Wearable laser therapy device

Abstract

A wearable photobiostimulation system includes a laser configured to emit laser radiation, a strap coupled to the laser and configured to hold the laser in position relative to a patient, and a computing device operable to control the laser. The computing device is programmed to automatically determine a treatment protocol for a patient based on at least one patient characteristic, activate the laser in accordance with the treatment protocol, and prevent activation of the laser in violation of the treatment protocol.

Description

Atty. Dkt. No.: 141127-0103WEARABLE LASER THERAPY DEVICECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 723,427, filed November 21, 2024, the entire disclosure of which is incorporated by reference herein.BACKGROUND

[0002] The present disclosure relates generally to photobiostimulation (photobiomodulation), for example for use in the treatment of diabetes or other condition. Irradiating a patient’s tissue and / or bloodstream with light (e.g., laser light) may enhance insulin sensitivity, promote more efficient glucose metabolism, reduce inflammation, and / or provide other benefits. However, existing light therapy solutions typically involve large equipment operated by experts at medical care facilities, limiting the access to care.SUMMARY

[0003] Some implementations of the present disclosure include a photobiostimulation system. The photobiostimulation system includes a laser configured to emit laser radiation, a strap coupled to the laser and configured to hold the laser in a position relative to a patient such that the laser is wearable by the patient, and a computing device operable to control the laser. The computing device is programmed to automatically determine a treatment protocol for a patient based on at least one patient characteristic, cause activation of the laser in accordance with the treatment protocol, and prevent the activation of the laser in violation of the treatment protocol.

[0004] Some implementations of the present disclosure include a method of providing photobiostimulation therapy. The method includes coupling, by a wearable device, to a patient, automatically determining, by a computing device, a photobiostimulation treatment protocol for the patient based on a plurality of patient characteristics, and controlling, by the computing-1-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 device, a laser of the wearable device to irradiate the patient in accordance with the treatment protocol.

[0005] This summary is illustrative only and is not intended to be in any way limiting.BRIEF DESCRIPTION OF THE FIGURES

[0006] The disclosure will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements, in which:

[0007] FIG. 1 is an illustration of a wearable laser therapy system, according to some embodiments.

[0008] FIG. 2 is another illustration of a wearable laser therapy system, according to some embodiments.

[0009] FIG. 3 is a block diagram of a wearable laser therapy system, according to some embodiments.

[0010] FIG. 4 is a first flowchart of a process of applying therapy by a wearable laser therapy system, according to some embodiments,

[0011] FIG. 5 is a second flowchart of a process of applying therapy by a wearable laser therapy system, according to some embodiments.

[0012] FIG. 6 is an illustration of a oral laser therapy device, according to some embodiments.

[0013] FIG. 7 is another illustration of the oral laser therapy device of FIG. 6, according to some embodiments.

[0014] FIG. 8 is another illustration of the oral laser therapy device of FIG. 6, according to some embodiments.-2-4878-7129-2400.1Atty. Dkt. No.: 141127-0103DETAILED DESCRIPTION

[0015] Referring generally to the figures, a wearable laser therapy system is shown, for example a wearable photobiomodulation or photobiostimulation therapy system can. As will be apparent from the following description, wearable laser therapy systems in accordance with the embodiments herein enable patients to self-administer laser therapy with an easy-to-use, mobile, wearable device and by implementing an automated laser therapy protocol as a function of one or more user characteristics (e.g., age, sex, body mass index, height, weight cholesterol, blood pressure, body temperature, use of blood thinners or other medication, HbAlC, etc.) and, in some embodiments, by automatically restricting the user from over-applying laser therapy. The teachings herein can thus provide patients with custom laser therapy without requiring repeated visits to healthcare facilities and / or assistance from healthcare professionals.

[0016] Wearable laser therapy systems in accordance with the present disclosure can provide photobiomodulation and / or photobiostimulation therapy, which can refer to the application of coherent monochromatic light (laser radiation) which causes photo-biochemcial reactions in cells. Photons (of the laser radiation) are absorbed by receptors, for example chromophores, within the cells. Chromophores, endogenous porphyrins, mitochondrial and membranal cytochromes, hemoglobin and other photosensitive molecules have the ability to absorb laser radiation, and such absorb can lead to increased production of cellular biochemical energy, i.e., adenosine triphosphotase (ATP). Increased ATP production can provide positive physiological responses including normalization of cell morphology and cell function and increase in cellular metabolism.

[0017] The teachings herein provide a wearable laser therapy system configured to provide laser therapy by adapting laser wavelength, the amount of energy provided for absorption, the strength of the laser in wattage, and the time that the laser is applied in a manner which provides optimal therapeutic device without any side effects and / or while minimizing side effects. For example, the wearable laser therapy system can provide laser light which stimulates a user’s mitochondria to create substances, to accelerate cell renewal and restore damage, for example-3-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 using a laser wavelength of 650 nm which can cause a biochemical reaction in at least the mitochondria, the nucleus and the chromophores (photoreceptors). The wearable laser therapy system herein can thus provide improved mitochondrial function, for example, which may be helpful for patients with mitochondrial diseases (e.g., potentially benefitting patients with multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, or any other neurodegenerative disease). Energy from laser light provided by the wearable laser therapy system herein can also be absorbed by red blood cells, such that the wearable laser therapy system provides red blood cells with energy to better provide oxygen transport and remain flexible throughout the lifecycle of such cells, while activating and neutralizing inflammatory mediators like IL-10 and TNF-a. These and other advantages can be provided in accordance with the detailed description below with reference to the FIGURES.

