Selective organ cooling apparatus and method

• US 6,464,716 B1
• Filed: 06/30/2000
• Issued: 10/15/2002
• 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., Werneth, Randell L., Dobak, John D. III
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/607,799
• Time in Patent Office: 837 Days
• Field of Search: 606/20-26, 607/98, 607/104-105
• 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: 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

An endovascular heat transfer device which can have a smooth exterior surface, or a surface with ridges and grooves. The device can have a plurality of elongated, articulated segments, with each having such a surface. A flexible joint connects adjacent elongated, articulated segments. The flexible joints can be bellows or flexible tubes. 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. An endovascular 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 comprising a plurality of heat transfer segments, each said heat transfer segment being encompassed by a smooth metallic surface;

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element; and

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

wherein said flexible joint comprises a bellows.

2. 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;

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

a plurality of heat transfer segments on said heat transfer element, each said segment being encompassed by a smooth metallic surface;

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

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element;

wherein said flexible joint comprises a bellows.

3. A 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; and

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

4. 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, wherein the thermal conductivity of said heat transfer tip is greater than or substantially equal to that of a doped polymer; and

structures on the exterior of said heat transfer tip 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.

5. The catheter recited in claim 4, wherein said heat transfer tip is made of a doped polymer.

6. The catheter recited in claim 5, wherein said heat transfer tip further includes mixing-inducing surface features.

7. The catheter recited in claim 6, wherein said mixing-inducing surface features comprise protrusions.

8. The catheter recited in claim 6, wherein said mixing-inducing surface features comprise a helix.

9. The catheter recited in claim 4, 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.

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

a catheter shaft having first and second lumens therein;

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, wherein the thermal conductivity of said heat transfer tip is greater than or substantially equal to that of a doped polymer;

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

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

11. A heat transfer device comprising:

first and second elongated segments, each said segment having a mixing-inducing irregular exterior surface, said irregular exterior surface comprising a plurality of protrusions capable of producing a Nusselt number of at least 5 in blood flowing around said 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.

12. A heat transfer device comprising:

first and second elongated segments, each said segment having a mixing-inducing irregular exterior surface, said irregular exterior surface comprising at least one helix capable of producing a Nusselt number of at least 5 in blood flowing around said 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.

13. A heat transfer device comprising:

first and second elongated segments, each said segment having a mixing-inducing irregular exterior surface, said irregular exterior surface capable of producing a Nusselt number of at least 5 in blood flowing around said 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.

14. A 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; and

a bellows disposed between each pair of said plurality of heat transfer segments, such that the local convective heat transfer coefficient of each of said segments is greater than that of each said bellows;

wherein said bellows is adapted to create a jet effect in working fluid flowing through said heat transfer device, as said working fluid passes from said bellows into an adjacent said heat transfer segment.

15. A method of treating an organ, comprising:

providing a segmented heat transfer element, each pair of said segments being separated by a flexible tubular joint;

inserting said heat transfer element into a feeder artery; and

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

16. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery; and

changing the temperature of said 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;

wherein said mixing is characterized by a Nusselt number of at least about 5.

17. The method recited in claim 16, further comprising providing mixing-inducing features on the exterior surface of said heat transfer element.

18. The method recited in claim 17, further comprising providing helices as said mixing-inducing features.

19. The method recited in claim 17, further comprising providing protrusions as said mixing-inducing features.

20. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery, wherein said heat transfer element has a mixing-inducing interior surface; and

circulating a working fluid through the interior of said heat transfer element to change the temperature of said heat transfer element in part by inducing mixing in said working fluid, to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

21. A method of treating an organ, comprising:

inserting a flexible conductive heat transfer element, said heat transfer element being formed at least partially of a doped polymer, into a feeder artery; and

changing the temperature of said 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.

22. A method of treating an organ, comprising:

inserting a flexible conductive heat transfer element formed at least partially of a doped polymer into a feeder artery; and

recirculating a working fluid through the interior of said heat transfer element, and inducing mixing in said working fluid, to change the temperature of said heat transfer element and to modify the temperature of the blood in the feeder artery, thereby selectively modifying the temperature of the organ.

23. An endovascular heat transfer device, comprising:

a working fluid supply, including a gear pump;

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 comprising a plurality of heat transfer segments, each said heat transfer segment being encompassed by a smooth metallic surface; and

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

24. The device recited in claim 23, wherein said gear pump is a helical tooth gear pump.

25. A selective organ heat transfer device comprising:

a working fluid supply, including a gear pump;

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

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

a plurality of heat transfer segments on said heat transfer element;

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

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

26. The device recited in claim 25, wherein said gear pump is a helical tooth gear pump.

27. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery;

circulating a working fluid through said heat transfer element;

imparting an azimuthal velocity to said working fluid in the interior of said heat transfer element, thereby creating a continuous exchange of fluid between the core and the perimeter of said working fluid flow as it moves longitudinally through said heat transfer element; and

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

28. The method recited in claim 27, further comprising providing helical features within said heat transfer element to impart said azimuthal velocity to said working fluid.

