A plantable support material with an adjustable decomposition profile.

Abstract

A compressible supplemental material kit for use with a staple cartridge is provided, the kit including a biocompatible supplemental material and a pretreatment fluid. The biocompatible supplemental material is configured to be releasably retained on the staple cartridge and delivered to tissue by deployment of staples in the staple cartridge. The supplemental material may be in the form of a porous polymeric body. The pretreatment fluid is configured to be applied to the supplemental material to transform the supplemental material from an untreated state to a treated state. The supplemental material in the untreated state is configured to exhibit a first degradation profile when delivered to tissue. The supplemental material in the treated state is configured to exhibit a second degradation profile when delivered to tissue, the second degradation profile being different from the first degradation profile.

Description

[Technical Field]

[0001] This disclosure generally relates to compressible materials and methods for using compressible materials. [Background technology]

[0002] Surgical staples 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 intravascular or intravisceral passages like the stomach, or they may be created by a surgeon during a surgical procedure, such as by forming a bypass or anastomosis through tissue or vascular puncture, or by tissue incision during the stapling procedure.

[0003] Most staplers have a handle with an elongated shaft, the shaft having a pair of movable, opposing jaws at its end formed to hold and shape 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 the 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 shaped. Some staplers include a knife 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.

[0004] Surgical staplers have been improved over the years, but they still have many problems. One common problem is that staples can leak because they form holes when they penetrate the tissue or other object they are placed on. Blood, air, gastrointestinal fluids, and other fluids can seep through the openings created by the staples, even after the staples have fully formed. The tissue being treated may also become inflamed due to trauma from stapling. [Overview of the project] [Problems that the invention aims to solve]

[0005] While various implantable materials have been developed for use in combination with various staple-fastened tissues, there remains a need for improved materials that address some of the aforementioned problems. [Means for solving the problem]

[0006] Generally, compressible auxiliaries and methods for tissue repair are provided. In one embodiment, a compressible auxiliary kit for use with a staple cartridge is provided, the kit comprising a biocompatible auxiliary material and a pretreatment fluid. The biocompatible auxiliary material is configured to be releasably held on the staple cartridge and to be delivered to the tissue by the deployment of staples in the staple cartridge. The auxiliary material may be in the form of a porous polymer body. The pretreatment fluid is configured to be applied to the auxiliary material to change it from an untreated state to a treated state. The untreated auxiliary material is configured to exhibit a first degradation profile when delivered to the tissue. The treated auxiliary material is configured to exhibit a second degradation profile, different from the first degradation profile, when delivered to the tissue.

[0007] The pretreatment fluid can have a variety of configurations. In one embodiment, the pretreatment fluid may be configured to increase the degradation rate of a second degradation profile relative to a first degradation profile. In another embodiment, the pretreatment fluid may be configured to increase the pH adjacent to the treated auxiliary material when delivered to the tissue. In yet another embodiment, the pretreatment fluid may be configured to increase the degree of hydrophilicity of the treated auxiliary material. In yet another embodiment, the pretreatment fluid may be configured to decrease the degradation rate of a second degradation profile relative to a first degradation profile. In yet another embodiment, the pretreatment fluid may be configured to form a coating deposited on at least a portion of the treated auxiliary material. In yet another embodiment, the pretreatment fluid may be configured to react with the auxiliary material to alter the terminal functional groups of at least a portion of the polymer chains that form the treated porous polymer body. In yet another embodiment, the pretreatment fluid may be configured to increase the degree of hydrophobicity of the treated auxiliary material compared to the untreated state. In yet another embodiment, the pretreatment fluid may be configured to form a sealant that seals at least a portion of the pores within the porous polymer body. In other embodiments, the pretreatment fluid may be configured to terminate at least some of the polymer chains of a porous polymer such that the average length of the polymer chains of the treated polymer is shorter than the average length of the polymer chains of the untreated polymer.

[0008] In another embodiment, a surgical method is provided, which includes processing an untreated biocompatible auxiliary material comprising a porous polymer body to produce a treated auxiliary material having a modified degradation profile relative to the untreated auxiliary material. The method also includes releasably holding the treated auxiliary material on a staple cartridge and activating a surgical stapling device having the staple cartridge and the treated auxiliary material thereon to staple the treated auxiliary material to tissue.

[0009] In one embodiment, treating a biocompatible auxiliary material involves immersing the auxiliary material in a pretreatment fluid. The altered degradation profile may have a higher degradation rate than the degradation profile of the untreated auxiliary material. In another embodiment, treating the auxiliary material increases the pH adjacent to the treated auxiliary material when delivered to tissue. In yet another embodiment, treating the auxiliary material increases the degree of hydrophilicity of the treated auxiliary material compared to the untreated auxiliary material. In yet another embodiment, the altered degradation profile has a lower degradation rate than the degradation profile of the untreated auxiliary material.

[0010] In another embodiment, a coating is applied to at least a portion of the auxiliary material by processing it. In another embodiment, processing the auxiliary material involves applying a pretreatment fluid that reacts with the porous polymer body of the auxiliary material and alters the terminal functional groups of the polymer chains that form the polymer body. In another embodiment, processing the auxiliary material increases the degree of hydrophobicity of the processed auxiliary material compared to the untreated auxiliary material. In another embodiment, processing the auxiliary material involves applying a pretreatment fluid that forms a sealant that seals at least a portion of the pores of the porous body.

[0011] In another embodiment, processing the auxiliary material involves applying a pretreatment fluid that terminates at least a portion of the polymer chains of the polymer body such that the average length of the polymer chains of the polymer body of the treated auxiliary material is shorter than the average length of the polymer chains of the polymer body of the untreated auxiliary material. The degradation rate of the second degradation profile increases compared to the first degradation profile.

[0012] In another embodiment, a compressible auxiliary material is provided for use with a staple cartridge, comprising a biocompatible auxiliary material configured to be releasably held on the staple cartridge and delivered to the tissue by the deployment of staples within the staple cartridge. The auxiliary material is formed of a porous polymer body and is configured to exhibit a first compressive stiffness that is substantially constant for a first period from contact with the tissue. The auxiliary material is further configured to exhibit a second compressive stiffness for a second period following the first period. The second stiffness is less than the first stiffness and is configured to decrease over time in response to at least one of oxidation, enzymatic hydrolysis, and pH changes resulting from interaction with at least one physiological element released from the tissue during tissue healing.

[0013] In one embodiment, the auxiliary material is configured to take on a second rigidity in response to oxidation resulting from a reaction with physiological elements containing reactive oxygen species. In another embodiment, the auxiliary material is configured to oxidize in response to a reaction with reactive oxygen species released by mature blood cells or fibroblasts (fybrocytes). The reactive oxygen species may include superoxide. In another embodiment, the auxiliary material is configured to oxidize in response to a reaction with reactive oxygen species released by inflammatory cells. The inflammatory cells may be at least one of leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes, and macrophages. In another embodiment, the reactive oxygen species is at least one of oxygen-containing enzymes, free radicals, superoxide, and peroxides. In another embodiment, the reactive oxygen species is O2 - It is at least one of H2O2, NO, and HOCl.

[0014] In another embodiment, the auxiliary material is configured to take on a second stiffness in response to enzyme-catalyzed hydrolysis. The enzyme may be lysozyme. In yet another embodiment, the auxiliary material is configured to take on a second stiffness in response to a decrease in pH due to the presence of at least one physiological element.

[0015] In other embodiments, a staple fastening assembly is provided, which comprises a staple cartridge, an anvil, and an auxiliary material. The staple cartridge has a plurality of internally disposed staples arranged in staple rows and configured to be deployed within tissue. The staple cartridge also includes knife slots extending through the staple cartridge between the staple rows to receive a knife for cutting tissue along a cutting line. The anvil is positioned on the opposite side of the staple cartridge. The auxiliary material is configured to be releasably held on the staple cartridge or anvil. The auxiliary material may be in the form of a biocompatible porous polymer material configured to be delivered to tissue by the deployment of a plurality of staples from the staple cartridge. The auxiliary material may have a first shape, and at least one first portion of the auxiliary material may be configured to exhibit a first expansion behavior in response to the reception of a unit volume of fluid, and at least one second portion of the auxiliary material may be configured to exhibit a second expansion behavior in response to the reception of a unit volume of fluid, different from the first expansion behavior, such that the auxiliary material takes on a second shape different from the first shape. The difference between the first and second expansion behaviors may be configured such that the auxiliary material applies different pressures to different parts of the tissue that are stapled together.

[0016] In one embodiment, the expansion amount of the auxiliary material is configured to provide hemostasis at the cutting line. In another embodiment, the expansion amount of the auxiliary material is configured to seal the holes formed in the tissue (issue) by multiple staples when the staples are injected into the tissue.

[0017] In another embodiment, at least one second portion of the auxiliary material is positioned adjacent to the knife slot, and at least one first portion of the auxiliary material is spaced a certain distance from the knife slot, and the second shape may be configured to apply greater pressure than the first shape.

[0018] In another embodiment, at least one second portion comprises a swelling material different from the biocompatible porous polymer material. The swelling material may include a hydrogel. In another embodiment, the swelling material includes a porous solid material, and the swelling material is contained in a fluid-soluble capsule in a compressed state. The capsule may be configured to release the swelling material after a predetermined period of contact with a fluid.

[0019] In another embodiment, the expansion rate of at least one second portion of the auxiliary material in response to the reception of a unit volume of fluid is greater than the expansion rate of at least one first portion of the auxiliary material in response to the reception of a unit volume of fluid.

[0020] In another embodiment, at least one staple of the plurality of staples includes at least one leg portion including a plurality of return portions. When the plurality of staples are injected into the auxiliary material and the tissue, the plurality of return portions are configured to allow expansion of the auxiliary material in a first direction and inhibit retraction of the auxiliary material in a second direction opposite to the first direction.

[0021] In another embodiment, at least one second portion includes a film covering the surface of the auxiliary material.

[0022] In another embodiment, the auxiliary material further includes a color transition dye that changes color during expansion of the auxiliary material. The color transition dye may be a hydrochromic ink configured to change color in response to contact with at least one of a fluid and a lipid.

[0023] In another embodiment, an auxiliary material for use with a staple cartridge is provided. The auxiliary material includes a biocompatible auxiliary material configured to be releasably held on a staple cartridge body and configured to be delivered to tissue by the deployment of staples within the cartridge body. The auxiliary material is formed as a porous body including a first polymer and a second polymer. The first polymer is configured to degrade according to a first degradation profile in response to at least one of hydrolysis in response to interaction with water and heating to physiological temperature. The second polymer is configured to degrade according to a second degradation profile in response to at least one of oxidation, enzyme-catalyzed hydrolysis, and a change in pH resulting from interaction with at least one physiological factor released from tissue during tissue healing.

[0024] In one aspect, the first polymer is configured to expand in response to absorption of water and exert a first compressive pressure on tissue having a magnitude that depends on the first degradation profile, and the second polymer is configured to expand in response to degradation of the first polymer and exert a second compressive pressure on tissue having a magnitude that depends on the first degradation profile and the second degradation profile, and the maximum magnitude of the second compressive pressure is less than the maximum magnitude of the first compressive pressure.

[0025] In another embodiment, the first polymer is configured to inhibit interaction between the second polymer and at least a portion of at least one physiological factor. The first polymer may overlap the second polymer.

[0026] In another embodiment, the degradation rate of the first polymer according to the first degradation profile is greater than the degradation rate of the second polymer according to the second degradation profile.

[0027] In another embodiment, the first polymer is a hygroscopic powder or foam.

[0028] In another embodiment, at least one physiological element includes a reactive oxygen species. The reactive oxygen species may include at least one of oxygen-containing enzymes, free radicals, superoxides, and peroxides.

[0029] In another embodiment, the auxiliary material includes a first drug, which is held by a first polymer and configured to be released during the degradation of the first polymer. The first drug may include a hemostatic agent. The auxiliary material may further include a second drug, which is held by a second polymer and configured to be released during the degradation of the second polymer. The second drug may be configured to promote tissue remodeling. In another embodiment, the second drug is configured for at least one of bolus release and sustained release, based on the geometric shape of the second polymer.

[0030] In one embodiment, a method for treating tissue is provided. This method involves stapling a porous biocompatible adjuvant to the tissue with one or more staples. The adjuvant may comprise a first polymer and a second polymer. The adjuvant receives at least one of water and heat sufficient to raise the temperature of the adjuvant to a physiological temperature, thereby causing the first polymer to degrade according to a first degradation profile. The adjuvant receives at least one physiological element released from the tissue during the healing process, thereby causing the second polymer to degrade according to a second degradation profile in response to at least one of oxidation, enzyme-catalyzed hydrolysis, and a change in pH resulting from interaction with the at least one physiological element.

[0031] In one embodiment, the first polymer expands in response to water absorption, exerting a first compressive pressure on the tissue having a magnitude dependent on a first degradation profile, and the second polymer expands in response to the degradation of the first polymer, exerting a second compressive pressure on the tissue having a magnitude dependent on at least the first and second degradation profiles. The maximum magnitude of the second compressive pressure is smaller than the maximum magnitude of the first compressive pressure.

[0032] In another embodiment, the second compression pressure depends on the first and second decomposition profiles.

[0033] In another embodiment, the first polymer inhibits the interaction between the second polymer and at least a portion of at least one physiological element. The at least one physiological element may include reactive oxygen species.

[0034] In another embodiment, the first polymer overlaps the second polymer. In yet another embodiment, the first polymer is at least one of a hygroscopic powder and a foam.

[0035] In another embodiment, the degradation rate of the first polymer by the first degradation profile is greater than the degradation rate of the second polymer by the second degradation profile.

[0036] In another embodiment, the auxiliary material further comprises a first drug held by the first polymer, which is released during the degradation of the first polymer. The first drug may be a hemostatic agent.

[0037] In another embodiment, the auxiliary material further comprises a second drug retained by the second polymer, which is released during the degradation of the second polymer. The second drug may promote tissue remodeling.

