Prosthetic Heart Valve Locking Assembly for Controlled Expansion
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Solution Overview
Problem
There is a need for improved transcatheter heart valves and delivery systems that can effectively expand and lock prosthetic valves at the implantation site with reduced clinical complications.
Innovation Solution
The prosthetic valve features a frame with an expansion and locking mechanism comprising an outer member, an inner member, and at least one plate that transitions between angled locking and non-locking orientations, facilitated by actuation and release mechanisms to control the expansion and locking process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a mechanical actuation mechanism is used to expand the prosthetic valve, then the valve can be delivered via catheter and expanded at the implantation site, but the risk of undesired recompression and delivery system disconnection increases
Solution Approach 1:
The expansion and locking mechanism is divided into separate functional components: an outer member coupled to the frame at a first location, an inner member coupled at a second location, and a plate that transitions between orientations. This segmentation allows each component to perform its specific function (expansion, locking, control) independently, improving reliability while maintaining ease of operation.
Solution Approach 2:
The plate is designed to dynamically transition between a first orientation (allowing expansion) and a second orientation (providing locking). This dynamic behavior enables the mechanism to adapt its function based on the expansion stage, preventing undesired recompression after expansion while maintaining the ability to expand when needed.
2Shape
If the valve frame is expanded radially to the desired diameter, then adequate directional flow is achieved, but axial foreshortening occurs during expansion
Solution Approach 1:
The frame is segmented with multiple coupling locations (first location and second location spaced apart axially) where the expansion mechanism is attached. This segmentation allows differential movement at different axial positions, enabling radial expansion while managing axial foreshortening through the relative movement of segmented components.
Solution Approach 2:
The mechanism converts axial movement (inner member moving relative to outer member) into radial expansion of the frame. By operating in the axial dimension to achieve radial expansion, the system manages the geometric transformation that inherently causes axial foreshortening, allowing control over the expansion process.
3Stability of the object's composition
If the plate transitions to the locked orientation to prevent recompression, then valve position stability is improved, but the ability to adjust diameter is reduced
Solution Approach 1:
The plate's ability to transition between orientations provides dynamic control: in the first orientation, the valve can be expanded and adjusted; in the second orientation, the valve is locked stable. This dynamic design resolves the contradiction by allowing the system to have both adaptability (when needed for expansion/adjustment) and stability (when locked in position), depending on the operational phase.
Solution Approach 2:
The expansion and locking process occurs in periodic stages: expansion phase (plate in first orientation allowing adjustment), locking phase (plate transitions to second orientation for stability), and potential re-adjustment phase. This periodic action allows the valve to achieve both adaptability during expansion and stability during the locked state.
Data Source
AI summary
The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to assemblies and methods for facilitating change in diameter of such prosthetic devices.