[0018] Referring now to FIG. 1, an illustration of a wearable laser therapy system 100 is shown, according to some embodiments. The wearable laser therapy system 100 is shown as including a wearable device 102 and a computing device 104 (e.g., smartphone, tablet, personal computer, handheld device, etc.). The wearable device 102 is shown as including a pod 106 and a strap 108 coupled to the pod. The strap 108 is configured for securing the pod 106 to a patient, for example by wrapping around an appendage (e.g., wrist, arm, leg, etc.) of a patient. The strap 108 can include a hook-and-loop fastener material, one or more buckles, one or more snaps, etc. to facilitate securing of the strap 108 about an appendage of a patient such that the pod 106 is held snuggly against the skin of the patient. In some scenarios, for example, the strap 108 is used to hold the pod 106 against the underside of the patient’s wrist proximate the ulnar artery.

[0019] As shown in Fig. 1, the pod 106 includes a light source, for example a laser 110. The laser 110 is configured to laser radiation, e.g., coherent light of a wavelength adapted for providing photobiostimulation therapy, for example a wavelength in the visible spectrum (e.g., red color, approximately 650 nm). The laser 110 may be operable at a power of approximately 20mW. The laser 110 can include various lenses, mirrors, etc. for directing, focusing, spreading, etc. laser radiation created by the laser 110 to an exterior of the pod 106. Accordingly, when the wearable device 102 is worn by a patient (e.g., held to the patient’s appendage by strap 108), the-4-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 laser 110 is positioned to and operable to provide laser radiation to the patient. The laser 110 may be off-center on the pod 106 so as to align with the ulnar artery of the patient when the pod 106 is positioned on an underside of the patient’s wrist, for example such that elements in the blood that is flowing through the ulnar artery is irradiated when the blood flows through the laser radiation provided by the laser 110.

[0020] The pod 106 can include various components in addition to the laser 110, as shown in FIG. 3 and described in reference thereto, for example for powering and controlling the laser 110 and communicating with the computing device 104. While the pod 106 is shown with a strap 108 in the example, the pod 106 may be rendered wearable by inclusion of various other garments, attachments, loops, etc. in various embodiments (e.g., coupled to or integrated in a sleeve, shirt, glove, sock, leg sleeve, headband, hat, ring, etc. in various embodiments; a diskshape coupled to such a garment). In other embodiments, the pod 106 is provided as a standalone device (e.g., having a handle to be holdable rather than wearable, etc.) and / or adapted for oral use as in the examples of FIGS. 6-8. Various such mechanical designs are within the scope of the present disclosure.

[0021] The computing device 104 can be a smartphone, tablet, personal computing device, virtual reality headset, augmented reality headset, etc., for example a device of a patient to receive photobiostimulation therapy using the wearable device 102. The computing device 104 can communicate with the wearable device 102, for example wirelessly via Bluetooth, WiFi, or other communications protocol. The computing device 104 can include communications ports (e.g., Ethernet ports), routing capabilities, a cellular modem, a wireless transceiver or beacon (e.g., Bluetooth, near-field communication), etc. in various embodiments in order to provide communications with the pod 106 and / or an external network (e.g., cellular network, Internet, etc.), and can include cryptographic capabilities to establish secure communications sessions. The computing device 104 can also include a display screen (e.g., touchscreen) and user input devices (e.g., button, touchscreen, keyboard, etc.) for displaying graphical user interfaces to a user and to receive inputs from a user. The computing device 104 can interoperate with the-5-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 wearable device 102 to provide custom photobiostimulation therapy to a patient, as described in further detail below with reference to FIGS. 3-5.

[0022] Referring now to FIG. 2, another illustration of a wearable laser therapy system 100 is shown, according to some embodiments. As shown in FIG. 2, the wearable laser therapy system 100 includes the wearable device 102 communicable with the computing device 104, with the pod 106 configured as a watch (e.g., smartwatch). In the example of FIG. 2, the strap 108 coupled to the pod 106 includes as optical fiber 200 extending along (e.g., in) the strap 108 from the pod 106 to an emission point 202. The optical fiber 200 is configured to direct laser irradiation from a laser 110 in the pod 106 along the optical fiber 200 to the emission point 202, such that the laser radiation is emitted from the wearable device 102 at the emission point 202 rather than from the pod at the laser 110 as in FIG. 1. In such an embodiment, the pod 106 (e.g., having a watch face) can be worn on a first side of an appendage (e.g., topside of a patient’s wrist) while the strap 108 and optical fiber 200 wrap to a second (e.g., opposing) side of the appendage (e.g., underside of the patient’s wrist proximate the ulnar artery) such that the patient’s appendage is between the pod 106 and the emission point 202. In such a scenario, the wearable device 102 can be worn like a watch while the optical fiber 200 directs laser radiation to be provided to the patient from the emission point 202 from the underside of the wrist (e.g., where the ulnar artery and / or other physiological feature make it easier for the laser radiation to reach bloodstream of the patient). The emission point 202 can include various optics (e.g., mirrors, lenses, etc.) for directing the laser radiation in desired direction.

