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Prosthetic meniscus

Assignee: Regen Corp
•
Filing: 1991-11-07
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Granted: 1992-10-27
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Expires: 2011-11-07
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Abstract

Abstract A prosthetic, resorbable meniscus and method of its fabrication are disclosed. The prosthetic meniscus can be implanted in a human knee where it can act as a scaffold for regrowth of native meniscal tissues. The meniscus comprises a dry, porous, matrix of biocompatible and bioresorbable fibers, at least a portion of which may be crosslinked. The fibers include natural polymers or analogs or mixtures thereof. The matrix is adapted to have in vivo an outer surface contour substantially the same as that of a natural meniscus. The matrix has pore size in the approximate range of greater than 50 microns to less than about 500 microns. With this configuration, the matrix establishes an at least partially bioresorbable scaffold adapted for ingrowth of meniscal fibrochondrocytes.

Inventors

  • 👤 Kevin R. Stone

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 18:17
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/58; A61F; A61F2/00; A61F2/02; A61F2/08; A61F2/28; A61F2/30; A61F2/38; A61F2/3872; A61L27/14; A61L27/20; A61L27/22; A61L27/227; A61L27/24; A61L27/26; A61L27/40; A61L27/44; A61L27/46; A61L27/48; A61L27/54; A61L27/56; A61F2/30756; A61F2/3094; A61F2/30965; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30062; A61F2002/30108; A61F2002/3011; A61F2002/30112; A61F2002/30131; A61F2002/30199; A61F2002/30205; A61F2002/30224; A61F2002/3023; A61F2002/30667; A61F2002/30677; A61F2/30721; A61F2/30734; A61F2002/30736; A61F2/30767; A61F2/30771; A61F2002/3082; A61F2002/30878; A61F2002/30879; A61F2002/30904; A61F2/30942; A61F2002/30957; A61F2/42; A61F2/4261; A61F2002/4271; A61F2002/4274; A61F2002/4276; A61F2002/4279; A61F2002/4282; A61F2002/4284; A61F2002/4287; A61F2002/4289; A61F2002/4292; A61F2002/4294; A61F2002/4297; A61F2210/00; A61F2210/0004; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0013; A61F2230/0063; A61F2230/0067; A61F2230/0069; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2300/00; A61L2300/20; A61L2300/23; A61L2300/236; A61L2300/40; A61L2300/452; A61L2430/00; A61L2430/06; A61L2430/38; Y; Y10; Y10S; Y10S623/00; Y10S623/909

Claims Analysis

Total Claims: 18
Claim 1
Independent Claim 152 words
A method for fabricating a prosthetic meniscus comprising the steps of: (a) placing a plurality of biocompatible and bioresorbable fibers into a mold, said fibers including natural polymers or analogs or mixtures thereof, and said mold defining a shape for a meniscal prosthesis that enables knee joint function; (b) subjecting said fibers to a first and a second cycle of freezing and thawing; (c) contacting said fibers with a chemical crosslinking agent such that said fibers assume the shape of said mold; and (d) lyophilizing said crosslinked fibers, thereby establishing a dry porous matrix adapted to have in vivo an outer surface contour substantially the same as that of a natural meniscus, said matrix having pore size in the approximate range of greater than 50 microns to less than about 500 microns, and establishing an at least partially bioresorbable scaffold adapted for ingrowth of meniscal fibrochondrocytes and for supporting meniscal load forces.
Claim 2
Independent Claim 152 words
A method for fabricating a prosthetic meniscus comprising the steps of: (a) placing a plurality of biocompatible and bioresorbable fibers into a mold, said fibers including natural polymers or analogs or mixtures thereof, and said mold defining a shape for a meniscal prosthesis that enables knee joint function; (b) subjecting said fibers to a first and a second cycle of freezing and thawing; (c) contacting said fibers with a chemical crosslinking agent such that said fibers assume the shape of said mold; and (d) lyophilizing said crosslinked fibers, thereby establishing a dry porous matrix adapted to have in vivo an outer surface contour substantially the same as that of a natural meniscus, said matrix having pore size in the approximate range of greater than 50 microns to less than about 500 microns, and establishing an at least partially bioresorbable scaffold adapted for ingrowth of meniscal fibrochondrocytes and for supporting meniscal load forces.
Claim 3
Dependent Claim 16 words
The method of claim 1 wherein said analog of said natural polymer is a biosynthetic analog.
Claim 4
Dependent Claim 25 words
The method of claim 1 wherein said fibers are selected from the group consisting of collagen, elastin, reticulin, cellulose, and analogs thereof, and mixtures thereof.
Claim 5
Dependent Claim 20 words
The method of claim 1 wherein said placing step further comprises placing a plurality of glycosaminoglycan molecules into said mold.
Claim 6
Dependent Claim 31 words
The method of claim 4 wherein said glycosaminoglycan molecules are selected from the group consisting of chondroitin 4-sulfate, chondroitin 6-sulfate, keratan sulfate, dermatan sulfate, heparin sulfate, hyaluronic acid, and mixtures thereof.
Claim 7
Dependent Claim 19 words
The method of claim 1 wherein said placing step further comprises the step of orienting said fibers substantially circumferentially.
Claim 8
Dependent Claim 47 words
The method of claim 6 wherein said orienting step comprises compressing said fibers in said mold with a piston, wherein piston motion is substantially directed along a compression axis, while during said compressing step said piston is rotated with respect to said mold about said compression axis.
Claim 9
Dependent Claim 19 words
The method of claim 6 wherein said orienting step comprises rotating said mold as said fibers are placed therein.
Claim 10
Dependent Claim 19 words
The method of claim 1 wherein said placing step further comprises the step of orienting said fibers substantially radially.
Claim 11
Dependent Claim 22 words
The method of claim 1 further comprising the step of compressing said fibers prior to said second cycle of freezing and thawing.
Claim 12
Dependent Claim 25 words
The method of claim 4 further comprising the step of compressing said fibers and said GAGs prior to said second cycle of freezing and thawing.
Claim 13
Dependent Claim 31 words
The method of claim 10 wherein said compressing step comprises applying a predetermined amount of pressure to a region of said matrix with a piston, said piston having a predetermined shape.
Claim 14
Dependent Claim 33 words
The method of claim 1 wherein said chemical crosslinking agent is selected from the group consisting of glutaraldehyde, formaldehyde, biocompatible and bifunctional aldehydes, carbodiimides, hexamethylene diisocyanate, bis-imidates, polyglycerol polyglycidylether, glyoxal, and mixtures thereof.
Claim 15
Dependent Claim 12 words
The method of claim 13 wherein said chemical crosslinking agent comprises glutaraldehyde.
Claim 16
Dependent Claim 14 words
The method of claim 13 wherein said chemical crosslinking agent comprises polyglycerol Polyglycidyl ether.
Claim 17
Dependent Claim 13 words
The method of claim 13 wherein said chemical crosslinking agent comprises 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide.
Claim 18
Dependent Claim 20 words
The method of claim 1 further comprising the additional step of subjecting said lyophilized matrix to a dehydrothermal crosslinking procedure.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1995-10-27 1996-04-27 1996-10-27 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1999-10-27 2000-04-27 2000-10-27 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2003-10-27 2004-04-27 2004-10-27 $7700.00 Window Closed / Lapsed

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