Osteoinductive bone material
First Claim
1. A formable, self-hardening, poorly crystalline apatitic (PCA) calcium phosphate paste suitable for use as a bone implant material comprising:
- (a) a powder component comprising;
(i) demineralized bone matrix (DBM) in an amount in the range of 25 to 70 wt %, wherein said DBM comprises particles having a particle size in the range of 53 μ
m to 850 μ
m;
(ii) a calcium phosphate powder in an amount in the range of 25 to about 60 wt %; and
(b) a physiologically-acceptable fluid in an amount to produce a cohesive, formable paste, wherein said paste retains its cohesiveness when introduced at an implant site in vivo and hardens to form a PCA calcium phosphate having a compressive strength in the range of 1 to 20 MPa.
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Abstract
Osteogenic bone implant compositions that approximate the chemical composition of natural bone are provided. The organic component of these implant compositions is osteoinductive despite the presence of the inorganic component and, further, is present in an amount sufficient to maximize the regenerative capabilities of the implant without compromising its formability and mechanical strength. The composition may be an osteoinductive powder, including demineralized bone matrix (DBM) particles, a calcium phosphate powder, and, optionally, a biocompatible cohesiveness agent. The powder may be combined with a physiologically-acceptable fluid to produce a formable, osteoinductive paste that self-hardens to form a poorly crystalline apatitic (PCA) calcium phosphate having significant compressive strength. The bone implant materials retain their cohesiveness when introduced at an implant site and are remodeled into bone in vivo. Methods for using these implant materials to repair damaged bone and a method of assaying the content of DBM particles, by weight, in a bone implant material are also provided.
154 Citations
32 Claims
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1. A formable, self-hardening, poorly crystalline apatitic (PCA) calcium phosphate paste suitable for use as a bone implant material comprising:
-
(a) a powder component comprising; (i) demineralized bone matrix (DBM) in an amount in the range of 25 to 70 wt %, wherein said DBM comprises particles having a particle size in the range of 53 μ
m to 850 μ
m;(ii) a calcium phosphate powder in an amount in the range of 25 to about 60 wt %; and (b) a physiologically-acceptable fluid in an amount to produce a cohesive, formable paste, wherein said paste retains its cohesiveness when introduced at an implant site in vivo and hardens to form a PCA calcium phosphate having a compressive strength in the range of 1 to 20 MPa. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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Specification