# US 10,441,679 B2 · Compositions for treating bone defects

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- Number: US 10,441,679 B2
- Document ID: US10441679B2
- Status: Granted
- Kind: B2
- Application number: 16/128,784
- Filed: 2018-09-12
- Published: 2019-01-10
- Granted: 2019-10-15
- Earliest claimed: 2007-12-04
- Assignees: Warsaw Orthopedic, Inc.
- Applicants: Warsaw Orthopedic Inc.
- Inventors: Jeffrey M. Gross; Steve Peckham; Jeffrey L. Scifert; Jeffrey Badura; Nelson Scarborough; Scott Vickers
- Web page: https://patentgrep.com/patent/US10441679B2

## CPC

- A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24}
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/48: with macromolecular fillers
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61P 19/00: Drugs for skeletal disorders
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- A61L 2300/414: Growth factors
- A61L 2300/602: Type of release, e.g. controlled, sustained, slow
- A61L 2400/18: Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
- A61L 2420/02: Methods for coating medical devices
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)

## Abstract

In certain described embodiments, implantable medical materials comprise a scaffolding material, a liquid organic binder, and entrapped calcium-containing particles. The medical materials can incorporate an osteoinductive factor such as a protein. The scaffolding material can bind the factor. In additional described embodiments, implantable medical materials include an osteoconductive scaffolding material, an incorporated osteoinductive factor, and a biodegradable barrier material effective to delay release of the factor from the scaffolding material. The scaffolding material can bind the factor. Also described a methods for preparing and implanting the described medical materials.

## Claims

### Claim 1

A method comprising providing an osteoinductive implant material comprising an osteoconductive scaffolding material; coating exterior surfaces of the osteoinductive implant material with a barrier substance to form a coated implant material; and implanting the coated implant material in a patient at a site at which bone growth is needed, wherein the osteoinductive implant material comprises about 60% to about 75% by weight of a liquid organic binder.

### Claim 2 (depends on 1)

The method of claim 1, wherein the osteoconductive scaffolding material incorporates an osteoinductive protein.

### Claim 3 (depends on 2)

The method of claim 2, wherein the barrier substance is effective to delay release of the osteoinductive protein from the osteoinductive implant material.

### Claim 4 (depends on 2)

The method of claim 2, wherein the osteoinductive protein comprises a bone morphogenic protein; and the osteoinductive implant material exhibits a capacity to bind the bone morphogenic protein.

### Claim 5 (depends on 2)

The method of claim 2, wherein the providing comprises incorporating the osteoinductive protein into the osteoconductive scaffolding material to prepare the osteoinductive implant material.

### Claim 6 (depends on 2)

The method of claim 2, further comprising binding sulfated glycosaminoglycan molecules to the osteoinductive implant material using end point binding, wherein the osteoinductive protein exhibits a capacity to bind to the sulfated glycosaminoglycan molecules.

### Claim 7 (depends on 6)

The method of claim 6, wherein the sulfated glycosaminoglycan molecules comprise at least one of heparin and dextran sulfate.

### Claim 8 (depends on 1)

The method of claim 1, wherein the barrier substance is biodegradable.

### Claim 9 (depends on 1)

The method of claim 1, wherein the coating is conducted in a sterile operating field.

### Claim 10

A method comprising providing an osteoinductive implant material; coating exterior surfaces of the osteoinductive implant material with a barrier substance to form a coated implant material; and implanting the coated implant material in a patient at a site at which bone growth is needed, wherein the osteoinductive implant material comprises about 60% to about 75% by weight of a liquid organic binder.

### Claim 11 (depends on 10)

The method of claim 10, wherein the osteoinductive implant material comprises an osteoinductive protein.

### Claim 12 (depends on 11)

The method of claim 11, wherein the barrier substance is effective to delay release of the osteoinductive protein from a scaffolding material of the osteoinductive implant material.

### Claim 13 (depends on 12)

The method of claim 12, wherein the osteoinductive protein comprises a bone morphogenic protein; and the scaffolding material exhibits a capacity to bind the bone morphogenic protein.

### Claim 14 (depends on 11)

The method of claim 11, wherein the providing comprises incorporating the osteoinductive protein into an osteoconductive scaffolding material to prepare the osteoinductive implant material.

### Claim 15

A method comprising providing an implant material; coating exterior surfaces of the implant material with a barrier substance to form a coated implant material; and implanting the coated implant material in a patient at a site at which bone growth is needed, wherein the implant material comprises about 60% to about 75% by weight of a liquid organic binder having a viscosity range from about 1 centipoise to about 200 centipoises.

### Claim 16 (depends on 15)

The method of claim 15, wherein the implant material is osteoinductive.

### Claim 17 (depends on 15)

The method of claim 15, wherein the implant material comprises an osteoinductive protein.

### Claim 18 (depends on 17)

The method of claim 17, wherein the barrier substance is effective to delay release of the osteoinductive protein from a scaffolding material of the implant material.

### Claim 19 (depends on 18)

The method of claim 18, wherein the osteoinductive protein comprises a bone morphogenic protein; and the scaffolding material exhibits a capacity to bind the bone morphogenic protein.

### Claim 20 (depends on 1)

The method of claim 1, wherein the osteoinductive implant material comprises about 15 wt. % insoluble noncollagenous fibers and 10 wt. % sodium alginate.