Minimally Invasive Heart Valve Prosthetic Device

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Solution Overview

Problem

Heart valve regurgitation, characterized by leakage from the outflow to the inflow side of a heart valve, reduces heart efficiency, leads to fatigue, shortness of breath, and can progress to congestive heart failure or death, and current treatments like open-heart surgery are invasive and not suitable for high-risk patients.

Innovation Solution

A minimally invasive prosthetic device with an anchoring member and an insert member configured for deployment between the leaflets of a native heart valve, such as the aortic valve, to create a tight seal and prevent regurgitation, using a stent for anchoring and a delivery catheter for percutaneous or minimally invasive procedures, allowing the native valve to function naturally while supplementing its function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery is used to replace the defective valve, then the valve function is improved, but the invasiveness and risk to high-risk patients increases

Engineering Contradiction:

Improvevalve functionVSAvoidinvasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into separate functional components: an anchoring member for securing to the valve annulus and an insert member for sealing between leaflets. This segmentation allows for minimally invasive delivery while maintaining effective valve function through coordinated action of specialized components.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insert member acts as an intermediary element positioned between the native valve leaflets to prevent regurgitation. This intermediary approach allows treatment of the valve defect without requiring complete valve replacement, thereby reducing invasiveness while improving reliability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If percutaneous valve replacement is used, then the invasiveness is reduced, but challenges with delivery techniques and perivalvular leakage remain

Engineering Contradiction:

ImproveinvasivenessVSAvoiddelivery reliability

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The insert member is specifically designed with sealing surfaces and geometry tailored to fit between the valve leaflets, creating localized sealing action that prevents perivalvular leakage. The anchoring member provides localized securing to the annulus, ensuring stable positioning during percutaneous delivery.

Inventive Principle:

Principle #3Local quality

3Object-affected harmful factors

If percutaneous valve replacement is used, then the invasiveness is reduced, but the durability of the valve is compromised

Engineering Contradiction:

ImproveinvasivenessVSAvoidvalve durability

Core Design Contradiction:

Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device utilizes composite construction combining an anchoring member (stent) with an insert member (valve leaflet prosthesis) to achieve both minimally invasive delivery and long-term durability. The stent provides structural stability and anchoring, while the insert member provides durable sealing function.

Inventive Principle:

Principle #40Composite materials

4Reliability

If the native valve is replaced, then the regurgitation is treated, but the native valve structure is destroyed

Engineering Contradiction:

Improveregurgitation treatmentVSAvoidnative valve preservation

Core Design Contradiction:

ReliabilityVSEase of repair

Solution Approach 1:

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS11839545B2Method of treating a defective heart valve

Publication Date: 2023.12.12 EDWARDS LIFESCIENCES CORP

AI summary

A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member self-expands to plug gaps between leaflets of the heart valve. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member. After deployment of the prosthetic device, the leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation when the leaflets are closed and wherein blood passes through the insert member when the leaflets are open.