BIOMIMETIC COLLAGEN-HYDROXYAPATITE COMPOSITE MATERIAL
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IPC분류정보
국가/구분
United States(US) Patent
공개
국제특허분류(IPC7판)
A61L-027/32
A61L-027/54
A61L-027/58
A61L-027/24
출원번호
US-0903394
(2014-07-18)
공개번호
US-0144071
(2016-05-26)
우선권정보
EP-13003647.8 (2013-07-19)
국제출원번호
PCT/EP2014/001966
(2014-07-18)
발명자
/ 주소
BUFLER, Michael
출원인 / 주소
GEISTLICH PHARMA AG
인용정보
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0인용 특허 :
0
초록▼
The invention relates to: a biomimetic collagen-hydroxyapatite composite material comprising an at least partially fibrous collagen scaffold including mature native collagen fibers possessing triple helicity as shown by Circular Dichroism Spectroscopy, wherein those mature native collagen fibers are
The invention relates to: a biomimetic collagen-hydroxyapatite composite material comprising an at least partially fibrous collagen scaffold including mature native collagen fibers possessing triple helicity as shown by Circular Dichroism Spectroscopy, wherein those mature native collagen fibers are at least partially covered with epitactically grown crystals of nanocrystalline hydroxyapatite, whereby the epitactically grown nanocrystals have the same morphology as human bone mineral and the same size as human bone mineral, i.e. a length of 30 to 50 nm and a width of 14 to 25 nm, a process of preparing the above biomimetic collagen-hydroxyapatite composite material comprising the steps of a) immersing an at least partially fibrous collagen scaffold including the above mature native collagen fibers in a saturated aqueous solution of saturated Ca2+/Hx-PO4(3-x) to start the formation process of the composite implant material whereby epitactically grown nanocrystals will be formed on the mature native collagen fibers, the epitactically grown nanocrystals having the same morphology and same size as human bone mineral, b) stopping the formation process of the composite implant material by separating solid material from the aqueous solution, rinsing with water and drying, and c) optionally sterilizing the separated material coming from step b), as well as the use of the above biomimetic collagen-hydroxyapatite composite material as an implant or prosthesis for bone formation, bone regeneration, bone repair and/or bone replacement at a defect site in a human subject or in an animal, or as an implant for combined bone and cartilage regeneration.
대표청구항▼
1. A biomimetic collagen-hydroxyapatite composite material comprising an at least partially fibrous collagen scaffold including mature native collagen fibers possessing triple helicity as shown by Circular Dichroism Spectroscopy, wherein those mature native collagen fibers are at least partially cov
1. A biomimetic collagen-hydroxyapatite composite material comprising an at least partially fibrous collagen scaffold including mature native collagen fibers possessing triple helicity as shown by Circular Dichroism Spectroscopy, wherein those mature native collagen fibers are at least partially covered with epitactically grown crystals of nanocrystalline hydroxyapatite, whereby the epitactically grown nanocrystals have the same morphology as human bone mineral and the same size as human bone mineral, namely a length of 30 to 50 nm and a width of 14 to 25 nm and wherein the epitactically grown crystals of nanocrystalline hydroxyapatite form a layer having a thickness of at least 30±15 nm, as determined by X-ray diffraction analysis. 2. The biomimetic collagen-hydroxyapatite composite of claim 1, wherein the at least partially fibrous collagen scaffold comprises on its external surface at least 2% of mature native collagen fibers as determined by picture analysis on SEM micrographs and Circular Dichroism Spectroscopy. 3. The biomimetic collagen-hydroxyapatite composite of claim 1, wherein the at least partially fibrous collagen scaffold comprises on its external surface at least 10% of mature native collagen fibers as determined by picture analysis on SEM micrographs and Circular Dichroism Spectroscopy. 4. The biomimetic collagen-hydroxyapatite composite material of claim 1 wherein the fibrous collagen scaffold has a w/w ratio to the epitactically grown crystals of nanocrystalline hydroxyapatite between 5:95 and 95:5. 5. The biomimetic collagen-hydroxyapatite composite material of claim 1 which is a shaped body. 6. The biomimetic collagen-hydroxyapatite composite material of claim 5, wherein the shaped body is a bone substitute material the structure of which has the profile of an osseous body part. 7. The biomimetic collagen-hydroxyapatite composite material of claim 5, wherein the shaped body has a resistance to torque of at least 30 Ncm in the dry state. 8. The biomimetic collagen-hydroxyapatite composite material of claim 1 which is membrane-shaped. 9. A process of preparing the biomimetic collagen-hydroxyapatite composite material of claim 1, the process comprising the steps of: a) immersing an at least partially fibrous collagen scaffold including mature native collagen fibers possessing triple helicity as shown by Circular Dichroism Spectroscopy in a saturated aqueous solution of saturated Ca2+/HxPO4(3-x), which is a phosphate buffer solution (PBS) containing finely dispersed alpha-TCP, beta-TCP, TTCP, octacalcium phosphate pentahydrate, dicalcium phosphate or dicalcium phosphate dihydrate , to perform the formation process of the composite implant material whereby epitactically grown hydroxyapatite nanocrystals are formed on those mature native collagen fibers, those epitactically grown hydroxyapatite nanocrystals having the same morphology and same size as human bone mineral,b) stopping the formation process of the composite implant material by separating solid material from the aqueous solution, rinsing with water and drying, andc) optionally sterilizing the separated material coming from step b). 10. The process of claim 9 wherein in step b) the pH of the aqueous solution remains within a range of 5.5 to 9.0. 11. The process of claim 9 wherein in step b) the pH of the aqueous solution remains within a range of 6.5 to 8.0. 12. The process claim 9 wherein the temperature in step b) is between 25 and 45° C. 13. The process of claim 9 wherein the temperature in step b) is between 35° C. and 42° C. 14. The biomimetic collagen-hydroxyapatite composite material of claim 1, in the form of an implant or prosthesis for bone formation, bone regeneration, bone repair and/or bone replacement at a defect site in a human subject or an animal. 15. The membrane-shaped biomimetic collagen-hydroxyapatite composite material according to claim 8, in the form of an implant for combined bone and cartilage regeneration. 16. A method of promoting bone formation, bone regeneration and/or bone repair at a defect site in a human subject or an animal by implanting the biomimetic collagen-hydroxyapatite composite material of claim 1 in said human subject or animal. 17. The biomimetic collagen-hydroxyapatite composite material of claim 4, wherein the w/w ratio is between 10:90 and 90:10.
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