Retrograde delivery catheter and method for inducing cardioplegic arrest

• US 5,558,644 A
• Filed: 01/12/1995
• Issued: 09/24/1996
• 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: Stevens, John H., Evard, Philip C., Boyd, Stephen W., Adams, Craig L.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/372,741
• Time in Patent Office: 621 Days
• Field of Search: 604/96-103, 604/118, 604/4, 606/192-196, 600/18
• US Class Current: 604/102.02
• 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

A 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 retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising:

a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally through a patient'"'"'s peripheral vein when the distal end is positioned in the coronary sinus;

an expandable member near the distal end configured to occlude the patient'"'"'s coronary sinus; and

a delivery lumen having an inlet port at the proximal end and an outlet port distal to the expandable member, the delivery lumen being configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm Hg;

the distal end of the shaft having a shape configured to position the expandable member in the patient'"'"'s coronary sinus when the proximal end of the shaft extends through the patient'"'"'s peripheral vein.

2. The retrograde delivery catheter of claim 1 wherein the delivery lumen has a cross-sectional area of at least about 4 mm² between the proximal and distal ends.

4. The retrograde delivery catheter of claim 1 further comprising a pressure lumen extending from the proximal end, the pressure lumen having a pressure port distal to the expandable member.

12. The retrograde delivery catheter of claim 1 wherein at least a portion of the shaft is radiopaque to facilitate positioning the delivery catheter under fluoroscopy.

13. The retrograde delivery catheter of claim 1 further comprising an inflation lumen extending through the shaft, the expandable member including an inflatable balloon having an interior in communication with the inflation lumen.

3. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising:

a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally through a patient'"'"'s peripheral vein when the distal end is positioned in the coronary sinus;

an expandable member positioned near the distal end and configured to occlude the patient'"'"'s coronary sinus; and

a delivery lumen having an inlet port at the proximal end to and an outlet port distal to the expandable member;

wherein a distal portion of the shaft has an outer diameter of less than about 4.6 mm, the distal portion having a length of at least 50 cm proximal to the distal end.

5. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising:

a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally to the peripheral vein when the distal end is positioned in the coronary sinus;

an expandable member near the distal end configured to occlude the coronary sinus; and

a delivery lumen having an inlet port at the proximal end and an outlet port distal to the expandable member, the delivery lumen being configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm.

the shaft having at least a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being in a range of about 20°

to 70°

from a longitudinal axis of a proximal portion of the retrograde delivery catheter proximal to the first bend.

10. The retrograde delivery catheter of claim 5 wherein the expandable member is attached to the shaft distal to the first bend.

11. The retrograde delivery catheter of claim 10 wherein the expandable member is at least about 15 mm from the distal end.

6. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising;

a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally through a patient'"'"'s peripheral vein when the distal end is positioned in the coronary sinus;

an expandable member near the distal end configured to occlude the coronary sinus; and

a delivery lumen having an inlet port at the proximal end and an outlet port distal to the expandable member;

the shaft having at least a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being between 20 mm and 40 mm from the distal end.

7. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally to the peripheral vein when the distal end is positioned in the coronary sinus, an expandable member near the distal end configured to occlude the coronary sinus, and a delivery lumen having an inlet port at the proximal end and an outlet port distal to the expandable member, the shaft having at least a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being between 20 mm and 40 mm from the distal end, the shaft having a second bend distal to the first bend.

8. The retrograde delivery catheter of claim 7 wherein the second bend is between 3 mm and 10 mm from the distal end.

9. The retrograde delivery catheter of claim 7 wherein a distal portion of the shaft distal to the second bend is between about 50°

and 110°

relative to the proximal portion of the shaft.

14. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally to the peripheral vein when the distal end is positioned in the coronary sinus, an expandable member near the distal end configured to occlude the coronary sinus, a delivery lumen having an inlet port at the proximal end and an outlet port distal to the expandable member, the delivery lumen being configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm, an inflation lumen extending through the shaft, the expandable member including an inflatable balloon having an interior in communication with the inflation lumen, the balloon being configured to be inflatable to a size larger than the coronary sinus, the retrograde delivery catheter further including pressure limiting means to maintain inflation pressure of the balloon below a predetermined value selected to avoid injury to coronary sinus tissue.

