Tissue Penetrating Catheters having Integral Imaging Transducers and Their Methods of Use

Abstract

A catheter device that is useable to penetrate from a blood vessel in which the catheter device is positioned to a target location comprises a flexible catheter advanceable into the first blood vessel, a tissue penetrator lumen adapted to receive an operative tissue penetrator which is usable to penetrate from the blood vessel to the target location when properly aimed. Further said catheter including an imaging transducer fixedly mounted on or within the catheter body to provide an imaging signal from which an image of the target location can be obtained. The catheter device may include an imageable marker on the catheter to form on the image obtainable from the imaging signal a penetrator path indication that indicates the path that will be followed by the tissue penetrator when the tissue penetrator exits from the catheter. Alternatively, or addition thereto, the imaging transducer may comprise a plurality of imaging elements which are located so that the penetrator path indication can be obtained. A method of utilizing such a catheter device to bypass an arterial obstruction is also disclosed.

1 - 19 . (canceled) 
     
     
         20 . A percutaneous, transluminal method for creating a flow channel between a first blood vessel that has a wall and a lumen and a second blood vessel that has a wall and a lumen, said method comprising the steps of:
 A. providing a catheter device that comprises:   i. a catheter having a proximal end and a distal end, said catheter being advanceable into the lumen of the first blood vessel;   ii. a tissue penetrator that is advanceable in a lateral direction from the catheter, said tissue penetrator being operative to penetrate from the lumen of a first blood vessel, through the walls of the first and second blood vessels and into the lumen of a second blood vessel when the catheter is positioned and rotationally oriented within the first blood vessel such that the tissue penetrator is aimed at the second blood vessel;   iii. an imaging transducer fixedly mounted on the catheter to provide an imaging signal from which an image of the second blood vessel and other anatomical structures located adjacent the first blood vessel can be obtained; and,   iv. an imageable marker on the catheter to provide, on the image obtainable from the imaging signal from the imaging transducer, a penetrator path indication indicative of the path that will be followed by the tissue penetrator when the tissue penetrator is advanced from the catheter;   B. percutaneously inserting and transluminally advancing the catheter into the first blood vessel;   C. actuating the imaging transducer and moving the catheter within the first blood vessel until the penetrator path indication is aimed at the lumen of the second blood vessel; and,   D. advancing the tissue penetrator from the catheter, through the walls of the first and second blood vessels and into the lumen of the second blood vessel.   
     
     
         21 . The method of  claim 20  wherein the tissue penetrator is an elongate member that has a lumen extending longitudinally therethrough and wherein said method further comprises the step of:
 E. advancing a first crossing guidewire through the lumen of the tissue penetrator and into the lumen of the second blood vessel.   
     
     
         22 . The method of  claim 21  wherein the method further comprises:
 F. retracting the tissue penetrator into the catheter leaving the first crossing guidewire in place such that it extends from the lumen of the first blood vessel into the lumen of the second blood vessel.   
     
     
         23 . The method of  claim 22  wherein the catheter device provided in Step A has a main guidewire lumen that extends longitudinally through at least a portion of the catheter and wherein the method further comprises the steps of:
 G. moving the first crossing guidewire from the lumen of the tissue penetrator, and reintroducing a crossing guidewire into the main guidewire lumen of the catheter; and,   H. readvancing the catheter over the first crossing guidewire to a position wherein the catheter extends through the lumen of the first blood vessel, through the openings created in the walls of the first and second blood vessels by advancement of the tissue penetrator in Step D, and into the lumen of the second blood vessel.   
     
     
         24 . The method of  claim 23  wherein the method further comprises the steps of:
 I. actuating the imaging transducer and moving the catheter within the second blood vessel as required to cause the penetrator path indication to be aligned with the lumen of the first blood vessel; and   J. advancing the tissue penetrator from the catheter, through the walls of the first and second blood vessels and into the lumen of the first blood vessel.   
     
     
         25 . The method of  claim 24  further comprising the step of:
 K. advancing a second crossing guidewire through the lumen of the tissue penetrator and into the lumen of the first blood vessel.   
     
     
         26 . The method of  claim 25  wherein the method further comprises:
 L. retracting the tissue penetrator into the catheter leaving the second crossing guidewire in place such that it extends from the lumen of the first blood vessel into the lumen of the second blood vessel and back into the lumen of the first blood vessel.   
     
     
         27 . The method of  claim 26  wherein the method further comprises the steps of:
 M. providing a connector delivery catheter accompanying a radially expandable connector;   N. advancing the connector delivery catheter over the second crossing guidewire and implanting the radially expandable connector such that the connector extends from the lumen of the first blood vessel, through the openings created in the walls of the first and second blood vessels in Step D, through the lumen of the second blood vessel, through the openings created in the walls of the first and second blood vessels in Step J and back into the lumen of the first blood vessel.   
     
     
         28 . The method of  claim 24  wherein the method is carried out to bypass an obstruction in the first blood vessel and wherein the openings created in the walls of the first and second blood vessels in Step D are proximal to the obstruction and the openings created in the walls of the first and second blood vessels in Step J are distal to the obstruction. 
     
     
         29 - 47 . (canceled)