[0038] In another embodiment, the method further includes at least one of bolus release and sustained release of the second drug based on the geometric shape of the second polymer. [Brief explanation of the drawing]

[0039] 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 2] Figure 1 is a top view of a staple cartridge for use with surgical staple fastening and cutting instruments. [Figure 3] Figure 1 is a perspective view of the launch bar of a surgical stapler. This launch bar has an E-beam at its distal end. [Figure 4] This is a perspective view of another embodiment of a surgical stapler. [Figure 5] This is a perspective view of yet another embodiment of a surgical stapler. [Figure 6] This is a longitudinal cross-sectional view of an exemplary embodiment of a staple cartridge having exemplary auxiliary material attached to the top surface, i.e., the deck surface. [Figure 7] This is a schematic diagram showing the auxiliary materials in Figure 6, representing the organizational deployment. [Figure 8] This plot shows exemplary decomposition profiles of auxiliary materials in their untreated state and in their treated state after application of pretreatment fluid. [Figure 9] This is a schematic diagram showing a top view of the upper tissue contact surface of one exemplary embodiment of a tissue thickness compensating aid in an undeformed state, i.e., pre-deployment state, configured to seal staples along the staple line. [Figure 10] This is a schematic diagram showing the end view of the microstructure thickness compensation auxiliary material in its non-deformed state, i.e., non-deployed state (Figure 9). [Figure 11] Figure 9 is a schematic diagram showing the end view of the microstructure thickness compensation auxiliary material in its deformed state, i.e., deployed state. The expanded portion of the auxiliary material contacts the staples extending through the interior and exerts sealing pressure. [Figure 12] This is a schematic diagram showing a top view of the upper tissue contact surface of another exemplary embodiment of an auxiliary material configured to apply pressure along a tissue cutting line. [Figure 13] This is a schematic diagram showing the end view of the microstructure thickness compensation auxiliary material in its non-deformed state, i.e., non-deployed state (Figure 12). [Figure 14] This is a schematic diagram showing the end view of the microstructure thickness compensation auxiliary material in its deformed state, i.e., deployed state, as shown in Figure 13. [Figure 15]This schematic diagram shows a side cross-sectional view of a staple fastening assembly in a pre-firing configuration, including an anvil and a staple cartridge, with another embodiment of a tissue compensation aid mounted on the anvil, which is configured to function in conjunction with staples fired from the staple cartridge to prevent the aid from retracting and coming into contact with the tissue after staple firing. [Figure 16] Figure 15 is a schematic diagram showing the staple assembly and auxiliary material immediately after the staples have been fired from the staple cartridge, passed through the auxiliary material and tissue, and released from the staple assembly. [Figure 17] This is a schematic diagram showing the stapled assembly and auxiliary materials of Figure 16 after they have absorbed water and / or other physiological fluids from the body. [Figure 18] This is a schematic diagram showing a side section view of a pre-launch configuration staple fastening assembly, including exemplary embodiments of a composite auxiliary material comprising a first polymer and a second polymer. [Figure 19] Figure 18 is a schematic diagram showing a side cross-sectional view of the composite auxiliary material. [Figure 20] This is a schematic diagram showing a side cross-section of the composite auxiliary material in Figure 19, immediately after the staple fastening assembly is fired and connected to the tissue by staples. [Figure 21] Figure 20 is a schematic diagram showing an enlarged cross-sectional view of the composite auxiliary material. [Figure 22] This is a schematic diagram showing a side cross-section of the composite auxiliary material in Figure 19, which is connected to the tissue by staples during a predetermined period after the firing of the staple-fastened assembly. [Figure 23] Figure 22 is a schematic diagram showing a side cross-sectional view of the composite auxiliary material. [Figure 24]A is a plot showing the healing event in the tissue linked to the composite auxiliary material over time. B is a plot showing the compressive pressure applied to the tissue by the first and second polymers of the composite auxiliary material in Figure 19 over time. C is a plot showing the release rates of the first and second drugs held by the first and second polymers of the composite auxiliary material in Figure 19 over time. [Modes for carrying out the invention]

[0040] Herein, specific exemplary embodiments are described to provide an overall understanding of the structure, function, manufacturing and use principles of the apparatus and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the apparatus and methods described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined solely by the claims. Features illustrated or described in relation to one exemplary embodiment can be combined with features of other embodiments. Such modifications and variations are included within the scope of the invention.

[0041] Furthermore, in this disclosure, components with similar names in embodiments generally have similar characteristics, and therefore, in a particular embodiment, each characteristic of each component with a similar name is not necessarily described in full detail. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in combination with such systems, devices, and methods. Those skilled in the art will recognize that dimensions equivalent to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of systems and devices, and their components, may depend at least on the anatomical structure of the object in which the systems and devices are used internally, the size and shape of the component in which the systems and devices are used, and the method and surgery in which the systems and devices are used.

[0042] It will be recognized that the terms “proximal” and “distal” in this specification are used relative to the user, such as a clinician holding the instrument's handle. Other spatial terms, such as “anterior” and “posterior,” similarly correspond to distal and proximal, respectively. For convenience and clarity, it will also be understood that spatial terms such as “vertical” and “horizontal” are used in relation to drawings. However, surgical instruments are used in many orientations and positions, and these spatial terms are not intended to be limited or absolute.

[0043] Various exemplary apparatuses and methods for performing surgical procedures are provided. In some embodiments, apparatuses and methods for incisional surgical procedures are provided, and in other embodiments, apparatuses and methods for laparoscopic, endoscopic, and other minimally invasive surgical procedures are provided. These apparatuses may be launched directly by a human user or remotely launched under the direct control of a robot or similar operating tool. However, those skilled in the art will understand that the various methods and apparatuses disclosed herein can be used in a number of surgical procedures and applications. Those skilled in the art will further recognize that the various instruments disclosed herein can be inserted into the body in any way, for example, through a natural orifice, through an incision or puncture hole formed in the tissue, or using an access device such as a trocar cannula. For example, the working part, i.e., the end-effector part, of these instruments can be inserted directly into the patient's body, or through an access device having a working channel through which the end-effector and elongated shaft of the surgical instrument can pass.

[0044] It may be desirable to use one or more biomaterials and / or synthetic materials, referred to herein as “auxiliaries,” in conjunction with surgical instruments to assist in improving surgical procedures. “Auxiliaries” are also referred to herein as “auxiliary materials.” Various different surgical end-effectors may benefit from the use of auxiliary materials, and in some exemplary embodiments, the end-effector may be a surgical stapler. When used with a surgical stapler, the auxiliary material(s) may be placed between and / or on the jaws of the stapler, incorporated into a staple cartridge placed on the jaws, or otherwise placed proximal to the staples. Once the staples are deployed, the auxiliary material(s) may remain at the treatment site with the staples, and as a result, can provide many benefits. For example, the auxiliary material(s) can reinforce the tissue at the treatment site to prevent it from being torn or ripped by the staples. Tissue reinforcement may be necessary to prevent staples from tearing the tissue when the tissue is pathological, healing, or experiencing circumstances that alter other tissue properties. In some cases, the auxiliary material can minimize tissue movement at and near the staple puncture site that may result from tissue deformation (e.g., lung expansion, gastrointestinal expansion) that occurs after stapling. Those skilled in the art will recognize that staple puncture sites can be areas of stress concentration, and the dimensions of the holes formed by staples increase when the surrounding tissue is subjected to tension. Limiting tissue movement near these puncture sites can minimize the size of the holes that may increase under tension. In some cases, the auxiliary material may be configured to draw up or absorb beneficial fluids that further promote healing, such as sealants, blood, or adhesives. Also in some cases, the auxiliary material may be configured to decompose to form a gel that further promotes healing, such as a sealant. In some cases, the auxiliary material(s) may be used to assist in sealing holes formed by staples when implanted in tissue, blood vessels, and various other objects or body parts.

[0045] In other embodiments, the auxiliary material can be used with surgical instruments configured to seal tissue without the use of staples (for example, by using energy such as RF or ultrasound), as described, for example, in U.S. Patent No. 10,172,611 (which is incorporated herein by reference in its entirety).

[0046] In some cases, the auxiliary material may be configured to compensate for variations in tissue thickness when the auxiliary material is stapled to the tissue. In such cases, the auxiliary material may also be called a “tissue thickness compensator.” The tissue thickness compensator has an incompressible (non-deformable), i.e., pre-deployment height that is greater than the height of the staples in the forming structure. Further details relating to exemplary tissue thickness compensators can be found in U.S. Patent No. 8,864,007, which is incorporated herein by reference in its entirety. The tissue thickness compensator may be attached to and released from a staple cartridge in various ways, as described, for example, in U.S. Patent Nos. 9,272,406 and 10,136,890 (each of which is incorporated herein by reference in its entirety).

[0047] In addition to the disclosures herein, further details relating to auxiliary materials and other exemplary auxiliary materials can be found, for example, in U.S. Patent Nos. 10,172,611 and 10,433,846, and U.S. Patent Application No. 17 / 009,769 (titled “Compressible Non-Fibrous Adjuncts,” filed September 1, 2020), each of which is incorporated herein by reference in its entirety.

[0048] Alternatively or additionally, the implantable material may be configured to promote tissue endografting. In a variety of situations, it is desirable to promote tissue endografting into the implantable implant to promote 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 implant may reduce the incidence, severity, and / or duration of inflammation at the surgical site. Tissue endografting into and / or around the implantable implant may, for example, control the spread of infection at the surgical site. For example, vascular, particularly leukocyte, endografting into and / or around the implantable implant may combat infection in and around the implantable implant and adjacent tissue. Tissue endografting may also assist the patient's body in accepting foreign bodies (e.g., implantable implants and staples) and reduce the likelihood of the patient's body rejecting them. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0049] Alternatively or additionally, the auxiliary material may have a drug on and / or inside it. The drug may be modified depending on the desired effect of the drug on the surrounding tissue. In a non-limiting example, the drug may be provided to affect hemostasis, inflammation, macrophages, and / or fibroblasts. The drugs may be mixed or combined in any combination, or the drugs may again be provided alone depending on the desired effect on the tissue. The drug may be eluted from the auxiliary material in a variety of different ways. In a non-limiting example, the coating on the auxiliary material may be modified to release the drug at different timings by being absorbed at different timings, the auxiliary material may be modified to allow the diffusion of the drug between auxiliary materials at a variable rate, the molecular weight and / or physical properties of the auxiliary material may be modified to release the drug at different timings, and so on. In addition to the disclosures herein, further details relating to drug elution aids can be found in U.S. Patents No. 9,232,941 and No. 10,569,071, each of which is incorporated herein by reference in whole.

[0050] Surgical staple fasteners Various surgical instruments may be used in conjunction with the auxiliary materials and / or agents disclosed herein. Surgical instruments may include surgical staplers. Various surgical staplers, such as linear and circular staplers, may be used. Generally, linear staplers can be configured to form a longitudinal staple line and may include an elongated jaw to which a cartridge containing a longitudinal row of staples is coupled. The elongated jaw may include a knife or other cutting member capable of forming cuts between the staple rows along the tissue held within the jaw. Generally, circular staplers can be configured to form annular staple lines and may include a circular jaw having a cartridge containing annular rows of staples. The circular jaw may include a knife or other cutting member capable of forming cuts inside the rows of staples to define an opening that penetrates the tissue held within the jaw. Staplers may be used in various different surgical procedures, for example, in thoracic or gastric surgery, for various different surgical procedures on various tissues.

[0051] Figure 1 illustrates an example of a linear surgical stapler 10 suitable for use with one or more auxiliary materials and / or drugs. The stapler 10 generally includes a handle assembly 12, a shaft 14 extending distally from the distal end 12d of the handle assembly 12, and an end effector 30 at the distal end 14d of the shaft 14. The end effector 30 has opposing lower jaws 32 and upper jaws 34, but other types of end effectors may be used with the shaft 14, the handle assembly 12, and their associated components. The lower jaw 32 has a staple channel 56 configured to support a staple cartridge 40. The upper jaw 34 faces the lower jaw 32 and has an anvil surface 33 configured to act as an anvil to assist in the deployment of staples (the staples are hidden in Figures 1 and 2) of the staple cartridge 40. At least one of the opposing lower jaws 32 and upper jaws 34 is movable relative to the other lower jaw 32 and upper jaw 34 to clamp tissue and / or other objects placed between them. In some implementations, one of the opposing lower jaws 32 and upper jaws 34 may be fixed or otherwise immovable. In some implementations, both of the opposing lower jaws 32 and upper jaws 34 may be movable. Components of the launching system may be configured to pass through at least a portion of the end effector 30 to eject staples into the clamped tissue. In various implementations, a knife blade 36 or other cutting member may be associated with the launching system to cut tissue during stapling.

[0052] The operation of the end effector 30 can be initiated by input from a user, such as a clinician or surgeon, at the handle assembly 12. The handle assembly 12 may have many different configurations designed to operate the end effector 30 connected thereto. In the illustrated embodiment, the handle assembly 12 has a pistol-grip type housing 18, which houses various mechanical and / or electrical components for operating various feature parts of the instrument 10. For example, the handle assembly 12 may include a rotary knob 26 mounted adjacent to its distal end 12d, which can facilitate the rotation of the shaft 14 and / or the end effector 30 around the longitudinal axis L of the shaft 14 relative to the handle assembly 12. The handle assembly 12 may further include a clamping component as part of a clamping system actuated by a clamping trigger 22, and a firing component as part of a firing system actuated by a firing trigger 24. The clamping trigger 22 and the firing trigger 24 may be biased to an open position relative to the stationary handle 20, for example, by a torsion spring. Movement of the clamp trigger 22 toward the stationary handle 20 can activate the clamp system described below, thereby tilting the jaws 32, 34 toward each other and thereby clamping tissue between them. Movement of the firing trigger 24 can activate the firing system described below, thereby releasing staples from the internally positioned staple cartridge 40 and / or advancing the knife blade 36 to cut the tissue trapped between the jaws 32, 34. Those skilled in the art will recognize that various configurations of mechanical, hydraulic, pneumatic, electromechanical, robotic, or other firing system components can be used for staple release and / or tissue cutting.

[0053] As shown in Figure 2, the illustrated end effector 30 has a lower jaw 32 that functions as a cartridge assembly or carrier, and an opposing upper jaw 34 that functions as an anvil. A staple cartridge 40 having multiple staples inside is supported in a staple tray 37, which in turn is supported in the cartridge channel of the lower jaw 32. The upper jaw 34 has multiple staple-forming pockets (not shown), each of which is positioned over a corresponding staple from the multiple staples housed in the staple cartridge 40. The upper jaw 34 can be connected to the lower jaw 32 in various ways, but in the illustrated configuration, the upper jaw 34 has a proximal pivot end 34p that is pivotably received in the proximal end 56p of the staple channel 56, just distal to the engagement portion with the shaft 14. When the upper jaw portion 34 pivots downward, it moves the anvil surface 33, causing the staple-forming pocket formed on the anvil surface 33 to move toward the opposing staple cartridge 40.

[0054] Various clamping components can be used to bring about the opening and closing of the jaws 32, 34, and selectively clamp tissue between them. As shown in the figure, the pivot end 34p of the upper jaw 34 includes a closing mechanism 34c distal to its pivotal attachment to the staple channel 56. Thus, at its distal end, a closure tube 46, which includes a horseshoe-shaped opening 46a that engages with the closure mechanism 34c, selectively provides an opening movement relative to the upper jaw 34 during the proximal longitudinal movement of the closure tube 46 and a closing movement relative to the upper jaw 34 during the distal longitudinal movement of the closure tube 46, in response to the clamp trigger 22. As described above, in various implementations, the opening and closing of the end effector 30 may be brought about by the relative movement of the lower jaw 32 relative to the upper jaw 34, the relative movement of the upper jaw 34 relative to the lower jaw 32, or the movement of both jaws 32, 34 relative to each other.

[0055] The firing component of the illustrated implementation includes a firing bar 35 having an E-beam 38 at its distal end, as shown in Figure 3. The firing bar 35 is contained within the shaft 14, for example, within the longitudinal firing bar slot 14s of the shaft 14, and is guided by a firing motion from the handle 12. The activation of the firing trigger 24 affects the distal motion of the E-beam 38 through at least a portion of the end effector 30, thereby firing the staples contained in the staple cartridge 40. As illustrated, a guide 39 protruding from the distal end of the E-beam 38 can engage with a wedge thread 47 shown in Figure 2. The wedge thread 47 can then push up the staple driver 48 through the staple cavity 41 formed within the staple cartridge 40. The upward movement of the staple driver 48 applies an upward force to each of the multiple staples in the cartridge 40, thereby pushing the staples upward against the anvil surface 33 of the upper jaw 34 and creating a formed staple.

