CA2434972A1 - Implantable device containing resorbable matrix material and anti-proliferative drugs for preventing or treating failure of hemodialysis vascular access and other vascular grafts - Google Patents

Implantable device containing resorbable matrix material and anti-proliferative drugs for preventing or treating failure of hemodialysis vascular access and other vascular grafts Download PDF

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Publication number
CA2434972A1
CA2434972A1 CA002434972A CA2434972A CA2434972A1 CA 2434972 A1 CA2434972 A1 CA 2434972A1 CA 002434972 A CA002434972 A CA 002434972A CA 2434972 A CA2434972 A CA 2434972A CA 2434972 A1 CA2434972 A1 CA 2434972A1
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CA
Canada
Prior art keywords
vascular
sleeve
matrix material
agent
hemodialysis
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Granted
Application number
CA002434972A
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French (fr)
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CA2434972C (en
Inventor
Sriram S. Iyer
Nicholas N. Kipshidze
Victor V. Nikolaychik
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Vascular Therapies Inc
Original Assignee
Vascular Therapies, Llc
Sriram S. Iyer
Nicholas N. Kipshidze
Victor V. Nikolaychik
Vascular Therapies, Inc.
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Application filed by Vascular Therapies, Llc, Sriram S. Iyer, Nicholas N. Kipshidze, Victor V. Nikolaychik, Vascular Therapies, Inc. filed Critical Vascular Therapies, Llc
Publication of CA2434972A1 publication Critical patent/CA2434972A1/en
Application granted granted Critical
Publication of CA2434972C publication Critical patent/CA2434972C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
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    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
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    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
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    • A61P37/00—Drugs for immunological or allergic disorders
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    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock
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    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
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    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
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    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
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    • A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
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    • A61M2202/00—Special media to be introduced, removed or treated
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Abstract

A therapeutic implant, apparatus and methods useful for preventing, suppressing (inhibiting) or treating failure of hemodialysis vascular access and other vascular grafts from outside the vascular or graft lumen and through the vascular wall (extravascularly or perivascularly). The implantable device contains resorbable matrix material (e.g. collagen, fibrin, chitosan) and antiproliverative agent(s), for instance3 Rapamycin, Paclitaxel, Tacrolimus etc. and other cell cycle inhibitor or similarly-functioning agents.

Claims (36)

1. A method of preventing or treating vasculoproliferative disease in vascular structures, which comprises the step of administering extravascularly and locally an antiproliferative effective amount of an antiproliferative agent to the vascular structure.
2. A method according to claim 1 wherein the agent comprises rapamycin.
3. A method according to claim 1 wherein the antiproliferative agent is administered perivascularly.
4. A method according to claim 1 wherein extravascular, local administration is accomplished by means of an implantable, antiproliferative agent eluting, perivascular vascular sleeve, the sleeve comprising a matrix material imbibed with the agent.
5. A method according to claim 4 wherein the sleeve is substantially circumvascular.
6. A method according to claim 4 wherein the matrix material comprises fibrin.
7. A method according to claim 4 wherein the agent comprises rapamycin and heparin.
8. A method according to claim 4 wherein the matrix material comprises collagen.
9. A method according to claim 4 wherein the matrix material comprises chitosan.
10. An implantable, antiproliferative agent-administering perivascular sleeve adapted to be placed in contact with the exterior of a vascular structure comprising:
a) A flexible, cylindrical, bioabsorbing, agent-eluting matrix material, the material having a vascular-sized lumen passing substantially through said matrix material, the matrix material having dispersed therein:
b) An antiproliferative agent.
11. The sleeve of claim 10 which further includes an support means, said means being circumferentially disposed about the exterior of the matrix material.
12. A method of treating vasculoproliferative disease in hemodialysis access sites which comprises the step of:
administering extravascularly and locally an antiproliferation effective amount of an antiproliferation agent to the access site.
13. A method of suppressing vasculoproliferative response in a vascular structure comprising the step of:

