Photobiomodulation systems and methods for improving immunity and treatment of respiratory tract infections - Patents.com

Abstract

1. A self-management system for improving immunity and treatment of respiratory tract infections in a subject, comprising: an illumination unit configured to deliver light energy into at least a portion of an in vivo target selected from the group consisting of the thymus, sternal bone marrow, and lungs; A system comprising:

Description

[Technical field]

[0001] The present invention relates to photobiomodulation, and more particularly to photobiomodulation systems and methods for the treatment of respiratory tract infections. [Background technology]

[0002] Respiratory tract infection A respiratory tract infection (RTI) is an infectious disease that involves the respiratory tract. This type of infection can be classified as an upper respiratory tract infection (URI) or a lower respiratory tract infection (LRI).

[0003] The upper respiratory tract is generally considered to be the airway above the glottis or vocal cords. This portion of the respiratory tract includes the nose, sinuses, pharynx, and larynx. Typical upper respiratory tract infections include tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, certain types of influenza, and the common cold. Symptoms of a URI may include cough, sore throat, runny nose, nasal congestion, headache, low-grade fever, facial pressure, and sneezing.

[0004] The lower respiratory tract consists of the trachea (throat), bronchi, bronchioles, and lungs. Lower respiratory tract infections are generally more severe than upper respiratory tract infections. LRIs are the leading cause of death among all infectious diseases. The two most common LRIs are bronchitis and pneumonia.

[0005] COVID-19 COVID-19 is a dreaded respiratory tract infection causing a global pandemic that began in 2019. As of early 2021, several vaccines with varying efficacy have been developed. However, there have been many problems with mass production of the vaccines. Many countries, including high-income countries, are dealing with vaccine shortages to vaccinate even the most vulnerable members of their populations.

[0006] Moreover, viruses have a strong tendency to mutate, so many versions of the virus can exist. This makes them a perpetually changing target for intervention by comprehensive treatments. For example, as a result of mutations, SARS-CoV-2, the predominant genotype in this pandemic, differs substantially from other viruses, such as the viruses that cause the common cold and various influenza variants, including four other types of coronaviruses (OC43, HKU1, NL63, and 229E). This is because treatments that are effective against well-known viruses are often ineffective against novel viruses such as SARS-CoV-2. The same problem arises with SARS-CoV-2 as new variants emerge.

[0007] Even as vaccines against COVID-19 were developed, variants were emerging at the same time. Variants include those from the UK and South Africa that some experts fear may be more easily transmissible, possibly resulting in a higher mortality rate. It is uncertain whether current vaccines will be equally effective against these new variants. Thus, there is a case to potentially call for coronavirus variant-independent interventions.

[0008] Photobiomodulation (PBM) Photobiomodulation (PBM), also known as low-level light therapy (LLLT), is a biomodulation technique that delivers photons (mainly of red and near-infrared wavelengths) to living tissue to modulate its function. PBM may even show promise in strengthening the immune system. Growth factors expressed in PBM activity accelerate tissue healing.

[0009] The biochemical mechanisms of PBM interaction include increasing the activity of ion channels such as Na+ / K+ATPase, and indirect effects include modulating important secondary messengers such as calcium, cyclic adenosine monophosphate (cAMP) and reactive oxygen species (ROS) that all result in diverse biological cascades that lead to effects such as the maintenance of homeostasis and activation of protective, antioxidant and proliferative gene factors, as well as organizational responses such as cerebral blood flow that are deficient in neurocognitive disorders.

