Prosthetic Heart Valve Support Structure for Percutaneous Replacement

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Solution Overview

Problem

Current prosthetic heart valves are not easily expandable to accommodate a replacement valve within a previously implanted prosthetic heart valve, requiring removal of the existing valve for proper seating and blood flow, which is impractical and invasive.

Innovation Solution

A prosthetic heart valve with a support structure that is initially rigid and expansion-resistant, but transforms into an expandable configuration using a dilation force, such as from a balloon, to receive a new prosthetic valve, allowing for later deployment of a replacement valve without excising the previous one.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a traditional rigid prosthetic heart valve is used, then the valve provides stable support structure and reliable blood flow, but the valve cannot accommodate a replacement valve within it without removal of the existing valve

Engineering Contradiction:

Improveability to receive replacement valveVSAvoidstructural complexity for expansion

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The support structure is designed to transition from a rigid state during initial valve deployment to an expandable state to accommodate a replacement valve. This dynamic transformation allows the same structure to serve multiple functions: providing stable support initially, then expanding to receive a new valve without requiring removal of the existing one.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The prosthetic heart valve is designed with a nested configuration where a replacement valve can be deployed within the lumen of the existing valve. The expandable support structure creates internal space to accommodate the new valve while maintaining the outer integrity of the original valve structure.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If the support structure is made rigid for stable blood flow, then valve function is maintained, but the valve cannot be expanded to receive a replacement valve

Engineering Contradiction:

Improvevalve function stabilityVSAvoidexpandability for replacement

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The support structure incorporates materials and designs that allow it to maintain rigidity during normal valve operation to ensure reliable blood flow, while also being capable of dynamic expansion when a replacement valve needs to be deployed. This dual-state capability resolves the contradiction between stability and adaptability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The support structure utilizes materials whose mechanical properties can change based on operational requirements. The structure can be in a compressed rigid state during normal function to maintain valve stability, and then expanded to a more flexible state to accommodate replacement valve deployment.

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If a percutaneous implantation method is used, then minimally invasive procedure is achieved, but the valve cannot be easily replaced without complex surgical intervention

Engineering Contradiction:

Improveminimally invasive implantationVSAvoidvalve replacement difficulty

Core Design Contradiction:

Ease of operationVSEase of repair

Solution Approach 1:

The replacement valve is deployed nested within the original valve structure through the same percutaneous access point. The expandable support structure allows the new valve to be inserted through the lumen of the existing valve, enabling replacement without requiring open-chest surgery or removal of the original valve.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The dynamic expandability of the support structure enables the same percutaneous access used for initial implantation to also facilitate replacement. The structure can be expanded through the catheter to create space for the new valve, maintaining the minimally invasive approach while enabling easy replacement.

Inventive Principle:

Principle #15Dynamics

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

Enables secure and efficient replacement of prosthetic heart valves within the same annulus, reducing the need for invasive procedures and facilitating easier maintenance of proper blood flow and valve function over time.

Implementation Method 1

The support structure is generally resistant to expansion when deployed in the patient's native heart valve annulus to replace the native heart valve, but is configured to transform to a generally expanded and/or expandable configuration

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3517075B1Prosthetic heart valve configured to receive a percutaneous prosthetic heart valve implantation

Publication Date: 2023.02.22 EDWARDS LIFESCIENCES CORP

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Figure 3A~3D

AI summary

The invention is a prosthetic heart valve, and associated methods therefore, configured to replace a native heart valve, and having a support frame (120) configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon.