Clothing, methods, and use of photobiomodulation therapy
A wearable garment with integrated near-infrared light sources and a controller addresses the challenge of delivering photobiomodulation therapy during daily activities, ensuring continuous treatment and enhanced mitochondrial activity.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- NIRAXX INC
- Filing Date
- 2022-04-08
- Publication Date
- 2026-05-29
AI Technical Summary
Existing photobiomodulation therapy systems require users to remain stationary during treatment, limiting their ability to engage in daily activities, and there is a need for a portable system that can deliver therapy continuously and in real-time.
A garment integrated with near-infrared light sources and a controller that emits near-infrared light at specific wavelengths and doses, allowing users to wear it during various activities, including a photobiomodulation therapy headband that positions light sources over the skull to treat brain areas.
Enables continuous and uninterrupted photobiomodulation therapy, allowing users to engage in daily activities while receiving treatment, with improved mitochondrial activity and ATP levels.
Smart Images

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Abstract
Description
[Technical Field]
[0001] This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 272,363 filed on 27 October 2021 and U.S. Provisional Patent Application No. 63 / 172,405 filed on 8 April 2021, the entire contents of which are incorporated herein by reference, and has the right to set a filing date in accordance with 35 U.S. SC § 119(e).
[0002] The subject matter of this patent application generally relates to devices and methods for treating diseases using near-infrared photobiomodulation therapy. [Background technology]
[0003] As background, photobiomodulation therapy involves applying near-infrared light to various parts of a subject's body, such as the skin. Photobiomodulation therapy induces photochemical reactions within cells, increasing mitochondrial activity and ATP levels. Near-infrared light is directed to pass through the skin, soft tissues, cartilage, cerebrospinal fluid, and bone structures for the purpose of providing treatment for various diseases. In the case of transcranial photobiomodulation therapy, a near-infrared light source is directed at the head, and the near-infrared light passes through the skull and reaches the brain to treat stress, fatigue, mental health-related symptoms such as ADHD, other psychiatric disorders, neuropsychiatric disorders, and neurodegenerative diseases. [Overview of the Initiative] [Problems that the invention aims to solve]
[0004] During treatment, one or more light sources must be held in place on the user's skin for an extended period. However, users may wish to continue their daily activities during treatment, requiring a portable system that remains in place during both sedentary and active activities to ensure the treatment is delivered accurately and uninterrupted. Furthermore, a portable system enables immediate, real-time use, allowing users to receive photobiomodulation therapy whenever needed.
[0005] Aspects of the present invention satisfy these needs and provide further relevant advantages, as described in the following summary. [Means for solving the problem]
[0006] Aspects of the present invention teach specific advantages in configurations and uses that result in the exemplary advantages described below.
[0007] This specification discloses a garment for photobiomodulation therapy, comprising a garment configured to be worn by a user on the skin surface, and one or more near-infrared light sources integrated with the garment. The near-infrared light sources are configured to emit near-infrared light toward one or more regions of interest on the skin at wavelengths of approximately 700 nm to approximately 1600 nm, with predetermined dose measurements and durations. A controller equipped with a processor and memory communicates with the near-infrared light sources to control the operating parameters of the near-infrared light sources.
[0008] Other features and advantages of aspects of the present invention will become apparent from the following more detailed description, in conjunction with the accompanying drawings illustrating the principles of aspects of the present invention.
[0009] The accompanying drawings incorporated herein and forming part thereof illustrate aspects of the disclosed subject matter in at least one of the exemplary embodiments, which are further defined in the following description. Features, elements, and aspects of this disclosure are referenced by similar reference numerals in different drawings that represent the same, equivalent, or similar features, elements, or aspects in one or more embodiments. The drawings are not necessarily to scale and are focused on illustrating the principles described herein and provided by the exemplary embodiments of the invention. [Brief explanation of the drawing]
[0010] [Figure 1] This is a front perspective view of an exemplary photobiomodulation therapy garment disclosed herein, worn by the user. [Figure 2] This is a rear plan view of an exemplary photobiomodulation therapy garment in an open configuration. [Figure 3] Figure 2 is an enlarged rear plan view of the photobiomodulation therapy garment, showing exemplary inter-group and intra-group configurations of near-infrared light sources. [Figure 4] Figure 2 is a rear perspective view of the garment used for photobiomodulation therapy. [Figure 5] Figure 2 is a front perspective view of the photobiomodulation therapy garment, showing the terminal rails with the controller removed. [Figure 6] Figure 2 is a front perspective view of a photobiomodulation therapy garment, showing the controller disclosed herein, which is fixed to the photobiomodulation therapy garment. [Figure 7] Figure 6 is a front perspective view of the photobiomodulation therapy garment in a closed configuration, showing the adjustable straps that close to form a band. [Figure 8] Figure 5 is an exploded perspective view of a garment used for photobiomodulation therapy. [Figure 9] This is a plan view of a photobiomodulation unit disclosed herein, comprising a flexible printed circuit board assembly. [Figure 10] This is an enlarged cross-sectional view of the photobiomodulation unit of Figure 9, viewed at 10-10, showing the sensor disclosed herein. [Figure 11] This is a plan view of a photobiomodulation unit disclosed herein, comprising a flexible printed circuit board assembly. [Figure 12] This is a plan view of a photobiomodulation unit disclosed herein, comprising a flexible printed circuit board assembly. [Figure 13] This is a plan view of a photobiomodulation unit disclosed herein, comprising a flexible printed circuit board assembly. [Figure 14] This is a plan view of a photobiomodulation unit disclosed herein, comprising a flexible printed circuit board assembly. [Figure 15] This is a disassembled rear perspective view of the photobiomodulation therapy garment disclosed herein, showing a liquid wire circuit assembly. [Figure 16] This is a disassembled rear perspective view of the photobiomodulation therapy garment disclosed herein, showing a liquid wire circuit assembly. [Figure 17] Figures 17A–17C show EEG scans of five participants from a research study who received transcranial photobiomodulation (tPBM) treatment using the photobiomodulation therapy garment disclosed herein, where Figure 17A shows the EEG scan of each participant before tPBM treatment, Figure 17B shows the EEG scan of each participant after tPBM treatment, and Figure 17C shows a merged view of the before and after EEG scans to highlight the differences. [Figure 18]Figures 18A and 18B show graphs of data obtained from EEG scans of participants using the photobiomodulation therapy garment disclosed herein. Figure 18A shows the percentage change in frequency during use of the photobiomodulation therapy garment disclosed herein, and Figure 18B shows the change in gamma power over time during use of the photobiomodulation therapy garment disclosed herein. [Modes for carrying out the invention]
[0011] The detailed description below, in relation to the attached drawings, is intended to describe embodiments of the present invention and is not intended to represent the only form in which the invention may be constructed and / or utilized. This description describes the structure and a series of steps for constructing and operating the invention in relation to the illustrated embodiments. However, it should be understood that the same or equivalent structures and steps may be achieved by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
[0012] In one or more embodiments, the system of the present invention provides garments for photobiomodulation therapy. The photobiomodulation therapy garments disclosed herein include garments configured to be worn on the user's skin surface, integrating one or more photobiomodulation units configured to perform photobiomodulation therapy in cooperation with a controller. The photobiomodulation units include one or more near-infrared light sources, one or more sensors, and optionally one or more stimulators electrically connected to a connector. The connector is also configured to operably receive a controller in a manner that establishes an electrical connection. Each of the one or more near-infrared light sources disclosed herein is configured to emit near-infrared light at wavelengths of 600 nm to 1600 nm, predetermined dose measurements, and durations. The controller disclosed herein has a processor and memory and is configured to control the operating parameters of the near-infrared light sources. During operation, the photobiomodulation units are configured to emit near-infrared light to one or more areas of the user's skin surface. In some embodiments, as shown in Figures 1 to 16, the photobiomodulation therapy garment 20 comprises a garment 30, a photobiomodulation unit 100, and a controller 200.
[0013] In some embodiments, as shown in Figures 1 to 7, the photobiomodulation therapy garment 20 can be configured as a photobiomodulation therapy headband 22 for the purpose of treating a specific area of the head H of a person P using transcranial photobiomodulation therapy. In this configuration, person P wears the photobiomodulation therapy headband 22 by wrapping it tightly around the head area H so that one or more near-infrared light sources disclosed herein, integrated into the photobiomodulation therapy headband 22, are positioned over and / or directed over the area of interest on the skin surface S to deliver therapeutic levels of near-infrared light to the area of interest. In some embodiments, the positioning of the photobiomodulation therapy headband 22 as shown in Figure 1, for the purpose of irradiating a brain area of person P through the skull with near-infrared light, one or more near-infrared light sources disclosed herein are positioned over the frontal bone area of person P's skull, approximately and / or substantially in the center of the median sagittal plane 320 (e.g., the center of the nose). Furthermore, in these embodiments, the photobiomodulation therapy headband 22 is positioned such that one of the near-infrared light sources disclosed herein is located above the brow ridge region (i.e., the brown ridge above the orbit) 322 and generally below the hairline (although the hairline varies from person to person). In at least one or more embodiments, at least one of the near-infrared light sources disclosed herein, integrated within the photobiomodulation therapy headband 22, should be positioned above the brow ridge region 322 or at least above the orbit to minimize exposure of the eyes to near-infrared light. In some embodiments, as shown in Figure 1, the photobiomodulation therapy headband 22 is positioned to cover a defined area of interest on the skin surface S, including one or more or all of the Fp1 area 300, Fpz area 302, Fp2 area 304, F3 area 306, Fz area 308, and F4 area 310, when the photobiomodulation therapy headband 22 is worn on the head H and properly positioned.
[0014] The photobiomodulation therapy garment 20 is exemplified as a photobiomodulation therapy headband 22 in Figures 1 to 16, but the photobiomodulation therapy garments disclosed herein can be constructed to fit various parts of the body. In some embodiments, the photobiomodulation therapy garments disclosed herein can be configured to wrap around or fit various body parts in such a way that they can be moved from one area of interest on the body to another. In some embodiments, the photobiomodulation therapy garments disclosed herein can be configured to fit specific body parts, such as a head cover, visor, neck wrap, shoulder wrap, wrist wrap, or abdominal wrap. In some embodiments, the photobiomodulation therapy garments disclosed herein can be configured to fit various parts of an individual's body in such a way that they can be worn by an individual, such as a hat, shirt, pants, or underwear.
[0015] The photobiomodulation therapy garment 20 includes clothing. The garment can be flexible, semi-rigid, or rigid, and is constructed to be comfortable to the user's body and is configured to feel like a clothing item or other wearable fashion accessory. In some embodiments, the garment disclosed herein is a fabric material made through weaving, knitting, opening, felting, stitching, crocheting, or bonding. In some embodiments, the garment consists of multiple layers of fabric material. For example, in some embodiments, the photobiomodulation therapy garment comprises an outer fabric sheet and an inner fabric sheet. The outer fabric sheet is sized and dimensional to serve as a base for mounting one or more photobiomodulation units and controllers disclosed herein, while the inner fabric assembly is sized and dimensional to at least cover one or more photobiomodulation units.
[0016] For example, in some embodiments, referring to Figures 2-4, 7, 8, 15, and 16, the photobiomodulation therapy headband 22 includes a garment 30 comprising an outer fabric sheet 40 and an inner fabric sheet 70, and a photobiomodulation unit 100 sandwiched between the outer fabric sheet 40 and the inner fabric sheet 70. The outer fabric sheet 40 can be made from a variety of natural or synthetic textiles, generally selected for aesthetic and / or protective qualities. The inner fabric sheet 70 is configured to lie against the skin surface S and can be made from a natural or synthetic textile or other material that is comfortable against the skin surface S, such as space cotton. As shown in Figures 2-7, the upper and lower parts of the outer fabric sheet 40 and the inner fabric sheet 70 are attached to each other so as to form the upper and lower edges 50 and 52 of the garment 30, with the photobiomodulation unit 100 surrounding it.
[0017] As shown in Figures 2, 4-6, 8, 15, and 16, the outer fabric sheet 40 of the garment 30 also includes a right head strap 64 extending longitudinally from the right portion 54 of the garment 30 and a left head strap 66 extending longitudinally from the left portion 56 of the garment 30. A slide buckle 60 allows for length adjustment of the right head strap 64, and a slide buckle 62 is connected to the right head strap 64 and held in place by the right head strap 64 via a loop formed by the slide buckle 60. The slide buckle 62 is configured to receive the free end of the left head strap 66, and the left head strap 66 may include a hook-loop fitting to make connection. This head strap configuration allows for easy adjustment of the photobiomodulation therapy headband 22 and secure attachment to the head H.
[0018] As shown in Figure 8, the outer fabric sheet 40 of the garment 30 includes a terminal rail mounting opening 58 that is sized and dimensioned to accept the terminal rail of the connecting terminals disclosed herein, thereby enabling proper engagement of the controller 200 to the terminal rail. Referring to Figures 2, 4-6, 8, 15, and 16, the outer fabric sheet 40 of the garment 30 also includes a controller strap 68 extending from the left portion 56 of the garment 30. The controller strap 68 is configured to wrap around the controller 200 when the controller 200 is operably engaged with the photobiomodulation unit 100, in order to securely hold the controller 200 against the outer fabric sheet 40. The controller strap 68 has a first end that is firmly attached to the garment 30 and a second end opposite to the first end that forms a loop around the attached controller 200, thereby reversibly securing the controller 200 to the garment 30 using, for example, a hook-and-loop fastener, buckle, or snap. The controller strap 68 can be made of an inelastic or elastic material.
[0019] As best seen in Figures 8, 15, and 16, the inner fabric sheet 70 of the garment 30 comprises one or more near-infrared light source apertures 76 and one or more sensor apertures 78. Each of the one or more near-infrared light source apertures 76 is a notch in the inner fabric sheet 70, and when assembled, each aperture 76 is aligned with an infrared light source disclosed herein, thereby allowing light from the infrared light source to radiate through the infrared light source aperture 76. Similarly, each of the one or more sensor apertures 78 is a notch in the inner fabric sheet 70, and when assembled, each aperture 78 is aligned with a sensor disclosed herein, thereby allowing the sensor to function properly and collect information from the user through the sensor aperture 78.
[0020] In some embodiments, referring to Figures 2–4 and 8, the inner fabric sheet 70 may include one or more sensor covers 79. Each sensor cover 79 is positioned over and protects each of the one or more sensors disclosed herein that are attached to the photobiomodulation unit 100. Furthermore, each of the one or more sensor covers 79 is configured to be in contact with or in close proximity to the skin surface S when the photobiomodulation therapy garment 20 is worn. Each sensor cover 79 can be attached to the inner fabric sheet 70 or the photobiomodulation unit 100 and / or sandwiched between them. In this exemplary embodiment, each sensor cover 79 is constructed of a thin sheet of PVC, allowing one or more sensors present beneath it to interact with the skin surface S to measure bodily functions such as temperature, heart rate, blood oxygen level, and one or more of other measurable functions. Furthermore, each sensor cover 79 provides a visual reference to assist the user in properly oriented and wearing the photobiomodulation therapy garment 20. For example, when the photobiomodulation therapy headband 22 is positioned around the head H, one or more sensor covers 79 can be manually aligned with the nose to position the sensor covers 79 substantially on the sagittal plane 320.
[0021] The photobiomodulation therapy garment 20 also includes a photobiomodulation unit. The photobiomodulation unit includes a connector, one or more near-infrared light sources, one or more sensors, and is configured to establish electronic communication with a controller 200. In some embodiments, referring to Figures 8, 9, and 11, the photobiomodulation unit 100 comprises a connector 160 and a flexible printed circuit board assembly 110 that provides a flexible substrate housing an electrical circuit for establishing electronic communication between the connector 160 and one or more near-infrared light sources 170, such as infrared, low-level lasers, and / or light-emitting diodes (LEDs), one or more sensors 180, and optionally one or more stimulators 194. An electronic circuit connector 162 is attached to the connector 160 (generally rigid or semi-rigid), and the electronic circuit connector 162 is configured to provide electronic communication between the controller 200 and the flexible printed circuit board assembly 110. In these embodiments, the flexible printed circuit board assembly 110 is configured to provide flexibility and comfort to the wearer. For example, since the photobiomodulation therapy headband 22 must fit snugly to the contour of the forehead, the flexible printed circuit board assembly 110 is designed to have strategic cutouts to allow for maximum flexibility and comfort. In some embodiments, as shown in Figures 8 and 10, the flexible printed circuit board assembly 110 includes a heat dissipation material 102 on the flexible board opposite the electrical circuit to dissipate the heat generated by the flexible printed circuit board assembly 110 during the operation of the photobiomodulation therapy garment 20.
[0022] In some embodiments, referring to Figures 9 and 11, the flexible printed circuit board assembly 110 is a thin, flat substrate including a first surface and a second surface opposite to the first surface, and is configured as a main strip 112 extending from the connector terminal 160, which is divided at the root portion 113 into three parts: a first strip 114, a second strip 116, and a sensor strip 140 extending from the center. The first strip 114 and the second strip 116 are distally connected by a connector portion 117, all defining the boundary of a notch portion 118. The first strip 114 and the second strip 116 have the electronic circuits necessary to establish electronic communication between each near-infrared light source 170 operably mounted on the first strip 114 or the second strip 116 and the connector terminal 160.
[0023] In some embodiments, the first strip 114 and the second strip 116 each include a series of tabs extending laterally outward from therefor for mounting a near-infrared light source disclosed herein on thereon. For example, as shown in Figures 9 and 11, the first strip 114 includes a first mounting portion 120, a second mounting portion 122, and a third mounting portion 124, wherein the first mounting portion 120 is separated from the second mounting portion 122 by a first notch 121 between them, and the third mounting portion 124 is separated from the second mounting portion 122 by a second notch 123 between them. Similarly, the second strip 116 includes a first mounting portion 130, a second mounting portion 132, and a third mounting portion 134, wherein the first mounting portion 130 is separated from the second mounting portion 132 by a first notch 131 between them, and the third mounting portion 134 is separated from the second mounting portion 132 by a second notch 133 between them. The first mounting portion 120, the second mounting portion 122, and the third mounting portion 124 of the first strip 114, and the first mounting portion 130, the second mounting portion 132, and the third mounting portion 134 of the second strip 116, function like gores, allowing for independent flexible bending of the flexible printed circuit board assembly 110. Such flexible bending allows the flexible printed circuit board assembly 110 to easily conform to the contours of one or more regions of interest of the skin region S, and each of the one or more near-infrared light sources disclosed herein can be positioned near the skin surface S with minimal or no gaps.
[0024] In some embodiments, referring to Figures 9 and 11, the sensor strip 140 includes a sensor mounting portion 142 and a free end 144. The sensor strip 140 extends from the base portion 113 into the notch 118 such that the notch 118 provides a gap between the sensor strip 140 and the first strip 114 and the second strip 116, except for the base portion 113. The sensor strip 140 includes the electronic circuitry necessary to establish electronic communication between each sensor 180 operably mounted on the sensor strip 140 and the connection terminal 160. The sensor strip 140 is made relatively thin and elongated to allow bending and slight movement of the sensor strip 140 relative to the rest of the flexible printed circuit board assembly 110, and the bending and slight movement of the sensor strip 140 is further enabled by the sensor opening 224 provided by the double-sided tape 220 (see Figures 8, 15, and 16), allowing it to be easily bent with little to no twisting of the flexible printed circuit board assembly 110 and fit around the head H.
[0025] In some embodiments, referring to Figures 5, 8, 9, 11, 15, and 16, a connector 160 is integrally mounted on one end of a flexible printed circuit board assembly 110. The connector 160 includes an electronic circuit connector 162 and a terminal rail mount 164. The electronic circuit connector 162 of the connector 160 is located on the same surface of the flexible printed circuit board assembly 110 to which one or more infrared light sources 170, one or more sensors 180, and one or more stimulators 194 are mounted, and which houses the electrical circuits used to establish electronic communication with the one or more infrared light sources 170, one or more sensors 180, and one or more stimulators 194. The terminal rail mount 164 of the connector 160 is located on the surface of the flexible printed circuit board assembly 110 opposite to the electronic circuit connector 162. The terminal rail mount 164 includes a plurality of contacts 166. The terminal rail mount 164 is configured to receive the controller 200 and establish electronic communication between the photobiomodulation unit 100 and the controller 200, which has corresponding contacts that mate with contacts 166 when connected. To enable rapid connection and disconnection, the controller 200 and the terminal rail mount 164 include a sliding joint (e.g., a dovetail or tongue-and-groove joint) to accommodate the controller 200 within the terminal rail mount 164 and force electrical contact between the contacts 166 of the terminal rail mount 164 and the corresponding contacts protruding through the controller 200. After the controller 200 is slid into the terminal rail mount 164, the controller strap 68 is wrapped around the controller 200 and secured to the inner portion 44 of the outer fabric sheet 40 by a releaseable connector such as a hook-and-loop.
[0026] In some embodiments, referring to Figures 15 and 16, the photobiomodulation unit 100 comprises a connection terminal 160 and a liquid wire circuit assembly 150 that provides electronic communication between one or more near-infrared light sources 170, such as infrared, low-level lasers, and / or light-emitting diodes (LEDs), one or more sensors 180, and optionally one or more stimulators 194. The liquid wire is composed of a type of metal that remains in liquid phase at room temperature, enclosed in a flexible tube. Due to its liquid-phase nature, the liquid metal can make good contact with objects of any shape and maintain excellent electrical properties even if the substrate or cover film is deformed. Examples of liquid metals, though not limited to them, include alloys such as gallium and gallium-indium eutectic. The liquid wire circuit assembly 150 includes the connection terminal 160 to which an electronic circuit connector 162 is attached, the electronic circuit connector 162 being configured to provide electrical communication between one or more liquid wire tubes of the circuit assembly 150 and the connection terminal 160. In these embodiments, the liquid wire circuit assembly 150 is configured to provide flexibility and comfort to the wearer. For example, since the photobiomodulation therapy headband 22 must conform closely to the contours of the forehead, the liquid wire circuit assembly 150 is designed to have strategically placed notches to allow for maximum flexibility and comfort.
[0027] In some embodiments, referring to Figures 15 and 16, the liquid wire circuit assembly 150 comprises a main liquid wire tube 152 extending from a connection terminal 160, which divides at a base 153 into three parts: a first liquid wire tube 154, a second liquid wire tube 156, and a sensor liquid wire tube 158, the sensor liquid wire tube 158 extending from the center and directly attached to the inner surface of the outer fabric sheet 40. The first and second liquid wire tubes 154, 156 each have the electronic circuits necessary to establish an electrical connection between the first or second liquid wire tube 154, 156, each near-infrared light source 170 operably mounted on the first or second liquid wire tube 154, 156 and the connection terminal 160, which provides an electrical connection to the controller 200. The sensor liquid wire tube 158 has the electronic circuitry necessary to establish electrical communication between each sensor 180 and / or each stimulator 194 operably mounted to the sensor liquid wire tube 158 and the connection terminal 160 that provides an electrical connection to the controller 200. By directly attaching the first and second liquid wire tubes 154, 156 and the sensor liquid wire tube 158 to the inner surface of the outer fabric sheet 40, the liquid wire circuit assembly 150 can easily conform to the contour of one or more regions of interest of the skin area S, and each of the one or more near-infrared light sources disclosed herein can be positioned near the skin surface S with minimal or no gaps. Although not shown, the liquid wire circuit assembly 150 can be configured in an arrangement similar to the arrangement shown for the flexible printed circuit board assembly 110 in Figures 12-14.
