WO2024209265A1

WO2024209265A1 - System and method for irradiating a brain and at least one body part of a user

Info

Publication number: WO2024209265A1
Application number: PCT/IB2024/000125
Authority: WO
Inventors: Sarah Turner
Original assignee: Cerathrive Ltd
Current assignee: Cerathrive Ltd
Priority date: 2023-04-05
Filing date: 2024-03-22
Publication date: 2024-10-10
Anticipated expiration: 2025-10-05
Also published as: CN121079127A; EP4688130A1

Abstract

A system for irradiating a brain and at least one body part of a user includes a headband, and a body pad. The headband includes a front portion, a rear portion, and at least one connecting member connecting the front portion with the rear portion. The front portion is adapted to be located on a forehead of a user. The front portion includes a plurality of light clusters configured for irradiating the forehead of the user. The rear portion is adapted to be located on a rear part of the head of the user. The body pad is adapted to be worn on any of body parts, other than head, of the user. The body pad includes a light assembly configured for irradiating the body part of the user.

Description

SYSTEM AND METHOD FOR IRRADIATING A BRAIN AND AT LEAST ONE BODY

PART OF A USER

TECHNICAL FIELD

[0001] The present invention generally relates to therapeutic devices. More specifically the present invention relates to light or electromagnetic radiation-based therapeutic devices.

BACKGROUND ART

[0002] Light therapy devices have been around for a considerable amount of time, with many of these devices being designed to be worn as headbands, face masks, armbands, or waist belts. Typically, these devices are constructed with an opaque outer layer that faces the environment and a transparent inner layer that faces a particular part of the user's body. Several light sources are located between these layers and are positioned to face the user's body part. These light sources may include LEDs, halogen lamps, lasers, or a combination of these sources. Additionally, the method of delivering light to the user's body part may involve continuous or pulsating irradiation, with a relatively constant frequency of pulses.

[0003] However, such devices generally generate singular effects, that is even if more than one device is worn on the body of the user, the devices operate independently of each other and produce minimal effect other than the sum of individual effects of the individual devices. Moreover, few such light therapy devices are designed for generating effects that might be beneficial for the development, maintenance, and repair of brain tissue. Whereas light therapy devices may have several potential positive effects on the brain of the user, improving focus, flow, and performance and treatment of an injury. The light therapy devices may also help in the treatment and/or management of brain -related diseases such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and Traumatic Brain Injury (TBI). However, the aforementioned beneficial potential of light therapy devices remains relatively untapped.

[0004] Therefore, there is a need for a system that overcomes the disadvantages and limitations associated with the prior art and provides a more satisfactory solution. OBJECTS OF THE INVENTION

[0005] Some of the objects of the invention are as follows:

[0006] An object of the present invention is to provide a system for irradiating a brain and at least one body part other than the brain of a user;

[0007] Another object of the present invention is to provide a system for irradiating the brain and the at least one body of the user with red and infrared wavelengths of light energy;

[0008] Another object of the invention is to provide a system for irradiating the brain and the at least one body part of the user, such that, the total effect of the system on the user is greater than the sum of individual effects of the devices that constitute the system;

[0009] Another object of the invention is to provide a system for irradiating the brain and the at least one body part of the user, that irradiates a gut -brain axis of a user;

[0010] Another object of the invention is to provide a system for irradiating the brain and the at least one body part of the user, that delivers pulses of electromagnetic energy, with a frequency that is not-uniform thereby more accurately mimicking the inherently flexibility and unpredictability of biological systems;

[0011] Another object of the present invention is to provide a system for irradiating the brain and the at least one body part of the user, such that, individual components of the system are able to communicate with each other, and also communicate with an external computing device; and

[0012] It is also an object of the present invention to create a system that can irradiate both the brain and at least one body part of the user. This system should be able to receive inputs from an external communication device in order to modify the irradiation characteristics of multiple light sources in the system.

SUMMARY OF THE INVENTION

[0013] According to a first aspect of the present invention, there is provided a system for irradiating a brain and at least one body part of a user. The system includes a headband and a body pad. The headband includes a front portion, a rear portion and at least one connecting member connecting the front portion with the rear portion. The front portion is adapted to be located on a forehead of a user. Further, the front portion includes a plurality of light clusters configured for irradiating the forehead of the user, and the rear portion is adapted to be located on a rear part of the head of the user. The body pad is adapted to be worn on any of body parts, other than head, of the user. The body pad includes a light assembly configured for irradiating the body part of the user.

[0014] According to a first aspect of the present invention, there is provided a system for irradiating a brain and at least one body part of a user. The system includes a headband and a body pad. The headband includes a front portion, a rear portion and at least one connecting member connecting the front portion with the rear portion. The front portion is adapted to be located on a forehead of a user. Further, the front portion includes a plurality of light clusters configured for irradiating the forehead of the user, and the rear portion is adapted to be located on a rear part of the head of the user. The body pad is adapted to be worn on any of body parts, other than head, of the user. The body pad includes a light assembly configured for irradiating the body part of the user.

[0015] In one embodiment of the invention, the plurality of light clusters includes at least three light clusters on the forehead and one cluster on the rear of the head.

[0016] In one embodiment of the invention, the plurality of light sources of the front portion is configured to irradiate Anterior Cingulate Cortex (ACC)Zmedial Prefrontal Cortex (mPFC), left Dorsolateral Prefrontal Cortex (DLPFC), and right DLPFC.

