System for cardiac procedures

• US 5,702,368 A
• Filed: 05/30/1995
• Issued: 12/30/1997
• 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: Machold, Timothy R., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/453,333
• Time in Patent Office: 945 Days
• Field of Search: 606/194, 606/192, 604/96, 604/97, 604/43, 604/171, 604/101, 604/102, 604/4, 604/35
• US Class Current: 604/171
• 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 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• 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. In an endovascular system comprising:

an occluding member for partitioning a patient'"'"'s ascending aorta between the coronary ostia and the brachiocephalic artery, a lumen coupled to a source of cardioplegic fluid for infusing cardioplegic fluid into the patient'"'"'s ascending aorta, a blood flow lumen, and an outflow port at a distal end in fluid communication with the blood flow lumen for infusing oxygenated blood into the patient'"'"'s arterial system, the blood flow lumen being coupled to a source of oxygenated blood, the lumen and occluding member being slidably and separably coupled to the blood flow lumen so that the lumen and occluding member may be removed and replaced when the outflow port is positioned in a patient'"'"'s artery, the lumen being carried by a catheter and the blood flow lumen being carried by a bypass cannula, the bypass cannula having a proximal end and a hemostasis valve, the distal end of the bypass cannula being configured for introduction into an artery of a patient, the catheter passing through the hemostasis valve and the blood flow lumen and being slidably and separably coupled to the bypass cannula, the catheter having a distal end, a proximal end, and an outlet fluidly coupled to the inner lumen, the occluding member being positioned proximal to the outlet.

2. In the system of claim 1, wherein the catheter includes a pressure lumen for measuring a pressure in the patient'"'"'s ascending aorta.

3. In the system of claim 1, further comprising a venous cannula configured to withdraw blood from the patient.

4. In the system of claim 1, wherein the blood flow lumen is configured to flow blood at a rate of at least 4 liters/minute at a pressure of less than about 250 mmHg when the catheter is positioned in the blood flow lumen.

5. In the system of claim 1, wherein the bypass cannula has an outer diameter of less than about 10 mm.

6. In the system of claim 1, wherein the catheter has a length of at least about 80 cm to facilitate transluminal positioning from a femoral artery to the ascending aorta.

7. In the system of claim 1, wherein the catheter includes an inflation lumen and the occluding member is a balloon.

8. In the system of claim 1, wherein the catheter has a three-lumen design provided by a T-shaped member within a cylindrical tube.