IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0507094
(2003-02-22)
|
등록번호 |
US-8153148
(2012-04-10)
|
우선권정보 |
EP-02005844 (2002-03-14) |
국제출원번호 |
PCT/EP03/01812
(2003-02-22)
|
§371/§102 date |
20040903
(20040903)
|
국제공개번호 |
WO03/075975
(2003-09-18)
|
발명자
/ 주소 |
- Maspero, Fabrizio Alessandro
- Ruffieux, Kurt
|
출원인 / 주소 |
|
대리인 / 주소 |
Buchanan Ingersoll & Rooney PC
|
인용정보 |
피인용 횟수 :
5 인용 특허 :
47 |
초록
▼
A biocompatible and biodegradable implant for a cavity in a bone of a living organism is made of biocompatible and biodegradable granules. The biocompatible and biodegradable granules are provided with a coating, which includes at least one layer of a biocompatible and biodegradable polymer. The bio
A biocompatible and biodegradable implant for a cavity in a bone of a living organism is made of biocompatible and biodegradable granules. The biocompatible and biodegradable granules are provided with a coating, which includes at least one layer of a biocompatible and biodegradable polymer. The biocompatible and biodegradable implants are obtained by fusing together the polymer-coated granules through polymer-linkage of the polymer coatings of neighboring granules.
대표청구항
▼
1. Biocompatible and biodegradable implant for filling a cavity in a living organism comprising polymer-coated biocompatible and biodegradable granules fused together through polymer linkage, said granules being made of biocompatible and biodegradable materials selected from the group consisting of
1. Biocompatible and biodegradable implant for filling a cavity in a living organism comprising polymer-coated biocompatible and biodegradable granules fused together through polymer linkage, said granules being made of biocompatible and biodegradable materials selected from the group consisting of biopolymers, bioglasses, bioceramics and a mixture thereof, and said granules having an equivalent-diameter in a range from about 350 μm to about 2000 μm; a major portion of the surface area of said granules being coated with at least one biocompatible and biodegradable layer of a polymer selected from the group consisting of poly(α-hydroxyesters), poly(ortho esters), polyanhydrides, poly(phosphazenes), polypropylene fumarate), polyester amides), polyethylene fumarate), polylactide, polyglycolide, polycaprolactone, poly(glycolide-co-trimethylene carbonate), polydioxanone, co-polymers thereof and a blend of the polymers, and said polymer layer having a thickness in a range of 2 μm to 300 μm corresponding to a weight fraction of about 4% to about 15% of the weight of said implant, wherein the polymer linkage is carried out such that after fusing the granules together, an open interconnected porosity with macropores having an average diameter in a range of about 100 μm to about 500 μm, is achieved. 2. Biocompatible and biodegradable implant as in claim 1, wherein the bioceramic is calcium sulfate or calcium phosphate. 3. Biocompatible and biodegradable implant as in claim 2, wherein the calcium phosphate is selected from the group consisting of monocalcium phosphate monohydrate, monocalcium phosphate anhydrous, dicalcium phosphate dehydrate, dicalcium phosphate anhydrous, tetracalcium phosphate, calcium orthophosphate phosphate, calcium pyrophosphate, α-tricalcium phosphate, β-tricalcium phosphate, apatite, hydroxyapatite and a mixture thereof. 4. Biocompatible and biodegradable implant as in claim 1, wherein the equivalent-diameter of said granules is in the range of about 500 μm to about 1000 μm. 5. Biocompatible and biodegradable implant as in claim 1, wherein said granules are of a regular shape. 6. Biocompatible and biodegradable implant as in claim 5, wherein said regular shape is a spherical shape. 7. Biocompatible and biodegradable implant as in claim 1, wherein the thickness of the polymer layer is in the range of about 5 μm to about 20 μm. 8. Biocompatible and biodegradable implant as in claim 1, wherein the average diameter of the macropores is in the range of about 200 μm to about 300 μm. 9. Biocompatible and biodegradable implant as in claim 1, wherein the biocompatible and biodegradable granules are selected from the group consisting of solid granules, porous granules, hollow granules, hollow granules with at least one opening in the granule wall enclosing the interior hollow space, and mixtures thereof. 