US4394370A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Bone graft material for osseous defects and method of making same
Assignee: Isotis Orthobiologics Inc
•
Filing: 1981-09-21
•
Granted: 1983-07-19
•
Expires: 2001-09-21
Abstract
Abstract Complexes of reconstituted collagen and demineralized bone particles or reconstituted collagen and a solubilized bone morphogenetic protein fabricated in a sponge suitable for in vivo implantation in osseous defects are disclosed. Both demineralized bone particles (DBP) and bone morphogenetic protein have demonstrated the ability to induce the formation of osseous tissue in animal and human experiments. Reconstituted collagen conjugate is highly biocapatible and can be fabricated in a variety of configurations, especially as a sponge. This material can be used as a grafting implant in plastic and reconstructive surgery, periodontal bone grafting, and in endodontic procedures. Structural durability is enhanced by cross-linking with glutaraldehyde which is also used to sterilize and disinfect the collagen conjugate prior to implantation.
Inventors
- 👤 Steven R. Jefferies
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:39
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3604; A61L27/3608; A61L27/14; A61L27/22; A61L27/227; A61L27/24; A61L27/3641; A61L27/3645; A61L27/365; A61L27/50; A61L27/56; A61F; A61F2/00; A61F2/02; A61F2/28; A61F2002/2835; A61F2/30; A61F2002/30001; A61F2002/30003; A61F2002/30004; A61F2002/30059; A61F2310/00; A61F2310/00005; A61F2310/00365; A61L2430/00; A61L2430/02; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/84
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
93 words
A bone graft material capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of a collagen conjugate containing: from about 65 to about 95 weight percent reconstituted collagen having dispersed substantially uniformly therein from about 35 to about 5 weight percent of (a) demineralized bone particles, (b) solubilized bone morphogenic protein, or (c) mixtures of demineralized bone particles and solubilized bone morphogenic protein, said bone graft material adapted to induce the formation of osseous tissue when implanted in an animal.
Claim 2
Dependent Claim
93 words
A bone graft material capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of a collagen conjugate containing: from about 65 to about 95 weight percent reconstituted collagen having dispersed substantially uniformly therein from about 35 to about 5 weight percent of (a) demineralized bone particles, (b) solubilized bone morphogenic protein, or (c) mixtures of demineralized bone particles and solubilized bone morphogenic protein, said bone graft material adapted to induce the formation of osseous tissue when implanted in an animal.
Claim 3
Dependent Claim
24 words
The bone graft material of claim 1 further including a cross-linking amount of glutaraldehyde to confer additional structural integrity to the bone graft material.
Claim 4
Dependent Claim
27 words
The bone graft material of claim 1 or 2 wherein the demineralized bone powder, when present, has a particle size of no greater than about 70 millimicrons.
Claim 5
Dependent Claim
16 words
A lyophilized sponge for in vivo implantation composed of the bone graft material of claim 1.
Claim 6
Dependent Claim
16 words
A lyophilized sponge for in vivo implantation composed of the bone graft material of claim 2.
Claim 7
Dependent Claim
16 words
A lyophilized sponge for in vivo implantation composed of the bone graft material of claim 3.
Claim 8
Dependent Claim
35 words
The bone graft material of claim 1 or 2 wherein the amount of reconstituted collagen is about 80 to about 90% and the amount of (a), (b) or (c) is about 20 to about 10%.
Claim 9
Dependent Claim
23 words
The bone graft material of claim 2 wherein the gluteraldehyde is present in an amount of about 1 to about 5 weight percent.
Claim 10
Dependent Claim
19 words
The bone graft material of claim 1, 2 or 8 wherein the reconstituted collagen is complexed with alkaline phosphatase.
Claim 11
Dependent Claim
107 words
A biocompatible bone graft material composed of a collagen conjugate and capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of, in weight percent: (i) from about 65 to about 95% reconstituted collagen complexed with alkaline phosphatase, the collagen having dispersed substantially uniformly therein (ii) from about 35% to about 5% of dimineralized bone particles, and (iii) a cross-linking amount of gluteraldehyde to confer structural integrity to the bone graft material, said bone graft material adapted to induce osteogenesis, substantially non-inflammatory and biocompatible with the tissue in the animal in which it is implanted.
Claim 12
Dependent Claim
107 words
A biocompatible bone graft material composed of a collagen conjugate and capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of, in weight percent: (i) from about 65 to about 95% reconstituted collagen complexed with alkaline phosphatase, the collagen having dispersed substantially uniformly therein (ii) from about 35% to about 5% of dimineralized bone particles, and (iii) a cross-linking amount of gluteraldehyde to confer structural integrity to the bone graft material, said bone graft material adapted to induce osteogenesis, substantially non-inflammatory and biocompatible with the tissue in the animal in which it is implanted.
Claim 13
Dependent Claim
108 words
A biocompatible bone graft material composed of a collagen conjugate and capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of, in weight percent: (i) from about 65 to about 95% reconstituted collagen complexed with alkaline phosphatase, the collagen having dispersed substantially uniformly therein (ii) from about 35 to about 5% of solubilized bone morphogenic protein, and (iii) a cross-linking amount of gluteraldehyde to confer structural integrity to the bone graft material, said bone graft material adapted to induce osteogenesis, substantially non-inflammatory and biocompatible with the tissue in the animal in which it is implanted.
Claim 14
Dependent Claim
108 words
A biocompatible bone graft material composed of a collagen conjugate and capable of inducing the formation of osseous tissue in the animal in which it is implanted, said bone graft material consisting essentially of, in weight percent: (i) from about 65 to about 95% reconstituted collagen complexed with alkaline phosphatase, the collagen having dispersed substantially uniformly therein (ii) from about 35 to about 5% of solubilized bone morphogenic protein, and (iii) a cross-linking amount of gluteraldehyde to confer structural integrity to the bone graft material, said bone graft material adapted to induce osteogenesis, substantially non-inflammatory and biocompatible with the tissue in the animal in which it is implanted.
Claim 15
Dependent Claim
21 words
The bone graft material of claim 10 or 11 wherein the amount of gluteraldehyde is from about 1 to about 5%.
References Cited (Backward Citations)
US3843446A
Cited
US3767437A
Cited
US3919773A
Cited
US3892648A
Cited
US4038703A
Cited
US4066083A
Cited
US4193813A
Cited
US4294753A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1986-07-18 | 1987-01-17 | 1987-07-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1990-07-18 | 1991-01-17 | 1991-07-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1994-07-18 | 1995-01-17 | 1995-07-19 | $7700.00 | Window Closed / Lapsed |