US5716394A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Blood contact surfaces using extracellular matrix synthesized in vitro
Assignee: W.L. Gore and Associates Inc
•
Filing: 1995-04-19
•
Granted: 1998-02-10
•
Expires: 2015-04-19
Abstract
Abstract This invention is directed to improved blood contact devices such as vascular prostheses rendered substantially nonthrombogenic through addition of a preserved layer of extracellular subendothelial matrix. The preserved subendothelial matrix layer, which serves as the blood interface of the device, is analogous to the subendothelial matrix layer beneath the endothelium of native vascular surfaces. The device consists of a permanent synthetic base material, preferably porous expanded polytetrafluoroethylene, on which this biologic layer of subendothelial matrix is grown in situ. The biologic layer is produced using in vitro tissue culture methods whereby living cells synthesize and deposit extracellular matrix components, after which the cells are killed and/or removed and the subendothelial matrix layer preserved before implantation. A key aspect of this invention is that no living Cells are present in the final configuration, so that the likelihood of recipient immunological response is minimized. This invention results in vascular prostheses that are particularly useful for arterial bypass requiring a diameter of 6 mm or less.
Inventors
- 👤 William Carl Bruchman
- 👤 Paul Christopher Begovac
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 13:40
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/507; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; Y; Y10; Y10S; Y10S623/00; Y10S623/915; Y10S623/916
Claims Analysis
Total Claims: 55
Claim 1
Independent Claim
54 words
A blood contact material comprising: a synthetic base material; a first layer comprised of cells attached to the synthetic base material; and a second layer comprised of a subendothelial matrix layer substantially free of endothelial cells attached to the first layer; wherein the sub endothelial matrix layer serves as a direct blood contact surface.
Claim 2
Dependent Claim
54 words
A blood contact material comprising: a synthetic base material; a first layer comprised of cells attached to the synthetic base material; and a second layer comprised of a subendothelial matrix layer substantially free of endothelial cells attached to the first layer; wherein the sub endothelial matrix layer serves as a direct blood contact surface.
Claim 3
Dependent Claim
15 words
The blood contact material of claim 1 wherein the first layer is comprised of fibroblasts.
Claim 4
Dependent Claim
17 words
The blood contact material of claim 1 wherein the first layer is comprised of smooth muscle cells.
Claim 5
Dependent Claim
17 words
The blood contact material of claim 3 wherein the smooth muscles cells are vascular smooth muscle cells.
Claim 6
Dependent Claim
22 words
The blood contact material of claim 1 wherein the second layer comprises a preserved subendothelial matrix layer substantially free of endothelial cells.
Claim 7
Dependent Claim
23 words
The blood contact material of claim 1 wherein the synthetic base material comprises a polymeric material to which the first layer will adhere.
Claim 8
Dependent Claim
33 words
The blood contact material of claim 6 wherein the synthetic base material is selected from the group consisting of at least one of polytetrafluoroethylene, polyethylene terepthalate, fluorinated ethylene propylene, polyethylene, polypropylene, and siloxane.
Claim 9
Dependent Claim
16 words
The blood contact material of claim 6 wherein the synthetic base material comprises an expanded polytetrafluoroethylene.
Claim 10
Dependent Claim
25 words
The blood contact material of claim 8 wherein the expanded polytetrafluoroethylene has a microstructure with an average fibril length of less than about 60 μm.
Claim 11
Dependent Claim
48 words
The blood contact material of claim 1 wherein the synthetic base material comprises a tube having an exterior and an interior; wherein the first layer is attached to the interior of the tube; and wherein the second layer is attached to the first layer to form a covering.
Claim 12
Dependent Claim
21 words
The blood contact material of claim 10 wherein the tube having the subendothelial matrix layer covering serves as an implantable appliance.
Claim 13
Dependent Claim
23 words
The blood contact material of claim 5 wherein the synthetic base material comprises a polymeric material to which the first layer will adhere.
Claim 14
Dependent Claim
33 words
The blood contact material of claim 12 wherein the synthetic base material is selected from the group consisting of at least one of polytetrafluoroethylene, polyethylene terepthalate, fluorinated ethylene propylene, polyethylene, polypropylene, and siloxane.
Claim 15
Dependent Claim
16 words
The blood contact material of claim 12 wherein the synthetic base material comprises an expanded polytetrafluoroethylene.
Claim 16
Dependent Claim
25 words
The blood contact material of claim 14 wherein the expanded polytetrafluoroethylene has a microstructure with an average fibril length of less than about 60 μm.
Claim 17
Dependent Claim
48 words
The blood contact material of claim 5 wherein the synthetic base material comprises a tube having an exterior and an interior; wherein the first layer is attached to the interior of the tube; and wherein the second layer is attached to the first layer to form a covering.
Claim 18
Dependent Claim
22 words
The blood contact material of claim 9 wherein the tube having the preserved subendothelial matrix layer covering serves as an implantable appliance.
Claim 19
Dependent Claim
34 words
The blood contact material of claim 1 wherein the second layer contains at least one protein in a group consisting of chondroitin sulfate proteoglycans, collagen I, collagen III, collagen IV, elastin, laminin, and fibronectin.
Claim 20
Dependent Claim
34 words
The blood contact material of claim 5 wherein the second layer contains at least one protein in a group consisting of chondroitin sulfate proteoglycans, collagen I, collagen III, collagen IV, elastin, laminin, and fibronectin.