[0023] In some embodiments, the laser 110 and / or the emission point 202 is configured such that the patient surface irradiated by laser radiation is in a range between 0.5 cm2and 100 cm2, for example about 1 cm2or 2 cm2. An aspect of the present disclosure is an observation that the average mean blood velocity in the ulnar artery is 10 cm / second such that the wearable device 102 can expose blood to the laser radiation for 0.1 seconds each time the blood passes through the space irradiated by the laser 110. The laser 110 and / or the emission point 202 may be configured to achieve a penetration depth into a patient (into skin, into epidermis) of 15 mm-6-4878-7129-2400.1Atty. Dkt. No.: 141127-0103(e.g., by tuning of wavelength and power), so as to reach the ulnar artery; for example, light of 650 nm wavelength can penetrate the epidermis and blood vessel wall.

[0024] As described in further detail below, the surface area, power, emissions pattern, wavelength, etc. of the laser irradiation can be adjusted by the wearable laser therapy system 100 based on one or more patient characteristics to provide a patient-customized therapy protocol. For example, where a patient characteristic is indicative of faster or slower blood flow, the irradiation area and / or laser power can be adjusted to provide a therapeutically-appropriate level of biostimulation therapy (e.g., increased irradiation area for faster blood flow to achieve a target amount of irradiation time or irradiation energy). In some embodiments, for example the laser 110 is operated to provide energy of between approximately 3 Joules / cm2and 4 Joules / cm2, for example 3.6 Joules / cm2over the course of a therapy session (e.g., over an approximately thirty minute therapy session), in some embodiments based on sensor-based feedback relating to physiological response which can be used to control the laser 110 from providing a higher level of energy which may lead to cell inhibition rather than cell activation.

[0025] Referring now to FIG. 3, a block diagram of the wearable laser therapy system 100 is shown, according to some embodiments. As shown in FIG. 3, the computing device 104 runs an application (app) 300 (e.g., program instructions stored on non- transitory computer-readable media of the computing device 104 and executing on one or more processors of the computing device 104) programmed to receive user data 302 and provide a treatment protocol to the wearable device 102. The app 300 can generate a user-specific (customized, personalized, etc.) treatment protocol based on the user data 302, and can cause the wearable device 102 to provide photobiostimulation therapy in accordance with the user-specific treatment protocol by communicating with the wearable device 102 as shown in FIG. 3 (e.g., via Bluetooth, WiFi, ethernet, USB, USB-C, etc.).

[0026] The wearable device 102 is shown as including the laser 110 (shown as a laser diode 110) which is driven by a laser diode driver 304 in accordance with control signals from a microchip 306. The wearable device 102 is also shown as including a battery 308 (e.g.,-7-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 rechargeable battery) configured to provide electrical power to other elements of the wearable device 102, for example via the microchip 306 as shown in FIG. 3. As shown, the battery 308 can provide an indication of its charge level (battery level) to the app 300, for example such that the app 300 can notify a user via the computing device 104 to charge the battery 308. The battery 308 may range between approximately 10 and 25000mAh, for example approximately 320 mAh, and for example providing voltage in a range between 0.1 volts and 2500 volts, for example 3.7 volts.

[0027] The microchip 306 is shown as being interoperable with the app 300 via an activation circuit 310 (e.g., activation / deactivation circuit). The activation circuit 310 is configured to receive the treatment protocol and / or indication thereof from the app 300 and to implement activation or deactivation of the wearable device 102 in accordance with the treatment protocol. The activation circuit 310 can include a Bluetooth transceiver or other communications hardware to establish a secure communications session between the wearable device 102 and the app 300 of the computing device 104. The activation circuit 310 can also include one or more physical or digital switches that operate in accordance with the treatment protocol so as to prevent activation of laser therapy when the treatment protocol indicates no treatment is to be provided and to trigger activation of other components of the wearable device 102 when the treatment protocol indicates that treatment is to be provided. The activation circuit 310 can also provide settings relating to the treatment protocol (e.g., duration, wavelength, power, etc.) to the microchip 306 for use in controlling the laser diode driver 304.

[0028] As shown in FIG. 3, when activated, the microchip 306 is configured to control the laser diode driver 304 to cause the laser diode 110 to emit laser radiation in accordance with the treatment protocol. The microchip 306 can provide control signals to the laser diode driver 304 relating to power, wavelength, etc. or other target parameters of radiation to be output by the laser diode 110, and the laser diode driver 304 can affect voltage, current, etc. provided to the laser diode 110 to cause the laser diode 110 to provide radiation having such target parameters. In some embodiments, the laser diode driver 304 includes one or more actuators configured to move one or more optics components (e.g., lenses, mirrors, etc.) relative to the laser diode 110 -8-4878-7129-2400.1Atty. Dkt. No.: 141127-0103(or the laser diode 110 relative to such optics components) to affect a direction, spread, focus, etc. of the laser radiation output by the laser diode 110, in accordance with the treatment protocol. As shown in Fig. 3, the laser diode driver 304 may receive data relating to the laser output from the laser diode 110, for example such that the laser diode driver 304 can implement a feedback control process for causing the laser diode 110 to output laser radiation to the patient in accordance with settings provided in the treatment protocol. In some embodiments, the laser diode 110 is configured to output laser radiation in a power range between approximately 5 mW and 50 mW (e.g., between approximately 15 mW and 25 mW) and with wavelengths between approximately 640 nm and 660 nm (e.g., approximately 650 nm).

