood vessels, ducts, shunts or other objects or body parts associated with a particular procedure. The openings can be naturally existing, such as within a blood vessel or a passage within a viscera such as the stomach, or can be formed by a surgeon during a surgical procedure, such as by forming a bypass or anastomosis by tissue or blood vessel puncture, or by tissue incision during a stapling procedure.

[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 Initiative] [Means for solving the problem]

[0005] According to one embodiment of the present invention, a method is provided for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive. The method may include depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge. The method may also include attaching the auxiliary material to the biocompatible adhesive. The biocompatible adhesive may have components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature. In some embodiments, the components may include hydrophobic components.

[0006] According to one embodiment of the present invention, a method is provided for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive. The method may include depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge. The method may include attaching the auxiliary material to the biocompatible adhesive. The biocompatible adhesive may be configured to selectively separate from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material. [Brief explanation of the drawing]

[0007] 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]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) disposed within and connected to the elongated channel, showing the anvil in a closed position with no tissue between it and the auxiliary material. [Figure 7] These are schematic diagrams showing the auxiliary materials in Figures 6A and 6B, illustrating the organizational deployment. [Figure 8] This is a perspective view of an exemplary cartridge assembly. [Figure 9] This flowchart illustrates an exemplary method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive. [Figure 10] This flowchart illustrates an exemplary method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive. [Modes for carrying out the invention]

[0008] 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.

[0009] 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%.

[0010] As used herein, the term "polyurethane" refers to the polymer reaction product of an isocyanate and a polyol, and is not limited to polymers containing only urethane bonds or polyurethane bonds. It is well understood by those skilled in the art of preparing polyurethanes that the polyurethane polymer may also include bonds such as allophanate, carbodiimide, and other bonds described herein.

[0011] The expressions "reaction system", "reactive formulation", "reaction product", and "reactive mixture" are used interchangeably herein and all refer to combinations of reactive compounds used to make the bioabsorbable materials according to the present disclosure.

[0012] The term "room temperature" refers to a temperature of about 20°C, which means it refers to temperatures in the range of 18°C to 25°C. Such temperatures include 18°C, 19°C, 20°C, 21°C, 22°C, 23°C, 24°C, and 25°C.

[0013] Unless otherwise specified, the "weight percent" of a component in a composition (expressed as %wt. or wt.%) refers to the weight of the component relative to the total weight of the composition in which it is present, and is expressed as a percentage.

[0014] The "glass transition temperature" and "T" g referred to herein refer to the temperature at which a reversible transition occurs from a hard glassy state to a rubbery state.

[0015] 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 endoplasticity when the auxiliary material is stapled to the tissue. As discussed herein, the auxiliary material may include bioabsorbable materials such as foams.

[0016] 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.

[0017] Figure 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable aids. The illustrated surgical stapling and cutting device 100 includes an end effector 106 having an anvil 102 pivotally coupled to an elongate channel 104. As a result, the end effector 106 can move between an open position as shown in Figure 1 and a closed position where the anvil 102 is positioned adjacent to the elongate channel 104 and tissue is engaged therebetween. The end effector 106 can be attached at its proximal end to an elongate shaft 108 that forms an implementation portion 110. When the end effector 106 is closed or at least substantially closed (e.g., when the anvil 102 moves from the open position of Figure 1 towards the elongate channel), the implementation portion 110 can present a sufficiently small cross-section suitable for inserting the end effector 106 through a trocar. The device 100 is configured to staple and cut tissue, but surgical devices configured to staple tissue without cutting it are also contemplated herein.

[0018] In various situations, the end effector 106 can be operated by a handle 112 connected to the elongate shaft 108. The handle 112 includes a user control such as a rotation knob 114 that rotates the elongate shaft 108 and the end effector 106 about the longitudinal axis (Ls) of the elongate shaft 108, and an articulation axis (T) that is substantially transverse to the longitudinal axis (Ls) of the elongate shaft 108. AThe 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.