[0028] Referring to Figures 9 to 15, the photobiomodulation unit 100 also comprises one or more near-infrared light sources 170, each configured to emit near-infrared light in the wavelength range of 700 nm to 1600 nm. In some embodiments, the near-infrared light sources 170 emit light having wavelengths of, for example, about 700 nm, about 750 nm, about 800 nm, about 900 nm, about 1000 nm, about 1100 nm, about 1200 nm, about 1300 nm, about 1400 nm, or about 1500 nm. In some embodiments, the near-infrared light sources 170 emit light having wavelengths of, for example, at least 700 nm, at least 750 nm, at least 800 nm, at least 850 nm, at least 900 nm, at least 1000 nm, at least 1100 nm, at least 1200 nm, at least 1300 nm, at least 1400 nm, or at least 1500 nm. In some embodiments, the near-infrared light source 170 emits light having wavelengths of, for example, at most 700 nm, at most 750 nm, at most 800 nm, at most 850 nm, at most 900 nm, at most 1000 nm, at most 1100 nm, at most 1200 nm, at most 1300 nm, at most 1400 nm, or at most 1500 nm.
[0029] In some embodiments, the near-infrared light source 170 is, for example, approximately 700nm to approximately 750nm, approximately 700nm to approximately 800nm, approximately 700nm to approximately 900nm, approximately 700nm to approximately 1000nm, approximately 700nm to approximately 1100nm, approximately 700nm to approximately 1200nm, approximately 700nm to approximately 1300nm, approximately 700nm to approximately 1400nm, approximately 700nm to approximately 1500nm, approximately 750nm to approximately 800nm, approximately 750nm to approximately 850nm, approximately 750nm to approximately 900nm, approximately 750nm to approximately 1000nm. m, about 750 nm to about 1100 nm, about 750 nm to about 1200 nm, about 750 nm to about 1300 nm, about 750 nm to about 1400 nm, about 750 nm to about 1500 nm, about 800 nm to about 850 nm, about 800 nm to about 900 nm, about 8 00nm to about 1000nm, about 800nm to about 1100nm, about 800nm to about 1200nm, about 800nm to about 1300nm, about 800nm to about 1400nm, about 800nm to about 1500nm, about 850nm to about 900nm, about 850nm ~about 1000nm, about 850nm to about 1100nm, about 850nm to about 1200nm, about 850nm to about 1300nm, about 850nm to about 1400nm, about 850nm to about 1500nm, about 900nm to about 1000nm, about 900nm to about 1100nm, approximately 900nm ~ approximately 1200nm, approximately 900nm ~ approximately 1300nm, approximately 900nm ~ approximately 1400nm, approximately 900nm ~ approximately 1500nm, approximately 1000nm ~ approximately 1100nm, approximately 1000nm ~ approximately 1200nm, approximately 1000nm ~ It emits light with wavelengths of approximately 1300nm, approximately 1000nm to approximately 1400nm, approximately 1000nm to approximately 1500nm, approximately 1100nm to approximately 1200nm, approximately 1100nm to approximately 1300nm, approximately 1100nm to approximately 1400nm, approximately 1100nm to approximately 1500nm, approximately 1200nm to approximately 1300nm, approximately 1200nm to approximately 1400nm, approximately 1200nm to approximately 1500nm, approximately 1300nm to approximately 1400nm, approximately 1300nm to approximately 1500nm, or approximately 1400nm to approximately 1500nm.
[0030] In some embodiments, one or more near-infrared light sources 170 are configured to emit near-infrared light in the pulse wave (or frequency) range of about 1 Hz to about 100 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, about 10 Hz, about 20 Hz, about 30 Hz, about 40 Hz, about 50 Hz, about 60 Hz, about 70 Hz, about 80 Hz, about 90 Hz, or about 100 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, at least 10 Hz, at least 20 Hz, at least 30 Hz, at least 40 Hz, at least 50 Hz, at least 60 Hz, at least 70 Hz, at least 80 Hz, at least 90 Hz, or at least 100 Hz. In some embodiments, the near-infrared light source 170 emits light having pulse waves of, for example, at most 10 Hz, at most 20 Hz, at most 30 Hz, at most 40 Hz, at most 50 Hz, at most 60 Hz, at most 70 Hz, at most 80 Hz, at most 90 Hz, or at most 100 Hz.In a particular embodiment, the near-infrared light source 170 is, for example, approximately 10Hz to approximately 20Hz, approximately 10Hz to approximately 30Hz, approximately 10Hz to approximately 40Hz, approximately 10Hz to approximately 50Hz, approximately 10Hz to approximately 60Hz, approximately 10Hz to approximately 70Hz, approximately 10Hz to approximately 80Hz, approximately 10Hz to approximately 90Hz, approximately 10Hz to approximately 100Hz, approximately 20Hz to approximately 30Hz, approximately 20Hz to approximately 40Hz, approximately 20Hz to approximately 50Hz, approximately 20Hz to approximately 60Hz, approximately 20Hz to approximately 70Hz, approximately 20Hz to approximately 80Hz, approximately 20Hz to approximately 90Hz, approximately 20Hz to approximately 100Hz, approximately 30Hz to approximately 40Hz, approximately 30Hz to approximately 50Hz, approximately 30Hz to approximately 60Hz, approximately 30Hz to approximately 70Hz, approximately 30Hz to approximately 80Hz, and approximately 30 It emits light having pulse waves in the following frequencies: Hz to approximately 90Hz, approximately 30Hz to approximately 100Hz, approximately 40Hz to approximately 50Hz, approximately 40Hz to approximately 60Hz, approximately 40Hz to approximately 70Hz, approximately 40Hz to approximately 80Hz, approximately 40Hz to approximately 90Hz, approximately 40Hz to approximately 100Hz, approximately 50Hz to approximately 60Hz, approximately 50Hz to approximately 70Hz, approximately 50Hz to approximately 80Hz, approximately 50Hz to approximately 90Hz, approximately 50Hz to approximately 100Hz, approximately 60Hz to approximately 70Hz, approximately 60Hz to approximately 80Hz, approximately 60Hz to approximately 90Hz, approximately 60Hz to approximately 100Hz, approximately 70Hz to approximately 80Hz, approximately 70Hz to approximately 90Hz, approximately 70Hz to approximately 100Hz, approximately 80Hz to approximately 90Hz, approximately 80Hz to approximately 100Hz, or approximately 90Hz to approximately 100Hz.
[0031] In some embodiments, one or more near-infrared light sources 170 are configured to emit near-infrared light in the pulse wave (or frequency) range of about 100 Hz to about 1000 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, about 100 Hz, about 200 Hz, about 300 Hz, about 400 Hz, about 500 Hz, about 600 Hz, about 700 Hz, about 800 Hz, about 900 Hz, or about 1000 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, at least 100 Hz, at least 200 Hz, at least 300 Hz, at least 400 Hz, at least 500 Hz, at least 600 Hz, at least 700 Hz, at least 800 Hz, at least 900 Hz, or at least 1000 Hz. In some embodiments, the near-infrared light source 170 emits light having pulse waves of, for example, at most 100 Hz, at most 200 Hz, at most 300 Hz, at most 400 Hz, at most 500 Hz, at most 600 Hz, at most 700 Hz, at most 800 Hz, at most 900 Hz, or at most 1000 Hz.In the Process embodiment, the near-infrared light source 170 is, for example, approximately 100Hz to approximately 200Hz, approximately 100Hz to approximately 300Hz, approximately 100Hz to approximately 400Hz, approximately 100Hz to approximately 500Hz, approximately 100Hz to approximately 600Hz, approximately 100Hz to approximately 700Hz, approximately 100Hz to approximately 800Hz, approximately 100Hz to approximately 900Hz, approximately 100Hz to approximately 1000Hz, approximately 200Hz to approximately 300Hz, approximately 2 00Hz to approx. 400Hz, approx. 200Hz to approx. 500Hz, approx. 200Hz to approx. 600Hz, approx. 200Hz to approx. 700Hz, approx. 200Hz to approx. 800Hz, approx. 200Hz to approx. 900Hz, approx. 0Hz to about 1000Hz, about 300Hz to about 400Hz, about 300Hz to about 500Hz, about 300Hz to about 600Hz, about 300Hz to about 700Hz, about 300Hz to about 800Hz, about 300 Hz ~ about 900Hz, about 300Hz - about 1000Hz, about 400Hz - about 500Hz, about 400Hz - about 600Hz, about 400Hz - about 700Hz, about 400Hz - about 800Hz, about 400 Hz~900Hz, 400Hz~1000Hz, 500Hz~600Hz, 500Hz~700Hz, 500Hz~800Hz, 500Hz~900Hz, 500H It emits light having pulse waves of approximately z~1000Hz, approximately 600Hz~700Hz, approximately 600Hz~800Hz, approximately 600Hz~900Hz, approximately 600Hz~1000Hz, approximately 700Hz~800Hz, approximately 700Hz~900Hz, approximately 700Hz~1000Hz, approximately 800Hz~900Hz, approximately 800Hz~1000Hz, or approximately 900Hz~1000Hz.
[0032] In some embodiments, one or more near-infrared light sources 170 are configured to emit near-infrared light in a pulse wave (or frequency) range of about 1000 Hz to about 5000 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, about 1000 Hz, about 2000 Hz, about 3000 Hz, about 4000 Hz, or about 5000 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, at least 1000 Hz, at least 2000 Hz, at least 3000 Hz, at least 4000 Hz, or at least 5000 Hz. In some embodiments, the near-infrared light sources 170 emit light having pulse waves of, for example, at most 1000 Hz, at most 2000 Hz, at most 3000 Hz, at most 4000 Hz, or at most 5000 Hz. In the Method embodiment, the near-infrared light source 170 emits light having pulse waves of, for example, about 1000Hz to about 2000Hz, about 1000Hz to about 3000Hz, about 1000Hz to about 4000Hz, about 1000Hz to about 5000Hz, about 2000Hz to about 3000Hz, about 2000Hz to about 4000Hz, about 2000Hz to about 5000Hz, about 3000Hz to about 4000Hz, about 3000Hz to about 5000Hz, or about 4000Hz to about 5000Hz.
[0033] In some embodiments, one or more near-infrared light sources 170 are configured to emit near-infrared radiation in the radiant energy range of about 100 J to about 1100 J. In some embodiments, the near-infrared light sources 170 have radiant energies of, for example, about 100 J, about 200 J, about 300 J, about 400 J, about 500 J, about 600 J, about 700 J, about 800 J, about 900 J, about 1000 J, or about 1100 J. In some embodiments, the near-infrared light sources 170 have radiant energies of, for example, at least 100 J, at least 200 J, at least 300 J, at least 400 J, at least 500 J, at least 600 J, at least 700 J, at least 800 J, at least 900 J, at least 1000 J, or at least 1100 J. In some embodiments, the near-infrared light source 170 has a radiant energy of, for example, at most 100 J, at most 200 J, at most 300 J, at most 400 J, at most 500 J, at most 600 J, at most 700 J, at most 800 J, at most 900 J, at most 1000 J, or at most 1100 J.In some embodiments, the near-infrared light source 170 is, for example, approximately 100J to approximately 200J, approximately 100J to approximately 300J, approximately 100J to approximately 400J, approximately 100J to approximately 500J, approximately 100J to approximately 600J, approximately 100J to approximately 700J, approximately 100J to approximately 800J, approximately 100J to approximately 900J, approximately 100J to approximately 1000J, approximately 100J to approximately 1100J, approximately 200J to approximately 300J, approximately 200J to approximately 400J, approximately 200J to approximately 500J, about 200J to about 600J, about 200J to about 700J, about 200J to about 800J, about 200J to about 900J, about 200J to about 1000J, about 200J to about 1100J, about 300J to about 400J , about 300J to about 500J, about 300J to about 600J, about 300J to about 700J, about 300J to about 800J, about 300J to about 900J, about 300J to about 1000J, about 300J to about 1100J, about 40 0J to about 500J, about 400J to about 600J, about 400J to about 700J, about 400J to about 800J, about 400J to about 900J, about 400J to about 1000J, about 400J to about 1100J, about 500J to about 600J, about 500J to about 700J, about 500J to about 800J, about 500J to about 900J, about 500J to about 1000J, about 500J to about 1100J, about 600J to about 700J, about 600J to about 800J It has a radiant energy of approximately 600J to 900J, approximately 600J to 1000J, approximately 600J to 1100J, approximately 700J to 800J, approximately 700J to 900J, approximately 700J to 1000J, approximately 700J to 1100J, approximately 800J to 900J, approximately 800J to 1000J, approximately 800J to 1100J, approximately 900J to 1000J, approximately 900J to 1100J, or approximately 1000J to 1100J.
[0034] In some embodiments, one or more near-infrared light sources 170 each emit approximately 5 mW / cm² 2 ~about 100mW / cm 2 It is configured to emit near-infrared light within the irradiance (luminous flux density) range. In some embodiments, the near-infrared light source 170 is, for example, about 5 mW / cm². 2 , about 10mW / cm 2 , about 15mW / cm 2 , about 20mW / cm 2 , about 25mW / cm2 , about 30 mW / cm 2 , about 35 mW / cm 2 , about 40 mW / cm 2 , about 50 mW / cm 2 , about 60 mW / cm 2 , about 70 mW / cm 2 , about 80 mW / cm 2 , about 90 mW / cm 2 , or about 100 mW / cm 2 has an irradiance (light beam density). In some embodiments, the near-infrared light source 170 is, for example, at least 5 mW / cm 2 , at least 10 mW / cm 2 , at least 15 mW / cm 2 , at least 20 mW / cm 2 , at least 25 mW / cm 2 , at least 30 mW / cm 2 , at least 35 mW / cm 2 , at least 40 mW / cm 2 , at least 50 mW / cm 2 , at least 60 mW / cm 2 , at least 70 mW / cm 2 , at least 80 mW / cm 2 , at least 90 mW / cm 2 , or at least 100 mW / cm 2 has an irradiance (light beam density). In some embodiments, the near-infrared light source 170 is, for example, at most 5 mW / cm 2 , at most 10 mW / cm 2 , at most 15 mW / cm 2 , at most 20 mW / cm 2 , at most 25 mW / cm 2 , at most 30 mW / cm 2 , at most 35 mW / cm 2 , at most 40 mW / cm 2 , at most 50 mW / cm 2 , at most 60 mW / cm 2 , at most 70 mW / cm 2 , at most 80 mW / cm 2 , at most 90 mW / cm 2 , or at most 100 mW / cm 2It has an irradiance (luminous flux density) of approximately 5 mW / cm². In some embodiments, the near-infrared light source 170 is, for example, approximately 5 mW / cm². 2 ~about 10mW / cm 2 , about 5mW / cm 2 ~about 15mW / cm 2 , about 5mW / cm 2 ~about 20mW / cm 2 , about 5mW / cm 2 ~about 25mW / cm 2 , about 5mW / cm 2 ~about 30mW / cm 2 , about 5mW / cm 2 ~about 35mW / cm 2 , about 10mW / cm 2 ~about 15mW / cm 2 , about 10mW / cm 2 ~about 20mW / cm 2 , about 10mW / cm 2 ~about 25mW / cm 2 , about 10mW / cm 2 ~about 30mW / cm 2 , about 10mW / cm 2 ~about 35mW / cm 2 , about 15mW / cm 2 ~about 20mW / cm 2 , about 15mW / cm 2 ~about 25mW / cm 2 , about 15mW / cm 2 ~about 30mW / cm 2 , about 15mW / cm 2 ~about 35mW / cm 2 , about 20mW / cm 2 ~about 25mW / cm 2 , about 20mW / cm 2 ~about 30mW / cm 2 , about 20mW / cm 2 ~about 35mW / cm 2 , about 25mW / cm 2 ~about 30mW / cm 2 , about 25mW / cm 2 ~about 35mW / cm 2 , or approximately 30 mW / cm² 2 ~about 35mW / cm 2has an irradiance (light beam density). In some embodiments, the near-infrared light source 170 is, for example, about 20 mW / cm 2 ~ about 50 mW / cm 2 、about 20 mW / cm 2 ~ about 60 mW / cm 2 、about 20 mW / cm 2 ~ about 70 mW / cm 2 、about 20 mW / cm 2 ~ about 80 mW / cm 2 、about 20 mW / cm 2 ~ about 90 mW / cm 2 、about 20 mW / cm 2 ~ about 100 mW / cm 2 、about 30 mW / cm 2 ~ about 60 mW / cm 2 、about 30 mW / cm 2 ~ about 70 mW / cm 2 、about 30 mW / cm 2 ~ about 80 mW / cm 2 、about 30 mW / cm 2 ~ about 90 mW / cm 2 、about 30 mW / cm 2 ~ about 100 mW / cm 2 、about 40 mW / cm 2 ~ about 60 mW / cm 2 、about 40 mW / cm 2 ~ about 70 mW / cm 2 、about 40 mW / cm 2 ~ about 80 mW / cm 2 、about 40 mW / cm 2 ~ about 90 mW / cm 2 、about 40 mW / cm 2 ~ about 100 mW / cm 2 、about 50 mW / cm 2 ~ about 60 mW / cm 2 、about 50 mW / cm 2 ~ about 70 mW / cm 2 、about 50 mW / cm 2 ~ about 80 mW / cm 2 、about 50 mW / cm 2 ~ about 90 mW / cm 2 、about 50 mW / cm 2 ~ about 100 mW / cm 2 、about 60 mW / cm 2 ~ about 70 mW / cm2 , about 60mW / cm 2 ~about 80mW / cm 2 , about 60mW / cm 2 ~about 90mW / cm 2 , about 60mW / cm 2 ~about 100mW / cm 2 , about 70mW / cm 2 ~about 80mW / cm 2 , about 70mW / cm 2 ~about 90mW / cm 2 , about 70mW / cm 2 ~about 100mW / cm 2 , about 80mW / cm 2 ~about 90mW / cm 2 , about 80mW / cm 2 ~about 100mW / cm 2 , or approximately 90 mW / cm² 2 ~about 100mW / cm 2 It has the following irradiance (luminous flux density).
[0035] In some embodiments, one or more near-infrared light sources 170 each emit approximately 100 mW / cm². 2 ~About 1000mW / cm 2 It is configured to emit near-infrared light within the irradiance (luminous flux density) range. In some embodiments, the near-infrared light source 170 emits, for example, about 100 mW / cm². 2 , about 200mW / cm 2 , about 300mW / cm 2 , about 400mW / cm 2 , about 500mW / cm 2 , about 600mW / cm 2 , about 700mW / cm 2 , about 800mW / cm 2 , about 900mW / cm 2 , or approximately 1000 mW / cm² 2 It has an irradiance (luminous flux density) of the following: In some embodiments, the near-infrared light source 170 has, for example, at least 100 mW / cm². 2 at least 200 mW / cm² 2 at least 300 mW / cm² 2 at least 400 mW / cm² 2at least 500 mW / cm² 2 at least 600 mW / cm² 2 at least 700 mW / cm² 2 at least 800 mW / cm² 2 at least 900 mW / cm² 2 , or at least 1000 mW / cm² 2 It has an irradiance (luminous flux density) of the following: In some embodiments, the near-infrared light source 170 has, for example, at most 100 mW / cm². 2 At most 200 mW / cm 2 At most 300 mW / cm 2 At most 400 mW / cm 2 At most 500 mW / cm 2 At most 600 mW / cm 2 At most 700 mW / cm 2 At most 800 mW / cm 2 At most 900 mW / cm 2 , or at most 1000 mW / cm 2 It has an irradiance (luminous flux density) of the following: In some embodiments, the near-infrared light source 170 has, for example, about 100 mW / cm². 2 ~about 200mW / cm 2 , about 100mW / cm 2 ~about 300mW / cm 2 , about 100mW / cm 2 ~about 400mW / cm 2 , about 100mW / cm 2 ~about 500mW / cm 2 , about 100mW / cm 2 ~about 600mW / cm 2 , about 100mW / cm 2 ~about 700mW / cm 2 , about 100mW / cm 2 ~about 800mW / cm 2 , about 100mW / cm 2 ~about 900mW / cm 2 , about 100mW / cm 2 ~About 1000mW / cm 2 , about 200mW / cm 2 ~about 300mW / cm 2 , about 200mW / cm 2 ~about 400mW / cm 2Approximately 200mW / cm 2 ~approximately 500mW / cm 2 Approximately 200mW / cm 2 ~approximately 600mW / cm 2 Approximately 200mW / cm 2 ~approximately 700mW / cm 2 Approximately 200mW / cm 2 ~approximately 800mW / cm 2 Approximately 200mW / cm 2 ~approximately 900mW / cm 2 Approximately 200mW / cm 2 ~approximately 1000mW / cm 2 Approximately 300mW / cm 2 ~approximately 400mW / cm 2 Approximately 300mW / cm 2 ~approximately 500mW / cm 2 Approximately 300mW / cm 2 ~approximately 600mW / cm 2 Approximately 300mW / cm 2 ~approximately 700mW / cm 2 Approximately 300mW / cm 2 ~approximately 800mW / cm 2 Approximately 300mW / cm 2 ~approximately 900mW / cm 2 Approximately 300mW / cm 2 ~approximately 1000mW / cm 2 Approximately 400mW / cm 2 ~approximately 500mW / cm 2 Approximately 400mW / cm 2 ~approximately 600mW / cm 2 Approximately 400mW / cm 2 ~approximately 700mW / cm 2 Approximately 400mW / cm 2 ~approximately 800mW / cm 2 Approximately 400mW / cm 2 ~approximately 900mW / cm 2 Approximately 400mW / cm 2 ~approximately 1000mW / cm 2 Approximately 500mW / cm 2 ~approximately 600mW / cm 2 Approximately 500mW / cm 2 ~approximately 700mW / cm 2 Approximately 500mW / cm 2~about 800mW / cm 2 , about 500mW / cm 2 ~about 900mW / cm 2 , about 500mW / cm 2 ~About 1000mW / cm 2 , about 600mW / cm 2 ~about 700mW / cm 2 , about 600mW / cm 2 ~about 800mW / cm 2 , about 600mW / cm 2 ~about 900mW / cm 2 , about 600mW / cm 2 ~About 1000mW / cm 2 , about 700mW / cm 2 ~about 800mW / cm 2 , about 700mW / cm 2 ~about 900mW / cm 2 , about 700mW / cm 2 ~About 1000mW / cm 2 , about 800mW / cm 2 ~about 900mW / cm 2 , about 800mW / cm 2 ~About 1000mW / cm 2 , or approximately 900 mW / cm² 2 ~About 1000mW / cm 2 It has the following irradiance (luminous flux density).
