Systems and Methods for Delivering Drugs to Selected Locations Within the Body

Abstract

A transvascular system ( 10 ) for delivering a drug to a tissue region from a blood vessel, such as a coronary vein, includes a catheter ( 12 ) having a distal portion ( 26 ) with puncturing ( 14 ), orientation ( 16 ), drug delivery ( 62 ), and imaging elements ( 18 ). The puncturing element ( 14 ) is deployable for penetrating the vessel wall to access the tissue region. The orientation element ( 16 ), e.g. a “cage” including a plurality of struts ( 38 ) ( 40 ) and/or a radiopaque marker, has a predetermined relationship with the puncturing element ( 14 ), the imaging element ( 18 ) detecting the location of the orientation element ( 16 ) with respect to the tissue region to orient the puncturing element. The catheter ( 12 ) is percutaneously introducing into the vessel, the puncturing element ( 14 ) is oriented towards the tissue region, the puncturing element ( 14 ) is deployed to access the tissue region, and the drug is delivered to the tissue region. An ablation device ( 230 ) may also be deployed to create a cavity or fluid reservoir in the tissue region for receiving the drug therein, or an indwelling catheter ( 214 ) may be advanced into and left in the tissue region.

What is claimed is: 
     
         1 . A multiple needle catheter device useable for delivering a therapeutic substance to locations within a body of a human subject, the device comprising:
 an elongate flexible catheter body;   a plurality of needles, each needle having at least one lumen in fluid communication with at least one outflow opening, wherein the needles are alternately moveable between (a) retracted positions wherein the needles are within the catheter body, and (b) advanced positions wherein the needles extend out of and laterally away from the catheter body; and   a needle stopping apparatus configured to selectively control advancement of the needles.   
     
     
         2 . The device of  claim 1  wherein the catheter body further comprises a plurality of needle lumens terminating in corresponding needle outlet openings, and wherein the plurality of needles, when in their retracted positions, are housed within the corresponding needle lumens. 
     
     
         3 . The device of  claim 2  wherein the catheter body has a side wall, and wherein the needle outlet openings are formed at spaced-apart locations in the side wall of the catheter body. 
     
     
         4 . The device of  claim 2  wherein the needle outlet openings are formed at a distal portion of the catheter body. 
     
     
         5 . The device of  claim 1 , further comprising a handle from which the catheter body extends, and wherein the handle comprises a control apparatus whereby a user controls advancement and retraction of the needles. 
     
     
         6 . The device of  claim 1  wherein the needle stopping apparatus is selectively adjustable by a user. 
     
     
         7 . The device of  claim 1  wherein the needles are configured to advance and retract simultaneously. 
     
     
         8 . The device of  claim 1  wherein the needles are configured to advance and retract separately. 
     
     
         9 . A method for delivering a substance to a plurality of treatment regions outside of a blood vessel in a human patient, the method comprising:
 intravascularly delivering a distal portion of a catheter through the blood vessel of the patient and proximate to the plurality of treatment regions, wherein the distal portion of the catheter includes a plurality of needles, each needle having at least one lumen in fluid communication with at least one outflow opening;   advancing the needles from the catheter to corresponding treatment regions, wherein the needles are advanced from (a) retracted positions within the distal portion of the catheter to (b) extended positions such that at least a portion of each needle extends through a wall of the blood vessel and the at least one outflow opening of each needle is at or proximate to the corresponding treatment region;   infusing a substance through the outflow openings of the needles to the corresponding treatment regions;   retracting each needle to its retracted position; and   removing the catheter from the patient.   
     
     
         10 . The method of  claim 9  wherein infusing a substance through the outflow openings of the needles to the corresponding treatment regions further comprises ablating tissue at the treatment regions. 
     
     
         11 . The method of  claim 9 , further comprising performing an imaging procedure to verify proper positioning and orientation of the distal portion of the catheter before advancing the needles from the catheter. 
     
     
         12 . The method of  claim 11  wherein the imaging procedure further comprises imaging of the needles in their extended positions after the needles have been advanced from the catheter to corresponding treatment regions. 
     
     
         13 . The method of  claim 12  wherein the substance comprises a radiographic agent, and wherein the imaging procedure further comprises imaging the substance after it has been infused to verify delivery of the substance to corresponding treatment regions. 
     
     
         14 . The method of  claim 12  wherein the substance comprises a radiographic agent, and wherein the imaging procedure further comprises imaging the substance after it has been infused to determine tissue regions to which the substance has flowed.