[0029] The wearable device 102 is also shown as including at least one sensor 312. The at least one sensor 312 can measure one or more physical parameters of or relating to the patient, for example heartrate, blood pressure, blood oxygenation, blood glucose level, body temperature, etc., in various embodiments. The at least one sensor 312 can provide at least one measurement to the app 300 as shown in FIG. 3, such that the app 300 can use the at least one measurement in generating the treatment protocol. Accordingly, the treatment protocol can be generated by the app 300 using physiological feedback collected by the sensor 312, in some embodiments. In some scenarios, the treatment protocol is dynamically updated during a therapy session based on measurements from the at least one sensor 312, for example such that a wavelength, power, or other parameter of the laser radiation is modified to improve a physiological response measurable by the at least one sensor 312. In some embodiments, the at least one sensor 312 is omitted.0

[0030] Referring now to FIGS. 4-5, flowcharts of processes for operating the wearable laser therapy system 100 are shown, according to some embodiments. FIG. 4 shows a process 400 and FIG. 5 shows a process 500. The process 400 and / or the process 500 can be executed by the wearable laser therapy system 100, for example executed by the computing device 104 and the wearable device 102, in various embodiments. For example, the computing device 104 and / or the wearable device 102 can include non-transitory computer-readable media storing program instructions that, when executed by one or more processors of the computing device 104 and / or-9-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 the wearable device 102, cause the one or more processors to perform the operations of process 400 and / or process 500. Operations of FIGS. 4-5 can be provided by or using app 300, in some embodiments.

[0031] As illustrated in FIG. 4, process 400 can include operations associated with app 300. In a first instance, the app is opened on the computing device 104 at block 402 and a unique user account is created at block 404. The app 300 may interoperate with a provider computing system (e.g., cloud server, etc.) to facilitate creation of a user account unique to a patient and associated with the patient in an electronic health record or the like. In other embodiments, creation of an account at block 402 is performed entirely locally on the computing device 104. With the unique account created, the app 300 can be logged into with the user account at block 406, initiating a session associated with a particular patient. Upon login, the app 300 may present the patient (e.g., via a graphical user interface of the computing device 104) with a questionnaire 408. As shown in FIG. 4, the questionnaire prompts a user for answers relating to various patient-specific data, for example to input various demographic information (e.g., age, sex), physical measurements (e.g., body mass index, length (height), weight), physiological parameters (e.g., cholesterol level(s), blood pressure, body temperature, HbAlc value), pharmaceutical usage (e.g., indication of blood thinner usage), and / or other patient-specific data which may be usable for generation of a treatment protocol. At block 410, answers to the questionnaire can be collected, for example based on direct user inputs to the computing device 104, from sensor measurements from one or more connected sensors (e.g., scale, blood pressure measurement device, thermometer, etc.), from electronic health records associated with the user account (e.g., from data collected by healthcare professionals at earlier patient appointments), etc., in various embodiments, for example such that patient-specific data is collected at block 410.

[0032] A treatment protocol can then be generated at block 412, for example as a function of at least one patient characteristic indicated by patient-specific data (e.g., by answers to questionnaire 408). Generating the treatment protocol at block 412 can be performed using one or more look-up tables, charts, etc. for selecting a treatment protocol from a set of selectable-10-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 treatment protocols (e.g., pre-defined treatment protocols) based on at least one patient characteristic. Generating the treatment protocol at block 412 can include using a formula or other function for calculating one or more parameters of a treatment protocol (e.g., duration, frequency, wavelength, power, etc.) using the at least one patient characteristic as an input. Generating the treatment protocol at block 412 can include applying the at least one patient characteristic as an input to a machine learning classifier (e.g., neural network), for example such that the machine learning classifier uses the various patient-specific data to classify (label, sort, etc.) the patient into a classification associated with a particular treatment protocol. Generating the treatment protocol at block 412 can include applying the at least one patient characteristic as an input to a generative artificial intelligence model configured to generate the treatment protocol using a large language model or the like based on the at least one patient characteristic. Various such approaches for generating the treatment protocol, and any combination thereof, can be implemented in various embodiments.

[0033] Still referring to process 400 of FIG. 4, the generated protocol can be used to generate a notification according to the protocol at block 412, for example by presenting a push notification to a user of the computing device 104 (e.g., displaying the notification on screen, causing the computing device 104 to vibrate, emitting an audible notification such as a beep, ring, chime, etc.). The notification can be provided to notify a user at such time as the treatment protocol indicates that a patient (e.g., the user of the computing device 104) should receive treatment in accordance with the treatment protocol.

[0034] The notification can prompt the user to open (launch, start, load, etc.) the app 300 at block 414 (or automatically cause the app 300 to be opened). At block 416, a connection (e.g., wireless communication session such as a Bluetooth communication session) can is established or confirmed between the computing device 104 and the wearable device 102. Via the connection, at block 418, the app 300 can provide a signal to the wearable device 102 to activate the wearable device 102, for example causing the activation circuit 310 of the wearable device 102 to set the microchip 306 and / or other components of the wearable device 102 to an active (online, in-use) mode. In some embodiments, the user is prompted via the app 300 to confirm-11-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 that the device should be activated (e.g., via user input to a graphical user interface of the app 300), and the app 300 activates the wearable device 102 in response to such a confirmation from the user.

[0035] In response to activation of the wearable device 102, laser irradiation is provided at block 420. Providing laser irradiation at block 420 can include controlling the laser 110 to emit the laser irradiation such that the patient (e.g., the patient’s blood such as at an ulnar artery of the patient) is irradiated by laser radiation in accordance with the treatment protocol. Block 420 can include controlling the laser 110 (e.g., by the microchip 306 via the laser diode driver 304) to vary in wavelength, power, or other property over the course of a treatment session in accordance with the treatment protocol. During a treatment session, data can be collected at block 422 and, for example, shared with a user (e.g., the patient) via the app 300. The app 300 can present the patient with information relating to progress through the treatment protocol and / or the patient’s physiological response to the treatment protocol, in various embodiments. At block 424, for example based on the collected data from block 422 and / or based on information from the questionnaire 408, the treatment protocol can be adjusted and laser irradiation updated accordingly.

