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EP0246638A2
Expired / Lapsed
EP
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Biologically modified synthetic grafts
Assignee: Cordis Corp
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Filing: 1987-05-20
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Granted: —
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Expires: 2007-05-20
Abstract
Abstract Synthetic porous grafts are provided that have been modified with a conjugate in order to enhace their biocompatibility. The thus modified synthetic grafts have the conjugate formed in place within their pores from collagen materials coupled to anticoagulant materials. Cell attachment protein material may also be included on the conjugate. A method for forming the conjugate in place is also described, as are conjugates incorporating type III collagen fibrils.
Inventors
- 👤 Seymour P. Halbert
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 08:13
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/50; A61L27/56; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61L27/36; A61L33/00; A61L33/0005; A61L33/0011; A61L33/0029
Claims Analysis
Total Claims: 36
Claim 1
Independent Claim
93 words
A biologically modified synthetic graft, comprising: a body member made from synthetic material, said body member including a plurality of pores within said synthetic material; a conjugate member within said pores for modifying the biological properties of the synthetic body member, said conjugate member including collagen material and heparinous material coupled by a crosslinking component, said collagen material including collagen fibrils that are coupled together by said crosslinking component into a collagen fibril network within said pores, said collagen fibril network of the conjugate member having been formed in place within said pores.
Claim 2
Dependent Claim
93 words
A biologically modified synthetic graft, comprising: a body member made from synthetic material, said body member including a plurality of pores within said synthetic material; a conjugate member within said pores for modifying the biological properties of the synthetic body member, said conjugate member including collagen material and heparinous material coupled by a crosslinking component, said collagen material including collagen fibrils that are coupled together by said crosslinking component into a collagen fibril network within said pores, said collagen fibril network of the conjugate member having been formed in place within said pores.
Claim 3
Dependent Claim
93 words
The biologically modified synthetic graft according to claim l, wherein said body member includes a plurality of layers of biocompatible polymeric fiber material, said fiber layers having been formed by extrusion of a fiber-forming polymer through an orifice to form an elongated fiber that was wound on a mandrel to form a plurality of windings defining said plurality of layers, said plurality of windings defining a non-woven graft body having overlying fibers that intersect one another to form said pores and at least one porous wall that is conducive to tissue ingrowth thereinto.
Claim 4
Dependent Claim
22 words
The biologically modified synthetic graft according to claim l and/or 2, wherein said synthetic graft body is made from a polyurethane material.
Claim 5
Dependent Claim
46 words
The biologically modified synthetic graft according to any of claims l - 3, wherein said synthetic material body member is a polymeric material including said pores, said pores having been formed by eluting elutable particles from a mixture of the polymeric material and such elutable particles.
Claim 6
Dependent Claim
29 words
The biologically modified synthetic graft according to any of claims l - 4, wherein said pores have a size not greater than on the order of about 70 microns.
Claim 7
Dependent Claim
25 words
The biologically modified synthetic graft according to any of claims l - 5, wherein said collagen material of the conjugate member includes type III collagen.
Claim 8
Dependent Claim
25 words
The biologically modified synthetic graft according to any of claims l - 5, wherein said collagen material of the conjugate member includes type I collagen.
Claim 9
Dependent Claim
29 words
The biologically modifed synthetic graft according to any of claims l - 5, wherein said collagen material of the conjugate member includes type I collagen and type III collagen.
Claim 10
Dependent Claim
36 words
The biologically modified synthetic graft according to any of claims l - 8, wherein said heparinous material of the conjugate member is a highly active heparin fraction isolated by affinity chromatography on anti-thrombin III sepharose columns.
Claim 11
Dependent Claim
26 words
l0. The biologically modified synthetic graft according to any of claims l - 9, wherein said crosslinking component of the conjugate member is a multi-functional aldehyde.
Claim 12
Dependent Claim
42 words
The biologically modified synthetic graft according to any of claims l - l0, wherein said formed-in-place collagen network of the conjugate member had been formed from solubilized collagen materials placed within said pores and reassociated within said pores into said collagen fibrils.
Claim 13
Dependent Claim
37 words
The biologically modified synthetic graft according to any of claims l - ll, wherein said conjugate member further includes cell attachment protein, said cell attachment protein being generally on at least one surface of said body member.
Claim 14
Dependent Claim
48 words
The biologically modified synthetic graft according to claim l2, wherein said body member is generally tubular and includes a lumen to define a luminal surface of the conjugate member, and said cell attachment protein of the conjugate member is coupled to said luminal surface of the conjugate member.
Claim 15
Dependent Claim
22 words
The biologically modified synthetic graft according to claim l2 and/or l3, wherein said cell attachment protein of the conjugate member is fibronectin.
Claim 16
Independent Claim
138 words
A method for manufacturing a biologically modified synthetic graft, comprising: making a body member from synthetic material, said making procedure including forming a plurality of pores within said synthetic material; dissolving collagen fibrils within a solvent in order to form a solution of collagen material; passing said collagen solutions into said pores of the body member; reassociating said collagen fibrils from said collagen solution within said pores by contacting said body member having collagen solution within its pores with a collagen fibril reassociating agent; treating said resulting reassociated collagen fibrils within said pores with a crosslinking component whereby collagen fibrils are formed into a collagen fibril network within said pores; and contacting anticoagulant material with said collagen fibrils and in the presence of said crosslinking agent to form a synthetic graft that is biologically modified with said conjugate.
