Transcatheter Heart Valve Container With Tapered Crimping Channel

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Solution Overview

Problem

There is a need for a storage and preparation system for transcatheter heart valves that prevents damage during storage and allows for easy and safe removal, preparation, and crimping of the valve prior to implantation, as existing systems leave the valve susceptible to damage during manipulation.

Innovation Solution

A storage container with a crimping mechanism that allows the heart valve to be stored in its expanded configuration and easily converted to a crimped configuration upon removal, featuring a container housing and a crimping mechanism with a tapered channel and rotatable top cover to facilitate the transition from expanded to crimped state.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the heart valve is stored in expanded configuration in a jar with sterilant solution, then the valve is protected from damage during storage, but the valve becomes susceptible to damage during removal and manipulation prior to implantation

Engineering Contradiction:

Improvevalve protection during storageVSAvoidvalve handling safety

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent combines the storage container and crimping mechanism into a single integrated system. The container housing stores the valve in expanded configuration while the crimping mechanism, incorporated into the same container, enables safe crimping operations without requiring removal of the valve from the protective container environment.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The valve is pre-positioned within the container housing in its expanded configuration before use. The container is designed with integrated crimping features that are prepared in advance, allowing the valve to be crimped safely within the container rather than requiring external handling and manipulation after removal from storage.

Inventive Principle:

Principle #10Preliminary action

2Ease of manufacture

If the valve is removed from the storage jar for crimping, then the valve can be prepared for implantation, but the valve is exposed to damage risk during manipulation

Engineering Contradiction:

Improvevalve preparation capabilityVSAvoiddamage risk during handling

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The storage and preparation functions are merged into a single container system. The crimping mechanism is incorporated directly into the container housing, allowing the valve to be crimped within the protective container environment rather than requiring removal to external crimping tools or surfaces.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The container housing serves as an intermediary structure that provides a controlled environment for both storage and preparation operations. The housing includes integrated features such as the crimping mechanism that mediate the transition from storage to preparation without requiring direct external manipulation of the valve.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If a separate storage jar and external crimping process are used, then the valve can be stored and prepared, but the process becomes complex and increases handling steps

Engineering Contradiction:

Improvevalve protectionVSAvoidstorage and preparation system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent integrates multiple functions into a single container system. The storage container housing incorporates the crimping mechanism directly within it, eliminating the need for separate storage jars and external crimping apparatus. This integration reduces the number of components and simplifies the overall system while maintaining protective capabilities.

Inventive Principle:

Principle #5Merging (Combining)

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 system effectively protects the valve during storage, minimizes handling-induced damage, and enables efficient crimping for transcatheter delivery, enhancing the safety and ease of valve preparation for implantation.

Implementation Method 1

The crimping mechanism is operable to convert the heart valve from its expanded configuration to its crimped configuration

Methodology Applied

Scientific EffectMechanical compression: Compression

Implementation Method 2

featuring a container housing and a crimping mechanism with a tapered channel and rotatable top cover to facilitate the transition from expanded to crimped state

Methodology Applied

Scientific EffectMechanical force: Mechanical Force

Data Source

PatentUS10918473B2Transcatheter heart valve storage container and crimping mechanism

Publication Date: 2021.02.16 EDWARDS LIFESCIENCES CORP

AI summary

Disclosed herein is a storage container for an expandable prosthetic heart valve that crimps the valve upon opening the container and removal of the valve from the container. The container includes a housing sized to receive the heart valve in its expanded configuration and a crimping mechanism. The crimping mechanism is incorporated into the container and engages the heart valve so as to operably convert the heart valve from its expanded configuration to its smaller crimped configuration upon opening the container and removing the valve.