Mitral Valve Annuloplasty Implant with Segmented Posterior Support

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Solution Overview

Problem

Ischemic heart disease leads to mitral regurgitation due to papillary muscle dysfunction and mitral valve annulus dilation, causing incomplete coaptation of valve leaflets, increased stroke volume, and cardiac output reduction.

Innovation Solution

An implantable structure comprising a flexible sleeve with a contracting assembly that can be actuated to tighten the mitral valve annulus, using tissue anchors and a closure mechanism to prevent dilation, while preserving the anterior portion's length and preventing long-term resizing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a partial annuloplasty ring is implanted to tighten the mitral valve annulus, then mitral regurgitation is reduced, but the anterior portion of the annulus may dilate long-term due to lack of support

Engineering Contradiction:
Improvemitral regurgitation reductionVSAvoidanterior annulus length
Core Design Contradiction:
ReliabilityVSLength of stationary object

Solution Approach 1:

The annuloplasty device is divided into two distinct portions: a rigid posterior portion that provides structural support and prevents dilation, and a flexible anterior portion that maintains natural annulus motion and prevents long-term dilation. This segmentation allows each portion to address specific functional requirements independently.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the annulus are treated with different material properties: the posterior annulus receives rigid support where structural stability is critical, while the anterior annulus receives flexible support where motion preservation is critical. This local differentiation optimizes the therapeutic effect while minimizing adverse effects.

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If the implant structure is made fully adjustable, then post-operative tuning is possible, but device complexity increases

Engineering Contradiction:
Improvepost-operative adjustabilityVSAvoidcontracting assembly complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The device incorporates a contracting assembly with a contracting member that can be dynamically adjusted after implantation. The assembly includes a contracting mechanism that can modify the circumference of the implant structure, allowing post-operative tuning of the annulus size based on patient response and clinical outcomes.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The contracting member acts as an intermediary element that transmits force from the contracting mechanism to the implant structure. This intermediary component enables adjustable contraction while maintaining structural integrity and simplifying the control interface.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS12138165B2Annuloplasty implants
Publication Date: 2024.11.12 EDWARDS LIFESCIENCES INNOVATION (ISRAEL) LTD
  • US12138165B2 patent drawing
  • US12138165B2 patent drawing
  • US12138165B2 patent drawing

AI summary

A method for treating a native heart valve of a patient includes anchoring a plurality of anchors of an implant into tissue around an annulus of the valve. At the annulus, a force-distribution element is incorporated into the implant such that the force-distribution element extends along a longitudinal portion of the elongate contracting member. The method can also include circumferentially tightening the annulus by pulling the plurality of anchors closer together, such as by actuating a contracting mechanism of a contracting system, such that (i) the contracting mechanism, coupled to an elongate contracting member of the implant, applies a longitudinal tensioning force to the elongate contracting member, and (ii) the force-distributing element distributes the longitudinal tensioning force over at least two of the anchors. Other embodiments are also described.