Coated polymeric material

Abstract

To provide modified tissue products having one or more of improved resistance to surface damage, improved resistance to wear, resistance to formation of adhesions with surrounding tissues, or reduced friction when in contact with other materials.SOLUTION: A tissue composition comprises a polymeric material including polypropylene, and a crosslinked coating disposed on at least a surface of the polymeric material, the coating comprising a group of acellular tissue matrix particles, transglutaminase, and an at least partially denatured collagen including gelatin, wherein the group of acellular tissue matrix particles is contained in the denatured collagen.SELECTED DRAWING: None

Description

Technical Field

[0001] The present disclosure relates to tissue products comprising acellular tissue matrix particles, transglutaminase, and a coating of at least partially denatured collagen on a polymer material that has been treated or coated therewith.

[0002] This application claims priority to U.S. Provisional Application No. 62 / 854,740, filed on Jun. 7, 2019, under 35 U.S.C. § 119, the entire content of which is hereby incorporated by reference.

Background Art

[0003] A variety of tissue-derived products are used to regenerate, repair, or otherwise treat diseased or damaged tissues and organs. Such products can include intact tissue grafts or acellular or reconstituted acellular tissues (e.g., acellular tissue matrices derived from skin, intestine, or other tissues, with or without cell seeding). Such products can also include hybrid or composite materials, e.g., materials that include synthetic elements such as a polymer mesh substrate having a coating or cover that includes a tissue-derived material.

[0004] Accordingly, the present application provides devices and methods that provide improved tissue products having a transglutaminase coating. Those devices and methods can provide one or more of improved resistance to surface damage, improved resistance to abrasion, resistance to the formation of adhesions with surrounding tissue, or reduction of friction when in contact with other materials.

Summary of the Invention

[0005] In one embodiment, a tissue composition is provided. The tissue composition can include a polymeric material and a coating disposed on at least the surface of the polymeric material. The coating includes a group of acellular tissue matrix particles, transglutaminase, and at least partially denatured collagen. In some embodiments, the group of acellular tissue matrix particles includes acellular dermal tissue matrix particles. In some embodiments, the group of acellular tissue matrix particles includes porcine acellular tissue matrix particles. In some embodiments, the group of acellular tissue matrix particles is treated with an enzyme solution. In a further embodiment, the enzyme solution includes a proteolytic enzyme. In some embodiments, the composition is lyophilized. In some embodiments, the coating includes about 0.1% to 25% acellular tissue matrix particles. In some embodiments, the coating includes about 0.5% to 10% transglutaminase. In some embodiments, the coating includes about 0.5% to 10% gelatin. In some embodiments, the polymeric material is a synthetic polymer. In some embodiments, the polymeric material is biodegradable. In some embodiments, the polymeric material is polypropylene. In some embodiments, the at least partially denatured collagen is gelatin. In a further embodiment, the gelatin is transglutaminase-treated gelatin.

[0006] In another embodiment, a method of manufacturing a tissue composition is provided. The method can include suspending a group of acellular tissue matrix particles in a solution, mixing the solution with transglutaminase, mixing the solution with at least partially denatured collagen, and coating a polymeric material with the solution. In some embodiments, the group of acellular tissue matrix particles includes acellular dermal tissue matrix particles. In some embodiments, the group of acellular tissue matrix particles includes porcine acellular tissue matrix particles.

[0007] In some embodiments, the method further includes treating the acellular tissue matrix particles with an enzyme solution. In further embodiments, the enzyme solution contains a proteolytic enzyme.

[0008] In some embodiments, the solution contains about 0.1% to 25% acellular tissue matrix particles. In some embodiments, the solution contains about 0.5% to 10% transglutaminase. In some embodiments, the solution contains about 0.5% to 10% gelatin.

[0009] In some embodiments, coating the polymeric material includes pouring a portion of the solution into a mold, placing the polymeric material on top of the solution, and pouring the remaining solution over the polymeric material. In some embodiments, the method further includes lyophilizing the coated polymeric material. In some embodiments, the method further includes stabilizing the coated polymeric material by heat treatment under dehydration. In some embodiments, the polymeric material is a synthetic polymer. In some embodiments, the polymeric material is biodegradable. In some embodiments, the polymeric material is polypropylene. In some embodiments, at least partially denatured collagen is gelatin. In further embodiments, the gelatin is transglutaminase-treated gelatin.

