Bone replacement material on the basis of carbonate and alkali containing calciumphosphate apatites

• US 4,917,702 A
• Filed: 02/09/1988
• Issued: 04/17/1990
• Est. Priority Date: 09/10/1984
• Status: Expired due to Fees

• Current Assignee: Eberhard Wendler, Hans Scheicher
• Original Assignee: Eberhard Wendler, Hans Scheicher
• Inventors: Wendler, Eberhard, Scheicher, Hans
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/153,885
• Time in Patent Office: 798 Days
• Field of Search: 623/16, 501/1, 501/151, 433/201.1, 433/212.1, 106/35
• US Class Current: 424/423
• CPC Class Codes: A61F 2/2803 for mandibular reconstruction temporo-mandibular joints A61F2/3099; bone plates for the jaw A61B17/8071
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2002/2853 Humerus
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00796 Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61K 6/17 Particle size
• CPC Class Codes: A61K 6/54 Filling; Sealing
• CPC Class Codes: A61K 6/71 Fillers
• CPC Class Codes: A61K 6/75 Apatite
• CPC Class Codes: A61K 6/77 Glass
• CPC Class Codes: A61K 6/79 Initiators
• CPC Class Codes: A61K 6/831 comprising non-metallic elements or compounds thereof, e.g. carbon
• CPC Class Codes: A61K 6/873 Carbonates
• CPC Class Codes: A61K 6/887 Compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61K 6/891 Compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 27/12 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: A61L 27/32 : Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: C08L 33/02 : Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 5/00 : Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 67/00 : Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 77/04 : Polyamides derived from alpha-amino carboxylic acids C08L77/10 takes precedence

Abstract

This invention sets forth an agent for filling bone and tooth defects, for building up bone, for bone-contact layers and for the replacement of bones and the roots of teeth, which contains calcium phosphate apatite having carbonate and alkali portions, all ions being definedly integrated in the crystal lattice; use is optionally made together with additives and/or diluents both tolerated by the body. Furthermore, it sets forth the use of this apatite for filling bone and tooth defects, for building up bone, for bone-contact layers, as a replacement for bones and the roots of teeth and as an implant article consisting completely or partially of this apatite or consisting of a material known for implant articles and being coated completely or partially with a layer of this apatite.

Claims

1. An agent for filling bone defects, for building up bone, for forming bone-contact layers on the replacements of bones and roots of teeth and for making independent smaller bone replacement parts or implant articles, comprising a calcium phosphate apatite having carbonate and alkali portions, all ions being definedly integrated in the crystal lattice, of the following formula:

space="preserve" listing-type="equation">Ca.sub.10-a-b-x Me.sup.II.sub.a Me.sup.I.sub.b (PO.sub.4).sub.6-x (CO.sub.3).sub.x (OH).sub.2-b-x (H.sub.2 O).sub.w

wherein

Me^I is a singly charged metal ion,

Me^II is a doubly charged metal ion,

a represents the number of double charged metal ions with the exception of Ca and is a value from 0 to 1.0,

b represents the number of singly charged metal ions and is a value from 0.05 to 1.2,

x represents the number of carbonate ions and is a value from 0.02 to 1.2, the sum b+x being a maximum of 2.0, and

w represents the number of water molecules integrated in the crystal lattice and is a value from 0 to b+x

wherein at least a portion of the Me^I ions are alkali ions and the CO₃ ions are positioned at the PO₄ positions within the apatite lattice.

2. An agent according to claim 1, further comprising at least one compound selected from the group consisting of conventional physiologically acceptable additives and diluents of bone replacement materials.

3. An agent according to claim 2, comprising at least one compound selected from the group consisting of organic binders, inorganic binders, physiological salt solutions, medicaments and hormones as physiologically acceptable additives.

4. An agent according to claim 1, containing 1 to 100% by weight of calcium phosphate apatite of the formula.

5. The agent according to claim 1, wherein, in the calcium phosphate apatite of formula I, a portion of the hydroxy ions is exchanged for halide ions and/or a portion of the Ca²⁺ ions and OH^- ions is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

10. An agent according to claim 2, containing 1 to 100% by weight of calcium phosphate apatite having carbonate and alkali portions according to the formula.

11. An agent according to claim 3, containing 1 to 100% by weight of calcium phosphate apatite having carbonate and alkali portions according to the formula.

