US6206931B1
Expired / Lapsed
US
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Graft prosthesis materials
Assignee: Elutia Med LLC
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Filing: 1997-08-22
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Granted: 2001-03-27
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Expires: 2017-08-22
Abstract
Abstract A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.
Inventors
- 👤 William A. Cook
- 👤 Michael C. Hiles
- 👤 Thomas G. Kozma
- 👤 Umesh H. Patel
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 03:43
CPC Classifications
A; A61; A61F; A61F2/00; A61L; A61L27/00; A61L27/14; A61L27/22; A61L27/24; A61L2/00; A61L2/16; A61L2/18; A61L27/36; A61L27/3604; A61L27/3641; A61L27/3645; A61L27/3662; A61L27/3683; A61L27/3695; A61L27/38; A61L27/3839; A61L27/3843; A61L27/386; A61L29/00; A61L29/005; A61L31/00; A61L31/005; A61P; A61P17/00; A61P17/02; A61F2/02; A61F2/04; A61F2/06; A61F2/07; A61L2103/00; A61L2103/05; Y; Y10; Y10S; Y10S623/00; Y10S623/924; Y10S623/925
Claims Analysis
Total Claims: 44
Claim 1
Independent Claim
43 words
A graft prosthesis, comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a contaminant level making said purified structure biocompatible, said purified structure further having an endotoxin level of less than 12 endotoxin units per gram.
Claim 2
Dependent Claim
43 words
A graft prosthesis, comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a contaminant level making said purified structure biocompatible, said purified structure further having an endotoxin level of less than 12 endotoxin units per gram.
Claim 3
Dependent Claim
19 words
The graft prosthesis of claim 1 , wherein said endotoxin level is less than 10 endotoxin units per gram.
Claim 4
Dependent Claim
19 words
The graft prosthesis of claim 2 , wherein said endotoxin level is less than 5 endotoxin units per gram.
Claim 5
Dependent Claim
19 words
The graft prosthesis of claim 3 , wherein said endotoxin level is less than 1 endotoxin unit per gram.
Claim 6
Dependent Claim
24 words
The graft prosthesis of claim 1 , wherein said purified structure has a bioburden level of less than 2 colony forming units per gram.
Claim 7
Dependent Claim
20 words
The graft prosthesis of claim 5 , wherein said bioburden level is less than 1 colony forming unit per gram.
Claim 8
Dependent Claim
20 words
The graft prosthesis of claim 6 , wherein said bioburden level is less than 0.5 colony forming units per gram.
Claim 9
Dependent Claim
24 words
The graft prosthesis of claim 1 , wherein said purified structure has a nucleic acid content level of less than 10 micrograms per milligram.
Claim 10
Dependent Claim
19 words
The graft prosthesis of claim 8 , wherein said nucleic acid content is less than 2 micrograms per milligram.
Claim 11
Dependent Claim
24 words
The graft prosthesis of claim 1 , wherein said purified structure has a virus level of less than 500 plaque forming units per gram.
Claim 12
Dependent Claim
20 words
The graft prosthesis of claim 10 , wherein said virus level is less than 100 plaque forming units per gram.
Claim 13
Dependent Claim
20 words
The graft prosthesis of claim 11 , wherein said virus level is less than 1 plaque forming unit per gram.
Claim 14
Dependent Claim
25 words
The graft prosthesis of claim 1 , wherein said purified structure has a processing agent level of less than 100,000 parts per million per kilogram.
Claim 15
Dependent Claim
21 words
The graft prosthesis of claim 13 , wherein said processing agent level is less than 1,000 parts per million per kilogram.
Claim 16
Dependent Claim
21 words
The graft prosthesis of claim 14 , wherein said processing agent level is less than 100 parts per million per kilogram.
Claim 17
Dependent Claim
24 words
The graft prosthesis of claim 1 , wherein said purified structure has a fungus level of less than 2 colony forming units per gram.
Claim 18
Dependent Claim
20 words
The graft prosthesis of claim 16 , wherein said fungus level is less than 1 colony forming units per gram.
Claim 19
Dependent Claim
20 words
The graft prosthesis of claim 17 , wherein said fungus level is less than 0.5 colony forming units per gram.
Claim 20
Dependent Claim
18 words
The graft prosthesis of claim 1 , wherein said purified structure comprise s a delaminated submucosa tissue source.
