# US 10,864,348 B2 · Systems for enhancing sleep

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- Number: US 10,864,348 B2
- Document ID: US10864348B2
- Status: Granted
- Kind: B2
- Application number: 16/046,700
- Filed: 2018-07-26
- Published: 2018-12-27
- Granted: 2020-12-15
- Earliest claimed: 2013-01-02
- Assignees: Ebb Therapeutics, Inc.
- Applicants: Ebb Therapeutics, Inc.
- Inventors: Rick W. Walker; Edward P. G. Doughertry; Jason A. Belton; Robert E. Tucker; Jeffrey J. Schirm
- Web page: https://patentgrep.com/patent/US10864348B2

## CPC

- A61M 21/02: for inducing sleep or relaxation, e.g. by direct nerve stimulation, hypnosis, analgesia (for massage A61H; electrotherapy A61N, e.g. applying alternating or intermittent electric currents for producing anaesthesia A61N1/36021)
- A61F 7/02: Compresses or poultices for effecting heating or cooling
- A61F 2007/0007: {Forehead, e.g. headbands}
- A61F 2007/0054: {with a closed fluid circuit, e.g. hot water}
- A61F 2007/0072: {remote from the spot to be heated}
- A61F 2007/0076: {remote from the spot to be heated or cooled}
- A61F 2007/0093: {programmed}
- A61M 2021/0066: {with heating or cooling}
- A61M 2021/0083: {especially for waking up}
- A61M 2205/3368: Temperature
- A61M 2205/3389: Continuous level detection (A61M2205/3393 takes precedence)
- A61M 2205/362: by gas flow
- A61M 2205/3626: by controlled mixing of fluids at different temperatures
- A61M 2205/3633: thermally insulated
- A61M 2205/3653: by Joule effect, i.e. electric resistance
- A61M 2205/366: by liquid heat exchangers
- A61M 2205/3673: thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
- A61M 2205/42: Reducing noise
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/583: by visual feedback
- A61M 2209/088: on the body
- A61M 2210/06: Head
- A61M 2210/0693: Brain, cerebrum
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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

Methods, devices and systems for improving sleep (including reducing sleep onset and maintenance of sleep duration), enhancing, or increasing sleep, including (but not limited to) treating sleeping disorders such as insomnia.

## Claims

### Claim 1

A thermal system for enhancing a subject's sleep, the system comprising:
a thermal regulator unit having a housing, the thermal regulator unit configured to control the temperature of a thermal transfer fluid;
a thermal applicator configured to be worn against the subject's forehead over the subject's prefrontal and frontal cortex, wherein the thermal applicator is configured to pass thermal transfer fluid from the thermal regulator unit;
a controller within the thermal regulator unit configured to regulate the temperature of the thermal transfer fluid based on one or more thermal control profiles to modulate the subject's sleep by controlling a temperature of the thermal applicator; and
a cartridge containing thermal transfer fluid in a reservoir and configured to insert into a top of the thermal regulator unit, the cartridge having a valve on a bottom of the cartridge and a vent on a top of the cartridge, wherein the vent comprises a material that is air-permeable but not liquid-permeable and is configured to allow air into the reservoir.

### Claim 2 (depends on 1)

The system of claim 1, wherein the controller is configured to maintain the temperature of the thermal transfer fluid so that the temperature of the thermal applicator is at a target temperature selected from the range consisting of: about 10 degrees C. to about 41 degrees C.

### Claim 3 (depends on 1)

The system of claim 1, wherein the thermal regulator unit comprises one or more of: a Peltier device, a resistive heater, and a fan.

### Claim 4 (depends on 1)

The system of claim 1, wherein the thermal applicator is adapted to thermally regulate only the region of the subject's head over the prefrontal and frontal cortex, but not other regions of the subject's head and face including the eye orbits.

### Claim 5 (depends on 1)

The system of claim 1, wherein the controller comprises a plurality of thermal control profiles configured to cause the controller to regulate the temperature of the thermal transfer fluid.

### Claim 6 (depends on 1)

The system of claim 1, wherein the thermal regulator unit comprises a thermal electric module configured to heat, cool, or heat and cool the thermal transfer fluid.

