Tapered 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 master, time-consuming, and impart undue stress on the valve, while also struggling to securely engage the stent with the retaining element, which complicates minimally invasive procedures.
Innovation Solution
A loading assembly comprising a compression member with a tapered wall, a support member with a longitudinal slit, and a constricting member that aids in the radial compression and secure attachment of the prosthetic device within a delivery device, allowing for efficient loading and air displacement to prevent tissue damage during deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional crimping devices are used to compress the stent for loading into the delivery device, then the valve can be loaded into the delivery device, but the assembly becomes bulky and difficult to master
Solution Approach 1:
The loading device is divided into distinct functional segments: a compression member with tapered surface for radial compression, a support member with throughbore for receiving the stent, and a constricting member for securing the loaded assembly. Each segment performs a specific function, making the overall device easier to operate while maintaining effectiveness.
Solution Approach 2:
The support member acts as an intermediary between the compression member and the stent, providing a stable platform for loading while the compression member applies force through its tapered surface. This intermediary structure simplifies the loading process by mediating the interaction between compression forces and the stent.
2Productivity
If conventional crimping devices are used to compress the stent, then the valve can be loaded, but the procedure becomes time-consuming
Solution Approach 1:
The support member is pre-configured with a throughbore and positioning features that allow the stent to be received in the correct orientation before compression begins. The compression member's tapered surface is pre-shaped to guide the compression process, eliminating the need for complex real-time adjustments during the loading procedure.
Solution Approach 2:
The complex mechanical crimping process is replaced by a simpler system where the tapered surface of the compression member automatically guides the radial compression as the assembly is pushed together, eliminating the need for complex mechanical crimping mechanisms and reducing procedure time.
3Ease of manufacture
If conventional crimping devices are used to compress the stent, then the valve can be loaded, but undue stress is imparted on the stented valve
Solution Approach 1:
The compression force is distributed non-uniformly through the tapered surface of the compression member, which applies gentle progressive compression rather than abrupt uniform force. This local variation in compression quality protects the biological valve tissue from stress concentrations while still achieving the necessary radial compression for loading.
Solution Approach 2:
The support member provides a cushioning effect by distributing the compression forces across the stent structure before the actual crimping occurs. The tapered surface of the compression member gradually increases compression force, cushioning the valve tissue from sudden stress impacts during the loading process.
4Reliability
If conventional crimping devices are used, then the valve can be compressed, but it is difficult to securely engage the stent to the retaining element
Solution Approach 1:
The constricting member is nested within the support member's throughbore, creating a secure engagement mechanism where the constricting member can be positioned to lock the stent and compression assembly together. This nested configuration ensures reliable engagement while maintaining ease of operation through simple axial movements.
Solution Approach 2:
The constricting member provides dynamic engagement capability, allowing the operator to secure the loaded assembly at any point during the loading process by simple axial movement. This dynamic engagement mechanism replaces complex locking procedures with simple positional adjustment, improving both reliability and ease of operation.
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 facilitates efficient, stress-reduced loading of self-expanding prosthetic heart valves into minimally invasive delivery devices, ensuring secure attachment and minimizing air bubbles to prevent vascular complications during implantation.
Implementation Method 1
at least a portion of the prosthetic device is radially compressed by the tapered wall of the compression member as the prosthetic device advances through the open space
Data Source
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AI summary
An assembly for loading a self-expanding prosthetic device into a delivery device includes a compression member (202), a support member (204) and a constricting member (300). The compression member has a tapered wall between its first open end and its second open end, the tapered wall defining an open space adapted to receive the valve. The support member has a base (220) and a recess adapted to receive an end of the prosthetic device. The support member and the compression member are movable toward one another to compress the valve and push it through a relatively small aperture in the second open end of the compression member. The second end of the constricting member is sized to receive the compressed valve from the second open end of the compression member for loading into a delivery device.