Selective organ cooling apparatus and method

• US 6,224,624 B1
• Filed: 04/14/1999
• Issued: 05/01/2001
• 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., Werneth, Randell L., Dobak, John D. III
• Primary Examiner(s): Cohen, Lee
• Assistant Examiner(s): Kearney, R.
• Application Number:
  US09/291,824
• Time in Patent Office: 748 Days
• Field of Search: 607/96, 607/104, 607/105, 607/106, 607/113, 606/27, 606/28, 606/23, 606/20, 606/21, 606/22, 606/31, 606/191, 606/192, 606/194, 604/96, 604/97, 604/113, 128/898
• US Class Current: 607/105
• 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

Abstract

The present invention involves a selective organ heat transfer device having a flexible coaxial catheter capable of insertion into a selected feeding artery in the vascular system of a patient. A heat transfer element is attached to a distal portion of the catheter as well as a turbulence-enhancing element which is adapted to enhance turbulent blood flow along the heat transfer element. The heat transfer element may include the turbulence-enhancing element and/or a turbulence-enhancing element may be located proximal of the heat transfer element.

Claims

1. A heat transfer device for transferring heat to or from surrounding blood flow to heat or cool the surrounding blood flow, comprising:

a catheter capable of insertion into a selected blood vessel in the vascular system of a patient;

a heat transfer element attached to a distal portion of said catheter and adapted to transfer heat to or from surrounding blood flow to heat or cool the surrounding blood flow, the heat transfer device including more than one heat transfer segment forming a blood mixing-enhancing element adapted to enhance mixing of blood flow along said heat transfer element, the blood mixing-enhancing element including a plurality of exterior surface irregularities, said surface irregularities comprise a helical ridge and a helical groove formed on each said heat transfer segment, and said helical ridge and helical groove on each said heat transfer segment has an opposite helical twist to said helical ridge and helical groove on an adjacent heat transfer segment so as to create repetitively changing directions of blood flow in surrounding blood.

2. A heat transfer device for transferring heat to or from surrounding blood flow to heat or cool the surrounding blood flow, comprising:

a catheter capable of insertion into a selected blood vessel in the vascular system of a patient;

a heat transfer element attached to a distal portion of said catheter and adapted to transfer heat to or from surrounding blood flow to heat or cool the surrounding blood flow; and

a blood mixing-enhancing element attached to a distal portion of said catheter and adapted to enhance mixing of blood flow along said heat transfer element, said blood mixing-enhancing element located proximal of said heat transfer element.

3. The device of claim 2, wherein said blood mixing-enhancing element includes an expandable micro-balloon.

4. The device of claim 2, wherein said blood mixing-enhancing element includes an expandable micro-ring balloon.

5. The device of claim 2, wherein said blood mixing-enhancing element includes multiple axially staggered and circumferentially overlapping protrusions located along an exterior surface.

6. A heat transfer device for transferring heat to or from surrounding blood flow to heat or cool the surrounding blood flow, comprising:

a catheter capable of insertion into a selected blood vessel in the vascular system of a patient;

a heat transfer element attached to a distal portion of said catheter and adapted to transfer heat to or from surrounding blood flow to heat or cool the surrounding blood flow;

a blood mixing-enhancing element attached to a distal portion of said catheter and adapted to enhance mixing of blood flow along said heat transfer element, said blood mixing-enhancing element located proximal of said heat transfer element and including a temperature sensor wire helically wound around an exterior surface and having a temperature sensor in thermal contact with said heat transfer element for feedback control of said heat transfer element.

7. The device of claim 6, wherein said temperature sensor is a member from the group consisting of thermocouple and thermistor.

8. A heat transfer device for transferring heat to or from surrounding blood flow to heat or cool the surrounding blood flow, comprising:

a catheter capable of insertion into a selected blood vessel in the vascular system of a patient;

a heat transfer element attached to a distal portion of said catheter and adapted to transfer heat to or from surrounding blood flow to heat or cool the surrounding blood flow;

a blood mixing-enhancing element located proximal of said heat transfer element and attached to a distal portion of said catheter and adapted to enhance mixing of blood flow along said heat transfer element; and

wherein said catheter includes a longitudinal axis and said blood mixing-enhancing element includes a fan adapted to rotate about an axis coaxial with said longitudinal axis of said catheter.

9. The device of claim 8, wherein said fan is adapted to rotate upon fluid flow past the fan.

10. The device of claim 8, further including a driving mechanism adapted to rotate said fan.

11. The device of claim 8, wherein said fan includes multiple blades adapted to have a low profile when said fan is at rest and expand when in motion.

