Methods and apparatus for regional and whole body temperature modification

• US 6,620,188 B1
• Filed: 08/24/1998
• Issued: 09/16/2003
• Est. Priority Date: 08/24/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, legally incapacitated, Robert, Machold, Timothy R., Dineen, Michael T.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/138,830
• Time in Patent Office: 1,849 Days
• Field of Search: 607/96, 607/104-107, 607/108-112, 607/114
• 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

Methods and apparatus for temperature modification of selected body regions including an induced state of local hypothermia of the brain region for neuroprotection. A heat exchange catheter is provided with heat transfer fins projecting or extending outward from the catheter which may be inserted into selected blood vessels or body regions to transfer heat with blood or fluid in the selected blood vessels or body regions. Another aspect of the invention further provides methods and apparatus for controlling the internal body temperature of a patient. By selectively heating or cooling a portion of the catheter lying within a blood vessel, heat may be transferred to or from blood flowing within the vessel to increase or decrease whole body temperature or the temperature of a target region. Feed back from temperature sensors located within the patient'"'"'s body allow for control of the heat transfer from the catheter to automatically control the temperature of the patient or of the target region within the patient. The apparatus may include a blood channeling sleeve that directs body fluid over a heat exchanger where the body fluid'"'"'s temperature is altered, and then is discharged out the distal end of the sleeve to a desired location, for example, cooled blood to the brain for neuroprotection. The catheter may be used alone or in conjunction with other heat exchangers to cool one region of a patient'"'"'s body while heating another.

Claims

1. A method for maintaining or changing the temperature of at least a portion of the body of a human or veterinary patient, said method comprising the steps of:

A. providing a heat exchange system which comprises i) an elongate flexible heat exchange catheter having at least one recirculating-fluid-type intracorporeal heat exchanger, said catheter being insertable into the vasculature of the patient such that the intracorporeal heat exchanger is in contact with the patient'"'"'s blood;

ii) an extracorporeal heat exchange member configured to contain a quantity of thermal exchange fluid, said heat exchange member being attachable to the catheter in such manner as to form a substantially enclosed fluid flow path through which thermal exchange fluid is circulated from the extracorporeal heat exchange member through the intracorporeal heat exchanger of the catheter, and iii) an extracorporeally located device for heating or cooling thermal exchange fluid contained within the extracorporeal heat exchange member, the extracorporeal heat exchange member being insertable into and removable from the device for heating or cooling;

iv) at least one temperature sensor for determining the temperature of at least the portion of the patient'"'"'s body wherein temperature is to be changed or maintained, and v) a controller that receives input of a target body temperature as well as body temperature information from the temperature sensor and, in response to such target body temperature input and body temperature information received from the temperature sensor, controls the amount and direction of heat exchange occurring through the intracorporeal heat exchanger while avoiding heating or cooling of the heat exchanger to any temperature that will cause substantial destruction of blood cells;

B. inserting the catheter into the patient'"'"'s vasculature and positioning the catheter such that the intracorporeal heat exchanger is positioned in a blood vessel through which blood flows;

C. inserting the extracorporeal heat exchange member on or in the extracorporeally located device for heating or cooling such that heat exchange fluid within the extracorporeal heat exchange member is heated or cooled; and

D. positioning the temperature sensor so as to sense the temperature of at least the portion of the patient'"'"'s body wherein temperature is to be changed or maintained;

E. inputting into the controller a target body temperature and, thereafter, operating the system such that the controller controls the amount and direction of heat exchange between the patient'"'"'s blood and the intracorporeal heat exchanger to control the sensed body temperature relative to the input target body temperature while avoiding heating or cooling of the intracorporeal heat exchanger to any temperature that will cause substantial destruction of blood cells.

2. The method of claim 1 wherein the selected region of the patient'"'"'s body is selected from the group consisting of:

the brain;

a selected portion of the brain;

the spinal chord;

an organ;

an intra-abdominal organ;

the spleen;

the liver;

the heart;

a portion of the heart;

a lung;

a kidney;

a muscle;

a tumor;

a site where trauma has occurred; and

,

a site where hemorrhage has occurred.

