Flexible Annuloplasty Ring Segmentation for Minimally Invasive Delivery

Solution Overview

Problem

Current heart valve repair techniques, especially minimally invasive surgeries, face challenges due to limited surgical field size and complexity in manipulating instruments, leading to increased trauma, risk, recovery time, and pain for patients.

Innovation Solution

Development of flexible annuloplasty rings with discrete control points that allow for compression into a narrow shape for minimally invasive procedures, enabling easier passage through small incisions while maintaining structural rigidity and flexibility to accommodate cardiac cycles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If traditional open heart surgery techniques are used, then adequate surgical field access and structural support are achieved, but patient trauma, recovery time, and surgical complexity increase

Engineering Contradiction:

Improvepatient traumaVSAvoidsurgical field access

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The annuloplasty ring is divided into multiple segments that can be collapsed and delivered through a catheter, then assembled at the implantation site. This segmentation allows minimally invasive delivery while maintaining the structural integrity needed for surgical support.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The ring structure transitions from a collapsed flexible state during delivery to an expanded rigid state at the implantation site. This dynamic transformation enables the device to pass through small incisions while providing adequate structural support once deployed.

Inventive Principle:

Principle #15Dynamics

2Strength

If rigid annuloplasty rings are used, then structural support during cardiac cycles is maintained, but ability to pass through small incisions is lost

Engineering Contradiction:

Improvestructural supportVSAvoiddevice compressibility

Core Design Contradiction:

StrengthVSLength of moving object

Solution Approach 1:

The ring structure transitions from a collapsed flexible state during delivery to an expanded rigid state at the implantation site. This dynamic transformation enables the device to pass through small incisions while providing adequate structural support once deployed.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The ring incorporates flexible materials and thin-walled structures that allow compression for delivery while maintaining sufficient strength when expanded to provide structural support during cardiac cycles.

Inventive Principle:

Principle #30Flexible shells and thin films

3Loss of time

If minimally invasive techniques are used, then patient trauma and recovery time are reduced, but instrument manipulation complexity and surgical field limitations increase

Engineering Contradiction:

Improverecovery timeVSAvoidinstrument manipulation

Core Design Contradiction:

Loss of timeVSDevice complexity

Solution Approach 1:

The annuloplasty ring is divided into multiple segments that can be collapsed and delivered through a catheter, then assembled at the implantation site. This segmentation allows minimally invasive delivery while maintaining the structural integrity needed for surgical support.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A delivery catheter system serves as an intermediary tool that simplifies the manipulation of the segmented ring structure, guiding it through the vasculature and facilitating assembly at the implantation site without requiring complex external manipulation.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 flexible annuloplasty rings facilitate minimally invasive heart valve repair by allowing for smaller incisions, reducing trauma and recovery time, and providing sufficient structural support during cardiac cycles, thus improving surgical efficiency and patient outcomes.

Implementation Method 1

The flexible core member has a first elastic modulus sufficiently flexible to enable the core member to be compressed from its relaxed ring shape into a narrow shape suitable for passage through a tubular access device

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

The control points create localized regions of higher elastic modulus than the flexible core member

Methodology Applied

Scientific EffectElastic modulus variation: Elasticity

Data Source

PatentUS20210251755A1Methods of delivering a flexible annuloplasty ring

Publication Date: 2021.08.19 EDWARDS LIFESCIENCES CORP

AI summary

Methods of delivering and using an annuloplasty ring to reshape a valve annulus are disclosed. The methods include obtaining an annuloplasty ring having an elastic inner core member. The elastic inner core member can be defined by a multi-stranded braided cable. The inner core member has an unstressed closed or open ring shape and a first elastic modulus that enables the core member to be compressed from the unstressed ring shape into a stressed narrow shape and enables the annuloplasty ring to reshape a native heart valve annulus. The methods can include converting the annuloplasty ring from the unstressed ring shape into the stressed narrow shape, passing the annuloplasty ring through an access tube positioned with a distal tip adjacent a native valve annulus, and expelling the annuloplasty ring from the distal tip of the access tube so that it self-converts back towards the unstressed ring shape.