US5762600A
Expired / Lapsed
US
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Blood contact surfaces employing natural subendothelial matrix and methods for making and using the same
Assignee: W.L. Gore and Associates Inc
•
Filing: 1996-06-18
•
Granted: 1998-06-09
•
Expires: 2016-06-18
Abstract
Abstract This invention relates to improved vascular prostheses derived from mammalian blood vessels. The prostheses are fabricated from arterial segments from which the donor endothelium has been removed. A key aspect of this invention is the preservation of the subendothelial extracellular matrix that will serve as the blood interface of the vascular prostheses. The vessel segments are treated to reduce the likelihood of calcification and fixed with a tissue preservative. This invention results in vascular prostheses that are particularly useful for small diameter applications, such as arterial replacement requiring a diameter of 6 mm or less.
Inventors
- 👤 William Carl Bruchman
- 👤 Anita Jean Switzer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 04:31
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/507; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06
Claims Analysis
Total Claims: 72
Claim 1
Independent Claim
100 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; treating the donor blood vessel to preserve the subendothelial matrix layer in situ; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance.
Claim 2
Independent Claim
100 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; treating the donor blood vessel to preserve the subendothelial matrix layer in situ; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance.
Claim 3
Dependent Claim
51 words
The method of claim 1 which further comprises: surrounding the donor blood vessel with a sheath comprised of a material that permits the passage of macromolecules across the thickness of the sheath to and from the blood vessel while resisting ingrowth of cells from tissues surrounding the blood vessel when implanted.
Claim 4
Dependent Claim
23 words
The method of claim 1 which further comprises: eating the donor blood vessel to prevent calcification with a solution of chloroform and methanol.
Claim 5
Dependent Claim
27 words
The method of claim 1 wherein the proteolytic enzyme is selected from at least one member of a group consisting of collagenase, papain, trypsin, chymotrypsin, and elastase.
Claim 6
Independent Claim
132 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer, having an exterior surface and an interior surface; treating the donor blood vessel so as to remove the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer in situ; surrounding the exterior surface of the donor blood vessel with a sheath comprised of a material that permits the passage of macromolecules across the thickness of the sheath to and from the blood vessel while resisting ingrowth of cells from tissues surrounding the blood vessel when implanted; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance comprising an artificial blood vessel.
Claim 7
Independent Claim
132 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer, having an exterior surface and an interior surface; treating the donor blood vessel so as to remove the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer in situ; surrounding the exterior surface of the donor blood vessel with a sheath comprised of a material that permits the passage of macromolecules across the thickness of the sheath to and from the blood vessel while resisting ingrowth of cells from tissues surrounding the blood vessel when implanted; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance comprising an artificial blood vessel.
Claim 8
Dependent Claim
23 words
The method of claim 5 which further comprises: treating the donor blood vessel to prevent calcification with a solution of chloroform and methanol.
Claim 9
Dependent Claim
113 words
A process of producing a direct blood contact surface on an artificial blood vessel which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer in situ; surrounding the donor blood vessel with a sheath comprising a porous polytetrafluoroethylene material that is permeable to macromolecules but resistant to cell ingrowth; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 10
Dependent Claim
113 words
A process of producing a direct blood contact surface on an artificial blood vessel which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer in situ; surrounding the donor blood vessel with a sheath comprising a porous polytetrafluoroethylene material that is permeable to macromolecules but resistant to cell ingrowth; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 11
Dependent Claim
23 words
The process of claim 7 which further comprises: treating the donor blood vessel to prevent calcification with a solution of chloroform and methanol.
Claim 12
Dependent Claim
113 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the donor blood vessel to reduce the outer diameter of the blood vessel with a proteolytic enzyme, while protecting the subendothelial matrix layer from the proteolytic enzyme; treating the blood contact surface to preserve the subendothelial matrix layer in situ; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 13
Dependent Claim
113 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the donor blood vessel to reduce the outer diameter of the blood vessel with a proteolytic enzyme, while protecting the subendothelial matrix layer from the proteolytic enzyme; treating the blood contact surface to preserve the subendothelial matrix layer in situ; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 14
Dependent Claim
51 words
The process of claim 9 which further comprises: surrounding the donor blood vessel with a sheath comprised of a material that permits the passage of macromolecules across the thickness of the sheath to and from the blood vessel while resisting ingrowth of cells from tissues surrounding the blood vessel when implanted.
