Prosthetic Valve Flow Testing With Dual-Drive Pulsatile Simulation

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Solution Overview

Problem

Current testing apparatuses for prosthetic devices, such as heart valves, do not accurately model performance under physiological conditions and are often large, complex, and costly to maintain, making them inefficient for testing prosthetic devices effectively.

Innovation Solution

A dual-drive pulsatile testing apparatus that simulates physiological conditions by mimicking the pumping action of the human heart, using a calibration device to account for optical distortions and cylindrical geometry, and includes a method for measuring flow properties like effective orifice area and leaflet coaptation of prosthetic valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a closed loop system with pump is used to measure flow through prosthetic device, then flow measurement is achieved, but the apparatus becomes large and complex

Engineering Contradiction:
Improveflow measurement accuracyVSAvoidapparatus complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts the pump and closed loop system from the testing apparatus, replacing them with a simpler open channel flow system. The test article is positioned in an open channel where flow is driven by gravity and pressure differential, eliminating the need for complex pumping infrastructure while maintaining measurement capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a simplified model of physiological flow conditions using an open channel system that replicates essential flow characteristics without copying the entire closed loop cardiovascular system. This allows accurate measurement of flow properties through the test article using a much simpler apparatus.

Inventive Principle:
Principle #26Copying

2Measurement precision

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

Engineering Contradiction:
Improveflow measurement accuracyVSAvoidmaintenance cost
Core Design Contradiction:
Measurement precisionVSEase of repair

Solution Approach 1:

The patent removes the pump and closed loop infrastructure that require extensive maintenance, replacing them with a passive open channel system that has fewer moving parts and lower maintenance requirements while preserving measurement accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

3Measurement precision

If traditional testing apparatus is used, then flow measurement is possible, but it does not accurately model physiological conditions

Engineering Contradiction:
Improveflow measurement capabilityVSAvoidphysiological condition modeling accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent changes the fundamental operating parameters of the testing system from closed loop pressure-driven flow to open channel gravity-assisted flow. This allows the system to better model physiological conditions such as those found in venous return or certain arterial conditions where flow is not maintained by a centralized pump.

Inventive Principle:
Principle #35Parameter changes

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 more accurate and efficient testing of prosthetic devices under physiological conditions, reducing complexity and maintenance costs while improving the assessment of flow properties and 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 EffectFluid pressure: 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 EffectFluid pressure: Pressure Gradient

Data Source

PatentEP4040425B1Testing apparatus for prosthetic device
Publication Date: 2023.03.22 EDWARDS LIFESCIENCES CORP
  • EP4040425B1 patent drawingFigure 1
  • EP4040425B1 patent drawingFigure 2
  • EP4040425B1 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.