Transcatheter Heart Valve Delivery with Selective Stent Release
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Solution Overview
Problem
Current percutaneous transcatheter delivery systems for prosthetic heart valves face challenges in accurately deploying and securely retaining stented prosthetic heart valves during minimally invasive procedures, particularly in maintaining partial deployment states while avoiding damage and ensuring consistent full deployment, due to the rigid nature of the stent frames and complex component interactions.
Innovation Solution
A delivery device comprising a delivery sheath assembly, an inner shaft, and a capture assembly with release features that allow for selective coupling and release of the stent frame, enabling partial and full deployment of the prosthetic heart valve while maintaining the stent's integrity and facilitating precise positioning and expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the stent frame is made rigid to maintain structural integrity during deployment, then the reliability of valve positioning is improved, but the ease of operation for partial deployment and recapture is worsened
Solution Approach 1:
The stent frame is divided into multiple segments or sections that can be independently controlled. The delivery device includes separate control mechanisms for different portions of the stent, allowing the operator to deploy the distal portion while retaining proximal control for potential recapture. This segmentation enables selective deployment without requiring the entire stent to be deployed simultaneously, resolving the contradiction between structural rigidity and operational flexibility.
Solution Approach 2:
The delivery device incorporates dynamic control mechanisms that allow transition between different deployment states. The system can move from a fully retained state to a partially deployed state and potentially back to retained state, providing dynamic control over the deployment process. This dynamic capability maintains reliability while improving ease of operation during partial deployment scenarios.
2Reliability
If the delivery device securely retains the prosthetic heart valve during delivery, then the reliability of device function is improved, but the ease of release for deployment is worsened
Solution Approach 1:
A release mechanism acts as an intermediary between the delivery device and the stent frame. This intermediary component provides a controlled interface for retention and release, allowing secure holding during delivery while enabling straightforward release when deployment is desired. The release mechanism translates simple operator actions into the necessary forces for secure retention or controlled release, resolving the contradiction between secure retention and ease of release.
Solution Approach 2:
The retention force between the delivery device and stent frame can be dynamically changed through parameter adjustments in the release mechanism. The system can maintain high retention forces during delivery, then transition to low retention forces for easy release. This parameter change capability allows the same mechanism to provide both secure retention and ease of release, resolving the identified contradiction.
3Manufacturing precision
If complex component interactions are used to control deployment, then the precision of positioning is improved, but the device complexity increases
Solution Approach 1:
The delivery device incorporates self-aligning and self-regulating features that automatically ensure precise positioning without requiring complex control mechanisms. The design includes self-correcting geometries and automatic locking features that guide the deployment process, reducing the need for complex component interactions while maintaining high positioning precision. This self-service approach resolves the contradiction by achieving precision through simplified mechanisms.
Data Source
AI summary
A delivery system for percutaneously delivering and deploying a stented prosthetic heart valve. The delivery device includes a delivery sheath slidably disposed over an inner shaft, and a capture assembly. The capture assembly includes at least one release feature for releasing the stented prosthetic heart valve from the delivery device.