[0036] In some embodiments, one or more near-infrared light sources 170 each emit approximately 5 J / cm² 2 ~About 100J / cm 2 It is configured to emit near-infrared light in the fluence range of [specify range]. In some embodiments, the near-infrared light source 170 emits, for example, about 5 J / cm². 2 , about 10J / cm 2 , about 15J / cm 2 , about 20J / cm 2 , about 30J / cm 2 , about 40J / cm 2 , about 50J / cm 2 , about 70J / cm 2 , about 70J / cm 2 , about 75J / cm 2 , about 80J / cm 2, about 90J / cm 2 , or approximately 100 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 has, for example, at least 5 J / cm². 2 at least 10 J / cm² 2 at least 15 J / cm 2 at least 20 J / cm² 2 at least 30 J / cm² 2 at least 40 J / cm² 2 at least 50 J / cm² 2 at least 70 J / cm² 2 at least 70 J / cm² 2 at least 75 J / cm² 2 at least 80 J / cm² 2 at least 90 J / cm² 2 , or at least 100 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 has, for example, at most 5 J / cm². 2 At most 10 J / cm 2 At most 15 J / cm 2 At most 20 J / cm 2 At most 30 J / cm² 2 At most 40 J / cm² 2 At most 50 J / cm² 2 At most 70 J / cm² 2 At most 70 J / cm² 2 At most 75 J / cm 2 At most 80 J / cm² 2 At most 90 J / cm² 2 , or at most 100 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 is, for example, about 5 J / cm². 2 ~about 10J / cm 2 , about 5J / cm 2 ~About 15J / cm 2 , about 5J / cm 2 ~About 20J / cm 2 , about 5J / cm 2 ~About 30J / cm 2 , about 5J / cm 2 ~about 40J / cm 2 , about 5J / cm2 ~approximately 50 J / cm 2 Approximately 5 J / cm 2 ~approximately 60 J / cm 2 Approximately 5 J / cm 2 ~approximately 70 J / cm 2 Approximately 5 J / cm 2 ~approximately 75 J / cm 2 Approximately 5 J / cm 2 ~approximately 80 J / cm 2 Approximately 5 J / cm 2 ~approximately 90 J / cm 2 Approximately 5 J / cm 2 ~approximately 100 J / cm 2 Approximately 10 J / cm 2 ~approximately 15 J / cm 2 Approximately 10 J / cm 2 ~approximately 20 J / cm 2 Approximately 10 J / cm 2 ~approximately 30 J / cm 2 Approximately 10 J / cm 2 ~approximately 40 J / cm 2 Approximately 10 J / cm 2 ~approximately 50 J / cm 2 Approximately 10 J / cm 2 ~approximately 60 J / cm 2 Approximately 10 J / cm 2 ~approximately 70 J / cm 2 Approximately 10 J / cm 2 ~approximately 75 J / cm 2 Approximately 10 J / cm 2 ~approximately 80 J / cm 2 Approximately 10 J / cm 2 ~approximately 90 J / cm 2 Approximately 10 J / cm 2 ~approximately 100 J / cm 2 Approximately 20 J / cm 2 ~approximately 30 J / cm 2 Approximately 20 J / cm 2 ~approximately 40 J / cm 2 Approximately 20 J / cm 2 ~approximately 50 J / cm 2 Approximately 20 J / cm 2 ~approximately 60 J / cm 2 Approximately 20 J / cm 2 ~approximately 70 J / cm 2 Approximately 20 J / cm 2 ~approximately 75 J / cm 2Approximately 20 J / cm 2 ~approximately 80 J / cm 2 Approximately 20 J / cm 2 ~approximately 90 J / cm 2 Approximately 20 J / cm 2 ~approximately 100 J / cm 2 Approximately 30 J / cm 2 ~approximately 40 J / cm 2 Approximately 30 J / cm 2 ~approximately 50 J / cm 2 Approximately 30 J / cm 2 ~approximately 60 J / cm 2 Approximately 30 J / cm 2 ~approximately 70 J / cm 2 Approximately 30 J / cm 2 ~approximately 75 J / cm 2 Approximately 30 J / cm 2 ~approximately 80 J / cm 2 Approximately 30 J / cm 2 ~approximately 90 J / cm 2 Approximately 30 J / cm 2 ~approximately 100 J / cm 2 Approximately 40 J / cm 2 ~approximately 50 J / cm 2 Approximately 40 J / cm 2 ~approximately 60 J / cm 2 Approximately 40 J / cm 2 ~approximately 70 J / cm 2 Approximately 40 J / cm 2 ~approximately 75 J / cm 2 Approximately 40 J / cm 2 ~approximately 80 J / cm 2 Approximately 40 J / cm 2 ~approximately 90 J / cm 2 Approximately 40 J / cm 2 ~approximately 100 J / cm 2 Approximately 50 J / cm 2 ~approximately 60 J / cm 2 Approximately 50 J / cm 2 ~approximately 70 J / cm 2 Approximately 50 J / cm 2 ~approximately 75 J / cm 2 Approximately 50 J / cm 2 ~approximately 80 J / cm 2 Approximately 50 J / cm 2 ~approximately 90 J / cm 2 Approximately 50 J / cm 2 ~approximately 100 J / cm2 , about 60J / cm 2 ~about 70J / cm 2 , about 60J / cm 2 ~about 80J / cm 2 , about 60J / cm 2 ~About 90J / cm 2 , about 60J / cm 2 ~About 100J / cm 2 , about 70J / cm 2 ~about 80J / cm 2 , about 70J / cm 2 ~About 90J / cm 2 , about 70J / cm 2 ~About 100J / cm 2 , about 80J / cm 2 ~About 90J / cm 2 , about 80J / cm 2 ~About 100J / cm 2 , or approximately 90 J / cm² 2 ~About 100J / cm 2 It has radiation exposure (fluence).
[0037] In some embodiments, one or more near-infrared light sources 170 each emit approximately 100 J / cm². 2 ~About 1000J / cm 2 It is configured to emit near-infrared light in the fluence range. In some embodiments, the near-infrared light source 170 emits, for example, about 100 J / cm². 2 , about 200J / cm 2 , about 300J / cm 2 , about 400J / cm 2 , about 500J / cm 2 , about 600J / cm 2 , about 700J / cm 2 , about 800J / cm 2 , about 900J / cm 2 , or approximately 1000 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 has, for example, at least 100 J / cm². 2 at least 200 J / cm² 2 at least 300 J / cm² 2 at least 400 J / cm² 2at least 500 J / cm² 2 at least 600 J / cm² 2 at least 700 J / cm² 2 at least 800 J / cm² 2 at least 900 J / cm² 2 , or at least 1000 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 has, for example, at most 100 J / cm². 2 At most 200 J / cm² 2 At most 300 J / cm² 2 At most 400 J / cm² 2 At most 500 J / cm² 2 At most 600 J / cm² 2 At most 700 J / cm² 2 At most 800 J / cm² 2 At most 900 J / cm² 2 , or at most 1000 J / cm² 2 It has a radiation exposure (fluence). In some embodiments, the near-infrared light source 170 is, for example, about 100 J / cm². 2 ~About 200J / cm 2 , about 100J / cm 2 ~About 300J / cm 2 , about 100J / cm 2 ~About 400J / cm 2 , about 100J / cm 2 ~about 500J / cm 2 , about 100J / cm 2 ~about 600J / cm 2 , about 100J / cm 2 ~about 700J / cm 2 , about 100J / cm 2 ~about 800J / cm 2 , about 100J / cm 2 ~About 900J / cm 2 , about 100J / cm 2 ~About 1000J / cm 2 , about 200J / cm 2 ~About 300J / cm 2 , about 200J / cm 2 ~about 400J / cm 2 , about 200J / cm 2 ~Approx. 500J / cm2 Approximately 200 J / cm 2 ~approximately 600 J / cm 2 Approximately 200 J / cm 2 ~approximately 700 J / cm 2 Approximately 200 J / cm 2 ~approximately 800 J / cm 2 Approximately 200 J / cm 2 ~approximately 900 J / cm 2 Approximately 200 J / cm 2 ~approximately 1000 J / cm 2 Approximately 300 J / cm 2 ~approximately 400 J / cm 2 Approximately 300 J / cm 2 ~approximately 500 J / cm 2 Approximately 300 J / cm 2 ~approximately 600 J / cm 2 Approximately 300 J / cm 2 ~approximately 700 J / cm 2 Approximately 300 J / cm 2 ~approximately 800 J / cm 2 Approximately 300 J / cm 2 ~approximately 900 J / cm 2 Approximately 300 J / cm 2 ~approximately 1000 J / cm 2 Approximately 400 J / cm 2 ~approximately 500 J / cm 2 Approximately 400 J / cm 2 ~approximately 600 J / cm 2 Approximately 400 J / cm 2 ~approximately 700 J / cm 2 Approximately 400 J / cm 2 ~approximately 800 J / cm 2 Approximately 400 J / cm 2 ~approximately 900 J / cm 2 Approximately 400 J / cm 2 ~approximately 1000 J / cm 2 Approximately 500 J / cm 2 ~approximately 600 J / cm 2 Approximately 500 J / cm 2 ~approximately 700 J / cm 2 Approximately 500 J / cm 2 ~approximately 800 J / cm 2 Approximately 500 J / cm 2 ~approximately 900 J / cm 2 Approximately 500 J / cm2 ~About 1000J / cm 2 , about 600J / cm 2 ~about 700J / cm 2 , about 600J / cm 2 ~about 800J / cm 2 , about 600J / cm 2 ~About 900J / cm 2 , about 600J / cm 2 ~About 1000J / cm 2 , about 700J / cm 2 ~about 800J / cm 2 , about 700J / cm 2 ~About 900J / cm 2 , about 700J / cm 2 ~About 1000J / cm 2 , about 800J / cm 2 ~About 900J / cm 2 , about 800J / cm 2 ~About 1000J / cm 2 , or approximately 900 J / cm² 2 ~About 1000J / cm 2 It has radiation exposure (fluence).
[0038] In some embodiments, the near-infrared light source 170 is a high-power infrared light source. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, about 400 mW, about 425 mW, about 450 mW, about 500 mW, about 525 mW, about 550 mW, about 575 mW, or about 600 mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, at least 400 mW, at least 425 mW, at least 450 mW, at least 500 mW, at least 525 mW, at least 550 mW, at least 575 mW, or at least 600 mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, at most 400mW, at most 425mW, at most 450mW, at most 500mW, at most 525mW, at most 550mW, at most 575mW, or at most 600mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, about 400mW to about 450mW, about 400mW to about 500mW, about 400mW to about 550mW, about 400mW to about 600mW, about 450mW to about 500mW, about 450mW to about 550mW, about 450mW to about 600mW, about 500mW to about 550mW, or about 550mW to about 600mW.
[0039] In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, about 100 mW, about 200 mW, about 300 mW, about 400 mW, about 500 mW, about 600 mW, about 700 mW, about 800 mW, about 900 mW, or about 1000 mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, at least 100 mW, at least 200 mW, at least 300 mW, at least 400 mW, at least 500 mW, at least 600 mW, at least 700 mW, at least 800 mW, at least 900 mW, or at least 1000 mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, at most 100mW, at most 200mW, at most 300mW, at most 400mW, at most 500mW, at most 600mW, at most 700mW, at most 800mW, at most 900mW, or at most 1000mW.In some embodiments, the high-power near-infrared light source is, for example, about 100mW to about 200mW, about 100mW to about 300mW, about 100mW to about 400mW, about 100mW to about 500mW, about 100mW to about 600mW, about 100mW to about 700mW, about 100mW to about 800mW, about 100mW to about 900mW, about 100mW to about 1000mW, about 200mW to about 300mW, about 2 00mW~Approx. 400mW, Approx. 200mW~Approx. 500mW, Approx. 200mW~Approx. 600mW, Approx. 200mW~Approx. 700mW, Approx. 200mW~Approx. 800mW, Approx. 200mW~Approx. 900mW, Approx. 0mW~Approx. 1000mW, Approx. 300mW~Approx. 400mW, Approx. 300mW~Approx. 500mW, Approx. 300mW~Approx. 600mW, Approx. 300mW~Approx. 700mW, Approx. 300mW~Approx. 0mW to approximately 900mW, approximately 300mW to approximately 1000mW, approximately 400mW to approximately 500mW, approximately 400mW to approximately 600mW, approximately 400mW to approximately 700mW, approximately 400mW to approximately 800mW, approximately 400mW to approximately 900mW, approximately 400mW to approximately 1000mW, approximately 500mW to approximately 600mW, approximately 500mW to approximately 700mW, approximately 500mW to approximately 800mW, approximately 500mW to approximately 900mW, approximately 50 It has a radiant flux (power output) of 0mW to approximately 1000mW, approximately 600mW to approximately 700mW, approximately 600mW to approximately 800mW, approximately 600mW to approximately 900mW, approximately 600mW to approximately 1000mW, approximately 700mW to approximately 800mW, approximately 700mW to approximately 900mW, approximately 700mW to approximately 1000mW, approximately 800mW to approximately 900mW, approximately 800mW to approximately 1000mW, or approximately 900mW to approximately 1000mW.
[0040] In some embodiments, the high-power near-infrared light source has a radiant intensity (luminance) of, for example, about 150 mW / sr, about 200 mW / sr, about 250 mW / sr, about 300 mW / sr, about 350 mW / sr, about 400 mW / sr, about 450 mW / sr, about 500 mW / sr, about 550 mW / sr, about 600 mW / sr, about 650 mW / sr, about 700 mW / sr, or about 750 mW / sr. In some embodiments, the high-power near-infrared light source has a radiant intensity (luminance) of, for example, at least 150 mW / sr, at least 200 mW / sr, at least 250 mW / sr, at least 300 mW / sr, at least 350 mW / sr, at least 400 mW / sr, at least 450 mW / sr, at least 500 mW / sr, at least 550 mW / sr, at least 600 mW / sr, at least 650 mW / sr, at least 700 mW / sr, or at least 750 mW / sr. In some embodiments, the high-power near-infrared light source has a radiant intensity (luminance) of, for example, at most 150 mW / sr, at most 200 mW / sr, at most 250 mW / sr, at most 300 mW / sr, at most 350 mW / sr, at most 400 mW / sr, at most 450 mW / sr, at most 500 mW / sr, at most 550 mW / sr, at most 600 mW / sr, at most 650 mW / sr, at most 700 mW / sr, or at most 750 mW / sr.In some embodiments, the high-power near-infrared light source is, for example, approximately 150 mW / sr to approximately 200 mW / sr, approximately 150 mW / sr to approximately 300 mW / sr, approximately 150 mW / sr to approximately 400 mW / sr, approximately 150 mW / sr to approximately 500 mW / sr, approximately 150 mW / sr to approximately 600 mW / sr, approximately 150 mW / sr to approximately 700 mW / sr, and approximately 150 mW / sr ~ approx. 800mW / sr, approx. 200mW / sr ~ approx. 300mW / sr, approx. 200mW / sr ~ approx. 400mW / sr, approx. 200mW / sr ~ approx. 500mW / sr, Approx. 200mW / sr~Approx. 600mW / sr, Approx. 200mW / sr~Approx. 700mW / sr, Approx. 200mW / sr~Approx. 800mW / sr, Approx. 300mW / sr~Approx. 400mW / sr, approx. 300mW / sr ~ approx. 500mW / sr, approx. 300mW / sr ~ approx. 600mW / sr, approx. 300mW / sr ~ approx. 700mW / sr, approx. 300mW / sr ~ approx. 800mW / sr, approx. 400mW / sr ~ approx. 500mW / sr, approx. 400mW / sr ~ approx. 600mW / sr, approx. 400mW / sr ~ approx. 700mW / sr, approx. 400mW / It has a luminance range (or radiant intensity) of approximately sr to 800mW / sr, approximately 500mW / sr to 600mW / sr, approximately 500mW / sr to 700mW / sr, approximately 500mW / sr to 800mW / sr, approximately 600mW / sr to 700mW / sr, approximately 600mW / sr to 800mW / sr, or approximately 700mW / sr to 800mW / sr.
[0041] In some embodiments, the near-infrared light source 170 is a low-power infrared light source. In some embodiments, the low-power near-infrared light source has a radiant flux (power) of, for example, about 30 mW, about 35 mW, about 40 mW, about 45 mW, about 50 mW, about 55 mW, about 60 mW, about 65 mW, about 70 mW, or about 75 mW. In some embodiments, the low-power near-infrared light source has a radiant flux (power) of, for example, at least 30 mW, at least 35 mW, at least 40 mW, at least 45 mW, at least 50 mW, at least 55 mW, at least 60 mW, at least 65 mW, at least 70 mW, or at least 75 mW. In some embodiments, the low-power near-infrared light source has a radiant flux (output) of, for example, at most 30mW, at most 35mW, at most 40mW, at most 45mW, at most 50mW, at most 55mW, at most 60mW, at most 65mW, at most 70mW, or at most 75mW. In some embodiments, the low-power near-infrared light source has a radiant flux (output) of, for example, about 30mW to about 40mW, about 30mW to about 50mW, about 30mW to about 60mW, about 30mW to about 70mW, about 30mW to about 75mW, about 40mW to about 50mW, about 40mW to about 60mW, about 40mW to about 70mW, about 40mW to about 75mW, about 50mW to about 60mW, about 50mW to about 70mW, about 50mW to about 75mW, about 60mW to about 70mW, or about 60mW to about 75mW.
[0042] In some embodiments, the low-power near-infrared light source is configured to have a radiant intensity (luminance) of, for example, about 25 mW / sr, about 50 mW / sr, about 75 mW / sr, about 100 mW / sr, about 125 mW / sr, or about 150 mW / sr. In some embodiments, the low-power near-infrared light source has a luminance (or radiant intensity) of, for example, at least 25 mW / sr, at least 50 mW / sr, at least 75 mW / sr, at least 100 mW / sr, at least 125 mW / sr, or at least 150 mW / sr. In some embodiments, the near-infrared light source 170 has a radiant intensity (luminance) of, for example, at most 25 mW / sr, at most 50 mW / sr, at most 75 mW / sr, at most 100 mW / sr, at most 125 mW / sr, or at most 150 mW / sr. In some embodiments, the low-power near-infrared light source is, for example, approximately 25 mW / sr to approximately 50 mW / sr, approximately 25 mW / sr to approximately 75 mW / sr, approximately 25 mW / sr to approximately 100 mW / sr, approximately 25 mW / sr to approximately 125 mW / sr, approximately 25 mW / sr to approximately 150 mW / sr, approximately 50 mW / sr to approximately 75 mW / sr, approximately 50 mW / sr to approximately 100 mW / sr, approximately 50 mW / It has a radiant intensity (luminance) of approximately 125 mW / sr, approximately 50 mW / sr to approximately 150 mW / sr, approximately 75 mW / sr to approximately 100 mW / sr, approximately 75 mW / sr to approximately 125 mW / sr, approximately 75 mW / sr to approximately 150 mW / sr, approximately 100 mW / sr to approximately 125 mW / sr, approximately 100 mW / sr to approximately 150 mW / sr, or approximately 125 mW / sr to approximately 150 mW / sr.
[0043] Referring to Figures 9 to 15, the photobiomodulation unit 100 also includes one or more sensors 180 configured to detect and collect information on one or more parameters, including operational information of the photobiomodulation therapy garment 20, user biometric information, or other useful information to ensure proper use and effectiveness. Operational information includes, but is not limited to, location and safety information of the photobiomodulation therapy garment 20. Biometric information includes, but is not limited to, physiometric measurements and calculations related to the user. Examples of biometric sensors that are not limited to these include nerve conduction sensors, galvanometer sensors, oxygen level sensors, carbon dioxide level sensors, cerebral oxygen level sensors, heart rate sensors, cortical blood flow sensors, temperature sensors, electroencephalogram sensors, or any combination thereof. One or more sensors 180 can also measure, record, and analyze information and / or transmit it to a controller 200, which can measure, record, and analyze the information.
[0044] In one or more embodiments, as shown in Figures 9, 11, 15, and 16, the sensor cover 79 and one or more sensors 180 beneath or near it are positioned between the second near-infrared light source group 172 and the fifth near-infrared light source group 175. Due to the position of the sensor cover 79, the sensor cover 79 and one or more sensors 180 beneath it are positioned substantially above the sagittal plane 320 of the forehead region. In some embodiments, if the second near-infrared light source group 172 and / or the fifth near-infrared light source group 175 are absent, the sensor cover 79 and one or more sensors 180 beneath or near it can be positioned on the photobiomodulation therapy headband 22 configured such that the sensor cover 79 is substantially above the sagittal plane 320 when properly fitted. In some embodiments, the sensor cover 79 and one or more sensors 180 beneath or near it are positioned between the first near-infrared light source group 171 and the fourth near-infrared light source group 174. In some embodiments, the sensor cover 79 and one or more sensors 180 located beneath or near it are positioned between the third near-infrared light source group 173 and the sixth near-infrared light source group 176. In some embodiments, if two sensors 180 need to be spaced apart to function properly, one sensor cover 79 and one or more sensors 180 located beneath or near it are positioned between the first near-infrared light source group 171 and the fourth near-infrared light source group 174 (or outside such groups in the direction toward the left portion 56), and one sensor cover 79 and one or more sensors 180 located beneath or near it are positioned between the third near-infrared light source group 173 and the sixth near-infrared light source group 176 (or outside such groups in the direction toward the right portion 54).
[0045] In some embodiments, the sensor 180 includes a heart rate sensor and a temperature sensor. Referring to Figures 9 and 11-14, one or more sensors 180 include a cardiovascular sensor 182 that detects blood flow pulse waves, oxygen levels, and other cardiovascular characteristics. Referring to Figure 10, a longitudinal cross-sectional view of the sensor mounting section 142, the cardiovascular sensor 182 comprises LED light sources 184, 186 and a photodetector 188. Light from the LED light sources 184, 186 strikes blood vessels directly beneath the skin surface S, and a portion of the reflected light is captured by the photodetector 188. The signal from the cardiovascular sensor 182 is transmitted to the controller 200 to determine the user's cardiovascular parameters. Similarly, referring to Figures 9 and 11-14, one or more sensors 180 include a temperature sensor 192 that detects skin parameters such as skin temperature, skin density, and skin opacity (color). The signal from the temperature sensor 192 is transmitted to the controller 200 to determine the user's skin parameters.
[0046] The photobiomodulation unit 100 may include one or more stimulators 194 configured to optionally provide brain stimulation or inhibition signals. Examples of stimulators that are not limited to these include components that can generate a magnetic field useful for stimulating nerve cells in the brain, such as magnetic materials that can be magnetized using electric current (electromagnets). Such magnetic field generating components can be used to administer transcranial magnetic stimulation therapy. In some embodiments, one or more stimulators 194 are operably mounted to an electronic circuit connector 162 or sensor liquid wire tube 158 having the electronic circuits necessary to establish electrical communication between each of the one or more stimulators 194 and a connection terminal 160.
[0047] Referring to Figures 1, 6, and 7, the photobiomodulation therapy garment 20 also includes a controller 200. In one or more embodiments, the controller 200 includes a housing enclosing an input unit, a hardware processor, memory, and an output unit, and may include one or more of each of these elements. In one or more exemplary embodiments, the controller 200 may include a single-board computer, a system-on-a-chip, or other similar and / or known computing device or circuit. The input unit may include one or more USB connectors and / or short-range wireless devices (e.g., a Bluetooth module, a Wi-Fi module, or other wireless communication device or system) for communicating with an external computer such as a smartphone, desktop, laptop, tablet, other wearable computing device, or server. The controller 200 can operate autonomously or semi-autonomously, or can read executable software instructions, code, or other information from memory or computer-readable media, or can receive information or instructions via input from a user, healthcare provider, or from any other source logically connected to another networked computer, server, or computer or device such as an artificial intelligence (AI) or machine learning system. In some embodiments, the controller 200 can be remotely accessed and operated by a third-party individual, such as a healthcare professional, enabling monitoring of the use of the personal photobiomodulation therapy garment 20, modification of operating parameters, and / or collection of data from the photobiomodulation therapy garment 20, thereby providing a remote digital healthcare platform that helps the user receive the most effective biomodulation therapy.In some embodiments, the controller 200 can be a “virtual controller,” and the controller 200’s access to and operation of the photobiomodulation therapy garment 20 is performed via a cloud computing element by a healthcare provider or any other source logically connected to a computer or device such as another networked computer or server or an AI or machine learning-based system. The controller 200 can be accessed and operated by pre-programmed instructions and / or parameters, real-time instructions and / or parameters, or both.
