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.

What is claimed is: 
     
         1 . 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, said imaging transducer comprising a plurality of transducer elements at radially spaced-apart locations, one of said transducer elements being a penetrator path indicating element which creates an image that is enhanced or otherwise visually discernible from the images produced by the other transducer elements, thereby providing a penetrator path indication which indicates the lateral direction in which the penetrator will subsequently advance from the catheter body; 
   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.   
     
     
         2 . A method according to  claim 1  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. 
 
     
     
         3 . A method according to  claim 2  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. 
 
     
     
         4 . A method according to  claim 3  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) re-advancing 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. 
 
     
     
         5 . A method according to  claim 4  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. 
 
     
     
         6 . The method of  claim 5  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. 
 
     
     
         7 . A method according to  claim 6  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. 
 
     
     
         8 . A method according to  claim 7  wherein the method further comprises the steps of:
 M) providing a connector delivery catheter accompanying a radially expandable connector; and 
 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. 
 
     
     
         9 . A method according to  claim 5  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. 
     
     
         10 . A catheter device comprising:
 a catheter having a proximal end and a distal end, said catheter being advanceable into the lumen of the first blood vessel;   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; and   an imaging transducer fixedly mounted on the catheter to provide an imaging signal from which an image of a target location located can be obtained, said imaging transducer comprising a plurality of transducer elements at radially spaced-apart locations, one of said transducer elements being a penetrator path indicating element which creates an image that is enhanced or otherwise visually discernible from the images produced by the other transducer elements, thereby providing a penetrator path indication which indicates the lateral direction in which the penetrator will subsequently advance from the catheter body.   
     
     
         11 . A catheter device according to  claim 10  wherein the imaging transducer comprises a radial phased array ultrasound transducer. 
     
     
         12 . A system comprising a catheter device according to  claim 10  in combination with a display having a screen on which there is displayed the image of the target location and the penetrator path indicator received from the imaging transducer. 
     
     
         13 . A system according to  claim 12  wherein hash marks appear on the display screen to divide the display screen into quadrants and the imaging transducer is fixedly mounted within the catheter such that its penetrator path indicating transducer element is in the 12 o'clock position and aligned with a top vertical hash mark on the display screen such that the top vertical hash mark thereby functions as the penetrator path indicator. 
     
     
         14 . A system according to  claim 13  wherein the catheter is rotatable within a blood vessel in which it is positioned so that, if the top vertical hash mark is not initially aimed at the target location, the catheter may be rotated to an orientation within the blood vessel that causes the top vertical hash to be aimed at the target location, thereby indicating that subsequent advancement of the penetrator will cause the penetrator to advance toward the target location.