Balloon Catheter With Elastomeric Sheath and Methods

Abstract

Balloon catheters that include a balloon and an elastomeric sheath, each having a surface with a therapeutic agent disposed thereon, along with methods of making and methods of using the disclosed balloon catheters.

What is claimed: 
     
         1 . A balloon catheter comprising:
 an elongated catheter shaft having proximal and distal ends, wherein the catheter shaft defines a longitudinal axis extending between the proximal and distal ends;   an inflatable balloon located close to the distal end of the catheter shaft, wherein the balloon comprises a polymeric material having a surface with a first therapeutic agent disposed thereon; and   an elastomeric sheath comprising an elastomeric material having a surface with a second therapeutic agent disposed thereon;   wherein in a first configuration the inflatable balloon is located within the elastomeric sheath such that expansion of the inflatable balloon to an inflated state expands the elastomeric sheath, and wherein in a second configuration the inflatable balloon is located outside of the elastomeric sheath, and further wherein the balloon and the elastomeric sheath are configured for movement relative to each other along the longitudinal axis between the first configuration and the second configuration when deployed within a body lumen.   
     
     
         2 . The balloon catheter of  claim 1  wherein the inflatable balloon is in a folded state when in the first configuration. 
     
     
         3 . The balloon catheter of  claim 1  wherein the first and second therapeutic agents are different therapeutic agents. 
     
     
         4 . The balloon catheter of  claim 1  wherein the first and second therapeutic agents are the same therapeutic agent. 
     
     
         5 . The balloon catheter of  claim 1  wherein the first and second therapeutic agents are at different concentrations. 
     
     
         6 . The balloon catheter of  claim 1  wherein the first and second therapeutic agents are at the same concentrations. 
     
     
         7 . The balloon catheter of  claim 1  further comprising a protective sheath positioned around the elastomeric sheath, wherein the protective sheath is configured for movement relative to the elastomeric sheath along the longitudinal axis, when deployed in a body lumen, between a first configuration in which the elastomeric sheath is positioned within the protective sheath and a second configuration in which at least a portion of the elastomeric sheath is located outside of the protective sheath. 
     
     
         8 . A method of manufacturing the balloon catheter of  claim 1 , the method comprising:
 providing an elongated catheter shaft having proximal and distal ends with an inflatable balloon located close to the distal end of the catheter shaft, wherein the balloon comprises a polymeric material having a surface;   positioning a delivery sheath around the balloon, wherein the delivery sheath comprises a polymeric material having a therapeutic agent impregnated therein or coated thereon; and   applying conditions effective to transfer the therapeutic agent from the delivery sheath to the surface of the inflatable balloon.   
     
     
         9 . The method of  claim 8  further comprising:
 removing the delivery sheath from the balloon; 
 positioning an elastomeric sheath around the balloon, wherein the elastomeric sheath comprises an elastomeric material having a surface; 
 positioning a delivery sheath around the elastomeric sheath, wherein the delivery sheath comprises a polymeric material having a therapeutic agent impregnated therein or coated thereon; and 
 applying conditions effective to transfer the therapeutic agent from the delivery sheath to the surface of the elastomeric sheath. 
 
     
     
         10 . A method of delivering one or more therapeutic agents to a diseased vessel, the method comprising:
 providing a balloon catheter of  claim 1 ;   advancing the balloon catheter into the diseased vessel;   inflating the inflatable balloon to form an inflated balloon and an expanded sheath that contacts the wall of the diseased vessel and thereby delivers the second therapeutic agent from the surface of the expanded sheath to a first site of the diseased vessel;   deflating the inflated balloon to reform the inflatable balloon into a reformed inflatable balloon;   removing the elastomeric sheath from around the reformed inflatable balloon; and   inflating the reformed inflatable balloon to contact the wall of the diseased vessel with the first therapeutic agent to deliver the first therapeutic agent from the surface of the inflated balloon to the first site, or to a different site of the same or a different diseased vessel if the reformed inflatable balloon is moved to the different site after the expanded sheath contacts the wall of the diseased vessel and before inflating the reformed inflatable balloon.   
     