[0017] In one embodiment of the invention, the rear portion includes at least one light cluster configured for irradiating the Cerebellum on the rear part of the head of the user.

[0018] In one embodiment of the invention, the at least one light cluster of the rear portion is configured to irradiate Cerebellum of the user.

[0019] In one embodiment of the invention, the at least one light cluster of the rear portion of the headband is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm.

[0020] In one embodiment of the invention, the light assembly of the body pad, includes a plurality of clusters of Light Emitting Diodes (LEDs). [0021] In one embodiment of the invention, wherein the light assembly of the body pad includes a plurality of uniformly distributed LEDs.

[0022] In one embodiment of the invention, the plurality of light clusters of the headband, and the light assembly of the body pad, are configured to emit radiation in red and infrared wavelength ranges of the electromagnetic spectrum.

[0023] In one embodiment of the invention, the plurality of light clusters of the front portion of the headband are configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm.

[0024] In one embodiment of the invention, the light assembly of the body pad is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, and 845 to 855 nm.

[0025] In one embodiment of the invention, the plurality of light clusters of the front portion of the headband, and the light assembly of the body pad, are configured to operate in a pulsed mode.

[0026] In one embodiment of the invention, frequencies of pulses corresponding to the irradiation from the plurality of light clusters of the front portion of the headband, and the light assembly of the body pad, are configured to follow a predetermined frequency protocol.

[0027] In one embodiment of the invention, the predetermined frequency protocol includes variation of a frequency within a predetermined range about a mean value, the predetermined range being determined from adding and subtracting a fraction of the mean value, to and from the mean value, respectively.

[0028] In one embodiment of the invention, a value of the fraction is 10 per cent.

[0029] In one embodiment of the invention, the body part is selected from a group consisting of a gut, a chest, an adipose tissue of the thigh, and a limb of the user.

[0030] In one embodiment of the invention, the headband and body pad are designed to emit radiation to the gut-brain axis of the user. This radiation promotes a mutually beneficial cycle of enhancing brain and gut health, working together synergistically. [0031] In one embodiment of the invention, the system further includes at least one controller provided in at least one of the headband and the body pad. The at least one controller is configured to modify irradiation characteristics of one or more of the plurality of light clusters of the front portion and the light assembly of the body pad.

[0032] In one embodiment of the invention, the at least one controller is a physical button provided with either the headband and/or the body pad.

[0033] In one embodiment of the invention, at least one of the headband and the body pad includes a communication interface configured to communicate with an external computing device over at least one of a wired and a wireless network.

[0034] In one embodiment of the invention, the at least one controller is configured to receive a modification input signal from the external computing device, through the communication interface, for modification of irradiation characteristics of one or more of the plurality of light clusters of the front portion and the light assembly of the body pad.

[0035] In one embodiment of the invention, the headband includes a first controller and a first communication interface, and the body pad includes a second controller and a second communication interface. The first controller is configured to independently communicate with the external computing device, through the first communication interface. Also, the second controller is configured to independently communicate with the external computing device, through the second communication interface.

[0036] In one embodiment of the invention, the first controller is configured to communicate with the second controller, through the first communication interface and the second communication interface.

[0037] In one embodiment of the invention, each one of the headband and the body pad comprises one or more batteries to power the plurality of light clusters ofthe front portion, and the light assembly ofthe body pad, respectively.

[0038] In one embodiment of the invention, the one or more batteries are rechargeable batteries.

[0039] According to another aspect of the present invention, there is provided a method for irradiating a brain and at least one body part of a user. The method includes attaching a headband on a head of the user. The headband includes a plurality of light clusters in a front portion of the headband. The front portion being located on the forehead of the user. The headband includes a unit with light clusters to target the back of the head of the user. Further, the method includes attaching a body pad on a body part, other than head, of the user. The body part includes a light assembly. Also, the method includes targeting a gutbrain axis of the user by synergistic irradiation through the plurality of light clusters of the headband, and the light assembly of the body pad.

[0040] In the context of the specification, the term “processor” refers to one or more of microprocessors, a microcontroller, a general-purpose processor, a Field Programmable Gate Array (FPGA) or an Application Specific Integrated Circuit (ASIC), and the like.

[0041] In the context of the specification, the phrase “memory unit” refers to one or more of a volatile storage memory, such as Static Random Access Memory (SRAM) and Dynamic Random Access Memory (DRAM) of types such as Asynchronous DRAM, Synchronous DRAM, Double Data Rate SDRAM, Rambus DRAM, and Cache DRAM, etc., or a non-volatile storage memory such as EPROM, EEPROM or flash memory or the like.

[0042] In the context of the specification, the phrase “communication interface” refers to a device or a module enabling direct connectivity via wires and connectors such as USB, HDMI, VGA, or wireless connectivity such as Bluetooth or Wi-Fi or Local Area Network (LAN) or Wide Area Network (WAN) implemented through TCP/IP, IEEE 802.x, GSM, CDMA, LTE or other equivalent protocols.