12. An agent according to claim 2, wherein, in the calcium phosphate apatite of the formula, a portion of the hydroxy ions is exchanged for halide ions, and/or a portion of the Ca²⁺ ions and OH ions is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

13. An agent according to claim 3, wherein, in the calcium phosphate apatite of the formula, a portion of the hydroxy ions is exchanged for halide ions and/or a portion of the Ca²⁺ ions and OH ions is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

14. An agent according to claim 4, wherein, in the calcium phosphate apatite of the formula, a portion of the hydroxy ions is exchanged for halide ions, and/or a portion of the Ca²⁺ ions and OH ions is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

15. An agent according to claim 1, wherein all of said Me^I are alkali ions.

16. An agent according to claim 1, wherein Me^I is Na³⁰ , K³⁰ , Ag⁺, the combination Ca²⁺ +OH or combinations thereof.

17. An agent according to claim 1, wherein Me^II is Mg²⁺, Pb²⁺, Sr²⁺, Cd²⁺, Mn²⁺, Ca²⁺ or combinations thereof.

18. An agent according to claim 1, wherein Me^I is Na³⁰ .

19. An agent according to claim 1, wherein at least a portion of said Me^I ions are K⁺ ions.

20. An agent according to claim 1, wherein F ions are incorporated into the apatite lattice at the OH positions.

21. An agent according to claim 2, wherein said agent comprises about 30-80 weight percent of said calcium phosphate apatite and about 20-70 weight percent of at least one compound of said conventional physiologically acceptable additives.

6. A process for filling bone and tooth defects, for building up bone, for providing bone-contact layers, for bone replacement, or for tooth-root replacement comprising bringing into contact the affected region of bone or tooth with a material containing a calcium phosphate apatite having alkali and carbonate portions, in which all ions are definedly integrated in the crystal lattice, of the following formula:

space="preserve" listing-type="equation">Ca.sub.10-a-b-x Me.sup.II.sub.a Me.sup.I.sub.b (PO.sub.4).sub.6-x (CO.sub.3).sub.x (OH).sub.2-b-x (H.sub.2 O).sub.w

wherein

Me^I is a singly charged metal ion,

Mw^II is a doubly charged metal ion,

a represents the number of doubly charged metal ions with the exception of Ca and is a value from 0 to 1.0,

b represents th number of singly charged metal ions and is a value from 0.05 to 1.2,

x represents the number of carbonate ions and is a value from 0.2 to 1.2, the sum b+x being a maximum of 2.0, and

w represents the number of water molecules integrated in the crystal lattice and is a value from 0 to b+x,

wherein at least a portion of the Me^I ions are alkali ions and the CO₃ ions are positioned at the PO₄ positions within the apatite lattice.

7. The process according to claim 6, wherein, in the calcium phosphate apatite of formula I, a portion of the hydroxy ions is exchanged for halide ions, and/or a portion of the Ca²⁺ ions and OH^- ions is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

8. An implant article containing calcium phosphate apatite having alkali and carbonate portions, all ions being definedly integrated in the crystal lattice, wherein the apatite has the formula:

space="preserve" listing-type="equation">Ca.sub.10-a-b-x Me.sup.II.sub.a Me.sup.I.sub.b (PO.sub.4).sub.6-x (CO.sub.3).sub.x (OH).sub.2-b-x (H.sub.2 O).sub.w

wherein

Me^I is a singly charged metal ion,

Me^II is a doubly charged metal ion,

a represents the number of doubly charged metal ions with the exception of Ca and is a value from 0 to 1.0,

b represents the number of singly charged metal ions and is a value from 0.05 to 1.2,

x represents the number of carbonate ions and is a value from 0.2 to 1.2, the sum b+x being a maximum of 2.0, and

w represents the number of water molecules integrated in the crystal lattice and is a value from 0 to b+x,

wherein at least a portion of the Me^I ions are alkali ions and the CO₃ ions are positioned at the PO₄ positions within the apatite lattice.

9. The implant article according to claim 8, wherein, in the calcium phosphate apatite of formula I, a portion of the hydroxy ions is exchanged for halide ions, and/or a portion of the Ca²⁺ ions and OH^- is exchanged for singly charged metal ions and/or a portion of the Ca²⁺ ions is exchanged for doubly charged metal ions.

22. An implant article according to claim 8, wherein said implant article consists entirely of said calcium phosphate apatite.

23. An implant article according to claim 8, wherein said article is an endoprosthesis which is at least partially coated with said calcium phosphate apatite.

24. An implant article according to claim 8, wherein said article comprises a hydroxyapatite core with an external coating of said calcium phosphate apatite.

25. An implant article according to claim 8, wherein said article is an implant of biocompatible material with a uniform outer coating of said calcium phosphate apatite.