Method of producing biodegradable prosthesis and products therefrom

• US 4,655,777 A
• Filed: 12/19/1983
• Issued: 04/07/1987
• Est. Priority Date: 12/19/1983
• Status: Expired due to Fees

• Current Assignee: Southwest Research Institute
• Original Assignee: Southwest Research Institute
• Inventors: Casper, Robert A., Dunn, Richard L.
• Primary Examiner(s): Kight, John
• Assistant Examiner(s): Morgan, Kriellion
• Application Number:
  US06/563,191
• Time in Patent Office: 1,205 Days
• Field of Search: 3/1, 3/1.9, 128/92 C, 128/92 G
• US Class Current: 424/423
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• 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: C08K 7/08 Oxygen-containing compounds
• CPC Class Codes: C08L 67/02 Polyesters derived from dicarboxylic acids and dihydroxy compounds C08L67/06 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 69/00 Compositions of polycarbonates; Compositions of derivatives of polycarbonates
• CPC Class Codes: C08L 77/04 Polyamides derived from alpha-amino carboxylic acids C08L77/10 takes precedence
• CPC Class Codes: C08L 77/12 Polyester-amides

Abstract

Method of producing biodegradable prostheses comprising a composite of resorbable fibers reinforcing a biodegradable polymer matrix and the use thereof in medical applications such as bone plates and other orthopedic devices. The fibers include ceramic powders, β-TCP and CaAl and a biodegradable glass, CMP.

Claims

1. A method of producing a totally biodegradable prosthesis or implant comprising the steps of

(a) encasing an effective amount of fibers selected from the group consisting of calcium phosphate, and calcium aluminate in a matrix of a polymer selected from the group consisting of polyglycolide, poly(DL-lactide), poly(L-lactide), polycaprolactone, polydioxanone, polyesteramides, copolyoxalates, polycarbonate, poly(glutamic-co-leucine) and blends, copolymers and terpolymers thereof to form a composite;

and

(b) forming said composite to the desired shape.

2. A method as defined in claim 1 wherein said calcium phosphate fibers are comprised of β

-tricalcium phosphate.

3. A method as defined in claim 1 wherein said calcium phosphate fibers are comprised of calcium metaphosphate.

4. A method a defined in claim 1 wherein said effective amount ranges from 10-90% by volume.

5. A method as defined in claim 1 wherein said effective amount is preferably 30-80% by volume.

6. A method as defined in claim 1 wherein the aspect ratio of said fibers ranges from 10:

1 to 1,000,000;

1.

7. A biodegradable prosthesis or implant, comprising

(a) a matrix formed from a polymer selected from the group consisting of polyglycolide, poly(DL-lactide), poly(L-lactide), polycaprolactone, polydioxanone, polyesteramides, copolyoxalates, polycarbonate, poly(glutamic-co-leucine) and blends, copolymers and terpolymers thereof;

and

(b) fibers selected from the group consisting of calcium phosphate and calcium aluminate incorporated within said matrix in an amount ranging from 10-90% by volume and said fibers having an aspect ratio of 10;

1 to 1,000,000;

1.

8. A biodegradable prosthesis or implant as defined in claim 7 wherein said matrix is a film of said polymer and said prosthesis or implant comprises a predetermined number of alternating layers of said film and said fibers.

9. A method of repairing fractured bone segments in animals, comprising the step of surgically implanting adjacent said bone segments a prosthesis or implant formed of a composite of fibers selected from the group consisting of calcium phosphate and calcium aluminate, said fibers reinforcing a matrix formed from a polymer selected from the group consisting of polyglycolide, poly(DL-lactide), poly(L-lactide), polycaprolactone, polydioxanone, polyesteramides, copolyoxalates, polycarbonate, poly(glutamic-co-leucine) and blends, copolymers and terpolymers thereof.

10. A method of producing a totally biodegradable composite material for prosthetic and implant devices, comprising the step of encasing an effective amount of a reinforcing material in the form of fibers selected from the group consisting of calcium phosphate and calcium aluminate in a matrix of a polymer selected from the group consisting of polyglycolide, poly(DL-lactide), poly(L-lactide), polycaprolactone, polydioxanone, polyesteramides, copolyoxalates, polycarbonate, poly(glutamic-co-leucine) and blends, copolymers and terpolymers thereof.

11. A totally biodegradable composite material for prosthetic and implant devices, comprising:

(a) from 10-90% by volume of a reinforcing material in the form of fibers selected from the group consisting of calcium phosphate and calcium aluminate; and

(b) a polymer encasing said reinforcing material, said polymer being selected from the group consisting of polyglycolide, poly(DL-lactide), poly(L-lactide), polycaprolactone, polydioxanone, polyesteramides, copolyoxalates, polycarbonate, poly(glutamic-co-leucine) and blends, copolymers and terpolymers thereof.