Transcranial Stimulation Control System for Safe Home Use
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Solution Overview
Problem
Current direct current stimulation systems for neurological treatments require specialized personnel for administration, limiting their application and increasing costs due to the need for clinical settings, and lack secure credential verification methods for safe home use.
Innovation Solution
A system that separates credential verification from the stimulation device, using an external control device to authenticate prescribers and limit treatment sessions, ensuring safe and controlled administration through pre-cabled electrodes and secure communication channels.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If direct current stimulation is administered only in specialized clinical centers by specialized personnel, then safety and efficacy of the treatment are ensured, but the range of possible application is limited and costs increase
Solution Approach 1:
The system enables patients to administer the treatment themselves at home through a user-friendly interface that guides them through the entire process, including credential verification, electrode placement, and treatment administration. The automated system performs safety checks and monitors treatment parameters, allowing patients to independently manage their therapy without requiring specialized clinical personnel for each administration.
Solution Approach 2:
The patent introduces an intermediary authentication system that verifies the credentials of both the patient and the treating specialist before allowing treatment administration. This intermediary layer ensures that only authorized individuals can access and administer the treatment, maintaining safety while enabling home-based administration. The system acts as a mediator between the specialized medical knowledge and the patient's independent administration.
2Productivity
If treatment is administered daily for multiple consecutive days in specialized centers, then therapeutic efficacy is maximized, but associated costs increase due to personnel, hospitalization, and transport requirements
Solution Approach 1:
The system enables patients to administer the treatment themselves at home through a user-friendly interface that guides them through the entire process, including credential verification, electrode placement, and treatment administration. The automated system performs safety checks and monitors treatment parameters, allowing patients to independently manage their therapy without requiring specialized clinical personnel for each administration.
Solution Approach 2:
The patent replaces the mechanical presence of specialized personnel at each treatment session with an automated electronic system that handles credential verification, parameter monitoring, and safety checks. This substitution eliminates the need for continuous human intervention while maintaining treatment efficacy, thereby reducing personnel costs and enabling patients to receive daily treatments without traveling to specialized centers.
3Ease of operation
If credential verification is performed directly on the stimulating device, then authentication is simplified, but security is compromised as credentials can be programmed or extracted
Solution Approach 1:
The patent introduces an intermediary authentication system that verifies the credentials of both the patient and the treating specialist before allowing treatment administration. This intermediary layer ensures that only authorized individuals can access and administer the treatment, maintaining safety while enabling home-based administration. The system acts as a mediator between the specialized medical knowledge and the patient's independent administration.
Solution Approach 2:
The credential verification function is extracted from the stimulating device and placed in a separate, secure authentication server. This extraction prevents credentials from being stored on the device, eliminating the risk of credential programming or extraction. The server performs verification remotely, maintaining security while allowing the device to operate independently at the patient's location.
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
Enables safe and controlled direct current stimulation treatments in a domestic setting without specialized personnel, enhancing accessibility and safety by ensuring only authorized personnel can set stimulation parameters and limiting treatment frequency, thus reducing costs and adverse effects.
Implementation Method 1
The difference between direct current stimulation and other electrical stimulations is the presence of this net positive charge passing through the tissue and obtained through mono-directional currents, called 'direct currents'
Implementation Method 2
through the delivery, for a finite time length, of an electrical field generating a current flow and a net relative electrical charge passing through the biological tissue itself
Implementation Method 3
Direct current stimulation is applied through a current generator connected to a pair (or more) electrodes applied on the skin, soaked with a saline solution, so that the electrical charge can be transmitted to the tissue
Implementation Method 4
The impedance on the current generator is mainly due to the resistance of the electrodes that are, therefore, kept wet though saline solutions and conductive gels
Data Source
AI summary
The invention proposes a system and a method for controlling the process of prescription and administration of direct current stimulation treatments in humans. In the proposed system, the stimulation parameters are all set by a specialist whose credentials are verified through a specific control device different from the device that delivers electrical stimulation. The stimulating device can deliver the stimulation only if the credentials of the specialized subject making the prescription are verified and if the prescription is made according to safety criteria. The system is composed by at least one device for the administration of electrical current connected to two electrodes applied over the skin and by a control device. The control device is connected to one or more devices for the administration of the direct current through a communication channel. The specialist gives his own credentials and is authorized at making the prescription and, accordingly, programming the stimulating device. The prescription defines the stimulus intensity, waveform, polarity, duration, the minimum interval between two consecutive stimulations and the maximum number of stimulations allowed. The stimulating device delivers the stimulation only if the credentials of the specialist are verified and only according to the prescription.