Valve Clamp with Nested Clamping Arms for Mitral Valve Repair

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Solution Overview

Problem

Current treatments for mitral valve regurgitation, such as surgical edge-to-edge suture and existing interventional devices like MitraClip, are invasive, costly, and complex, with limited effectiveness and high risk, especially for high-risk patients, and there is a lack of minimally invasive devices available for treating mitral valve regurgitation in the market.

Innovation Solution

A valve clamp with inclined clamping arms and a locking mechanism that can be implanted minimally invasively through the apex cordis or peripheral artery, featuring a pair of V-shaped clamping arms and a connecting part with a locking bar and clamping ring, designed to clip the mitral valve leaflets effectively, reducing the complexity and cost of the procedure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical edge-to-edge suture or MitraClip is used to treat mitral valve regurgitation, then therapeutic effect is improved, but device complexity and manufacturing cost increase

Engineering Contradiction:

Improvetherapeutic effectVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The valve clamp is divided into first and second clamp parts, each with multiple clamping arms that can independently engage with valve leaflets. This segmentation allows the device to achieve effective clamping while simplifying the overall structure compared to single-unit complex devices like MitraClip

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The first and second clamp parts are designed to be nested within each other during delivery, with one clamp part positioned inside the other. This nesting approach reduces delivery profile complexity while maintaining the functional benefits of multiple clamping arms, thereby reducing device complexity without compromising therapeutic effect

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If MitraClip is used to treat mitral valve regurgitation, then therapeutic effect is improved, but manufacturing cost increases

Engineering Contradiction:

Improvetherapeutic effectVSAvoidmanufacturing cost

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

By dividing the device into modular first and second clamp parts that can be manufactured separately and then assembled, the manufacturing process becomes more straightforward and cost-effective compared to producing a single integrated complex device like MitraClip

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The clamp parts are designed with universal features that can engage with different valve leaflet configurations, allowing a single design to serve multiple clinical scenarios. This universality reduces the need for multiple specialized components, thereby lowering manufacturing costs while maintaining therapeutic effectiveness

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Reliability

If complex delivery system with multiple turning points is used, then valve clamping capability is improved, but procedure time and operational complexity increase

Engineering Contradiction:

Improvevalve clamping capabilityVSAvoidprocedure time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The nested configuration of the first and second clamp parts allows them to be delivered through a streamlined catheter system with fewer turning points. The nested design reduces the radial profile and simplifies navigation through the heart, thereby reducing procedure time while maintaining the capability to effectively clamp the valve leaflets

Inventive Principle:

Principle #7Nested doll (Nesting)

4Reliability

If traditional open-chest surgery is used to treat mitral valve regurgitation, then therapeutic effect is improved, but patient trauma and recovery time increase

Engineering Contradiction:

Improvetherapeutic effectVSAvoidpatient trauma

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The valve clamp acts as an intermediary device that can be delivered percutaneously through the femoral vein and navigated to the mitral valve position without requiring open-chest surgery. This intermediary approach maintains therapeutic effectiveness while avoiding the trauma of traditional surgery, allowing treatment of high-risk patients who would otherwise be inoperable

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentEP3323353B1Valve clamp

Publication Date: 2021.06.23 ZHONGSHAN HOSPITAL FUDAN UNIV

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AI summary

The present invention discloses a valve clamp for treating the cardiac valve regurgitation. The valve clamp includes a first clamp part, a second clamp part, and a connecting part. The first clamp part has the first clamping arms. The second clamp part has a corresponding number of second clamping arms. The first clamping arm and the second clamping arm can clip an object therebetween through the interaction force generated by closing and pushing against each other. Moreover, the valve clamp can also include a closed ring, which is sleeved outside the periphery of the first clamp part and the periphery of the second clamp part, such that the clamping arms can close as needed, and the clamping is tighter. The valve clamp has the advantages of a minimally invasive implantation, a simple manufacture, a low difficulty of operation, good effects, etc. The valve clamp can be used to treat mitral valve regurgitation or tricuspid valve regurgitation, and can also be used in other minimally invasive surgeries that require clamping several pieces of tissues.