[0048] The controller 200 is programmed to supply electrical signals that power each of the one or more near-infrared light sources 170, each of the one or more sensors 180, and each of the one or more stimulators 194. Furthermore, in one or more embodiments, the controller 200 is a computing device programmed or configured to implement methods and algorithms that can operably control each of the one or more near-infrared light sources 170, each of the one or more sensors 180, and each of the one or more stimulators 194. For example, in some embodiments, the controller 200 operably controls the operating time of one or more near-infrared light sources 170, the fluence level of one or more near-infrared light sources 170, the irradiance level of one or more near-infrared light sources 170, whether one or more near-infrared light sources 170 operate continuously or pulsed, which of the one or more near-infrared light sources 170 are activated or deactivated, and one or more of a predetermined dose measurement level. Furthermore, the controller 200 controls each of the one or more sensors 180 to be operational, and receives and analyzes the information collected from each of the one or more sensors 180. In some embodiments, the controller 200 controls one or more of the operating times of one or more stimulators 194, the output levels of one or more stimulators 194, whether one or more stimulators 194 operate continuously or pulsed, which of the one or more stimulators 194 are activated or deactivated, or any combination thereof to be operational.
[0049] In some embodiments, the controller 200 operationally commands to activate one or more infrared light sources 170 located on the left side of the median sagittal plane 320 and deactivate one or more infrared light sources 170 located on the right side of the median sagittal plane 320, or vice versa. In some embodiments, the controller 200 operationally commands to activate one or more infrared light sources 170 located on both the left and right sides of the median sagittal plane 320, such that one or more infrared light sources 170 located on the right side of the median sagittal plane 320 are activated at a higher irradiance level than one or more infrared light sources 170 located on the left side of the median sagittal plane 320, or vice versa.
[0050] In some embodiments, the controller 200 dynamically adjusts the operating parameters of the photobiomodulation therapy garment 20 using information collected from each of the one or more sensors 180, information provided by the user, or information remotely input by a third-party individual. The controller 200 then processes such input information against information stored in an operational database using one or more algorithms, and based on an analysis performed when comparing the collected, provided, or input information with the information stored in such a database using one or more algorithms, the operating parameters of each of the one or more near-infrared light sources 170, each of the one or more sensors 180, and each of the one or more stimulators 194 are adjusted by executable commands provided by the controller 200.
[0051] For example, the cardiovascular sensor 182 acquires cardiovascular parameters from the user during the operation of the photobiomodulation therapy garment 20. This input information is analyzed and compared against cardiovascular parameters stored in an operational database to evaluate the actual cardiovascular parameters and adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected by the user or a third-party individual. In some embodiments, when the cardiovascular sensor 182 detects a decrease in heart rate variability and transmits it to the controller 200, the controller 200 provides executable commands to optimize the pulse wave by increasing the frequency of light emitted from one or more near-infrared light sources 170 in situations where the user or a third-party individual has selected awakening therapy. As an example, the initial pulse wave of the photobiomodulation therapy garment 20 may be set to 40 Hz, and based on the detected heart rate variability, the controller 200 may increase the frequency of light emitted from one or more near-infrared light sources 170 to 50 Hz. Continuous monitoring and analysis of heart rate variability by the cardiovascular sensor 182 and controller 200 allows for maintaining a pulse wave setting of 50 Hz or increasing it to 60 Hz or 70 Hz or higher to establish an appropriate pulse wave for arousal therapy emitted from one or more near-infrared light sources 170. Such dynamic monitoring of heart rate variability by the cardiovascular sensor 182 and controller 200 results in continuous adjustment of the pulse wave to achieve the optimal pulse wave for the selected arousal therapy.
[0052] In some embodiments, when an increase in heart rate variability is detected by the cardiovascular sensor 182 and transmitted to the controller 200, the controller 200 provides executable commands to optimize the pulse wave by reducing the frequency of light emitted from one or more near-infrared light sources 170 in situations where the user or a third-party individual has selected sedation or relaxation therapy. As an example, the initial pulse wave of the photobiomodulation therapy garment 20 may be set to 40 Hz, and based on the detected heart rate variability, the controller 200 may reduce the frequency of light emitted from one or more near-infrared light sources 170 to 30 Hz. Continuous monitoring and analysis of heart rate variability by the cardiovascular sensor 182 and controller 200 will determine whether to maintain the 30 Hz pulse wave setting or reduce it to 10 Hz or 1 Hz to establish an appropriate pulse wave for sedation or relaxation therapy emitted from one or more near-infrared light sources 170. Such dynamic monitoring of heart rate variability by the cardiovascular sensor 182 and controller 200 results in continuous adjustment of the pulse wave to achieve the optimal pulse wave for the selected sedation or relaxation therapy.
[0053] As another example, the skin sensor 192 acquires information about skin parameters from the user during the operation of the photobiomodulation therapy garment 20. This input information is analyzed and compared with skin information stored in an operational database to evaluate the actual skin parameters and adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected by the user or a third-party individual. In some embodiments, when the skin sensor 192 detects a decrease in skin temperature and transmits it to the controller 200, the controller 200 provides executable commands to optimize the skin temperature by increasing the irradiance of light emitted from one or more near-infrared light sources 170 in situations where the user or a third-party individual has selected an awakening therapy. As an example, the initial irradiance of the photobiomodulation therapy garment 20 is 250 mW / cm². 2It can be set to 500 mW / cm², and based on the detected skin temperature, the controller 200 sets the irradiance of the light emitted from one or more near-infrared light sources 170 to 500 mW / cm². 2 It can be increased to 500 mW / cm². Continuous monitoring and analysis of skin temperature by the skin sensor 192 and controller 200 allows for this increase. 2 Maintain the irradiance setting at 750 mW / cm² to establish an appropriate skin temperature for arousal therapy. 2 or 1000 mW / cm² 2 This increases the intensity to the above. Such dynamic monitoring of skin temperature by the skin sensor 192 and controller 200 results in continuous adjustment of irradiance to achieve the optimal skin temperature for the selected arousal therapy.
[0054] In some embodiments, when a rise in skin temperature is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable commands to optimize the skin temperature by reducing the irradiance of light emitted from one or more near-infrared light sources 170 in situations where the user or a third party individual has selected sedation or relaxation therapy. As an example, the initial irradiance of the photobiomodulation therapy garment 20 is 250 mW / cm². 2 The controller 200 can be set to 100 mW / cm² based on the detected skin temperature, and based on the detected skin temperature, the irradiance of the light emitted from one or more near-infrared light sources 170 can be set to 100 mW / cm². 2 This can be reduced to 125 mW / cm². Continuous monitoring and analysis of skin temperature by the skin sensor 192 and controller 200 indicates that the level is 125 mW / cm². 2 Maintain the irradiance setting at 75 mW / cm² to establish an appropriate skin temperature for sedation or relaxation therapy. 2 or 25 mW / cm 2 The following reductions are achieved: Such dynamic monitoring of skin temperature by the skin sensor 192 and controller 200 results in continuous adjustment of irradiance to achieve the optimal skin temperature for the selected sedation or relaxation therapy.
[0055] In some embodiments, when a decrease in skin temperature is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions to optimize the skin temperature by increasing the duty cycle of the light emitted from one or more near-infrared light sources 170 in a situation where the user or a third-party individual has selected arousal therapy. As an example, the initial duty cycle of the photobiomodulation therapy garment 20 may be set to 50%, and based on the detected skin temperature, the controller 200 may increase the duty cycle of the light emitted from one or more near-infrared light sources 170 to 60%. Continuous monitoring and analysis of skin temperature by the skin sensor 192 and controller 200 may be used to maintain the 60% duty cycle setting or increase it to 75% or more to establish an appropriate skin temperature for arousal therapy. Such dynamic monitoring of skin temperature by the skin sensor 192 and controller 200 results in continuous adjustment of the duty cycle to achieve the optimal skin temperature for the selected arousal therapy.
[0056] In some embodiments, when a rise in skin temperature is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions for optimizing the skin temperature by reducing the duty cycle of the light emitted from one or more near-infrared light sources 170 in situations where the user or a third-party individual has selected sedation or relaxation therapy. As an example, the initial duty cycle of the photobiomodulation therapy garment 20 may be set to 50%, and based on the detected skin temperature, the controller 200 may reduce the duty cycle of the light emitted from one or more near-infrared light sources 170 to 40%. Continuous monitoring and analysis of skin temperature by the skin sensor 192 and controller 200 allows for maintaining the 40% duty cycle setting or reducing it to 25% or less to establish an appropriate skin temperature for relaxation therapy. Such dynamic monitoring of skin temperature by the skin sensor 192 and controller 200 results in continuous adjustment of the duty cycle to achieve the optimal skin temperature for the selected sedation or relaxation therapy.
[0057] In some embodiments, when the skin sensor 192 detects higher skin opacity indicating skin with a higher melanin content and transmits this to the controller 200, the controller 200 provides executable instructions for optimizing skin penetration by adjusting the wavelength or combination of wavelengths of light emitted from one or more near-infrared light sources 170 to provide optimal photopenetration for the selected therapy. For example, the initial wavelength of the photobiomodulation therapy garment 20 can be set to 900 nm, and based on the detected skin opacity, the controller 200 may increase the wavelength of light emitted from one or more near-infrared light sources 170 to approximately 970 nm. Continuous monitoring and analysis of skin opacity by the skin sensor 192 and controller 200 may be used to maintain the wavelength setting or increase it to 1000 nm or higher to establish appropriate wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of skin opacity by the skin sensor 192 and controller 200 results in continuous adjustment of wavelengths to achieve optimal skin penetration for the selected therapy.
[0058] In some embodiments, when a lower skin opacity indicating skin with a lower melanin content is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions for optimizing skin penetration by adjusting the wavelength or combination of wavelengths of the light emitted from one or more near-infrared light sources 170 to provide optimal light penetration for the selected therapy. As an example, the initial wavelength of the photobiomodulation therapy garment 20 can be set to 900 nm, and based on the detected skin opacity, the controller 200 can reduce the wavelength of the light emitted from one or more near-infrared light sources 170 to about 810 nm. Continuous monitoring and analysis of the skin opacity by the skin sensor 192 and the controller 200 maintains the wavelength setting or reduces it below 790 nm to establish proper wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of the skin opacity by the skin sensor 192 and the controller 200 results in continuous adjustment of the wavelength to achieve optimal skin penetration for the selected therapy.
[0059] In some embodiments, when a higher skin density indicating skin with a higher fat content is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions for optimizing skin penetration by adjusting the wavelength of the light emitted from one or more near-infrared light sources 170 to provide optimal light penetration for the selected therapy. As an example, the initial wavelength of the photobiomodulation therapy garment 20 can be set to 900 nm, and based on the detected skin density, the controller 200 can increase the wavelength of the light emitted from one or more near-infrared light sources 170 to about 970 nm. Continuous monitoring and analysis of the skin density by the skin sensor 192 and the controller 200 maintains the wavelength setting or increases it above 1000 nm to establish proper wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of the skin density by the skin sensor 192 and the controller 200 results in continuous adjustment of the wavelength to achieve optimal skin penetration for the selected therapy.
[0060] In some embodiments, when a lower skin density indicative of skin with a lower fat content is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions for optimizing skin penetration by adjusting the wavelength of the light emitted from one or more near-infrared light sources 170 to provide optimal light penetration for the selected therapy. As an example, the initial wavelength of the clothing 20 for photobiomodulation therapy can be set to 900 nm, and based on the detected skin density, the controller 200 can reduce the wavelength of the light emitted from one or more near-infrared light sources 170 to about 810 nm. Continuous monitoring and analysis of the skin density by the skin sensor 192 and the controller 200 maintains the wavelength setting or reduces it below 790 nm to establish proper wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of the skin density by the skin sensor 192 and the controller 200 results in continuous adjustment of the wavelength to achieve optimal skin penetration for the selected therapy.
[0061] As another example, information can be provided by the user or a third-party individual during the operation of the photobiomodulation therapy garment 20, and this input information is used directly to adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected by the user, or is analyzed in comparison with user-defined or third-party personal-defined information stored in the operational database to adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected. For example, the initial therapy of the photobiomodulation therapy garment 20 can be set to an awakening therapy, and based on user input (e.g., "still tired" or "feeling good") or individual third-party input (e.g., based on monitoring of the user's physiological or vital signs), the controller 200 will adjust the characteristics of the light emitted from one or more near-infrared light sources 170. Continuous input from the user or individual third parties to the controller 200 establishes the appropriate light characteristics for the selected awakening therapy. Such dynamic monitoring of user or individual third-party input to the controller 200 results in continuous adjustment of the light characteristics to achieve the optimal effect of the selected awakening therapy.
[0062] As another example, the sensor 180 acquires information on mitochondrial function from the user during the operation of the photobiomodulation therapy garment 20. This input information is analyzed and compared with mitochondrial function information stored in the operational database to evaluate actual mitochondrial function and adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected by the user or a third-party individual. For example, the initial therapy of the photobiomodulation therapy garment 20 can be set to an awakening therapy, and based on the detected mitochondrial function (e.g., NAD+ level or NADH level), the controller 200 adjusts the characteristics of the light emitted from one or more near-infrared light sources 170. Continuous monitoring and analysis of skin opacity by the sensor 180 and controller 200 establish the appropriate light characteristics for the selected awakening therapy emitted from one or more near-infrared light sources 170. Such dynamic monitoring of mitochondrial function by the sensor 180 and controller 200 results in continuous adjustment of the light characteristics to achieve optimal skin penetration of the selected awakening therapy.
[0063] The adjustments performed by the controller 200, as described in the examples in the paragraphs above, and the processing performed on various types of information, may be carried out in conjunction with a machine learning-based framework that applies elements of artificial intelligence (AI) to analyze information provided as input to a model trained on historical data or known data, such as data stored in the aforementioned operational database, in order to improve such adjustments to the operating parameters of each of the one or more near-infrared light sources 170, one or more sensors 180, and one or more stimulators 194. Accordingly, the present invention may include such a machine learning-based framework that can consist of multiple elements that perform some of the processing modes performed by the controller 200 as models instantiated together or separately.
[0064] The modeling performed within the machine learning-based framework involves many different types of machine learning, and many different mathematical techniques can be applied to analyze information and generate outputs that improve the results of the continuous tuning of the operating parameters of each of the one or more near-infrared light sources 170, one or more sensors 180, and one or more stimulators 194 described herein. For example, in some embodiments of the present invention, the machine learning-based framework may consist of algorithms that apply supervised learning, reinforcement learning, and other techniques of machine learning and artificial intelligence to further evaluate the input to the controller 200.
[0065] Machine learning-based frameworks can consist of one of several different mathematical methods. These may include statistical analysis, which is a non-deterministic mathematical method that enables the calculation of the probability of an event occurring or not occurring. Regression analysis is a type of statistical analysis that uses a model to estimate the relationship between variables of interest, such as a dependent variable and one or more independent variables (often called "predictors"). This type of machine learning is used to infer causal relationships between independent and dependent variables, and to predict and forecast outcomes if such causal relationships affect future states regarding the application of the overall model underway. There are many types of regression analysis, such as linear and nonlinear regression, and specific methods such as logistic regression, which allows the interpretation of the importance of the maximum value in the form of log odds using derived parameters when calculating probability values. For example, other types of logistic functions and other types of regression analysis can also be used to calculate probabilities in this invention, and they are within the scope of this invention. Other methods that may be used include, but are not limited to, decision trees, random forest classifiers, support vector machines, and probits. Therefore, it should be further understood that the present invention and this specification are not limited to any one type of mathematical model or statistical process referred to herein, in particular to its application in one or more layers of machine learning.
[0066] Modeling within machine learning-based frameworks can also involve the application of neural networks. Neural networks generally consist of nodes, which are computing units with one or more biased input / output connections. Such biased connections act as transfer (or activation) functions that combine inputs and outputs in some way. The nodes are organized into multiple layers that form the neural network. Many types of neural networks exist, and they are, by example, computing systems that "learn" to perform tasks without being programmed with task-specific rules.
[0067] Neural networks are generally based on arrays of connected aggregate nodes (or "neurons") that transmit signals to each other in multiple layers via biased input / output connections. As mentioned above, the connections are activation functions or transfer functions that "fire" these nodes and combine inputs according to mathematical formulas or equations. Different types of neural networks generally have different configurations of layers of connected aggregate nodes, but they can generally be described as input layers, hidden or intermediate layers, and output layers. These layers can perform various transformations on various inputs using various mathematical calculations or functions.
[0068] Signals are transmitted between nodes via connections, and the output of each node is calculated using a nonlinear function that sums all inputs to that node. Typically, a weight matrix and bias are applied to each node and each connection, and these weights and biases are adjusted as the neural network processes inputs and transmits them across nodes and connections. These weights represent increases or decreases in signal intensity at a particular connection. Furthermore, nodes may have thresholds such that a signal is transmitted only if the aggregated output at that node exceeds that threshold. Weights generally represent the time required for the activation function, while biases represent when such a function begins; together, they help minimize the gradient over time. At least in the case of weights, they are initialized and can change (i.e., decay) over time as the system learns what the weights should be and how to adjust them. In other words, neural networks evolve with learning, and the formulas and functions that make up the neural network design can change over time as the system itself improves.
[0069] The application of neural networks within a machine learning-based framework may involve instantiation of various networks for various purposes. These include both “production” neural networks configured to refine algorithms run within the overall modeling framework to generate output data (e.g., as tuned operating parameters for each of one or more near-infrared light sources 170, one or more sensors 180, and one or more stimulators 194), and “training” neural networks configured to train the production network using improvements based on historical results learned to date.
[0070] A recurrent neural network is a type of neural network in which the connections between nodes follow a directed time sequence, enabling the network to model temporal dynamic behavior and process variable-length input sequences. These types of neural networks are deployed when it is necessary to recognize and / or act based on such sequences. As with general neural networks, many types of recurrent neural networks exist.
[0071] Neural networks with a recurrent architecture also have memory or controlled internal states that enable storage under the direct control of the neural network, making them more suitable for inputs with a temporal nature. This storage can be in the form of connections or gates that act as time delays or feedback loops, allowing nodes or connections to hold data temporally ahead to model such temporal dynamic behavior. Such controlled internal states are called gate states or gated memory and are part of LSTM (long short-term memory network) and GRU (gated recurrent unit), which are names for various types of recurrent neural network architectures. This type of neural network design is used when the desired output of the system is motivated by the need for memory as storage, and when the system is designed to process inputs consisting of time-specified data sequences, as mentioned above. Examples of such time-specified data sequences include video, speech recognition, and handwriting, whose processing requires the analysis of time-varying data. In this invention, when the output data is in the form of operating parameters for one or more near-infrared light sources 170, one or more sensors 180, and one or more stimulators 194, understanding the effects of various events on the state over a period of time leads to much more accurate and reliable operating parameters that can affect at least the amount of time the stimulus is provided.
[0072] Many other types of recurrent neural networks exist. These include, for example, fully recurrent neural networks, Hopfield networks, bidirectional associative memory networks, Echo-state networks, and neural Turing machines, all of which exhibit the ability to model temporally dynamic behavior. It should be understood that the instantiation of such neural networks in this invention includes one or more of these types, and that the neural networks applied within a machine learning-based framework may include different types of such networks. Thus, this invention intends that many types of neural networks can be implemented, at least depending on the type of problem being analyzed.
[0073] The controller 200 is reversibly connected to the photobiomodulation therapy garment 20 by operably engaging with the terminal rail mount 164. The controller 200 may optionally include a rechargeable battery located within the housing. The controller 200 can be detached from the terminal rail mount 164 to charge its internal rechargeable battery by using a charging connector such as USB-C or micro-USB. Furthermore, the charging connector can provide wired data communication with a remote computer such as a smartphone, laptop, desktop, or other computer device. In one or more embodiments, this allows for tracking usage and / or updating or changing operating parameters such as desired dose measurements, duration, and pulse operation, and / or updating the controller firmware, and / or changing the type of photobiomodulation therapy garment 20 to which the controller 200 is attached. The controller 200 can be a universal controller so that it can be connected to multiple embodiments of photobiomodulation therapy clothing 20, such as a photobiomodulation therapy headband 22, neck area clothing, posterior neck area clothing, wrist area clothing, and abdominal area clothing, which are configured to cover each area when worn.
[0074] One or more near-infrared light sources 170 of the photobiomodulation unit 100 can be arranged in one or more separate near-infrared light source groups that are arranged in several inter-group patterns relative to one or more regions of interest on one or more skin areas S treated by photobiomodulation therapy. For example, there may be one near-infrared light source group, two near-infrared light source groups, three near-infrared light source groups, four near-infrared light source groups, five near-infrared light source groups, six near-infrared light source groups, seven near-infrared light source groups, eight near-infrared light source groups, nine near-infrared light source groups, or ten near-infrared light source groups. Each near-infrared light source group is spaced apart from adjacent groups, and the spacing between groups can be the same between each near-infrared light source group or can be varied according to the desired dose measurement and the relative position of the desired region of interest. The relative pattern of the near-infrared light source groups is configured to arrange each group on the photobiomodulation therapy garment 20 so as to at least partially cover each region of interest on the skin surface S, and may appear to be a random pattern at first glance. The spacing between groups of near-infrared light sources can be defined by the column distance d1 and the row distance d2. The distance between groups can be measured from the center of the light source. In one or more embodiments, the column distance d1 and the row distance d2 are at least 5 mm, or at least 10 mm, or at least 15 mm, or at least 20 mm, or at least 25 mm, or at least 30 mm, or at least 35 mm, or at least 40 mm. In a rectangular array, the row distance d2 can be the same distance as the column distance d1, or it can be a different distance.
[0075] In some embodiments, the photobiomodulation unit 100 of the photobiomodulation therapy garment 20 comprises one or more near-infrared light source groups. Each of the one or more near-infrared light source groups is arranged in a pattern configured to direct each light source to a specific region of interest when the photobiomodulation therapy garment 20 is properly positioned over the forehead of person P. In some embodiments, the photobiomodulation unit 100 comprises one or more near-infrared light source groups arranged such that each of the one or more near-infrared light source groups is positioned to at least partially overlap or substantially center on a regular meridian, a major extraordinary meridian, a minor extraordinary meridian, or any combination thereof when the photobiomodulation therapy garment 20 is properly fitted. The regular meridians include, but are not limited to, the heart meridian, pericardium meridian, lung meridian, spleen meridian, liver meridian, kidney meridian, small intestine meridian, large intestine meridian, triple burner meridian, stomach meridian, gallbladder meridian, and bladder meridian. The major extraordinary meridians include, but are not limited to, the Ren meridian and the Du meridian. Minor extraordinary meridians include, but are not limited to, the Chong Meridian, Dai Meridian, Yinwei Meridian, Yinqiao Meridian, Yangwei Meridian, and Yangqiao Meridian.
