PORTABLE WHOLE-BODY PHOTON THERAPY DEVICE
20210393973 · 2021-12-23
Assignee
Inventors
Cpc classification
A61N2005/0633
HUMAN NECESSITIES
A61N5/0624
HUMAN NECESSITIES
International classification
Abstract
A portable photon therapy system is disclosed herein comprising a chassis, legs, headrest and footrest. When not in use, the legs can be folded, and the headrest and footrest detached and stored inside the chassis, which can be contained within a travel case. The device with case will comply with airline checked baggage requirements for size and weight. The chassis houses arrays of light-emitting diodes (LEDs) on printed circuit boards (PCBs) beneath an acrylic surface (device bed), which emit a plurality of light wavelengths at therapeutic irradiance levels. After device setup and upon selection of the desired light wavelengths (e.g. red or infrared or both) and mode (pulsed or continuous wave) via the control panel, one lays down on the device bed to undergo photon therapy. The present invention comprises a foldable 2-piece chassis for consumer photon therapy, and a single-piece chassis for patient photon therapy by medical professionals.
Claims
1. A portable table housing a therapeutic photon therapy system, comprising: a) a substantially hollow chassis consisting of, one or two flat acrylic sheet(s), aligned end-to-end, positioned for a patient to lie down upon; four light-emitting diodes (LEDs) array printed circuit boards (PCBs) positioned in parallel beneath the flat acrylic sheet(s), wherein each LED array PCB houses a plurality of LEDs configured to emit photons at a plurality of light wavelengths that pass through the acrylic sheet(s) and into the patient; two driver PCBs, each driving two of the LED arrays PCBs, wherein the LEDs are arranged in strings and configured to provide each string a specific amperage and voltage to produce a level of therapeutic irradiance; four LED blowers, each positioned beneath one of the LED array PCBs for cooling the LEDs; a control panel connected to a control PCB for entering and executing patient therapeutic or preventive photon treatment protocols for one or more of the following: to reduce inflammation; to inactivate pathogens in a patient; to facilitate endurance, strength, and recovery in an athlete; and wherein the control panel is configured to receive user input for the treatment protocol comprising: a selection of light wavelengths, and a mode of pulsed or continuous wavelengths; a power supply unit able to transmit current and/or voltage from a wall outlet to the control PCB to the two driver PCBs; one to five thermal sensors positioned within each LED array PCB, able to shut off the LEDs when the LED array PCB temperature exceeds a safety level to prevent overheating; a hollow inner cavity within the hollow chassis, wherein the headrest and footrest are detachable from the hollow chassis and able to be stored inside the chassis hollow inner cavity when the portable table is not in use; b) a plurality of foldable legs; c) wherein the legs are able to be folded into the chassis when the portable table is not in use; d) a detachable headrest extending from an end of the chassis, positioned to support a patient's head in both a supine and a prone position; and e) a detachable footrest extending from an end of the chassis.
2. The system of claim 1, further comprising one or more safety features consisting of: a) an internal timer positioned within the control PCB, able to shut off the system after a set time duration to prevent over-exposure; b) an emergency stop button on the control panel that disables the power supply unit; c) an electrical circuitry within the driver PCB configured to prevent overvoltage, undervoltage, and short circuits in the LED array PCB; and/or d) wherein the system is compliant with electro-magnetic interference (EMI) conducted and radiated emission standards and immunity standards for a photon therapy device to treat muscles and joints, increase blood circulation, decrease inflammation, and inactivate pathogens, in environments comprising: a home, a hotel room, a sports team facility, a medical facility, and a hospital.
3. (canceled)
4. The system of claim 1, wherein the hollow chassis consists of two flat acrylic sheets able to fold with the chassis in half to fit within a travel briefcase that meets an airline standard checked baggage requirements comprising less than or equal to 62 linear inches in total dimensions, and a maximum of 50 pounds.
5. The system of claim 1, wherein the hollow chassis consists of one flat acrylic sheet, and the chassis is stored in a substantially rectangular shaped travel case that meets an airline oversized/overweight checked baggage requirements comprising less than or equal to 126 linear inches in total dimensions, and a maximum of 100 pounds.