[0019] 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 be a combination of both. A manual firing release lever 126 allows the firing system to be retracted if necessary before it completes its movement for firing, and further allows a surgeon or other clinician to retract the firing system if it becomes stuck and / or malfunctions.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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 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. In addition, 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 helps guide the 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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 fired 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.

[0032] Accordingly, various embodiments of auxiliary materials are provided that can be configured to compensate for varying thicknesses of tissue captured within fired (deployed) staples, thereby avoiding the need to consider staple height when stapling tissue during surgery. 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 a set 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 stapled tissue, 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 absorbed into the body over a period of 100 to 300 days, depending on the implantation site and the health of the tissue.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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 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.

[0038] 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 fired height of the staples 300 deployed in the staple cartridge 200 (e.g., the height (H) of the fired staples 606a 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 fired staples (e.g., the staples in the molded configuration).

[0039] 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.

[0040] 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 606a. Each fired staple 606a 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 606a is at least partially limited by the height (H) of the fired staple 606a.

[0041] Figure 8 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 604b, and a distal end 604c. 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.

[0042] 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.

[0043] 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.

[0044] Referring to Figures 9-10, the auxiliary material (e.g., 604) may be attached to a surgical staple cartridge (e.g., 200) using a biocompatible adhesive. For the delivery of the stapled auxiliary material, as discussed herein, the use of a biocompatible adhesive can help ensure that the auxiliary material remains on the endoscopic instrument during trocar insertion and potential tissue manipulation. Current attachment methods, such as the use of pressure-sensitive adhesives, typically present challenges such as low adhesive or cohesive strength, the potential need to re-seat the adhesive (e.g., depreciation of adhesive strength as a function of shelf life), and / or sensitivity to moisture or temperature fluctuations. Therefore, the attachment methods described herein can help achieve a balance between the force required to hold the auxiliary material on the instrument and the force required to release the auxiliary material during stapling or other surgical procedures. The attachment methods described herein can provide a balance between material selection, surface coverage, and / or cohesive strength of the auxiliary material. For example, the cohesive strength of the auxiliary material may be higher than the adhesive strength of either the instrument / adhesive or adhesive / auxiliary material interface, or the cohesive strength of the adhesive.

[0045] Specifically with respect to Figure 9, the method 900 used to attach an auxiliary material to a surgical staple cartridge using a biocompatible adhesive may include, as particularly shown in Figure 2B, depositing a biocompatible adhesive 216 onto the upper surface 206 of the surgical staple cartridge 200 (step 902), and attaching an auxiliary material 604 to the biocompatible adhesive 216 (step 904), as particularly shown in Figure 6A.

[0046] In some embodiments, the biocompatible adhesive may contain components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature. For example, the biocompatible adhesive may be sensitive to temperatures above about 40°C and / or relative humidity above 60%. The components may be hydrophobic components such as high-melting-point waxes or reactive adhesives (e.g., polyurethanes).

[0047] High-melting-point waxes can help reduce the temperature sensitivity of biocompatible adhesives. The waxes may have a melting temperature of at least about 60°C. Furthermore, the waxes may be hydrophobic, thereby minimizing the hygroscopicity of the biocompatible adhesives. Waxes may include, for example, candelilla wax, microcrystalline wax, montan wax, and / or white wax. The waxes may have a rapid viscosity transition as a function of temperature (e.g., a transition from solid to liquid within 5°C).

[0048] Various applications can be used to attach auxiliary materials to surgical staple cartridges using wax, including immersion coating, electro-spraying, ultrasonic spray coating, inkjet, direct deposition, screen printing, and spin coating. These application techniques can be carried out either via batch processes or in situ, thereby allowing continuous application processes to be used in either extrusion or web-based material handling operations. The conformal nature of these techniques can be controlled by temperature control of the wax and substrate, deposition rate, substrate movement / speed, etc. In addition, these application techniques can provide spatial resolution to auxiliary materials and / or endoscopic instruments, which can enable different adhesive properties based on different surface area coverage rates and / or mass (e.g., balance of adhesive and wax cohesive strength for fault location optimization), as well as accuracy to avoid critical features of endoscopic instruments (e.g., instrument 100) (e.g., staple pockets).