[0076] In some embodiments, as shown in Figures 3, 9, 11, 12, 15, and 16, the photobiomodulation unit 100 comprises six near-infrared light source groups, namely, a first near-infrared light source group 171, a second near-infrared light source group 172, a third near-infrared light source group 173, a fourth near-infrared light source group 174, a fifth near-infrared light source group 175, and a sixth near-infrared light source group 176. In some embodiments, referring not only to Figures 3, 15, and 16 but also to Figures 9 and 11, the near-infrared light source groups 171, 172, 173, 174, 175, and 176 of the near-infrared light sources 170 present on the photobiomodulation unit 100 are arranged in a 3x2 rectangular array pattern, with each near-infrared light source group separated by a column distance d1 and a row distance d2. In these embodiments, the near-infrared light source groups 171, 172, 173, 174, 175, and 176 are arranged in a pattern configured to direct each light source to a specific region of interest when the photobiomodulation therapy headband 22 is properly positioned on the forehead of person P. For example, in some embodiments, the near-infrared light source groups 171, 172, 173, 174, 175, and 176 are configured within the photobiomodulation therapy headband 22 such that when worn on the forehead of person P, the first, second, third, fourth, fifth, and sixth near-infrared light source groups 171, 172, 173, 174, 175, and 176 are arranged at least above the eye sockets of person P, and the photobiomodulation therapy headband 22 is positioned substantially above the brow ridge region 322.In some embodiments, each of the near-infrared light source groups 171, 172, 173, 174, 175, and 176 of the near-infrared light source 170 is positioned such that when the photobiomodulation therapy headband 22 is properly fitted, the first near-infrared light source group 171 of the near-infrared light source 170 is positioned at least partially overlapping or substantially centered on the Fp1 site 300, the second near-infrared light source group 172 of the near-infrared light source 170 is positioned at least partially overlapping or substantially centered on the Fpz site 302, and the third near-infrared light source group 173 of the near-infrared light source 170 is positioned at the Fp2 site The near-infrared light sources are arranged such that a fourth near-infrared light source group 174 of the near-infrared light source 170 is located in a third position that at least partially overlaps with or is substantially centered on position 304, a fifth near-infrared light source group 175 of the near-infrared light source 170 is located in a fifth position that at least partially overlaps with or is substantially centered on position 308, and a sixth near-infrared light source group 176 of the near-infrared light source 170 is located in a sixth position that at least partially overlaps with or is substantially centered on position 310.
[0077] In some embodiments, as shown in Figure 12, the photobiomodulation unit 100 comprises six near-infrared light source groups of near-infrared light source 170, namely, a first near-infrared light source group 171, a second near-infrared light source group 172, a third near-infrared light source group 173, a fourth near-infrared light source group 174, a fifth near-infrared light source group 175, and a sixth near-infrared light source group 176. The six near-infrared light source groups are organized into two inverted triangles, with the first, second, third, and fourth near-infrared light source groups 171, 172, 173, and 174 arranged in the upper row, and the fifth and sixth near-infrared light source groups 175 and 176 arranged in the lower row. The first and second near-infrared light source groups 171 and 172 are arranged to cover the region including parts F3 306 and Fz308 of the head H, and the third and fourth light source groups 173 and 174 are arranged to cover the region including parts Fz308 and F4 310 of the head H. The fifth near-infrared light source group 175 is arranged to cover the region including part Fp1 300, and the sixth near-infrared light source group 176 is arranged to cover the region including part Fp2 304. In these embodiments, one or more sensors 180 are arranged between the lower fifth and sixth near-infrared light source groups 175 and 176.
[0078] In some embodiments, as shown in Figure 13, the photobiomodulation unit 100 comprises five near-infrared light source groups of near-infrared light source 170, namely, a first near-infrared light source group 171, a second near-infrared light source group 172, a third near-infrared light source group 173, a fourth near-infrared light source group 174, and a fifth near-infrared light source group 175. The first, second, and third near-infrared light source groups 171, 172, and 173 are arranged in the upper row, and the fourth and fifth near-infrared light source groups 174 and 175 are arranged in the lower row, with the fourth near-infrared light source group 174 located below the first near-infrared light source group 171 and the fifth near-infrared light source group 175 located below the third near-infrared light source group 173. The first, second, and third near-infrared light source groups 171, 172, and 173 are arranged to cover the region including parts F3 306, Fz308, and F4 310 of the head H. The fourth near-infrared light source group 174 is arranged to cover the region including part Fp1 300, and the fifth near-infrared light source group 175 is arranged to cover the region including part Fp2 304. In these embodiments, one or more sensors 180 are positioned in the lower row, below the second near-infrared light source group 172, and between the fourth near-infrared light source group 174 and the fifth near-infrared light source group 175.
[0079] In some embodiments, as shown in Figure 14, the photobiomodulation unit 100 comprises three near-infrared light source groups of near-infrared light source 170, namely, a first near-infrared light source group 171, a second near-infrared light source group 172, and a third near-infrared light source group 173. The first, second, and third near-infrared light source groups 171, 172, and 173 are arranged in a row and positioned to cover a region including parts F3 306, Fz308, and F4 310 of the head H. In these embodiments, one or more sensors 180 are positioned below the second near-infrared light source group 172.
[0080] In some embodiments, each of the near-infrared light source groups includes a single-light near-infrared light source 170. For example, as shown in FIGS. 11 to 14 and FIG. 16, each of the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the photobiomodulation unit 100 includes a single-light near-infrared light source 170. In an embodiment where only the single-light near-infrared light source 170 exists within the near-infrared light source group, such a near-infrared light source 170 is preferably a high-output near-infrared light source having a radiation intensity (luminance) range of about 150 mW / sr or more, more preferably about 250 mW / sr or more.
[0081] In some embodiments, each of the near-infrared light source groups includes a multi-light near-infrared light source 170. For example, as shown in FIGS. 9 and 15, each of the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the photobiomodulation unit 100 includes a nine-light near-infrared light source 170. In an embodiment where a multi-light near-infrared light source 170 exists within the near-infrared light source group, all such near-infrared light sources 170 can be low-output near-infrared light sources having a radiation intensity (luminance) range of 125 mW / sr or less. In other embodiments where a multi-light near-infrared light source 170 exists within the near-infrared light source group, all such near-infrared light sources 170 can be a combination of both a high-output near-infrared light source having a radiation intensity (luminance) range of about 150 mW / sr or more, more preferably about 250 mW / sr or more, and a low-output near-infrared light source having a radiation intensity (luminance) range of 125 mW / sr or less.
[0082] Furthermore, in embodiments where the near-infrared light source group comprises multiple near-infrared light sources 170, there is an intra-group spacing between each individual near-infrared light source 170 and adjacent near-infrared light sources 170 within the same group. The intra-group spacing of each near-infrared light source 170 within the near-infrared light source group can be the same between each individual near-infrared light source 170, or it can be varied according to the desired dose measurement and the relative position of the desired region of interest. In some embodiments, each individual near-infrared light source 170 in each near-infrared light source group is arranged in a pattern configured for a desired therapeutic effect, in which each individual near-infrared light source 170 is random relative to other individual near-infrared light sources 170 within the same near-infrared light source group, and / or in a pattern determined by a combination of factors including the desired therapeutic effect, cost, manufacturing capability, etc. The relative pattern of the near-infrared light source group is configured to arrange each near-infrared light source 170 on the photobiomodulation therapy garment 20 so as to at least partially cover each region of interest on the skin surface S, and may appear to be a random pattern at first glance.
[0083] Each individual near-infrared light source 170 within a near-infrared light source internal group is positioned at a distance equal to the inter-group light source interval from all other individual near-infrared light sources 170 within the same internal group. Each near-infrared light source 170 within a near-infrared light source internal group can be arranged in a pattern that corresponds to the locations of multiple regions of interest on the skin surface S. Thus, the resulting near-infrared light source internal group appears to be arranged in an irregular pattern, which corresponds to the locations of multiple regions of interest on the skin surface S, with each region of interest being at least partially covered simultaneously by the corresponding group. Consequently, the spacing between near-infrared light source internal groups and the relative positions of each near-infrared light source 170 within a near-infrared light source internal group can be varied according to the locations of regions of interest on the skin surface S.
[0084] In some embodiments, for example, in a rectangular array as shown in Figure 3, the spacing between each near-infrared light source 170 in the internal near-infrared light source group can be defined by the column spacing d3 and the row spacing d4. The group spacing can be measured from the center of the near-infrared light source 170. In some embodiments, the column spacing d3 and the row spacing d4 are at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, at least 12 mm, or at least 15 mm. In the rectangular array, the row spacing d3 can be the same distance as the column spacing d4, or it can be a different distance. In such a rectangular array, each near-infrared light source 170 in the internal near-infrared light source group is arranged in an n1 × n2 array, where n1 and n2 represent the number of individual near-infrared light sources 170 in the row and column, respectively. For example, the infrared light source internal group can be a 2x2 array, 2x3 array, 3x2 array, 3x3 array, 3x4 array, 4x3 array, 4x4 array, 2x5 array, 5x2 array, 3x5 array, 5x3 array, 4x5 array, 5x4 array, 5x5 array, etc. In some embodiments, each near-infrared light source 170 in the near-infrared light source internal group can be configured as a radial array or circular array around a single circle or multiple concentric circles. In these embodiments, the spacing between groups can be measured from the center of the light source.
[0085] In some embodiments, each of the near-infrared light sources of the photobiomodulation therapy garment 20 is configured as a near-infrared light source internal group comprising multiple near-infrared light sources 170 arranged in an in-group array. In some embodiments, the near-infrared light source groups 171, 172, 173, 174, 175, and 176 of the photobiomodulation therapy garment 20 are each configured as a near-infrared light source internal group comprising multiple near-infrared light sources 170 arranged in an in-group array, the first near-infrared light source group 171 comprises multiple near-infrared light sources 170 configured in the first near-infrared light source internal group, and the second near-infrared light source group 172 comprises multiple near-infrared light sources 170 configured in the second near-infrared light source internal group The third near-infrared light source group 173 comprises a plurality of near-infrared light sources 170 composed of the third near-infrared light source internal group, the fourth near-infrared light source group 174 comprises a plurality of near-infrared light sources 170 composed of the fourth near-infrared light source internal group, the fifth near-infrared light source group 175 comprises a plurality of near-infrared light sources 170 composed of the fifth near-infrared light source internal group, and the sixth near-infrared light source group 176 comprises a plurality of near-infrared light sources 170 composed of the sixth near-infrared light source internal group.
[0086] In some embodiments, referring to Figures 3, 9, and 12, the near-infrared light source groups 171, 172, 173, 174, 175, and 176 of the photobiomodulation therapy headband 22 are configured as near-infrared light source internal groups, each comprising nine near-infrared light sources 170 arranged in a 3x3 array of 3 columns and 3 rows. In this example, d3 is greater than d4, and therapeutic effects can be produced by the combination and overlap of light patterns incident on the skin surface S, as well as by strategic gaps or areas with less overlap of light patterns. In the illustrated exemplary embodiment, d3 = 6mm to 7mm and d4 = 9mm to 10mm. The overlapping patterns of incident light create regions of varying power levels incident on the skin surface S within and around each array or group, regions of maximum irradiance and fluence immediately below each individual near-infrared light source 170, regions of lower irradiance and fluence between closely spaced near-infrared light sources 170, and regions of minimum irradiance and fluence between the furthest
[0087] In one or more embodiments, during operation, all groups of near-infrared light sources can be activated by the controller 200 using the same operating parameters (e.g., all groups are activated simultaneously, all in pulse mode, and all with the same output settings). In one or more embodiments, during operation, each group of near-infrared light sources can be activated by the controller 200 with different operating parameters, where one or more selected groups are activated and the others remain off. Furthermore, in one or more embodiments, the controller 200 has the ability to control the output level and / or pulse / continuous operation of each group of near-infrared light sources independently of other groups of near-infrared light sources on the photobiomodulation therapy garment 20. There is considerable flexibility in the available operating parameters. Not only can each individual group of near-infrared light sources be operated individually, but each individual near-infrared light source 170 within each near-infrared group can be individually addressed and controlled using individual operating parameters. In this way, each individual near-infrared light source 170 may be individually addressable as a unit so that it can be activated / turned on or deactivated / turned off independently of all other individual near-infrared light sources 170. Furthermore, in one or more embodiments, each individual near-infrared light source 170 can be operated in pulse mode or continuous mode independently of all other individual near-infrared light sources 170. Furthermore, in one or more embodiments, each individual near-infrared light source 170 can be operated using an output profile independent of all other individual light sources. In this way, several predetermined patterns can be initiated via executable commands from the controller 200, and the pattern of the activated light source can be varied according to the desired therapeutic effect and location of the region of interest.
[0088] Referring here to Figures 8, 15, and 16, in some embodiments, the photobiomodulation therapy garment 20 is assembled by sandwiching a photobiomodulation unit 100 between an outer fabric sheet 40 and an inner fabric sheet 70. In some embodiments, as shown in Figure 8, a hot-melt adhesive film 210 is sized and shaped to cover most or all of the flexible printed circuit board assembly 110 but not the terminal rail mount 164 of the connector terminals 160, and is placed between the outer fabric sheet 40 and the photobiomodulation unit 100. In some embodiments, as shown in Figures 15 and 16, the liquid wire circuit assembly 150 is attached directly to the outer fabric sheet 40, for example, by using adhesive or by weaving it into the outer fabric sheet 40. In embodiments in which the photobiomodulation unit 100 comprises a flexible printed circuit board assembly 110, the photobiomodulation unit 100 is positioned on the outer fabric sheet 40 in such a manner that the terminal rail mount 164 of the connector terminals 160 can be inserted through the terminal rail mount opening 58. In embodiments in which the photobiomodulation unit 100 includes a liquid wire circuit assembly 150, the connection terminal 160 is attached to the outer fabric sheet 40 during the construction of the liquid wire circuit assembly 150 onto the outer fabric sheet 40.
[0089] Referring further to Figures 8, 15, and 16, once the photobiomodulation unit 100 is positioned on the outer fabric sheet 40, a layer of double-sided tape 220, sized and shaped to cover most or all of the photobiomodulation unit 100, is placed between the photobiomodulation unit 100 and the inner fabric sheet 70. The double-sided tape 220 includes one or more near-infrared light source apertures 222 and one or more sensor apertures 224, which are notches configured to provide clearance for the respective components so that the double-sided tape 220 does not interfere with the operation of one or more near-infrared light sources 170 and one or more sensors 180. If present, a sensor cover 79 is properly positioned over the corresponding sensor 180. Next, the inner fabric sheet 70 is aligned with the outer fabric sheet 40 and the photobiomodulation unit 100, and positioned so that each of the one or more near-infrared light sources 170 and each of the one or more sensors 180 are properly positioned with the corresponding near-infrared light source aperture 76 and sensor aperture 78, thereby enabling the proper functioning of these components. The inner fabric sheet 70 can then be fixed to the outer fabric sheet 40 by sewing its edges to the outer fabric sheet 40.
[0090] The photobiomodulation therapy garments disclosed herein are useful for providing photobiomodulation therapies, including transcranial photobiomodulation therapy. Such non-invasive, light-based neuromodulation therapies do not require medication and deliver long-term effects by altering the function of the user's brain at the neuronal level by providing a variety of positive photochemical reactions. For example, photobiomodulation therapy can increase the production of energy and adenosine triphosphate (ATP) in neuronal mitochondria, thereby increasing cellular energy production. Furthermore, the transmission of light energy can also trigger the production of reactive oxygen species (ROS), which can suppress inflammation at the cellular and tissue levels and improve cell repair and healing; the production of nitric oxide (NO), which is important for good vascular health and optimal blood flow; and the delivery of nutrients and removal of waste products. This is important because insufficient blood flow and circulation in the brain can cause memory lapses, forgetfulness, decreased concentration, and even dementia. Enhanced cellular energy and increased cerebral blood flow lead to increased neurogenesis and neuroplasticity, enhanced neuroprotection, improved nerve repair, and reduced inflammation. Furthermore, such photobiomodulation therapy offers both sedative and relaxation benefits, as well as improved concentration and performance, resulting in enhanced mental productivity, mental health, and overall cognitive function.
[0091] In some embodiments, the photobiomodulation therapy garment disclosed herein is used as the sole treatment device. In some embodiments, the photobiomodulation therapy garment disclosed herein is used in conjunction with another treatment method. In some embodiments, the photobiomodulation therapy garment disclosed herein is used in conjunction with another cognitive behavioral therapy.
[0092] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with other photobiomodulation therapies, such as high-power irradiance photobiomodulation therapy. In some embodiments, the individual is exposed to approximately 55 mW / cm². 2 In conjunction with low-power transcranial photobiomodulation therapy using the photobiomodulation therapy garment disclosed herein, which can provide the following irradiance: approximately 250 mW / cm² 2 The patient receives high-power transcranial photobiomodulation therapy using a stationary device capable of providing the above irradiance. In some embodiments, high-power photobiomodulation therapy is performed in a clinical or other healthcare facility setting, while low-power photobiomodulation therapy is performed in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, low-power transcranial photobiomodulation therapy is used to enhance the effects of high-power transcranial photobiomodulation therapy and to improve the treatment of an individual's depression and depressive symptoms. In some embodiments, circadian-based timing dosing disclosed herein would be used to time the administration of high-power transcranial photobiomodulation therapy, low-power transcranial photobiomodulation therapy, or both.
[0093] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with transcranial magnetic stimulation (TMS). In some embodiments, the individual is subjected to approximately 20 mW / cm² 2 ~about 500mW / cm 2TMS is received in conjunction with low-power transcranial photobiomodulation therapy using photobiomodulation therapy garments disclosed herein that can provide a certain irradiance. In some embodiments, TMS is performed in a clinical or other healthcare facility setting, while low-power photobiomodulation therapy is performed in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, low-power transcranial photobiomodulation therapy is used to enhance the effects of TMS and improve the treatment of an individual's depression and depressive symptoms. In some embodiments, circadian-based timing dosing disclosed herein would be used to time the administration of TMS, low-power transcranial photobiomodulation therapy, or both.
[0094] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with evidence-based mental health practices. In some embodiments, individuals experience approximately 55 mW / cm² 2Low-power transcranial photobiomodulation therapy is performed in conjunction with evidence-based mental health practices using photobiomodulation therapy garments disclosed herein that can provide the following irradiances. Evidence-based mental health practices include, but are not limited to, evidence-based psychotherapy (EBT), cognitive behavioral therapy (CBT), dialectical behavior therapy (DBT), exposure therapy, functional family therapy (FFT), comprehensive community living support (ACT), acceptance and commitment therapy (ACT), prolonged exposure therapy (PE), cognitive training and rehabilitation, and motivational interviewing (MI). In some embodiments, evidence-based mental health practices are performed by a therapist in a clinical or other healthcare facility setting, while low-power photobiomodulation therapy is performed in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, evidence-based mental health practices are performed by a therapist in a virtual setting, while low-power photobiomodulation therapy is performed in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, the evidence-based mental health practice is a digital-based artificial intelligence (AI) therapy, while the low-intensity photobiomodulation therapy is performed in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, low-intensity transcranial photobiomodulation therapy is used to enhance the effects of the evidence-based mental health practice and to improve the treatment of an individual's depression and depressive symptoms. In some embodiments, the circadian-based timing dosing disclosed herein would be used to time the administration of the evidence-based mental health practice, low-intensity transcranial photobiomodulation therapy, or both.
[0095] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with ocular phototherapy, such as high-intensity light therapy or blue light therapy. In some embodiments, individuals are exposed to approximately 20 mW / cm². 2 ~about 500mW / cm 2Ocular phototherapy is received in conjunction with transcranial photobiomodulation therapy using photobiomodulation therapy garments disclosed herein that can provide a certain irradiance. In some embodiments, transcranial photobiomodulation therapy may be administered daily during and / or between two or more ocular phototherapy sessions. In some embodiments, transcranial photobiomodulation therapy is used to enhance the effects of ocular phototherapy by increasing relaxation, sedation, and well-being. In some embodiments, circadian-based timing dosing disclosed herein may be used to time the administration of ocular phototherapy, transcranial photobiomodulation therapy, or both.
[0096] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with mindfulness therapy. In some embodiments, the individual experiences approximately 20 mW / cm² 2 ~about 300mW / cm 2 Mindfulness therapy is practiced in conjunction with transcranial photobiomodulation therapy using photobiomodulation therapy garments disclosed herein that can provide irradiance. In some embodiments, transcranial photobiomodulation therapy may be administered daily during and / or between two or more mindfulness therapy sessions. In some embodiments, transcranial photobiomodulation therapy is used to enhance the effects of mindfulness therapy by increasing relaxation, sedation, and well-being. In some embodiments, circadian-based timing dosing disclosed herein may be used to time the administration of mindfulness therapy, transcranial photobiomodulation therapy, or both.
[0097] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with meditation therapy. In some embodiments, the individual experiences approximately 20 mW / cm² 2 ~about 300mW / cm2 Meditation therapy is practiced in conjunction with transcranial photobiomodulation therapy using photobiomodulation therapy garments disclosed herein that can provide a certain irradiance. In some embodiments, transcranial photobiomodulation therapy may be administered daily during and / or between two or more meditation sessions. In some embodiments, transcranial photobiomodulation therapy is used to enhance the effects of meditation therapy by increasing relaxation, sedation, and well-being. In some embodiments, circadian-based timing dosing disclosed herein may be used to time the administration of meditation therapy, transcranial photobiomodulation therapy, or both.
[0098] In some embodiments, photobiomodulation therapy using the photobiomodulation therapy garment disclosed herein is administered alone or in combination with another therapy, based on the individual's circadian rhythm. In some embodiments, the individual receives transcranial photobiomodulation therapy using the photobiomodulation therapy garment disclosed herein during the morning hours, for example, between 6:00 a.m. and 10:00 a.m. In some embodiments, the individual receives transcranial photobiomodulation therapy using the photobiomodulation therapy garment disclosed herein during the afternoon / evening hours, for example, between 3:00 p.m. and 7:00 p.m. Approximately 20 mW / cm² 2 ~about 500mW / cm 2 Photobiomodulation therapy garments disclosed herein, capable of providing irradiance, would be used for such circadian-based timing administration. In some embodiments, circadian-based timing administration would be useful for treating depression and depressive symptoms in individuals.
