Photobiomodulation Therapy Garments, Methods, and Uses Thereof
Patent Information
- Application Number
- JP2023561170
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-10-27
- Filing Date
- 2022-04-08
- Publication Date
- 2025-04-15
- Estimated Expiration
- 2042-04-08
AI Technical Summary
Existing photobiomodulation therapy systems require users to maintain light sources in place for extended periods, limiting their ability to engage in daily activities, and there is a need for a portable system that can deliver therapy during both sedentary and vigorous activities.
A photobiomodulation therapy garment integrated with near-infrared light sources and a controller, allowing users to wear the system over the skin surface, providing flexible and adjustable coverage for various body parts, and enabling real-time therapy delivery.
The system enables continuous photobiomodulation therapy while allowing users to engage in daily activities, ensuring accurate and unimpeded treatment delivery through adjustable and portable garment designs.
Smart Images

Figure 00000000_0000_ABST
Abstract
Description
[Technical field]
[0001] This patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 272,363, filed October 27, 2021, and U.S. Provisional Patent Application No. 63 / 172,405, filed April 8, 2021, the entire contents of which are incorporated herein by reference, and is entitled to a filing date pursuant to 35 U.S.C. § 119(e).
[0002] The subject matter of this patent application relates generally to devices and methods for treating disease using near-infrared photobiomodulation therapy. [Background technology]
[0003] By way of background, photobiomodulation therapy involves the application of near-infrared light to various parts of a subject's body, for example, to the skin. Photobiomodulation therapy induces photochemical reactions in cells, increasing mitochondrial activity and ATP levels. The near-infrared light is modulated to pass through the skin, soft tissue, cartilage, cerebrospinal fluid, and bone structures to provide treatment for various disorders. In an example of transcranial photobiomodulation therapy, a near-infrared light source is directed to the head and the near-infrared light penetrates the skull and illuminates the brain to treat mental health-related symptoms such as stress, fatigue, ADHD, and other psychiatric, neuropsychiatric, and neurodegenerative disorders. Summary of the Invention [Problem to be solved by the invention]
[0004] During treatment, one or more light sources must be held in a fixed position on the user's skin for an extended period of time. However, the user may want to continue with their daily activities during the treatment period, which necessitates a portable system that remains in place during sedentary and active activities so that treatment can be delivered accurately and unhindered. Furthermore, a portable system allows for immediate real-time use, allowing the user to receive photobiomodulation therapy whenever they need it.
[0005] Aspects of the present invention fulfill these needs and provide further related advantages, as described in the following summary. [Means for solving the problem]
[0006] Aspects of the present invention teach certain advantages in construction and use that provide exemplary advantages that are described below.
[0007] The present disclosure discloses a photobiomodulation therapy garment having a garment configured to be worn by a user on a 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 at wavelengths between about 700 nm and about 1600 nm, at predetermined dosimetry and durations, toward one or more areas of interest on the skin. A controller with a processor and memory is in communication with the near-infrared light sources to control 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, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of aspects of the present invention.
[0009] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate aspects of the disclosed subject matter in at least one of its exemplary embodiments, as more fully defined in the following description. Features, elements, and aspects of the disclosure are referenced with like numerals in the different drawings, which represent the same, equivalent, or similar features, elements, or aspects according to one or more embodiments. The drawings are not necessarily to scale, with emphasis instead being placed on illustrating principles described herein and provided by exemplary embodiments of the invention. [Brief description of the drawings]
[0010] [Figure 1] FIG. 1 is a front perspective view of an exemplary photobiomodulation therapy garment disclosed herein worn by a user. [Diagram 2] FIG. 13 is a rear plan view of an exemplary photobiomodulation therapy garment in an open configuration. [Diagram 3] FIG. 3 is an enlarged rear plan view of the photobiomodulation therapy garment of FIG. 2 showing an exemplary inter-group and intra-group configuration of near-infrared light sources. [Figure 4] FIG. 3 is a rear perspective view of the photobiomodulation therapy garment of FIG. [Diagram 5] FIG. 3 is a front perspective view of the photobiomodulation therapy garment of FIG. 2 showing the terminal rail with the controller removed. [Figure 6] FIG. 3 is a front perspective view of the photobiomodulation therapy garment of FIG. 2 showing a controller as disclosed herein secured to the photobiomodulation therapy garment. [Figure 7] FIG. 7 is a front perspective view of the photobiomodulation therapy garment of FIG. 6 in a closed configuration, showing the adjustment straps closed to form a band. [Figure 8] FIG. 6 is an exploded perspective view of the photobiomodulation therapy garment of FIG. [Figure 9] FIG. 1 is a plan view of a photobiomodulation unit disclosed herein comprising a flexible printed circuit board assembly. [Figure 10] FIG. 10 is an enlarged cross-sectional view of the photobiomodulation unit of FIG. 9 taken at 10-10, showing a sensor as disclosed herein. [Figure 11] FIG. 1 is a plan view of a photobiomodulation unit disclosed herein comprising a flexible printed circuit board assembly. [Figure 12] FIG. 1 is a plan view of a photobiomodulation unit disclosed herein comprising a flexible printed circuit board assembly. [Figure 13] FIG. 1 is a plan view of a photobiomodulation unit disclosed herein comprising a flexible printed circuit board assembly. [Figure 14] FIG. 1 is a plan view of a photobiomodulation unit disclosed herein comprising a flexible printed circuit board assembly. [Figure 15] FIG. 1 is an exploded rear perspective view of a photobiomodulation therapy garment disclosed herein showing the liquid wire circuit assembly. [Figure 16] FIG. 1 is an exploded rear perspective view of a photobiomodulation therapy garment disclosed herein showing the liquid wire circuit assembly. [Figure 17] 17A-17C show EEG scans of five participants from a research study who underwent transcranial photobiomodulation (tPBM) treatment using the photobiomodulation therapy garment disclosed herein, where FIG. 17A shows an EEG scan for each participant before tPBM treatment, FIG. 17B shows an EEG scan for each participant after tPBM treatment, and FIG. 17C shows a merged before and after EEG scans to highlight the differences. [Figure 18]18A-18B show graphs of data obtained from EEG scans of participants using a photobiomodulation therapeutic garment as disclosed herein, where FIG. 18A shows the percent change in frequency during use of a photobiomodulation therapeutic garment as disclosed herein, and FIG. 18B shows the change in gamma power over time during use of a photobiomodulation therapeutic garment as disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0011] The detailed description set forth below in conjunction with the accompanying drawings is intended to describe embodiments of the invention and is not intended to represent the only manner in which the invention may be constructed and / or utilized. The description describes the structure and sequence of steps for constructing and operating the invention in conjunction with an illustrated embodiment. However, it should be understood that the same or equivalent structure and steps may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
[0012] The system of the present invention in one or more embodiments provides a photobiomodulation therapy garment. The photobiomodulation therapy garment disclosed herein includes a garment configured to be worn by a user on a skin surface, incorporating one or more photobiomodulation units configured to cooperate with a controller to administer photobiomodulation therapy. 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 connection terminal. The connection terminal is also configured to operably receive the controller in a manner to establish an electrical connection. Each of the one or more near-infrared light sources disclosed herein is configured to emit near-infrared light at a wavelength between 600 nm and 1600 nm, a predetermined dosimetry, and a duration. The controller disclosed herein has a processor and a memory and is configured to control operating parameters of the near-infrared light sources. During operation, the photobiomodulation units are configured to emit near-infrared light at one or more regions of the skin surface of the user. In some embodiments, photobiomodulation therapy garment 20 includes garment 30, photobiomodulation unit 100, and controller 200, as shown in FIGS.
[0013] In some embodiments, as shown in Figures 1-7, photobiomodulation therapy garment 20 can be configured as a photobiomodulation therapy headband 22 for the purpose of treating a particular region of person P's head H with transcranial photobiomodulation therapy. In this configuration, person P wears photobiomodulation therapy headband 22 by wrapping it snugly around head region H such that one or more near-infrared light sources disclosed herein integrated into photobiomodulation therapy headband 22 are positioned and / or directed over the region of interest on skin surface S to deliver therapeutic levels of near-infrared light to the region of interest. In some embodiments, positioning of photobiomodulation therapy headband 22 as shown in Figure 1 positions one or more near-infrared light sources disclosed herein approximately and / or substantially centered (e.g., center of nose) in midsagittal plane 320 over the frontal bone region of person P's skull for the purpose of irradiating near-infrared light through the skull to a brain region of person P to treat a disease. Further, in these embodiments, the photobiomodulation therapy headband 22 is positioned such that one of the near-infrared light sources disclosed herein is located approximately above the brow ridge region (i.e., the brown ridge above the eye socket) 322 and generally below the hairline (although hairline may vary from person to person). At least in one or more embodiments, the at least one near-infrared light source disclosed herein integrated within the photobiomodulation therapy headband 22 should be positioned above the brow ridge region 322 or at least above the eye socket to minimize exposure of the eyes to near-infrared light. In some embodiments, as shown in FIG. 1, the photobiomodulation therapy headband 22 is positioned to cover a defined region of interest on the skin surface S, including one or more or all of Fp1 region 300, Fpz region 302, Fp2 region 304, F3 region 306, Fz region 308, and F4 region 310, when the photobiomodulation therapy headband 22 is placed on the head H and properly positioned.
[0014] Although photobiomodulation therapy garment 20 is illustrated in FIGS. 1-16 as a photobiomodulation therapy headband 22, photobiomodulation therapy garments disclosed herein can be constructed for various parts of the body. In some embodiments, photobiomodulation therapy garments disclosed herein can be configured to wrap around or conform to various body parts while being movable from one area of interest on the body to another area of interest. In some embodiments, photobiomodulation therapy garments disclosed herein can be configured to specifically fit a particular body part, such as, for example, a head cover, a visor, a neck wrap, a shoulder wrap, a wrist wrap, or a belly wrap. In some embodiments, photobiomodulation therapy garments disclosed herein can be configured to fit various body parts of an individual while being worn by the individual, such as, for example, a hat, a shirt, pants, or underwear.
[0015] The photobiomodulation therapy garment 20 comprises a garment. The garment can be flexible, semi-rigid, or rigid, and is constructed to be comfortable to the user's body and configured to feel similar to an item of clothing or other worn fashion accessory. In some embodiments, the garments disclosed herein are fabric materials made through weaving, knitting, opening, felting, stitching, crocheting, or bonding. In some embodiments, the garment is made of multiple layers of fabric materials. 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 dimensioned to act as a base for mounting one or more photobiomodulation units and controllers disclosed herein, while the inner fabric assembly is sized and dimensioned to at least cover one or more photobiomodulation units.
[0016] For example, in some embodiments, and referring to Figures 2-4, 7, 8, 15, and 16, photobiomodulation therapy headband 22 includes garment 30 including outer fabric sheet 40 and inner fabric sheet 70, and photobiomodulation unit 100 sandwiched between outer fabric sheet 40 and inner fabric sheet 70. Outer fabric sheet 40 can be made of a variety of natural or synthetic textiles, typically selected for their aesthetic and / or protective qualities. Inner fabric sheet 70 is configured to lie against skin surface S, and can be made of natural or synthetic textiles or other materials that are comfortable against skin surface S, such as space cotton. As shown in Figures 2-7, the upper and lower portions of outer fabric sheet 40 and inner fabric sheet 70 are attached to each other to form upper and lower edges 50 and 52 of garment 30 in a manner that encloses photobiomodulation unit 100 therein.
[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 is retained to the right head strap 64 via a loop formed by the slide buckle 60. The slide buckle 62 is configured to receive a free end of the left head strap 66, which may include a hook-and-loop fitting to make the 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 FIG. 8, the outer fabric sheet 40 of the garment 30 includes a terminal rail mounting opening 58 sized and dimensioned to receive a terminal rail of a connection terminal disclosed herein to allow proper engagement of the controller 200 to the terminal rail. With reference to FIGS. 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 operatively engaged to the photobiomodulation unit 100 to hold the controller 200 securely against the outer fabric sheet 40. The controller strap 68 has a first end that is securely affixed to the garment 30 and a second end opposite the first end that loops around the attached controller 200 to reversibly secure the controller 200 to the garment 30 using, for example, a hook-and-loop fastener, a buckle, or a snap. The controller strap 68 may be constructed of a non-elastic or elastic material.
[0019] As best seen in Figures 8, 15, and 16, the inner fabric sheet 70 of the garment 30 includes one or more near-infrared light source openings 76 and one or more sensor openings 78. Each of the one or more near-infrared light source openings 76 is a cut-out in the inner fabric sheet 70 such that, when assembled, each opening 76 aligns with an infrared light source as disclosed herein, thereby allowing light from the infrared light source to radiate through the infrared light source opening 76. Similarly, each of the one or more sensor openings 78 is a cut-out in the inner fabric sheet 70 such that, when assembled, each opening 78 aligns with a sensor as disclosed herein, thereby allowing the sensor to function properly and collect information from the user through the sensor opening 78.
[0020] In some embodiments, referring to FIGS. 2-4 and 8, the inner fabric sheet 70 may include one or more sensor covers 79. Each sensor cover 79 is disposed over and protects a respective one or more sensors disclosed herein attached to the photobiomodulation unit 100. Additionally, each of the one or more sensor covers 79 is configured to be placed in contact with or in close proximity to the skin surface S when the photobiomodulation therapy garment 20 is worn. Each sensor cover 79 may be attached to and / or sandwiched between the inner fabric sheet 70 or the photobiomodulation unit 100. Each sensor cover 79 is constructed of a thin sheet of PVC in this exemplary embodiment that allows one or more sensors present thereunder to interact with the skin surface S to measure bodily functions such as one or more of temperature, heart rate, blood oxygen levels, and other measurable functions. Additionally, each sensor cover 79 provides a visual reference to assist the user in properly orienting and wearing the photobiomodulation therapy garment 20. For example, when the photobiomodulation therapy headband 22 is placed around the head H, one or more sensor covers 79 can be manually aligned with the nose to position the sensor cover 79 substantially above the sagittal plane 320.
[0021] The photobiomodulation therapy garment 20 also includes a photobiomodulation unit. The photobiomodulation unit includes a connection terminal, one or more near-infrared light sources, one or more sensors, and is configured to establish electronic communication with the controller 200. In some embodiments, referring to FIGS. 8, 9, and 11, the photobiomodulation unit 100 includes a flexible printed circuit board assembly 110 that provides a flexible substrate that houses electrical circuitry that establishes electronic communication between the connection terminal 160 and one or more near-infrared light sources 170, e.g., infrared, low-level lasers, and / or light-emitting diodes (LEDs), one or more sensors 180, and optionally one or more stimulators 194. Attached to the connection terminal 160 (typically rigid or semi-rigid) is an electronic circuit connector 162 that 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, because the photobiomodulation therapy headband 22 must conform to the contours of the forehead, the flexible printed circuit board assembly 110 is designed with 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 heat dissipation material 102 on the flexible board opposite the electrical circuitry that dissipates heat generated by the flexible printed circuit board assembly 110 during operation of the photobiomodulation therapy garment 20.
[0022] 9 and 11, in some embodiments, the flexible printed circuit board assembly 110 is a thin flat substrate including a first surface and a second surface opposite the first surface, configured as a main strip 112 extending from a connection terminal 160, and splitting at a root portion 113 into 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 connection portion 117, and all define a boundary of a notch 118. The first strip 114 and the second strip 116 have electronic circuitry necessary to establish electronic communication between the connection terminal 160 and each near-infrared light source 170 operably attached to the first strip 114 or the second strip 116.
[0023] In some embodiments, the first strip 114 and the second strip 116 each include a series of tabs extending laterally outward therefrom for mounting a near-infrared light source disclosed herein 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, where the first mounting portion 120 is separated from the second mounting portion 122 by a first notch 121 therebetween, and the third mounting portion 124 is separated from the second mounting portion 122 by a second notch 123 therebetween. Similarly, the second strip 116 includes a first mounting portion 130, a second mounting portion 132, and a third mounting portion 134, where the first mounting portion 130 is separated from the second mounting portion 132 by a first notch 131 therebetween, and the third mounting portion 134 is separated from the second mounting portion 132 by a second notch 133 therebetween. 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 to enable independent flexible bending of the flexible printed circuit board assembly 110. Such flexing allows the flexible printed circuit board assembly 110 to easily follow the contours of one or more areas of interest in the skin area S, allowing each of the one or more near-infrared light sources disclosed herein to be positioned adjacent to the skin surface S with minimal or no gaps.
[0024] 9 and 11 , in some embodiments, the sensor strip 140 includes a sensor mounting portion 142 and a free end 144. The sensor strip 140 extends from the root portion 113 into the notch 118 in a manner that provides clearance of the sensor strip 140 from the first strip 114 and the second strip 116 such that the sensor strip 140 is separated from the first strip 114 and the second strip 116 except for the root portion 113. The sensor strip 140 includes electronic circuitry necessary to establish electronic communication between each sensor 180 operably attached to the sensor strip 140 and the connection terminals 160. The sensor strip 140 is relatively thin and elongated to permit bending and slight movement of the sensor strip 140 relative to the remainder of the flexible printed circuit board assembly 110, which is further permitted by the sensor opening 224 provided by the double-sided tape 220 (see Figures 8, 15, and 16), allowing the flexible printed circuit board assembly 110 to easily bend and fit around the head H with little or no twisting.
[0025] In some embodiments, referring to Figures 5, 8, 9, 11, 15, and 16, a connection terminal 160 is integrally attached to one end of the flexible printed circuit board assembly 110. The connection terminal 160 includes an electronic circuit connector 162 and a terminal rail mount 164. The electronic circuit connector 162 of the connection terminal 160 is disposed on the same surface of the flexible printed circuit board assembly 110 as the surface to which the one or more infrared light sources 170, the one or more sensors 180, and the one or more stimulators 194 are attached and which contains electrical circuitry used to establish electronic communication with the one or more infrared light sources 170, the one or more sensors 180, and the one or more stimulators 194. The terminal rail mount 164 of the connection terminal 160 is disposed on the surface of the flexible printed circuit board assembly 110 opposite the electronic circuit connector 162. The terminal rail mount 164 includes a plurality of contacts 166. Terminal rail mount 164 is configured to receive controller 200 and establish electronic communication between photobiomodulation unit 100 and controller 200 with corresponding contacts that mate with contacts 166 upon connection. To allow for quick connection and disconnection, controller 200 and terminal rail mount 164 include sliding connections (e.g., dovetail, or tongue and groove type connections) to capture controller 200 within terminal rail mount 164 and force electrical contact between contacts 166 of terminal rail mount 164 and corresponding contacts protruding through controller 200. After sliding controller 200 into terminal rail mount 164, controller strap 68 is wrapped over controller 200 and secured to inner portion 44 of outer fabric sheet 40 by a releasable connection, such as a hook and loop.