[0049] The use of high-melting-point waxes can offer additional benefits such as reduced sensitivity to temperature during transport or storage, reduced sensitivity to moisture during surgical procedures, and ease of application during manufacturing.

[0050] The moisture and / or temperature sensitivity of biocompatible adhesives can be reduced by using reactive adhesives such as polyurethane, epoxy, and acrylate. This can be achieved by specific adhesive patterning and / or minimizing surface area. The reactivity of the adhesive can allow for application at low viscosity (e.g., about 5 cmpoise (cP) or higher), which can increase the fidelity of surface coating, and this can help minimize the amount of material, the coverage area (e.g., placement on a low surface area to minimize interference with other endoscopic instrument features), and / or the complexity of the instrument. Various applications such as electrospinning, electrospraying, dipping coating, thermal spraying, screen printing, and direct deposition can be used to attach auxiliary materials to surgical staple cartridges using reactive adhesives.

[0051] The use of reactive adhesives can offer additional benefits such as minimal material usage, lower surface area coverage, and ease of application during manufacturing.

[0052] In some embodiments, biocompatible adhesives may contain components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature. The use of hydrogel adhesives can allow for a balance of adhesive strength before and during surgical procedures. In the package, and during manufacturing, the hydrogel may be in a dehydrated state that can have significant adhesive and cohesive strength. The main mode of adhesive strength is specific chemical interactions (e.g., hydrogen bonding, dipole-dipole bonding, etc.) with the stapler and endoscopic instruments. These interactions can be significantly higher than those of pressure-sensitive adhesives (e.g., up to approximately 20 kJ / mol) given the hydrophilicity of the hydrogel. Furthermore, the dehydrated state can also be adjusted to have significant cohesive strength by crosslinking agent concentration and specific intramolecular hydrogen bonding. When the hydrogel is rehydrated during surgical procedures, both cohesive and adhesive strengths may be reduced, allowing for the release of the stapler from the endoscopic instruments.

[0053] Another characteristic of hydrogels is the use of either covalent crosslinking and / or ionic crosslinking. Most synthetic hydrogels may contain a covalently crosslinked network with irreversible bonds. Another type of hydrogel utilizes reversible, ion-dependent ionic crosslinking. These hydrogels have polyvalent ions that act as crosslinking centers to increase the mechanical strength of the hydrogel. In the presence of more electronegative ions, counterion exchange can occur. Switching between polyvalent and monovalent ions (e.g., from calcium ions to sodium ions) can lead to a decrease in mechanical strength down to the dissolution point in an aqueous environment. This has the potential advantage of rapid dissolution in a surgical environment because the polyvalent counterion is exchanged with sodium. In this mode, there are two mechanisms for release in a surgical environment: water swelling due to the aqueous environment and counterion exchange that causes the dissolution of the hydrogel. Furthermore, the use of ionic crosslinking can increase the biocompatibility of the entire system and may allow the use of naturally occurring materials (e.g., carrageenan, alginates, polysaccharide-based cellulose derivatives, etc.).

[0054] If the hydrogel is designed to remain attached to the stapling aid after the procedure, it can be used to deliver therapeutic agents (e.g., active pharmaceutical ingredients (APIs), growth factors, etc.). These can be designed for either long-term or short-term treatment through different microencapsulation techniques or drug solubility properties. Furthermore, hydrogels can be used to contain living cells. By including a bioink for cell viability, cell loading can be facilitated either before or after the stapling aid is opened within the surgical suite.

