Intradural Spinal Cord Electrode Device for Focused Stimulation

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Solution Overview

Problem

Current spinal cord stimulation devices are suboptimal for treating intractable pain and spinal cord injuries, as they often provide incomplete or temporary relief, and are associated with side effects like paresthesia and high power demands due to the need for frequent battery recharges.

Innovation Solution

A spinal cord stimulation device configured for implantation within the dura mater, with electrodes in direct contact with cerebrospinal fluid, allowing for customized electrical stimulation to interrupt pain mediating neural signals, and featuring a design that reduces power consumption and minimizes off-target stimulation by positioning electrodes intradurally rather than extradurally.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If electrodes are positioned extradurally for spinal cord stimulation, then the device structure is simpler and implantation is easier, but stimulation focus is reduced and off-target stimulation increases

Engineering Contradiction:
Improveease of implantationVSAvoidstimulation focus
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent introduces an intermediary structure (the dural membrane) between the electrode array and the spinal cord. The electrodes are positioned intradurally, using the dura as a natural barrier and positioning reference, which simplifies implantation while maintaining precise stimulation focus through direct contact with the CSF and spinal cord surface.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent transitions from extradural to intradural positioning, changing the spatial dimension of electrode placement. This dimensional shift allows electrodes to be positioned closer to the spinal cord in the intradural space, improving stimulation focus while the dural membrane provides a natural anchoring plane that simplifies the implantation process.

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

2Measurement precision

If electrodes are positioned intradurally for focused stimulation, then stimulation focus is improved and off-target stimulation is minimized, but device complexity and implantation difficulty increase

Engineering Contradiction:
Improvestimulation focusVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The dural membrane serves as an intermediary that simplifies intradural electrode positioning. By anchoring the electrode array to the dural membrane, the patent avoids the need for complex anchoring mechanisms within the spinal cord tissue itself, reducing overall device complexity while maintaining precise intradural positioning.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If high power stimulation is delivered to achieve therapeutic effects, then pain relief is improved, but battery life is reduced and power consumption increases

Engineering Contradiction:
Improvetherapeutic effectVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent changes the electrical parameters of stimulation by positioning electrodes intradurally in direct contact with CSF. This positioning improves electrical coupling efficiency, allowing for more effective stimulation at lower power levels, thereby extending battery life while maintaining therapeutic effects.

Inventive Principle:
Principle #35Parameter changes

4Power

If frequent battery recharges are required to maintain therapy, then power delivery capability is maintained, but patient convenience and device reliability are reduced

Engineering Contradiction:
Improvepower delivery capabilityVSAvoidbattery life
Core Design Contradiction:
PowerVSDuration of action of stationary object

Solution Approach 1:

The patent optimizes electrical stimulation parameters and improves electrode-tissue coupling by intradural positioning, which increases energy efficiency. This allows for extended battery operation between recharges while maintaining effective power delivery for pain relief, improving patient convenience and device reliability.

Inventive Principle:
Principle #35Parameter changes

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

The device provides more focused and durable therapeutic effects with reduced side effects and extended battery life by directly stimulating the spinal cord through the cerebrospinal fluid, enhancing patient safety and clinical efficacy while minimizing power consumption.

Implementation Method 1

electrodes in direct contact with cerebrospinal fluid, allowing for customized electrical stimulation to interrupt pain mediating neural signals

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP3801745B1Transdural electrode device for stimulation of the spinal cord
Publication Date: 2024.08.14 DIRECT SPINAL THERAPEUTICS INC
  • EP3801745B1 patent drawingFigure 1~2
  • EP3801745B1 patent drawingFigure 3~4
  • EP3801745B1 patent drawingFigure 5A~6

AI summary

The spinal cord stimulation device of this invention is configured for implantation into a patient so as to traverse the dura mater that surrounds the spinal cord. Placing the device in this location provides direct contact between the electrode and the cerebrospinal fluid (CSF), in close proximity to the spinal cord. The device has an intradural portion and an extradural portion that compresses and seals the dural membrane between them, securing the device in position and preventing leakage of CSF. It is electronically powered by an implanted pulse generator that produces a spectrum of signals to interrupt or otherwise attenuate transmission of pain mediating neural signals through the spinal cord. Once the device is implanted into a patient, it provides improved stimulation efficiency, reduced power requirements, and potentially an improved clinical outcome, compared with previously available technology.