[0010] Also provided is a treatment method using the device of the present disclosure.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0012] Reference will now be made in detail to certain exemplary embodiments according to the present disclosure. Specific examples thereof are shown in the accompanying drawings. To the extent possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts.

[0013] In this application, the use of the singular includes the plural unless specifically stated otherwise. In this application, the use of "or" means "and / or" unless specifically stated otherwise. Further, the term "comprising" and the use of other forms such as "comprises" and "comprised of" are not limiting. Any range recited herein is to be understood to include both end points and all values therebetween.

[0014] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. All documents or portions of documents cited in this application, including but not limited to patents, patent applications, articles, books, and papers, are hereby expressly incorporated by reference in their entirety for any purpose.

[0015] A variety of human and animal tissues can be used to manufacture products for treating patients. For example, a variety of tissue products have been manufactured for the regeneration, repair, augmentation, reinforcement, and / or treatment of human tissue damaged or lost due to various diseases and / or structural injuries (e.g., trauma, surgery, atrophy, and / or long-term wear and tear or degeneration). Such products can include, for example, acellular tissue matrices, tissue allografts or xenografts, and / or reconstituted tissues (i.e., at least partially decellularized tissues seeded with cells to provide a growth-capable material).

[0016] A variety of tissue products are manufactured for treating soft and hard tissues. For example, ALLODERM® and STRATTICE® (LIFECELL CORPORATION, Branchburg, New Jersey) are two acellular dermal tissue matrices made from human dermis and porcine dermis, respectively. Such materials are very useful for treating certain diseases, but it is desirable to modify the tissue matrix or other tissue products to change the surface mechanical properties, or to improve resistance to abrasion or damage, or to prevent the occurrence of adhesion to surrounding tissues, or to reduce friction when the tissue product is in contact with other substances such as body tissues.

[0017] The source tissue is used to create an acellular tissue matrix that is used to form a variety of formable tissue matrix products and compositions. The acellular tissue matrix can be derived from human or animal tissue matrices. Suitable tissue sources for the acellular tissue matrix can include allograft tissue, autograft tissue, or xenograft tissue. Human tissue may be obtained from cadavers. Additionally, human tissue can also be obtained from living donors (i.e., autologous tissue).

[0018] The tissue product can include a tissue matrix such as a decellularized or partially decellularized tissue matrix. Examples of tissues that can be used include, but are not limited to, skin, a part of the skin (e.g., dermis), fascia, muscle (skeletal, smooth, or cardiac muscle), adipose tissue, pericardial tissue, dura mater, umbilical cord tissue, placental tissue, heart valve tissue, ligament tissue, tendon tissue, vascular tissue (such as arterial and venous tissue), cartilage, bone, nerve connective tissue, bladder tissue, ureter tissue, and intestinal tissue. For example, some biological scaffold materials that can be used for tissue matrices are described in “Extracellular Matrix as a Biological Scaffold Material: Structure and Function” by Badylak et al., Acta Biomaterialia (2008), doi:10.1016 / j.actbio.2008.09.013.

[0019] Some examples of non-human tissue sources that can be used for xenograft tissue matrices include pigs, cows, dogs, cats, or other animals from domestic or wild sources, and / or any other suitable mammalian or non-mammalian xenograft tissue source. In some exemplary embodiments, the acellular tissue matrix may be derived from a source dermal matrix harvested from an animal such as a pig. In one exemplary embodiment, the source dermal matrix can include one or more layers of skin removed from the animal.

[0020] When a porcine or other animal source is used, the tissue can be further processed to remove antigenic components such as 1,3-α-galactose moieties that are present in pigs and other mammals but not in humans or primates. In some embodiments, for example, tissue can be obtained from animals that have been genetically modified to lack the expression of antigenic moieties such as 1,3-α-galactose. See Xu, Hui, et al., “A Porcine-Derived Acellular Dermal Scaffold that Supports Soft Tissue Regeneration: Removal of Terminal Galactose-α-(1,3)-Galactose and Retention of Matrix Structure”, Tissue Engineering, Vol. 15, 1-13 (2009). This document is hereby incorporated by reference in its entirety.

