US6726923B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Apparatus and methods for preventing or treating failure of hemodialysis vascular access and other vascular grafts
Assignee: Vascular Therapies Inc
•
Filing: 2002-01-16
•
Granted: 2004-04-27
•
Expires: 2022-01-16
Abstract
Abstract This invention is a prosthetic device generally placed on the outside surface of the vessel or graft which then elutes antiproliferative drugs or agents from a drug-eluting matrix material. Methods of perivascular antiproliferative drug administration also are disclosed.
Inventors
- 👤 Sriram S. Iyer
- 👤 Nicholas N. Kipshidze
- 👤 Victor V. Nikolaychik
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 12:09
CPC Classifications
A; A61; A61K; A61K31/00; A61K31/33; A61K31/395; A61K31/435; A61K31/4353; A61K31/436; A61K31/12; A61K31/122; A61K31/335; A61K31/337; A61K31/56; A61K31/57; A61K31/573; A61K31/70; A61K31/715; A61K31/726; A61K31/727; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0024; A61L; A61L27/00; A61L27/14; A61L27/20; A61L27/22; A61L27/225; A61L27/40; A61L27/44; A61L27/50; A61L27/54; A61L31/00; A61L31/14; A61L31/16; A61M; A61M1/00; A61M1/36; A61M1/3621; A61M1/3653; A61M1/3655; A61M39/00; A61M39/02; A61M39/0247; A61P; A61P31/00; A61P37/00; A61P37/02; A61P37/06; A61P41/00; A61P43/00; A61P7/00; A61P7/02; A61P7/08; A61P9/00; A61P9/10; A61L2300/00; A61L2300/20; A61L2300/204; A61L2300/252; A61L2300/40; A61L2300/416; A61M1/14; A61M1/16; A61M2039/0258; A61M2039/0261; A61M2202/00; A61M2202/04; A61M2202/0468; A61M2202/0478
Claims Analysis
Total Claims: 48
Claim 1
Independent Claim
65 words
A method of prophylactically treating vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamnycin to the vascular structure.
Claim 2
Independent Claim
65 words
A method of prophylactically treating vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamnycin to the vascular structure.
Claim 3
Independent Claim
68 words
A method of prophylactically treating vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying localy and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with analogue(s) of rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 4
Independent Claim
68 words
A method of prophylactically treating vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying localy and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with analogue(s) of rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 5
Independent Claim
65 words
A method of treating established vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with Rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 6
Independent Claim
65 words
A method of treating established vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with Rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 7
Independent Claim
67 words
A method of treating established vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 8
Independent Claim
67 words
A method of treating established vasculoproliferative disease in a vascular structure following the construction of an arterio-venous graft, an arterial-arterial graft or an arterio-venous fistula, the method comprising applying locally and external to the vascular structure, perivascularly, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 9
Independent Claim
87 words
A method of prophylactically treating vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 10
Independent Claim
87 words
A method of prophylactically treating vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 11
Independent Claim
89 words
A method of prophylactically treating vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 12
Independent Claim
89 words
A method of prophylactically treating vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 13
Independent Claim
87 words
A method of treating established vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or aterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 14
Independent Claim
87 words
A method of treating established vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or aterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin thereby enabling delivery of an antiproliferative effective amount of rapamycin to the vascular structure.
Claim 15
Independent Claim
89 words
A method of treating established vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 16
Independent Claim
89 words
A method of treating established vasculoproliferative disease in vascular structures including at least one anastamotic site wherein the vasculoproliferative disease includes tissue encroaching on the lumen of the vascular structure following the construction of arterio-venous grafts, arterial-arterial grafts or arterio-venous fistulae, the method comprising applying locally and external to the vascular structure, perivascularly, adjacent to the site of anastamosis, a therapeutic agent-eluting sleeve, the sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s) thereby enabling delivery of an antiproliferative effective amount of rapamycin analogue(s) to the vascular structure.
Claim 17
Independent Claim
16 words
A method according to claims 1 - 8 wherein the graft comprises synthetic or biologic materials.
Claim 18
Independent Claim
55 words
A method of prophylactically treating vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin; and contacting external to the vascular structure perivascularaly and locally with the sleeve wherein an antiproliferative effective amount of rapamiycin is administered to the vascular structure.
Claim 19
Independent Claim
55 words
A method of prophylactically treating vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin; and contacting external to the vascular structure perivascularaly and locally with the sleeve wherein an antiproliferative effective amount of rapamiycin is administered to the vascular structure.
Claim 20
Independent Claim
57 words
A method of prophylactically treating vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s); and contacting external to the vascular structure perivascularaly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin analogue(s) is administered to the vascular structure.
Claim 21
Independent Claim
57 words
A method of prophylactically treating vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s); and contacting external to the vascular structure perivascularaly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin analogue(s) is administered to the vascular structure.
Claim 22
Independent Claim
55 words
A method of treating established vasculoproliferative disease in one or more vascular structures comprising; providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin; and contacting external to the vascular structure pelivascularly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin is admnistered to the vascular structure.
