Shape Sensing Hub for Rotational Tracking in Guidewire Devices

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Solution Overview

Problem

Current medical devices with shape sensing optical fibers for over-the-wire applications face challenges in determining the orientation of the device due to the lack of rotational coupling between the guidewire and the device, leading to inefficiencies in positioning and deployment, particularly in procedures like EVAR where incorrect placement can result in complications such as endoleaks and ischemia.

Innovation Solution

A system that includes a shape sensing hub capable of tracking the position and rotation of a guidewire, allowing for registration of anatomical images and enabling precise positioning and orientation of over-the-wire devices by deforming the guidewire into a known shape profile, which can be detected using optical fibers, thereby addressing the rotational coupling issue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If shape sensing optical fibers are embedded in over-the-wire devices, then device localization and navigation capability is improved, but the ability to determine rotational orientation deteriorates due to lack of rotational coupling between guidewire and device

Engineering Contradiction:
Improvedevice localization precisionVSAvoidrotational orientation information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

A hub component is introduced as an intermediary between the guidewire and the over-the-wire device. The hub includes a shape profile that creates a known geometric relationship with the guidewire, allowing the shape sensing system to infer rotational orientation of the device through mathematical registration rather than direct mechanical coupling

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the traditional mechanical rotational coupling system with an optical sensing system combined with mathematical registration. Instead of mechanically linking the guidewire rotation to the device orientation, the system uses optical fiber shape sensing and hub-based geometric registration to determine orientation information

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

2Measurement precision

If a hub with shape profile is introduced to enable rotational tracking, then orientation determination capability is improved, but device complexity increases

Engineering Contradiction:
Improveorientation determination precisionVSAvoiddevice structural complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system is segmented into distinct functional components: the guidewire with embedded optical fibers, the hub with a specific shape profile, and the over-the-wire device. This segmentation allows each component to be optimized independently while maintaining overall system functionality

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The hub serves multiple functions: it provides structural support for the over-the-wire device, creates a known geometric relationship with the guidewire for shape sensing, and enables both positional and rotational tracking through its shape profile, replacing the need for multiple separate components

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

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

This solution enables accurate positioning and orientation of medical devices, reducing complications like endoleaks and ischemia by providing precise registration and visualization of the device's position and rotation, thereby improving the efficiency and safety of procedures like EVAR.

Implementation Method 1

One principle involved makes use of distributed strain measurement in the optical fiber using characteristic Rayleigh backscatter or controlled grating patterns

Methodology Applied
Scientific EffectRayleigh backscatter: Rayleigh Scattering

Implementation Method 2

Optical shape sensing (OSS) or Fiber-Optical RealShape employs light along a multicore optical fiber for device localization and navigation during surgical intervention

Methodology Applied
Scientific EffectOptical shape sensing: Optical Fibre

Data Source

PatentUS10994095B2Hub for device placement with optical shape sensed guidewire
Publication Date: 2021.05.04 KONINKLIJKE PHILIPS NV
  • US10994095B2 patent drawing
  • US10994095B2 patent drawing
  • US10994095B2 patent drawing

AI summary

A system for deploying a device includes an elongated flexible instrument (108) and a shape sensing system (104) coupled to the flexible instrument. A hub (106) includes a shape profile configured to receive and maintain the flexible instrument with the shape sensing system therein. The shape profile includes a shape to track a position or a rotation of the hub relative to a reference position using the shape sensing system. The hub is configured to be coupled to a deployable device (102) such that a change in the position or rotation of the hub indicates a corresponding change in the deployable device.