[0026] In some embodiments, referring to FIG. 15 and FIG. 16, the photobiomodulation unit 100 comprises a liquid wire circuit assembly 150 that provides electronic communication between a connection terminal 160 and one or more near-infrared light sources 170, such as infrared, low level laser, 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 a liquid phase at room temperature, enclosed in a flexible tube. Due to its liquid nature, the liquid metal can make good contact with objects of any shape and maintain good electrical properties even when the substrate or cover film is deformed. Non-limiting examples of liquid metals include alloys such as gallium and gallium-indium eutectic. The liquid wire circuit assembly 150 includes a connection terminal 160 with an electronic circuit connector 162 attached thereto, 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, because the photobiomodulation therapy headband 22 must conform to the contours of the forehead, the liquid wire circuit assembly 150 is designed with strategic cutouts that allow for maximum flexibility and comfort.
[0027] 15 and 16, in some embodiments, the liquid wire circuit assembly 150 comprises a main liquid wire tube 152 extending from a connection terminal 160, which is divided at a root portion 153 into 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 have electronic circuitry necessary to establish an electrical connection between each near-infrared light source 170 operably attached to the first or second liquid wire tube 154, 156 and the connection terminal 160 that provides an electrical connection to the controller 200. The sensor liquid wire tube 158 has the necessary electronic circuitry to establish electrical communication between each sensor 180 and / or each stimulator 194 operably attached thereto and a connection terminal 160 that provides an electrical connection to the controller 200. By attaching the first and second liquid wire tubes 154, 156 and the sensor liquid wire tube 158 directly to the inner surface of the outer fabric sheet 40, the liquid wire circuit assembly 150 can easily follow the contours of one or more areas of interest in the skin area S and position each of the one or more near-infrared light sources disclosed herein in close proximity to 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 that shown for the flexible printed circuit board assembly 110 in FIGS. 12-14.
[0028] 9-15, photobiomodulation unit 100 also includes 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, near-infrared light source 170 emits light having a wavelength 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, near-infrared light source 170 emits light having a wavelength 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 a wavelength 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 has a wavelength of, for example, about 700 nm to about 750 nm, about 700 nm to about 800 nm, about 700 nm to about 900 nm, about 700 nm to about 1000 nm, about 700 nm to about 1100 nm, about 700 nm to about 1200 nm, about 700 nm to about 1300 nm, about 700 nm to about 1400 nm, about 700 nm to about 1500 nm, about 750 nm to about 800 nm, about 750 nm to about 850 nm, about 750 nm to about 900 nm, about 750 nm to about 1000 nm, etc. 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 ~ The light having a wavelength of about 1300 nm, about 1000 nm to about 1400 nm, about 1000 nm to about 1500 nm, about 1100 nm to about 1200 nm, about 1100 nm to about 1300 nm, about 1100 nm to about 1400 nm, about 1100 nm to about 1500 nm, about 1200 nm to about 1300 nm, about 1200 nm to about 1400 nm, about 1200 nm to about 1500 nm, about 1300 nm to about 1400 nm, about 1300 nm to about 1500 nm, or about 1400 nm to about 1500 nm.
[0030] In some embodiments, the one or more near-infrared light sources 170 are each configured to emit near-infrared light in a pulse wave (or frequency) range of about 1 Hz to about 100 Hz. In some embodiments, the near-infrared light source 170 emits light having a pulse wave 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 source 170 emits light having a pulse wave 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 a pulse wave 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 some embodiments, the near-infrared light source 170 may have a frequency of, for example, about 10 Hz to about 20 Hz, about 10 Hz to about 30 Hz, about 10 Hz to about 40 Hz, about 10 Hz to about 50 Hz, about 10 Hz to about 60 Hz, about 10 Hz to about 70 Hz, about 10 Hz to about 80 Hz, about 10 Hz to about 90 Hz, about 10 Hz to about 100 Hz, about 20 Hz to about 30 Hz, about 20 Hz to about 40 Hz, about 20 Hz to about 50 Hz, about 20 Hz to about 60 Hz, about 20 Hz to about 70 Hz, about 20 Hz to about 80 Hz, about 20 Hz to about 90 Hz, about 20 Hz to about 100 Hz, about 30 Hz to about 40 Hz, about 30 Hz to about 50 Hz, about 30 Hz to about 60 Hz, about 30 Hz to about 70 Hz, about 30 Hz to about 80 Hz, about 30 Hz to about 90 Hz, about 30 Hz to about 100 Hz, about 30 Hz to about 40 Hz, about 30 Hz to about 50 Hz, about 30 Hz to about 60 Hz, about 30 Hz to about 70 Hz, about 30 Hz to about 80 Hz, about 30 Hz to about 80 Hz, about 30 Hz to about 90 Hz, about 30 Hz to about 100 Hz, about 30 Hz to about 40 Hz, about 30 Hz to about 50 Hz, about 30 Hz The pulse wave emitted is light having a pulse wave of about 50Hz to about 90Hz, about 30Hz to about 100Hz, about 40Hz to about 50Hz, about 40Hz to about 60Hz, about 40Hz to about 70Hz, about 40Hz to about 80Hz, about 40Hz to about 90Hz, about 40Hz to about 100Hz, about 50Hz to about 60Hz, about 50Hz to about 70Hz, about 50Hz to about 80Hz, about 50Hz to about 90Hz, about 50Hz to about 100Hz, about 60Hz to about 70Hz, about 60Hz to about 80Hz, about 60Hz to about 90Hz, about 60Hz to about 100Hz, about 70Hz to about 80Hz, about 70Hz to about 90Hz, about 70Hz to about 100Hz, about 80Hz to about 90Hz, about 80Hz to about 100Hz, or about 90Hz to about 100Hz.
[0031] In some embodiments, the one or more near-infrared light sources 170 are each configured to emit near-infrared light in a pulse wave (or frequency) range of about 100 Hz to about 1000 Hz. In some embodiments, the near-infrared light source 170 emits light having a pulse wave 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 source 170 emits light having a pulse wave 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 a pulse wave 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 some embodiments, the near-infrared light source 170 may be, for example, about 100 Hz to about 200 Hz, about 100 Hz to about 300 Hz, about 100 Hz to about 400 Hz, about 100 Hz to about 500 Hz, about 100 Hz to about 600 Hz, about 100 Hz to about 700 Hz, about 100 Hz to about 800 Hz, about 100 Hz to about 900 Hz, about 100 Hz to about 1000 Hz, about 200 Hz to about 300 Hz, about 200 Hz to about 400 Hz, about 2 ...200 Hz to about 600 Hz, about 200 Hz to about 700 Hz, about 200 Hz to about 800 Hz, about 200 Hz to about 900 Hz, about 100 Hz to about 1000 Hz, about 200 Hz to about 1000 Hz, about 200 Hz to about 1000 Hz, about 200 Hz to about 1000 Hz, about 200 Hz to about 1000 Hz, about 200 Hz to about 1000 Hz, about 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 ~ about 900Hz, about 400Hz - about 1000Hz, about 500Hz - about 600Hz, about 500Hz - about 700Hz, about 500Hz - about 800Hz, about 500Hz - about 900Hz, about 500H The pulse wave of the pulse generator emits light having a pulse wave of about 1 to about 1000 Hz, about 600 Hz to about 700 Hz, about 600 Hz to about 800 Hz, about 600 Hz to about 900 Hz, about 600 Hz to about 1000 Hz, about 700 Hz to about 800 Hz, about 700 Hz to about 900 Hz, about 700 Hz to about 1000 Hz, about 800 Hz to about 900 Hz, about 800 Hz to about 1000 Hz, or about 900 Hz to about 1000 Hz.
[0032] In some embodiments, the one or more near-infrared light sources 170 are each 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 source 170 emits light having a pulse wave 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 source 170 emits light having a pulse wave 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 source 170 emits light having a pulse wave 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 some embodiments, near-infrared light source 170 emits light having a pulse wave of, for example, about 1000 Hz to about 2000 Hz, about 1000 Hz to about 3000 Hz, about 1000 Hz to about 4000 Hz, about 1000 Hz to about 5000 Hz, about 2000 Hz to about 3000 Hz, about 2000 Hz to about 4000 Hz, about 2000 Hz to about 5000 Hz, about 3000 Hz to about 4000 Hz, about 3000 Hz to about 5000 Hz, or about 4000 Hz to about 5000 Hz.
[0033] In some embodiments, the one or more near-infrared light sources 170 are each configured to emit near-infrared light in a range of radiation energy from about 100 J to about 1100 J. In some embodiments, the near-infrared light source 170 has a radiation energy 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 source 170 has a radiation energy 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 has an output of, for example, about 100 J to about 200 J, about 100 J to about 300 J, about 100 J to about 400 J, about 100 J to about 500 J, about 100 J to about 600 J, about 100 J to about 700 J, about 100 J to about 800 J, about 100 J to about 900 J, about 100 J to about 1000 J, about 100 J to about 1100 J, about 200 J to about 300 J, about 200 J to about 400 J, about 200 J to about 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 , about 600J to about 900J, about 600J to about 1000J, about 600J to about 1100J, about 700J to about 800J, about 700J to about 900J, about 700J to about 1000J, about 700J to about 1100J, about 800J to about 900J, about 800J to about 1000J, about 800J to about 1100J, about 900J to about 1000J, about 900J to about 1100J, or about 1000J to about 1100J.
[0034] In some embodiments, the one or more near infrared light sources 170 each have an intensity of about 5 mW / cm 2 ~about 100mW / cm 2 In some embodiments, the near-infrared light source 170 is configured to emit near-infrared light in an irradiance (luminous flux density) range of about 5 mW / cm. 2 , about 10mW / cm 2 , about 15mW / cm 2 , about 20mW / cm 2 , about 25mW / cm2 , about 30mW / cm 2 , about 35mW / cm 2 , about 40mW / cm 2 , about 50mW / cm 2 , about 60mW / cm 2 , about 70mW / cm 2 , about 80mW / cm 2 , about 90mW / cm 2 , or about 100 mW / cm 2 In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of at least 5 mW / cm, for example. 2 , at least 10 mW / cm 2 , at least 15mW / cm 2 , at least 20mW / cm 2 , at least 25 mW / cm 2 , at least 30mW / cm 2 , at least 35mW / cm 2 , at least 40mW / cm 2 , at least 50mW / cm 2 , at least 60mW / cm 2 , at least 70mW / cm 2 , at least 80mW / cm 2 , at least 90mW / cm 2 , or at least 100 mW / cm 2 In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of, for example, at most 5 mW / cm 2 , at most 10mW / cm 2 , at most 15mW / cm 2 , at most 20mW / cm 2 , at most 25mW / cm 2 , at most 30mW / cm 2 , at most 35mW / cm 2 , at most 40mW / cm 2 , at most 50mW / cm 2 , at most 60mW / cm 2 , at most 70mW / cm 2 , at most 80mW / cm 2 , at most 90mW / cm 2 , or at most 100mW / cm 2In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of, for example, about 5 mW / cm 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 about 30 mW / cm 2 ~about 35mW / cm 2In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of, for example, about 20 mW / cm 2 ~about 50mW / cm 2 , about 20mW / cm 2 ~about 60mW / cm 2 , about 20mW / cm 2 ~about 70mW / cm 2 , about 20mW / cm 2 ~about 80mW / cm 2 , about 20mW / cm 2 ~about 90mW / cm 2 , about 20mW / cm 2 ~about 100mW / cm 2 , about 30mW / cm 2 ~about 60mW / cm 2 , about 30mW / cm 2 ~about 70mW / cm 2 , about 30mW / cm 2 ~about 80mW / cm 2 , about 30mW / cm 2 ~about 90mW / cm 2 , about 30mW / cm 2 ~about 100mW / cm 2 , about 40mW / cm 2 ~about 60mW / cm 2 , about 40mW / cm 2 ~about 70mW / cm 2 , about 40mW / cm 2 ~about 80mW / cm 2 , about 40mW / cm 2 ~about 90mW / cm 2 , about 40mW / cm 2 ~about 100mW / cm 2 , about 50mW / cm 2 ~about 60mW / cm 2 , about 50mW / cm 2 ~about 70mW / cm 2 , about 50mW / cm 2 ~about 80mW / cm 2 , about 50mW / cm 2 ~about 90mW / cm 2 , about 50mW / cm 2 ~about 100mW / cm 2 , about 60mW / cm 2 ~about 70mW / 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 about 90 mW / cm 2 ~about 100mW / cm 2 It has a radiance (luminous flux density) of
[0035] In some embodiments, the one or more near infrared light sources 170 each have an intensity of about 100 mW / cm 2 ~About 1000mW / cm 2 In some embodiments, the near-infrared light source 170 is configured to emit near-infrared light in an irradiance (luminous flux density) range of about 100 mW / cm. 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 about 1000 mW / cm 2 In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of at least 100 mW / cm, for example. 2 , at least 200 mW / cm 2 , at least 300mW / cm 2 , at least 400mW / cm 2, at least 500mW / cm 2 , at least 600mW / cm 2 , at least 700mW / cm 2 , at least 800mW / cm 2 , at least 900mW / cm 2 , or at least 1000 mW / cm 2 In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of, for example, at most 100 mW / cm 2 , at most 200mW / cm 2 , at most 300mW / cm 2 , at most 400mW / cm 2 , at most 500mW / cm 2 , at most 600mW / cm 2 , at most 700mW / cm 2 , at most 800mW / cm 2 , at most 900mW / cm 2 , or at most 1000mW / cm 2 In some embodiments, the near-infrared light source 170 has an irradiance (luminous flux density) of, for example, about 100 mW / cm 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 2, about 200mW / cm 2 ~About 500mW / cm 2 , about 200mW / cm 2 ~About 600mW / cm 2 , about 200mW / cm 2 ~About 700mW / cm 2 , about 200mW / cm 2 ~About 800mW / cm 2 , about 200mW / cm 2 ~About 900mW / cm 2 , about 200mW / cm 2 ~About 1000mW / cm 2 , about 300mW / cm 2 ~About 400mW / cm 2 , about 300mW / cm 2 ~About 500mW / cm 2 , about 300mW / cm 2 ~About 600mW / cm 2 , about 300mW / cm 2 ~About 700mW / cm 2 , about 300mW / cm 2 ~About 800mW / cm 2 , about 300mW / cm 2 ~About 900mW / cm 2 , about 300mW / cm 2 ~About 1000mW / cm 2 , about 400mW / cm 2 ~About 500mW / cm 2 , about 400mW / cm 2 ~About 600mW / cm 2 , about 400mW / cm 2 ~About 700mW / cm 2 , about 400mW / cm 2 ~About 800mW / cm 2 , about 400mW / cm 2 ~About 900mW / cm 2 , about 400mW / cm 2 ~About 1000mW / cm 2 , about 500mW / cm 2 ~About 600mW / cm 2 , about 500mW / cm 2 ~About 700mW / cm 2 , about 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 about 900 mW / cm 2 ~About 1000mW / cm 2 It has a radiance (luminous flux density) of
[0036] In some embodiments, the one or more near infrared light sources 170 each have an intensity of about 5 J / cm 2 ~About 100J / cm 2 In some embodiments, the near-infrared light source 170 is configured to emit near-infrared radiation in a radiant exposure (fluence) range of about 5 J / cm. 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 about 100 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, at least 5 J / cm 2 , at least 10 J / cm 2 , at least 15 J / cm 2 , at least 20 J / cm 2 , at least 30 J / cm 2 , at least 40 J / cm 2 , at least 50 J / cm 2 , at least 70 J / cm 2 , at least 70 J / cm 2 , at least 75 J / cm 2 , at least 80 J / cm 2 , at least 90 J / cm 2 , or at least 100 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, at most 5 J / cm 2 , at most 10 J / cm 2 , at most 15J / cm 2 , at most 20 J / cm 2 , at most 30J / cm 2 , at most 40J / cm 2 , at most 50 J / cm 2 , at most 70J / cm 2 , at most 70J / cm 2 , at most 75J / cm 2 , at most 80J / cm 2 , at most 90 J / cm 2 , or at most 100 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, about 5 J / cm 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 ~About 50J / cm 2 , about 5J / cm 2 ~About 60J / cm 2 , about 5J / cm 2 ~About 70J / cm 2 , about 5J / cm 2 ~About 75J / cm 2 , about 5J / cm 2 ~About 80J / cm 2 , about 5J / cm 2 ~About 90J / cm 2 , about 5J / cm 2 ~About 100J / cm 2 , about 10J / cm 2 ~About 15J / cm 2 , about 10J / cm 2 ~About 20J / cm 2 , about 10J / cm 2 ~About 30J / cm 2 , about 10J / cm 2 ~About 40J / cm 2 , about 10J / cm 2 ~About 50J / cm 2 , about 10J / cm 2 ~About 60J / cm 2 , about 10J / cm 2 ~About 70J / cm 2 , about 10J / cm 2 ~About 75J / cm 2 , about 10J / cm 2 ~About 80J / cm 2 , about 10J / cm 2 ~About 90J / cm 2 , about 10J / cm 2 ~About 100J / cm 2 , about 20J / cm 2 ~About 30J / cm 2 , about 20J / cm 2 ~About 40J / cm 2 , about 20J / cm 2 ~About 50J / cm 2 , about 20J / cm 2 ~About 60J / cm 2 , about 20J / cm 2 ~About 70J / cm 2 , about 20J / cm 2 ~About 75J / cm 2, about 20J / cm 2 ~About 80J / cm 2 , about 20J / cm 2 ~About 90J / cm 2 , about 20J / cm 2 ~About 100J / cm 2 , about 30J / cm 2 ~About 40J / cm 2 , about 30J / cm 2 ~About 50J / cm 2 , about 30J / cm 2 ~About 60J / cm 2 , about 30J / cm 2 ~About 70J / cm 2 , about 30J / cm 2 ~About 75J / cm 2 , about 30J / cm 2 ~About 80J / cm 2 , about 30J / cm 2 ~About 90J / cm 2 , about 30J / cm 2 ~About 100J / cm 2 , about 40J / cm 2 ~About 50J / cm 2 , about 40J / cm 2 ~About 60J / cm 2 , about 40J / cm 2 ~About 70J / cm 2 , about 40J / cm 2 ~About 75J / cm 2 , about 40J / cm 2 ~About 80J / cm 2 , about 40J / cm 2 ~About 90J / cm 2 , about 40J / cm 2 ~About 100J / cm 2 , about 50J / cm 2 ~About 60J / cm 2 , about 50J / cm 2 ~About 70J / cm 2 , about 50J / cm 2 ~About 75J / cm 2 , about 50J / cm 2 ~About 80J / cm 2 , about 50J / cm 2 ~About 90J / cm 2 , about 50J / cm 2 ~About 100J / 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 about 90 J / cm 2 ~About 100J / cm 2 has a radiation exposure (fluence).