[0043] In the context of this specification, terms like “light”, “radiation”, “irradiation”, “emission” and “illumination”, etc. refer to electromagnetic radiation in frequency ranges varying from the visible light frequencies to Infrared (IR) frequencies and wavelength, wherein the range is inclusive of IR frequencies and wavelengths. IR radiation may be categorized into several categories according to respective wavelength ranges which are again envisaged to be within the scope of this invention. A commonly used subdivision scheme for IR radiation includes Near IR(0.75-1.4 pm), Short-Wave length IR( 1.4-3 pm), Mid-Wavelength IR (3-8 pm), Long-Wavelength IR (8-15 pm) and Far IR (15-1000 pm). [0044] In the context of the specification, “Light Emitting Diodes (LEDs)” are envisaged to be characterized by their superior power efficiencies, smaller sizes, rapidity in switching, physical robustness, and longevity when compared with incandescent or fluorescent lamps. In that regard, the plurality of LEDs may be Surface Mounted LEDs, Bi-color LEDs, Pulse Width Modulated RGB (Red-Green-Blue) LEDs, and high-power LEDs, etc.

[0045] Materials used in the one or more LEDs may vary from one embodiment to another depending upon the frequency of radiation required. Different frequencies can be obtained from LEDs made from pure or doped semiconductor materials. Commonly used semiconductor materials include nitrides of Silicon, Gallium, Aluminum, and Boron, and Zinc Selenide, etc. in pure form or doped with elements such as Aluminum and Indium, etc. For example, red and amber colors are produced from Aluminum Indium Gallium Phosphide (AlGalnP) based compositions, while blue, green, and cyan use Indium Gallium Nitride based compositions. White light may be produced by mixing red, green, and blue lights in equal proportions, while varying proportions may be used for generating a wider color gamut. White and other colored lightings may also be produced using phosphor coatings such as Yttrium Aluminum Garnet (YAG) in combination with a blue LED to generate white light and Magnesium doped potassium fluorosilicate in combination with blue LED to generate red light.

[0046] In addition to conventional mineral-based LEDs, one or more LEDs may also be provided on an Organic LED (OLED) based flexible panel or an inorganic LED-based flexible panel. Such OLED panels may be generated by depositing organic semiconducting materials over Thin Film Transistor (TFT) based substrates. Further, discussion on generation of OLED panels can be found in Bardsley, J. N (2004), “International OLED Technology Roadmap”, IEEE Journal of Selected Topics in Quantum Electronics, Vol. 10, No. 1, that is included herein in its entirety, by reference. An exemplary description of flexible inorganic light -emitting diode strips can be found in granted U.S. Pat. No. 7,476,557 B2, titled “Roll-to-roll fabricated light sheet and encapsulated semiconductor circuit devices”, which is included herein in its entirety, by reference. [0047] In several embodiments, the one or more LEDs may also be micro-LEDs described through U.S. Pat. Nos. 8,809,126 B2, 8,846,457 B2, 8,852,467 B2, 8,415,879 B2, 8,877,101 B2, 9,018,833 B2 and their respective family members, assigned to NthDegree Technologies Worldwide Inc., which are included herein by reference, in their entirety. The one or more LEDs, in that regard, may be provided as a printable composition of the micro-LEDs, printed on a substrate.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0048] The accompanying drawings depict the optimal approach for implementing the invention as it is currently conceived and described below. To provide a comprehensive understanding of the present invention, please refer to the detailed explanation of the preferred embodiments, which is accompanied by the drawings. Throughout the figures in the drawings, similar reference letters and numerals are utilized to denote corresponding parts.

[0049] Figure 1 illustrates a perspective view of a user wearing a system for irradiating a brain and at least one body part of a user, in accordance with an embodiment of the present invention;

[0050] Figure 2A illustrates a rear perspective view of a headband of the system of Figure 1, in accordance with an embodiment of the present invention;

[0051] Figure 2B illustrates a plurality of light clusters of the headband, in accordance with an embodiment of the present invention;

[0052] Figure 2C illustrates a front perspective view of the headband of Figure 2A;

[0053] Figure 2D illustrates a control architecture of the headband, in accordance with an embodiment of the present invention;

[0054] Figure 3A illustrates a bottom perspective view of a body pad of the system of Figure 1, in accordance with an embodiment of the present invention;

[0055] Figure 3B illustrates a bottom perspective view of the body pad, in accordance with another embodiment of the present invention; [0056] Figure 3C illustrates a top perspective view of the body pad, in accordance with an embodiment of the present invention;

[0057] Figure 4 illustrates a network diagram depicting data connections between the headband, the body pad, and an external computing device, in accordance with an embodiment of the present invention; and

[0058] Figure 5 illustrates a method for irradiating the brain and the at least one body part of the user.

DETAILED DESCRIPTION

[0059] Embodiments of the present invention disclosure will be described more fully hereinafter with reference to the accompanying drawings in which like numerals represent like elements throughout the figures, and in which example embodiments are shown.

[0060] The detailed description and the accompanying drawings illustrate the specific exemplary embodiments by which the disclosure may be practiced. These embodiments are described in detail to enable those skilled in the art to practice the invention illustrated in the disclosure. It is to be understood that other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the present disclosure. The following detailed description is therefore not to be taken in a limiting sense, and the scope of the present invention disclosure is defined by the appended claims. Embodiments of the claims may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

[0061] It is envisaged that a system and a method be provided that deliver light energy through irradiation of a brain, and a body part, other than the brain, of a user, simultaneously. In that regard, the system may include two or more devices. At least one of the two or more devices is envisaged to be worn as a headband, and at least one to be worn as a body pad. The headband is envisaged to irradiate the forehead and a rear part of the head of the user. The body pad is envisaged to irradiate a body part, other than the head, of the user. For example, the body pad may be adapted to irradiate the gut of the user or the abdomen or the chest or the adipose tissue of the thigh or a limb, etc. The head band and the body pad may also be adapted to irradiate a gut -brain axis of the user, more particularly vagus nerve and microbiome of the gut-brain axis. While the brain is getting irradiated by the headband, a synergistic effect is generated on the brain tissue and the gut of the user, such that, the irradiation of the gut enhances brain function which in turn enhances the functioning of the gut, and the irradiation of the brain enhances the functioning of the gut which in turn enhances the brain function. In that manner, the total effect of the irradiation by the system would be significantly higher than the sum of individual and discrete irradiation of the gut and the brain.

