Tissue repair fabric

• US 5,733,337 A
• Filed: 04/07/1995
• Issued: 03/31/1998
• Est. Priority Date: 04/07/1995
• Status: Expired due to Term

• Current Assignee: Organogenesis Inc. (Organogenesis Holdings, Inc.)
• Original Assignee: Organogenesis Inc. (Organogenesis Holdings, Inc.)
• Inventors: Termin, Paul L., Carr, Robert M. Jr., Condon, Kimberlie D.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/417,868
• Time in Patent Office: 1,089 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 623/8, 623/13, 623/15, 623/16, 606/194, 606/213, 606/214, 530/356
• US Class Current: 435/325
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

This invention is directed to prosthesis, which, when implanted into a mammalian patient, serve as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patient'"'"'s living cells. The prosthesis of this invention, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.

Claims

1. A prosthesis comprising two or more superimposed, bonded layers of collagenous tissue material,

(a) wherein the layers of collagenous tissue material are sourced from a mammalian source and is the tunica submucosa of the small intestine, fascia lata, dura mater, or pericardium

(b) wherein the layers are bonded together by heat welding from about 50°

C. to about 75°

C.,

(c) wherein said prosthesis is crosslinked with a crosslinking agent that permits bioremodeling, and,

(d) wherein said prosthesis is sterilized with peracetic acid, which, when implanted into a mammalian patient, the prosthesis undergoes controlled biodegradation occurring with adequate replacement by the patient'"'"'s living cells such that the implanted prosthesis is remodeled by the living cells.

2. The prosthesis of claim 1 wherein the shape of said prosthesis is flat, tubular, or complex.

3. The prosthesis of claim 1, wherein said prosthesis is crosslinked with the crosslinking agent 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride.

4. The prosthesis of claim 1, wherein sulfo-N-hydroxysuccinimide is added to the crosslinking agent.

5. The prosthesis of claim 1, wherein acetone is added to the crosslinking agent.

6. The prosthesis of claim 1, wherein said prosthesis is non-immunogenic.

7. The prosthesis of claim 1 wherein one or more surfaces of said prosthesis is coated with a collagenous dispersion or gel which acts as a smooth flow surface.

8. The prosthesis of claim 1 wherein said prosthesis further contains pores.

9. The prosthesis of claim 1 wherein said prosthesis is further composed of chopped collagen fibers.

10. The prosthesis of claim 1 wherein said prosthesis is further composed of collagen threads.

11. The prosthesis of claim 10 wherein said collagen threads are arranged to form a felt, a bundle, a weave or a braid.

12. The prosthesis of any of claims 9-11 wherein said collagen fibers or threads are partially or completely crosslinked.

13. The prosthesis of claim 1 wherein said prosthesis additionally contains an anticoagulant;

one or more antibiotics, or one or more growth factors.

15. The prosthesis of claim 1, wherein heat for said heat welding is applied between from 60°

C. to 65°

C.

16. The prosthesis of claim 15, wherein heat for said heat welding is applied at 62°

C.

17. The prosthesis of claim 1 wherein heat for said heat welding is applied between from about 7 minutes to about 24 hours.

18. The prosthesis of claim 17, wherein heat for said heat welding is applied for about one hour.

21. The prosthesis of claims 18 or 19, wherein said prosthesis contains an anticoagulant, one or more antibiotics, or one or more growth factors.

22. The prosthesis of claims 18 or 19, wherein said crosslinking agent is 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride.

23. The prosthesis of claim 18, wherein said layers are bonded at the periphery to form an inner hollow region.

14. A method of repairing or replacing a damaged tissue comprising implanting a prosthesis in a patient comprising two or more superimposed, bonded layers of collagenous tissue material

(a) wherein the layers of collagenous tissue material are sourced from a mammalian source and is the tunica submucosa of the small intestine, fascia lata, dura mater, or pericardium,

(b ) wherein the layers are bonded together by heat welding from about 50°

C. to about 75°

C.,

(c) wherein said prosthesis is crosslinked with a crosslinking agent that permits bioremodeling, and,

(d) wherein said prosthesis is sterilized with peracetic acid,

which, when implanted into a mammalian patient, the prosthesis undergoes controlled biodegradation occurring with adequate replacement by the patient'"'"'s living cells such that the implanted prosthesis is remodeled by the living cells.

19. A prosthesis comprising two or more layers of collagenous tissue,

(a) wherein the layers of collagenous tissue material are sourced from a mammalian source and is the tunica submucosa of the small intestine, fascia lata, dura mater, or pericardium,

(b) wherein the layers are formed into a flat prosthesis,

(c) wherein the layers are bonded together by heat welding from about 50°

C. to about 75°

C.,

(d) wherein said prosthesis is crosslinked with a crosslinking agent that permits bioremodeling, and,

(e) wherein said prosthesis is sterilized with peracetic acid, which when said prosthesis is implanted into a mammalian patient, undergoes controlled biodegradation with adequate replacement by the patient'"'"'s living cells such that the implanted prosthesis is remodeled by the living cells.

24. The prosthesis of claim 19, wherein the periphery of said layers are bonded to form an inner hollow region.

20. A prosthesis comprising two or more layers of collagenous tissue,

(a) wherein the layers of collagenous tissue material are sourced from a mammalian source and is the tunica submucosa of the small intestine, fascia lata, dura mater, or pericardium,

(b) wherein the layers are formed into a tubular prosthesis,

(c) wherein the layers are bonded together by heat welding from about 50°

C. to about 75°

C.,

(d) wherein said prosthesis is crosslinked with a crosslinking agent that permits bioremodeling, and,

(e) wherein said prosthesis is sterilized with peracetic acid, which when said prosthesis is implanted into a mammalian patient, undergoes controlled biodegradation with adequate replacement by the patient'"'"'s living cells such that the implanted prosthesis is remodeled by the living cells.