6. The system of claim 1, wherein the LEDs emit therapeutic wavelengths between about 200 nm ultraviolet to about 1064 nm infrared, and at a therapeutic irradiance level between about 25 mW/cm.sup.2 to about 100 mW/cm.sup.2.
7. The system of claim 6, wherein the LEDs are arranged in an array pattern to ensure delivery of a consistent irradiance and dosage.
8. The system of claim 1, wherein the control panel further comprises two depress-able buttons for three operation options comprising: a primary wavelength, a secondary wavelength, or both the primary and the secondary wavelength.
9. The system of claim 8, wherein the control panel further comprises a switch to enable one to select between pulsed or continuous wavelengths.
10. The system of claim 8, wherein the control panel further comprises a timer button to set the duration of treatment; and a digital display indicating a treatment time.
11. The system of claim 1, wherein the system further comprises a non-transitory computer readable medium storing computer executable code, wherein the computer executable code, when executed by a processor on a mobile electronic computing device, is configured to: receive, transmit and display information between said mobile device and said chassis for controlling the operation of the system, comprising: a treatment time duration; a pulsed or continuous mode; and administration of a primary wavelength, a secondary wavelength, or both.
12. A method of treatment or prevention of a medical condition requiring photon therapy, comprising: a) opening a travel case or briefcase, removing from, and assembling a portable photon therapy system, comprising, a substantially hollow chassis consisting of, one or two flat acrylic sheet(s), aligned end-to-end, positioned for a patient to lie down upon; four light-emitting diodes (LEDs) array printed circuit boards (PCBs) positioned in parallel beneath the flat acrylic sheet(s), wherein each LED array PCB houses a plurality of LEDs configured to emit photons at a plurality of light wavelengths that pass through the acrylic sheet(s) and into the patient; two driver PCBs, each driving two of the LED arrays PCBs, wherein the LEDs are arranged in strings and configured to provide each string a specific amperage and voltage to produce a level of therapeutic irradiance; four LED blowers, each positioned beneath one of the LED array PCBs for cooling the LEDs; a control panel connected to a control PCB for entering and executing patient therapeutic or preventive photon treatment protocols for one or more of the following: to reduce inflammation; to inactivate pathogens in a patient; to facilitate endurance, strength, and recovery in an athlete; and wherein the control panel is configured to receive user input for the treatment protocol comprising: a selection of light wavelengths, and a mode of pulsed or continuous wavelengths; a power supply unit able to transmit current and/or voltage from a wall outlet to the control PCB to the two driver PCBs; one to five thermal sensors positioned within each LED array PCB, able to shut off the LEDs when the PCB temperature exceeds a safety level to prevent overheating; a hollow inner cavity within the chassis, wherein the headrest and footrest are detachable from the chassis and able to be stored inside the chassis hollow inner cavity when the portable table is not in use; a plurality of foldable legs; wherein the legs are able to be folded into the chassis when the portable table is not in use; a detachable headrest extending from an end of the chassis, positioned to support a patient's head in both a supine and a prone position; and a detachable footrest extending from an end of the chassis; b) selecting on the control panel the treatment protocols; c) activating the power for the plurality of LEDs to on and lying down on the chassis top surface; d) when the duration of treatment expires, the system automatically or manually turning the power off; and e) cleaning the chassis top surface, disassembling and packing the portable photon therapy system in the travel case or briefcase.
13. The method of claim 12, further comprising one or more safety features consisting of: a) an internal timer positioned within the control PCB, able to shut off the system after a set time duration to prevent over-exposure; b) an emergency stop button on the control panel that disables the power supply unit; c) an electrical circuitry within the driver PCB configured to prevent overvoltage, undervoltage, and short circuits in the LED array PCB; and/or d) wherein the system is compliant with electro-magnetic interference (EMI) conducted and radiated emission standards and immunity standards for a photon therapy device to treat muscles and joints, increase blood circulation, decrease inflammation, and inactivate pathogens, in environments comprising: a home, a hotel room, a sports team facility, a medical facility, and a hospital.
