# US 2019/0167853 A1 · Moldable bone graft compositions

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- Number: US 2019/0167853 A1
- Document ID: US20190167853A1
- Status: Published application
- Kind: A1
- Application number: 16/047,420
- Filed: 2018-07-27
- Published: 2019-06-06
- Earliest claimed: 2014-11-13
- Assignees: Bioventus, LLC
- Applicants: Bioventus, LLC
- Inventors: John E. Brunelle; Russell L. Cook; Duraid S. Antone
- Web page: https://patentgrep.com/patent/US20190167853A1

## CPC

- A61L 27/58: Materials at least partially resorbable by the body
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2400/06: Flowable or injectable implant compositions
- 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)

## Abstract

The present disclosure relates to compositions useful in synthetic bone graft applications. Particularly, the disclosure teaches moldable bone graft compositions, methods of making said compositions, and methods of utilizing the same.

## Claims

### Claim 1

A moldable bone graft composition, comprising:
a) one or more bioresorbable polymers;
b) biphasic calcium phosphate particles comprising hydroxyapatite and tricalcium phosphate; and
c) a bioactive glass component,
wherein said biphasic calcium phosphate particles and said bioactive glass together comprise about 20-60% by weight of the moldable bone graft composition.

### Claim 2 (depends on 1)

The moldable bone graft composition of claim 1, wherein the bioactive glass component comprises about 1-40% by weight of the moldable bone graft composition.

### Claim 3 (depends on 1)

The moldable bone graft composition of claim 1, wherein the one or more bioresorbable polymers comprise a polyalkylene oxide polymer having at least one of the following: a molecular weight of about 500-1500 grams/mole; a specific gravity of about 1.0-1.3 (at 25° C.); a viscosity of about 10-40 cSt (at 210° C.); or a melting temperature of about 38-50° C.

### Claim 4 (depends on 1)

The moldable bone graft composition of claim 1, wherein the biphasic calcium phosphate particles comprise about 20-60% hydroxyapatite and about 40-80% tricalcium phosphate.

### Claim 5 (depends on 1)

The moldable bone graft composition of claim 1, wherein the biphasic calcium phosphate particles have interconnected macro- and microporosity.

### Claim 6 (depends on 1)

The moldable bone graft composition of claim 1, wherein about 30-90% of the biphasic calcium phosphate particles have a particle size of about 1000-2000 μm; about 10-70% of the biphasic calcium phosphate particles have a particle size of about 425-1000 μm, about 10-50% of the biphasic calcium phosphate particles have a particle size of about 710-1000 μm; and about 1-30% of the biphasic calcium phosphate particles have a particle size of about 425-710 μm.

### Claim at position 7

-9. (canceled)

### Claim 10 (depends on 1)

The moldable bone graft composition of claim 1, wherein at least 80% of the bioactive glass is in the form of particles having a particle size of about 212-425 μm.

### Claim 11 (depends on 1)

The moldable bone graft composition of claim 1, wherein the bioactive glass is in the form of irregular granules, approximately spherical particles, or fibers.

### Claim at position 10

-13. (canceled)

### Claim 14 (depends on 1)

The moldable bone graft composition of claim 1, wherein about 60-90% of the biphasic calcium phosphate particles and bioactive glass together are in the form of particles having a particle size of about 425-2000 μm, and about 10-40% of the particles have a particle size of about 1-425 μm.

### Claim at position 12

-23. (canceled)

### Claim 24 (depends on 1)

The moldable bone graft composition of claim 1, further comprising: a melt skin layer disposed on the outer surface of the composition, wherein the melt skin layer comprises the bioresorbable polymer.

### Claim at position 14

-39. (canceled)

### Claim 40

A moldable bone graft composition, comprising:
a) at least about 40% by weight of one or more bioresorbable polymers;
b) at least about 10% by weight of biphasic calcium phosphate particles comprising hydroxyapatite and tricalcium phosphate; and
c) a bioactive glass component,
wherein said biphasic calcium phosphate particles and said bioactive glass together comprise at least about 20% by weight of the moldable bone graft composition.

### Claim 41 (depends on 40)

The moldable bone graft composition of claim 40, wherein the bioactive glass component comprises about 1-40% by weight of the moldable bone graft composition.

### Claim 42 (depends on 40)

The moldable bone graft composition of claim 40, wherein the one or more bioresorbable polymers comprise a polyalkylene oxide polymer having at least one of the following: a molecular weight of about 500-1500 grams/mole; a specific gravity of about 1.0-1.3 (at 25° C.); a viscosity of about 10-40 cSt (at 210° C.); or a melting temperature of about 38-50° C.

### Claim 43 (depends on 40)

The moldable bone graft composition of claim 40, wherein the biphasic calcium phosphate particles comprise about 20-60% hydroxyapatite and about 40-80% tricalcium phosphate.

### Claim 44 (depends on 40)

The moldable bone graft composition of claim 40, wherein the biphasic calcium phosphate particles have interconnected macro- and microporosity.

### Claim 45 (depends on 40)

The moldable bone graft composition of claim 40, wherein about 30-90% of the biphasic calcium phosphate particles have a particle size of about 1000-2000 μm; about 10-70% of the biphasic calcium phosphate particles have a particle size of about 425-1000 μm, about 10-50% of the biphasic calcium phosphate particles have a particle size of about 710-1000 μm; and about 1-30% of the biphasic calcium phosphate particles have a particle size of about 425-710 μm.

### Claim 46 (depends on 40)

The moldable bone graft composition of claim 40, wherein at least 80% of the bioactive glass is in the form of particles having a particle size of about 212-425 μm.

### Claim 47 (depends on 40)

The moldable bone graft composition of claim 40, wherein the bioactive glass is in the form of irregular granules, approximately spherical particles, or fibers.

### Claim 48 (depends on 40)

The moldable bone graft composition of claim 40, wherein about 60-90% of the biphasic calcium phosphate particles and bioactive glass together are in the form of particles having a particle size of about 425-2000 μm, and about 10-40% of the particles have a particle size of about 1-425 μm.

### Claim 49 (depends on 40)

The moldable bone graft composition of claim 40, further comprising: a melt skin layer disposed on the outer surface of the composition, wherein the melt skin layer comprises the bioresorbable polymer.
