Retrograde delivery catheter and method for inducing cardioplegic arrest

• US 5,913,842 A
• Filed: 02/11/1998
• Issued: 06/22/1999
• 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: Boyd, Stephen W., Stevens, John H., Evard, Philip C., Adams, Craig L.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US09/022,066
• Time in Patent Office: 496 Days
• Field of Search: 604/28, 604/27, 604/49, 604/96, 606/192-194, 600/18
• US Class Current: 604/28
• 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 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• 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

retrograde delivery catheter includes at its distal end a balloon configured to occlude the coronary sinus of a patient'"'"'s heart, and has a length and flexibility which allow the distal end to be positioned in the coronary sinus with the proximal end extending transluminally to a peripheral vein such as an internal jugular vein and out of the body through a puncture therein. The delivery catheter has a delivery lumen extending between its proximal and distal ends which is configured to allow a cardioplegic fluid to be delivered at a flow rate of at least 200 ml/min with a pump pressure less than 300 mm Hg, thereby allowing cardioplegic arrest to be maintained using a blood cardioplegic fluid without causing excessive hemolysis. In a method of inducing cardioplegic arrest according to the invention, the patient is placed on cardiopulmonary bypass, the coronary arteries are isolated from remainder of the arterial system, and the delivery catheter is positioned transluminally in the coronary sinus from a peripheral vein. A cardioplegic fluid is then delivered to the coronary sinus through the delivery catheter at a flow rate of at least 200 ml/min and a pump pressure less than 300 mm Hg. The heart may be vented by withdrawing blood from the pulmonary artery through a catheter introduced through a peripheral vein, or withdrawing blood from the aortic root through an aortic catheter introduced through a peripheral artery.

Claims

1. A method of inducing cardioplegic arrest of a patient'"'"'s heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising:

withdrawing blood from a peripheral vein;

oxygenating the withdrawn blood;

returning the oxygenated blood to a peripheral artery;

isolating the coronary arteries from the oxygenated blood returned to the peripheral artery;

venting fluid from the heart;

positioning a retrograde delivery catheter in a peripheral vein and advancing the retrograde delivery catheter transluminally into a coronary sinus in the heart; and

delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the retrograde delivery catheter to the coronary sinus at a flow rate of at least 200 m/min. and at a pump pressure of less than 300 mm Hg.

2. The method of claim 1 wherein the cardioplegic fluid has a viscosity of at least about 3.0 centipoise.

3. The method of claim 1 wherein the cardioplegic fluid comprises a mixture of blood and a cardioplegic agent in a ratio of at least about two parts blood to one part cardioplegic agent by volume.

4. The method of claim 3 wherein the cardioplegic agent comprises an aqueous KCl solution.

5. The method of claim 1 wherein the cardioplegic fluid is cooled to a temperature of 3°

C.-10°

C. before delivery to the coronary sinus.

6. The method of claim 1 further comprising expanding an expandable member on a distal end of the retrograde delivery catheter to occlude the coronary sinus during the step of delivering cardioplegic fluid.

7. The method of claim 1 wherein the step of positioning comprises advancing the retrograde delivery catheter over a guidewire slidably positioned in a lumen in the retrograde delivery catheter.

8. The method of claim 1 wherein the retrograde delivery catheter has at least two bends in a distal portion thereof, the method further comprising straightening the two bends during the step of positioning.

9. The method of claim 1 wherein the step of positioning comprises using fluoroscopy to observe the position of the retrograde delivery catheter in the heart.

10. The method of claim 9 wherein the positioning step further comprises injecting a radiopaque contrast fluid through the retrograde delivery catheter to determine the position thereof using fluoroscopy.

11. The method of claim 1 wherein the step of isolating comprises positioning an endoaortic catheter in a peripheral artery, advancing the endoaortic catheter into the aorta, and expanding an expandable member on the distal end of the endoaortic catheter to occlude an aortic lumen between the coronary arteries and the brachiocephalic artery.

12. The method of claim 11 wherein the step of venting comprises withdrawing fluid from the aortic lumen upstream of the expandable member through a lumen in the endoaortic catheter.

13. The method of claim 1 wherein the step of venting comprises withdrawing fluid from a pulmonary artery through a venting catheter positioned in a peripheral vein and extending translurninally through the heart into the pulmonary artery.