System for cardiac procedures

• US 20010044591A1
• Filed: 02/02/2001
• Published: 11/22/2001
• Est. Priority Date: 07/16/1991
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Machold, Timothy R., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Granted Patent: US 6,866,650 B2
• Time in Patent Office: Days
• US Class Current: 604/6.11
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00232 having an irregular shape
• CPC Class Codes: A61B 2018/00261 arranged in a line
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3623 Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• 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 2202/047 cardioplegic
• CPC Class Codes: A61M 2205/11 with means for preventing cross-contamination when used for multiple patients
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0041 : pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0125 : Catheters carried by the bloodstream, e.g. with parachutes; Balloon catheters specially designed for this purpose
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 : Guide tubes
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A system for accessing a patient'"'"'s cardiac anatomy which includes an endovascular aortic partitioning device that separates the coronary arteries and the heart from the rest of the patient'"'"'s arterial system. The endovascular device for partitioning a patient'"'"'s ascending aorta comprises a flexible shaft having a distal end, a proximal end, and a first inner lumen therebetween with an opening at the distal end. The shaft may have a preshaped distal portion with a curvature generally corresponding to the curvature of the patient'"'"'s aortic arch. An expandable means, e.g. a balloon, is disposed near the distal end of the shaft proximal to the opening in the first inner lumen for occluding the ascending aorta so as to block substantially all blood flow therethrough for a plurality of cardiac cycles, while the patient is supported by cardiopulmonary bypass. The endovascular aortic partitioning device may be coupled to an arterial bypass cannula for delivering oxygenated blood to the patient'"'"'s arterial system. The heart muscle or myocardium is paralyzed by the retrograde delivery of a cardioplegic fluid to the myocardium through patient'"'"'s coronary sinus and coronary veins, or by antegrade delivery of cardioplegic fluid through a lumen in the endovascular aortic partitioning device to infuse cardioplegic fluid into the coronary arteries. The pulmonary trunk may be vented by withdrawing liquid from the trunk through an inner lumen of an elongated catheter. The cardiac accessing system is particularly suitable for removing the aortic valve and replacing the removed valve with a prosthetic valve.

Claims

1. A cardiopulmonary bypass catheter system for arresting a patient'"'"'s heart and maintaining arterial circulation comprising:

a return cannula having an elongated cannula body, a distal end adapted for positioning in a blood vessel, a proximal end, a return lumen in the cannula body adapted for flowing blood therethrough, a return outlet at the distal end in communication with the return lumen, a return inlet at the proximal end in communication with the return lumen, a catheter port at the proximal end in communication with the return lumen and adapted to removably receive a catheter therein, and a hemostasis valve in the catheter port adapted to seal around a catheter positioned in the catheter port; and

an occlusion catheter slidably and removably positioned through the catheter port and the return lumen, the occlusion catheter having an infusion lumen with an infusion inlet and an infusion outlet, the infusion inlet being adapted for connection to a source of cardioplegic fluid, and an expandable occlusion member proximal to the infusion outlet having a collapsed configuration adapted for introduction through the return lumen and an expanded configuration adapted for occlusion of the ascending aorta between the coronary ostia and the brachiocephalic artery;

wherein the return lumen is adapted to deliver blood when the occlusion catheter is positioned therein at a flow rate sufficient to maintain arterial circulation with the heart arrested.

2. The cardiopulmonary bypass catheter system of

claim 1

further comprising a venting port in communication with the infusion lumen, the venting port being adapted for connection to a pump for withdrawing fluids from the ascending aorta through the infusion lumen.

3. The cardiopulmonary bypass catheter system of

claim 1

wherein the return lumen is adapted to deliver blood at a flow rate of at least about 4 l/min and a pressure of less than about 250 mm Hg.

4. The cardiopulmonary bypass catheter system of

claim 1

wherein the return lumen has an inner diameter of about 5-9 mm.

5. The cardiopulmonary bypass catheter system of

claim 4

wherein the occlusion catheter has an outer diameter of about 2-5 mm.

6. The cardiopulmonary bypass catheter system of

claim 1

further comprising a source of cardioplegic fluid coupled to the infusion port.

7. The cardiopulmonary bypass catheter system of

claim 1

further comprising a source of oxygenated blood coupled to the infusion port.

8. The cardiopulmonary bypass catheter system of

claim 1

further comprising a pump coupled to the return inlet adapted for pumping oxygenated blood through the return lumen.

9. The cardiopulmonary bypass catheter system of

claim 8

wherein the pump is adapted to pump oxygenated blood through the return lumen at a rate of at least about 4 l/min. at a pressure of less than about 250 mm Hg with the occlusion catheter positioned in the return lumen.

10. The cardiopulmonary bypass catheter system of

claim 1

wherein the infusion lumen is configured to deliver cardioplegic fluid at a rate of at least 250 ml/min at a pressure of less than about 300 mm Hg.

11. The cardiopulmonary bypass catheter system of

claim 10

wherein the infusion lumen has a cross-sectional area of at least about 4.5 mm².

12. The cardiopulmonary bypass catheter system of

claim 1

further comprising a venous cannula positionable in a vein and an oxygenator fluidly coupled to the venous cannula, the oxygenator being fluidly coupled to the return inlet.

13. The cardiopulmonary bypass catheter system of

claim 1

wherein the return cannula is positionable in a femoral artery and the occlusion catheter has a length of at least about 80 cm such that the occlusion member is positionable in the ascending aorta.

14. The cardiopulmonary bypass catheter system of

claim 1

wherein the occlusion catheter has a pre-shaped distal portion configured to conform to at least a portion of the aortic arch.

15. The cardiopulmonary bypass catheter system of

claim 1

wherein the occlusion catheter has a pressure lumen with a pressure outlet distal to the occlusion member and a pressure port proximal to the occlusion member adapted for connection to a pressure monitoring device.

16. A cardiopulmonary bypass catheter system for arresting a patient'"'"'s heart and maintaining arterial circulation comprising:

a return cannula having an elongated cannula body, a distal end adapted for positioning in a blood vessel, a proximal end, a return lumen in the cannula body adapted for flowing blood therethrough, a return outlet at the distal end in communication with the return lumen, a return inlet at the proximal end in communication with the return lumen, a catheter port at the proximal end in communication with the return lumen and adapted to removably receive a catheter therein, and a hemostasis valve in the catheter port adapted to seal around a catheter positioned in the catheter port;

an occlusion catheter slidably and removably positioned through the catheter port and the return lumen, the occlusion catheter having an infusion lumen with an infusion inlet and an infusion outlet, a venting port in communication with the infusion lumen, and an expandable occlusion member proximal to the infusion outlet having a collapsed configuration adapted for introduction through the return lumen and an expanded configuration adapted for occlusion of the ascending aorta between the coronary ostia and the brachiocephalic artery;

a return pump coupled to the return inlet and adapted for pumping oxygenated blood through the return lumen with the occlusion catheter positioned therein at a flow rate sufficient to maintain arterial circulation with the heart arrested;

a source of cardioplegic fluid coupled to the infusion port; and

a venting pump coupled to the venting port for withdrawing fluids from the ascending aorta through the infusion lumen.