Deep Brain Stimulation Lead Fault Detection via Signal Correlation

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Solution Overview

Problem

Deep brain stimulation (DBS) systems face challenges in detecting component failures, such as intermittent open or short circuits, which can go undetected through acute impedance measurements, leading to a loss of therapy benefits due to undetected electrical shunts or shorts.

Innovation Solution

A system and method that utilize sensors to sense signals at one location and associate them with signals introduced at another location, using processors to determine faults based on signal characteristics, including evoked potentials and impedance measurements, to identify compromised components like leads or lead extensions with short circuits or electrical shunts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If acute impedance measurements are used to detect component failures, then the measurement process is simple and quick, but intermittent open or short circuits may go undetected leading to loss of therapy benefits

Engineering Contradiction:
Improvesimplicity of detection methodVSAvoiddetection reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system performs preliminary actions by introducing a test signal through the lead before attempting to detect faults. This proactive approach allows the system to actively probe the integrity of the lead and associated components, rather than passively relying on impedance measurements that may miss intermittent faults. The test signal is introduced at one location and sensed at another, creating an active diagnostic pathway.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses an intermediary test signal as a mediator to detect faults. Instead of directly measuring impedance, the system introduces a known test signal and observes its characteristics after transmission through the lead. This intermediary signal acts as a probe that reveals faults by showing how it is affected during transmission, enabling detection of intermittent opens and shorts that would otherwise be missed.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Device complexity

If only acute impedance measurements are performed, then the system operation is simple, but faults that manifest only during certain movements or positions cannot be detected

Engineering Contradiction:
Improvedetection system complexityVSAvoidfault detection capability
Core Design Contradiction:
Device complexityVSDifficulty of detecting and measuring

Solution Approach 1:

The system applies dynamics by introducing motion or positional changes during the diagnostic process. The test signal is introduced and sensed while the lead is moved or positioned in different configurations, allowing faults that only manifest during certain movements to be detected. This dynamic approach transforms a static measurement problem into a dynamic diagnostic process that reveals position-dependent faults.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent employs periodic action by repeatedly introducing test signals at different times and positions. Rather than a single measurement, the system performs multiple diagnostic measurements periodically, allowing intermittent faults to manifest during the measurement sequence. This periodic testing ensures that faults occurring only at certain moments or positions are captured.

Inventive Principle:
Principle #19Periodic action

3Measurement precision

If a test signal is introduced through the lead to detect faults, then detection accuracy improves, but the system complexity increases due to additional sensing and processing requirements

Engineering Contradiction:
Improvefault detection precisionVSAvoidsystem structural complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies universality by designing the test signal introduction and sensing mechanism to serve multiple functions. The same electrodes and circuitry used for therapy delivery are also used for introducing test signals and sensing their characteristics. This multi-functionality allows fault detection without requiring entirely separate diagnostic hardware, thereby limiting the increase in system complexity while maintaining high detection precision.

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

Solution Approach 2:

The system performs self-service by using its own existing components to conduct diagnostic testing. The lead, electrodes, and sensing circuitry that are already part of the therapy system are utilized to introduce and detect test signals. This self-service approach enables sophisticated fault detection without adding external diagnostic equipment, thus maintaining system simplicity while improving measurement precision.

Inventive Principle:
Principle #25Self-service

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 approach allows for the detection of faults that would otherwise be missed, ensuring continued efficacy of DBS therapy by identifying and addressing component failures that affect system connection integrity.

Implementation Method 1

a sensor configured to sense a first signal at a first location of an anatomy of a patient

Methodology Applied
Scientific EffectElectrical field sensing: Electric Field

Implementation Method 2

one or more processors configured to associate a portion of the first signal with a second signal introduced at a second location of the anatomy of the patient

Methodology Applied
Scientific EffectSignal correlation analysis:

Implementation Method 3

Such impedance information may provide information on how the system components are interacting with the tissue and/or with one another

Methodology Applied
Scientific EffectElectrical impedance measurement: Electrical Resistance

Data Source

PatentUS11998748B2Identification of compromised components in a medical system
Publication Date: 2024.06.04 MEDTRONIC INC
  • US11998748B2 patent drawing
  • US11998748B2 patent drawing
  • US11998748B2 patent drawing

AI summary

In some examples of selecting a target therapy delivery site for treating a patient condition, a relatively high frequency electrical stimulation signal is delivered to at least two areas within a first region (e.g., an anterior nucleus of the thalamus) of a brain of a patient, and changes in brain activity (e.g., as indicated by bioelectrical brain signals) within a second region (e.g., a hippocampus) of the brain of the patient in response to the delivered stimulation are determined. The target therapy delivery site, an electrode combination, or both, may be selected based on the changes in brain activity.