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.

1 - 14 . (canceled) 
     
     
         15 . A catheter device for delivering a therapeutic substance to a perivascular treatment site, the catheter device comprising:
 an elongate catheter device extending along a catheter axis and having a distal portion advanceable within a blood vessel of a human subject;   a needle at the distal portion of the catheter device, wherein the needle has a needle lumen in fluid communication with an outlet opening, and wherein the needle is moveable in a lateral direction relative to the catheter axis, and further wherein the needle is configured to penetrate a wall of the blood vessel;   an injection port at a proximal portion of the catheter, the injection port being in fluid communication with the needle lumen; and   at least one imageable marker useable to determine, by an imaging procedure, the lateral direction in which the needle will move from the distal portion of the catheter device while the distal portion of the catheter device is within the blood vessel.   
     
     
         16 . The catheter device of  claim 15  wherein the imageable marker is configured to indicate a radial location from which the needle will move laterally from the catheter device. 
     
     
         17 . The catheter device of  claim 15  wherein a depth to which the needle will penetrate into the blood vessel wall is adjustable. 
     
     
         18 . The catheter device of  claim 15  wherein the imageable marker is radiographically imageable. 
     
     
         19 . The catheter device of  claim 15 , further comprising an injection device configured to inject a mixture comprising a therapeutic substance and a radiographic agent through the needle lumen and out of the needle outlet opening. 
     
     
         20 . A method for delivering a therapeutic substance to a perivascular treatment site within a body of a human subject, the method comprising:
 advancing a distal portion of a catheter device within a blood vessel of the subject near the perivascular treatment site, wherein the catheter device includes—   a needle at the distal portion of the catheter device, the needle having a needle lumen in fluid communication with an outlet opening; and   an imageable marker useable to determine a direction that the needle will move from the distal portion of the catheter device while the distal portion of the catheter device is within the body of the subject;   connecting an injector to an injection port at a proximal portion of the catheter device, wherein the injector contains the therapeutic substance;   imaging the imageable marker to determine the direction in which the needle will move from the distal portion of the catheter;   advancing the needle laterally relative to a longitudinal axis of the catheter device such that the needle penetrates a wall of the blood vessel; and   injecting the therapeutic substance from the injector to the perivascular treatment site via the outlet opening of the needle.   
     
     
         21 . The method of  claim 20  wherein the imageable marker is radiographically imageable, and wherein imaging the imageable marker is performed using a fluoroscope. 
     
     
         22 . The method of  claim 20  wherein injecting the therapeutic substance further comprises ablating tissue at the perivascular treatment site. 
     
     
         23 . The method of  claim 20  wherein the therapeutic substance is combined with a radiographic agent, and wherein the method further comprises imaging the therapeutic substance after it has been injected to the perivascular treatment site to determine the tissue regions to which the therapeutic substance has flowed. 
     
     
         24 . The method of  claim 20  wherein the therapeutic substance is combined with a radiographic agent, and wherein the method further comprises imaging the therapeutic substance after it has been injected to verify that the therapeutic substance has reached the perivascular treatment site. 
     
     
         25 . The method of  claim 20 , further comprising adjusting a position of the distal portion of the catheter within the blood vessel as necessary based on imaging from the imageable marker.