[0055] Overall, hydrogels can be composed of naturally occurring materials or photocurable networks. Photocurable formulations may include photoinitiators, solvents, inhibitors, photocurable oligomers or monomers, light absorbers, or mixtures thereof.

[0056] Various applications such as stereolithography / lithography, holographic printing, inkjet printing, direct deposition, thermal spraying, cold dynamic spraying, cold spraying, electrospraying, ultrasonic spray coating, immersion coating, screen printing, and spin coating can be used with hydrogel networks to attach auxiliary materials to surgical staple cartridges.

[0057] The use of hydrogels may offer additional benefits such as controlled strength during shipping, packaging, or surgical procedures, the use of naturally sourced materials, the possibility of delivering therapeutic agents, reduced temperature sensitivity, the use of stapling aids with lower cohesive strength, and ease of application during manufacturing.

[0058] Specifically, with respect to Figure 10, a method 1000 used to attach an auxiliary material to a surgical staple cartridge using a biocompatible adhesive may include: depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge (step 1002); and attaching the auxiliary material to the biocompatible adhesive (step 1004). The biocompatible adhesive may include components configured to selectively separate from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material.

[0059] In some embodiments, biocompatible adhesives may include enteric-coated adhesives. Enteric-coated adhesives can be used for selective separation as a function of pH. For example, in an acidic environment (e.g., an environment with a pH less than about 6.0), the adhesive does not allow water infiltration and maintains its adhesive strength. When placed in an environment close to neutral pH (e.g., an environment with a pH greater than about 6.0), the adhesive delaminates due to water infiltration. This can be used when a staple-fastening aid needs to bypass gastric juices while adhered. Upon reaching another cavity or location in the gastrointestinal tract, the staple-fastening aid is released with a lower separation force. Possible materials include, but are not limited to, cellulose derivatives and methacrylate copolymers. Enteric-coated adhesives can be applied by one or more application techniques described herein.

[0060] In some embodiments, biocompatible adhesives may include stimulus-responsive materials. The use of stimulus-responsive materials to both in vivo and externally applied stimuli eliminates the balance between adhesive strength and cohesive strength of the stapling aid, and thus can increase the range of mechanical properties of the aids that can be used. In vivo stimuli may be pH or counterion exchange, as further discussed herein. The transition from acidic triangular form to basic tetrahedral form can be observed through ultraviolet (UV) absorption and thus can be quantified for various combinations of arylboronic acids, styrylpyrene, o-nitrobenzyl, coumarin, and polyols. Since dissociation is based on the bonding constant, multilayer systems can be designed to unfold within a set pH range or to respond based on changes in the local environment. In this way, adhesives can be designed to have specific behavior (e.g., mechanical strength) before and after surgical implantation.

[0061] Stimulus-responsive materials may be applied externally via light mediation, and consequently, bonding can be constructed based on exposure to light of different wavelengths (e.g., approximately 300–475 nanometers (nm)). Activation of these systems for adhesion control can be achieved using wavelengths that can be transmitted through tissue, or using endoscopic procedures for activation (e.g., photoreversible cyclization of styrylpyrene). These molecular changes can be tuned to allow for macroscopic geometric changes.

[0062] Stimulus-responsive materials can also be used to design structurally transformable polymers through dynamic covalent chemistry, which can be divided among redox, photo-responsive, and mechanistic chemistry. Sufficient molecular mobility can enable transitions from linear to complex structures, resulting in dimensional changes within the system. Stimulus-responsive adhesives can be applied by one or more of the application techniques described herein.

[0063] The use of stimulus-responsive adhesives can offer additional benefits such as maintaining full mechanical strength over a given time frame (e.g., induction period per external excitation), reduced susceptibility to moisture and heat, the possibility of including controlled APIs, and a balance in the cohesive properties of the adhesive and stapling aids.

[0064] 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.

[0065] 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: Clause 1: A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive comprises a hydrophobic component configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature.

[0066] Clause 2: The method according to Clause 1, wherein the hydrophobic component comprises a wax having a melting temperature of at least about 60°C.

