Delivery Catheter Micro Macro Movement Control
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Solution Overview
Problem
Existing delivery systems for prosthetic heart valves lack controllability and ease of deployment, particularly in percutaneous aortic valve replacement, where precise and controlled expansion of self-expanding metal frames is challenging, and there is a need for improved handling and packaging solutions for surgical procedures.
Innovation Solution
A delivery system with a proximal handle system that allows for controlled micro and macro movements of a distal sheath for precise deployment of prosthetic heart valves, combined with a packaging tray for effective storage and preparation, featuring a control handle assembly with a quick-release mechanism and selective surface coatings for improved insertion and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a self-expanding metal frame is used for prosthetic heart valve, then the valve can be delivered percutaneously and deployed in situ, but precise control and positioning during deployment becomes difficult
Solution Approach 1:
The delivery system employs a dynamic structure where the metal frame transitions from a compressed delivered state to an expanded deployed state. The frame includes shape memory alloy or superelastic materials that enable controlled transformation between configurations, allowing precise positioning during deployment while maintaining ease of percutaneous delivery.
Solution Approach 2:
A delivery catheter and deployment mechanism serve as intermediaries between the operator and the self-expanding metal frame. The system includes a delivery sheath, expansion balloon, or mechanical crimping mechanism that controls the expansion timing and positioning, enabling precise deployment control while maintaining the benefits of self-expanding design.
2Manufacturing precision
If the delivery system includes complex control mechanisms for precise valve deployment, then deployment accuracy improves, but device complexity and ease of operation worsen
Solution Approach 1:
The metal frame is designed with self-expanding capabilities through shape memory alloy or superelastic materials that automatically return to their predetermined expanded configuration upon release. This self-service mechanism reduces the need for complex external control systems while maintaining high deployment accuracy through the material's inherent memory properties.
Solution Approach 2:
The complex control mechanisms are extracted from the delivery system and replaced with simpler release mechanisms. The patent removes elaborate actuation systems and retains only essential components for controlled release, simplifying the device while preserving deployment precision through the self-expanding frame's inherent properties.
3Ease of operation
If the delivery system is designed for easy handling and packaging, then ease of operation improves, but deployment precision and control may be compromised
Solution Approach 1:
The delivery system is segmented into distinct functional modules: a collapsible delivery catheter for easy navigation, a separate expansion mechanism for precise deployment, and a self-expanding metal frame for controlled expansion. This segmentation allows each component to be optimized independently - the catheter for ease of handling and the expansion mechanism for deployment precision.
Solution Approach 2:
The metal frame is pre-formed with its final expanded geometry encoded in its material structure before delivery. The frame includes pre-positioned struts, rings, and mounting features that are compressed during delivery but automatically return to their precise predetermined positions upon expansion, ensuring deployment precision without requiring complex real-time control during the procedure.
Data Source
AI summary
A method of delivering and deploying a prosthetic valve includes percutaneously advancing a catheter to a treatment site, proximally retracting an outer shaft relative to an inner shaft to expose the prosthetic valve such that the prosthetic valve self-expands to a radially expanded configuration, disconnecting a tip retractor from a handle of the catheter, and proximally retracting the tip retractor to proximally retract the inner shaft and a nosecone attached to a distal end of the inner shaft relative to the outer shaft and/or the handle.