[0037] In some embodiments, the one or more near-infrared light sources 170 each have an intensity of about 100 J / cm 2 ~About 1000J / cm 2 In some embodiments, the near-infrared light source 170 is configured to emit near-infrared radiation in a radiant exposure (fluence) range of about 100 J / cm. 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 about 1000 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, at least 100 J / cm. 2 , at least 200 J / cm 2 , at least 300 J / cm 2 , at least 400 J / cm 2, at least 500 J / cm 2 , at least 600 J / cm 2 , at least 700 J / cm 2 , at least 800 J / cm 2 , at least 900 J / cm 2 , or at least 1000 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, at most 100 J / cm 2 , at most 200 J / cm 2 , at most 300 J / cm 2 , at most 400 J / cm 2 , at most 500 J / cm 2 , at most 600 J / cm 2 , at most 700 J / cm 2 , at most 800 J / cm 2 , at most 900 J / cm 2 , or at most 1000 J / cm 2 In some embodiments, the near-infrared light source 170 has a radiation exposure (fluence) of, for example, about 100 J / cm. 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 ~about 500J / cm2 , about 200J / cm 2 ~About 600J / cm 2 , about 200J / cm 2 ~About 700J / cm 2 , about 200J / cm 2 ~About 800J / cm 2 , about 200J / cm 2 ~About 900J / cm 2 , about 200J / cm 2 ~About 1000J / cm 2 , about 300J / cm 2 ~About 400J / cm 2 , about 300J / cm 2 ~About 500J / cm 2 , about 300J / cm 2 ~About 600J / cm 2 , about 300J / cm 2 ~About 700J / cm 2 , about 300J / cm 2 ~About 800J / cm 2 , about 300J / cm 2 ~About 900J / cm 2 , about 300J / cm 2 ~About 1000J / cm 2 , about 400J / cm 2 ~About 500J / cm 2 , about 400J / cm 2 ~About 600J / cm 2 , about 400J / cm 2 ~About 700J / cm 2 , about 400J / cm 2 ~About 800J / cm 2 , about 400J / cm 2 ~About 900J / cm 2 , about 400J / cm 2 ~About 1000J / cm 2 , about 500J / cm 2 ~About 600J / cm 2 , about 500J / cm 2 ~About 700J / cm 2 , about 500J / cm 2 ~About 800J / cm 2 , about 500J / cm 2 ~About 900J / cm 2 , about 500J / 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 about 900 J / cm 2 ~About 1000J / cm 2 has a 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 (power) 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 (power) 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 400 mW, at most 425 mW, at most 450 mW, at most 500 mW, at most 525 mW, at most 550 mW, at most 575 mW, or at most 600 mW. In some embodiments, the high-power near-infrared light source has a radiant flux (output) of, for example, about 400 mW to about 450 mW, about 400 mW to about 500 mW, about 400 mW to about 550 mW, about 400 mW to about 600 mW, about 450 mW to about 500 mW, about 450 mW to about 550 mW, about 450 mW to about 600 mW, about 500 mW to about 550 mW, about 500 mW to about 600 mW, or about 550 mW to about 600 mW.
[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 100 mW, at most 200 mW, at most 300 mW, at most 400 mW, at most 500 mW, at most 600 mW, at most 700 mW, at most 800 mW, at most 900 mW, or at most 1000 mW.In some embodiments, the high-output near-infrared light source may be, for example, about 100 mW to about 200 mW, about 100 mW to about 300 mW, about 100 mW to about 400 mW, about 100 mW to about 500 mW, about 100 mW to about 600 mW, about 100 mW to about 700 mW, about 100 mW to about 800 mW, about 100 mW to about 900 mW, about 100 mW to about 1000 mW, about 200 mW to about 300 mW, about 200 mW to about 400 mW, about 2 ...200 mW to about 600 mW, about 200 mW to about 700 mW, about 200 mW to about 800 mW, about 200 mW to about 900 mW, about 100 mW to about 1000 mW, about 200 mW to about 1000 mW, about 200 mW to about 1000 mW, about 200 mW to about 250 mW, about 200 mW to about 300 mW, about 200 mW to about 400 mW, about 200 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 about 900mW, about 300mW to about 1000mW, about 400mW to about 500mW, about 400mW to about 600mW, about 400mW to about 700mW, about 400mW to about 800mW, about 400mW to about 900mW, about 400mW to about 1000mW, about 500mW to about 600mW, about 500mW to about 700mW, about 500mW to about 800mW, about 500mW to about 900mW, about 50 The laser has a radiant flux (output) of 0 mW to about 1000 mW, about 600 mW to about 700 mW, about 600 mW to about 800 mW, about 600 mW to about 900 mW, about 600 mW to about 1000 mW, about 700 mW to about 800 mW, about 700 mW to about 900 mW, about 700 mW to about 1000 mW, about 800 mW to about 900 mW, about 800 mW to about 1000 mW, or about 900 mW to about 1000 mW.
[0040] In some embodiments, the high power near infrared light source has a radiant intensity (brightness) 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 (brightness) 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 radiation intensity (brightness) 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 may be, for example, about 150 mW / sr to about 200 mW / sr, about 150 mW / sr to about 300 mW / sr, about 150 mW / sr to about 400 mW / sr, about 150 mW / sr to about 500 mW / sr, about 150 mW / sr to about 600 mW / sr, about 150 mW / sr to about 700 mW / sr, about 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, about 300mW / sr~about 500mW / sr, about 300mW / sr~about 600mW / sr, about 300mW / sr~about 700mW / sr, about 300mW / sr~about 800mW / sr, approx. 400mW / sr ~ approx. 500mW / sr, approx. 400mW / sr ~ approx. 600mW / sr, approx. 400mW / sr ~ approx. 700mW / sr, approx. 400mW / The luminance range (or radiation intensity) is about 500mW / sr to about 800mW / sr, about 500mW / sr to about 600mW / sr, about 500mW / sr to about 700mW / sr, about 500mW / sr to about 800mW / sr, about 600mW / sr to about 700mW / sr, about 600mW / sr to about 800mW / sr, or about 700mW / sr to about 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 (power) of, for example, at most 30 mW, at most 35 mW, at most 40 mW, at most 45 mW, at most 50 mW, at most 55 mW, at most 60 mW, at most 65 mW, at most 70 mW, or at most 75 mW. In some embodiments, the low-power near-infrared light source has a radiant flux (output) of, for example, about 30 mW to about 40 mW, about 30 mW to about 50 mW, about 30 mW to about 60 mW, about 30 mW to about 70 mW, about 30 mW to about 75 mW, about 40 mW to about 50 mW, about 40 mW to about 60 mW, about 40 mW to about 70 mW, about 40 mW to about 75 mW, about 50 mW to about 60 mW, about 50 mW to about 70 mW, about 50 mW to about 75 mW, about 60 mW to about 70 mW, or about 60 mW to about 75 mW.
[0042] In some embodiments, the low-power near-infrared light source is configured to have a radiant intensity (brightness) 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 radiant intensity (brightness) 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 (brightness) 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 may be, for example, about 25 mW / sr to about 50 mW / sr, about 25 mW / sr to about 75 mW / sr, about 25 mW / sr to about 100 mW / sr, about 25 mW / sr to about 125 mW / sr, about 25 mW / sr to about 150 mW / sr, about 50 mW / sr to about 75 mW / sr, about 50 mW / sr to about 100 mW / sr, or about 50 mW / sr. sr to about 125mW / sr, about 50mW / sr to about 150mW / sr, about 75mW / sr to about 100mW / sr, about 75mW / sr to about 125mW / sr, about 75mW / sr to about 150mW / sr, about 100mW / sr to about 125mW / sr, about 100mW / sr to about 150mW / sr, or about 125mW / sr to about 150mW / sr.
[0043] 9-15, the photobiomodulation unit 100 also includes one or more sensors 180 configured to detect and collect information regarding one or more parameters, including operational information of the photobiomodulation therapeutic garment 20, biometric information of the user, or other useful information to ensure proper use and effectiveness. Operational information includes, but is not limited to, location information and safety information of the photobiomodulation therapeutic garment 20. Biometric information includes, but is not limited to, body measurements and calculations related to the user. Non-limiting examples of biometric sensors include nerve conduction sensors, galvanometric 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. The one or more sensors 180 may also measure, record, and analyze information and / or transmit information to the controller 200, where the information may be measured, recorded, and analyzed.
[0044] In one or more embodiments, as shown in FIG. 9, FIG. 11, FIG. 15, and FIG. 16, the sensor cover 79 and the one or more sensors 180 thereunder are positioned between the second near-infrared light source group 172 and the fifth near-infrared light source group 175. This position of the sensor cover 79 positions the sensor cover 79 and the one or more sensors 180 thereunder substantially above the sagittal plane 320 of the forehead area. In some embodiments, in the absence of the second near-infrared light source group 172 and / or the fifth near-infrared light source group 175, the sensor cover 79 and the one or more sensors 180 thereunder can be positioned on the photobiomodulation therapy headband 22 in a position configured such that the sensor cover 79 is substantially above the sagittal plane 320 when properly worn. In some embodiments, the sensor cover 79 and the one or more sensors 180 thereunder 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 below or nearby are disposed 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 below or nearby are disposed between the first near-infrared light source group 171 and the fourth near-infrared light source group 174 (or outside such groups in a direction toward the left portion 56), and one sensor cover 79 and one or more sensors 180 below or nearby are disposed between the third near-infrared light source group 173 and the sixth near-infrared light source group 176 (or outside such groups in a direction toward the right portion 54).
[0045] In some embodiments, the sensor 180 includes a heart rate sensor and a temperature sensor. With reference to FIG. 9 and FIG. 11-14, the one or more sensors 180 include a cardiovascular sensor 182 that detects blood flow pulse waves, oxygen levels, and other cardiovascular features. With reference to FIG. 10, which is a longitudinal cross-sectional view of the sensor mounting portion 142, the cardiovascular sensor 182 includes LED light sources 184, 186 and a photodetector 188. Light from the LED light sources 184, 186 hits blood vessels beneath the skin surface S, and a portion of the reflected light is captured by the photodetector 188. A signal from the cardiovascular sensor 182 is transmitted to the controller 200 for determining the cardiovascular parameters of the user. Similarly, with reference to FIG. 9 and FIG. 11-14, the one or more sensors 180 include a temperature sensor 192 that detects skin parameters such as, for example, skin temperature, skin density, and skin opacity (color). A signal from the temperature sensor 192 is transmitted to the controller 200 for determining the skin parameters of the user.
[0046] The photobiomodulation unit 100 may optionally include one or more stimulators 194 configured to provide brain stimulation or inhibition signals. Non-limiting examples of stimulators include components capable of generating magnetic fields useful for stimulating neural cells in the brain, such as, for example, magnetic materials that can be magnetized using an electric current (electromagnets). Such magnetic field generating components can be used to administer transcranial magnetic stimulation therapy. In some embodiments, the one or more stimulators 194 are operably attached to an electronics connector 162 or sensor liquid wire tube 158 having the necessary electronic circuitry to establish electrical communication between each of the one or more stimulators 194 and the connection terminal 160.
[0047] 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, a hardware processor, a memory, and an output, and may include one or more 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 may include one or more USB connectors and / or short-range wireless devices (e.g., BLUETOOTH modules, Wi-Fi modules, or other wireless communication devices or systems) for communicating with an external computer, such as a smartphone, desktop, laptop, tablet, other wearable computing device, server, etc. Controller 200 may operate autonomously or semi-autonomously, or may read executable software instructions, code, or other information from a memory or computer readable medium, or may receive information or instructions via input from a user, a healthcare provider, or from any other source logically connected to the computer or device, such as another networked computer, a server, or an artificial intelligence (AI) or machine learning system. In some embodiments, controller 200 may be remotely accessed and operated by a third party individual, such as a healthcare professional, to monitor usage of, alter operating parameters of, and / or collect data from, the personal photobiomodulation therapy garment 20, thereby providing a remote digital healthcare platform to assist users in receiving the most effective biomodulation therapy.In some embodiments, controller 200 may be a "virtual controller" and access to and operation of photobiomodulation therapeutic garment 20 by controller 200 is performed via a cloud computing element by a health care provider or any other source logically connected to the computer or device, such as another networked computer or server or an AI or machine learning based system. Controller 200 may 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 provide 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. Additionally, the controller 200 in one or more embodiments is a computing device that is programmed or configured to implement methods and algorithms that can operatively 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 operatively controls one or more of the following: operation times of the one or more near-infrared light sources 170, fluence levels of the one or more near-infrared light sources 170, irradiance levels of the one or more near-infrared light sources 170, whether the one or more near-infrared light sources 170 operate continuously or in a pulsed manner, which of the one or more near-infrared light sources 170 are activated or deactivated, and a predetermined dosimetry level. Additionally, the controller 200 operatively controls each of the one or more sensors 180, and receives and analyzes information collected from each of the one or more sensors 180. In some embodiments, the controller 200 operatively controls one or more of the operation times of the one or more stimulators 194, the output levels of the one or more stimulators 194, whether the one or more stimulators 194 operate continuously or in a pulsed manner, which of the one or more stimulators 194 are activated or deactivated, or any combination thereof.
[0049] In some embodiments, the controller 200 operationally commands activation of one or more infrared light sources 170 on the left side of the midsagittal plane 320 and deactivation of one or more infrared light sources 170 on the right side of the midsagittal plane 320, or vice versa. In some embodiments, the controller 200 operationally commands activation of one or more infrared light sources 170 on the left and right side of the midsagittal plane 320 with one or more infrared light sources 170 on the left side of the midsagittal plane 320 being activated at a higher irradiance level relative to one or more infrared light sources 170 on the right side of the midsagittal plane 320, or vice versa.
[0050] In some embodiments, the controller 200 uses 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 to dynamically adjust the operating parameters of the photobiomodulation therapy garment 20. Such input information is then processed by the controller 200 against information stored in an operational database in one or more algorithms, and based on the analysis made in comparing the collected or provided or input information in one or more algorithms with the information stored in such database, 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 instructions provided by the controller 200.
[0051] For example, the cardiovascular sensor 182 obtains cardiovascular parameters from the user during operation of the photobiomodulation therapy garment 20, and this input information is analyzed against the cardiovascular parameters stored in the 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 third person. In some embodiments, when a decrease in heart rate variability is detected by the cardiovascular sensor 182 and transmitted to the controller 200, the controller 200 provides executable instructions to optimize the pulse wave by increasing the frequency of light emitted from the one or more near-infrared light sources 170 in a situation where the user or third person selects an awakening therapy. As an example, the initial pulse wave of the photobiomodulation therapy garment 20 can be set to 40 Hz, and based on the detected heart rate variability, the controller 200 can increase the frequency of light emitted from the one or more near-infrared light sources 170 to 50 Hz. Through continuous monitoring and analysis of heart rate variability by the cardiovascular sensor 182 and controller 200, the 50 Hz pulse wave setting is maintained or increased to 60 Hz or 70 Hz or more to establish the proper pulse wave for the arousal therapy emitted from the 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 instructions to optimize the pulse wave by decreasing the frequency of light emitted from the one or more near-infrared light sources 170 in the situation where the user or a third party individual selects a 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 decrease the frequency of light emitted from the one or more near-infrared light sources 170 to 30 Hz. Continuous monitoring and analysis of the heart rate variability by the cardiovascular sensor 182 and the controller 200 maintains the 30 Hz pulse wave setting or decreases it to 10 Hz or 1 Hz to establish the proper pulse wave for the sedation or relaxation therapy emitted from the one or more near-infrared light sources 170. Such dynamic monitoring of the heart rate variability by the cardiovascular sensor 182 and the 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, skin sensor 192 obtains information regarding skin parameters from the user during operation of photobiomodulation therapy garment 20, and this input information is analyzed against skin information stored in the operational database to assess the actual skin parameters and adjust the operation of photobiomodulation therapy garment 20 based on a therapy selected by the user or third party individual. In some embodiments, when a decrease in skin temperature is detected by skin sensor 192 and transmitted to controller 200, controller 200 provides executable instructions to optimize skin temperature by increasing the irradiance of light emitted from one or more near-infrared light sources 170 in situations where the user or third party individual selects an awakening therapy. As an example, the initial irradiance of photobiomodulation therapy garment 20 is 250 mW / cm 2and based on the detected skin temperature, the controller 200 may set the irradiance of the light emitted from the one or more near-infrared light sources 170 to 500 mW / cm 2 Continuous monitoring and analysis of the skin temperature by the skin sensor 192 and controller 200 may increase the power consumption to 500 mW / cm. 2 or 750 mW / cm to establish proper skin temperature for wakefulness therapy. 2 or 1000mW / cm 2 Such dynamic monitoring of skin temperature by skin sensor 192 and controller 200 provides for continuous adjustment of irradiance to achieve the optimal skin temperature for the selected arousal therapy.
