Spinal Cord Electrode Layout for Stable ECAP Recording

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Solution Overview

Problem

Existing spinal cord stimulation and recording technologies face challenges in achieving precise electrode placement, movement during patient movement, and inadequate recording of evoked compound action potentials, particularly with paddle leads, which are invasive and prone to lead migration.

Innovation Solution

An apparatus with elongated central reference electrodes and multiple electrodes arranged symmetrically on both sides, providing a counter potential for stimulation and recording, combined with a non-conducting base material and guiding tunnels or protrusions for stabilization, allows for improved electrode positioning and reduced migration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If paddle leads are used to improve stimulation capability and positioning, then stimulation effectiveness is improved, but invasiveness increases and lead migration occurs

Engineering Contradiction:
Improvestimulation effectivenessVSAvoidinvasiveness and lead migration
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The lead is divided into a paddle portion with multiple electrodes and a separate fixation portion with fixation elements. This segmentation allows the stimulation function to be separated from the fixation function, enabling the paddle to provide effective stimulation while the fixation elements prevent migration without requiring invasive laminectomy procedures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Fixation elements act as intermediaries between the lead and the tissue. These elements provide anchoring to the tissue without requiring invasive surgical procedures, thereby preventing lead migration while maintaining the non-invasive nature of the implantation process.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If multiple columns and rows of electrodes are arranged to target specific sensory tracts, then stimulation precision is improved, but device complexity increases

Engineering Contradiction:
Improvestimulation precisionVSAvoidelectrode arrangement complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Different regions of the paddle lead are designed with different electrode configurations to provide localized stimulation for specific sensory tracts. The first and second sets of electrodes can be independently activated to target different dermatome zones, providing precise local control without requiring complex overall device architecture.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The paddle lead is designed with multiple electrode sets that can be configured for various stimulation patterns and targets. This multi-functionality allows a single device to address multiple clinical indications and target different sensory tracts, reducing the need for multiple specialized devices.

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

3Ease of manufacture

If percutaneous leads with small profile are used to reduce invasiveness, then ease of implantation is improved, but electrode arrangement capability is limited

Engineering Contradiction:
Improveease of implantationVSAvoidelectrode arrangement capability
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The lead transitions from a small-profile percutaneous insertion path to a larger paddle configuration at the target site. The paddle portion is deployed in the epidural space where it can provide extensive electrode arrangements, while the lead itself maintains a small profile for easy implantation. This dimensional transition allows both ease of implantation and comprehensive electrode capability.

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

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 localized stimulation and recording of spinal cord nerve fibers, reduces lead migration, and facilitates accurate control over dermatome zones and evoked compound action potential recording, improving therapeutic efficacy and patient comfort.

Implementation Method 1

The electrodes are in conductive connection with a neurostimulation device via leads. Further, the electrodes are usually provided at the end of the leads or on a substrate at the end of the leads. The neurostimulation device provides sequences of neurostimulation pulses to the stimulation leads and, thereby, to the electrodes.

Methodology Applied
Scientific EffectElectrical field: Electric Field

Implementation Method 2

The elongated base material comprises a guiding tunnel configured to receive and guide at least one wire element, preferably a wire electrode, more preferably to at least partially surround the spinal cord.

Methodology Applied
Scientific EffectMechanical constraint: Physical Containment

Implementation Method 3

one or more protrusions, extending from the base material such that a force is provided pushing the apparatus towards the spinal cord during use.

Methodology Applied
Scientific EffectMechanical force: Mechanical Force

Data Source

PatentEP4474001B1Apparatus and system for stimulating and / or recording signals travelling along nerve fibers
Publication Date: 2026.02.11 CEREGATE GMBH
  • EP4474001B1 patent drawingFigure 1
  • EP4474001B1 patent drawingFigure 2
  • EP4474001B1 patent drawingFigure 3

AI summary

The present disclosure relates to an apparatus, neurostimulation device, system, and computer program for stimulating and / or recording signals travelling along nerve fibers of a spinal cord. According to aspects of the present disclosure, the apparatus comprises one or more first electrode arrangements arranged on an elongated and nonconducting base material, each first electrode arrangement comprising: an elongated first central reference electrode extending along a longitudinal direction of the elongated base material; and a plurality of first electrodes arranged on both sides of the elongated first central reference electrode; wherein a length of the elongated first central reference electrode is at least two times larger or at least three times larger than an average length of the plurality of first electrodes; and wherein the elongated first central reference electrode is configured to provide a counter potential for stimulating and / or a reference potential for recording of the nerve fibers of the spinal cord via the plurality of first electrodes.