[0099] Aspects of this specification may also be described by the following embodiments: 1. A garment for photobiomodulation therapy, worn on a skin surface having a region of interest, comprising: a flexible outer sheet; a flexible inner sheet having a portion that allows the passage of near-infrared light and configured to face the skin surface; a flexible circuit board disposed between the outer sheet and the inner sheet; a near-infrared light source mounted on the flexible circuit board, aligned with a portion of the flexible inner sheet, and configured to emit near-infrared light with a wavelength of 600 nm to 1600 nm and a predetermined dose measurement toward the region of interest on the skin surface during photobiomodulation therapy; and a controller having a processor and memory and electrically communicating with the near-infrared light source through the flexible circuit board, wherein the processor and memory consist of executable instructions for controlling one or more of the following: light source operating time, light source fluence level, light source irradiance level, light source pulse operation, and light source continuous operation. 2. The garment for photobiomodulation therapy according to Embodiment 1, wherein the near-infrared light source is part of a group of near-infrared light sources arranged on a flexible circuit board and configured to be directed towards a region of interest on the skin surface during photobiomodulation therapy. 3. The photobiomodulation therapy garment according to Embodiment 1 or Embodiment 2, wherein the group of near-infrared light sources is arranged with a group light source spacing of at least 2 mm, or at least 3 mm, or at least 4 mm, or at least 5 mm, or at least 6 mm, or at least 7 mm, or at least 8 mm, or at least 9 mm, or at least 10 mm. 4. The photobiomodulation therapy garment according to any one of Embodiments 1 to 3, wherein the region of interest is one of the Fp1, Fpz, Fp2, F3, Fz, and F4 regions, the posterior neck region, the carpal region, and the abdominal region, and the group of near-infrared light sources is configured to at least partially overlap the region of interest. 5. The photobiomodulation therapy garment according to any one of Embodiments 1 to 4, wherein the sensor is configured to detect one or more parameters indicating position and then transmit a position signal to the controller so that the position on the skin surface can be determined. 6. The photobiomodulation therapy garment according to any one of Embodiments 1 to 5, wherein the group of near-infrared light sources is configured to at least partially overlap the Fp1 region, the second group of near-infrared light sources is configured to at least partially overlap the Fpz region, the third group of near-infrared light sources is configured to at least partially overlap the Fp2 region, the fourth group of near-infrared light sources is configured to at least partially overlap the F3 region, the fifth group of near-infrared light sources is configured to at least partially overlap the Fz region, and the sixth group of near-infrared light sources is configured to at least partially overlap the F4 region. 7. The photobiomodulation therapy garment according to any one of Embodiments 1 to 6, wherein the sensor is configured to detect one or more positional parameters and then transmit a position signal to a controller so that the position on the skin surface can be determined, and the sensor is positioned between a second group of near-infrared light sources and a fifth group of near-infrared light sources. 8. The photobiomodulation therapy garment according to any one of Embodiments 1 to 7, wherein each of the group of near-infrared light sources, the second group of near-infrared light sources, the third group of near-infrared light sources, the fourth group of near-infrared light sources, the fifth group of near-infrared light sources, and the sixth group of near-infrared light sources are separated from each other to the minimum extent of an inter-group light source spacing of more than 5 mm, or more than 10 mm, or more than 15 mm, or more than 20 mm, or more than 25 mm, or more than 30 mm. 9. The photobiomodulation therapy garment according to any one of Embodiments 1 to 8, wherein the group of near-infrared light sources is arranged in a first 3x3 array. 10. A photobiomodulation therapy garment according to any one of Embodiments 1 to 9, further comprising a second group of near-infrared light sources arranged in a second 3x3 array, a third group of near-infrared light sources arranged in a third 3x3 array, a fourth group of near-infrared light sources arranged in a fourth 3x3 array, a fifth group of near-infrared light sources arranged in a fifth 3x3 array, and a sixth group of near-infrared light sources arranged in a sixth 3x3 array. 11. The photobiomodulation therapy garment according to any one of Embodiments 1 to 10, wherein the first 3x3 array, the second 3x3 array, the third 3x3 array, the fourth 3x3 array, the fifth 3x3 array, and the sixth 3x3 array are minimally separated from each other by an inter-group light source spacing of more than 5 mm, or more than 10 mm, or more than 15 mm, or more than 20 mm, or more than 25 mm, or more than 30 mm. 12. The photobiomodulation therapy garment according to any one of Embodiments 1 to 11, wherein the first 3x3 array, the second 3x3 array, the third 3x3 array, the fourth 3x3 array, the fifth 3x3 array, and the sixth 3x3 array are separated from each other to the minimum extent that the inter-group light source spacing is sufficient to prevent substantial light bleeding between them. 13. The photobiomodulation therapy garment according to any one of Embodiments 1 to 12, wherein the region of interest is one or more of the Fp1, Fpz, Fp2, F3, Fz, F4 regions on the skin surface, the posterior neck region, the carpal region, and the abdominal region. 14. A photobiomodulation therapy garment according to any one of Embodiments 1 to 13, wherein the near-infrared light source is configured to emit near-infrared light toward the Fp1 region, the second near-infrared light source is configured to emit near-infrared light toward the Fpz region, the third near-infrared light source is configured to emit near-infrared light toward the Fp2 region, the fourth near-infrared light source is configured to emit near-infrared light toward the F3 region, the fifth near-infrared light source is configured to emit near-infrared light toward the Fz region, and the sixth near-infrared light source is configured to emit near-infrared light toward the F4 region, with the Fp1 region being a region of interest, the Fpz region being a second region of interest, the Fp2 region being a third region of interest, the F3 region being a fourth region of interest, the Fz region being a fifth region of interest, and the F4 region being a sixth region of interest. 15. The photobiomodulation therapy garment according to any one of Embodiments 1 to 14, wherein the sensor is configured to detect one or more positional parameters and then transmit a position signal to a controller so that the position on the skin surface can be determined, and the sensor is positioned between the second near-infrared light source array and the fifth near-infrared light source. 16. The photobiomodulation therapy garment according to any one of Embodiments 1 to 15, wherein the sensor is either a heart rate sensor or a temperature sensor or both. 17. The photobiomodulation therapy garment according to any one of Embodiments 1 to 16, wherein each of the near-infrared light source, second near-infrared light source, third near-infrared light source, fourth near-infrared light source, fifth near-infrared light source, and sixth near-infrared light source is separated from each other by a light source spacing of more than 5 mm, or more than 10 mm, or more than 15 mm, or more than 20 mm, or more than 25 mm, or more than 30 mm. 18. A garment for photobiomodulation therapy according to any one of Embodiments 1 to 9, wherein the near-infrared light source is from the first group of near-infrared light sources, the second near-infrared light source is from the second group of near-infrared light sources, the third near-infrared light source is from the third group of near-infrared light sources, the fourth near-infrared light source is from the fourth group of near-infrared light sources, the fifth near-infrared light source is from the fifth group of near-infrared light sources, and the sixth near-infrared light source is from the sixth group of near-infrared light sources. 19. A photobiomodulation therapy garment according to any one of Embodiments 1 to 18, wherein the group of near-infrared light sources is arranged in a first 3x3 array, the second group of near-infrared light sources is arranged in a second 3x3 array, the third group of near-infrared light sources is arranged in a third 3x3 array, the fourth group of near-infrared light sources is arranged in a fourth 3x3 array, the fifth group of near-infrared light sources is arranged in a fifth 3x3 array, and the sixth group of near-infrared light sources is arranged in a sixth 3x3 array. 20. A photobiomodulation therapy garment according to any one of Embodiments 1 to 19, wherein each of the first 3x3 array, second 3x3 array, third 3x3 array, fourth 3x3 array, fifth 3x3 array, and sixth 3x3 array are minimally separated from each other by an inter-group light source spacing of more than 5 mm, or more than 10 mm, or more than 15 mm, or more than 20 mm, or more than 25 mm, or more than 30 mm. 21. The photobiomodulation therapy garment according to any one of Embodiments 1 to 20, wherein the first 3x3 array, the second 3x3 array, the third 3x3 array, the fourth 3x3 array, the fifth 3x3 array, and the sixth 3x3 array are separated from each other by a sufficient inter-group light source interval to prevent substantial light bleeding between them. 22. A photobiomodulation therapy garment according to any one of Embodiments 1 to 21, further comprising one or more stimulators. 23. The photobiomodulation therapy garment according to Embodiment 22, wherein the one or more stimulators include a component capable of generating a magnetic field. 24. A garment for photobiomodulation therapy, comprising: a garment structure configured to be worn by a user on the surface of the skin; a first near-infrared light source integrated with the garment structure; a second near-infrared light source integrated with the garment structure and positioned at a distance from the first near-infrared light source; and a controller having a processor and memory, electrically communicating with the first near-infrared light source and the second near-infrared light source, and comprising executable instructions for independently controlling the operation of the first near-infrared light source and the second near-infrared light source, wherein the first near-infrared light source and the second near-infrared light source are configured to emit near-infrared light with wavelengths of 600 nm to 1600 nm and a predetermined dose measurement; and the first near-infrared light source is configured to be directed towards a region of interest on a first skin surface when worn during photobiomodulation therapy, and the second near-infrared light source is configured to be directed towards a region of interest on a second skin surface. 25. The photobiomodulation therapy garment according to Embodiment 24, wherein the executable command is configured to control one or more of the following: light source operating time, light source fluence level, light source irradiance level, light source pulse operation, and light source continuous operation. 26. The photobiomodulation therapy garment according to Embodiment 24 or Embodiment 25, wherein the sensor is integrated with the garment structure and configured to detect one or more parameters indicating a reference position on the skin surface, and when the sensor is positioned over the reference position on the skin surface, the first near-infrared light source is positioned over a first region of interest on the skin surface, and the second near-infrared light source is positioned over a second region of interest on the skin surface. 27. The photobiomodulation therapy garment according to any one of embodiments 24 to 26, wherein the sensor is either a heart rate sensor or a temperature sensor or both. 28. The photobiomodulation therapy garment according to any one of Embodiments 24 to 27, wherein the first near-infrared light source is part of a first group of near-infrared light sources, and the second near-infrared light source is part of a second group of near-infrared light sources. 29. A photobiomodulation therapy garment according to any one of embodiments 24 to 28, wherein each of the first group of near-infrared light sources and the second group of near-infrared light sources is arranged with an intra-group light source spacing of at least 2 mm, or at least 3 mm, or at least 4 mm, or at least 5 mm, or at least 6 mm, or at least 7 mm, or at least 8 mm, or at least 9 mm, or at least 10 mm. 30. The photobiomodulation therapy garment according to any one of Embodiments 24 to 29, wherein the first group of near-infrared light sources and the second group of near-infrared light sources are separated from each other to the minimum extent of an inter-group light source spacing of more than 5 mm, or more than 10 mm, or more than 15 mm, or more than 20 mm, or more than 25 mm, or more than 30 mm. 31. A photobiomodulation therapy garment according to any one of embodiments 24 to 30, wherein the first group of near-infrared light sources is arranged in a first 3x3 array, and the second group of near-infrared light sources is arranged in a second 3x3 array. 32. A photobiomodulation therapy garment according to any one of Embodiments 24 to 31, further comprising a third group of near-infrared light sources arranged in a third 3x3 array, a fourth group of near-infrared light sources arranged in a fourth 3x3 array, a fifth group of near-infrared light sources arranged in a fifth 3x3 array, and a sixth group of near-infrared light sources arranged in a sixth 3x3 array. 33. A photobiomodulation therapy garment according to any one of Embodiments 24 to 32, wherein the Fp1 region is a first region of interest, the Fpz region is a second region of interest, the Fp2 region is a third region of interest, the F3 region is a fourth region of interest, the Fz region is a fifth region of interest, and the F4 region is a sixth region of interest, and the first 3x3 array is configured to emit near-infrared light toward the Fp1 region, the second 3x3 array is configured to emit near-infrared light toward the Fpz region, the third 3x3 array is configured to emit near-infrared light toward the Fp2 region, the fourth 3x3 array is configured to emit near-infrared light toward the F3 region, the fifth 3x3 array is configured to emit near-infrared light toward the Fz region, and the sixth 3x3 array is configured to emit near-infrared light toward the F4 region. 34. The photobiomodulation therapy garment according to any one of Embodiments 24 to 33, wherein the first region of interest is one of the following: Fp1, Fpz, Fp2, F3, Fz, and F4, the posterior neck, the wrist, and the abdomen. 35. The photobiomodulation therapy garment according to any one of Embodiments 24 to 34, wherein the second region of interest is one of the following: Fp1, Fpz, Fp2, F3, Fz, and F4, posterior neck, carpal region, and abdominal region. 36. A photobiomodulation therapy garment according to any one of embodiments 24 to 35, further comprising a third near-infrared light source, a fourth near-infrared light source, a fifth near-infrared light source, and a sixth near-infrared light source. 37. A photobiomodulation therapy garment according to any one of Embodiments 24 to 36, wherein the Fp1 region is a first region of interest, the Fpz region is a second region of interest, the Fp2 region is a third region of interest, the F3 region is a fourth region of interest, the Fz region is a fifth region of interest, and the F4 region is a sixth region of interest; the first near-infrared light source is configured to emit near-infrared light toward the Fp1 region; the second near-infrared light source is configured to emit near-infrared light toward the Fpz region; the third near-infrared light source is configured to emit near-infrared light toward the Fp2 region; the fourth near-infrared light source is configured to emit near-infrared light toward the F3 region; the fifth near-infrared light source is configured to emit near-infrared light toward the Fz region; and the sixth near-infrared light source is configured to emit near-infrared light toward the F4 region. 38. A photobiomodulation therapy garment according to any one of embodiments 24 to 37, further comprising one or more stimulators. 39. The photobiomodulation therapy garment according to Embodiment 38, wherein the one or more stimulators include a component capable of generating a magnetic field.
[0100] Aspects of this specification may also be described by the following embodiments: 1. A garment for photobiomodulation therapy, configured to be worn by a user on the surface of the skin, comprising a first surface and a second surface opposite to the first surface, the first surface being configured to face the skin surface when worn; a photobiomodulation unit integrated within the garment, comprising a connection terminal, one or more near-infrared light sources, and one or more sensors, the connection terminal communicating electronically with the one or more near-infrared light sources and the one or more sensors, each of the one or more near-infrared light sources being configured to emit near-infrared light at wavelengths of 600 nm to 1600 nm and predetermined dose measurements; and a processor and memory, configured to operably engage with the terminal rail of the connection terminal in such a manner as to establish electronic communication with the connection terminal. A controller comprising, the first surface of the garment includes a first portion having one or more light source apertures, each of the one or more near-infrared light sources being operably aligned with the one or more light source apertures to allow near-infrared light from the one or more near-infrared light sources to pass through properly, the first surface of the garment includes a second portion having one or more sensor apertures, each of the one or more sensors being operably aligned with the one or more sensor apertures to allow proper functioning of the one or more sensors through the one or more sensor apertures, the processor and the memory comprising executable instructions for independently controlling each of the one or more near-infrared light sources and each of the one or more sensors, Clothing for photobiomodulation therapy. 2. The garment for photobiomodulation therapy according to Embodiment 1, wherein the garment is configured to cover or conform to a portion of the body and can be moved from one portion of the body to another. 3. The photobiomodulation therapy garment according to Embodiment 2, wherein the area of the body is the head area, neck area, shoulder area, torso area, hand area, wrist area, arm area, foot area, or leg area, or any combination thereof. 4. The garment for photobiomodulation therapy according to Embodiment 2, wherein the garment is a band, wrap, scarf, shawl, cape, robe, or blanket. 5. The photobiomodulation therapy garment according to Embodiment 1, wherein the garment is sized and dimensions to fit particularly well to specific parts of the body. 6. The photobiomodulation therapy garment according to Embodiment 5, wherein the specific body part is the head region, neck region, shoulder region, torso region, hand region, wrist region, arm region, foot region, or leg region, or any combination thereof. 7. The garment for photobiomodulation therapy according to Embodiment 4, wherein the garment is a hat, visor, shirt, pants, socks, gloves, or underwear. 8. The photobiomodulation therapy garment according to any one of Embodiments 1 to 7, wherein each of the one or more near-infrared light sources is a near-infrared light-emitting diode. 9. The photobiomodulation therapy garment according to any one of Embodiments 1 to 8, wherein each of the one or more sensors is configured to detect and collect information on one or more parameters of the garment, the photobiomodulation unit and its components, the controller and its components, and the user, and then transmit the information to the controller. 10. The photobiomodulation therapy garment according to Embodiment 9, wherein the one or more parameters include operational information of the garment, the photobiomodulation unit and its components, the controller and its components, the user's biometric information, or any combination thereof. 11. The photobiomodulation therapy garment according to any one of Embodiments 1 to 10, wherein the executable command independently controls each of the one or more near-infrared light sources. 12. The photobiomodulation therapy garment according to Embodiment 11, wherein the executable commands control the activation, duration of activation, deactivation, duration of deactivation, activation pattern and timing, deactivation pattern and timing, fluence level, irradiance level, dose measurement level, pulse operation, continuous operation, operation time, cycle duration, or any combination thereof for each of the one or more near-infrared light sources. 13. The photobiomodulation therapy garment according to any one of Embodiments 1 to 12, wherein the executable command independently controls each of the one or more sensors. 14. The photobiomodulation therapy garment according to Embodiment 13, wherein the executable command controls the collection and analysis of information from each of the one or more sensors. 15. The photobiomodulation therapy garment according to any one of Embodiments 1 to 14, wherein the one or more near-infrared light sources are near-infrared light sources arranged at multiple intervals. 16. The garment for photobiomodulation therapy according to Embodiment 15, wherein the multiple near-infrared light sources arranged at intervals are 3 to 6 near-infrared light sources. 17. The photobiomodulation therapy garment according to Embodiment 15 or Embodiment 16, wherein the multiple near-infrared light sources arranged at intervals are arranged in a single row. 18. The photobiomodulation therapy garment according to Embodiment 15 or Embodiment 16, wherein the multiple near-infrared light sources arranged at intervals are arranged in multiple rows. 19. The garment for photobiomodulation therapy according to Embodiment 18, wherein the plurality of rows are 2 to 6. 20. The photobiomodulation therapy garment according to any one of embodiments 15 to 19, wherein the multiple near-infrared light sources arranged at intervals are arranged in multiple rows. 21. The photobiomodulation therapy garment according to Embodiment 20, wherein the plurality of rows are 2 to 8. 22. The photobiomodulation therapy garment according to any one of Embodiments 15 to 17, Embodiment 20, or Embodiment 21, wherein the plurality of near-infrared light sources are arranged in a row x column 1 x 2 array, 1 x 3 array, 1 x 4 array, 1 x 5 array, 1 x 6 array, 1 x 7 array, or 1 x 8 array. 23. The photobiomodulation therapy garment according to any one of Embodiments 15 to 17, Embodiment 20, or Embodiment 21, wherein the plurality of near-infrared light sources include three near-infrared light sources arranged in a row x column 1 x 3 array. 24. A photobiomodulation therapy garment according to Embodiment 17, or any one of Embodiments 20 to 23, wherein the spacing between each of the multiple near-infrared light sources included in the single row is 0.5 cm to 4 cm, and the spacing between each of the multiple near-infrared light sources included in each of the multiple columns is 0.5 cm to 4 cm. 25. The photobiomodulation therapy garment according to any one of Embodiments 15, 16, 18 to 21, wherein the plurality of near-infrared light sources are arranged in a row x column 2x2 array, 2x3 array, 2x4 array, 2x5 array, 2x6 array, 2x7 array, 2x8 array, 3x2 array, 3x3 array, 3x4 array, 3x5 array, 3x6 array, 3x7 array, or 3x8 array. 26. The photobiomodulation therapy garment according to any one of Embodiments 15, 16, 18 to 21, wherein the plurality of near-infrared light sources include six near-infrared light sources arranged in a 2x3 array of rows and columns. 27. The garment for photobiomodulation therapy according to any one of Embodiments 15, 16, 18 to 21, wherein the plurality of near-infrared light sources include six near-infrared light sources arranged such that four near-infrared light sources are present in the upper row and two near-infrared light sources are present in the lower row. 28. A photobiomodulation therapy garment according to any one of Embodiments 18 to 21 or Embodiments 25 to 27, wherein the spacing between each of the multiple near-infrared light sources included in each of the multiple rows is 0.5 cm to 4 cm, and the spacing between each of the multiple near-infrared light sources included in each of the multiple columns is 0.5 cm to 4 cm. 29. The garment for photobiomodulation therapy according to any one of Embodiments 15 to 28, wherein the plurality of near-infrared light sources are arranged in a plurality of near-infrared light source groups arranged at a plurality of intervals, and each of the plurality of near-infrared light source groups comprises a plurality of near-infrared light sources. 30. The photobiomodulation therapy garment according to Embodiment 29, wherein the multiple groups of near-infrared light sources arranged at intervals are arranged in a single row. 31. The photobiomodulation therapy garment according to Embodiment 29, wherein the group of near-infrared light sources arranged at intervals is arranged in multiple rows. 32. The garment for photobiomodulation therapy according to Embodiment 31, wherein the plurality of rows are 2 to 6. 33. The photobiomodulation therapy garment according to any one of embodiments 29 to 32, wherein the group of near-infrared light sources arranged at intervals is arranged in a plurality of rows. 34. The photobiomodulation therapy garment according to embodiment 33, wherein the plurality of rows are 2 to 8. 35. The photobiomodulation therapy garment according to any one of Embodiments 29, 30, 33, or 34, wherein the plurality of near-infrared light source groups are arranged in a row x column 1 x 2 array, 1 x 3 array, 1 x 4 array, 1 x 5 array, 1 x 6 array, 1 x 7 array, or 1 x 8 array. 36. Photobiomodulation therapy garment according to Embodiment 30, or any one of Embodiments 33 to 35, wherein the spacing between each of the multiple near-infrared light source groups contained in the single row is 0.5 cm to 4 cm, and the spacing between each of the multiple near-infrared light source groups contained in each of the multiple columns is 0.5 cm to 4 cm. 37. The photobiomodulation therapy garment according to any one of Embodiments 29, 31 to 34, wherein the plurality of near-infrared light source groups are arranged in a row x column 2x2 array, 2x3 array, 2x4 array, 2x5 array, 2x6 array, 2x7 array, 2x8 array, 3x2 array, 3x3 array, 3x4 array, 3x5 array, 3x6 array, 3x7 array, or 3x8 array. 38. A photobiomodulation therapy garment according to any one of Embodiments 31 to 34 or Embodiment 37, wherein the spacing between each of the multiple near-infrared light source groups contained in each of the multiple rows is 0.5 cm to 4 cm, and the spacing between each of the multiple near-infrared light source groups contained in each of the multiple columns is 0.5 cm to 4 cm. 39. The photobiomodulation therapy garment according to any one of embodiments 29 to 38, wherein the multiple near-infrared light sources arranged at intervals are arranged in a single row. 40. The photobiomodulation therapy garment according to any one of embodiments 29 to 38, wherein the multiple near-infrared light sources arranged at intervals are arranged in multiple rows. 41. The garment for photobiomodulation therapy according to Embodiment 40, wherein the plurality of rows are 2 to 6. 42. The photobiomodulation therapy garment according to any one of embodiments 39 to 41, wherein the multiple near-infrared light sources arranged at intervals are arranged in multiple rows. 43. The photobiomodulation therapy garment according to embodiment 42, wherein the plurality of rows are 2 to 8. 44. The photobiomodulation therapy garment according to any one of Embodiment 39, Embodiment 42, or Embodiment 43, wherein the plurality of near-infrared light sources are arranged in a row x column 1 x 2 array, 1 x 3 array, 1 x 4 array, 1 x 5 array, 1 x 6 array, 1 x 7 array, or 1 x 8 array. 45. The photobiomodulation therapy garment according to Embodiment 39, or any one of Embodiments 42 to 44, wherein the spacing between each of the multiple near-infrared light sources included in the single row is 1 mm to 4 mm, and the spacing between each of the multiple near-infrared light sources included in each of the multiple columns is 1 mm to 4 mm. 46. The photobiomodulation therapy garment according to any one of Embodiments 40 to 43, wherein the plurality of near-infrared light sources are arranged in a row x column 2x2 array, 2x3 array, 2x4 array, 2x5 array, 2x6 array, 2x7 array, 2x8 array, 3x2 array, 3x3 array, 3x4 array, 3x5 array, 3x6 array, 3x7 array, or 3x8 array. 47. The garment for photobiomodulation therapy according to any one of embodiments 40 to 43, wherein the plurality of near-infrared light sources include nine near-infrared light sources arranged in a 3x3 array of rows and columns. 48. A photobiomodulation therapy garment according to any one of embodiments 40 to 43, embodiment 46, or embodiment 47, wherein the spacing between each of the multiple near-infrared light sources included in each of the multiple rows is 1 mm to 4 mm, and the spacing between each of the multiple near-infrared light sources included in each of the multiple columns is 1 mm to 4 mm. 49. A photobiomodulation therapy garment according to any one of Embodiments 1 to 48, further comprising one or more stimulators. 50. The photobiomodulation therapy garment according to Embodiment 49, wherein the one or more stimulators include a component capable of generating a magnetic field. 51. The photobiomodulation therapy garment according to any one of Embodiments 1 to 50, wherein the skin surface includes the forehead, the back of the neck, the wrist, the abdomen, or any combination thereof. 52. The photobiomodulation therapy garment according to Embodiment 51, wherein the forehead area includes the dorsolateral prefrontal cortex region, the frontal eye field region, or both. 53. The photobiomodulation therapy garment according to Embodiment 51, wherein the forehead area includes the Fp1 area, Fpz area, Fp2 area, F3 area, Fz area, F4 area, or any combination thereof.
