US4865602A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Gamma irradiation of collagen/mineral mixtures
Assignee: Neucoll Inc
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Filing: 1986-11-06
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Granted: 1989-09-12
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Expires: 2006-11-06
Abstract
Abstract A process for sterilization of collagen/mineral compositions using γ radiation is conducted under conditions which produce a product of desired handling and biocompatibility properties.
Inventors
- 👤 Thomas L. Smestad
- 👤 Daniel Prows
- 👤 George H. Chu
- 👤 Diana M. Hendricks
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 23:43
CPC Classifications
A; A61; A61L; A61L2/00; A61L2/02; A61L2/08; A61L2/081; A61L27/00; A61L27/40; A61L27/44; A61L27/46; A61L2103/00; A61L2103/05; Y; Y10; Y10S; Y10S128/00; Y10S128/08; Y10S623/00; Y10S623/92; Y10S623/923
Claims Analysis
Total Claims: 12
Claim 1
Independent Claim
115 words
A process for preparing a biocompatible bone implant preparation having a compressive modulus of at least 10 N/cm 2 and a sterility assurance factor at least as low as 10 -6 ; wherein said preparation comprises a collagen/mineral composition which is a mixture of 2-40% reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight exclusive of moisture; which process comprises: drying the collagen/mineral composition to a moisture content ofless than 1%; rehydrating said composition to a mopisture content of 1-6%, where percentage moisture is determined as the weight of water in said composition divided by the total weight of said composition including said water; and irradiating said composition with 0.5-4 Mrad γ radiation.
Claim 2
Dependent Claim
115 words
A process for preparing a biocompatible bone implant preparation having a compressive modulus of at least 10 N/cm 2 and a sterility assurance factor at least as low as 10 -6 ; wherein said preparation comprises a collagen/mineral composition which is a mixture of 2-40% reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight exclusive of moisture; which process comprises: drying the collagen/mineral composition to a moisture content ofless than 1%; rehydrating said composition to a mopisture content of 1-6%, where percentage moisture is determined as the weight of water in said composition divided by the total weight of said composition including said water; and irradiating said composition with 0.5-4 Mrad γ radiation.
Claim 3
Dependent Claim
24 words
The process of claim 1 wherein said rehydration is conducted by incubating the collagen/mineral composition at 35°-45° C. at 50°-95% RH for 6-24 hours.
Claim 4
Dependent Claim
12 words
The process of claim 1 wherein the radiation dosage is 1-3 Mrad.
Claim 5
Dependent Claim
14 words
The process of claim 1 wherein the collagen content of the mixture is 2-5%.
Claim 6
Dependent Claim
119 words
A process for preparing a biocompatible bone implant preparation having a compressive modulus of at least 10 N/cm 2 and a sterility assurance factor at least as low as 10 -6 ; wherein said preparation comprises a collagen/mineral composition which is a mixture of 2-40% reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight exclusive of moisture; which process copmrises irradiating said composition with 0.5-4 Mrad γ radiation; wherein said composition has previously been heat treated when it contains 0.5-1% moisture to effect cross-linking corresponding to a compression modulus of 10-45N/cm 2 , where percentage moisture is determined as the weight of water in said composition divided by the total weight of said composition including said water.
Claim 7
Dependent Claim
119 words
A process for preparing a biocompatible bone implant preparation having a compressive modulus of at least 10 N/cm 2 and a sterility assurance factor at least as low as 10 -6 ; wherein said preparation comprises a collagen/mineral composition which is a mixture of 2-40% reconstituted fibrillar atelopeptide collagen and 60-98% calcium phosphate mineral by weight exclusive of moisture; which process copmrises irradiating said composition with 0.5-4 Mrad γ radiation; wherein said composition has previously been heat treated when it contains 0.5-1% moisture to effect cross-linking corresponding to a compression modulus of 10-45N/cm 2 , where percentage moisture is determined as the weight of water in said composition divided by the total weight of said composition including said water.
Claim 8
Dependent Claim
18 words
The process of claim 5 wherein the heat treatment is 4-24 hours at 60°-90° C. and 20-80% RH.
Claim 9
Dependent Claim
11 words
The process of claim 5 whewrein the radiation dosgae is 1-3Mrad.
Claim 10
Dependent Claim
14 words
The process of claim 5 wherein the collagen content of the mixture is 2-5%.
Claim 11
Dependent Claim
11 words
A bone implant material prepared by the process of claim 5.
Claim 12
Dependent Claim
17 words
The bone implant material of claim 9 which has a compressive modulus of 25-45 N/cm 2 .
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-09-11 | 1993-03-13 | 1993-09-12 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-09-11 | 1997-03-13 | 1997-09-12 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-09-11 | 2001-03-13 | 2001-09-12 | $7700.00 | Window Closed / Lapsed |