Transmembrane access systems and methods

A stabilizer sheath, comprising

• an elongate shaft having an inner lumen;
• a side port disposed in a distal section of the elongate tubular shaft in fluid communication with the inner lumen;
• a deflecting surface disposed in the inner lumen opposite the side port;
• and
• an ultrasound emission member and an ultrasound receiver disposed at the distal section of the stabilizer sheath system.

A transmembrane access system, comprising:

• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state;
• a tissue penetration member which is axially extendable from a distal end of the guide catheter for membrane penetration;
• and
• an ultrasound emission member and an ultrasound receiver disposed adjacent the shaped distal section of the guide catheter.

A method of accessing the left atrium of a patient's heart from the right atrium of the patient's heart, comprising

• providing a transmembrane access system, including:
• a stabilizer sheath having an inner lumen extending therein and having a side port disposed on a distal section of the sheath and in communication with the inner lumen,
• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state and an outer surface which is configured to move axially within a portion of the inner lumen of the stabilizer sheath that extends from the proximal end of the stabilizer sheath to the side port,
• a tissue penetration member which is configured to move axially within an inner lumen of the guide catheter and which is axially extendable from a distal end of the guiding catheter for membrane penetration, and
• an ultrasound emission member and an ultrasound receiver disposed at the distal section of the stabilizer sheath;
• advancing the stabilizer sheath through a superior vena cava of the patient and positioning the stabilizer sheath with the distal end of the sheath within the inferior vena cava with the side port of the stabilizer sheath facing the right atrium of the patient's heart;
• advancing the distal end of the guide catheter through the inner lumen of the stabilizer sheath and out of the side port until the distal end of the guide catheter is positioned adjacent a desired site of the septum of the patient's heart;
• advancing the tissue penetration member from the distal end of the guide catheter;
• emitting ultrasound energy from the ultrasound emission member directed towards the desired site;
• receiving reflected ultrasound energy with the ultrasound receiver;
• generating information about the desired site from the reflected ultrasound energy;
• and
• activating the tissue penetration member and advancing the tissue penetration member distally through the septum.

A method of accessing a second side of a tissue membrane from a first side of a tissue membrane, comprising

• providing a transmembrane access system, having
• a guide catheter with a shaped distal section that has a curved configuration in a relaxed state,
• a tissue penetration member which is disposed within a distal end of the guide catheter and which is axially extendable from the distal end of the guide catheter for membrane penetration, and
• an ultrasound emission member and ultrasound receiver disposed at a distal portion of the guide catheter;
• positioning the distal end of the guide catheter until the distal end of the guide catheter is adjacent a desired site on the first side of the tissue membrane;
• advancing the tissue penetration member distally from the guide catheter until the distal end of the tissue penetration member is adjacent the tissue membrane;
• emitting ultrasound energy from the ultrasound emission member directed to the desired site;
• receiving reflected ultrasound energy from the desired site with the ultrasound receiver and generating information about the tissue membrane from the reflected ultrasound energy;
• and
• activating the tissue penetration member so as to penetrate distally through the tissue membrane.

A method of positioning an access catheter within a chamber of a patient's body, comprising

• providing an access system, including:
• a stabilizer sheath having a tubular configuration with an inner lumen extending therein and having a side port disposed on a distal section of the stabilizer sheath and in communication with the inner lumen,
• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state and an outer surface which is configured to move axially within a portion of the inner lumen of the stabilizer sheath that extends from the proximal end of the stabilizer sheath to the side port, and
• an ultrasound emission member and an ultrasound receiver disposed at the distal section of the stabilizer sheath;
• advancing the stabilizer sheath through a first tubular structure of the patient which is in fluid communication with the chamber and positioning the stabilizer sheath with the side port of the stabilizer sheath adjacent the chamber of the patient's body and with a portion of the stabilizer sheath distal of the side port into a second tubular structure which is also in fluid communication with the chamber;
• advancing the distal end of the guide catheter through the inner lumen of the stabilizer sheath until the distal end of the guide catheter exits the side port of the stabilizer sheath;
• emitting ultrasound energy from the ultrasound emission member directed towards a desired site within the chamber;
• receiving reflected ultrasound energy with the ultrasound receiver;
• generating information about the desired site from the reflected ultrasound energy;
• positioning the distal end of the guide catheter is positioned adjacent the desired site of the chamber.

A transmembrane access system, comprising:

• a stabilizer sheath having an inner lumen extending therein, having a side port disposed on a distal section of the sheath and in communication with the inner lumen and having a curled section on a distal portion of the distal section wherein the discharge axis of the distal end of the elongate tubular shaft is greater than 180 degrees from the longitudinal axis of the stabilizer sheath proximal of the curled section and wherein the curled section is directed opposite the side port with respect to circumferential orientation about the stabilizer sheath;
• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state and an outer surface which is configured to move axially within a portion of the inner lumen of the stabilizer sheath that extends from the proximal end of the stabilizer sheath to the side port;
• and
• a tissue penetration member which is configured to move axially within an inner lumen of the tubular guide catheter and which is axially extendable from a distal end of the guide catheter for membrane penetration.

