Heart Valve Compression Member with Pivotable Arms

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Solution Overview

Problem

Current methods for loading collapsible prosthetic heart valves into delivery devices are inefficient due to high loading forces required and the tendency of the outer cuff to catch on device edges, as well as strut entanglement issues during collapse, making it difficult to successfully and accurately deploy the valve.

Innovation Solution

A compression member with pivotable arms and a translating member is used to compress the prosthetic heart valve, along with a separation tool featuring ribs to guide and separate the stent struts, facilitating a controlled collapse that reduces loading forces and prevents cuff entanglement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Length of moving object

If the valve is collapsed to reduce circumferential size for delivery, then the valve can be delivered less invasively via catheter, but the outer cuff increases collapsed size and requires higher loading forces

Engineering Contradiction:

Improvecircumferential size of valveVSAvoidloading force required

Core Design Contradiction:

Length of moving objectVSForce

Solution Approach 1:

The compression member is divided into multiple compression elements (fingers) that can independently compress the valve. Each compression element has a compression surface that contacts the outer cuff, distributing the compression force and reducing the force required to achieve adequate collapse while managing the bulk of the outer cuff effectively

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The compression member pre-compresses the valve before loading into the delivery device. The compression surfaces are positioned to contact the outer cuff first, initiating the collapse sequence and reducing the force needed during the actual loading process

Inventive Principle:

Principle #10Preliminary action

2Length of moving object

If the valve is collapsed to reduce circumferential size, then invasive delivery is enabled, but the outer cuff catches on delivery device edges

Engineering Contradiction:

Improvecircumferential size of valveVSAvoidcuff catching on device edges

Core Design Contradiction:

Length of moving objectVSObject-affected harmful factors

Solution Approach 1:

The compression member pre-compresses the outer cuff before loading, causing it to fold inward toward the stent. This preliminary compression ensures the cuff is in a controlled position that prevents it from catching on the delivery device edges during insertion

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The compression surfaces of the compression elements act as intermediaries between the outer cuff and the delivery device. These surfaces guide the cuff's movement and positioning, preventing direct contact between the cuff and potentially harmful edges of the delivery device

Inventive Principle:

Principle #24Intermediary (Mediator)

3Length of moving object

If the valve is collapsed to reduce circumferential size, then invasive delivery is enabled, but struts become entangled requiring detangling

Engineering Contradiction:

Improvecircumferential size of valveVSAvoidtime required for detangling struts

Core Design Contradiction:

Length of moving objectVSLoss of time

Solution Approach 1:

The compression member pre-compresses and organizes the struts during the collapse process. The compression surfaces guide the struts into a controlled configuration that prevents entanglement, eliminating the need for time-consuming detangling operations before loading

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The compression member's geometry and movement are designed to automatically organize and separate the struts during compression. The struts are guided into proper alignment by the compression surfaces themselves, making the system self-sufficient in preventing entanglement without requiring additional manual intervention

Inventive Principle:

Principle #25Self-service

4Shape

If traditional compression methods are used, then valve collapse is achieved, but loading into delivery device is difficult and may cause damage

Engineering Contradiction:

Improvecollapsed shape of valveVSAvoidsuccessful loading without damage

Core Design Contradiction:

ShapeVSReliability

Solution Approach 1:

Different compression elements have different compression surfaces optimized for specific locations on the valve. The compression surfaces are shaped to match the local geometry of the outer cuff and stent at different positions, ensuring uniform compression and preventing stress concentrations that could cause damage

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The compression member allows for dynamic adjustment of compression force and distribution. The compression elements can move independently or in coordinated sequences, adapting the compression profile to the valve's mechanical properties and preventing excessive forces that could cause damage while achieving the required collapsed shape

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS11109968B2Apparatus and methods for improved loading of a transcatheter heart valve

Publication Date: 2021.09.07 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

An assembly for collapsing a prosthetic heart valve includes a compression member having a plurality of arms pivotable between a first orientation in which side edges of adjacent arms are spaced apart from one another and a second orientation in which the adjacent arms contact one another. A translating member is movable along the arms to pivot the arms from the first orientation to the second orientation to collapse the prosthetic heart valve. A separation tool includes ribs defining channels sized to receive the struts of a stent of a prosthetic heart valve to keep the struts separated from one another as the prosthetic heart valve is collapsed.