Composition for Intravascular Delivery of Therapeutic Composition

Abstract

The present invention relates to a pharmaceutical composition for intravascular delivery of a therapeutic agent, such as paclitaxel, rapamycin, or an analog thereof. The composition includes the therapeutic agent and a biocompatible solvent, such as glycofurol. The composition can aid tissue penetration by the therapeutic agent. A catheter assembly that protects the pharmaceutical composition from the surroundings can be used for its intravascular delivery.

1 - 14 . (canceled) 
     
     
         15 . A pharmaceutical composition comprising about 1 to about 50 wt-% therapeutic agent and about 50 to about 99 wt-% biocompatible solvent; wherein:
 the therapeutic agent comprises paclitaxel; and   the biocompatible solvent comprises glycofurol, wherein the biocompatible solvent delivers the therapeutic agent within a tissue.   
     
     
         16 . The composition of  claim 15 , comprising about 5 to about 40 wt-% therapeutic agent and about 60 to about 95 wt-% biocompatible solvent. 
     
     
         17 . The composition of  claim 15 , comprising about 2 to about 20 wt-% therapeutic agent and about 80 to about 98 wt-% biocompatible solvent. 
     
     
         18 . The composition of  claim 15 , comprising about 5 to about 10 wt-% therapeutic agent and about 90 to about 95 wt-% biocompatible solvent. 
     
     
         19 . The composition of  claim 15 , comprising about 10 to about 30 wt-% therapeutic agent and about 70 to about 90 wt-% biocompatible solvent. 
     
     
         20 . The composition of  claim 15 , comprising about 5 to about 15 wt-% therapeutic agent and about 85 to about 95 wt-% biocompatible solvent. 
     
     
         21 . The composition of  claim 15 , comprising about 10 to about 20 wt-% therapeutic agent and about 80 to about 90 wt-% biocompatible solvent. 
     
     
         22 . The composition of  claim 15 , comprising about 20 to about 30 wt-% therapeutic agent and about 70 to about 80 wt-% biocompatible solvent. 
     
     
         23 . An intravascular catheter comprising a reservoir; the reservoir containing a pharmaceutical composition comprising about 1 to about 50 wt-% biodegradable polymer and about 50 to about 99 wt-% glycofurol. 
     
     
         24 . The catheter of  claim 23 , wherein a third lumen defines the reservoir. 
     
     
         25 . The catheter of  claim 23 , wherein two balloons define the reservoir. 
     
     
         26 . The catheter of  claim 23 , wherein the catheter is a catheter assembly comprising:
 an inner expandable and collapsible structure, an outer expandable and collapsible structure, the inner and outer expandable and collapsible structures each being configured to expand between a contracted state and a dilated state;   the inner and outer expandable and collapsible structures defining a reservoir therebetween, the reservoir being configured to contain a benefit composition;   the outer expandable and collapsible structure defining openings, the openings being configured to be closed when the assembly is in the contracted state and open when the assembly is in the dilated state; when open, the openings provide fluid communication from the cavity to surroundings of the assembly.   
     
     
         27 . A method of delivering a biodegradable polymer to a site in a body, the method comprising:
 placing the catheter of  claim 23  at the site; and   releasing the biodegradable polymer at the site.   
     
     
         28 . A method of delivering a pharmaceutical composition to a site in a body, the method comprising:
 placing a catheter at the site; and releasing the pharmaceutical composition at the site, the pharmaceutical composition comprising about 1 to about 50 wt-% therapeutic agent and about 50 to about 99 wt-% biocompatible solvent;   wherein the therapeutic agent comprises paclitaxel; and the biocompatible solvent comprises glycofurol; and   wherein the biocompatible solvent delivers the therapeutic agent within a tissue.   
     
     
         29 . The method of  claim 28 , wherein the therapeutic agent is delivered as a solid or semisolid.