Balloon Catheter Systems

Abstract

A balloon catheter and balloon system particularly useful with drug-coated balloons is described. In some embodiments, the balloon catheter system includes various features designed to address problems with drug rubbing off due to contract friction during delivery of the balloon—including by utilizing a protective sleeve to shield the drug-coated balloon. In some embodiments, the balloon catheter system includes an inner high-pressure balloon and an outer drug-coated balloon to mitigate the time associated with performing vessel dilation.

1 - 17 . (canceled) 
     
     
         18 . A balloon catheter adapted for insertion into a hemostasis valve of a guide catheter comprising:
 a slit sleeve configured to be positioned within the hemostasis valve of the guide catheter;   a drug coated balloon of the balloon catheter configured to be inserted through the slit sleeve positioned within the hemostasis valve of the guide catheter;   a longitudinal opening extending along an entire length of only a side of the slit sleeve;   the slit sleeve forming a generally tubular shape and having a first non-flared section in which the longitudinal opening has a first width, and a second flared end section in which the longitudinal opening has a second width that is larger than the first width and increases in width in a direction away from the first non-flared section;   wherein the first width of the longitudinal opening in the first non-flared section of the slit sleeve is about 0.002 inch.   
     
     
         19 . The balloon catheter of  claim 18 , wherein the drug-coated balloon is coated with one of Paclitaxel, Sirolimus, or Zotarolimus. 
     
     
         20 . The balloon catheter of  claim 18 , wherein the second width of the longitudinal opening in the second flared end section of the slit sleeve is tapered and has a maximum opening size of 0.17 inches to 0.23 inches. 
     
     
         21 . The balloon catheter of  claim 18 , wherein the second flared end section of the slit sleeve has a diameter of 0.285 inches to 0.345 inches. 
     
     
         22 . The balloon catheter of  claim 18 , wherein the first non-flared section of the slit sleeve has a diameter of 0.115 inches to 0.12 inches. 
     
     
         23 . The balloon catheter of  claim 18 , wherein the second flared end section of the slit sleeve has a length of 0.5 inches to 1 inch. 
     
     
         24 . The balloon catheter of  claim 18 , wherein the slit sleeve has a length of 2.75 inches to 3.75 inches. 
     
     
         25 . The balloon catheter of  claim 18 , wherein the slit sleeve is composed of a polymeric material. 
     
     
         26 . The balloon catheter of  claim 18 , wherein the second flared end section of the slit sleeve sits over a strain relief of the balloon catheter. 
     
     
         27 . The balloon catheter of  claim 18 , further comprising a protective tube over the drug coated balloon. 
     
     
         28 . The balloon catheter of  claim 27 , wherein the slit sleeve is sized to fit over the protective tube, to aid in removing the protective tube prior to inserting the drug coated balloon through the hemostasis valve of the guiding sheath. 
     
     
         29 . The balloon catheter of  claim 27 , wherein the slit sleeve has a larger diameter than that of the protective tube. 
     
     
         30 . A system for loading a drug coated balloon of a balloon catheter into a hemostasis valve of a guide catheter to minimize drug loss from the drug coated balloon comprising:
 a slit sleeve configured to be positioned within the hemostasis valve of the guide catheter;   the drug coated balloon of the balloon catheter configured to be inserted through the slit sleeve positioned within the hemostasis valve of the guide catheter;   a longitudinal opening extending along an entire length of only a side of the slit sleeve;   the slit sleeve forming a generally tubular shape and having a first non-flared section in which the longitudinal opening has a first width, and a second flared end section in which the longitudinal opening has a second width that is larger than the first width and increases in width in a direction away from the first non-flared section;   wherein the first width of the longitudinal opening in the first non-flared section of the slit sleeve is about 0.002 inch.   
     
     
         31 . The system of  claim 30 , wherein the second flared end section of the slit sleeve has a diameter of 0.285 inches to 0.345 inches. 
     
     
         32 . The system of  claim 30 , wherein the first non-flared section of the slit sleeve has a diameter of 0.115 inches to 0.12 inches. 
     
     
         33 . The system of  claim 30 , wherein the second flared end section of the slit sleeve has a length of 0.5 inches to 1 inch. 
     
     
         34 . The system of  claim 30 , wherein the slit sleeve has a length of 2.75 inches to 3.75 inches. 
     
     
         35 . A drug coated balloon adapted for insertion into a hemostasis valve of a guide catheter comprising:
 a slit sleeve configured to be positioned within the hemostasis valve of the guide catheter;   the drug coated balloon configured to be inserted through the slit sleeve positioned within the hemostasis valve of the guide catheter;   a longitudinal opening extending along an entire length of only a side of the slit sleeve;   the slit sleeve forming a generally tubular shape and having a first non-flared section in which the longitudinal opening has a first width, and a second flared end section in which the longitudinal opening has a second width that is larger than the first width and increases in width in a direction away from the first non-flared section;   wherein the first width of the longitudinal opening in the first non-flared section of the slit sleeve is about 0.002 inch.   
     
     
         36 . The drug coated balloon of  claim 35 , wherein the second flared end section of the slit sleeve has a diameter of 0.285 inches to 0.345 inches. 
     
     
         37 . The drug coated balloon of  claim 35 , wherein the slit sleeve has a length of 2.75 inches to 3.75 inches.