[0021] An acellular tissue matrix can provide a suitable tissue scaffold that enables cell ingrowth and tissue regeneration. In some embodiments, the starting material for forming an injectable tissue product includes an acellular dermal matrix (“ADM”). In some embodiments, the ADM is a porcine acellular dermal matrix (“pADM”). In some embodiments, the ADM is a human ADM. As described above, other sources of ADM can also be used. The starting ADM material can include substantially uncrosslinked collagen to allow infiltration of host cells including fibroblasts and vascular elements. Nevertheless, some degree of collagen crosslinking may occur upon processing the ADM.

[0022] FIG. 1 shows a flowchart of an exemplary method for manufacturing a coated polymeric material. The method begins at step 110 by processing source tissue to produce an acellular tissue matrix. The source tissue can be processed as described above. In some embodiments, the source tissue is dermal tissue. In further embodiments, the tissue is porcine dermal tissue.

[0023] Next, in step 120, the acellular tissue matrix is formed into particles. The acellular tissue matrix particles are formed by subjecting the source tissue matrix to mechanical and / or chemical processing steps. Mechanical processing generally removes unwanted tissue and changes the source tissue into smaller particles. For example, a sheet of acellular tissue matrix can be shredded into particles. Mechanical processing can include grinding, milling, freeze-drying, crushing, or other processes that break the tissue apart. In some embodiments, the acellular tissue matrix is ground with a meat chopper. The source tissue matrix can be cut after checking for adipose tissue to remove the tissue and / or to prevent entanglement of the tissue matrix pieces. The source tissue matrix can be frozen and thawed prior to mechanical processing.

[0024] In some embodiments, the tissue matrix particles are classified by size. In an exemplary embodiment, wire screens of sequentially varying sizes filter the particles into groups of particles within similar size ranges.

[0025] Next, in step 130, the acellular tissue matrix particles are treated with enzymes. Enzymes such as lipase, DNAses, RNAses, α-galactosidase, or proteolytic enzymes such as alcalase, trypsin, bromelain, papain, ficin can be used to reliably destroy nuclear material, antigens from foreign sources, residual cellular components, and / or viruses.

[0026] Various enzyme activities and treatment times can be used. For example, the enzyme can have an activity of 1×10 6 Anson units / mL to 0.015 Anson units / mL, 1×10 6 units / mL to 1.5×10 3 Anson units / mL, or about 2×10 5 Anson units / mL to about 4×10 5It can be provided in a solution with an activity of Anderson units / mL. Further, the treatment time can be varied between about 4 hours and 5 days.

[0027] Step 130 can further include a decellularization treatment. Any conventional decellularization method can be employed. In some embodiments, multiple decellularization solutions are used. In further embodiments, centrifugation and pellet resuspension steps follow each treatment with the decellularization solution.

[0028] Next, in step 140, the enzyme-treated particles are suspended in a buffer. In some embodiments, the buffer includes phosphate-buffered saline. In some embodiments, the buffer includes sodium citrate. In further embodiments, the buffer is a 10 mM solution of sodium citrate. In further embodiments, the sodium citrate solution contains 10% solids.

[0029] Next, in step 145, the suspended particles are mixed with transglutaminase and at least partially denatured collagen. The mixture of acellular tissue matrix particles, transglutaminase, and collagen may be a slurry. In some embodiments, the slurry includes concentrations of about 0.1% - 25% acellular tissue matrix particles, about 0.5% - 10% denatured collagen, and about 0.5% - 10% transglutaminase. In further embodiments, the slurry includes concentrations of about 2.5% - 5% acellular tissue matrix particles, about 1.5% - 3% denatured collagen, and about 0.5% - 1% transglutaminase.

[0030] Transglutaminase is an enzyme expressed in bacteria, plants, and animals that catalyzes the binding of the gamma-carboxamide group of a glutamine residue to the amino group of a lysine residue or another primary amino group. Transglutaminase is used in the food industry to bind protein-rich foods such as meat, yogurt, and tofu and improve their physical properties. Transglutaminase is also currently being studied for use in the medical device industry as hydrogels and sealants. See Aberle, T. et al., “Cell-type Specific Four Component Hydrogel”, PLoS ONE 9(1):e86740 (Jan. 2004).

[0031] For example, transglutaminase can be provided in solution or formed from a storage form (e.g., dry powder or other suitable storage form) into solution. The solution can contain any suitable buffer, such as phosphate buffered saline, or other biologically compatible buffer that will maintain or support enzyme activity and will not damage the enzyme or tissue product.

