Method of preparation of bioabsorbable porous reinforced tissue implants and implants thereof

• US 8,895,045 B2
• Filed: 05/08/2012
• Issued: 11/25/2014
• Est. Priority Date: 03/07/2003
• Status: Active Grant

• Current Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Original Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Inventors: Jamiolkowski, Dennis D., Brown, Kelly R., Chun, Iksoo, Melican, Mora Carolynne
• Primary Examiner(s): DICKINSON, PAUL W
• Application Number:
  US13/466,448
• Publication Number:
  US 20130123937A1
• Time in Patent Office: 931 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 2430/34 for soft tissue reconstruction
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biocompatible tissue implant. The tissue implant may be bioabsorbable, consists of a biocompatible polymeric foam. The tissue implant also includes a biocompatible reinforcement member. The polymeric foam and the reinforcement member are soluble in a lyophilizing solvent. The reinforcement may be annealed and/or coated.

Claims

1. A method of manufacturing a biocompatible tissue implant, comprising:

providing a solution comprising a foam forming, biocompatible polymer in a lyophilizing solvent, said solvent having a freezing point;

providing a biocompatible polymeric reinforcement member, said reinforcement member comprising a polymer that is soluble in the lypophilizing solvent, and, a biocompatible polymeric coating having a thickness applied to said member, wherein said polymeric coating comprises a coating polymer that is substantially insoluble in the lyophilizing solvent;

placing the polymeric reinforcement member in a cavity of a suitable mold;

adding the solution to the cavity of the mold such that at least a part of the cavity is filled with the solution and at least part of the reinforcing member is in contact with the solution; and

,

cooling the reinforcement member and solution to below the freezing point of the solvent, and lyophilizing.

2. The method of claim 1, comprising the additional step of orienting the reinforcement member in the cavity of the mold in a particular configuration.

3. The method of claim 1, wherein the reinforcement member is annealed prior to placement in the cavity of the mold.

4. The method of claim 1, wherein the reinforcement member is placed under tension prior to placement in the cavity of the mold.

5. The method of claim 1, wherein the mold is cooled to below the freezing point of the solvent prior to placement of the reinforcement member in the cavity of the mold.

6. The method of claim 1, wherein a solid that does not react with the foam forming polymer or the solvent is added to the solution.

7. The method of claim 6, wherein the solid comprises a particle selected from the group consisting of demineralized bone, calcium phosphate, calcium sulfate, and calcium carbonate.

8. The method of claim 6, wherein the solid comprises a member selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, glucose, fructose, dextrose, maltose, lactose sucrose, starch, alginate, chitosan, gelatin and agarose.

9. The method of claim 6, wherein the solid comprises a member selected from the group consisting of stainless steel, cobalt chrome, titanium, titanium alloys, alumina, and zirconia.

10. The method of claim 6, wherein the solid comprises a member selected from the group consisting of polyethylene, polyvinylacetate, polyethylene oxide, polymethylmethacrylate, silicone, polyethylene glycol, polyurethanes, cellulose, chitin, keratin, and fluorinated polymers.

11. The method of claim 1, wherein the polymeric foam comprises a bioabsorbable polymer.

12. The method of claim 1, wherein the polymeric foam comprises a polymer selected from the group consisting aliphatic polyesters, poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, and copolymers and blends thereof.

13. The method of claim 1, wherein the polymeric reinforcement member comprises a bioabsorbable polymer.

14. The method of claim 1, wherein the reinforcement member comprises a polymer selected from the group consisting of aliphatic polyesters, poly(alpha-hydroxy acids), poly(amino acids), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, polyorthoesters, polyoxaesters, polyamidoesters, polylactides, and copolymers and blends thereof.

15. The method of claim 1, wherein the reinforcement member comprises comprising a copolymer of polymerized lactide and glycolide.

16. The method of claim 1, wherein the coating comprises a polymer selected from the group consisting of polydioxanone, and its copolymers with L(−

)lactide, D(+)-lactide, meso- lactide, trimethylene carbonate, epsilon-caprolactone, or glycolide, or combinations thereof, with the provision that polymerized dioxanone is at least 50 weight percent.

17. The method of claim 1, wherein the coating comprises poly(pdioxanone).

18. The method of claim 1, wherein the thickness of the coating is sufficient to effectively prevent the lyophilizing solvent from contacting said reinforcement member.

19. The method of claim 1, wherein the thickness of the coating is greater than 1.0 mil.

20. The method of claim 1, wherein the lyophilizing solvent is selected from the group consisting of p(dioxane) and trioxane.

21. The method of claim 1, wherein the lyophilizing solvent comprises p(dioxane).

22. The method of claim 1, wherein the mold is cooled to below 25°

C. prior to placement of the reinforcement member in the cavity of the mold, pre-chilling the solution below 25°

C. but above the freezing point of the solution prior to adding the solution to the cavity of the mold.