Claim 15
Dependent Claim
23 words
The process of claim 9 which further comprises: treating the donor blood vessel to prevent calcification with a solution of chloroform and methanol.
Claim 16
Dependent Claim
27 words
The process of claim 9 wherein the proteolytic enzyme is selected from at least one member of a group consisting of collagenase, papain, trypsin, chymotrypsin, and elastase.
Claim 17
Independent Claim
99 words
A method of producing a direct blood contact surface with improved patency performance which comprises: providing a natural blood contact surface derived from a donor, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the subendothelial matrix layer with a solution of ammonium hydroxide to improve patency; treating the subendothelial matrix layer to preserve the subendothelial matrix layer; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 18
Independent Claim
99 words
A method of producing a direct blood contact surface with improved patency performance which comprises: providing a natural blood contact surface derived from a donor, including an endothelial cell layer attached to a subendothelial matrix layer; stripping the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the subendothelial matrix layer with a solution of ammonium hydroxide to improve patency; treating the subendothelial matrix layer to preserve the subendothelial matrix layer; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 19
Dependent Claim
53 words
The method of claim 13 which further comprises: surrounding the blood contact surface with a sheath comprised of a material that permits the passage of macromolecules across the thickness of the sheath to and from the blood contact surface while resisting ingrowth of cells from tissues surrounding the blood contact surface when implanted.
Claim 20
Dependent Claim
23 words
The method of claim 13 which further comprises: treating the blood contact surface to prevent calcification with a solution of chloroform and methanol.
Claim 21
Dependent Claim
42 words
The method of claim 13 which further comprises: treating the blood contact surface with a proteolytic enzyme to reduce the outer diameter of the blood contact surface of the blood contact surface, while protecting the subendothelial matrix layer from the proteolytic enzyme.
Claim 22
Dependent Claim
27 words
The method of claim 16 wherein the proteolytic enzyme is selected from at least one member of a group consisting of collagenase, papain, trypsin, chymotrypsin, and elastase.
Claim 23
Dependent Claim
14 words
The method of claim 1 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 24
Dependent Claim
14 words
The method of claim 18 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 25
Dependent Claim
13 words
The method of claim 18 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 26
Dependent Claim
13 words
The method of claim 19 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 27
Dependent Claim
14 words
The method of claim 5 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 28
Dependent Claim
14 words
The method of claim 22 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 29
Dependent Claim
13 words
The method of claim 22 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 30
Dependent Claim
13 words
The method of claim 23 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 31
Dependent Claim
14 words
The method of claim 7 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 32
Dependent Claim
14 words
The method of claim 26 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 33
Dependent Claim
13 words
The method of claim 26 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 34
Dependent Claim
13 words
The method of claim 27 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 35
Dependent Claim
14 words
The method of claim 9 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 36
Dependent Claim
14 words
The method of claim 30 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 37
Dependent Claim
13 words
The method of claim 30 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 38
Dependent Claim
13 words
The method of claim 31 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 39
Dependent Claim
14 words
The method of claim 13 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 40
Dependent Claim
14 words
The method of claim 34 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 41
Dependent Claim
13 words
The method of claim 34 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 42
Dependent Claim
13 words
The method of claim 35 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 43
Independent Claim
99 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove only the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance.
Claim 44
Independent Claim
99 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove only the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; and employing the subendothelial matrix layer as a direct blood contact surface in an appliance.
Claim 45
Dependent Claim
14 words
The method of claim 38 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 46
Dependent Claim
14 words
The method of claim 39 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 47
Dependent Claim
13 words
The method of claim 39 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 48
Dependent Claim
13 words
The method of claim 40 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 49
Independent Claim
138 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove only the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer; employing the subendothelial matrix layer as a direct blood contact surface in an appliance, wherein the appliance comprises an artificial blood vessel having an exterior surface and an interior surface; and surrounding the exterior surface of the donor blood vessel with a sheath, wherein the sheath comprises a material which permits the passage of macromolecules across the thickness of the sheath to and from the donor blood vessel while resisting ingrowth of cells from tissue surrounding the donor blood vessel when implanted.
