Patient temperature regulation method and apparatus

• US 6,843,800 B1
• Filed: 08/11/1999
• Issued: 01/18/2005
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• Current Assignee: Philips Electronics North America Corporation (Koninklijke Philips N.V.)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Dobak, John D. III
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/373,112
• Time in Patent Office: 1,987 Days
• Field of Search: 607/96, 607/104, 607/105, 607/106, 607/113, 606 20- 24
• 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 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A device and method for providing body cooling. The cooling device applies cooling to blood flowing in a vena cavae that is then distributed throughout the body. The cooling can be assisted by use of thermoregulatory drugs or warming devices to prevent shivering and vasoconstriction.

Claims

1. A method for cooling a patient'"'"'s body intravascularly, comprising:

providing a catheter having a cooling element attached to a distal end thereof, the cooling element having mixing-inducing surface features thereon;

inserting the catheter through the vascular system of the patient to place the cooling element in a vein that drains into the heart of a patient;

circulating fluid through the cooling element;

transferring heat from the blood in the vein to the cooling element; and

administering an antishivering drug to the patient.

2. The method of claim 1, wherein the antishivering drug is selected from the group consisting of clonidine, meperidine, propofol, magnesium, dexmedetomidine, and combinations thereof.

3. The method of claim 1, wherein the cooling element is disposed in a vein selected from the group consisting of the superior vena cava, the inferior vena cava, the iliac vein, the femoral vein, or combinations of the above.

4. A method for changing a patient'"'"'s body temperature intravascularly while controlling patient shivering, comprising:

providing a catheter having a heat exchange element at a portion thereof;

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

circulating fluid through the heat exchange element;

transferring heat from the blood in the vessel to the heat exchange element; and

administering an antishivering drug to the patient.

5. The method of claim 4, wherein the antishivering drug is selected from the group consisting of clonidine, meperidine, propofol, magnesium, dexmedetomidine, and combinations thereof.

6. A method for cooling a patient'"'"'s body intravascularly, comprising:

determining a target hypothermic temperature to be achieved;

providing a catheter having a cooling element attached to a distal end thereof;

inserting the catheter through the vascular system of the patient to place the cooling element in a vein that drains into the heart of a patient;

circulating fluid through the cooling element;

monitoring the patient temperature with a temperature probe;

transferring heat from the blood in the vein to the cooling element and controlling the temperature of the patient so that the target temperature is substantially reached and so that the maximum temperature differential between the blood stream and the cooling element is limited to approximately 32°

C.; and

administering an antishivering drug to the patient.

7. The method of claim 6, further comprising inducing mixing in the blood stream.

8. The method of claim 6, wherein the antishivering drug is selected from the group consisting of clonidine, meperidine, propofol, magnesium, dexmedetomidine, and combinations thereof.

9. A method for cooling a patient'"'"'s body intravascularly, comprising:

providing a catheter having a cooling element attached to a distal end thereof, the cooling element having mixing-inducing surface features thereon;

inserting the catheter through the vascular system of the patient to place the cooling element in a vein that drains into the heart of a patient;

circulating fluid through the cooling element;

transferring heat from the blood in the vein to the cooling element; and

administering a thermoregulatory drug to the patient with the proviso that the thermoregulatory drug does not include vasodilatory drugs.

10. The method of claim 9, wherein the thermoregulatory drug is selected from the group consisting of clonidine, meperidine, propofol, magnesium, dexmedetomidine, and combinations thereof.

11. The method of claim 9, wherein the cooling element is disposed in a vein selected from the group consisting of the superior vena cava, the inferior vena cava, the iliac vein, the femoral vein, or combinations of the above.

12. A method for changing a patient'"'"'s body temperature intravascularly while controlling patient shivering, comprising:

providing a catheter having a heat exchange element at a portion thereof;

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

circulating fluid through the heat exchange element;

transferring heat from the blood in the vessel to the heat exchange element; and

administering a thermoregulatory drug to the patient with the proviso that the thermoregulatory drug does not include vasodilatory drugs.

13. The method of claim 12, wherein the thermoregulatory drug is selected from the group consisting of clonidine, meperidine, propofol, magnesium, dexmedetomidine, and combinations thereof.

14. A method for cooling a patient'"'"'s body intravascularly, comprising:

determining a target hypothermic temperature to be achieved;

providing a catheter having a cooling element attached to a distal end thereof;

inserting the catheter through the vascular system of the patient to place the cooling element in a vein that drains into the heart of a patient;

circulating fluid through the cooling element;

monitoring the patient temperature with a temperature probe;

transferring heat from the blood in the vein to the cooling element and controlling the temperature of the patient so that the target temperature is substantially reached and so that the maximum temperature differential between the blood stream and the cooling element is limited to approximately 32°

C.; and

administering a thermoregulatory drug to the patient with the proviso that the thermoregulatory drug does not include vasodilatory drugs.

15. The method of claim 14, further comprising inducing mixing in the blood stream.

16. The method of claim 14, wherein the thermoregulatory drug is selected from the group consisting of clonidine, meperdine, propofol, magnesium, dexmedetomidine, and combinations thereof.