Inversion Delivery Device for Prosthetic Valve Positioning
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Solution Overview
Problem
Percutaneous valve replacement methods face challenges such as leakage around the prosthetic valve, stent-related emboli, non-conformity to native lumen, tradeoff between strength and compressibility, irretrievability, and non-adjustable stent strength, which complicate the procedure and patient recovery.
Innovation Solution
A delivery device that attaches to the aortic flare for precise positioning and inversion of a braided implant, using an attachment mechanism that stabilizes the device during inversion and allows for anchor locking, enabling complete valve function verification before release and potential repositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a stent is used to support the prosthetic valve, then the valve structure is stabilized, but the stent creates emboli and does not conform to the native lumen
Solution Approach 1:
The patent removes the stent component from the valve assembly, extracting the harmful elements (emboli generation and non-conformity) while retaining the essential support function through alternative means such as annular reinforcement elements integrated directly into the valve structure
Solution Approach 2:
The delivery device acts as an intermediary that provides temporary support and positioning during implantation, allowing the valve to be deployed without a permanent stent that would cause emboli and non-conformity issues
2Object-affected harmful factors
If the catheter is inserted through the vasculature to position the collapsed stent, then the physical impact to the patient is reduced, but leakage around the prosthetic valve occurs
Solution Approach 1:
The patent inverts the traditional approach by deploying the valve without a stent framework, allowing the native valve tissue and surrounding structures to provide the sealing surface, thereby eliminating paravalvular leakage while maintaining percutaneous access benefits
3Strength
If the stent is made stronger to provide adequate support, then the valve structure is more stable, but the stent becomes less compressible
Solution Approach 1:
By removing the stent entirely, the patent eliminates the strength-compressibility tradeoff, achieving adequate structural support through the valve annulus and surrounding native structures without requiring a compressible yet strong stent framework
4Stability of the object's composition
If the stent is deployed to fix the valve, then the valve position is stabilized, but the stent cannot be retrieved or repositioned
Solution Approach 1:
The delivery device provides dynamic control during implantation, allowing for positioning adjustments and retrieval before final deployment, while the implanted valve achieves stability through integration with native structures rather than a permanent fixed stent
Data Source
AI summary
A delivery device usable to deliver an inverting implant is provided that includes a positioning mechanism that automatically initiates the inversion process once a predetermined length of the implant has exited a delivery catheter. The positioning mechanism allows the implant to be safely and accurately deployed with reduced operator experience and in a greater variety of target locations.