# US 2023/0053789 A1 · Bone graft composition

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- Number: US 2023/0053789 A1
- Document ID: US20230053789A1
- Status: Published application
- Kind: A1
- Application number: 17/759,093
- Filed: 2020-09-25
- Published: 2023-02-23
- Earliest claimed: 2019-09-25
- Assignees: SurGenTec, LLC
- Applicants: Surgentec, LLC
- Inventors: TRAVIS GREENHALGH; ANDREW SHOUP
- Web page: https://patentgrep.com/patent/US20230053789A1

## CPC

- A61F 2/4601: {for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity}
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61F 2/28: Bones
- A61F 2/3094: {Designing or manufacturing processes}
- A61L 27/10: Ceramics or glasses
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/20: Polysaccharides
- A61L 27/3608: {Bone, e.g. demineralised bone matrix [DBM], bone powder}
- A61L 27/46: with phosphorus-containing inorganic fillers
- A61L 27/58: Materials at least partially resorbable by the body
- C03B 19/06: by sintering, {e.g. by cold isostatic pressing of powders and subsequent sintering, by hot pressing of powders, by sintering slurries or dispersions not undergoing a liquid phase reaction}
- A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material}
- A61F 2002/30985: {using three dimensional printing [3DP]}
- A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite
- A61F 2310/00329: Glasses, e.g. bioglass
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- 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)
- C03B: MANUFACTURE, SHAPING, OR SUPPLEMENTARY PROCESSES

## Abstract

A particle comprising hydroxyapatite, β-tricalcium phosphate, α-tricalcium phosphate, and/or bioactive glass is provided. The particle can be useful in bone graft compositions further comprising a carrier. The composition can include a quadphasic particle having hydroxyapatite, β-tricalcium phosphate, α-tricalcium phosphate, bioactive glass, and a carrier. The particle can have a size in the range of 50 microns to 2.5 mm. A method of repairing a bone defect is also provided. The method can include a step of applying the bone graft composition to a subject having the bone defect, such as a spinal bone defect. The subject receiving the bone graft composition can be a mammal, namely a human, pet, or domestic animal.

## Claims

### Claim 1

A particle comprising hydroxyapatite, β-tricalcium phosphate, α-tricalcium phosphate, and bioactive glass; and,
wherein the particle has a particle size of about 50 microns to about 2.5 mm.

### Claim 2 (depends on 1)

The particle of claim 1, wherein the particle comprises:
about 40 wt. % to about 60 wt. % hydroxyapatite;
about 30 wt. % to about 50 wt. % β-tricalcium phosphate;
about 2.5 wt. % to about 25 wt. % α-tricalcium phosphate; and
about 5 wt. % to about 20 wt. % bioactive glass.

### Claim 3 (depends on 1)

The particle of claim 1 wherein the particle is from sintering particles of hydroxyapatite, particles of α-tricalcium phosphate, particles of bioactive glass and particles of β-tricalcium phosphate;
wherein the particle size of the hydroxyapatite ranges from about 2 μm to about 20 μm;
wherein the particle size of the β-tricalcium phosphate ranges from about 2 μm to about μm;
wherein the particle size of the α-tricalcium phosphate ranges from about 50 μm to about 100 μm; and
wherein the particle size of the bioactive glass ranges from about 20 μm to about 90 μm.

### Claim 4 (depends on 1)

A bone graft composition comprising the particle of claim 1 and a carrier.

### Claim 5 (depends on 4)

The bone graft composition of claim 4, further comprising additional hydroxyapatite particles having a particle size in the range of about 50 nm to about 100 μm.

### Claim 6 (depends on 4, 5)

The bone graft composition of claim 4 or 5, wherein the carrier comprises a bioresorbable polymer.

### Claim 7 (depends on 4)

The bone graft composition of claim 4, wherein the carrier comprises polyethylene glycol (PEG) or methylcellulose.

### Claim 8 (depends on 7)

The bone graft composition of claim 7, wherein the polyethylene glycol (PEG) comprises a PEG having a molecular weight in a range of about 500 grams/mole to about 3000 grams/mole.

### Claim 9 (depends on 8)

The bone graft composition of claim 8, wherein the polyethylene glycol (PEG) comprises a PEG having a molecular weight in a range of about 1500 grams/mole to about 2500 grams/mole.

### Claim 10 (depends on 7)

The bone graft composition of claim 7, wherein the composition comprises between about 30 wt % and about 50 wt % methylcellulose.

### Claim 11 (depends on 4)

The bone graft composition of claim 4, wherein the carrier further comprises glycerol.

### Claim 12 (depends on 4)

The bone graft composition of claim 4, wherein the quadriphasic particle comprises about 30 wt. % to about 70 wt. % of the composition.

### Claim 13 (depends on 4)

The bone graft composition of claim 4, wherein the carrier comprises about 40 wt. % to about 60 wt. % of the composition.

### Claim 14 (depends on 4)

The bone graft composition of claim 4, wherein the quadphasic particle size is in a range of about 50 microns to about 1 millimeter.

