Inflatable catheter for selective organ heating and cooling and method of using the same

• US 7,651,518 B2
• Filed: 11/14/2003
• Issued: 01/26/2010
• Est. Priority Date: 01/23/1998
• Status: Expired due to Fees

• 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): Cohen; Lee S
• Application Number:
  US10/714,070
• Publication Number:
  US 20040106969A1
• Time in Patent Office: 2,265 Days
• Field of Search: 606 20- 26, 607104-106, 604/7, 604/8
• 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

Abstract

A catheter system and method are provided which change the temperature of a fluid, such as blood, by heat transfer. Selective cooling or heating of an organ may be performed by changing the temperature of the blood feeding the organ. The catheter system includes an inlet lumen and an outlet lumen structured and arranged to carry a working fluid having a temperature different from the adjacent blood. The outlet lumen is configured to induce turbulence in the adjacent fluid passing adjacent the outlet lumen.

Claims

1. A catheter system to change the temperature of blood by heat transfer to or from a circulating working fluid, comprising:

an inlet lumen to introduce a circulating working fluid; and

at least one outlet lumen to extract a circulating working fluid, the outlet lumen having a structure disposed within the outlet lumen to maintain its shape, a shape that induces mixing in blood flowing past the outlet lumen or in the working fluid,

wherein the outlet lumen and the inlet lumen are configured such that blood flows between the outlet lumen and the inlet lumen.

2. The catheter system of claim 1, wherein the inlet lumen and the outlet lumen are made of a flexible material.

3. The catheter system of claim 2, wherein the flexible material is a material capable of undergoing inflation.

4. The catheter system of claim 2, wherein the flexible material is rubber.

5. The catheter system of claim 2, wherein the flexible material is capable of undergoing inflation.

6. The catheter system of claim 5, wherein the structure causes the outlet to maintain its approximate uninflated position.

7. The catheter system of claim 1, wherein the working fluid is saline.

8. The catheter system of claim 1, further comprising a working fluid supply including a pump, and wherein the pump circulates the working fluid.

9. The catheter system of claim 1, wherein the structure comprises a wire.

10. The catheter system of claim 1, wherein the outlet lumen is made of a flexible material.

11. A catheter system to rewarm a patient, comprising:

a working fluid supply configured to circulate a working fluid, wherein the working fluid supply is configured to produce a working fluid at a temperature of greater than about 37°

C.;

an inlet lumen to introduce the circulating working fluid; and

at least one outlet lumen to extract a circulating working fluid, the outlet lumen having a structure disposed within the outlet lumen to maintain its shape, a shape that induces mixing in blood flowing past the outlet lumen or in the working fluid,

wherein the outlet lumen and the inlet lumen are configured such that blood flows between the outlet lumen and the inlet lumen.

12. The catheter system of claim 11, wherein the structure comprises a wire.

13. The catheter system of claim 11, wherein the outlet lumen is made of a flexible material.

14. The catheter system of claim 13, wherein the flexible material is rubber.

15. The catheter system of claim 13, wherein the flexible material is capable of undergoing inflation.

16. The catheter system of claim 15, wherein the structure causes the outlet to maintain its approximate uninflated position.

17. A catheter method of inducing a therapeutic state of hypothermia in a patient comprising:

inserting an inflatable heat transfer element, formed by at least an inlet lumen and a single outlet lumen, into an artery or vein, the outlet lumen having a structure disposed within the outlet lumen to maintain its shape;

inflating the inflatable heat transfer element by delivering a working fluid to the inflatable heat transfer element, the temperature of the working fluid lower than that of the blood; and

passing the working fluid through a mixing inducing path formed by the outlet lumen, wherein an open path between the inlet lumen and the outlet lumen allows blood flow therethrough, thereby enhancing heat transfer between the working fluid and the blood,

wherein the outlet lumen and the inlet lumen are configured such that blood flows between the outlet lumen and the inlet lumen.

18. A method for warming a body of a patient, comprising:

introducing a catheter having an inflatable heat transfer element, formed by at least an inlet lumen and a single outlet lumen, the outlet lumen having a mixing inducing shape and a structure within the outlet lumen to maintain its shape, into a blood vessel;

circulating a working fluid through the heat transfer element, wherein the working fluid is removed from the heat transfer element by passing through the outlet lumen, the working fluid having a temperature greater than the temperature of the blood vessel; and

such that heat is added to the blood to warm the body,

wherein the outlet lumen and the inlet lumen are configured such that blood flows between the outlet lumen and the inlet lumen.