Controllably Expandable Annuloplasty Structure for Variable Annulus Sizing

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Solution Overview

Problem

Current methods for repairing dilated valve annuli, such as the mitral or tricuspid valves, often require precise measurement of annulus size and may not accommodate varying sizes effectively, leading to inefficiencies and potential interference with cardiac valve function.

Innovation Solution

A controllably expandable annuloplasty structure with flexible material sections and control wires that can be expanded or shortened to fit different annulus sizes, allowing for minimally invasive positioning and attachment without prior size measurement, using a system that includes a body portion with controllably-expandable sections and a contracting mechanism for adjustment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a fixed-size annuloplasty structure is used, then the structure is simple to manufacture and implant, but it cannot accommodate varying annulus sizes effectively

Engineering Contradiction:
Improveadaptability to different annulus sizesVSAvoidstructure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The annuloplasty structure is divided into multiple modular segments that can be selectively connected or disconnected. Each segment can be independently positioned and attached to the annulus, allowing the overall structure to be customized to fit different annulus sizes and shapes while maintaining a relatively simple base design for each segment.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The annuloplasty structure incorporates adjustable and reconfigurable elements that allow it to be dynamically modified after implantation. The structure can be expanded, contracted, or reconfigured to adapt to the specific geometry of the patient's annulus, transforming a static device into a dynamic one that responds to anatomical variations.

Inventive Principle:
Principle #15Dynamics

2Manufacturing precision

If precise measurement of annulus size is required before implantation, then the fit can be optimized, but the procedure becomes more complex and time-consuming

Engineering Contradiction:
Improvefit precisionVSAvoidprocedure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The annuloplasty structure incorporates self-measuring and self-adjusting capabilities that eliminate or reduce the need for external measurement tools and complex pre-surgical planning. The structure can automatically adapt to the annulus geometry through inherent mechanical properties or integrated sensors that guide proper positioning and sizing during implantation.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The annuloplasty structure utilizes materials or mechanisms that allow for easy adjustment of key parameters such as size, shape, or stiffness after implantation. This enables the structure to be fine-tuned to achieve optimal fit without requiring precise pre-measurement, as the parameters can be modified in situ based on observed performance or anatomical landmarks.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If a standardized annuloplasty structure is used, then manufacturing and implantation are simplified, but it may interfere with cardiac valve function in varying annulus configurations

Engineering Contradiction:
Improveimplantation easeVSAvoidvalve function reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The annuloplasty structure incorporates regions with different properties tailored to specific functional requirements. Different segments or zones of the structure have varying stiffness, flexibility, or attachment characteristics optimized for their local anatomical context, allowing the overall structure to maintain simplicity while ensuring reliable valve function through localized customization.

Inventive Principle:
Principle #3Local quality

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

Enables flexible and precise fitting of the annuloplasty structure to various annulus sizes, minimizing interference with cardiac valves and allowing for effective remodeling of the valve annulus, thereby improving cardiac function without the need for pre-measurement.

Implementation Method 1

a body portion (23) including flexible material and shaped and/or configured so as to define one or more controllably-expandable sections (40)... each one of the one or more controllably-expandable sections (40) having a respective first length... movable to facilitate expansion each one of the one or more controllably-expandable sections (40) to assume a respective second length that is greater than the respective first length

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP3801390B1Implantable annuloplasty structures to fit multiple annulus sizes
Publication Date: 2024.04.24 EDWARDS LIFESCIENCES INNOVATION (ISRAEL) LTD
  • EP3801390B1 patent drawingFigure 1
  • EP3801390B1 patent drawingFigure 2
  • EP3801390B1 patent drawingFigure 3

AI summary

An annuloplasty structure (122) includes a body portion (123) and a contracting member (30). The body portion can include flexible material and be shaped to define one or more controllably-expandable sections (40). Each of the controllably-expandable sections has a respective first length (Ll). Each of the controllably-expandable sections can be expanded or reduced to assume a respective second length (L2) that is different from the respective first length. The contracting member is coupled to the body portion, and is configured to contract the body portion independently of the mechanism that expands the controllably-expandable sections. Other embodiments are also described.