Methods and devices for delivering drugs using drug-delivery or drug-coated guidewires

Abstract

The present invention relates to a method of delivering drugs having e.g., anti-proliferative activity in the vascular, preferably, the cardiovascular, system locally or systematically using an at least partially drug-coated guidewire. The drug-coated guidewire, particularly an expansion member or portion thereof, is brought into contact with the target tissue or in circulation and the drugs are quickly released into the area surrounding the device in a short time after the contact step. Once the therapeutic drugs are released, they are quickly and effectively absorbed by the surrounding cells or circulation.

What is claimed is: 
     
         1 . A guidewire, comprising:
 a) a core member extending along a longitudinal axis from a proximal core member portion to a distal core member end;   b) a distal atraumatic tip connected to the distal core member end;   c) a first coil extending from a first coil proximal end to a first coil distal end, wherein the first coil distal end is affixed to the core member; and   d) a tubular member supported on the core member and extending from a tubular member proximal portion to a tubular member distal end, wherein the tubular member distal end is connected to the first coil proximal end, and wherein the first coil proximal end has a first outer diameter when in an unexpanded state,   e) wherein torsional manipulation of the tubular member proximal portion in a first directed about the longitudinal axis of the core member causes the first coil to unwind from the unexpanded state having the first outer diameter to an expanded state having a second outer diameter, the second diameter being greater than the first diameter, and   f) wherein torsional manipulation of the tubular member in a second direction, opposite the first direction, causes the first coil to rewind from the expanded state having the second outer diameter to a third diameter less than the second diameter.   
     
     
         2 . The guidewire of  claim 1  wherein the core member is a core wire. 
     
     
         3 . The guidewire of  claim 1  wherein the core member is an inner helically wound coil that is wound about the longitudinal axis in a direction opposite to that of the first coil. 
     
     
         4 . The guidewire of  claim 3  wherein the inner helically wound coil comprises from one to four helical filars. 
     
     
         5 . The guidewire of  claim 1  further including a therapeutic agent or drug coated on the first coil. 
     
     
         6 . The guidewire of  claim 5  wherein the therapeutic agent or drug is selected from the group consisting of paclitaxel, sirolimus, everolimus, ABT-578 biological agents, and mixtures thereof. 
     
     
         7 . The guidewire of  claim 5  wherein the therapeutic agent or drug is encapsulated within a liposome. 
     
     
         8 . The guidewire of  claim 7  wherein the liposome is no greater than 100 nm in size. 
     
     
         9 . The guidewire of  claim 5  wherein the therapeutic agent or drug is mixed with a release carrier selected from the group consisting of semi-synthetic polyacryl starch microparticles, ethyl cellulose, poly-L-lactic acid, heptakis (2,6-di-O-ethyl)-beta-cyclodextrin, polyalkylcyanoacrylate nano capsules, polymethylacrylate, monocarboxycellulose, alginic acid, hyaluronic acid, lipid bilayer beads, polyvinylpyrollidone, polyvinyl alcohol, albumin, lipid carriers of continuous phase (non-microparticle type), and spherical or non-spherical polymeric nanoparticles from 30 nm to 500 nm in diameter. 
     
     
         10 . The guidewire of  claim 9  wherein the release carrier is selected from the group consisting of fibrin gels, hydrogels, and glucose. 
     
     
         11 . The guidewire of  claim 5  wherein a biodegradable porous layer is positioned over the therapeutic agent or drug coated on the first coil. 
     
     
         12 . The guidewire of  claim 1  further comprising a second coil extending from a second coil proximal end to a second coil distal end, wherein the second coil distal end contacts the core wire at the atraumatic tip, and wherein the second coil proximal end abuts the first coil distal end affixed to the core wire. 
     
     
         13 . The guidewire of  claim 12  wherein the second coil is of a radiopaque material. 
     
     
         14 . The guidewire of  claim 1  wherein the first coil comprises from one to four helical winds. 
     
