System and method for customizing the mechanical strength of stimulus-responsive bioabsorbable materials

Abstract

The disclosed technology includes a bioabsorbable material configured to be delivered to tissue. The material includes a shape-memory polymer that is compressible in a delivery configuration and configured to swell within a given period of time. The shape-memory polymer includes one or more functional groups for reversible bonding between adjacent functional groups so that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 522,660, filed on 22 June 2023, and U.S. Non-Provisional Patent Application No. 18 / 484,929, filed on 11 October 2023, under Section 119 of the U.S. Patent Act, which are incorporated herein in their entirety by reference.

[0002] (Field of invention) The present invention relates, as a whole, to a system and method for customizing the mechanical properties of bioabsorbable materials via stimulus-responsive functional groups. [Background technology]

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

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

[0005] According to one embodiment of the present invention, a bioabsorbable material configured to be delivered to tissue is provided. The material comprises a shape-memory polymer that is compressible in a delivery configuration and configured to swell within a predetermined period of time. The shape-memory polymer comprises one or more functional groups for reversible bonding between adjacent functional groups such that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer.

[0006] According to an exemplary embodiment of the present invention, a shape memory polymer is provided that is compressible in a delivery configuration and configured to swell within a predetermined period of time upon exposure to a stimulus. The shape memory polymer may include a polyurethane backbone and one or more functional groups for reversibly bonding between adjacent functional groups so as to transition between a substantially linear polymer and a substantially nonlinear polymer.

[0007] According to one embodiment of the present invention, a method for forming a bioabsorbable material is provided. This method may include the steps of adding a functional group to a polyurethane polymer and chemically bonding the polyurethane polymer and the functional group to form a shape memory polymer. The functional group may include at least one of diene and dienophile moieties, styrylpyrene moieties, azo moieties, ortho-nitrobenzyl moieties, coumarin moieties, anthracene moieties, disulfide moieties, diselenide moieties, or a combination thereof. [Brief explanation of the drawing]

[0008] The present invention will be more fully understood by reading the following embodiments in conjunction with the accompanying drawings. [Figure 1] This is a perspective view of an exemplary embodiment of a conventional surgical staple fastening and cutting instrument. [Figure 2A] Figure 1 is a top view of a staple cartridge for use with surgical staple fastening and cutting instruments. [Figure 2B] Figure 2A is a side view of the staple cartridge. [Figure 3] Figure 2A is a side view of a staple in an unfired (pre-deployment) configuration, which may be placed inside the staple cartridge of the surgical cartridge assembly. [Figure 4] Figure 1 is a perspective view of the knife and launching bar ("E-shaped beam section") of the surgical staple fastening and cutting instrument. [Figure 5] Figure 1 is a perspective view of the wedge thread of the staple cartridge for a surgical staple fastening and cutting instrument. [Figure 6A] This is a longitudinal cross-sectional view of an exemplary surgical cartridge assembly having a compressible, non-fibrous auxiliary material attached to the top or deck surface of a staple cartridge. [Figure 6B]A longitudinal cross-sectional view of a surgical end effector having an anvil pivotally coupled to an elongated channel and a surgical cartridge assembly of FIG. 6A disposed within and coupled to the elongated channel, showing the anvil in a closed position with no tissue between the anvil and the auxiliary member. [Figure 7A] A partial schematic view showing the auxiliary members of FIGS. 6A and 6B with tissue disposed thereon. [Figure 7B] A view showing an enlarged portion of an exemplary auxiliary member having a porous structure. [Figure 8] A perspective view of an exemplary cartridge assembly. [Figure 9A] A side view of an exemplary end effector having an auxiliary member of a bioabsorbable material in a delivery configuration. [Figure 9B] A side view of an exemplary end effector having an auxiliary member of a bioabsorbable material after firing and release from the cartridge. [Figure 9C] Shows an exemplary reversible conversion of a linear polymer to a complex structure. [Figure 9D] Shows an exemplary reversible conversion of a linear polymer to a complex structure. [Figure 10A] A perspective view from above of an exemplary auxiliary member after use. [Figure 10B] A side view of an exemplary auxiliary member after use. [Figure 11] A flowchart showing an exemplary method of forming a surgical auxiliary member using spatial control of the mechanical properties of a bioabsorbable material.

Modes for Carrying Out the Invention

[0009] The following detailed description should be read in reference to the drawings, where similar elements in different drawings are numbered identically. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative of the principles of the invention, not limiting, but illustrating them as examples. This specification describes several embodiments, adaptations, modifications, alternatives, and uses of the invention, including those that are currently considered to be the best modes for carrying out the invention, which will make it obvious to those skilled in the art how to make and use the invention.

[0010] In this specification, a range can be expressed as a range from one specific value to another specific value, also denoted as "about," "approximately," or "substantially." When expressing such a range, other exemplary embodiments also include a range from one specific value and / or other specific values. Furthermore, "about" means within the allowable error range for a particular value determined by those skilled in the art, which depends to some extent on the method by which the value is measured or determined, i.e., on the limitations of the measurement system. For example, "about" may mean within an allowable standard deviation, according to the practices in the art. Alternatively, "about" may mean a range of up to ±20%, preferably up to ±10%, more preferably up to ±5%, and even more preferably up to ±1% of a given value. Or, particularly with respect to biological systems or processes, the term may mean within one order of magnitude, preferably up to twice, of a given value. When a specific value is stated in this application and claims, unless otherwise specified, the term “about” is implicit and in this context means that the value is within the acceptable margin of error.

[0011] Furthermore, throughout this disclosure, various aspects of the disclosure may be presented in scope form. It should be understood that scope form descriptions are merely for convenience and brevity and should not be interpreted as a firm limitation on the scope of the disclosure. Therefore, scope descriptions should be considered to specifically disclose all possible sub-scopes and the individual numbers within those scopes. For example, a scope description such as 1–6 should be considered to have specifically disclosed sub-scopes such as 1–3, 1–4, 1–5, 2–4, 2–6, 3–6, and the individual numbers within those scopes, e.g., 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the scope.

[0012] Similarly, as used herein, the characterizations “substantially excluding” or “substantially pure” and similar descriptions may include both “at least substantially excluding” or “at least substantially pure” something, and “completely excluding” or “completely pure” something.

[0013] "Comprising," "containing," or "including" means that at least the specified compound, element, particle, or process step is present in the composition, article, or method, but does not exclude the presence of other such compounds, substances, particles, or process steps, even if those other compounds, substances, particles, or process steps have the same function as the specified one.

[0014] As used herein, the terms “aliphatic” or “aliphatic group” mean a straight (i.e., unbranched) or branched substituted or unsubstituted hydrocarbon chain having a single bond site to the remainder of the molecule, containing one or more fully saturated or unsaturated units, or a monocyclic or bicyclic hydrocarbon that is fully saturated or contains one or more unsaturated units but is not aromatic (also referred to herein as “carbocyclic” or “alicyclic”). Unless otherwise specified, an aliphatic group contains 1 to 6 aliphatic carbon atoms. In some embodiments, an aliphatic group contains 1 to 5 aliphatic carbon atoms. In other embodiments, an aliphatic group contains 1 to 4 aliphatic carbon atoms. In yet another embodiment, an aliphatic group contains 1 to 3 aliphatic carbon atoms, and in yet another embodiment, an aliphatic group contains 1 to 2 aliphatic carbon atoms. Suitable aliphatic groups include, but are not limited to, linear or branched substituted or unsubstituted alkyl, alkenyl, and alkynyl groups, and hybrids thereof, such as cycloalkyl, (cycloalkyl)alkyl, (cycloalkenyl)alkyl, or (cycloalkyl)alkenyl.

[0015] As used herein, the term "alkyl" means, unless otherwise indicated, a monovalent aliphatic hydrocarbon radical having a linear, branched, monocyclic, or polycyclic moiety, or a combination thereof, wherein one or more carbon atoms of the linear, branched, monocyclic, or polycyclic moiety, or a combination thereof, are optionally substituted with one or more substituents at each carbon atom, and these substituents are independently C1-C 10It is alkyl. In some embodiments, “cycloalkyl” (or “carbocyclic”) refers to a monocyclic C3-C6 hydrocarbon that is not aromatic, is fully saturated or contains one or more unsaturated units, and has a single bond site to the remainder of the molecule. Under certain circumstances, a carbocyclic may be a bridging bicyclic or condensed ring, such as an ortho-condensed carbocyclic or spiro-condensed carbocyclic. Examples of “alkyl” groups include, but are not limited to, methyl, ethyl, propyl, isopropyl, butyl, isobutyl, sec-butyl, tert-butyl, pentyl, hexyl, heptyl, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, norbornyl, and others.

[0016] The term "alkylene" refers to a divalent alkyl group. An "alkylene chain" is a polymethylene group, i.e., -(CH2) n -, where n is a positive integer, preferably 1-6, 1-4, 1-3, 1-2, or 2-3. A substituted alkylene chain is a polymethylene group in which one or more methylene hydrogen atoms are substituted with substituents. Preferred substituents include those listed below for substituted aliphatic groups.

[0017] The term "alkenylene" refers to a divalent alkenyl group. A substituted alkenylene chain is a polymethylene group containing at least one double bond in which one or more hydrogen atoms are substituted by substituents. Preferred substituents include those listed below for substituted aliphatic groups.

[0018] The term "alkoxy" refers to an alkyl group linked via an oxygen-bonding atom, and is represented as -O-alkyl. For example, "(C1-C4) alkoxy" includes methoxy, ethoxy, propoxy, and butoxy.

[0019] The term "aryl" is used alone or as part of a larger part to refer to a monocyclic or bicyclic ring system having a total of 5 to 14 ring members, where at least one ring in the system is aromatic, and each ring in the system contains 3 to 7 ring members. The term "aryl" may be used interchangeably with the term "aryl ring." In certain embodiments of the compounds described herein, "aryl" refers to aromatic ring systems, including but not limited to phenyl, naphthyl, and anthracele, which may have one or more substituents. It will be understood that the "aryl" group may contain carbon and heteroatom ring members.

