Bone substitute compositions and method of use

• US 20050251149A1
• Filed: 04/27/2005
• Published: 11/10/2005
• Est. Priority Date: 04/27/2004
• Status: Active Grant

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Wenz, Robert
• Granted Patent: US 8,168,692 B2
• Time in Patent Office: Days
• US Class Current: 606/94
• CPC Class Codes: A61L 2400/06 Flowable or injectable implant compositions
• CPC Class Codes: A61L 2430/38 for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/446 with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
• 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: C08L 71/02 Polyalkylene oxides

Abstract

The present invention relates to novel bone substitute compositions and methods of use. It further encompasses the use of these novel bone substitute compositions for bone augmentation and the treatment of disease conditions. The invention also contemplates a kit including bone substitute compositions and a percutaneous delivery device.

Claims

1. A composition comprising:

a mineral component that hardens in an aqueous environment; and

a non-aqueous component having an aqueous replacement characteristic that causes the composition to harden when replaced with aqueous body fluid.

2. The composition of claim 1, wherein said composition further comprises a radiopacifier.

3. The composition of claim 1, wherein said mineral component is selected from the group consisting of calcium sulfate, calcium sulfate α

-hemihydrate, calcium sulfate β

-hemihydrate, calcium sulfate anhydrous, calcium sulfate-dihydrate, magnesium hydroxyphosphate, tri-magnesium phosphate, di-ammonium hydroxyphosphate, di-ammonium sulfate, di-potassium hydroxyphosphate, potassium di-hydroxyphosphate, di-sodium-, sodium-di-hydroxyphosphate, magnesium carbonate, silicon dioxide, aluminum oxide, iron oxide, calcium oxide, calcium phosphates, and combinations thereof.

4. The composition of claim 1, wherein said mineral component consists of calcium sulfate-anhydrous and calcium sulfate-dihydrate.

5. The composition of claim 1, wherein said mineral component consists of calcium sulfate α

- or β

-hemihydrate and calcium sulfate-dihydrate.

6. The composition of claim 1, wherein said mineral component consists of calcium sulfate-anhydrous, calcium sulfate α

-hemihydrate and calcium sulfate-dihydrate.

7. The composition of claim 1, wherein said non-aqueous component is selected from the group consisting of polyethylene glycol (PEG), glycerin, polyvinylalcohol, polyvinylpyrolidon (PVP), propandiol, propanol, glycosaminoglycan (GAG), C-chondroitinsulfate, dextran, dextran sulfate, chitosan, polylactic acid (PLA), polyglycolic acid (PGA), polylacticglycolic acid (PLGA), poly-L-lactide (PLLA), and combinations thereof.

8. The composition of claim 7, wherein said PEG has a molecular weight (MW) of about 200 for flowable cements and about 1500 for non-flowable cements.

18. A method comprising:

providing a composition of claim 1;

and

delivering said composition to a bone, wherein said non-aqueous component is replaced with aqueous body fluid, thereby hardening said composition to provide a hardened bone substitute material in contact with the bone.

19. The composition of claim 18, wherein said composition is pre-mixed prior to use.

20. The composition of claim 19, wherein said composition is further pre-loaded in a percutaneous delivery device prior to use and delivered through the device.

22. A kit comprising:

a percutaneous delivery device; and

a composition of claim 1.

23. A kit as in claim 22, further comprising instructions for use and setting forth a method comprising providing said composition;

and delivering said composition to a bone, wherein said non-aqueous component is replaced with aqueous body fluid, thereby hardening said composition to provide a hardened bone substitute material in contact with the bone.

24. The kit of claim 22, wherein said percutaneous delivery device is selected from the group consisting of a bone filler device, a syringe, a needle, a cement gun, a reduced diameter bone filler device, and a modified tip to enable directional flow.

25. The kit of claim 24, further comprising a heating device or heat-pack.

26. A method comprising:

providing the kit of claim 22, wherein said composition is ready for use; and

delivering said composition to a bone, wherein the non-aqueous component is replaced with aqueous body fluid, thereby hardening said composition to provide a hardened bone substitute material in contact with the bone.

27. A composition of claim 1, wherein the mineral component is calcium phosphate and the non-aqueous component is polyethylene glycol (PEG).

28. A composition of claim 1, wherein the mineral component is calcium aluminate and the non-aqueous component is polyethylene glycol (PEG).

9. A composition comprising:

calcium sulfate-anhydrous;

calcium sulfate-dihydrate; and

polyethylene glycol (PEG).

10. The composition of claim 9, wherein said composition is stable at a temperature range from about 0°

C. to about 50°

C.

11. The composition of claim 9, wherein said calcium sulfate-anhydrous is a powder and said calcium sulfate-dihydrate consists of at least one seed.

12. The composition of claim 9, wherein the composition comprises about 10 weight percent to about 50 weight percent PEG;

about 30 weight percent to about 80 weight percent calcium sulfate-anhydrous, and about 0 weight percent to about 60 weight percent calcium sulfate-dihydrate.

13. The composition of claim 9, wherein said PEG is replaced with aqueous body fluid in situ to harden said composition.

14. The composition of claim 9, wherein the calcium sulfate-anhydrous comprises calcium sulfate α

- or β

-hemihydrate.

15. The composition of claim 14, wherein the composition comprises about 20 weight percent to about 40 weight percent PEG;

about 80 weight percent to about 60 weight percent calcium sulfate α

- or β

-hemihydrate, and about 0 weight percent to about 40 weight percent calcium sulfate-dihydrate.

16. A composition comprising:

calcium sulfate-anhydrous;

calcium sulfate α

-hemihydrate;

calcium sulfate-dihydrate; and

polyethylene glycol (PEG).

17. The composition of claim 16, wherein said calcium sulfate-dihydrate is about 0 to about 25 weight percent.

21. A method comprising:

providing a composition including a mineral component and a non-aqueous component having an aqueous replacement characteristic;

inserting an expandable device into a bone;

expanding said expandable device to create a cavity or space within the bone; and

delivering said composition to the bone through a delivery device, wherein said non-aqueous component is replaced with aqueous body fluid, thereby hardening said composition to provide a hardened bone substitute material.