Medical procedure

• US 7,371,254 B2
• Filed: 09/03/2004
• Issued: 05/13/2008
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Dobak, John D. III
• Primary Examiner(s): Gibson; Roy D.
• Assistant Examiner(s): ROANE, AARON F
• Application Number:
  US10/934,096
• Publication Number:
  US 20050076924A1
• Time in Patent Office: 1,348 Days
• Field of Search: 607/96, 607104-107, 607/113
• US Class Current: 607/104
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/0288 during operations
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

The use of an intravascular cooling element to induce hypothermia in connection with a medical procedure. According to a first aspect of the present, invention, a coronary bypass procedure is conducted in which a patient'"'"'s blood is oxygenated with the patient'"'"'s lungs and in which blood is circulated using the patient'"'"'s heart or using an intracorporeal pump. The procedure preferably comprises: (a) positioning a heat transfer element in a blood vessel of a patient; (b) cooling the body of the patient to less than 35° C., more preferably 32±2° C., using the heat transfer element; and (c) forming a fluid communicating graft between an arterial blood supply and the coronary artery. The body of the patient is preferably heated to about 37° C. using the heat transfer element subsequent to the step of forming the fluid communicating graft. According to a further aspect of the invention, a hypothermic medical procedure is provided while a patient is in a conscious or semiconscious state, comprising (a) administering a beta-blocking drug to the patient; (b) delivering a heat transfer element to a blood vessel of the patient; and (c) cooling a region of the patient or the body of the patient to less than 35° C. using the heat transfer element.

Claims

1. A coronary bypass procedure comprising:

positioning a heat transfer element in a blood vessel of a patient, wherein the heat transfer element comprises;

an inlet lumen to introduce a circulating working fluid; and

an outlet lumen to extract a circulating working fluid, the outlet lumen having a helical shape to induce turbulence in blood flowing past the outlet lumen and in the working fluid;

cooling the body of the patient to less than 35°

C. using said heat transfer element; and

forming a fluid communicating graft between an arterial blood supply and the coronary artery;

wherein the patient'"'"'s blood is oxygenated with the patient'"'"'s lungs and wherein blood is circulated using the patient'"'"'s heart or using an intracorporeal pump.

2. The coronary bypass procedure of claim 1, wherein the heat transfer element absorbs at least 150 Watts of heat during cooling.

3. The coronary bypass procedure of claim 1, further comprising warming the body of the patient to about 37°

C. using said heat transfer element, subsequent to the step of forming the fluid communicating graft.

4. The coronary bypass procedure of claim 1, wherein the step of forming a fluid communicating graft between the arterial blood supply and the coronary artery is preformed on a beating heart during bradycardia of the heart.

5. The coronary bypass procedure of claim 1, wherein the heart is arrested or nearly arrested during at least a portion of the step of forming the fluid communicating graft.

6. The coronary bypass procedure of claim 5, wherein the heart is chemically arrested.

7. The coronary bypass procedure of claim 5, wherein the heart is electrically arrested.

8. The coronary bypass procedure of claim 5, wherein the patient'"'"'s circulation is supported with a pump positioned in the patient'"'"'s vasculature.

9. The coronary bypass procedure of claim 8, wherein the pump is at least partially positioned in the left ventricle.

10. The coronary bypass procedure of claim 9, wherein the pump is introduced through the femoral artery.

11. The coronary bypass procedure of claim 1, wherein the heartbeat is intermittently arrested and stimulated;

and wherein at least a portion of the step of forming the fluid communicating graft is carried out during periods of heartbeat arrest.

12. The coronary bypass procedure of claim 11, wherein the heart is chemically arrested and wherein the heartbeat is electrically stimulated.

13. The coronary bypass procedure of claim 12, wherein the heart is chemically arrested using one or more beta-blockers.

14. The coronary bypass procedure of claim 11, wherein the heart is electrically arrested and electrically stimulated.

15. The coronary bypass procedure of claim 1, wherein the heat transfer element is positioned in the venous vasculature.

16. The coronary bypass procedure of claim 15, wherein the heat transfer element is positioned in the inferior vena cava.

17. The coronary bypass procedure of claim 16, wherein the heat transfer element is introduced into the femoral vein.

18. The coronary bypass procedure of claim 17, wherein the heat transfer element is about 4 to 5 mm in diameter.

19. The catheter system of claim 1, wherein the inlet lumen and the outlet lumen are made of a flexible material.

20. The catheter system of claim 19, wherein the flexible material is rubber.

21. The catheter system of claim 19, wherein the flexible material is a material capable of undergoing inflation.

22. The catheter system of claim 1, further comprising more than one outlet lumen, each outlet lumen having a helical shape.

23. The catheter system of claim 1, wherein the working fluid is saline.

24. The catheter system of claim 1, wherein the helical shape of the outlet lumen is tapered when inflated.

25. The catheter system of claim 24, wherein the helical shape of the outlet lumen is segmentally tapered when inflated.

26. The catheter system of claim 1, wherein a radius of the inlet lumen decreases such that the inlet lumen is tapered when inflated.

27. The catheter system of claim 1, wherein a radius of the outlet lumen decreases such that the outlet lumen is tapered when inflated.

28. The catheter system of claim 1, wherein the helical shape of the outlet lumen is structured and shaped to have a geometry so as to induce turbulence within a free stream of blood flow when disposed in a blood vessel.

29. The catheter system of claim 1, wherein the inlet lumen is substantially straight.

30. The catheter system of claim 1, wherein the outlet lumen helically encircles the inlet lumen.

31. The coronary bypass procedure of claim 1, wherein the use of a cardiopulmonary bypass system and obstruction of the ascending aorta are avoided.

32. The coronary bypass procedure of claim 1, wherein the body of the patient is cooled to 32±

2°

C. using said heat transfer element.

33. The coronary bypass procedure of claim 6, wherein the heart is arrested using a beta-blocker.