Flushable Loading Base for Prosthetic Heart Valves
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Solution Overview
Problem
Conventional crimping devices for loading prosthetic heart valves into delivery devices are cumbersome, difficult to use, and apply undue stress on the valve, making it challenging to securely engage the stent with the delivery device, especially for bioprosthetic valves with two separate cuff layers.
Innovation Solution
A loading assembly comprising a support member with a hollow body and a backing plate, including a recess with a seating surface and outlet ports, and a compression member with a frustoconical shape, which together facilitate the collapse and secure loading of the prosthetic heart valve into a minimally invasive delivery device, reducing loading forces and preventing valve damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional crimping devices are used to collapse the stented valve, then the valve can be loaded into the delivery device, but the devices are bulky and difficult to operate
Solution Approach 1:
The support member is divided into distinct functional components: a hollow body for structural support, a backing plate for engagement, and a recess for positioning the valve. This segmentation allows each component to be optimized independently while simplifying the overall operation.
Solution Approach 2:
The invention extracts the essential function of valve support and positioning from complex crimping mechanisms, isolating it into a simple support member with a recess that accommodates the valve in its collapsed state without requiring elaborate crimping apparatus.
2Object-affected harmful factors
If conventional crimping devices are used to collapse the stented valve, then the valve can be loaded, but the devices impart undue stress on the stented valve
Solution Approach 1:
The hollow body and backing plate structure provides cushioning support to the valve during the collapsing and loading process, distributing forces evenly and preventing concentrated stress that could damage the valve structure.
Solution Approach 2:
The support member acts as an intermediary between the valve and the delivery device, facilitating the loading process while protecting the valve from direct contact with potentially damaging forces from the delivery device or operator hands.
3Loss of time
If direct radial assemblies are used for crimping, then the valve can be collapsed, but the assemblies are bulky and time consuming to use
Solution Approach 1:
The invention extracts only the essential support and positioning functions from complex radial crimping assemblies, eliminating bulky crimping mechanisms while retaining the core capability to hold and load the collapsed valve efficiently.
Solution Approach 2:
The support member with its recess is designed to automatically accommodate and position the collapsed valve without requiring complex active crimping mechanisms, allowing the valve to be loaded through simple insertion movements rather than time-consuming crimping operations.
4Reliability
If conventional devices are used, then the valve can be loaded, but it is difficult to securely engage the stent with the retaining element of the delivery device
Solution Approach 1:
The seating surface in the recess provides a distinct engagement interface that visually and physically indicates proper positioning of the valve, ensuring secure engagement with the retaining element through clear feedback on alignment and contact.
Solution Approach 2:
The invention replaces complex mechanical engagement systems with a simple geometric interface consisting of the recess and seating surface, where the shape and position of these features inherently guide and secure the valve engagement without requiring elaborate locking mechanisms.
Data Source
AI summary
An assembly for loading a self-expanding prosthetic heart valve into a delivery device includes a support member including a body and a backing plate. The body has a longitudinal axis, a base end, a second end, and a recess extending along the longitudinal axis from the second end toward the base end. The recess has a bottom member defining a seating surface adapted to support the prosthetic heart valve. The backing plate is fixed to the body so as to define a void space between the backing plate and the body. The backing plate includes an inlet port and the recess includes a plurality of outlet ports. The inlet and outlet ports are in fluid communication with the void space. When the heart valve is received on the seating surface, each outlet port is rotationally aligned with a corresponding pocket formed between first and second cuffs of the heart valve.


