Bone repair composite material

• US 6,692,532 B1
• Filed: 05/18/2001
• Issued: 02/17/2004
• Est. Priority Date: 09/19/1998
• Status: Expired due to Fees

• Current Assignee: Fite Holdings Limited
• Original Assignee: Fite Holdings Limited
• Inventors: Healy, David Michael, Gilchrist, Thomas
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US09/787,384
• Time in Patent Office: 1,005 Days
• Field of Search: 623/23.51, 623/23.61, 623/23.71, 623/23.73, 623/11.11, 623/16.11, 623/23.63, 623/23.56, 623/23.62, 623/17.11, 523/115, 523/116
• US Class Current: 623/23.51
• CPC Class Codes: A61L 24/0068 Inorganic materials not covered by groups A61L24/0057 or A61L24/0063
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/10 Ceramics or glasses
• CPC Class Codes: A61L 27/3608 Bone, e.g. demineralised bone matrix [DBM], bone powder
• CPC Class Codes: A61L 27/365 Bones
• CPC Class Codes: A61L 27/427 of other specific inorganic materials not covered by A61L27/422 or A61L27/425
• CPC Class Codes: C03C 12/00 Powdered glass C03C8/02 takes precedence; Bead compositions
• CPC Class Codes: C03C 3/16 containing phosphorus
• CPC Class Codes: C03C 4/0007 for biologically-compatible glass
• CPC Class Codes: C03C 4/0014 Biodegradable glass

Abstract

There is provided an admixture comprising morsellised bone particles and particles of water-soluble biodegradable glass. The particle size distribution and diameter range is pre-selected to produce an aggregate. Addition of the glass enables an admixture having aggregate characteristics and thus increased shear strength to be produced whilst simultaneously enabling bone regeneration to occur within the treated defect. The admixture is therefore useful in the repair of bone defects, especially primary joint arthroplasties, such as hip replacement operations.

Claims

1. An admixture of biocompatible water-soluble glass particles comprising 30 to 85 mole % P₂O₅, and morsellised bone particles for use in bone repair, wherein the particle size range and particle size distribution of the whole admixture is pre-selected to be capable of forming a well graded aggregate wherein said admixture does not comprise SiO₂.

2. The admixture as claimed in claim 1 wherein the diameters of the biocompatible water-soluble glass particles and of the morsellised bone particles are from 0.1 mm to 10.0 mm.

3. The admixture as claimed in claim 2 wherein the diameters of the biocompatible water-soluble glass particles and of the morsellised bone particles are from 0.5 mm to 6.0 mm.

4. The admixture as claimed in claim 1 wherein the size distribution of the particles in the admixture is selected to approximate to the Fuller curve.

5. The admixture as claimed in claim 1 comprising at least 40% by volume of morsellised bone particles.

6. The admixture as claimed in claim 1 wherein the morsellised bone particles are washed prior to use.

7. The admixture as claimed in claim 1 wherein said biocompatible water-soluble glass particles dissolve over a time period compatible with bone repair.

8. The admixture as claimed in claim 7 wherein said water-soluble glass has the composition:

20-35 mole_% Na₂O;

18-30 mole_% CaO; and

45-60 mole % P₂O₅.

9. The admixture as claimed in claim 1 wherein the water-soluble glass comprises an active ingredient to stimulate bone repair which is controllably released upon dissolution of the glass.

10. A composition for use in repair of bone defects, said composition comprising a well graded aggregate of water-soluble glass particles and morsellised bone particles, said water-soluble glass particles comprising 30 to 85 mole % P₂O₅ and wherein said well graded aggregate does not comprise SiO₂.

11. A composition as claimed in claim 10 wherein the diameter of said water soluble glass particles and morsellised bone particles is from 0.1 mm to 10.0 mm.

12. The composition as claimed in claim 10 comprising at least 25% by volume of water-soluble glass particles.

13. The composition as claimed in claim 12 comprising at least 40% by volume of water-soluble glass particles.

14. The composition as claimed in claim 10 wherein the morsellised bone particles are washed prior to use.

15. The composition as claimed in claim 10 wherein said water soluble glass particles dissolve over a time period compatible with bone repair.

16. The composition as claimed in claim 15 wherein said water-soluble glass particles have the composition:

20-35 mole_% Na₂O;

18-30 mole_% CaO; and

45-60 mole % P₂O₅.

17. The composition as claimed in claim 10 wherein the water-soluble glass particles comprise an active ingredient to promote bone repair which is controllably released by dissolution of the glass.

18. A method of repairing bone defects, said method comprising packing at least part of said defect with an admixture of biocompatible watersoluble glass particles comprising, 30 to 85 mole % P₂O₅ and morsellised bone particles, wherein the particle size range and particle size distribution of the whole admixture is pre-selected to be capable of forming a well graded aggregate and wherein said admixture does not comprise SiO₂.

19. The method as claimed in claim 18 wherein a prosthesis is located in said bone defect and wherein said admixture is used therearound.

20. The method as claimed in claim 18 wherein said defect is a primary joint arthroplasty.

21. A method of repairing bone defects, said method comprising packing at least part of said defect with a composition comprising a well graded aggregate of water-soluble glass particles and morsellised bone particles, said water-soluble glass particles comprising 30 to 85 mole % P₂O₅ and wherein said well graded aggregate does not comprise SiO₂.

22. The method as claimed in claim 21 wherein a prosthesis is located in said bone defect and wherein said composition is used therearound.

23. The method as claimed in claim 21 wherein said defect is a primary joint arthroplasty.