Collapsible Heart Valve Loading Assembly with 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, making minimally invasive procedures inefficient.
Innovation Solution
A loading assembly comprising a compression member with a funnel-shaped design, a support member, and a constricting member that allows for radial compression of the valve, along with a locking mechanism and seals to securely attach the valve to the delivery device, facilitating efficient loading and minimizing stress on the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
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
Solution Approach 1:
The loading assembly is divided into distinct functional components: a compression member with a tapered interior surface for radial compression, a support member with a recess to receive and stabilize the stented valve, and a constricting member with a lumen to guide the compressed valve into the delivery device. This segmentation allows each component to perform its specific function efficiently while reducing overall device complexity and improving ease of use.
Solution Approach 2:
The compression member acts as an intermediary tool that facilitates the transition of the stented valve from its expanded storage condition to a compressed loading condition. The tapered interior surface of the compression member gradually compresses the valve as it is pushed through, distributing stress evenly and avoiding the undue stress imparted by conventional crimping devices.
2Productivity
If conventional crimping devices are used, then the valve can be compressed, but the procedures are time-consuming
Solution Approach 1:
The support member is prepared in advance with a recess specifically shaped to receive the stented valve in its expanded condition. This preliminary preparation allows the valve to be quickly positioned and stabilized before compression, eliminating time-consuming adjustments during the crimping process and significantly reducing overall loading time.
3Productivity
If conventional crimping devices are used, then the valve can be collapsed, but undue stress is imparted on the stented valve
Solution Approach 1:
The compression member features a tapered interior surface with varying geometry along its length, creating different compression zones. The gradual taper allows for distributed, progressive compression that locally adapts to the valve structure, reducing stress concentration and preventing damage to the stented valve while achieving effective compression.
4Productivity
If the stented valve is compressed for extended periods, then it can be loaded into the delivery device, but the integrity of the biological valve is compromised
Solution Approach 1:
The loading assembly enables rapid compression and loading of the stented valve into the delivery device, minimizing the time the valve remains in the compressed state. The coordinated action of the compression member, support member, and constricting member allows the valve to be quickly loaded and then released from compression, preventing extended compression that would compromise biological valve integrity.
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 reduces the forces required for loading the valve by 13% and minimizes distal sheath flaring by 67%, enhancing the efficiency and precision 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 valve through the open space such that the valve is radially compressed by the wall of the compression member
Data Source
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AI summary
An assembly (200) for collapsing a self - expanding prosthetic heart valve 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 (226) adapted to receive an end of the valve. 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.