Composite material for tissue repair

• US 8,808,730 B2
• Filed: 11/05/2013
• Issued: 08/19/2014
• Est. Priority Date: 12/12/2006
• Status: Active Grant

• Current Assignee: Synthasome, Inc.
• Original Assignee: Synthasome, Inc.
• Inventors: Ratcliffe, Anthony
• Primary Examiner(s): DICKINSON, PAUL W
• Application Number:
  US14/072,099
• Publication Number:
  US 20140065201A1
• Time in Patent Office: 287 Days
• Field of Search: None
• US Class Current: 424/443
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2002/0894 Muscles non-implantable A61F2002/5066
• CPC Class Codes: A61K 31/77 of oxiranes
• CPC Class Codes: A61L 26/0052 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders

Abstract

The present disclosure provides a biocompatible composite and method for its use in repairing tissue defects, including defects in cartilage. The biocompatible composite includes a fibrous polymeric component and a polymerizable agent, which is capable of forming the biocompatible composite in situ at the site of a tissue defect. In embodiments, the repair site at which the biocompatible composite is to be applied may be treated with a priming agent, permitting polymerization of the polymerizable agent to the tissue located at the repair site.

Claims

1. A biocompatible composite comprising

a woven fibrous material;

a hydrogel at least partially encasing the woven fibrous material, the hydrogel formed in situ at a site of a periosteum defect, at least a portion of the hydrogel covalently bonded to periosteum; and

a morphogenic protein associated with the woven fibrous material.

2. The biocompatible composite of claim 1, wherein the woven fibrous material is made from a material selected from the group consisting of polyhydroxy acids, polyamino acids, polyamides, polyesters, polyolefins, polyacrylates, polycarbonates, polyhydroxyalkanoates, and combinations thereof.

3. The biocompatible composite of claim 1, wherein the woven fibrous material is made from a material selected from the group consisting of polylactic acid, polyglycolic acid, polycaprolactone, polydioxanone, trimethylene carbonate, hyaluronic acid, gelatin, cellulose, nitrocellulose, nylon, polyethylene terephthalate, polypropylene, polyethylene, polytetrafluoroethylene, and combinations thereof.

4. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material selected from the group consisting of polyalkylene oxides, poloxamines, celluloses, hydroxyalkylated celluloses, polypeptides, polysaccharides, carbohydrates, proteins, copolymers thereof, and combinations thereof.

5. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material selected from the group consisting of poly(ethylene glycol), poly(ethylene oxide), poly(vinyl alcohol), poly(vinylpyrrolidone), poly(ethyloxazoline), poly(ethylene oxide)-co-polypropylene oxide) block copolymers, carboxymethyl cellulose, hydroxyethyl cellulose, methylhydroxypropyl cellulose, polysucrose, hyaluronic acid, dextran, heparan sulfate, chondroitin sulfate, heparin, alginate, gelatin, collagen, albumin, ovalbumin, copolymers thereof, and combinations thereof.

6. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material possessing at least one free radical polymerizable group selected from the group consisting of acrylates, diacrylates, oligoacrylates, dimethacrylates, oligomethacrylates, and combinations thereof.

7. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material that is polymerizable when exposed to a source of ultraviolet radiation.

8. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material that is polymerizable when exposed to a chemical agent.

9. The biocompatible composite of claim 1, wherein the hydrogel is derived from a cross-linker selected from the group consisting of poly(L-lysine), polyethyleneimine, poly(vinylamine), poly(allylamine), chitosan, sulfonated polystyrene, glutaraldehyde, carbodiimide, 2,2′

t-Azobis (N,N′

dimethyleneisobutyramidine) dihydrochloride, benzoyl peroxide, and combinations thereof.

10. The biocompatible composite of claim 1, further comprising a therapeutic agent.

11. The biocompatible composite of claim 1, wherein the fibrous polymeric component is combined with the polymerizable agent prior to application to the tissue defect.

12. The biocompatible composite of claim 1, wherein the periosteum defect is primed with a priming agent prior to application of the fibrous polymeric component in combination with the polymerizable agent.

13. The biocompatible composite of claim 12, wherein the priming agent is selected from the group consisting of hydrogen peroxide, citric acid, peracetic acid, nitric acid, peroxyhalogen acids, hydroxyperoxides, and combinations thereof.

14. The biocompatible composite of claim 1, wherein the hydrogel is derived from a material that is polymerizable when exposed to an enzymatic agent.

15. The biocompatible composite of claim 14, wherein the enzymatic agent comprises a chondroitinase.

16. The biocompatible composite of claim 1, wherein the hydrogel is covalently bonded to periosteum in the absence of a priming agent.