Aortic Occlusion Catheter

• US 20130116654A1
• Filed: 11/08/2011
• Published: 05/09/2013
• Est. Priority Date: 11/08/2011
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Dehdashtian, Mark, Jimenez, Teodoro S. Jr., Boudewijn, Lex, Schulting, Edwin, Hayes, RB, Larsen, Amanda
• Application Number:
  US13/291,920
• Publication Number:
  US 20130116654A1
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: F04C 2270/0421 Controlled or regulated

Abstract

An cardioplegic fluid delivery catheter includes an expandable member for occluding the ascending aorta of a patient. A length of the catheter allows the distal end to be within the ascending aorta while the proximal end extends from a peripheral artery. The delivery catheter has a multi-lumen construction with a primary lumen extending configured to allow a cardioplegic fluid to be delivered to the aorta. Secondary lumens provide for balloon inflation and aortic root pressure monitoring. The delivery catheter includes a shaft having a pre-determined curve profile at a distal end of the delivery catheter. The pre-determined curve profile generally corresponds to the curve of the bottom surface of the aortic arch. The shaft may be eccentric to the expandable member such that retraction of the shaft causes a distal tip to be parallel within the ascending aorta.

Claims

1. A device for occluding a patient'"'"'s ascending aorta, comprising:

a hub having one or more ports;

an elongated body having opposing proximal and distal ends, the elongated body defining one or more lumens extending at least partially between the proximal and distal ends of the elongated body, and each of the one or more lumens being in fluid communication with at least one of the one or more ports of the hub, wherein the elongated body has a pre-configured, selectively actuated curve profile at least proximate the distal end of the elongated body; and

an expandable member at the distal end of the elongated body, the expandable member being selectively changeable between expanded and contracted states.

2. The device recited in claim 1, wherein the elongated body is a shaft.

3. The device recited in claim 1, wherein the elongated body is a multi-lumen extrusion.

4. The device recited in claim 3, wherein each of a plurality of lumens of the multi-lumen extrusion is in fluid with at least one of the one or more ports, the plurality of lumens collectively being configured for:

inflation of the expandable member;

cardioplegic fluid delivery;

cardiac characteristic monitoring; and

root venting.

5. The device recited in claim 1, wherein the elongated body has a distal tip that is enveloped by the expandable member while the expandable member is in a contracted state.

6. The device recited in claim 1, wherein the elongated body is not reinforced by a wire mesh or frame.

7. The device recited in claim 1, further comprising a core extending within one of the one or more lumens of the elongated body.

8. The device recited in claim 7, wherein the core is a wire having a tapered distal end.

9. The device recited in claim 7, wherein the core substantially defines the pre-configured, selectively actuated curve profile of the elongated body.

10. The device recited in claim 7, wherein the core is formed of a memory material, the memory material defining the pre-configured, selectively actuated curve profile of the elongated body.

11. The device recited in claim 10, wherein the memory material is selectively actuated at one or more temperatures.

12. The device recited in claim 11, wherein the memory material is selectively actuated at or near body temperature.

13. The device recited in claim 1, wherein the pre-configured, selectively actuated curve profile defines a curve radius of between about 15 and about 21 millimeters.

14. The device recited in claim 1, wherein the pre-configured, selectively actuated curve profile defines a curve radius of between about 17 and about 19 millimeters.

15. The device recited in claim 1, wherein the hub indicates a direction of the curve profile of the elongated body.

16. The device recited in claim 15, wherein an asymmetry of the hub indicates the direction of the curve profile.

17. A device for occluding a patient'"'"'s ascending aorta, comprising:

a hub;

an elongated shaft connected to the hub, the elongated shaft having opposing proximal and distal ends, the elongated body defining a plurality of lumens extending at least partially between the proximal and distal ends of the elongated shaft; and

an expandable member at least proximate the distal end of the elongated shaft, the expandable member being selectively changeable between expanded and contracted states, wherein in the expanded state, the expandable member defines a central axis offset from the elongated shaft, and has upper and lower surfaces of differing lengths.

18. The device recited in claim 17, wherein the shaft has an eccentricity between about 5% and about 36% relative to the central axis of the expandable member.

19. The device recited in claim 17, wherein the expandable member is elongated.

20. The device recited in claim 17, wherein the expandable member is substantially symmetrical about an axis separating distal and proximal portions of the expandable member, and substantially asymmetrical about the central axis.

21. The device recited in claim 17, wherein a distal tip of the elongated shaft is connected to a distal end of the expandable member, wherein an angle between the distal end of the expandable member and an upper surface of the expandable member is between about 13°

and about 20°

.

22. The device recited in claim 17, wherein the elongated shaft includes or is attached to a distal tip, the distal tip being substantially enclosed within the expandable member.

23. The device recited in claim 22, wherein the expandable member extends distally relative to the distal tip.

24. The device recited in claim 17, wherein at least two of said plurality of lumens are open at a distal tip of the elongated shaft.

25. The device recited in claim 17, wherein the elongated shaft has a pre-determined curve profile.

26. The device recited in claim 25, wherein the pre-determined curve profile is selectively activated.

27. The device recited in claim 17, wherein the pre-determined curve profile generally corresponds to a curve of an interior surface of the patient'"'"'s aortic arch.

28. A method of delivering antegrade cardioplegic fluid to a heart of a patient, the method comprising:

introducing at least a distal end of an antegrade cardioplegic delivery catheter into a peripheral artery of the patient;

advancing the distal end of the antegrade cardioplegic delivery catheter from the peripheral artery into an ascending aorta of the heart of the patient, wherein advancing the distal end of the antegrade cardioplegic delivery catheter changing a curve profile of the delivery catheter to a predetermined curve profile configured to generally correspond to a bottom surface of an aortic arch of the patient;

occluding the ascending aorta with an occlusion device of the antegrade cardioplegic delivery catheter;

positioning a distal tip of the antegrade cardioplegic delivery catheter in a generally parallel alignment within the ascending aorta; and

delivering a fluid to the heart through a lumen of the antegrade cardioplegic delivery catheter.

29. The method recited in claim 28, further comprising after occluding the ascending aorta with the occlusion device, removing slack within the antegrade cardioplegic delivery catheter by retracting the antegrade cardioplegic delivery catheter.

30. The method recited in claim 29, wherein positioning the distal tip in a generally parallel alignment within the ascending aorta occurs following retraction of the antegrade cardioplegic delivery catheter.

31. The method recited in claim 29, wherein removing slack includes removing all slack by retracting less than about 3 centimeters of the antegrade cardioplegic delivery catheter.

32. The method recited in claim 28, wherein the predetermined curve profile has a radius of curvature between about 15 millimeters and about 21 millimeters.

33. The method recited in claim 28, wherein the occlusion device includes a balloon, wherein the antegrade cardioplegic delivery catheter is eccentric relative to the balloon.

34. The method recited in claim 28, wherein the occlusion device is asymmetrical relative to a central axis extending between distal and proximal ends of the occlusion device.

35. The method recited in claim 28, wherein the antegrade cardioplegic delivery catheter includes a core wire, the core wire being at least partially formed of a memory material, the memory material being configured to remember the predetermined curve profile upon selective activation of the memory material.

36. The method recited in claim 35, further comprising selectively activating the memory material by heating the core wire to about body temperature.