Navigational Reference Dislodgement Detection in Catheter Systems

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Solution Overview

Problem

The challenge in navigating medical devices through a patient's heart and vasculature is the instability of reference electrodes, which can become dislodged due to collisions, entanglement, or patient movement, leading to invalid position measurements unless detected and corrected.

Innovation Solution

A method and system for detecting and correcting the dislodgement of navigational references by monitoring output signals, providing guidance for repositioning, and using servo-controlled catheters to secure the reference electrodes, allowing for continuous accurate location data generation even after dislodgement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a catheter-mounted reference electrode is inserted into the heart and positioned in a fixed location to establish the origin of the coordinate system, then the three-dimensional coordinate system has a stable reference point, but the reference electrode may become dislodged due to collisions, entanglement, or patient movement

Engineering Contradiction:

Improvestability of reference electrode positionVSAvoidreliability of reference electrode position

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The system performs preliminary actions by continuously monitoring the reference electrode position and detecting dislodgement before it affects measurement accuracy. The dislodgement detection mechanism is activated in advance to alert operators and enable corrective actions before invalid measurements are taken.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system implements feedback by continuously monitoring the position of the reference electrode and providing real-time information about its stability. When dislodgement is detected, the system generates alerts and can trigger corrective actions, creating a closed-loop control system that maintains measurement reliability.

Inventive Principle:

Principle #23Feedback

2Measurement precision

If the reference electrode is positioned close to the mapping catheter for coordinate system stability, then the reference point is proximate and desirable for measurements, but the mapping catheter may collide or become entangled with the reference electrode

Engineering Contradiction:

Improveprecision of three-dimensional coordinate measurementsVSAvoidcollisions and entanglement between catheter and reference electrode

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system preemptively detects potential collisions or entanglement by monitoring reference electrode position changes. When abnormal movement patterns are detected that suggest impending collision, the system can alert operators to adjust catheter positioning before actual contact occurs.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The reference electrode serves as an intermediary element that enables precise measurement of catheter position without requiring direct physical contact between the catheter and the coordinate system origin. The electrode acts as a stable reference point that mediates the measurement process, allowing indirect positioning that avoids direct catheter-reference contact.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If continuous monitoring of reference electrode position is implemented to detect dislodgement, then valid position measurements are maintained, but the system complexity increases

Engineering Contradiction:

Improvevalidity of position measurementsVSAvoidcomplexity of monitoring and detection system

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The reference electrode system is self-monitoring, using the electrode itself as both the reference point and the object being monitored. The same electrode that establishes the coordinate origin also serves as the sensor for detecting its own position changes, eliminating the need for separate monitoring hardware and reducing system complexity.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The reference electrode performs multiple functions: it establishes the coordinate system origin, serves as a measurement reference point, and simultaneously acts as a position sensor for detecting its own dislodgement. This multi-functionality reduces the number of separate components needed and simplifies the overall system architecture.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11766205B2Navigational reference dislodgement detection method and system

Publication Date: 2023.09.26 ST JUDE MEDICAL ATRIAL FIBRILLATION DIVISION INC

AI summary

A method of tracking a position of a catheter within a patient includes securing a navigational reference at a reference location within the patient, defining the reference location as the origin of a coordinate system, determining a location of an electrode moving within the patient relative to that coordinate system, monitoring for a dislodgement of the navigational reference from the initial reference location, for example by measuring the navigational reference relative to a far field reference outside the patient's body, and generating a signal indicating that the navigational reference has dislodged from the reference location. Upon dislodgement, a user may be provided with guidance to help reposition and secure the navigational reference to the initial reference location, or the navigational reference may be automatically repositioned and secured to the initial reference location. Alternatively, a reference adjustment may be calculated to compensate for the changed reference point/origin.