[0054] In some embodiments, when an increase in skin temperature is detected by skin sensor 192 and transmitted to controller 200, controller 200 provides executable instructions to optimize skin temperature by reducing the irradiance of light emitted from one or more near-infrared light sources 170 in situations where a user or third party individual has selected sedation or relaxation therapy. As an example, the initial irradiance of photobiomodulation therapy garment 20 may be 250 mW / cm 2 and based on the detected skin temperature, the controller 200 may set the irradiance of the light emitted from the one or more near-infrared light sources 170 to 100 mW / cm 2 Continuous monitoring and analysis of skin temperature by the skin sensor 192 and controller 200 can reduce the power consumption to 125 mW / cm 2 or 75 mW / cm to establish proper skin temperature for sedation or relaxation therapy. 2 or 25mW / cm 2 Such dynamic monitoring of skin temperature by skin sensor 192 and controller 200 provides for 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 for optimizing the skin temperature by increasing the duty cycle of the light emitted from the one or more near-infrared light sources 170 in the situation where the user or a third party individual selects the wake therapy. As an example, the initial duty cycle of the photobiomodulation therapeutic 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 the one or more near-infrared light sources 170 to 60%. Continuous monitoring and analysis of the skin temperature by the skin sensor 192 and the controller 200 maintains the 60% duty cycle setting or increases it to 75% or more to establish the proper skin temperature for the wake therapy. Such dynamic monitoring of the skin temperature by the skin sensor 192 and the controller 200 results in continuous adjustment of the duty cycle to achieve the optimal skin temperature for the selected wake therapy.
[0056] In some embodiments, when an increase 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 reducing the duty cycle of the light emitted from the one or more near-infrared light sources 170 in the situation where the user or a third party individual selects a 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 the one or more near-infrared light sources 170 to 40%. Continuous monitoring and analysis of the skin temperature by the skin sensor 192 and the controller 200 maintains the 40% duty cycle setting or reduces it to 25% or less to establish the proper skin temperature for the wakefulness therapy. Such dynamic monitoring of the skin temperature by the skin sensor 192 and the 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 higher skin opacity, indicative of skin with higher melanin content, is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions to optimize skin penetration by adjusting the wavelength or combination of wavelengths of light emitted from the 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 may be set to 900 nm, and based on the detected skin opacity, the controller 200 may increase the wavelength of light emitted from the one or more near-infrared light sources 170 to approximately 970 nm. Continuous monitoring and analysis of the skin opacity by the skin sensor 192 and controller 200 maintains the wavelength setting or increases it to 1000 nm or more to establish the proper wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of the skin opacity by the skin sensor 192 and controller 200 results in continuous adjustment of the wavelength to achieve optimal skin penetration of the selected therapy.
[0058] In some embodiments, when lower skin opacity, indicative of skin with lower melanin content, is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions to optimize skin penetration by adjusting the wavelength or combination of wavelengths of light emitted from the 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 may be set to 900 nm, and based on the detected skin opacity, the controller 200 may reduce the wavelength of light emitted from the one or more near-infrared light sources 170 to approximately 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 to 790 nm or below to establish the 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 of the selected therapy.
[0059] In some embodiments, when a higher skin density, indicative of 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 to optimize skin penetration by adjusting the wavelength of light emitted from the 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 may be set at 900 nm, and based on the detected skin density, the controller 200 may increase the wavelength of light emitted from the one or more near-infrared light sources 170 to approximately 970 nm. Continuous monitoring and analysis of the skin density by the skin sensor 192 and controller 200 maintains the wavelength setting or increases it to 1000 nm or more to establish the proper wavelength penetration into the skin for the selected therapy. Such dynamic monitoring of the skin density by the skin sensor 192 and controller 200 results in continuous adjustment of the wavelength to achieve optimal skin penetration of the selected therapy.
[0060] In some embodiments, when a lower skin density, indicative of skin with less fat content, is detected by the skin sensor 192 and transmitted to the controller 200, the controller 200 provides executable instructions to optimize skin penetration by adjusting the wavelength of light emitted from the 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 may be set at 900 nm, and based on the detected skin density, the controller 200 may reduce the wavelength of light emitted from the one or more near-infrared light sources 170 to approximately 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 to 790 nm or less to establish the 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 of the selected therapy.
[0061] As another example, information can be provided by a user or a third party individual during operation of the photobiomodulation therapy garment 20, and this input information can be used directly to adjust the operation of the photobiomodulation therapy garment 20 based on a therapy selected by the user, or analyzed against user-defined or third party-defined information stored in the operational database to adjust the operation of the photobiomodulation therapy garment 20 based on the selected therapy. As an 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 light characteristics emitted from the one or more near-infrared light sources 170. Continuous user or individual third party input to the controller 200 establishes the proper light characteristics for the selected awakening therapy. Such dynamic monitoring of the 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 obtains information regarding mitochondrial function from the user during operation of the photobiomodulation therapy garment 20, and this input information is analyzed against mitochondrial function information stored in the operational database to assess actual mitochondrial function and adjust the operation of the photobiomodulation therapy garment 20 based on the therapy selected by the user or a third person. As an example, the initial therapy of the photobiomodulation therapy garment 20 can be set to an awake therapy, and based on the detected mitochondrial function (e.g., NAD+ levels or NADH levels, etc.), the controller 200 adjusts the characteristics of the light emitted from the one or more near-infrared light sources 170. Continuous monitoring and analysis of skin opacity by the sensor 180 and the controller 200 establishes the appropriate light characteristics for the selected awake therapy emitted from the one or more near-infrared light sources 170. Such dynamic monitoring of mitochondrial function by the sensor 180 and the controller 200 results in continuous adjustment of the light characteristics to achieve optimal skin penetration of the selected awake therapy.
[0063] The adjustments made by controller 200 and described in the examples in the paragraphs above, and the processing performed on various types of information, may be performed in conjunction with a machine learning based framework that applies elements of artificial intelligence (AI) to analyze information provided as input in models trained on historical or known data, such as data stored in the operational database described above, to improve such adjustments to the operating parameters of one or more near-infrared light sources 170, each of one or more sensors 180, and each of one or more stimulators 194. Thus, the present invention may include such a machine learning based framework, which may be comprised of multiple elements that perform some of the processing aspects performed by controller 200 as models instantiated together or separately.
[0064] The modeling performed within the machine learning based framework may include many different types of machine learning and may apply many different mathematical techniques to analyze information and generate outputs that improve the results of the ongoing adjustments of the operating parameters of each of the one or more near-infrared light sources 170, the one or more sensors 180, and the one or more stimulators 194 described herein. For example, in some embodiments of the present invention, the machine learning based framework may be comprised of algorithms that apply techniques of supervised learning, reinforcement learning, and other techniques of machine learning and artificial intelligence to further evaluate inputs to the controller 200.
[0065] Machine learning based frameworks may consist of any of several different mathematical techniques. These may include statistical analysis, which is a non-deterministic mathematical technique that allows the calculation of the probability that an event will or will not occur. Regression analysis is a type of statistical analysis in which a model is used 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 forecast and predict outcomes when such causal relationships affect future states of the overall modeling application being performed. There are many types of regression analysis, such as linear and non-linear regression, and specific techniques, such as logistic regression, that allow the interpretation of the significance of maxima 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 may also be used to calculate probabilities in the present invention and are within the scope of the present invention. Other techniques that may be used include, but are not limited to, decision trees, random forest classifiers, support vector machines, and probit. It should therefore 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, and in particular its application at one or more layers of machine learning.
[0066] Modeling within a machine learning based framework may also include the application of neural networks. Neural networks are generally composed of nodes, which are computational units with one or more biased input / output connections. Such biased connections act as transfer (or activation) functions that combine the inputs and outputs in some way. The nodes are organized into layers that form neural networks. There are many types of neural networks, which are computing systems that "learn" to perform tasks based on examples and without being programmed with task-specific rules.
[0067] Neural networks are generally based on an array of connected aggregate nodes (or "neurons") that send signals to each other in multiple layers via biased input / output connections. As mentioned above, the connections are activation or transfer functions that "fire" these nodes and combine inputs according to a mathematical formula or expression. Different types of neural networks generally have different configurations of layers of connected aggregate nodes, but they can generally be described as an input layer, an intermediate or "hidden" layer, and an output layer. These layers may perform different transformations on different inputs using different mathematical calculations or functions.
[0068] Signals are sent between nodes via connections, and the output of each node is calculated with a nonlinear function that sums all the 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 the inputs and sends them across the nodes and connections. These weights represent the increase or decrease in the strength of the signal at a particular connection. Additionally, nodes may have thresholds such that a signal is sent only if the aggregated output at that node exceeds that threshold. Weights generally represent the time that the activation function takes, while biases represent when such functions start, both of which help minimize the gradient over time. At least in the case of weights, the weights are initialized and may 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 as they learn, and the formulas and functions that make up the neural network design may change over time as the system itself improves.
[0069] The application of neural networks within a machine learning based framework may include instantiation of different networks for different purposes, including both "production" neural networks configured to improve algorithms executed within the overall modeling framework to generate output data (e.g., as adjusted operating parameters of one or more near-infrared light sources 170, each of one or more sensors 180, and each of one or more stimulators 194), and "training" neural networks configured to train the production networks using improvements based on past historical results learned so far.
[0070] Recurrent neural networks is the name given to a type of neural network in which the connections between nodes follow a directed time sequence, allowing the neural network to model dynamic behavior in time and to process input sequences of variable length. These types of neural networks are deployed when there is a need to recognize and / or act on such sequences. As with neural networks in general, there are many types of recurrent neural networks.
[0071] Neural networks with recurrent architectures also have memory or controlled internal states that allow storage under the direct control of the neural network, making them more suitable for inputs that are of a temporal nature. This storage can be in the form of connections or gates that act as time delays or feedback loops that allow nodes or connections to hold data ahead in time to model such temporal dynamic behavior. Such controlled internal states are called gated states or gated memories and are part of the names of various types of recurrent neural network architectures: long short-term memory network (LSTM) and gated recurrent unit (GRU). 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, as mentioned above, when the system is designed to process inputs that consist of timed data sequences. Examples of such timed data sequences include video, speech recognition, and handwriting, the processing of which requires the analysis of time-varying data. In the present invention, where the output data is in the form of operating parameters of 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, understanding the impact of various events on the condition over a period of time can lead to much more accurate and reliable operating parameters, which may affect at least the amount of time stimulation 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, neural Turing machines, etc., all of which exhibit the ability to model temporal dynamic behavior. It should be understood that instantiations of such neural networks in the present invention include one or more of these types, and that neural networks applied within a machine learning-based framework may include different ones of such types. Thus, the present invention contemplates that many types of neural networks may be implemented, depending at least 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 disposed within the housing. The controller 200 may be removed from the terminal rail mount 164 to charge the internal rechargeable battery by using a charging connector such as USB-C, micro-USB, or the like. Additionally, the charging connector may provide wired data communication with a remote computer such as a smartphone, laptop, desktop, or other computing device. In one or more embodiments, this allows for tracking of usage and / or updating or changing operating parameters such as desired dosimetry, duration, 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 may be a universal controller such that the controller 200 can be connected to multiple embodiments of the photobiomodulation therapy garment 20, such as a photobiomodulation therapy headband 22, a garment for the neck region, a garment for the posterior neck region, a garment for the carpal region, and a garment for the abdominal region, each configured to cover a respective region when worn.
[0074] The one or more near-infrared light sources 170 of the photobiomodulation unit 100 can be arranged into one or more separate near-infrared light source groups that are arranged in several intergroup patterns relative to one another on one or more regions of interest of the skin area S to be treated with 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 an adjacent group, and the intergroup spacing can be the same between each near-infrared light source group or can vary depending on the desired dose measurements and can vary depending on the relative location 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 to at least partially cover a respective region of interest on the skin surface S, which may appear at first glance to be a random pattern. The spacing of the inter-group pattern between each near-infrared light source group can be defined by a column distance d1 and a row distance d2. The distance between the 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 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 particular area of interest when the photobiomodulation therapy garment 20 is properly positioned on the forehead of the 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 in a manner at least partially overlapping or substantially centered on a normal meridian, a major paradoxical meridian, a minor paradoxical meridian, or any combination thereof when the photobiomodulation therapy garment 20 is properly worn. The normal meridians include, but are not limited to, the heart meridian, the pericardium meridian, the lung meridian, the spleen meridian, the liver meridian, the kidney meridian, the small intestine meridian, the large intestine meridian, the triple burner meridian, the stomach meridian, the gallbladder meridian, and the bladder meridian. The major paradoxical meridians include, but are not limited to, the Ren meridian and the Du meridian. Minor paradoxical meridians include, but are not limited to, the Chong, Dai, Yinwei, Yinjiao, Yangwei, and Yangjiao.
[0076] In some embodiments, as shown in Figures 3, 9, 11, 12, 15, and 16, photobiomodulation unit 100 includes six near-infrared light source groups, namely, first near-infrared light source group 171, second near-infrared light source group 172, third near-infrared light source group 173, fourth near-infrared light source group 174, fifth near-infrared light source group 175, and sixth near-infrared light source group 176. In some embodiments, referring to Figures 3, 15, 16 as well as Figures 9 and 11, the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the near-infrared light source 170 present on photobiomodulation unit 100 are arranged in a rectangular array pattern of three columns and two rows, with each near-infrared light source group separated by a column distance d1 and a row distance d2. In these embodiments, near-infrared light source groups 171, 172, 173, 174, 175, 176 are arranged in a pattern configured to direct each light source toward a particular region of interest when photobiomodulation therapy headband 22 is properly positioned on the forehead of person P. For example, in some embodiments, near-infrared light source groups 171, 172, 173, 174, 175, 176 are configured within photobiomodulation therapy headband 22 such that, when worn on the forehead of person P, photobiomodulation therapy headband 22 is positioned substantially above brow ridge region 322 with first, second, third, fourth, fifth, and sixth near-infrared light source groups 171, 172, 173, 174, 175, 176 being arranged at least above the orbits of person P.In some embodiments, each of the near-infrared light source groups 171, 172, 173, 174, 175, 176 is configured such that when the photobiomodulation therapy headband 22 is properly worn, the first near-infrared light source group 171 of the near-infrared light source 170 is in a first position at least partially overlapping or substantially centered on the Fp1 region 300, the second near-infrared light source group 172 of the near-infrared light source 170 is in a second position at least partially overlapping or substantially centered on the Fpz region 302, and the third near-infrared light source group 173 of the near-infrared light source 170 is in a second position at least partially overlapping or substantially centered on the Fp2 region 303. the fourth near-infrared light source group 174 of the near-infrared light source 170 is at a third position at least partially overlapping or substantially centered on the F3 portion 306, the fifth near-infrared light source group 175 of the near-infrared light source 170 is at a fifth position at least partially overlapping or substantially centered on the Fz portion 308, and the sixth near-infrared light source group 176 of the near-infrared light source 170 is at a sixth position at least partially overlapping or substantially centered on the F4 portion 310.
[0077] 12, photobiomodulation unit 100 includes six near-infrared light source groups of near-infrared light sources 170: first near-infrared light source group 171, second near-infrared light source group 172, third near-infrared light source group 173, fourth near-infrared light source group 174, fifth near-infrared light source group 175, and sixth near-infrared light source group 176. The six near-infrared light source groups are organized into two inverted triangles, with first, second, third, and fourth near-infrared light source groups 171, 172, 173, 174 arranged in the top row and fifth and sixth near-infrared light source groups 175, 176 arranged in the bottom row. The first and second near-infrared light source groups 171, 172 are arranged to cover an area including the parts F3 306 and Fz 308 of the head H, and the third and fourth light source groups 173, 174 are arranged to cover an area including the parts Fz 308 and F4 310 of the head H. The fifth near-infrared light source group 175 is arranged to cover an area including the part Fp1 300, and the sixth near-infrared light source group 176 is arranged to cover an area including the part Fp2 304. In these embodiments, one or more sensors 180 are arranged between the fifth and sixth near-infrared light source groups 175, 176 of the lower tier.
[0078] 13, the photobiomodulation unit 100 includes five near-infrared light source groups of near-infrared light sources 170: 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, 173 are arranged in an upper row, and the fourth and fifth near-infrared light source groups 174, 175 are arranged in a 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, 173 are arranged to cover an area including the parts F3 306, Fz 308, and F4 310 of the head H. The fourth near-infrared light source group 174 is arranged to cover an area including the part Fp1 300, and the fifth near-infrared light source group 175 is arranged to cover an area including the part Fp2 304. In these embodiments, the one or more sensors 180 are arranged in a lower tier, 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] 14, the photobiomodulation unit 100 includes three near-infrared light source groups of near-infrared light sources 170: 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, 173 are aligned and positioned to cover an area of the head H including areas F3 306, Fz 308, and F4 310. In these embodiments, the 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 comprises a single-beam near-infrared light source 170. For example, as shown in Figures 11-14 and 16, each of the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the photobiomodulation unit 100 comprises a single-beam near-infrared light source 170. In embodiments in which only a single-beam near-infrared light source 170 is present in a near-infrared light source group, such near-infrared light source 170 is preferably a high-power near-infrared light source having a radiant intensity (brightness) range of about 150 mW / sr or greater, more preferably about 250 mW / sr or greater.
[0081] In some embodiments, each of the near-infrared light source groups comprises a multi-beam near-infrared light source 170. For example, as shown in FIG. 9 and FIG. 15, each of the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the photobiomodulation unit 100 comprises a nine-beam near-infrared light source 170. In embodiments where there are multiple near-infrared light sources 170 in a near-infrared light source group, all such near-infrared light sources 170 can be low-power near-infrared light sources having a radiant intensity (brightness) range of 125 mW / sr or less. In other embodiments where there are multiple near-infrared light sources 170 in a near-infrared light source group, all such near-infrared light sources 170 can be a combination of both high-power near-infrared light sources having a radiant intensity (brightness) range of about 150 mW / sr or more, more preferably about 250 mW / sr or more, and low-power near-infrared light sources having a radiant intensity (brightness) range of 125 mW / sr or less.
