Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable and rotatable within said blood vessel;
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body, a substantially open working lumen extending through said elongate tissue penetrating member such that a guidewire may be passed therethrough;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member comprising an elongate member having a distal end and a lumen extending longitudinally therethrough, said lumen being connectable to a source of negative pressure so as to draw tissue into said lumen through the distal end of the tissue penetrating member, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body, wherein said tissue-penetrating member comprises:
• a pre-bent resilient, tubular sheath having an open distal end;
• and,
• an elongate member having a sharpened distal tip, said elongate member being disposed within said tubular sheath and advanceable therethrough, such that the sharpened distal tip will emerge out of the open distal end of the sheath;
• said elongate member being constructed of material which is sufficiently flexible to conform to the pre-bent configuration of the tubular sheath;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location, and
• a side housing to house therewithin an imaging element such that the imaging element may be utilized to observe the wall of the blood vessel in which the catheter body is positioned relative to the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body, wherein the tissue penetrating member comprises an elongate member disposed within a lumen formed in the catheter body, said catheter body being formed of a flexible plastic material, and wherein a rigid tubular reinforcement member is disposed about a portion of said lumen to prevent the tissue-penetrating member from penetrating into the plastic material of the catheter body when the tissue-penetrating member is retracted into the catheter body;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• and
• a handpiece mounted on the proximal end of said catheter body, said handpiece having an actuator which is moveable in a first direction to advance said tissue-penetrating member out of said catheter body, and retractable in a second direction to retract said tissue-penetrating member into the lumen of said catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• and
• an imaging apparatus;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body, wherein the tissue-penetrating member includes a guide wire lumen extending longitudinally therethrough such that a guide wire may be advanced through said guide wire lumen after the tissue penetrating member has been advanced to said target location;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• a fluid lumen which extends through said catheter body;
• at least one fluid outlet aperture through which fluid may flow from said fluid lumen into the blood vessel in which the catheter is positioned;
• and,
• a balloon formed on the catheter body to temporarily block flow through the blood vessel in which the catheter is positioned, at a site proximal to said at least one fluid outlet aperture;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• and
• a balloon which is inflatable to stabilize the catheter device as the tissue penetrating member is passed therefrom;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body;
• and
• a deflection member for deflecting said tissue penetrating member as it passes out of the catheter body;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body, wherein said orientation marker is configured and positioned such that said indication includes an image of said marker as well as an image of said target location;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.

A catheter device that is insertable into the lumen of a blood vessel and useable in conjunction with an imaging apparatus to penetrate through the wall of that blood vessel and to a target location, said device comprising:

• a flexible catheter body having a distal portion that is positionable within said blood vessel
• an elongate, tissue penetrating member having a distal end, said tissue penetrating member being initially disposed in a retracted position and subsequently advanceable to an extended position wherein it extends substantially laterally from said catheter body;
• and
• at least one orientation marker positioned on the catheter body and useable in conjunction with said imaging apparatus to provide an indication of the direction in which the tissue penetrating member will extend as it advances from the catheter body, wherein the marker is located on the catheter body at a first location and wherein the potion of the catheter body proximal to said first location is capable of transferring torque such that, when the distal portion of the catheter body is inserted into the blood vessel and a proximal portion of the catheter body remains exteriorized, the operator may rotate the exteriorized proximal portion of the catheter body to cause said first location to rotate correspondingly, thereby bringing said image of the marker into said predetermined position relative to the image of the target;
• at least a portion of said catheter body being rotatable after the catheter has been placed in the blood vessel, such that an image of the marker obtained by the imaging apparatus may be positioned in a predetermined position relative to an image of the target, thereby indicating that when the tissue penetrating member is subsequently advanced toward its extended position the tissue penetrating member will enter the target location.