[0010] The most well-explored mechanism of action of PBM is its functional effect on mitochondrial function. PBM has been demonstrated to increase the activity of complexes in the mitochondrial electron transport chain, including complexes I, II, III, IV, and succinate dehydrogenase. In complex IV, the enzyme cytochrome c oxidase (CCO) acts as a transducer as well as a photoreceptor. CCO specifically receives and converts red (620nm-700nm) and near-infrared (780nm-1400nm) light, the wavelengths of light that can be processed by PBM. This process increases the amount of ATP produced as well as cyclic AMP (cAMP) and reactive oxygen species (ROS). The increase in ATP increases the activity of ion channels that regulate cAMP and calcium, which in turn stimulates diverse biological cascades and activates up to 110 genes for transcription, thereby leading to healing, recovery of activity, and extended energy production by mitochondria. One of the most prominent responses to PBM is the activation of the sodium pump and Na+ / K+ ATPase, leading to greater membrane stability and resistance to depolarization. Summary of the Invention [Problem to be solved by the invention]

[0011] It would be advantageous to use a non-invasive therapy such as PBM for the treatment of respiratory tract infections such as COVID-19. [Means for solving the problem]

[0012] In one aspect, the present invention provides a method for producing a method for manufacturing a semiconductor device comprising: Subjects A system for improving immunity and treatment of respiratory tract infections in A configured irradiation unit comprising a portable hollow casing having fixed dimensions, a sized internal spatial volume, and an external surface configuration suitable for application to a chest, the portable hollow casing of the configured irradiation unit comprising: (i) a light energy transmitting material forming at least a portion of the configured exterior surface for the hollow casing of the configured illumination unit; and (ii) at least one light generating unit housed and contained within the interior spatial volume of the hollow casing of the configured illumination unit and capable of generating light energy of at least one preselected wavelength selected from the group consisting of near infrared light wavelengths and visible red light wavelengths at a predetermined energy intensity for a preset duration and at a predetermined pulse frequency sufficient to collectively penetrate the skin on demand and advance to at least a portion of an in vivo target selected from the group consisting of the thymus, sternal bone marrow, and lungs. It is composed of Thereby, the configured irradiation unit can emit light energy after being applied to the breast, so as to achieve that the emitted light energy passes through the skin and into at least a portion of the in vivo target. An irradiation unit; a frame suitable for supporting said configured illumination unit and for positioning at will said light transmitting exterior surface of said configured illumination unit in a fixed position and desired illumination direction on said chest; a handheld controller assembly capable of controlling on-demand delivery of light energy from said configured illumination unit into at least a portion of said thymus, said sternal bone marrow, and / or said lungs in vivo, said handheld controller assembly being operable to control ... (a) a source of on-demand direct current; (b) a central processing unit for controlling and directing such flow of direct current; (c) at least one connector in electrical communication with the power source for carrying direct current on demand to the central processing unit; and (d) at least one connector in electrical communication with the configured illumination units for carrying direct current from the central processing unit to the light-generating units on demand; a portable controller assembly including: The object of the present invention is to provide a system comprising:

[0013] In another aspect, the present invention provides a method for producing a method for manufacturing a semiconductor device comprising: Subjects 1. A method for improving immunity and treatment of respiratory tract infections in A. A light energy emitting device, comprising: A configured irradiation unit comprising a portable hollow casing having fixed dimensions, a sized internal spatial volume, and an external surface configuration suitable for application to a chest, the portable hollow casing of the configured irradiation unit comprising: (i) a light energy transmitting material forming at least a portion of the configured exterior surface for the hollow casing of the configured illumination unit; and (ii) at least one light generating unit housed and contained within the interior spatial volume of the hollow casing of the configured illumination unit and capable of generating light energy of at least one preselected frequency selected from the group consisting of near infrared light wavelengths and visible red light wavelengths at a predetermined energy intensity for a preset duration and at a predetermined pulse frequency sufficient to collectively on demand penetrate the skin and advance to at least a portion of an in vivo target selected from the group consisting of the thymus, sternal bone marrow, and lungs; It is composed of Thereby, the configured irradiation unit can emit light energy after being applied to the breast, so as to achieve that the emitted light energy passes through the skin and into at least a portion of an in vivo target. Irradiation unit, a frame adapted to support said configured illumination unit and to position at will said light-transmitting outer surface of said configured illumination unit in a fixed position and desired illumination direction on the chest; a handheld controller assembly capable of controlling on-demand delivery of light energy from said configured illumination unit into at least a portion of a thymus, sternal bone marrow, and / or lung in vivo, said handheld controller assembly comprising: (a) a source of on-demand direct current; (b) a central processing unit for controlling and directing such flow of direct current; (c) at least one connector in electrical communication with the power source for carrying direct current on demand to the central processing unit; and (d) at least one connector in electrical communication with the configured illumination unit for carrying direct current from the central processing unit to the light-generating unit on demand; A portable controller assembly including: obtaining a light energy emitting device comprising: B. generating light energy in the light generating unit of the positioned and configured illumination unit at least one preselected wavelength selected from the group consisting of near infrared light wavelengths and visible red light wavelengths at a predetermined energy intensity for a predetermined duration and at a predetermined pulse frequency sufficient collectively to penetrate the skin of the subject on demand and travel to at least a portion of the in vivo target; The object of the present invention is to provide a method for