[0082] Additionally, in embodiments where a 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 in the same group. The intra-group spacing of each near-infrared light source 170 in a near-infrared light source intra-group can be the same between each individual near-infrared light source 170, or can vary depending on the desired dosimetry measurements and can vary depending on the relative location of the desired region of interest. In some embodiments, each individual near-infrared light source 170 in each of the near-infrared light source groups is arranged in a pattern configured for a desired therapeutic effect where each individual near-infrared light source 170 is random relative to other individual near-infrared light sources 170 in 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 capabilities, etc. The relative pattern of the near-infrared light source groups is configured to arrange each near-infrared light source 170 on the photobiomodulation therapy garment 20 to at least partially cover a respective region of interest on the skin surface S, which may appear at first glance to be a random pattern.
[0083] Each individual near-infrared light source 170 in a near-infrared light source internal group is spaced apart from all other individual near-infrared light sources 170 in the same internal group by an intra-group light source spacing. Each near-infrared light source 170 in a near-infrared light source internal group can be arranged in a pattern that matches the location of multiple regions of interest on the skin surface S. Thus, the resulting near-infrared light source internal groups appear to be arranged in an irregular pattern that corresponds to the location of multiple regions of interest on the skin surface S, with each region of interest being at least partially covered by a corresponding group at the same time. As a result, the spacing between the near-infrared light source internal groups and the relative location of each near-infrared light source 170 in the near-infrared light source internal group can be varied depending on the location of the region of interest on the skin surface S.
[0084] In some embodiments, for example, in a rectangular array as shown in FIG. 3, the spacing between each near-infrared light source 170 of the near-infrared light source inner group can be defined by a column spacing d3 and a row spacing d4. The intra-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 a rectangular array, the row spacing d3 can be the same distance as the column spacing d4, or can be a different distance. In such a rectangular array, each near-infrared light source 170 of the near-infrared light source inner 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 inner group can be a 2x2 array, a 2x3 array, a 3x2 array, a 3x3 array, a 3x4 array, a 4x3 array, a 4x4 array, a 2x5 array, a 5x2 array, a 3x5 array, a 5x3 array, a 4x5 array, a 5x4 array, a 5x5 array, etc. In some embodiments, each near-infrared light source 170 of the near-infrared light source inner group can be configured as a radial array or a circular array around a single circle or multiple concentric circles. In these embodiments, the spacing between the 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 a plurality of near-infrared light sources 170 arranged in an intra-group array. In some embodiments, the near-infrared light source groups 171, 172, 173, 174, 175, 176 of the photobiomodulation therapy garment 20 are each configured as a near-infrared light source internal group comprising a plurality of near-infrared light sources 170 arranged in an intra-group array, with the first near-infrared light source group 171 comprising a plurality of near-infrared light sources 170 configured in the first near-infrared light source internal group, the second near-infrared light source group 172 comprising a plurality of near-infrared light sources 170 configured in the second near-infrared light source internal group, and so on. 70, the third near-infrared light source group 173 comprises a plurality of near-infrared light sources 170 configured in 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 configured in 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 configured in 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 configured in the sixth near-infrared light source internal group.
[0086] In some embodiments, referring to Figures 3, 9, and 12, near-infrared light source groups 171, 172, 173, 174, 175, 176 of photobiomodulation therapy headband 22 are configured as near-infrared light source inner groups each comprising nine near-infrared light sources 170 arranged in a 3x3 array with three columns and three rows. In this example, d3 is greater than d4, allowing for a combination and overlap of light patterns incident on skin surface S, as well as strategic gaps or areas of less overlapping light patterns to produce a therapeutic effect. In the illustrated exemplary embodiment, d3=6mm-7mm and d4=9mm-10mm. The overlapping patterns of incident light result in regions of various power levels incident on the skin surface S within and around each array or group, regions of maximum irradiance and fluence immediately beneath each individual near-infrared light source 170, regions of lower irradiance and fluence between closely spaced individual near-infrared light sources 170, and regions of minimum irradiance and fluence between the individual near-infrared light sources 170 that are furthest from each other. Additionally, although each of the near-infrared light source intra-groups of near-infrared light source groups 171, 172, 173, 174, 175, 176 are shown as each having the same intra-group pattern, each intra-group pattern may be comprised of a different pattern and number of individual near-infrared light sources 170, which may be determined based on the desired treatment regime and dosimetry required for each region of interest.
[0087] In one or more embodiments, during operation, the groups of near-infrared light sources can all be activated by the controller 200 using the same operating parameters (e.g., all groups activated at the same time, all in pulsed mode, all with the same power settings). In one or more embodiments, during operation, the groups of near-infrared light sources can each be activated by the controller 200 with different operating parameters where one or more selected groups are activated and other groups remain off. Furthermore, in one or more embodiments, the controller 200 has the ability to control the power level and / or pulsed / continuous operation of each group of near-infrared light sources independently from other groups of near-infrared light sources on the photobiomodulation therapy garment 20. There is great flexibility in the operating parameters available. Not only can each individual group of near-infrared light sources be operated individually, but each individual near-infrared light source 170 within each group of near-infrared light sources can be individually addressed and controlled using individual operating parameters. In this manner, each individual near-infrared light source 170 may be individually addressable as a unit such that it can be activated / turned on or deactivated / turned off, respectively, independent of all other individual near-infrared light sources 170. Furthermore, in one or more embodiments, each individual near-infrared light source 170 may be operated in a pulsed or continuous mode, independent of all other individual near-infrared light sources 170. Furthermore, in one or more embodiments, each individual near-infrared light source 170 may be operated using an output profile independent of all other individual light sources. In this manner, several predefined patterns may be initiated via executable instructions from the controller 200, and the pattern of activated light sources may vary depending on the desired therapeutic effect and the location of the area of interest.
[0088] 8, 15, and 16, in some embodiments, the photobiomodulation therapy garment 20 is assembled by sandwiching the photobiomodulation unit 100 between the outer fabric sheet 40 and the inner fabric sheet 70. In some embodiments, as shown in FIG. 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 mounts 164 of the connecting terminals 160 and is placed between the outer fabric sheet 40 and the photobiomodulation unit 100. In some embodiments, as shown in FIGS. 15 and 16, the liquid wire circuit assembly 150 is attached directly to the outer fabric sheet 40, for example, by using an adhesive or by being woven 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 aligned with the outer fabric sheet 40 in a manner that allows the terminal rail mounts 164 of the connecting terminals 160 to be inserted through the terminal rail mount openings 58. In embodiments in which the photobiomodulation unit 100 comprises a liquid wire circuit assembly 150, the connection terminals 160 are attached to the outer fabric sheet 40 during construction of the liquid wire circuit assembly 150 on the outer fabric sheet 40.
[0089] 8, 15, and 16, once the photobiomodulation unit 100 is placed 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 openings 222 and one or more sensor openings 224, which are cutouts configured to provide clearance for the respective components such that the double-sided tape 220 does not interfere with the operation of the one or more near-infrared light sources 170 and the one or more sensors 180. If present, a sensor cover 79 is properly positioned over the corresponding sensor 180. The inner fabric sheet 70 is then aligned with the outer fabric sheet 40 and the photobiomodulation unit 100 and positioned such 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 openings 76 and sensor openings 78, thereby enabling proper functioning of these components. The inner fabric sheet 70 can then be secured to the outer fabric sheet 40 by sewing the edges of the inner fabric sheet 70 to the outer fabric sheet 40.
[0090] The photobiomodulation therapy garments disclosed herein are useful for providing photobiomodulation therapy, including transcranial photobiomodulation therapy. Such non-invasive light-based neuromodulation therapy does not require medication and provides long-term effects by altering the user's brain function from the neuronal level by providing a variety of positive photochemical reactions. For example, photobiomodulation therapy can increase neuromitochondrial energy and adenosine triphosphate (ATP) production, resulting in increased cellular energy production. In addition, the delivery of light energy can also trigger the production of reactive oxygen species (ROS), which can reduce inflammation and improve cellular repair and healing at the cellular and tissue levels, the production of nitric oxide (NO), which is important for good vascular health and optimal blood flow, the delivery of nutrients, and the removal of waste products. This is important because insufficient cerebral blood flow and circulation can cause memory blur, forgetfulness, poor concentration, and even dementia in the brain. Enhanced cellular energy and increased cerebral blood flow result in increased neurogenesis and neuroplasticity, increased neuroprotection, enhanced neurorepair, and reduced inflammation. Furthermore, such photobiomodulation therapy provides both calming and relaxation benefits, as well as improved focus and performance, resulting in improved mental productivity, mental health, and overall cognitive function.
[0091] In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used as the sole treatment device. In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with another treatment modality. In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with another cognitive behavioral therapy.
[0092] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with another photobiomodulation therapy, such as, for example, a high power irradiance photobiomodulation therapy. In some embodiments, an individual receives approximately 55 mW / cm 2 In conjunction with low-power transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein that can provide an irradiance of about 250 mW / cm 2 The individual receives high-power transcranial photobiomodulation therapy using a stationary device capable of delivering an irradiance of 10 ...
[0093] In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with transcranial magnetic stimulation (TMS). In some embodiments, an individual receives approximately 20 mW / cm 2 ~about 500mW / cm 2The subject receives TMS in conjunction with low-power transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein capable of delivering an irradiance of 1000 nm to 1000 nm. In some embodiments, the TMS is administered in a clinical or other healthcare facility setting, and the low-power photobiomodulation therapy is administered in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, the low-power transcranial photobiomodulation therapy is used to enhance the effects of TMS and improve the treatment of depression and depressive symptoms in an individual. In some embodiments, the circadian-based timing administration disclosed herein may be used to time the administration of the TMS, the low-power transcranial photobiomodulation therapy, or both.
[0094] In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with evidence-based mental health practices. In some embodiments, an individual receives approximately 55 mW / cm 2The patient receives evidence-based mental health practices in conjunction with low-power transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein that can provide an irradiance of: 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-based living (ACT), acceptance and commitment therapy (ACT), sustained exposure therapy (PE), cognitive training and rehabilitation, and motivational interviewing (MI). In some embodiments, the evidence-based mental health practices are delivered by a therapist in a clinical or other health care facility setting, while the low-power photobiomodulation therapy is delivered in a non-clinical setting, such as, for example, at home, in a park, or while traveling in a vehicle. In some embodiments, the evidence-based mental health practices are delivered by a therapist in a virtual environment, while the low-power photobiomodulation therapy is delivered in a non-clinical setting, such as, for example, 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-power photobiomodulation therapy is administered in a non-clinical setting, such as at home, in a park, or while traveling in a vehicle. In some embodiments, the low-power transcranial photobiomodulation therapy is used to enhance the effectiveness of the evidence-based mental health practice and improve the treatment of depression and depressive symptoms in an individual. In some embodiments, the circadian-based timing of administration disclosed herein may be used to time the administration of the evidence-based mental health practice, the low-power transcranial photobiomodulation therapy, or both.
[0095] In some embodiments, the photobiomodulation therapy garments disclosed herein are used in conjunction with ocular light therapy, such as bright light therapy or blue light therapy. In some embodiments, an individual receives approximately 20 mW / cm 2 ~about 500mW / cm 2The patient receives ocular light therapy in conjunction with transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein capable of providing an irradiance of 100 nm to 100 nm. In some embodiments, the transcranial photobiomodulation therapy can be administered daily during the ocular light therapy and / or between two or more ocular light therapies. In some embodiments, the transcranial photobiomodulation therapy is used to enhance the effects of the ocular light therapy by enhancing relaxation, sedation, and well-being. In some embodiments, the circadian-based timing administration disclosed herein will be used to time the administration of the ocular light therapy, the transcranial photobiomodulation therapy, or both.
[0096] In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with mindfulness therapy. In some embodiments, an individual receives approximately 20 mW / cm 2 ~about 300mW / cm 2 Mindfulness therapy is practiced in conjunction with transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein that can provide an irradiance of 1000 nm to 1000 nm. In some embodiments, the transcranial photobiomodulation therapy can be administered daily during and / or between two or more mindfulness therapies. In some embodiments, the transcranial photobiomodulation therapy is used to enhance the effects of mindfulness therapy by enhancing relaxation, sedation, and well-being. In some embodiments, the circadian-based timing administration disclosed herein will be used to time the administration of the mindfulness therapy, the transcranial photobiomodulation therapy, or both.
[0097] In some embodiments, the photobiomodulation therapeutic garments disclosed herein are used in conjunction with meditation therapy. In some embodiments, an individual receives approximately 20 mW / cm 2 ~about 300mW / cm2 Meditation therapy is practiced in conjunction with transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein capable of providing an irradiance of 1000 nm to 1000 nm. In some embodiments, transcranial photobiomodulation therapy can be administered daily during a meditation therapy and / or between two or more meditation therapy sessions. In some embodiments, transcranial photobiomodulation therapy is used to enhance the effects of meditation therapy by enhancing relaxation, sedation, and well-being. In some embodiments, circadian-based timing administration as disclosed herein will be used to time administration of meditation therapy, transcranial photobiomodulation therapy, or both.
[0098] In some embodiments, photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein is administered based on an individual's circadian rhythm, alone or in conjunction with another therapy. In some embodiments, an individual receives transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein during the morning hours, such as between 6:00 AM and 10:00 AM. In some embodiments, an individual receives transcranial photobiomodulation therapy using a photobiomodulation therapy garment disclosed herein during the afternoon / evening hours, such as between 3:00 PM and 7:00 PM. Approximately 20 mW / cm 2 ~about 500mW / cm 2 Photobiomodulation therapy garments disclosed herein capable of providing an irradiance of up to 100 nm may be used for such circadian-based timing administration. In some embodiments, circadian-based timing administration may be useful for treating depression and depressive symptoms in an individual.
[0099] Aspects of the present specification can also be described by the following embodiments: 1. A photobiomodulation therapy garment for placement over a skin surface having an area of interest, the photobiomodulation therapy garment comprising: a flexible outer sheet; a flexible inner sheet having a portion that allows for the passage of near-infrared radiation 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 and aligned with a portion of the flexible inner sheet and configured to emit near-infrared radiation at a wavelength between 600 nm and 1600 nm and a predetermined dosimetry measurement toward the area of interest on the skin surface during photobiomodulation treatment; and a controller having a processor and memory and in electrical communication with the near-infrared light source through the flexible circuit board, the processor and memory configured with executable instructions for controlling one or more of a light source operation time, a light source fluence level, a light source irradiance level, a light source pulsed operation, and a light source continuous operation. 2. A photobiomodulation therapy garment as described in 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 toward an area of interest on the skin surface during photobiomodulation treatment. 3. A photobiomodulation therapy garment as described in embodiment 1 or embodiment 2, wherein the groups of near-infrared light sources are 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. 4. The photobiomodulation therapy garment of any one of embodiments 1 to 3, wherein the region of interest is one of an Fp1 region, an Fpz region, an Fp2 region, an F3 region, an Fz region, and an F4 region, a posterior neck region, a wrist region, and an abdominal region, and the group of near-infrared light sources is configured to at least partially overlap the region of interest. 5. A photobiomodulation therapy garment as described in any one of embodiments 1 to 4, wherein the sensor is configured to detect one or more parameters indicative of position and then transmit a position signal to the controller so that the position on the skin surface can be determined. 6. A photobiomodulation therapy garment as described in 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. A photobiomodulation therapy garment as described in any one of embodiments 1 to 6, wherein the sensor is configured to detect one or more parameters indicative of a position and then transmit a position signal to a controller so that a position on the skin surface can be determined, and the sensor is positioned between the second group of near-infrared light sources and the fifth group of near-infrared light sources. 8. A photobiomodulation therapy garment as described in 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 minimally separated from each other by an inter-group light source spacing of greater than 5 mm, or greater than 10 mm, or greater than 15 mm, or greater than 20 mm, or greater than 25 mm, or greater than 30 mm. 9. A photobiomodulation therapy garment as described in 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 as described in any one of embodiments 1 to 9, further comprising a second group of near-infrared light sources arranged in a second 3 x 3 array, a third group of near-infrared light sources arranged in a third 3 x 3 array, a fourth group of near-infrared light sources arranged in a fourth 3 x 3 array, a fifth group of near-infrared light sources arranged in a fifth 3 x 3 array, and a sixth group of near-infrared light sources arranged in a sixth 3 x 3 array. 11. A photobiomodulation therapy garment as described in 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 one another by an inter-group light source spacing of greater than 5 mm, or greater than 10 mm, or greater than 15 mm, or greater than 20 mm, or greater than 25 mm, or greater than 30 mm. 12. A photobiomodulation therapy garment as described in 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 minimally separated from one another by an inter-group light source spacing sufficient to prevent substantial light bleed therebetween. 13. A photobiomodulation therapy garment as described in any one of embodiments 1 to 12, wherein the area of interest is one or more of the Fp1 area, Fpz area, Fp2 area, F3 area, Fz area, F4 area, posterior neck area, wrist area, and abdominal area on the skin surface. 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 an Fp1 region, the second near-infrared light source is configured to emit near-infrared light toward an Fpz region, the third near-infrared light source is configured to emit near-infrared light toward an Fp2 region, the fourth near-infrared light source is configured to emit near-infrared light toward an F3 region, the fifth near-infrared light source is configured to emit near-infrared light toward an Fz region, and the sixth near-infrared light source is configured to emit near-infrared light toward an F4 region, wherein the Fp1 region is a 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. 15. A photobiomodulation therapy garment as described in any one of embodiments 1 to 14, wherein the sensor is configured to detect one or more parameters indicative of a position and then transmit a position signal to a controller so that a 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. A photobiomodulation therapy garment described in any one of embodiments 1 to 15, wherein the sensor is one or both of a heart rate sensor and a temperature sensor. 17. A photobiomodulation therapy garment described in any one of embodiments 1 to 16, wherein each of the near-infrared light source, the second near-infrared light source, the third near-infrared light source, the fourth near-infrared light source, the fifth near-infrared light source, and the 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 photobiomodulation therapy garment as described in any one of embodiments 1 to 9, wherein the near-infrared light source is a first group of near-infrared light sources, the second near-infrared light source is a second group of near-infrared light sources, the third near-infrared light source is a third group of near-infrared light sources, the fourth near-infrared light source is a fourth group of near-infrared light sources, the fifth near-infrared light source is a fifth group of near-infrared light sources, and the sixth near-infrared light source is a sixth group of near-infrared light sources. 19. A photobiomodulation therapy garment as described in 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 as described in any one of embodiments 1 to 19, wherein each of 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 greater than 5 mm, or greater than 10 mm, or greater than 15 mm, or greater than 20 mm, or greater than 25 mm, or greater than 30 mm. 21. A photobiomodulation therapy garment as described in 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 one another by an inter-group light source spacing sufficient to prevent substantial light bleed therebetween. 22. A photobiomodulation therapy garment described in any one of embodiments 1 to 21, further comprising one or more stimulators. 23. A photobiomodulation therapy garment as described in embodiment 22, wherein the one or more stimulators include a component capable of generating a magnetic field. 24. A photobiomodulation therapy garment comprising: a clothing structure configured to be worn by a user on a skin surface; a first near-infrared light source integrated with the clothing structure; a second near-infrared light source integrated with the clothing structure and spaced apart from the first near-infrared light source; and a controller having a processor and memory, in electrical communication with the first near-infrared light source and the second near-infrared light source and configured with executable instructions for independently controlling operation of each 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 at a wavelength between 600 nm and 1600 nm and a predetermined dosimetry, wherein the first near-infrared light source is configured to be directed toward an area of interest on a first skin surface and the second near-infrared light source is configured to be directed toward an area of interest on a second skin surface when worn during a photobiomodulation therapy. 25. A photobiomodulation therapy garment as described in embodiment 24, wherein the executable instructions are configured to control one or more of light source operation time, light source fluence level, light source irradiance level, light source pulsed operation, and light source continuous operation. 26. A photobiomodulation therapy garment as described in embodiment 24 or embodiment 25, wherein a sensor is integrated with the clothing structure and configured to detect one or more parameters indicative of 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 area of interest on the skin surface and the second near-infrared light source is positioned over a second area of interest on the skin surface. 27. A photobiomodulation therapy garment described in any one of embodiments 24 to 26, wherein the sensor is one or both of a heart rate sensor and a temperature sensor. 28. A photobiomodulation therapy garment described in 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 described in 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. A photobiomodulation therapy garment as described in 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 minimally separated from each other by an inter-group light source spacing of greater than 5 mm, or greater than 10 mm, or greater than 15 mm, or greater than 20 mm, or greater than 25 mm, or greater than 30 mm. 31. A photobiomodulation therapy garment described in any one of embodiments 24 to 30, wherein a first group of near-infrared light sources are arranged in a first 3x3 array and a second group of near-infrared light sources are arranged in a second 3x3 array. 32. A photobiomodulation therapy garment described in any one of embodiments 24 to 31, further comprising a third group of near-infrared light sources arranged in a third 3 x 3 array, a fourth group of near-infrared light sources arranged in a fourth 3 x 3 array, a fifth group of near-infrared light sources arranged in a fifth 3 x 3 array, and a sixth group of near-infrared light sources arranged in a sixth 3 x 3 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, the first 3×3 array is configured to emit near-infrared radiation toward the Fp1 region, the second 3×3 array is configured to emit near-infrared radiation toward the Fpz region, the third 3×3 array is configured to emit near-infrared radiation toward the Fp2 region, the fourth 3×3 array is configured to emit near-infrared radiation toward the F3 region, the fifth 3×3 array is configured to emit near-infrared radiation toward the Fz region, and the sixth 3×3 array is configured to emit near-infrared radiation toward the F4 region. 34. A photobiomodulation therapy garment described in any one of embodiments 24 to 33, wherein the first area of interest is one of the Fp1 area, the Fpz area, the Fp2 area, the F3 area, the Fz area, and the F4 area, the posterior neck area, the wrist area, and the abdominal area. 35. A photobiomodulation therapy garment described in any one of embodiments 24 to 34, wherein the second area of interest is one of the Fp1 area, the Fpz area, the Fp2 area, the F3 area, the Fz area, and the F4 area, the posterior neck area, the wrist area, and the abdominal area. 36. A photobiomodulation therapy garment described in 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 described in any one of embodiments 24 to 37, further comprising one or more stimulators. 39. A photobiomodulation therapy garment as described in embodiment 38, wherein the one or more stimulators include a component capable of generating a magnetic field.