[0020] As described herein, the compounds described herein may include “optionally substituted” moieties. Generally, the term “substituted” means that one or more hydrogens of a given moiety are substituted with a preferred substituent, whether or not the term “optionally” precedes it. Unless otherwise specified, an “optionally substituted” group may have preferred substituents at each substituted position of the group, and if two or more positions in any given structure can be substituted with two or more substituents selected from a particular group, the substituents may be the same or different at all positions. The substituent combinations envisioned herein preferably result in the formation of a stable or chemically feasible compound. As used herein, “stable” means a compound that remains substantially unchanged when subjected to conditions that enable their generation, detection, and, in particular embodiments, their recovery, purification, and use for one or more purposes disclosed herein.

[0021] As used herein, the term “polyurethane” refers to the polymer reaction product of an isocyanate and a polyol, and is not limited to polymers containing only urethane bonds or polyurethane bonds. It will be well understood by those skilled in the art to prepare polyurethanes that polyurethane polymers may also contain bonds such as allophanates, carbodiimides, and other bonds described herein, in addition to urethane bonds.

[0022] The terms “reaction system,” “reactive formulation,” “reaction product,” and “reactive mixture” are used interchangeably herein and all refer to combinations of reactive compounds used to produce the bioabsorbable materials according to this disclosure.

[0023] The term "room temperature" refers to a temperature of approximately 20°C, which means a temperature range of 18°C ​​to 25°C. Such temperatures include 18°C, 19°C, 20°C, 21°C, 22°C, 23°C, 24°C, and 25°C.

[0024] Unless otherwise specified, the "weight percentage" (indicated as %wt. or wt.%) of a component in a composition refers to the weight of the component relative to the total weight of the composition in which it is present, and is expressed as a percentage.

[0025] The terms "glass transition temperature" and "T" as used herein refer to. g This refers to the temperature at which a reversible transition occurs from a hard glassy state to a rubbery elastic state.

[0026] Surgical staple fastening assemblies, as well as methods for manufacturing and using the same, are provided. Generally, a surgical staple fastening assembly may include a staple cartridge in which staples are disposed internally, and an auxiliary material configured to be releasably held on the staple cartridge. As discussed herein, the various auxiliary materials provided may be configured to compensate for changes in tissue properties, such as changes in tissue thickness, and / or to promote tissue endoplasticity when the auxiliary material is stapled to the tissue. As discussed herein, the auxiliary material may include bioabsorbable materials such as foams.

[0027] An exemplary staple fastening assembly, as described herein and shown in the drawings, may include various features to facilitate the application of surgical staples. However, it will be understood by those skilled in the art that a staple fastening assembly may include only some of these features, and / or may include various other features known in the art. The staple fastening assemblies described herein are intended to represent specific exemplary embodiments only. Furthermore, although auxiliary materials are described in relation to surgical staple cartridge assemblies, auxiliary materials may be used in relation to the reloading of staples that are not cartridge bases or any type of surgical instrument.

[0028] Figure 1 shows an exemplary surgical stapling and cutting device 100 suitable for use with implantable auxiliary materials. The illustrated surgical stapling and cutting device 100 includes an end effector 106 having an anvil 102 pivotally connected to an elongated channel 104. As a result, the end effector 106 can move between an open position, as shown in Figure 1, and a closed position in which the anvil 102 is positioned adjacent to the elongated channel 104 and engages tissue between them. The end effector 106 can be attached at its proximal end to an elongated shaft 108 that forms an implement 110. When the end effector 106 is closed, or at least substantially closed (for example, when the anvil 102 moves from the open position in Figure 1 toward the elongated channel), the implement 110 can present a cross-section small enough to be suitable for inserting the end effector 106 through a trocar. Device 100 is configured to staple and cut tissue, but surgical devices configured to staple tissue but not cut it are also contemplated herein.

[0029] In various situations, the end effector 106 can be operated by a handle 112 connected to an elongated shaft 108. The handle 112 includes a user control unit such as a rotary knob 114 that rotates the elongated shaft 108 and the end effector 106 around the longitudinal axis (Ls) of the elongated shaft 108, and an articulated axis (T) which is substantially transverse to the longitudinal axis (Ls) of the elongated shaft 108. A The system may include an articulation control unit 115 that can articulate the end effector 106 around the pistol grip 118. Further control units may include a closing trigger 116 that can pivot relative to the pistol grip 118 to close the end effector 106. For example, when the closing trigger 116 is clamped, a closing release button 120 may be provided on the outside of the handle 112, so that pressing the closing release button 120 releases the clamp on the closing trigger 116 and opens the end effector 106. The handle 112 may also take the form of an interface for connection to a surgical robot.

[0030] In some embodiments, the firing trigger 122 can pivot relative to the closing trigger 116, thereby allowing the end effector 106 to simultaneously cut and staple the tissue clamped inside it. The firing trigger 122 may be powered, require user force to engage, or be a combination of both. A manual firing release lever 126 allows the firing system to be retracted if necessary before it completes its movement for firing, and further allows a surgeon or other clinician to retract the firing system if it becomes stuck and / or malfunctions.

[0031] Further details regarding surgical stapling and cutting devices 100 and other surgical stapling and cutting devices suitable for use with the present disclosure are described, for example, in U.S. Patent No. 9,332,984 and U.S. Patent Application Publication No. 2009 / 0090763, which are incorporated herein by reference in their entirety. Furthermore, surgical stapling and cutting devices do not need to include a handle and instead may have a housing configured to be coupled to a surgical robot, as described, for example, in U.S. Patent Application Publication No. 2019 / 0059889, which are also incorporated herein by reference in their entirety.

[0032] As further shown in Figure 1, the staple cartridge 200 can be used with the apparatus 100. When in use, the staple cartridge 200 is positioned and connected within the elongated channel 104. The staple cartridge 200 can have various configurations, but in this illustrated embodiment, the staple cartridge 200 shown in detail in Figures 2A and 2B has a proximal end 202a and a distal end 202b, with the longitudinal axis (LC) of the cartridge extending between the proximal end 202a and the distal end 202b. As a result, when the staple cartridge 200 is inserted into the elongated channel 104 (Figure 1), the longitudinal axis (LC) is substantially or approximately parallel to the longitudinal axis (LS) of the elongated shaft 108. Furthermore, the staple cartridge 200 includes a longitudinal slot 210 defined by two opposing walls 210a, 210b and configured to receive at least a portion of a launching member of a launching assembly, such as the launching assembly 400 in Figure 4, as will be discussed further below. As shown, the longitudinal slot 210 extends from the proximal end 202a to the distal end 202b of the staple cartridge 200. It is also intended herein that the longitudinal slot 210 may be omitted in other embodiments.

[0033] The illustrated staple cartridge 200 includes defined staple cavities 212, 214, each of which is configured to removably accommodate at least a portion of staples (not shown). The number, shape, and position of the staple cavities can vary and depend at least on the size and shape (e.g., mouth-like shape) of the staples removably disposed inside. In this illustrated embodiment, the staple cavities are arranged in two sets of three longitudinal rows, with the staple cavities 212 of the first set located on the first side of the longitudinal slot 210, and the staple cavities 214 of the second set located on the second side of the longitudinal slot 210. On each side of the longitudinal slot 210, and therefore for each set of rows, the first longitudinal row of staple cavities 212a, 214a extends along the longitudinal slot 210, the second row of staple cavities 212b, 214b extends along the first row of staple cavities 212a, 214a, and the third row of staple cavities 212c, 214c extends along the second row of staple cavities 212b, 214b. Each row may be substantially parallel, and the staple cavities constituting the row may be oriented substantially parallel to the longitudinal slot 210. As shown in Figure 2A, each staple cavity 212, 214 may include a maximum length SL of about 0.122 inches to about 0.124 inches and a maximum width SW of about 0.023 inches to about 0.027 inches. Furthermore, at least the centers of the two adjacent cavities 212 and 214 are spaced approximately 0.158 inches apart.

[0034] The staples, which are releasably stored within the staple cavities 212 and 214, can have various configurations. An exemplary staple 300, which can be releasably stored in each of the staple cavities 212 and 214, is shown in its un-launched (pre-deployment, unformed) configuration in Figure 3. The illustrated staple 300 includes a crown (base) 302 and two legs 304 extending from each end of the crown 302. In this example, the crown 302 extends linearly, and the staple legs 304 have the same unformed height. Furthermore, before the staple 300 is deployed, the staple crown 302 can be supported by a staple driver positioned within the staple cartridge 200, and at the same time, the staple legs 304 can be at least partially housed within the staple cavities 212 and 214. Furthermore, the staple leg 304 can extend beyond the upper surface, such as the upper surface 206 of the staple cartridge 200, when the staple 300 is in the non-firing position. In certain circumstances, as shown in Figure 3, the tip 306 of the staple leg 304 can be sharp and pointed, capable of cutting and penetrating tissue.

[0035] During use, the staple 300 can be deformed from an unfired position to a firing position such that the staple legs 304 move through the staple cavities 212, 214, penetrate tissue positioned between the anvil 102 and the staple cartridge 200, and contact the anvil 102. As the staple legs 304 deform relative to the anvil 102, the legs 304 of each staple 300 can capture a portion of the tissue within each staple 300 and apply compressive force to the tissue. Furthermore, the legs 304 of each staple 300 can deform downward toward the crown 302 of the staple 300 to form a staple capture region into which tissue can be captured. In various cases, the staple capture region may be defined between the inner surface of the deformed leg and the inner surface of the crown of the staple. The size of the staple capture region may depend on several factors, such as the length of the leg, the diameter of the leg, the width of the crown, and / or the degree of leg deformation.

[0036] In some embodiments, all staples arranged within the staple cartridge 200 may have the same unfired (pre-deployed, unformed) configuration. In other embodiments, the staples may include at least two groups of staples, each having different unfired (pre-deployed, unformed) configurations, such as differing in height and / or shape from one another.

[0037] Referring again to Figures 2A and 2B, the staple cartridge 200 extends from the top or deck surface 206 to the bottom surface 208, with the top surface 206 configured as the surface facing the tissue and the bottom surface 208 configured as the surface facing the channel. As a result, as shown in Figure 1, when the staple cartridge 200 is inserted into the elongated channel 104, the top surface 206 faces the anvil 102 and the bottom surface 208 (which is obscured) faces the elongated channel 104.

