Head-Positioned Sensing Reference Electrode for DBS Signal Accuracy

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Solution Overview

Problem

Deep Brain Stimulation Systems face challenges in accurately sensing tissue signals due to interference from biological processes and movement artifacts, which can obscure neural responses and other biometric signals.

Innovation Solution

Incorporating a head-positioned sensing reference electrode, positioned either on a scalp-implantable lead or within the burr hole plug, to facilitate differential sensing and reduce interference, while maintaining the case electrode for stimulation and common mode voltage provision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a case electrode is used for stimulation and common mode voltage provision, then stimulation function is maintained, but sensing accuracy deteriorates due to interference from respiration, cardiac rhythms, and movement artifacts

Engineering Contradiction:
Improvetissue signal sensing accuracyVSAvoidelectrical interference from respiration, cardiac rhythms, and movement artifacts
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

A head-positioned sensing reference electrode is introduced as an intermediary component between the case electrode and the brain tissue. This reference electrode is positioned on the scalp or within the burr hole plug to serve as a stable reference point for differential sensing, isolating the sensing measurement from the harmful electrical interference generated by the case electrode during stimulation. The reference electrode acts as a mediator that enables accurate tissue signal detection while maintaining the case electrode's stimulation function.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The electrode system is segmented into distinct functional components: the case electrode dedicated to stimulation and common mode voltage provision, and a separate head-positioned sensing reference electrode dedicated to providing a stable reference for differential sensing. This segmentation allows each component to perform its specific function without interfering with the other, resolving the contradiction between maintaining stimulation capability and achieving accurate sensing.

Inventive Principle:
Principle #1Segmentation

2Device complexity

If the case electrode is used for both stimulation and sensing reference, then device complexity is reduced, but sensing accuracy deteriorates due to movement artifacts and electrical interference

Engineering Contradiction:
Improveelectrode configuration complexityVSAvoidtissue signal sensing accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The head-positioned sensing reference electrode serves as an intermediary that provides a stable reference potential for differential sensing without being involved in stimulation. By positioning this reference electrode on the scalp or within the burr hole plug, the system achieves accurate tissue signal measurement while maintaining relatively simple device architecture, as the reference electrode integrates with the existing lead or burr hole plug structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If a head-positioned sensing reference electrode is added, then sensing accuracy is improved by reducing electrical interference, but device complexity increases

Engineering Contradiction:
Improvetissue signal sensing accuracyVSAvoidelectrode array complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The head-positioned sensing reference electrode is designed to serve multiple functions: providing a stable reference for differential sensing, maintaining a known electrical potential, and enabling accurate measurement of tissue signals. By positioning the reference electrode on the scalp or within the burr hole plug, the system achieves enhanced sensing accuracy while minimizing the increase in device complexity, as the reference electrode can be integrated with existing lead structures or burr hole plugs rather than requiring a completely separate electrode system.

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

Enhances the accuracy of tissue signal sensing by minimizing electrical interference from respiration, cardiac rhythms, and movement artifacts, allowing for better monitoring of neural responses and adjustment of stimulation parameters.

Implementation Method 1

In an example, the tissue signal is sensed by coupling the at least one of the one or more first electrodes to a first input of the sense amplifier circuitry and by coupling the at least one of the one or more second electrodes to a second input of the sense amplifier circuitry.

Methodology Applied
Scientific EffectDifferential sensing:

Data Source

PatentUS20240335655A1Sensing of Tissue Signals in a Deep Brain Stimulation System Using a Head-Positioned Sensing Reference Electrode
Publication Date: 2024.10.10 BOSTON SCI NEUROMODULATION CORP
  • US20240335655A1 patent drawing
  • US20240335655A1 patent drawing
  • US20240335655A1 patent drawing

AI summary

Disclosed are solutions for providing a sensing reference electrode useful for sensing tissue signal in a Deep Brain Stimulation application. The sensing reference electrode is head-positioned and placed proximate to the patient's brain tissue, but not within the brain tissue itself where the primary sensing electrode is located. The sensing reference electrode may be placed under the scalp, within a burr hole plug used to secure the DBS leads, or within the cerebrospinal fluid just under the skull. The sensing reference electrode can comprise one or more electrodes on a scalp-implantable lead separate from the brain-implantable lead that includes the primary sensing electrodes. The sensing reference electrode can also comprise an additional electrode added to an otherwise standard brain-implantable lead, with the sensing reference electrode being significantly proximal on the lead such that it is not brain-implantable.