System for cardiac procedures

• US 5,769,812 A
• Filed: 10/16/1996
• Issued: 06/23/1998
• Est. Priority Date: 07/16/1991
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Nguyen, A. T.
• Application Number:
  US08/732,076
• Time in Patent Office: 615 Days
• Field of Search: 604/418, 604/30, 604/35, 604/52, 604/53, 604/96-103, 604/902, 606/192, 606/194, 600/18, 128/772
• US Class Current: 604/4.01
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• 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: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• 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 method of delivering cardioplegia to a patient'"'"'s heart and placing the patient on cardiopulmonary bypass, comprising the steps of:

providing an aortic occlusion catheter having an occluding member, a lumen, and an outlet coupled to the lumen, the outlet being positioned distal to the occluding member, the occluding member being sized to occlude a patient'"'"'s ascending aorta;

passing the aortic occlusion catheter through a peripheral artery of a patient so that the occluding member is positioned in the ascending aorta;

coupling the lumen to a source of cardioplegic fluid;

passing cardioplegic fluid from the source of cardioplegic fluid through the lumen and out the outlet thereby stopping heart contractions;

providing a coronary sinus catheter having an occluding member, a distal end, a lumen and an outlet coupled to the lumen, the occluding member being configured to occlude the patient'"'"'s coronary sinus;

passing the coronary sinus catheter through a peripharal vein and into the patient'"'"'s right atrium;

inserting the distal end of the coronary sinus catheter into the patient'"'"'s coronary sinus;

occluding the patient'"'"'s coronary sinus with the occluding member of the coronary sinus catheter; and

delivering a fluid through the coronary sinus catheter and into the patient'"'"'s coronary sinus through the lumen.

2. The method of claim 1, wherein:

the coronary sinus catheter passing step is carried out with the peripheral vein being the patient'"'"'s internal jugular vein; and

the aortic occlusion catheter passing step is carried out with the catheter extending through the patient'"'"'s fermoral artery.

3. The method of claim 1, further comprising the steps of:

passing an endovascular vent through the patient'"'"'s tricuspid and pulmonary valves, the vent including a lumen having an outlet positioned in the patient'"'"'s pulmonary artery when the vent extends through the tricuspid and pulmonary valves; and

withdrawing blood from the patient'"'"'s pulmonary artery through the lumen of the vent.

4. A method of arresting a patient'"'"'s heart and venting blood from the pulmonary artery, comprising the steps of:

providing an aortic occlusion catheter having an occluding member, a lumen, and an outlet coupled to the lumen, the outlet being positioned distal to the occluding member, the occluding member being sized to occlude a patient'"'"'s ascending aorta;

passing the aortic occlusion catheter through a peripheral artery of a patient so that the occluding member is positioned in the patient'"'"'s ascending aorta;

coupling the lumen of the aortic occlusion catheter to a source of cardioplegic fluid;

passing cardioplegic fluid from the source of cardioplegic fluid through the lumen and out the outlet thereby stopping heart contractions;

passing a vent through a peripheral vein in the patient and through the patient'"'"'s tricuspid and pulmonary valves, the vent including an opening having an outlet positioned in the pulmonary artery; and

withdrawing blood from the patient'"'"'s pulmonary artery through the vent.

5. The method of claim 4, wherein:

the vent passing step is carried out with the vent having means for directing a distal end of the vent through the patient'"'"'s tricuspid and pulmonary valves.

6. The method of claim 4, wherein:

the vent passing step is carried out with the peripheral vein being the patient'"'"'s internal jugular vein and

the catheter passing step is carried out with the catheter extending through the patient'"'"'s femoral artery.