Moldable bone-implant material

• US 4,645,503 A
• Filed: 08/27/1985
• Issued: 02/24/1987
• Est. Priority Date: 08/27/1985
• Status: Expired due to Fees

• Current Assignee: Lifecore Biomedical Incorporated
• Original Assignee: Orthomatrix, Inc.
• Inventors: Lin, Steve T., Conjeevaram, Seshadri, Henderson, Don J.
• Primary Examiner(s): McNeill, Gregory E.
• Application Number:
  US06/769,940
• Time in Patent Office: 546 Days
• Field of Search: 623/16, 433/173, 433/121, 128/334 R
• US Class Current: 623/23.58
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/00 Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 77/00 Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers

Abstract

A moldable bone-implant material containing between about 65%-95% hard filler particles and a binder composed of between about 35%-5% of a biocompatible, biodegradable, thermoplastic polymer which has fluidic flow properties at or below about 60° C. One preferred binder is polylactic acid having a molecular weight between about 400 and 5,000 daltons, and a preferred hard filler is hydroxylapatite. In use, the material is warmed to a temperature which allows molding, and the bone site is filled with the moldable material, which then forms a contour-fitting, semi-rigid implant. The implant retains its contour fit and acquires a rigid final state as the binder in the implant is gradually biodegraded and replaced through tissue ingrowth from the surrounding bone site.

Claims

1. A moldable bone-implant material comprising a cohesive mixture of hard filler particles and a biocompatible, biodegradable thermoplastic polymeric binder having fluid-flow properties at or below about 60°

C.

2. The material of claim 1, wherein particles are hydroxylapatite.

3. The material of claim 1, wherein the binder constitutes less than about one-third of the material'"'"'s total volume.

4. The material of claim 1, wherein the binder is biodegradable to normal biochemical metabolite(s).

5. The material of claim 4, wherein the polymer is biodegradable over a period of about three days to six weeks, with the material operatively placed in a bone site.

6. The material of claim 4, wherein the binder is selected from the group consisting of polylactic acid, polyglycolic acid, polyhydroxybutyric acid, polymalic acid, polyglutamine acid, and polylactone.

7. The material of claim 6, wherein the polymer includes polylactic acid having molecular weights between about 400 and 5,000 daltons.

8. The material of claim 7, which is moldable by hand at a selected temperature at or below about 37°

C., and the polylactic acid is in the molecular weight range between about 400 and 2,000 daltons.

9. The material of claim 7, which is moldable by hand at a selected temperature above about 40°

C., and substantially rigid below about 37°

C., and the polylactic acid is in the molecular weight range between about 2,000 and 5,000 daltons.

10. A moldable bone-implant material comprising

between about 65%-95% hydroxylapatite particles;

and

a binder composed of between about 35%-5% of a polylactic acid polymer having a molecular weight between about 400 and 5,000 daltons.

11. A method of filling a bone site with a contour-fitting, rigid-particle bone implant, comprising

providing hard filler particles in the form of a moldable bone-implant material composed of a cohesive mixture of the particles and a biocompatible, biodegradable, thermoplastic polymer binder which has fluid-flow properties at a selected temperature at or below about 60°

C.,

heating the material to a temperature which allows the material to be molded by hand, and

14. The method of claim 11, wherein the binder is formed of a polymer having molecular chain sizes which produce such fluid-flow properties at the selected temperature, and

allow gradual polymer biodegradation over about three days to six weeks, with the material in the bone site.

17. The method of claim 11, wherein said providing includes mixing hydroxylapatite particles with no more than about one-third volume of binder.

18. The method of claim 11, wherein the material becomes moldable only above a temperature of about 40°

C., and following said filling, the material cools to form a relatively rigid implant.

12. filling the bone site with the moldable material to form a contour-fitting implant at the site,

15. The method of claim 12, wherein the binder is formed by synthesizing the polymer and terminating polymerization when the polymer exhibits such fluid-flow properties at the selected temperature.

13. where gradual biodegradation of the binder and concommitant ingrowth of surrounding tissue acts to rigidify the implant over a period of several weeks.

16. The method of claim 13, wherein the binder is formed by polymerizing a lactide to form polylactic acid under conditions which lead to polymers in the molecular weight range between about 400-5,000 daltons.