[0062] It is further envisaged that the light energy is provided through several light clusters (for example, clusters of Light Emitting Diodes (LEDs) and/or LASERs) in the headband and combinations of light clusters and uniform distribution of LEDs in the body pad. Moreover, it is envisaged that the light energy through the several light clusters and the uniformly distributed LEDs be provided in a pulse mode. The frequencies of corresponding pulses may be designed to be non-uniform to more accurately mimic biological systems. The irradiation through the clusters of light and the uniformly distributed LEDs may be provided to the user in the red or infrared ranges of wavelengths. The system is also envisaged to include a controller that is configured to control the irradiation characteristics of the light clusters and the uniformly distributed LEDs. The controller further may be able to connect with an external computing device, enabling the user to modify the irradiation characteristics with the help of the external computing device.

[0063] The method may include the application of the aforementioned system to the body of the user. In that regard, the method may include attachment of the headband and the body pad to the head and the body of the user, respectively, and activation of irradiation from the light clusters and the uniformly distributed LEDs. The irradiation characteristics of the light clusters and the uniformly distributed LEDs may be controlled through the controller directly or with the help of an external computing device. Referring to the drawings, the invention will now be described in detail.

[0064] Figure 1 illustrates a perspective view of a user wearing a system 100 for irradiating a brain and at least one body part of a user, in accordance with an embodiment of the present invention. The system 100 includes a headband 102 and a body pad 104. The headband 102 has been worn by the user on their forehead, while the body pad 104 has been worn by the user on their abdomen region. However, the body pad 104 may be worn on other parts of the body such as limbs, adipose tissue, gut, etc. without departing from the scope of the invention.

[0065] Figure 2A illustrates a rear perspective view of the headband 102 in accordance with an embodiment of the present invention. The headband 102 includes a front portion 202 and a rear portion 204. The front 202 and the rear 204 portions are connected by a connecting member 206. In several embodiments of the invention, the connecting member 206 may be selected from a group consisting of a rubber strap, a fabric belt, a leather belt, a soft polymer-based belt, a stretchable string, or rigid members with tightening mechanisms. The front portion 202 is adapted to be located on a forehead of the user. The rear portion 204 is adapted to be located on a rear part of the head of the user. Further, the front portion 202 includes a plurality of light clusters 208 oriented towards the forehead of the user. The plurality of light clusters 208 is configured to irradiate the forehead of the user.

[0066] Each cluster of the plurality of light clusters 208 is constituted by several light sources. Such light sources may include but are not limited to, LEDs and lasers. A light cluster is capable of combining the light emitted by all the constituent light sources to deliver light with relatively higher energy density, thereby increasing the penetration of the light emitted by several light sources. Figure 2B illustrates the plurality of light clusters 208 in accordance with an embodiment of the present invention. In the embodiment illustrated in Figure 2B, the plurality of light clusters 208 includes at least three light clusters such as a first light cluster 252, a second light cluster 254, and a third light cluster 256.

[0067] In several embodiments of the invention, the plurality of light clusters 208 of the front portion 202 is configured to emit radiation in red and infrared wavelength ranges of the electromagnetic spectrum. In several embodiments of the invention, the infrared wavelength may predominantly include Near Infrared (NIR) wavelengths. The NIR radiation is known to penetrate the head and reach the brain. Further, NIR radiation is absorbed by cytochrome C oxidase in mitochondria, leading to increased blood flow, energy, neuroprotection, reduction in inflammation, and brain repair. The NIR radiation is known to provide several other benefits which can be studied from the following publication, which is included herein, in their entirety, by reference.

[0068] Michael R. Hamblin, Shining light on the head: Photobiomodulation for brain disorders, BBA Clinical, Volume 6, 2016, Pages 113-124, ISSN 2214-6474, https ://doi. org/10.1016/j. bbacli.2016.09.002.

[0069] In several embodiments of the invention, the plurality of light clusters 208 of the front portion 202 of the headband 102 is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm. The plurality of light clusters 208 of the front portion 202 is configured to irradiate the frontal cortex of the user. More specifically, the plurality of light clusters 208 is configured to irradiate neuro -systems such as Anterior Cingulate Cortex (ACC)Zmedial Prefrontal Cortex (mPFC), left Dorsolateral Prefrontal Cortex (DLPFC), and right DLPFC. These neuro-systems may be deployed to guide the light energy through deeper portions of the human brain. It has been found through several studies that irradiation of frontal portions of the brain helps in the repair and enhancement of cognitive function and repair of damaged brain cells in patients suffering from diseases like Alzheimer’ s disease and Parkinson’s disease. Further potential applications of the irradiation of the frontal portions of the brain include treatment of Attention Deficit/Hyperactivity Disorder (ADHD), Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury (TBI), depression, and concussive injuries. Some of the references supporting the aforementioned potential applications are listed below, and are included herein by reference, in their entirety.

