Transcatheter Coaptation Assistance Element for Mitral Valve Repair

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Solution Overview

Problem

Current treatments for mitral valve regurgitation are invasive, costly, and often require exceptional surgical skills, with existing devices facing challenges in maintaining long-term functionality and accurate positioning due to tissue movement and fatigue issues, and there is a need for a less invasive method that directly enhances leaflet coaptation without disrupting anatomy.

Innovation Solution

The development of coaptation assistance elements that are thin, elongate, and conformable, extending laterally across the valve opening to assist in leaflet coaptation, with features like annular hubs, anchors, and purse-string sutures for secure attachment and deployment, allowing for adjustable positioning and retrieval, and can be delivered minimally invasively without the need for heart-lung machines.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional surgical methods are used to treat mitral valve regurgitation, then effective treatment can be achieved, but the procedure becomes highly invasive requiring heart-lung machines and exceptional surgical skills

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidsurgical procedure complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent replaces traditional mechanical surgical intervention with a transcatheter delivery system that uses a delivery catheter to implant coaptation assistance elements. This substitution eliminates the need for heart-lung machines and open-heart surgery, reducing procedural complexity while maintaining treatment effectiveness through minimally invasive access via vascular routes

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The coaptation assistance elements are designed as thin, flexible structures that can be compressed within the delivery catheter and then expanded at the target site. These flexible elements conform to the valve anatomy and provide coaptation support without requiring rigid surgical instrumentation, enabling percutaneous delivery while achieving effective valve repair

Inventive Principle:

Principle #30Flexible shells and thin films

2Reliability

If existing valve repair devices are used, then some treatment benefit is achieved, but long-term functionality is compromised due to tissue movement and fatigue issues

Engineering Contradiction:

Improveinitial treatment effectVSAvoiddevice long-term functionality

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The coaptation assistance elements are designed with dynamic characteristics that allow them to move and flex with the native valve tissue during the cardiac cycle. The elements can assume different configurations during valve opening and closing, maintaining functionality despite tissue movement and preventing fatigue failure through controlled flexibility rather than rigid fixation

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent incorporates features such as flexible connection elements and compliant anchoring mechanisms that anticipate and accommodate tissue movement before fatigue can occur. The design includes built-in flexibility and movement tolerance that cushions against the cumulative stress of repeated cardiac cycles, addressing long-term durability concerns from the outset

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If traditional surgical approaches are employed, then valve function can be restored, but the procedure requires exceptional surgical skills and is highly invasive

Engineering Contradiction:

Improvevalve function restorationVSAvoidsurgical skill requirement

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces complex manual surgical techniques with a standardized transcatheter delivery system. The delivery catheter and deployment mechanisms provide controlled, repeatable implantation that does not depend on exceptional surgical skill, making the procedure more accessible while achieving reliable valve function restoration through precise catheter-based positioning

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The coaptation assistance elements are designed to self-position and self-anchor within the valve structure through the delivery system. The elements utilize the valve's own anatomy and pressure gradients to achieve proper positioning and secure attachment, reducing the skill requirement for precise manual placement while ensuring reliable functional restoration

Inventive Principle:

Principle #25Self-service

4Reliability

If coaptation assistance elements are deployed to enhance leaflet coaptation, then regurgitation is reduced, but the device must maintain functionality despite tissue movement

Engineering Contradiction:

Improvecoaptation enhancementVSAvoiddevice positioning stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The coaptation assistance elements are designed with dynamic flexibility that allows them to move with the native valve tissue during the cardiac cycle. This controlled movement capability maintains stable functional positioning and coaptation enhancement while accommodating physiological tissue motion, preventing dislodgement or malfunction

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20230147741A1Device, system, and method for transcatheter treatment of valvular regurgitation

Publication Date: 2023.05.11 POLARES MEDICAL INC

AI summary

The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation assistance element for implantation across the valve; a system including the coaptation assistance element and anchors for implantation; a system including the coaptation assistance element and delivery catheter; and a method for transcatheter implantation of a coaptation element across a heart valve.