[0067] Clause 3: The method described in Clause 2, wherein the wax includes candelilla wax, microcrystalline wax, montan wax, white wax, or a combination thereof.

[0068] Clause 4: The method according to Clause 1, wherein the hydrophobic component includes polyurethane.

[0069] Clause 5: The method according to Clause 1, wherein the deposition of a biocompatible adhesive onto the upper surface of a surgical staple cartridge is carried out via direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or a combination thereof.

[0070] Clause 6: A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive is configured to selectively separate from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material.

[0071] Clause 7: The method according to Clause 6, wherein the biocompatible adhesive includes an enteric-coated material.

[0072] Clause 8: The method according to Clause 7, wherein the enteric-coated material comprises at least one cellulose derivative or methacrylate copolymer.

[0073] Clause 9: The method according to Clause 7, wherein the enteric-coated material is configured to adhere to a surgical staple cartridge when the pH of the environment is less than approximately 6.0.

[0074] Clause 10: The method according to Clause 7, wherein the enteric-coated material is configured to separate from the surgical staple cartridge when the pH of the environment is at least about 6.0.

[0075] Clause 11: A biocompatible adhesive is the method described in Clause 6, comprising an irritation-responsive material.

[0076] Clause 12: The method according to Clause 11, wherein the stimulus-responsive material comprises at least one of arylboronic acid, styrylpyrene, o-nitrobenzyl, coumarin, or polyol.

[0077] Clause 13: The method according to Clause 11, wherein the stimulus-responsive material is configured to reduce the sensitivity of the biocompatible adhesive to moisture and temperature.

[0078] Clause 14: The method according to Clause 11, wherein the biocompatible adhesive is further configured to selectively separate from the surgical staple cartridge based on exposure to light of one or more wavelengths.

[0079] Clause 15: The method according to Clause 14, wherein one or more wavelengths are approximately 300-475 nm.

[0080] Clause 16: The method according to Clause 11, wherein the stimulus-responsive material includes at least one of a redox-responsive material, a photoresponsive material, or a mechanically responsive material.

[0081] Clause 17: The method according to Clause 6, wherein the deposition of a biocompatible adhesive onto the upper surface of a surgical staple cartridge is carried out via direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or a combination thereof.

[0082] Clause 18: A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive comprises components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature.

[0083] Clause 19: The method according to Clause 18, wherein the components include a hydrogel network configured to exhibit adhesive strength based on one or more chemical interactions.

[0084] Clause 20: The method according to Clause 19, wherein one or more chemical interactions include at least one of hydrogen bonding or dipole-dipole interaction.

[0085] Clause 21: A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive comprises components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature.

[0086] Clause 22: The method according to Clause 21, wherein the components include hydrophobic components.

[0087] Clause 23: The method according to any one of Clauses 21 to 22, wherein the components include a wax having a melting temperature of at least about 60°C.

[0088] Clause 24: The wax as described in Clause 23, including candelilla wax, microcrystalline wax, montan wax, white wax, or a combination thereof.

[0089] Clause 25: The method described in any one of Clauses 21 to 22, wherein the components include polyurethane.

[0090] Clause 26: The method according to Clause 21, wherein the biocompatible adhesive is configured to selectively separate from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material.

[0091] Clause 27: The method described in any one of Clauses 21 and 26, wherein the biocompatible adhesive includes an enteric-coated material.

[0092] Clause 28: The method according to Clause 27, wherein the enteric-coated material comprises at least one cellulose derivative or methacrylate copolymer.

[0093] Clause 29: The method according to any one of Clauses 27-28, wherein the enteric-coated material is configured to adhere to a surgical staple cartridge when the pH of the environment is less than approximately 6.0.

[0094] Clause 30: The method according to any one of Clauses 27-29, wherein the enteric-coated material is configured to separate from the surgical staple cartridge when the pH of the environment is at least about 6.0.