[0056] In addition to firing staples, the E-beam 38 may be configured to facilitate the closure of the jaws 32, 34, the separation of the upper jaw 34 from the staple cartridge 40, and / or the cutting of tissue trapped between the jaws 32, 34. Specifically, a pair of apex pins and a pair of bottom pins may engage with one or both of the upper jaws 32 and the lower jaws 34 to press the jaws 32, 34 toward each other as the firing bar 35 advances through the end effector 30. Simultaneously, a knife 36 extending between the apex and bottom pins may be configured to cut tissue trapped between the jaws 32, 34.

[0057] During use, the surgical stapler 10 can be placed inside a cannula or port and positioned at the surgical site. The tissue to be incised and stapled may be positioned between the jaws 32 and 34 of the surgical stapler 10. The features of the stapler 10 can be manipulated by the user as desired to achieve the desired position of the jaws 32 and 34 in relation to the surgical site and tissue. After proper positioning is achieved, the clamping system can be activated by pulling the clamp trigger 22 toward the stationary handle 20. The trigger 22 can activate the components of the clamping system such that the occluding tube 46 moves distally through at least a portion of the shaft 14, tilting at least one of the jaws 32 and 34 toward the other and clamping the tissue positioned between them. Subsequently, the trigger 24 can be pulled toward the stationary handle 20 to activate the components of the firing system, causing the firing bar 35 and / or E-beam 38 to advance distally through at least a portion of the end effector 30, resulting in the firing of staples and optionally cutting the trapped tissue between the jaws 32, 34.

[0058] Another example of a surgical instrument in the form of a linear surgical stapler 50 is shown in Figure 4. The stapler 50 can generally be configured and used in the same way as the stapler 10 in Figure 1. Similar to the surgical instrument 10 in Figure 1, the surgical instrument 50 includes a handle assembly 52 with a shaft 54, the shaft 54 ​​extending distally from the handle assembly 52 and having an end effector 60 at its distal end for treating tissue. The upper jaw 64 and lower jaw 62 of the end effector 60 may be configured to capture tissue between them, staple the tissue by firing staples from a cartridge 66 located in the lower jaw 62, and / or to form an incision in the tissue. In this configuration, a mounting portion 67 at the proximal end of the shaft 54 ​​may be configured to allow the shaft 54 ​​and the end effector 60 to be detachably attached to the handle assembly 52. Specifically, the mating mechanism 68 of the mounting portion 67 can mate with the auxiliary mating mechanism 71 of the handle assembly 52. ​​The mating mechanisms 68 and 71 may be configured to connect with each other by means of, for example, a snap-fit ​​coupling, a bayonet coupling, etc., but any number of auxiliary mating mechanisms and any type of coupling can be used to detachably connect the shaft 54 ​​to the handle assembly 52. ​​In the illustrated configuration, the entire shaft 54 ​​is configured to be detachable from the handle assembly 52, but in some configurations, the mounting portion 67 may be configured so that only the distal portion of the shaft 54 ​​can be removed. The detachable connection of the shaft 54 ​​and / or the end effector 60 allows for the selective mounting of the desired end effector 60 for a particular procedure, and / or the reuse of the handle assembly 52 for a number of different procedures.

[0059] The handle assembly 52 may have one or more mechanisms on it for operating the end effector 60. In a non-limiting example, a rotary knob 72 attached to the distal end of the handle assembly 52 may facilitate the rotation of the shaft 54 ​​and / or the end effector 60 relative to the handle assembly 52. ​​The handle assembly 52 may include a clamping component as part of a clamping system actuated by a movable trigger 74, and a firing component as part of a firing system, which may also be actuated by the trigger 74. Thus, in some implementations, the movement of the trigger 74 toward the stationary handle 70 through a first range of motion may actuate the clamping component, bringing the opposing jaws 62, 64 toward each other and closer to the closed position. In some implementations, only one of the opposing jaws 62, 64 may move toward the closed position toward the jaws 62, 64. Further movement of the trigger 74 through the second range of motion toward the stationary handle 70 can activate the firing component to release staples from the staple cartridge 66 and / or advance a knife or other cutting member (not shown) to cut tissue trapped between the jaws 62, 64.

[0060] An example of a surgical instrument in the form of an annular surgical stapler 80 is shown in Figure 5. The stapler 80 is generally configured and can be used in the same way as the linear staplers 10 and 50 in Figures 1 and 4, but some mechanisms are adapted to its function as an annular stapler. Similar to the surgical instruments 10 and 50, the surgical instrument 80 comprises a handle assembly 82 with a shaft 84, the shaft 84 extending distally from the surgical instrument 80 and having an end effector 90 at its distal end for treating tissue. The end effector 90 may include a cartridge assembly 92 and an anvil 94, each having a substantially circular shape and a surface that contacts tissue. The cartridge assembly 92 and anvil 94 can be connected via a shaft 98 extending from the anvil 94 of the stapler 80 to the handle assembly 82, and by operating an actuator 85 on the handle assembly 82, the shaft 98 can be moved back and forth to move the anvil 94 relative to the cartridge assembly 92. The anvil 94 and cartridge assembly 92 can perform various functions and can be configured to capture tissue between them, staple tissue by firing staples from the cartridge 96 of the cartridge assembly 92, and / or to form an incision in the tissue. Generally, the cartridge assembly 92 can house a cartridge containing staples, and by deploying the staples against the anvil 94, a circular staple pattern can be formed, for example, to staple around the outer circumference of a tubular internal organ.

[0061] In one implementation, the shaft 98 may consist of first and second parts (not shown) configured to be releasably connected to each other so that the anvil 94 can be separated from the cartridge assembly 92, thereby providing greater flexibility in positioning the anvil 94 and cartridge assembly 92 in the patient's body. For example, the first part of the shaft may be located inside the cartridge assembly 92 and extend distally to the outside of the cartridge assembly 92, terminating at a distal fitting mechanism. The second part of the shaft may be located inside the anvil 94 and extend proximal to the outside of the cartridge assembly 92, terminating at a proximal fitting mechanism. In use, the anvil 94 and cartridge assembly 92 can be moved relative to each other by connecting the proximal and distal fitting mechanisms.

[0062] The handle assembly 82 of the stapler 80 can be equipped with various actuators that can control the operation of the stapler. For example, the handle assembly 82 can be equipped with a rotary knob 86 for facilitating the positioning of the end effector 90 by rotation, and / or a trigger 85 for activating the end effector 90. Movement of the trigger 85 toward the stationary handle 87 through a first range of motion can be activated to move components of the clamping system toward the jaws (for example, to move the anvil 94 toward the cartridge assembly 92). Movement of the trigger 85 toward the stationary handle 87 through a second range of motion can be activated to activate components of the firing system to deploy staples from the staple cartridge assembly 92 and / or advance the knife to cut the tissue trapped between the cartridge assembly 92 and the anvil 94.

[0063] The illustrated examples of surgical stapling devices 10, 50, and 80 provide only a few examples of many different configurations and associated uses, which can be used in conjunction with the disclosures provided herein. Although all illustrated embodiments are configured for use in minimally invasive procedures, it will be understood that devices configured for use in incisional surgical procedures, such as open linear staplers as described in U.S. Patent No. 8,317,070 (titled "Surgical Stapling Devices That Produce Formed Staples Having Different Lengths," filed February 28, 2007), can also be used in conjunction with the disclosures provided herein. Further details of the illustrated embodiments, as well as further embodiments of surgical staplers, their components, and related methods of use, are provided in U.S. Patent Application Publication No. 2013 / 0256377 (title of invention, "Layer Comprising Deployable Attachment Members," filed February 8, 2013), U.S. Patent No. 8,393,514 (title of invention, "Selectively Orientable Implantable Fastener Cartridge," filed September 30, 2010), U.S. Patent No. 8,317,070 (title of invention, "Surgical Stapling Devices That Produce Formed Staples Having Different Lengths," filed February 28, 2007), and U.S. Patent No. 7,143.U.S. Patent Publication No. 925 (Title of invention: "Surgical Instrument Incorporating EAP Blocking Lockout Mechanism," filed June 21, 2005), U.S. Patent Application Publication No. 2015 / 0134077 (Title of invention: "Sealing Materials For Use In Surgical Stapling," filed November 8, 2013), (Title of invention: "Sealing Materials for Use in Surgical Procedures," filed November 8, 2013), same Patent Publication No. 2015 / 0134076 (Title of invention: "Hybrid Adjunct Materials for Use in Surgical Stapling," filed November 8, 2013), same Patent Publication No. 2015 / 0133996 (Title of invention: "Positively Charged Implantable Materials and Method of Forming the The invention is provided in the following patent applications: "Same" (filed November 8, 2013), No. 2015 / 0129634 (title of invention "Tissue Ingrowth Materials and Method of Using the Same", filed November 8, 2013), No. 2015 / 0133995 (title of invention "Hybrid Adjunct Materials for Use in Surgical Stapling", filed November 8, 2013), No. 14 / 226,142 (title of invention "Surgical Instrument Comprising a Sensor System", filed March 26, 2014), and No. 14 / 300,954 (title of invention "Adjunct Materials and Methods of Using Same in Surgical Methods for Tissue Sealing", filed June 10, 2014). These documents are incorporated herein by reference in their entirety.

[0064] Planting support material As described above, various implantable auxiliary materials are provided for use with surgical staple ring instruments. When used with a surgical stapler, the auxiliary material(s) may be positioned between and / or on the jaws of the stapler, incorporated into a staple cartridge positioned on the jaws, or otherwise positioned proximal to the staples. For example, as shown in Figure 6, the auxiliary material 104 is positioned in contact with the staple cartridge 102. For simplification, the auxiliary material 104 is schematically shown in Figure 6, and various structural configurations of the auxiliary material are described in more detail below. Partially obscured in Figure 6, the staple cartridge 102 includes staples 106 configured to be deployed in tissue. Staples 106 may have any preferred unformed (pre-deployment) height. For example, staples 106 may have an unformed height of approximately 2 mm to 4.8 mm. The crown portion of the staple may be supported by a staple driver (not shown) before deployment.

[0065] In the illustrated embodiments, the auxiliary material 104 can be releasably fitted to at least a portion of the top surface, i.e., the deck surface 108, of the staple cartridge 102. In some embodiments, the top surface 108 of the staple cartridge 102 may include one or more surface features. Alternatively, or additionally, one or more adhesives may be used to releasably fit the auxiliary material to the staple cartridge 102. One or more surface features and / or one or more adhesives may be configured to engage with the auxiliary material 104 to prevent undesirable movement of the auxiliary material 104 relative to the staple cartridge 102 and / or to prevent premature release of the auxiliary material 104 from the staple cartridge 102. Exemplary surface features are described in U.S. Patent Application Publication 2016 / 0106427, which is incorporated herein by reference in its entirety. Further details relating to adhesives for temporary attachment to fixtures and other exemplary adhesives can be found in U.S. Patents 9,282,962, 10,172,617, 10,172,618, 10,258,332, 10,517,592, 10,548,593, 10,568,621, and 10,588,623, each of which is incorporated herein by reference in its entirety. Further details regarding the mounting method and other exemplary methods can be found in U.S. Patent Nos. 10,166,023 and 10,349,939, and U.S. Patent Application No. 17 / 022,520 (titled “Method of Applying Buttress to End Effector of Surgical Stapler,” filed September 16, 2020), each of which is incorporated herein by reference in its entirety.

[0066] In certain cases, the auxiliary material is compressible and can be compressed to various heights to compensate for different tissue thicknesses trapped within the deployed staples. For example, as shown in Figure 6, the auxiliary material 104 has an uncompressible (undeformed) height, i.e., a pre-deployment height, and is configured to deform to one of several compressible (deformed) heights, i.e., deployment heights. Thus, the auxiliary material 104 may have an uncompressible height that is higher than the post-launch height of the staple 106 deployed in the staple cartridge 102 (e.g., the height (H) of the launched staple 106a in Figure 7). That is, the auxiliary material 104 may have an undeformed state in which the maximum height of the auxiliary material 104 is higher than the maximum height of the launched staple (e.g., the staple in the formation configuration). In such cases, the auxiliary material may be called a "tissue thickness compensator." In one embodiment, the uncompressed height of the auxiliary material 104 can be about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% higher than the post-launch height of the staple 106. In a particular embodiment, the uncompressed height of the auxiliary material 104 can be, for example, more than 100% higher than the post-launch height of the staple 106.

[0067] Auxiliary materials can have various configurations and can be formed from various materials. Generally, auxiliary materials can be formed from one or more films, foams, injection-molded thermoplastics, vacuum thermoformed materials, fibrous structures, additive manufacturing materials, and hybrids thereof. Auxiliary materials may also include one or more bio-derived materials and one or more drugs. Each of these materials will be discussed in more detail below.

[0068] The auxiliary material may be formed from a foam, such as a closed-cell foam, an open-cell foam, or a sponge. An example of a method for producing such an auxiliary material is from animal-derived collagen, such as pig tendon, which is then processed and freeze-dried to obtain a foamed structure. Various examples of foaming auxiliary materials are further described in U.S. Patent No. 8,393,514 (titled “Selectively Orientable Implantable Fastener Cartridge,” filed September 30, 2010), which is incorporated herein by reference in its entirety.

[0069] Furthermore, the auxiliary material may be formed from a film made of any suitable material or combination thereof as considered below. The film may contain one or more layers, each of which may have a different decomposition rate. In addition, the film may have various regions formed internally, for example, reservoirs that can release one or more agents in many different forms into the interior. The reservoir containing at least one agent placed inside may be sealed using one or more different coating layers that may contain absorbent or non-absorbent polymers. The film may be formed in various ways. For example, the film may be an extruded film or a compression-molded film.

[0070] Furthermore, the auxiliary material may be formed from injection-molded thermoplastic material or vacuum thermoformed material. Examples of various forming auxiliary materials are further described in U.S. Patent Application Publication No. 2013 / 0221065 (title of the invention, “Fastener Cartridge Comprising A Releasably Attached Tissue Thickness Compensator,” filed February 8, 2013), which is incorporated herein by reference in its entirety. The auxiliary material may also be a fiber-based grid. The grid may be a woven fabric, a knitted fabric, or a nonwoven fabric such as a meltblown, needle-punched, or heat-constructed loose woven fabric. The auxiliary material may have multiple regions, which may be formed from the same type of grid or different types of grids, which can together form the auxiliary material in many different ways. For example, fibers may be woven, braided, knitted, or otherwise bound together to form a regular or irregular structure. The fibers may be bound together so that the resulting auxiliary material is relatively loose. Alternatively, the auxiliary material may include densely interwoven fibers. The auxiliary material may be in the form of a sheet, tube, helix, or any other structure which may include softer and / or stiffer reinforcing sections. The auxiliary material may be configured such that certain areas have denser fibers, while other areas have less dense fibers. The fiber density may vary in different directions along one or more dimensions of the auxiliary material, based on its intended use.

[0071] In other embodiments, the auxiliary material may be formed using a 3D printing process compatible with the absorbent polymer. Not limited examples of suitable 3D printing processes, as will be understood by those skilled in the art, include stereolithography (SLA or SL), material jetting, selective laser sintering (SLS), and fused filament fabrication.