[0101] Examples The following non-limiting examples are provided for illustrative purposes only to facilitate a more complete understanding of the representative embodiments currently conceivable. These examples should not be construed as limiting any of the embodiments described herein, including those relating to photobiomodulation therapy garments or methods and their use disclosed herein.
[0102] Example 1 Clothing for photobiomodulation therapy In one exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has six infrared light source intergroups arranged in two rows, with three intergroups in each row. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 such that each intergroup at least partially overlaps or substantially centers on sites Fp1 300, Fpz 302, Fp2 304, F3 5306, Fz 308, and F4 310. The estimated total area of the skin surface S and underlying tissue exposed to near-infrared light is approximately 5.3 cm². 2 ~Approx. 5.7cm 2This system provides photobiomodulation therapy to the dorsolateral prefrontal cortex (dlPFC) and frontal eye field (FEF). Each infrared light source intergroup has nine LEDs in a 3x3 rectangular array. Each LED has an output of approximately 55mW, with a peak light output of approximately 99mW, emitting infrared light with an average wavelength of 800nm to approximately 850nm and a pulsed wave of 40Hz. The average irradiance across the treatment area is approximately 16mW / cm². 2 ~about 20mW / cm 2 Therefore, the region with the highest irradiance is potentially up to approximately 240 mW / cm². 2 ~Approx. 365mW / cm 2 The average fluence across the treatment area is approximately 40 J / cm². 2 ~About 45J / cm 2 Therefore, the region of maximum fluence is potentially up to approximately 665 J / cm². 2 ~Approx. 998J / cm 2 The total incident energy during the treatment session is approximately 2.0 kJ to 2.5 kJ. The controller 200 operates the LED continuously (not in pulses) for 10 to 25 minutes.
[0103] In an alternative configuration, one or more of the six infrared light source intergroups of the photobiomodulation therapy headband 22 have a combination of both high-power infrared light sources 170 and low-power infrared light sources 170. For example, the upper left and upper right infrared light source intergroups can have the central infrared light source 170 of the 3x3 array be a high-power infrared light source, and the remaining infrared light sources 170 be low-power infrared light sources.
[0104] In an alternative configuration, the average irradiance across the treatment area exhibited by the photobiomodulation therapy headband 22 is approximately 31 mW / cm². 2 ~about 35mW / cm 2 Therefore, the region with the highest irradiance is potentially up to approximately 445 mW / cm². 2 ~about 670mW / cm 2 Furthermore, the average fluence across the treatment area is approximately 38 J / cm². 2 ~about 60J / cm 2Therefore, the region of maximum fluence is potentially up to approximately 665 J / cm². 2 ~Approx. 1,005J / cm 2 The total incident energy during a treatment session is approximately 2.0 kJ to 5.0 kJ.
[0105] Example 2 Clothing for photobiomodulation therapy In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has three infrared light source intergroups arranged in a single row. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 such that each intergroup at least partially overlaps or substantially centers on sites Fp1 300, Fpz 302, and Fp2 304. The estimated total area of the skin surface S and underlying tissue exposed to near-infrared light is approximately 2.8 cm². 2 ~Approx. 3.3cm 2 This system provides photobiomodulation therapy to the frontal eye field (FEF). Each infrared light source intergroup has nine low-power LEDs in a 3x3 rectangular array. Each LED has an output of approximately 55 mW, with a peak light output of approximately 99 mW, emitting infrared radiation with an average wavelength of 800 nm to approximately 850 nm and a pulsed wave of 40 Hz (ranging from 0 Hz to 100 Hz). The average irradiance across the treatment area is approximately 31 mW / cm². 2 ~about 35mW / cm 2 Therefore, the region with maximum irradiance is potentially up to approximately 80 mW / cm². 2 ~about 105mW / cm 2 The average fluence across the treatment area is approximately 58 J / cm². 2 ~About 63J / cm 2 Therefore, the region of maximum fluence is potentially up to approximately 145 J / cm². 2 ~About 185J / cm 2The total incident energy during the treatment session is approximately 1.2 kJ to 3.0 kJ. The controller 200 operates the LED continuously (not pulsed) for 10 to 40 minutes.
[0106] In an alternative configuration, the controller 200 operates the LEDs in pulsed mode at 40Hz and a 50% duty cycle (with a variable range of 5% to 100%) for 30 to approximately 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as described above, with a peak irradiance of approximately 66 mW / cm². 2 ~about 67mW / cm 2 Therefore, the peak area of maximum irradiance is potentially up to approximately 160 mW / cm². 2 ~about 205mW / cm 2 Therefore, the maximum peak fluence across the therapeutic area is potentially up to approximately 145 J / cm². 2 ~About 185J / cm 2 That is the case.
[0107] In an alternative configuration, the controller 200 operates the LEDs in pulsed mode at 40Hz and a 33% duty cycle (with a variable range of 5% to 100%) for 30 to approximately 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as described above, with a peak irradiance of approximately 99 mW / cm². 2 ~Approx. 101mW / cm 2 Therefore, the peak area of maximum irradiance is potentially up to approximately 240 mW / cm². 2 ~Approx. 310mW / cm 2 Therefore, the maximum peak fluence across the therapeutic area is potentially up to approximately 145 J / cm². 2 ~About 185J / cm 2 The total incident energy during the treatment session is approximately 2.3 kJ.
[0108] In an alternative configuration, the controller 200 operates the LEDs in pulsed mode at 10Hz or 40Hz with a 20% duty cycle (variable range is 5% to 100%) for 30 to approximately 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as described above, with a peak irradiance of approximately 165 mW / cm². 2 ~Approx. 167mW / cm 2 The peak area of maximum irradiance is potentially up to approximately 405 mW / cm². 2 ~Approx. 510mW / cm 2 Therefore, the maximum peak fluence across the therapeutic area is potentially up to approximately 145 J / cm². 2 ~About 185J / cm 2 The total incident energy during the treatment session is approximately 2.3 kJ.
[0109] Example 3 Clothing for photobiomodulation therapy In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has six infrared light source intergroups arranged in two rows, with four intergroups in the upper row and two intergroups in the lower row, organized as two inverted triangles. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 such that one inverted triangular arrangement at least partially overlaps or substantially centers on sites F3 306, Fz308, and Fp1 300, and the other inverted triangular arrangement at least partially overlaps or substantially centers on sites Fz308, F4 310, and Fp2 304. The estimated total area of the skin surface S and underlying tissue exposed to near-infrared light is approximately 7.5 cm². 2 ~about 9cm 2 (Each inverted triangle arrangement is approximately 3.75cm) 2 ~about 4.5cm 2It covers the dorsolateral prefrontal cortex (dlPFC) and provides photobiomodulation therapy. Each infrared light source intergroup has one high-power LED. Each LED has an output of 500mW, with a peak light output of 500mW to 1,000mW, and emits infrared radiation with an average wavelength of 800nm to approximately 850nm and pulse waves of 10Hz to approximately 40Hz (ranging from 0Hz to 5,000Hz). The average irradiance across the treatment area is approximately 50mW / cm². 2 ~about 300mW / cm 2 The region with the highest irradiance is potentially up to approximately 500 mW / cm². 2 ~Approx. 1,000mW / cm 2 The average fluence across the treatment area is approximately 40 J / cm². 2 ~Approx. 120J / cm 2 Therefore, the region of maximum fluence is potentially up to approximately 450 J / cm². 2 ~Approx. 1,025J / cm 2 The total incident energy during the treatment session is approximately 0.4 kJ to 2.1 kJ. The controller 200 operates the LEDs in pulsed mode at approximately 10 Hz to 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 to 40 minutes.
[0110] In the alternative configuration, each LED has an output of 500mW and emits infrared radiation with an average wavelength of 960nm to approximately 1,100nm and pulsed waves of 0Hz to approximately 100Hz, potentially up to 5,000Hz.
[0111] Example 4 Clothing for photobiomodulation therapy In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has two rows of five infrared light source intergroups arranged in two tiers, with three intergroups in the upper tier and two intergroups in the lower tier, such that one of each intergroup is located below one of the outer intergroups from the upper tier. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 such that the upper infrared light source intergroups at least partially overlap or substantially center on sites F3 306, Fz 308, and F4 310, one of the lower intergroups at least partially overlap or substantially center on site Fp1 300, and the other lower intergroup at least partially overlap or substantially center on site Fp2 304. The estimated total area of the skin surface S and the tissue beneath it exposed to near-infrared light is approximately 7.5 cm². 2 ~about 8cm 2 This system provides photobiomodulation therapy to the dorsolateral prefrontal cortex (dlPFC) and frontal eye field (FEF). Each infrared light source intergroup has one high-power LED. Each LED has an output of 500mW, with a peak light output of 500mW to 1,000mW, and emits infrared light with an average wavelength of 800nm to approximately 850nm and a pulse wave of 10Hz to approximately 40Hz (adjustable in the range of 0Hz to 5,000Hz). The average irradiance across the treatment area is approximately 50mW / cm². 2 ~about 300mW / cm 2 The region with the highest irradiance is potentially up to approximately 500 mW / cm². 2 ~Approx. 1,000mW / cm 2 The average fluence across the treatment area is approximately 40 J / cm². 2 ~Approx. 120J / cm 2 Therefore, the region of maximum fluence is potentially up to approximately 450 J / cm². 2 ~Approx. 1,025J / cm 2The total incident energy during the treatment session is approximately 0.4 kJ to 2.1 kJ. The controller 200 operates the LEDs in pulsed mode at approximately 10 Hz to 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 to 40 minutes.
[0112] In the alternative configuration, each LED has an output of 500mW and emits infrared radiation with an average wavelength of 960nm to approximately 1,100nm and pulsed waves of 0Hz to approximately 100Hz, potentially up to 5,000Hz.
[0113] Example 5 Clothing for photobiomodulation therapy In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has three infrared light source intergroups arranged in a single row. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 such that each intergroup at least partially overlaps or substantially centers on sites F3 306, Fz 308, and F4 310. The estimated total area of the skin surface S and underlying tissue exposed to near-infrared light is approximately 2.8 cm². 2 ~Approx. 3.3cm 2 This system provides photobiomodulation therapy to the dorsolateral prefrontal cortex (dlPFC). Each infrared light source intergroup has one high-power LED. Each LED has an output of 500mW, with a peak light output of 500mW to 1,000mW, and emits infrared light with an average wavelength of 800nm to approximately 850nm and pulsed waves of 10Hz to approximately 40Hz. The average irradiance across the treatment area is approximately 50mW / cm². 2 ~about 300mW / cm 2 The region with the highest irradiance is potentially up to approximately 500 mW / cm². 2 ~Approx. 1,000mW / cm 2 The average fluence across the treatment area is approximately 6 J / cm². 2 ~About 12J / cm 2 Therefore, the region of maximum fluence is potentially up to approximately 450 J / cm². 2~Approx. 1,025J / cm 2 The total incident energy during the treatment session is approximately 0.15 kJ to 1.8 kJ. The controller 200 operates the LEDs in pulsed mode at approximately 10 Hz to 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 to 40 minutes.
[0114] In the alternative configuration, each LED has an output of 500mW and emits infrared radiation with an average wavelength of 860nm to approximately 1,100nm and pulsed waves of 0Hz to approximately 100Hz, potentially up to 5,000Hz.
[0115] Example 6 tPBM therapy increases neuronal functional conduction. A research study was conducted to evaluate the neuronal conduction effects of transcranial photobiomodulation (tPBM) therapy using the photobiomodulation therapy garment disclosed herein. Each participant underwent an 8-minute EEG analysis prior to tPBM treatment to establish a baseline. Each participant then received tPBM treatment using the photobiomodulation therapy garment disclosed herein. Each tPBM treatment was bilateral, applied to the frontal region at two application sites on the left side, two on the right side, and two along the midline [frontal EEG sites F3, Fpl, F4, Fp2, and Fz, left forehead, right forehead, and center of the forehead on Fpz]. Once accurate placement was confirmed, tPBM treatment was initiated by pressing a button in a specific telephone application to activate the probe that delivers LED light. The duration of irradiation was 40 minutes per treatment. tPBM treatment followed the specifications: energy was delivered at a radiation wavelength of 850 nm, and the irradiance (IR) was 18 mW / cm². 2 The fluence is up to 43 joules / cm². 2 The energy delivered in one session is a maximum of 2.4 kJ, and each treatment window area is 55 cm². 2 After completion of tPBM treatment, a second 8-minute EEG analysis was performed on each participant.
[0116] The results of this study showed that participants exhibited increased neuronal functional connectivity (measured by EEG activity) compared to sham participants. For example, Figures 17A–17C show the results for five participants. EEG scans performed after tPBM treatment show focused light spots compared to scans acquired before tPBM treatment (Figure 17A) (Figure 17B). These differences are further highlighted by Figure 17C, which illustrates the focused light before and after the scan. These findings indicate improved connectivity between neurons. Increased functional connectivity allows neurons to transmit information faster and more accurately. The results were reproducible and not evident in sham participants.
[0117] Example 7 tPBM therapy increases brain activity. A research study was conducted to evaluate the effects of transcranial photobiomodulation (tPBM) therapy using the photobiomodulation therapy garment disclosed herein on brain activity. Each participant underwent an 8-minute EEG analysis prior to tPBM treatment to establish a baseline. Subsequently, each participant received tPBM treatment using the photobiomodulation therapy garment disclosed herein. Each tPBM treatment was bilateral, applied to the frontal region at two application sites on the left side, two on the right side, and two along the midline [frontal EEG sites F3, Fpl, F4, Fp2, and Fz, left forehead, right forehead, and center of the forehead on Fpz]. Once accurate placement was confirmed, tPBM treatment was initiated by pressing a button in a specific phone application to activate the probe that delivers LED light. The duration of irradiation was 40 minutes per treatment. The tPBM treatment followed the specifications below: energy was delivered at a radiation wavelength of 850 nm, and the irradiance (IR) was 18 mW / cm². 2 The fluence is up to 43 joules / cm². 2 The energy delivered in one session is a maximum of 2.4 kJ, and each treatment window area is 55 cm². 2 After completion of tPBM treatment, a second 8-minute EEG analysis was performed on each participant.
[0118] The results of this study showed that participants exhibited increased brain gamma oscillations during treatment with 40 Hz pulsed waves compared to sham participants. For example, Figures 18A and 18B show representative results from one participant. As shown in the shaded block in Figure 18A, there was a significant increase of over 35% in brain gamma oscillations at a frequency of 40 Hz. Furthermore, as shown in Figure 18B, there was a significant peak in gamma power between approximately 250 and 350 seconds, at which point the gamma power level decreased but remained at a higher level compared to the baseline gamma power level. These findings indicate brain gamma wave stimulation, which underlies many cognitive functions, including perception. Increased brain gamma wave stimulation promotes brain activity, leading to faster and more accurate information transmission. The results were reproducible and not evident in sham participants.
[0119] Example 8 tPBM treatment for depression in adults An 8-week open-label pilot clinical study was conducted to evaluate the safety and efficacy of tPBM treatment using the photobiomodulation therapy garments disclosed herein in adults with active depressive symptoms. The study enrolled 19 participants clinically diagnosed with moderate to severe depressive symptoms according to Beck's Depressive Inventory (BDI, baseline score 25).
[0120] Participants received tPBM treatment twice daily at home for eight weeks using the photobiomodulation therapy garment disclosed herein. Each tPBM treatment was bilateral and applied to the frontal region at two application sites on the left side, two on the right side, and two along the midline [frontal EEG sites F3, Fpl, F4, Fp2, and Fz, left forehead, right forehead, and center of the forehead on Fpz]. Once accurate placement was confirmed, tPBM treatment was initiated by pressing a button in a specific telephone application to activate the probe that delivers LED light. The duration of irradiation was 40 minutes per treatment. The tPBM treatment followed the specifications below: energy was delivered at a radiation wavelength of 850 nm, and the irradiance (IR) was 18 mW / cm².2 The fluence is up to 43 joules / cm². 2 The energy delivered in one session is a maximum of 2.4 kJ, and each treatment window area is 55 cm². 2 That is the case.
[0121] At the end of an 8-week clinical study of tPBM treatment using the photobiomodulation therapy garments disclosed herein for depression, researchers detected a significant reduction in depressive symptoms among participants. For example, as assessed by Beck's Depression Inventory, participants experienced a 43% reduction in depressive symptoms at week 8. This finding was a statistically significant change from baseline (significance p=0.001). Interestingly, the improvement was maintained for at least 4 weeks after discontinuation of tPBM treatment. In fact, as assessed by Beck's Depression Inventory, researchers detected a mean 48% reduction in depressive symptoms compared to baseline at week 12. This finding was also a significant change from baseline (significance p<0.0001). Subsequent analysis revealed that the improvement in depression was at least partially explained by an improvement in sleep quality.
[0122] Example 9 tPBM treatment for depression in children To evaluate the safety and efficacy of tPBM treatment using the photobiomodulation therapy garments disclosed herein in children with active depressive symptoms assessed through the Child Behavior Checklist (CBCL), an 8-week open-label pilot clinical study will be conducted. The study will enroll 20-30 participants aged 6–17 years who currently experience a CBCL T score of 60 or higher on the Anxiety / Depression Scale. Each participant is clinically evaluated through responses to a series of clinically administered questionnaires and scales, including: 1) CBCL, a parent-reported questionnaire that assesses both internalized and externalized maladaptive behaviors and emotional problems in children aged 6–18; 2) PQ-LES-Q (Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire), a parent-reported form consisting of 15 questions designed to help children assess the enjoyment and satisfaction they experienced in the past week; 3) BRIEF-P (Behavior Rating Inventory of Executive Functioning - Parent Report), a 78-item rating scale for assessing the level of executive function impairment; and 4) SRS (Social Responsiveness Scale), a 65-item rating scale completed by parents and used to measure social behavioral disorders occurring in natural environments.
[0123] Participants will receive tPBM treatment daily for eight weeks. The photobiomodulation therapy garment disclosed herein, used in tPBM treatment, is bilateral and applied to the frontal region at two application sites on the left side, two on the right side, and two along the midline [frontal EEG sites F3, Fpl, F4, Fp2, and Fz, left forehead, right forehead, and center of the forehead on Fpz]. Once correct placement is confirmed, tPBM treatment is initiated by pressing a button on a specific phone application to activate the probe that delivers LED light. The duration of irradiation begins at 10 minutes per treatment during the first week (days 1-7), increases to 20 minutes per treatment during the second week (days 7-14), and increases to 30 minutes per treatment during the third week (days 14-21). If the increase is hindered by side effects (or if a therapeutic response has already occurred), a lower dose will be maintained to ensure good tolerability and treatment adherence. If no improvement is observed on day 21 despite good tolerability, the clinician recommends a 40-minute treatment. tPBM treatment should follow these specifications: energy is delivered at a radiation wavelength of 850 nm, and the irradiance (IR) is 18 mW / cm². 2 The fluence is up to 43 joules / cm². 2 The energy delivered in one session is a maximum of 2.4 kJ, and each treatment window area is 55 cm². 2 That is the case.
[0124] Participants are evaluated weekly for the first four weeks, and then bi-weekly thereafter. At each visit, safety and efficacy measures are obtained using assessments of psychiatric symptoms and function, as well as scales for side effects. Further evaluations by clinicians and participants are completed at the midpoint (end of week 4) and at the final study visit (week 8 or end). The response to treatment is assessed using the following evaluation scales: 1) the CGI-Depression (Clinician completed Depression Specific Clinical Global Impression), which includes the CGI-S (Clinical Global Severity), CGI-I (Clinical Global Improvement), and CGI-EI (CGI-Efficacy Index) scales, completed by the physician at each visit; 2) the ARI-P (Affective Reactivity Index-Parent Report), a parent report form consisting of seven concise questions assessing irritability and short temper, completed by the parent at week 0 (baseline), week 4, and week 8; 3) the CASI-Anx (Childhood Anxiety Sensitivity Index), a 38-item scale assessing anxiety symptoms, completed by the parent at week 0 (baseline), week 4, and week 8; and 4) CDI (Children's Depression Inventory), parents complete a 27-item scale to assess depressive symptoms at week 0 (baseline), week 4, and week 8.
[0125] The results are expected to indicate that tPBM treatment is safe and effective in reducing depressive symptoms in children.
[0126] Example 10 tPBM treatment for autistic traits in children with Attention Deficit Hyperactivity Disorder (ADHD) A 10-week open-label pilot clinical study will be conducted to evaluate the tolerability, safety, and efficacy of tPBM treatment using the photobiomodulation therapy garments disclosed herein in children diagnosed with ADHD who also exhibit at least moderate autistic traits. The study will enroll 90 to 100 participants aged 9 to 17 years who meet the DSM-5 diagnostic criteria for ADHD and exhibit symptoms of moderate to severe autism spectrum disorder, with a raw score of 75 or higher as established by the Social Responsiveness Scale (SRS-2, 2nd Edition) or a CGI-AT (Clinical Global Impressions - Autistic Traits) severity score of 4 or higher.Each participant was clinically assessed for ADHD and autism characteristics by a certified clinician, and all participants' parents / guardians underwent a brief demographic interview and completed the MGH-SECS (Massachusetts General Hospital Social-Emotional Competence Scale) questionnaire, which includes the CGI-AT (Autism Trait Specific Clinical Global Impression) scales (CGI-S (Clinical Global Severity), CGI-I (Clinical Global Improvement), and CGI-EI (CGI-Efficacy Index) scales), BRIEF-P (Behavior Rating Inventory of Executive Function-Parent Version), CBCL (Child Behavior Checklist), CTAE (Clinician-Rated Treatment Emergent Adverse Events Log), GAF (Global Assessment of Functioning Scale), MGH-SECS-I (MGH-SECS-Informant Rated), and MGH-SECS-C (MGH-SECS Clinician Rated), and MGH-ASD-SCL (MGH The patient undergoes a series of assessments, including the Autism Spectrum Disorder (DSM-5 Diagnostic Symptom Checklist) and the SRR-2 questionnaire.