[0036] After a treatment session in accordance with the treatment protocol is completed, laser irradiation is stopped in accordance with the treatment protocol at block 426. In some embodiments, block 426 includes preventing (e.g., by the app 300) the wearable device from being activated in violation of the treatment protocol, such that the laser 110 does not emit laser radiation except in accordance with the treatment protocol. Prevention of activation of laser therapy in violation of the treatment protocol can prevent a patient from self-administering greater than a therapeutic dose of laser therapy and / or enable time a desired physiological response associated with a period following turning off of the laser radiation.

[0037] For example, one aspect of the present disclosure is an observation that physiological response to photobiostimulation therapy can diminish if the body becomes accustomed to the therapy (e.g., via a treatment habituation mechanism), which is overcome in some embodiments-12-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 by automated prevention of activation of the laser radiation for at least a first number of days (e.g., 14 days) in response to determining that the laser therapy treatments have been provided for at least a second number of days (e.g., 6 days, 7 days). Accordingly, process 400 can be arranged so as to provide photobiostimulation therapy for approximately two weeks (e.g., twice a day for approximately thirty minutes per session with intervals between of at least six hours) followed by a period of approximately one week in which the wearable laser therapy system 100 self-prevents activation of the laser radiation. Such activation and deactivation timing, frequency, activation periods, deactivation periods, therapy session durations, intervals between therapy sessions, can be automatically determined as part of generation of the treatment protocol in accordance with process 400 and / or the various other teachings herein.

[0038] Referring now to FIG. 5, a process 500 of operation of a wearable laser therapy system is shown, according to some embodiments. The process 500 involves various similarities to process 400, with additional or different features described in the following. As illustrated in FIG. 5, the process 500 illustrates that the app 300 can prompt a user for answers to questions about wellbeing (e.g., energy level, fatigue, illness symptoms, physical activity level, mental state) which can be stored together with a log of therapy adherence (e.g., together with a record of therapy sessions in accordance with a treatment protocol and / or missed therapy sessions). Such a log of therapy adherence can be stored and used to generate a report for the patient and / or for a healthcare provider (e.g., the patient’s doctor) which may show information relating to improvement in patient wellbeing associated with adherence to the treatment protocol. The stored data (e.g., logs of therapy adherence and wellbeing-related answers) can also be used, in some embodiments, to train treatment protocol intelligence, for example in reinforcement learning of an artificial intelligence model used to generate the treatment protocol provided to a user. Automated generation of and adherence to treatment protocols can thus be provided by the teachings herein.

[0039] Referring now to FIGS. 6-8, views of an oral laser therapy device 600 is shown, according to some embodiments. The oral laser therapy device 600 can be used in the therapy system 100 in place of the wearable laser therapy device 102, for example with the oral laser-13-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 therapy device 600 in communication with the computing device 104 and configured to operate in a manner adapted from the teachings above. FIG. 6 shows a perspective view, FIG. 7 shows a side view, and FIG. 8 shows a top view of the oral laser therapy device 600.

[0040] As shown in FIGS. 6-8, the oral laser therapy device 600 includes a body 602, a curved panel 604, and a neck 606, with the body 602 coupled to the curved panel 604 via the neck 606. The curved panel 604 is shown as having a concave curvature facing away from the neck 606 and the body 604, in particular a curvature along a length of the curved panel 604. The curved panel 604 has a greater height (a vertical direction from the perspective of FIG. 7) and length (a vertical direction from the perspective of FIG. 8) than the neck 606. The oral laser therapy device 600 is thereby structured so that the curved panel 604 can be held in a patient's mouth with the patient's teeth and / or lips extending around the curved panel 604 so as to retain the curved panel 604 in the patient's mouth with the neck 606 and body 602 extending outward from the patient's mouth.

[0041] As is visible from the perspective of FIG. 6, the laser 110 is arranged so as to emit laser radiation from the curved panel 604, for example substantially centered on a convex surface of the curved panel 604, pointing away from the neck 604 and the body 602. Different numbers of lasers, emissions points, etc. can be included in the oral laser therapy device 600 in various embodiments, for example such that laser radiation is emitted from multiple points across the curved panel 604. Accordingly, when the curved panel 604 is positioned in a patient’s mouth, the laser 110 can operate to irradiate an interior of the patient’s mouth (e.g., tongue, roof of mouth, tonsils, etc.). Irradiation of the interior of the mouth enables laser energy to reach blood flow in corresponding vasculature, which may be closer to a surface in the mouth than at other parts of the body (i.e., less skin or other tissue between the laser 110 and the targeted blood flow thereby reducing transmissivity requirements).

[0042] The body 602 is configured to contain electronics components of the oral laser therapy device 600, for example the activation circuit 310, microchip 306, battery 308, and laser diode driver 304 of FIG. 3. The activation circuit 310 of the body 602 can be communicable (e.g.,-14-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 wirelessly communicable) with an external computing device, for example computing device 104 as illustrated in FIG. 3). The laser diode 110 can be conductively coupled to the laser diode driver 304 via the neck 604. In some embodiments, the oral laser therapy device 600 also includes a sensor, for example positioned at the body 602, at the neck 606, or at the curved panel 604, for example a sensor configured to measure a parameter indicative of whether the oral therapy device 600 is held in a mouth of a user and / or provide other data relating to the patient and / or the laser therapy (e.g., a pressure sensor arranged on the neck 606, a temperature sensor arranged on the curved panel 604, etc.).

