Self-Expanding Mitral Valve Framework with Diamond-Shaped Members

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current transcatheter prosthetic heart valves face challenges such as insufficient articulation and sealing, perivalvular leakage, poor fit within the native mitral annulus, and lack of customization, particularly for the mitral valve, which complicates the procedure and increases morbidity and cost.

Innovation Solution

A self-expanding wire frame prosthetic cardiovascular valve with a cylindrical framework featuring diamond-shaped members and a flexible cuff made of shape-memory materials like Nitinol, which conforms to the anatomical shape of the mitral annulus, provides a tight seal and adjustable compliance to accommodate the complex geometry of the heart, minimizing leakage and ensuring proper deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional open heart surgery is used for valve replacement, then the valve can be replaced with good structural support, but the procedure carries high morbidity and requires extra-corporeal circulation

Engineering Contradiction:

Improvevalve replacement successVSAvoidmorbidity from extra-corporeal circulation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that can deploy the valve through a catheter, eliminating the need for thoracotomy, heart-lung machine, and direct surgical manipulation of the heart

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The prosthetic valve is nested within a delivery catheter in a compressed state, allowing it to be delivered through peripheral vessels to the heart, then deployed in situ to replace the native valve

Inventive Principle:

Principle #7Nested doll (Nesting)

2Device complexity

If a simple cylindrical framework is used for the prosthetic valve, then the device structure is simplified, but insufficient articulation and sealing occur within the native annulus

Engineering Contradiction:

Improveframework structureVSAvoidvalve sealing performance

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The framework incorporates diamond-shaped members that can dynamically adjust and articulate to conform to the irregular geometry of the native mitral annulus, enabling the rigid framework to adapt to dynamic anatomical variations

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The diamond-shaped members provide asymmetric geometry that better matches the asymmetric and irregular shape of the mitral annulus compared to a simple circular framework, improving articulation and sealing

Inventive Principle:

Principle #4Asymmetry

3Reliability

If the prosthetic valve is made to fit the mitral annulus, then sealing is improved, but the complex geometry of the mitral valve increases procedure difficulty

Engineering Contradiction:

Improveperivalvular sealingVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The self-expanding framework automatically articulates and conforms to the mitral annulus geometry upon deployment, eliminating the need for complex manual positioning and adjustment procedures

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The framework is pre-formed with diamond-shaped members configured to self-articulate upon expansion, performing the complex adaptation to annular geometry automatically during the deployment process

Inventive Principle:

Principle #10Preliminary action

4Strength

If a rigid framework is used for structural support, then the valve maintains its shape, but poor fit within the native mitral annulus occurs

Engineering Contradiction:

Improvestructural supportVSAvoidfit to native annulus geometry

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The framework transitions from a static rigid structure to a dynamic system where diamond-shaped members can articulate and adjust their configuration to match the native annulus while maintaining overall structural integrity

Inventive Principle:

Principle #15Dynamics

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 solution effectively reduces perivalvular leakage, improves atrial drainage, and provides structural integrity to withstand intracardiac forces, allowing for a more precise fit and reduced morbidity during valve replacement surgeries.

Implementation Method 1

A self-expanding wire frame prosthetic cardiovascular valve with a cylindrical framework featuring diamond-shaped members and a flexible cuff made of shape-memory materials like Nitinol

Methodology Applied

Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 2

A self-expanding wire frame prosthetic cardiovascular valve with a cylindrical framework featuring diamond-shaped members

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS11617645B2Structural members for prosthetic mitral valves

Publication Date: 2023.04.04 TENDYNE HOLDINGS INC

AI summary

A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.