Methods of performing medical procedures that promote bone growth, method of making compositions that promote bone growth, and apparatus for use in such methods

• US 7,964,207 B2
• Filed: 03/24/2005
• Issued: 06/21/2011
• Est. Priority Date: 03/22/2002
• Status: Active Grant

• Current Assignee: Abyrx, Inc., Doctors Research Group, Inc. (Abyrx, Inc.)
• Original Assignee: Doctors Research Group, Inc. (Abyrx, Inc.)
• Inventors: Sendijarevic, Aisa, Deslauriers, Richard
• Primary Examiner(s): Hartley; Michael G
• Assistant Examiner(s): DICKINSON, PAUL W
• Application Number:
  US11/089,489
• Publication Number:
  US 20050220771A1
• Time in Patent Office: 2,280 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• 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: B01F 35/7139 Removing separation walls, plugs which close off the different compartments, e.g. by rotation or axially sliding
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

Methods of performing medical procedures, and methods of making bone-growth-promoting compositions useful in performing medical procedures are provided. Apparatus useful both in methods of performing medical procedures, and in methods of making bone-growth-promoting compositions useful in performing medical procedures, are provided. The bone-growth-promoting compositions made according to the disclosed methods are biocompatible, and are adapted to stimulate bone growth when positioned in contact with, or in the vicinity of, a bone of a mammal.

Claims

1. A bone-growth promoting composition, comprising:

an osteoconductive polyurethane composition having in its cured state an average pore size ranging from about 5 microns to about 500 microns and a compressive strength consistent for use in bone repair, wherein the polyurethane composition is suitable for use in vivo;

calcium carbonate present in an amount ranging from about 0.01% to about 55% by weight of the composition, wherein the polyurethane composition is made by the process of combining a polyol, an isocyanate, and water, and the water is present in an amount ranging from about 0.05% to about 1% by weight of the composition.

2. The composition of claim 1, wherein the water is present in an amount ranging from about 0.1% to about 1% by weight of the composition.

3. The composition of claim 1, wherein the polyol is a naturally-occurring polyol, a biocompatible, synthetic polyol or both.

4. The composition of claim 1, further comprising one or more of bone, calcium phosphate, calcium pyrophosphate, hydroxyapatite, poly methyl methacrylate, glass-ionomer, calcium sulfate, or tricalcium phosphate.

5. The composition of claim 1, wherein the isocyanate is an aromatic isocyanate.

6. The composition of claim 1, wherein the compressive strength is at least 50 MPa.

7. The composition of claim 1, wherein the composition is initially in a moldable state and cures into a solid state.

8. The composition of claim 7, wherein the composition cures into a solid state at room temperature about 20 minutes to about 30 minutes after formulation.

9. The composition of claim 1, wherein the composition in its cured state has a tensile strength of at least 40 MPa.

10. The composition of claim 1, wherein the composition in its cured state has a Modulus of Elasticity of at least 1,500 MPa.

11. The composition of claim 1, wherein the calcium carbonate is present in an amount ranging from about 25% to about 35% by weight of the composition.

12. The composition of claim 1, wherein the process further comprises the inclusion of a cross-linker.

13. The composition of claim 12, wherein the cross-linker is a trifunctional castor-oil based polyol.

14. The composition according claim 1, wherein the calcium carbonate is an osteoconductive component.

15. The composition according to claim 1, wherein the calcium carbonate contributes to the generation of the porosity in the composition.

16. The composition according to claim 1, wherein the calcium carbonate has a particle size distribution that enhances resorption of calcium or bone remodeling within the body of a mammal after implantation.