[0100] Aspects of the present specification can also be described by the following embodiments: 1. A photobiomodulation therapy garment configured to be worn by a user on a skin surface, the garment comprising a first surface and a second surface opposite the first surface, the first surface configured to face the skin surface when worn; and a photobiomodulation unit integrated within the garment, the photobiomodulation unit comprising a connection terminal, one or more near-infrared light sources, and one or more sensors, the connection terminal being in electronic communication 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 a wavelength between 600 nm and 1600 nm and a predetermined dosimetry; and a photobiomodulation unit including a processor and memory and configured to operably engage a terminal rail of the connection terminal in a manner to establish electronic communication with the connection terminal. and a controller including: a first surface of the garment including a first portion including one or more light source openings, each of the one or more near-infrared light sources being operatively aligned with the one or more light source openings to allow proper passage of near-infrared light from the one or more near-infrared light sources; a second surface of the garment including one or more sensor openings, each of the one or more sensors being operatively aligned with the one or more sensor openings to allow proper functioning of the one or more sensors through the one or more sensor openings; and wherein the processor and the memory are configured with executable instructions to independently control each of the one or more near-infrared light sources and each of the one or more sensors. Photobiomodulation therapy clothing. 2. A photobiomodulation therapy garment as described in embodiment 1, wherein the garment is configured to wrap or conform to a body part area and can be moved from one body part area to another body part area on the body. 3. A photobiomodulation therapy garment as described in embodiment 2, wherein the body part region is a head region, a neck region, a shoulder region, a torso region, a hand region, a wrist region, an arm region, a foot region, or a leg region, or any combination thereof. 4. A photobiomodulation therapy garment as described in embodiment 2, wherein the garment is a band, wrap, scarf, shawl, cape, robe, or blanket. 5. A photobiomodulation therapy garment as described in embodiment 1, wherein the garment is sized and dimensioned to specifically fit a particular part of the body. 6. A photobiomodulation therapy garment as described in embodiment 5, wherein the specific body part is a head region, a neck region, a shoulder region, a torso region, a hand region, a wrist region, an arm region, a foot region, or a leg region, or any combination thereof. 7. A photobiomodulation therapy garment as described in embodiment 4, wherein the garment is a hat, visor, shirt, pants, socks, gloves, or underwear. 8. A photobiomodulation therapy garment described in 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. A photobiomodulation therapy garment as described in any one of embodiments 1 to 8, wherein each of the one or more sensors is configured to detect and collect information of 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. A photobiomodulation therapy garment as described in embodiment 9, wherein the one or more parameters include operational information of the garment, the photobiomodulation unit and its components, and the controller and its components, biometric information of a user, or any combination thereof. 11. A photobiomodulation therapy garment as described in any one of embodiments 1 to 10, wherein the executable instructions independently control each of the one or more near-infrared light sources. 12. A photobiomodulation therapy garment as described in embodiment 11, wherein the executable instructions control the activation, activation duration, deactivation, deactivation duration, activation pattern and timing, deactivation pattern and timing, fluence level, irradiance level, dosimetry level, pulsed operation, continuous operation, operation time, cycle duration, or any combination thereof, of each of the one or more near-infrared light sources. 13. A photobiomodulation therapy garment as described in any one of embodiments 1 to 12, wherein the executable instructions independently control each of the one or more sensors. 14. A photobiomodulation therapy garment as described in embodiment 13, wherein the executable instructions control the collection and analysis of information from each of the one or more sensors. 15. A photobiomodulation therapy garment described in 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. A photobiomodulation therapy garment as described in embodiment 15, wherein the plurality of spaced near-infrared light sources are 3 to 6 near-infrared light sources. 17. A photobiomodulation therapy garment as described in embodiment 15 or embodiment 16, wherein the multiple spaced near-infrared light sources are arranged in a single row. 18. A photobiomodulation therapy garment as described in embodiment 15 or embodiment 16, wherein the multiple spaced near-infrared light sources are arranged in multiple rows. 19. A photobiomodulation therapy garment as described in embodiment 18, wherein the plurality of rows is 2 to 6. 20. A photobiomodulation therapy garment as described in any one of embodiments 15 to 19, wherein the multiple spaced near-infrared light sources are arranged in multiple rows. 21. A photobiomodulation therapy garment as described in embodiment 20, wherein the plurality of rows is 2 to 8. 22. A photobiomodulation therapy garment as described in any one of embodiments 15 to 17, embodiment 20, or embodiment 21, wherein the multiple near-infrared light sources are arranged in a row by column 1x2 array, 1x3 array, 1x4 array, 1x5 array, 1x6 array, 1x7 array, or 1x8 array. 23. A photobiomodulation therapy garment as described in any one of embodiments 15 to 17, embodiment 20, or embodiment 21, wherein the multiple near-infrared light sources include three near-infrared light sources arranged in a 1 x 3 array of rows and columns. 24. A photobiomodulation therapy garment described in any one of embodiment 17 or embodiment 20 to embodiment 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. A photobiomodulation therapy garment as described in any one of embodiments 15, 16, and 18 to 21, wherein the multiple near-infrared light sources are arranged in a row by 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. A photobiomodulation therapy garment described in any one of embodiments 15, 16, and 18 to 21, wherein the plurality of near-infrared light sources includes six near-infrared light sources arranged in a 2 x 3 array of rows and columns. 27. A photobiomodulation therapy garment described in any one of embodiments 15, 16, and 18 to 21, wherein the multiple near-infrared light sources include six near-infrared light sources arranged so that there are four near-infrared light sources in the upper row and two near-infrared light sources in the lower row. 28. A photobiomodulation therapy garment described in 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. A photobiomodulation therapy garment as described in any one of embodiments 15 to 28, wherein the multiple near-infrared light sources are arranged in multiple spaced near-infrared light source groups, each of the multiple near-infrared light source groups comprising multiple near-infrared light sources. 30. A photobiomodulation therapy garment as described in embodiment 29, wherein the multiple spaced near-infrared light source groups are arranged in a single row. 31. A photobiomodulation therapy garment as described in embodiment 29, wherein the plurality of spaced apart near-infrared light source groups are arranged in a plurality of rows. 32. A photobiomodulation therapy garment as described in embodiment 31, wherein the plurality of rows is 2 to 6. 33. A photobiomodulation therapy garment as described in any one of embodiments 29 to 32, wherein the plurality of spaced apart near-infrared light source groups are arranged in a plurality of rows. 34. A photobiomodulation therapy garment as described in embodiment 33, wherein the plurality of rows is 2 to 8. 35. A photobiomodulation therapy garment as described in any one of embodiment 29, embodiment 30, embodiment 33, or embodiment 34, wherein the multiple near-infrared light source groups are arranged in a row by column 1x2 array, 1x3 array, 1x4 array, 1x5 array, 1x6 array, 1x7 array, or 1x8 array. 36. A photobiomodulation therapy garment described in embodiment 30, or any one of embodiments 33 to 35, wherein the spacing between each of the multiple near-infrared light source groups included in the single row is 0.5 cm to 4 cm, and the spacing between each of the multiple near-infrared light source groups included in each of the multiple columns is 0.5 cm to 4 cm. 37. A photobiomodulation therapy garment as described in any one of embodiments 29, and embodiments 31 to 34, wherein the multiple near-infrared light source groups are arranged in a row by 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 described in any one of embodiments 31 to 34, or embodiment 37, wherein the spacing between each of the multiple near-infrared light source groups 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 source groups included in each of the multiple columns is 0.5 cm to 4 cm. 39. A photobiomodulation therapy garment as described in any one of embodiments 29 to 38, wherein the multiple spaced near-infrared light sources are arranged in a single row. 40. A photobiomodulation therapy garment as described in any one of embodiments 29 to 38, wherein the multiple spaced near-infrared light sources are arranged in multiple rows. 41. A photobiomodulation therapy garment as described in embodiment 40, wherein the plurality of rows is 2 to 6. 42. A photobiomodulation therapy garment as described in any one of embodiments 39 to 41, wherein the multiple spaced near-infrared light sources are arranged in multiple rows. 43. A photobiomodulation therapy garment as described in embodiment 42, wherein the plurality of rows is 2 to 8. 44. A photobiomodulation therapy garment as described in any one of embodiment 39, embodiment 42, or embodiment 43, wherein the multiple near-infrared light sources are arranged in a row by column 1x2 array, 1x3 array, 1x4 array, 1x5 array, 1x6 array, 1x7 array, or 1x8 array. 45. A photobiomodulation therapy garment described in 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. A photobiomodulation therapy garment as described in any one of embodiments 40 to 43, wherein the multiple near-infrared light sources are arranged in a row by 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. A photobiomodulation therapy garment described in any one of embodiments 40 to 43, wherein the plurality of near-infrared light sources includes nine near-infrared light sources arranged in a 3 x 3 array of rows and columns. 48. A photobiomodulation therapy garment described in 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 described in any one of embodiments 1 to 48, further comprising one or more stimulators. 50. A photobiomodulation therapy garment as described in embodiment 49, wherein the one or more stimulators include a component capable of generating a magnetic field. 51. A photobiomodulation therapy garment described in any one of embodiments 1 to 50, wherein the skin surface includes the forehead area, the back of the neck area, the wrist area, the abdominal area, or any combination thereof. 52. A photobiomodulation therapy garment as described in embodiment 51, wherein the forehead area includes the dorsolateral prefrontal cortex region, the frontal eye field region, or both. 53. A photobiomodulation therapy garment as described in embodiment 51, wherein the forehead area includes an Fp1 area, an Fpz area, an Fp2 area, an F3 area, an Fz area, an F4 area, or any combination thereof.
[0101] Working Example The following non-limiting examples are provided for illustrative purposes only to facilitate a more complete understanding of representative embodiments presently contemplated, and should not be construed as limiting any of the embodiments described herein, including those relating to the photobiomodulation therapeutic garments or methods and uses thereof disclosed herein.
[0102] Example 1 Photobiomodulation Therapy Clothing In one exemplary configuration, the transcranial photobiomodulation therapy garment 20, and 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 in a manner such that each intergroup at least partially overlaps or is substantially centered on a site 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 radiation is approximately 5.3 cm2. 2 ~Approx. 5.7cm 2and delivers photobiomodulation therapy to the dorsolateral prefrontal cortex (dlPFC) and frontal eye field (FEF). Each infrared light source intergroup has nine LEDs in a 3 × 3 rectangular array. Each LED has a power output of about 55 mW, with a peak light output of about 99 mW, emitting infrared light with a mean wavelength of 800 nm to about 850 nm and a pulse wave of 40 Hz. The average irradiance over the treatment area is about 16 mW / cm. 2 ~about 20mW / cm 2 , and the area of maximum irradiance is potentially up to about 240 mW / cm 2 ~Approx. 365mW / cm 2 The average fluence over the treatment area is approximately 40 J / cm 2 ~About 45J / cm 2 , the area of maximum fluence is potentially up to about 665 J / cm 2 ~Approx. 998J / cm 2 The total incident energy during a treatment session is about 2.0 kJ to about 2.5 kJ. The controller 200 operates the LEDs continuously (not pulsed) 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 and low power infrared light sources 170. For example, the top left and top right infrared light source intergroups can have the central infrared light source 170 in the 3×3 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 photobiomodulation therapy headband 22 exhibits an average irradiance across the treatment area of about 31 mW / cm 2 ~about 35mW / cm 2 , and the area of maximum irradiance is potentially up to about 445 mW / cm 2 ~about 670mW / cm 2 Furthermore, the average fluence over the treatment area is approximately 38 J / cm 2 ~about 60J / cm 2, the area of maximum fluence is potentially up to about 665 J / cm 2 ~Approx. 1,005J / cm 2 The total incident energy during a treatment session is about 2.0 kJ to about 5.0 kJ.
[0105] Example 2 Photobiomodulation Therapy Clothing In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, and specifically the photobiomodulation therapy headband 22, has three infrared light source intergroups arranged in a row. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 in a manner such that each intergroup at least partially overlaps or is substantially centered on a site Fp1 300, Fpz 302, and Fp2 304. The estimated total area of the skin surface S and underlying tissue exposed to near infrared radiation is approximately 2.8 cm2. 2 ~Approx. 3.3cm 2 and delivers photobiomodulation therapy to the frontal eye field (FEF). Each infrared light source intergroup has nine low power LEDs in a 3 x 3 rectangular array. Each infrared light source intergroup has nine LEDs in a 3 x 3 rectangular array. Each LED has a power output of about 55 mW, with a peak optical output of about 99 mW, emitting infrared light with a mean wavelength of 800 nm to about 850 nm and a pulse wave of 40 Hz (range 0 Hz to 100 Hz). The average irradiance over the treatment area is about 31 mW / cm. 2 ~about 35mW / cm 2 , and the area of maximum irradiance is potentially up to about 80 mW / cm 2 ~about 105mW / cm 2 The average fluence over the treatment area is approximately 58 J / cm 2 ~About 63J / cm 2 , the area of maximum fluence is potentially up to about 145 J / cm 2 ~About 185J / cm 2The total incident energy during a treatment session is about 1.2 kJ to about 3.0 kJ. The controller 200 operates the LEDs continuously (not pulsed) for a period of 10 to 40 minutes.
[0106] In an alternative configuration, the controller 200 operates the LEDs in a pulsed operation at 40 Hz and a 50% duty cycle (variable range is 5% to 100%) for a period of 30 minutes to about 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as previously described, with a peak irradiance of about 66 mW / cm. 2 ~about 67mW / cm 2 , and the maximum irradiance peak area is potentially up to about 160 mW / cm 2 ~about 205mW / cm 2 , with the maximum peak fluence over the treatment area potentially being up to approximately 145 J / cm 2 ~About 185J / cm 2 It is.
[0107] In an alternative configuration, the controller 200 operates the LEDs in a pulsed operation at 40 Hz and a 33% duty cycle (variable range is 5% to 100%) for a period of 30 minutes to about 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as previously described, with a peak irradiance of about 99 mW / cm. 2 ~Approx. 101mW / cm 2 , and the maximum irradiance peak area is potentially up to about 240 mW / cm 2 ~Approx. 310mW / cm 2 , with the maximum peak fluence over the treatment area potentially being up to approximately 145 J / cm 2 ~About 185J / cm 2 The total incident energy during a treatment session is approximately 2.3 kJ.
