Implantable Lead Position Tracking Sensor

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Solution Overview

Problem

Current implantable lead assemblies for medical devices, such as pacemakers and neurostimulators, face complications during implantation due to angiography, including cardiac arrhythmia, kidney damage, and allergic reactions to contrast agents, necessitating a safer method for monitoring lead assembly placement.

Innovation Solution

Incorporating a position tracking sensor within the lead assembly that generates electric position signals when exposed to an external magnetic field, allowing for real-time monitoring and accurate placement without the need for angiography, while also enabling the lead assembly to sense electric activity and deliver stimulus pulses.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If angiography is used to monitor lead assembly implantation, then placement accuracy is improved, but patient safety deteriorates due to risks of arrhythmia, kidney damage, and allergic reactions

Engineering Contradiction:
Improveplacement accuracyVSAvoidpatient safety
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent extracts the harmful contrast agent from the imaging process and replaces it with an intrinsically safe electromagnetic tracking system. The position tracking sensor embedded in the lead assembly generates position signals through electromagnetic coupling with external antennas, eliminating the need for contrast agents entirely while maintaining placement monitoring capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent replaces the mechanical/chemical angiography system with an electromagnetic field-based tracking system. External transmitting antennas generate electromagnetic fields that couple with the position tracking sensor in the lead, producing position signals that are processed to determine lead location without any physical contrast injection

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

2Object-affected harmful factors

If a position tracking sensor is added to the lead assembly, then patient safety is improved by avoiding angiography, but device complexity increases

Engineering Contradiction:
Improvepatient safetyVSAvoiddevice complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The position tracking sensor serves multiple functions: it generates position signals for tracking, can function as an electrode for sensing cardiac signals, and can deliver stimulus pulses. This multi-functionality reduces the need for separate components and minimizes overall device complexity while maintaining patient safety benefits

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

Solution Approach 2:

The patent merges the position tracking sensor with the electrode structure, allowing the same component to serve both tracking and cardiac stimulation/sensing functions. The sensor is integrated into the lead assembly body, combining multiple functionalities into a unified structure rather than adding separate discrete components

Inventive Principle:
Principle #5Merging (Combining)

3Measurement precision

If angiography is used for lead assembly implantation, then placement monitoring is achieved, but treatment cost increases due to contrast agent requirements

Engineering Contradiction:
Improveplacement monitoringVSAvoidtreatment cost
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The position tracking sensor uses inexpensive conductive materials such as conductive polymer coatings or conductive ink printed on the lead surface. These materials are significantly cheaper than contrast agents and require no special disposal procedures, reducing treatment costs while maintaining placement monitoring capability

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

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 safe and precise implantation of lead assemblies by avoiding the risks associated with angiography, ensuring accurate placement and effective sensing or stimulation of cardiac or neural signals without causing adverse reactions.

Implementation Method 1

The tracking sensor generates an electric position signal representative of a position of the tracking sensor when the body is in the patient

Methodology Applied
Scientific EffectElectromagnetic induction: Electromagnetic Induction

Data Source

PatentUS8571684B2Implantable lead assembly having a position tracking sensor and method of manufacturing the lead assembly
Publication Date: 2013.10.29 PACESETTER INC
  • US8571684B2 patent drawing
  • US8571684B2 patent drawing
  • US8571684B2 patent drawing

AI summary

A lead assembly of an implantable medical device includes an elongated body, electrodes on the body, and a tracking sensor located in the body. The body extends between a connector end and a leading end and has conductors disposed in the body. The connector end of the body includes terminals coupled with the conductors. The electrodes disposed on the body can be located at or near an anatomy of interest in a patient and are conductively coupled with the terminals of the body by the conductors. The electrodes are configured to sense electric activity of the anatomy of interest and/or deliver stimulus pulses to the anatomy of interest. The tracking sensor is conductively coupled with the terminals of the body by the conductors. The tracking sensor generates an electric position signal representative of a position of the tracking sensor in the heart when the body is in the patient.