[0043] The oral laser therapy device 600 can be operable to prevent, treat, and / or otherwise provide benefits relating to oral mucositis, which can arise as a result of chemotherapy or radiotherapy. The oral laser therapy device 600 (e.g., together with a user device 104) can provide oral photobiostimulation therapy which is adjusted (e.g., in duration) by grade of oral mucositis, which is clinically classified into five grades (Grade 0: Initial lesions without symptoms; Grade I: Redness and mild pain in the mouth; Grade II: Redness and small painful ulcers in the mouth; solid food can still be eaten; Grade III: Large painful ulcers in the mouth; only liquid food can still be consumed; Grade IV: Severe pain, ulcers, and bleeding in the mouth and oral food intake is no longer possible). The oral laser therapy device 600 can provide longer duration of treatment for higher grades, for example. In some embodiments, the treatment protocol (enforced automatically as described above) is provided as 14 days of use with twice a day treatments spaced apart by at least six hours, starting one week before chemotherapy or radiotherapy and set to Grade 0. The laser 110 irradiates the inside of the patient’s mouth, providing mitochondria in the immune cells to have sufficient energy to actively process inflammation and to support activation of certain cytokines such as IL 10, thereby speeding up healing.

[0044] In other aspects, in accordance with the teachings herein, a device is provided which can be used to lower the blood-glucose level of type 1 and type 2 diabetes patients, to provide adjuvant treatment and immunotherapy for the treatment of cancers (e.g., by stimulation of the immune system). A device and / or method in accordance with the teachings herein can provide-15-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 the optimal amount of laser energy that chromophores of red blood cells can absorb, while also providing laser energy to mitochondria of white blood cells. A device and / or method in accordance with the teachings herein can stimulate or downregulate specific interleukins that are linked to the treatment of cancer, inflammation, injury, Alzheimer’s disease, Parkinson’s disease, or any other neurodegenerative disease. The device and / or methods herein can additionally or alternatively provide improvement of blood viscosity, for example by limiting the effect of glycation. These and various other benefits can be achieved using the teachings herein.

[0045] In this regard, the present disclosure observes that many cells in the human body use mitochondria to meet their energy needs, while a red blood cell has no mitochondria but gets its energy through glycolysis. In glycolysis, electrons are involved in several steps of the process, specifically in the form of electron carriers such as NAD+ (nicotinamide adenine dinucleotide) and NADH. Glycolysis is the metabolic pathway that breaks down glucose into pyruvate, producing a small amount of ATP and electron carriers. As an overview of glycolysis and the role of electrons: (1) in Glucose Phosphorylation: Glucose is initially phosphorylated, and this process involves the transfer of a phosphate group - this step requires the input of two ATP molecules; (2) Splitting Phase: The phosphorylated glucose molecule is split into two molecules of glyceraldehyde-3-phosphate (G3P); (3) Oxidation and Electron Transfer: In the subsequent steps, each G3P molecule is oxidized, and electrons are transferred to NAD+, resulting in the formation of NADH - this is a key step in glycolysis where electrons play a role in redox reactions; (4) ATP Production: The oxidation of G3P is coupled with the production of ATP - the electrons released during the oxidation reactions are used to generate ATP; (5) Pyruvate Formation: The final product of glycolysis is two molecules of pyruvate - during glycolysis, a net gain of two ATP molecules and two NADH molecules per glucose molecule is produced. While electrons are involved in the redox reactions of glycolysis, glycolysis itself does not completely oxidize glucose. The end product, pyruvate, still contains a substantial amount of energy, which is further extracted through processes like the citric acid cycle and oxidative phosphorylation if oxygen is available. As red blood cells lack mitochondria and, consequently, oxidative phosphorylation, they rely on glycolysis as their primary means of energy production.-16-4878-7129-2400.1Atty. Dkt. No.: 141127-0103

[0046] An aspect of the present disclosure is an observation that to prevent glycation, the red blood cell should have enough energy to perform glycolysis. When exposed to laser radiation in accordance with the therapy provided by the teachings herein, the chromophores in the hemoglobin molecule are able to absorb the energy from the laser radiation to keep the hemoglobin molecules active and flexible. After the heme chromophore absorbs one photon, the jump in energy density is roughly the photon energy divided by a nm3 volume: this is about 305 J / cm3. For comparison, the energy density of boiling water is 418 J / cm3. This energy jump enables the red blood cell to prevent glycation because of the sufficient amount of energy, and to continue to do so over its lifespan (e.g., typically around 120 days), providing therapeutic benefits of the systems and methods described herein.

[0047] As yet additional observations relating to the systems and method herein, armed effector cytotoxic CD8 T cells are important in defending the host against pathogens residing in the cytosol, with viruses being the most common. These cytotoxic T cells can kill any cell containing such pathogens by recognizing foreign peptides transported to the cell surface, bound to MHC class I molecules. Cytotoxic CD8 T cells carry out their killing function by releasing two types of pre-formed cytotoxic proteins: the granzymes, which seem to induce apoptosis in any type of target cell, and the pore-forming protein perforin, which punches holes in the membrane of the target cell allowing the granzymes to enter. With these properties, the cytotoxic T cell can attack and destroy virtually any cell infected with a cytosolic pathogen. A membranebound molecule, Fas ligand, expressed by CD8 and some CD4 T cells, is also capable of inducing apoptosis by binding to Fas expressed by some target cells. Cytotoxic CD8 T cells also produce IFN-y, which inhibits viral replication and is a key inducer (activator) of MHC class I expression and macrophage activation. Cytotoxic T cells kill infected targets with great precision, sparing adjacent normal cells. This precision is crucial for minimizing tissue damage while still eradicating infected cells.

