Indwelling heat exchange catheter

• US 6,589,271 B1
• Filed: 12/13/2001
• Issued: 07/08/2003
• Est. Priority Date: 04/21/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Alsius Corporation
• Inventors: Adzich, Vaso, Collins, Kenneth A., Barker, Peter, Worthen, William J., Evans, Scott M., Tzeng, Elbert, Balding, David P., Pompa, Hortensia, Winter, Suzanne C.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/015,505
• Time in Patent Office: 572 Days
• Field of Search: 607/104-106, 607/113, 606/20-23, 606/27-28, 604/113
• US Class Current: 607/105
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2007/0056 for cooling
• 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
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/39044 in combination with cardiopulmonary resuscitation [CPR] therapy

Abstract

Catheters adapted to exchange heat with a body fluid flowing through a body conduit employ helical elongate lumens for heat transfer with the body fluid. The helical elongate lumen of a catheter forms multiple turns extending longitudinally of a portion of the catheter with the turns each being bonded to the catheter along a fraction of the length of the turn. The length of the lumen and its orientation in each turn has the lumen otherwise displaced over a major portion of its length from the elongate body. The turns of the helical lumen can be arranged in sets having different lengths to encounter all areas of the flow. One or more infusion lumens may also extend to an infusion port or ports. The helical elongate lumen is defined by an elongate, thin-walled element. This lumen is in fluid communication with a heater/chiller supplying a working fluid for heat transfer through the wall of the elongate element defining the helical elongate lumen. A proximal hub may be associated with the catheter to establish at least one suture anchor and to receive the heater/chiller flow through input and output lumens associated with the catheter and in fluid communication with the helical elongate lumens. The elongated lumens may also be arranged in non-helical arrangements such as in a semi-circular configuration, a figure-eight loop configuration or a random loop configuration.

Claims

1. A catheter adapted to exchange heat with a body fluid flowing through a body conduit, the catheter comprising

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming multiple turns, each turn of a plurality of the multiple turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

2. The catheter of claim 1, the lengths of the turns of the plurality of the turns being substantially equal.

3. The catheter of claim 1, the turns of the plurality of the turns being of two sets, the lengths of the first set being equal, the lengths of the second set being equal and the lengths of the first set being unequal with the lengths of the second set.

4. The catheter of claim 1, the elongate body lying within the plurality of the turns.

5. The catheter of claim 4, each turn of the plurality of the turns bonded along a fraction of the length at the elongate body being at only one location.

6. A catheter adapted to exchange heat with a body fluid flowing through a body conduit, the catheter comprising

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming a helix of multiple turns and extending longitudinally of the elongate body, each turn of a plurality of the turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

7. The catheter of claim 6, the lengths of the turns of the plurality of the turns being substantially equal.

8. The catheter of claim 6, the turns of the plurality of the turns being of two sets, the lengths of the first set being equal, the lengths of the second set being equal and the lengths of the first set being unequal with the lengths of the second set.

9. The catheter of claim 6, the elongate body lying within the plurality of the turns.

10. The catheter of claim 9, each turn of the plurality of the turns bonded along a fraction of the length at the elongate body being at only one location.

11. The catheter of claim 6 further comprising an infusion lumen extending with the at least one input lumen and the at least one output lumen.

12. The catheter of claim 11, the infusion lumen being through the elongate body.

13. The catheter of claim 12, one of the at least one input lumen and the at least one output lumen being through the elongate body.

14. The catheter of claim 12, at least one of the at least one input lumen being through the elongate body.

15. The catheter of claim 6, one of the at least one input lumen and the at least one output lumen being through the elongate body.

16. The catheter of claim 15, the at least one input lumen being through the elongate body.

17. The catheter of claim 6, each turn of the plurality of turns having a pitch substantially shorter than the lengths.

18. The catheter of claim 6, the at least one input lumen and the at least one output lumen extending within the elongate body.

19. The catheter of claim 6, the at least one elongate element being thin-walled and collapsible under fluid pressure of the body fluid with the heat transfer lumen at atmospheric pressure.

20. The catheter of claim 6, the at least one elongate element and the at least one input lumen having substantially equal cross-sectional areas.

21. A catheter adapted to exchange heat with a body fluid flowing through a body conduit, the catheter comprising

an elongate body;

an input lumen;

an output lumen;

an elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, the heat transfer lumen being in fluid communication with the input lumen at the first end and in fluid communication with the output lumen at the second end, the elongate element further including a first portion between the first and second ends forming a helix of multiple turns extending longitudinally of the elongate body, the elongate element and the input lumen having substantially equal cross-sectional areas, a plurality of the turns each forming a loop area substantially greater than the major cross-sectional dimension of the elongate body when inflated.

