Selective organ cooling catheter and method of using the same

• US 6,096,068 A
• Filed: 06/23/1998
• Issued: 08/01/2000
• Est. Priority Date: 01/23/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Lasheras, Juan C., Dobak, John D. III
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/103,342
• Time in Patent Office: 770 Days
• Field of Search: 607/104, 607/105, 606/20-23, 165/DIG. 44, 165/46, 165/142, 165/179, 165/184, 604/101, 604/53
• US Class Current: 607/105
• 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 2018/0212 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 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A heat transfer device has first and second elongated, articulated segments, each having a turbulence-inducing exterior surface. A flexible joint connects the first and second elongated, articulated segments. An inner coaxial lumen is disposed within the first and second elongated, articulated segments. The inner coaxial lumen is capable of transporting a pressurized working fluid to a distal end of the first elongated, articulated segment.

Claims

1. A heat transfer device comprising:

first and second elongated segments, each segment having a turbulence-inducing irregular exterior surface;

a flexible articulating joint connecting the first and second elongated segments; and

a tubular conduit disposed substantially coaxially within the first and second elongated, articulated segments, the conduit having an inner lumen for transporting a pressurized working fluid to a distal end of the elongated, articulated segments.

2. The device of claim 1, wherein the first and second elongated, articulated segments each have an irregular interior surface to induce turbulence within a pressurized working fluid.

3. The device of claim 1, wherein irregularities on the turbulence-inducing exterior surface are shaped and sized to induce a turbulence intensity within a free stream blood flow greater than 0.05.

4. The device of claim 1, wherein the turbulence-inducing exterior surfaces comprise invaginations configured to have a depth which is greater than a thickness of a boundary layer of blood which develops within an arterial flow.

5. The device of claim 1, wherein the first and second elongated, articulated segments comprise alternating clockwise and counter-clockwise invaginations.

6. The device of claim 1, wherein the first and second elongated, articulated segments are formed from highly conductive material.

7. The device of claim 1 further comprising:

a coaxial supply catheter having an inner catheter lumen coupled to the inner coaxial lumen within the first and second elongated, articulated segments; and

a working fluid supply configured to dispense the pressurized working fluid and having an output coupled to the inner catheter lumen.

8. The device of claim 7, wherein the working fluid supply is configured to produce the pressurized working fluid at about 0°

C. and at a pressure below 5 atmospheres of pressure.

9. The device of claim 1, further comprising:

at least one additional elongated segment having a turbulence-inducing irregular exterior surface; and

at least one additional flexible articulating joint connecting the at least one additional elongated segment to one of the first and second elongated segments.

10. The device of claim 9, wherein the elongated, articulated segments comprise alternating clockwise and counter-clockwise invaginations.

11. The device of claim 1, wherein the turbulence-inducing exterior surface is a clot-inhibiting surface.

12. The device of claim 1, further comprising a stent coupled to a distal end of the elongated, articulated segments.

13. The device of claim 1, wherein the flexible joint comprises an axially compressible bellows section.

14. A method of treating an organ, comprising:

inserting a flexible, conductive heat transfer element into a feeder artery from a distal location; and

circulating a working fluid through the flexible, conductive heat transfer element to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

15. The method of claim 14, further comprising regulating the temperature and pressure of the working fluid to cause the flexible, conductive heat transfer element to absorb more than about 75 Watts of heat.

16. The method of claim 14, further comprising inducing turbulence within the free stream blood flow within the feeder artery.

17. The method of claim 16, further comprising inducing blood turbulence with a turbulence intensity greater than 0.05 within the feeder artery.

18. The method of claim 15, further comprising inducing blood turbulence throughout the period of the cardiac cycle within the feeder artery.

19. The method of claim 16, further comprising inducing blood turbulence throughout greater than 20% of the period of the cardiac cycle within the feeder artery.

20. The method of claim 14, further comprising inducing turbulent flow of the working fluid through the flexible, conductive heat transfer element.

21. The method of claim 18, wherein pressure of the working fluid is maintained below 5 atmospheres of pressure.

22. The method of claim 18, wherein the working fluid is aqueous.

23. A catheter for modifying the temperature of an organ, comprising:

a catheter shaft having first and second lumens therein;

a heat transfer tip adapted to transfer heat between blood surrounding the heat transfer tip and a working fluid circulated in through the first lumen and out through the second lumen; and

turbulence-inducing structures on the exterior of the heat transfer tip, the turbulence-inducing structures being shaped and sized to induce free stream turbulence in blood flowing within a blood vessel;

wherein the turbulence-inducing structures are shaped and sized to induce a turbulence intensity of at least about 0.05.

24. A catheter for modifying the temperature of an organ, comprising:

a catheter shaft having first and second lumens therein;

a heat transfer tip adapted to transfer heat between blood surrounding the heat transfer tip and a working fluid circulated in through the first lumen and out through the second lumen;

turbulence-inducing structures on the exterior of the heat transfer tip, the turbulence-inducing structures being shaped and sized to induce free stream turbulence in blood flowing within a blood vessel; and

turbulence-inducing structures on the interior of the heat transfer tip, the turbulence-inducing structures being shaped and sized to induce turbulence within the working fluid.

25. A catheter for modifying the temperature of an organ, comprising:

a catheter shaft having first and second lumens therein;

a heat transfer tip adapted to transfer heat between blood surrounding the heat transfer tip and a working fluid circulated in through the first lumen and out through the second lumen; and

turbulence-inducing structures on the exterior of the heat transfer tip, the turbulence-inducing structures being shaped and sized to induce free stream turbulence in blood flowing within a blood vessel;

wherein the turbulence-inducing structures comprise invaginations which have a depth sufficient to disrupt the free stream blood flow in the blood vessel.

