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

VSEngineering 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

Engineering Contradiction:
Improvestructural strengthVSAvoidflexibility
Core Design Contradiction:
StrengthVSAdaptability or versatility

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

Inventive Principle:
Principle #35Parameter changes

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

Inventive Principle:
Principle #40Composite materials

2Reliability

If a traditional replacement valve is implanted, then valve replacement is achieved, but the valve may move or migrate after implantation

Engineering Contradiction:
Improvevalve placement stabilityVSAvoidvalve mobility
Core Design Contradiction:
ReliabilityVSEase of operation

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

Inventive Principle:
Principle #15Dynamics

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

Inventive Principle:
Principle #1Segmentation

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

Engineering Contradiction:
Improvevalve functionVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If a collapsible braided frame is used, then flexibility and adaptability are improved, but device complexity increases

Engineering Contradiction:
ImproveflexibilityVSAvoidframe structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

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

Inventive Principle:
Principle #30Flexible shells and thin films

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

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

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

Methodology Applied
Scientific EffectFriction: Friction

Data Source

PatentUS20240374381A1Devices, Systems, and Methods for a Valve Replacement
Publication Date: 2024.11.14 REVALVE SOLUTIONS INC
  • US20240374381A1 patent drawing
  • US20240374381A1 patent drawing
  • US20240374381A1 patent drawing

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.