     
         15 . A guidewire, comprising:
 a) a core wire extending along a longitudinal axis from a proximal core wire portion to a distal core wire end;   b) a distal atraumatic tip connected to the distal core wire end;   c) a first coil extending from a first coil proximal end to a first coil distal end, wherein the first coil distal end is affixed to the core wire;   d) a tubular member supported on the core wire and extending from a tubular member proximal portion to a tubular member distal end, wherein the tubular member distal end is connected to the first coil proximal end, and wherein the first coil proximal end has a first outer diameter when in an unexpanded state; and   e) a second coil of a radiopaque material extending from a second coil proximal end to a second coil distal end, wherein the second coil distal end contacts the core wire at the atraumatic tip, and wherein the second coil proximal end abuts the first coil distal end affixed to the core wire,   f) wherein torsional manipulation of the tubular member proximal portion in a first directed about the longitudinal axis of the core wire causes the first coil to unwind from the unexpanded state having the first outer diameter to an expanded state having a second outer diameter, the second diameter being greater than the first diameter, and   g) wherein torsional manipulation of the tubular member in a second direction, opposite the first direction, causes the first coil to rewind from the expanded state having the second outer diameter to a third diameter less than the second diameter.   
     
     
         16 . A method for delivering a therapeutic agent or drug to vascular tissue, comprising the steps of:
 a) providing a guidewire comprising:
 i) a core wire extending along a longitudinal axis from a proximal core wire portion to a distal core wire end; 
 ii) a distal atraumatic tip connected to the distal core wire end; 
 iii) a first coil extending from a first coil proximal end to a first coil distal end, wherein the first coil distal end is affixed to the core wire; 
 iv) a tubular member supported on the core wire and extending from a tubular member proximal portion to a tubular member distal end, wherein the tubular member distal end is connected to the first coil proximal end, and wherein the first coil proximal end has a first outer diameter when in an unexpanded state; and 
 v) a therapeutic agent or drug coated on the first coil; 
   b) inserting the guidewire into a vasculature until the first coil is adjacent to a tissue to be treated;   c) manipulating the tubular member proximal portion in a first directed about the longitudinal axis of the core wire to thereby cause the first coil to unwind from the unexpanded state having the first outer diameter to an expanded state having a second outer diameter, the second diameter being greater than the first diameter, wherein in the expanded state, the therapeutic agent or drug coated on the first coil contacts the tissue intended to be treated;   d) after treating the tissue, manipulating the tubular member in a second direction, opposite the first direction, to thereby cause the first coil to rewind from the expanded state having the second outer diameter in contact with the tissue to a third diameter less than the second diameter; and   e) removing the guidewire from the vasculature.   
     
     
         17 . The method of  claim 16  including selecting the therapeutic agent or drug from the group consisting of paclitaxel, sirolimus, everolimus, ABT-578 biological agents, and mixtures thereof. 
     
     
         18 . The method of  claim 16  including encapsulating the therapeutic agent or drug within a liposome. 
     
     
         19 . The method of  claim 18  including providing the liposome being no greater than 100 nm in size. 
     
     
         20 . The method of  claim 16  including mixing the therapeutic agent or drug with a release carrier selected from the group consisting of semi-synthetic polyacryl starch microparticles, ethyl cellulose, poly-L-lactic acid, heptakis (2,6-di-O-ethyl)-beta-cyclodextrin, polyalkylcyanoacrylate nano capsules, polymethylacrylate, monocarboxycellulose, alginic acid, hyaluronic acid, lipid bilayer beads, polyvinylpyrollidone, polyvinyl alcohol, albumin, lipid carriers of continuous phase (non-microparticle type), and spherical or non-spherical polymeric nanoparticles from 30 nm to 500 nm in diameter. 
     
     
         21 . The method of  claim 20  including selecting the release carrier from the group consisting of fibrin gels, hydrogels, and glucose. 
     
     
         22 . The method of  claim 16  including positioning a biodegradable porous layer over the therapeutic agent or drug coated on the first coil. 
     
     
         23 . The method of  claim 16  wherein the guidewire further comprises a second coil of a radiopaque material extending from a second coil proximal end to a second coil distal end, and including contacting the second coil distal end to the core wire at the atraumatic tip, and abutting the second coil proximal end to the first coil distal end affixed to the core wire. 
     
     
         24 . The method of  claim 16  including providing the first coil comprising from one to four helical winds.