US6358284B1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Tubular grafts from purified submucosa
Assignee: Cook Biotech Inc
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Filing: 1999-06-02
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Granted: 2002-03-19
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Expires: 2019-06-02
Abstract
Abstract An easy-to-produce and mechanically strong tube of an implantable graft prosthesis has been developed which is manufactured in any desired length, wall thickness, or diameter. The construct produced by the method of the invention may be used as grafts for arteries, veins, ureters, urethras, shunts, or in any application where a compliant, tissue-compatible tube is needed. The manufacture of the graft prosthesis generally involves wrapping multiple sheets of a purified, collagen-based matrix structure around a mandrel, compressing and drying the tissue on the mandrel before removing the construct for eventual use.
Inventors
- 👤 Neal E. Fearnot
- 👤 Michael C. Hiles
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 15:35
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/04; A61L; A61L27/00; A61L27/36; A61L27/3604; A61F2/06; A61L27/14; A61L27/22; A61L27/24; A61L27/3629; A61L27/3683; A61L27/3687; A61F2310/00; A61F2310/00005; A61F2310/00365
Claims Analysis
Total Claims: 22
Claim 1
Independent Claim
172 words
A unitary multi-layered graft prosthesis comprising a first sheet of a collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the first sheet having a first edge and a second opposite edge, formed in the shape of a tube, wherein the second opposite edge of the first sheet extends over the first edge of the first sheet to define a multiple layered overlapped region, wherein the layers in the overlapped region are fixed to one another; and a second sheet of a collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the second sheet having a first edge and a second opposite edge, wherein said second sheet is in adherent contact with the tube of said first sheet and the first edge and second opposite edge of the second sheet are joined together along the length of the tube without perforating the underlying tube of said first sheet.
Claim 2
Dependent Claim
172 words
A unitary multi-layered graft prosthesis comprising a first sheet of a collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the first sheet having a first edge and a second opposite edge, formed in the shape of a tube, wherein the second opposite edge of the first sheet extends over the first edge of the first sheet to define a multiple layered overlapped region, wherein the layers in the overlapped region are fixed to one another; and a second sheet of a collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the second sheet having a first edge and a second opposite edge, wherein said second sheet is in adherent contact with the tube of said first sheet and the first edge and second opposite edge of the second sheet are joined together along the length of the tube without perforating the underlying tube of said first sheet.
Claim 3
Dependent Claim
23 words
The prosthesis of claim 1 , wherein the first and second opposite edges of the first sheet are substantially parallel to one another.
Claim 4
Dependent Claim
20 words
The prosthesis of claim 2 , wherein the tube comprises two layers and the multiple overlapped region comprises three layers.
Claim 5
Dependent Claim
29 words
The prosthesis of claim 1 , wherein the multiple layers of said matrix structure in the overlapped region are fixed to one another by treatment with a cross-linking agent.
Claim 6
Dependent Claim
33 words
The prosthesis of claim 4 , wherein the tube of said first sheet and the second sheet are fused to one another by compressing the matrix structures under conditions conducive to dehydration thereof.
Claim 7
Dependent Claim
12 words
The prosthesis of claim 4 , wherein the cross-linking agent is glutaraldehyde.
Claim 8
Dependent Claim
65 words
The prosthesis of claim 1 , wherein the multiple layers of the first sheet in the overlapped region are fixed to one another by sutures, the first edge and second opposite edge of the second sheet are joined together along the length of the tube by sutures, and the overlapped region is offset from the sutures formed in the second sheet of the matrix structure.
Claim 9
Dependent Claim
35 words
The prosthesis of claim 7 , wherein the tube of the first sheet and the second sheet are fused to one another by compressing the matrix structures under conditions conducive to dehydration of the tissue.
Claim 10
Dependent Claim
19 words
The prosthesis of claim 1 , wherein the matrix structure comprises purified tela submucosa removed from a submucosa source.
Claim 11
Dependent Claim
29 words
The prosthesis of claim 1 , wherein the tube is formed to have the abluminal side of the sheet of the matrix structure on the exterior of the tube.
Claim 12
Dependent Claim
12 words
The prothesis of claim 1 , wherein the matrix structure is purified.
Claim 13
Dependent Claim
19 words
The prosthesis of claim 11 , wherein the matrix structure has a contaminant level making said purified structure biocompatible.
Claim 14
Dependent Claim
15 words
The prosthesis of claim 1 , wherein the collagen-based matrix structure comprises small intestinal submucosa.
Claim 15
Dependent Claim
22 words
The prosthesis of claim 1 , wherein the mature structure has a bioburden level less than 2 colony forming units per gram.
Claim 16
Dependent Claim
85 words
A unitary multi-layered graft prosthesis comprising a sheet of a purified collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the sheet having a first edge and a second opposite edge, formed in the shape of a tube, wherein the second opposite edge of the sheet extends over the first edge of the sheet to define a multiple layered overlapped region, wherein the layers in the overlapped region are fixed to one another.
Claim 17
Dependent Claim
85 words
A unitary multi-layered graft prosthesis comprising a sheet of a purified collagen-based matrix structure removed from a submucosa tissue source and having an endotoxin level less than 12 endotoxin units per gram, the sheet having a first edge and a second opposite edge, formed in the shape of a tube, wherein the second opposite edge of the sheet extends over the first edge of the sheet to define a multiple layered overlapped region, wherein the layers in the overlapped region are fixed to one another.
Claim 18
Dependent Claim
14 words
The prosthesis of claim 1 , wherein the collagen-based matrix structure comprises stomach submucosa.
Claim 19
Dependent Claim
15 words
The prosthesis of claim 1 , wherein the collagen-based matrix structure comprises urinary bladder submucosa.
Claim 20
Dependent Claim
14 words
The prosthesis of claim 1 , wherein the collagen-based matrix structure is uterine submucosa.
Claim 21
Dependent Claim
31 words
The prosthesis of claim 15 , wherein the collagen-based matrix structure includes a material selected from the group consisting of small intestinal submucosa, stomach submucosa, urinary bladder submucosa, and uterine submucosa.
Claim 22
Dependent Claim
15 words
The prosthesis of claim 15 , wherein the collagen-based matrix structure includes small intestinal submucosa.
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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) | 2005-03-18 | 2005-09-17 | 2006-03-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2009-03-18 | 2009-09-17 | 2010-03-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2013-03-18 | 2013-09-17 | 2014-03-19 | $7700.00 | Window Closed / Lapsed |