# US 10,478,113 B2 · Bladder event detection for diagnosis of urinary incontinence or treatment of lower urinary tract dysfunction

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- Number: US 10,478,113 B2
- Document ID: US10478113B2
- Status: Granted
- Kind: B2
- Application number: 15/142,704
- Filed: 2016-04-29
- Published: 2016-12-08
- Granted: 2019-11-19
- Earliest claimed: 2015-04-29
- Assignees: The Cleveland Clinic Foundation; Case Western Reserve University; The U.S. Gov't AS Represented By the Dept of Veterans Affairs
- Applicants: The Cleveland Clinic Foundation; Case Western Reserve University; The United States Government as represented by the Department of Veterans Affairs
- Inventors: Margot S. Damaser; Swarup Bhunia; Robert Karam; Steve Majerus; Dennis Bourbeau; Hui Zhu
- Web page: https://patentgrep.com/patent/US10478113B2

## CPC

- A61B 5/205: {Determining bladder or urethral pressure}
- A61B 5/076: {Permanent implantation}
- A61B 5/202: {Assessing bladder functions, e.g. incontinence assessment}
- A61B 5/6874: {Bladder}
- A61B 5/721: {using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured}
- A61B 5/726: {using Wavelet transforms}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61N 1/3606: {adapted for a particular treatment}
- A61N 1/36135: {using physiological parameters}
- A61N 1/36167: {Timing, e.g. stimulation onset}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/03: Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure {; Measuring pressure in body tissues or organs (determining bladder or urethral pressure A61B5/205)}
- A61B 2560/0214: of power generation or supply
- A61B 2560/0219: of externally powered implanted units
- A61B 2562/0247: Pressure sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

The present disclosure relates generally to using detected bladder events for the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction. A system includes a sensing device comprising a pressure sensor to directly detect a pressure within a bladder. The sensing device is adapted to be located within the bladder. The system also includes a signal processing device to: receive a signal indicating the detected pressure within the bladder; detect a bladder event based the detected pressure within the signal; and characterize the bladder event as a bladder contraction event or a non-contraction event. The characterization of the bladder event can be used in the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction.

## Claims

### Claim 1

A system comprising:
a sensing device adapted to be implanted within a patient's bladder, comprising:
a pressure sensor comprising a bridge-type circuit adapted to directly detect a pressure within the patient's bladder;
a wireless transceiver adapted to transmit a signal indicating the pressure within the patient's bladder; and
a battery adapted to provide power to the pressure sensor,
wherein at least one of the circuit, the wireless transceiver, and the battery is sealed within a biocompatible housing; and
a signal processing device comprising:
a wireless transceiver adapted to receive the signal indicating the detected pressure within the patient's bladder;
a processor to execute instructions stored in memory to process the signal and at least:
filter the signal indicating the detected pressure with a low-pass filter with a cutoff frequency tuned for the patient to provide a filtered signal;
apply a multi-level discrete wavelet transform to the filtered signal to provide a transformed signal in a wavelet domain;
apply an adaptive thresholding procedure to the transformed signal in the wavelet domain to detect a bladder event and characterize the bladder event as a voiding contraction event, a non-voiding contraction event, or a non-contraction event based on at least one property of the bladder event according to one or more tunable parameters customized for the patient.

### Claim 2 (depends on 1)

The system of claim 1, wherein the signal processing device signals a neuromodulation device to deliver a stimulation to prevent voiding when the bladder event corresponds to the voiding contraction event.

### Claim 3 (depends on 2)

The system of claim 2, wherein one or more parameters of the stimulation are configured based on the detected pressure.

### Claim 4 (depends on 1)

The system of claim 1, wherein the signal processing device signals a neuromodulation device to deliver a stimulation configured to prevent bladder leakage when the bladder event corresponds to the non-voiding contraction event.

### Claim 5 (depends on 1)

The system of claim 1, further comprising an external sensing device,
wherein the external sensing device further comprises a three-axis accelerometer configured to be located on a torso of a subject to detect an acceleration of the body,
wherein the signal indicating the detected pressure correlates to a signal from the three-axis accelerometer, and
wherein the signal processing device characterizes the bladder event as the non-contraction event based on the signal from the three-axis accelerometer.

### Claim 6 (depends on 1)

The system of claim 1, wherein the signal processing device is adapted to be implantable within the patient or external to the patient.

### Claim 7 (depends on 1)

The system of claim 1, wherein the signal processing device is an application-specific integrated circuit (ASIC), an embedded circuit running software, a custom programmable hardware, or software on a hardware computing device.

### Claim 8 (depends on 1)

The system of claim 1, wherein the sensing device is adapted to be implanted within a wall of the bladder.

### Claim 9

A method comprising:
receiving, by a signal processing device comprising a processor, a signal indicating a pressure detected from a sensing device, wherein the sensing device is implanted within a patient's bladder and comprises:
a pressure sensor comprising a bridge-type circuit adapted to directly detect the pressure within the patient's bladder;
a wireless transceiver adapted to transmit the signal indicating the pressure within the patient's bladder; and
a battery adapted to provide power to the pressure sensor,
wherein at least one of the circuit, the wireless transceiver, and the battery is sealed within a biocompatible housing; and
processing, by the signal processing device, the signal indicating the pressure comprising:
applying, by the signal processing device, a low pass filter to the signal with a cutoff frequency to remove noise from the signal, wherein the cutoff frequency is tuned for the patient;
applying, by the signal processing device, a multi-level discrete wavelet transform to the filtered signal to provide a transformed signal in a wavelet domain; and
applying, by the signal processing device, an adaptive thresholding procedure to the transformed signal in the wavelet domain to detect a bladder event and characterizing the bladder event as a voiding contraction event, a non-voiding contraction event, or a non-contraction event.

### Claim 10 (depends on 9)

The method of claim 9,
when the bladder event is characterized as the voiding contraction event, instructing a neuromodulation event to deliver a stimulation configured to the patient to block voiding, or
when the bladder event is characterized as the non-voiding contraction event, instructing the neuromodulation device to deliver the stimulation configured to block leakage,
wherein one or more parameters of the stimulation are configured based on the detected pressure.

### Claim 11 (depends on 9)

The method of claim 9, wherein the bladder event is characterized as the non-contraction event based on a signal from an external sensor correlated to the signal from the pressure sensor.