[0038] Referring to Figures 4 and 5, a launch assembly, such as launch assembly 400, can be used in conjunction with a surgical stapling and cutting device, such as device 100 in Figure 1. The launch assembly 400 may be configured to advance a wedge thread 500, which has a wedge 502 configured to deploy staples from a staple cartridge 200, into tissue trapped between an anvil, such as an anvil 102 in Figure 1, and a staple cartridge, such as the staple cartridge 200 in Figure 1. Furthermore, an E-shaped beam section 402 at the distal portion of the launch assembly 400 may launch staples from the staple cartridge. During launch, the E-shaped beam section 402 can also pivot the anvil toward the staple cartridge, and thus move the end effector from an open position to a closed position. The illustrated E-shaped beam section 402 includes a pair of upper pins 404, a pair of intermediate pins 406 which may be along a portion 504 of the wedge thread 500, and a lower pin or foot 408. The E-shaped beam section 402 may also include a sharp cutting edge 410 configured to cut captured tissue as the launch assembly 400 advances distally, and thus toward the distal end of the staple cartridge. In addition, integrally molded upper guides 412 and intermediate guides 414, which bracket each vertical end of the cutting edge 410 and project proximally, may further define a tissue staging area 416 that helps guide the tissue toward the sharp cutting edge 410 before cutting the tissue. The intermediate guides 414 may also function to engage with and launch staples in the staple cartridge by abutting a stepped central member 506 of the wedge thread 500, which enables staple forming by the end effector 106.

[0039] During use, the anvil 102 in Figure 1 is moved to the closed position by pressing down the closing trigger in Figure 1, which advances the E-shaped beam section 402 in Figure 4. The anvil 102 can position the tissue relative to at least the upper surface 206 of the staple cartridge 200 in Figures 2A and 2B. Once the anvil is properly positioned, the staples 300 in Figure 3, which are arranged inside the staple cartridge, can be deployed.

[0040] To deploy staples from the staple cartridge, as described above, the thread 500 in Figure 5 can be moved from the proximal end to the distal end of the cartridge body, and therefore from the proximal end to the distal end of the staple cartridge. As the firing assembly 400 in Figure 4 advances, the thread can contact the staple driver in the staple cartridge and lift it upward within the staple cavities 212, 214. In at least one example, the thread and staple driver may each include one or more inclined surfaces, i.e., beveled surfaces, which work together to move the staple driver upward from its unfired position. Once the staple driver is lifted upward within each staple cavity, the staples advance upward, exiting the staple cavity and penetrating into the tissue. In various cases, the thread may move several staples upward simultaneously as part of the firing sequence.

[0041] As described above, the stapling device can be used in combination with a compressible auxiliary material. While such auxiliary materials are shown and described below, those skilled in the art will understand that the auxiliary materials disclosed herein can be used with other surgical instruments and do not need to be connected to a stapling cartridge as described. Furthermore, those skilled in the art will understand that the stapling cartridge does not need to be replaceable.

[0042] As mentioned above, with some surgical staplers, surgeons are often required to select the appropriate staple with the appropriate staple height for the tissue being stapled. For example, surgeons use tall staples for thick tissue and short staples for thin tissue. However, in some situations, the stapled tissue does not have a consistent thickness, and therefore the staple cannot achieve the desired post-launch configuration for all parts of the stapled tissue (e.g., parts of thick tissue and parts of thin tissue). If staples of the same or substantially higher height are used due to the inconsistent thickness of the tissue, undesirable leakage and / or tearing of the tissue may occur at the staple site, especially if the staple site is exposed to internal pressure at that site and / or along the row of staples.

[0043] Accordingly, various embodiments of auxiliary materials are provided that can be configured to compensate for varying thicknesses of tissue captured within fired (deployed) staples, thereby avoiding the need to consider staple height when stapling tissue during surgery. That is, the auxiliary materials described herein can also, in combination with the auxiliary material, provide appropriate tissue compression within and between fired staples, while enabling the use of a set of staples of the same or similar height when stapling tissue of varying thicknesses (e.g., from thin to thick tissue). Thus, the auxiliary materials described herein can maintain suitable compression for thin or thick stapled tissue, thereby minimizing leakage and / or tearing of tissue at the staple site. In addition, the exemplary auxiliary materials described herein may be configured to be absorbed into the body over a period of 100 to 300 days, depending on the implantation site and the health of the tissue.

[0044] Alternatively or in addition, the implantable material may be configured to promote tissue endografting. In various situations, it is desirable to promote tissue endografting into the implantable material in order to promote the healing of the tissue being treated (e.g., stapled and / or incised tissue) and / or to accelerate the patient's recovery. More specifically, tissue endografting into the implantable material may reduce the incidence, severity, and / or duration of inflammation at the surgical site. Tissue endografting into and / or around the implantable material may, for example, control the spread of infection at the surgical site. For example, vascular, particularly leukocyte, endografting into and / or around the implantable material may combat infection in and around the implantable material and adjacent tissue. Tissue endografting may also assist the patient's body in accepting foreign bodies (e.g., implantable materials and staples) and may reduce the likelihood of the patient's body rejecting foreign bodies. Rejection of foreign bodies can lead to infection and / or inflammation at the surgical site.

[0045] Generally, the auxiliary materials provided herein are designed and positioned on top of a staple cartridge, such as a staple cartridge 200. When a staple is fired (deployed) from the cartridge, the staple penetrates the auxiliary material and enters the tissue. When the legs of the staple are deformed upon contact with an anvil positioned on the opposite side of the staple cartridge, the deformed legs capture a portion of the auxiliary material and a portion of the tissue within each staple. That is, when a staple is fired into the tissue, at least a portion of the auxiliary material is positioned between the tissue and the fired staple. While the auxiliary materials described herein may be configured to be attached to a staple cartridge, it is also intended herein that the auxiliary materials may be configured to mate with components of other instruments, such as an anvil for a surgical stapler. Those skilled in the art will understand that the auxiliary materials provided herein may be used for reloading staples that are not replaceable cartridges or cartridge-based.

[0046] In various embodiments, the auxiliary materials or bioabsorbable materials disclosed herein may consist of absorbent polymers. In certain embodiments, the auxiliary materials may consist of foams, films, fibrous fabrics, fibrous nonwoven polyurethanes, polyether urethanes, polyester urethanes, polyester urea, polyesters, polycarbonates, polyorthoesters, polyanhydrides, polyesteramides, polyphosphazenes, polyphosphoesters, polysaccharides, and / or polyoxaesters. In other embodiments, the auxiliary materials may be copolymers including, for example, PGA (polyglycolic acid), PGA / PCL (poly(glycolic acid-co-caprolactone)), PLA / PCL (poly(lactic acid-co-polycaprolactone)), PLLA / PCL, PGA / TMC (poly(glycolic acid-co-trimethylene carbonate)), PDS, PEPBO, and the like. In various embodiments, the auxiliary materials may include organic materials such as, for example, carboxymethylcellulose, sodium alginate, hyaluronic acid, and / or oxidized regenerated cellulose. In various embodiments, the auxiliary material has a juroty hardness in the range of 3 to 7 Shore A (30 to 50 Shore 00) with a maximum stiffness of 15 Shore A (65 Shore 00). In some embodiments, the auxiliary material can be subjected to, for example, 40% compression under a load of 3 lbf, 60% compression under a load of 6 lbf, and / or 80% compression under a load of 20 lbf. In some embodiments, one or more gases, such as air, nitrogen, carbon dioxide, and / or oxygen, can be bubbled through the auxiliary material and / or contained within the auxiliary material.

[0047] How to staple tissue Figures 6A and 6B show exemplary embodiments of a staple fastening assembly 600 including a staple cartridge 200 and an auxiliary material 604. For simplicity, the auxiliary material 604 is schematically shown in Figures 6A and 6B, and various configurations of the auxiliary material will be described in more detail below. As shown, the auxiliary material 604 is positioned relative to the staple cartridge 200. Although partially obscured in Figures 6A and 6B, the staple cartridge 200 includes staples 300 configured to be deployed within the structure. The staples 300 may have any preferred unformed (pre-deployment) height.

[0048] In the illustrated embodiments, the auxiliary material 604 can be fitted to at least a portion of the top surface or deck surface 206 of the staple cartridge 602. In some embodiments, the top surface 206 of the staple cartridge 200 may include one or more surface features that engage with the auxiliary material 604 and / or prevent premature release of the auxiliary material 604 from the staple cartridge 200. Exemplary surface features are described further later and are included in U.S. Patent No. 10,052,104, which is incorporated herein by reference in whole.

[0049] Figure 6B shows a staple fastening assembly 600 positioned within and connected to the elongated channel 610 of the surgical end effector 106. The anvil 102 is pivotally connected to the elongated channel 610 and is therefore movable between an open position and a closed position relative to the elongated channel 610, and thus to the staple cartridge 200. The anvil 102 is shown in the closed position in Figure 6B, and the interstitial gap T formed between the staple cartridge 602 and the anvil 612 is visible. G1 This shows that. More specifically, the interstitial space T G1is defined by the distance between the tissue compression surface 102a of the anvil 102 (e.g., the tissue engagement surface between staple - forming pockets within the anvil) and the tissue contact surface 604a of the auxiliary member 604. In this illustrated example, both the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the auxiliary member 604 are planar or substantially planar (e.g., planar within manufacturing tolerances). As a result, when the anvil 102 is in the closed position, as shown in FIG. 6B, the tissue gap T G1 is generally uniform (e.g., nominally the same within manufacturing tolerances) when no tissue is disposed therein. In other words, the tissue gap T G1 is generally constant (e.g., constant within manufacturing tolerances) across the end effector 106 (e.g., in the y - direction). In other embodiments, the tissue compression surface of the anvil includes a stepped surface having longitudinal steps between adjacent longitudinal portions, and thus can form a stepped profile (e.g., in the y - direction). In such an example, the tissue gap T G1 can vary.

[0050] The auxiliary member 604 is compressible and can be compressed to various heights to compensate for the different tissue thicknesses captured within the staples deployed thereby. The auxiliary member 604 has an uncompressed (undeformed) or pre - deployment height and is configured to deform to one of a plurality of compressed (deformed) or deployment heights. For example, the auxiliary member 604 can have an uncompressed height that is greater than the post - firing height of the staple 300 disposed within the staple cartridge 200 (e.g., the height (H) of the fired staple 300a in FIG. 7A). That is, the auxiliary member 604 can have an undeformed state where the maximum height of the auxiliary member 604 is greater than the maximum height of the fired staple (e.g., the staple in the formed configuration).

