Dual-Drive Prosthetic Valve Testing for Physiological Flow Measurement

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current testing apparatuses for prosthetic devices, such as heart valves, do not accurately model performance under physiological conditions and are often complex and expensive to maintain, with large sizes accommodating large pumps and flow loops.

Innovation Solution

A dual-drive pulsatile testing apparatus that simulates physiological conditions by using two fluid drivers to mimic the systolic and diastolic phases of the heart, along with a calibration device to account for optical distortions and cylindrical geometry, allowing for precise measurement of prosthetic valve properties like effective orifice area and leaflet coaptation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a closed loop system with large pump is used to measure flow through prosthetic device, then flow measurement capability is achieved, but device size becomes large and maintenance cost increases

Engineering Contradiction:
Improveflow measurementVSAvoidsystem size
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the pump function from the traditional closed-loop system and replaces it with a reservoir that relies on gravity and pressure differential. This eliminates the need for a large mechanical pump while maintaining flow measurement capability through a simplified open-loop configuration where fluid flows from an elevated reservoir through the test article.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses hydraulic principles by employing a fluid coupling device that transmits force through hydraulic pressure. The system uses a master cylinder and slave cylinder arrangement where hydraulic pressure generated by manual or automated actuation of the master cylinder drives the slave cylinder to produce controlled fluid flow through the test article, eliminating the need for a large mechanical pump.

Inventive Principle:
Principle #29Pneumatics and hydraulics

2Ease of operation

If steady flow is used to determine pressure gradient, then measurement is simplified, but physiological accuracy is reduced

Engineering Contradiction:
Improvemeasurement simplicityVSAvoidphysiological accuracy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent transitions from static steady-flow measurement to dynamic pulsatile flow measurement that mimics physiological conditions. The system generates pulsatile flow patterns through the fluid coupling device that replicate the cyclic nature of blood flow through heart valves, allowing accurate assessment of valve performance under conditions that match in vivo operation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements periodic action by generating pulsatile flow that cycles between systolic and diastolic phases, replicating the natural rhythm of cardiac function. This periodic flow pattern allows the test article to be evaluated under physiologically relevant conditions while maintaining controlled measurement parameters through the fluid coupling system.

Inventive Principle:
Principle #19Periodic action

3Measurement precision

If complex testing apparatus is used to simulate physiological conditions, then measurement accuracy improves, but maintenance difficulty and cost increase

Engineering Contradiction:
Improveperformance measurement accuracyVSAvoidmaintenance difficulty
Core Design Contradiction:
Measurement precisionVSEase of repair

Solution Approach 1:

The patent segments the testing system into modular components: a reservoir, a test article holder, a fluid coupling device with master and slave cylinders, and measurement instrumentation. This segmentation allows each component to be independently maintained or replaced, simplifying repair operations while maintaining the capability to simulate physiological conditions through the coordinated function of discrete modules.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system incorporates self-service features through the reservoir design that can be easily refilled and the fluid coupling device that uses simple hydraulic principles requiring minimal specialized maintenance. The open-loop configuration eliminates the need for complex pump maintenance while the modular design allows users to perform basic maintenance tasks without requiring specialized service personnel.

Inventive Principle:
Principle #25Self-service

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 apparatus provides accurate and efficient testing of prosthetic valves under physiological conditions, reducing complexity and cost while improving measurement precision, enabling better evaluation of valve performance.

Implementation Method 1

A first fluid driver may be coupled to the first end portion of the flow channel and configured to move to flow the test fluid through the prosthetic valve in an outflow direction of the prosthetic valve, and configured to provide a pressure of the test fluid on an inflow side of the prosthetic valve

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

A second fluid driver may be coupled to the second end portion of the flow channel and configured to move to flow the test fluid through the prosthetic valve in the outflow direction of the prosthetic valve, and configured to provide a pressure of the test fluid on an outflow side of the prosthetic valve

Methodology Applied
Scientific EffectPressure gradient: Pressure Gradient

Data Source

PatentEP3914191B1Testing apparatus for prosthetic device
Publication Date: 2022.10.19 EDWARDS LIFESCIENCES CORP
  • EP3914191B1 patent drawingFigure 1
  • EP3914191B1 patent drawingFigure 2
  • EP3914191B1 patent drawingFigure 3~4

AI summary

A testing apparatus is disclosed herein for testing properties of a prosthetic device. The testing apparatus may comprise a dual-drive pulsatile flow tester with the ability to determine coaptation of valve leaflets of a prosthetic device. The testing apparatus may be able to test prosthetic heart valves and reproduce physiological conditions of a prosthetic heart valve.