[0014] The present invention may be better understood and more readily appreciated when taken in conjunction with the accompanying drawings. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of a preferred system of the present invention. [Diagram 2] FIG. 2 is another perspective view of a preferred system of the present invention. [Diagram 3] FIG. 1 is a side view of a preferred system of the present invention applied to a subject. [Figure 4] FIG. 1 is a front view of a preferred system of the present invention applied to a subject. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] Use of PBM for viral infections It has been repeatedly demonstrated that the human body has the ability to adapt to ever-changing microbes and viruses. The ability to overcome these changing targets is highly dependent on the state of the immune system. It therefore makes sense to invest in ways to support and strengthen the body's innate wisdom of the immune system. The inventors recognize that PBM physical therapy may be part of the solution as it supports the body's innate wisdom to restore functional homeostasis while simultaneously strengthening the immune response to infectious diseases such as COVID-19.

[0017] The inventors propose that PBM can treat viral infections by strengthening the immune system. Furthermore, PBM reduces inflammation and the overactivation of inflammatory cytokines characteristic of COVID-19 cases. Growth factors expressed by PBM activity accelerate the healing of tissues damaged by severe infections and inflammatory responses.

[0018] Preferred System / Apparatus Components The systems and devices of the present invention preferably comprise at least (1) A portable hollow casing; (2) one or more light-generating units housed and contained within the interior spatial volume of the hollow casing; (3) A source of electric current; (4) a process controller assembly; and (5) Optionally, a smart phone, tablet computer, or other computing device The component parts are as follows:

[0019] These components may be electrically coupled together, preferably by at least one connector for transmitting direct current from a current source to the controller assembly, and at least one connector for carrying direct current from the controller assembly to the light-generating unit.

[0020] 1. Portable hollow casing The present invention provides a method for manufacturing a cellular telephone using a fixed dimension, sized internal space volume, and Subjects The portable casing includes at least one portable hollow casing having an exterior surface configuration suitable for application to a device. The intended purpose and goal of the portable casing is to comprise two parts: (i) Subjects and (ii) act as a containment chamber configured to easily accommodate the emitted light waves. Subjects The function of the lens is to direct the light toward the object.

[0021] Preferably, the portable casing may be constructed and formed from a light-transmitting material over at least a portion of its exterior surface, surrounding a volumetric zone intended to house and contain at least one light-generating unit. By definition, such light-transmitting materials include and encompass transparent, semi-transparent, and opaque materials. However, in most instances, completely clear transparent materials are preferred.

[0022] 2. One or more light-generating units The light generating unit can deliver therapeutic light at wavelengths including, but not limited to, (i) visible red light wavelengths ranging from about 620 nm to 780 nm in the visible color spectrum range, and (ii) near infrared light wavelengths ranging from about 780 nm to 1400 nm in the non-visible spectrum range. Furthermore, the waves and particles of light energy generated can alternatively be (i) coherent (such as lasers) or non-coherent (such as non-laser light emitting diodes (LEDs)), (ii) pulsed or non-pulsed (continuous wave) in delivery, (iii) constant or non-constant in intensity, (iv) uniform or non-uniform in phase, (v) polarized and non-polarized, and (vi) have regular or irregular flux.

[0023] Any conventionally known means for generating electromagnetic radiation or article for propagating radiant energy is acceptable for use in the present device. It is contemplated and expected that most of the embodiments will employ low level laser units or LEDs as the light generating unit or units for illumination purposes.

