Tamper-proof electrode for transcranial neuromodulation

Abstract

The invention relates to the field of medical devices and more specifically the field of medical technologies related to cerebral neuromodulation. The device is a tamper-proof electrode for transcranial neuromodulation, the design of which prevents the patient from manipulating the electrodes once they have been positioned, ensuring that the treatment is properly carried out.

Description

[0001] DESCRIPTION

[0002] NON-MANIPULATIVE ELECTRODE FOR TRANSCRANIAL NEUROMODULATION

[0003] Technology sector

[0004] The invention is aimed at the medical device sector and more specifically at the sector of medical technologies related to brain neuromodulation.

[0005] Background of the invention

[0006] Transcranial direct current stimulation (tDCS) is a non-invasive technique used to stimulate specific brain regions using electrodes placed on the patient's scalp. These electrodes are typically integrated into a positioning cap or helmet to facilitate placement and maintain stability during treatment. The prior art focuses primarily on the stimulation devices, detailing their control units and how the currents are applied. Other inventions closer to the present one relate to means of retaining the electrodes using various elastic bands, caps, or helmets, but do not address how to prevent the user from removing an electrode and placing it in another area. This necessitates medical supervision during treatment, especially in patients with mental disorders.This poses a risk to the effectiveness of the treatment, as well as potentially compromising patient safety.

[0007] The applicant is unaware of any technical solutions that would solve the problem in a manner as advantageous as the proposed invention.

[0008] Explanation of the invention

[0009] The present invention relates to a non-tamperable electrode for transcranial neuromodulation, whose innovative design prevents the patient from manipulating the electrodes once installed, thus ensuring the correct application of the treatment. This electrode consists of a metal pivot whose structure comprises a body of revolution with a disc-shaped base. From this base, a cylindrical body emerges coaxially, featuring two recesses. These recesses define two housing areas with specific functions for securing the electrode and connecting it to the neuromodulation system.

[0010] The first housing, located closer to the base of the pivot, works in conjunction with a toothed pressure washer. This washer fits into the housing to secure the circular silicone electrode and the positioning cap fabric, fixing both components to the pivot. The design of this toothed washer ensures that, once in place, it prevents the electrode from being removed without specialized tools. This guarantees that the patient cannot alter its position or manipulate it during treatment. As mentioned, this allows for outpatient therapy with minimal supervision. The fixation system is key to ensuring that the electrode remains in place throughout the entire transcranial neuromodulation session.

[0011] The second pivot housing is designed to accommodate a snap connector, which provides the necessary electrical connection between the neuromodulation system and the electrode. This arrangement ensures that the galvanic current used during treatment can be transmitted efficiently and safely. Simultaneously, the snap connector provides additional mechanical fixation of the electrode to the pivot, reinforcing the stability of the assembly during therapy.

[0012] For the sake of clarity, the installation process is explained below. To place the electrode in the positioning cap, a piercing tool is used, preferably a metal punch protruding perpendicularly from a disc. This tool creates a hole in the cap fabric, the diameter of which is proportional to that of the cylindrical body of the metal pivot. This allows for precise insertion of the pivot, ensuring a proper fit between the electrode, the cap, and the patient's scalp. After piercing the hole, the silicone electrode is placed on the base of the pivot, and the assembly is inserted into the hole created in the positioning cap. The toothed pressure washer then secures the assembly.To ensure proper attachment of the pressure washer, a tightening tool is used. This tool has a tubular shape and is designed to apply the necessary pressure to the washer. The thickness of its walls is adjusted to the non-serrated edge of the washer, allowing the healthcare professional to apply the appropriate force to secure it without damaging the cap or electrode. Finally, the invention incorporates a conventional electrode sponge, placed between the circular silicone electrode and the patient's scalp. This sponge improves electrode contact with the skin, facilitating the transmission of the galvanic current used in neuromodulation therapy.

[0013] Overall, this invention offers a complete solution to prevent patients from manipulating the electrodes during therapy, thus improving treatment safety and efficacy. The design ensures the electrode remains securely in place, and its easy installation by healthcare personnel using simple tools guarantees an efficient and safe process. This solution is particularly useful in outpatient settings or for patients with cognitive or mental impairments who might attempt to tamper with the equipment.

[0014] Brief description of the drawings

[0015] To complement the description being made and in order to help a better understanding of the characteristics of the invention, a set of drawings is included as an integral part of said description, in which, for illustrative and non-limiting purposes, the following has been represented:

[0016] Figure 1. Shows an exploded front view of the device of the invention, where the connection pivot (1), circular silicone electrode (2), toothed pressure washer (3) and tightening tool (4) can be seen.