[0070] Chao Linda, Barlow Cody, Karimpoor Mahta, Lim Lew, Changes in Brain Function and Structure After Self-Administered Home Photobiomodulation Treatment in a Concussion Case, Frontiers in Neurology, VOLUME 11, 2020, URL=https://www.frontiersin. org/articles/10.3389/fneur.2020.00952, DOI 10.3389/fneur.2020.00952, ISSN=I 664-2295

[0071] C. Jara, D. Buendia, A. Ardiles, P. Munoz, and C. Tapia-Rojas, “Transcranial Red LED Therapy: A Promising Non-Invasive Treatment to Prevent Age-Related Hippocampal Memory Impairment, ” Hippocampus - Cytoarchitecture and Diseases, Jan. 2022, doi: 10.5772/intechopen.100620.

[0072] Yao, L., Qian, Z., Liu, Y., Fang, Z., Li, W., and Xing, L. (2021). Effects of stimulating frequency of NIR LEDs light irradiation on forehead as quantified by EEG measurements. J. Innov. Optical Health Sci. 14:2050025. doi: 10.1142/S179354582050025X.

[0073] Figure 2C illustrates a front perspective view of the headband 102 of Figure 2A. The front portion 202 is connected to the rear portion 204 through the at least one connecting member 206. Further, the rear portion 204 is illustrated to include at least one light cluster 210. The at least one light cluster 210 of the rear portion 204 may be electrically coupled to the front portion 202 through a power cord 216. In several embodiments of the invention, the at least one light cluster 210 of the rear portion 204 of the headband 102 is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm. In an example, the headband 102 may have a treatment dose of 20 - 60 J/cm² divided over all wavelengths.

[0074] The at least one light cluster 210 is configured to irradiate the rear part of the head of the user. For example, the at least one light cluster 210 may be configured to irradiate a cerebellum of the user. More specifically, the at least one light cluster 210 is configured to irradiate Cerebellum of the user. The at least one light cluster 210 of the rear portion 204 and the plurality of light clusters 208 of the front portion 202 enable transcranial irradiation of the head of the user. Transcranial irradiation is known to treat psychiatric disorders such as Major Depressive Disorder (MDD) and improve stroke outcomes. Some of the references in regards to potential applications of transcranial irradiation are presented below, and are included herein by references, in their entirety.

[0075] Cassano, Paolo. (2015). Near-infrared transcranial radiation for major depressive disorder: Proof of concept study. Psychiatry J.. 2015.

[0076] losifescu, D.V.; Collins, K.A.; Hurtado-Puerto, A.; Irvin, M.K.; Clancy, J. A.; Sparpana, A.M.; Sullivan, E.F.; Parincu, Z.; Ratai, E.-M.; Funes, C.J.; Weerasekera, A.;

Dmochowski, J.P.; Cassano, P. Grant Report on the Transcranial near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE) Study. Photonics 2023,

[0077] Mohammed, H.S., Khadrawy, Y.A. Antidepressant and antioxidant effects of transcranial irradiation with 830-nm low-power laser in an animal model of depression. Lasers Med Sci 37, 1615-1623 (2022). https://doi.org/10.1007/sl0103-021-03410-l

[0078] The system 100 is designed to include at least one controller provided in at least one of the headband 102 and the body pad 104. In several embodiments of the invention, the at least one controller is a physical button provided with at least one of the headband 102 and the body pad 104. For example, the headband 102 has been provided with a first physical button 212. The at least one controller is envisaged to be configured to modify irradiation characteristics of one or more of the plurality of light clusters 208 of the front portion 202 and the at least one light cluster 210 of the rear portion 204. In simplest form the physical button 212 is capable of modifying the irradiation characteristics of the one or more of the plurality of light clusters 208 and the at least one light cluster 210 by turning on and turning off the irradiation. However, in several embodiments of the invention, the headband 102 may be provided with a processor or a System on Chip (SoC) based controller.

[0079] Figure 2D illustrates a control architecture 275 of the headband 102, in accordance with an embodiment of the present invention. The control architecture 275 includes a processor 277 and a memory unit 279. The memory unit 279 is configured to store machine readable instructions that when executed by the processor 277 would enable the processor 277 to control the irradiation characteristics of the one or more of the plurality of light clusters 208 and the at least one light cluster 210. The plurality of irradiation characteristics may include, but are not limited to, modes of operation, such as continuous or pulsating, frequency of pulses, length and/or time duration of each pulse, etc. The controller of the headband 102 in that regard may be referred to as a first controller.

[0080] The system 100 is further envisaged to include a communication interface provided in at least one of the headband 102 and the body pad 104. The communication interface is configured to communicate with an external communication device (illustrated in the following discussion) over at least one of a wired or wireless network. In the embodiment illustrated in Figure 2C, the front portion 202 includes the communication interface embodied as a first communication port 214. The first communication port 214 may be one of a Universal Serial Bus (USB) type A, B, or C port, a High-Definition Media Interface (HDMI) port, an Ethernet port, etc. In several embodiments of the invention, the first communication port 214 may also be deployed to provide electrical power to the headband 102.

[0081] In several embodiments of the invention, the communication interface may also be embodied as a Bluetooth and/or Wi-Fi based communication interface. In that regard, the headband 102 may be able to communicate with the external communication device through both wired means using the first communication port 214, and wireless means through Bluetooth and/or Wi-Fi based communication interface. The headband 102 has been provided with a wireless communication toggle switch 215 configured to turn on and turn off wireless communication between the external communication device and the headband 102. This may be helpful in scenarios where a user wants to deactivate the wireless communication once a treatment program has been selected. The communication interface of the headband 102 in that regard may be referred to as a first communication interface.