administering vascular extravascularly and locally an antiproliferation effective amount of an antivasculoproliferation agent to the vascular structure.
14. A method of treating smooth muscle cell (SMC) hyperplasia in vascular structures which comprises the step of:
administering, extravascularly and locally, an antiSMC effective amount of an anti SMC agent to the vascular structure.
15. A method according to claim 13 wherein the vascular structure is a hemodialysis access site.
16. A method according to claim 13 wherein the vascular structure is a vascular graft.
17. A method according to claim 13 wherein the vascular structure is a graft anastomatic site.
18. A method according to claim 13 wherein the vascular structure is a vein.
19. A method according to claim 13 wherein the vascular structure is a venous conduit or anastomatic site.
20. A method of preventing or delaying failure of a hemodialysis access site by the extravascular and local administration of agents that prevent suppress or treat vasculoproliferative response or SMC hyperplasia.
21. The method of claim 20 wherein the failure mode of the hemodialysis vascular access is selected from the group consisting of thrombosis, infection, foreign body reaction, luminal narrowing or occlusion of the anastamotic sites, narrowing or occlusion of the vein, artery or prosthetic conduits.
22. The method of claim 20 wherein the extravascular, local administration of agent is achieved by delivering drug from a drug eluting sleeve placed in contact with the access site.
23. The method of claim 22 wherein the sleeve is placed in contact with the access site by the securement techniques selected from the group consisting of suturing, stapling, gluing, or using a self-interlocking mechanism.
24. The method of claim 20 wherein the agent used to prevent, to suppress, or to treat hyperproliferative vascular disease is selected from the group consisting of rapamycin or rapamycin analogue, paclitaxel, paclitaxel analogue(s), other taxanes, tacrolimus, tacrolimus analogue(s), actinomycin D, dexamethasone, steroids, fractionated herparin, unfractionated heparin, metalloproteinase inhibitors, Flavoperidol, human autologous, heterologous vascular, bone marrow cells, other cells, stem cells, genetically modified human cells, IIBIIIA antagonists, and antibioitics.
25. The method of claim 22 wherein the sleeve is made from natural or synthetic polymers that are biodegradable.
26. The method of claim 22 wherein the sleeve is made of Type I Collagen.
27. The method of claim 22 wherein the sleeve comprises fibrin.
28. The method of claim 22 wherein the sleeve comprises chitosan.
29. The method of claim 22 wherein the sleeve comprises a biodegradable material.
30. The method of claim 22 wherein the sleeve comprises a non-biodegradable material.
31. The method according to claim 22 wherein the drug is combined with the sleeve matrix material using the method selected from the group consisting of, saturation, dispersion, and immobilization.
32. The method of claim 23 wherein the suture used to secure the drug eluting sleeve to the access site is coated with an antiproliferative drug.
33. An apparatus for local administration of agents for preventing or delaying failure of a hemodialysis vascular access site.
34. The apparatus of claim 33 comprising a collagen matrix material formed combined with a drug, the matrix material being formed into the shape of a spiral.
35. The apparatus of claim 34 with an interlocking feature.
36. An apparatus comprising a vascular graft combined with one or more antiproliferative drugs.
CA2434972A 2001-01-16 2002-01-16 Implantable device containing resorbable matrix material and anti-proliferative drugs for preventing or treating failure of hemodialysis vascular access and other vascular grafts Expired - Lifetime CA2434972C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US26213201P 2001-01-16 2001-01-16
US60/262,132 2001-01-16
PCT/US2002/001375 WO2002062335A2 (en) 2001-01-16 2002-01-16 Implantable device containing resorbable matrix material and anti-proliferative drugs for preventing or treating failure of hemodialysis vascular access and other vascular grafts

Publications (2)

Publication Number Publication Date
CA2434972A1 true CA2434972A1 (en) 2002-08-15
CA2434972C CA2434972C (en) 2010-06-08

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CA2434972A Expired - Lifetime CA2434972C (en) 2001-01-16 2002-01-16 Implantable device containing resorbable matrix material and anti-proliferative drugs for preventing or treating failure of hemodialysis vascular access and other vascular grafts

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US (5) US6726923B2 (en)
EP (2) EP1351681B1 (en)
JP (2) JP4584537B2 (en)
CN (1) CN1492759A (en)
AP (1) AP2003002828A0 (en)
AT (1) ATE481097T1 (en)
AU (1) AU2002249958B2 (en)
BR (1) BR0206464A (en)
CA (1) CA2434972C (en)
CY (1) CY1119109T1 (en)
DE (1) DE60237671D1 (en)
DK (1) DK2314293T3 (en)
ES (1) ES2621652T3 (en)
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