Meniscal augmentation device

• US 5,681,353 A
• Filed: 05/27/1994
• Issued: 10/28/1997
• 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:
  US08/250,008
• Time in Patent Office: 1,250 Days
• Field of Search: 623/1, 623/11, 623/12, 623/16, 623/66, 623/18
• US Class Current: 623/14.12
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30734 Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
• 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 2/4261 for wrists
• 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 2/461 of knees
• 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 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• 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 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2300/236 : Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2300/252 : Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/406 : Antibiotics
• CPC Class Codes: A61L 2300/414 : Growth factors
• 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 27/22 : Polypeptides or derivatives thereof , e.g. degradation products
• 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 27/36 : containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3641 : characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/46 : with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/48 : with macromolecular fillers
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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: A61P 19/02 : for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: C08L 1/00 : Compositions of cellulose, modified cellulose or cellulose derivatives
• CPC Class Codes: C08L 1/02 : Cellulose; Modified cellulose
• 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 5/08 : 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
• CPC Class Codes: Y10S 623/901 : Method of manufacturing prosthetic device

Abstract

The present invention relates to a meniscal augmentation device of biocompatible and at least partially bioresorbable fibers for implantation into a segmental defect of a meniscus in a subject. Upon implantation, the composite of the device and the meniscus establishes a scaffold adapted for ingrowth of meniscal fibrochondrocytes. The invention further pertains to methods of fabricating and using the device.

Claims

1. A meniscal augmentation device for implantation into a segmental defect of a meniscus in a subject, the device comprising a plurality of biocompatible and at least partially bioresorbable fibers, wherein the device has an outer surface contour substantially complementary to the segmental defect of the meniscus, and the fibers are selected from the group consisting of natural polymers, analogs of natural polymers, and mixtures of natural polymers and/or analog polymers,

wherein the device, when implanted into the segmental defect of the meniscus, establishes a biocompatible and an at least partially bioresorbable scaffold which comprises a dry, porous volume matrix having a pore size ranging from about 50 microns to about 500 microns and is adapted for the ingrowth of meniscal fibrochondrocytes, the scaffold and the ingrown meniscal fibrochondrocytes support natural meniscal load forces, and the in vivo outer surface of the composite of said meniscus and said device is substantially the same as that of a natural meniscus without segmental defects.

2. The device of claim 1 wherein the matrix has a density of about 0.10 to about 0.25 gram matrix per cubic centimeter.

3. The device of claim 1 wherein the matrix has an intrafibrillary and interfibrillary space of about 2 to 25 cubic centimeters per gram matrix.

4. The device of claim 1 wherein the natural polymers are selected from the group of polymers derived from humans and non-human animals.

5. The device of claim 4 wherein the human-derived and non-human animal-derived polymers are selected from the group consisting of collagen, elastin, reticulin, cellulose, analogs thereof, and mixtures thereof.

6. The device of claim 5 wherein the polymer is collagen.

7. The device of claim 6 wherein the collagen is selected from the group consisting of Type I collagen, Type II collagen, and combinations thereof.

8. The device of claim 1 wherein at least a portion of the fibers are crosslinked.

9. The device of claim 1 further comprising a plurality of glycosaminoglycan molecules interspersed with the fibers of the matrix.

10. The device of claim 9 wherein at least a portion of the glycosaminoglycan molecules are crosslinked with at least a portion of the fibers of the matrix.

11. The device of claim 9 wherein the fibers are present at a concentration of about 75-100% by dry weight and the glycosaminoglycan molecules are present at a concentration of about 0-25% by dry weight.

12. The device of claim 9 wherein the glycosaminoglycan molecules are selected from the group consisting of chondroitin 4-sulfate, chondroitin 6-sulfate, keratan sulfate, dermatan sulfate, heparan sulfate, heparin, hyaluronic acid, and mixtures thereof.

13. The device of claim 8 wherein the crosslinks are formed by a chemical crosslinking agent.

14. The device of claim 10 wherein the crosslinks are formed by a chemical crosslinking agent.

15. The device of claim 13 wherein the crosslinking agent is selected from the group consisting of glutaraldehyde, formaldehyde, biocompatible bifunctional aldehydes, carbodiimides, hexamethylene diisocyanate, bis-imidates, polyglycerol polyglycidyl ether, glyoxal, and mixtures thereof.

16. The device of claim 14 wherein the crosslinking agent is selected from the group consisting of glutaraldehyde, formaldehyde, biocompatible bifunctional aldehydes, carbodiimides, hexamethylene diisocyanate, bis-imidates, polyglycerol polyglycidyl ether, glyoxal, and mixtures thereof.

17. The device of claim 15 wherein the crosslinking agent is formaldehyde.

18. The device of claim 15 wherein the crosslinking agent is glutaraldehyde.

19. The device of claim 16 wherein the crosslinking agent is formaldehyde.

20. The device of claim 16 wherein the crosslinking agent is glutaraldehyde.

21. The device of claim 1 further comprising a growth factor.

22. The device of claim 21 wherein the growth factor is transforming growth factor-α

, transforming growth factor-β

, fibroblast growth factor, epidermal growth factor, platelet derived growth factor, or combinations thereof.

23. The device of claim 1 further comprising an adhesion molecule.

24. The device of claim 23 wherein the adhesion molecule is fibronectin, chondronectin, osteonectin, or combinations thereof.

25. A method for regenerating meniscal tissue in vivo, comprising:

(a) fabricating a meniscal augmentation device for implantation into a segmental defect in a meniscus in a subject,

the meniscal augmentation device comprising biocompatible and at least partially bioresorbable fibers, wherein the device has an outer surface contour substantially complementary to the segmental defect in the meniscus, and the fibers are selected from the group consisting of natural polymers, analogs of natural polymers, and mixtures of natural polymers,

wherein the device is implantable into the segmental defect in the meniscus to establish a biocompatible and an at least partially bioresorbable scaffold which comprises a dry, porous volume matrix having a pore size ranging from about 50 microns to about 500 microns and is adapted for the ingrowth of meniscal fibrochondrocytes, and the scaffold and the ingrown meniscal fibrochondrocytes support natural meniscal load forces; and

(b) implanting the device into the segmental defect in the meniscus in the subject whereby the in vivo outer surface of the composite of said device and said meniscus is substantially the same as natural meniscus without a segmental defect.

26. The method of claim 25 wherein the device fabricated in (a) assumes the shape of the segmental defect in the meniscus when implanted in (b).