3. The method of claim 1 wherein the catheter device provided in Step A comprises:

i) an elongate, flexible catheter having a proximal end and a distal end;

ii) at least one fluid lumen through which a thermal exchange fluid may be circulated from the extracorporeal heat exchange member through the catheter; and

,

wherein said heat exchanger is located at a first location on the catheter and is operative to exchange heat between blood which flows in heat exchanging proximity to the heat exchanger and the thermal exchange fluid which is circulated through said catheter.

5. The method of claim 1 wherein the catheter device provided in Step A further comprises (iv) a body fluid channeling sleeve formed about a segment of said catheter whereon said heat exchanger is located such that a fluid flow space exists between said catheter and said body fluid channeling sleeve, said body fluid channeling sleeve having a body fluid inlet located proximal to the heat exchanger and a body fluid outlet located distal to said heat exchanger, and wherein the catheter is positioned in Step B such that body fluid which exists the body fluid outlet will flow to the anatomical conduit through which body fluid flows to the selected region of the patient'"'"'s body.

6. The method of claim 5 wherein the catheter is further positioned in Step B such that the body fluid outlet is within a first anatomical conduit which leads to said selected region and the body fluid inlet is within a second anatomical conduit, body fluid from said second anatomical conduit being thereby channeled through the body fluid channeling sleeve in heat exchanging proximity to the heat exchanger, and subsequently flowing into said first anatomical conduit to change the temperature of said selected region of the patient'"'"'s body.

7. The method of claim 1 further comprising the steps of:

D. providing a second catheter having a heat exchanger which is operative to exchange heat between blood which flows in heat exchanging proximity to said heat exchanger;

E. inserting the second catheter into a second anatomical conduit of the patient'"'"'s body through which a body fluid flows from the selected region of the patient'"'"'s body, and positioning the catheter such that body fluid which has changed the temperature of the selected region will pass in heat exchanging proximity to the heat exchanger of the second catheter; and

,

F. utilizing the heat exchanger of the second catheter device to change the temperature of the body fluid which passes in heat exchanging proximity to the heat exchanger, such that said body fluid will be approximately the same as it was before it had undergone the previous temperature change in Step C of the method.

8. The method of claim 1 wherein Step D is carried out until the region of the patient'"'"'s body is warmed to temperature above normal body temperature.

9. The method of claim 1 wherein Step D is carried out until the selected region of the patient'"'"'s body is cooled to a temperature below normal body temperature.

10. The method of claim 1 wherein the catheter provided in Step A further comprises a working lumen and wherein the positioning of the catheter in Step B is accomplished by advancing the catheter over a guide wire.

11. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

D. infusing a medicament through the working lumen of the catheter.

12. The method of claim 11 wherein the medicament 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;

an agent to prevent platelet activation; and

,

an agent to deter the adhesion of platelets.

13. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

D. infusing a radiographic contrast agent through the working lumen of the catheter to permit imaging in the selected region of the patient'"'"'s body.

14. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

D. passing a therapeutic apparatus through the working lumen of the catheter and using such therapeutic apparatus to perform a therapeutic task in the selected region of the patient'"'"'s body.

15. The method of claim 14 wherein the therapeutic apparatus passed through the working lumen of the catheter in Step D is selected from the group of therapeutic apparatus consisting of:

an angioplasty catheter;

an embolectomy catheter;

an occlusion member delivering catheter;

an embolization member delivering catheter;

an electro-cautery device; and

,

a microcatheter.

16. The method of claim 1 wherein the catheter device provided in Step A further comprises a working lumen and wherein the method further comprises the step of:

D. passing a diagnostic device through the working lumen of the catheter and using such diagnostic device to perform a diagnostic procedure.

17. The method of claim 16 wherein the diagnostic device is selected from the group consisting of:

an angiographic catheter;

a sensor.

18. A method according to claim 1 wherein the heat exchange system provided in Step A further comprises a priming inlet port that is connectable to a source of fluid for priming the substantially closed fluid flow path.

4. The method of Step 3 wherein Step C of the method is carried out by circulating a thermal exchange fluid from the extracorporeal heat exchange member and through the fluid lumen of the catheter.