Deformable Annuloplasty Ring Core for Valve-in-Ring Support

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Solution Overview

Problem

Current annuloplasty rings used in heart valve repair, particularly for mitral and tricuspid valves, face challenges such as excess rigidity, uniplanar shape, and difficulty in becoming fully circular, which can lead to suboptimal results during valve-in-ring procedures, including leakage and deformation of transcatheter heart valves.

Innovation Solution

The development of annuloplasty rings with a core capable of deformation between configurations, featuring flexible or weakened portions, a resilient intermediate layer, and a fabric cover, allowing for adjustable rigidity and shape adaptation, including the use of materials like Elgiloy, Nitinol, and PEEK, and an attachment mechanism to convert incomplete rings into complete ones for improved anchoring and support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If rigid annuloplasty rings are used to provide strong support and prevent annular dilatation, then the durability and support function are improved, but the ability to adapt to annular motion during cardiac cycle is lost and surgical complexity increases

Engineering Contradiction:
Improvesupport functionVSAvoidadaptability to annular motion
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The annuloplasty ring incorporates a shape memory alloy core that can dynamically change its mechanical properties between rigid and flexible states through temperature control, allowing it to adapt to annular motion during cardiac cycle while maintaining structural support when needed

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The ring's rigidity parameter is made variable through the use of shape memory alloy that changes its modulus of elasticity in response to temperature changes, enabling transition from a rigid state for structural support to a flexible state for accommodating physiological motion

Inventive Principle:
Principle #35Parameter changes

2Strength

If rigid annuloplasty rings are used to provide strong support, then the support function is improved, but the ring cannot be deformed into a circular shape for optimal valve-in-ring procedures

Engineering Contradiction:
Improvesupport functionVSAvoiddeformability
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The shape memory alloy core enables the ring to transition between rigid and flexible states dynamically, allowing deformation into circular shape during procedures when flexibility is needed, while maintaining rigidity for structural support when required

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

Temperature-controlled parameter changes in the shape memory alloy allow the ring to switch between deformable and rigid states, facilitating ease of operation during implantation while maintaining structural integrity for support

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If incomplete annuloplasty rings are used to simplify implantation, then ease of implantation is improved, but anchoring strength and support are reduced

Engineering Contradiction:
Improveease of implantationVSAvoidanchoring strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The shape memory alloy core allows the incomplete ring to be dynamically transformed into a complete circular configuration after implantation, providing both ease of implantation and subsequent anchoring strength through the phase transition capability

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

Temperature-induced parameter changes enable the ring to transition from an incomplete open configuration during implantation to a complete closed circular configuration afterward, achieving both ease of implantation and adequate anchoring strength

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution enables annuloplasty rings to maintain shape and provide durable support during heart valve repair, facilitating successful valve-in-ring procedures by allowing deformation into a circular shape and providing a stable anchor for transcatheter heart valves, reducing the risk of leakage and deformation.

Implementation Method 1

a core defining a closed ring and including one or more flexible portions, wherein the core is capable of deformation about the flexible portion between a first configuration and a second configuration upon application of a predetermined force

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

a resilient intermediate layer

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS20210369457A1Apparatus and methods for in-heart valve surgery
Publication Date: 2021.12.02 THE TRUSTEES OF COLUMBIA UNIV IN THE CITY OF NEW YORK
  • US20210369457A1 patent drawing
  • US20210369457A1 patent drawing
  • US20210369457A1 patent drawing

AI summary

An annuloplasty ring is provided including a core defining a closed ring and comprising one or more flexible portions, wherein the core is capable of deformation about the flexible portion between a first configuration and a second configuration upon application of a predetermined force; a resilient intermediate layer; and a fabric cover layer.