14. (canceled)
15. The method of claim 12, wherein the hollow chassis consists of two acrylic sheets able to fold with the chassis in half to fit within a travel briefcase that is able to meet an airline standard checked baggage requirements comprising 62 linear inches in total dimensions, and a maximum of 50 pounds.
16. The method of claim 12, wherein the hollow chassis consists of one acrylic sheet, and the chassis is stored in a substantially rectangular shaped travel case meeting an airline oversized/overweight checked baggage requirements comprising less than or equal to 126 linear inches in total dimensions, and a maximum of 100 pounds.
17. The method of claim 12, wherein the LEDs emit therapeutic wavelengths between about 200 nm ultraviolet to about 1064 nm infrared, and at a therapeutic irradiance level between about 25 mW/cm.sup.2 to about 100 mW/cm.sup.2.
18. The method of claim 17, wherein the LEDs are arranged in an array pattern to ensure delivery of a consistent irradiance and dosage.
19. The method of claim 12, wherein the control panel further comprises two depress-able buttons for three operation options comprising: a primary wavelength, a secondary wavelength, or both the primary and the secondary wavelength.
20. The method of claim 19, wherein the control panel further comprises a switch to enable one to select between pulsed or continuous wavelengths.
21. The method of claim 19, wherein the control panel further comprises a timer button to set the duration of treatment; and a digital display indicating a treatment time.
22. The method of claim 12, wherein the system further comprises a non-transitory computer readable medium storing computer executable code, wherein the computer executable code, when executed by a processor on a mobile electronic computing device, is configured to: receive, transmit and display information between said mobile device and said chassis for controlling the operation of the system, comprising: a treatment time duration; a pulsed or continuous mode; and administration of a primary wavelength, a secondary wavelength, or both.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The above and other features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawing herein.
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DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0034] Before the present invention is described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
[0035] As used herein, the term “photon therapy” refers to photobiomodulation, when pertaining to modulation of cells, and/or the inactivation of pathogens (viruses and bacteria).
[0036] As used herein, the term “photobiomodulation therapy (PMBT)” refers to the modulation (stimulation or inhibition) of numerous cell types (muscle, neural, macrophage, fibroblast, osteoblast, adipose) via photons (light) from light emitting diodes arranged in the device of the present invention.
[0037] As used herein, the term “system” refers to the photon therapy device (table) alone in an embodiment. In another embodiment, the term “system” refers to the photon therapy device and/or travel case and/or mobile application for controlling the chassis electronics.
[0038] As used herein, the term “Software” or “Computer Program Product” or “Mobile Application or App” refers to computer program instructions adapted for execution by a hardware element, such as a processor, wherein the instruction comprises commands that when executed cause the processor to perform a corresponding set of commands. The software may be written or coded using a programming language and stored using any type of non-transitory computer-readable media or machine-readable media well known in the art. Examples of software in the present invention comprise any software components, code, modules, programs, applications, computer programs, application programs, system programs, machine programs, and operating system software. The software, or computer program product is installed within memory on a computing device.
[0039] And although any methods, devices and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and preferred methods, devices, and materials are now described.
[0040] A whole-body photon therapy device is provided herein with a horizontal design which is portable, lightweight, and runs on universal power from 110V to 240V. The device allows for practical global transport (checked baggage weight and dimensions for air transport) of the device while still enabling photon therapy at therapeutic wavelengths and irradiance levels. Main components of the device include a chassis, a plurality of legs, as well as a headrest and a footrest.
[0041] In some embodiments, for consumer photobiomodulation therapy (e.g. treatment of muscle and joints and increasing blood circulation, such as for an athlete), the folded or disassembled two-piece chassis fits into a travel case that meets major airline standard checked baggage restrictions of 62 linear (length+width+height) total dimension inches (158 centimeters). In this embodiment, the entire system with travel case also meets major airline checked baggage weight restrictions of a maximum of 50 pounds (23 kilograms).
