Bladder event detection for diagnosis of urinary incontinence or treatment of lower urinary tract dysfunction

• US 10,478,113 B2
• Filed: 04/29/2016
• Issued: 11/19/2019
• Est. Priority Date: 04/29/2015
• Status: Active Grant

• Current Assignee: Case Western Reserve University, Cleveland Clinic Foundation, US Department of Veterans Affairs (Government of the United States of America)
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Damaser, Margot S., Bhunia, Swarup, Karam, Robert, Majerus, Steve, Bourbeau, Dennis, Zhu, Hui
• Primary Examiner(s): Abouelela, May A
• Application Number:
  US15/142,704
• Publication Number:
  US 20160354028A1
• Time in Patent Office: 1,299 Days
• Field of Search: 600300, 600561, 600573, 600549, 600562
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

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

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.

2. 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.

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

4. 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.

5. 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.

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

7. 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.

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

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.

10. 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.

11. 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.