MRI Compatible Steerable Sheath and Control Handle

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Solution Overview

Problem

Conventional steerable sheaths and control handles are not compatible with MRI environments, leading to RF-induced heating, image artifacts, and unwanted device movement due to metallic materials, which pose safety risks and degrade image quality during interventional procedures.

Innovation Solution

A steerable sheath and control handle constructed from non-magnetic materials, such as reinforced polymer tubes with non-metallic reinforcing materials and pull-wires, and using paramagnetic or diamagnetic materials in the control handle, along with active or passive visualization markers, to enable safe and effective tool delivery and tracking within MRI environments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If metallic materials are used in steerable sheaths and control handles, then structural strength and steerability are improved, but RF-induced heating and image artifacts occur in MRI environments

Engineering Contradiction:
Improvestructural strengthVSAvoidRF-induced heating
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameter from metallic to non-magnetic alloys or polymers with specific magnetic susceptibility values. The control handle uses paramagnetic or diamagnetic materials that minimize RF induced heating while maintaining structural integrity and steerability in MRI environments.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material structures combining non-magnetic alloys, polymers, and reinforcing materials that provide necessary mechanical strength without the harmful RF heating properties of traditional metallic materials.

Inventive Principle:
Principle #40Composite materials

2Strength

If metallic materials are used in steerable sheaths and control handles, then structural strength and steerability are improved, but image artifacts and unwanted device movement occur in MRI environments

Engineering Contradiction:
Improvestructural strengthVSAvoidimage quality
Core Design Contradiction:
StrengthVSReliability

Solution Approach 1:

The patent changes the magnetic susceptibility parameter of the materials used in the sheath and control handle to be compatible with MRI environments, eliminating image artifacts and unwanted device movement while preserving structural strength.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent converts the potential harm of metallic materials causing image artifacts into a benefit by using non-magnetic materials that are actually advantageous for maintaining image quality and device stability in MRI environments.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

3Object-affected harmful factors

If non-magnetic materials are used in steerable sheaths and control handles, then RF-induced heating and image artifacts are eliminated, but manufacturing complexity increases

Engineering Contradiction:
ImproveRF-induced heatingVSAvoidmanufacturing complexity
Core Design Contradiction:
Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The patent specifies particular material parameters (magnetic susceptibility, strength, flexibility) that balance RF safety with manufacturability, selecting materials that are both MRI compatible and practical to manufacture.

Inventive Principle:
Principle #35Parameter changes

4Reliability

If non-magnetic materials are used in steerable sheaths and control handles, then image quality is maintained, but device complexity increases

Engineering Contradiction:
Improveimage qualityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent adjusts material parameters to achieve the desired balance between image quality maintenance and device simplicity, selecting non-magnetic materials that provide necessary functionality without excessive complexity.

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 allows for safe and effective delivery of tools into the body during MRI procedures without RF-induced heating or image artifacts, maintaining clinical-grade image quality and preventing unwanted device movement, thus enhancing the safety and efficacy of interventional procedures.

Implementation Method 1

MRI uses three fields to image patient anatomy: a large static magnetic field, a time-varying magnetic gradient field, and a radiofrequency (RF) electromagnetic field.

Methodology Applied
Scientific EffectMagnetic field interaction: Magnetic Field

Implementation Method 2

One important safety risk is the heating that may result from an interaction between the RF field of the MRI scanner and the medical device (RF-induced heating), especially medical devices that have elongated conductive structures

Methodology Applied
Scientific EffectRF-induced heating: Dielectric Heating

Implementation Method 3

The static field of the MRI will cause magnetically induced displacement torque on any device containing ferromagnetic materials and has the potential to cause unwanted device movement.

Methodology Applied
Scientific EffectMagnetic susceptibility: Magnetism

Data Source

PatentEP2931111B1MRI compatible handle and steerable sheath
Publication Date: 2019.05.01 IMRICOR MEDICAL SYSTEMS INC
  • EP2931111B1 patent drawingFigure 1
  • EP2931111B1 patent drawingFigure 2
  • EP2931111B1 patent drawingFigure 3

AI summary

An MR compatible deflectable catheter and method of using the same is provided. The MR compatible deflectable catheter includes a steerable sheath having a tubular shaft. The tubular shaft receives first and second longitudinal movement wires at a distal end thereof. A control handle is coupled to a proximal end of the first and second longitudinal movement wires and causes longitudinal movement of the wires.