Expandable Prosthetic Heart Valve Locking Assembly for Controlled Deployment
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Solution Overview
Problem
There is a need for improved transcatheter heart valves and delivery systems that can reliably expand and lock prosthetic valves at the desired implantation site with minimal clinical complications.
Innovation Solution
The prosthetic valve includes 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 a delivery apparatus with actuation and release assemblies 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 with less invasive technique, but the device complexity increases due to actuation and locking assemblies
Solution Approach 1:
The patent combines the actuation function and locking function into a single integrated expansion and locking assembly. The actuation member, when moved axially, simultaneously expands the valve frame and engages the locking mechanism through the plate's angled orientation, eliminating the need for separate actuation and locking mechanisms.
Solution Approach 2:
The expansion and locking assembly serves multiple functions: it acts as the actuation mechanism for valve expansion, the locking mechanism for maintaining expanded position, and the release mechanism for valve deployment. The single assembly performs what would traditionally require multiple separate components.
2Reliability
If the prosthetic valve is expanded to a desired diameter at the implantation site, then adequate directional flow is assured, but the risk of undesired recompression increases without a locking mechanism
Solution Approach 1:
The locking mechanism utilizes dynamic geometry through the angled plate. When the inner member is in the retracted position, the plate's angled orientation creates a mechanical lock that prevents compression. The system transitions from a locked state to an unlocked state through axial movement of the inner member, providing dynamic stability control.
Solution Approach 2:
The plate is configured with a specific angled orientation relative to the inner member, creating an asymmetric geometry that provides locking in one direction (preventing compression) while allowing controlled expansion in the opposite direction through axial movement of the inner member.
3Productivity
If the actuation member is disconneced from the valve actuation assembly, then the delivery system can be retrieved, but the valve position must be securely locked to prevent migration
Solution Approach 1:
The locking mechanism is engaged automatically as part of the expansion process before the actuation member is disconnected. The axial movement that expands the valve simultaneously activates the locking mechanism through the angled plate, securing the valve in its expanded position prior to delivery system removal.
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.