Claim 21
Dependent Claim
24 words
The blood contact material of claim 1 wherein the second layer comprises chondroitin sulfate proteoglycans, collagen I, collagen III, collagen IV, elastin, and fibronectin.
Claim 22
Dependent Claim
24 words
The blood contact material of claim 5 wherein the second layer comprises chondroitin sulfate proteoglycans, collagen I collagen III, collagen IV, elastin, and fibronectin.
Claim 23
Dependent Claim
64 words
A blood contact material comprising: a synthetic base material; a first layer comprised of cells attached to the synthetic base material; and a second layer comprised of a preserved subendothelial matrix layer substantially free of endothelial cells attached to the first layer; wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans; and wherein the subendothelial matrix layer serves as a direct blood contact surface.
Claim 24
Dependent Claim
64 words
A blood contact material comprising: a synthetic base material; a first layer comprised of cells attached to the synthetic base material; and a second layer comprised of a preserved subendothelial matrix layer substantially free of endothelial cells attached to the first layer; wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans; and wherein the subendothelial matrix layer serves as a direct blood contact surface.
Claim 25
Dependent Claim
16 words
The blood contact material of claim 22 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 26
Dependent Claim
15 words
The blood contact material of claim 22 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 27
Dependent Claim
15 words
The blood contact material of claim 23 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 28
Dependent Claim
15 words
The blood contact material of claim 22 wherein the subendothelial matrix layer further comprises elastin.
Claim 29
Dependent Claim
15 words
The blood contact material of claim 23 wherein the subendothelial matrix layer further comprises elastin.
Claim 30
Dependent Claim
15 words
The blood contact material of claim 24 wherein the subendothelial matrix layer further comprises elastin.
Claim 31
Dependent Claim
15 words
The blood contact material of claim 25 wherein the subendothelial matrix layer further comprises elastin.
Claim 32
Dependent Claim
15 words
The blood contact material of claim 25 wherein the subendothelial matrix layer further comprises collagen.
Claim 33
Dependent Claim
27 words
The blood contact material of claim 30 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 34
Dependent Claim
15 words
The blood contact material of claim 23 wherein the subendothelial matrix layer further comprises collagen.
Claim 35
Dependent Claim
27 words
The blood contact material of claim 32 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 36
Dependent Claim
15 words
The blood contact material of claim 24 wherein the subendothelial matrix layer further comprises collagen.
Claim 37
Dependent Claim
27 words
The blood contact material of claim 34 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 38
Dependent Claim
15 words
The blood contact material of claim 31 wherein the subendothelial matrix layer further comprises collagen.
Claim 39
Dependent Claim
27 words
The blood contact material of claim 36 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 40
Dependent Claim
15 words
The blood contact material of claim 26 wherein the subendothelial matrix layer further comprises collagen.
Claim 41
Dependent Claim
27 words
The blood contact material of claim 38 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 42
Dependent Claim
15 words
The blood contact material of claim 27 wherein the subendothelial matrix layer further comprises collagen.
Claim 43
Dependent Claim
27 words
The blood contact material of claim 40 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 44
Dependent Claim
15 words
The blood contact material of claim 28 wherein the subendothelial matrix layer further comprises collagen.
Claim 45
Dependent Claim
27 words
The blood contact material of claim 42 wherein the collagen is selected from the group consisting of collagen Type I, collagen Type III, and collagen Type IV.
Claim 46
Dependent Claim
15 words
The blood contact material of claim 22 wherein the first layer is comprised of fibroblasts.
Claim 47
Dependent Claim
17 words
The blood contact material of claim 22 wherein the first layer is comprised of smooth muscle cells.
Claim 48
Dependent Claim
17 words
The blood contact material of claim 45 wherein the smooth muscles cells are vascular smooth muscle cells.
Claim 49
Dependent Claim
23 words
The blood contact material of claim 22 wherein the synthetic base material comprises a polymeric material to which the first layer will adhere.
Claim 50
Dependent Claim
33 words
The blood contact material of claim 47 wherein the synthetic base material is selected from the group consisting of at least one of polytetrafluoroethylene, polyethylene terepthalate, fluorinated ethylene propylene, polyethylene, polypropylene, and siloxane.
Claim 51
Dependent Claim
16 words
The blood contact material of claim 47 wherein the synthetic base material comprises an expanded polytetrafluoroethylene.
Claim 52
Dependent Claim
25 words
The blood contact material of claim 49 wherein the expanded polytetrafluoroethylene has a microstructure with an average fibril length of less than about 60 μm.
Claim 53
Dependent Claim
48 words
The blood contact material of claim 22 wherein the synthetic base material comprises a tube having an exterior and an interior; wherein the first layer is attached to the interior of the tube; and wherein the second layer is attached to the first layer to form a covering.
Claim 54
Dependent Claim
21 words
The blood contact material of claim 51 wherein the tube having the subendothelial matrix layer covering serves as an implantable appliance.
Claim 55
Dependent Claim
21 words
The blood contact material of claim 50 wherein the tube having the subendothelial matrix layer covering serves as an implantable appliance.
References Cited (Backward Citations)
US3953566A
Cited
US4539716A
Cited
US4546500A
Cited
US4960423A
Cited
US4804381A
Cited
US4804382A
Cited
US4883755A
Cited
US5037378A
Cited
EP0531547A1
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-02-09 | 2001-08-11 | 2002-02-10 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-02-09 | 2005-08-11 | 2006-02-10 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-02-09 | 2009-08-11 | 2010-02-10 | $7700.00 | Window Closed / Lapsed |