Adaptive Leaflet Coaptation Element for Mitral Regurgitation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing treatments for mitral valve regurgitation, such as pharmacological therapies and invasive surgical procedures, are inadequate due to patient compliance issues, invasiveness, high costs, and dependence on surgical skill, while existing minimally invasive implants face challenges in sealing and fatigue failure during heartbeats.

Innovation Solution

A coaptation assistance element that remains within the blood flow path, conformable across the valve opening, with anchors that engage tissue to enhance leaflet coaptation without disrupting anatomy, deployable via a less-invasive approach without a heart-lung machine, and can be retrieved or adjusted during procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery is performed to replace or repair a dysfunctional mitral valve, then severe valvular regurgitation can be treated effectively, but the procedure is very invasive with high morbidity and mortality

Engineering Contradiction:

Improveeffectiveness of treating severe valvular regurgitationVSAvoidinvasiveness and surgical risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The mitral valve repair procedure is segmented into distinct components: annuloplasty ring implantation to reshape the annulus, and separate coaptation assistance element implantation to enhance leaflet sealing. This allows the complex repair to be performed through less invasive catheter-based approaches rather than requiring full open-heart surgery.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A coaptation assistance element serves as an intermediary structure between the annulus and the leaflets. This element mediates the force transmission and provides additional support for leaflet coaptation, enabling effective repair through minimally invasive delivery methods while avoiding the high risks of traditional open surgery.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If pharmacological agents are used to treat mild mitral valve regurgitation, then patient compliance becomes an issue as many fail to take medications regularly

Engineering Contradiction:

Improvesimplicity of treatment administrationVSAvoidpatient compliance

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The implantable coaptation assistance element provides self-service therapy by mechanically assisting leaflet coaptation throughout the cardiac cycle without requiring patient action. The device autonomously corrects the regurgitation mechanism, eliminating compliance issues associated with pharmacological therapy while providing reliable, continuous treatment.

Inventive Principle:

Principle #25Self-service

3Object-affected harmful factors

If existing minimally invasive implants are used, then the approach is less invasive, but sealing and fatigue failure during heartbeats remain challenging

Engineering Contradiction:

ImproveinvasivenessVSAvoidsealing effectiveness and fatigue resistance

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The coaptation assistance element utilizes composite material construction combining flexible portions for conformability with rigid portions for structural support. This composite design enables the implant to withstand repeated cardiac cycle stresses without fatigue failure while maintaining effective sealing between leaflets through the flexible adaptation to tissue movement.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The coaptation assistance element incorporates dynamic characteristics with flexible portions that adapt to the natural movement and deformation of heart tissues during the cardiac cycle. This dynamic design allows the implant to maintain sealing effectiveness under varying physiological conditions while distributing mechanical stresses to prevent fatigue failure.

Inventive Principle:

Principle #15Dynamics

4Reliability

If open mitral valve surgery is performed, then valve function can be corrected, but the timing becomes a challenge as sicker patients need surgery more but are less able to withstand it

Engineering Contradiction:

Improvevalve function correctionVSAvoidsurgical tolerance

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implantable coaptation assistance element replaces the need for mechanical open-heart surgery with a minimally invasive catheter-based delivery system. This substitution allows valve function correction to be achieved through percutaneous or transapical approaches, enabling treatment of high-risk patients who would otherwise be ineligible for traditional surgical repair.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12478474B2Device, system, and method with an adaptive leaflet

Publication Date: 2025.11.25 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.