# US 11,305,113 B2 · Nocturia reduction system

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- Number: US 11,305,113 B2
- Document ID: US11305113B2
- Status: Granted
- Kind: B2
- Application number: 16/142,258
- Filed: 2018-09-26
- Published: 2019-05-16
- Granted: 2022-04-19
- Earliest claimed: 2017-11-11
- Assignees: Neurostim Solutions, LLC
- Applicants: Neurostim Solutions LLC
- Inventors: Hoo-Min D. Toong
- Web page: https://patentgrep.com/patent/US11305113B2

## CPC

- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- A61B 8/4227: {characterised by straps, belts, cuffs or braces}
- A61B 8/5223: {for extracting a diagnostic or physiological parameter from medical diagnostic data (for algorithms to analyse biomedical images G06T7/0012)}
- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- A61N 1/36031: {using physiological parameters for adjustment}
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 5/204: {Determining bladder volume}
- A61B 5/4812: {Detecting sleep stages or cycles}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Example inventions reduce nocturia for a user. Examples determine that the user is sleeping, determine that the user has an urge to urinate, and then apply external electrical stimulation to a tibial nerve of the user.

## Claims

### Claim 1

A method of reducing nocturia for a user, the method comprising:
affixing a patch externally on a dermis of a user adjacent to a tibial nerve of the user;
determining that the user is sleeping during a sleep period that comprises a beginning sleep period and an ending sleep period;
while the user is sleeping, anticipating that the user may experience an urge to urinate based on detecting a state of a bladder of the user; and
while the user is sleeping during the sleep period and in response to anticipating that the user may experience the urge to urinate, applying external electrical stimulation to the tibial nerve of the user via the patch, the external electrical stimulation adapted to cause the anticipated urge to urinate to be suppressed and the applying comprising an initial electrical stimulation that begins only during the sleep period and only in response to the anticipation that the user may experience the urge to urinate.

### Claim 2 (depends on 1)

The method of claim 1, the determining that the user is sleeping further comprises determining whether the user is in a prone state or a non-prone state, and when it is determined that the user is in the non-prone state after the beginning sleep period, automating activating lighting on a route to a toilet.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
determining a sleep cycle of the user while the user is sleeping; and
applying external electrical stimulation to the tibial nerve of the user during a rapid eye movement (REM) sleep cycle or during Stages 3 and 4 sleep cycles.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
determining a sleep cycle of the user while the user is sleeping; and
cancelling the application of external electrical stimulation to the tibial nerve of the user during a non-rapid eye movement (NREM) sleep cycle.

### Claim 5 (depends on 3)

The method of claim 3, further comprising:
in response to anticipating that the user may experience the urge to urinate, waking up the user at a time not during the REM sleep cycle or not during the Stages 3 and 4 sleep cycles.

### Claim 6 (depends on 1)

The method of claim 1, the anticipating that the user may experience the urge to urinate comprises using a machine learning model that was trained from a sleep history of a plurality of users.

### Claim 7 (depends on 1)

The method of claim 1, the applying external electrical stimulation to the tibial nerve of the user is automatically activated in response to a signal from a bladder monitoring device, the patch comprising a flexible substrate, a processor directly coupled to the substrate, and electrodes directly coupled to the substrate.

### Claim 8

A nocturia reduction system comprising:
a patch configured to be coupled to an ankle of a user and comprising a processor, electrodes and a communication device, the patch comprising a flexible substrate, the processor, the electrodes and the communication device directly coupled to the substrate;
a bladder monitoring device configured to determine a state of a bladder of the user while the user is sleeping to anticipate that the user may experience an urge to urinate; and
a sleep detection device configured to determine a sleep state of the user comprising determining that the user is sleeping during a sleep period that comprises a beginning sleep period and an ending sleep period;
the patch further configured to apply external electrical stimulation via the electrodes to a tibial nerve of the user in response to an activation signal while the user is sleeping during the sleep period and in response to anticipating that the user may experience the urge to urinate, the external electrical stimulation adapted to cause the anticipated urge to urinate to be suppressed and the applying comprising an initial electrical stimulation that begins only during the sleep period and only in response to the anticipation that the user may experience the urge to urinate.

