Prosthesis parts provided with a coating of a bio-active material

• US 4,365,356 A
• Filed: 07/21/1980
• Issued: 12/28/1982
• Est. Priority Date: 10/18/1975
• Status: Expired due to Term

• Current Assignee: Ernst Leitz Wetzlar GmbH (ACM Project Development Co.)
• Original Assignee: Ernst Leitz Wetzlar GmbH (ACM Project Development Co.)
• Inventors: Broemer, Heinz, Hedrich, Friedhelm, Adam, Werner
• Primary Examiner(s): Silverberg, Sam
• Application Number:
  US06/170,805
• Time in Patent Office: 890 Days
• Field of Search: 3/1.91, 3/1.9, 3/1.912, 427/2, 128/92 C
• US Class Current: 623/23.51
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2002/30037 differing in coefficient of thermal expansion or dila(ta)tion
• CPC Class Codes: A61F 2002/30929 having at least two superposed coatings
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61F 2310/00203 containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00592 Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00928 Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
• CPC Class Codes: A61F 2310/00934 Coating made of enamel
• CPC Class Codes: A61L 27/30 Inorganic materials
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: C04B 41/5022 with vitreous materials composition of vitreous glazes and enamels C03C; ceramic pigments C09C1/0009
• CPC Class Codes: C04B 41/86 Glazes; Cold glazes
• CPC Class Codes: C23D 5/00 Coating with enamels or vitreous layers
• CPC Class Codes: Y10S 623/923 Bone

Abstract

Disclosed are novel prosthesis parts of improved properties which are obtained by providing a material as used for prosthesis with an enamel or enamel-like coating and incorporating in said enamel layer, while in a viscous state, a bio-active material. Such prosthesis parts have a satisfactory adhesive strength and coefficient of expansion, are substantially free of pores, are highly corrosion resistant, and readily grow intimately and firmly together with the bone tissue without the use of bone cement.

Claims

1. A prosthesis working piece comprising:

a structural core element;

at least one carrier layer substantially free of pores applied to said core element, said carrier layer comprising an inorganic enamel which is compatible with the body; and

a multitude of particles of a bio-active material at least partly embedded in said carrier layer to provide a multitude of exposed areas of the particles on which the bone tissue can grow together with the prosthesis, said bio-active material particles having a particle size of at least about 50 μ

m.

2. A prosthesis working piece according to claim 1, wherein said bio-active material particles protrude from the surface of said carrier layer.

3. A prosthesis working piece according to claim 1, wherein the surfaces of said bio-active material particles are flush with the surface of said carrier layer.

4. A prosthesis working piece according to claim 1, wherein said bio-active material particles have a particle size between about 50 μ

m and 250 μ

m.

5. A prosthesis working piece according to claim 4, wherein said bio-active material particles have a particle size between about 80 μ

m and 180 μ

m.

6. A prosthesis working piece according to claim 1, wherein said bio-active material comprises a bio-glass ceramic composition.

7. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂) from about 50 to 65 weight %

Boron trioxide (B₂ O₃) from about 0 to 12 weight %

Phosphorous pentoxide (P₂ O₅) from about 0 to 3 weight %

Sodium oxide (Na₂ O) from about 3 to 12 weight %

Potassium oxide (K₂ O) from about 0 to 5 weight %

Calcium oxide (CaO) from about 0 to 3 weight %

Barium oxide (BaO) from about 0 to 1 weight %

Aluminum oxide (Al₂ O₃) from about 2 to 7 weight %

Titanium dioxide (TiO₂) from about 6 to 14 weight %.

8. A prosthesis working piece according to claim 7, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--60.0 weight %

Boron trioxide (B₂ O₃)--7.5 weight %

Phosphorous pentoxide (P₂ O₅)--1.5 weight %

Sodium oxide (Na₂ O)--9.0 weight %

Potassium oxide (K₂ O)--3.5 weight %

Calcium oxide (CaO)--1.0 weight %

Barium oxide (BaO)--0.5 weight %

Aluminum oxide (Al₂ O₃)--5.0 weight %

Titanium dioxide (TiO₂)--12.0 weight %.

9. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂) from about 35 to 45 weight %

Boron trioxide (B₂ O₃) from about 4 to 8 weight %

Magnesium metaphosphate (Mg(PO₃)₂) from about 6 to 12 weight %

Lithium oxide (Li₂ O) from about 1 to 5 weight %

Sodium oxide (Na₂ O) from about 4 to 12 weight %

Magnesium oxide (MgO) from about 0 to 3 weight %

Calcium oxide (CaO) from about 12 to 20 weight %

Bismuth trioxide (Bi₂ O₃) from about 1 to 5 weight %

Titanium dioxide (TiO₂) from about 4 to 12 weight %

Cryolite (Na₃ AlF₆) from about 3 to 7 weight %.

10. A prosthesis working piece according to claim 9, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--38 weight %

Boron trioxide (B₂ O₃)--6 weight %

Magnesium metaphosphate (Mg(PO₃)₂)--10 weight %

Lithium oxide (Li₂ O)--3 weight %

Sodium oxide (Na₂ O)--10 weight %

Magnesium oxide (MgO)--1 weight %

Calcium oxide (CaO)--16 weight %

Bismuth trioxide (Bi₂ O₃)--3 weight %

Titanium dioxide (TiO₂)--8 weight %

Cryolite (Na₃ AlF₆)--5 weight %.

11. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂) from about 12 to 20 weight %

Boron trioxide (B₂ O₃) from about 10 to 18 weight %

Phosphorous pentoxide (P₂ O₅) from about 22 to 28 weight %

Lithium oxide (Li₂ O) from about 2 to 6 weight %

Sodium oxide (Na₂ O) from about 8 to 16 weight %

Potassium oxide (K₂ O) from about 1 to 5 weight %

Magnesium oxide (MgO) from about 0 to 3 weight %

Aluminum oxide (Al₂ O₃) from about 14 to 20 weight %

Titanium dioxide (TiO₂) from about 5 to 10 weight %

Cryolite (Na₃ AlF₆) from about 0 to 2 weight %.

12. A prosthesis working piece according to claim 11, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--15.25 weight %

Boron trioxide (B₂ O₃)--13.84 weight %

Phosphorous pentoxide (P₂ O₅)--24.70 weight %

Lithium oxide (Li₂ O)--3.21 weight %

Sodium oxide (Na₂ O)--13.18 weight %

Potassium oxide (K₂ O)--2.99 weight %

Magnesium oxide (MgO)--1.17 weight %

Aluminum oxide (Al₂ O₃)--17.93 weight %

Titanium dioxide (TiO₂)--7.43 weight %

Cryolite (Na₃ AlF₆)--0.30 weight %.

13. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂) from about 8 to 16 weight %

Boron trioxide (B₂ O₃) from about 6 to 14 weight %

Magnesium metaphosphate (Mg(PO₃)₂) from about 7 to 15 weight %

Calcium metaphosphate (Ca(PO₃)₂) from about 35 to 45 weight %

Lithium oxide (Li₂ O) from about 3 to 6 weight %

Sodium oxide (Na₂ O) from about 10 to 16 weight %

Potassium oxide (K₂ O) from about 3 to 6 weight %

Titanium dioxide (TiO₂) from about 4 to 10 weight %.

14. A prosthesis working piece according to claim 13, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--10.6 weight %

Boron trioxide (B₂ O₃)--8.5 weight %

Magnesium metaphosphate (Mg(PO₃)₂)--9.8 weight %

Calcium metaphosphate (Ca(PO₃)₂)--41.5 weight %

Lithium oxide (Li₂ O)--4.5 weight %

Sodium oxide (Na₂ O)--13.5 weight %

Potassium oxide (K₂ O)--4.5 weight %

Titanium dioxide (TiO₂)--7.1 weight %.

15. A prosthesis working piece according to claim 6, wherein said bio-glass ceramic composition comprises

Silicon dioxide (SiO₂) from about 42 to 48.5 weight %

Calcium metaphosphate (Ca(PO₃)₂) from about 12.5 to 18 weight %

Sodium oxide (Na₂ O) from about 3.5 to 6 weight %

Potassium oxide (K₂ O) from about 0 to 1.5 weight %

Magnesium oxide (MgO) from about 0 to 1.5 weight %

Calcium oxide (CaO) from about 28 to 35 weight %.

16. A prosthesis working piece according to claim 15, wherein said bio-glass ceramic composition comprises

Silicon dioxide (SiO₂)--46 weight %

Sodium oxide (Na₂ O)--5 weight %

Calcium oxide (CaO)--33 weight %

Calcium metaphosphate (Ca(PO₃)₂)--16 weight %.

17. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--61.0 weight %

Boron trioxide (B₂ O₃)--4.7 weight %

Sodium oxide (Na₂ O)--16.7 weight %

Titanium dioxide (TiO₂)--10.8 weight %

Lithium oxide (Li₂ O)--0.9 weight %

Magnesium oxide (MgO)--4.7 weight %

Cryolite (Na₃ AlF₆)--1.2 weight %.

18. A prosthesis working piece according to claim 1, wherein said inorganic enamel composition comprises

Silicon dioxide (SiO₂)--49.0 weight %

Boron trioxide (B₂ O₃)--15.0 weight %

Sodium oxide (Na₂ O)--14.5 weight %

Titanium dioxide (TiO₂)--10.0 weight %

Lithium oxide (Li₂ O)--2.5 weight %

Magnesium oxide (MgO)--4.0 weight %

Cryolite (Na₃ AlF₆)--5.0 weight %.

19. A prosthesis working piece according to claim 1, wherein said bio-active material comprises a bio-glass composition or a bio-glass ceramic composition.

20. A prosthesis working piece according to claim 1, wherein said structural core element comprises a metal or metal alloy.

21. A prosthesis working piece according to claim 1, wherein said bio-active material particles are partly embedded in said carrier layer by the steps of converting said carrier layer into a viscous state at a temperature which is not high enough to adversely affect the bio-active properties of said bio-active material or change the structural properties of the core element, incorporating said bio-active material particles into the viscous carrier layer and thereafter causing the carrier layer to solidify.

22. A prosthesis working piece according to claim 1, comprising a plurality of inorganic enamel carrier layers.

23. A prosthesis working piece according to claim 22, wherein at least two of said inorganic enamel carrier layers have a different coefficient of thermal expansion.