# US 8,999,366 B2 · Porous biomaterial on hydroxyapatite

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- Number: US 8,999,366 B2
- Document ID: US8999366B2
- Status: Granted
- Kind: B2
- Application number: 12/865,573
- Filed: 2009-02-02
- Published: 2011-03-10
- Granted: 2015-04-07
- Earliest claimed: 2009-02-02
- Assignees: ApaTech Limited
- Applicants: Thomas Buckland; Charles Campion
- Inventors: Thomas Buckland; Charles Campion
- Web page: https://patentgrep.com/patent/US8999366B2

## CPC

- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 27/025: {Other specific inorganic materials not covered by A61L27/04 - A61L27/12}
- A61L 27/12: Phosphorus-containing materials, e.g. apatite
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61F 2/28: Bones
- A61L 2400/08: Methods for forming porous structures using a negative form which is filled and then removed by pyrolysis or dissolution
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- Y10T 428/2982: Particulate matter [e.g., sphere, flake, etc.]
- 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
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

The present invention provides a synthetic non-resorbable silicon-containing calcium phosphate biomaterial having a microporosity of 23% by volume or greater, wherein the surface free energy of the biomaterial is 19 mJ/m.

## Claims

### Claim 1

A synthetic non-resorbable silicon-containing calcium phosphate biomaterial having a microporosity of 25-35% by volume, wherein the surface free energy of the biomaterial is 30 mJ/m2 or greater, and wherein micro-pores resulting in the microporosity have an interconnection diameter of 50 nm to 10 μm as measured by mercury porosimetry analysis, wherein the mean interconnected diameter of micro-pores resulting in the microporosity is 0.5 μm to 10 μm.

### Claim 2 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the calcium phosphate biomaterial comprises a hydroxyapatite material.

### Claim 3 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the silicon is substituted into the crystal lattice of the calcium phosphate material.

### Claim 4 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the calcium phosphate forming the calcium phosphate material has substantially no impurity phases of calcium oxide and/or tricalcium phosphate.

### Claim 5 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the calcium phosphate forming the calcium phosphate material has a phase purity, as measured by X-ray diffraction, of at least 90%.

### Claim 6 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1 containing from 0.1% to 1.6% by weight of silicon.

### Claim 7 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the material has a permeability resulting from the microporosity of 0.206 nm2 or greater.

### Claim 8 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the material has a capillary pressure in water of 3.7 kPa or greater.

### Claim 9 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the surface free energy of the material is 35 mJ/m2 or greater.

### Claim 10 (depends on 1)

The silicon-containing calcium phosphate biomaterial of claim 1, wherein the material also contains macro-pores.

### Claim 11 (depends on 1)

The biomaterial of claim 1, wherein the total wicking capacity (vol/vol %) of the biomaterial is 400% by volume or more.

### Claim 12

A silicon-containing sintered calcium phosphate biomaterial having a microporosity of 25-35% by volume and a surface free energy of 30 mJ/m2 or greater, wherein micro-pores resulting in the microporosity have an interconnection diameter of 50 nm to 10 μm as measured by mercury porosimetry analysis, wherein the mean interconnected diameter of micro-pores resulting in the microporosity is 0.5 μm to 10 μm.

### Claim 13

A synthetic silicon-substituted calcium phosphate biomaterial having a microporosity of 25-35% by volume and a surface free energy of 30 mJ/m2 or greater, wherein the biomaterial comprises substantially no impurity phases of calcium oxide and/or tricalcium phosphate, wherein micropores resulting in the microporosity have an interconnection diameter of 50 nm to 10 μm as measured by mercury porosimetry analysis, wherein the mean interconnected diameter of micropores resulting in the microporosity is 0.5 μm to 10 μm.

### Claim 14 (depends on 1)

A synthetic calcium phosphate biomaterial as defined in claim 1 for use in medicine.

### Claim 15 (depends on 1)

A method of treating bone fractures, achieving spinal fusions, repairing bone tumours or vertebral compression fractures, the method comprising implanting a biomaterial according to claim 1 in a patient or animal.

### Claim 16

A method of selecting a synthetic porous osteoinductive biomaterial and providing osteoinduction of bone to treat a patient or animal, the method comprising:
(a) selecting an osteoinductive synthetic non-resorbable silicon-containing calcium phosphate biomaterial having a microporosity of 25-35% by volume, a surface free energy of 30 mJ/m2 or greater and micropores resulting in the microporosity have an interconnection diameter of 50 nm to 10 μm as measured by mercury porosimetry analysis, wherein the mean interconnected diameter of micropores resulting in the microporosity is 0.5 μm to 10 μm;
(b) configuring said osteoinductive biomaterial as a replacement bone-material to provide for osteoinduction; and
(c) implanting said osteoinductive biomaterial in the patient or animal.