Claim 17
Independent Claim
138 words
A method for manufacturing a biologically modified synthetic graft, comprising: making a body member from synthetic material, said making procedure including forming a plurality of pores within said synthetic material; dissolving collagen fibrils within a solvent in order to form a solution of collagen material; passing said collagen solutions into said pores of the body member; reassociating said collagen fibrils from said collagen solution within said pores by contacting said body member having collagen solution within its pores with a collagen fibril reassociating agent; treating said resulting reassociated collagen fibrils within said pores with a crosslinking component whereby collagen fibrils are formed into a collagen fibril network within said pores; and contacting anticoagulant material with said collagen fibrils and in the presence of said crosslinking agent to form a synthetic graft that is biologically modified with said conjugate.
Claim 18
Independent Claim
48 words
The method according to claim l5, wherein said making procedure includes forming a generally tubular synthetic body member having a lumen, and wherein said collagen solution passing procedure includes tying off one end of said lumen and injecting said collagen solution into the other end of said lumen.
Claim 19
Independent Claim
16 words
The method according to claim l5 and/or l6, wherein said collagen fibrils include type III collagen.
Claim 20
Independent Claim
16 words
The method according to claim l5 and/or l6, wherein said collagen fibrils include type I collagen.
Claim 21
Independent Claim
19 words
The method according to claim l5 and/or l6, wherein said collagen fibrils include type I and type III collagen.
Claim 22
Independent Claim
18 words
The method according to any of claims l5 - l9, wherein said anticoagulant material includes a heparinous material.
Claim 23
Dependent Claim
31 words
2l. The method according to claim 20, wherein said anticoagulant material includes a heparinous material that is a highly active heparin fraction isolated by affinity chromatography on anti-thrombin III sepharose columns.
Claim 24
Independent Claim
17 words
The method according to any of claims l5 - 2l, wherein said crosslinking agent is a dialdehyde.
Claim 25
Independent Claim
77 words
The method according to any of claims l5 - 22, wherein said making procedure includes: extruding a fiber-forming biocompatible polymeric material through an orifice in order to form an elongated fiber; winding said elongated fiber on a mandrel such that the continuous fiber forms a plurality of windings that define a non-woven cylinder having overlying fibers that contact one another to form said pores and at least one porous surface that is conducive to tissue ingrowth thereinto.
Claim 26
Independent Claim
41 words
The method according to any of claims l5 - 23, wherein said making procedure includes providing and shaping a mixture of polymeric material and elutable particles and eluting said elutable particles from the shaped polymer in order to form said pores.
Claim 27
Independent Claim
20 words
The method according to any of claims l5 - 24, further including coupling a cell attachment protein to said conjugate.
Claim 28
Dependent Claim
64 words
A process for the improvement of in vivo compatibility between blood and an implanted synthetic porous graft, said process comprising forming a conjugate in place within the pores of the synthetic porous graft, said conjugate including collagen material and anticoagulant material coupled by a crosslinking component, said conjugate including collagen fibrils that are coupled together by said crosslinking component into a collagen fibril network.
Claim 29
Dependent Claim
64 words
A process for the improvement of in vivo compatibility between blood and an implanted synthetic porous graft, said process comprising forming a conjugate in place within the pores of the synthetic porous graft, said conjugate including collagen material and anticoagulant material coupled by a crosslinking component, said conjugate including collagen fibrils that are coupled together by said crosslinking component into a collagen fibril network.
Claim 30
Dependent Claim
14 words
The process according to claim 26, wherein said collagen material includes type III collagen.
Claim 31
Dependent Claim
27 words
The process according to claim 26 and/or 27, wherein said anticoagulant material is a highly active heparin fraction isolated by affinity chromatography on anti-thrombin III sepharose columns.
Claim 32
Dependent Claim
29 words
The process according to any of claims 26 - 28, wherein said procedure of forming the conjugate in place further includes coupling cell attachment protein to said conjugate network.
Claim 33
Dependent Claim
28 words
A conjugate for improving the biocompatibility of synthetic grafts, said conjugate having been made according to the process of claim 26, said anticoagulant material being a heparinous material.
Claim 34
Dependent Claim
21 words
3l. The conjugate according to claim 30, wherein said collagen material includes type I collagen fibrils and type III collagen fibrils.
Claim 35
Dependent Claim
31 words
The conjugate according to claim 30 and/or 3l, wherein said heparinous material of the conjugate member is a highly active heparin fraction isolated by affinity chromatography on anti-thrombin III sepharose columns.
Claim 36
Dependent Claim
26 words
The conjugate according to any of claims 30 - 32, wherein said conjugate further includes cell attachment protein coupled to the conjugate through said crosslinking component.
References Cited (Backward Citations)
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