     
         11 . A method of delivering one or more therapeutic agents to a diseased vessel, the method comprising:
 providing a balloon catheter comprising:
 an elongated catheter shaft having proximal and distal ends; 
 a folded inflatable balloon located close to the distal end of the catheter shaft, wherein the balloon comprises a polymeric material having a surface with a first therapeutic agent disposed thereon; and 
 an elastomeric sheath positioned around the folded inflatable balloon such that the inflatable balloon is located within the elastomeric sheath, wherein the sheath comprises an elastomeric material having a surface with a second therapeutic agent disposed thereon; 
   advancing the balloon catheter into the diseased vessel;   inflating the folded inflatable balloon to form an inflated balloon and an expanded sheath that contacts the wall of the diseased vessel and thereby delivers the second therapeutic agent from the surface of the expanded sheath to a first site of the diseased vessel;   deflating the inflated balloon after delivering the second therapeutic agent to the first site to reform the inflatable balloon into a reformed inflatable balloon;   removing the elastomeric sheath from around the reformed inflatable balloon; and   inflating the reformed inflatable balloon to contact the wall of the diseased vessel with the first therapeutic agent to deliver the first therapeutic agent from the surface of the inflated reformed inflatable balloon to the first site, or to a different site of the same or a different diseased vessel if the reformed inflatable balloon is moved to the different site after the expanded sheath contacts the wall of the diseased vessel and before inflating the reformed inflatable balloon.   
     
     
         12 . The method of  claim 11  wherein the balloon catheter further comprises a protective sheath positioned around the elastomeric sheath and the inflatable balloon located in the elastomeric sheath, and the method further comprises removing the protective sheath from the elastomeric sheath after advancing the balloon catheter into the diseased vessel. 
     
     
         13 . The method of  claim 11  wherein the diseased vessel comprises a vascular lesion having a length that is longer than the length of the balloon. 
     
     
         14 . The method of  claim 11  wherein removing the elastomeric sheath from around the reformed inflatable balloon comprises retracting the sheath towards the proximal end of the catheter shaft. 
     
     
         15 . The method of  claim 11  wherein removing the elastomeric sheath from around the reformed inflatable balloon comprises advancing the reformed inflatable balloon to a second site of the diseased vessel that is distal from the first site. 
     
     
         16 . The method of  claim 11  wherein the elastomeric sheath is longer than the inflatable balloon; and wherein after inflating the inflatable balloon to form the inflated balloon and the expanded sheath and prior to removing the elastomeric sheath from around the reformed inflatable balloon, the method comprises:
 retracting the inflatable balloon proximally towards the proximal end of the catheter shaft within the elastomeric sheath; 
 inflating the inflatable balloon after retracting the inflatable balloon proximally so that the elastomeric sheath contacts the wall of the diseased vessel and thereby delivers the second therapeutic agent to a second site that is located proximally from the first site of the diseased vessel; and 
 deflating the inflated balloon after delivering the second therapeutic agent at the second site. 
 
     
     
         17 . A method of delivering one or more therapeutic agents to a diseased vessel, the method comprising:
 providing a balloon catheter comprising:
 an elongated catheter shaft having proximal and distal ends; 
 an inflatable balloon located close to the distal end of the catheter shaft, wherein the balloon has a proximal end and a distal end, and wherein the balloon comprises a polymeric material having a surface with a first therapeutic agent disposed thereon; 
 an elastomeric sheath positioned around the inflatable balloon such that the inflatable balloon is located within the elastomeric sheath, wherein the sheath comprises an elastomeric material having a surface with a second therapeutic agent disposed thereon, and wherein the elastomeric sheath is longer than the inflatable balloon; and 
 a protective sheath positioned around the elastomeric sheath and the inflatable balloon; 
   advancing the balloon catheter into the diseased vessel;   retracting the protective sheath towards the proximal end of the catheter shaft so that the inflatable balloon is not located in the protective sheath;   inflating the inflatable balloon to form an inflated balloon and an expanded sheath that contacts the wall of the diseased vessel and thereby delivers the second therapeutic agent from the surface of the expanded sheath to a first site of the diseased vessel;   deflating the inflated balloon after delivering the second therapeutic agent to the first site to reform the inflatable balloon into a reformed inflatable balloon;   retracting the protective sheath proximally towards the proximal end of the catheter shaft so that the reformed inflatable balloon is not located in the protective sheath after delivering the second therapeutic agent to the first site;   retracting the reformed inflatable balloon proximally towards the proximal end of the catheter shaft within the elastomeric sheath;   inflating the reformed inflatable balloon so that the elastomeric sheath contacts the wall of the diseased vessel and thereby delivers the second therapeutic agent to a second site that is located proximally from the first site of the diseased vessel;   deflating the reformed inflated balloon to again reform a reformed inflatable balloon after delivering the second therapeutic agent to the second site;   retracting the elastomeric sheath proximally towards the proximal end of the catheter shaft so that the reformed inflatable balloon is not located in the protective sheath or the elastomeric sheath after delivering the second therapeutic agent to the second site; and   inflating the reformed inflatable balloon to form an inflated balloon that contacts the wall of the diseased vessel and thereby delivers the first therapeutic agent from the surface of the inflated balloon to the second site of the diseased vessel, or to a third site of the diseased vessel if the inflated balloon is moved to the different site after delivering the second therapeutic agent to the second site.