Bracelet and system for regulating the circadian rhythm

Abstract

The present invention relates to a bracelet and system for regulating the circadian rhythm, the bracelet comprising an electronic control module integrated into an enclosing body, said module being connected to a core in direct contact with the user's skin. The control module comprises a communication module connected to a microcontroller including a digital timer, the communication module and the microcontroller being connected to an electrical power source. The core comprises an activation mechanism including an actuator, connected to the microcontroller of the control module that acts on a melatonin microsphere reservoir, which is in contact with distribution microchannels that are connected to biodegradable microneedles in contact with the user's skin and which apply the melatonin transdermally. Said bracelet is integrated into a system.

Description

[0001] DESCRIPTION

[0002] BRACELET AND SYSTEM FOR REGULATING CIRCADIAN RHYTHM

[0003] Object of the invention

[0004] The present invention relates to a bracelet designed to act transdermally in the application of melatonin to the skin of a user for the regulation of the circadian rhythm, especially in people who experience frequent changes in schedules and suffer from sleep disturbances or disorders; where this bracelet is also integrated into a system where the user can act in the programming of application parameters of the substance contained in a reservoir of the aforementioned bracelet.

[0005] The field of application of the invention is included within the technical sector of the manufacture and marketing of bracelets and systems for the regulation of a user's circadian rhythm.

[0006] Background of the invention

[0007] Currently, various types of bracelets are known that include electronic components that go beyond conventional use. For example, document U202031244, entitled “Bracelet for measuring and monitoring physiological parameters,” discloses a bracelet consisting of multiple physiological sensors connected to a processor that generates signals based on the parameters received from the wearer; or document U202032473, entitled “Bracelet for the control and monitoring of body temperature,” which is designed to continuously monitor body temperature in children and consists of a temperature sensor, an electronic module, and electrical charging elements.or document U202131439 entitled “emotional and / or behavioral state detector bracelet” where a bracelet is disclosed that allows the detection of variability in specific nuances of vocal intonation along with variations in heart rate, and is made up of a pulse sensor, a microphone and a vibration element electronically powered through an electrical power supply.;

[0008] In all these cases, the bracelets are defined by different types of sensors that monitor and / or alert the wearer to their physical condition. However, in none of these known cases does the bracelet act on the user's skin to regulate possible alterations or desynchronizations of the user's circadian rhythms by activating a mechanism that releases melatonin microspheres into the wearer's epidermis, as contemplated by the present invention.

[0009] Therefore, the present invention is aimed at solving the problems of sleep disorders, especially in people with alterations of the circadian cycle caused, for example, by shift work, jet lag or similar, by means of a bracelet that the user fits on the arm, which comprises a structural configuration that allows the application of melatonin microspheres in the stratum corneum of the user's epidermis, through biodegradable microneedles; and where, in addition, this application is carried out in a regulated manner by a control module that is programmable from a mobile electronic device in a wireless connection, in a different and improved way to what is known to date in this sector.

[0010] In this regard, the applicant is unaware of a solution that is either similar or as effective to the problem posed as that described in the present invention.

[0011] A detailed description of the invention follows, which complements these general ideas introduced at this point.

[0012] Description of the invention

[0013] The circadian rhythm regulating bracelet of the present invention comprises a strap or wrap-around body of hypoallergenic material comprising an integrated electronic control module connected to a core, which is in direct contact with the user's skin; wherein the control module comprises a communication module connected to a microcontroller, both being connected to an electrical power supply; and wherein

[0014] The core comprises an activation mechanism, connected to the microcontroller of the control module, which acts on a reservoir of melatonin microspheres, which is in contact with distribution microchannels that connect to biodegradable microneedles in contact with the user's epidermis.

[0015] Furthermore, the bracelet is part of a system, where this bracelet is wirelessly connected through its communication module to a mobile electronic device, by means of a programmable electronic application that allows the regulation of the bracelet's microcontroller for the transdermal dispensing of melatonin microspheres to the user.

[0016] The bracelet of the invention achieves a programmed and gradual release of a melatonin compound located in a reservoir of microspheres within the bracelet's core. The microcontroller in the control module activates the core's mechanism, which releases a dose of these microspheres through distribution microchannels to microneedles in contact with the user's skin. This transdermal release offers the advantages of eliminating the need for oral supplements, providing a discreet and convenient solution. Furthermore, it improves adherence and offers a preventative approach to circadian rhythm disruption, as the bracelet can be programmed according to parameters such as the user's sleep-wake cycle, reducing the risk of forgetting to take the dose.