[0051] When used, a surgical stapling and cutting device such as device 100 in Figure 1 is directed toward the surgical site, and the tissue is positioned between the anvil 102 and the stapling assembly 600 so that the anvil 102 is positioned adjacent to a first side of the tissue and the stapling assembly 600 is positioned adjacent to a second side of the tissue (for example, the tissue can be positioned relative to the tissue contact surface 604a of the auxiliary material 604). Once the tissue is positioned between the anvil 102 and the stapling assembly 600, the surgical stapler is operated, for example as described above, thereby clamping the tissue between the anvil 102 and the stapling assembly 600 (for example, between the tissue compression surface 102a of the anvil 102 and the tissue contact surface 604a of the auxiliary material 604), deploying staples from the cartridge through the auxiliary material into the tissue, and stapling and attaching the auxiliary material to the tissue.

[0052] As shown in Figure 7A, when the staple 300 is fired, a portion of the tissue (T) and auxiliary material 604 is captured by the fired (formed) staple 300a. Each fired staple 300a defines a capture area within itself to accommodate the captured auxiliary material 604 and tissue (T), as described above. The capture area defined by the fired staple 300a is at least partially limited by the height (H) of the fired staple 300a.

[0053] Referring to Figure 7B, the auxiliary material 604 is, for example, approximately 0.022 mm 3 such as approximately 0.025 mm 3 ~about 0.300mm 3 The auxiliary member 604 may have holes 632 having a median hole diameter. In some embodiments, the auxiliary member 604 may have one or more support posts 634 between the holes 632 to provide support and strength to the auxiliary member 604. Specifically, the auxiliary member 604 may include a plurality of support posts 634 having a median support post thickness ST of about 0.025 mm to about 0.300 mm, for example, about 0.08 mm.

[0054] Figure 8 shows a perspective view of a staple cartridge assembly 600 having an auxiliary material 604 and a staple cartridge 200. The auxiliary material 604 has a tissue contact surface 604a, a proximal end 604c, and a distal end 604b. The auxiliary material 604 may include a slot / slit 808 that separates or partially separates two parallel portions of the auxiliary material 604. In one example, the auxiliary material 604 may include a slot 808 that separates two parallel portions of the auxiliary material 604, while in another example, the auxiliary material 604 may include a slit 808 that separates two parallel portions of the auxiliary material 604, and one or more bridges (e.g., five bridges) 802 that connect the two parallel portions of the auxiliary material 604. At least one bridge has a longitudinal length of about 0.035 inches to about 0.046 inches. The auxiliary material 604 has a length L of approximately 40 mm to approximately 80 mm, such as approximately 60 mm to approximately 65 mm, approximately 66.04 mm to approximately 66.3 mm, approximately 45 mm to approximately 55 mm, or approximately 51.12 mm to approximately 51.38 mm. The auxiliary material 604 has a width W of approximately 8 mm to approximately 12 mm, such as approximately 9.75 mm to approximately 10.25 mm or approximately 10.025 mm to approximately 10.035 mm. The auxiliary material 604 may also have a thickness or height TH of approximately 2.5 mm to approximately 3.5 mm, for example, approximately 2.85 mm to approximately 3.15 mm, or approximately 2.95 mm to approximately 3.05 mm.

[0055] Cartridge 200 has a height CH of approximately 6.3 mm to approximately 8.1 mm, a width CW of approximately 8.9 mm to approximately 14 mm, and a length CL of approximately 80 mm to approximately 90 mm, for example, approximately 86.7 mm.

[0056] The staple cartridge 200 may include one or more raised ledges 804 along one or more sides of the auxiliary material 604 to help align the auxiliary material 604 on the deck of the staple cartridge 200. Although not shown in Figure 8, the staple cartridge 200 may also include an adhesive or buttress adhesive material for attaching the auxiliary material 604. The auxiliary material 604 may be attached to the cartridge 200 using about 100 mg to about 120 mg of the adhesive or buttress adhesive material.

[0057] Adjustment of mechanical properties using stimulus-responsive materials The strength required to hold staples, sutures, screws, etc., may conflict with the requirements for endoscope deployment. As described above, the end effector 106 (shown in Figure 1), equipped with cartridge 200 and auxiliary material 604, is closed or substantially closed for insertion into the delivery site through the trocar. As the strength of the implant increases (to maintain staples and hemostatic seals), the force required to compress the implant for insertion through the trocar increases. Therefore, the surgical auxiliary material 604 needs to have adjustable mechanical properties so that the material is sufficiently compressible during delivery through the trocar, but increases in strength at the delivery site to hold staples, sutures, and screws and to maintain hemostatic seals during the recovery period.

[0058] As described herein, surgical adjuvants 604 may be modified for specific purposes before, during, and after surgical procedures, but may have one or more of the functional groups described below that modulate their mechanical properties. In particular, the described adjuvants 604 have one or more stimulus-responsive functional groups that respond to specific stimuli either in vitro or in vivo, so that the compressibility of the adjuvants 604 can be modified during delivery and after firing.

[0059] Figure 9A is a side view of the end effector 106 in a delivery configuration in which the auxiliary material 604 is compressible between the anvil 102 and the cartridge 200. As shown, the end effector 106 may include a staple cartridge 200, and the bioabsorbable auxiliary material 604 may include a shape memory polymer 624 that is compressible in the delivery configuration. In certain embodiments, the auxiliary material 604 is releasedly held on the cartridge 200. As illustrated in Figure 9A, when the end effector 106 closes around the tissue T, the auxiliary material 604 can be compressed from the thickness UT of the uncompressible auxiliary material to the thickness CT of the compressible auxiliary material, depending on the variation in tissue thickness.

[0060] Figure 9B is a side view of the end effector 106 after firing of the staple 300, where the auxiliary material 604 is no longer compressed between the anvil 102 and the cartridge 200. As shown, the auxiliary material 604 is ejected from the cartridge 200 after firing. The auxiliary material 604 is shown to maintain the thickness CT of the compressed auxiliary material and the thickness UT of the uncompressed auxiliary material from before firing in Figure 9A.

[0061] In some embodiments, the auxiliary material 604 may undergo a change in its mechanical properties before the staple is fired, and as a result, the uncompressible and compressible partial CTs are maintained after the auxiliary material 604 and tissue T are fired and released. In other embodiments, the auxiliary material 604 may undergo a change in its mechanical properties after firing and within a predetermined period. In such examples, the uncompressible and compressible partial CTs may expand or contract in accordance with the staple height and tissue thickness as the tissue heals. As will be understood by those skilled in the art, the change in the mechanical properties of the auxiliary material 604 may be advantageous in ensuring a hemostatic seal during the changes in the tissue inflammatory response and throughout the healing process.

[0062] To control the mechanical properties of the bioabsorbable material, the auxiliary material 604 includes a shape-memory polymer 624 that can swell via a reversible conversion from a linear polymer system 625 to a non-linear polymer system 626, as shown in Figures 9C and 9D. Stimulus-responsive functional groups can enable transitions from the linear polymer system to complex structures such as star-shaped, cyclic, or hyperbranched systems. The transition from the linear polymer 625 to the non-linear polymer 626 may include bonding between adjacent functional groups along the same polymer strand, as shown by the dashed lines in Figures 9C and 9D. Alternatively, or in addition, the bonding may be crosslinking between functional groups along adjacent polymer strands, as shown by the dotted line between the primary strand in Figure 9C and the secondary strand in Figure 9D (the secondary polymer strand is not shown in Figure 9C for clarity). The shape memory polymer may contain a backbone comprising one or more polymers selected from polyurethane, polyether urethane, polyester urethane, polyester urea, polyester, polycarbonate, polyorthoester, polyanhydride, polyesteramide, polyphosphazene, polyphosphoester, polysaccharide, and / or polyoxaester.

[0063] As those skilled in the art will understand, polymer skeletons can be further functionalized after their formation. For example, a polyurethane skeleton can be synthesized via a reaction between an isocyanate and a polyol. Additional functional groups can be added after the formation of the polyurethane skeleton. Alternatively, or in addition, a polymer skeleton precursor can be pre-functionalized with one or more functional groups. In a non-limiting example of such a case, an isocyanate functionalized with one functional group may react with a polyol functionalized with a second functional group, such that a polyurethane skeleton is formed with a pendant functional group in the same process.

[0064] In certain embodiments, the shape memory polymer 624 may be configured to modulate its mechanical properties through either physical expansion (swelling) or a phase change of the material. Mechanical properties such as compressive strength (compression of the polymer), tensile strength (stretching of the polymer), flexural strength (bending of the polymer), torsional strength (torsion of the polymer), impact strength (under the influence of direct hammering or firing), tear resistance, ultimate elongation, and / or Young's modulus (stress-to-strain ratio) may be configured to increase after the shape memory polymer 624 is released from the staple cartridge 200. Functional groups can reversibly bond with adjacent functional groups via stimuli including at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, pH, etc. As will be understood by those skilled in the art, each functional group may be selectively transitioned by only one type of stimulus, or by a combination of stimuli.

[0065] The mechanical properties can be reversed when using damping implants, for example, when using auxiliary materials 604 that need to be sutured in vivo. To prevent damage during implant manipulation and suturing procedures, the shape memory polymer 624 may be configured to have enhanced mechanical properties, but may be specially tuned to maintain a rubbery state (to prevent rupture) when exposed to biological conditions (e.g., elevated temperature, pH).

[0066] In some embodiments, the shape memory polymer 624 is used as an auxiliary material 604, and the programming temperature T D At a constant load speed (for example, 0.01s) -1 ) Maximum change in compression (e max ) is transformed by, and then e max While maintaining the load temperature (T L It can be programmed via temperature to cool to ). Outside of potential relaxation (Δe), the recovery temperature (T R When the temperature rises to ), the strain recovers. Generally, auxiliary material 604 has a glass transition temperature (T g ) is T L and T RIt may be designed to be between the two. In addition, the auxiliary material 604 may also be designed so that a transition occurs through effective plasticization or decomposition, thereby effective T g This reduces the risk and allows for recovery during the pre-deployment liquid emergence process. The liquid emergence can be body water or any in vivo fluid at the delivery site.

[0067] In other specific embodiments, the shape memory polymer 624 may be designed around light-mediated bonding such that functional group bonds are generated or broken upon exposure to light of different wavelengths. Activation or deactivation of these bonds in the system may be performed using wavelengths that can be transmitted through tissue or within endoscopic procedures.