[0127] Participants will receive tPBM treatment daily for eight weeks, with post-study follow-up at week 10. The photobiomodulation therapy garment disclosed herein, used in tPBM treatment, is bilateral and applied to the frontal region at two application sites on the left side, two on the right side, and two along the midline [frontal EEG sites F3, Fpl, F4, Fp2, and Fz, left forehead, right forehead, and center of the forehead on Fpz]. Once correct placement is confirmed, tPBM treatment is initiated by pressing a button on a specific phone application to activate the probe that delivers LED light. The duration of irradiation begins at 10 minutes per treatment during the first week (days 1-7), increases to 20 minutes per treatment during the second week (days 7-14), and increases to 30 minutes per treatment during the third week (days 14-21). If the increase is hindered by side effects (or if a therapeutic response has already occurred), a lower dose is maintained to ensure good tolerability and treatment adherence. On day 21, if no improvement is observed despite good tolerability, the clinician recommends a 40-minute treatment. tPBM treatment follows these specifications: energy is delivered at a radiation wavelength of 850 nm, and the irradiance (IR) is 18 mW / cm². 2 The fluence is up to 43 joules / cm². 2 The energy delivered in one session is a maximum of 2.4 kJ, and each treatment window area is 55 cm². 2 That is the case.
[0128] Participants are evaluated weekly for the first four weeks, and then bi-weekly thereafter. At each visit, safety and efficacy measures are obtained using assessments of psychiatric symptoms and function, as well as scales for side effects. Further evaluations by clinicians and participants are completed at the midpoint (end of week 4) and at the final study visit (week 8 or end). Response to treatment is assessed using the following assessment scales: 1) CGI-AT, including the CGI-S, CGI-I, and CGI-EI scales, completed by the physician at weeks 0 (baseline), 1, 2, 3, 4, 6, and 8; 2) GAF and CTAE, completed by the physician at weeks 0 (baseline), 1, 2, 3, 4, 6, and 8; 3) ADHD-SC (Attention Deficit Hyperactivity Disorder Symptom Checklist), completed by the physician at weeks 0 (baseline), 4, and 8; 4) TSRQ (tPBM Self-Report Questionnaire), completed by the parent / guardian at weeks 1, 2, 3, 4, 6, and 8; 5) SRS-2 and CBCL, completed by the physician at weeks 4 and 8; 6) BRIEF-P and MGH-SECS-I, completed by the parent / guardian at week 8; and 7) MGH-SECS-C, completed by the physician at week 8. In week 10, each participant will be assessed using the CGI-AT, GAF, CTAE, SRS-1, ADHD-SC, and TSRQ, including the CGI-S, CGI-I, and CGI-EI scales.
[0129] The results are expected to indicate that tPBM treatment is safe and effective in mitigating autistic traits in children diagnosed with ADHD.
[0130] In conclusion, the above description of embodiments of the present invention is presented for illustrative and explanatory purposes only. While aspects of the present invention are emphasized by reference to specific embodiments, it will be understood that those skilled in the art will immediately recognize that these described embodiments are merely illustrative of the principles constituting the present invention. Accordingly, the specific embodiments are not intended to be exhaustive or to limit the present invention to the exact forms disclosed. Therefore, it should be understood that embodiments of the subject matter disclosed are by no means limited to the specific elements, compounds, compositions, components, articles, apparatus, methodologies, uses, protocols, steps, and / or limitations described herein, unless expressly stated otherwise.
[0131] Furthermore, any grouping of alternative embodiments, elements, steps, and / or limitations of the present invention should not be construed as limitations. Each such grouping may be referenced and claimed individually or in any combination with other groupings disclosed herein. It is anticipated that one or more alternative embodiments, elements, steps, and / or limitations of a group may be included in or removed from a group for convenience and / or patentability reasons. When such inclusion or removal occurs, this specification shall be deemed to include groupings that satisfy the descriptions of all Markush groups used in the supplementary claims, as modified.
[0132] Furthermore, those skilled in the art will recognize that certain changes, modifications, substitutions, alternatives, additions, deletions, and partial combinations thereof can be made in accordance with the teachings herein without departing from the spirit of the invention. Furthermore, the following appendix claims and the claims introduced herein are intended to be construed as including all such changes, modifications, substitutions, alternatives, additions, deletions, and partial combinations that fall within their true spirit and scope. Therefore, the scope of the invention is not limited to those precisely shown and described herein.
[0133] Specific embodiments of the Invention, including the best mode known to the inventors for carrying out the Invention, are described herein. Of course, variations of these described embodiments will be obvious to those skilled in the art by reading the above description. The inventors anticipate that those skilled in the art will appropriately adopt such variations, and intend that the Invention may be carried out in ways other than those specifically described herein. Accordingly, the Invention includes all modifications and equivalents of the subject matter described in the accompanying claims, as permitted by applicable law. Furthermore, any combination of all possible variations of the above embodiments is incorporated into the Invention unless otherwise specified herein or unless it is clearly inconsistent with the context.
[0134] The words, phrases, and terms used herein are intended solely to describe specific embodiments, elements, steps, and / or limitations and are not intended to limit the scope of the invention as defined solely by the claims. Furthermore, such words, phrases, and terms are understood not only in their generally defined sense but also to include structures, materials, or functions beyond the scope of their generally defined sense by special definition herein. Thus, where an element, step, or limitation can be understood to encompass more than one meaning in the context of this specification, its use in a claim should be understood to be general to all possible meanings supported by this specification and the word itself.
[0135] Accordingly, the definitions and meanings of elements, steps, or limitations described in the claims below are defined herein to include not only combinations of elements, steps, or limitations as literally shown, but also all equivalent structures, materials, or actions to perform substantially the same function in substantially the same manner to obtain substantially the same results. In this sense, it is intended that equivalent substitutions of two or more elements, steps, or limitations may be made for any one of the elements, steps, or limitations of the claims below, or that a single element, step, or limitation may be replaced by two or more elements, steps, or limitations of such claims. While elements, steps, or limitations are described above as acting in a particular combination and may initially be claimed as such, it is clearly understood that one or more elements, steps, or limitations from a claimed combination may, in some cases, be removed from the combination, and that a claimed combination may cover a partial combination or a variation of a partial combination. Therefore, despite the fact that the elements, steps, and / or limitations of the claims are shown below in specific combinations, it should be clearly understood that the present invention includes other combinations of fewer, more, or different elements, steps, and / or limitations disclosed above, even if such combinations were not initially claimed. Furthermore, it is clearly considered that minor changes from the claimed subject matter, which are now publicly known or will be later devised, are equivalently within the scope of the claims. Thus, obvious substitutions, which are now publicly known or will later be publicly known to those skilled in the art, are defined as being within the scope of the defined elements. Accordingly, the claims are understood to include those specifically illustrated and described above, conceptually equivalents, obviously replaceables, and those essentially incorporating the essential idea of the present invention.
[0136] Unless otherwise specified, all numbers used in this specification and in the claims to represent features, items, quantities, parameters, properties, terms, etc., are understood to be modified in all cases by the term “approximately.” As used herein, “approximately” means that the feature, item, quantity, parameter, property, or term thus modified includes a range of ±10 percent above and below the value of the described feature, item, quantity, parameter, property, or term. Therefore, unless otherwise stated, numerical parameters described herein and in the accompanying claims are variable approximations. For example, since mass spectrometers can vary slightly when determining the mass of a given analyte, the term “approximately” in relation to the mass of an ion or the mass / charge ratio of an ion refers to + / - 0.50 atomic mass units. At a minimum, and not as an attempt to limit the application of the doctrine of equivalents to the claims, each numerical representation should be interpreted by applying ordinary rounding techniques, at least in light of the reported number of significant figures.
[0137] Although the numerical ranges and values representing the broad scope of the present invention are approximations, the numerical ranges and values shown in specific embodiments are reported as accurately as possible. However, numerical ranges or values inherently include certain errors that inevitably arise from the standard deviation found in each test measurement. The enumeration of numerical ranges of values herein is merely intended to serve as a simple way to individually refer to the individual numerical values that fall within those ranges. Unless otherwise specified herein, individual values within numerical ranges are incorporated herein as if they were individually described herein.
[0138] The use of the terms “may” or “can” with respect to an embodiment or aspect of an embodiment also carries the alternative meaning of “cannot” or “cannot.” Therefore, where this specification discloses that an embodiment or aspect of an embodiment may or may be included as part of the subject matter of the invention, a negative limitation or exclusive condition is also explicitly intended, meaning that the embodiment or aspect of an embodiment may or may not be included as part of the subject matter of the invention. Similarly, the use of the term “optionally” with respect to an embodiment or aspect of an embodiment means that such an embodiment or aspect may or may not be included as part of the subject matter of the invention. Whether such a negative limitation or exclusive condition applies depends on whether the negative limitation or exclusive condition is stated in the claimed subject matter.
[0139] In the context describing the present invention (particularly in the context of the following claims), the terms “a,” “an,” “the,” and similar references are to be interpreted as encompassing both singular and plural forms unless otherwise specified herein or unless clearly contradicted by the context. Furthermore, order designations for identified elements, such as “first,” “second,” “third,” etc., are used to distinguish elements and, unless otherwise specifically stated, do not indicate or imply a required or limited number of such elements, nor do they indicate a particular position or order of such elements. All methods described herein may be carried out in any suitable order unless otherwise specified herein or unless clearly contradicted by the context. The use of any and all examples or illustrative language provided herein (e.g., “etc.”) is merely intended to better illustrate the present invention and does not limit the scope of the invention to any other claimed invention. The language herein should not be interpreted as indicating any unclaimed elements essential to the carrying out of the invention.
[0140] When used in the claims, whether at the time of filing or added by amendment, the open-ended transitional term “comprising,” its variations such as “comprise” and “comprises,” and its equivalent open-ended transitional phrases such as “contain,” “equip,” and “have,” encompass all explicitly enumerated elements, limitations, steps, integers, and / or features, either alone or in combination with unenumerated subject matter, where the specified elements, limitations, steps, integers, and / or features are essential, but other unspecified elements, limitations, steps, integers, and / or features may be added to still constitute the scope of the claims. Certain embodiments disclosed herein may be further limited in the claims by using the closed-ended transitional phrase “consisting of” or “consisting essentially of” (or its variations such as “consist of,” “consists of,” “consist essentially of,” and “consists essentially of,” instead of or as a modification of “comprising.” When used in the claims, whether at the time of filing or added by amendment, the closed-end transitional clause “consisting of” excludes any elements, limitations, steps, integers, or features not expressly described in the claims. The closed-end transitional clause “essentially consisting of” limits the scope of the claims to the explicitly enumerated elements, limitations, steps, integers, and / or features, and any other elements, limitations, steps, integers, and / or features that do not essentially affect the basic and novel features of the claimed subject matter. Thus, the meaning of the open-end transitional clause “including” is defined as encompassing all specifically enumerated elements, limitations, steps, and / or features, as well as any optional, additional, unspecified ones.The closed-end transitional clause “consisting of” is defined as including only the elements, limitations, steps, integers, and / or features specifically enumerated in the claims, whereas the closed-end transitional clause “essentially consisting of” is defined as including only the elements, limitations, steps, integers, and / or features specifically enumerated in the claims, and elements, limitations, steps, integers, and / or features that do not essentially affect the basic and novel features of the claimed subject matter. Thus, the open-end transitional clause “including” (and its equivalent open-end transitional clauses) to the extent of its meaning include, in limited cases, the claimed subject matter specified by the closed-end transitional clause “consisting of” or “essentially consisting of”. In this way, embodiments described herein or claimed in the “including” language explicitly and expressly provide explanation, activation, enabling, and support for the “essentially consisting of” and “consisting of” language.
[0141] Finally, all patents, patent publications, and other references cited and identified herein are incorporated herein individually and expressly by reference in their entirety, for example, to describe and disclose compositions and methodologies described in such publications that may be used in conjunction with the present invention. These publications are provided solely for their disclosures that precede the filing date of this application. In this regard, the inventors do not acknowledge, nor should be construed as acknowledging, that they do not have prior rights to such disclosures for the sake of prior art or for any other reason. All statements regarding dates or expressions regarding the contents of these documents are based on information available to the applicant and do not constitute an acknowledgment of the accuracy of the dates or contents of these documents. [Explanation of symbols]
[0142] P: person S:Skin surface H: Head area d1: Spacing between column groups d2: Spacing between row groups d3: Spacing within column group d4: Spacing within row group 20: Clothing for photobiomodulation therapy 22: Photobiomodulation Therapy Headband 30: Clothing for photobiomodulation therapy 20, 22 garments 40: Outer fabric sheet for clothing 24 42: Outer surface of the outer fabric seat 40 44: Inner surface of outer fabric seat 40 46: Treatment area of outer fabric sheet 40 50: Upper edge of garment 30 52: Lower edge of garment 30 54: Right side of clothing item 30 56: Left part of clothing item 30 58: Clothing 30 terminal rail mount opening 60: Clothing 30 slide buckle 62: Clothing 30 slide buckle 64: Right head strap of clothing 30 66: Clothing 30 left head strap 68: Clothing 30 Controller Straps 70: Clothing 24 Inner Fabric Sheet 72: Inner fabric seat 70 outer surface 74: Inner fabric seat 70 inner surface 76: Near-infrared opening of the inner fabric seat 70 78: Sensor opening in the inner fabric seat 70 79: Inner fabric seat 70 sensor cover 100: Photobiomodulation therapy clothing 20, 22 photobiomodulation units 102: Heat dissipation material for photobiomodulation 100 110: Photobiomodulation 100 Flexible Printed Circuit Board Assembly 112: Main strip of flexible printed circuit board assembly 110 113: Base of the flexible printed circuit board assembly 110 114: First strip of flexible printed circuit board assembly 110 116: Second strip of flexible printed circuit board assembly 110 117: Connection part of flexible printed circuit board assembly 110 118: Sensor strip notch of flexible printed circuit board assembly 110 120: First mounting portion of the first strip 114 121: First notch of the first strip 114 122: Second mounting portion of the first strip 114 123: Second notch of the first strip 114 124: Third mounting portion of the first strip 114 130: First mounting portion of the second strip 116 131: First notch of the second strip 116 132: Second mounting portion of the second strip 116 133: Second notch of the second strip 116 134: Third mounting portion of the second strip 116 140: Sensor strip for flexible printed circuit board assembly 110 142: Sensor mounting section of sensor strip 140 144: Sensor strip 140, free end of sensor strip 150: Liquid Wire Circuit Assembly for Photobiomodulation 100 152: Main liquid wire tube of liquid wire circuit board assembly 150 153: Base of liquid wire circuit board assembly 150 154: First liquid wire tube of liquid wire circuit board assembly 150 156: Second liquid wire tube of liquid wire circuit board assembly 150 158: Liquid wire circuit board assembly 150 sensor liquid wire tube 160: Connection terminals of circuit board assembly 84 162: Electronic circuit connector with terminal 160 164: Terminal rail mount for connection terminal 160 166: Contacts of terminal rail mount 164 170: Near-infrared light source for photobiomodulation 100 171: First near-infrared light source group of near-infrared light source 170 172: Second near-infrared light source group of near-infrared light source 170 173: Third near-infrared light source group of near-infrared light source 170 174: Fourth near-infrared light source group of near-infrared light source 170 175: Fifth near-infrared light source group of near-infrared light source 170 176: The 6th near-infrared light source group of near-infrared light source 170 180: Sensor of photobiomodulation unit 100 182: Photobiomodulation 100 Cardiovascular Sensor 184: Green LED of cardiovascular sensor 182 186: Green LED of cardiovascular sensor 182 188: Photodetector of cardiovascular sensor 182 or 114 192: Photobiomodulation 100 Temperature Sensor 194: Stimulator of Photobiomodulation Unit 100 200: Controllers for photobiomodulation therapy clothing 20, 22 210: Hot melt adhesive film for photobiomodulation therapy clothing 20, 22 220: Double-sided tape layer of photobiomodulation therapy garments 20, 22 222: Near-infrared light source aperture of double-sided tape layer 220 224: Sensor opening of double-sided tape layer 220 300: Person P's Fp1 part 302: Fpz portion of human P 304: Fp2 part of human P 306: F3 area of human P 308: Fz part of human P 310: F4 part of human P 320: Sagittal plane of person P 322: Person P's brow arch area
Claims
1. Clothing for photobiomodulation therapy, A garment configured to be worn by a user on the surface of their skin, comprising a first surface and a second surface opposite to the first surface, wherein the first surface is configured to face the skin surface when worn, A photobiomodulation unit is integrated into the garment and comprises a connection terminal, one or more near-infrared light sources, and one or more sensors, wherein the connection terminal communicates electronically with the one or more near-infrared light sources and the one or more sensors, and each of the one or more near-infrared light sources is configured to emit near-infrared light at wavelengths of 600 nm to 1600 nm and at predetermined dose measurement values. A controller including a processor and memory, configured to operably engage with the terminal rail of the connection terminal in such a manner that it establishes electronic communication with the connection terminal, Equipped with, The first surface of the garment includes a first portion having one or more light source openings, each of the one or more near-infrared light sources being operably aligned with the one or more light source openings to allow near-infrared light from the one or more near-infrared light sources to pass through properly. The first surface of the garment includes a second portion having one or more sensor openings, each of the one or more sensors being operably aligned with the one or more sensor openings to enable the proper functioning of the one or more sensors through the one or more sensor openings. The processor and the memory are comprised of executable instructions for controlling each of the one or more near-infrared light sources and each of the one or more sensors. When multiple near-infrared light sources or multiple sensors are present, the processor and the memory are configured with executable instructions for independently controlling each of the multiple near-infrared light sources and each of the multiple sensors. Clothing for photobiomodulation therapy.
2. The garment for photobiomodulation therapy according to claim 1, wherein the garment is configured to cover or conform to a portion of the body and can be moved from one portion of the body to another portion of the body.
3. The garment for photobiomodulation therapy according to claim 1, wherein the garment is sized and dimensions to fit particularly well to specific parts of the body.
4. The photobiomodulation therapy garment according to claim 3, wherein the specific body part is the head region, neck region, shoulder region, torso region, hand region, wrist region, arm region, foot region, leg region, or any combination thereof.
5. The garment for photobiomodulation therapy according to claim 4, wherein the garment is a headband, hat, visor, shirt, pants, socks, gloves, or underwear.
6. The photobiomodulation therapy garment according to claim 1, wherein each of the one or more near-infrared light sources is a near-infrared light-emitting diode or a near-infrared low-level laser.
7. The photobiomodulation therapy garment according to claim 1, wherein each of the one or more sensors is configured to detect and collect information on one or more parameters of the garment, the photobiomodulation unit and its components, the controller and its components, and the user, and then transmit the information to the controller.
8. The photobiomodulation therapy garment according to claim 7, wherein the one or more parameters include operational information of the garment, the photobiomodulation unit and its components, and the controller and its components, the user's biometric information, or any combination thereof.
9. The garment for photobiomodulation therapy according to claim 1, wherein the executable command independently controls each of the one or more near-infrared light sources.
10. The photobiomodulation therapy garment according to claim 9, wherein the executable commands control the activation, duration of activation, deactivation, duration of deactivation, activation pattern and timing, deactivation pattern and timing, fluence level, irradiance level, dose measurement level, pulse operation, continuous operation, operation time, cycle duration, or any combination thereof for each of the one or more near-infrared light sources.
11. The garment for photobiomodulation therapy according to claim 1, wherein the executable command controls each of the one or more sensors independently.
12. The garment for photobiomodulation therapy according to claim 11, wherein the executable command controls the collection and analysis of information obtained from each of the one or more sensors.
13. The photobiomodulation therapy garment according to claim 1, wherein the one or more near-infrared light sources are near-infrared light sources arranged at multiple intervals.
14. The garment for photobiomodulation therapy according to claim 13, wherein the one or more near-infrared light sources are arranged in a plurality of near-infrared light source groups that are spaced apart, and each of the plurality of near-infrared light source groups comprises a subset of the one or more near-infrared light sources.
15. The photobiomodulation therapy garment according to claim 1, further comprising one or more stimulators.
16. The photobiomodulation therapy garment according to claim 15, wherein the one or more stimulators include a component capable of generating a magnetic field.
17. The photobiomodulation therapy garment according to claim 1, wherein the processor and the memory are comprised of executable instructions for dynamically controlling each of the one or more near-infrared light sources and each of the one or more sensors.
18. The photobiomodulation therapy garment according to claim 1, wherein the skin surface includes the forehead, the back of the neck, the wrist, the abdomen, or any combination thereof.
19. The photobiomodulation therapy garment according to claim 18, wherein the forehead area includes the dorsolateral prefrontal cortex region, the frontal eye field region, or both.
20. Each of the one or more near-infrared light sources is configured to emit near-infrared wavelengths of 700 nm to 1200 nm or 800 nm to 1100 nm, or each of the one or more near-infrared light sources emits at least 20 mW / cm² 2 Up to 400 mW / cm² 2 The photobiomodulation therapy garment according to claim 1, configured to emit an irradiance of or the one or more near-infrared light sources configured to emit a radiant flux of at least 900 mW.
21. A photobiomodulation therapy garment according to any one of claims 1 to 20, for use in providing photobiomodulation therapy.
22. The photobiomodulation therapy garment according to claim 21, wherein the photobiomodulation therapy is transcranial photobiomodulation therapy.
23. The photobiomodulation therapy garment according to claim 21, wherein the photobiomodulation therapy garment is either the sole treatment device or used in conjunction with a second treatment method.
24. The photobiomodulation therapy garment according to claim 23, wherein the second treatment method is high-intensity irradiance photobiomodulation therapy, cognitive behavioral therapy, transcranial magnetic stimulation, ocular phototherapy, evidence-based mental health practices, mindfulness therapy, and meditation therapy.
25. The photobiomodulation therapy garment according to claim 21, wherein the administration of the photobiomodulation therapy results in increasing cellular energy production, increasing nerve mitochondrial energy, increasing adenosine triphosphate (ATP) production, increasing reactive oxygen species production, reducing inflammation at the cellular and tissue levels, improving cell repair and healing, increasing nitric oxide production, increasing cerebral blood flow, increasing neurogenesis, increasing neuroplasticity, increasing neuroprotection, enhancing nerve repair, reducing inflammation, or any combination thereof.
26. The use of the photobiomodulation therapy garment delivers at least 500 J of radiant energy during the therapy, or the use of the photobiomodulation therapy garment delivers at least 30 J / cm² of radiant energy during the therapy. 2 Up to 200 J / cm² 2 The delivery of radiation exposure or the use of the photobiomodulation therapy garment is at least 30 mW / cm². 2 Up to 400 mW / cm² 2 The photobiomodulation therapy garment according to claim 21, which delivers the radiation intensity of the following.