Funnel-Shaped Compression Member for Heart Valve Loading
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Solution Overview
Problem
Conventional crimping devices for loading stented bioprosthetic heart valves into delivery devices are cumbersome, difficult to operate, and can compromise the integrity of the valve, often causing undue stress and failure to securely engage the stent with the delivery device.
Innovation Solution
A loading assembly comprising a compression member with a funnel-shaped design and a support member with a tubular restrainer, allowing for controlled compression and secure engagement of the valve, minimizing stress and facilitating easy loading into a minimally invasive delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If direct radial crimping devices are used to compress the stented valve, then the valve can be collapsed for loading, but the devices are bulky and difficult to operate
Solution Approach 1:
The crimping device is divided into two separate members: a compression member with a tapered bore for applying radial compressive force, and a support member with a recess for positioning the valve. This segmentation allows each component to be simpler and easier to operate while maintaining the overall crimping function.
Solution Approach 2:
The support member is disposed within the compression member, creating a nested configuration. The support member's recess receives the stented valve, and the compression member's tapered bore surrounds the support member. This nesting allows compact operation while maintaining distinct functional zones.
2Reliability
If conventional crimping methods are used, then the valve can be compressed, but undue stress is imparted on the stented valve compromising its integrity
Solution Approach 1:
The compression member has a tapered bore with varying diameter along its length, creating different compression zones. The gradual taper allows controlled, progressive compression rather than sudden uniform force, reducing stress concentration on the valve structure while maintaining compression effectiveness.
Solution Approach 2:
The support member with its recess provides a cushioning interface between the valve and the compression member. This support structure distributes the compressive force and prevents direct, concentrated stress on critical valve components during the crimping process.
3Productivity
If conventional crimping devices are used, then compression can be achieved, but the procedure is time consuming
Solution Approach 1:
The support member is pre-configured with a recess that automatically positions and secures the stented valve before compression begins. This preliminary positioning eliminates time-consuming manual alignment steps and ensures the valve is ready for immediate compression when the compression member is engaged.
Solution Approach 2:
The compression member and support member are designed to move relative to each other along a longitudinal axis, allowing dynamic adjustment during the crimping process. This dynamic configuration enables quick engagement and disengagement, reducing the overall time required for the loading procedure.
4Reliability
If conventional crimping methods are used, then the valve can be collapsed, but it is difficult to securely engage the stent with the delivery device
Solution Approach 1:
The support member serves multiple functions: it positions the valve, provides support during compression, and facilitates secure engagement with the delivery device. This multi-functionality is achieved through its recess geometry and interaction with the compression member, eliminating the need for separate engagement mechanisms.
Solution Approach 2:
The support member acts as an intermediary between the compressed valve and the delivery device. Its recess provides a stable interface that secures the valve during compression and facilitates reliable engagement with the delivery device, simplifying the engagement process while improving reliability.
Data Source
AI summary
An assembly for loading a self-expanding prosthetic heart valve into a delivery device, includes a compression member having a longitudinal axis, a first open end with a first diameter, a second open end with a second diameter less than the first diameter, and a wall decreasing in diameter from the first open end to the second open end, a support member having a longitudinal axis, a base and a recess extending along the longitudinal axis and adapted to receive an end of the valve, the support member and the compression member being movable between an initial position and an operative position, and a substantially tubular restrainer disposed within the support member and, in the operative position of the compression member and the support member, defining a passageway for accepting a portion of the delivery device and leaflets of the valve when the valve is assembled on the support member.