[0024] 3. Source of current It is preferred that there is a portable, replenishable source of on-demand direct current as a component part of the devices and systems of the present invention. The therapeutic treatment systems and methods provided by the present invention are intended to deliver a specific energy dosage (measured in Joules) that is deemed effective per therapeutic treatment as a function of power (in Watts) and time (in seconds).

[0025] The power source typically delivers energy in the form of direct current. For example, it may deliver a suitable amount of current repeatedly from a single battery source or from a combination of several dry cell batteries coupled together in series or parallel. In some other desired embodiments, the source of power takes the form of a rechargeable mobile battery, i.e., a direct current battery unit (which can be recharged from a regular household AC outlet), or exists as alternating current (AC) via a power adapter. It is expected and intended that there will be several alternative embodiments with different combinations of these components, suitable for different power supply configurations, energy dosages, and treatment times.

[0026] With regard to positioning, in some preferred embodiments, the power source is a separate entity that is held and contained entirely within the interior boundaries of the controller assembly. However, in other preferred embodiments, the source of current may be a self-contained, separate, stand-alone unit in electrical communication with the controller assembly via an electrical cable and connector module connection, such as a portable, rechargeable power bank. In alternative embodiments, the source of current is obtained by plugging the system and device into the local power grid via a power adapter.

[0027] 4. Processing Controller Assembly The process controller assembly has at least three structural features: (i) a receiving circuit for receiving such current as it is transmitted from the current source to the controller assembly; (ii) a central processing unit (CPU) for controlling and directing the flow of such current as received over time by the controller assembly; and (iii) a distribution circuit for delivering direct current from the controller assembly to one or more light-generating units; The portable unit components include:

[0028] The process controller assembly is intended and expected to be electrically coupled to other essential components of the apparatus, and thus typically also includes: (a) at least one connector for transmitting direct current from a source of current to a controller assembly; (b) at least one connector for carrying direct current from the controller assembly to the one or more light-generating units; These connectors are typically formed as insulated copper wire cables and jack modules that allow quick and easy coupling and electrical communication with both a current source and one or more light-generating units.

[0029] It is intended and expected that any conventionally known interchangeable electrical cables and connectors will be used to couple the controller assembly to the illumination lens, which also provides a distinct advantage and benefit to the user, namely, the option to replace one configured illumination lens (capable of transmitting light at a first wavelength) with another illumination lens (also capable of transmitting light at a second, different wavelength), thereby enabling the use of different lasers and alternative light emitting diodes capable of delivering different wavelengths of visible and non-visible light energy with one single controller assembly.

[0030] In some preferred embodiments, the source of electrical current is internal and contained within the interior spatial volume of the controller assembly and appears as a battery (either a dry cell or a rechargeable unit). In this example, the controller assembly also has a socket suitable for attaching an insulated copper wire cable and a modular jack connector whose other end is coupled to a light-generating unit located inside the hollow casing.

[0031] The central processing unit ("CPU") of the controller assembly preferably controls the wavelength, coherence / tunability, energy (Joules (J)), power (Watts (W) or milliwatts (mW)) or irradiance (W / cm 2 ), radiation exposure (J / cm 2The light energy can be adjusted with respect to many different parameters, including but not limited to, the light intensity, exposure time (seconds), pulse mode (continuous or pulsed), frequency (Hertz (Hz)), duty cycle (percentage), fractionation protocol (number of patient treatment sessions), light beam size (area of ​​the impinging beam), and light beam penetration (delivery) distance.

[0032] The processing controller assembly will not operate in the absence of a source of current. Moreover, the controller assembly is a circuit arrangement that provides power to properly and efficiently drive the one or more light-generating units, except that it preferably switches off the units after a predefined time. The controller also ensures that the power delivered to the one or more light-generating units is stable. Thus, the controller desirably monitors the battery level when the source is a mobile battery or battery, and switches off the units if the mobile battery or battery cannot provide enough power to properly drive the circuit arrangement.

[0033] In a preferred embodiment, the controller is part of the same part of the system that houses the light-generating unit or units, or alternatively, the controller is detached from this part but connected via a communication cable.