[0082] Figure 3A illustrates a bottom perspective view of the body pad 104, in accordance with an embodiment of the present invention. The body pad 104 is adapted to be worn on any one or more body parts of the user, other than the head of the user. For example, the body part irradiated by the body pad 104 may be selected from a group consisting of a gut, a chest, an adipose tissue of the thigh, and a limb of the user. Further, the body pad 102 may be made of neoprene material. In several embodiments of the invention, the body pad 104, in combination of the headband 102, is configured to irradiate the gut-brain axis of the user. It is widely accepted that brain health affects the function of the gut and gut health in turn affects brain function. For example, if a person is suffering from a depressive disorder, they may not have a proper bowel movement, absorption of water, and/or absorption of nutrients in their gut. Similarly, a person suffering from a gut-related disorder such as Irritable Bowel Syndrome (IBS) or Crohn’s disease is more likely to have psychiatric disorders such as depression and anxiety. [0083] The gut-brain axis consists of bidirectional communication between the central and the enteric nervous system, linking the emotional and cognitive centers of the brain with peripheral intestinal functions. The pathways involved in gut-brain interactions include, but are not limited to, a vagus nerve, neuroendocrine signaling, interference with tryptophan metabolism, hypothalamic -pituitary-adrenal (HPA) axis, endocannabinoid system, and the immune system, and modulation of the microbiome. The system 100 is configured to simultaneously irradiate the brain of the user through headband 102 and the gut-brain axis through the headband 102 and the body pad 104. When the brain is getting irradiated by the headband 102, and the gut-brain axis is being irradiated by the body pad 104, a synergistic effect on the brain tissue and the gut of the user is generated, such that, the irradiation of the gut enhances brain function which in turn enhances the functioning of the gut. Moreover, the irradiation of the brain enhances the functioning of the gut which in turn enhances brain function. In that manner, the total effect of the irradiation by the system 100 would be significantly higher than the sum of individual and discrete irradiation of the gut and the brain.

[0084] The body pad 104, as illustrated in Figure 3A includes a central structure 302 and a belt 304 passing through two openings 311, 313 provided with the central structure 302. The central structure 302 is illustrated to be rectangular in shape, but the central structure 302 can be embodied as any given such as circular, triangular, trapezoidal, etc. The body pad 104 includes a light assembly 325 configured to irradiate the body part of the body on which the body pad 104 has been worn. Further, the light assembly 325 has been disposed at an inner surface 303 of the central structure 302. In several alternate embodiments of the light assembly 325 includes a plurality of uniformly distributed LEDs as illustrated in Figure 3A. Figure 3B illustrates a bottom perspective view of the body pad 104, in accordance with another embodiment of the present invention. In several embodiments of the present invention, the light assembly 325 may include a plurality of clusters of LEDs. For example, the embodiment illustrated in Figure 3B illustrates a cluster of LEDs in the central structure 302 of the body pad 104.

[0085] In several alternate embodiments, the light assembly 325 may include a combination of the plurality of clusters of LEDs in certain sections of the central structure 302 and the plurality of uniformly distributed LEDs in other sections of the body pad 104. For example, one-half of the central structure 302 may be provided with the plurality of clusters of LEDs and another half of the central structure 302 may be provided with the plurality of uniformly distributed LEDs. In another example, the plurality of clusters of LEDs may be interspersed in the gaps between the plurality of uniformly distributed LEDs.

[0086] In several embodiments of the invention, the light assembly 325 is configured to emit radiation in red and infrared wavelength ranges of the electromagnetic spectrum. Further, in several embodiments of the invention, the light assembly 325 is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, and 845 to 855 nm. The advantages of red, infrared, and NIR radiation have already been discussed in the preceding discussion. In an example scenario, the body pad 104 may have a treatment dose of 10 ± 1 J/cm2, for the wavelength range of 625 to 635 nm, and a treatment dose of 30 ± 3 J/cm2 for the wavelength range of 845 to 855 nm.

[0087] Figure 3C illustrates a top perspective view of the body pad 104 in accordance with an embodiment of the present invention. The belt 304 is provided with a fastening arrangement 330. In several embodiments of the invention, the fastening arrangement 330 may be selected from a group consisting of loops and hooks based fasteners, buckle type fastening arrangements, snap-fit arrangement type fasteners, etc. The body pad 104 further includes a push button 332 provided on an outer surface 305 of the central structure 302. The push button 332 may act as the at least one controller. In several alternate embodiments of the invention, the body pad 104 may be provided a processor or an SoC based controller. Further, the body pad 104 includes a second communication port 334 similar to, but may or may not be identical to, the first communication port 214 of the headband 102. The second communication port 334 of the body pad 104 may act as a communication interface and/or a port for receiving power from a power source. For example, the second communication port 334 of the body pad 104 may be USB type A, B, or C port, an Ethernet port, or an HDMI port, etc. Further, similar to the first communication port 214, the second communication port 334 of the body pad 104 may be capable of communicating with the external computing device through a wired or wireless network (as will be discussed in the following discussion). In several embodiments of the invention, the at least controller of the body pad 104 may be referred to as a second controller, and the second communication port 334 of the body pad may be referred to as a second communication interface.

