Endoluminal Drug Delivery Devices and Methods

Abstract

A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

1 . A method comprising the steps of:
 inserting a medical device into a vessel;   advancing the medical device through the vessel;   advancing an endoluminal device over the inserted medical device to a first location of the vessel, wherein at least a portion of the medical device is positioned within an endoluminal device first lumen, the endoluminal device further comprising an endoluminal device second lumen and at least one exit port;   advancing a needle through the endoluminal device second lumen, wherein a distal portion of the needle is advanced through the at least one exit port;   delivering a fluid through the needle to a first target location of the vessel;   retracting the distal portion of the needle through the at least one exit port and into the endoluminal device second lumen;   removing the endoluminal device from the vessel; and   delivering energy to the vessel of the patient, wherein the delivered energy results in closure of the vessel.   
     
     
         2 . The method of  claim 1 , wherein the endoluminal device further comprises an endoluminal device first lumen distal end located a selected distance distal to the at least one exit port. 
     
     
         3 . The method of  claim 1 , wherein the endoluminal device further comprises a handpiece assembly. 
     
     
         4 . The method of  claim 3 , wherein the handpiece assembly comprises an activation element coupled to the needle. 
     
     
         5 . The method of  claim 1 , wherein the step of delivering energy comprises delivering RF energy to the vessel. 
     
     
         6 . The method of  claim 1 , wherein a shape of a cross-section of the endoluminal device second lumen is one of circular, oblong, egg-shaped, or polygonal. 
     
     
         7 . The method of  claim 1 , wherein the medical device is a guidewire. 
     
     
         8 . The method of  claim 1 , wherein the step of delivering energy comprises delivering laser energy to the vessel. 
     
     
         9 . The method of  claim 1 , further comprising the step of retracting the endoluminal device proximally over the medical device to a second location of the vessel. 
     
     
         10 . The method of  claim 9 , further comprising the step of advancing the distal portion of the needle through the at least one exit port after the endoluminal device has been placed at the second location of the vessel. 
     
     
         11 . The method of  claim 10 , further comprising the step of delivering fluid to a second target location through the needle. 
     
     
         12 . The method of  claim 11 , further comprising the step of retracting the distal portion of the needle into the endoluminal device second lumen. 
     
     
         13 . A method comprising the steps of:
 inserting a medical device into a vessel;   advancing the medical device through the vessel;   advancing an endoluminal device to a first location over the inserted medical device, wherein at least a portion of the medical device is positioned within an endoluminal device first lumen, the endoluminal device further comprising an endoluminal device second lumen and a plurality of exit ports;   advancing a needle through the endoluminal device second lumen, wherein a distal portion of the needle is advanced through a first exit port of the plurality of exit ports;   delivering a fluid to a first target location of the vessel through the needle;   retracting the distal portion of the needle through the first exit port and into the endoluminal device second lumen;   moving the needle to a second exit port of the plurality of exit ports;   advancing the distal portion of the needle through the second exit port;   delivering the fluid through the needle to a second target location of the vessel;   retracting the distal portion of the needle through the second exit port and into the endoluminal device second lumen;   delivering energy to the vessel of the patient, wherein the delivered energy results in closure of the vessel.   
     
     
         14 . The method of  claim 13 , wherein the endoluminal device further comprises a handpiece assembly. 
     
     
         15 . The method of  claim 13 , wherein the step of delivering energy comprises delivering RF energy to the vessel. 
     
     
         16 . The method of  claim 13 , wherein the step of moving the needle to the second exit port of the plurality of exit ports further comprises advancing the needle in a distal direction. 
     
     
         17 . The method of  claim 13 , wherein the step of moving the needle to the second exit port of the plurality of exit ports further comprises retracting the needle in a proximal direction. 
     
     
         18 . The method of  claim 13 , wherein the endoluminal device remains stationary at the first location when moving the needle to the second exit port. 
     
     
         19 . The method of  claim 13 , wherein the step of delivering energy comprises delivering laser energy to the vessel. 
     
     
         20 . The method of  claim 13 , wherein the medical device is a guidewire.