Prosthetic Heart Valve Crimping for Uniform Leaflet Folding

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Solution Overview

Problem

Current crimping technologies for prosthetic heart valves face challenges in reducing the crimped profile while minimizing damage to the leaflets and other components, and in addressing complications such as vascular injury, mispositioning, and leaflet damage during the crimping process.

Innovation Solution

The use of non-simultaneous and non-uniform crimping methods for the valve frame, which involves a crimper device that gradually or stepwise reduces the frame's diameter from the inflow side to the outflow side, facilitating a uniform folding pattern of the leaflets and reducing the crimped outer diameter profile of the prosthetic heart valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If the frame size is reduced to achieve smaller crimp diameter, then the crimped profile is reduced, but the strength of the cardiovascular device after expansion is compromised

Engineering Contradiction:

Improvecrimped profileVSAvoiddevice strength

Core Design Contradiction:

Volume of moving objectVSStrength

Solution Approach 1:

The patent applies parameter changes by transitioning from traditional materials (stainless steel, cobalt-chromium alloys) to shape memory alloys (Nitinol, CuAlNi, CuZnAl). This material parameter change enables the frame to achieve both small crimped profile and sufficient expanded strength through the shape memory effect, resolving the contradiction between size reduction and strength maintenance

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent utilizes phase transitions of shape memory alloys during the crimping and expansion processes. The alloy undergoes martensitic transformation during crimping (allowing small profile) and austenitic transformation during expansion (restoring strength and shape), thereby resolving the contradiction between reduced crimped dimensions and maintained device strength

Inventive Principle:

Principle #36Phase transitions

2Volume of moving object

If non-simultaneous and non-uniform crimping is applied to reduce crimped profile, then the outer diameter is reduced, but the complexity of the crimping process increases

Engineering Contradiction:

Improveouter diameterVSAvoidcrimping process complexity

Core Design Contradiction:

Volume of moving objectVSDevice complexity

Solution Approach 1:

The patent applies segmentation by dividing the crimping process into sequential stages affecting different portions of the frame. The crimping device applies non-simultaneous crimping forces to different sections (e.g., first portion then second portion), enabling progressive profile reduction while managing process complexity through structured segmentation

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent employs dynamics by using a crimping device with adjustable and variable crimping forces that can be applied non-uniformly across different portions of the frame. The device transitions from static uniform crimping to dynamic non-uniform crimping, allowing optimal profile reduction while adapting to the specific geometric requirements of the frame

Inventive Principle:

Principle #15Dynamics

3Device complexity

If traditional uniform crimping is used, then the process is simple, but void spaces between leaflets increase and leaflet damage risk increases

Engineering Contradiction:

Improvecrimping process simplicityVSAvoidleaflet damage

Core Design Contradiction:

Device complexityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by implementing non-uniform crimping forces at different locations and stages of the crimping process. Specific portions of the frame receive differentiated crimping forces to achieve uniform leaflet folding patterns, reducing void spaces and minimizing leaflet damage while maintaining process simplicity through localized force application

Inventive Principle:

Principle #3Local quality

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

This approach effectively reduces the crimped profile of the prosthetic heart valve, minimizes damage to the leaflets during crimping, and addresses the limitations of existing crimping technologies by allowing for smaller crimping diameters and reducing vascular complications.

Implementation Method 1

The frame can be formed of a shape memory alloy such as, but not limited to, Nitinol (50 wt. % nickel, 50 wt. % titanium), and the frame is crimped by causing a longitudinal portion of the frame to bend toward a longitudinal axis of the frame

Methodology Applied

Scientific EffectShape memory effect: Pseudoelasticity

Data Source

PatentUS20250041052A1Crimper systems, devices, and methods of using the same

Publication Date: 2025.02.06 MIRUS LLC

AI summary

Crimper systems, devices, and methods for reducing the crimped profile of a prosthetic heart valve by the non-simultaneous and/or non-uniform crimping of the valve frame during the crimping process. The crimper system is configured to facilitate in the desired folding profile of the leaflets of a prosthetic heart valve during the crimping of the frame of the prosthetic heart valve to reduce the number and volume of void spaces between and about the leaflets and to reduce the crimped outer diameter profile of the prosthetic heat valve, while reducing the risk of damage to the leaflets and other components of the prosthetic heart valve during the crimping process.