# US 10,945,846 B2 · Implants for bone and cartilage repair

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- Number: US 10,945,846 B2
- Document ID: US10945846B2
- Status: Granted
- Kind: B2
- Application number: 15/241,568
- Filed: 2016-08-19
- Published: 2016-12-08
- Granted: 2021-03-16
- Earliest claimed: 2012-06-22
- Assignees: Collagen Matrix, Inc.
- Applicants: Collagen Matrix, Inc.
- Inventors: Shu-Tung Li; Hui-Chen Chen; Debbie Yuen
- Web page: https://patentgrep.com/patent/US10945846B2

## CPC

- A61F 2/28: Bones
- A61F 2/30756: {Cartilage endoprostheses (A61F2/3603 takes precedence)}
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61L 27/24: Collagen
- A61L 27/3847: {Bones}
- A61L 27/3852: {Cartilage, e.g. meniscus}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/58: Materials at least partially resorbable by the body
- A61F 2002/2839: {Bone plugs or bone graft dowels}
- A61F 2002/30016: {differing in hardness, e.g. Vickers, Shore, Brinell}
- A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive}
- A61F 2002/30293: {Cylindrical body made by spirally rolling up a sheet or a strip around itself}
- A61F 2002/3092: {having an open-celled or open-pored structure}
- A61F 2310/00371: Collagen
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61L 2430/06: for cartilage reconstruction, e.g. meniscus
- 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)
- 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)

## Abstract

An implant for the repair of bone and cartilage that includes a cell conductive zone that contains biopolymeric fibers and an osteoconductive zone that contains biopolymeric fibers and calcium-containing mineral particles. The biopolymeric fibers from one zone overlap with the fibers in the other zone forming a stable physical and mechanical integration of the two zones, thus conferring in vivo stability to the implant.

## Claims

### Claim 1

A biocompatible and bioresorbable implant having a physically and mechanically stable bi-phasic structure for the repair of bone and cartilage, comprising a cell conductive zone that contains a first matrix of first type I collagen fibers, the first type I collagen fibers having a length of 1 cm to 50 cm, and an osteoconductive zone consisting of a second matrix of second type I collagen fibers also having a length of 1 cm to 50 cm and calcium-containing mineral particles, wherein the first matrix of first type I collagen fibers is a demineralized bone matrix, the calcium-containing mineral particles include carbonate apatite and have a size of 0.2 mm to 1.5 mm, the cell conductive zone is free of calcium-containing mineral particles, the first type I collagen fibers extend into the osteoconductive zone and overlap with the second type I collagen fibers, and the cell conductive zone overlaps with and is in direct contact with the osteoconductive zone.

### Claim 2 (depends on 1)

The implant of claim 1, wherein the first matrix has a density of 0.03 g/cm3 to 0.8 g/cm3 and a compressive modulus of 0.05 N/cm2 to 10 N/cm2.

### Claim 3 (depends on 2)

The implant of claim 2, wherein the shape of the implant is a circular cylinder.

### Claim 4 (depends on 3)

The implant of claim 3, wherein the implant has a length of 0.3 cm to 2 cm and a diameter of 0.2 cm to 3 cm.

### Claim 5 (depends on 4)

The implant of claim 4, wherein a content of the calcium-containing mineral particles is from 30% to 95% by weight of the implant.

### Claim 6 (depends on 5)

The implant of claim 5, wherein a length of the cell conductive zone is 10% to 60% of the length of the implant.

### Claim 7 (depends on 6)

The implant of claim 6, wherein the implant length is 0.5 cm to 1.25 cm, the diameter is 0.5 cm to 1.5 cm, the content of the calcium-containing mineral particles is from 60% to 90% by weight of the implant, the length of the cell conductive zone is 15% to 40% of the length of the implant, and the first matrix has a density of 0.05 g/cm3 to 0.5 g/cm3 and a compressive modulus of 0.1 N/cm2 to 5.0 N/cm2.

### Claim 8 (depends on 1)

The implant of claim 1, wherein the cell conductive zone further contains a bioactive molecule.

### Claim 9 (depends on 8)

The implant of claim 8, wherein the bioactive molecule is a growth factor, a cell adhesive molecule, a cytokine, a glycoprotein, a proteoglycan, an antibiotic, or a polysaccharide.

### Claim 10 (depends on 1)

The implant of claim 1, wherein the cell conductive zone further contains cells.

### Claim 11 (depends on 10)

The implant of claim 10, wherein the cells are osteoblasts, chondrocytes, stem cells, or bone marrow cells.

### Claim 12

A biocompatible and bioresorbable implant for the repair of bone and cartilage, comprising a matrix consisting of type I collagen fibers having a length of 1 cm to 50 cm, the implant having a cell conductive zone and an osteoconductive zone, wherein the matrix of type I collagen fibers is a demineralized bone matrix, the osteoconductive zone includes calcium-containing mineral particles, the calcium-containing mineral particles include carbonate apatite and have a size of 0.2 mm to 1.5 mm, the cell conductive zone is free of calcium-containing mineral particles, the type I collagen fibers extend from the cell conductive zone into the osteoconductive zone, and the cell conductive zone is in direct contact with the osteoconductive zone.

### Claim 13 (depends on 12)

The implant of claim 12, wherein the calcium-containing mineral particles are present at 60% to 90% by weight of the implant.

### Claim 14 (depends on 13)

The implant of claim 13, wherein the implant is cylindrical, having a length of 0.5 cm to 1.25 cm and a diameter of 0.5 cm to 1.5 cm, and the cell conductive zone has a length equal to 15% to 40% of the implant length.

### Claim 15 (depends on 14)

The implant of claim 14, wherein the cell conductive zone has a density of 0.05 g/cm3 to 0.5 g/cm3 and a compressive modulus of 0.1 N/cm2 to 5 N/cm2.
