Automated Cavity Compliance Testing for Elastic Medical Products

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Solution Overview

Problem

Existing methods for testing the compliance of rubber-elastic medical products, such as gloves and catheters, require manual input of product parameters and are prone to errors, leading to delays or product damage due to incorrect fluid volume and pressure settings, especially when dealing with varying product sizes and potential leakages.

Innovation Solution

A medical-technical device that automatically determines the cavity characteristics by regulating fluid supply and pressure, using a combination of a fluid reservoir, regulated pump, measuring device, pressure sensor, and electronic computing unit to calculate necessary operating parameters, including methods to account for leakages and adjust settings for optimal testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual input of product parameters is used, then device settings can be adjusted, but human errors occur leading to incorrect fluid volume and pressure settings

Engineering Contradiction:
Improvemanual parameter inputVSAvoidaccuracy of product parameter input
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device automatically determines cavity characteristics and calculates operating parameters without requiring manual input of product parameters. The system performs self-measurement and self-adjustment, eliminating human error in parameter input while maintaining ease of operation through automated functionality

Inventive Principle:
Principle #25Self-service

2Ease of operation

If fixed fluid volume and pressure settings are used, then device operation is simplified, but product damage occurs due to incorrect settings for varying product sizes

Engineering Contradiction:
Improvefixed settings operationVSAvoidadaptability to varying product sizes
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The device dynamically adjusts fluid volume and pressure settings based on real-time measurement of cavity characteristics. The system transitions from fixed settings to adaptive, variable settings that automatically match the specific product being tested, maintaining simplicity while achieving versatility across different product sizes

Inventive Principle:
Principle #15Dynamics

3Reliability

If automatic determination of cavity characteristics is implemented, then human error is reduced, but device complexity increases

Engineering Contradiction:
Improveaccuracy of compliance determinationVSAvoidautomation system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces manual mechanical adjustment systems with automated electronic measurement and control systems. Pressure sensors, flow meters, and microprocessors automatically determine cavity characteristics and adjust testing parameters, reducing human error while the electronic automation manages the inherent complexity through integrated software control

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

4Speed

If pressure measurement is performed continuously during fluid supply, then real-time pressure data is obtained, but pressure equilibrium cannot be established leading to inaccurate measurements

Engineering Contradiction:
Improvereal-time pressure measurementVSAvoidaccuracy of cavity pressure
Core Design Contradiction:
SpeedVSMeasurement precision

Solution Approach 1:

The system performs periodic pressure measurements at specific intervals during the fluid supply process. Pressure is measured initially before fluid supply to establish baseline, then after fluid supply stops to allow equilibrium, enabling both real-time monitoring and accurate equilibrium pressure measurement through timed measurement cycles

Inventive Principle:
Principle #19Periodic action

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 device ensures accurate and efficient determination of compliance, reducing human error and product damage by automatically adjusting fluid flow and pressure, enabling precise testing of medical products of varying sizes and conditions.

Implementation Method 1

A pressure sensor (6) for determining the dynamic and static pressure of the fluid

Methodology Applied
Scientific EffectPressure measurement:

Implementation Method 2

A measuring device for the volumetric flow (5)

Methodology Applied
Scientific EffectVolumetric flow measurement:

Implementation Method 3

A regulated pump (actuator or supply unit) (4) for supplying the fluid in a regulated manner

Methodology Applied
Scientific EffectFluid supply under pressure: Pressure Gradient

Data Source

PatentUS20230241307A1Method for Determining the Compliance of a Cavity of Elastic Medical Products fror Leakage Testing
Publication Date: 2023.08.03 WOM WORLD OF MEDICINE GMBH
  • US20230241307A1 patent drawing
  • US20230241307A1 patent drawing
  • US20230241307A1 patent drawing

AI summary

The invention relates to a method for determining cavity volumes of rubber-elastic medical products (e.g., latex products) for destruction-free leakage testing and to devices for carrying out said method.