Bioactive ceramic cement

• US 6,479,565 B1
• Filed: 08/16/1999
• Issued: 11/12/2002
• Est. Priority Date: 08/16/1999
• Status: Expired due to Fees

• Current Assignee: Harold R. Stanley
• Original Assignee: Harold R. Stanley
• Inventors: Stanley, Harold R.
• Primary Examiner(s): MEDLEY, MARGARET B
• Application Number:
  US09/374,778
• Time in Patent Office: 1,184 Days
• Field of Search: 523/115, 523/116, 523/122, 523/114, 264/1.7, 501/12, 501/39, 501/57, 501/58, 623/16.11, 623/923
• US Class Current: 523/114
• CPC Class Codes: A61F 2002/4631 the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/43 Hormones, e.g. dexamethasone
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0084 containing fillers of phosphorus-containing inorganic compounds, e.g. apatite
• CPC Class Codes: A61L 24/0089 containing inorganic fillers not covered by groups A61L24/0078 or A61L24/0084
• 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 27/46 with phosphorus-containing inorganic fillers
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C03C 4/0007 for biologically-compatible glass
• CPC Class Codes: C03C 8/16 with vehicle or suspending agents, e.g. slip
• CPC Class Codes: Y10S 623/923 Bone

Abstract

The present invention provides a solution to the problems with known cements by providing a composition comprising (a) microscopic anhydrous pellets or particles containing the most important components of biological fluids or synthetic biological fluids (SBFs), (b) bioactive glass or other bioactive ceramic particles and (c) an appropriate resin such as, but not limited to, bisphenol-alpha-glycidyl methacrylate (BIS-GMA), to form a bone-forming cement which enhances (accelerates) bone production and bone bonding.

Claims

1. A composition comprising:

(a) a bioactive ceramic;

(b) anhydrous particles comprising at least one component of a biological fluid or of a synthetic biological fluid; and

(c) a biocompatible resin.

2. The composition according to claim 1 wherein said anhydrous particles comprise Na⁺ ions, K⁺ ions, Mg²⁺ ions, Ca²⁺ ions, Cl⁻

ions, HCO₃⁻

ions, SO₄²⁻

ions, or HPO₄²⁻

or combinations thereof.

3. The composition according to claim 2 wherein said ions are dispersed in tris-(hydroxymethyl) aminomethane.

4. The composition according to claim 1 wherein said biocompatible resin is bisphenol-alpha-glycidyl methacrylate.

5. The composition according to claim 1 wherein said bioactive ceramic is a bioactive glass comprising Si, Ca, Na, O₂, H and P.

6. The composition according to claim 5 wherein said bioactive glass is 45S5 bioactive glass.

7. The composition of claim 2 wherein said composition comprises an intimate mixture of (a) said bioactive ceramic;

(b) said anhydrous particles comprising the components of said biological fluid or said synthetic biological fluid; and

(c) said biocompatible resin, whereby said composition is implanted into a recipient in need thereof without the need for measuring individual components at the time of implantation thereof.

8. The composition according to claim 1 comprising (a) 45S5 or other bioactive glass, (b) anhydrous particles comprising the components of biological or synthetic biological fluid comprising Na⁺ ions, K⁺ ions, Mg²⁺ ions, Ca²⁺ ions, Cl⁻

ions, HCO₃⁻

ions, SO₄²⁻

ions, and HPO₄²⁻

ions, and (c) bisphenol-alpha-glycidyl methacrylate.

9. The composition according to claim 7 wherein said biocompatible resin is a liquid.

10. The composition according to claim 7 wherein said composition is in the form of a paste or slurry.

11. The composition according to claim 7, said composition is comprised of discrete particles, wherein said discrete particles have an average size in the range between about 90 μ

m and about 1000 μ

m.

12. The composition according to claim 11 wherein said discrete particles have an average size in the range between about 150 μ

m and about 250 μ

m.

13. The composition according to claim 7, additionally comprising an implant having a surface, wherein said composition is applied to the surface of said implant.

14. The composition according to claim 1 further comprising growth factors, hormones, proteins, peptides, nucleic acids, and combinations thereof.

29. The composition of claim 1 wherein said anbydrous particles arc provided as pellets, which are dispersed in the composition.

31. The composition according to claim 1, wherein said bioactive ceramic is a bioactive glass.

15. A method for inducing bone formation about an implant which comprises

contacting a bone implant site and an implant with a composition comprising (a) a bioactive ceramic;

(b) anhydrous particles comprising at least one component of a biological fluid or of a synthetic biological fluid; and

(c) a biocompatible resin.

16. The method according to claim 15 wherein said anhydrous particles comprising the components of biological fluid or synthetic biological fluid comprises Na⁺ions, K⁺ ions, Mg²⁺ ions, Ca²⁺ ions, Cl⁻

ions, HCO₃ ions, SO₄²⁻

ions, or HPO₄²⁻

ions, or combinations thereof.

17. The method according to claim 16 wherein said ions are dispersed in tris-(hydroxymethyl) aminomethane.

18. The method according to claim 15 wherein said biocompatible resin is bisphenolalpha-glycidyl methacrylate.

19. The method according to claim 15 wherein said bioactive ceramic is a bioactive glass comprising Si, Ca, Na, O₂, H and P.

20. The method according to claim 19 wherein said bioactive glass is 45S5 bioactive glass.

21. The method according to claim 15 wherein said composition comprises an intimate mixture of (a) said bioactive ceramic;

(b) said anhydrous particles comprising the components of a biological fluid or of a synthetic biological fluid; and

(c) said biocompatible resin, such that said composition may be implanted into a recipient in need thereof without the need for measuring individual components at the time of implantation thereof.

22. The method according to claim 15 comprising (a) 45S5 or other bioactive glass, (b) anhydrous particles comprising the components of biological or synthetic biological fluid comprising Na⁺ ions, K⁺ ions, Mg²⁺ ions, Ca²⁺ ions, Cl⁻

ions, HCO₃⁻

ions, SO₄²⁻

ions, and HPO₄² ions, and (c) bisphenol-alpha-glycidyl methacrylate.

23. The method according to claim 21 wherein said biocompatible resin is a liquid.

24. The method according to claim 21 wherein said composition is in the form of a paste or slurry.

25. The method according to claim 21 wherein said composition is comprised of discrete particles, wherein said discrete particles have an average size in the range between about 90 μ

m and about 1000 μ

m.

26. The method according to claim 25 wherein said discrete particles have an average size in the range between about 150 μ

m and about 250 μ

m.

27. The method according to claim 21 wherein said composition is applied to the surface of an implant.

28. The method according to claim 15 wherein said composition further comprises growth factors, hormones, proteins, peptides, nucleic acids, and combinations thereof.

30. The method of claim 15 wherein said anhydrous particles are provided as pellets, which are dispersed in the composition.