[0017] As previously mentioned, the bracelet of the invention comprises a strap or wrap-around body made of hypoallergenic material, preferably made of hypoallergenic medical silicone and with a protection rating of IP67 (according to international standard CEI 60529) without water or dust leakage into the wrap-around body, which includes an electronic control module integrated into its body in connection with a core, the latter being in direct contact with the user's skin.

[0018] The control module manages the programmed release of melatonin microspheres contained in a reservoir within the bracelet's core. To accomplish this, the control module comprises a programmable microcontroller that activates a mechanism in the core; a communication module connected to the microcontroller, enabling an external wireless connection to the bracelet; and a power source, such as a battery, connected to both the microcontroller and the power module.

[0019] Specifically, the microcontroller is a low-power device, preferably a commercially available ARM Cortex-MO or equivalent, and includes an integrated digital timer with configurable programming for cycles of at least 24 hours and custom adaptations. In one possible embodiment, the power supply is a rechargeable lithium-polymer battery with a capacity of at least 200 mAh, and includes a USB Type-C charging port with overcharge protection.

[0020] For its part, the core integrated into the bracelet comprises a plurality of isolated internal chambers in connection which are: an activation mechanism, a reservoir of melatonin microspheres, distribution microchannels and biodegradable microneedles that are arranged on the user's epidermis.

[0021] As previously mentioned, the control module's microcontroller is responsible for operating the activation mechanism through electronic programming. This activation mechanism is based on a pressure system controlled by an internal actuator and is preferably located in a central area of ​​the core to facilitate uniform pressure distribution over the microsphere reservoir. The operation of this activation mechanism is controlled by an internal digital timer, which receives programmed electronic signals from the microcontroller that activates it. Therefore, the activation mechanism controls the pressure and regulates the release of melatonin microspheres, contained in a reservoir, according to a pre-established program of parameters such as activation times, total quantity to be released, and similar settings.

[0022] The microsphere reservoir contained within the bracelet's core consists of a pressurized container that ensures the thermal and mechanical stability of the encapsulated compound. It is designed to release a plurality of microspheres into distribution microchannels upon activation. In one possible embodiment, the microsphere reservoir is made of biodegradable synthetic polymers such as polylactic-co-glycolic acid (PLA-PGA), which have a high capacity for sustained and controlled release of active compounds. It is configured to store encapsulated melatonin for gradual release through microchannels.

[0023] Specifically, the microchannels integrated into the core of the bracelet transport the dissolved microspheres uniformly to the microneedles, ensuring the integrity of the compound. Therefore, these microchannels are connected to both the reservoir and the microneedles. In one possible embodiment, the microchannels are made of flexible, biocompatible polymers, such as polydimethylsiloxane (PDMS).

[0024] The biodegradable microneedles receive the direct flow from the microchannels and precisely deliver melatonin transdermally to the user. In one possible embodiment, these microneedles are made of chitosan and polycaprolactone (PCL) biopolymers that penetrate the epidermis superficially. They are 300–500 microns long, calibrated for safe and non-invasive access, and have a diameter of less than 200 microns, minimizing pain and maximizing distribution. Another feature of the microneedles is their biodegradable nature, which allows them to dissolve after administration, eliminating the need for manual removal.Therefore, the bracelet of the invention allows the release of melatonin in the epidermis of a user, by means of the action of a plurality of isolated internal chambers in connection, which form a core, which is activated by the action of a programmable control module in a safe, convenient and totally different manner from what is known to date in this sector.

[0025] On the other hand, the invention also relates to a system comprising at least one bracelet wirelessly connected to at least one mobile computing device, such as a mobile phone, tablet or similar, so that at least one electronic device can regulate the activation mechanism of at least one bracelet for the application of melatonin to at least one user in a programmed and remote manner.

[0026] To this end, each electronic device in the system of the invention comprises a computer application where the digital timer of each bracelet's microprocessor can be programmed. Consequently, the activation of each of the core activation mechanisms of each wirelessly connected bracelet regulates the release of melatonin microspheres from at least one user. All of this is done according to parameters programmed and sent by at least one electronic device, such as activation times, total quantity to be released, or similar parameters.

[0027] In this way, the bracelet user can program their own bracelet with a mobile device and / or a specific individual of the medical, medical or similar type can remotely program the melatonin release parameters with their mobile device to one or more users wearing a bracelet, improving the regulation of the user's circadian rhythm transdermally, in a way that is completely different from what has been known to date in this sector.