[0042] In other embodiments, for medical professionals delivering photon treatments (e.g. PBMT or inactivation of pathogens), the case and one-piece chassis would meet the airline oversized/overweight checked baggage restrictions of 126 linear (length+width+height) total dimension inches (320 centimeters) and the weight restrictions of a maximum of 100 pounds (45 kilograms).
[0043] The chassis houses a plurality of arrays of light-emitting diodes (LEDs) on printed circuit boards (PCBs) beneath an acrylic surface (device bed), which emit a plurality of light wavelengths at therapeutic irradiance levels under the operational control of a control panel. After device setup and upon selection of the desired light wavelengths and mode using the control panel (e.g.
[0044] Turning to the figures,
[0045] The device may be used in an indoor and temperature-controlled environment so that it may be protected from inclement weather and overheating. This environment may be, by way of non-limiting examples: a home, a hotel room, a sports team facility, a medical facility, or a hospital.
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[0047]
[0048] Underneath the acrylic sheet(s) 108 are four substantially rectangular shaped LED Array printed circuit boards (PCB's) 116, aligned long end-to-short end (i.e. joining at the length side of the rectangular PCB 116). As used herein, “array” refers to the pattern of rows and columns of aligned light emitting diodes (LEDs) 120 in each PCB 116. Other patterns of LEDs are envisioned for the device and depend upon the anatomical body part and/or injury type and/or medical condition being treated. Chassis 104 creates an enclosure for device electronics and LED Array printed circuit boards (PCBs) 116 upon which a plurality of light-emitting diode (LED) 120 are soldered. In an embodiment, LEDs 120 are positioned in altering rows or columns of red (660 nm) and IR (850 nm) LEDs, or violet (405 nm) and IR (850 nm) LEDs. In another embodiment, each LED 120 comprises a single emitter with multiple dies (e.g. one red and one IR or two violet and one IR) which can further optimize the consistency of device irradiance. The LEDs 120 can operate in continuous emission mode, or pulsed mode. These embodiments are only a few examples of the combination of device wavelengths whereas other embodiments will provide different therapeutic wavelengths for PMBT and pathogen inactivation.
[0049] In an embodiment, the LED Array PCBs 116 may further comprise several thermal sensors 123 per PCB 116, such as one in each corner of the board 116 and in the center, to function as a safety feature to ensure the board does not overheat. Both pairs of PCBs 116 are under the operational control of a separate PCB 117 (as illustrated in
[0050] The device 100 provides photon therapy through the utilization of the plurality of light-emitting diodes (LEDs) 120, either at continuous or pulsed emissions. The device is activated after plugging in the power cord 148 and adjusting the control panel 136 via buttons where one may activate different wavelengths of light and the mode of operation (continuous or pulsed). Next, one lays down on the acrylic sheet(s) 108 where one is exposed to the light from the LEDs 120, which is emitted through sheet(s) 108 so that one is not in direct contact with the LEDs 120; and thus undergoes photon therapy.
[0051] The modular design of device 100 allows for some components to be attached and detached from the chassis 104. The headrest 126 can be attached at the chassis front end 170 to provide support for one's head; and, the footrest 128 can be attached at the chassis rear end 172 to provide support for one's feet. This modular design factors into the portability of the device 100.
[0052] Headrest 126 comprises in an embodiment: an oval head pad, about 7×9×2 inches in dimensions, with oval hole in the middle and a thin support panel with a similar outline to the head pad with an L-bracket that facilitates attachment to the main chassis via slots.
[0053] Footrest 128 comprises in an embodiment: a thin rectangular panel, about 10×16 inches in dimensions, upon which a thin rectangular cushioned pad is adhered, and the panel has a L-bracket that facilitates attachment to the main chassis via slots.
[0054] The plurality of legs 112 comprises in an embodiment (
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[0062] Upon the removal of the headrest 126 and the footrest 128, and folding of the legs 112, the device 100 is significantly shortened in length and height with only the chassis 104 left to contribute the greatest dimensions. In a two-piece chassis embodiment (e.g.
