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.

What is claimed is: 
     
         1 . A method of delivering a fluid to tissue surrounding a body lumen having a wall, the method comprising:
 percutaneously inserting a guidewire into the body lumen through the wall;   inserting a distal end of an endoluminal drug delivery device into the body lumen by tracking a first lumen of the device over the guidewire, the device comprising:
 a catheter having a proximal end and a distal end; 
 the first lumen extending from the proximal end to the distal end; 
 a second lumen extending between the proximal end and an exit port, a section of the catheter distal to the exit port being self-dilating during tracking; and 
 a needle configured to bias away from the second lumen and out of the exit port when the needle is longitudinally distally advanced; 
   when the exit port is in a first position advancing the needle out of the second lumen through the exit port;   advancing the needle through the wall to the tissue;   delivering the fluid to the tissue through the needle; and   retracting the needle into the catheter.   
     
     
         2 . The method of  claim 1 , further comprising:
 tracking the device over the guidewire within the body lumen;   when the exit port is in a second position advancing the needle out of the second lumen through the exit port;   advancing the needle through the wall to the tissue;   delivering the fluid to the tissue through the needle; and   retracting the needle into the catheter.   
     
     
         3 . The method of  claim 1 , wherein the fluid comprises tumescent. 
     
     
         4 . The method of  claim 1 , wherein the body lumen is an insufficient vein. 
     
     
         5 . The method of  claim 1 , further comprising treating the body lumen with laser or radio frequency ablation. 
     
     
         6 . An endoluminal drug delivery device comprising:
 a flexible catheter having a proximal end and a distal end;   a first lumen extending from the proximal end to the distal end and configured to house a guidewire;   a second lumen extending between the proximal end and an exit port, a section of the catheter distal to the exit port being self-dilating; and   a needle configured to bias out of the exit port and away from the second lumen when the needle is longitudinally distally advanced, the needle including a needle lumen configured to be in fluid communication with a drug delivery system.   
     
     
         7 . The device of  claim 6 , wherein the exit port is proximate to the distal end. 
     
     
         8 . The device of  claim 6 , wherein a distal portion of the catheter comprises a taper at least partially defined by a decrease in an outer diameter of the catheter from a proximal end of the taper to the distal end of the catheter. 
     
     
         9 . The device of  claim 6 , wherein the catheter comprises a deflection surface. 
     
     
         10 . The device of  claim 6 , further comprising a lumen splitter coupled to the catheter proximate to the proximal end of the catheter. 
     
     
         11 . The device of  claim 6 , further comprising a handpiece assembly coupled to a proximal end of the device, the handpiece assembly comprising a button coupled to the needle, wherein actuation of the button causes relative longitudinal movement between the needle and the catheter. 
     
     
         12 . The device of  claim 11 , wherein longitudinal movement of the button causes 1:1 longitudinal movement of the needle in the second lumen. 
     
     
         13 . The device of  claim 6 , wherein the needle is rotationally fixed relative to the catheter. 
     
     
         14 . The device of  claim 6 , wherein the catheter comprises polyethylene. 
     
     
         15 . The device of  claim 6 , wherein the catheter has a length between about 45 cm and about 55 cm. 
     
     
         16 . The device of  claim 6 , wherein a portion of the second lumen proximate to the exit port comprises a rigid lining. 
     
     
         17 . The device of  claim 6 , wherein the needle comprises a shape memory material. 
     
     
         18 . The device of  claim 17 , wherein the needle comprises nitinol. 
     
     
         19 . The device of  claim 6 , wherein a distal portion of the needle is curved when at least partially outside the second lumen. 
     
     
         20 . The device of  claim 6 , wherein the needle comprises a beveled distal tip. 
     
     
         21 . An endoluminal drug delivery system comprising: the device of  claim 6 ; and tubing configured to couple the needle lumen to a drug delivery system. 
     
     
         22 . The system of  claim 21 , wherein the drug delivery system comprises a dual check valve configured to be connected to a fluid source and a syringe. 
     
     
         23 . The system of  claim 21 , wherein the drug delivery system comprises a pump configured to be connected to a fluid source. 
     
     
         24 . A method of manufacturing an endoluminal drug delivery device, the method comprising: inserting a needle into a second lumen of a catheter comprising: a first lumen extending from a proximal end to a distal end and configured to house a guidewire; and the second lumen extending between the proximal end and an exit port, a section of the catheter distal to the exit port being self-dilating; the needle configured to bias out of the exit port and away from the second lumen when the needle is longitudinally distally advanced, the needle including a needle lumen configured to be in fluid communication with a drug delivery system. 
     
     
         25 . The method of  claim 24 , further comprising inserting a guide tube into the second lumen, the guide tube surrounding the needle. 
     
     
         26 . The method of  claim 24 , further comprising coupling a lumen splitter to the catheter proximate to the proximal end of the catheter. 
     
     
         27 . The method of  claim 24 , further comprising connecting a handpiece assembly to a proximal end of the device. 
     
     
         28 . The method of  claim 27 , wherein the handpiece assembly comprises a driver and wherein connecting the handpiece assembly to the proximal end of the device comprises connecting a proximal end of the needle to a distal end of the driver. 
     
     
         29 . The method of  claim 24 , further comprising forming a distal end of the needle into a beveled tip. 
     
     
         30 . The method of  claim 24 , further comprising shape setting a distal portion of the needle into a curved configuration.