Apparatus and methods for enhanced drug delivery

Abstract

Systems and method for using a sleeve for enhanced drug delivery are described. The sleeve may incorporate porous materials and may be coated or treated with various drugs and/or therapeutic agents. The sleeve may be utilized in cooperation with balloon catheters and/or other devices. When acting as a reservoir for holding various drugs and/or therapeutic agents, the drug delivery sleeve provides a means of reducing drug losses as well as a controlled mechanism for drug release. The materials for the sleeve, constructed by various techniques, may be circumferentially distensible, may be elastic, and may have varying degrees of recoil as needed for any particular purpose.

What is claimed is: 
     
         1 . A method for making a system for delivering a first therapeutic agent within a bodily conduit, comprising:
 associating the first therapeutic agent with an inflatable balloon; and   positioning a sleeve over the inflatable balloon;   wherein the sleeve includes at least one layer of porous material comprised of a plurality of microstructural elements having a native porosity, the plurality of microstructural elements of at least a portion of the at least one layer of porous material are arranged to decrease the native porosity of the at least one layer of porous material to inhibit the first therapeutic agent from being released through the at least one layer of porous material when the inflatable balloon and the sleeve are inserted within the bodily conduit and to allow the first therapeutic agent to be released through the at least one layer of porous material for delivery at the desired location within the bodily conduit, via spacings that are formed between adjacent ones of the arranged plurality of microstructural elements, when the sleeve is subsequently caused to be distended by use of an expansion device cooperable with the inflatable balloon, and the first therapeutic agent comprises a gelatinous component.   
     
     
         2 . The method as recited in  claim 1 , wherein the first therapeutic agent further comprises a powdered component. 
     
     
         3 . The method as recited in  claim 2 , wherein the first therapeutic agent further comprises a polymeric component. 
     
     
         4 . The method as recited in  claim 1 , further comprising thermally and physically manipulating the at least one layer of porous material to decrease the native porosity of the at least one layer of porous material. 
     
     
         5 . The method as recited in  claim 1 , further comprising bonding together a plurality of layers of porous film material to form the at least one layer of porous material. 
     
     
         6 . The method as recited in  claim 1 , further comprising attaching at least an end of the sleeve to a part of the expansion device. 
     
     
         7 . The method as recited in  claim 1 , wherein associating the first therapeutic agent with the inflatable balloon comprises placing the first therapeutic agent on at least a portion of an outer surface of the inflatable balloon. 
     
     
         8 . The method as recited in  claim 1 , wherein associating the first therapeutic agent with the inflatable balloon comprises placing the first therapeutic agent on at least an inner surface of the sleeve. 
     
     
         9 . The method as recited in  claim 1 , wherein the first therapeutic agent is selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         10 . The method as recited in  claim 7 , further comprising placing the first therapeutic agent on at least a portion of an outer surface of the sleeve. 
     
     
         11 . The method as recited in  claim 7 , further comprising infiltrating the first therapeutic agent within pores of the sleeve. 
     
     
         12 . The method as recited in  claim 7 , wherein the first therapeutic agent is selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         13 . The method as recited in  claim 1 , further comprising associating a second therapeutic agent different than the first therapeutic agent with the sleeve. 
     
     
         14 . The method as recited in  claim 13 , wherein the second therapeutic agent comprises a gelatinous component. 
     
     
         15 . The method as recited in  claim 14 , wherein the second therapeutic agent further comprises a powdered component. 
     
     
         16 . The method as recited in  claim 15 , wherein the second therapeutic agent further comprises a polymeric component. 
     
     
         17 . The method as recited in  claim 13 , further comprising infiltrating the second therapeutic agent different within pores of the sleeve. 
     
     
         18 . The method as recited in  claim 13 , further comprising placing the second therapeutic agent on at least a portion of an outer surface of the sleeve. 
     
     
         19 . The method as recited in  claim 13 , wherein the first therapeutic agent and the second therapeutic agent are each selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         20 . The method as recited in  claim 1 , further comprising providing a treatment to the sleeve to inhibit a passing of a bodily fluid through the sleeve in a non-distended state of the sleeve. 
     
     
         21 . The method as recited in  claim 1 , further comprising decreasing the native porosity of the at least one layer of porous material by causing the plurality of microstructural elements of at least a portion of the at least one layer of porous material to be generally linearly aligned to thereby reduce a spacing therebetween to a degree that will inhibit the first therapeutic agent from being released through the at least one layer of porous material when the inflatable balloon and the sleeve are inserted within the bodily conduit. 
     
     
         22 . The method as recited in  claim 21 , wherein associating the first therapeutic agent with the inflatable balloon comprising placing the first therapeutic agent on at least a portion of an outer surface of the inflatable balloon. 
     
     
         23 . The method as recited in  claim 22 , wherein the first therapeutic agent is selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         24 . The method as recited in  claim 21 , wherein associating the first therapeutic agent with the inflatable balloon comprising placing the first therapeutic agent on at least a portion of an inner surface of the sleeve. 
     
     
         25 . The method as recited in  claim 23 , further comprising placing the first therapeutic agent on at least a portion of an outer surface of the sleeve. 
     
     
         26 . The method as recited in  claim 23 , further comprising infiltrating the first therapeutic agent within pores of the sleeve. 
     
     
         27 . The method as recited in  claim 23 , further comprising placing a second therapeutic agent different than the first therapeutic agent on at least a portion of an outer surface of the sleeve. 
     
     
         28 . The method as recited in  claim 22 , further comprising infiltrating a second therapeutic agent different than the first therapeutic agent within pores of the sleeve. 
     
     
         29 . The method as recited in  claim 27 , wherein the first therapeutic agent and the second therapeutic agent are each selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         30 . The method as recited in  claim 28 , wherein the first therapeutic agent and the second therapeutic agent are each selected from a group consisting of heparin, anti-platelet agents, platelet derived growth agents, antibiotics, steroids, agents that inhibit cell growth of all types, agents that inhibit cell division, agents that enhance cell growth of all types, and seed and/or progenitor cells. 
     
     
         31 . The method as recited in  claim 21 , further comprising providing a treatment to the sleeve to facilitate a passing of a bodily fluid through the sleeve in a non-distended state of the sleeve. 
     
     
         32 . The method as recited in  claim 21 , further comprising providing a treatment to the sleeve to inhibit a passing of a bodily fluid through the sleeve in a non-distended state of the sleeve. 
     
     
         33 . The method as recited in  claim 1 , further comprising providing the sleeve with a plurality of cut openings.