Claim 23
Independent Claim
55 words
A method of treating established vasculoproliferative disease in one or more vascular structures comprising; providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin; and contacting external to the vascular structure pelivascularly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin is admnistered to the vascular structure.
Claim 24
Independent Claim
57 words
A method of treating established vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s); and contacting external to the vascular structure perivascularly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin analogue(s) is administered to the vascular structure.
Claim 25
Independent Claim
57 words
A method of treating established vasculoproliferative disease in one or more vascular structures comprising: providing an implantable antiproliferative agent-eluting perivascular sleeve comprising a biocompatible matrix material imbibed with rapamycin analogue(s); and contacting external to the vascular structure perivascularly and locally with the sleeve wherein an antiproliferative effective amount of rapamycin analogue(s) is administered to the vascular structure.
Claim 26
Independent Claim
18 words
A method according to claims 1 - 8 and 10 - 13 wherein the sleeve is substantially circumvascular.
Claim 27
Independent Claim
25 words
A method according to claims 1 - 8 and 10 - 13 wherein a combination of rapamycin and heparin is administered to the vascular structure.
Claim 28
Dependent Claim
24 words
A method according to claim 15 wherein the amounts of rapamycin and heparin are sufficient to exhibit a synergistic effect in treating vasculoproliferative disease.
Claim 29
Dependent Claim
44 words
A method according to claim 15 wherein the amount of rapamycin is about 2 micrograms/cm 2 to about 10.0 mgs/cm 2 and the amount of heparin is about 70 units/cm 2 to about 20,000 units/cm 2 before contacting the sleeve to the vascular structure.
Claim 30
Independent Claim
26 words
A method according to claims 1 - 8 and 10 - 13 wherein a combination of rapamycin analogue(s) and heparin is administered to the vascular structure.
Claim 31
Dependent Claim
25 words
A method according to claim 18 wherein the amounts of rapamycin analogues and heparin are sufficient to exhibit a synergistic effect in treating vasculoproliferative disease.
Claim 32
Independent Claim
18 words
A method according to claims 1 - 8 and 10 - 13 wherein the biocompatabile matrix is biodegradable.
Claim 33
Independent Claim
18 words
A method according to claims 1 - 8 and 10 - 13 wherein the biocompatabile matrix is non-biodegradable.
Claim 34
Independent Claim
19 words
A method according to claims 1 - 8 and 10 - 13 wherein the biocompatible biodegradable matrix is collagen.
Claim 35
Dependent Claim
14 words
A method according to claim 22 wherein the collagen is Type I Bovine collagen.
Claim 36
Dependent Claim
29 words
A method according to claim 22 wherein the collagen is selected from the group consisting of Type I, Type II, Type III, Type IV, Type XI, and mixtures thereof.
Claim 37
Dependent Claim
14 words
A method according to claim 22 wherein the collagen is manufactured using recombinant techniques.
Claim 38
Independent Claim
24 words
A method according to claims 1 - 8 and 10 - 13 wherein the biocompatabile matrix comprises a combination of biodegradable and non-biodegradable materials.
Claim 39
Independent Claim
28 words
A method according to claims 1 - 8 and 10 - 13 wherein the sleeve comprises a rapamycin imbibed inner matrix layer and an external support skeletal layer.
Claim 40
Dependent Claim
22 words
A method according to claim 27 wherein the inner matrix layer comprises collagen and the external support skeletal layer comprises polytetrafluoro-ethylene (PTFE).
Claim 41
Independent Claim
28 words
A method according to claims 1 - 8 and 10 - 13 wherein the sleeve comprises a rapamycin analogue-imbibed inner matrix layer and an external support skeletal layer.
Claim 42
Dependent Claim
22 words
A method according to claim 29 wherein the inner matrix layer comprises collagen, and the external support skeletal layer is polytetrafluroethylene (PTFE).
Claim 43
Independent Claim
35 words
A method according to claims 1 - 8 and 10 - 13 wherein the amount of rapamycin is about 2 micrograms/cm 2 to about 10.0 mgs/cm 2 before contacting the sleeve to the vascular structure.
Claim 44
Independent Claim
21 words
A method according to claims 1 - 8 and 10 - 13 wherein the matrix material is further imbibed with dexamethasone.
Claim 45
Independent Claim
24 words
A method according to claims 1 - 8 and 10 - 13 wherein the vascular structure is an artery, vein, graft, or anastamotic site.
Claim 46
Independent Claim
29 words
A method according to claims 1 - 8 and 10 - 13 wherein the matrix material is selected from the group consisting of collagen, fibrin, chitosan and mixtures thereof.
Claim 47
Independent Claim
20 words
A method according to claims 1 - 8 and 10 - 13 wherein rapamycin is administered to the vascular structure.
Claim 48
Independent Claim
22 words
A method according to claims 1 - 8 and 10 - 13 wherein a rapamycin analogue is administered to the vascular structure.
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