10. Biocompatible and biodegradable implant as in claim 9, wherein porous biocompatible and biodegradable granules are used. 11. Biocompatible and biodegradable implant as in claim 10, wherein the porous biocompatible and biodegradable granules include micropores having an average diameter in a range of more than 0 to about 10 μm. 12. Biocompatible and biodegradable implant as in claim 11, wherein the opening in the granule wall of the hollow granules is larger than the average diameter of the micropores in the porous granules. 13. Biocompatible and biodegradable implant as in claim 12, wherein the average diameter of the micropores is in the range of about 0.1 μm to about 6 μm. 14. Biocompatible and biodegradable implant as in claim 11, wherein the porous granules include macropores having an average diameter in a range of more than about 10 μm to about 500 μm. 15. Biocompatible and biodegradable implant as in claim 14, wherein the average diameter of the macropores is in the range of about 100 μm to about 300 μm. 16. Biocompatible and biodegradable implant as in claim 1, further comprising at least one biological active substance that is integrated into the granules and/or into the biocompatible and biodegradable coating, and/or forming a coating layer itself. 17. Biocompatible and biodegradable implant as in claim 1, wherein mixtures of non-coated and polymer-coated granules are fused together. 18. Biocompatible and biodegradable implant as in claim 1, wherein said biodegradable and biocompatible implant is made of two or more kinds of granules, said two or more kinds of granules being made of different biocompatible materials and/or comprising polymer-coatings that are distinct from each other and/or having different equivalent diameters. 19. Biocompatible and biodegradable implant as in claim 18, wherein the two or more kinds of granules are solid granules, porous granules, hollow granules, and/or hollow granules with at least one opening in the granule wall, or mixtures thereof, and said implant being shaped in a manner to accommodate the granules. 20. Biocompatible and biodegradable implant as in claim 1, wherein the granules are mixed with microspheres made of a biodegradable and biocompatible material and loaded with at least one biologically active substance. 21. Biocompatible and biodegradable implant as in claim 1, wherein said biocompatible and biodegradable granules are spray-coated with a biocompatible and biodegradable polymer to form a polymer coating. 22. Biocompatible and biodegradable implant as in claim 21, wherein said biocompatible and biodegradable granules are spray-coated in a fluidized bed machine. 23. Biocompatible and biodegradable implant as in claim 21, wherein the thickness of the polymer coating is in the range of about 5 μm to about 20 μm. 24. Biocompatible and biodegradable implant as in claim 1, wherein said granules are fused together in a mold in a pressurized CO2 atmosphere under a pressure in a range of about 20 bar to about 200 bar, for at least about 3 seconds. 25. Biocompatible and biodegradable implant as in claim 24, wherein the pressure is about 50 bar. 26. Biocompatible and biodegradable implant as in claim 24, wherein the granules are under pressure for a range of about 3 seconds to about 180 seconds. 27. Biocompatible and biodegradable implant as in claim 1, wherein said granules are fused together by subjecting them within a mold to a heat treatment at a temperature in a range of about 70° C. to about 220° C. for at least about 10 seconds. 28. Biocompatible and biodegradable implant as in claim 27, wherein the temperature is in the range of about 75° C. to about 90° C. 29. Biocompatible and biodegradable implant as in claim 27, wherein the granules are heat treated for a range of about 10 seconds to about 5 minutes. 30. Biocompatible and biodegradable implant as in claim 1, wherein said granules are fused together in a mold in a pressurized CO2 atmosphere under a pressure in a range of about 20 bar to about 200 bar for at least about 3 seconds, or said granules are fused together by subjecting them within a mold to a heat treatment at a temperature in a range of about 70° C. to about 220° C. for at least about 10 seconds. 31. Biocompatible and biodegradable implant as in claim 1, wherein the granules are entirely coated with the at least one biocompatible and biodegradable layer of a polymer.
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