Mitral Valve Replacement Using Expandable Retainer Anchoring

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Solution Overview

Problem

Current prosthetic heart valve devices face challenges in effectively replacing the mitral valve due to its irregular, asymmetric shape and lack of radial support, leading to issues like leaks and distortion, and existing procedures are invasive and risky.

Innovation Solution

A prosthetic heart valve device with a flexible valve support and expandable retainer that conforms to the mitral valve's shape, mechanically isolating the support from distorting forces, and includes arms to engage leaflets for secure anchoring, allowing for less-invasive percutaneous deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a rigid, symmetric valve support is used, then the prosthetic valve maintains its shape and structural integrity, but it cannot adapt to the irregular, asymmetric mitral valve anatomy, leading to leaks and distortion

Engineering Contradiction:
Improvevalve support shape stabilityVSAvoidadaptation to mitral valve anatomy
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The valve support is divided into multiple independent arms that can move relative to each other. Each arm can independently adapt to the irregular mitral valve anatomy while maintaining overall structural integrity through their connection to the central body.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve support transitions from a static, rigid structure to a dynamic, adaptable structure. The arms can move and adjust their positions to conform to the asymmetric mitral valve shape, allowing the device to adapt to varying anatomical conditions.

Inventive Principle:
Principle #15Dynamics

2Reliability

If the valve support is directly engaged with the mitral valve tissue, then anchoring is achieved, but distorting forces from the irregular anatomy cause valve distortion and leaks

Engineering Contradiction:
Improveanchoring securityVSAvoidvalve shape stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The retainer acts as an intermediary element between the valve support and the mitral valve tissue. It engages with the annulus and leaflets to provide secure anchoring while isolating the valve support from distorting forces, preventing valve distortion.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The retainer is extracted as a separate functional component from the valve support. This separation allows the retainer to handle the anchoring function and absorb distorting forces, while the valve support maintains its shape and structural integrity.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If traditional surgical replacement procedures are used, then complete valve replacement is achieved, but the procedures are invasive, painful, and require long recovery periods

Engineering Contradiction:
Improvevalve replacement effectivenessVSAvoidprocedure invasiveness and patient morbidity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the traditional mechanical surgical approach (sternotomy, direct surgical implantation) with a percutaneous delivery system. The valve device is delivered through a catheter inserted through a peripheral vessel, eliminating the need for open chest surgery.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The valve support and retainer are nested within a delivery catheter in a compressed state. Once positioned at the mitral valve, the device is deployed and expanded from its compact delivery configuration to its functional expanded configuration.

Inventive Principle:
Principle #7Nested doll (Nesting)

Data Source

PatentUS12370042B2Devices, systems and methods for heart valve replacement
Publication Date: 2025.07.29 TWELVE INC
  • US12370042B2 patent drawing
  • US12370042B2 patent drawing
  • US12370042B2 patent drawing

AI summary

A heart valve repair device may include a support configured to extend through a native annulus of a native heart valve, wherein the support comprises an upstream portion and a downstream portion; an annular expandable retainer extending from the upstream portion of the support, and an arm extending from the downstream portion of the support. The annular expandable retainer may include a C-shaped cross-section that is open inwardly. The arm may be configured to reach behind a leaflet of the native heart valve and sandwich the leaflet between the arm and the support.