Integrated EM Navigation Tool for IM Nail Locking Alignment

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Solution Overview

Problem

Current electromagnetic navigation systems for surgical procedures, such as IM nailing, face challenges with accuracy due to metal interference, manufacturing tolerances, and radiation exposure, particularly in aligning tools with hidden targets like distal locking holes in IM nails, where existing methods are time-consuming and expose the surgical team to radiation.

Innovation Solution

A hand tool with an integrated electromagnetic sensor tool and field generator, designed for precise attachment to tools like drills, which includes a self-centering tip and flexible shaft for IM nails, and a navigation unit that corrects for measurement distortions, allowing real-time feedback and alignment without blocking the target feature, and a detachable user interface for sterilization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional electromagnetic navigation systems are used for aligning tools with hidden targets, then alignment capability is provided, but measurement precision deteriorates due to metal interference from surgical tools

Engineering Contradiction:
Improvealignment accuracyVSAvoidmetal interference
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a non-metallic electromagnetic field generator housing that acts as an intermediary between the metal drill tool and the navigation system. This housing contains the field generator while preventing metal interference from affecting measurement precision, allowing accurate tracking without the harmful effects of metallic components in the electromagnetic field.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent extracts the field generator from its traditional metallic housing and places it within a non-metallic housing specifically designed to eliminate metal interference. This separation of the field generator from metallic structures removes the source of measurement distortion while maintaining the navigation system's alignment capability.

Inventive Principle:
Principle #2Taking out (Extraction)

2Extent of automation

If the field generator is integrated with the tool, then navigation capability is improved, but device complexity increases

Engineering Contradiction:
Improvenavigation capabilityVSAvoidsystem integration
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The patent merges the field generator with the tool handle in an integrated navigation system, combining navigation functionality with the surgical tool. This integration provides real-time navigation capability while the non-metallic housing design keeps the system manageable in size and prevents interference, balancing automation improvement with controlled complexity.

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If the tool blocks the target feature for alignment, then tool positioning is achieved, but visibility of target feature is lost

Engineering Contradiction:
Improvetool positioning accuracyVSAvoidtarget feature visibility
Core Design Contradiction:
Measurement precisionVSIllumination intensity

Solution Approach 1:

The patent transitions from two-dimensional visual alignment to three-dimensional spatial tracking by using electromagnetic fields for navigation. The system provides navigation information from multiple angles and positions, allowing surgeons to align tools with hidden targets through spatial coordinates rather than direct line-of-sight visualization, thus maintaining target visibility while achieving precise positioning.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

4Difficulty of detecting and measuring

If radiation-based imaging is used to locate hidden targets, then target location is determined, but harmful radiation exposure increases

Engineering Contradiction:
Improvetarget location detectionVSAvoidradiation exposure
Core Design Contradiction:
Difficulty of detecting and measuringVSObject-affected harmful factors

Solution Approach 1:

The patent replaces radiation-based imaging systems with an electromagnetic field-based navigation system. This substitution eliminates harmful radiation exposure while maintaining the ability to detect and measure target locations through non-ionizing electromagnetic fields that track tool and target positions without exposing the surgical team to harmful radiation.

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

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

Enhances precision and reduces radiation exposure by providing accurate, real-time alignment of tools with hidden targets, minimizing measurement errors and improving surgical efficiency while maintaining sterility.

Implementation Method 1

an electromagnetic sensor tool integrated with the tool and configured to generate a signal indicative of a position of the tool relative to a field generator

Methodology Applied
Scientific EffectElectromagnetic field interaction: Electromagnetic Induction

Data Source

PatentEP2676101B1Tool with integrated navigation and guidance system
Publication Date: 2021.04.14 DEPUY SYNTHES PROD INC
  • EP2676101B1 patent drawingFigure 1~1a
  • EP2676101B1 patent drawingFigure 2~2a
  • EP2676101B1 patent drawingFigure 3

AI summary

Methods and apparatus for integrating an electromagnetic navigation system and a tool and aligning the tool with a target are presented, including a sensor tool, a tool, a field generator, a display, and a computer. The sensor tool attaches to a target component in a unique position relative to target features. The field generator is fixed relative to the tool except in rotation about a tool axis. The display is adjustably mounted to the tool and automatically adjusts image parameters. Target registration and error compensation methods are provided. The system detects magnetic field and signal disturbances that may lead to inaccurate navigation, filters navigation data, and adjusts filtering parameters based on detected conditions. Apparatus for proximally locking anIM nail such that a clear passage through the cannulation of the nail is maintained are provided.