12. A method for selectively controlling the temperature of blood flow, said method comprising:

providing a catheter having a heat transfer element and a blood mixing-enhancing element attached to a distal portion thereof, the blood mixing-enhancing element located proximal of the heat transfer element;

inserting said catheter through the vascular system of the patient to place said heat transfer element and blood mixing-enhancing element in a desired blood vessel;

creating pre-mixing of blood flow proximal of said heat transfer element with said blood mixing-enhancing element;

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 said heat transfer element and the blood flow in the blood vessel, whereby said pre-mixing of blood flow proximal of said heat transfer element enhances the transfer of heat between said heat transfer element and blood.

13. A method as recited in claim 12, wherein said blood mixing-enhancing element is an expandable micro-balloon and is located proximal of said heat transfer element, and creating pre-mixing by changing the direction of the velocity vectors of the blood flow contacting said heat transfer element with said expandable micro-balloon.

14. A method as recited in claim 12, wherein said blood mixing-enhancing element is an expandable micro-ring balloon and is located proximal of said heat transfer element, and creating pre-mixing by changing the direction of the velocity vectors of the blood flow contacting said heat transfer element with said expandable micro-ring balloon.

15. A method as recited in claim 12, wherein said blood mixing-enhancing element includes multiple axially staggered and circumferentially overlapping protrusions located along an exterior surface of said catheter proximal to said heat transfer element, and creating pre-mixing by changing the direction of the velocity vectors of the blood flow contacting said heat transfer element with said protrusions.

16. A method as recited in claim 12, wherein said blood mixing-enhancing element is a temperature sensor wire helically wound around said catheter proximal to said heat transfer element, said temperature sensor wire having a temperature sensor in thermal contact with said heat transfer element, and said temperature sensor wire enhances mixing by altering the direction of the blood flow contacting said heat transfer element and by creating pre-mixing of the blood flow prior to contacting said heat transfer element, and said method further including feedback controlling the temperature of the circulating fluid based on the temperature of said heating element.

17. A method for selectively controlling the temperature of blood flow, said method comprising:

providing a catheter having a heat transfer element and a blood mixing-enhancing element attached to a distal portion thereof, said heat transfer element including said blood mixing-enhancing element, said blood mixing-enhancing element including a plurality of segments of helical ridges and grooves having alternating directions of helical rotation;

inserting said catheter through the vascular system of the patient to place said heat transfer element and blood mixing-enhancing element in a desired blood vessel;

creating mixing of blood flow around said heat transfer element by establishing repetitively alternating directions of helical blood flow with said alternating helical rotations of said ridges and grooves;

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 said heat transfer element and the blood flow in the blood vessel, whereby said mixing of blood flow induced around said heat transfer element enhances the transfer of heat between said heat transfer element and blood.

18. A method for selectively controlling the temperature of blood flow, said method comprising:

providing a catheter having a heat transfer element and a blood mixing-enhancing element attached to a distal portion thereof, said blood mixing-enhancing element including a temperature sensor wire helically wound around said catheter, said temperature sensor wire having a temperature sensor located distal of said heat transfer element;

inserting said catheter through the vascular system of the patient to place said heat transfer element and blood mixing-enhancing element in a desired blood vessel;

creating mixing of blood flow around said heat transfer element with said blood mixing-enhancing element;

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;

transferring heat between said heat transfer element and the blood flow in the blood vessel, whereby said mixing of blood flow induced around said heat transfer element enhances the transfer of heat between said heat transfer element and blood; and

feedback controlling the temperature of the circulating fluid based on the temperature of blood downstream of said heating element.

19. A method for selectively controlling the temperature of blood flow, said method comprising:

providing a catheter having a heat transfer element and a blood mixing-enhancing element attached to a distal portion thereof, said blood mixing-enhancing element including a rotating fan;

inserting said catheter through the vascular system of the patient to place said heat transfer element and blood mixing-enhancing element in a desired blood vessel;

creating mixing of blood flow around said heat transfer element with said rotating fan;

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 said heat transfer element and the blood flow in the blood vessel, whereby said mixing of blood flow induced around said heat transfer element enhances the transfer of heat between said heat transfer element and blood.

20. A heat transfer device for transferring heat to or from surrounding blood flow to heat or cool the surrounding blood flow, comprising:

a catheter for insertion in a blood vessel of a patient;

a heat transfer element attached to a distal end of said catheter and adapted to transfer heat to or from surrounding blood flow to heat or cool the surrounding blood flow;

a plurality of exterior surface irregularities formed on said heat transfer element, said surface irregularities being shaped and arranged to create repetitively changing directions of blood flow in surrounding blood; and

a blood mixing-enhancing element associated with said heating element for imparting pre-mixing to blood prior to the blood reaching said heating element.