# US 8,784,863 B2 · Particulate cadaveric allogenic cartilage system

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- Number: US 8,784,863 B2
- Document ID: US8784863B2
- Status: Granted
- Kind: B2
- Application number: 12/976,704
- Filed: 2010-12-22
- Published: 2012-04-12
- Granted: 2014-07-22
- Earliest claimed: 2003-12-11
- Assignees: Zimmer, Inc.
- Applicants: Neil Kizer; Robert Spiro; Jian Yao; Cheryl Renee Blanchard
- Inventors: Neil Kizer; Robert Spiro; Jian Yao; Cheryl Renee Blanchard
- Web page: https://patentgrep.com/patent/US8784863B2

## CPC

- A61L 27/3683: {subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment}
- A61F 2/30756: {Cartilage endoprostheses (A61F2/3603 takes precedence)}
- A61K 35/32: Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
- A61L 27/3612: {Cartilage, synovial fluid}
- A61L 27/3654: {Cartilage, e.g. meniscus}
- A61L 27/3817: {Cartilage-forming cells, e.g. pre-chondrocytes}
- A61L 27/3852: {Cartilage, e.g. meniscus}
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 19/04: for non-specific disorders of the connective tissue
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- C12N 5/0655: {Chondrocytes; Cartilage}
- A61F 2/28: Bones
- A61F 2002/30764: {Cartilage harvest sites}
- A61F 2002/30766: {Scaffolds for cartilage ingrowth and regeneration}
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00365: Proteins; Polypeptides; Degradation products thereof
- A61F 2310/00377: Fibrin
- A61L 2430/06: for cartilage reconstruction, e.g. meniscus
- C12N 2533/56: Fibrin; Thrombin
- C12N 2533/80: Hyaluronan
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention is directed to compositions having at least one neocartilage particle, juvenile cartilage particle or a combination thereof and a matrix, and methods and devices that include the compositions.

## Claims

### Claim 1

A cartilage treatment kit comprising:
cadaveric, allogenic human juvenile cartilage particles including viable chondrocytes;
biocompatible chondro-conductive/inductive matrix;
a biocompatible storage solution; and
a sealed, sterile container in which the cartilage particles and storage solution are disposed;
wherein the container is positioned within a sealed, sterile pouch having a hollow interior.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the container comprises:
a tray having a lip surrounding a receptacle; and
a removable cover attached to the lip of the tray for sealing the receptacle.

### Claim 3 (depends on 1)

The kit of claim 1, wherein the storage solution comprises at least one preservative.

### Claim 4 (depends on 3)

The kit of claim 3, wherein the preservative comprises a buffer, an amino acid, a sugar, a salt, a mineral or combinations thereof.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the juvenile cartilage particles are from cadaveric juvenile donors less than fifteen years of age.

### Claim 6 (depends on 5)

The kit of claim 5, wherein the juvenile cartilage particles are from cadaveric juvenile donors less than two years of age.

### Claim 7 (depends on 5)

The kit of claim 5, wherein the juvenile cartilage particles are from cadaveric juvenile donors from about 20 weeks to about 13 years of age.

### Claim 8 (depends on 1, 3, 5)

The kit of any one of claim 1, 3 or 5, wherein the kit comprises juvenile cartilage particles having a dimension from about one to about three millimeters.

### Claim 9 (depends on 5)

The kit of claim 5, wherein the juvenile cartilage particles are from a cartilage site scored in a grid pattern.

### Claim 10 (depends on 9)

The kit of claim 9, wherein the grid pattern is a square grid pattern.

### Claim 11 (depends on 1, 3, 5)

The kit of any one of claim 1, 3 or 5, wherein the kit comprises juvenile cartilage particles range in size from about 1 to about 27 mm3.

### Claim 12 (depends on 1, 3, 5)

The kit of any one of claim 1, 3 or 5, wherein the juvenile cartilage particles comprise at least 1×106 chondrocytes.

### Claim 13 (depends on 1, 3, 5)

The kit of any one of claim 1, 3 or 5, comprising at least 60 mg of juvenile cartilage particles.

### Claim 14 (depends on 1, 3, 5)

The kit of any one of claim 1, 3 or 5, wherein the cartilage particles comprise articular cartilage.

### Claim 15 (depends on 14)

The kit of claim 14, wherein the articular cartilage is harvested from a femoral condyle a tibial plateau or an interior surface of a patella.

### Claim 16 (depends on 1)

The kit of claim 1, wherein the cartilage is distributed throughout substantially all of the matrix or just a portion of the matrix.

### Claim 17 (depends on 1)

The kit of claim 1, wherein the chondro-conductive/inductive matrix comprises fibrinogen, fibrinogen/thrombin, albumin, in-situ forming poly(ethylene glycol) (PEG) hydrogel, fibrin/hyaluronate, fibrin/collagen/hyaluronate, PEG/hyaluronate, PEG/collagen, plasma and protein-based adhesives and sealants, natural adhesives and sealants and any combination thereof.

### Claim 18 (depends on 1)

The kit of claim 1 further comprising an osteo-conductive matrix.

### Claim 19 (depends on 18)

The kit of claim 18, wherein the osteo-conductive matrix comprises fibrinogen, fibrinogen/thrombin, fibrin/tri-calcium phosphate, fibrin/collagen/tri-calcium phosphate, fibrin/hyaluronate/tri-calcium phosphate, in-situ forming PEG hydrogel sealants, PEG/tri-calcium phosphate, PEG/collagen, demineralized bone matrix, and any combination thereof.

### Claim 20 (depends on 18)

The kit of claim 18 further comprising an associated matrix comprising collagen, polylactic acid (PLA), polyglycolic acid (PGA), and combinations thereof.