### Claim 15 (depends on 14)

The bone graft composition of claim 14, wherein the quadphasic particle size is in a range of about 250 microns to about 1 millimeter.

### Claim 16 (depends on 4)

The bone graft composition of claim 4, wherein the particle comprises about 25 wt. % to about 75 wt. % of hydroxyapatite.

### Claim 17 (depends on 16)

The bone graft composition of claim 16, wherein the particle comprises about 40 wt. % to about 60 wt. % of hydroxyapatite.

### Claim 18 (depends on 4)

The bone graft composition of claim 4, wherein the particle comprises:
about 30 wt. % to about 50 wt. % of β-tricalcium phosphate; and
about 5 wt. % to about 25 wt. % of α-tricalcium phosphate.

### Claim 19 (depends on 4)

The bone graft composition of claim 4, wherein the bone graft composition exhibits a quadphasic resorption profile.

### Claim 20 (depends on 4)

The bone graft composition of claim 4, wherein the composition comprises a surface texturing.

### Claim 21 (depends on 20)

The bone graft composition of claim 20, wherein the surface texturing is osteoconductive.

### Claim 22 (depends on 20)

The bone graft composition of claim 20, wherein the surface texturing comprises nano, micro or sub-micron hydroxyapatite.

### Claim 23 (depends on 4)

The bone graft composition of claim 4, further comprising demineralized bone matrix.

### Claim 24 (depends on 23)

The bone graft composition of claim 23, comprising about 10% to about 90% by weight of demineralized bone matrix.

### Claim 25 (depends on 24)

The bone graft composition of claim 24, comprising about 20% to about 80% by weight of demineralized bone matrix.

### Claim 26 (depends on 25)

The bone graft composition of claim 25, comprising about 40% to about 60% by weight of demineralized bone matrix.

### Claim 27

The bone graft composition of claim [26, comprising about 15% to about 45% by volume of demineralized bone matrix.

### Claim 28 (depends on 25)

The bone graft composition of claim 25, comprising about 10% to about 50% by volume of demineralized bone matrix.

### Claim 29 (depends on 4)

The bone graft composition of claim 4, further comprising an embedded hydroxyapatite substrate,
wherein the embedded hydroxyapatite substrate comprises micro-hydroxyapatite, submicron-hydroxyapatite, and/or nano-hydroxyapatite particles.

### Claim 30 (depends on 29)

The bone graft composition of claim 29, wherein the particles of the embedded hydroxyapatite substrate have a size from about 50 nm to about 100 μm.

### Claim 31 (depends on 30)

The bone graft composition of claim 30, wherein the particles of the embedded hydroxyapatite substrate have a size from about 20 nm to about 50 μm.

### Claim 32 (depends on 31)

The bone graft composition of claim 31, wherein the particles of the embedded hydroxyapatite substrate have a size from about 5 μm to about 35 μm.

### Claim 33 (depends on 32)

The bone graft composition of claim 32, comprising about 40 wt. % to about 55 wt. % of the embedded hydroxyapatite substrate; wherein the additional hydroxyapatite particles are present in an amount of about 40 wt. % to about 55 wt. %.

### Claim 34 (depends on 4)

A prefilled cartridge for a delivery device, wherein the prefilled cartridge contains the bone graft composition of claim 4.

### Claim 35 (depends on 1)

A method of preparing the particle of claim 1 comprising:
admixing the particles of hydroxyapatite, the particles of β-tricalcium phosphate, the particles of α-tricalcium phosphate, and the particles of bioactive glass;
sintering the admixed particles at a temperature from about 500° C. to about 1700° C. to obtain sintered particles; and
adjusting the size of sintered particles to be in the range of 50 microns to about 2.5 mm.

### Claim 36 (depends on 4)

A method of repairing a bone defect, comprising applying the bone graft composition of claim 4 to a subject having the bone defect and in need of repair of the bone defect.

### Claim 37 (depends on 36)

The method of claim 36, wherein the subject is a mammal, or a primate mammal, or a non-human primate mammal, or a human, or wherein the mammal is a canine or dog, a feline or domestic house cat, a bovine or a cow or a bull, an ovine or a sheep or a ewe, a porcine or a pig or a sow or a gilt or a boar, an equine or a horse, a cumulus or a camel, or a caprinae or a goat.

### Claim 38 (depends on 36)

The method of claim 36, wherein the bone defect is a spinal bone defect.

### Claim 39 (depends on 1, 4, 36)

Use of particles of claim 1 for preparing or manufacturing the bone graft composition of claim 4, for performing a method of repairing a bone defect of claim 36.

### Claim 40 (depends on 4)

A kit comprising the bone graft composition of claim 4 and a delivery device for administering the bone graft composition to a subject having a bone defect; and optionally instructions for use.

### Claim 41 (depends on 40)

The kit of claim 40, further comprising an additional implantation device.

### Claim 42 (depends on 41)

The kit of claim 41, wherein the additional implantation device is a 3D printed cage.

### Claim 43 (depends on 41)

The kit of claim 41, wherein the additional implantation device is a loading case.