[0028] Throughout the description and claims, it is understood that the term "comprises" and / or its variants are not intended to exclude other technical features or additional elements. Brief description of the figures of the invention

[0029] To complete the description being made and to help in a better understanding of the characteristics of the invention, a set of drawings is included as an integral part thereof, in which the following has been represented for illustrative and non-limiting purposes:

[0030] Figure 1 is a schematic representation of the bracelet for regulating the circadian rhythm that is the subject of the invention, showing the internal connections of the bracelet between the electronic control module and each of the isolated chambers that make up the core, with respect to the positioning of the user's skin.

[0031] Figure 2 is a schematic representation of the system for regulating the circadian rhythm that is the subject of the invention, showing a bracelet of the invention, according to Figure 1, in wireless connection with a mobile computer device.

[0032] Description of some ways of carrying out the invention

[0033] As can be seen in detail in the figures, in one possible embodiment the bracelet for regulating the circadian rhythm comprises, integrated into a strap or wrap-around body, an electronic control module (2) connected to a core (3), which is in direct contact with the user's skin (4); wherein the control module (2) comprises a communication module (22) connected to a microcontroller (23) which, in turn, comprises a digital timer; the communication module (22) and the microcontroller (23) being connected to an electrical power supply (21); and

[0034] where the core (3) comprises an activation mechanism (31), in connection with the microcontroller (23) of the control module (2), which acts on a reservoir (32) of melatonin microspheres, which is in contact with distribution microchannels (33) that connect with biodegradable microneedles (34) in contact with the user's skin (4) and apply the melatonin transdermally. For its part, the figures also represent a possible embodiment of the system for regulating the circadian rhythm, which comprises a bracelet (P) in wireless connection, through its communication module (22), with a mobile computing device (5) comprising a computer application.Specifically, the mobile device computer application (5) wirelessly connects to the communication module (22) of the wristband (P), where an individual can configure the programming of a digital timer of the microcontroller (23), which is the element of the control module (2) that connects to the core of the wristband (P) and activates the release of the melatonin contained in the reservoir for transdermal application to the skin (4) of the user.

Claims

CLAIMS 1.- Bracelet for regulating the circadian rhythm characterized in that it comprises integrated in an enveloping body an electronic control module (2) in connection with a core (3), which is in direct contact with the skin (4) of the user; where the control module (2) comprises a communication module (22) connected to a microcontroller (23) which, in turn, comprises a digital timer; the communication module (22) and the microcontroller (23) being connected to an electrical power supply (21); and where the core (3) comprises an activation mechanism (31) comprising an actuator, in connection with the microcontroller (23) of the control module (2) acting on a reservoir (32) of melatonin microspheres, which is in contact with distribution microchannels (33) that connect to biodegradable microneedles (34) in contact with the user's skin (4) and that apply melatonin transdermally.

2. Bracelet, according to claim 1, wherein the enveloping body is made of hypoallergenic material. 3.- Bracelet, according to claim 2, wherein the hypoallergenic material is silicone with a protection rating of IP67. 4.- Bracelet, according to claim 1, wherein the power supply comprises a USB charging port.

5. Bracelet, according to claim 4, wherein the USB charging port is type C and comprises an overcharge protection system.

6. Bracelet, according to claim 1, wherein the reservoir (32) is made of degradable synthetic polymers.

7. Bracelet, according to claim 6, wherein the degradable synthetic polymers are made of polylactic-co-glycolic acid. 8.- Bracelet, according to claim 1, wherein the microchannels (33) are made of biocompatible flexible polymers.

9. Bracelet, according to claim 8, wherein the biocompatible flexible polymers are of the polydimethylsiloxane type.

10. Bracelet, according to claim 1, wherein microneedles (34) are made of biopolymers.

11. Bracelet, according to claim 9, wherein the biopolymers are chitosan and polycaprolactone.

12. System for regulating the circadian rhythm, which is characterized by comprising: at least one wristband (P) defined according to any one of claims 11, wherein the wristband is wirelessly connected via the communication module (22) to at least one mobile device (5); and where the mobile device (5) comprises a computer application with which an individual programs the digital timer of the microcontroller (23) of the wristband (P) and activates the release of melatonin microspheres contained in the reservoir (32) for transdermal application to the skin (4) of a user.

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