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-11419533-B2
Publication Date
2022-08-23
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 present disclosure relates to systems and methods for using detected bladder events to diagnose urinary incontinence or treat lower urinary tract dysfunction. The invention utilizes a sensing device with a pressure sensor positioned within the bladder to directly detect bladder pressure. A signal processing device receives the detected pressure signal, detects bladder events from the signal, and characterizes these events as bladder contraction or non-contraction events. This characterization aids in diagnosis or treatment.
The problem being solved addresses limitations of traditional two-sensor systems and urodynamics testing that are inconvenient, uncomfortable, and non-physiological for extended or ambulatory monitoring. Existing electrical stimulation treatments use open-loop neuromodulation, which can lead to habituation and decreased efficacy. A single-sensor approach with real-time categorization enables closed-loop control without the need for multiple sensors, improving diagnostic accuracy and treatment effectiveness for urinary incontinence and lower urinary tract dysfunction.
Claims Coverage
The patent includes two independent claims covering a system and a method, each focused on detecting and characterizing bladder events using a signal from a pressure sensor within the bladder and applying adaptive signal processing.
Detection and characterization of bladder events using signal processing
The system or method receives a pressure signal detected within a patient's bladder by a sensing device positioned in the bladder. It filters the signal with a low-pass filter with a cutoff frequency tuned for the patient, applies a multi-level discrete wavelet transform to obtain a wavelet domain signal, and applies an adaptive thresholding procedure to detect bladder events. The bladder events are characterized as voiding contraction events, non-voiding contraction events, or non-contraction events based on one or more tunable parameters customized for the patient.
Single sensing device with bridge-type pressure sensor implanted within patient's bladder
The system includes a sensing device that has a circuit with a bridge-type pressure sensor adapted to directly detect bladder pressure, configured to be positioned within the patient's bladder. The sensing device further comprises a wireless transceiver adapted to transmit the pressure signal and a battery to power the pressure sensor.
Signal processing device for receiving and processing bladder pressure signals
The system includes a signal processing device with memory and processor to execute instructions performing filtering, wavelet transform, and adaptive thresholding. The device also includes a wireless transceiver to receive signals from the sensing device and may be implantable or external. It may be implemented as ASIC, embedded circuit, programmable hardware, or software on computing hardware.
Correlation with external sensor signal to characterize non-contraction events
The system or method can characterize bladder events as non-contraction events based on correlating the bladder pressure signal with a signal from an external sensor, allowing rejection of artifacts or motions that affect bladder pressure but are unrelated to contractions.
The independent system and method claims are directed to a bladder event detection and characterization apparatus and method that applies patient-customized, adaptive multi-level wavelet thresholding to signals from a single implanted bladder pressure sensor, enabling differentiation of voiding, non-voiding, and non-contraction events, with optional correlation to external sensor signals to enhance accuracy.
Stated Advantages
Provides a less invasive and more comfortable solution by requiring only a single implanted pressure sensor instead of multiple sensors or catheters.
Enables real-time, high accuracy detection and classification of bladder events with low false positive rates.
Improves diagnosis of urinary incontinence and treatment of lower urinary tract dysfunction through automated, patient-specific categorization of bladder events.
Facilitates closed-loop neuromodulation by providing real-time feedback of bladder activity to avoid habituation associated with continuous stimulation.
The system is customizable with tunable parameters for individual patients, optimizing detection accuracy and stimulation parameters.
Documented Applications
Diagnosis of urinary incontinence.
Treatment of lower urinary tract dysfunction.
Conditional bladder stimulation to block voiding or prevent leakage based on detection of bladder contraction events.
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