[0088] One or more of the first controller of the headband 102 and the second controller of the body pad 104 may be deployed to operate the plurality of light clusters 208 of the front portion 202, the at least one light cluster 210 of the rear portion 204, and the light assembly 225 of the body pad 104, in a pulsed mode. It is envisaged that the pulses of electromagnetic radiation may be provided in a random or semi-random manner. In other words, the frequency of the pulses of electromagnetic radiation would be non-uniform to effectively mimic the inherent flexibility and unpredictability in biological systems. In that regard, frequencies of pulses corresponding to the irradiation from the plurality of light clusters 208 of the front portion 202, the at least one light cluster 210 of the rear portion 204, and the light assembly 325 of the body pad 104, are configured to follow a predetermined frequency protocol.

[0089] In a non-limiting example, the predetermined frequency protocol includes variation of the frequency within a predetermined range about a mean value, the predetermined range is determined by adding and subtracting a fraction of the mean value, to and from the mean value, respectively. In a non-limiting example, the value of the fraction maybe 10 percent. One way to introduce variation in a pulsed light signal would be to use a stochastic modulation method, which adds a random component to the signal. The resulting signal would have an average frequency of 40 Hz, but with fluctuations around this mean value that would introduce variation in the signal. For example, for a mean value of 40 Hz, if the variation was set to 10%, the variation of frequency would be within ± 4 Hz of the mean value of 40 Hz, leading to a randomized deviation from the nominal 40 Hz frequency. This type of randomized delivery has been used in other neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) and deep brain stimulation, but not in Photobiomodulation.

[0090] Figure 4 illustrates a network diagram 400 depicting data connections between the headband 102, the body pad 104, and an external computing device 404, in accordance with an embodiment of the present invention. The headband 102, the body pad 104, and the external computing device 404 are connected through a network 402. The network 402 in that regard, maybe a wired network, a wireless network, or a combination of wired and wireless connections. For example, the network 402 may be implemented through combinations of Ethernet cables, Bluetooth connections, Wireless Fidelity (Wi-Fi) connections, and data connections made through 3GPP protocols such HSPA, HSDPA, LTE, etc. The network 402 allows the first controller to independently communicate with the external computing device 404 through the first communication interface and allows the second controller to independently communicate with the external computing device 404 through the second communication interface.

[0091] At least one of the first controller and the second controller is configured to receive a modification input signal from the external computing device 404 through at least one of the first communication interface and the second communication interface, respectively. The modification input signal may be received for modification of the irradiation characteristics of the one or more of the plurality of light clusters 208 of the front portion 202, the at least one light cluster 210 of the rear portion 204, and the light assembly 325 of the body pad 104. The irradiation characteristics may include but are not limited to, mode of operation, such as continuous or pulsating, frequency of pulses, length and/or time duration of each pulse, etc. The network 402 also allows the first controller to communicate with the second controller, through the first communication interface and the second communication interface. In such a scenario, only one of the first controller and the second controller may need to communicate with the external computing device 404. In an alternate scenario, one of the first and the second controller are configured to communicate with the external computing device 404 and then transmit the modification input signal to the other controller. In an alternate scenario, the control of the system 100 may be divided between the first controller and the second controller.

[0092] The headband 102 and the body pad 104 may be provided with several batteries (not shown) to power the system 100. The headband 102 may be provided with one or more batteries to power the plurality of light clusters 208 of the front portion 202 and the at least one light cluster 210 of the rear portion 204. The body pad 104 may be provided with one or more batteries to power the light assembly 325. Further, the batteries may be rechargeable batteries, such as lithium-ion batteries, lithium-polymer batteries, nickel- metal hydride batteries, etc. The one or more batteries of the headband 102 may be charged through the first communication port 214, and the one or more batteries of the body pad 104 may be charged through the second communication port 334. Moreover, the one or more batteries of the headband 102 have been shielded from any potential effects of Electro -Motive Force(EMF) acting on the one or more batteries.

[0093] Figure 5 illustrates a method 500 for irradiating the brain and the at least one body part of the user. The method 500 begins at step 502 by attaching the headband 102 to the head of the user. The headband 102 includes the front portion 202 including the plurality of light clusters 208, and the rear portion 204 including the at least one light cluster 210. The plurality of light clusters 208 are configured to irradiate the forehead of the user, and the at least one light cluster 210 is configured to irradiate the rear part of the head of the user.

[0094] At step 504, the body pad 104 is attached to the body part of the user. The body part may be selected from a group consisting of the abdomen, the gut, the limbs, and the adipose tissue of the thighs of the user. The body pad includes the light assembly 325. The light assembly 325 may include the plurality of clusters of LEDs or uniformly distributed LEDs or combinations of the plurality of clusters of LEDs and uniformly distributed LEDs.

[0095] At step 506, the gut-brain axis of the user is targeted by synergistic irradiation through the plurality of light clusters 208 of the headband 102, and the light assembly 325 of the body pad 104. In several embodiments of the invention, the rear part of the head of the user may also be irradiated by the at least one light cluster 210. The irradiation has wavelengths lying in red, infrared, and Near Infrared (NIR) ranges of the electromagnetic spectrum. The transcranial irradiation of the brain by the headband 102 and simultaneous irradiation of the body part of the user (such as the gut) provides synergistic therapeutic effects which are greater in efficacy when compared with the sum of individual therapeutic effects of the headbands and the body pads known in the art.