[0108] In an alternative configuration, the controller 200 operates the LEDs in pulsed operation at 10 Hz or 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 30 minutes to about 40 minutes. The average irradiance, average area of maximum irradiance, and average fluence are as previously described, with a peak irradiance of about 165 mW / cm. 2 ~Approx. 167mW / cm 2 , and the maximum irradiance peak area is potentially up to about 405 mW / cm 2 ~Approx. 510mW / cm 2 , with the maximum peak fluence over the treatment area potentially being up to approximately 145 J / cm 2 ~About 185J / cm 2 The total incident energy during a treatment session is approximately 2.3 kJ.
[0109] Example 3 Photobiomodulation Therapy Clothing In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, and specifically the photobiomodulation therapy headband 22, has six infrared light source intergroups arranged in two tiers, with four intergroups in the top tier and two intergroups in the bottom tier, organized as two inverted triangles. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 in a manner such that one inverted triangular array at least partially overlaps or is substantially centered on the sites F3 306, Fz 308, and Fp1 300, and the other inverted triangular array at least partially overlaps or is substantially centered on the sites Fz 308, F4 310, and Fp2 304. The estimated total area of the skin surface S and underlying tissue exposed to near infrared radiation is approximately 7.5 cm2. 2 ~about 9cm 2 (Each inverted triangle array is approximately 3.75 cm 2 ~about 4.5cm 2The infrared light source intergroup has one high-power LED. Each LED has a power of 500 mW, with a peak light output of 500 mW to 1,000 mW, emitting infrared light with a mean wavelength of 800 nm to about 850 nm and a pulse wave of 10 Hz to about 40 Hz (range 0 Hz to 5,000 Hz). The average irradiance over the treatment area is about 50 mW / cm. 2 ~about 300mW / cm 2 , and the area of maximum irradiance is potentially up to about 500 mW / cm 2 ~Approx. 1,000mW / cm 2 The average fluence over the treatment area is approximately 40 J / cm 2 ~Approx. 120J / cm 2 , and the area of maximum fluence is potentially up to about 450 J / cm 2 ~Approx. 1,025J / cm 2 The total incident energy during a treatment session is about 0.4 kJ to about 2.1 kJ. The controller 200 operates the LEDs in a pulsed operation at about 10 Hz to about 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 minutes to about 40 minutes.
[0110] In an alternative configuration, each LED has an output of 500 mW and emits infrared radiation with an average wavelength of 960 nm to about 1,100 nm and a pulse frequency of 0 Hz to about 100 Hz, potentially up to 5,000 Hz.
[0111] Example 4 Photobiomodulation Therapy Clothing In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, specifically the photobiomodulation therapy headband 22, has five infrared light source intergroups arranged in two rows, with three intergroups in the top row and two intergroups in the bottom row, organized in such a manner that one of each intergroup is below one of the intergroups from the top row. The infrared light source intergroups are arranged on the photobiomodulation therapy headband 22 such that the infrared light source intergroups in the top row at least partially overlap or are substantially centered on the sites F3 306, Fz 308, and F4 310, one of the intergroups in the bottom row at least partially overlap or are substantially centered on the site Fp1 300, and the other intergroup in the bottom row at least partially overlap or are substantially centered on the site Fp2 304. The estimated total area of the skin surface S and underlying tissue exposed to near infrared radiation is approximately 7.5 cm2. 2 ~about 8cm 2 and delivers 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 a power of 500 mW, with a peak light output of 500 mW to 1,000 mW, emitting infrared light with a mean wavelength of 800 nm to about 850 nm and a pulse wave of 10 Hz to about 40 Hz (adjustable in the range of 0 Hz to 5,000 Hz). The average irradiance over the treatment area is about 50 mW / cm. 2 ~about 300mW / cm 2 , and the area of maximum irradiance is potentially up to about 500 mW / cm 2 ~Approx. 1,000mW / cm 2 The average fluence over the treatment area is approximately 40 J / cm 2 ~Approx. 120J / cm 2 , and the area of maximum fluence is potentially up to about 450 J / cm 2 ~Approx. 1,025J / cm 2The total incident energy during a treatment session is about 0.4 kJ to about 2.1 kJ. The controller 200 operates the LEDs in a pulsed operation at about 10 Hz to about 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 minutes to about 40 minutes.
[0112] In an alternative configuration, each LED has an output of 500 mW and emits infrared radiation with an average wavelength of 960 nm to about 1,100 nm and a pulse frequency of 0 Hz to about 100 Hz, potentially up to 5,000 Hz.
[0113] Example 5 Photobiomodulation Therapy Clothing In another exemplary configuration, the transcranial photobiomodulation therapy garment 20, and specifically the photobiomodulation therapy headband 22, has three infrared light source intergroups arranged in a row. The infrared light source intergroups are configured on the photobiomodulation therapy headband 22 in a manner such that each intergroup at least partially overlaps or is substantially centered 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 radiation is approximately 2.8 cm2. 2 ~Approx. 3.3cm 2 and delivers photobiomodulation therapy to the dorsolateral prefrontal cortex (dlPFC). Each infrared light source intergroup has one high-power LED. Each LED has a power output of 500 mW, with a peak light output of 500 mW to 1,000 mW, emitting infrared light with a mean wavelength of 800 nm to about 850 nm and a pulse wave of 10 Hz to about 40 Hz. The average irradiance over the treatment area is about 50 mW / cm. 2 ~about 300mW / cm 2 , and the area of maximum irradiance is potentially up to about 500 mW / cm 2 ~Approx. 1,000mW / cm 2 The average fluence over the treatment area is approximately 6 J / cm 2 ~About 12J / cm 2 , and the area of maximum fluence is potentially up to about 450 J / cm 2~Approx. 1,025J / cm 2 The total incident energy during a treatment session is about 0.15 kJ to about 1.8 kJ. The controller 200 operates the LEDs in a pulsed operation at about 10 Hz to about 40 Hz and a 20% duty cycle (variable range is 5% to 100%) for 10 minutes to about 40 minutes.
[0114] In an alternative configuration, each LED has an output of 500 mW and emits infrared radiation with an average wavelength of 860 nm to about 1,100 nm and a pulse frequency of 0 Hz to about 100 Hz, potentially up to 5,000 Hz.
[0115] Example 6 tPBM treatment increases functional conductivity of neurons A research study was conducted to evaluate the neuronal conduction effects of transcranial photobiomodulation (tPBM) treatment 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 with two application sites on the left, two on the right, and two on the midline [left forehead, right forehead, and center of forehead on frontal EEG sites F3, Fpl, F4, Fp2, and Fz, Fpz]. Once correct placement was confirmed, the tPBM treatment was initiated by pressing a button on a specific phone application to activate a probe that delivers LED light. The duration of exposure was 40 minutes per treatment. The tPBM treatment followed the following specifications: energy was administered at a radiation wavelength of 850 nm, with an irradiance (IR) of 18 mW / cm 2 and the fluence is up to 43 Joules / cm 2 , the energy delivered in one session is up to 2.4 kJ, and each treatment window area is 55 cm 2 After completing tPBM treatment, each participant underwent a second 8-minute EEG analysis.
[0116] The results of this research study showed that participants exhibited increased functional connectivity of neurons (measured by EEG activity) compared to sham participants. For example, Figures 17A-17C show the results of five participants. Scans of the EEG analysis taken after tPPB treatment exhibit focused spots of light (Figure 17B) compared to scans acquired before tPBM treatment (Figure 17A). These differences are further highlighted by Figure 17C, which illustrates the focused light before and after the scan. These findings indicate that the connections between neurons have improved. With increased functional connectivity, neurons can transmit information faster and more accurately. The results were reproducible and were not evident in sham participants.
[0117] Example 7 tPBM treatment increases brain activity A research study was conducted to evaluate the brain activity effects of transcranial photobiomodulation (tPBM) treatment 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 with two application sites on the left, two on the right, and two on the midline [left forehead, right forehead, and center of forehead on frontal EEG sites F3, Fpl, F4, Fp2, and Fz, Fpz]. Once correct placement was confirmed, the tPBM treatment was initiated by pressing a button on a specific phone application to activate a probe that delivers LED light. The duration of the exposure was 40 minutes per treatment. The tPBM treatment followed the following specifications: energy was administered at a radiation wavelength of 850 nm, with an irradiance (IR) of 18 mW / cm 2 and the fluence is up to 43 Joules / cm 2 , the energy delivered in one session is up to 2.4 kJ, and each treatment window area is 55 cm 2 After completing tPBM treatment, each participant underwent a second 8-minute EEG analysis.
[0118] The results of this research study showed that participants exhibited increased brain gamma oscillations during treatment with 40 Hz pulsed waves compared to sham participants. For example, Figures 18A-18B show representative results from one participant. There was a significant increase of over 35% in brain gamma oscillations at a frequency of 40 Hz, as shown by the shaded block in Figure 18A. Additionally, as shown in Figure 18B, there was a notable peak in gamma power between approximately 250 seconds and approximately 350 seconds, at which point the gamma power level drops but remains at a higher level compared to the baseline gamma power level. These findings are indicative of brain gamma wave stimulation underlying many cognitive operations, including perception. Increased brain gamma wave stimulation promotes brain activity and transmits information faster and more accurately. The results were reproducible and were not evident in sham participants.
[0119] Example 8 tPBM Treatment of 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 garment disclosed herein in adults with active depressive symptoms. The study enrolled 19 participants who were clinically diagnosed with moderate to severe depressive symptoms according to the Beck's Depressive Inventory (BDI, baseline score 25).
[0120] Participants received tPBM treatments at home twice daily for 8 weeks using the photobiomodulation therapy garment disclosed herein. Each tPBM treatment was bilateral, with two left, two right, and two midline application sites on the frontal region (left forehead, right forehead, and center of forehead on frontal EEG sites F3, Fpl, F4, Fp2, and Fz, Fpz). Once correct placement was confirmed, tPBM treatment was initiated by pressing a button on a specific phone application to activate a probe that delivers LED light. Duration of exposure was 40 minutes per treatment. tPBM treatments were according to the following specifications: energy was administered at a radiation wavelength of 850 nm, with an irradiance (IR) of 18 mW / cm2.2 and the fluence is up to 43 Joules / cm 2 , the energy delivered in one session is up to 2.4 kJ, and each treatment window area is 55 cm 2 It is.
[0121] At the end of an 8-week clinical study of tPBM treatment using the photobiomodulation therapy garment disclosed herein for depression, the researchers detected a significant reduction in depressive symptoms among participants. For example, participants experienced a 43% reduction in depressive symptoms at week 8, as assessed by the Beck's Depression Inventory. This finding was a statistically significant change from baseline (significance p=0.001). Interestingly, the improvement was maintained for at least 4 weeks after tPBM treatment was stopped. In fact, the researchers detected a mean 48% reduction in depressive symptoms compared to baseline at week 12, as assessed by the Beck's Depression Inventory. 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 improved sleep quality.
[0122] Example 9 tPBM Treatment of Pediatric Depression An 8-week, open-label, pilot clinical study will be conducted to evaluate the safety and efficacy of tPBM treatment using the photobiomodulation therapy garment disclosed herein in children with active depressive symptoms as assessed via the Child Behavioral Checklist (CBCL). The study will enroll 20-30 participants ages 6-17 who are currently experiencing a CBCL T-score of 60 or greater on the anxiety / depression scale. Each participant will be clinically assessed with a battery of clinically administered questionnaires and scales, including: 1) the CBCL, a parent-report questionnaire assessing maladaptive behaviors and emotional problems, both internalizing and externalizing, in children aged 6-18 years; 2) the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q), a parent-report form consisting of 15 questions designed to assist in the assessment of enjoyment and satisfaction experienced by children over the past week; 3) the Behavior Rating Inventory of Executive Function-Parent Report (BRIEF-P), a 78-item rating scale to assess levels of executive dysfunction; and 4) the Social Responsiveness Scale (SRS), a 65-item rating scale completed by parents used to measure social behavior disorders occurring in natural environments.
[0123] Participants receive daily tPBM treatments for 8 weeks. The photobiomodulation therapy garments disclosed herein used in tPBM treatments are bilateral and applied to the frontal region with two application sites on the left, two on the right, and two on the midline [left forehead, right forehead, and center of forehead on frontal EEG sites F3, Fpl, F4, Fp2, and Fz, Fpz]. Once correct placement is confirmed, tPBM treatments are initiated by pressing a button on a specific phone application to activate a probe that delivers LED light. Duration of exposure begins at 10 minutes per treatment during the first week (days 1-7), increases to 20 minutes per treatment during the second week of treatment (days 7-14), and increases to 30 minutes per treatment during the third week of treatment (days 14-21). If side effects prevent an increase (or if a treatment response has already occurred), a lower dose is maintained to ensure good tolerability and treatment adherence. On day 21, if no improvement is seen despite good tolerance, the clinician recommends a 40-minute treatment. tPBM treatment follows the following specifications: energy is delivered at a radiation wavelength of 850 nm and irradiance (IR) is 18 mW / cm 2 and the fluence is up to 43 Joules / cm 2 , the energy delivered in one session is up to 2.4 kJ, and each treatment window area is 55 cm 2 It is.
[0124] Subjects are assessed weekly for the first 4 weeks and then biweekly thereafter. At each visit, safety and efficacy measures are obtained using assessments of psychiatric symptoms and functioning, and side effect scales. Further clinician and subject assessments are completed at midpoint (end of week 4) and at the final study visit (week 8 or termination). Response to treatment is assessed by the following scales: 1) the Clinician completed Depression Specific Clinical Global Impression (CGI-Depression), which includes the Clinical Global Severity (CGI-S), Clinical Global Improvement (CGI-I), and CGI-Efficacy Index (CGI-EI) scales, completed by the clinician at each visit; 2) the Affective Reactivity Index-Parent Report (ARI-P), a brief 7-question parent report form assessing irritability and irritability, completed by the parent at weeks 0 (baseline), 4, and 8; 3) the Childhood Anxiety Sensitivity Index (CASI-Anx), a 38-item scale assessing anxiety symptoms, completed by the parent at weeks 0 (baseline), 4, and 8; and 4) the Children's Depression Specific Clinical Global Impression (CDI). The Depressive Symptoms Inventory (DSA), a 27-item scale assessing depressive symptoms, is completed by parents at weeks 0 (baseline), 4, and 8.
[0125] Results are expected to show that tPBM treatment is safe and effective in reducing depressive symptoms in children.
[0126] Example 10 tPBM treatment of 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 garment disclosed herein in children diagnosed with ADHD who also exhibit at least moderate autistic traits. The study will enroll 90-100 participants ages 9-17 who meet DSM-5 diagnostic criteria for ADHD and exhibit moderate to severe symptoms of autism spectrum disorder as established by the Social Responsiveness Scale, 2nd Edition (SRS-2) raw score ≥ 75 or CGI-AT (Clinical Global Impressions - Autistic Traits) severity score ≥ 4.Each participant was clinically evaluated by a board-certified clinician for ADHD and autistic traits, and the parent / guardian of all participants completed a brief demographic interview and the Autism Trait Specific Clinical Global Impression (CGI-AT) including the Clinical Global Severity (CGI-S), Clinical Global Improvement (CGI-I), and CGI-Efficacy Index (CGI-EI) scales; Behavior Rating Inventory of Executive Function-Parent Version (BRIEF-P); Child Behavior Checklist (CBCL); Clinician-Rated Treatment Emergent Adverse Events Log (CTAE); Global Assessment of Functioning Scale (GAF); Massachusetts General Hospital Social-Emotional Competence Scale (MGH-SECS) questionnaires including MGH-SECS-Informant Rated (MGH-SECS-I) and MGH-SECS Clinician Rated (MGH-SECS-C); They underwent a series of assessments, including the Autism Spectrum Disorder DSM-5 Diagnostic Symptom Checklist, and the SRR-2 questionnaire.
[0127] Participants receive daily tPBM treatments for 8 weeks, with a post-study follow-up at week 10. The photobiomodulation therapy garments disclosed herein used in tPBM treatments are bilateral and applied to the frontal region with two application sites on the left, two on the right, and two on the midline [left forehead, right forehead, and mid-forehead on frontal EEG sites F3, Fpl, F4, Fp2, and Fz, Fpz]. Once correct placement is confirmed, tPBM treatments are initiated by pressing a button on a specific phone application to activate a probe that delivers LED light. The duration of exposure begins at 10 minutes per treatment during week 1 (days 1-7), increases to 20 minutes per treatment during week 2 of treatment (days 7-14), and increases to 30 minutes per treatment during week 3 of treatment (days 14-21). If side effects prevent an increase (or a treatment response has already occurred), a lower dose is maintained to ensure good tolerability and treatment adherence. On day 21, if no improvement occurs despite good tolerance, clinicians recommend a 40-minute treatment. tPBM treatment follows the following specifications: energy is delivered at a radiation wavelength of 850 nm and irradiance (IR) is 18 mW / cm. 2 and the fluence is up to 43 Joules / cm 2 , the energy delivered in one session is up to 2.4 kJ, and each treatment window area is 55 cm 2 It is.
[0128] Subjects are assessed weekly for the first 4 weeks and then biweekly thereafter. At each visit, safety and efficacy measures are obtained using assessments of psychiatric symptoms and functioning, and side effect scales. Further clinician and subject assessments are completed at midpoint (end of week 4) and at the final study visit (week 8 or termination). Response to treatment will be assessed by the following assessment scales: 1) CGI-AT, including CGI-S, CGI-I, and CGI-EI scales, administered by a physician at 0 (baseline), 1, 2, 3, 4, 6, and 8 weeks; 2) GAF and CTAE, administered by a physician at 0 (baseline), 1, 2, 3, 4, 6, and 8 weeks; 3) Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SC), administered by a physician at 0 (baseline), 4, and 8 weeks; 4) tPBM Self-Report Questionnaire (TSRQ), administered by a parent / guardian at 1, 2, 3, 4, 6, and 8 weeks; 5) SRS-2 and CBCL, administered by a physician at 4 and 8 weeks; 5) BRIEF-P and MGH-SECS-I, administered by a parent / guardian at 8 weeks; and 6) MGH-SECS-C, administered by a physician at 8 weeks. At week 10, each participant will be assessed with the CGI-AT, GAF, CTAE, SRS-1, ADHD-SC, and TSRQ, which include the CGI-S, CGI-I, and CGI-EI scales.