A transmembrane access system, comprising:

• a stabilizer sheath having an inner work lumen extending therein, having a port disposed on a distal end of the sheath and in communication with the inner lumen and having a stabilizer member lumen substantially parallel to a longitudinal axis of the stabilizer sheath disposed at the distal section;
• an elongate stabilizer member that is configured to extend distally from the stabilizer member lumen and provide lateral support to the distal end of the stabilizer sheath;
• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state and an outer surface which is configured to move axially within a portion of the inner work lumen of the stabilizer sheath that extends from the proximal end of the stabilizer sheath to the port;
• and
• a tissue penetration member which is configured to move axially within an inner lumen of the tubular guide catheter and which is axially extendable from a distal end of the guide catheter for membrane penetration.

A method of accessing the left atrium of a patient's heart from the right atrium of the patient's heart, comprising

• providing a transmembrane access system, including:
• a stabilizer sheath having an inner work lumen extending therein, having a port disposed on a distal end of the sheath and in communication with the inner lumen and having a stabilizer member lumen substantially parallel to a longitudinal axis of the stabilizer sheath disposed at the distal section,
• an elongate stabilizer member that is configured to extend from the stabilizer member lumen and provide lateral support to the distal end of the stabilizer sheath,
• a guide catheter having a shaped distal section that has a curved configuration in a relaxed state and an outer surface which is configured to move axially within a portion of the inner lumen of the stabilizer sheath that extends from the proximal end of the stabilizer sheath to the port;
• and
• a tissue penetration member which is configured to move axially within an inner lumen of the guide catheter and which is axially extendable from a distal end of the guide catheter for membrane penetration;
• advancing the stabilizer sheath through a superior vena cava of the patient and positioning the stabilizer sheath with the stabilizer member within the inferior vena cava and with the port of the stabilizer sheath adjacent the right atrium of the patient's heart;
• advancing the distal end of the guide catheter through the inner work lumen of the stabilizer sheath until the distal end of the guide catheter is positioned adjacent a desired site of the septum of the patient's heart;
• advancing the tissue penetration member from the distal end of the guide catheter;
• and
• activating the tissue penetration actuator and advancing the tissue penetration member distally through the septum.

A transmembrane access system, comprising:

• a guide catheter having a shaped distal section that includes a curved configuration in a relaxed state, having an inner work lumen extending within a length thereof, having a port disposed on a distal end of the guide catheter and in communication with the inner work lumen and having a stabilizer member lumen which is substantially parallel to a nominal longitudinal axis of the guide catheter and which has a distal port disposed proximal of the shaped distal section;
• an elongate stabilizer member that is configured to extend distally from the distal port of the stabilizer member lumen of the guide catheter and provide lateral support to the distal section of the guide catheter;
• and
• a tissue penetration member which is configured to move axially within the inner work lumen of the guide catheter and which is axially extendable from a distal end of the guide catheter for membrane penetration.

A transmembrane access system, comprising

• an elongate guide catheter having an inner work lumen and a distal port disposed in fluid communication with the inner work lumen, a shaped distal section that includes a curved configuration in a relaxed state, and a stabilizer member lumen which is substantially parallel to a longitudinal axis of the guide catheter, which has an intermediate port disposed proximal to the shaped distal section of the guide catheter and a distal port which is disposed in the shaped distal section of the guide catheter;
• an elongate stabilizer member that is configured to extend from the intermediate port and distal port of the stabilizer member lumen and provide lateral support to a distal portion of the guide catheter;
• and
• a tissue penetration member which is configured to move axially within the inner work lumen of the guide catheter and which is axially extendable from a distal end of the guide catheter for membrane penetration.

A method of accessing the left atrium of a patient's heart from the right atrium of the patient's heart, comprising

• providing a transmembrane access system, including:
• a guide catheter having a shaped distal section that includes a curved configuration in a relaxed state, having an inner work lumen extending therein, having a port disposed on a distal end of the guide catheter and in communication with the inner work lumen and having a stabilizer member lumen substantially parallel to a nominal longitudinal axis of the guide catheter proximal of the shaped distal section;
• an elongate stabilizer member that is configured to extend from a distal port of the stabilizer member lumen and provide lateral support to the distal end of the stabilizer sheath, and
• a tissue penetration member which is configured to move axially within the inner work lumen of the guide catheter and which is axially extendable from the distal end of the guide catheter for membrane penetration;
• advancing the guide catheter through a superior vena cava of the patient and positioning the guide catheter with the stabilizer member within the inferior vena cava and with the port of the guide catheter positioned adjacent a desired site of the septum of the patient's heart;
• advancing the tissue penetration member from the port on the distal end of the guide catheter;
• and
• activating the tissue penetration actuator and advancing the tissue penetration member distally through the septum.