Bio-Impedance Bladder Monitoring for Catheter-Free Volume Tracking
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Solution Overview
Problem
Current methods for measuring urine output (UO) and total body water (TBW) in patients with heart failure and similar conditions are inaccurate and prone to errors, particularly in semi-ambulatory settings, due to reliance on population-specific assumptions and manual data collection, which can lead to incomplete data and increased infection risk.
Innovation Solution
A self-learning, non-invasive bladder volume monitoring system using bio-impedance spectroscopy (BIS) that integrates with a patient's healthcare workflow, employing sensor arrays and logic to iteratively refine bladder volume measurements by comparing pre- and post-voiding electrical impedance values, and optionally incorporating total body water measurements, to enhance accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If indwelling urinary catheters or external catheter systems are used to measure urine output, then measurement capability is provided, but infection risk increases
Solution Approach 1:
The patent replaces mechanical/invasive catheter-based measurement systems with a non-invasive electrical impedance-based monitoring system. The system uses impedance sensors to detect changes in bladder tissue properties that correlate with urine volume, eliminating the need for indwelling catheters and their associated infection risks while maintaining measurement capability.
Solution Approach 2:
The patent introduces electrical impedance as an intermediary parameter to indirectly measure bladder volume. Instead of directly contacting the bladder with catheters, the system measures electrical impedance changes in the bladder wall and surrounding tissues, which serve as a mediator to infer urine volume without invasive intervention.
2Measurement precision
If portable ultrasound bladder scanners are used for intermittent catheterization assessment, then bladder volume measurement is achieved, but provider time and patient interruption increase
Solution Approach 1:
The patent implements continuous monitoring using wearable or bedside impedance sensors that continuously track bladder volume changes without requiring periodic provider intervention. The system provides ongoing measurement capability, eliminating the time loss associated with repeated portable ultrasound assessments and enabling real-time detection of voiding events.
Solution Approach 2:
The system enables automatic detection and recording of voiding events through continuous impedance monitoring, eliminating the need for provider-assisted intermittent scanning. The automated system independently tracks bladder volume changes, detects voiding events, and records data without requiring provider time or patient interruption for manual assessments.
3Ease of manufacture
If population-specific regression algorithms are used for total body water measurement, then measurement capability is provided, but accuracy for atypical patients deteriorates
Solution Approach 1:
The patent performs preliminary individualized calibration by having patients undergo initial measurements with reference methods (such as bioelectrical impedance analysis or deuterium oxide dilution). These preliminary data points are used to establish patient-specific impedance-to-volume relationships before routine monitoring begins, ensuring accurate measurements for atypical patients without requiring complex population-based algorithms.
Solution Approach 2:
The patent transitions from using fixed population-based regression parameters to dynamically adjusting measurement parameters based on individual patient characteristics. The system modifies impedance frequency, amplitude, or analysis methods according to patient-specific factors such as body composition, age, and clinical condition, thereby maintaining high accuracy across diverse patient populations.
4Ease of operation
If manual measurement and recording of urine output by patient or clinician is used, then measurement capability is provided, but error risk and cross-contamination risk increase
Solution Approach 1:
The patent replaces manual collection and recording processes with an automated electronic monitoring system. Impedance sensors automatically detect voiding events, and the system electronically records volume data, eliminating manual intervention entirely. This substitution removes the sources of human error and cross-contamination inherent in manual handling of urine collection devices.
Solution Approach 2:
The system performs self-measurement and self-recording of urine output data. The impedance monitoring system automatically detects voiding events, calculates volume changes, and stores data in electronic format without requiring patient or clinician involvement in the measurement process, thereby ensuring consistent accuracy and eliminating cross-contamination risks.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides precise and continuous monitoring of bladder volume and TBW, reducing errors and infection risks, while adapting to individual patient variations, thus improving clinical assessment and treatment efficacy.
Implementation Method 1
These devices can use bio-impedance spectroscopy ('BIS') to accurately determine a patient's TBW/UO values
Implementation Method 2
a training system configured to receive a urine output value for a volume of fluid voided from the bladder, and a logic configured to determine a difference between the pre- and post-void bladder volume values and the urine output value and iteratively modify the model to reduce the difference
Data Source
AI summary
Embodiments disclosed herein are directed to a self-learning bladder volume monitoring system. The system can include a bladder volume (BV) system configured to measure an electrical impedance of a bladder region of a patient and determine a volume of fluid disposed therein using an impedance to bladder volume model (“By model”). Further, the system can measure a total body water (“TBW”) for the patient and modify the BV model to account for variations in TBW within the tissues surrounding the bladder providing a more accurate bladder volume measurement. The system can include a “training unit” which can include one of a user input interface, an automatic urine output monitoring system, an ultrasound system, and an intrabladder pressure system configured to verify a volume of fluid within or voided from the bladder and train the BV model.