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

a retrograde delivery catheter having a distal end, a proximal end, a delivery lumen having an inlet port at the proximal end and an outlet port at the distal end, and an expandable member near the distal end configured to occlude the coronary sinus of a patient when expanded, the retrograde delivery catheter having sufficient length and flexibility so that the distal end may be positioned in the patient'"'"'s coronary sinus with the proximal end extending intraluminally to a peripheral vein, and the delivery lumen being configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm Hg;

a venous cannula configured for introduction into a peripheral vein of the patient for withdrawing blood therefrom;

means for oxygenating the blood withdrawn from the peripheral vein, the oxygenating means being fluidly coupled to the venous cannula;

an arterial cannula configured for introduction into a peripheral artery for returning the blood from the oxygenating means to the peripheral artery, the arterial cannula being fluidly coupled to the oxygenating means, the peripheral artery being in communication with the aorta;

venting means for withdrawing fluid from the heart of the patient; and

occlusion means for preventing blood flow from the arterial cannula into the coronary arteries of the patient while allowing blood flow from the arterial cannula into the brachiocephalic artery of the patient.

16. The system of claim 15 wherein the delivery lumen has a cross-sectional area of no less than about 4 mm² between the proximal and distal ends.

17. The system of claim 15 wherein the retrograde delivery catheter has a distal portion with an outer diameter of less than about 4.6 mm, the distal portion comprising a length of the shaft from the distal end to at least 30 cm proximal to the distal end.

18. The system of claim 15 wherein the length of the retrograde delivery catheter between the proximal and distal ends is at least about 50 cm.

19. The system of claim 15 wherein the retrograde delivery catheter has a first and a second bend near the distal end to facilitate positioning the distal end in the coronary sinus.

20. The system of claim 19 wherein the first bend is in a range of about 20°

to 70°

relative to a longitudinal axis of a proximal portion of the retrograde delivery catheter.

21. The system of claim 19 wherein the first bend is between 20 mm and 40 mm from the distal end.

22. The system of claim 21 wherein the second bend is between 3 and 10 mm from the distal end.

23. The system of claim 20 wherein a distal portion of the shaft distal to the second bend is between about 50°

and 110°

relative to the proximal portion of the shaft.

24. The retrograde delivery catheter of claim 18 wherein the expandable member is disposed at least about 13 mm from the distal end.

25. The retrograde delivery catheter of claim 18 wherein at least a portion of the shaft is radiopaque to facilitate positioning the delivery catheter under fluoroscopy.

26. The system of claim 15 wherein the occlusion means comprises an endoaortic catheter having a distal end, a proximal end, a length selected to facilitate positioning the distal end in the aorta between the coronary arteries and the brachiocephalic artery with the proximal end extending transluminally to a peripheral artery, and an expandable member at the distal end configured to occlude an aortic lumen in the aorta between the coronary arteries and the brachiocephalic artery when expanded.

27. The system of claim 15 wherein the venting means comprises a lumen and an occluding member catheter, the lumen having a port distal to the occluding member for withdrawing fluid from the aorta.

28. The system of claim 15 wherein the venting means comprises a venting catheter having a distal end, a proximal end, and a venting lumen having a port at the distal end and a port at the proximal end, the venting catheter being configured to allow the distal end to be positioned in a pulmonary artery with the proximal end extending transluminally through the heart to a peripheral vein.

29. A retrograde delivery catheter adapted to be introduced into a peripheral vein and advanced into a coronary sinus of a patient'"'"'s heart for retrograde delivery of a fluid into a coronary vasculature, the retrograde delivery catheter comprising:

a flexible, elongated shaft having a proximal end and a distal end, the shaft having sufficient length and flexibility so that the proximal end may extend intraluminally through a patient'"'"'s peripheral vein when the distal end is positioned in the coronary sinus;

an expandable member positioned near the distal end and configured to occlude the patient'"'"'s coronary sinus;

a delivery lumen having an inlet port at the proximal end to and an outlet port distal to the expandable member; and

a pressure limiting device coupled to the delivery lumen, the pressure limiting device limiting an inflation pressure of the balloon below a predetermined value selected to avoid injury to the coronary sinus.