[0032] Furthermore, various transglutaminases can be used, including anything that is biologically compatible, can be implanted in a patient, and has sufficient activity to provide the desired catalytic result within the desired time frame. Transglutaminases are known and can include enzymes made by microorganisms, plants, animals, or recombinant techniques. Depending on the specific enzyme used, alterations such as the addition of cofactors, pH control, or temperature or other environmental condition control may be required to enable appropriate enzyme activity. Microbial transglutaminase may be effective as it may not require the presence of metal ions, but any suitable transglutaminase can be used.

[0033] As an alternative to transglutaminase, fibrin glue, in-situ polymerizable polyurethane, albumin glutaraldehyde, laccase, tyrosinase or lysyl oxidase can also be used. Additionally, non-enzymatic based cross-linking agents such as carbodiimide, bis(sulfosuccinimidyl)suberate, genipin, 1,4-butanediol diglycidyl ether can be used additionally or alternatively. Consideration of non-enzymatic based cross-linking agents as bioadhesives is described in “A review:enzymatic cross-linking of proteins applicable to foods” by MATHEIS,GUNTER and JOHN R.WHITAKER, Journal of Food Biochemistry 11.4(1987):309-327. This document is hereby incorporated by reference into this specification.

[0034] In some embodiments, at least partially denatured collagen is gelatin. In some embodiments, the gelatin is porcine gelatin. In a further embodiment, the porcine gelatin has a gel strength (Bloom number) of 300. In some embodiments, the gelatin is derived from cold-water fish.

[0035] Next, in step 150, a portion of the slurry is poured onto the bottom of the mold. The “mold” relates to any three-dimensional structure having an open area configured to receive the slurry.

[0036] The polymer material is placed on top of the slurry within the mold. The polymer material can include, for example, a mesh formed of filaments such as polypropylene. In one aspect, the polymer material can be made substantially non-absorbent or non-biodegradable. In another aspect, the polymer material can be made absorbent. The absorbent mesh can be a polymer selected from the group consisting of polyhydroxyalkanoate, polyglycolic acid, poly-L-lactic acid, polylactic acid / polyglycolic acid (PLGA), polygalactin 910, and carboxymethyl cellulose. The polymer can include poly-4-hydroxybutyrate. The polymer material can be a synthetic substrate, and the synthetic substrate can include polypropylene. After placing the polymer material, the remaining slurry is poured on top of the polymer material and the previously poured slurry. By adjusting the amount of slurry poured on top of the polymer material, the coating thickness of the resulting coated material can be controlled.

[0037] Next, in step 160, the slurry and the polymer material are cured. In some embodiments, the slurry and the polymer material cure overnight. In some embodiments, the slurry and the polymer material cure at room temperature. While the slurry and the polymer material are solidifying, transglutaminase may cause crosslinking. In some embodiments, the slurry and the polymer material are stored in an environment having a temperature in the range of 0°C to 60°C.

[0038] Next, in step 170, the slurry and the polymer material are lyophilized to form the coated polymer material. By performing lyophilization, a tissue product that is not brittle and can be stretched is obtained. Further, lyophilization increases the porosity of the tissue product.

[0039] Finally, in step 180, the coated polymeric material is stabilized by a dehydration heat treatment such as heating the material in a vacuum. In an exemplary embodiment, the dehydration heat treatment is performed by heating a cell-free tissue matrix formed in a vacuum, under reduced pressure or in a vacuum, between about 70°C to about 120°C, or between about 80°C to about 110°C, or at about 80°C, or at any temperature within the specified range. As used herein, "reduced pressure" means a pressure that is at least about 10 percent (10%) lower than the standard atmospheric pressure of 760 mmHg.

[0040] Figure 2 shows a top view and a cross-sectional view of an exemplary coated polymeric material 200. In some embodiments, the coating 210 comprises a dried and stabilized mixture of cell-free tissue matrix particles, transglutaminase, and at least partially denatured collagen. In some embodiments, the cell-free tissue matrix particles are dermal particles. In some embodiments, the cell-free tissue matrix particles are porcine particles. In some embodiments, the at least partially denatured collagen is gelatin. In some embodiments, the coating 210 has a three-dimensional structure.