[0068] Temperature-induced structural transformations can be achieved within this system through the use of thermally unstable functional groups. Exemplary thermally unstable functional groups include Diels-Alder adducts and / or azo groups. For example, the Diels-Alder bond based on the furan-maleimide reaction can be formed at relatively low temperatures, in the range of approximately room temperature (about 25°C) to about 60°C. The furan-maleimide reaction can be reversed at higher temperatures, e.g., above about 90°C. The reverse cyclic addition of the furan-maleimide reaction produces a free furan moiety and a maleimide moiety. Generally, in the case of the Diels-Alder thermal transition, the increase in the mechanical properties of the auxiliary material 604 can occur in the range of about 34°C to about 60°C, such as in the range of about 34°C to about 40°C.

[0069] In some embodiments, the backbone of the shape memory polymer 624 may include diene and dienophile moieties to achieve a change in mechanical properties under a Diels-Alder reaction. The diene and dienophile moieties may be incorporated into the monomer backbone of the polymer or as pendant groups.

[0070] In some embodiments, the shape memory polymer 624 may contain a suitable diene, such as a substituted or unsubstituted alkene. In some embodiments, suitable dienes may include, but are not limited to, furan, thiophene, or pyrrole. While not intended to restrict, some exemplary dienes include, but are not limited to, substituted or unsubstituted 1,2-propadiene, isoprene, 1,3-butadiene, 2,4-octanedione, 1,5-cyclooctadiene, norbornadiene, 2-pyrrone, dicyclopentadiene, 1H-pyrrole-2-carboxylic acid, 1H-pyrrole-3-carboxylic acid, 3,5-dimethyl-1H-pyrrole-2-carboxylic acid, 1,5-dimethyl-1H-pyrrole-2-carboxylic acid, 2,4,5-trimethyl-1H-pyrrole-3-carboxylic acid, 5-phenyl-1H-pyrrole-2-carboxylic acid, 2,4-dimethyl-1H-pyrrole-3-carboxylic acid, 2,5-dimethyl-1H-pyrrole-3-carboxylic acid, 3-methyl-1H-pyrrole-2-carboxylic acid, and 5-(3,4-dimethylphenyl)-2-methyl-1H-pyrrole-3 Examples include carboxylic acids, 1-methyl-1H-pyrrole-2-carboxylic acid, 2-methyl-1H-pyrrole-3-carboxylic acid, furan-2-carboxylic acid, furan-3-carboxylic acid, 2-(furan-2-yl)acetic acid, 3-(5-methylfuran-2-yl)propanoic acid, 5-ethylfuran-2-carboxylic acid, 5-isobutyl-2-methylfuran-3-carboxylic acid, 4,5-dimethylfuran-2-carboxylic acid, thiophene-2-carboxylic acid, 4,5-dimethylthiophene-2-carboxylic acid, 3-methylthiophene-2-carboxylic acid, 5-methylthiophene-2-carboxylic acid, 5-phenylthiophene-2-carboxylic acid, 2-(thiophene-2-yl)acetic acid, thiophene-3-carboxylic acid, 2-(thiophene-3-yl)acetic acid, 5-ethylthiophene-2-carboxylic acid, and 5-methyl-4-phenylthiophene-3-carboxylic acid.

[0071] In some embodiments, the diene undergoes a Diels-Alder cycloaddition reaction with a suitable dienophile, which may include either substituted or unsubstituted alkenes or alkynes. In some embodiments, suitable dienophiles include substituted or unsubstituted maleimides, acrolein, methyl vinyl ketone, acrylic acid, methyl acrylate, acrylic acid, dimethyl maleate, dimethyl fumarate, maleic anhydride, maleonitrile, butenolide, α-methylene γ-butyrolactone, N-methyl maleimide, N-ethyl maleimide, dimethylacetylenedicarboxylate, 6-maleimidohexanoic acid, 2-butenal, 2-maleimidoacetic acid, 3-maleimidopropionic acid, 3-maleimidobenzoic acid, 3-(2,5-dioxopyrrole-1-yl)hexanoic acid, 4-maleimidobutyric acid, 4-maleimidobenzoic acid, 4-(2,5-dioxopyrrole-1-yl)hexanoic acid, 4-(2,5-dioxo-2,5-dihydropyrrole-1-yl)benzoic acid, 5-maleimopentanoic acid, 6- Maleimidohexanoic acid, 6-(3-methyl-2,5-dioxopyrrole-1-yl)hexanoic acid, 6-(2,5-dioxopyrrole-1-yl)-2-methylhexanoic acid, 6-(2,5-dioxopyrrole-1-yl)-4-methylhexanoic acid, 7-(2,5-dioxo-2,5-dihydro-1H-pyrrole-1-yl)heptanoic acid, 9-(2,5-dioxopyrrole-1-yl)nonanoic acid, 10-( Examples include, but are not limited to, 2,5-dioxopyrrole-1-yl)decanoic acid, 11-maleimidoundecanoic acid, 13-(2,5-dioxo-2,5-dihydro-1H-pyrrole-1-yl)tridecanoic acid, N-(carboxyheptyl)maleimide, N-(4-carboxy-3-hydroxyphenyl)maleimide, and α-maleimidyl-ω-carboxylpoly(ethylene glycol).

[0072] In some embodiments, the backbone of the shape memory polymer 624 may include an azo moiety to achieve a change in mechanical properties under thermal triggering. The azo moiety can be incorporated into the monomer backbone of the polymer or as a pendant group. Generally, in the case of azo thermal transition, the increase in the mechanical properties of the auxiliary material 624 may occur in the range of about 60°C to about 110°C. Alternatively, or in addition, if the azo compound contains substituted or unsubstituted aryl or heteroaryl groups within the azo molecule, the azo moiety may be cleaved under photostimulation. The photoresponsive behavior of the azo moiety in the shape memory polymer 624 can be selected based on the azo compound. For example, an azo moiety having trans-cis isomerization may be responsive to different wavelengths. For illustrative purposes, the azo moiety may experience photoresponsiveness at wavelengths in the range of about 350 nm to about 370 nm in the trans isomer, while the cis isomer may experience photoresponsiveness at wavelengths in the range of about 430 nm to about 460 nm. As those skilled in the art will understand, a shape memory polymer containing one or more azo moieties can be tuned to specific wavelengths and / or temperature triggers.

[0073] In some embodiments, the shape memory polymer 624 may contain a suitable monozo, disazo, trisazo, polyazo, or azoic moiety. The monoazo moiety can be schematically represented by the formula Zn=NW (wherein Z and W are substituted or unsubstituted aryl or heterocyclic groups). The diazo moiety contains two -N=N- groups and may be symmetric or asymmetric. The polyazo moiety is characterized by three or more repetitions of azo groups within the same molecule. Suitable azo moieties include, but are not limited to, substituted or unsubstituted triazolidinediones, poly(vinylcarbazole), 1,1'-azobis(cyclohexanecarbonile) or ACHN, 4,4'-azobis(4-cyanovaleric acid), azobenzene, 4,4-dihydroxyazobenzene, p-azobenzenearsonate, 2,2'-azobis(2-amidinopropane) dihydrochloride, 4,4'-azobis(4-cyanopentanoic acid), azobisisobutyronitrile, azodicarbonamide, azoxy compounds, para-azoxyanisole, azoxybenzene, balsalazide, 3-hydroxy-4-[(2-hydroxy-5-methylphenyl)azo]-1-naphthalenesulfonic acid ("calmagite"), azodicarboxylate diethyl, and diimide. , diisopropyl azodicarboxylate, 4,4'-dinitro-3,3'-diazenofloxane, 1,3-diphenyltriazene, disodium 4,4'-dinitrostilbene-2,2'-disulfonate, phazadinium bromide, 4H-124-triazol-345-triamine having 5,5'-(1,2-diazendiyl)bis[2H-tetrazole] ("G2ZT"), glycoazo dyes, methylazoxymethanol, methylazoxymethanol acetate, olsalazine (also known by the trade name "Dipentum"), phenazopyridine, 3-phenylazoacetylacetone, 7,18-bis(4-phenyldiazenylphenyl)-7,18-diazaheptacyclo[14.6.2.22,5.03,12.04,9.013,23.[020,24]Hexacosa-1(23),2,4,9,11,13,15,20(24),21,25--Decaene-6,8,17,19-Tetron ("Red Pigment No. 178"), Potassium azodicarboxylate, 4-[(E)-{4-Formyl-5-hydroxy-6-methyl-3-[(phosphonooxy)methyl]pyridine-2-yl}diazenyl]benzene-1,3-disulfonic acid ("PPADS"), 6-methyl-2-(phenylazo) Examples include -3-pyridinol ("SIB-1757"), 4-phenyldiazenylphenol ("Solvent Yellow No. 7"), sulfasalazine, tetramethylazodicarboxamide, 3-hydroxy-4-[(2-arsonophenyl)diazenyl]naphthalene-2,7-disulfonate disodium ("Torin"), and 1,3,5-tri(p-glycosyloxyphenylazo)-2,4,6-trihydroxybenzene ("Yarib Reagent").

[0074] In some embodiments, the backbone of the shape memory polymer 624 may include a styrylpyrene moiety to achieve a change in mechanical properties under photostimulation. The styrylpyrene moiety can be incorporated into the monomer backbone of the polymer or as a pendant group. The photoresponsive behavior of the styrylpyrene moiety within the shape memory polymer 624 can be selected to tune the wavelength of light required to initiate a change in mechanical properties. For example, a shape memory polymer 624 having a styrylpyrene moiety may be configured to undergo a reversible transition of mechanical properties when exposed to light with wavelengths in the range of about 310 nm to about 450 nm.

[0075] In some embodiments, the shape memory polymer 624 may contain a suitable styrylpyrene moiety. Suitable styrylpyrene moieties include, but are not limited to, substituted or unsubstituted 1-styrylpyrene, phenanthrasene, 3,4-benzopyrene, 1,2:5,6-dibenzoanthracene, 1,2-benzoanthracene, 7,12-dimethylbenzanthracene ("DMBA"), 1-[(1R,2S,4R)-5,6-dimethyl-2-bicyclo[2.2.1]heptanyl]pyrene, 1-(2-phenylethenyl)acenaphthylene, 2-(2-phenylethyl)dibenzofuran, 3-(2-phenylsulfanylethyl)-2-thia-3-azatricyclo[6.3 Examples include [1.04,12] dodeca-1(11),4,6,8(12),9-pentaene, 1-(2-phenylethenyl)phenanthrene, 4-(2-phenylethenyl)pyrene, 2-(pyridine-2-ylmethoxy)-1,10-phenanthrolin, 1-(3-phenylpropyl)imidazo[2,1-b][1,3]benzothiazole, tri-methyl-(4-pyrene-1-ylphenyl)silane, 1-methyl-2-methylidene-6-(1-methylnaphthalene-2-yl)-3-propa-2-enyl-3,3a-dihydro-1H-acenaphthylene.

