Sterile Cranial Drape With Embedded Electrodes For Brain Mapping

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Solution Overview

Problem

Current surgical procedures for brain surgeries, especially those involving the central nervous system, face challenges in maintaining a sterile field and accurately mapping brain regions using evoked electrophysiological responses, particularly in sedated patients, where traditional methods may not provide real-time, accurate, and safe functional localization.

Innovation Solution

A sterile surgical cranial drape embedded with electrodes and a brain mapping system that includes a probe with multiple contacts for stimulating and recording electrophysiological responses, allowing for the segmentation of brain regions based on evoked responses, even in sedated patients, using redundant electrical leads for reliable data transmission and a flexible design to accommodate varying skull sizes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a sterile surgical drape is used to maintain aseptic field, then sterility is improved, but the ability to perform real-time brain mapping and electrophysiological monitoring is limited

Engineering Contradiction:
Improvesterility maintenanceVSAvoidreal-time brain mapping capability
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent combines the sterile surgical drape with embedded electrodes and brain mapping capabilities into a single integrated system. The drape incorporates multiple electrodes, redundant electrical leads, and signal processing components while maintaining sterility, allowing simultaneous infection prevention and real-time electrophysiological monitoring during CNS surgery.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The surgical drape serves multiple functions: maintaining sterile barrier, recording electrophysiological signals, stimulating brain regions, and providing real-time feedback for functional mapping. This multi-functional design eliminates the need for separate sterile draping and monitoring equipment.

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

2Ease of operation

If traditional electrode placement methods are used, then surgical simplicity is maintained, but accuracy in reaching specific brain targets is reduced

Engineering Contradiction:
Improveelectrode placement simplicityVSAvoidbrain target localization accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system provides real-time electrophysiological feedback through recorded signals that indicate electrode proximity to specific brain structures. The redundant electrical leads transmit multiple signal types (evoked potentials, local field potentials, single-unit activity) that give immediate feedback on electrode positioning, allowing precise target localization while maintaining operational simplicity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The drape is pre-configured with electrodes positioned to contact specific brain regions upon placement. The embedded electrode array and redundant leads are prepared in advance to automatically capture electrophysiological signals as soon as the drape is applied, eliminating the need for complex post-placement adjustments.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If awake patient monitoring is required for electrode positioning, then positioning accuracy is improved, but patient comfort and surgical efficiency deteriorate

Engineering Contradiction:
Improveelectrode positioning accuracyVSAvoidsurgical efficiency
Core Design Contradiction:
Measurement precisionVSProductivity

Solution Approach 1:

The system allows sedated or anesthetized patients to provide electrophysiological responses that automatically indicate electrode positioning accuracy. The recorded brain signals serve as self-generated feedback, eliminating the need for patient awareness or active participation while maintaining positioning precision through objective physiological measurements.

Inventive Principle:
Principle #25Self-service

4Reliability

If redundant electrical leads are implemented for reliable data transmission, then system reliability is improved, but device complexity increases

Engineering Contradiction:
Improvedata transmission reliabilityVSAvoidelectrical lead system complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The redundant electrical leads are integrated into a flexible printed circuit board or thin film substrate within the drape. This allows multiple electrical pathways to be laid out in a compact, organized manner that maintains reliability through redundancy while minimizing overall system complexity through efficient spatial arrangement and standardized manufacturing processes.

Inventive Principle:
Principle #30Flexible shells and thin films

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 solution provides a sterile barrier for surgical procedures while enabling accurate and real-time mapping of brain regions, reducing the risk of adverse effects and allowing for precise electrode placement, even in sedated patients, by utilizing a flexible and redundant electrical lead system for reliable data transmission.

Implementation Method 1

a plurality of electrodes operably coupled to said film, wherein at least one of said plurality of electrodes being in contact with a patient's organ

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 2

a probe with multiple contacts for stimulating and recording electrophysiological responses

Methodology Applied
Scientific EffectElectrical stimulation: Electric Field

Data Source

PatentEP3188683B1Surgical drape and evoked response probes
Publication Date: 2024.11.06 ALPHA OMEGA ENG LTD
  • EP3188683B1 patent drawingFigure 1~2
  • EP3188683B1 patent drawingFigure 3~4
  • EP3188683B1 patent drawingFigure 5~6

AI summary

The disclosure relates to a surgical cranial drape, probe for mapping brain of a subject and their methods of use. Specifically, the disclosure relates to a sterile surgical cranial drape embedded with electrodes; an system for mapping physiologically functional brain regions using evoked electrophysiological responses in a first and a second region; and their methods of use in combination or separately.