Bladder event detection for diagnosis of urinary incontinence or treatment of lower urinary tract dysfunction
Inventors
Damaser, Margot S. • Bhunia, Swarup • Karam, Robert • Majerus, Steve • Bourbeau, Dennis • Zhu, Hui
Assignees
Cleveland Clinic Foundation • Case Western Reserve University • US Department of Veterans Affairs
Publication Number
US-10478113-B2
Publication Date
2019-11-19
Expiration Date
2036-04-29
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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.
Core Innovation
The invention relates to systems and methods for categorizing detected bladder events to aid in the diagnosis of urinary incontinence or the treatment of lower urinary tract dysfunction. It uses a single sensing device implanted within the bladder, specifically a pressure sensor, to directly detect pressure changes and characterize bladder events as contraction events or non-contraction events. This categorization supports automated and accurate diagnosis and targeted treatment.
The problem being solved is the discomfort and impracticality of traditional urinary incontinence diagnosis and lower urinary tract dysfunction treatments that rely on multiple sensors and non-physiological test conditions. Existing methods require two or more pressure sensors and fast cystometric filling, which can be inconvenient for extended ambulatory urodynamics. Additionally, state-of-the-art neuromodulation treatment uses open-loop electrical stimulation without feedback, which can cause habituation and reduced effectiveness. This invention addresses the need for a less invasive, accurate, and feedback-driven system.
The disclosed system includes a sensing device implanted within the bladder wall, equipped with a pressure sensor, wireless transceiver, and rechargeable battery, which transmits bladder pressure signals to a processing device. The processing device applies signal conditioning techniques including digital filtering and multi-level wavelet transform, followed by a multi-resolution context-aware adaptive thresholding procedure to detect and classify bladder events in real-time. The system can tune parameters to individual patients to optimize accuracy, enabling classifications such as voiding contraction, non-voiding contraction, or non-contraction events. Outputs can be used both for diagnosis and for guiding conditional neuromodulation therapy.
Claims Coverage
The claims include one independent system claim and one independent method claim, each describing key inventive features related to sensing bladder pressure, signal processing, and event classification.
Single-sensor bladder pressure detection system
A system comprising a sensing device adapted for implantation within a patient’s bladder, including a bridge-type pressure sensor to directly detect bladder pressure, a wireless transceiver to transmit signals indicating detected pressure, and a battery within a biocompatible housing.
Adaptive signal processing for bladder event detection and characterization
A signal processing device receiving the transmitted bladder pressure signal, performing low-pass filtering with a patient-tuned cutoff frequency, applying multi-level discrete wavelet transform, and performing adaptive thresholding to detect bladder events and characterize them as voiding contraction, non-voiding contraction, or non-contraction events using tunable parameters customized for the patient.
Neuromodulation device signaling based on bladder event characterization
The signal processing device signaling a neuromodulation device to deliver stimulation to prevent voiding upon detection of a voiding contraction event or to prevent leakage upon detection of a non-voiding contraction event, with stimulation parameters configurable based on detected pressure.
Use of external sensing device to improve event characterization
Inclusion of an external sensing device comprising a three-axis accelerometer on the subject’s torso to detect body acceleration; correlating these signals with the bladder pressure signal to aid in classifying bladder events, particularly to recognize and exclude non-contraction events caused by motion artifacts.
The claims collectively protect a patient-implantable system using a single bladder pressure sensor coupled with adaptive signal processing and classification methods to accurately detect and characterize bladder events. This system supports closed-loop neuromodulation therapy by signaling stimulation devices based on real-time bladder activity detected by the system.
Stated Advantages
The system provides accurate detection and categorization of bladder events using only a single implanted pressure sensor, reducing invasiveness and discomfort compared to multi-sensor systems.
The use of multi-resolution context-aware adaptive thresholding with tunable parameters allows patient-specific customization for improved detection accuracy and minimized false positives.
The system facilitates closed-loop neuromodulation by reliably signaling stimulation devices to prevent voiding or leakage based on detected bladder events.
Signal processing techniques effectively remove noise and distinguish true bladder contractions from artifacts such as abdominal pressure changes or motion, improving reliability in ambulatory settings.
Documented Applications
Diagnosis of urinary incontinence by classifying bladder events into voiding contractions, non-voiding contractions, or non-contraction events.
Treatment of lower urinary tract dysfunction through conditional bladder stimulation controlled in a closed-loop fashion based on detected bladder events.
Use in ambulatory urodynamics testing with a single sensor implant to monitor bladder activity under natural physiological conditions for extended periods.
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