Anchored Leaflet Device for Transcatheter Valve Repair

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Solution Overview

Problem

Existing transcatheter valve repair devices for conditions like mitral and tricuspid regurgitation face challenges such as potential for mitral stenosis, inability to replace valves without cutting native leaflets, and risks associated with prosthetic valves.

Innovation Solution

A transcatheter-delivered leaflet repair device comprising an implantable leaflet with a coaptation edge, a repair chord connected to the coaptation edge, and anchors to secure the chord and leaflet to native heart structures, allowing for improved coaptation and reduced invasive procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If clip devices or leaflet apposition therapies are used to close the gap between leaflets, then valve regurgitation is treated, but the risk of mitral stenosis increases and native leaflets cannot be replaced without cutting

Engineering Contradiction:

Improvevalve regurgitation treatment effectivenessVSAvoidmitral stenosis risk and limitation on native leaflet replacement

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device segments the valve repair function into distinct components: an implantable leaflet with coaptation edge for creating a new sealing surface, repair chords for tensioning and positioning, and separate anchors for securing the structure. This segmentation allows the new leaflet to be positioned and tensioned independently, achieving effective regurgitation closure without the harmful side effects of traditional clip devices that permanently affix leaflets and risk causing stenosis.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The implantable leaflet acts as an intermediary element between the native leaflets, creating a new coaptation surface that facilitates proper valve closure without requiring direct manipulation or cutting of the native leaflet tissue. The repair chords serve as intermediaries to tension and position the implantable leaflet, achieving the desired valve function while preserving native tissue integrity.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If artificial cords are used to treat degenerative disease, then leaflet height is reduced and coaptation is restored, but the treatment cannot be used in functional regurgitation, rheumatic disease, or other pathological conditions with restricted leaflet mobility

Engineering Contradiction:

Improvetreatment applicability to different pathological conditionsVSAvoidtreatment effectiveness in non-degenerative conditions

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The device employs dynamic repair chords that can be tensioned and adjusted to accommodate different pathological conditions. The repair chords allow for dynamic positioning and tensioning of the implantable leaflet, enabling the device to adapt to various degrees of leaflet mobility restriction while maintaining effective coaptation. This dynamic adjustment capability makes the treatment versatile across different pathological conditions including functional regurgitation and rheumatic disease.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device allows for parameter changes in chord tension and leaflet positioning to accommodate different pathological conditions. By adjusting the tension and positioning parameters of the repair chords and implantable leaflet, the device can be adapted to treat various conditions including degenerative disease, functional regurgitation, and rheumatic disease, where leaflet mobility and anatomy differ significantly.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If functional replacement valves are deployed, then mitral regurgitation is completely relieved, but risks of thrombosis, infection, and degeneration increase along with surgical placement requirements

Engineering Contradiction:

Improvemitral regurgitation relief effectivenessVSAvoidthrombosis, infection, and degeneration risks

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device extracts only the essential function of a replacement valve (creating a coaptation surface) while eliminating the harmful aspects of full prosthetic valves. By implanting only a leaflet portion rather than a complete prosthetic valve, the treatment achieves effective regurgitation relief while significantly reducing the risks of thrombosis, infection, and degeneration associated with full prosthetic replacements, and avoiding the need for surgical placement.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The implantable leaflet is designed as a minimally invasive, transcatheter-delivered component that provides the essential valve function without the complexity and long-term risks of full prosthetic valves. This simplified approach achieves the necessary therapeutic effect with reduced material and structural complexity, thereby reducing the risks of thrombosis, infection, and degeneration.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS20250017731A1Anchored Leaflet Device And Methods For Transcatheter Valve Repair

Publication Date: 2025.01.16 4C MEDICAL TECHNOLOGIES INC

AI summary

A leaflet repair device for a heart valve of a human heart comprises an implantable leaflet with a coaptation edge; a repair chord connected at one end to near the coaptation edge; a chord anchor for anchoring the repair chord to native structure of the human heart; and at least one annulus anchor for anchoring the leaflet to native structure of the human heart. In at least one embodiment, the leaflet repair device may overlap a diseased, prolapsed, or otherwise inferior leaflet that is not creating proper coaptation with a mating leaflet.