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[0064] One would take the two separate panels 108 of the chassis 104 and rotate them as depicted in
[0065] In a two-piece chassis embodiment (e.g.
[0066] In a one-piece chassis embodiment (e.g.
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Method of Treatment
[0071] After device 100 setup and upon selection of the desired light wavelengths (e.g. red at 660 nm and infrared at 850 nm) and mode (pulsed or continuous wave) via switches on the control panel, one lays down on the device bed to undergo photon therapy for a specific duration of time. Photon research studies provide a vast and increasing amount of therapeutic protocols to utilize with this device. The research protocols typically define the wavelengths, the mode, and the fluence (dosage) for a given indication of use (ex. increase endurance, decrease inflammation, adjunct to weight loss, etc.). Given the fluence (dosage), which is measured in J/cm.sup.2, one can determine the duration of treatment based on the irradiance (photon power density) of this device which, in an embodiment, is targeted to provide between 25 mW/cm.sup.2 and 50 mW/cm.sup.2 depending on configuration. The photon therapy device 100 also comprises an internal timer 119 that shuts down the device, after 30 minutes in an embodiment, to prevent overexposure. In an embodiment, one utilizes their smartphones (listening to music, texting, etc.) during treatment and therefore would use the phone timer to set and track session duration alarms. In another embodiment, control panel
[0072] A common athletic PBMT protocol, which targets muscle cell types, prescribes daily therapy using continuous-wave red (660 nm) and IR (850 nm) wavelengths at fluences (dosages) ranging from 10 to 50 J/cm.sup.2. This device is targeted to deliver an irradiance levels (photon power densities) of between 25 mW/cm.sup.2 and 50 mW/cm.sup.2 depending on wavelengths and mode selected. With an output of 25 mW/cm.sup.2, one would need to spend 10 minutes per prone and supine positions to obtain a fluence (dose) of 15 J/cm.sup.2 (Joules=Watts×seconds), which is both effective and efficient.
[0073] The device also supports PBMT protocols that may reduce complications from COVID-19, the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Pneumonia with acute respiratory distress (ARDS) is one of the more severe complications, with symptoms including pulmonary inflammation, airway edema, and lung fibrosis. Numerous PBMT rodent studies have demonstrated significant reductions in pulmonary inflammation, airway edema, and lung fibrosis in induced models of asthma and ARDS with effective fluences of 1 J/cm2 to 9 J/cm2 using both red and IR wavelengths (Rigonato-Oliveira et al., 2019 [6]), (Oliveira et al., 2014 [7]), (Brochetti et al., 2017 [8]). There have also been several human studies utilizing PBMT for treatment of both pneumonia and bronchial asthma with varying protocols that have significantly improved patient outcomes with faster recovery times, reduced inflammation, and improved biomarkers (Lutai et al., 2001 [9]), (Ostronosova et al., 2006 [10]), (Milojević et al., 2003 [11]), (Dabbous et al., 2017 [12]). Further studies are warranted to determine the optimal protocol including fluences (dosage), wavelengths, device mode, and treatment frequency for ARDS.
[0074] Method of use of device: open case and assemble device; select wavelengths of light and mode, set timer on mobile phone (not included), or on the control panel, or via the device mobile phone application, lay on chassis top surface; when timer expires turn over (from prone to supine or vice-versa), set timer, when timer expires device turns off (in device equipped with timers) or manually turn off (in device without timer), after; clean top surface with antibiotic cleaner and dry, disassemble, and pack the device in the travel case.
[0075] The device has numerous safety related features incorporated into the design. The safety stop switch 140 on the control panel 136 as illustrated in
[0076] The Driver PCBs 117 also have open-LED protection, short-circuit protection, as well as undervoltage and overvoltage lockouts for the LEDs 120 on the LED Array PCBs 116, which all assist in ensuring the electronics operate within specifications. The device has been designed to be compliant with EMI (electro-magnetic interference) conducted and radiated emission standards and immunity standards per IEC (International Electrotechnical Commission) 60601-1-2:2014 Edition 4 medical electrical equipment standards.