### Claim 9 (depends on 8)

The nocturia reduction system of claim 8, in which the determining the sleep state comprises determining whether the user is in a prone state or a non-prone state and when it is determined that the user is in the non-prone state after the beginning sleep period, automating activating lighting on a route to a toilet.

### Claim 10 (depends on 8)

The nocturia reduction system of claim 8, in which the determining the sleep state comprises determining a sleep cycle of the user while the user is sleeping; and
the apply external electrical stimulation to the tibial nerve of the user configured to occur during a rapid eye movement (REM) sleep cycle or during Stages 3 and 4 sleep cycles.

### Claim 11 (depends on 8)

The nocturia reduction system of claim 8, the determine the sleep state further comprises determining a sleep cycle of the user while the user is sleeping; and
cancelling the application of external electrical stimulation to the tibial nerve of the user during a non-rapid eye movement (NREM) sleep cycle.

### Claim 12 (depends on 10)

The nocturia reduction system of claim 10, further comprising a wake up device configured to, in response to the anticipating that the user may experience the urge to urinate, waking up the user at a time not during the REM sleep cycle or not during the Stages 3 and 4 sleep cycles.

### Claim 13 (depends on 8)

The nocturia reduction system of claim 8, the state of the bladder further comprising an urge of the user to urinate, the state determined using a machine learning model that is trained from a sleep history of a plurality of users.

### Claim 14 (depends on 8)

The nocturia reduction system of claim 8, the activation signal automatically generated by the bladder monitoring device.

### Claim 15

A non-transitory computer readable medium having instructions stored thereon that, when executed by one or more processors, cause the processors to reduce nocturia for a user via a patch externally affixed on a dermis of a user adjacent to a tibial nerve of the user, the reducing comprising:
determining that the user is sleeping during a sleep period that comprises a beginning sleep period and an ending sleep period;
while the user is sleeping, anticipating that the user may experience an urge to urinate based on detecting a state of a bladder of the user; and
while the user is sleeping during the sleep period and in response to anticipating that the user may experience the urge to urinate, applying external electrical stimulation to the tibial nerve of the user via the patch, the external electrical stimulation adapted to cause the anticipated urge to urinate to be suppressed and the applying comprising an initial electrical stimulation that begins only during the sleep period and only in response to the anticipation that the user may experience the urge to urinate.

### Claim 16 (depends on 15)

The non-transitory computer readable medium of claim 15, the determining that the user is sleeping further comprises determining whether the user is in a prone state or a non-prone state, and when it is determined that the user is in the non-prone state after the beginning sleep period, automating activating lighting on a route to a toilet.

### Claim 17 (depends on 15)

The non-transitory computer readable medium of claim 15, the reducing further comprising:
determining a sleep cycle of the user while the user is sleeping; and
applying external electrical stimulation to the tibial nerve of the user during a rapid eye movement (REM) sleep cycle or during Stages 3 and 4 sleep cycles.

### Claim 18 (depends on 15)

The non-transitory computer readable medium of claim 15, the reducing further comprising:
determining a sleep cycle of the user while the user is sleeping; and
cancelling the application of external electrical stimulation to the tibial nerve of the user during a non-rapid eye movement (NREM) sleep cycle;
the patch comprising a flexible substrate, the one or more processors directly coupled to the substrate, and electrodes directly coupled to the substrate.

### Claim 19 (depends on 17)

The non-transitory computer readable medium of claim 17, the reducing further comprising:
in response to anticipating that the user may experience the urge to urinate, waking up the user at a time not during the REM sleep cycle or not during the Stages 3 and 4 sleep cycles.

### Claim 20 (depends on 15)

The non-transitory computer readable medium of claim 15, the anticipating that the user may experience the urge to urinate further comprises using a machine learning model that is trained from a sleep history of a plurality of users.

### Claim 21 (depends on 1)

The method of claim 1, the anticipating that the user may experience the urge to urinate comprising:
collecting a user's biometric data;
determining when a user has an urge to urinate;
correlating the user's biometric data with the urge to urinate to detect urination patterns; and
creating a user profile of urination patterns based on the urination patterns.

### Claim 22 (depends on 21)

The method of claim 21, further comprising integrating a user's medical data into the user profile.