[0076] In some embodiments, the backbone of the shape memory polymer 624 may include an ortho-nitrobenzyl moiety to achieve a change in mechanical properties under photostimulation. The ortho-nitrobenzyl moiety can be incorporated into the monomer backbone of the polymer or as a pendant group. Generally, the shape memory polymer 624 having an ortho-nitrobenzyl moiety is configured to undergo a reversible transition when exposed to light with wavelengths in the range of about 310 nm to about 440 nm.

[0077] In some embodiments, the shape memory polymer 624 may contain a suitable ortho-nitrobenzyl moiety. Suitable ortho-nitrobenzyl moieties include, but are not limited to, substituted or unsubstituted [4-[(2-nitro-phenyl)methyl]phenyl]methanediol, 1-(4,5-dimethoxy-2-nitro-phenyl)-buto-3-en-1-ol, 4-((1-(4,5-dimethoxy-2-nitro-phenyl)buto-3-en-1-yl)oxy)-4-oxobutyric acid, 3-((2-acryloyloxymethyl-2-hydro Xy-methyl)propionyloxy)methyl-2-nitrobenzyl, 4-cyano-4-(phenylcarbonothioylthio)pentanoate ("ANCP"), 2-nitrobenzylcyclohexylcarbamate, 2-[(2-nitrobenzyl)oxy]-1H-isoindole-1,3(2H)-dione, 2-[(2-nitro-phenyl)methylthio]-1,3-benzoxazole, 2-(2-methyl-5-nitroim Dazole-1-yl)ethylthiophene-2-carboxylate, (E)-3-(2-chlorophenyl)-N-cyclopentyl-2-propenamide, (2E)-N-(5-chloropyridine-2-yl)-3-(2-methoxyphenyl)acrylamide, N-[(2-nitrophenyl)methylideneamino]thiophene-2-carboxamide, N-cyclohexyl-3-(2-methoxyphenyl)propane-2-enamide (2E)-N-cycloheptyl-3-(2-nitrophenyl)propaneamide, 2-(2-nitrophenyl)-N-(thiophen-2-ylmethyl)acetamide, N-(3,5-dichloro-4-methylpyridine-2-yl)-2-(1-oxidepyridine-1-ium-2-yl)sulfanylacetamide, 1-(2-nitrophenyl)-3-phenyl-2-thiourea, N-bicyclo[2.2.1]Hepto-2-yl-2-(2-nitrophenyl)acetamide, 2-[2-(2-chloroanilino)-2-oxoethyl]sulfanylbenzoic acid, N-(2,5-dimethylphenyl)-3-methyl-1-oxo-3,4-dihydro-1H-isochromen-3-carboxamide, [(2-nitrophenyl)amino]-N-(1,3,4-thiadiazol-2-yl)carboxamide, 2-cyano- N-(2-methylcyclohexyl)-3-(5-methylthiophen-2-yl)prop-2-enamide, (E)-2-cyano-N-(2-methylcyclohexyl)-3-(3-methylthiophen-2-yl)prop-2-enamide, (E)-1-(2-nitrophenyl)-N-phenylmethoxymethanymine, N-(2-nitrophenyl)-N'-pyridine-2-ylurea, 2-(2,4-di Examples include methyl-6-nitrophenoxy)-N-(5-methyl-1,2-oxazole-3-yl)propanamide, 2-(2-nitrophenoxy)-1-(2-phenylpyrrolidine-1-yl)ethanone, 4-chloro-1-[2-(4-methoxyphenoxy)ethylsulfanyl]-2-nitrobenzene, 2-[2-oxo-2-(thiophen-2-ylmethylamino)ethyl]sulfanylbenzoic acid, 1-(2-nitrophenyl)-N-phenylmethoxymethanimine, N-(2-chloropyridine-3-yl)-2-[(2-nitrothien-3-yl)thio]acetamide, 2-(2-nitrothiophen-3-yl)sulfanyl-1-pyrrolidine-1-ylethanone, and (2-nitrophenyl)methyl N-[1-(2-hydroxyethoxy)-5-methylhexane-3-yl]carbamate.

[0078] In some embodiments, the backbone of the shape memory polymer 624 may be a coumarin moiety in order to achieve a change in mechanical properties. The coumarin moiety can be incorporated into the monomer backbone of the polymer or as a pendant group. When irradiated with specific wavelengths in the UV region, the coumarin moiety undergoes a reversible [2πs + 2πs] cycloaddition reaction, which is applied to impart inherent healing, shape memory, and reversible properties to the polymer. During light irradiation, four different types of coumarin dimers are formed: anti-head-to-head, anti-head-to-tail, thin-head-to-head, and thin-head-to-tail.

[0079] In some embodiments, the shape memory polymer 624 may contain suitable coumarin or coumarin derivative moieties, including dihydrofuranocoumarin, furanocoumarin, pyranocoumarin, phenylcoumarin, and bicoumarin. Suitable coumarin and / or coumarin derivative moieties may include, but are not limited to, substituted or unsubstituted 2H-1-benzopyran-2-one ("coumarin"), 2-(dimethylamino)ethyl methacrylate (DMAEMA), 7-(2-methacryloyloxyethoxy)-4-methylcoumarin (CMA), poly(DMAEMA-co-CMA), dimethylaminoethyl acrylate (DMAEA), 6-iodo-2H-chromen-2-one, 4-hydroxycoumarin, 3-hydroxycoumarin, 6-methoxycoumarin, and 4-trimethylsiloxycoumarin. In some embodiments, the shape memory polymer 624 may be functionalized with coumarinyl terminal groups so that a single polymer strand can undergo photodimerization.

[0080] In some embodiments, the backbone of the shape memory polymer 624 may be anthracene moieties in order to achieve changes in mechanical properties. The anthracene moieties can be incorporated into the monomer backbone of the polymer or as pendant groups. Generally, anthracene groups undergo [4+4] photodimerization when irradiated with UV light (λ>300nm) and can be reversed back to the original monomer by exposure to higher energy UV light (λ<300nm).

[0081] In some embodiments, the shape memory polymer 624 may contain a suitable anthracene or anthracene derivative moiety. Suitable anthracene and / or anthracene derivative moieties include, but are not limited to, substituted or unsubstituted benzo[a]pyrene, phenothiazine, anthranol, dibenzothiophene 5-oxide, 1,4,5-trimethylnaphthalene, 4-methyldibenzothiophene, pyrene, 10-methylacridine-9(10H)-one, γ-fagarine, 9-hydroxymethyl-10-methylanthracene, 2-dodecylphenanthrene, phenanthrene, 2-dodecyl-9,10-dihydro-2-octyltriphenylene, 8a-methyl-3,5-dimethylidene-3a,4,4a, Examples include 6,7,8,9,9a-octahydrobenzo[f][1]benzofuran-2-one, furanoeremophyllan, 4-[(E)-2-(1-naphthyl)vinyl]biphenyl, 1,7-diazatriacyclo[7.3.0.03,7]dodeca-3,5,9,11-tetraen-2,8-dione ("pyrocol"), (3R,4aR,8aR)-5,8a-dimethyl-3-propen-2-yl-2,3,4,4a,7,8-hexahydro-1H-naphthalene ("α-selinene"), 3,4-dihydro-2H-pyrimido[1,2-b][1,2]benzothiazole, etc. In some embodiments, the shape memory polymer 624 may be functionalized with anthracene-terminated groups so that a single polymer strand can undergo photodimerization.

[0082] In some embodiments, the backbone of the shape memory polymer 624 may include disulfide moieties to achieve changes in mechanical properties. The disulfide moieties are functional groups having the formula RSS-R' (wherein R and R' are either the same group or different groups). The disulfide moieties can be incorporated into the monomer backbone of the polymer or as pendant groups.

[0083] Generally, disulfide moieties can be redox responsive. Redox-active disulfide bonds are reversible and respond to changes in the redox potential of the surrounding environment. The formation or reduction of these disulfide bonds plays a role in increasing the mechanical properties of the shape memory polymer 624 after firing and delivery. The disulfide moieties may be intramolecular (oxidoreductase, allosteric disulfide, etc.) or mixed disulfides between cysteine ​​residues and small thiol molecules, resulting in glutathione and cysteine ​​adducts.

[0084] In some embodiments, the shape memory polymer 624 may contain, but is not limited to, a suitable disulfide moiety comprising a substituted or unsubstituted diamine with a disulfide group, a thiol with a disulfide group, or an initialize with a disulfide group. Suitable disulfide moieties may include, but are not limited to, substituted or unsubstituted thioredoxine disulfide and 2-(2'-bromoisobutyryloxy)ethyl-2''-methacryloyloxyethyl disulfide.

[0085] In some embodiments, the backbone of the shape memory polymer 624 may be a diselenide moiety in order to achieve a change in mechanical properties. The diselenide moiety can be incorporated into the monomer backbone of the polymer or as a pendant group.

[0086] In general, the diselenide moiety can be redox responsive. The selenolate-diselenide equilibrium is the same as that of their sulfur-containing counterpart, the thiolate-diselenide equilibrium, and involves the reversible formation of diselenide from selenolate via two-electron oxidation of the selenolate group.

[0087] In some embodiments, the shape memory polymer 624 may contain, but is not limited to, a suitable diserenide moiety, including substituted or unsubstituted selenols, diserenides, selenides, selenoxides, selenoketones, selenones, selenic acid, or selenic acid. Suitable diserenide moieties include, but are not limited to, substituted or unsubstituted diserenocarbonates such as selenocysteamine, selenocystine, selenocystine, glutathione, oxidized glutathione, and selenocystamine.

[0088] In some embodiments, in order to achieve changes in mechanical properties, the backbone of the shape memory polymer 624 may be at least one of diene and dienophile moieties, styrylpyrene moieties, azo moieties, ortho-nitrobenzyl moieties, coumarin moieties, anthracene moieties, disulfide moieties, diselenide moieties, or combinations thereof.

