Tissue penetrating catheters having integral imaging transducers and their methods of use

A catheter device that is useable to facilitate penetration from the lumen of a blood vessel within a patient's body in which the catheter device is positioned to a target location within the patient's body, said catheter device comprising:

• a flexible catheter having a proximal end and a distal end, said catheter being transluminally advanceable into said blood vessel;
• a tissue penetrator that is advanceable from the catheter to penetrate from the lumen of a blood vessel to a target location, provided that the catheter is rotationally oriented within the blood vessel such that the tissue penetrator is aimed at the target location;
• an imaging transducer that comprises a plurality of imaging elements fixedly mounted on the catheter to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained;
• and
• said imaging elements being mounted on the catheter at known circumferential locations relative to the path that will be followed by the tissue penetrator as the tissue penetrator advances from the catheter, said imaging transducer being thereby useable by the operator to rotationally orient the catheter such that, when the tissue penetrator is advanced from the catheter, the tissue penetrator will extend into the target location as desired.

A catheter comprising:

• a catheter body having a proximal end, a distal end and a peripheral wall;
• said catheter of body being receivable within a blood vessel of a human patient;
• said catheter body having a penetrator lumen that terminates distally at an exit location on the peripheral wall of the catheter;
• a penetrator operatively engaged to exit from the penetrator lumen, out of the exit location, and to advance away from the catheter body on a predetermined penetrator path;
• and
• a phased array transducer fixedly mounted to the catheter body, said phased array transducer comprising a plurality of transducer elements positioned at circumferentially spaced apart locations, at least one of said transducer elements being in a known circumferential location relative to said exit port to provide an imaging signal from which an image of the target location and other anatomical structures located adjacent the blood vessel can be obtained to enable the operator to rotationally orient the catheter until the target location is aligned with the location of the exit port such that when the tissue penetrator is advanced from the catheter it will extend into the target location as desired.

A catheter comprising:

• an elongated catheter body having a proximal end, a distal end, a guidewire lumen opening at the distal end of the catheter body and a peripheral wall, at least a distal region of said catheter body being flexible;
• said catheter body being receivable within a first blood vessel of a human patient;
• said catheter body having a penetrator lumen terminating distally at an exit location on the peripheral wall and a penetrator disposed within said lumen and advanceable out of said exit location;
• said catheter body including a major section which includes the proximal end and said exit location and a distal tip section extending from the major section to the distal end of the catheter body;
• said distal portion of the distal tip section being of smaller cross sectional area than the adjacent region of the major section;
• and
• an active imaging apparatus carried by the catheter body and including imaging elements the distal tip section and a lead extending proximally from said imaging elements.

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 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.