Adjustable Leaflet Tension in Prosthetic Heart Valves

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Solution Overview

Problem

Prosthetic heart valves face challenges in expanding to a wide range of diameters while maintaining proper leaflet coaptation, as overexpansion or under-expansion can lead to impaired function due to stretching or loosening of leaflets, necessitating mechanisms to adjust leaflet tension for optimal fit and function.

Innovation Solution

The implementation of adjustable commissure supports with rotatable or twistable arms that allow for the adjustment of leaflet tension by winding tabs around the arms, ensuring proper coaptation across various expansion diameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the prosthetic valve is expanded to a wide range of diameters, then the adaptability to different patient anatomies is improved, but the leaflet coaptation deteriorates due to overstretching or loosening

Engineering Contradiction:

Improveadaptability to different patient anatomiesVSAvoidleaflet coaptation

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The commissure supports are designed with rotatable arms that can dynamically adjust the tension of leaflet tabs. This dynamic adjustment mechanism allows the valve to maintain proper leaflet coaptation across a wide range of expansion diameters, resolving the contradiction between adaptability and reliability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The invention changes the physical state of the commissure supports from fixed to adjustable by enabling rotation of the arms. This parameter change allows the tension applied to the leaflet tabs to be modified, ensuring adequate coaptation regardless of the expansion diameter, thus maintaining reliability while improving adaptability.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If the frame is overexpanded to match larger patient anatomy, then the adaptability is improved, but the leaflet tension is reduced causing impaired coaptation

Engineering Contradiction:

Improveexpansion diameter rangeVSAvoidleaflet tension

Core Design Contradiction:

Adaptability or versatilityVSForce

Solution Approach 1:

The rotatable arms of the commissure supports provide a dynamic mechanism to compensate for reduced leaflet tension in overexpanded frames. By rotating the arms, the tension can be increased to maintain proper coaptation, allowing the valve to adapt to larger anatomies without sacrificing leaflet force.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The adjustable commissure supports act as an intermediary between the frame and the leaflet tabs. They mediate the force transmission, allowing adjustment of the tension applied to the leaflets regardless of the frame's expansion diameter, thus maintaining adequate leaflet force across different sizes.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If the frame is under-expanded to match smaller patient anatomy, then the adaptability is improved, but the leaflet tension is excessive causing impaired coaptation

Engineering Contradiction:

Improveexpansion diameter rangeVSAvoidleaflet tension

Core Design Contradiction:

Adaptability or versatilityVSForce

Solution Approach 1:

The rotatable arms enable dynamic reduction of leaflet tension when the frame is under-expanded. By rotating the arms in the appropriate direction, excessive tension can be relieved, allowing the valve to adapt to smaller anatomies while maintaining proper coaptation.

Inventive Principle:

Principle #15Dynamics

4Device complexity

If fixed commissure supports are used, then the device complexity is reduced, but the ability to maintain coaptation across different diameters deteriorates

Engineering Contradiction:

Improvecommissure support structureVSAvoidexpansion diameter range

Core Design Contradiction:

Device complexityVSAdaptability or versatility

Solution Approach 1:

The invention introduces a dynamic element (rotatable arms) to the commissure support structure. While this increases complexity, it enables the valve to maintain coaptation across a wide range of expansion diameters, achieving adaptability that would be impossible with fixed supports.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The adjustable commissure supports serve multiple functions: they provide structural support, enable tension adjustment, and accommodate various expansion diameters. This multi-functionality allows a single valve design to be universally applicable across different patient anatomies, improving adaptability without requiring multiple valve sizes.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS20230165678A1Devices and methods for adjusting the tensions of leaflets mounted within prosthetic valves

Publication Date: 2023.06.01 EDWARDS LIFESCIENCES CORP

AI summary

The present invention relates to implantable prosthetic devices, such as prosthetic heart valves with mechanisms for adjusting the tension of leaflets mounted therein, and to methods, adjustment assemblies and delivery assemblies for, and including, such devices.