Selective organ cooling apparatus and method

• US 6,471,717 B1
• Filed: 05/12/2000
• Issued: 10/29/2002
• Est. Priority Date: 03/24/1998
• 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): GIBSON, ROY DEAN
• Application Number:
  US09/570,075
• Time in Patent Office: 900 Days
• Field of Search: 607/104, 607/105, 606/21-24, 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 2018/0022 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 2007/126 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: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter

Abstract

A selective organ heat transfer device with deep irregularities in a turbulence-inducing exterior surface. The device can have a plurality of elongated, articulated segments, each having a turbulence-inducing exterior surface. A flexible joint connects adjacent elongated, articulated segments. An inner lumen is disposed within the heat transfer segments. The inner lumen is capable of transporting a pressurized working fluid to a distal end of the heat transfer element.

Claims

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

a catheter shaft having first and second lumens therein;

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

structures on the exterior of the heat transfer tip shaped and sized to induce a turbulence intensity of at least 0.05 in blood flowing around the heat transfer tip.

2. A selective organ heat transfer device, comprising:

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

a single heat transfer segment attached to a distal end of said catheter; and

a helical ridge and a helical groove formed on said single heat transfer segment.

3. The heat transfer device recited in claim 2, further comprising an inner tube disposed within said heat transfer segment, said inner tube being connected in fluid flow communication with an inner tube within said catheter.

4. A selective organ heat transfer device, comprising:

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

a plurality of heat transfer segments attached to a distal end of said catheter;

a flexible joint disposed between each pair of said plurality of heat transfer segments, such that the local convective heat transfer coefficient of each said segment is greater than that of each said flexible joint.

5. The heat transfer device recited in claim 4, further comprising an inner tube disposed within said heat transfer segments, said inner tube being connected in fluid flow communication with an inner tube within said catheter.

6. 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 heat transfer element attached to a distal end of said catheter, said heat transfer element comprising a plurality of heat transfer segments;

a flexible joint connecting each of said heat transfer segments to adjacent said heat transfer segments;

a helical ridge and a helical groove formed on each said heat transfer segment, said helical ridge and helical groove being shaped and arranged to create mixing in surrounding fluid; and

an inner tube disposed within said heat transfer element, said inner tube being connected in fluid flow communication with an inner tube within said catheter;

wherein said helical ridge on each said heat transfer segment has an opposite helical twist to said helical ridges on adjacent said heat transfer segments.

7. 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 heat transfer element attached to a distal end of said catheter, said heat transfer element having an exterior diameter substantially less than the inner diameter of the selected feeding artery;

a plurality of protrusions axially staggered along an exterior surface of said heat transfer element, said protrusions having a height at least equal to the boundary layer thickness of flow in the feeding artery; and

an inner coaxial tube disposed within said heat transfer element, said inner coaxial tube being connected in fluid flow communication with an inner coaxial tube within said catheter.

8. 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 heat transfer element attached to a distal end of said catheter;

a plurality of exterior surface irregularities on said heat transfer element, said exterior surface irregularities being shaped and arranged to create turbulence in surrounding fluid, said exterior surface irregularities having a depth at least equal to the boundary layer thickness of flow in the feeding artery;

a plurality of protrusions axially staggered along an interior surface of said heat transfer element, said interior protrusions being shaped and arranged to create turbulence in fluid within said heat transfer element, said interior protrusions having a height at least equal to the boundary layer thickness of flow within said heat transfer element; and

an inner coaxial tube disposed within said heat transfer element, said inner coaxial tube being connected in fluid flow communication with an inner coaxial tube within said catheter.

9. A selective organ heat transfer device comprising:

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

a heat transfer element comprising a plurality of heat transfer segments attached to a distal end of said catheter;

a helical ridge and a helical groove on each said heat transfer segment, each said helical groove having a depth at least equal to the boundary layer thickness of flow in the feeding artery;

a flexible joint connecting each of said heat transfer segments to adjacent said heat transfer segments; and

an inner coaxial tube disposed within said heat transfer element, said inner coaxial tube being connected in fluid flow communication with an inner coaxial tube within said catheter;

wherein said helical ridge on each said heat transfer segment has an opposite helical twist to said helical ridges on adjacent said heat transfer segments.

10. A selective organ heat transfer device, comprising:

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

a heat transfer element attached to a distal end of said catheter, said heat transfer element being formed of a single segment;

a helical ridge and a helical groove formed on said heat transfer segment, said helical groove having a depth great enough to create turbulence in fluid surrounding said heat transfer segment; and

an inner tube disposed within said heat transfer segment, said inner tube being connected in fluid flow communication with an inner tube within said catheter.

11. A heat transfer device as claimed in claim 10, further comprising:

a plurality of said heat transfer segments; and

a flexible joint connecting each of said heat transfer segments to adjacent said heat transfer segments.

12. A heat transfer device as recited in claim 11, wherein said flexible joint comprises a bellows.

13. A heat transfer device as recited in claim 11, wherein:

a single helical ridge and a single helical groove are formed on each said heat transfer segment; and

said helical ridge on each said heat transfer segment has an opposite helical twist to said helical ridge on each adjacent said heat transfer segment.