[0095] Clause 31: A biocompatible adhesive is the method described in any one of Clauses 21 and 26, comprising a stimuli-responsive material.

[0096] Clause 32: The method according to Clause 31, wherein the stimulus-responsive material comprises at least one of arylboronic acid, styrylpyrene, o-nitrobenzyl, coumarin, or polyol.

[0097] Clause 33: The biocompatible adhesive is further configured to selectively separate from a surgical staple cartridge based on exposure to light of one or more wavelengths, according to any one of Clauses 31-32.

[0098] Clause 34: The method according to Clause 33, wherein one or more wavelengths are approximately 300-475 nm.

[0099] Clause 35: The method described in any one of Clauses 31 to 34, wherein the stimulus-responsive material comprises at least one of a redox-responsive material, a photoresponsive material, or a mechanically responsive material.

[0100] Clause 36: The method according to Clause 21, wherein the components include a hydrogel network configured to exhibit adhesive strength based on one or more chemical interactions.

[0101] Clause 37: The method according to Clause 36, wherein one or more chemical interactions include at least one of hydrogen bonding or dipole-dipole interaction.

[0102] Clause 38: The hydrogel network according to any one of Clauses 36 to 37, utilizing at least one of covalent crosslinks or ionic crosslinks.

[0103] Clause 39: The method according to any one of Clauses 36 to 38, wherein the hydrogel network releases a biocompatible adhesive into the environment surrounding the auxiliary material based on at least one of water swelling or counterion exchange.

[0104] Clause 40: The method according to any one of Clauses 36 to 39, wherein the hydrogel network comprises at least one of carrageenan, alginate, polysaccharide, or cellulose.

[0105] Clause 41: The method according to any one of Clauses 36 to 40, wherein the hydrogel network is configured to deliver one or more therapeutic agents into the environment surrounding the adjuvant.

[0106] Clause 42: The method according to any one of Clauses 21 to 41, wherein the deposition of a biocompatible adhesive onto the upper surface of a surgical staple cartridge is carried out via direct deposition, spray coating, spin coating, dip coating, ultrasonic spray coating, screen printing, electrospinning, electrospray, thermal spray, or at least one of these combinations.

[0107] Clause 43: The method according to any one of Clauses 21 to 42, wherein the deposition of a biocompatible adhesive onto the upper surface of a surgical staple cartridge is carried out by at least one of a batch process or a continuous process.

[0108] [Implementation Method] (1) A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive comprises components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature. (2) The method according to Embodiment 1, wherein the component includes a hydrophobic component. (3) The method according to any one of Embodiments 1 to 2, wherein the component comprises a wax having a melting temperature of at least about 60°C, and the wax comprises candelilla wax, microcrystalline wax, montan wax, white wax, or a combination thereof. (4) The method according to any one of Embodiments 1 to 2, wherein the component comprises a hydrogel network configured to exhibit adhesive strength based on one or more chemical interactions, the one or more chemical interactions comprising at least one of hydrogen bonding or dipole-dipole interactions, and the hydrogel network utilizes at least one of covalent crosslinking or ionic crosslinking. (5) The method according to Embodiment 4, wherein the hydrogel network releases the biocompatible adhesive into the environment surrounding the auxiliary material based on at least one of water swelling or counterion exchange, the hydrogel network comprises at least one of carrageenan, alginate, polysaccharide, or cellulose, and the hydrogel network is configured to deliver one or more therapeutic agents into the environment surrounding the auxiliary material.

[0109] (6) The method according to Embodiment 3, wherein the biocompatible adhesive is configured to selectively separate from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material. (7) The method according to any one of Embodiments 1 and 6, wherein the biocompatible adhesive comprises an enteric material containing at least a cellulose derivative or a methacrylate copolymer. (8) The method according to Embodiment 7, wherein the enteric material comprises at least one cellulose derivative or methacrylate copolymer. (9) The method according to any one of embodiments 7 to 8, wherein the enteric material is configured to adhere to the surgical staple cartridge when the pH of the environment is less than about 6.0. (10) The method according to any one of embodiments 7 to 9, wherein the enteric material is configured to separate from the surgical staple cartridge when the pH of the environment is at least about 6.0.