[0072] Furthermore, the auxiliary material can be a hybrid structure such as a laminated composite or Meltlock interbonded fibers. Examples of various hybrid structural auxiliary materials are further described in U.S. Patent Application Publication No. 2013 / 0146643 (titled "Adhesive Film Laminate," filed February 8, 2013) and U.S. Patent No. 7,601,118 (titled "Minimally Invasive Medical Implant And Insertion Device And Method For Using The Same," filed September 12, 2007). These documents are incorporated herein by reference in their entirety.

[0073] material Auxiliary materials based on the described techniques can be formed from a variety of materials. These materials can be used in various embodiments for different purposes. The materials can be selected according to the desired treatment to be provided to the tissue in order to promote tissue endothelial growth. The materials described below can be used to form auxiliary materials in any desired combination.

[0074] The materials may include bioabsorbable and biocompatible polymers, including homopolymers and copolymers. Non-limiting examples of homopolymers and copolymers include p-dioxanone (PDO or PDS), polyglycolic acid (PGA) (e.g., Dexon and Neoveil), poly(lactic acid-coglycolic acid) (PLGA), polycaprolactone (PCL), polyglycolide (PGL), trimethylene carbonate (TMC), polylactic acid (PLA) (e.g., Linvatec Bioscrew and Bionx Implants Smart). Screw), poly(trimethylene carbonate) (PTMC), polyethylene diglycolate (PEDG), poly(propylene fumarate) (PPF), polyethylene ether (PEE), poly(ethylene glycol) (PEG), poly(N-isopropylacrylamide, poly(amino acids), poly(epoxy carbonate), poly(2-oxypropylene carbonate), poly(diol citrate), polymethacrylate anhydride, poly(ethoxyethylene diglycolate), poly(glycolic acid-co-lactic acid) (PLA / PGA) (e.g., PLA / PGA materials used in Vicryl, Vicryl Rapide, PolySorb, and Biofix), polyurethane (e.g., Elastane, Biospan, Tecoflex, Biolate, and Pellethane fibers), polyoltoesters, polyanhydrides (e.g., Gliadel and Biodel polymers), polyoxaesters, polyesteramides (e.g., REVA Examples include ReZolve stents and tyrosine-based polyester amides (e.g., TYRX).Copolymers also include poly(lactic acid-co-polycaprolactone) (PLA / PCL) (e.g., hydrolyzed for 16-18 months), poly(L-lactic acid-co-polycaprolactone) (PLLA / PCL), poly(glycolic acid-co-trimethylene carbonate) (PGA / TMC) (e.g., Maxon), poly(glycolic acid-co-caprolactone) (PCL / PGA) (e.g., Monocryl and Capgly), PDS / PGA / TMC (e.g., Biosyn), PDS / PLA, PGA / PCL / TMC / PLA (e.g., Caprosyn), LPLA / DLPLA (e.g., Optima), PLGA-PCL (e.g., 15:85 (PCL: 50% D,L-lactide: 50% glycolide), 40:60 (PCL: 50% D,L-lactide: 50%). Examples include glycosides, 40:60 (PCL:85% D,L-lactide:15% glycosides), PLGA-PCL-PLGA, and PLGA-PEG-PLGA.

[0075] The auxiliary materials may also include (meth)acrylates and special polymer ends such as organically derived polymers. Non-limiting examples of organically derived polymers include those derived from collagen (e.g., Avitene, Endoavitene, Instat, Integran, Veritas, and Microfibrillar Collagen (MFC)).

[0076] Furthermore, auxiliary materials include activators, such as active cell cultures (e.g., dice-shaped autologous tissues), and activators used in stem cell therapy (e.g., Biosutures and Cellex). This may also include SL), hemostatic agents, and tissue healing agents. Non-limiting examples of hemostatic agents include cellulose, e.g., oxidized regenerated cellulose (ORC) (e.g., Surgicel and Interceed), fibrin / thrombin (e.g., Thrombin-JMI, TachoSil, Tiseel, Floseal, Evicel, TachoComb, Vivostat, and Everest), autologous platelet-rich plasma, gelatin (e.g., Gelfilm and Gelfoam), hyaluronic acid, e.g., microfibers (e.g., yarns and fabrics) or other hyaluronic acid-based structures, or hyaluronic acid-based hydrogels. Hemostatic agents may also include polymer sealants, e.g., bovine serum albumin and glutaraldehyde, human serum albumin and polyethylene crosslinkers, as well as ethylene glycol and trimethylene carbonate. An example of a polymer encapsulant is FocalSeal surgical encapsulant developed by Focal Inc.

[0077] The auxiliary materials described herein may contain, in a manner that allows for the release of at least one drug. The drug may be selected from a number of different drugs. The drug may include, but is not limited to, drugs or other agents that are contained within or associated with the auxiliary material and have the desired function. Examples of drugs may include, but are not limited to, antibacterial agents, such as antimicrobial agents and antibiotics, antifungal agents, antiviral agents, anti-inflammatory agents, growth factors, analgesics, anesthetics, tissue matrix degeneration inhibitors, anticancer agents, hemostatic agents, and other agents that induce a biological response.

[0078] Non-limiting examples of antibacterial agents include silver ions, aminoglycosides, streptomycin, polypeptides, bacitracin, triclosan, tetracycline, doxycycline, minocycline, demeclocycline, tetracycline, oxytetracycline, chloramphenicol, nitrofuran, furazolidone, nitrofurantoin, beta-lactam, penicillin, amoxicillin, amoxicillin + clavulanic acid, azurocillin, flucloxacillin, ticarcillin, piperacillin + tazobactam, tazocin, and Biopiper. TZ, Zosyn, Carbapenem, Imipenem, Meropenem, Ertapenem, Doripenem, Biapenem, Panipenem / Betamipron, Quinolone, Ciprofloxacin, Enoxacin, Gatifloxacin, Gemifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Nalidixic acid, Norfloxacin, Sulfonamide, Mafenide, Sulfacetoamide, Sulfadiazine, Silver sulfadiazine, Sulfadimethoxine, Sulfamethisole, Sulfamethoxazole, Sulfasalazine, Sulfisoxazole, Bactrim, Prontosil, Ansamycin, Geldanamycin, Herbimycin, Fidaxomicin, Glycopeptide, Te Examples include icoplanin, vancomycin, teravancin, darbabasin, oritabancin, lincosamide, clindamycin, lincomycin, lipopeptides, daptomycin, macrolides, azithromycin, clarithromycin, erythromycin, roxithromycin, telithromycin, spiramycin, oxazolidinone, linezolid, aminoglycosides, amikacin, gentamicin, kanamycin, neomycin, netylmycin, tobramycin, paromycin, paromomycin, cephalosporins, ceftobiprole, ceftolozane, cefclizine, flomoxef, monobactam, aztreonam, colistin, and polymyxin B.

[0079] Non-limited examples of antifungal agents include triclosan, polyenes, amphotericin B, candicidine, philipin, hamycin, natamycin, nystatin, rimocidine, azole, imidazole, triazole, thiazole, allylamine, amorolfine, butenafine, naphthifine, terbinafine, echinocandin, anidurafandin, caspofandin, micafandin, cyclopirox, and benzoic acid.

[0080] Non-limited examples of antiviral agents include uncoating inhibitors, such as amantadine, rimantadine, and preconalil; reverse transcription inhibitors, such as acyclovir, lamivudine, antisense, fomivirsen, morpholino, ribozyme, and rifampicin; and antiviral drugs, such as cyanobilin-N, griffiscin, cytobilin, α-lauryl-L-arginine ethyl ester (LAE), and silver ions.

[0081] Non-limiting examples of anti-inflammatory agents include nonsteroidal anti-inflammatory drugs (e.g., salicylates, aspirin, diflunisal, propionic acid derivatives, ibuprofen, naproxen, fenoprofen, and loxoprofen), acetate derivatives (e.g., tolmetine, sulindac, and diclofenac), enolic acid derivatives (e.g., piroxicam, meloxicam, droxicam, and lornoxicam), anthranilic acid derivatives (e.g., mefenamic acid, meclofenamic acid, and flufenamic acid), selective COX-2 inhibitors (e.g., celecoxib (Celebrex), parecoxib, rofecoxib (Vioxx), sulfonanilide, nimeslide, and clonixin), immunoselective anti-inflammatory derivatives, corticosteroids (e.g., dexamethasone), and iNOS inhibitors.

[0082] Non-limiting examples of growth factors include factors that are cell signaling molecules that stimulate cell growth, healing, reformation, proliferation, and differentiation. Exemplary growth factors may be short-range (paracrine), long-range (endocrine), or autocrine. Further examples of growth factors include growth hormone (e.g., recombinant growth factors, neutropin, humatrope, genotropin, norditropin, saizen, omnitrope, and biosynthetic growth factors), epidermal growth factor (EGF) (e.g., inhibitors, gefitinib, erlotinib, afatinib, and cetuximab), heparin-bound EGF-like growth factors (e.g., epiregulin, betacellulin, amphiregulin, and epigen), transforming growth factor α (TGF-α), neuroregulin 1-4, fibroblast growth factor ( Examples include FGFs (e.g., FGF-1-2, FGF2, FGF11-14, FGF18, FGF15 / 19, FGF21, FGF23, FGF7, or keratinocyte growth factor (KGF), FGF10, or KGF2, and phenytoin), insulin-like growth factor (IGF) (e.g., IGF-1, IGF-2, and platelet-derived growth factor (PDGF)), and vascular endothelial growth factor (VEGF) (e.g., inhibitors, bevacizumab, ranibizumab, VEGF-A, VEGF-B, VEGF-C, VEGF-D, and becaprelmin).

[0083] Further non-limiting examples of growth factors include cytokines, e.g., granulocyte-macrophage colony-stimulating factor (GM-CSF) (e.g., inhibitors that inhibit inflammatory responses and GM-CSF produced using recombinant DNA technology and recombinant yeast-derived sources), granulocyte colony-stimulating factor (G-CSF) (e.g., filgrastim, lenograstim, and neupogen), tissue growth factor beta (TGF-B), leptin, and interleukins (IL) (e.g., IL-1a, IL-1b, canakinumab, IL-2, aldesleukin, interking, denileukin, difutitox, IL-3, IL-6, IL-8, IL-10, IL-11, and oprelbekin). Further non-limiting examples of growth factors include erythropoietins (e.g., darbepoetin, epocept, dynepo, epomax, neorecolmon, silapo, and retacrit).

[0084] Analgesics are not limited to anesthetics, opioids, morphine, codeine, oxycodone, hydrocodone, buprenorphine, tramadol, non-anesthetics, paracetamol, acetaminophen, NSAIDs, and flupirin.

[0085] Non-limiting examples of anesthetics include local anesthetics (e.g., lidocaine, benzocaine, and ropivacaine) and general anesthetics.

[0086] Non-limiting examples of tissue matrix degradation inhibitors that inhibit the action of metalloproteinases (MMPs) and other proteases include MMP inhibitors (e.g., exogenous MMP inhibitors, hydroxymate MMP inhibitors, batimastat (BB-94), ilomast (GM6001), marimast (BB2516), thiols, periostat (doxycycline), squalane, BB-1101, hydroxyurea, hydrazine, endogenous, carbamoyl phosphate, beta-lactam, and tissue inhibitors of MMPs (TIMPs)).

[0087] Non-limiting examples of anticancer drugs include monoclonal antibodies, bevacizumab (Avastin), cell / chemoattractants, alkylating agents (e.g., bifunctional cyclophosphamide, mechloretamine, chlorambucil, melphalan; monofunctional nitrosourea, and temozolomide), anthracyclines (e.g., daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone, and barurubicin), and cytoskeletal disruptors (e.g., paclitaxel and Docetaxel), epotilones that restrict cell division by inhibiting microtubule function, inhibitors that block various enzymes necessary for cell division or specific cellular functions, histone deacetylase inhibitors (e.g., vorinostat and romidepsin), topoisomerase I inhibitors (e.g., irinotecan and topotecan), topoisomerase II inhibitors (e.g., etoposide, teniposide, and tafluposide), kinase inhibitors (e.g., bortezomib, erlotin) (Nib, gefitinib, imatinib, vemurafenib, and bismodegib), nucleotides themselves (e.g., azacitidine, azathioprine, capecitabine, cytarabine, doxifluridine, fluorouracil, 5-FU, adorucyl, Carac, Efudix, Efudex, Fluoroplex, gemcitabine, hydroxyurea, mercaptopurine, and thioguanine), peptide antibiotics that cleave DNA and interfere with DNA unwinding / wrapping. Agents (e.g., bleomycin and actinomycin), platinum-based antitumor agents that cross-link DNA and inhibit DNA repair and / or synthesis (e.g., carboplatin, cisplatin, oxaliplatin, and eloxatin), retinoids (e.g., tretinoin, alitretinoin, and bexarotene), vinca alkaloids that inhibit mitosis and microtubule formation (e.g., vinblastine, vincristine, vindesine, vinorelbine), cell growth or cell proliferation (cellAngiogenesis inhibitors that inhibit expansion (e.g., axitinib (Inlyta), bevacizumab (Avastin), cabozantinib (Cometriq), everolimus (Afinitor, Zortress), lenalidomide (Revlimid), pazopanib (Votrient), ramucirumab (Cyramza), regorafenib (Stivarga), sorafenib (Nexavar), sunitinib ( Examples include Sutent, thalidomide (Synovir, Thalomid), vandetanib (Caprelsa), Zib-aflibercept (Zaltrap), anti-angiogenic polysaccharides, apridin (dehydrodydemnin B), sapogenins (i.e., 20(S)-protopanaxadiol and 20(S)-protopanaxatriol), anti-ileus agents, exercise stimulants, immunosuppressants (e.g., tacrolimus), blood aspect modifier agents (e.g., vasodilators, Viagra, and nifedipine), 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase inhibitors (e.g., atorvastatin), and anti-angiogenic agents.

[0088] Exemplary agents also include activators that passively contribute to wound healing, such as nutrients, oxygen scavenging agents, amino acids, collagen synths, glutamine, insulin, butyrates, and dextran. Exemplary agents also include anti-adhesive agents. Non-limiting examples include hyaluronic acid / carboxymethylcellulose (seprafilm), oxidized regenerated cellulose (Interceed), and icodextrin 4% (Extraneal, Adept).

[0089] Examples of drugs include those for coronary artery disease (CAD) (e.g., VEGF). 165 Protein, AdVEGF 165 AdVEGF 121 , and VEGF 165 Plasmids) or peripheral artery disease (PAD) (e.g., VEGF) 165 Plasmid, AdVEGF 121 SB-509 (SFP-VEGF plasmid), AdVEGF 165Examples include drugs that promote blood supply regeneration after the Ad2-HIF1α-VP16 (WALK trial).

[0090] Drug release Augmented materials based on the described technology can be associated with at least one agent in many different ways to provide a desired effect in a desired manner, for example, on tissue endothelial growth. At least one agent may be configured to be released from the augmented material in multiple spatial and temporal patterns to trigger a desired healing process at the treatment site. The agent may be placed within the augmented material, bound to the augmented material, incorporated into the augmented material, dispersed within the augmented material, or otherwise associated with the augmented material. For example, an augmented material may have one or more regions internally that are releaseably holding one or more different agents. These regions may be separate reservoirs of various sizes and shapes, holding the agents internally in various ways, or other separate or continuous regions within the augmented material. In some embodiments, a particular configuration of the augmented material allows one or more different agents to be releaseably held internally.

[0091] Regardless of how the drug is placed within the adjuvant, an effective amount of at least one drug may be encapsulated in a pellet, which may be in the form of a container, such as a microcapsule, microbead, or any other container. This container may be formed from a bioabsorbable polymer.

