Heart Valve Loading Assembly Tapered Compression

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Solution Overview

Problem

Conventional crimping devices for collapsing stented bioprosthetic heart valves are cumbersome, difficult to master, time-consuming, and impart undue stress on the valve, while also struggling to securely engage the stent with the delivery device, especially when loading into minimally invasive delivery systems.

Innovation Solution

A loading assembly comprising a compression member with a tapered wall, a support member with a recess, and a constricting member, along with a spacer, which allows for radial compression of the heart valve and secure engagement with the delivery device, minimizing stress and facilitating efficient loading into a minimally invasive delivery system.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional crimping devices are used to collapse the stented valve, then the valve can be compressed for loading, but the devices are bulky, difficult to master, time-consuming, and impart undue stress on the valve

Engineering Contradiction:
Improveease of crimping operationVSAvoidcomplexity of crimping device
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The crimping device is divided into two separate members: a compression member with a tapered bore that applies radial compressive force, and a support member with a recess that provides stable support for the stented valve. This segmentation allows each component to be simpler in design while collectively achieving the crimping function more effectively.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of using a complex mechanism to directly crimp the valve, the invention inverts the approach by using a tapered compression member that naturally guides and concentrates the crimping force through its geometry, while the support member provides passive support. This reverses the traditional active-passive role distribution.

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If conventional crimping devices are used to collapse the stented valve, then the valve can be compressed, but the process is time-consuming

Engineering Contradiction:
Improvespeed of valve loadingVSAvoidtime required for crimping operation
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The support member is prepared in advance with a recess of specific depth to accommodate the stented valve in a predetermined position. This preliminary preparation eliminates the need for complex positioning operations during the actual crimping process, reducing overall procedure time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The compression member features a tapered bore with a curved surface that naturally guides the crimping action. This geometric design allows for smoother, more efficient compression compared to flat or angular surfaces, reducing the time and force required to achieve valve collapse.

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Ease of operation

If conventional crimping devices are used to collapse the stented valve, then the valve can be compressed, but undue stress is imparted on the stented valve

Engineering Contradiction:
Improvecontrol of compression forceVSAvoidstress on stented valve
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The compression force is distributed locally through the tapered bore of the compression member, which concentrates force at specific points along the valve stent. This localized compression allows for more controlled and uniform stress distribution compared to conventional devices, reducing peak stresses that could damage the valve.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The support member acts as an intermediary between the compression member and the stented valve. By providing a stable recess that supports the valve during compression, it mediates the interaction to ensure force is applied evenly and prevents excessive stress concentration at any single point.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Reliability

If conventional crimping devices are used, then the valve can be loaded, but it is difficult to securely engage the stent with the delivery device

Engineering Contradiction:
Improveengagement reliabilityVSAvoidease of engagement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The engagement function is separated into distinct components: the compression member engages the stent during crimping, and the support member provides stable positioning. This segmentation allows each component to be optimized for its specific engagement task, improving overall reliability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The curved tapered surface of the compression member and the contoured recess of the support member work together to guide the stent into proper engagement with the delivery device. This geometric design ensures secure engagement through natural mechanical guidance rather than complex locking mechanisms.

Inventive Principle:
Principle #14Spheroidality (Curvature)

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 assembly effectively compresses and secures the heart valve for loading, reducing the time and effort required, minimizing stress on the valve, and ensuring proper engagement with the delivery device, thereby enhancing the efficiency of the minimally invasive procedure.

Implementation Method 1

movement of the support member and the compression member from the initial position to the operative position pushes the heart valve through the open space such that the heart valve is radially compressed by the tapered wall of the compression member

Methodology Applied
Scientific EffectRadial compression: Compression

Data Source

PatentEP2736454B1System for loading a collapsible heart valve
Publication Date: 2015.09.23 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP2736454B1 patent drawingFigure 1~2
  • EP2736454B1 patent drawingFigure 3
  • EP2736454B1 patent drawingFigure 4

AI summary

An assembly (200) for collapsing a self-expanding prosthetic heart valve (100) includes a compression member (202), a support member (204), a constricting member (300), and a spacer (270) which may be used for smaller sized heart valves. The compression member has a tapered wall (206) between its first open end and its second open end, the tapered wall defining an open space adapted to receive the heart valve. The support member has a base (220) and a recess (226) adapted to receive an end of the heart valve. The support member and the compression member are movable toward one another to compress the heart valve and push it through a relatively small aperture (218) in the second open end of the compression member. The second end (306) of the constricting member is sized to receive the compressed heart valve from the second open end of the compression member for loading into a delivery device (10).