29. The method recited in claim 27, further comprising providing at least one helical ridge and at least one helical groove within said heat transfer element to impart said azimuthal velocity to said working fluid.

30. A method of treating a patient, comprising:

inserting a heat transfer element into a blood vessel;

circulating a working fluid through said heat transfer element;

imparting an azimuthal velocity to said working fluid in the interior of said heat transfer element, thereby creating a continuous exchange of fluid between the core and the perimeter of said working fluid flow as it moves longitudinally through said heat transfer element; and

changing the temperature of said working fluid to change the temperature of said heat transfer element to modify the temperature of the blood in the blood vessel, thereby modifying a temperature of a patient.

31. The method recited in claim 30, further comprising providing helical features within said heat transfer element to impart said azimuthal velocity to said working fluid.

32. The method recited in claim 30, further comprising providing at least one helical ridge and at least one helical groove within said heat transfer element to impart said azimuthal velocity to said working fluid.

33. An endovascular 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 comprising a plurality of heat transfer segments, each said heat transfer segment having a plurality of longitudinal ribs on its surface; and

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element.

34. The heat transfer device recited in claim 33, further comprising a flexible joint connecting each of said heat transfer segments to adjacent said heat transfer segments.

35. The heat transfer device recited in claim 34, wherein said flexible joint comprises a bellows.

36. The heat transfer device recited in claim 34, wherein said flexible joint comprises a flexible tube.

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;

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

a plurality of heat transfer segments on said heat transfer element, each said segment having a plurality of longitudinal ribs on its surface;

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

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element.

38. The heat transfer device recited in claim 37, wherein said flexible joint comprises a bellows.

39. The heat transfer device recited in claim 37, wherein said flexible joint comprises a flexible tube.

40. A method for selectively controlling a temperature of a patient, said method comprising:

providing a catheter having a heat transfer element attached to a distal end thereof, said heat transfer element having a plurality of longitudinally ribbed heat transfer segments separated by flexible joints;

inserting said catheter through the vascular system of the patient to place said heat transfer element in a blood vessel;

circulating fluid into said heat transfer element via an internal lumen of said catheter and via an internal lumen of said heat transfer element;

circulating fluid out of said heat transfer element via an external lumen of said heat transfer element; and

transferring heat between the longitudinally ribbed surface of said heat transfer segments and the blood in the vessel to selectively control the temperature of the patient.

41. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery, wherein said heat transfer element has a plurality of longitudinal ribs on its surface; and

circulating a working fluid through the interior of said heat transfer element to change the temperature of the longitudinally ribbed surface of said heat transfer element, to modify the temperature of the blood in the feeder artery in part by inducing mixing in said working fluid, thereby selectively modifying the temperature of the organ.

42. An endovascular 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 comprising a plurality of heat transfer segments, each said heat transfer segment having a plurality of longitudinal invaginations on its surface; and

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element.

43. 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;

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

a plurality of heat transfer segments on said heat transfer element, each said segment having a plurality of longitudinal invaginations on its surface;

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

an inner tube disposed within said heat transfer element, said inner tube being adapted to supply heat transfer fluid to the interior of said heat transfer element.

44. A method for selectively controlling a temperature of a patient, said method comprising:

providing a catheter having a heat transfer element attached to a distal end thereof, said heat transfer element having a plurality of longitudinally invaginated heat transfer segments separated by flexible joints;

inserting said catheter through the vascular system of the patient to place said heat transfer element in a blood vessel;

circulating fluid into said heat transfer element via an internal lumen of said catheter and via an internal lumen of said heat transfer element;

circulating fluid out of said heat transfer element via an external lumen of said heat transfer element; and

transferring heat between the longitudinally invaginated surface of said heat transfer segments and the blood in the vessel to selectively control the temperature of the patient.

45. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery, wherein said heat transfer element has a plurality of longitudinal invaginations on its surface; and

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

46. A method of treating an organ, comprising:

inserting a heat transfer element into a feeder artery, wherein said heat transfer element has a plurality of longitudinal invaginations on its surface; and

circulating a working fluid through the interior of said heat transfer element to change the temperature of the longitudinally invaginated surface of said heat transfer element, to modify the temperature of the blood in the feeder artery in part by inducing mixing in said working fluid, thereby selectively modifying the temperature of the organ.