Articles and methods of treating vascular conditions

Abstract

The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

What is claimed is: 
     
         1 . A catheter-based implantable medical vascular device having a first diameter and a first surface area, and expandable to a second diameter and a second surface area within a vascular structure, in use;
 the device comprising at least one thixotropic, turbid, hydrogel material applied to at least a portion of said medical device, wherein the hydrogel material is applied to a surface of the device to create an applicated device of the first diameter and the first surface area;   the hydrogel material comprising cyclodextrin, an aqueous solvent component and a polymer chain component, and at least one bioactive agent capable of treating vascular tissue upon release of said bioactive agent from said hydrogel material.   
     
     
         2 . The catheter-based implantable medical vascular device as claimed in  claim 1 , the hydrogel material comprising a pharmacologically effective amount of the at least one bioactive agent, wherein the polymer chain component comprises ethylene glycol units that form the hydrogel with the cyclodextrin, wherein the cyclodextrin and the polymer chain unit self-assemble to form the hydrogel by spontaneous association and are present in the composition in respective amounts effective to make the hydrogel thixotropic. 
     
     
         3 . The catheter-based implantable medical vascular device of  claim 1  wherein catheter-based implantable medical vascular device is a nitinol wire reinforced expanded polytetrafluoroethylene-based vascular prosthesis. 
     
     
         4 . The catheter-based implantable medical vascular device of  claim 1  wherein catheter-based implantable medical vascular device is an endovascular angioplasty balloon. 
     
     
         5 . The catheter-based implantable medical vascular device of  claim 1 , further comprising a surface having the hydrogel material impregnated therein. 
     
     
         6 . The catheter-based implantable medical vascular device of  claim 1 , wherein the polymer chain component comprises polyethers such as polyethylene glycol, polypropylene glycol, poly(ethylene glycol-co-propylene glycol), copolymers of polyethylene glycol, and copolymers of polypropylene glycol; polyols such as polyvinyl alcohol and polyallyl alcohol; polyanions such as polyacrylic acid and poly(methacrylic acid); polyanionic polysaccharides such as alginate, heparin, heparin sulfate, dextran sulfate, xanthan, carrageenan, gum arabic, tragacanth, arabinogalactan, and pectin; neutral polysaccharides such as agar, agarose, hyaluronic acid, carboxymethylcellulose, and dextran; macrocyclic polysaccharides such as cyclodextrin and hydroxypropyl cyclodextrin; polycations such as poly(lysine), poly(allylamine), poly(ethyleneimine), poly(guanidine), polyvinylamine), α,ω-polyethyleneglycol-diamine, and poly(quaternary amine); polyanionic polysaccharides such as chitin and chitosan; polyacrylonitriles such as hydrolyzed polyacrylonitrile, poly(acrylamide-co-acrylonitrile), and their copolymers; and/or protein based polymers such as gelatin, collagen, thrombin, and fibrin. 
     
     
         7 . The catheter-based implantable medical vascular device according to  claim 1 , wherein the hydrogel material comprises α-cyclodextrin (αCD) and polyethylene glycol (PEG). 
     
     
         8 . The catheter-based implantable medical vascular device according to  claim 1 , wherein the hydrogel material comprises polyethylene glycol, α-cyclodextrin (αCD), and hydroxypropyl-β-cyclodextrin (HPβCD). 
     
     
         9 . The catheter-based implantable medical vascular device according to  claim 1 , wherein the hydrogel material comprises polyvinyl alcohol, sodium borate, and polyoxyethylene sorbitol ester. 
     
     
         10 . The catheter-based implantable medical vascular device according to  claim 1 , wherein the hydrogel material comprises sodium alginate, calcium chloride, and hydroxypropyl-β-cyclodextrin (HPβCD). 
     
     
         11 . The catheter-based implantable medical vascular device according to  claim 1 , wherein the hydrogel material comprises dextran, potassium chloride, and hydroxypropyl-β-cyclodextrin (HPβCD).