[0092] Targeted delivery and release of at least one drug from an adjuvant can be achieved in many ways depending on various factors. Generally, at least one drug may be released from the adjuvant as a bolus dose so that the drug is released substantially immediately after the adjuvant is delivered to the tissue. Alternatively, at least one drug may be released from the adjuvant over a specific period of time, which may be minutes, hours, days, or longer. The rate of timed release and the amount of drug released may depend on various factors, such as the rate of degradation of the area from which the drug is released, the rate of degradation of one or more coatings or other structures used to retain the drug within the adjuvant, the environmental conditions of the treatment site, and various other factors. In some embodiments, if the adjuvant has two or more drugs placed inside, the bolus dose release of the first drug may be regulated so that the release of the second drug begins after the release of the first drug. The adjuvant may contain multiple drugs, each of which may affect the release of one or more other drugs in any appropriate way.

[0093] The release of at least one drug, either as a bolus dose or as a timed release, may occur or begin substantially immediately after the auxiliary material is delivered to the tissue, or it may be delayed for a predetermined time. The delay may depend on the structure and properties of the auxiliary material or one or more of its regions.

[0094] Auxiliary materials may have a structure that facilitates the distribution of one or more effective amounts of drugs held within the auxiliary material and may be configured to produce a desired effect. For example, targeted drug delivery may be achieved by incorporating the drug into a region within the auxiliary material (e.g., a reservoir, e.g., pores, or other structure) formed in a pattern that allows for a specific spatial distribution of the drug based on its delivery. The drug placed in the reservoir may be incorporated into a separate container. The reservoir may contain two or more different drugs. One or more drugs may be eluted from the auxiliary material in a homogeneous or heterogeneous spatial and / or temporal manner to provide the desired treatment. The structure of the auxiliary material and the manner in which the drugs are released from it may be used to influence or control tissue regrowth. Furthermore, tissue regrowth may be enhanced at specific locations in the treatment site and inhibited at other locations in the treatment site.

[0095] A plantable support material with an adjustable decomposition profile. As described above, embodiments of the augmented material can be used for various functions, such as tissue reinforcement at the treatment site, minimizing tissue migration within and near the staple puncture site, and compensating for tissue thickness. This function depends on one or more mechanical properties of the augmented material, such as strength (e.g., compressive strength, tensile strength) and modulus / stiffness, which remain above a predetermined level after implantation to ensure that the function of the augmented material is achieved. However, after implantation, the augmented material may absorb bodily fluids (e.g., water and / or hydrous fluids). Bodily fluids can chemically react with the augmented material (e.g., via hydrolysis), causing the augmented material to decompose over time and resulting in changes to its mechanical properties.

[0096] For a given augmented material, the change in its mechanical properties over time can be characterized in the form of a decomposition profile. However, it will be understood that surgeons may want to adjust the decomposition profile of the augmented material based on considerations such as the implantation site and the type of surgery. Therefore, embodiments of the present disclosure provide a compressible augmented material having an adjustable decomposition profile, as will be described in detail below.

[0097] In one embodiment, a compressible auxiliary kit for use with a staple cartridge is provided, which may include a biocompatible auxiliary material and a pretreatment fluid. The auxiliary material is configured to be releasably held on the staple cartridge body or anvil and to be delivered to tissue by the deployment of staples within the cartridge body. The auxiliary material may be in the form of a porous polymer. Before implantation, the pretreatment fluid can be applied to the auxiliary material to transform it from a stock state, i.e., an untreated state, configured to exhibit a first degradation profile when delivered to tissue, to a treated state, configured to exhibit a second degradation profile when delivered to tissue. The first and second degradation profiles may differ from each other.

[0098] Figure 8 is a plot showing several exemplary decomposition profiles, one plotting an untreated auxiliary material and two plotting a treated auxiliary material. A decomposition profile is in the form of a curve representing the values ​​of the mechanical properties of a given auxiliary material over time. As shown, the decomposition rate of the treated auxiliary material, represented by the slope of the decomposition profile, may be greater than or less than the decomposition rate of the untreated auxiliary material. Embodiments of the kit may include at least one pretreatment fluid configured to increase or decrease the decomposition rate. In particular embodiments, the kit may include multiple pretreatment fluids configured to increase or decrease the decomposition rate to a predetermined decomposition rate, thus allowing the user to select a pretreatment fluid configured to produce a desired decomposition rate.

[0099] As will be discussed in more detail below, pretreatment fluids can increase or decrease the rate of degradation of auxiliary materials when delivered to tissue using various mechanisms. In one embodiment, the pretreatment fluid can increase or decrease the rate of chemical reactions (e.g., hydrolysis) between water-containing body fluids and the treated auxiliary material compared to untreated auxiliary materials. In another embodiment, the pretreatment fluid may be configured to increase or decrease the surface area of ​​the auxiliary material that can come into contact with and thus chemically react with body fluids, by promoting or inhibiting the absorption of body fluids by the auxiliary material. By increasing or decreasing the surface area of ​​the treated auxiliary material that comes into contact with body fluids compared to untreated auxiliary materials, the rate of degradation of the treated auxiliary material can be increased or decreased compared to the untreated auxiliary material.

[0100] In further embodiments, before mounting to a staple cartridge or anvil, a compressive force can be applied to the auxiliary material to alter the connectivity between the pores of the auxiliary material, and thus the relative ease with which fluids can flow into the interior of the auxiliary material. As described above, the pores of the auxiliary material can be classified as either open or closed. Open pores can allow fluid to flow through them, while closed pores cannot. In one embodiment, a compressive force applied to the auxiliary material can convert closed pores into open pores by forming channels (e.g., cracks) between adjacent pores. By thus opening the porosity, the flow of fluid through the auxiliary material can be promoted, increasing the surface area of ​​the auxiliary material available for contact with bodily fluids, and thus increasing the rate of decomposition of the auxiliary material. In other embodiments, a compressive force applied to the auxiliary material can convert open pores into closed pores by closing channels between adjacent pores. By thus closing the porosity, the flow of fluid through the auxiliary material can be inhibited, reducing the surface area of ​​the auxiliary material available for contact with bodily fluids, and thus decreasing the rate of decomposition of the auxiliary material.

[0101] The pretreatment fluid can be applied to the auxiliary material in various ways. In one embodiment, the auxiliary material may be immersed in a container containing the pretreatment fluid. In another embodiment, the pretreatment fluid may be applied to the auxiliary material using a delivery device (e.g., a pipette, eyedropper, etc.). In a particular embodiment, the pretreatment fluid is applied to the auxiliary material when it is separated from the staple cartridge. In another embodiment, the pretreatment fluid is applied to the auxiliary material while it is held on the staple cartridge or anvil.

[0102] Certain embodiments of the pretreatment fluid may be configured to increase the degradation rate of the treated auxiliary material compared to the untreated auxiliary material, using various mechanisms. In one embodiment, the pretreatment fluid is configured to alter (e.g., increase) the pH of any hydrated tissue or hydrated fluid adjacent to the auxiliary material when implanted. As an example, the pretreatment fluid may be mixed with water contained in a fluid that comes into contact with the auxiliary material and / or with a hydrated fluid adjacent to the auxiliary material. By increasing the pH at the location of the auxiliary material, the hydrolysis rate of the auxiliary material can be increased, thereby increasing the degradation rate of the treated auxiliary material. Examples of pretreatment fluids effective in increasing pH include, but are not limited to, fluids containing one or more salts, bicarbonates, or other buffering mechanisms. In one embodiment, the pretreatment fluid is a solution of sodium chloride and water (e.g., physiological saline).

[0103] In another embodiment, the pretreatment fluid is configured to make the auxiliary material more hydrophilic. For example, the pretreatment fluid can form a coating or film on at least a portion of the surface of the auxiliary material (e.g., the outer surface, inner surface, etc., of pores). Generally, when water comes into contact with the surface of a hydrophilic material, the water tends to spread across the surface, i.e., "wet" the surface. As the degree of hydrophilicity of the surface increases, the contact area between a given volume of water and the surface increases. Therefore, increasing the hydrophilicity of an auxiliary material can increase the decomposition rate of the auxiliary material due to the increased contact area between the auxiliary material and water and / or aqueous bodily fluids. Examples of pretreatment fluids effective in increasing the hydrophilicity of an auxiliary material include, but are not limited to, wetting agents or surfactants such as loosely crosslinked polymers.

[0104] In further embodiments, crosslinking can be used alone or in combination with a pretreatment fluid to increase the hydrophilicity of auxiliary materials. For example, auxiliary materials can be physically crosslinked (e.g., by irradiation with ultraviolet (UV) and gamma rays, and by dehydration heat treatment) or chemically crosslinked (e.g., by the use of chemical crosslinking agents such as genipine and glutaraldehyde). In certain embodiments, the pretreatment fluid may contain one or more chemical crosslinking agents. Non-limiting examples of chemical crosslinking agents include bifunctional / polyfunctional molecules, chromium sulfate, aldehydes, and isocyanates that crosslink free carboxylic acid groups, amino groups, and hydroxyl groups between adjacent polymer molecules (e.g., glutaraldehyde, polyepoxides, and isocyanates).

[0105] In alternative embodiments, the pretreatment fluid may be configured, using various mechanisms, to reduce the degradation rate of the auxiliary material compared to the untreated auxiliary material. In one embodiment, the pretreatment fluid may be configured to make the auxiliary material more hydrophilic. As an example, the pretreatment fluid can form a coating or film on at least a portion of the surface of the auxiliary material (e.g., the outer surface, inner surface, etc. of pores). Generally, when water comes into contact with the surface of a hydrophobic material, it tends to form beads rather than spread across the surface, i.e., "wet" the surface. As the degree of surface hydrophobicity increases, the contact area between a given volume of water and the surface increases. Therefore, increasing the hydrophobicity of the auxiliary material can reduce the degradation rate of the auxiliary material due to a decrease in the contact area between the auxiliary material and water and / or aqueous bodily fluids. Examples of such pretreatment fluids include, but are not limited to, silicone and other materials suitable for increasing the hydrophobicity of the surface of the auxiliary material.

[0106] In another embodiment, the pretreatment fluid may be configured to form a coating deposited on at least a portion of the surface of the treated auxiliary material (e.g., the outer surface, inner surface, etc. of pores). The coating forms a barrier that prevents contact between the auxiliary material and water and / or aqueous bodily fluids. That is, water or aqueous fluid must penetrate the coating (e.g., by diffusion) before it can react with the auxiliary material and decompose it. Since the penetration of the coating is not instantaneous and requires some time to be achieved, the presence of the coating delays the initiation of hydrolysis, increases the time to achieve a given amount of decomposition, and thereby reduces the rate of decomposition. Examples of such pretreatment fluids include, but are not limited to, oils (e.g., mineral oil, food oil), greases, biocompatible lubricants, and perfluoropolyethers (PFPEs).

[0107] In a further embodiment, the pretreatment fluid is configured to form a sealant that seals at least a portion of the pores of a porous polymer body, thereby preventing the intrusion of water or aqueous bodily fluids into the bulk of the auxiliary material. As an example, the sealant formed by the pretreatment fluid may be positioned on and / or inside the auxiliary material such that it partially and / or completely blocks each channel from the surface of the auxiliary material to the pores in the bulk of the auxiliary material. Thus, the sealant can reduce the rate of degradation of the auxiliary material due to a reduction in the contact area between the auxiliary material and water and / or aqueous bodily fluids. Examples of such pretreatment fluids include, but are not limited to, oils (e.g., mineral oil, food oil), greases, biocompatible lubricants, and other highly viscous materials that can block the flow of fluid into the pores of the auxiliary material, as well as perfluoropolyethers (PFPEs).

[0108] In another embodiment, the pretreatment fluid is configured to alter at least some of the terminal functional groups of the polymer chains that react with the auxiliary material (e.g., by substitution) to form a porous polymer body in the treated state, compared to the untreated state. The difference in terminal functional groups inhibits contact between the polymer auxiliary material and water or a hydrated body liquid. Therefore, the terminal functional groups can reduce the decomposition rate of the auxiliary material due to a reduction in the contact area between the auxiliary material and water and / or a hydrated body liquid. Examples of such pretreatment fluids include, but are not limited to, physiological saline and acids (e.g., carbonic acid).

[0109] As a further example, the pretreatment fluid may be configured to terminate at least some of the polymer chains of a porous polymer body. As a result, the average length of the polymer chains in the treated polymer body is shorter than the average length of the polymer chains in the untreated polymer body. This reduction in average chain length reduces the contact area between the polymer auxiliary material and water, thereby reducing the rate of decomposition of the auxiliary material.

[0110] As described above, the auxiliary material can be used with a staple cartridge or anvil to treat tissue. Before implantation, the auxiliary material can be treated with a pretreatment fluid either before or after attachment to a staple cartridge, such as the staple cartridge 102 shown in Figure 6, or to an anvil (e.g., the upper jaw surface 34 shown in Figure 2). As a result, the pretreatment fluid may be present at least on the surface of the auxiliary material. In certain embodiments, the pretreatment fluid can also flow from the surface of the auxiliary material into the interior or bulk of the auxiliary material through open pores. Once properly treated, the treated auxiliary material is releasably held on the anvil or staple cartridge, and with the cartridge positioned within the jaws of a surgical staple such as the stapler 10 or Figure 1, the device can be operated to engage the tissue between the jaws 32, 34, as shown in Figure 7, for example, and the device can be activated to fire the staple through the auxiliary material and tissue, thereby fixing the auxiliary material to the tissue.

[0111] Once implanted, the pre-treated auxiliary material may interact with water adjacent to it. Such water may be in the form of water alone or a mixture with other bodily fluids. In addition, water may be present on the surface of the auxiliary material and within at least a portion of its interior (for example, through flow through fluid passages such as open pores that are in fluid communication with the surface of the auxiliary material).

[0112] The composition of the pretreatment fluid determines whether the pretreatment fluid increases or decreases the decomposition rate of the auxiliary material. Embodiments of pretreatment fluid configured to increase the decomposition rate of the auxiliary material can do so by increasing the rate of chemical reaction (e.g., hydrolysis) between the auxiliary material and water, or by increasing the contact area between water and the auxiliary material. In one example, the pretreatment fluid can be mixed with water that comes into contact with the surface of the auxiliary material (e.g., the outer or inner surface of the pores). The mixture of pretreatment fluid and water has a higher pH than water alone and can increase the hydrolysis reaction rate with the auxiliary material. In another example, the pretreatment fluid can form a coating or film on the surface of the auxiliary material (e.g., the outer or inner surface of the pores) that increases the hydrophilicity of these surfaces. The increased hydrophilicity allows water in contact with these surfaces to spread and wet the surfaces, increasing the contact surface area between the auxiliary material and water, and thereby increasing the decomposition rate of the auxiliary material.