[0034] 5. Smartphones, tablet computers, or other computing devices In a generational embodiment, the functions of the controller assembly are controlled in whole or in part by a smart phone, a smartwatch, a tablet computer, a laptop computer, a desktop computer, or any suitable computing device. The smart phone may operate, for example, on one of the more common mobile platforms. One or more light-generating units can be connected to the smart phone via a cable or wirelessly. The smart phone carries a downloadable software application that largely replicates the software functions in the controller assembly. A modified fixture that contains the interface processing software in a computer chip provides a physical connection between the controller and the surrounding smart phone platform. The software application also contains more software controls and a graphic interface. Alternatives to the smart phone include a smartwatch, a tablet computer, a laptop computer, a desktop computer, or any suitable computing device with a downloaded software application.

[0035] In yet another embodiment, the controller assembly operates in combination with a smart phone, smart watch, tablet computer, laptop computer, desktop computer, or any suitable computing device. In particular, the computing device (i) turns the controller assembly on and off, and / or (ii) transmits commands to the controller assembly to adjust the wavelength, coherence / tunability, energy (Joules (J)), power (Watts (W) or milliwatts (mW)), or irradiance (W / cm2). 2 ), radiation exposure or dose or fluence density (J / cm 2The user has downloaded a software application that allows the light energy parameters of each individual light-generating unit to be adjusted, including but not limited to, the power output (W) of the light-generating unit, exposure time (seconds), pulse mode (continuous or pulsed), frequency (Hertz (Hz)), duty cycle (percentage), fractionation protocol (number of patient treatment sessions), light beam size (area of ​​the impinging beam), and light beam penetration (delivery) distance.

[0036] Additionally, the computing device acts as a system interface through which a user inputs commands to turn the controller assembly on and off and / or adjust the light energy parameters of each of the individual light-generating units. The commands may be input by any known input component, such as a touch screen, a mouse, a keypad, a keyboard, a microphone, a camera, or a video camera. When a user inputs a command into the system interface, the command is transmitted to the controller assembly, which then adjusts the parameters of the light energy being delivered by the light-generating units.

[0037] In these embodiments, the computing device can be coupled to the controller assembly using any conventionally known interchangeable electrical cable and connector. Alternatively, the computing device may communicate with the controller assembly by wireless means. Connections between any of these components are implemented using appropriate wired or wireless communications via protocols such as Bluetooth, Wi-Fi, Near Field Communication (NFC), Radio Frequency Identification (RFID), 3G, Long Term Evolution (LTE), Universal Serial Bus (USB), and other protocols and technologies known to those skilled in the art.

[0038] Two unique components of the preferred system of the present invention 1. Intranasal LED device applied in the nasal cavity 2. LED instrument module positioned on the sternum may have a role in treating RTIs such as COVID-19.

[0039] Any of the unique components of the preferred systems of the present invention may also contribute to the additional beneficial systemic effects unique to PBM.

[0040] Mechanism of action The system of the present invention delivers light of specific wavelengths, powers, and durations to the body. The body recovers functional homeostatic balance in response to harnessing and converting energy into numerous interacting elements. The beneficial result is immune system regulation. PBM using the system of the present invention enhances a weakened immune system and is preventative in healthy individuals.

[0041] The basic mechanism of action of PBM is based on inducing photons to mitochondria at the cellular level. PBM has a regulatory effect on the mitochondrial respiratory chain, where the temporary release of non-cytotoxic levels of reactive oxygen species (ROS) leads to favorable effects. PBM plays a regulatory role through crosstalk with nuclear factor kappa-light-chain-enhancer of activated B cell (NF-κB) to manage various conditions, including immune-related conditions. In immune-compromised systems, the chain of action leads to increased production of appropriate levels of white blood cells while managing inflammation. Appropriate doses of mitochondria-directed PBM can positively modulate the immune system.

[0042] Actions against COVID-19 With regard to COVID-19, the coronaspike proteins of the SARS-COVID membrane are more prone to absorbing light from ultraviolet to infrared. This process may transform the viral envelope and, as a result, weaken the virus, making it particularly receptive to the subsequent action of PBM in the red and NIR spectrum used by the system of the present invention.