26. A catheter for modifying the temperature of an organ, comprising:

a catheter shaft having first and second lumens therein;

a heat transfer tip adapted to transfer heat between blood surrounding the heat transfer tip and a working fluid circulated in through the first lumen and out through the second lumen; and

turbulence-inducing structures on the exterior of the heat transfer tip, the turbulence-inducing structures being shaped and sized to induce free stream turbulence in blood flowing within a blood vessel;

wherein the turbulence-inducing structures comprise staggered protrusions which have a height sufficient to disrupt the free stream flow of blood in the blood vessel.

27. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element; and

cooling blood in the feeding artery by contact with the cooled heat transfer element.

28. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element;

cooling blood in the feeding artery by contact with the cooled heat transfer element; and

cooling the organ by flow of the cooled blood through the feeding artery while maintaining the core body temperature at a substantially constant level.

29. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element;

cooling blood in the feeding artery by contact with the cooled heat transfer element; and

cooling the organ by flow of the cooled blood through the feeding artery such that the organ temperature decreases substantially prior to reduction of the core body temperature.

30. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element, the working fluid being a liquid at temperatures in the range of about zero degrees Celsius to thirty-five degrees Celsius;

cooling blood in the feeding artery by contact with the cooled heat transfer element; and

cooling the organ by flow of the cooled blood through the feeding artery while maintaining the core body temperature at a substantially constant level.

31. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element, the working fluid being a liquid at temperatures in the range of about zero degrees Celsius to thirty-five degrees Celsius;

cooling blood in the feeding artery by contact with the cooled heat transfer element; and

cooling the organ by flow of the cooled blood through the feeding artery such that the organ temperature decreases substantially prior to reduction of the core body temperature.

32. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof, the flexible metallic heat transfer element having at least one external flow-mixing feature disposed thereon;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element;

cooling blood in the feeding artery by contact with the cooled heat transfer element, the cooling enhanced by the external flow-mixing feature; and

cooling the organ by flow of the cooled blood through the feeding artery while maintaining the core body temperature at a substantially constant level.

33. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof, the flexible metallic heat transfer element having at least one external flow-mixing feature disposed thereon;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element;

cooling blood in the feeding artery by contact with the cooled heat transfer element, the cooling enhanced by the external flow-mixing feature; and

cooling the organ by flow of the cooled blood through the feeding artery such that the organ temperature decreases substantially prior to reduction of the core body temperature.

34. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof, the flexible metallic heat transfer element having at least one external flow-mixing feature disposed thereon;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element, the working fluid being a liquid at temperatures in the range of about zero degrees Celsius to thirty-five degrees Celsius; and

cooling blood in the feeding artery by contact with the cooled heat transfer element, the cooling enhanced by the external flow-mixing feature.

35. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof, the flexible metallic heat transfer element having at least one external flow-mixing feature disposed thereon;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element, the working fluid being a liquid at temperatures in the range of about zero degrees Celsius to thirty-five degrees Celsius;

cooling blood in the feeding artery by contact with the cooled heat transfer element, the cooling enhanced by the external flow-mixing feature; and

cooling the organ by flow of the cooled blood through the feeding artery while maintaining the core body temperature at a substantially constant level.

36. A method of selectively inducing at least partial hypothermia in an organ of a patient, comprising:

providing a catheter with a flexible metallic heat transfer element disposed at a distal end thereof, the flexible metallic heat transfer element having at least one external flow-mixing feature disposed thereon;

inserting the catheter and heat transfer element into the vascular system of a patient to place at least a portion of the heat transfer element in a feeding artery of an organ;

circulating a working fluid through the catheter and through the heat transfer element to lower the temperature of the heat transfer element, the working fluid being a liquid at temperatures in the range of about zero degrees Celsius to thirty-five degrees Celsius;

cooling blood in the feeding artery by contact with the cooled heat transfer element, the cooling enhanced by the external flow-mixing feature; and

cooling the organ by flow of the cooled blood through the feeding artery such that the organ temperature decreases substantially prior to reduction of the core body temperature.

37. A selective organ heat transfer device, comprising:

a flexible catheter capable of insertion to a selected feeding artery in the vascular system of a patient;

a plurality of heat transfer segments attached to a distal end of said catheter, at least one helical ridge and at least one helical groove formed on each of said plurality of heat transfer segments, said helical groove having a depth capable of inducing mixing in blood flow in the feeding artery, adjacent ones of said plurality of heat transfer segments disposed in close enough relation such that mixing arterial blood flow past one of said plurality of heat transfer segments does not relaminarize prior to passing an adjacent one of said plurality of heat transfer segments;

a bellows disposed between each of said plurality of heat transfer segments; and

an inner tube disposed within each of said plurality of heat transfer segments and within each of said bellows, said inner tube being connected in fluid flow communication with an inner tube within said catheter.

38. A selective organ heat transfer device, comprising:

a flexible catheter capable of insertion to a selected vessel in the vascular system of a patient;

at least one heat transfer segment attached to a distal end of said catheter, said heat transfer segment having at least one mixing-inducing surface feature disposed thereon;

a bellows disposed adjacent and coaxial to said at least one heat transfer segment; and

an inner tube disposed within said at least one heat transfer segment and within said bellows, said inner tube being connected in fluid flow communication with an inner tube within said catheter.