Selective organ cooling catheter with guidewire apparatus and temperature-monitoring device

• US 6,312,452 B1
• Filed: 03/04/1999
• Issued: 11/06/2001
• 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): Dvorak, Linda C. M.
• Assistant Examiner(s): Kearney, R
• Application Number:
  US09/262,805
• Time in Patent Office: 978 Days
• Field of Search: 607/104-106, 606/20, 606/21, 606/22, 606/23, 165/142, 165/179, 165/181, 165/184, 604/52, 604/53, 604/93
• 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: G05D 23/1919 characterised by the type of controller
• CPC Class Codes: G05D 23/22 the sensing element being a thermocouple
• CPC Class Codes: G05D 23/24 the sensing element having a resistance varying with temperature, e.g. a thermistor

Abstract

A guidable catheter for heating or cooling a surrounding fluid in a feeding vessel in a vasculature of a patient. The catheter includes a heat transfer element, the heat transfer element having a plurality of exterior surface irregularities shaped and arranged to create turbulence in a surrounding fluid. The surface irregularities have a depth at least equal to the boundary layer thickness of flow of the surrounding fluid in the feeding vessel. The catheter assembly also includes a supply catheter having a portion disposed within the heat transfer element to deliver a working fluid to an interior of the heat transfer element. The catheter assembly further includes a return catheter to return a working fluid from the interior of the heat transfer element. A guidewire tube is provided adjacent one of the supply catheter or the return catheter and runs substantially parallel to the axis of the guidable catheter to receive a guidewire disposed within the guidewire tube. The guidable catheter may further have a temperature-monitoring device disposed at the distal tip of the guidewire. The temperature-monitoring device may be a thermocouple or a thermistor. Feedback may further be provided to control the temperature of a source of working fluid. A method is also provided for selectively controlling the temperature of a selected volume of blood in a patient. The method includes introducing a guidewire into a blood vessel feeding a selected volume of blood in a patient and introducing a catheter assembly into the blood vessel feeding a selected volume of blood in a patient by inserting the guidewire into a guidewire tube in the catheter assembly. A working fluid is delivered from a source of working fluid through a supply catheter in the catheter assembly and returned through a return catheter in the catheter assembly. Heat is transferred between a heat transfer element forming a distal end of the catheter assembly and the volume of blood in the feeding vessel. The temperature is monitored of the volume of blood in the feeding vessel by measuring the temperature with a temperature-monitoring device disposed at or near the distal tip of the guidewire.

Claims

1. A guidable catheter for heating or cooling a surrounding fluid in a vessel in the vasculature of a patient comprising:

a heat transfer element, the heat transfer element having at least one exterior surface irregularity shaped and arranged to create mixing in a surrounding fluid in a vessel, wherein the heat transfer element has coupled thereto at least one eyelet configured to receive the guidewire threaded therethrough;

a supply catheter having a portion disposed within the heat transfer element to deliver a working fluid to an interior of the heat transfer element;

a return catheter to return a working fluid from the interior of the heat transfer element; and

a guidewire tube adjacent one of the supply catheter or the return catheter and running substantially parallel to the axis of the guidable catheter to receive a guidewire, wherein the heat transfer element is formed from at least two heat transfer segments, adjacent heat transfer segments joined by bellows, and wherein the eyelets are attached to the heat transfer element at the bellows.

2. The device of claim 1, wherein:

the surface irregularity includes a helical ridge and a helical groove formed on each of successive heat transfer segments; and

the helical ridge on each heat transfer segment has an opposite helical twist to the helical ridges on adjacent heat transfer segments.

4. The device of claim 1, wherein the thin tube is formed of a metal.

5. The device of claim 1, wherein the thin tube is formed of a polymer material.

3. A guidable catheter for heating or cooling a surrounding fluid in a vessel in the vasculature of a patient, comprising:

a heat transfer element, the heat transfer element having at least one exterior surface irregularity shaped and arranged to create mixing in a surrounding fluid in a vessel, wherein the heat transfer element has coupled thereto at least one eyelet configured to receive the guidewire threaded therethrough;

a supply catheter having a portion disposed within the heat transfer element to deliver a working fluid to an interior of the heat transfer element;

a return catheter to return a working fluid from the interior of the heat transfer element; and

a guidewire tube adjacent one of the supply catheter or the return catheter and running substantially parallel to the axis of the guidable catheter to receive a guidewire wherein the heat transfer element is formed from at least two heat transfer segments, adjacent heat transfer segments joined by a thin tube, and wherein the eyelets are attached to the heat transfer element at the thin tube.