Sensing device for ambulatory urodynamics having a pressure sensitive housing
Inventors
Damaser, Margot S. • Majerus, Steve • Zhu, Hui • Gill, Bradley C. • Gonzalez, Ricardo • Greene, Daniel • Poliquin, Joe • Craig, Glenn • Lorentz, Marie • Banco, Gino
Assignees
Cleveland Clinic Foundation • Parker Hannifin Corp • US Department of Veterans Affairs
Publication Number
US-12156746-B2
Publication Date
2024-12-03
Expiration Date
2039-05-28
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Abstract
A sensing device can be used for ambulatory urodynamics. The sensing device can include an elongated outer housing constructed of flexible material that can curve within a patient's bladder. At least a portion of the outer housing can be filled with a non-compressible fluid. A flexible printed circuit board can be disposed within the outer housing to curve with the outer housing. The printed circuit board can include a pressure sensor, comprising a diaphragm, to collect pressure data; a microcontroller running control software; and a wireless transmitter to transmit the pressure data. A battery can be disposed within the outer housing and coupled to the printed circuit board. The flexible material of the outer housing is configured to be displaced by a pressure within the patient's bladder, the displacement is transmitted through the non-compressible fluid to the pressure sensor that provides the pressure data based on the displacement.
Core Innovation
The invention relates to a sensing device for ambulatory urodynamics designed to reduce the need for implanted or externally worn sensors. The device features an elongated outer housing constructed entirely of flexible material configured to curve within the patient's bladder. A portion or entirety of this housing is filled with a non-compressible fluid, and a flexible printed circuit board is disposed within the housing, which includes a pressure sensor with a diaphragm, a microcontroller running control software, and a wireless transmitter to send pressure data.
The core functionality of the device is based on displacement of the flexible outer housing in response to bladder pressure. This displacement is transmitted through the non-compressible fluid to the pressure sensor, which detects it and provides corresponding pressure data. This configuration allows the entire surface area of the flexible housing to be pressure sensitive, increasing the ability and resolution for sensing pressure within the bladder, improving over traditional devices that rely only on localized diaphragm deformation within a rigid housing.
The problem addressed arises from the limitations of current laboratory-based and ambulatory urodynamics tests. Laboratory methods often cause patient discomfort and anxiety due to catheter placement and require voiding in an unnatural environment, reducing reliability. Existing ambulatory systems either require implanted sensors, increasing cost and recovery time, or externally worn sensors that can cause noncompliance. The invention solves these issues by providing a single, non-surgically insertable, free-floating sensing device that reduces discomfort, cost, and increases patient compliance.
Claims Coverage
The patent contains two independent claims covering the sensing device and its method of use with several key inventive features.
Sensing device with flexible housing filled with non-compressible fluid
An elongated outer housing constructed entirely of flexible material and configured to curve within a patient's bladder, filled with a volume of a non-compressible fluid. The housing deforms in response to bladder pressure, displacing the fluid volume sealed by end tips.
Flexible printed circuit board with integrated pressure sensor system
The flexible printed circuit board curves with the housing and includes a pressure sensor with diaphragm to detect fluid displacement, a microcontroller running control software, and a wireless transmitter to transmit pressure data. The PCB is coupled to a battery positioned within the housing.
Power management using two-stage wakeup and pressure sensor co-processor
The device conserves power with a low power mode and full power mode. A pressure sensor co-processor detects pressure above a predefined threshold during low power mode and activates the device to full power mode, enabling efficient battery use.
Method for sensing bladder pressure using a free-floating device
Inserting the sensing device in low power mode into the bladder, triggering activation to full power upon insertion pressure detection, deforming the flexible housing by bladder pressure to displace fluid, transmitting forces through the fluid to the pressure sensor, detecting displacement, and producing pressure data based on the displacement.
Delivery and removal method of the sensing device
The device is delivered straight through a catheter into the bladder, where it curves into a coiled, c-shaped, heart-shaped, or s-shaped configuration. Removal can be performed by pulling a string attached to the device through the urethra.
The independent claims cover a flexible, fluid-filled sensing device with integrated pressure sensing and wireless communication, a method for implanting and sensing bladder pressure non-surgically, and power-saving features enabling practical ambulatory urodynamics without implanted or external sensors.
Stated Advantages
Reduces the need for invasive implanted sensors and externally worn sensors, lowering testing costs and patient recovery time.
Increases patient compliance and comfort by avoiding catheters and laboratory environments.
The entire flexible housing is pressure sensitive, improving pressure sensing ability and resolution.
Power conservation via a two-stage wakeup process extends battery life and enables device miniaturization.
Allows free-floating placement inside the bladder without affecting sensing accuracy regardless of orientation.
Documented Applications
Ambulatory urodynamics testing to assess bladder pressure and potentially volume during normal daily activities.
Non-surgical insertion into the bladder through the urethra using a catheter and pusher device system.
Removal of the sensing device from the bladder via a string attached to the device extending through the urethra.
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