Claim 50
Independent Claim
138 words
A method of producing a blood contact surface which comprises: providing a donor blood vessel, including endothelial cells attached to a subendothelial matrix layer; treating the donor blood vessel so as to remove only the endothelial cells while leaving the subendothelial matrix layer in situ; treating the donor blood vessel to preserve the subendothelial matrix layer; employing the subendothelial matrix layer as a direct blood contact surface in an appliance, wherein the appliance comprises an artificial blood vessel having an exterior surface and an interior surface; and surrounding the exterior surface of the donor blood vessel with a sheath, wherein the sheath comprises a material which permits the passage of macromolecules across the thickness of the sheath to and from the donor blood vessel while resisting ingrowth of cells from tissue surrounding the donor blood vessel when implanted.
Claim 51
Dependent Claim
14 words
The method of claim 43 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 52
Dependent Claim
14 words
The method of claim 44 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 53
Dependent Claim
13 words
The method of claim 44 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 54
Dependent Claim
13 words
The method of claim 45 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 55
Dependent Claim
108 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; surrounding the donor blood vessel with a sheath comprised of a porous polytetrafluoroethylene material that is permeable to macromolecules, but resistant to cell ingrowth; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 56
Dependent Claim
108 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; surrounding the donor blood vessel with a sheath comprised of a porous polytetrafluoroethylene material that is permeable to macromolecules, but resistant to cell ingrowth; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 57
Dependent Claim
14 words
The method of claim 48 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 58
Dependent Claim
14 words
The method of claim 49 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 59
Dependent Claim
13 words
The method of claim 49 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 60
Dependent Claim
13 words
The method of claim 50 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 61
Dependent Claim
112 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 62
Dependent Claim
112 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 63
Dependent Claim
14 words
The method of claim 53 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 64
Dependent Claim
14 words
The method of claim 54 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 65
Dependent Claim
13 words
The method of claim 54 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 66
Dependent Claim
13 words
The method of claim 55 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 67
Dependent Claim
133 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme, wherein the proteolytic enzyme selected from at least one member of a group consisting of collagenase, papain, trypsin, chymotrypsin, and elastase; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 68
Dependent Claim
133 words
A process of producing a direct blood contact surface which comprises: providing a natural blood contact surface derived from a donor blood vessel, including an endothelial cell layer attached to a subendothelial matrix layer; stripping only the endothelial cell layer from the subendothelial matrix layer so as to leave the subendothelial matrix layer in situ; treating the blood contact surface to preserve the subendothelial matrix layer; treating the donor blood vessel with a proteolytic enzyme to reduce the outer diameter of the blood vessel, while protecting the subendothelial matrix layer from the proteolytic enzyme, wherein the proteolytic enzyme selected from at least one member of a group consisting of collagenase, papain, trypsin, chymotrypsin, and elastase; and employing the preserved subendothelial matrix layer substantially free of endothelial cells as a direct blood contact surface.
Claim 69
Dependent Claim
14 words
The method of claim 58 wherein the subendothelial matrix layer comprises chondroitin sulfate proteoglycans.
Claim 70
Dependent Claim
14 words
The method of claim 59 wherein the subendothelial matrix layer further comprises glycosaminoglycan-bearing proteoglycans.
Claim 71
Dependent Claim
13 words
The method of claim 59 wherein the subendothelial matrix layer further comprises fibronectin.
Claim 72
Dependent Claim
13 words
The method of claim 60 wherein the subendothelial matrix layer further comprises fibronectin.
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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) | 2001-06-08 | 2001-12-08 | 2002-06-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-06-08 | 2005-12-08 | 2006-06-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-06-08 | 2009-12-08 | 2010-06-09 | $7700.00 | Window Closed / Lapsed |