[0110] (11) The method according to any one of embodiments 1 and 6, wherein the biocompatible adhesive comprises a stimulus-responsive material. (12) The method according to Embodiment 11, wherein the stimulus-responsive material comprises at least one of arylboronic acid, styrylpyrene, o-nitrobenzyl, coumarin, or polyol. (13) The method according to any one of embodiments 11 to 12, wherein the biocompatible adhesive is further configured to selectively separate from the surgical staple cartridge based on exposure to one or more wavelengths of light. (14) The method according to Embodiment 13, wherein the wavelength of one or more of the light is approximately 300 to 475 nm. (15) The method according to any one of embodiments 11 to 14, wherein the stimulus-responsive material includes at least one of a redox-responsive material, a photoresponsive material, or a mechanically responsive material.

Claims

1. A method for attaching an auxiliary material to a surgical staple cartridge using a biocompatible adhesive, the method comprising depositing the biocompatible adhesive onto the upper surface of the surgical staple cartridge and attaching the auxiliary material to the biocompatible adhesive, wherein the biocompatible adhesive comprises components configured to reduce the biocompatible adhesive's sensitivity to moisture and temperature.

2. The method according to claim 1, wherein the aforementioned component includes a hydrophobic component.

3. The method according to any one of claims 1 to 2, wherein the component comprises a wax having a melting temperature of at least about 60°C, and the wax comprises candelilla wax, microcrystalline wax, montan wax, white wax, or a combination thereof.

4. The method according to any one of claims 1 to 2, wherein the component comprises a hydrogel network configured to exhibit adhesive strength based on one or more chemical interactions, the one or more chemical interactions comprising at least one of hydrogen bonding or dipole-dipole interaction, and the hydrogel network utilizes at least one of covalent crosslinking or ionic crosslinking.

5. The method according to claim 4, wherein the hydrogel network releases the biocompatible adhesive into the environment surrounding the auxiliary material based on at least one of water swelling or counterion exchange, the hydrogel network comprises at least one of carrageenan, alginate, polysaccharide, or cellulose, and the hydrogel network is configured to deliver one or more therapeutic agents into the environment surrounding the auxiliary material.

6. The method according to claim 3, wherein the biocompatible adhesive is configured to be selectively separated from the surgical staple cartridge based on the pH of the environment surrounding the auxiliary material.

7. The method according to any one of claims 1 and 6, wherein the biocompatible adhesive comprises an enteric material containing at least a cellulose derivative or a methacrylate copolymer.

8. The method according to claim 7, wherein the enteric-coated material comprises at least one of a cellulose derivative or a methacrylate copolymer.

9. The method according to claim 7, wherein the enteric-coated material is configured to adhere to the surgical staple cartridge when the pH of the environment is less than about 6.

0.

10. The method according to claim 7, wherein the enteric material is configured to separate from the surgical staple cartridge when the pH of the environment is at least about 6.

0.

11. The method according to any one of claims 1 and 6, wherein the biocompatible adhesive comprises a stimulus-responsive material.

12. The method according to claim 11, wherein the stimulus-responsive material comprises at least one of arylboronic acid, styrylpyrene, o-nitrobenzyl, coumarin, or polyol.

13. The method according to claim 11, wherein the biocompatible adhesive is further configured to selectively separate from the surgical staple cartridge based on exposure to one or more wavelengths of light.

14. The method according to claim 13, wherein the wavelength of one or more of the light is approximately 300 to 475 nm.

15. The method according to claim 11, wherein the stimulus-responsive material includes at least one of a redox-responsive material, a photoresponsive material, or a mechanically responsive material.

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