Bone growth particles and osteoinductive composition thereof

• US 7,718,616 B2
• Filed: 12/21/2006
• Issued: 05/18/2010
• Est. Priority Date: 12/21/2006
• Status: Active Grant

• Current Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Orthobiologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Thorne, Kevin J.
• Primary Examiner(s): KAM, CHIH MIN
• Application Number:
  US11/614,422
• Publication Number:
  US 20080152687A1
• Time in Patent Office: 1,244 Days
• Field of Search: 530/356, 514/2, 514/12, 514/8, 514/54, 424/602, 424/488, 424/489, 424/490, 424/497, 424/423, 536/551
• US Class Current: 514/17.2
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 35/14 Blood; Artificial blood perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61K 38/18 Growth factors; Growth regulators
• CPC Class Codes: A61K 38/39 Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

A biocompatible synthetic bone growth composition comprising a fibrillar collagen component and a calcium phosphate component. The composition is formed into particles, and then formed into a unitary article that may be provided at the site of a skeletal defect. An osteoinductive component may be further added, either before or after forming the unitary article. The composition may be formulated as a paste or putty and facilitates bone growth and/or repair.

Claims

1. A process for producing a bone growth composition comprising combining a fibrillar collagen component with an acidic calcium phosphate component to produce a mineralized collagen component, and creating particles of the mineralized collagen component, wherein the mineralized collagen component comprises the form of a crosslinked sponge prior to creating the particles, wherein creation of the particles includes milling.

2. The process of claim 1 wherein the mineralized collagen component comprises the form of a gel prior to creating the particles.

3. The process of claim 1 comprising adding an osteoinductive component to the composition.

4. The process of claim 3 wherein the osteoinductive component is added after the particles are formed.

5. The process of claim 1 wherein combining a fibrillar collagen component with an acidic calcium phosphate component to produce a mineralized collagen component further comprises preparing a collagen gel.

6. The composition of claim 5 further comprising lyophilizing the mineralized collagen compomnent.

7. The process of claim 1 wherein the acidic calcium phosphate is selected from the group consisting of monocalcium phosphate [Ca(H₂PO₄)₂], calcium phosphate dibasic [CaHPO₄], calcium pyrophosphate [2CaO.P₂O₅], and combinations thereof.

8. The process of claim 7 wherein the acidic calcium phosphate comprises calcium phosphate dibasic [CaHPO₄].

9. The process of claim 1 wherein collagen is dehydrothermally crosslinked.

10. A process for producing a bone growth composition comprising combining a fibrillar collagen component with an acidic calcium phosphate component to produce a mineralized collagen component, and creating particles of the mineralized collagen component, wherein the mineralized collagen component comprises the form of a crosslinked sponge prior to creating the particles, further comprising including the particles in a kit.

11. The process of claim 10 wherein the kit includes a device for mixing the particles with a fluid.

12. The process of claim 10 wherein the kit includes a receptacle for mixing the particles with a fluid.

13. A process for producing a bone growth composition comprising combining a fibrillar collagen component with an acidic calcium phosphate component to produce a mineralized collagen component, and creating particles of the mineralized collagen component, wherein the mineralized collagen component comprises the form of a crosslinked sponge prior to creating the particles, further comprising sizing the particles.

14. The process of claim 13 wherein the size of the particles is selected by sieving.