Low-Profile Prosthetic Valve Structure Using Nested Delivery
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Solution Overview
Problem
Designing a prosthetic valve that can be compressed to fit within a small catheter for percutaneous delivery while ensuring proper function, anchoring, and minimizing recovery time, as conventional methods are invasive and risky, and existing low-profile designs are limited in their ability to maintain structural integrity and prevent perivalvular leakage.
Innovation Solution
A prosthetic valve device comprising a stent, tissue sleeve, and braided anchoring mechanism connected to a wireform, with a support structure that folds inwardly to reduce catheter size, featuring a preformed fold and hinged connection to maintain valve orientation during deployment, allowing the valve assembly to invert into the stent for a low-profile configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If the prosthetic valve is compressed to fit within a small catheter, then the catheter size is reduced for easier percutaneous delivery, but the structural integrity and anchoring capability of the valve may be compromised
Solution Approach 1:
The valve assembly is nested within the delivery catheter in a compressed state, with the stent and tissue sleeve folded or collapsed to fit within the catheter lumen. The anchoring mechanism is also compacted within the catheter, allowing the entire valve assembly to be delivered through a small-bore catheter while maintaining the capability to expand to full structural integrity at the implantation site
Solution Approach 2:
The valve transitions from a static compressed state within the catheter to a dynamic expanded state at the implantation site. The stent is designed to expand radially, the tissue sleeve unfolds, and the anchoring mechanism deploys to engage with the native valve annulus, transforming the device from a low-profile delivered configuration to a fully functional implanted configuration with robust structural integrity
2Object-affected harmful factors
If the prosthetic valve is compressed to fit within a small catheter, then the invasiveness of the procedure is reduced, but the ability to anchor the valve securely may be worsened
Solution Approach 1:
The anchoring mechanism is segmented into multiple independent anchoring elements or struts that can deploy radially outward from the valve assembly. These segmented anchoring elements can engage with the native valve annulus at multiple discrete points, providing secure anchoring while allowing the overall device to be delivered through a small catheter in a compressed state
Solution Approach 2:
The anchoring mechanism acts as an intermediary between the valve assembly and the native valve annulus. It provides a transition zone that allows the valve to be securely anchored to the native annulus while maintaining the capability to be delivered through a small catheter, mediating between the constrained delivered state and the fully anchored implanted state
3Length of moving object
If the prosthetic valve uses a folded configuration to reduce catheter size, then the delivery catheter can be smaller for percutaneous access, but the complexity of the device structure increases
Solution Approach 1:
The stent and tissue sleeve are designed with pre-formed curves or folds that allow them to collapse into a compact, curved configuration for delivery through a small catheter. These curved geometries are engineered to naturally unfold or expand into the desired three-dimensional valve structure at the implantation site, reducing the need for complex mechanical actuation mechanisms
Solution Approach 2:
The stent and tissue sleeve are pre-formed with predetermined folds or curves during manufacturing that facilitate automatic unfolding or expansion upon deployment. This preliminary shaping eliminates the need for complex real-time manipulation mechanisms during the procedure, reducing device complexity while enabling compact delivery through a small catheter
4Loss of time
If the prosthetic valve is designed with a low-profile configuration for catheter delivery, then recovery time is reduced due to less invasive procedure, but the risk of perivalvular leakage may increase
Solution Approach 1:
The valve assembly features localized sealing elements or sealing rings positioned at critical interfaces between the valve components and the native valve annulus. These localized sealing structures provide targeted prevention of perivalvular leakage at specific high-risk areas, allowing the overall device to maintain a compact low-profile configuration for catheter delivery while addressing leakage prevention at critical local zones
Data Source
AI summary
A prosthetic valve assembly that includes a stent, a tissue sleeve and an anchoring mechanism. By loading the three components of the valve assembly into a delivery catheter in a series formation, such that no two components are located within each other, the size of the delivery catheter can be reduced.