[0041] The polymeric material 220 can comprise, for example, a mesh formed of filaments such as polypropylene. In one aspect, the polymeric material 220 can be substantially non-absorbent or non-biodegradable. In another aspect, the polymeric material 220 can be absorbent. The absorbent mesh can be a polymer selected from the group consisting of polyhydroxyalkanoate, polyglycolic acid, poly-L-lactic acid, polylactic acid / polyglycolic acid (PLGA), polygalactin 910, and carboxymethylcellulose. The polymer can include poly-4-hydroxybutyrate. The polymer 220 can be a synthetic substrate, and the synthetic substrate can include polypropylene.

[0042] The coated polymer material 200 may be in any form suitable for treating a tissue site. In some embodiments, the polymer material may be in the form of a sheet. Depending on the specific polymer material and the intended use of the final tissue product, other forms may also be possible.

[0043] The tissue product and its manufacturing method can be used for the treatment of various diseases. For example, the tissue product can be used in the treatment of hernias (e.g., abdominal wall hernias and inguinal hernias), tendon or ligament reinforcement, or reconstructive surgery. The tissue product can be used for any application suitable for the application of synthetic mesh or coated synthetic mesh.

[0044] Example 1 An exemplary coated polymer material as described above was tested to identify the structural properties of the material. The tested coated polymer material contained concentrations of 2.5% acellular tissue matrix, 1.5% denatured collagen, and 0.5% transglutaminase. Figure 3 shows the maximum tensile strength exhibited by the exemplary coated polymer material. The blue bars in the graph indicate the load at which the coating cracks and the polypropylene material is exposed. The orange bars indicate the load at which the coated material is completely destroyed.

[0045] Figure 4 shows an image of the tensile load test of an exemplary coated polymer material. Panel A shows the coated material at the start of the test. Panel B shows the coated material at the point when the coating is damaged. The damage occurred in the region labeled 410.

[0046] Figure 5 is a bar graph showing the bursting strength of an exemplary coated polymer material. Specifically, this graph shows the maximum compressive load of the coated material. The maximum compressive load refers to the load at which the coated material is completely broken. The compressive load at the preset point refers to the load at which the coating cracks.

[0047] Figure 6 shows images of the burst strength test of an exemplary coated polymeric material. Panel A shows the coated material at the start of the test. Panel B shows the coated material being stretched by a metal ball. Panel C shows the coated material when cracks have appeared in the coating. Panel D shows the point at which the coated material (including the polypropylene material) has completely broken.

[0048] Figure 7 provides scanning electron microscope (SEM) images of an exemplary coated polymeric material. The density and porosity of the coating around the polymeric material can be altered by changing the concentration of acellular tissue matrix particles, transglutaminase, and at least partially denatured collagen. The coated material shown in Figure 7 comprises a coating of acellular dermal tissue matrix particles, transglutaminase, and gelatin. The polymeric material is polypropylene. Panel A shows a coating with a higher density and lower porosity, containing a high concentration of acellular dermal tissue matrix particles, transglutaminase, and gelatin (5%, 1%, and 3% respectively). Panel B shows a coating with a lower density and higher porosity, containing a low concentration of acellular dermal tissue matrix particles, transglutaminase, and gelatin (2.5%, 0.5%, and 1.5% respectively).

[0049] Figure 8 includes hematoxylin and eosin stained sections of polypropylene material versus an exemplary coated polymeric material after implantation in rats. In a rat subcutaneous model, the presence of a foreign body reaction was induced by implantation of polypropylene alone, but was not present after implantation of the exemplary coated material.

[0050] Figure 9 includes hematoxylin and eosin stained sections of exemplary coated polymeric materials after implantation in rats. These sections show cell infiltration, angiogenesis, and minimal inflammation in the rat subcutaneous model. The formation of blood vessels is emphasized. The rat tissues were harvested 12 weeks after implantation.

[0051] Figure 10 is an overall image of explants of polypropylene implant materials versus exemplary coated polymeric materials after 4 weeks of implantation in a rat full-thickness abdominal wall defect model. The coating prevented visceral adhesions that occurred in the case of uncoated polypropylene materials.

[0052] Figure 11 includes hematoxylin and eosin stained sections of polypropylene materials versus exemplary coated polymeric materials after 4 weeks of implantation in a rat full-thickness abdominal wall defect model. The exemplary coated polymeric material resulted in greater tissue ingrowth compared to the uncoated polypropylene mesh (Panels A and C). The inflammation and foreign body reaction induced by the polypropylene mesh were significantly reduced after implantation of the exemplary coated material (Panels B and D).

