Catheter system for surgical access and circulatory support of the heart

• US 6,110,145 A
• Filed: 04/14/1998
• Issued: 08/29/2000
• Est. Priority Date: 04/16/1996
• Status: Expired due to Fees

• Current Assignee: Cardeon Corporation
• Original Assignee: Cardeon Corporation
• Inventors: Macoviak, John A.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/060,412
• Time in Patent Office: 868 Days
• Field of Search: 604/35, 604/43, 604/53, 604/101, 604/908, 604/914, 604/917
• US Class Current: 604/101.01
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2210/127 Aorta
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Described is a closed chest intravascular catheter system for a simultaneous biventricular approach to (1) intravascular cardiopulmonary surgery; (2) acute or prolonged mechanical circulatory support. The catheter system includes a left heart catheter and a right heart catheter with flow control members which segment the circulatory system into subcirculations of cardiopulmonary support. The left heart catheter has an elongated shaft with a first flow control member positioned at the entry site into a peripheral artery, a second flow control member positioned in the proximal descending aorta, a third flow control member positioned in the ascending aorta, and a fourth flow control member positioned within the left ventricle. The right heart catheter has an elongated shaft with a first flow control member positioned at the entry site into a vein, a second flow control member positioned within the right atrium, a third flow control member positioned within the coronary sinus, and a fourth flow control member positioned through the pulmonic valve. Alternatively, in a transseptal approach, the left or right heart catheter can be advanced across the atrial septum of the heart. Each catheter has a main lumen for insertion of an imaging system and robotic instruments into the chambers of the heart. Each catheter includes a flexible distal section with a removable guide for directing the catheter through the chambers of the heart and, optionally, a proximal limb branch with a fifth flow control member for perfusing or draining the peripheral vessel at the entry site.

Claims

1. A biventricular vascular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support, and for circulatory arrest of the heart comprising:

(a) an elongated catheter shaft advanceable from a peripheral vessel to and through one or more chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration;

(b) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within the patient'"'"'s heart, wherein the succession of flow control members includes one or more flow control members comprising a flow control valve.

2. The catheter of claim 1, wherein the one or more flow control valves are independently deployable.

3. A biventricular vascular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support, and for circulatory arrest of the heart comprising:

(a) an elongated catheter shaft advanceable from a peripheral vessel to and through one or more chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration, a first inner channel extending therein from a port in the distal end of the shaft to a location in the proximal end,

(b) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within the patient'"'"'s heart, and wherein the succession of flow control members comprises at least two flow control members which may be deployed at desired locations to isolate subcirculation regions within the patient,

wherein the succession of flow control members comprises a first expandable member located at the proximal end of the catheter shaft at the site of entry of the shaft into the patient, a second flow control member located distal to the first flow control member, and which is dimensioned and configured so that it seats in the proximal descending thoracic aorta, a third flow control member, distal to the second flow control member, which is dimensioned and configured so that it seats between the coronary ostia and the brachiocephalic artery, and a fourth flow control member, distal to the third flow control member, which is dimensioned and configured so that it seats in the left ventricular outflow tract.

4. A biventricular vascular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support, and for circulatory arrest of the heart comprising:

(a) an elongated catheter shaft advanceable from a peripheral vessel to and through one or more chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration,

(b) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within the patient'"'"'s heart, and wherein the succession of flow control members comprises at least two flow control members which may be deployed at desired locations to isolate subcirculation regions within the patient, wherein the succession of flow control members includes one or more flow control members comprising a flow control valve.

5. The catheter of claim 4, wherein the one or more flow control valves are independently deployable.

6. A method for performing a surgical procedure using a biventricular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support and for circulatory arrest of the heart, the method comprising:

(a) advancing such catheter to a location within a patient'"'"'s left heart from a peripheral vessel, wherein such catheter comprises

(i) an elongated catheter shaft configured to be advanced from a peripheral vessel to and through at least two chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration; and

(ii) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within a chamber of the patient'"'"'s heart, and wherein the succession of flow control members comprises at least two flow control members which may be deployed at desired locations to isolate subcirculation regions within the patient;

(b) selectively perfusing one or more subcirculation regions within the patient; and

(c) perfusing the pulmonary artery.

8. The method of claim 6, further comprising the step (d) draining one or more chambers of the heart.

7. A method for performing a surgical procedure using a biventricular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support and for circulatory arrest of the heart, the method comprising:

(a) advancing such catheter to a location within a patient'"'"'s left heart from a peripheral vessel, wherein such catheter comprises

(i) an elongated catheter shaft configured to be advanced from a peripheral vessel to and through at least two chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration; and

(ii) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within a chamber of the patient'"'"'s heart, and wherein the succession of flow control members comprises at least two flow control members which may be deployed at desired locations to isolate subcirculation regions within the patient;

(b) selectively perfusing one or more subcirculation regions within the patient; and

(c) draining one or more chambers of the heart.

9. A method for performing a trans-septal surgical procedure on the heart using a biventricular catheter for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support and for circulatory arrest of the heart, the method comprising:

(a) advancing such catheter to a location within a patient'"'"'s left heart from a peripheral vessel, wherein such catheter comprises;

(i) an elongated catheter shaft configured to be advanced from a peripheral vessel to and through at least two chambers of the heart, having a proximal end adapted to move and extend out of the patient and a distal end adapted move through the chambers of the heart, said distal end having at least one fenestration, wherein the elongated catheter shaft is configured to be advanced across a septum between chambers of the heart;

(ii) a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within a chamber of the patient'"'"'s heart.

(b) further advancing the catheter through an atrial or ventricular septum; and

(c) selectively perfusing one or more subcirculation regions within the patient.

10. A biventricular vascular catheter system for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support, and for circulatory arrest of the heart comprising:

(a) a first elongated catheter shaft advanceable from a peripheral vessel to and through one or more chambers of the heart, including across a septum, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration, and

a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within the patient'"'"'s heart,

(b) a second elongated catheter shaft advanceable from a peripheral vessel to and through one or more chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration, and

a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within the patient'"'"'s heart, wherein the succession of flow control members in one or more catheters includes one or more flow control members comprising a flow control valve.

11. The catheter system of claim 10, wherein the one or more flow control valves are independently deployable.

12. A method for performing a surgical procedure using a biventicular catheter system for providing access to a patient'"'"'s heart for cardiopulmonary surgery, for cardiopulmonary circulatory support and for circulatory arrest of the heart, wherein such system comprises a first elongated catheter shaft configured to be advanced from a peripheral vessel to and through at least two chambers of the heart, including across a septum, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration, and a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within a chamber of the patient'"'"'s heart, a second elongated catheter shaft configured to be advanced from a peripheral vessel to and through at least two chambers of the heart, having a proximal end adapted to extend out of the patient and a distal end adapted to move through the chambers of the heart, said distal end having at least one fenestration, and a succession of flow control members positioned along the catheter shaft such that after the catheter has been positioned in the patient'"'"'s body, one or more of the flow control members are positioned within a chamber of the patient'"'"'s heart, the method comprising:

(a) advancing the first catheter of said system to a location within a patient'"'"'s heart from a peripheral vessel,

(b) advancing the second catheter of said system to a location within a patient'"'"'s heart from a peripheral vessel, and

(c) selectively perfusing one or more subcirculation regions within the patient wherein the one or more subcirculation regions includes the pulmonary artery.

13. The method of claim 12, further comprising the step (d) draining one or more chambers of the heart.

14. The method of claim 12, further comprising the step (d) draining one or more chambers of the heart.