[0048] The energy levels in cytotoxic cells, such as cytotoxic T cells and natural killer (NK) cells, are important for the production and release of granzymes during the immune response. The energy generated through cellular respiration, specifically the production of adenosine-17-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 triphosphate (ATP), plays a significant role in supporting the various activities of cytotoxic cells. Cytotoxic CD8 T cells, Killer T cells, carry out their killing function by releasing two types of preformed cytotoxic proteins: the granzymes, which can induce apoptosis in any type of tumor cell, and the pore-forming protein perforin, which punches holes in the membrane of the tumor cell allowing the granzymes to enter. As a summary of how energy levels are linked to granzyme and perforin production: (1) ATP for Cellular Activities: Cytotoxic cells require ATP to carry out essential cellular functions, including the synthesis and secretion of granzymes and perforin - ATP is used as an energy source for the processes involved in the recognition, binding, and destruction of target cells; (2) Cytotoxic Activity: The release of perforin and granzymes by cytotoxic cells is a highly energy-demanding process - Granzymes are released to induce programmed cell death (apoptosis) in target cells, and this process requires energy to execute the biochemical and molecular events involved in apoptosis; (3) Mitochondrial Function: Mitochondria, the cellular organelles responsible for ATP production, play a central role in maintaining the energy levels needed for cytotoxic cell function; Proper mitochondrial function is critical for supporting the energy demands of cytotoxic cells during their response to infections or abnormal cells; (4) Metabolic Regulation: The metabolic state of cytotoxic cells, influenced by pathways such as glycolysis and oxidative phosphorylation, can impact their overall energy status; Metabolic regulation is intricately connected to the activation and function of immune cells, including cytotoxic cells. In summary, adequate energy levels, primarily derived from cellular respiration, are essential for cytotoxic cells to carry out their immune functions effectively, including the production and release of granzymes and perforin during the elimination of target cells. Maintaining a balance in cellular energy metabolism is crucial for the overall efficiency of the immune response. By applying laser radiation using the system and methods described herein, the balance in cellular energy is maintained because the chromophores on the mitochondria are able absorb the laser radiation energy and transform this into ATP.

[0049] As yet another observation relating to the systems and method herein, Tumor Necrosis Factor-alpha (TNF-a) is a cytokine involved in various physiological and pathological processes, including inflammation, immune response, and cancer. Photobiomodulation (PBM) at a-18-4878-7129-2400.1Atty. Dkt. No.: 141127-0103 wavelength of approximately 650 nm has been observed to downregulate pro-inflammatory (“unfavorable”) cytokines, including TNF-a, IL-10, IL-6, IFN-y, and IL-17, while upregulating anti-inflammatory (“favorable”) cytokines, including IL- 10, IL-4, IL-13, and TGF-0.

[0050] The role of TNF-a in cancer is complex and can have both anti-tumor and pro-tumor effects depending on the context. Anti-Tumor Effects can be provided as TNF-a can exhibit antitumor effects by promoting cell death (apoptosis) in cancer cells. It activates signaling pathways that lead to programmed cell death, which is a mechanism to eliminate abnormal or damaged cells. In some cases, TNF-a has been studied as a potential therapeutic agent for certain cancers, particularly in the context of cancer immunotherapy. Pro-Inflammatory Effects can be provided, as TNF-a is a pro-inflammatory cytokine, and chronic inflammation is associated with an increased risk of cancer development and progression. In this context, TNF-a may contribute to the promotion of cancer by creating an inflammatory microenvironment that supports tumor growth and survival. Prolonged exposure to elevated levels of TNF-a may lead to tissue damage and genomic instability, which can contribute to the initiation and progression of cancer. Angiogenesis Regulation can be provided, as TNF-a plays a role in regulating angiogenesis, the process of new blood vessel formation. While angiogenesis is crucial for normal tissue repair, it can also support tumor growth by supplying nutrients and oxygen to cancer cells. TNF-a can influence angiogenesis by modulating the expression of factors involved in blood vessel formation. Immune Modulation can be provided, as TNF-a can modulate the immune response by influencing the activity of immune cells. It may enhance the immune system's ability to recognize and eliminate cancer cells. On the other hand, excessive TNF-a production may contribute to immunosuppression, which can be exploited by tumors to evade the immune system.

[0051] The dual nature of TNF-a in cancer reflects its diverse effects on different cellular processes and the complex interplay between the immune system, inflammation, and tumor development. Therapeutic approaches that aim to modulate TNF-a levels or activity, included by uses of the systems and method herein to modulate TNF-a levels or activity using photobiostimulation, can by implementations of the teachings herein.-19-4878-7129-2400.1Atty. Dkt. No.: 141127-0103

[0052] The present disclosure contemplates methods, systems and program products on memory or other machine-readable media for accomplishing various operations. The embodiments of the present disclosure may be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwired system. Embodiments within the scope of the present disclosure include program products or memory comprising machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general-purpose or special purpose computer or other machine with a processor. By way of example, such machine- readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machine-executable instructions or data structures and which can be accessed by a general-purpose or special-purpose computer or other machine with a processor. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general-purpose computer, special-purpose computer, or special-purpose processing machines to perform a certain function or group of functions.