Mobile Application
[0077] As illustrated in
[0078] The mobile application 290 comprises a computer program product, comprising a non-transitory machine-readable storage medium having encoded therein executable code of one or more software programs, wherein the one or more software programs when executed by at least one processor on a user electronic computing device performs the following steps of: remotely controlling the operation of the photon therapy device via wirelessly (e.g. Bluetooth chip or wireless chip) connecting to the control panel (
[0079] In an embodiment, the system 100 further comprises a non-transitory computer readable medium storing computer executable code, wherein the computer executable code, when executed by a processor on the mobile electronic computing device 200, is configured to: receive, transmit and display information between said mobile device 200 and said chassis for controlling the operation of the system, comprising for example: treatment time duration; pulsed or continuous mode; and primary (e.g. red light) wavelength, secondary (e.g. IR) wavelength, or both.
[0080] An exemplary illustrated in
[0081] Memory 205 has installed therein the photon therapy mobile application/module 290 of the present invention, which may further comprise the use of one or more application program interfaces (API's). The memory 205 or other data storage unit (e.g. a cloud account) stores data, such as history of operation and treatment sessions, security alerts (e.g. overheating of device 100 and automatic shutoff), instructions from health care providers, etc.
[0082] Additionally, memory 205 (which may include one or more computer readable storage mediums) also comprises high-speed random-access memory and may also include non-volatile memory, such as one or more magnetic disk storage devices, flash memory devices, or other non-volatile solid-state memory devices. Access to memory 205 by other components of the device 200, such as the CPU 210, may be controlled by a memory controller 225.
[0083] The RF (radio frequency) subsystem 230 receives and sends RF signals by converting electrical signals to/from electromagnetic signals and communicates with communications networks and other communications devices via the electromagnetic signals. The RF subsystem comprises well-known circuitry for performing these functions, including but not limited to a Bluetooth chip, a wireless chip, an antenna system, an RF transceiver, one or more amplifiers, a tuner, one or more oscillators, a digital signal processor, a CODEC chipset, a subscriber identity module (SIM) card, memory, and so forth. The RF subsystem communicates wirelessly via WiFi (e.g. 802.11ax) or wireless broadband (e.g. LTE, GSM/EDGE, CDMA) with the Internet (e.g. public network) or an intranet (e.g. private home or business network). The RF subsystem also communicates wirelessly via Bluetooth (e.g. v5.0) to other devices such as printers and headphones.
Conclusion
[0084] It will be appreciated that the methods and compositions and compounds of the present disclosure can be incorporated in the form of a variety of embodiments, only a few of which are disclosed herein. It will also be apparent for the expert skilled in the field that other embodiments exist and do not depart from the spirit of the invention. Thus, the described embodiments are illustrative and should not be construed as restrictive.
[0085] Accordingly, the preceding exemplifications merely illustrate the principles of the various embodiments. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the embodiments and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the invention as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. The scope of the various embodiments, therefore, is not intended to be limited to the exemplary embodiments shown and described herein.
[0086] The technology illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising,” “consisting essentially of,” and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible within the scope of the technology claimed. The term “a” or “an” can refer to one of or a plurality of the elements it modifies (e.g., “a reagent” can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described.
[0087] The term “about” as used herein refers to a value within 10% of the underlying parameter (i.e., plus or minus 5%), and use of the term “about” at the beginning of a string of values modifies each of the values (i.e., “about 1, 2 and 3” refers to about 1, about 2 and about 3). Further, when a listing of values is described herein (e.g., about 50%, 60%, 70%, 80%, 85% or 86%) the listing includes all intermediate and fractional values thereof (e.g., 54%, 85.4%). Thus, it should be understood that although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered within the scope of this technology.
[0088] As used herein, the term “substantially” refers to approximately the same shape as stated, and recognizable by one of ordinary skill in the art.
[0089] Trademarks: the product names used in this document are for identification purposes only; and are the property of their respective owners.
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