Braided Nitinol Heart Valve with Multipoint Anchoring
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Solution Overview
Problem
Current heart valve replacement technologies face issues such as degradation of leaflets, frame failure, undesirable size changes in the native valve annulus, and the inability to securely and flexibly adapt to the heart's dynamic movements, leading to potential trauma and complications during and after implantation.
Innovation Solution
A valve replacement system featuring a braided, collapsible frame with a multipoint anchoring system that includes supra-annular and sub-annular anchoring, allowing for secure fixation and flexibility, and a 're-valvable' design that can be easily expanded and retracted via a catheter for precise placement and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a rigid laser-cut frame is used for the replacement valve, then structural strength is improved, but flexibility and adaptability to the heart's dynamic movements deteriorate
Solution Approach 1:
The patent changes the material parameter from rigid laser-cut metal to flexible braided nitinol wire, transforming the frame from rigid to flexible while maintaining strength through the braided structure's inherent mechanical properties
Solution Approach 2:
The patent uses braided nitinol wire as a composite structure that combines flexibility and strength, where the braided configuration provides both mechanical integrity and the ability to deform with cardiac movements
2Reliability
If a traditional replacement valve is implanted, then valve replacement is achieved, but the valve may move or migrate after implantation
Solution Approach 1:
The patent incorporates a dynamic anchoring system with expandable anchors that can adapt to cardiac movements while maintaining secure attachment to the annulus, allowing the valve to move with the heart rather than resisting movement
Solution Approach 2:
The patent divides the anchoring function into separate expandable anchors that can independently engage with the annulus tissue, providing distributed securement that prevents migration while allowing overall valve flexibility
3Reliability
If a replacement valve is implanted to treat valve disease, then valve function is improved, but the valve is not readily retrievable and may damage surrounding tissue
Solution Approach 1:
The patent creates a dynamic retrieval capability where the collapsible frame can be compressed and the valve can be pulled back through the catheter, allowing safe removal without damaging surrounding tissue when retrieval is needed
4Adaptability or versatility
If a collapsible braided frame is used, then flexibility and adaptability are improved, but device complexity increases
Solution Approach 1:
The patent uses a braided wire structure that functions as a flexible skeleton, where the braided configuration provides structural integrity while allowing compression and expansion without complex mechanical components
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides a secure, flexible, and adaptable solution for heart valve replacement, minimizing trauma and complications by anchoring securely to the native valve tissue, accommodating the heart's natural movements, and allowing for future interventions without damaging surrounding tissue.
Implementation Method 1
A valve replacement system featuring a braided, collapsible frame
Implementation Method 2
a multipoint anchoring system that utilizes a combination of supra-annular anchoring that anchors to the top of the annulus of the native heart valve, sub-annular anchoring that anchors to the bottom of the annulus of the native heart valve
Data Source
AI summary
Disclosed are valve replacement devices, systems, and methods. Valve replacement devices may comprise one- or two-piece systems comprising an adapter body and a valve assembly with leaflets positioned within the adapter body. In two-piece systems, the valve assembly may be removable from the adapter body such that both can be delivered together or separately, and the adapter body may remain implanted while the valve assembly may be removed and replaced (i.e., “revalved”). Also described are devices (such as a delivery catheter device), systems, and methods related to such delivering and revalving the valve replacement. Such delivery methods may include transseptal insertion of a new minimum leaflet structure, and securement of the valve replacement using several securement type (e.g., supra-annular, sub-annular, radial, leaflet securement, etc.). Also described is a braided helical design that mimics the heart's natural movement, and a flange structure for assisting the functioning of the valve replacement.


