Apparatus and methods for preventing or treating failure of hemodialysis vascular access and other vascular grafts

• US 20040197409A1
• Filed: 04/26/2004
• Published: 10/07/2004
• Est. Priority Date: 01/16/2001
• Status: Active Grant

• Current Assignee: Vascular Therapies, Inc.
• Original Assignee: Vascular Therapies, LLC
• Inventors: Nikolaychik, Victor V., Iyer, Sriram S., Kipshidze, Nicholas N.
• Granted Patent: US 7,807,191 B2
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 31/122 having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/395 having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/225 Fibrin; Fibrinogen
• CPC Class Codes: A61L 27/44 having a macromolecular matrix
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0261 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
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2202/0478 : Heparin
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 41/00 : Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/08 : Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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.

Claims

1-9. -9 (canceled).

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.

37. A sleeve according to claim 10 wherein the sleeve is substantially circumvascular.

38. A sleeve according to claim 10 wherein the antiproliferative agent is rapamycin or its analogues.

39. A sleeve according to claim 10 wherein the antiproliferative agent comprises rapamycin and heparin.

40. A sleeve according to claim 10 wherein the matrix material comprises collagen.

41. A sleeve according to claim 10 wherein the matrix material comprises chitosan.

42. A sleeve according to claim 10 wherein the matrix material comprises biocompatible matrix material.

12-36. -36 (canceled).