Percutaneous bypass apparatus and method

A method of bypassing a restriction in a vessel, comprising the steps of:

• providing an intravascular catheter having a tissue penetrating member disposed therein, a proximal end of the penetrating member slidably disposed in the catheter and a distal end of the tissue penetrating member having an adjustable tip portion having an adjustable orientation and the adjustable tip portion including a tissue penetrating mechanism;
• navigating a distal end of the catheter to a position adjacent the restriction;
• remotely adjusting the orientation of the adjustable tip portion of the tissue penetrating member;
• and
• slidably advancing the tissue penetrating member relative to the catheter to form an extravascular passageway.

A method of bypassing a restriction comprising the steps of:

• providing an intravascular catheter including a tissue penetrating member slideably disposed in the catheter and including a tissue penetrating mechanism at a distal tip of the tissue penetrating member;
• navigating the catheter through a vessel proximate to a restriction to form an extravascular passageway between body vessels;
• slidably advancing the tissue penetrating member relative to the intravascular catheter to form the extravascular passageway and injecting radiopaque contrast media through a lumen of the penetrating member;
• and
• observing the penetrating member and the contrast media under fluoroscopy to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.

A method of bypassing a restriction comprising the steps of:

• providing an intravascular catheter including a tissue penetrating member slideably disposed relative to the intravascular catheter and including a tissue penetrating mechanism proximate to a distal end of the penetrating member;
• navigating the catheter through a vessel proximate to the restriction and slidably advancing the tissue penetrating member to form an extravascular passageway between body vessels;
• measuring pressure at the distal end of the penetrating member;
• and
• observing the pressure as the penetrating member penetrates a wall of the vessel to monitor advancement of the penetrating member to form the extravascular passageway between the body vessels.

An intravascular device comprising:

• an elongated shaft having a proximal end and a distal end and having a first inflation lumen extending therethrough;
• an inflatable balloon having a proximal end and a distal end and an inflatable portion open to the inflation lumen;
• a second lumen having a proximal end and a distal end and extending along a length of the elongated shaft and along a length portion of the inflatable balloon and having a distal opening between the proximal and distal ends of the inflatable balloon;
• and
• a tissue penetrating member having a tissue penetrating mechanism slidably disposed through the second lumen and having a tip portion extending through the distal opening between the proximal and distal ends of the inflatable balloon.

An intravascular catheter comprising:

• an elongated shaft having a proximal end and a distal end and an elongated length therebetween;
• a tissue penetrating member having a proximal end and a distal end and slidably coupled to the elongated shaft to move between a first position and a second extended position and the tissue penetrating member including a tissue penetrating mechanism and an adjustable distal tip portion having an adjustable orientation;
• and
• a distal tip actuator including a distal portion operably coupled to the distal tip portion of the tissue penetrating member and an external control portion remote from the distal tip portion and operable to adjust the distal tip portion of the tissue penetrating member in a plurality of orientations.