[0113] Embodiments of pretreatment materials configured to increase the decomposition rate of auxiliary materials can increase the decomposition rate by reducing the contact area between water and the auxiliary material through physical or chemical mechanisms. Pretreatment fluids that physically reduce the contact area may include coatings or sealants. A coating of the pretreatment fluid can be formed by the flow of the pretreatment fluid onto the surface of the auxiliary material (e.g., the outer or inner surface of pores). Once the coating is present on the surface of the auxiliary material, it can form a physical barrier against the interaction between water and the auxiliary material. The pretreatment fluid can form a sealant by flowing onto adjacent surfaces of the auxiliary material, which function as fluid passages between the outer surface and the interior of the auxiliary material, and by being present between them. Once the sealant is present in the flow passage, it can block the flow of water through it and isolate the interior region of the auxiliary material from interaction with water. Alternatively, the pretreatment fluid can react with polymer chains forming the auxiliary material to cleave these polymer chains, physically reducing the polymer chain length and thus reducing the area of ​​the auxiliary material that can come into contact with water. Pretreatment fluids that chemically reduce the contact area may include hydrophobic agents and substitution agents. Hydrophobic agents can form coatings or films on the surfaces of auxiliary materials (e.g., the outer or inner surfaces of pores) that increase the hydrophobicity of these surfaces. Increased hydrophobicity causes water that comes into contact with these surfaces to form droplets rather than spreading out and wetting the surface. Substituting agents can chemically react with the polymer chains forming the auxiliary material to change the terminal groups of the polymer chains into functional groups that inhibit interaction with water.

[0114] A compressible implantable support material that decomposes based on the progression of healing. When an adjuvant is implanted adjacent to severed tissue, one function of the adjuvant may be to apply pressure to the tissue (e.g., the cut line) when stapled to the tissue to promote the healing process (e.g., hemostasis). As healing progresses, it may be even more desirable to reduce the pressure (compressive pressure) applied to the tissue in order to promote the formation of blood vessels (angiogenesis). Existing adjuvants may be configured to decompose over time, and thus reduce the pressure applied to the tissue through decomposition resulting from a chemical reaction with water (hydrolysis). However, such decomposition and pressure reduction do not directly correlate with tissue healing. Therefore, the level of pressure maintained by an existing degradable adjuvant at a given point in time may be inappropriate for the degree of healing progress at that point in time and may actually inhibit the healing process rather than promote it.

[0115] Accordingly, in further embodiments, implantable augments are provided that may be configured to exhibit a decrease in rigidity after implantation. The decrease in rigidity may result from the decomposition of the augment material by chemical reactions with physiological elements released during the healing process. When stapled to tissue, the decrease in rigidity further results in a decrease in the pressure applied to the tissue by the augment material. In this way, the applied pressure correlates with the progress of tissue healing rather than simply with the time exposed to water.

[0116] In one embodiment, the biocompatible auxiliary material is configured to be releasably held on a staple cartridge and delivered to the tissue by the deployment of staples within the staple cartridge. The auxiliary material may be in the form of a porous polymer body exhibiting a first compressive stiffness that is substantially constant during a first period from contact with the tissue. After the first period, the porous polymer body may further exhibit a second compressive stiffness that is less than the first compressive property. The second compressive property may decrease over time due to interactions (e.g., chemical reactions) with at least one physiological element released from the tissue during the healing process. In other words, as the healing process progresses, physiological elements released from the tissue at different stages of the healing process interact with the auxiliary material, thereby altering the compressive properties of the auxiliary material. Examples of interactions between the porous polymer body and at least one physiological element, as will be discussed in more detail below, include oxidation, enzymatic hydrolysis, and changes in pH adjacent to the auxiliary material.

[0117] The first period represents the period before the porous polymer body substantially reacts with at least one physiological element; that is, the period during which any change in the first compressive stiffness is very small (e.g., less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%). In contrast, the second period may represent the period during which the reaction between the porous polymer body and at least one physiological element occurs.

[0118] In one embodiment, the interaction between the porous polymer and at least one physiological element results in the progression of the healing response and enzymatic degradation resulting from the introduction of the body of at least one physiological element into the healing site when the wound is reconstructed.

[0119] As described above, in one embodiment, the interaction between the porous polymer and at least one physiological element is an oxidation reaction, and the at least one physiological element is an oxygen-containing enzyme. Generally, wound healing can be divided into four stages: hemostasis, inflammation, proliferation, and reconstruction, and almost all stages in the wound healing process may require oxygen, as outlined below.

[0120] The healing tissue requires energy generated from the oxidative metabolism of glucose. In the aerobic metabolism of glucose, cells use oxygen to produce adenosine triphosphate (ATP), which fuels most of the cellular processes during wound healing. Therefore, in the healing tissue, the oxygen requirement increases. The increased oxygen consumption then causes hypoxia, activating the initial stages of the healing process by enhancing the activity of reactive oxygen species.

[0121] During the inflammatory stage of healing progression, the inflammatory area is the site for significant production of reactive oxygen species. In one aspect, this production is due to phagocytosis, the uptake of cells or other substances by phagocytes as a defense against infection, and the occurrence of invasion by foreign substances. The presence of reactive oxygen species further stimulates the recruitment and activation of inflammatory cells such as leukocytes (white blood cells) at the wound site, as well as other functions necessary for wound repair such as the activation of fibroblasts. Examples of leukocytes include neutrophils, basophils, eosinophils, lymphocytes, monocytes, and macrophages. These inflammatory cells can also produce at least one physiological factor in the form of highly reactive oxygen species. Examples of classes of highly reactive oxygen species can include at least one of oxygen-containing enzymes, free radicals, superoxide, and peroxides. Specific examples of reactive oxygen species can include O 2- , H2O2, NO, and HOCl. At this point, a set of growth factors can be released that stimulate and attract the components of wound healing (e.g., wound leukocytes and fibroblasts). Hydrogen peroxide (H2O2) can be a mediator of these interactions. As wound healing progresses, cell proliferation and migration occur due to the redox signaling of reactive oxygen species. The last step, or stage, of wound healing is remodeling. During remodeling, the wound acquires tensile strength and the wound contracts as the collagen fibers contract. The most prominent mediators of the collagen process are compounds released by macrophages, keratinocytes, endothelial cells, and fibroblasts / fibroblasts, all of which are oxygen-dependent.

[0122] In further embodiments, reactive oxygen species may be directed from other areas of the body to the wound healing site. Generally, cells typically consume oxygen during their function. The body provides oxygen to keep cells alive, typically through biological processes such as hemoglobin transport. Because there are more cells in a certain area of ​​the body, angiogenesis grows blood pathways to that area to supply nutrients and oxygen and maintain the cell population.

[0123] From the above, it can be understood that the healing process leads to the production and / or induction of reactive oxygen species at the wound healing site. These reactive oxygen species may participate in oxidation reactions with polymer auxiliary materials, causing polymer chain severance and contributing to the degradation of the auxiliary materials. Specifically, O 2- This can accelerate the decomposition of polymers such as aliphatic polyesters by cleaving ester bonds through nucleophilic attack. Oxygen-inducible decomposition chemically breaks down polymer auxiliary materials, weakening them, reducing their rigidity, and thus altering the pressure (e.g., compressive force) applied to the tissue. Since the concentration of reactive oxygen species available for reaction with polymer auxiliary materials depends on the healing process, the degree of oxygen-inducible decomposition of polymer auxiliary materials, and therefore the pressure applied to the tissue by the auxiliary materials, also depends on the healing process.

[0124] In further embodiments, enzyme-catalyzed hydrolysis may contribute to the degradation of the polymer and the resulting decrease in the rigidity of the auxiliary material. For example, the adsorption and rate of the hydrolysis reaction may be affected by (i) the physiological and chemical properties of the polymer (e.g., molecular weight, chemical composition, crystallinity, surface area, etc.), (ii) the properties of the specific enzyme (e.g., activity, stability, local concentration, amino acid composition, and three-dimensional conformation, etc.), and (iii) culture medium conditions such as pH and temperature. The presence of stabilizers, activators, and / or inhibitory products (e.g., resulting from the degradation of the auxiliary material or leaching of processing additives) in the local environment adjacent to the auxiliary material may also affect the enzyme-catalyzed reaction by affecting enzyme adsorption and activity. Examples of such enzymes include, but are not limited to, hydrolases such as proteases, esterases, glycosidases, phosphatases, and other suitable hydrolases.

[0125] In further embodiments, chemical modifications to the polymer (e.g., crosslinking, removal or introduction of chemical groups into polymer chains) may affect the enzymatic degradation rate. In particular, depending on the degree of chemical modification, it may impair the ability of enzymes to recognize the modified polymer. For example, lysozyme, an enzyme involved in the degradation of peptidoglycan and chitin materials, shows low activity towards highly deacetylated chitosan or crosslinked chitosan. Examples of such enzymes include, but are not limited to, lysozyme.

[0126] In other embodiments, degradation may be related to other physiological and chemical changes in situ. For example, pH is one of the changes most affected within the local chemical environment due to the progression of healing of infection. The pH value adjacent to a wound directly and indirectly affects at least some, and up to all, of the biochemical reactions that occur in the wound healing process. As an example, the surface pH of a wound plays a crucial role in wound healing as it supports infection control, as well as increased antimicrobial activity, oxygen release, angiogenesis, protease activity, and biological toxicity. Therefore, pH values ​​can affect normal cellular events in wound healing.

[0127] Furthermore, wounds with a high alkaline pH have a lower healing rate compared to wounds with a near-neutral pH, in both acute and chronic wounds. In other words, as the pH rises to an alkaline level, the progression of wound healing decreases. The environment of acute and chronic wounds progresses from an alkaline state to a neutral state, and then to an acidic state, once healing begins.

[0128] Therefore, embodiments of the auxiliary material may be configured to adopt a second rigidity in response to a decrease in pH in the local environment adjacent to the polymer body, due to the presence of at least one physiological element. As described above, the pH of water or hydrated biological material involved in the hydrolysis reaction can affect the hydrolysis rate. Specifically, the hydrolysis rate may decrease with decreasing pH. Since the pH in the local environment of a wound decreases with the progression of healing, it can be expected that the decrease in pH will also be experienced by water and hydrated fluids involved in the hydrolysis reaction with the auxiliary material. Therefore, the hydrolysis rate of the auxiliary material, and the relative contribution of hydrolysis to the decomposition of the auxiliary material, may decrease over time compared to the relative contribution of oxidation to the decomposition of the auxiliary material. However, it can be understood that the overall decomposition rate of the auxiliary material resulting from the combination of oxidation and hydrolysis processes may exceed the decomposition rate due to oxidation alone.

[0129] As described above, the auxiliary material can be used with a staple cartridge or anvil of a surgical stapler 10 to treat a staple cartridge, such as the staple cartridge 102 shown in Figure 6, or an anvil (e.g., the upper jaw surface 34) shown in Figure 2. During implantation, the auxiliary material can be delivered to the tissue by deploying staples in the staple cartridge body, fixing the auxiliary material to the tissue, and causing the auxiliary material to apply pressure (e.g., compressive pressure) to the wound (e.g., the cutting line).

[0130] During use, the healing process occurs within the tissue connected to the auxiliary material. The healing process begins with hemostasis, which is the cessation of blood flow from the wound. Generally, it is beneficial for the auxiliary material to apply relatively high pressure (compressive pressure) to the wound in order to promote hemostasis. As described above, the auxiliary material may be compressed when delivered to the tissue by the deployment of staples (for example, by the upper jaw portion 22 and the lower jaw portion 34) and expand when released. Therefore, the auxiliary material may be configured to exhibit a first rigidity in a compressed state such that, once deployed, the compressive pressure exerted by the auxiliary material when it expands in contact with the tissue is high enough to assist in hemostasis of the tissue.

[0131] The auxiliary material may be further configured to maintain a first stiffness at a nearly constant level during a first period following contact with the tissue. That is, the auxiliary material may experience little to no degradation during the first period due to reactions with bodily fluids such as water or a water-containing fluid (e.g., oxidation, enzymatic hydrolysis, etc.). By maintaining a first stiffness at a nearly constant level during the first period, the compressive pressure applied to the tissue by the auxiliary material is also maintained at a nearly constant level.

[0132] The auxiliary material may be configured in various ways to maintain a first rigidity over a first period. As described above, in one embodiment, the auxiliary material may be treated with a pretreatment fluid as described above to reduce the rate of decomposition of the auxiliary material. In another embodiment, the auxiliary material may be mechanically compressed to close at least a portion of the porosity of the auxiliary material and obstruct the flow of bodily fluids. It can be understood that one or more other mechanisms for reducing the rate of decomposition of the auxiliary material may be used alone or in any combination with the mechanisms described above, and may be used without limitation.

[0133] As the healing process progresses through the inflammatory, proliferative, and reconstructive stages, it may be desirable to reduce the compressive pressure applied to the tissue by the auxiliary material in order to promote vascular formation. Therefore, the auxiliary material may be configured to exhibit a second stiffness lower than the first stiffness during the second period following the first period.

[0134] For example, during the second period, these later healing stages may occur, and the tissue may release at least one physiological element to promote healing. For example, at least one physiological element may be reactive oxygen species. Reactive oxygen species are produced to provide energy for the healing process, but they may also interact with auxiliary materials and cause degradation. Examples of such interactions include oxidation via reaction with reactive oxygen species, hydrolysis catalyzed by enzymes (e.g., oxygen-containing enzymes), and changes in pH due to the presence of at least one physiological element in the local fluid environment of the auxiliary materials. Oxidation may contribute to the degradation of auxiliary materials by polymer chain severance, while enzyme-catalyzed hydrolysis may contribute to the degradation of polymer auxiliary materials by chemical degradation. pH may contribute to degradation by influencing the rate of degradation, and the increase in the rate of degradation may be maximal when the pH is relatively high (e.g., alkaline relatively early in the healing process). Minimum oxidation may depend on the healing process, as it depends on the concentration of reactive oxygen species produced during healing. As a result, the breakdown of the auxiliary material may occur in accordance with the progress of healing, and consequently, the auxiliary material exhibits a second stiffness that is less than the first stiffness, decreasing as the healing process progresses. Beneficially, as mentioned above, the reduction in the stiffness of the auxiliary material from the first stiffness to the second stiffness may promote angiogenesis.

[0135] A tissue thickness compensation aid with different expansion regions. As described above, in certain embodiments, the auxiliary material may be configured to compensate for variations in tissue thickness when stapled to the tissue, and the auxiliary material is configured to exhibit an uncompressed (undeformed) height, i.e., the pre-deployment height, and deform to one of several compressed (deformed) heights, i.e., the deployed height. It can be understood that leakage of bodily fluids (e.g., blood, air, gastrointestinal fluid, etc.) may occur when the staple penetrates the auxiliary material and tissue. In particular, by penetrating the auxiliary material, the staple may form a hole in the auxiliary material that is larger than the diameter of the staple leg. Furthermore, when the tissue is cut before hemostasis begins, blood may flow along the cut line. Therefore, it may be desirable to use an auxiliary material to seal the staple puncture hole and / or to apply pressure to the staple wire to facilitate hemostasis.

[0136] Further embodiments, described in detail below, are provided for tissue thickness compensating augers, which are formed of a material that swells when exposed to moisture and have a structure in which the thickness and / or pressure changes depending on the location within the auger. As an example, certain portions of the auger are configured to allow or inhibit the expansion of the auger, and thus alter the sealing pressure applied to the tissue in these given portions of the auger. In one embodiment, portions of the auger adjacent to each initial staple line, through which the staple legs are intended to penetrate the auger, may be configured to expand when exposed to moisture compared to portions of the auger away from the initial staple line. This expansion of the auger can bring the auger material into contact with the staple legs and seal the staple holes. In another embodiment, portions of the auger adjacent to an initial cutting line, through which a knife is expected to pass and cut the tissue and the auger, may be configured to expand when exposed to moisture compared to portions of the auger away from the initial cutting line. This expansion of the auger may allow the auger to apply compressive pressure to the cutting line and / or the area of ​​tissue adjacent to the cutting line, thereby promoting hemostasis.