[0053] As utilized herein with respect to numerical ranges, the terms “approximately,” “about,” “substantially,” and similar terms generally mean + / - 10% of the disclosed values. When the terms “approximately,” “about,” “substantially,” and similar terms are applied to a structural feature (e.g., to describe its shape, size, orientation, direction, etc.), these terms are meant to cover minor variations in structure that may result from, for example, the manufacturing or assembly process and are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and claimed are considered to be within the scope of the disclosure as recited in the appended claims.-20-4878-7129-2400.1Atty. Dkt. No.: 141127-0103

[0054] The term “coupled” and variations thereof, as used herein, means the joining of two members directly or indirectly to one another. Such joining may be stationary (e.g., permanent or fixed) or moveable (e.g., removable or releasable). Such joining may be achieved with the two members coupled directly to each other, with the two members coupled to each other using a separate intervening member and any additional intermediate members coupled with one another, or with the two members coupled to each other using an intervening member that is integrally formed as a single unitary body with one of the two members. If “coupled” or variations thereof are modified by an additional term (e.g., directly coupled), the generic definition of “coupled” provided above is modified by the plain language meaning of the additional term (e.g., “directly coupled” means the joining of two members without any separate intervening member), resulting in a narrower definition than the generic definition of “coupled” provided above. Such coupling may be mechanical, electrical, or fluidic.

[0055] References herein to the positions of elements (e.g., “top,” “bottom,” “above,” “below”) are merely used to describe the orientation of various elements in the FIGURES. It should be noted that the orientation of various elements may differ according to other exemplary embodiments, and that such variations are intended to be encompassed by the present disclosure.

[0056] Although the figures and description may illustrate a specific order of method steps, the order of such steps may differ from what is depicted and described, unless specified differently above. Also, two or more steps may be performed concurrently or with partial concurrence, unless specified differently above. Such variation may depend, for example, on the software and hardware systems chosen and on designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations of the described methods could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps-21-4878-7129-2400.1

Claims

Atty. Dkt. No.: 141127-0103WHAT IS CLAIMED IS:

1. A photobiostimulation system, comprising: a laser configured to emit laser radiation; a strap coupled to the laser and configured to hold the laser in a position relative to a patient such that the laser is wearable by the patient; a computing device operable to control the laser and programmed to: automatically determine a treatment protocol for a patient based on at least one patient characteristic; cause activation of the laser in accordance with the treatment protocol; and prevent activation of the laser in violation of the treatment protocol.

2. The photobiostimulation system of any other of claims 1-16, comprising a pod coupled to the strap, wherein the computing device is wirelessly communicable with the laser.

3. The photobiostimulation system of any other of claims 1-16, wherein the laser radiation is of a wavelength adapted for penetration of skin of the patient and for reception by blood cells of the patient.

4. The photobiostimulation system of any other of claims 1-16, wherein the at least one patient characteristic comprises blood pressure.

5. The photobiostimulation system of any other of claims 1-16, wherein the at least one patient characteristic comprises height and weight or body mass index.

6. The photobiostimulation system of any other of claims 1-16, wherein the at least one patient characteristic comprises an HbAlc value.

7. The photobiostimulation system of any other of claims 1-16, wherein the at least one patient characteristic comprises pharmaceutical use of the patient.-22-4878-7129-2400.1Atty. Dkt. No.: 141127-01038. The photobiostimulation system of any other of claims 1-16, comprising an optical fiber positioned along the strap and coupled to the laser such that the laser radiation is transmitted through the optical fiber from the laser to an emission point of the optical fiber.

9. The photobiostimulation system of any other of claims 1-16, wherein the computing system is configured to prevent activation of the laser in violation of the treatment protocol by: determining completion of a first number of days of activating the laser in accordance with the treatment protocol; and preventing the activation of the laser for at least a second number of days following the first number of days in response to the completion of the first number of days.

10. The photobiostimulation system of Claim 9, wherein the second number of days is six days.

11. The photobiostimulation system of any other of claims 1-16, wherein the laser is configured to emit the laser radiation with an irradiation area of approximately 1 cm2.

12. The photobiostimulation system of any other of claims 1-16, wherein the laser has a power of approximately 20mW.

13. The photobiostimulation system of any other of claims 1-16, wherein the laser radiation has a wavelength of approximately 650 nm.

14. The photobiostimulation system of any other of claims 1-16, further comprising a sensor communicable with the computing system, wherein the at least one patient characteristic comprises a measurement from the sensor.

15. The photobiostimulation system of any other of claims 1-16, further comprising a battery coupled to the strap.234878-7129-2400.1Atty. Dkt. No.: 141127-010316. The photobiostimulation system of any other of claims 1-16, wherein the computing device is programmed to prevent the patient from modifying the treatment protocol.

17. A method of providing photobiostimulation therapy, comprising: coupling, by a wearable device, to a patient; automatically determining, by a computing device, a photobiostimulation treatment protocol for the patient based on a plurality of patient characteristics; and controlling, by the computing device, a laser of the wearable device to irradiate the patient in accordance with the treatment protocol.

18. The method of Claim 17, 19, or 20, wherein the plurality of patient characteristics comprise age, sex, height, and weight.

19. The method of Claim 17, 18, or 20, wherein the plurality of patient characteristics comprise blood pressure and HbAlC values.

20. The method of Claim 17, 18, or 19, further comprising preventing, by the computing device, operation of the laser in violation of the treatment protocol including by preventing user manual activation of the laser in violation of the treatment protocol.244878-7129-2400.1

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