14. A selective organ heat transfer device, comprising:

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

a heat transfer element attached to a distal end of said catheter;

a single helical ridge and a single helical groove formed on said heat transfer element, said helical groove having a depth great enough to create turbulence in fluid surrounding said heat transfer element; and

an inner tube disposed within said heat transfer element, said inner tube being connected in fluid flow communication with an inner tube within said catheter.

15. A heat transfer device as claimed in claim 14, wherein said heat transfer element comprises a plurality of heat transfer segments, and further comprising a flexible joint connecting each of said heat transfer segments to adjacent said heat transfer segments.

16. A heat transfer device as recited in claim 15, wherein said flexible joint comprises a bellows.

17. A heat transfer device as recited in claim 15, wherein:

a single helical ridge and a single helical groove are formed on each said heat transfer segment; and

said helical ridge on each said heat transfer segment has an opposite helical twist to said helical ridge on each adjacent said heat transfer segment.

18. A catheter for modifying the temperature of a body, comprising:

a catheter shaft;

a flexible, thermally conductive, heat transfer tip adapted to transfer heat between blood flowing around said heat transfer tip and an interior of said heat transfer tip; and

structures on the exterior of said heat transfer tip, said structures being shaped and sized to induce mixing in blood flowing around said heat transfer tip to a turbulence intensity level of at least about 0.05.

19. The catheter recited in claim 18, further comprising:

first and second lumens in said catheter shaft; and

a working fluid circulated in through said first lumen and out through said second lumen to accomplish said heat transfer.

20. The catheter recited in claim 18, wherein said heat transfer tip is made of metal.

21. The catheter recited in claim 18, further comprising mixing-inducing surface features disposed on said interior of said heat transfer tip.

22. The catheter recited in claim 21, wherein said mixing-inducing surface features are protrusions.

23. The catheter recited in claim 21, wherein said mixing-inducing surface features include a helix.

24. A catheter for modifying the temperature of a body, comprising:

a catheter shaft;

first and second lumens in said catheter shaft;

a flexible, thermally conductive, heat transfer tip adapted to transfer heat between blood flowing around said heat transfer tip and an interior of said heat transfer tip;

a working fluid circulated in through said first lumen and out through said second lumen to accomplish said heat transfer; and

structures on said interior of said heat transfer tip, said structures being shaped and sized to induce mixing in said working fluid to a turbulence intensity level of at least about 0.05.

25. A heat transfer device, comprising:

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

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

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

26. The device recited in claim 25, further comprising protrusions on said mixing-inducing exterior surface.

27. The device recited in claim 26, wherein said protrusions are arranged in axial rows, with said protrusions in adjacent said rows being axially offset from each other.

28. The device recited in claim 26, wherein said protrusions are arranged sufficiently close together to prevent relaminarization of flow between adjacent said protrusions.

29. The device recited in claim 26, wherein said protrusions induce a turbulence intensity level of at least about 0.05 in fluid flowing past said exterior surface.

30. The device recited in claim 25, further comprising helices on said mixing-inducing exterior surface.

31. The device recited in claim 30, wherein said helices on adjacent said segments have alternating helical twist directions.

32. The device recited in claim 30, wherein said helices are arranged sufficiently close together to prevent relaminarization of flow between adjacent said helices.

33. The device recited in claim 30, wherein said protrusions induce a turbulence intensity level of at least about 0.05 in fluid flowing past said exterior surface.

34. The device recited in claim 25, wherein said mixing results in a turbulence intensity level of at least about 0.05 in fluid flowing past said exterior surface.

35. A method of treating an organ, comprising:

providing a segmented heat transfer element for insertion into a feeder artery;

inserting the heat transfer element into a feeder artery from a distal location; and

changing the temperature of the heat transfer element to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

36. The method recited in claim 35, further comprising providing a segmented heat transfer element, said segments being separated by flexible joints.

37. The method recited in claim 36, further comprising providing a segmented heat transfer element, said segments being separated by flexible joints including bellows.

38. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery from a distal location;

inducing mixing in blood flowing in the feeder artery to induce a turbulence intensity level of at least about 0.05; and

changing the temperature of the heat transfer element to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

39. The method recited in claim 38, further comprising providing said heat transfer element with mixing-inducing features on an exterior surface thereof.

40. The method recited in claim 39, further comprising providing mixing-inducing helices on an exterior surface of said heat transfer element.

41. The method recited in claim 39, further comprising providing mixing-inducing protrusions on an exterior surface of said heat transfer element.

42. A method of treating an organ, comprising:

providing a flexible conductive metallic heat transfer element for insertion into a feeder artery;

inserting the heat transfer element into a feeder artery from a distal location; and

changing the temperature of the heat transfer element and inducing mixing in blood flowing in the feeder artery to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

43. A method of treating an organ, comprising:

providing a flexible conductive metallic heat transfer element for insertion into a feeder artery;

inserting the heat transfer element into a feeder artery from a distal location;

circulating a working fluid through the heat transfer element to accomplish heat transfer;

inducing mixing in the working fluid; and

changing the temperature of the heat transfer element to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.