### Claim 7 (depends on 1)

The system of claim 1, further comprising a fluid conduit connecting the thermal regulator unit and the thermal applicator, the fluid conduit configured to transfer thermal transfer fluid between the thermal regulator unit and the thermal applicator.

### Claim 8 (depends on 1)

The system of claim 1, further comprising a fluid level detector within the thermal regulator unit configured to monitor the level of thermal transfer fluid within the system.

### Claim 9 (depends on 1)

The system of claim 1, further comprising a control in communication with the thermal regulator unit configured to allow the subject to select the one or more thermal control profiles.

### Claim 10 (depends on 1)

The system of claim 1, wherein the thermal regulator unit comprises a second reservoir for thermal transfer fluid within an internal plumbing of the thermal regulator that is configured to be thermally regulated by a thermal electric module of the thermal regulator unit, and a second valve configured to transfer fluid between the reservoir of the cartridge and the second reservoir to maintain a level of thermal transfer fluid within the second reservoir.

### Claim 11

A thermal system for enhancing a subject's sleep, the system comprising:
a thermal regulator unit having a housing, the thermal regulator unit configured to control the temperature of a thermal transfer fluid;
a thermal electric module within the thermal regulator unit configured to heat, cool, or heat and cool the thermal transfer fluid;
a first reservoir of thermal transfer fluid within an internal plumbing of the thermal regulator, wherein the first reservoir is configured to be thermally regulated by the thermal electric module;
a second reservoir of thermal transfer fluid that is not thermally regulated by the thermal electric module, wherein the second reservoir comprises a removable cartridge configured to insert into a top of the thermal regulator unit, the cartridge having a first valve on a bottom of the cartridge and a vent on a top of the cartridge, wherein the vent comprises a material that is air-permeable but not liquid-permeable and is configured to allow air into the second reservoir;
a second valve configured to transfer fluid between the first reservoir and the second reservoir to maintain a level of thermal transfer fluid within the first reservoir;
a thermal applicator configured to be worn against a subject's forehead over the subject's prefrontal and frontal cortex, wherein the thermal applicator is configured to pass thermal transfer fluid from the thermal regulator unit; and
a controller within the thermal regulator unit configured to regulate the temperature of the thermal transfer fluid based on one or more thermal control profiles to modulate the subject's sleep by controlling a temperature of the thermal applicator, wherein the controller is configured to modify the temperature of the thermal transfer fluid.

### Claim 12 (depends on 11)

The system of claim 11, wherein the controller is configured to maintain the temperature of the thermal transfer fluid in the first reservoir so that the temperature of the thermal applicator is at a target temperature selected from the range consisting of: about 10 degrees C. to about 41 degrees C.

### Claim 13 (depends on 11)

The system of claim 11, further wherein the controller is configured to modify the temperature of the thermal transfer fluid at a predetermined wakeup time.

### Claim 14 (depends on 11)

The system of claim 11, further comprising a clock having a clock display.

### Claim 15 (depends on 11)

The system of claim 11, wherein the thermal applicator is adapted to thermally regulate only the region of the subject's head over the prefrontal and frontal cortex, but not other regions of the subject's head and face including the eye orbits.

### Claim 16 (depends on 11)

The system of claim 11, wherein the controller comprises a plurality of thermal control profiles configured to cause the controller to regulate the temperature of the thermal transfer fluid.

### Claim 17 (depends on 11)

The system of claim 11, wherein the thermal regulator unit comprises one or more of: a Peltier device, a resistive heater, and a fan.

### Claim 18 (depends on 11)

The system of claim 11, further comprising a fluid conduit connecting the thermal regulator unit and the thermal applicator, the fluid conduit configured to transfer thermal transfer fluid between the first reservoir and the thermal applicator.

### Claim 19 (depends on 11)

The system of claim 11, further comprising a fluid level detector within the first reservoir configured to monitor the level of thermal transfer fluid within the first reservoir.

### Claim 20 (depends on 11)

The system of claim 11, further comprising a control in communication with the thermal regulator unit configured to allow the subject to select the one or more thermal control profiles.

### Claim 21 (depends on 11)

The system of claim 11, further comprising a headgear configured to maintain the thermal applicator in contact with just the region of the subject's head over the prefrontal and frontal cortex.
