# US 10,369,044 B2 · Inhibition of platelet activation, aggregation and/or adhesion by hypothermia

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- Number: US 10,369,044 B2
- Document ID: US10369044B2
- Status: Granted
- Kind: B2
- Application number: 15/174,690
- Filed: 2016-06-06
- Published: 2016-12-08
- Granted: 2019-08-06
- Earliest claimed: 2001-02-21
- Assignees: Zoll Circulation, Inc.
- Applicants: ZOLL Circulation Inc.
- Inventors: Michael W. Dae; Timothy R. Machold; Wade A. Keller
- Web page: https://patentgrep.com/patent/US10369044B2

## CPC

- A61F 7/12: Devices for heating or cooling internal body cavities
- A61F 7/123: {using a flexible balloon containing the thermal element}
- A61F 2007/126: {for invasive application, e.g. for introducing into blood vessels}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method for treating acute coronary syndromes (i.e., unstable angina or non-Q-wave MI) or transient ischemic attacks in a human or animal patient by placing a heat exchange apparatus in the patient=s vasculature and using that heat exchange apparatus to cool the patient to a temperature (e.g. 30-36 degrees C.) at which platelet inhibition (i.e., inhibition of platelet activation and/or aggregation and/or adhesion) occurs. Anti-shivering drugs or anesthesia may be administered to patients whose body temperature is cooled below that patient=s shivering threshold (typically approximately 35.5 degrees C.). If it is determined that platelet inhibition is no longer desirable, such as when the patient is about to undergo a surgical or interventional procedure wherein bleeding could be problematic, the hypothermia-induced platelet inhibition may be rapidly reversed by using the intravascular heat exchange apparatus to re-warm the patient=s body to normothermia or near normothermia.

## Claims

### Claim 1

A method for causing temporary platelet inhibition in a human or veterinary patient in whom an initial diagnosis or clinical impression has been reached indicating that the patient suffers from an acute coronary syndrome, transient ischemic attack or other disorder that may benefit from therapeutic platelet inhibition, said method comprising the steps of:
placing an intravascular heat exchange apparatus within the vasculature of the patient; and,
using the intravascular heat exchange apparatus to cool at least a portion of the patient's body to a temperature which causes platelet inhibition to occur and maintaining said temperature for a period of time, and, thereafter,
rewarming said at least a portion of the patient's body to a temperature at which platelet inhibition is no longer caused to occur.

### Claim 2 (depends on 1)

A method according to claim 1 wherein:
the intravascular heat exchange apparatus comprises a heat exchange catheter having a heat exchange region; and
the placing Step comprises inserting the heat exchange catheter into the vasculature of a patient and positioning said catheter so that the heat exchange region is in contact with blood flowing to the heart; and
the using Step comprises exchanging heat with the blood at the heat exchange region; and
said period of time comprises a time period sufficient to cause said platelet inhibition.

### Claim 3 (depends on 1)

A method as in claim 1 wherein the said period of time is less than 4 hours.

### Claim 4 (depends on 1)

A method according to claim 1 wherein said temperature which causes platelet inhibition to occur is below approximately 36° C. but greater than approximately 30° C.

### Claim 5 (depends on 4)

A method according to claim 4 wherein the temperature which causes platelet inhibition to occur is between approximately 32° C. and approximately 34° C.

### Claim 6 (depends on 1)

A method according to claim 1 wherein the intravascular heat exchange apparatus comprises an elongate flexible catheter that comprises a heat exchanger.

### Claim 7 (depends on 6)

A method according to claim 6 wherein the heat exchanger of the catheter comprises less than the full length of the catheter that becomes placed in the patients vasculature.

### Claim 8 (depends on 1)

A method according to claim 1 wherein the heat exchange apparatus is placed in the patient's venous vasculature.

### Claim 9 (depends on 8)

A method according to claim 8 wherein the heat exchange apparatus is placed in the patient's vena cava.

### Claim 10 (depends on 9)

A method according to claim 9 wherein the heat exchange apparatus is placed in the patient's inferior vena cava.

### Claim 11 (depends on 9)

A method according to claim 9 wherein the heat exchange apparatus is placed in the patient's superior vena cava.

### Claim 12 (depends on 1)

A method according to claim 1 wherein at least one surface projection is formed on the heat exchange apparatus to increase the effective heat exchange surface area of the heat exchange apparatus.

### Claim 13 (depends on 12)

A method according to claim 12 wherein the at least one surface projection comprises a fin.

### Claim 14 (depends on 13)

A method according to claim 13 wherein said fin comprises a raised area on at least a blood-contacting surface of the heat exchange apparatus.

### Claim 15 (depends on 13)

A method according to claim 13 wherein said fin comprises a ridge.

### Claim 16 (depends on 13)

A method according to claim 13 wherein said fin comprises a bulge.

### Claim 17 (depends on 1)

A method according to claim 1 further comprising the steps of:
ceasing the use of the heat exchange apparatus to cool at least a portion of the patient's body; and,
removing the heat exchange apparatus from the patient's body.

### Claim 18 (depends on 1)

A method according to claim 1 wherein the method is carried out in a patient who has been diagnosed with unstable angina.

### Claim 19 (depends on 1)

A method according to claim 1 wherein the method is carried out in a patient who has been diagnosed with non-Q wave myocardial infarction.