[0096] Various modifications to these embodiments are apparent to those skilled in the art, from the description and the accompanying drawings. The principles associated with the various embodiments described herein may be applied to other embodiments. Therefore, the description is not intended to be limited to the embodiments shown along with the accompanying drawings but is to be providing the broadest scope consistent with the principles and the novel and inventive features disclosed or suggested herein. Accordingly, the invention is anticipated to hold on to all other such alternatives, modifications, and variations that fall within the scope of the present invention.

Claims

1. A system for irradiating a brain and at least one body part of a user, the system comprising : a headband; and a body pad, wherein the headband comprises a front portion, a rear portion, and at least one connecting member connecting the front portion with the rear portion, wherein the front portion is adapted to be located on a forehead of a user, the front portion comprising a plurality of light clusters configured for irradiating the forehead of the user, and the rear portion is adapted to be located on a rear part of the head of the user, wherein the body pad is adapted to be worn on any of body parts, other than head, of the user, the body pad comprising a light assembly configured for irradiating the body part of the user.

2. The system as claimed in claim 1, wherein the plurality of light clusters comprises at least three light clusters.

3. The system as claimed in claim 1 , wherein the plurality of light sources of the front portion is configured to irradiate Anterior Cingulate Cortex (ACC)Zmedial Prefrontal Cortex (mPFC), left Dorsolateral Prefrontal Cortex (DLPFC), and right DLPFC.

4. The system as claimed in claim 1, wherein the rear portion comprises at least one light cluster configured for irradiating the rear part of the head of the user.

5. The system as claimed in claim 4, wherein the at least one light cluster of the rear portion is configured to irradiate Precuneus of the user.

6. The system as claimed in claim 4, wherein the at least one light cluster of the rear portion of the headband is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm.

7. The system as claimed in claim 1, wherein the light assembly of the body pad, comprises a plurality of clusters of LEDs.

8. The system as claimed in claim 1, wherein the light assembly of the body pad comprises a plurality of uniformly distributed LEDs.

9. The system as claimed in claim 1, wherein the plurality of light clusters of the headband, and the light assembly of the body pad, are configured to emit radiation in red and infrared wavelength ranges of the electromagnetic spectrum.

10. The system as claimed in 9, wherein the plurality of light clusters of the front portion of the headband are configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, 845 to 855 nm, 935 to 945 nm, and 1065 to 1075 nm.

11. The system as claimed in claim 9, wherein the light assembly of the body pad is configured to emit radiation with wavelengths lying in ranges of 625 to 635 nm, and 845 to 855 nm.

12. The system as claimed in claim 1, wherein the plurality of light clusters of the front portion of the headband, and the light assembly of the body pad, are configured to operate in a pulsed mode.

13. The system as claimed in claim 12, wherein frequencies of pulses corresponding to the irradiation from the plurality of light clusters of the front portion of the headband, and the light assembly of the body pad, are configured to follow a predetermined frequency protocol.

14. The system as claimed in claim 13, wherein the predetermined frequency protocol comprises variation of a frequency within a predetermined range about a mean value, the predetermined range being determined from adding and subtracting a fraction of the mean value, to and from the mean value, respectively.

15. The system as claimed in claim 14, wherein a value of the fraction is 10 per cent.

16. The system as claimed in claim 1, wherein the body part is selected from a group consisting of a gut, a chest, an adipose tissue of the thigh, and a limb of the user.

17. The system as claimed in claim 16, wherein the body pad is configured to irradiate the gut-brain axis of the user, to promote a mutually beneficial cycle of enhancing brain and gut health, working together synergistically.

18. The system as claimed in claim 1, further comprising at least one controller provided in at least one of the headband and the body pad, wherein the at least one controller is configured to modify irradiation characteristics of one or more of the plurality of light clusters of the front portion and the light assembly of the body pad.

19. The system as claimed in claim 18, wherein the at least one controller is a physical button provided with at least one of the headband and the body pad.

20. The system as claimed in claim 18, wherein at least one of the headband and the body pad comprises a communication interface configured to communicate with an external computing device over at least one of a wired and a wireless network.

21. The system as claimed in claim 20, wherein the at least one controller is configured to receive a modification input signal from the external computing device, through the communication interface, for modification of irradiation characteristics of one or more of the plurality of light clusters of the front portion and the light assembly of the body pad.

22. The system as claimed in claim 20, wherein the headband comprises a first controller and a first communication interface, and the body pad comprises a second controller and a second communication interface, such that, the first controller is configured to independently communicate with the external computing device, through the first communication interface, and the second controller is configured to independently communicate with the external computing device, through the second communication interface.

23. The system as claimed in claim 22, wherein the first controller is configured to communicate with the second controller, through the first communication interface and the second communication interface.

24. The system as claimed in claim 1, wherein each one of the headband and the body pad comprises one or more batteries to power the plurality of light clusters of the front portion, and the light assembly of the body pad, respectively.

25. The system as claimed in claim 24, wherein the one or more batteries are rechargeable batteries.

26. A method for irradiating a brain and at least one body part of a user, the method comprising: ataching a headband on a head of the user, wherein the head band comprises a plurality of light clusters in a front portion of the headband, the front portion being located on the forehead of the user; ataching a body pad on a body part, other than head, of the user, wherein the body part comprises a light assembly; and targeting a brain-gut axis of the user by synergistic irradiation through the plurality of light clusters of the headband, and the light assembly of the body pad.