Urodynamic Flow Sleeve for Non-Invasive Detrusor Pressure Measurement

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Solution Overview

Problem

Traditional urodynamic investigations, such as the Voiding Pressure Study (VPS), are invasive and uncomfortable for patients, often provide inaccurate results due to difficulty in differentiating detrusor muscle pressure from abdominal contraction, and are underutilized in diagnosing bladder outlet obstruction, limiting their effectiveness in clinical practice.

Innovation Solution

A non-invasive urodynamic investigation apparatus and method using a tubular element with fittings and a sleeve element to regulate urine flow without interrupting it, combined with abdominal electromyography (EMG) to accurately measure detrusor pressure, and a cuff substitute distal to the urethra for improved data acquisition.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional VPS uses measurement catheters placed in the bladder and abdominal cavity to measure pressures, then pressure measurement capability is achieved, but patient comfort deteriorates and measurement precision worsens due to inability to differentiate detrusor pressure from abdominal contraction

Engineering Contradiction:
Improvepressure measurement accuracyVSAvoidpatient discomfort
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical catheter-based pressure measurement system with an electronic sensor system. Surface electrodes are placed on the abdominal skin to detect abdominal muscle contractions via electromyography (EMG), while a non-invasive bladder pressure sensor measures vesical pressure externally. This substitution eliminates the need for invasive catheter insertion while maintaining measurement capability and enabling differentiation between detrusor and abdominal pressures through signal processing.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary EMG detection system that measures abdominal muscle electrical activity as a mediator to infer abdominal pressure changes. By detecting the electrical signals from abdominal muscles before they translate into pressure changes, the system can subtract these abdominal contributions from the total bladder pressure measurement, thereby isolating the detrusor muscle pressure component without direct abdominal pressure measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If traditional VPS uses invasive catheters for pressure measurement, then pressure data can be obtained, but the procedure complexity and patient discomfort increase significantly

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces complex invasive mechanical catheter systems with simpler electronic sensing systems. Instead of requiring catheter insertion into the bladder and abdominal cavity, the system uses surface electrodes for EMG detection and non-invasive pressure sensors. This reduces procedural complexity while maintaining diagnostic reliability through electronic signal processing that differentiates between various pressure sources.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent enables the patient's own physiological signals (electrical activity of abdominal muscles) to serve the measurement function. The EMG system detects and utilizes the patient's natural muscle electrical activity as the measurement signal, eliminating the need for external mechanical intervention or invasive probing. The body's own signals provide the diagnostic information needed.

Inventive Principle:
Principle #25Self-service

3Quantity of substance

If the bladder is filled with sterile water for traditional VPS, then sufficient urine volume for measurement is achieved, but the procedure time and patient discomfort increase

Engineering Contradiction:
Improveurine volumeVSAvoidprocedure time
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent performs preliminary detection of abdominal muscle activity using surface EMG electrodes before the voiding event occurs. By pre-positioning and calibrating the electronic sensors on the patient's abdomen, the system is ready to capture signals immediately when voiding begins, eliminating the need for time-consuming catheter insertion and setup. The bladder can be naturally filled without artificial irrigation, reducing preparation time.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS12370342B2Urodynamic investigation apparatus, system, and methods
Publication Date: 2025.07.29 SRS MEDICAL SYSTEMS INC
  • US12370342B2 patent drawing
  • US12370342B2 patent drawing
  • US12370342B2 patent drawing

AI summary

A urodynamic investigation apparatus for receipt of urine from a bladder is provided. The apparatus is characterized by a tubular element, first and second fittings, and a sleeve element, for select passage of urine there through, within the tubular element. The tubular element is characterized by opposing first and second end portions, and a port. The fittings are adapted to be received by the opposing end portions of the tubular element so as to delimit an apparatus chamber. The sleeve element, suspended between the fittings within the chamber, has collapsed and open configurations. The collapsed configuration is indicative of a no urine flow condition, and the open configuration indicative of a urine flow condition, with the sleeve element urine flow condition being a function of pressure applied to the chamber via the port of the tubular element.