[0137] Figure 9 is a schematic diagram showing a top view (e.g., xy plane) of the upper tissue contact surface of one exemplary embodiment of a tissue thickness compensating auxiliary material 3000 in an undeformed state, i.e., pre-deployment state. The auxiliary material 3000 includes one or more first parts 3002 and one or more second parts 3004. The auxiliary material 3000 is configured to be releasably held on a staple cartridge or anvil of a staple fastening assembly, but the auxiliary material 3000 is shown separately for clarity.

[0138] A first portion 3002 of the auxiliary material 3000 may be formed of a first material configured to exhibit a first expansion behavior in response to the reception of a unit volume of fluid. A second portion 3004 of the auxiliary material 3000 may be configured to exhibit a second expansion behavior different from the first expansion behavior in response to the reception of a unit volume of fluid. The expansion behavior may include, but is not limited to, the expansion volume and / or expansion rate. In certain embodiments, the expansion volume and / or expansion rate due to the second expansion behavior of the second material is greater than the corresponding expansion volume and / or expansion rate due to the first expansion behavior of the first material.

[0139] The first portion 3002 may be formed from a biocompatible porous polymer, as described above. In contrast, the second portion 3004 may be formed from a swellable material different from the biocompatible porous polymer material of the first portion 3002. Examples of swellable materials include, but are not limited to, hydrogels, low molecular weight polymers (e.g., polymers with an average molecular weight sufficient to be removed from the patient's body, such as less than approximately 30,000 kDa), and polymers with a relatively low degree of crosslinking.

[0140] It can be understood that alternative embodiments of the auxiliary material may be configured to alter the relative expansion characteristics (e.g., expansion volume, expansion rate, etc.) of the first and second parts from those described above. For example, the expansion volume and / or expansion rate of the first part of the auxiliary material may be greater than that of the second part in response to the acceptance of approximately the same volume of moisture. Furthermore, although not shown, further embodiments of the auxiliary material may include three or more regions, each configured to swell by different amounts in response to the acceptance of approximately the same volume of moisture.

[0141] As described above, a common problem encountered when using surgical staples with auxiliary materials is that even after the staples have fully formed, one or more fluids (e.g., water, blood, air, gastrointestinal fluid, etc.) may seep through the openings formed by the staples. Therefore, in a further embodiment of the auxiliary material 3000, the relative arrangement of the first portion 3002 and the second portion 3004 may be configured to apply pressure to the staples along the staple line to seal the holes formed in the auxiliary material by the staples. As shown in the top view of Figure 9, the initial staple line 3006 extends along the length of the auxiliary material 3000 (e.g., longitudinal direction, i.e., x-direction). The second portion 3004 is substantially aligned with the initial staple line 3006 (e.g., substantially parallel) and has a greater width than the initial staple line 3006. In the presence of multiple initial staple lines 3006, these staple lines 3006 may be separated from each other in the width direction (e.g., the y-direction) by the first portion 3002, extend in the longitudinal direction (e.g., the x-direction) of the auxiliary material, and align with each other.

[0142] Figure 10 is an end view (e.g., yz plane) of the auxiliary member 3000 of Figure 9. As shown, the second portion 3004 may extend over the entire thickness (e.g., z direction) of the auxiliary member 3000.

[0143] Before deployment and before receiving water or other physiological fluids, the auxiliary material 3000 has a first shape. Upon implantation and receiving water or other fluids, as shown in Figure 11, the second portion 3004 expands to form a corresponding, expanded second portion 3004'', which takes on a second shape different from the first shape. As a result, the expansion of the second portions 3004 exerts a compressive force, i.e., pressure (arrow 3012), on the staple 3010, thereby partially or substantially completely sealing the hole formed through the auxiliary material 3000 by allowing the staple 3010 to pass through the interior. The expansion behavior of each expanded second portion 3004' may be identical or different depending on its position along the staple line 3006 (e.g., along the x-direction).

[0144] In another embodiment, the relative arrangement of the first portion 3002 and the second portion 3004 may be configured such that the expansion of at least one of the first portion 3002 and the second portion 3004 exerts sufficient pressure along and / or adjacent to the tissue cutting line to bring about hemostasis. Figure 12 is a schematic diagram showing a top view of the upper tissue contact surface of another exemplary embodiment of the tissue thickness compensating auxiliary material 3020 in an undeformed state, i.e., pre-deployment state. Figure 13 is an end view of the auxiliary material 3020 of Figure 12. Figure 14 is an end view of the auxiliary material 3020 in a deformed state, i.e., deployed state. The auxiliary material 3000 is configured to be releasably held on a staple cartridge or anvil of a staple fastening assembly, but the auxiliary material 3020 is shown separately for clarity.

[0145] As shown in Figures 12 and 13, similar to the auxiliary material 3000, the auxiliary material 3020 includes a first portion 3002 and a second portion 3004. However, in contrast to the auxiliary material 3000, the second portion 3004 overlaps at least the first portion 3002 on and / or adjacent to the initial tissue cutting line 3022. In other embodiments, the second portion may overlap substantially the entirety of the first portion. The auxiliary material 3020 may be positioned on the staple cartridge of a staple fastening assembly, with the first portion 3022 spaced at a certain distance from the expected path of the knife 36 defining the initial tissue cutting line 3022, as shown in Figure 3, and the second portion 3004 positioned on or adjacent to the knife path / initial tissue cutting line 3022. When configured in this way, when the auxiliary material 3020 receives water or other fluid (arrow 3024), the second portion 3004 expands relative to the first portion 3002, as shown in Figure 14, to form an expanded second portion 3004'. The expanded second portion 3004' exerts pressure (arrow 3026) along the cutting line 3022, promoting hemostasis. The expansion behavior of each expanded second portion 3004' may be the same or different depending on its position along the knife path / initial tissue cutting line 3022.

[0146] In further embodiments of the auxiliary materials 3000, 3020, the second portion 3004 may be formed of a porous solid material and contained in a compressed state within a fluid-soluble capsule. The capsule may be configured to decompose relatively rapidly in response to contact with water and / or other physiological fluids after a predetermined period (e.g., approximately a few seconds to a few minutes) for the release of the second portion therefrom. Beneficially, such encapsulation provides time-release control of the pressure applied to the tissue by the auxiliary materials 3000, 3020.

[0147] In other embodiments, the tissue thickness compensating aid may be configured to degrade over time, providing a short-term mechanism for tissue compression. As will be discussed in more detail below, such aids can be combined with other mechanisms that provide relatively long-term compression (e.g., staples). Together, these short-term and long-term compression mechanisms can promote tissue healing.

[0148] Generally, the mechanical properties of bioabsorbable auxiliary materials change over time (e.g., decrease) as the degree of decomposition of the auxiliary material increases. In one embodiment, the auxiliary material 3020 may be configured to decompose at a rate that maintains sufficient compression (e.g., by an expanded second portion 3004') by the body, allowing the body to coagulate / clot the bleeding within the area of ​​the cut line 3022. The compressive pressure provided by the staple may be provided to further reinforce the cut line for a longer period and to a lower degree compared to that provided by the auxiliary material. Beneficially, the relatively high compressive pressure provided by the auxiliary material 3020 in the short term promotes coagulation, while the relatively low compressive pressure provided by the staple in the long term reinforces the cut line 3022 without restricting blood flow.

[0149] In another embodiment, a tissue thickness compensating auxiliary material 3030 is provided, which works in conjunction with the staple 3036 to prevent the auxiliary material 3030 from retracting and coming into contact with the tissue 3038 after expansion. Figure 15 is a schematic diagram showing a side section view of a staple fastening assembly 3040 in a pre-launch configuration, which includes a first jaw portion having an anvil 3042 (partially shown) opposite a staple cartridge 3044 that houses a plurality of staples (only one staple 3036 is shown). The auxiliary material 3020 includes one or more first portions 3032 positioned on the anvil 3042 and below one or more second portions 3034. The first portions 3032 are in contact with the anvil 3042, and the second portions 3034 are spaced apart from the anvil 3042 and face the tissue. The auxiliary material 3030 in this pre-launch configuration has a total initial thickness s oThe first portion 3032 and the second portion 3034 are generally planar. However, other non-planar configurations may be used without limitation. In addition, although the embodiment in Figure 15 shows an auxiliary material positioned on an anvil, in an alternative embodiment the auxiliary material may be positioned on a staple cartridge.

[0150] During operation, as shown in Figure 16, the tissue 3038 is clamped between the anvil 3042 and the staple cartridge 3044, and one or more staples 3036 are fired from the staple cartridge through the auxiliary material 330 into the tissue 3038, thereby stapling the auxiliary material 3030 to the tissue 3038. As further shown in Figure 17, the auxiliary material 3030 and the tissue 3038 are then released from the staple fastening assembly 3040 after the staples have been fired. The total thickness of the auxiliary material 3030 after being released from the staple fastening assembly 3040 is the initial thickness s due to the removal of the clamping force applied by the staple fastening assembly 3040. o The thickness increases from the implanted thickness s1. The tissue 3038 has a thickness t1.

[0151] After being stapled to tissue 3038, the auxiliary material receives a unit volume of fluid (e.g., water and / or other physiological fluids). At least one of the first portion 3032 and the second portion 3034 is formed of a polymer configured to expand in response to the reception of water and / or other physiological fluids. In certain embodiments, the first portion 3032 may be formed of a water-absorbing, swelling polymer. The second portion 3034 may be formed of a semiporous film. The first portion 3032 is configured to expand in response to the reception of a unit volume of fluid according to a first expansion behavior. The second portion 3034 may be configured to expand in response to the reception of a unit volume of fluid according to a second expansion behavior different from the first expansion behavior. The second portion 3034 can further overlap the first portion 3032 and can be mechanically coupled to the first portion 3032 (e.g., by a biocompatible adhesive or other fastening mechanism). Since the second portion 3034 is semiporous, some of the water and / or other physiological fluids that are received and not absorbed in the second portion 3034 can flow through the second portion 3034 (e.g., through open porosity) to be received in the first portion 3032.

[0152] The expansion of the first portion 3032 applies a first pressure (e.g., a compressive pressure) to the tissue 3038, and the expansion of the second portion 3034 applies a second pressure to the tissue 3038. As the auxiliary material 3030 expands and the auxiliary material 3030 applies pressure to the tissue 3038, the thickness of the auxiliary material increases to a third thickness s2 and the thickness of the tissue 3038 decreases to t-2, as shown in Figure 17. In an alternative embodiment, the second portion does not expand substantially when receiving water and / or other physiological fluids, or expands to a significantly smaller extent than the first portion.

[0153] In other embodiments, the staple 3036 may include one or more feature portions 3046 configured to allow the auxiliary material 3030 to expand in a first direction (e.g., toward the tissue 3038) and to prevent the auxiliary material 3030 from retracting in a second direction opposite to the first direction (e.g., toward the tissue 3038). As shown in Figures 16 and 17, the one or more feature portions 3046 may include a plurality of barbs extending along one or more of the legs of the staple 3036. The plurality of barbs are positioned so that, after being fired into the auxiliary material, the barbs extend toward the base of the staple, opposite to the insertion direction of the staple toward the tissue 3038. When the auxiliary material 3030 expands (e.g., by the expansion of the first portion 3032 and / or the second portion 3034), the plurality of barbs engage with at least the second portion 3034. Since the second portion 3034 is mechanically connected to the first portion 3032, the engagement of the return portion with the second portion 3034 provides a ratchet-like effect that prevents the retraction of the auxiliary material 3030 from moving away from the tissue 3038 after the auxiliary material 3030 has expanded.

[0154] Embodiments of any portion of auxiliary materials 3000, 3020, and 3030 may be configured to exhibit a color change in response to expansion. As an example, the portion of auxiliary materials 3000, 3020, and 3030 that exhibits a color change may include a color transition dye. Examples of color transition dyes include hydrochromic inks configured to change color in response to at least one fluid, such as water and lipids. In further embodiments, the expandable portions of auxiliary materials 3030, 3020, and 3030 formed of a water or lipid-sensitive polymer may be thin and dry when undeployed, and may expand to a higher state when deployed and hydrated.

[0155] The ability of selected portions of auxiliary materials 3000, 3020, and 3030 to exhibit color change upon expansion may allow for rapid visual identification of expansion behavior. This can be useful in confirming that selected portions of auxiliary materials 3000, 3020, and 3030 are indeed expanding and therefore achieving the functions enabled by expansion, such as applying pressure to staple sealing or cutting lines, without requiring time-consuming measurements.

[0156] It can be understood that such visual identification of the expansion of the auxiliary material parts 3000, 3020, and 3030 may be used for stapling. Since the mass of the auxiliary material parts 3000, 3020, and 3030 that exhibit a color change is constant, it can be understood that the increase in volume resulting from the expansion decreases the density of these parts.

[0157] A composite auxiliary material that decomposes through multiple different mechanisms. As described above, in order to correlate the amount of compression applied to the tissue with the optimal amount of compression to promote tissue healing, it is sometimes desirable to use an auxiliary material exhibiting compressive properties that degrades in accordance with the healing process. In one embodiment, degradation can be correlated with the healing process by using an auxiliary material that degrades in response to a reaction with at least one physiological element released from the tissue during the healing process. In one example, a physiological element containing reactive oxygen species can promote degradation by participating in an oxidation reaction with the auxiliary material. In another example, an enzyme released during the healing process can catalyze a hydrolysis reaction, thereby increasing the degradation rate of the auxiliary material. This concept can be further applied in relation to composite auxiliary materials formed of two or more polymers, each degrading by a different mechanism. In this way, the degradation rate of the auxiliary material and the associated changes in mechanical properties can be controlled not by a single mechanism, but by two mechanisms, providing greater functionality.

[0158] Figure 18 is a schematic diagram showing a side section view of a pre-firing staple fastening assembly 3050, which includes a first jaw section having an anvil 3052 opposite a staple cartridge 3054 containing a plurality of staples 3056. As shown, an exemplary embodiment of the composite auxiliary 3060 is releasably held on the anvil 3052 and has a thickness S0. In an alternative embodiment (not shown), the composite auxiliary 3060 may be releasably held on either or both of the staple cartridge and the anvil for delivery to the tissue by the deployment of staples in the staple cartridge.

[0159] The composite auxiliary material 3060 is shown in detail in Figure 19. The composite auxiliary material 3060 is formed as a porous polymer body 3062 comprising a first polymer 3064 and a second polymer 3066. The first polymer 3064 overlaps the second polymer 3066, and the second polymer 3066 is compressed beneath the first polymer 3064. Although the first polymer 3064 and the second polymer 3066 are shown, the auxiliary material may contain any number of polymers. In certain embodiments, the first polymer 3064 holds internally at least one first drug 3070. In certain embodiments, the at least one first drug 3070 is a hemostatic agent. In further embodiments, the second polymer 3066 holds internally at least one second drug 3074 configured to promote tissue remodeling. The compression responses of the first polymer 3064 and the second polymer 3066, as well as the corresponding amounts of the first drug 3070 and the second drug 3074 released, are illustrated in Figures 24B and 24C, respectively, and will be discussed in more detail below. The healing mechanism that occurs over time is further shown in Figure 24A.