[0043] Another relevant component released during PBM is nitric oxide (NO). NO is commonly seen in vasodilation and improved blood circulation. However, in the context of the COVID-19 pandemic, the value of NO in potentially inhibiting coronavirus replication is far more important.

[0044] Considering the effect of PBM on the electron transport chain, such as on the enzyme cytochrome c oxidase (CCO), the inventors propose an inhibitory effect on coronavirus replication. The function of CCO as a photoacceptor is enhanced when photons obtained from the PBM process dissociate nitric oxide (NO) from CCO. NO can then inhibit coronavirus replication.

[0045] Preferred targets for the system / device of the present invention A. Thymus In PBM, low-level red and NIR light interacts with cells to produce changes at the molecular, cellular, and tissue levels. Aside from restoring immune function, PBM leads to stem cell development that progresses to embryonic cells for tissue repair and white blood cell production to support the immune system.

[0046] By applying a controlled dose of PBM to the thymus, improved T-lymphocyte maturation can occur. Although the thymus shrinks with age, PBM activates the remaining gland and the surrounding bone marrow to contribute to mesenchymal stem cell development. The overall effect helps boost the immune system to resist viral infections.

[0047] The system of the present invention has LED modules placed over the entire surface of the thymus to stimulate the production of T lymphocytes and the surrounding bone marrow.

[0048] B. Upper and lower respiratory tract Some viral respiratory infections, such as COVID-19, affect both the upper respiratory tract (nasal passages, pharynx, larynx) and the lower respiratory tract (trachea, main bronchi, lungs). One of the reasons for COVID-19's potential is its ability to migrate to the lungs and gain access to the host's type II alveolar cells, the most abundant type of alveolus, where gas exchange takes place. COVID-19 entry is facilitated through the enzyme ACE2, which is bound by the COVID-19 "corona" spike. As alveolar damage progresses, respiratory failure ensues and may subsequently result in death.

[0049] The present invention may preferably involve direct irradiation of the lower airways, specifically the lungs, where most of the significant symptoms of COVID-19 occur in symptomatic patients. One consequence of PBM-associated mitochondrial action is the liberation of nitric oxide (NO) dissociated from the respiratory chain. In viral infections, the effects of NO are complex and may be protective or detrimental. However, our investigations into COVID-19 symptoms have shown that NO has a beneficial effect in suppressing the SARS-CoV replication cycle.

[0050] In the present invention targeting the lungs, the PBM is preferably directed to the thoracic region, more preferably around the sternum. This is the same preferred location of the LED module targeting the thymus. This location therefore allows for a dual effect of illuminating the lungs as well as the thymus. The LED module of the present system for this site preferably emits light at about 810 nm. This wavelength was chosen to provide a depth of light penetration into mammalian tissue with minimal absorption by water.

[0051] C. Nasal cavity The nasal cavity has been preferably chosen for positioning the LEDs because it has a dense capillary network protected by a very thin membrane, making this site relatively easy for the light from the low power LED system of the present invention to reach the vasculature and the required tissues.

[0052] PBM has a systemic effect throughout the body mediated by ubiquitous, circulating, cell-free, respiration-capable mitochondria. This joins mitochondria embedded inside human eukaryotic cells. Thus, the positive effects of therapeutic light are delivered throughout the body by simply illuminating the capillaries in the nasal passages where these circulating mitochondria reside. This effect spreads in circulation throughout the body through major blood vessels, approximately three times per minute.

[0053] A study using red laser optical fiber to treat vasomotor rhinitis showed a significant increase in T-lymphocytes. A complex cascade mechanism starting from free-floating circulating mitochondria in the blood vessels surrounding the nasal cavity is likely the driving factor behind the results. PBM via the nasal cavity using the system of the present invention can boost the production of protective white blood cells, including T-lymphocyte cells, present throughout the body.

[0054] Intranasal System of the Present Invention Applicator The LEDs are preferably 6.5mW / cm 2 It is used to deliver 633nm red light at a safe power density of .

