Coated medical device

Abstract

A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

1 - 20 . (canceled) 
     
     
         21 . A method for delivering paclitaxel to a vascular vessel of a patient to inhibit restenosis, comprising:
 delivering the inflatable balloon of a medical device into a vascular vessel of the patient, wherein the inflatable balloon has a balloon wall in an initial folded condition adapted for insertion into a vascular vessel of the patient and to contact a wall of the vascular vessel upon inflation; wherein the medical device has a layer comprising paclitaxel coated directly on the balloon wall and providing an outermost surface of the device over the balloon, wherein the layer comprising paclitaxel is adapted to deliver a restenosis inhibiting amount of the paclitaxel to the vessel wall by direct contact with the vessel wall caused by inflating the balloon to move the balloon wall from the initial folded condition to an inflated condition for an inflation time of up to about one minute, with the direct contact causing adherence of paclitaxel to the vessel wall for subsequent transfer into cells of the vessel wall; and   inflating the inflatable balloon for an inflation time of up to about one minute.   
     
     
         22 . The method of  claim 21 , wherein the layer comprising paclitaxel extends circumferentially around the balloon such that upon said inflating, the balloon contacts the vessel wall and provides a full circumferential delivery of paclitaxel to an inner surface of the vessel wall. 
     
     
         23 . The method of  claim 22 , wherein the layer comprising paclitaxel consists essentially of paclitaxel. 
     
     
         24 . The method of  claim 22 , wherein upon said inflating, amounts of the layer comprising paclitaxel are delivered to the vessel wall by wiping contact of the layer comprising paclitaxel with the vessel wall. 
     
     
         25 . A method for delivering paclitaxel to a vascular vessel of a patient to inhibit restenosis, comprising:
 delivering the inflatable balloon of a medical device into a vascular vessel of the patient, wherein the medical device includes a medically implantable structure including a catheter shaft and the inflatable balloon attached to the catheter shaft, the inflatable balloon having a balloon wall in an initial folded condition adapted for insertion into a vascular vessel of the patient, wherein the medical device further includes paclitaxel-containing material coated on the balloon wall and providing an outermost surface of the device over the balloon, wherein the medical device is adapted to deliver a restenosis inhibiting amount of the paclitaxel to the vessel wall by wiping amounts of the paclitaxel-containing material onto the vessel wall when the inflatable balloon is inflated to move the balloon wall from the initial folded condition to an inflated condition for an inflation time of up to about one minute; and   inflating the inflatable balloon.   
     
     
         26 . The method of  claim 25 , wherein the paclitaxel-containing material consists essentially of paclitaxel. 
     
     
         27 . The method of  claim 25 , wherein upon said inflating, amounts of the paclitaxel-containing material are transferred to the wall of the vascular vessel by wiping contact of the paclitaxel-containing material with the wall of the vascular vessel. 
     
     
         28 . The method of  claim 25 , wherein the inflatable balloon is in a folded condition during said delivering. 
     
     
         29 . The method of  claim 28 , wherein upon said inflating, amounts of the layer comprising paclitaxel are transferred to the wall of the vascular vessel by wiping contact of the layer comprising paclitaxel with the wall of the vascular vessel. 
     
     
         30 . The method of  claim 25 , wherein the medical device does not have a stent mounted on the balloon. 
     
     
         31 . A method for delivering paclitaxel to a vascular vessel of a patient to inhibit restenosis, comprising:
 delivering an inflatable balloon of a medical device into a vascular vessel of the patient, the inflatable balloon having a balloon wall, the inflatable balloon adapted for insertion into the vascular vessel and to contact a wall of the vascular vessel upon inflation, the medical device having a layer comprising paclitaxel coated directly on the balloon wall and providing an outermost surface of the medical device over the balloon; and   inflating the inflatable balloon to deliver a restenosis inhibiting amount of the paclitaxel to the vessel wall by direct contact with the vessel wall during an inflation time of the balloon of up to about one minute.   
     
     
         32 . The method of  claim 31 , wherein the layer comprising paclitaxel extends circumferentially around the balloon such that upon said inflating, the balloon contacts the vessel wall and provides a full circumferential delivery of paclitaxel to an inner surface of the vessel wall. 
     
     
         33 . The method of  claim 31 , wherein the layer comprising paclitaxel consists essentially of paclitaxel. 
     
     
         34 . The method of  claim 31 , wherein upon said inflating, amounts of the layer comprising paclitaxel are transferred to the wall of the vascular vessel by wiping contact of the layer comprising paclitaxel with the wall of the vascular vessel. 
     
     
         35 . The method of  claim 31 , wherein the inflatable balloon is in a folded condition during said delivering. 
     
     
         36 . The method of  claim 35 , wherein upon said inflating, amounts of the layer comprising paclitaxel are transferred to the wall of the vascular vessel by wiping contact of the layer comprising paclitaxel with the wall of the vascular vessel. 
     
     
         37 . The method of  claim 31 , wherein the medical device does not have a stent mounted on the balloon.