[0089] In general, these molecular changes, mediated by bond formation and fracture, can be tuned to allow macroscopic geometric changes in the shape memory polymer 624. The deformation of the shape memory polymer 624 can be thermal, light, oxidation-reduction, or mechanically responsive.

[0090] In some embodiments, the functional groups along the shape memory polymer 624 are more highly concentrated along a portion of the auxiliary material 604 so as to form a compressive strength gradient along a portion of the porous body 634. Generally, the auxiliary material 604 may have a compressive strength of about 30 kPa to about 70 kPa, such as about 30 kPa to about 60 kPa (e.g., about 42 kPa), about 30 kPa to about 50 kPa, and about 32.5 kPa to about 37.5 kPa. In some embodiments, the auxiliary material 604 may have a compressive strength of about 15 to about 50 kPa in a second zone during delivery, after delivery through the trocar, but before staple firing, and a compressive strength of about 30 kPa to about 70 kPa. To test the compressive strength, the auxiliary material 604 was placed in a humid, warm environment at approximately 37°C, compressed to a first height, then compressed to a second height lower than the first height, and then released back to the first height when the compressive strength of the auxiliary material was measured.

[0091] In any of the embodiments described herein, the auxiliary material 604 may be configured to reversibly transition between a substantially linear polymer and a substantially nonlinear polymer within about 0.01 seconds to about 15 minutes, so that the swelling of the shape memory polymer 624 occurs between the time of deployment through the trocar and the firing of the staples, including various surgical procedure time delays. In some cases, the stimulus can cause the reversible transition to occur much faster, so that the shape memory polymer 624 reaches substantial swelling and compressive strength within a few seconds after being delivered through the trocar (e.g., within about 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 10 seconds, 15 seconds, 20 seconds, 30 seconds, and any time in between). In other embodiments, the shape memory polymer 624 may be configured to reach substantial swelling and compressive strength within a delayed period after exposure to the stimulus (e.g., after about 30 seconds, 45 seconds, 1 minute, 2 minutes, and any time in between).

[0092] In some embodiments, the auxiliary material 604 may have lower compressive strength during delivery, and its compressive strength or other mechanical properties may increase only after exposure to stimuli following unfolding. Alternatively, the auxiliary material 604 may be compressed to a thin thickness, which has high compressive strength but a better margin for delivery through the trocar.

[0093] In some embodiments, the auxiliary material 604 may have a tensile strength of about 30 kPa to about 90 kPa during delivery, such as about 45 kPa to about 85 kPa or about 55 kPa to about 75 kPa. After delivery, the auxiliary material 604 may increase its tensile strength from about 30 to about 45 kPa, or from about 45 kPa to about 65 kPa, or from about 55 kPa to about 75 kPa after exposure to the stimulus. In some embodiments, the auxiliary material 604 has a tensile strength of about 110 kPa to about 150 kPa during delivery, which may increase to a range of about 140 kPa to about 220 kPa after exposure to the stimulus.

[0094] Figures 10A and 10B show a top and side view of the auxiliary material 604 after the staple 300 has been fired and the tissue T has been cut. As shown in the figures, the auxiliary material 604 may be split into two after firing. When the auxiliary material 604 comes into contact with the tissue T, ridges 604e, 604f may be formed corresponding to variations in the texture and thickness of the tissue. This means that the auxiliary material 604 can adapt to different heights and compressions depending on the application.

[0095] Figure 11 is a flowchart of a method 1100 for forming a surgical adjuvant 604 comprising a bioabsorbable material that itself contains a shape memory polymer. The techniques for modifying the mechanical properties described herein may provide the additional benefit of increasing the strength and durability of the adjuvant when the adjuvant is delivered to a tissue site, in combination with positive in vivo interactions (e.g., biocompatibility, wound healing, tissue integration, chemotherapy, anti-inflammatory, bone growth and integration, ligament and tendon repair, etc.). Thus, the techniques described herein may enable the bioabsorbable material itself to assist in the healing process of the surrounding tissue. Furthermore, the implantation techniques described herein may provide the additional benefit of preventing fibrous encapsulation of the foam cushion and / or providing a tunable release profile of various medical additives delivered to the tissue site.

[0096] Specifically, with respect to Figure 11, Method 1100 used to form a bioabsorbable material (e.g., a foam) having a shape memory polymer may include a step (step 1102) of adding a functional group to a polyurethane polymer that can be reversibly crosslinked when exposed to a stimulus. The functional group may be at least one of diene and dienophile moieties, styrylpyrene moieties, azo moieties, ortho-nitrobenzyl moieties, coumarin moieties, anthracene moieties, disulfide moieties, diselenide moieties, or a combination thereof. Method 1100 may then include chemically bonding the polyurethane polymer and the functional group to form a shape memory polymer (step 1104). In some embodiments, the bioabsorbable material may include polyurethane, or it may include polyether urethane, polyester urethane, polyester urea, polyester, polycarbonate, polyorthoester, polyanhydride, polyesteramide, polyphosphazene, polyphosphoester, polysaccharide, and / or polyoxaester. Method 1100 also includes exposing the shape memory polymer to a stimulus including at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH (step 1106). After exposure to the stimulus, Method 1100 includes increasing the height of the shape memory polymer to a value greater than the delivery height (step 1108). Method 1100 may be terminated after step 1108, or optionally include adding a medical additive to the porous body. In such examples, the medical additive may include an agent for treating pain and / or for promoting wound healing, tissue growth, infection reduction, etc.

[0097] As those skilled in the art will understand, the embodiments described above are by illustrative reference only, and the present invention is not limited to those specifically illustrated and described herein. Rather, the scope of the present invention includes both combinations and partial combinations thereof of the various features described herein, as well as variations and modifications thereof not disclosed in the prior art, which will be conceivable to those skilled in the art by reading the above description.

[0098] In some embodiments, the disclosed devices (e.g., end effectors, surgical aids, and / or staple cartridges), and methods involving one or more of the disclosed devices, may include one or more of the following provisions:

[0099] Clause 1: A bioabsorbable material configured to be delivered to a tissue, the material comprising a shape memory polymer configured to be compressible in a delivery configuration and to swell within a given period of time, wherein the shape memory polymer comprises one or more functional groups for reversibly bonding between adjacent functional groups such that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer.

[0100] Clause 2: The bioabsorbable material according to Clause 1, wherein the shape memory polymer transitions from a delivery form to a swollen form when exposed to a temperature in the range of approximately 34°C to approximately 40°C.

[0101] Clause 3: The bioabsorbable material as described in Clause 1, wherein the stimulus includes at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH.

[0102] Clause 4: A shape memory polymer is a bioabsorbable material as described in Clause 1, comprising a reaction product of a polyol and an isocyanate.

[0103] Clause 5: The bioabsorbable material according to Clause 1, wherein the functional group comprises a diene moiety and a dienophile moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature in the range of approximately 34°C to approximately 40°C.

[0104] Clause 6: The bioabsorbable material according to Clause 1, wherein the functional group comprises a styrylpyrene moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with wavelengths in the range of approximately 310 nm to approximately 450 nm.

[0105] Clause 7: The bioabsorbable material according to Clause 1, wherein the functional group comprises an azo moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to temperatures above approximately 60°C.

[0106] Clause 8: The bioabsorbable material according to Clause 1, wherein the functional group comprises an ortho-nitrobenzyl moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with wavelengths in the range of approximately 310 nm to approximately 440 nm.

[0107] Clause 9: The bioabsorbable material according to Clause 1, wherein the functional group comprises a coumarin moiety, the shape memory polymer is configured to reversibly transition to a first compressive strength when exposed to light with wavelengths in the range of approximately 200 nm to approximately 260 nm, and the shape memory polymer is configured to reversibly transition to a second compressive strength when exposed to light with wavelengths in the range of approximately 350 nm to approximately 560 nm.

[0108] Clause 10: The bioabsorbable material according to Clause 1, wherein the functional group comprises an anthracene moiety, and the shape memory polymer is configured to reversibly transition to a nearly nonlinear configuration when exposed to light with a wavelength greater than approximately 300 nm, and to a nearly linear configuration when exposed to light with a wavelength less than approximately 300 nm.

[0109] Clause 11: The bioabsorbable material according to Clause 5, wherein the functional group comprises at least one of a disulfide moiety and a diselenide moiety, and the shape memory polymer is configured to undergo a reversible transition upon exposure to at least one of a change in temperature, a change in pH, a reactive oxygen species, or a combination thereof.

[0110] Clause 12: The specified period is in the range of approximately 0.01 seconds to approximately 120 seconds, the bioabsorbable material as described in Clause 1.

[0111] Clause 13: The bioabsorbable material as described in Clause 2, having a compressive strength of approximately 50 kPa to approximately 90 kPa in the delivery configuration and a compressive strength of approximately 30 kPa to approximately 70 kPa in the swelling configuration.

[0112] Clause 14: The bioabsorbable material according to Clause 1, which decomposes according to a decomposition profile in response to exposure to a fluid containing at least one of a predetermined temperature, an enzyme-catalyst, and a predetermined pH.

[0113] Clause 15: The bioabsorbable material according to Clause 1, further comprising one or more medical additives configured to remain chemically bonded to the shape memory polymer.

[0114] Clause 16: A bioabsorbable material as described in Clause 15, further comprising one or more medical additives that are released into or approach tissue.

[0115] Clause 17: A bioabsorbable material configured to be delivered to a tissue, the material comprising a shape memory polymer configured to be compressible in a delivery configuration and to swell within a predetermined period of time upon exposure to a stimulus, wherein the shape memory polymer comprises a polyurethane backbone and one or more functional groups for reversible bonding between adjacent functional groups to transition from a substantially linear polymer to a substantially nonlinear polymer.

[0116] Clause 18: The bioabsorbable material as described in Clause 17, wherein the stimulus includes at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH.

[0117] Clause 19: The specified period is in the range of approximately 0.01 seconds to approximately 120 seconds, the bioabsorbable material as described in Clause 1.

[0118] Clause 20: The bioabsorbable material according to Clause 17, wherein one or more functional groups comprise at least one of the following: diene and dienophile moieties, styrylpyrene moieties, azo moieties, ortho-nitrobenzyl moieties, coumarin moieties, anthracene moieties, disulfide moieties, diselenide moieties, or combinations thereof.