Claim 21
Dependent Claim
19 words
The graft prosthesis of claim 1 , wherein said purified structure comprises a disinfected and delaminated submucosa tissue source.
Claim 22
Dependent Claim
20 words
The graft prosthesis of claim 1 , wherein said purified structure comprises a disinfected and then delaminated submucosa tissue source.
Claim 23
Dependent Claim
30 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having an endotoxin level of less than 12 endotoxin units per gram.
Claim 24
Dependent Claim
30 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having an endotoxin level of less than 12 endotoxin units per gram.
Claim 25
Dependent Claim
43 words
A graft prosthesis, comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a nucleic acid content level of less than 2 micrograms per milligram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 26
Dependent Claim
43 words
A graft prosthesis, comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a nucleic acid content level of less than 2 micrograms per milligram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 27
Dependent Claim
43 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a virus level of less than 500 plaque forming units per gram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 28
Dependent Claim
43 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a virus level of less than 500 plaque forming units per gram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 29
Dependent Claim
44 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a processing agent level of less than 100,000 parts per million per kilogram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 30
Dependent Claim
44 words
A graft prosthesis comprising: a purified, collagen-based matrix structure removed from a submucosa tissue source, said purified structure having a processing agent level of less than 100,000 parts per million per kilogram and an endotoxin level of less than 12 endotoxin units per gram.
Claim 31
Dependent Claim
13 words
The graft prosthesis of claim 1 , wherein said purified structure is tubular.
Claim 32
Dependent Claim
18 words
The graft prosthesis of claim 1 , wherein said purified structure is further processed into a fluidized form.
Claim 33
Dependent Claim
18 words
The graft prosthesis of claim 1 , wherein said purified structure is further processed into a powder form.
Claim 34
Dependent Claim
18 words
The graft prosthesis of claim 1 , wherein said purified structure is adapted for tendon or ligament repair.
Claim 35
Dependent Claim
21 words
The graft prosthesis of claim 1 , comprising multiple layers, wherein each of said layers is formed of said collagen-based matrix.
Claim 36
Dependent Claim
34 words
The graft prosthesis of claim 1 , wherein said purified structure is comprised of tela submucosa in strip form, said graft prosthesis comprising a plurality of said tela submucosa strips fused to one another.
Claim 37
Dependent Claim
17 words
The graft prosthesis of claim 1 , also comprising a cultured epidermal graft on said collagen-based matrix.
Claim 38
Dependent Claim
16 words
The graft prosthesis of claim 32 , wherein said cultured epidermal graft comprises keratinocytes or fibroblasts.
Claim 39
Dependent Claim
63 words
A graft prosthesis, comprising: a purified collagen-containing matrix obtained from a mammalian tissue source, said matrix comprising tela submucosa and residual contaminants from said mammalian tissue source, said matrix obtainable by a process which comprises disinfecting said mammalian tissue and then removing said matrix from the disinfected mammalian tissue, said matrix having an endotoxin level of less than 12 endotoxin units Per gram.
Claim 40
Dependent Claim
63 words
A graft prosthesis, comprising: a purified collagen-containing matrix obtained from a mammalian tissue source, said matrix comprising tela submucosa and residual contaminants from said mammalian tissue source, said matrix obtainable by a process which comprises disinfecting said mammalian tissue and then removing said matrix from the disinfected mammalian tissue, said matrix having an endotoxin level of less than 12 endotoxin units Per gram.
Claim 41
Dependent Claim
20 words
The graft prosthesis of claim 34 , wherein said matrix has a contaminant level making said matrix biocompatible in humans.
Claim 42
Dependent Claim
19 words
The graft prosthesis of claim 34 , wherein said disinfecting comprises contacting said mammalian tissue with an oxidizing agent.
Claim 43
Dependent Claim
17 words
The graft prosthesis of claim 35 , wherein said mammalian tissue source is a porcine tissue source.
Claim 44
Dependent Claim
16 words
The graft prosthesis of claim 37 , wherein said porcine tissue source is porcine small intestine.
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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) | 2004-03-26 | 2004-09-25 | 2005-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-03-26 | 2008-09-25 | 2009-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-03-26 | 2012-09-25 | 2013-03-27 | $7700.00 | Window Closed / Lapsed |