Pulsatile Prosthetic Valve Testing for Physiological Flow Measurement

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Solution Overview

Problem

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

Innovation Solution

A dual-drive pulsatile testing apparatus that simulates physiological conditions by mimicking the pumping action of the human heart, with a calibration device to account for optical distortions and cylindrical geometry, allowing for precise measurement of flow properties and leaflet coaptation of prosthetic valves.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

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

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

Solution Approach 1:

The patent extracts the essential function of flow measurement from the complex closed-loop pump system and implements it using a simplified reservoir and tubing configuration. The test fluid flows through the prosthetic device in a controlled manner without requiring a large pump system, thereby maintaining measurement capability while reducing apparatus complexity

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a simplified model of physiological flow conditions that copies the essential characteristics of blood flow through heart valves without replicating the full complexity of a circulatory system. This allows accurate performance assessment using a much simpler apparatus than a complete closed-loop system

Inventive Principle:
Principle #26Copying

2Measurement precision

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

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

Solution Approach 1:

The patent removes the pump component from the testing system, which is the most complex and expensive maintenance element. By using gravity-driven or pressure-regulated flow through a simple reservoir system, the apparatus eliminates the need for pump maintenance while retaining adequate flow measurement capability for assessing prosthetic device performance

Inventive Principle:
Principle #2Taking out (Extraction)

3Device complexity

If testing is performed under steady flow conditions, then flow measurement is simplified, but accuracy under physiological conditions deteriorates

Engineering Contradiction:
Improvetesting procedure simplicityVSAvoidphysiological accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent transitions from static steady-flow testing to dynamic pulsatile flow testing that mimics the rhythmic nature of cardiac cycles. The system incorporates mechanisms to generate pulsating flow patterns that replicate systolic and diastolic phases, thereby improving physiological accuracy while maintaining manageable system complexity through controlled dynamic operation

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent implements periodic pulsatile flow cycles that replicate the natural rhythm of heartbeats. By creating repeating flow patterns with defined systolic ejection phases and diastolic filling phases, the system achieves physiological realism without requiring continuous complex control, as the periodic nature allows for standardized testing protocols

Inventive Principle:
Principle #19Periodic action

Data Source

PatentUS20230414359A1Testing apparatus for prosthetic device
Publication Date: 2023.12.28 EDWARDS LIFESCIENCES CORP
  • US20230414359A1 patent drawing
  • US20230414359A1 patent drawing
  • US20230414359A1 patent drawing

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.