VERTEBROPLASTY COMPOSITIONS & METHODS

• US 20070050043A1
• Filed: 10/26/2006
• Published: 03/01/2007
• Est. Priority Date: 03/15/2004
• Status: Abandoned Application

• Current Assignee: Broockeville Corporation N.V.
• Original Assignee: Broockeville Corporation N.V.
• Inventors: de VRIES, JAN
• Application Number:
  US11/553,403
• Publication Number:
  US 20070050043A1
• Time in Patent Office: Days
• US Class Current: 623/23.610
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/30069 elastomeric

Abstract

Vertebroplasty compositions and methods are provided. By providing an elastic form stable material which is capable of being delivered directly to a specific desired location within a living creature and provides increased strength and rigidity to the injected location, disorders of the vertebrae of a living creature, for example disorders derived from osteoporosis, are able to be effectively treated. In a method embodiment, elastic form stable material is injected directly into a vertebral body to reinforce and strengthen the vertebral body. Other embodiments are also claimed and described.

Claims

1. A vertebroplasty method to treat a disordered vertebral body comprising:

injecting a curable bone filler composition in said vertebral body, wherein the curable bone filler material comprises an elastic form stable material.

2. The method of claim 1, wherein said composition comprises a curable elastomer-precursor composition.

3. The method of claim 1, wherein said composition comprises a silicone elastomer.

4. The method of claim 3, wherein said silicone elastomer comprises poly (dimethyl siloxane).

5. The method of claim 1, wherein said composition comprises a cross-linking agent and a diluent.

6. The method of claim 1, wherein said composition comprises a radiopaque material.

7. The method of claim 6, wherein said radiopaque material comprises one of silver powder, barium sulfate, bismuth trioxide, zirconium dioxide, tantalum or titanium powders or fibers, calcium sulfate, calcium phosphate, hydroxyapetite, tri calcium phosphate, and other medically appropriate opacifier agents.

8. The method of claim 1, wherein the curable bone filler material further comprises:

between about 60% and 85% by weight based upon the weight of the entire composition of poly (dimethyl siloxane);

between about 2% and 5% by weight based upon the weight of the entire composition of the cross-linking agent;

between about 10% and 20% by weight based upon the weight of the entire composition of the diluent; and

between about 10% and 20% by weight based upon the weight of the entire composition of the radiopaque material.

9. The method of claim 1, wherein said composition is prepared in advance in a mixing-dispensing device.

10. The method of claim 1 wherein said composition is delivered to the vertebral body by inserting a needle into the internal cavity of the vertebral body and causing the filler material to flow through the needle into the vertebral body.

11. The method of claim 10, further comprising stopping the flow of the filler material when the vertebral body has been filled with the filler material, and withdrawing the needle from the vertebral body.

12. The method of claim 1, wherein said filler material flexible to move, shift, compress, and or elongate within the vertebral body, thereby providing varying actions or reactions.

13. A method to prepare a composition for injection into a disordered area of a body of a living creature, the composition comprising an elastic form stable material consisting of a curable elastomer-precursor composition and additives intermixed therewith, the composition having reduced toxicity.

14. The method of claim 13, wherein the curable elastomer-precursor composition comprises a silicone elastomer.

15. The method of claim 14, wherein said silicone elastomer is poly (dimethoxy siloxane).

16. The method of claim 13, wherein the additives comprise one of a cross-linking agent, a diluent, and a radiopaque material.

17. The method of claim 13, wherein the composition is a kit of parts, comprising a first container with said silicone elastomer, and a second container with said cross-linking agent.

18. The method of claim 17, wherein said kit of parts comprises a mixing-dispensing device, comprising said container and a temporary seal between the containers, wherein one container is provided with a movable stirrer.

19. The method of claim 13, further comprising thoroughly intermixing:

between about 60% and 85% by weight based upon the weight of the entire composition of poly (dimethyl siloxane);

between about 2% and 5% by weight based upon the weight of the entire composition of the cross-linking agent;

between about 10% and 20% by weight based upon the weight of the entire composition of the diluent; and

between about 10% and 20% by weight based upon the weight of the entire composition of the radiopaque material, thereby forming the desired inject, composition.