Dock Holder Packaging for Coil Separation and Valve Dock Integrity
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Solution Overview
Problem
Transcatheter heart valves face challenges in appropriately sizing and securing prosthetic valves within native mitral and tricuspid valves due to anatomical variations, leading to inefficiencies and paravalvular leakage.
Innovation Solution
A dock holder and packaging system that securely retains the dock assembly and dock delivery system within a container, using a base and lid configuration with depressions and protrusions to maintain the assembly's orientation and sterility, and a dock holder with helical threads to separate and protect the assembly's components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthetic valve is mounted on a flexible catheter and advanced through a blood vessel, then the valve can be implanted in a less invasive manner, but it is difficult to appropriately size and shape the valve for patients with varying mitral and tricuspid valve anatomy
Solution Approach 1:
The dock assembly includes a dock with a specific geometry that corresponds to the anatomy of the native valve, and the prosthetic valve is configured to engage with this dock. The dock's structure provides localized adaptation features that allow the valve to be properly sized and positioned for different patient anatomies while maintaining the less invasive catheter-based delivery approach
2Reliability
If a prosthetic valve is implanted in the native valve, then valve insufficiency can be treated, but the surrounding tissue may not be strong enough to hold the valve in position, leading to paravalvular leakage
Solution Approach 1:
The system separates the valve anchoring function from the valve itself by introducing a distinct dock assembly that engages with the native valve anatomy. The dock acts as an intermediate structure that provides stable anchoring points, while the prosthetic valve engages with the dock, thereby distributing the anchoring load and preventing paravalvular leakage without requiring the valve tissue to bear the full anchoring stress
3Reliability
If the dock assembly is packaged in a container with base and lid, then the assembly's orientation and sterility are maintained, but the device complexity increases
Solution Approach 1:
The packaging container integrates multiple functions into a single structure: the base defines both the engagement surface for the dock assembly and the overall container geometry, while the lid releasably engages with the base to provide both closure and orientation maintenance. This merging of functions reduces the need for separate components and simplifies the overall packaging structure while maintaining sterility and proper positioning
Data Source
AI summary
A dock holder configured to releasably secure a dock assembly to a container is disclosed. The dock holder includes a cylindrical body defining an exterior surface, where the dock holder is configured to receive a first portion of the dock assembly comprising two or more adjacent coils thereon, and where the exterior surface is configured to contact the first portion of the dock assembly. The dock holder further includes a protrusion configured to engage the first portion of the dock assembly and space a second portion of the dock assembly away from the dock holder, where the protrusion extends outward from the exterior surface in a radial direction and is configured to separate the two or more adjacent coils of the first portion of the dock assembly from one another.