[0129] Results are expected to show that tPBM treatment is safe and effective in reducing autistic traits in children diagnosed with ADHD.
[0130] In conclusion, the above description of the embodiments of the present invention has been presented for the purpose of illustration and description. Although aspects of the present invention are highlighted by reference to specific embodiments, it is understood that those skilled in the art will immediately recognize that these described embodiments are merely illustrative of the principles underlying the present invention. Thus, the specific embodiments are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Thus, it should be understood that embodiments of the disclosed subject matter are in no way limited to the specific elements, compounds, compositions, components, articles, devices, methodologies, uses, protocols, steps, and / or limitations described herein, unless expressly stated as such.
[0131] Moreover, groupings of alternative embodiments, elements, steps, and / or limitations of the invention are not to be construed as limitations. Each such grouping may be referenced and claimed individually or in any combination with the 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 deleted from a group for reasons of convenience and / or patentability. When such inclusions or deletions are made, the specification is deemed to include groupings as modified and therefore satisfy all Markush group descriptions used in the appended claims.
[0132] In addition, those skilled in the art will recognize that certain changes, modifications, substitutions, substitutions, additions, deletions, and subcombinations thereof may be made in accordance with the teachings herein without departing from the spirit of the invention. Moreover, it is intended that the following appended claims and the claims introduced below be construed to include all such changes, modifications, substitutions, substitutions, additions, deletions, and subcombinations that are within their true spirit and scope. Accordingly, the scope of the invention is not limited to that precisely shown and described herein.
[0133] Certain embodiments of the invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations of these described embodiments will become apparent to those of skill in the art upon reading the above description. The inventors anticipate that such variations will be adopted by those of skill in the art as appropriate, and the inventors intend the invention to be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of all possible variations of the above-described embodiments is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
[0134] The words, phrases, and terms used herein are intended only to describe particular embodiments, elements, steps, and / or limitations, and are not intended to limit the scope of the invention, which is defined solely by the claims. Moreover, such words, phrases, and terms are understood not only to be understood in their generally defined meanings, but also to include herein structures, materials, or acts that go beyond the scope of their generally defined meanings by special definitions. Thus, if an element, step, or limitation can be understood in the context of this specification as including more than one meaning, its use in the claims should be understood to be general to all possible meanings supported by the specification and the word itself.
[0135] Thus, the definitions and meanings of the elements, steps, or limitations set forth in the claims below are defined herein to include not only the literally recited combinations of elements, steps, or limitations, but also all equivalent structures, materials, or acts for performing substantially the same function in substantially the same manner to achieve substantially the same results. In this sense, therefore, it is contemplated 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 substituted for two or more elements, steps, or limitations of such claims. Although elements, steps, or limitations may be described above as acting in a particular combination and may initially be claimed as such, it is expressly understood that one or more elements, steps, or limitations from a claimed combination may, in some cases, be deleted from the combination, and that the claimed combination may be directed to a subcombination or a variation of the subcombination. Thus, notwithstanding the fact that claim elements, steps, and / or limitations are set forth below in a particular combination, the invention should be expressly understood to include other combinations of fewer, more, or different elements, steps, and / or limitations disclosed above, even if not originally claimed in such combination. Moreover, slight variations from the claimed subject matter, now known or later devised, that would be apparent to one of ordinary skill in the art, are expressly considered to be equally within the scope of the claims. Thus, obvious substitutions, now known or later known to those of ordinary skill in the art, are defined to be within the scope of the defined elements. Thus, the claims are understood to include what is specifically exemplified and described above, what is conceptually equivalent, what is obviously substitutable, and what essentially incorporates the essential ideas of the invention.
[0136] Unless otherwise specified, all numbers expressing features, items, quantities, parameters, characteristics, terms, etc. used in the specification and claims are understood to be modified in all instances by the term "about". The term "about" when used herein means that the feature, item, quantity, parameter, characteristic, or term so modified encompasses a range of ±10 percent above and below the value of the stated feature, item, quantity, parameter, characteristic, or term. Thus, unless stated to the contrary, the numerical parameters described in this specification and the appended claims are approximations that may vary. For example, mass spectrometry instruments may vary slightly in determining the mass of a given analyte, so the term "about" in the context of the mass of an ion or the mass / charge ratio of an ion refers to + / - 0.50 atomic mass units. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical designation should be construed, at least in light of the number of reported significant digits, by applying ordinary rounding techniques.
[0137] Although the numerical ranges and values setting forth the broad scope of the present invention are approximate, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. However, numerical ranges or values inherently contain certain errors necessarily resulting from the standard deviation found in each test measurement. The recitation of numerical ranges of values herein is merely intended to serve as a simple method of individually referencing each individual value falling within the range. Unless otherwise specified herein, each value in a numerical range is incorporated herein as if it were individually set forth herein.
[0138] The use of the term "may" or "can" with respect to an embodiment or an aspect of an embodiment also carries the alternative meaning of "cannot" or "cannot". Thus, where the specification discloses that an embodiment or an aspect of an embodiment may or may be included as part of the inventive subject matter, a negative limitation or exclusionary condition meaning that the embodiment or aspect of the embodiment may not or may not be included as part of the inventive subject matter is also expressly intended. In a similar manner, the use of the term "optionally" with respect to an embodiment or an aspect of an embodiment means that such embodiment or aspect of the embodiment may or may not be included as part of the inventive subject matter. Whether such a negative limitation or exclusionary condition applies depends on whether the negative limitation or exclusionary condition is recited in the claimed subject matter.
[0139] The terms "a," "an," "the," and similar references used in the context of describing the present invention (particularly in the context of the claims below) are intended to encompass both the singular and the plural, unless otherwise specified herein or clearly contradicted by context. Furthermore, ordinal designations, such as "first," "second," "third," and the like, for identified elements are used to distinguish elements, and do not indicate or imply a required or limited number of such elements, or a particular location or order of such elements, unless otherwise specified. All methods described herein can be performed in any suitable order, unless otherwise specified herein or clearly contradicted by context. The use of any and all examples or exemplary language (e.g., "etc.") provided herein is intended merely to better illustrate the invention, and does not impose limitations on the scope of the invention as otherwise claimed. No language herein should be construed as indicating any non-claimed element essential to the practice of the invention.
[0140] The open-ended transitional term "comprising," its variations, e.g., "comprise" and "comprises," and its equivalent open-ended transitional phrases, such as "containing," "comprising," and "having," when used in the claims, whether as filed or added by amendment, includes all explicitly recited elements, limitations, steps, integers, and / or features, either alone or in combination with unrecited subject matter, such that the specified elements, limitations, steps, integers, and / or features are essential, but that other unspecified elements, limitations, steps, integers, and / or features may be added and still fall within the scope of the claim. Certain embodiments disclosed herein may be further limited in the claims using the closed-ended transitional phrase "consisting of" or "consisting essentially of" (or variations thereof, e.g., "consist of," "consists of," "consist essentially of," and "consists essentially of") in place of or as an amendment to "comprising." The closed-ended transitional phrase "consisting of," when used in a claim, whether as filed or added by amendment, excludes any element, limitation, step, integer, or feature not expressly recited in the claim. The closed-ended transitional phrase "consisting essentially of" limits the scope of the claim to those elements, limitations, steps, integers, and / or features that are expressly recited, and any other elements, limitations, steps, integers, and / or features that do not materially affect the basic and novel characteristics of the claimed subject matter. The meaning of the open-ended transitional phrase "comprising" is therefore defined as including all elements, limitations, steps, and / or features that are specifically recited, as well as any optional additional unspecified ones.The meaning of the closed-ended transitional phrase "consisting of" is defined to include only those elements, limitations, steps, integers, and / or features specifically recited in the claim, while the meaning of the closed-ended transitional phrase "consisting essentially of" is defined to include only those elements, limitations, steps, integers, and / or features specifically recited in the claim and those elements, limitations, steps, integers, and / or features that do not materially affect the basic and novel characteristics of the claimed subject matter. Thus, the open-ended transitional phrase "comprising" (and its equivalent open-ended transitional phrases) includes, within its meaning, the claimed subject matter specified by the closed-ended transitional phrase "consisting of" or "essentially consisting of," in the limiting case. Thus, embodiments described herein or claimed with the language "comprising" explicitly and unambiguously provide explanation, enabling, and enabling, and support for the language "consisting essentially of" and "consisting of."
[0141] Finally, all patents, patent publications, and other references cited and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing, for example, the compositions and methodologies described in such publications that may be used in connection with the present invention. These publications are provided solely for their disclosure prior to the filing date of this application. No admission is made, or should be construed, in this regard that the inventors are not entitled to antedate such disclosure by reason of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicants and do not constitute any admission as to 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: Column group spacing d4:Spacing within row group 20: Clothing for photobiomodulation therapy 22: Photobiomodulation Therapy Headband 30: Photobiomodulation therapy clothing 20, 22 clothing 40: Outer fabric sheet of garment 24 42: Outer surface of outer fabric sheet 40 44: Inner surface of outer fabric sheet 40 46: Treatment area of outer fabric sheet 40 50: Top edge of garment 30 52: Bottom edge of clothing 30 54: Right part of clothing 30 56: Left part of clothing 30 58: Terminal rail mounting opening for garment 30 60:30 Slide Buckle for Clothing 62: Clothing 30 Slide Buckle 64: Right head strap of clothing 30 66: Left head strap of clothing 30 68: Clothing 30 controller straps 70:Inner fabric sheet for clothing 24 72: Outer surface of inner fabric sheet 70 74: Inner surface of the inner fabric sheet 70 76: Near-infrared opening of the inner fabric sheet 70 78: Sensor opening of inner fabric sheet 70 79: Sensor cover for inner fabric seat 70 100: Photobiomodulation therapy clothing 20, 22 photobiomodulation units 102: Photobiomodulation 100 heat dissipation material 110: Flexible printed circuit board assembly for photobiomodulation 100 112: Main strip of flexible printed circuit board assembly 110 113: Base portion of 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 portion of flexible printed circuit board assembly 110 118: Sensor strip cutout of flexible printed circuit board assembly 110 120: First attachment portion of first strip 114 121: First notch of first strip 114 122: Second attachment portion of first strip 114 123: second cutout portion of first strip 114 124: Third attachment portion of first strip 114 130: First attachment portion of second strip 116 131: First notch of second strip 116 132: Second attachment portion of second strip 116 133: second cutout portion of second strip 116 134: Third attachment portion of second strip 116 140: Sensor strip of flexible printed circuit board assembly 110 142: Sensor attachment portion of sensor strip 140 144: free end of sensor strip 140 150: Liquid Wire Circuit Assembly for Photobiomodulation 100 152: Main liquid wire tube of liquid wire circuit board assembly 150 153: Base portion of liquid wire circuit board assembly 150 154: First liquid wire tube of the liquid wire circuit board assembly 150 156: second liquid wire tube of the liquid wire circuit board assembly 150 158: Sensor liquid wire tube of liquid wire circuit board assembly 150 160: Connection terminal of circuit board assembly 84 162: Electronic circuit connector of connection terminal 160 164: Terminal rail mount for connection terminal 160 166: Terminal Rail Mount 164 Contacts 170: Near-infrared light source for photobiomodulation 100 171: First near-infrared light source group of near-infrared light sources 170 172: A second near-infrared light source group of the 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: Near-infrared light source 170, sixth near-infrared light source group 180: Sensor of photobiomodulation unit 100 182: Cardiovascular Sensors for Photobiomodulation 100 184: Green LED of cardiovascular sensor 182 186: Green LED of cardiovascular sensor 182 188: Photodetector of the cardiovascular sensor 182 or 114 192: Photobiomodulation 100 temperature sensor 194: Stimulator of photobiomodulation unit 100 200: Controller 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 clothing 20, 22 222: Near-infrared light source opening of double-sided tape layer 220 224: Sensor opening in double-sided tape layer 220 300: Human P Fp1 site 302: Fpz region of human P 304: Human P Fp2 site 306: Human P F3 region 308: Fz part of human P 310: Human P F4 part 320: Sagittal plane of person P 322: Person P's eyebrow region
Claims
1. A photobiomodulation therapy garment, comprising: a garment configured to be worn by a user on a skin surface, the garment having a first surface and a second surface opposite the first surface, the first surface configured to face the skin surface when worn; a photobiomodulation unit integrated within the garment, the photobiomodulation unit comprising a connection terminal, one or more near-infrared light sources, and one or more sensors, the connection terminal being in electronic communication 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 configured to emit near-infrared light at a wavelength between 600 nm and 1600 nm and a predetermined dosimetry; a controller including a processor and a memory, the controller being configured to operatively engage a terminal rail of the connection terminal in a manner to establish electronic communication with the connection terminal; Equipped with a first surface of the garment including a first portion having one or more light source openings, each of the one or more near-infrared light sources being operatively aligned with the one or more light source openings to allow proper passage of near-infrared light from the one or more near-infrared light sources; the first surface of the garment includes a second portion having one or more sensor openings, each of the one or more sensors being operatively aligned with the one or more sensor openings to enable proper functioning of the one or more sensors through the one or more sensor openings; the processor and the memory are configured with executable instructions for independently controlling each of the one or more near-infrared light sources and each of the one or more sensors. Photobiomodulation therapy clothing.
2. 10. The photobiomodulation therapy garment of claim 1 , wherein the garment is configured to wrap or conform to a body part region and can be moved from one body part region to another body part region on the body.
3. 10. The photobiomodulation therapy garment of claim 1, wherein the garment is sized and dimensioned to specifically fit a particular part of the body.
4. A photobiomodulation therapy garment as described in claim 3, wherein the specific part of the body is a head region, a neck region, a shoulder region, a torso region, a hand region, a wrist region, an arm region, a foot region, a leg region, or any combination thereof.
5. A photobiomodulation therapy garment as described in claim 4, wherein the garment is a headband, hat, visor, shirt, pants, socks, gloves, or underwear.
6. 10. The photobiomodulation therapy garment of 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. 10. The photobiomodulation therapy garment of claim 1, wherein each of the one or more sensors is configured to detect and collect information of one or more parameters of the garment, the photobiomodulation unit and its components, the controller and its components, and a user, and then transmit the information to the controller.
8. 8. The photobiomodulation therapy garment of 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, biometric information of a user, or any combination thereof.
9. The photobiomodulation therapy garment of claim 1 , wherein the executable instructions independently control each of the one or more near-infrared light sources.
10. 10. The photobiomodulation therapy garment of claim 9, wherein the executable instructions control activation, activation duration, deactivation, deactivation duration, activation pattern and timing, deactivation pattern and timing, fluence level, irradiance level, dosimetry level, pulsed operation, continuous operation, operation time, cycle duration, or any combination thereof, of each of the one or more near-infrared light sources.
11. The photobiomodulation therapeutic garment of claim 1 , wherein the executable instructions independently control each of the one or more sensors.
12. The photobiomodulation therapeutic garment of claim 11 , wherein the executable instructions control collection and analysis of information obtained from each of the one or more sensors.
13. 10. The photobiomodulation therapy garment of claim 1, wherein the one or more near-infrared light sources are multiple spaced near-infrared light sources.
14. 14. The photobiomodulation therapy garment of claim 13, wherein the one or more near-infrared light sources are arranged in a plurality of spaced near-infrared light source groups, each of the plurality of near-infrared light source groups comprising a subset of the one or more near-infrared light sources.
15. 10. The photobiomodulation therapy garment of claim 1, further comprising one or more stimulators.
16. 16. The photobiomodulation therapy garment of claim 15, wherein the one or more stimulators include a component capable of generating a magnetic field.
17. 10. The photobiomodulation therapy garment of claim 1, wherein the processor and the memory are configured with 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 of claim 1 , wherein the skin surface comprises a forehead area, a back neck area, a wrist area, an abdominal area, or any combination thereof.
19. 20. The photobiomodulation therapy garment of claim 18, wherein the forehead region includes the dorsolateral prefrontal cortex region, the frontal eye field region, or both.
20. The photobiomodulation therapy garment of claim 1, wherein each of the one or more near-infrared light sources is configured to emit a near-infrared wavelength of 700 nm to 1200 nm or 800 nm to 1100 nm, or each of the one or more near-infrared light sources is configured to emit a radiance of at least 50 mW / cm 2 to a maximum of 400 mW / cm 2, or each of the one or more near-infrared light sources is configured to emit a radiant flux of at least 900 mW.
21. A photobiomodulation therapy garment as described in any one of claims 1 to 20 for use in providing photobiomodulation therapy.
22. A photobiomodulation therapy garment as described in claim 21, wherein the photobiomodulation therapy is transcranial photobiomodulation therapy.
23. A photobiomodulation therapy garment as described in claim 21, wherein the photobiomodulation therapy garment is the only treatment device or is used in conjunction with a second treatment.
24. The photobiomodulation therapy garment of claim 23, wherein the second treatment is high-intensity photobiomodulation therapy, cognitive behavioral therapy, transcranial magnetic stimulation, ocular light therapy, evidence-based mental health practices, mindfulness therapy, or meditation therapy.
25. A photobiomodulation therapy garment as described in claim 21, wherein administration of the photobiomodulation therapy results in increased cellular energy production, increased neuromitochondrial energy, increased adenosine triphosphate (ATP) production, increased reactive oxygen species production, reduced inflammation at the cellular and tissue level, improved cellular repair and healing, increased nitric oxide production, increased cerebral blood flow, increased neurogenesis, increased neuroplasticity, increased neuroprotection, enhanced neurorepair, reduced inflammation, or any combination thereof.
26. A photobiomodulation therapy garment as described in claim 21, wherein use of the photobiomodulation therapy garment delivers a radiant energy of at least 500 J during therapy, or use of the photobiomodulation therapy garment delivers a radiant exposure of at least 30 J / cm 2 to a maximum of 200 J / cm 2 during therapy, or use of the photobiomodulation therapy garment delivers a radiant intensity of at least 30 mW / cm 2 to a maximum of 400 mW / cm 2.