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 sleeve for use in delivering a first therapeutic agent within a bodily conduit, comprising: at least one layer of porous material comprised of a plurality of microstructural elements having a native porosity, wherein 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 sleeve is in a first state and to allow the first therapeutic agent to be released through the at least one layer of porous material for delivery at a 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 placed into a second state. 
     
     
         2 . The sleeve as recited in  claim 1 , wherein the sleeve is placed into the second state when the sleeve is caused to be distended by use of an expansion device. 
     
     
         3 . The sleeve as recited in  claim 1 , wherein the expansion device comprises a balloon. 
     
     
         4 . The sleeve as recited in  claim 1 , wherein the at least one layer of porous material comprises a plurality of layers of porous film material that have been bonded together. 
     
     
         5 . The sleeve as recited in  claim 3 , wherein an end of the sleeve is adapted to be attached to a part of the expansion device. 
     
     
         6 . The sleeve as recited in  claim 1 , wherein the first therapeutic agent is placed on at least a portion of an outer surface of the sleeve. 
     
     
         7 . The sleeve as recited in  claim 1 , wherein the first therapeutic agent is infiltrated within pores of the sleeve. 
     
     
         8 . The sleeve as recited in  claim 6 , 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. 
     
     
         9 . The sleeve 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. 
     
     
         10 . The sleeve as recited in  claim 1 , wherein a second therapeutic agent different than the first therapeutic agent is placed on at least a portion of an outer surface of the sleeve. 
     
     
         11 . The sleeve as recited in  claim 1 , wherein a second therapeutic agent different than the first therapeutic agent is infiltrated within pores of the sleeve. 
     
     
         12 . The sleeve as recited in  claim 10 , 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. 
     
     
         13 . The sleeve as recited in  claim 11 , 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. 
     
     
         14 . The sleeve as recited in  claim 1 , wherein a treatment is provided to the sleeve to facilitate a passing of a bodily fluid through the sleeve in the first state. 
     
     
         15 . The sleeve as recited in  claim 1 , wherein a treatment is provided to the sleeve to inhibit a passing of a bodily fluid through the sleeve in the first state. 
     
     
         16 . The sleeve as recited in  claim 1 , wherein the plurality of microstructural elements of at least a portion of the at least one layer of porous material are arranged by being generally linearly aligned and by having a spacing therebetween that will inhibit the first therapeutic agent from being released through the at least one layer of porous material in the first state. 
     
     
         17 . The sleeve as recited in  claim 12 , wherein the first therapeutic agent is placed on at least a portion of an outer surface of the sleeve. 
     
     
         18 . The sleeve as recited in  claim 13 , wherein the first therapeutic agent is placed on at least a portion of an outer surface of the sleeve. 
     
     
         19 . The sleeve as recited in  claim 12 , wherein the first therapeutic agent is infiltrated within pores of the sleeve. 
     
     
         20 . The sleeve as recited in  claim 13 , wherein the first therapeutic agent is infiltrated within pores of the sleeve 
     
     
         21 . The sleeve as recited in  claim 12 , wherein a treatment is provided to the sleeve to facilitate a passing of a bodily fluid through the sleeve in the first state. 
     
     
         22 . The sleeve as recited in  claim 13 , wherein a treatment is provided to the sleeve to facilitate a passing of a bodily fluid through the sleeve in the first state. 
     
     
         23 . The sleeve as recited in  claim 12 , wherein a treatment is provided to the sleeve to inhibit a passing of a bodily fluid through the sleeve in the first state. 
     
     
         24 . The sleeve as recited in  claim 13 , wherein a treatment is provided to the sleeve to inhibit a passing of a bodily fluid through the sleeve in the first state 
     
     
         25 . The sleeve as recited in  claim 1 , wherein the sleeve is further provided with a plurality of laser cut openings. 
     
     
         26 . A system, comprising:
 a sleeve for use in delivering a first therapeutic agent within a bodily conduit, comprising at least one layer of porous material comprised of a plurality of microstructural elements having a native porosity, wherein 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 sleeve is in a first state and to allow the first therapeutic agent to be released through the at least one layer of porous material for delivery at a 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 placed into a second state; and   an expansion device coupled to the sleeve, wherein the sleeve is placed into the second state when the sleeve is caused to be distended by use of the expansion device.   
     
     
         27 . The system as recited in  claim 26 , wherein the expansion device comprises a balloon.