Prosthetic articular cartilage

• US 5,624,463 A
• Filed: 04/25/1994
• Issued: 04/29/1997
• Est. Priority Date: 07/20/1987
• Status: Expired due to Term

• Current Assignee: ReGen Biologics Incorporated
• Original Assignee: ReGen Biologics Incorporated
• Inventors: Li, Shu-Tung, Stone, Kevin R.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/232,743
• Time in Patent Office: 1,100 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 623/18, 623/20, 623/23, 623/66
• US Class Current: 623/23.61
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2002/30006 differing in density or specific weight
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30205 conical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2002/30808 parallel
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/30822 : Circumferential grooves
• CPC Class Codes: A61F 2002/30827 : Plurality of grooves
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30881 : Circumferential ribs, flanges or fins
• CPC Class Codes: A61F 2002/30891 : Plurality of protrusions
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4276 : Trapezium
• CPC Class Codes: A61F 2002/4279 : Trapezoid
• CPC Class Codes: A61F 2002/4282 : Capitate
• CPC Class Codes: A61F 2002/4284 : Hamate
• CPC Class Codes: A61F 2002/4289 : Scaphoid or navicular bone
• CPC Class Codes: A61F 2002/4292 : Lunate
• CPC Class Codes: A61F 2002/4294 : Triquetrum
• CPC Class Codes: A61F 2002/4297 : Pisiform bone
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0015 : differing in density or specific weight
• CPC Class Codes: A61F 2250/0057 : made from both cured and uncured parts
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/20 : Polysaccharides
• CPC Class Codes: A61L 27/227 : Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
• CPC Class Codes: A61L 27/24 : Collagen
• CPC Class Codes: A61L 27/26 : Mixtures of macromolecular compounds
• 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: A61L 27/58 : Materials at least partially resorbable by the body
• CPC Class Codes: C08L 1/00 : Compositions of cellulose, modified cellulose or cellulose derivatives
• CPC Class Codes: C08L 5/00 : Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/04 : Alginic acid; Derivatives thereof
• CPC Class Codes: C08L 5/08 : Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: C08L 5/10 : Heparin; Derivatives thereof
• CPC Class Codes: C08L 89/06 : derived from leather or skin , e.g. gelatin

Abstract

A prosthetic, resorbable articular cartilage and methods of its fabrication and insertion are disclosed. The prosthetic articular cartilage, when implanted in a humanoid joint, acts as a resorbable scaffold for ingrowth of native articular chondrocytes and supports natural articulating joint forces. The prosthetic articular cartilage is a dry, porous, volume matrix of biocompatible and bioresorbable fibers. These fibers include a natural polymer or analogs thereof, at least a portion of which may be crosslinked. The matrix is adapted to have an in vivo outer surface contour substantially the same as that of natural articular cartilage in an articulating joint, and has a pore size in the approximate range of about 100 microns to about 400 microns.

Claims

1. A prosthetic articular cartilage device comprising a dry porous volume matrix of biocompatible and at least bioresorbable fibers and further comprising a base component,

said fibers being natural polymers or analogs or mixtures thereof, said matrix being adapted to have an in vivo outer surface contour substantially the same as that of natural articular cartilage, and said matrix having a pore size in the approximate range of about 100 microns to about 400 microns,

whereby said matrix establishes a bioresorbable scaffold adapted for the ingrowth of articular chondrocytes, and for supporting natural articulating joint forces,

said base component configured to fit in a complementary aperture in cancellous bone thereby securing said articular cartilage device to said bone, said base component extending from portions of the outer surface of said matrix,

said base component being a composite material comprising a dispersion of collagen and a composition which is selected from the group consisting of tricalcium phosphate, hydroxyapatite, and a combination of tricalcium phosphate and hydroxyapatite.

2. The device of claim 1 further comprising crosslinks between at least a portion of said fibers.

3. The device of claim 1 further comprising a plurality of polysaccharide molecules interspersed with said fibers.

4. The device of claim 1 wherein at least a portion of said molecules provide crosslinks between ones of said fibers.

5. The device of claim 1 wherein said fibers are collagen, elastin, reticulin, cellulose, or mixtures thereof.

6. The device of claim 1 wherein said fibers are present at a concentration of about 75 to 100% by dry weight, and said polysaccharide molecules are present at a concentration of about 0 to 25% by dry weight.

7. The device of claim 1 wherein said polysaccharide molecules are chondroitin 4-sulfate, chondroitin 6-sulfate, keratan sulfate, dermatan sulfate, heparin sulfate, heparin, hyaluronic acid, alginic acid, chitosan, or mixtures thereof.

8. The device of claim 1 wherein said crosslinks are formed by a chemical crosslinking agent.

9. The device of claim 1 wherein said crosslinking agent is glutaraldehyde, formaldehyde, biocompatible bifunctional aldehydes, carbodiimides, hexamethylene diisocyanate, bisimidates, polyglycerol polyglycidyl ether, glyoxal, and mixtures thereof.

10. The device of claim 1 wherein said cartilage has a density of about 0.07 to 0.50 gram matrix per cubic centimeter.

11. The device of claim 1 wherein said cartilage has an intrafibrillary and interfibrillary space of about 2 to 14 cubic centimeters per gram matrix.

12. The device of claim 1 wherein said fibers are oriented in a substantially random fashion through said matrix.

13. The device of claim 1 wherein said fibers are oriented in a substantially ordered fashion through said matrix.

14. The device of claim 1 wherein said matrix comprises substantially circumferentially extending fibers.

15. The device of claim 1 wherein said matrix comprises substantially radially extending fibers.

16. The device of claim 1 wherein the density of said fibers is substantially uniform throughout said matrix.

17. The device of claim 1 wherein said polysaccharide molecules are dispersed substantially uniformly through said matrix.

18. The device of claim 1 wherein said polysaccharide molecules are dispersed nonuniformly through said matrix.

19. The device of claim 1 wherein the base component is at least partially resorbable.

20. The device of claim 1 wherein the base component includes a plurality of circumferentially extending ridges.

21. The device of claim 1 wherein the dispersion comprises about 90% by weight tricalcium phosphate and about 10% by weight collagen.

22. The device of claim 1 wherein the dispersion comprises about 90% by weight hydroxyapatite and about 10% by weight collagen.