Mitral Valve Clamp With Occluding Net for Regurgitation Closure

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Solution Overview

Problem

Current mitral valve repair devices, such as the MitraClip and Edwards PASCAL, face challenges in effectively occluding regurgitation on all sides and top of the valve, leading to incomplete closure and increased stress on leaflets, which can result in valvular stenosis and complications during the repair procedure.

Innovation Solution

A clamp with expandable arms and a central occluding woven net is designed to provide a mechanical locking mechanism that expands the clamping range, reducing central regurgitation and stress on the leaflets, while maintaining a firm closure to prevent the clamp from dropping after implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a single clip is used for edge-to-edge repair, then the procedure is simpler, but regurgitation leakage occurs on two sides and top of the clip

Engineering Contradiction:

Improveprocedure simplicityVSAvoidocclusion completeness

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The clamp is divided into multiple independent clamping units (first clamping unit with left and right arms, second clamping unit with left and right arms) that can be positioned at different locations on the mitral valve. Each unit independently occludes regurgitation from different directions, achieving complete coverage of all regurgitation sites without requiring multiple separate clips

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Multiple clamping units are integrated into a single clamp device that can be deployed simultaneously or sequentially. The first and second clamping units work together to occlude regurgitation on two sides and top of the valve, merging the functions of what would traditionally require multiple separate clips into one unified device

Inventive Principle:

Principle #5Merging (Combining)

2Reliability

If multiple clips are used to achieve complete occlusion, then regurgitation leakage is reduced, but the procedure becomes more difficult and risky

Engineering Contradiction:

Improveocclusion completenessVSAvoidprocedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The clamp incorporates multiple clamping units with different arm configurations (left arms and right arms with different curvature radii) that can be independently adjusted. This segmentation allows each unit to be optimized for specific anatomical variations while maintaining overall device simplicity

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The clamp features adjustable arms with different curvature radii that can be adapted to different patient anatomies. The first and second clamping units can be positioned and configured dynamically during the procedure to match the specific geometry of the mitral valve, reducing the need for complex procedural adjustments

Inventive Principle:

Principle #15Dynamics

3Device complexity

If the clamp uses elastic lower clamp assemblies, then the structure is simpler, but the closure force is not firm enough and the clamp drops easily

Engineering Contradiction:

Improvestructure simplicityVSAvoidclosure firmness

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

A locking mechanism acts as an intermediary between the elastic lower clamp assemblies and the upper clamp assemblies. This locking mechanism firmly closes the lower clamp assemblies in a mechanical locking manner, preventing the clamp from dropping while maintaining the simplicity of the elastic assembly structure

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The elastic closure mechanism is supplemented with a mechanical locking system that provides firm, reliable closure. The locking mechanism replaces the insufficient elastic force with a positive mechanical lock, ensuring the clamp remains securely positioned without requiring complex additional structures

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Stability of the object's composition

If the clamp arms are rigid for stable clamping, then the clamping range is limited, but the clamp structure is simpler

Engineering Contradiction:

Improveclamping stabilityVSAvoidclamping range

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The clamp arms are designed with different curvature radii (first left arm with first curvature radius, second left arm with second curvature radius different from the first) allowing them to adapt to different anatomical configurations. This dynamic geometry enables the clamp to reach different positions on the mitral valve while maintaining stable clamping when engaged

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20220314046A1clamp

Publication Date: 2022.10.06 SHANGHAI HANYU MEDICAL TECH CO LTD

AI summary

A clamp includes upper clamp assemblies, lower clamp assemblies, a base, a locking unit, a connecting rod arm, expandable arms and a central occluding woven net. The upper clamp assemblies and the lower clamp assemblies are quantitatively identical and cooperate in opening and closing to form a clamping portion. The clamp can effectively occlude the regurgitation on two sides of the clamp through the expandable arms on the two sides. By means of the central occluding woven net, the clamp can further reduce the central regurgitation, decrease the stress on the leaflet and prevent the damage to the leaflet; and the clamp firmly closes the lower clamp assemblies in a mechanical locking manner, such that the clamp does not drop easily after implanted into the body. The clamp can be implanted through the femoral vein puncture and transseptal puncture (TSP) with minimal invasion, to repair the mitral valve.