[0160] The first polymer 3064 may be configured to decompose according to a first decomposition profile in response to hydrolysis in response to interaction with water 3072 and heating to physiological temperature, or to at least one of these. The first polymer 3064 may further be configured to swell in response to the absorption of water 3072 and / or other physiological fluids. Examples of the first polymer 3064 include at least one of a hygroscopic powder and a hygroscopic foam.

[0161] The second polymer 3066 may be configured to degrade according to a second degradation profile in response to at least one of oxidation, enzymatic hydrolysis, and a change in pH resulting from interaction with at least one physiological element 3076 released from the tissue during tissue healing, as detailed below (Figure 23). The second polymer 3066 is further configured to swell in response to the degradation of the first polymer 3064.

[0162] As shown in Figures 19 and 21, the first polymer 3064 overlaps the second polymer 3064 and therefore mechanically restrains the second polymer 3064. As a result, during the first time window A, the compressive pressure applied to the tissue 3068 (Figure 24B) by the second polymer 3064 is relatively low and increases relatively slowly compared to that of the first polymer 3064. The relatively slow rate of increase in compressive pressure may be due to the moderate decomposition of the first polymer 3064 and the accompanying relaxation of the restraint of the second polymer 3064.

[0163] An example of the second polymer 3066 is a porous structure. An example of at least one physiological element is, but is not limited to, reactive oxygen species. Reactive oxygen species may include at least one of oxygen-containing enzymes, free radicals, superoxides, and peroxides.

[0164] In certain embodiments, the second polymer 3064 retains the second drug 3074 internally. Examples of at least one second drug 3074 include, but are not limited to, drugs configured to promote tissue remodeling. As shown in Figure 24C, no at least one second drug 3074 is released before launch (during condition time window A).

[0165] In certain embodiments, at least one second drug 3074 may be configured for at least one of bolus release or sustained release. In one example, as shown in Figure 21, the second drug 3074 may be encapsulated by a material 3074a (e.g., a material that degrades relatively slowly in response to interaction with water 3072 and / or other physiological fluids) configured for the sustained release of the second drug 3074. In another example, sustained release may be provided by one or more relatively large reservoirs formed within the second polymer, which are configured to release relatively small amounts of the second drug from there over a relatively short period of time during the degradation of the second polymer. As an example, a fluid limiting device (e.g., a valve) may be used in combination with the relatively large reservoir for sustained release. In other embodiments, sustained release may be provided by a plurality of relatively smaller reservoirs, which are configured to independently release relatively small amounts of the second drug over time via the degradation of the second polymer (e.g., release of the second drug into separate fluid passages that are not in fluid communication with each other).

[0166] In further embodiments, the bolus release of the second drug may be provided by one or more relatively large reservoirs formed within the second polymer, which are configured to provide the release of a relatively large amount of the second drug during the degradation of the second polymer. In alternative embodiments, bolus containment may be provided by a plurality of smaller reservoirs, which are configured to simultaneously combine the respective amounts of the second drug released from there over a relatively short period during the degradation of the second polymer (e.g., release of the second drug into one or more common fluid passages).

[0167] Figure 20 is a schematic diagram showing the auxiliary material 3060 immediately after the staple 3056 is fired through the auxiliary material 3060 and the tissue 3068 (time window B, Figure 24A). Figure 21 is a schematic diagram showing the auxiliary material 3060 in more detail. As shown, the first polymer 3064 expands in response to interaction with water 3072. As a result of this expansion, the first polymer 3064 exerts a first compressive pressure 3080 on the tissue 3068.

[0168] The first degradation profile of the first polymer 3064 during time window B (Figure 24A) depends on its interaction with water 3072 (e.g., chemical reaction) (hydrolysis). This configuration may be beneficial for hemostasis because it results in a first degradation profile showing a relatively rapid decrease from the peak value of the first compression pressure 3080. Therefore, in certain embodiments, the degradation rate of the first polymer 3064 by the first degradation profile is greater than the degradation rate of the second polymer 3066 by the second degradation profile.

[0169] Simultaneously, the release rate 3086 of the first drug 3070 also shows a relatively rapid decrease, falling from the maximum value of the degradation of the first polymer 3064. That is, at least one of the first drugs 3070 is configured for relatively rapid release. As described above, at least one of the first drugs 3070 can be a hemostatic agent. Therefore, the rapid release of at least one of the first drugs 3070 can further promote rapid hemostasis.

[0170] By compressing the second polymer 3066 beneath the first polymer 3064, the first polymer 3064 can suppress the expansion of the second polymer 3066. This is reflected in Figure 24B as a relatively slow rate of increase in the second compressive pressure 3082. However, the ability of the first polymer 3064 to restrain the second polymer 3066 decreases with the continuous decomposition of the first polymer 3064, and the rate of increase in the second compressive stress 2412 relative to the structure 3068 increases as time progresses within the second time window B. As a result, the thickness of the auxiliary material 3060 can increase from the initial thickness S0 to the first thickness S1. The structure thickness is the initial thickness t tissue1 The combination of the first compression pressure 3080 and the second compression pressure 3082 further promotes hemostasis and provides a region 3069 in which blood flow is restricted for coagulation.

[0171] In certain embodiments, the composite auxiliary may include a hydrogel in which at least one of the first and second polymers is configured to expand more than the surrounding polymer material. Thus, the resulting composite auxiliary can exhibit varying amounts of expansion. In this way, the auxiliary can apply different levels of compression to different areas of the tissue (e.g., cut lines, staple lines, etc.). As shown in Figure 20, the composite auxiliary 3060 applies two different levels of compression C1 and C2 in different areas. For example, compression C2 is greater than compression C1 and is located closer to the cut line, thereby increasing local pressure and sealing the area until healing.

[0172] As healing progresses during the second time window B (e.g., inflammatory phase and neutrophil release), the concentration of at least one physiological element 3076 received in the composite adjuvant 3060 increases. For example, neutrophils may be released along with the corresponding of the at least one physiological element 3076. Simultaneously, the degradation of the first polymer 3064 progresses over time, reducing its ability to inhibit the interaction between the second polymer 3066 and at least one physiological element 3076. Thus, as time progresses within the second time window B, the degradation rate of the second polymer 3066 increases, which is reflected as an increase in the release rate 2086 of at least one second drug 3074 from the second polymer 3066.

[0173] Figure 22 is a schematic diagram showing the auxiliary material 3060 at a predetermined time (time window B, Figure 24C) after the staple 3056 has been fired through the auxiliary material 3060 and the tissue 3068. Figure 23 is a schematic diagram showing the auxiliary material 3060 in more detail. As shown, the decomposition of the first polymer 3064 is substantially completed by a relatively small first compression pressure 3080 and a relatively low release rate 3084 of at least one of the first drugs 3070. That is, substantially all of at least one of the first drugs 3070 is released. Furthermore, with the decrease in the first compression pressure 3080, the thickness of the auxiliary material 3060 decreases from a first thickness S1 to a second thickness S2, and the thickness of the tissue 3068 decreases from the initial tissue thickness t tissue1 From the second tissue thickness t tissue2 It increases to [value]. Beneficially, the combination of the first compressive pressure 3080 and the second compressive pressure 3082 applied to tissue 3068 is at a level sufficient to enable angiogenesis.

[0174] Simultaneously, healing continues to progress from the inflammatory stage to the proliferative and maturation stages, resulting in the release of macrophages, fibroblasts, and lymphocytes, as well as their corresponding counterparts among at least one physiological element 3076, as shown in Figure 24A. The advanced degradation of the first polymer 3064 during time window C significantly reduces the ability of at least one first polymer 3064 to inhibit the interaction between the second polymer 3066 and at least one physiological element 3076. Thus, at least one physiological element 3076 can freely flow into the pores of the second polymer 3066. This increases the degradation rate of the second polymer 3066 and decreases the second compression pressure 3082.

[0175] The release rate of at least one second drug 3086 increases to a peak, increasing the degradation of the second polymer 3066, and then decreases from the peak. The relatively slow release of at least one second drug 3074 can promote tissue remodeling. Examples of drugs configured to promote tissue remodeling include drugs configured to treat pain or inflammation. Further examples of such drugs include, but are not limited to, MMP inhibitors. Examples of MMP inhibitors can be found in U.S. Patent Nos. 10,939,911 and 10,569,071, and U.S. Patent Application Publications 2018 / 0353659, 2018 / 0353175, and 2018 / 0353174, each of which is incorporated in whole by reference.

[0176] Those skilled in the art will recognize that the present invention has applications in conventional minimally invasive and open surgical instruments, as well as applications in robot-assisted surgery.

[0177] The devices disclosed herein may be designed to be discarded after a single use or to be designed for multiple uses. However, in either case, the devices may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembling the device, cleaning or replacing specific parts, and then reassembling. Specifically, the device may be disassembled, and any number of specific parts or components of the device may be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device may be reassembled for subsequent use either in a reconditioning facility or by a surgical team immediately before a surgical procedure. Those skilled in the art will understand that various techniques for disassembly, cleaning / replacement, and reassembly are available for the reconditioning of the device. The use of such techniques and the resulting reconditioned devices are all within the scope of this application.

[0178] Those skilled in the art will recognize further features and advantages of the present invention based on the embodiments described above. Therefore, the present invention is not limited to what has been specifically shown and described, except as provided by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

[0179] [Implementation Method] (1) A compressibility aid kit for use with a staple cartridge, wherein the compressibility aid is A biocompatible auxiliary material configured to be releasably held on a staple cartridge body and delivered to tissue by the deployment of staples within the staple cartridge, wherein the auxiliary material comprises a porous polymer body, A compressible auxiliary kit comprising: a pretreatment fluid configured to change the auxiliary material from an untreated state, which is applied to the auxiliary material and configured to exhibit a first degradation profile when delivered to tissue, to a treated state, which is configured to exhibit a second degradation profile different from the first degradation profile when delivered to tissue. (2) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to perform at least one of the following: increasing the decomposition rate of the second decomposition profile with respect to the first decomposition profile, and decreasing the decomposition rate of the second decomposition profile with respect to the first decomposition profile. (3) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to increase the pH adjacent to the treated auxiliary material when delivered to the tissue. (4) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to increase the degree of hydrophilicity of the auxiliary material in the treated state. (5) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to form a coating that is deposited on at least a portion of the auxiliary material in the treated state.

[0180] (6) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to react with the auxiliary material to change the terminal functional groups of at least some of the polymer chains that form the porous polymer body in the treated state. (7) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to increase the degree of hydrophobicity of the auxiliary material in the treated state compared to the untreated state. (8) The auxiliary material according to Embodiment 1, wherein the pretreatment fluid is configured to form a sealant that seals at least a portion of the pores within the porous polymer body. (9) The auxiliary material according to Embodiment 1, wherein the pretreatment is configured to terminate at least a portion of the plurality of polymer chains of the porous polymer body such that the average length of the plurality of polymer chains of the treated polymer body is shorter than the average length of the plurality of polymer chains of the untreated polymer body. (10) A surgical method, wherein the method is To process an untreated biocompatible auxiliary material containing a porous polymer to produce a treated auxiliary material having a modified degradation profile compared to the untreated auxiliary material, The processed auxiliary material is releasably held on the staple cartridge body, A method comprising operating a surgical stapling device having the staple cartridge body and the treated auxiliary material thereon to staple the treated auxiliary material to tissue.

[0181] (11) The method according to Embodiment 10, wherein the processing includes immersing the auxiliary material in a pretreatment fluid. (12) The method according to Embodiment 10, wherein the altered decomposition profile has a greater decomposition rate than the decomposition profile of the untreated auxiliary material. (13) The method according to Embodiment 10, wherein the auxiliary material is processed so that when it is delivered to the tissue, the auxiliary material increases the pH adjacent to the processed auxiliary material. (14) The method according to Embodiment 10, wherein the degree of hydrophilicity of the treated auxiliary material is increased compared to the untreated auxiliary material by processing the auxiliary material. (15) The method according to Embodiment 10, wherein the altered decomposition profile has a smaller decomposition rate than the decomposition profile of the untreated auxiliary material.

[0182] (16) The method according to Embodiment 10, wherein a coating is applied to at least a portion of the auxiliary material by processing the auxiliary material. (17) The method according to Embodiment 10, wherein processing the auxiliary material includes applying a pretreatment fluid to the auxiliary material that reacts with the porous polymer body of the auxiliary material and alters the terminal functional groups of the polymer chains forming the polymer body. (18) The method according to Embodiment 10, wherein the degree of hydrophobicity of the treated auxiliary material is increased compared to the untreated auxiliary material by processing the auxiliary material. (19) The method according to Embodiment 10, wherein processing the auxiliary material includes applying a pretreatment fluid that forms a sealant that seals at least a portion of the pores of the porous body. (20) The method according to Embodiment 10, wherein the processing of the auxiliary material includes applying a pretreatment fluid that terminates at least a portion of the polymer chains of the polymer body such that the average length of the polymer chains of the polymer body of the processed auxiliary material is shorter than the average length of the polymer chains of the polymer body of the untreated auxiliary material, thereby increasing the rate of decomposition of the altered decomposition profile.

Claims

1. A compressible auxiliary kit for use with a staple cartridge, wherein the auxiliary kit comprises: A biocompatible auxiliary material configured to be releasably held on a staple cartridge body and to be delivered to tissue by the deployment of staples within the staple cartridge, wherein the auxiliary material comprises a porous polymer body, The system includes a pretreatment fluid configured to change the auxiliary material from an untreated state, which is applied to the auxiliary material and configured to exhibit a first degradation profile when delivered to the tissue, to a treated state, which is configured to exhibit a second degradation profile different from the first degradation profile when delivered to the tissue, An auxiliary material kit wherein the pretreatment fluid is configured to increase the degree of hydrophobicity of the auxiliary material in the treated state compared to the untreated state.

2. A compressible auxiliary kit for use with a staple cartridge, wherein the auxiliary kit comprises: A biocompatible auxiliary material configured to be releasably held on a staple cartridge body and to be delivered to tissue by the deployment of staples within the staple cartridge, wherein the auxiliary material comprises a porous polymer body, The system includes a pretreatment fluid configured to change the auxiliary material from an untreated state, which is applied to the auxiliary material and configured to exhibit a first degradation profile when delivered to the tissue, to a treated state, which is configured to exhibit a second degradation profile different from the first degradation profile when delivered to the tissue, The pretreatment fluid is configured to terminate at least a portion of the polymer chains of the porous polymer body such that the average length of the polymer chains of the porous polymer body in the treated state is shorter than the average length of the polymer chains of the porous polymer body in the untreated state, in the auxiliary material kit.

3. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured to perform at least one of the following: increasing the decomposition rate of the second decomposition profile with respect to the first decomposition profile, and decreasing the decomposition rate of the second decomposition profile with respect to the first decomposition profile.

4. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured such that, when delivered to the tissue, the treated auxiliary material increases the pH adjacent to the auxiliary material.

5. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured to increase the degree of hydrophilicity of the auxiliary material in the treated state.

6. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured to form a coating that is deposited on at least a portion of the auxiliary material in the treated state.

7. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured to react with the auxiliary material to change the terminal functional groups of at least some of the polymer chains that form the porous polymer body in the treated state.

8. The auxiliary material kit according to claim 1 or 2, wherein the pretreatment fluid is configured to form a sealant that seals at least a portion of the pores within the porous polymer body.

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