Devices, systems, and methods for monitoring bladder function

Inventors

Beer, Marc D.Pulliam, Samantha J.McKinney, Jessica L.

Assignees

Axena Health Inc

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Publication Number

US-12295732-B2

Patent

Publication Date

2025-05-13

Expiration Date


Abstract

Featured are urodynamic catheters, intravaginal devices, and intrarectal devices, systems and kits thereof, and methods of using the devices, systems, and kits to observe pelvic floor movements in order to monitor bladder function in order to diagnose, treat, or prevent urinary incontinence disorders, such as urge incontinence and stress incontinence.

Core Innovation

The invention evaluates a bladder function of a subject by performing one or more urodynamic measurements with a system that includes a urodynamic catheter having multiple lumens and a plurality of positional sensors located along a length of the catheter, together with an intravaginal or intrarectal device having a plurality of positional sensors located along a length of the device. Each of the urodynamic catheter and the intravaginal or intrarectal device includes a transmitter and/or receiver that communicates positional data to an electronic device.

The positional data comprises sensor angle and time transmitted to the electronic device, where the electronic device processes the positional data to monitor a bladder function of the subject. The electronic device detects, diarizes, and discriminates among bladder-function events including voiding, urge, knack, cough, Valsalva, reflex levator response, pelvic floor muscle contraction, filling, emptying, capacity, sensation, compliance, and leaking.

In described implementations, the positional sensors along the catheter/device detect sensor angle over time to identify and diarize pelvic floor and bladder-related events such as a pelvic floor lift (PFL) and pelvic floor relaxation (PFR). Wireless data transmission is used to communicate sensor data to an electronic device for processing and display, and the disclosure includes example algorithms for detecting pelvic floor lifts and maintaining an automated voiding diary with event timestamping for diagnosis or therapy tracking.

Claims Coverage

The independent claim defines a method of evaluating bladder function using a multi-lumen urodynamic catheter together with an intravaginal or intrarectal positional-sensor device, where positional angle/time data is transmitted to an electronic device and processed to detect, diarize, and discriminate multiple bladder-function events.

Multi-lumen urodynamic catheter with spaced positional sensors

Performing one or more urodynamic measurements with a system comprising a urodynamic catheter comprising multiple lumens and a plurality of positional sensors located along a length of the catheter.

Intravaginal or intrarectal positional-sensor device

Providing an intravaginal or intrarectal device comprising a plurality of positional sensors located along a length of the device.

Transmitting positional data comprising sensor angle and time

Each of the urodynamic catheter and the intravaginal or intrarectal device comprises a transmitter and/or receiver that communicates positional data comprising sensor angle and time to an electronic device.

Processing positional data to detect, diarize, and discriminate bladder-function events

Transmitting the positional data to the electronic device to monitor a bladder function of the subject, wherein the electronic device processes the positional data to detect, diarize, and discriminate between a bladder function comprising one or more of voiding, urge, knack, cough, Valsalva, reflex levator response, pelvic floor muscle contraction, filling, emptying, capacity, sensation, compliance, and leaking.

Across the provided independent-claim structure, the core coverage combines a multi-lumen urodynamic catheter with positional sensors and an intravaginal or intrarectal positional-sensor device, transmits sensor angle and time to an electronic device, and uses electronic processing to detect, diarize, and discriminate multiple bladder-function events.

Stated Advantages

Documented Applications

Monitoring bladder function by detecting, diarizing, and discriminating bladder-function events including voiding, urge, knack, cough, Valsalva, reflex levator response, pelvic floor muscle contraction, filling, emptying, capacity, sensation, compliance, and leaking.

Maintaining an automated voiding diary with event timestamping, used for diagnosis or therapy tracking.

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