# US 10,869,778 B1 · Devices, systems, and methods for temperature management

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- Number: US 10,869,778 B1
- Document ID: US10869778B1
- Status: Granted
- Kind: B1
- Application number: 15/703,629
- Filed: 2017-09-13
- Granted: 2020-12-22
- Earliest claimed: 2016-09-13
- Assignees: Advanced Cooling Therapy, Inc.
- Applicants: Advanced Cooling Therapy, Inc.
- Inventors: Erik Kulstad
- Web page: https://patentgrep.com/patent/US10869778B1

## CPC

- A61F 7/12: Devices for heating or cooling internal body cavities
- A61F 2007/0054: {with a closed fluid circuit, e.g. hot water}
- 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

The present technology relates to systems and methods for managing core body temperature in a subject using, for example, an esophageal heat exchange device. In one aspect, the disclosure provides a method for reducing duration of a hospital stay in a subject undergoing core body temperature management.

## Claims

### Claim 1

A method for controlling core body temperature in a subject in need thereof, the method comprising the steps of:
providing a heat exchange device, the heat exchange device comprising a heat exchange region having at least one lumen providing a fluid path for flow of a heat exchange medium;
orally placing at least a portion of the heat exchange region of the heat exchange device in an esophagus of the subject, wherein a proximal portion of the heat exchange region extends beyond an oral cavity of the subject, wherein a thermally insulating sleeve surrounds at least part of an outer surface of the proximal portion of the heat exchange region extending beyond the oral cavity of the subject, wherein the thermally insulating sleeve comprises an elongate tubular structure;
positioning the thermally insulating sleeve between the proximal portion of the heat exchange region and exposed skin of the subject to reduce or prevent direct contact between the outer surface of the proximal portion of the heat exchange region and the exposed skin of the subject; and
initiating flow of the heat exchange medium through the fluid path.

### Claim 2 (depends on 1)

The method of claim 1, wherein the positioning step comprises securing the proximal portion of the heat exchange region with a securement device.

### Claim 3 (depends on 2)

The method of claim 2, wherein the securement device is an anchor pad.

### Claim 4 (depends on 1)

The method of claim 1, further comprising assessing the subject for a shivering response.

### Claim 5 (depends on 1)

The method of claim 1, further comprising providing at least one anti-shivering intervention if the subject demonstrates mild to severe shivering.

### Claim 6 (depends on 1)

The method of claim 1, wherein the device further comprises a heat exchange medium input region in fluid communication with the heat exchange region, wherein the input region comprises an input tube for delivering the heat exchange medium from a source to the lumen of the heat exchange region.

### Claim 7

A method for reducing duration of a hospital stay in a subject undergoing core body temperature management, the method comprising the steps of:
providing a heat exchange device, the heat exchange device comprising a heat exchange region having at least one lumen providing a fluid path for flow of a heat exchange medium;
orally placing the heat exchange region of the heat exchange device in an esophagus of the subject;
positioning a proximal portion of the heat exchange region that extends beyond an oral cavity of the subject to reduce or prevent direct contact between an outer surface of the proximal portion of the heat exchange region and exposed skin of the subject, wherein a thermally insulating sleeve comprises an elongate tubular structure that surrounds at least part of an outer surface of the proximal portion of the heat exchange region extending beyond the oral cavity of the subject;
initiating flow of the heat exchange medium through the fluid path to control core body temperature of the subject prior to initiation of any anti-shivering interventions;
assessing the subject for a shivering response; and
providing at least one anti-shivering intervention if and only if the subject demonstrates mild to severe shivering.

### Claim 8 (depends on 7)

The method of claim 7, wherein the positioning step comprises securing the proximal portion of the heat exchange region with a securement device.

### Claim 9 (depends on 8)

The method of claim 8, wherein the securement device is an anchor pad.

### Claim 10 (depends on 7)

The method of claim 7, wherein the anti-shivering intervention is a non-sedating anti-shivering intervention, the non-sedating anti-shivering intervention comprising (i) administering an anti-shivering agent selected from the group consisting of acetaminophen, buspirone, magnesium sulfate, nephopam, meperidine, and combinations thereof or (ii) skin counter-warming.