Methods for preparing a heat exchange catheter system and for heating and/or cooling a subject's body

• US 8,968,378 B2
• Filed: 02/07/2012
• Issued: 03/03/2015
• Est. Priority Date: 08/24/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert, Machold, Timothy R., Dineen, Michael T.
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): AVIGAN, ADAM JOSEPH
• Application Number:
  US13/367,956
• Publication Number:
  US 20120203201A1
• Time in Patent Office: 1,120 Days
• Field of Search: 607/96, 607104-106, 607/113
• US Class Current: 607/106
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• 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 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0093 programmed
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/0097 Blankets with active heating or cooling sources warming mats A61F7/08
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 2206/10 : Flow characteristics
• CPC Class Codes: A61M 2230/50 : Temperature
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Closed loop heat exchange catheter systems and methods for preparing and using such systems wherein a reservoir or fluid bag is connected to the catheter system and used for at least priming of the system with a heat exchange fluid.

Claims

1. A method for heating or cooling at least a portion of the body of a subject using a heat exchange catheter system that comprises i) a closed loop heat exchange catheter having a heat exchange region and a distal end, ii) an extracorporeally situated heat exchanger connected to the closed loop heat exchange catheter, iii) apparatus for heating or cooling heat exchange fluid that circulates through the heat exchanger and through the heat exchange catheter;

iv) a pump for circulating the heat exchange fluid through the heat exchanger and through the heat exchange catheter thereby causing heating or cooling the heat exchange region of the catheter;

v) a controller which controls the temperature of the heat exchange region of the catheter and vi) a temperature sensor is used to sense a patient body temperature and vii) a user interface whereby a user may enter a target patient temperature, said method comprising the steps of;

A) connecting to the system a reservoir or fluid bag that contains heat exchange fluid;

B) causing heat exchange fluid to flow from the reservoir or fluid bag into the heat exchange catheter system;

C) inserting the closed loop heat exchange catheter into the subject'"'"'s body so that its heat exchange region and distal end are positioned within the subject'"'"'s vasculature;

D) using the pump to circulate the heat exchange fluid through the extracorporeally situated heat exchanger and the closed loop heat exchange catheter; and

E) using the apparatus for heating or cooling to heat or cool the circulating heat exchange fluid, thereby heating or cooling the heat exchange region so as to cause heating or cooling of blood that flows in heat exchange proximity to the heat exchange region and resultant heating or cooling of at least a portion of the subject'"'"'s body; and

F) entering a target temperature via the user interface;

wherein the controller is programmed to receive an indication of the sensed temperature from the temperature sensor and to cause the heat exchange catheter system to switch back and forth between the active state and the inactive state so as to maintain the sensed temperature between an upper variance set point that is above the target temperature and a lower variance set point that is below the target temperature.

2. A method according to claim 1 wherein the heat exchange region of the catheter expands during performance of the method.

3. A method according to claim 1 wherein the heat exchange region of the catheter does not expand during performance of the method.

4. A method according to claim 1 wherein the heat exchange fluid is circulated through the extracorporeally situated heat exchanger in a first direction and blood flows through the vasculature in heat exchange proximity to the heat exchange region in a second direction, said second direction being opposite said first direction.

5. A method according to claim 1 wherein the closed loop heat exchange catheter further comprises a working lumen having an outlet opening located within the subject'"'"'s vasculature and wherein the method further comprises the step of infusing a substance through that lumen and out of the outlet opening.

6. A method according to claim 5 wherein the substance is selected from the group of medicaments consisting of:

a thrombolytic agent;

an anticoagulant;

a neuro-protectant;

a barbiturate;

a anti-seizure agent;

an oxygenated perfusate;

a vaso-dilator;

an agent which prevents vaso-spasm;

a radiographic contrast agent;

an agent to prevent platelet activation; and

, an agent to deter the adhesion of platelets.

7. A method according to claim 1 wherein the closed loop heat exchange catheter further comprises a working lumen having an outlet opening located within the subject'"'"'s vasculature and wherein the method further comprises the step of delivering an apparatus through that lumen and out of the outlet opening.

8. A method according to claim 7 wherein the apparatus passed through the lumen and out of the outlet opening is selected from the group consisting of:

a therapeutic device;

a diagnostic device;

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an embolization member delivering catheter;

an electro-cautery device;

an angiographic catheter;

a sensor; and

,

a microcatheter.

9. A method according to claim 1 wherein the heat exchange region of the catheter cools blood flowing in heat exchange proximity to it with a power of 150 to 350 Watts.

10. A method according to claim 1 wherein the extracorporeally situated heat exchanger has a serpentine flow path through which the heat exchange fluid is circulated.

11. A method according to claim 10 wherein the extracorporeally situated heat exchanger comprises a disposable heat exchanger component.

12. A method according to claim 1 wherein the pump comprises a disposable pump head assembly and a reusable pump drive assembly.