[0053] Figure 12 shows immunofluorescent stained sections using antibodies against specific macrophage phenotype markers of polypropylene materials versus exemplary coated polymeric materials after 4 weeks of implantation in a rat full-thickness abdominal wall defect model. The uncoated polypropylene mesh mainly induced a pro-inflammatory M1 macrophage response. The exemplary coated material did not induce an M1 macrophage response around the polymeric material and instead promoted a remodeling-promoting M2 macrophage response in the surrounding tissue.

[0054] Figure 13 provides scanning electron microscope (SEM) images of exemplary coated polymeric materials having different coating thicknesses. The thickness of the coating can be controlled by adjusting the amount of slurry poured around the polymeric material.

[0055] The foregoing description and embodiments are merely exemplary and should not be construed as limiting the spirit and scope of the present invention.

Claims

1. A tissue composition comprising: a polymer material; and a coating disposed on at least the surface of the polymer material, wherein the coating comprises acellular tissue matrix particle groups, transglutaminase, and at least partially denatured collagen,

2. The composition according to claim 1, wherein the acellular tissue matrix particle groups comprise acellular dermal tissue matrix particles.

3. The composition according to claim 1, wherein the acellular tissue matrix particle groups comprise acellular tissue matrix particles of a pig.

4. The composition according to claim 1, wherein the acellular tissue matrix particle groups are treated with an enzyme solution.

5. The composition according to claim 4, wherein the enzyme solution comprises a proteolytic enzyme.

6. The composition according to claim 1, wherein the composition is freeze-dried.

7. The composition according to claim 1, wherein the coating comprises about 0.1% to 25% acellular tissue matrix particles.

8. The composition according to claim 1, wherein the coating comprises about 0.5% to 10% transglutaminase.

9. The composition according to claim 1, wherein the coating comprises about 0.5% to 10% at least partially denatured collagen.

10. The composition according to claim 1, wherein the polymer material is a synthetic polymer.

11. The composition according to claim 1, wherein the polymer material is biodegradable.

12. The composition according to claim 1, wherein the polymer material is polypropylene.

13. The composition according to claim 1, wherein the at least partially denatured collagen is gelatin.

14. The composition according to claim 13, wherein the gelatin is transglutaminase-treated gelatin.

15. A method for manufacturing a tissue composition, comprising: suspending acellular tissue matrix particle groups in a solution; Mixing the solution containing the acellular tissue matrix particles with transglutaminase; Mixing the solution containing the acellular tissue matrix particles and transglutaminase with at least partially denatured collagen; A method comprising coating a polymeric material with a solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen.

16. In the method according to claim 15, The method, characterized in that the group of acellular tissue matrix particles contains acellular dermal tissue matrix particles.

17. In the method according to claim 15, The method, characterized in that the group of acellular tissue matrix particles contains acellular tissue matrix particles of pigs.

18. In the method according to claim 15, The method further comprising treating the group of acellular tissue matrix particles with an enzyme solution.

19. In the method according to claim 18, The method, characterized in that the enzyme solution contains a proteolytic enzyme.

20. In the method according to claim 15, The method, characterized in that the solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen contains about 0.1% to 25% of acellular tissue matrix particles.

21. In the method according to claim 15, The method, characterized in that the solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen contains about 0.5% to 10% of transglutaminase.

22. In the method according to claim 15, The method, characterized in that the solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen contains about 0.5% to 10% of gelatin.

23. In the method according to claim 15, Coating the polymeric material comprises: Pouring a portion of the solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen into a mold; Placing the polymeric material on the solution containing the acellular tissue matrix particles, transglutaminase and at least partially denatured collagen; A method comprising the step of pouring the remaining solution containing the acellular tissue matrix particles, transglutaminase, and at least partially denatured collagen onto the polymer material.

24. In the method according to claim 15, further comprising the step of lyophilizing the coated polymer material.

25. In the method according to claim 15, further comprising the step of stabilizing the coated polymer material by dehydration heat treatment.

26. In the method according to claim 15, wherein the polymer material is a synthetic polymer.

27. In the method according to claim 15, wherein the polymer material is biodegradable.

28. In the method according to claim 15, wherein the polymer material is polypropylene.

29. In the method according to claim 15, wherein the at least partially denatured collagen is gelatin.

30. In the method according to claim 29, wherein the gelatin is transglutaminase-treated gelatin.

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