[0017] Figure 2. Shows an exploded view with the same references as Figure 1.

[0018] Figure 3 shows a perspective view of the drilling element (7).

[0019] Figure 4 shows the connection pivot (1) with the circular silicone electrode inserted into its body and the positioning cap (5) on top of it, the assembly being held by the toothed pressure washer (3). The electrode sponge (6) can also be seen covering the base of the connection pivot and the circular silicone electrode under the cap.

[0020] Figures 5 and 6 show how a snap connector (8) is inserted into the upper portion of the connecting pivot.

[0021] Preferred embodiment of the invention

[0022] A preferred embodiment is cited as an example, independent of the object of the invention, the materials used in its manufacture, as well as the application methods and all accessory details that may arise, provided that they do not affect its essentiality.

[0023] In the present embodiment described in this document, the non-manipulating electrode for transcranial neuromodulation is configured to prevent manipulation by the patient, ensuring the correct application of the therapy, as shown in Figures 1-7. The electrode includes a metal pivot (1) made of AISI 304 stainless steel that acts as a central support for attaching the circular silicone electrode (2) and the positioning cap (5). The circular silicone electrode is made of conductive silicone, a biocompatible material that guarantees secure contact with the patient's scalp and / or the electrode sponge (6). Furthermore, its surface provides uniform conductive stimulation, ensuring a homogeneous distribution of the galvanic current across the contact surface, thus improving the efficacy of the neuromodulation.This electrode is inserted into the cylindrical body, and behind it the positioning cap where it is secured by a toothed pressure washer (3) which in this version is an internal toothed washer made of AISI 304 stainless steel; this washer allows both the electrode and the fabric of the positioning cap to be fixed, preventing their removal or manipulation without the use of specialized tools.

[0024] To optimize contact between the electrode and the patient's scalp, a polyurethane foam sponge (6) is placed between the electrode and the skin, figure 4. This sponge has the function of improving the energy transfer between the electrode and the scalp, providing a uniform conductive surface that facilitates the transmission of the electric current and reduces the resistance at the skin-electrode interface.

[0025] The positioning cap (5), which is single-use, allows the precise placement of the electrodes following the EEG 10-20 reference system. To install the electrode in the cap, a piercing element (7) is used, consisting of a metal punch made of stainless steel. The punch ensures a clean and precise perforation, allowing the metal pivot to be firmly inserted into the cap.

[0026] Once the electrode and cap are in position, a tightening tool (4) is used to secure the toothed pressure washer. This tool is made of nylon, a strong yet lightweight material, which allows the necessary force to be applied to effectively secure the washer. It features a tubular body whose wall thickness matches the non-toothed edge of the washer, ensuring a firm fit without damaging the system components.

[0027] The second recess in the metal pivot is designed to accommodate a snap-type connector (8), which provides both the electrical connection and additional fixation, ensuring that the electrode remains in the correct position throughout the treatment.

[0028] Overall, this design ensures that the electrode cannot be manipulated by the patient, increasing the safety and efficacy of neuromodulation therapy, especially in outpatient treatments or in patients who might attempt to interfere with the equipment. The combination of materials, such as conductive silicone and polyurethane foam, ensures effective and biocompatible stimulation, while the metal components and tightening tool guarantee quick and secure installation by medical personnel.

Claims

CLAIMS 1. Non-manipulating electrode for transcranial neuromodulation characterized by having means to prevent manipulation by the patient, comprising a metallic pivot (1) whose geometry is a body of revolution with a disc-shaped base from which a cylindrical body emerges coaxially with two recesses that define two housings, the one closest to the disc cooperates with a toothed pressure washer (3) and the height of this first housing allows retaining a circular silicone electrode (2) and on this the fabric of a positioning cap (5), the second housing cooperates with a snap-type connector;It has means for installing the device in the positioning cap by means of a cap piercing element where the diameter of the perforation is proportional to the diameter of the cylindrical body of the pivot, and a tubular tightening tool (4) whose wall thickness is in accordance with the non-toothed edge of the toothed tightening washer (3), comprising a conventional electrode sponge (6).

2. Non-manipulating electrode for transcranial neuromodulation according to claim 1 wherein the piercing element (7) is a metal punch emerging perpendicularly from a disc.

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