Magnetic Shape Sensing Catheters Without Fluoroscopic Radiation

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Solution Overview

Problem

Intravascular guidance of medical devices using fluoroscopic and optical methods exposes patients and clinicians to harmful radiation and is costly, and optical methods are delicate.

Innovation Solution

A shape-sensing system utilizing passive electromagnetoresponsive elements, a magnetic interrogator, and a console to generate and transduce magnetic fields for real-time 3D location data of medical devices, allowing for graphical representation of device location, shape, and orientation without the need for radiation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If fluoroscopic methods are used for intravascular guidance, then real-time imaging and navigation are achieved, but harmful X-ray radiation exposure occurs

Engineering Contradiction:
Improvereal-time imaging capabilityVSAvoidX-ray radiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces fluoroscopic imaging (electromagnetic radiation-based) with a magnetic field-based sensing system. Passive electromagnetoresponsive elements embedded in the medical device interact with external magnetic fields to provide real-time positional and shape data without requiring ionizing radiation, thus substituting a harmful electromagnetic system with a benign magnetic field system.

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

Solution Approach 2:

The patent introduces passive electromagnetoresponsive elements as intermediaries between the medical device and the sensing system. These elements respond to external magnetic fields and enable indirect measurement of device position and shape without direct radiation exposure to the patient or clinician.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If optical fiber-optic shape-sensing methods are used, then radiation exposure is eliminated, but system cost increases and device fragility worsens

Engineering Contradiction:
Improveradiation exposure eliminationVSAvoiddevice fragility
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent employs inexpensive passive electromagnetoresponsive elements (such as ferromagnetic particles or magnetic beads) that can be easily manufactured and integrated into medical devices. These elements are robust, non-fragile, and can withstand the harsh conditions of sterilization and clinical use, replacing delicate optical fibers with durable magnetic components.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent changes the sensing mechanism from optical parameter detection (light transmission through fibers) to magnetic parameter detection (response of electromagnetoresponsive elements to magnetic fields). This parameter change enables the use of robust magnetic materials instead of fragile optical components, while maintaining the ability to measure device shape and position.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If optical fiber-optic shape-sensing systems are used, then radiation-free operation is achieved, but manufacturing cost increases

Engineering Contradiction:
Improveradiation exposure eliminationVSAvoidsystem cost
Core Design Contradiction:
Object-affected harmful factorsVSEase of manufacture

Solution Approach 1:

The patent uses low-cost passive electromagnetoresponsive elements that can be manufactured using standard industrial processes. These elements do not require complex optical fiber integration or specialized handling, significantly reducing manufacturing costs compared to optical fiber-based systems while eliminating radiation exposure.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent substitutes complex optical fiber sensing infrastructure with a simpler magnetic field-based system. The magnetic interrogator and passive electromagnetoresponsive elements create a more manufacturable system with fewer delicate components, reducing both material and assembly costs.

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

4Reliability

If passive electromagnetoresponsive elements are used with magnetic field interrogation, then device robustness and cost-effectiveness improve, but system complexity increases

Engineering Contradiction:
Improvedevice robustnessVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent designs a magnetic interrogator system that can simultaneously interrogate multiple passive electromagnetoresponsive elements along the entire length of the medical device. This multi-functional approach allows a single system to provide comprehensive shape and position information for the entire device, managing complexity through universal interrogation capabilities rather than requiring separate sensors at each location.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent uses passive electromagnetoresponsive elements as intermediaries that simplify the overall system architecture. These passive elements require no power source or active electronics, reducing device complexity while enabling robust shape sensing through their interaction with external magnetic fields.

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

Provides safe, cost-effective, and robust guidance of medical devices through vasculature with real-time graphical representation, reducing radiation exposure and device fragility.

Implementation Method 1

The magnetic interrogator is configured to generate the external magnetic field

Methodology Applied
Scientific EffectMagnetic field generation: Electromagnet

Implementation Method 2

Each electromagnetoresponsive element of the electromagnetoresponsive elements is responsive to an external magnetic field. The magnetic interrogator is also configured to transduce responses of the electromagnetoresponsive elements to the external magnetic field

Methodology Applied
Scientific EffectElectromagnetoresponsive effect: Magnetoresistance

Data Source

PatentUS20250345562A1Systems and Methods of Shape Sensing Medical Devices with Electromagnetoresponsive Elements
Publication Date: 2025.11.13 BARD ACCESS SYSTEMS INC
  • US20250345562A1 patent drawing
  • US20250345562A1 patent drawing
  • US20250345562A1 patent drawing

AI summary

A shape-sensing system includes electromagnetoresponsive elements along a length of an elongate medical device that respond to an external magnetic field generated by a magnetic interrogator. The magnetic interrogator transduces responses of the electromagnetoresponsive elements, thereby collecting location-dependent response data therefrom as they move through the external magnetic field. A console converts the location-dependent response data into raw 3D location data. The console can interpolate the raw 3D location data, thereby generating estimated 3D location data for one or more portions of the medical device between any two electromagnetoresponsive elements to provide plottable 3D location data. The console can further plot the plottable 3D location data on a display screen of the console in real-time as the medical device and the electromagnetoresponsive elements associated therewith move through the external magnetic field, thereby displaying a graphical representation of the medical device per its location, shape, and orientation in 3D space.