22. The catheter of claim 21, the plurality of the turns each having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

23. The catheter of claim 21, the lengths of each of the plurality of the turns being substantially equal.

24. The catheter of claim 21, the elongate body lying within the plurality of the turns.

25. The catheter of claim 24, the plurality of the turns each being bonded only at one location to the elongate body.

26. The catheter of claim 21 further comprising an infusion lumen extending with the input lumen and the output lumen.

27. The catheter of claim 21, the elongate element being thin-walled and collapsible under fluid pressure of the body fluid with the heat transfer lumen at atmospheric pressure.

28. A catheter adapted to exchange heat with a body fluid flowing through a body conduit, the catheter comprising

an elongate body allowing fluid flow therethrough;

a helical elongate element extending about at least a part of the body and in fluid communication therewith, the helical elongate element extending such that the body fluid can flow between the element and the body to exchange heat with the working fluid.

29. The catheter of claim 28, the elongate body including a supply lumen in fluid communication with the helical elongate element.

30. The catheter of claim 29, the supply lumen extending distally and the helical elongate element extending proximally from the supply lumen.

31. The catheter of claim 28, the helical elongate element extending in turns about the elongate body, at least two turns having bond points and being bonded at the bond points to the elongate body.

32. The catheter of claim 28 further comprising

infusion lumens extending through the elongate body;

infusion ports in fluid communication with the infusion lumens, respectively, and displaced axially of the elongate body.

33. The catheter of claim 28 further comprising a proximal hub engaged with the elongate body and establishing at least one suture anchor.

34. The catheter of claim 33 further comprising a heater/chiller communicating with the elongate body through the proximal hub to heat/cool the flow therethrough.

35. A method for treating cardiac arrest in a patient comprising

defibrillating the patient;

lowering the patient'"'"'s temperature using at least one catheter placed in the venous system of the patient by circulating coolant through the catheter while the catheter is positioned in the patient'"'"'s central venous system, such that the coolant does not enter the patient'"'"'s bloodstream, wherein the catheter comprises;

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming multiple turns, each turn of a plurality of the multiple turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

36. The method of claim 35 further comprising administering a precordial thump to the patient.

37. The method of claim 35 further comprising ventilating the patient.

38. A method for treating cardiac arrest in a patient comprising

administering a precordial thump to the patient;

lowering the patient'"'"'s temperature using at least one catheter placed in the venous system of the patient by circulating coolant through the catheter while the catheter is positioned in the patient'"'"'s central venous system, such that the coolant does not enter the patient'"'"'s bloodstream, wherein the catheter comprises;

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming multiple turns, each turn of a plurality of the multiple turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

39. A method for treating myocardial infarction in a patient comprising

identifying the patient has myocardial infarction;

lowering the patient'"'"'s temperature using at least one catheter placed in the venous system of the patient by circulating coolant through the catheter while the catheter is positioned in the patient'"'"'s central venous system, such that the coolant does not enter the patient'"'"'s bloodstream, wherein the catheter comprises;

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming multiple turns, each turn of a plurality of the multiple turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body.

40. The method of claim 39 further comprising selecting a target temperature.

41. The method of claim 40 further comprising

monitoring the target temperature; and

adjusting the heater/chiller unit to provide coolant at a coolant temperature in accordance with the target temperature.

42. A method for treating myocardial infarction in a patient comprising

identifying that the patient has myocardial infarction;

selecting a target temperature;

measuring the patient'"'"'s temperature;

lowering the patient'"'"'s temperature using at least one catheter placed in the venous system of the patient by circulating coolant through the catheter while the catheter is positioned in the patient'"'"'s central venous system, such that the coolant does not enter the patient'"'"'s bloodstream, wherein the catheter comprises;

an elongate body;

at least one input lumen;

at least one output lumen;

at least one elongate element including a heat transfer lumen extending longitudinally therethrough with first and second ends, each heat transfer lumen being in fluid communication with one of the at least one input lumen at the first end and in fluid communication with one of the at least one output lumen at the second end, each of the at least one elongate element further including a portion between the first and second ends forming multiple turns, each turn of a plurality of the multiple turns having a length, being bonded to the elongate body along a fraction of the length and being otherwise displaced from the elongate body;

adjusting the coolant temperature based on the patient'"'"'s temperature.

43. The method of claim 42 further comprising removing the catheter from the patient once the target temperature is reached.

44. The method of claim 42 wherein the catheter is inserted into the jugular vein.

45. The method of claim 42 wherein the catheter is inserted into the subclavian vein.

46. A method for ameliorating the effects of myocardial infarction (MI) in a patient, comprising

administering at least one antithrombotic agent to the patient;

advancing a catheter into the venous system of the patient; and

inducing mild or moderate hypothermia in the patient by circulating a working fluid through the catheter without the fluid contacting the blood.

47. A method for combating the effects of myocardial infarction, comprising

making a cooling catheter available to a cardiac interventionist;

instructing the cardiac interventionist to advance the catheter into the venous system of the patient upon presentation of symptoms of myocardial infarction; and

instructing the cardiac interventionist to initiate coolant flow through the catheter to induce hypothermia in the patient.

48. The method of claim 47, further comprising instructing the cardiac interventionist to administer at least one antithrombotic agent to the patient.