[0119] Clause 21: A method for forming a bioabsorbable material configured to be placed in the human body, comprising the steps of: adding a functional group to a polyurethane polymer, the functional group comprising at least one of a diene and dienophile moiety, a styrylpyrene moiety, an azo moiety, an ortho-nitrobenzyl moiety, a coumarin moiety, anthracene moiety, a disulfide moiety, a diselenide moiety, or a combination thereof; and chemically bonding the polyurethane polymer and the functional group to form a shape memory polymer.

[0120] Clause 22: The method according to Clause 21, further comprising the step of exposing a shape memory polymer to a stimulus comprising at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH.

[0121] Clause 23: The method according to Clause 22, wherein the shape memory polymer is configured to reversibly transition between a substantially linear polymer and a substantially nonlinear polymer.

[0122] Clause 24: The shape memory polymer is compressible in the delivery form, as described in Clause 22.

[0123] Clause 25: The method according to Clause 21, wherein the bioabsorbable material, when in a delivery configuration, has a delivery height in the range of about 0.01 mm to about 1 mm.

[0124] Clause 26: The method according to Clause 25, further comprising the step of increasing the height of the shape memory polymer to a greater extent than the delivery height.

[0125] Clause 27: The method according to Clause 21, further comprising the step of exposing a bioabsorbable material to a fluid comprising at least one of a predetermined temperature, an enzyme catalyst, and a predetermined pH, such that the bioabsorbable material decomposes according to a decomposition profile.

[0126] Clause 28: A bioabsorbable material configured to be delivered to a tissue, the material comprising a shape memory polymer configured to be compressible in a delivery configuration and to swell within a given period of time, wherein the shape memory polymer comprises one or more functional groups for reversibly bonding between adjacent functional groups such that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer.

[0127] Clause 29: The shape memory polymer is the material described in Clause 28, which transitions from a delivery configuration to a swollen configuration when exposed to temperatures in the range of approximately 34°C to approximately 40°C.

[0128] Clause 30: The material described in Clause 28 or 29, wherein the stimulus includes at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH.

[0129] Clause 31: A shape memory polymer is a material according to any one of Clauses 28 to 30, comprising a reaction product of a polyol and an isocyanate.

[0130] Clause 32: The material according to any one of Clauses 28 to 31, wherein the functional group comprises a diene moiety and a dienophile moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature in the range of about 34°C to about 40°C.

[0131] Clause 33: The material according to any one of Clauses 28 to 31, wherein the functional group comprises a styrylpyrene moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with wavelengths in the range of approximately 310 nm to approximately 450 nm.

[0132] Clause 34: The material according to any one of Clauses 28 to 31, wherein the functional group comprises an azo moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature above approximately 60°C.

[0133] Clause 35: The material according to any one of Clauses 28 to 31, wherein the functional group comprises an ortho-nitrobenzyl moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with wavelengths in the range of about 310 nm to about 440 nm.

[0134] Clause 36: The material according to any one of Clauses 28 to 31, wherein the functional group comprises a coumarin moiety, the shape memory polymer is configured to reversibly transition to a first compressive strength when exposed to light with wavelengths in the range of about 200 nm to about 260 nm, and the shape memory polymer is configured to reversibly transition to a second compressive strength when exposed to light with wavelengths in the range of about 350 nm to about 560 nm.

[0135] Clause 37: The material according to any one of Clauses 28 to 31, wherein the functional group comprises an anthracene moiety, and the shape memory polymer is configured to reversibly transition to a nearly nonlinear configuration when exposed to light with a wavelength greater than approximately 300 nm, and to a nearly linear configuration when exposed to light with a wavelength less than approximately 300 nm.

[0136] Clause 38: The material according to any one of Clauses 28 to 31, wherein the functional group comprises at least one of a disulfide moiety and a diselenide moiety, and the shape memory polymer is configured to undergo a reversible transition upon exposure to at least one of a change in temperature, a change in pH, a reactive oxygen species, or a combination thereof.

[0137] Clause 39: The specified period is in the range of approximately 0.028 seconds to approximately 120 seconds, and the material is as described in any one of Clauses 28 to 38.

[0138] Clause 40: The bioabsorbable material is the material according to Clause 28 or 29, having a compressive strength of about 50 kPa to about 90 kPa in the delivery configuration and a compressive strength of about 30 kPa to about 70 kPa in the swelling configuration.

[0139] Clause 41: A bioabsorbable material as described in any one of Clauses 28 to 40, which decomposes according to a decomposition profile in response to exposure to a fluid containing at least one of a given temperature, an enzyme-catalyst, and a given pH.

[0140] Clause 42: The material according to any one of Clauses 28 to 41, further comprising one or more medical additives configured to remain chemically bonded to a shape memory polymer, wherein one or more medical additives are further configured to be released into or approach tissue.

[0141] [Implementation Method] (1) A bioabsorbable material configured to be delivered to tissue, wherein the material is The delivery configuration includes a shape memory polymer that is compressible and configured to swell within a predetermined period of time. The shape-memory polymer is a material comprising one or more functional groups for reversible bonding between adjacent functional groups such that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer. (2) The material according to Embodiment 1, wherein the shape memory polymer transitions from a delivery configuration to a swollen configuration when exposed to a temperature in the range of about 34°C to about 40°C. (3) The material according to Embodiment 1 or 2, wherein the stimulus comprises at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH. (4) The shape memory polymer is the material according to any one of Embodiments 1 to 3, comprising a reaction product of a polyol and an isocyanate. (5) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises a diene moiety and a dienophile moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature in the range of about 34°C to about 40°C.

[0142] (6) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises a styrylpyrene moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with a wavelength in the range of about 310 nm to about 450 nm. (7) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises an azo moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature above about 60°C. (8) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises an ortho-nitrobenzyl moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with a wavelength in the range of about 310 nm to about 440 nm. (9) The functional group includes a coumarin moiety, The shape memory polymer is configured to reversibly transition to a first compressive strength (lower / reduced) when exposed to light with a wavelength in the range of approximately 200 nm to approximately 260 nm. The material according to any one of Embodiments 1 to 4, wherein the shape memory polymer is configured to reversibly transition to a second (higher / increased) compressive strength when exposed to light with a wavelength in the range of approximately 350 nm to approximately 560 nm. (10) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises an anthracene moiety, and the shape memory polymer is configured to reversibly transition to the substantially nonlinear configuration when exposed to light with a wavelength greater than about 300 nm, and to transition to the substantially linear configuration when exposed to light with a wavelength less than about 300 nm.

[0143] (11) The material according to any one of Embodiments 1 to 4, wherein the functional group comprises at least one of a disulfide moiety and a diselenide moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to at least one of a change in temperature, a change in pH, a reactive oxygen species, or a combination thereof. (12) The material according to any one of embodiments 1 to 11, wherein the predetermined period is in the range of about 0.01 seconds to about 120 seconds. (13) The material according to Embodiment 1 or 2, wherein the bioabsorbable material has a compressive strength of about 50 kPa to about 90 kPa in the delivery configuration and a compressive strength of about 30 kPa to about 70 kPa in the swelling configuration. (14) The material according to any one of embodiments 1 to 13, wherein the bioabsorbable material decomposes according to a decomposition profile in response to exposure to a fluid containing at least one of a predetermined temperature, an enzyme-catalyst, and a predetermined pH. (15) The material according to any one of embodiments 1 to 14, further comprising one or more medical additives configured to remain chemically bonded to the shape memory polymer, wherein the one or more medical additives are further configured to be released into or approach the tissue.

Claims

1. A bioabsorbable material configured to be delivered to tissue, wherein the material is The delivery configuration includes a shape memory polymer that is compressible and configured to swell within a predetermined period of time. The shape-memory polymer is a material comprising one or more functional groups for reversible bonding between adjacent functional groups such that, upon exposure to a stimulus, it transitions between a substantially linear polymer and a substantially nonlinear polymer.

2. The material according to claim 1, wherein the shape memory polymer transitions from a delivery configuration to a swollen configuration when exposed to a temperature in the range of about 34°C to about 40°C.

3. The material according to claim 1 or 2, wherein the stimulus comprises at least one of heat, light, water, electricity, magnetism, electromagnetics, ultrasound, and pH.

4. The material according to claim 1, wherein the shape memory polymer comprises a reaction product of a polyol and an isocyanate.

5. The material according to claim 1, wherein the functional group comprises a diene moiety and a dienophile moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature in the range of about 34°C to about 40°C.

6. The material according to claim 1, wherein the functional group comprises a styrylpyrene moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with a wavelength in the range of about 310 nm to about 450 nm.

7. The material according to claim 1, wherein the functional group includes an azo moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to a temperature exceeding approximately 60°C.

8. The material according to claim 1, wherein the functional group comprises an ortho-nitrobenzyl moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to light with a wavelength in the range of about 310 nm to about 440 nm.

9. The aforementioned functional group includes a coumarin moiety. The shape memory polymer is configured to reversibly transition to a first compressive strength (lower / reduced) when exposed to light with a wavelength in the range of approximately 200 nm to approximately 260 nm. The material according to claim 1, wherein the shape memory polymer is configured to reversibly transition to a second (higher / increased) compressive strength when exposed to light with a wavelength in the range of about 350 nm to about 560 nm.

10. The material according to claim 1, wherein the functional group includes an anthracene moiety, and the shape memory polymer is configured to reversibly transition to the substantially nonlinear configuration when exposed to light with a wavelength greater than about 300 nm, and to transition to the substantially linear configuration when exposed to light with a wavelength less than about 300 nm.

11. The material according to claim 1, wherein the functional group comprises at least one of a disulfide moiety and a diselenide moiety, and the shape memory polymer is configured to undergo a reversible transition when exposed to at least one of a change in temperature, a change in pH, a reactive oxygen species, or a combination thereof.

12. The material according to claim 1, wherein the predetermined period is in the range of approximately 0.01 seconds to approximately 120 seconds.

13. The bioabsorbable material according to claim 1 or 2, wherein the bioabsorbable material has a compressive strength of about 50 kPa to about 90 kPa in the delivery configuration and a compressive strength of about 30 kPa to about 70 kPa in the swelling configuration.

14. The material according to claim 1, wherein the bioabsorbable material decomposes according to a decomposition profile in response to exposure to a fluid containing at least one of a predetermined temperature, an enzyme-catalyst, and a predetermined pH.

15. The material according to claim 1, further comprising one or more medical additives configured to remain chemically bonded to the shape memory polymer, wherein the one or more medical additives are further configured to be released into or approach the tissue.

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