Leaflet Folding Guides for Low-Profile Valve Crimping

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Solution Overview

Problem

Existing heart valve prostheses face challenges in maintaining a low profile for transcatheter delivery through the vasculature while preventing damage to the leaflets during crimping.

Innovation Solution

A leaflet folding accessory with flexible guide fingers, made of a soft material, holds the leaflets in a predetermined state during crimping, using a semi-spherical tip to contact the prosthetic valve component and prevent irregular folding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If the transcatheter valve prosthesis is radially compressed into a crimped configuration for delivery, then the delivery profile size is reduced, but the leaflets may be damaged during crimping

Engineering Contradiction:

Improvedelivery profile sizeVSAvoidleaflet damage

Core Design Contradiction:

Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

A leaflet folding accessory is introduced as an intermediary device between the crimping mechanism and the leaflets. The accessory includes guide fingers that contact the leaflets and hold them in a closed state against the inner shaft during crimping, preventing direct contact between the crimping force and the leaflets that would cause damage.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide fingers are positioned on the leaflets before crimping occurs, establishing a predetermined folding pattern in advance. This preliminary positioning ensures that when crimping applies radial compression, the leaflets fold in a controlled manner rather than randomly, preventing damage while achieving the required compact profile.

Inventive Principle:

Principle #10Preliminary action

2Volume of moving object

If the leaflets are held in a closed state against the inner shaft during crimping, then the delivery profile is minimized, but the folding pattern may become irregular without guidance

Engineering Contradiction:

Improvedelivery profile sizeVSAvoidfolding pattern regularity

Core Design Contradiction:

Volume of moving objectVSManufacturing precision

Solution Approach 1:

The guide fingers serve as intermediary elements that mediate between the crimping force and the leaflets. By contacting the leaflets and holding them in a closed state against the inner shaft, the guide fingers ensure uniform folding pattern while enabling compact delivery profile.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide fingers have semi-spherical tips that contact the leaflets. This curved geometry allows the guide fingers to evenly distribute contact forces across the leaflet surfaces, ensuring uniform folding pattern and preventing irregularities while achieving compact configuration.

Inventive Principle:

Principle #14Spheroidality (Curvature)

3Manufacturing precision

If a rigid structure is used to hold the leaflets during crimping, then the folding control is improved, but the leaflets may be damaged by excessive force

Engineering Contradiction:

Improvefolding controlVSAvoidleaflet damage

Core Design Contradiction:

Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The guide fingers are made of flexible material that can deform under crimping forces. This flexibility allows the guide fingers to conform to the leaflet surfaces and maintain contact during radial compression, providing precise folding control while the flexible nature prevents transmission of excessive forces that would damage the leaflets.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The guide fingers change their physical state from a relaxed configuration to a compressed configuration during crimping. The flexible material allows the guide fingers to adapt their shape and position in response to changing mechanical conditions, maintaining optimal contact with the leaflets throughout the crimping process while preventing damage.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS20260090884A1Mechanical guides for controlling leaflet folding behavior during crimping

Publication Date: 2026.04.02 MEDTRONIC INC

AI summary

An assembly including a transcatheter valve prosthesis and a leaflet folding accessory configured for use when compressing the transcatheter valve prosthesis into the crimped configuration. The transcatheter valve prosthesis includes a stent and a prosthetic valve component including at least one leaflet disposed within and secured to the stent. The transcatheter valve prosthesis has a crimped configuration for delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The leaflet folding accessory includes a plurality of guide fingers. Each guide finger is configured to contact the prosthetic valve component and hold the at least one leaflet in a predetermined configuration when the transcatheter valve prosthesis is compressed into the crimped configuration.