Composite bone repair material

• US 8,574,611 B2
• Filed: 06/30/2008
• Issued: 11/05/2013
• Est. Priority Date: 07/12/2007
• Status: Active Grant

• Current Assignee: Straumann Holding AG
• Original Assignee: Straumann Holding AG
• Inventors: Seibl, Reinhart, Molenberg, Aaldert Rens, Beuling, Nienke, Neidhardt, Astrid Sylvia
• Primary Examiner(s): KEMMERER, ELIZABETH
• Application Number:
  US12/667,496
• Publication Number:
  US 20100292146A1
• Time in Patent Office: 1,954 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/425 of phosphorus containing material, e.g. apatite
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

The present invention relates to a sliceable composite bone repair material comprising a porous block-shaped ceramic scaffold and a stabilizing polymer disposed therein. Said ceramic scaffold is a synthetic ceramic material or a naturally-derived material. Additionally said scaffold comprises interconnected macropores.

Claims

1. A sliceable composite bone repair material comprising:

a porous block-shaped scaffold comprising a bone substitute material comprising a synthetic ceramic material, and wherein said scaffold comprises interconnected macropores; and

a stabilizing polymer disposed therein, wherein the stabilizing polymer is a degradable polyethylene glycol hydrogel formed by a cross-linking Michael-type addition reaction of at least two precursor molecules, wherein said cross-linking reaction forms an ester linkage between the at least two precursor molecules, and

wherein said hydrogel is degradable in water.

2. Composite bone repair material of claim 1 wherein the scaffold is a synthetic ceramic material comprising a calcium phosphate.

3. Composite bone repair material of claim 2 wherein the calcium phosphate is selected from the group consisting of hydroxyapatite and tricalcium phosphate or a mixture thereof.

4. Composite bone repair material according to claim 1 wherein the ceramic scaffold has a total porosity between 75% and 95%.

5. Composite bone repair material according to claim 1 wherein the ceramic scaffold has at least a second portion with enhanced mechanical strength similar to cortical bone.

6. Composite bone repair material according to claim 1 further comprising a bioactive agent.

7. Composite bone repair material of claim 6, wherein the bioactive agent is released from the stabilizing polymer.

8. Composite bone repair material of claim 6, wherein the bioactive agent is selected from the group of parathyroid hormone, bone morphogenic protein and enamel matrix derivatives.

9. A device for the treatment of oral bone defects including the composite bone repair material of claim 1.

10. A kit for preparing a composite bone repair material according to claim 1 comprising the porous block-shaped synthetic ceramic scaffold and the stabilizing polymer.

11. A kit according to claim 10 comprising:

a) the porous block-shaped synthetic ceramic scaffold;

b) a multi-arm PEG-thiol;

c) a multi-arm PEG-acrylate, wherein the total number of arms is equal or larger than five; and

d) buffers for the multi-arm PEG-thiol and multi-arm PEG-acrylate.

12. A kit according to claim 10 additionally comprising a bioactive agent.

13. A kit according to claim 11 additionally comprising a bioactive agent premixed either with the multi-arm PEG-thiol or with the multi-arm PEG-acrylate.