Mitral Valve Orientation Device Using Pressure Sensors

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Solution Overview

Problem

Current percutaneous mitral valve repair procedures require complex and expensive imaging equipment for accurate access and orientation, which is not readily available in developing and third-world countries, complicating the access to heart valves due to the presence of sub-valvular apparatus like chordae tendineae and papillary muscles.

Innovation Solution

A percutaneous orientation device with a catheter equipped with pressure sensors and deployable arcuate commissural arms that can be navigated through the mitral valve without entanglement, using pressure measurements and shape memory alloys to ensure accurate positioning and orientation within the mitral valve annulus, allowing for minimally invasive procedures without disrupting blood flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If complex imaging equipment is used for accurate access and orientation, then measurement precision is improved, but device complexity and cost increase

Engineering Contradiction:
Improvepositioning accuracyVSAvoidimaging equipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex imaging systems with a mechanical sensing approach using pressure sensors that directly measure pressure gradients across the mitral valve. This mechanical measurement system provides adequate positioning information without requiring expensive imaging equipment, thereby reducing device complexity while maintaining measurement precision for catheter orientation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces commissural arms as intermediary structures that physically engage with the mitral valve commissures. These arms serve as mechanical mediators that provide tactile and pressure-based feedback for orientation, replacing the need for complex imaging intermediaries while achieving accurate positioning through direct mechanical interaction with valve anatomy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If transapical access is used to reach the mitral valve, then ease of operation is improved, but the risk of entanglement with sub-valvular apparatus increases

Engineering Contradiction:
Improveaccess easeVSAvoidentanglement risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent employs preliminary action by deploying the commissural arms to engage with the mitral valve commissures before performing the repair procedure. This preliminary engagement establishes a secure mechanical reference framework that guides subsequent operations, preventing entanglement with sub-valvular structures by pre-defining the safe operational zone within the valve annulus.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The commissural arms act as intermediary structures between the catheter and the mitral valve leaflets. These arms provide a mechanical interface that allows the operator to work within the valve annulus without directly manipulating structures that could become entangled with chordae tendineae or papillary muscles, thereby reducing entanglement risk while maintaining ease of operation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If specialized imaging equipment is required for orientation, then measurement precision is improved, but ease of operation in resource-limited settings deteriorates

Engineering Contradiction:
Improveorientation accuracyVSAvoidadaptability to resource-limited settings
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent replaces specialized imaging equipment with a mechanical pressure sensing system that uses readily available pressure measurement technology. This substitution maintains orientation accuracy through direct pressure gradient measurement across the valve while significantly improving adaptability to resource-limited settings by eliminating dependence on expensive, specialized imaging infrastructure.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent enables self-service orientation by using the device's own pressure sensors to provide real-time feedback on catheter position and orientation relative to the mitral valve. This self-contained measurement capability eliminates the need for external imaging equipment, allowing the device to achieve accurate orientation independently in any setting regardless of resource availability.

Inventive Principle:
Principle #25Self-service

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 accurate and cost-effective access to the mitral valve for repair or replacement surgeries without the need for complex imaging techniques, ensuring proper orientation and minimizing the risk of cardiac complications by using pressure sensors and shape memory alloys to navigate and secure the device within the valve.

Implementation Method 1

the device includes at least one pressure sensor at or near the distal end of the catheter

Methodology Applied
Scientific EffectPressure measurement:

Implementation Method 2

using pressure measurements and shape memory alloys to ensure accurate positioning and orientation within the mitral valve annulus

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentEP3013262B1Orientation device for use in mitral valve repair
Publication Date: 2020.04.22 STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
  • EP3013262B1 patent drawingFigure 1
  • EP3013262B1 patent drawingFigure 2A~2B
  • EP3013262B1 patent drawingFigure 3A~3B

AI summary

An orientation device (200) for use in mitral valve repair surgery is provided and includes a catheter (202) catheter insertable percutaneously through the mitral valve into a chamber of a heart. At least one pressure sensor (216, 218) and two generally arcuate commissural arms (208, 210) are provided at or near the distal end (204) of the catheter (202). The arms (208, 210) are deployable from a stowed condition, in which the catheter (202) can be introduced percutaneoulsy into the heart, to an operative condition in which they extend outwardly in generally opposite directions. Each arm (208, 210) is shaped to be locatable within a mitral valve commissure and has an indentation (212) shaped to extend, in use, at least partially about a mitral valve commissure to limit movement of the device (200) relative to the mitral valve in the axial direction of the catheter (202).