Catheter for introduction of medications to the tissues of a heart or other organ

Abstract

A positionable, direct-injection catheter that can access a specific region of the heart or other organ. The catheter is provided with one or two needle shafts, which may be located within respective sheaths that extend axially along the interior of the lumen of a main catheter shaft. Each needle shaft carries, at a distal end thereof a penetrable element that is normally retracted, but is subsequently deployed by a trigger. Each extended needle is curved to enter the organ wall in a flattened trajectory that both reduces the chance of puncture through the wall and anchors the needles into the wall during injection. A plurality of apertures which provide for more complete agent delivery rapidly, while maintaining a low delivery velocity to avoid the problems caused by high velocity delivery. The needles are typically arranged to exit the tip at contralateral orientations relative to each other.

What is claimed is:  
     
         1 . A direct injection catheter comprising:
 a hollow catheter shaft having a proximal end and a shaft distal end, the shaft distal end having a shaft tip, the shaft defining a main lumen and the shaft being constructed and arranged to bend so as to be steerable;   a retractable and extendable first hollow shaft and respective distal first injection needle extending through the main lumen;   a retractable and extendable second hollow shaft and respective distal second injection needle extending through the main lumen, wherein each of the main lumen, first hollow shaft and the second hollow shaft are constructed and arranged to each carry from a respective proximal end a separate agent to a respective distal end for delivery to organ tissue.   
     
     
         2 . The catheter as set forth in  claim 1  wherein each of the first distal injection needle and the second distal injection needle comprises a curved needle that, when extended, enters the organ tissue in a non-axial direction with respect to an axis of the shaft distal end. 
     
     
         3 . The catheter as set forth in  claim 2  wherein, when extended, the first distal injection needle projects in a direction opposite a direction of projection of the second distal injection needle when extended. 
     
     
         4 . The catheter as set forth in  claim 3  wherein the first distal injection needle and the second distal injection needle each include body apertures along at least a medial side thereof and a tip aperture. 
     
     
         5 . The catheter as set forth in  claim 1  wherein the first hollow shaft and the second hollow shaft are each separately retractable and extendable to engage at a desired region of the organ tissue. 
     
     
         6 . The catheter as set forth in  claim 1  wherein the first injection needle and the second injection needle are each constructed from memory metal. 
     
     
         7 . The catheter as set forth in  claim 1  wherein the main lumen includes a sensor that determines a predetermined characteristic adjacent to the shaft tip. 
     
     
         8 . The catheter as set forth in  claim 7  wherein the sensor comprises a pressure sensor that is operatively connected to a monitor. 
     
     
         9 . A steerable catheter having a retractable and extendable injection needle residing at a distal tip of a shaft of the catheter comprising:
 a first needle shaft assembly constructed from memory metal and including a programmed curved shape that assumes an approximately straight shape when retracted into the distal tip and a curved shape that is between approximately 70 and 80 degrees with respect to an axis of extension of a distal end of the catheter to enter adjacent tissue at in an angled orientation.   
     
     
         10 . The catheter as set forth in  claim 9  wherein the first needle shaft assembly includes a plurality of body apertures along an exposed area when extended from the distal tip. 
     
     
         11 . The catheter as set forth in  claim 9  wherein the catheter shaft includes a main lumen that delivers an agent to the adjacent tissue and further comprising a second needle shaft assembly constructed from memory metal and including a programmed curved shape that assumes an approximately straight shape when retracted into the distal tip and a curved shape that is between approximately 70 and 80 degrees with respect to an axis of extension of a distal end of the catheter to enter adjacent tissue at in an angled orientation. 
     
     
         12 . A method for delivering agents to an interior of a right ventricle of a heart comprising:
 inserting a catheter having a shaft into a subclavial vein and steering the shaft into the right ventricle;   moving a distal tip of the catheter into contact with a predetermined area of the right ventricle;   extending a first injection needle and a second injection needle from the distal tip in contralateral directions to engage tissue of the organ and anchor within the tissue; and   delivering through the injection needles a predetermined agent to the tissue.   
     
     
         13 . The method as set forth in  claim 12  wherein the step of delivering includes providing a separate agent to each of the first injection needle and the second injection needle. 
     
     
         14 . The method as set forth in  claim 12  wherein the step of delivering includes directing the agent through a plurality of body apertures.