Therapeutic heating and cooling via temperature management of a colon-inserted balloon

• US 6,726,708 B2
• Filed: 06/14/2001
• Issued: 04/27/2004
• Est. Priority Date: 06/14/2000
• 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.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/881,175
• Publication Number:
  US 20020004675A1
• Time in Patent Office: 1,048 Days
• Field of Search: 607/96, 607/104, 607/105, 607/113, 607/114, 606/20, 606/21, 606/22, 606/27
• US Class Current: 607/105
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

A method and apparatus is provided for heating or cooling at least a selected portion of a patient'"'"'s body. The method begins by inserting a catheter having a balloon into the colon or stomach of the patient. A heated or chilled fluid is conducted through a supply lumen of the catheter and into the balloon. The fluid is evacuated from the balloon through a return lumen of the catheter.

Claims

1. A method for heating or cooling at least a selected portion of a body, comprising:

inserting a catheter into the colon, the catheter including a supply lumen and a return lumen;

conducting a heated or chilled fluid through the supply lumen of the catheter; and

evacuating the fluid from the catheter through to return lumen,

wherein the fluid is conducted into the supply lumen with a periodically interrupted flow of fluid.

2. A method for heating or cooling at least a selected portion of a body, comprising:

inserting a catheter into the colon, the catheter including a supply lumen and a return lumen;

conducting a heated or chilled fluid through the supply lumen of the catheter;

evacuating the fluid from the catheter through the return lumen; and

monitoring a temperature differential between the fluid conducted into the supply lumen and the fluid flowing through the return lumen.

3. A method for heating or cooling at least a selected portion of a body, said method comprising:

inserting a catheter into the stomach, the catheter including a supply lumen and a return lumen;

conducting a heated or chilled fluid through the supply lumen of the catheter;

evacuating the fluid from the catheter through the return lumen; and

monitoring a temperature differential between the fluid conducted into the supply lumen and die fluid flowing through the return lumen.

4. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating a balloon inserted into the colon with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the balloon;

evacuating the fluid from the balloon; and

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the balloon,

wherein irrigating the balloon includes the step of irrigating the balloon with a pulsed flow of fluid.

5. The method of claim 4, further comprising maintaining the pressure of the heated or chilled fluid in the balloon to between about 0 and 10 psi.

6. The method of claim 5, further comprising maintaining the pressure of the heated or chilled fluid in the balloon to between about 0 and 3 psi.

7. The method of claim 4, wherein the conducting includes delivering the heated or chilled fluid at a substantially constant rate.

8. The method of claim 7, wherein the substantially constant rate is between about 0 and 200 cc/sec.

9. The method of claim 4 wherein the at least one measurable parameter is selected from the group consisting of the flow rate of the fluid, the pressure differential between the fluid flowing into and out of the balloon, and the temperature differential between the fluid flowing into and out of the balloon.

10. A method for heating or cooling at least a selected portion of a body, said method comprising:

irrigating a balloon inserted into the colon with a heated or chilled fluid;

controlling at least one measurable parameter of the fluid irrigating the balloon;

evacuating the fluid from the balloon;

monitoring, during the irrigation step, the at least one measurable parameter of fluid flowing out of the balloon; and

controlling a temperature, flow rate, or pressure of the heated or chilled fluid based on a monitored pressure.

11. An apparatus for heating or cooling at least a selected portion of a body, comprising:

a catheter for irrigating and evacuating a balloon for insertion into the colon with a heated or chilled fluid;

means, coupled to the catheter, for controlling at least one measurable parameter of the fluid irrigating the balloon; and

means for monitoring at least one parameter selected from the group consisting of;

the at least one measurable parameter of fluid flowing out of the balloon while it is being irrigated and a core temperature of the body,

wherein the at least one measurable parameter is the pressure differential between the fluid flowing into and out of the balloon.

12. The apparatus of claim 11, wherein the flow of the fluid is continuous.

13. The apparatus of claim 11, further comprising means for monitoring a temperature differential between the fluid flowing into and out of the balloon.

14. The apparatus of claim 11, wherein said catheter includes a supply lumen having an orifice at its distal end.

15. The apparatus of claim 14, wherein said catheter further includes a return lumen, said return lumen being fluidically coupled to said supply lumen via said orifice.

16. A catheter, comprising:

a manifold having a proximal end with at least first and second input ports and a distal end with an output port;

at least first and second flexible tubes defining a supply lumen and a return lumen, respectively, said first and second flexible tubes configured and structured for insertion into the colon and having proximal ends removably connectable to the output port of the manifold and having distal ends fluidically coupled via an orifice,

wherein said first and second flexible tubes are concentrically oriented with respect to one another.

17. The catheter of claim 16, further comprising an inflatable balloon coupled to said catheter for maintaining an operative position of said catheter when inserted into a patient.

18. The catheter of claim 16, further comprising

a gas-driven heat exchanger for chilling a working fluid.

19. The catheter of claim 16, further comprising

a resistive heater for heating a working fluid.

20. The catheter of claim 16, further comprising a means for monitoring a core temperature of the body, and wherein the means is an esophageal temperature monitor.

21. The catheter of claim 16, further comprising a means for monitoring the core temperature of the body, and wherein the means is a tympanic temperature monitor.