[0055] Ultraviolet (UV) C light may be useful in clearing the virus through direct exposure, but there is a risk of cancer with prolonged exposure, so there are suggestions that the most preferred wavelengths to use in the nasal cavity should undergo further scrutiny.

[0056] In essence, the application of PBM to the nasal cavity and thymus using light in the red and NIR range activates the body's immune response system throughout the body. These wavelengths also fall within and around the peak of the spectrum of action suitable for PBM effects. To achieve this effect, the system of the present invention preferably uses intranasal light delivering a wavelength of 633 nm. Applicator The penetration depth of this wavelength is estimated to be close to optimal for penetrating and irradiating the vascular network just beneath the thin membrane surrounding the nasal cavity.

[0057] Other Applications of the System / Device of the Present Invention: Cytokine Storm Syndrome Accumulating evidence suggests that a subgroup of patients with severe COVID-19 may have a cytokine storm syndrome. A "cytokine storm" is the overproduction of and activation of cytokines by immune cells, which is often associated with a surge of activated immune cells into the lungs. The resulting lung inflammation and fluid accumulation can cause respiratory distress and can become contaminated by secondary bacterial pneumonia, often increasing the patient's mortality.

[0058] It is essential to manage pulmonary inflammation and the cytokines that cause it. PBM can increase immune activation by enhancing NF-κB protein in normal cells. In the presence of inflammatory markers, PBM may have an anti-inflammatory effect. The anti-inflammatory properties of PBM are expected to calm potential cytokine storms in patients.

[0059] Post-infectious sepsis Damage to the lungs from the infection can lead to a subsequent risk of sepsis due to a weakened immune system working in overdrive. Statistics show that half of survivors of such infections suffer from other infections, kidney failure, or cardiovascular problems about three months after the outbreak.

[0060] Moreover, many sepsis patients suffer severe long-term functional, cognitive or psychological consequences, including paralysis, depression and anxiety. In 2017, the global burden of sepsis was the leading cause of 49 million cases and 11 million deaths.

[0061] Findings from animal studies suggest that PBM may be an effective, inexpensive and non-invasive treatment for sepsis.

[0062] Disease prevention PBM has been shown to modulate the body's own immune response both locally and systemically. The fact that PBM strengthens the immune system makes it a reliable method of prevention against diseases, including viral infections.

[0063] Preferred embodiments of the system of the present invention As shown in Figures 1-4, the present invention provides a preferred embodiment of an apparatus 100 having an airway light treatment unit 102. Optionally, an intranasal unit 200 is also present, as can be seen in Figures 1, 3, and 4.

[0064] The controller assembly 150 can act as a power source and central processing unit for both the airway light treatment unit 102 and the intranasal unit 200. In a preferred embodiment shown in Figures 1-4, the controller assembly 150 is located on the airway light treatment unit 102. In an alternative embodiment, the controller assembly 150 is a separate unit that can communicate with the airway light treatment unit 102 and the intranasal unit 200.

[0065] 1-4, the airway phototherapy unit 102 includes one or more configured illumination units 108, each of which has a fixed dimension, a sized internal spatial volume, and Subjects The device includes a portable hollow casing having an exterior surface configuration suitable for application to the chest 502 of the subject 500 .

[0066] The portable casing comprises (i) a light energy transmitting material forming at least a portion of a configured exterior surface for said hollow casing, and (ii) at least one light generating unit that is entirely contained and contained within said interior spatial volume of said hollow casing and is capable of generating light energy of at least one preselected wavelength selected from the group consisting of near infrared light wavelengths and visible red light wavelengths, at a predetermined energy intensity for a preset duration, and at a predetermined pulse frequency sufficient collectively to penetrate the chest 502 on demand and advance into the body.

[0067] A frame 118 is provided within the airway light treatment unit 102 to support the configured illumination unit 108 and accommodate the airway light treatment unit 102 to position at will the light-transmitting outer surface of the configured illumination unit 108 in a fixed position and desired illumination direction on the chest 502. Preferably, the frame 118 helps to fix the airway light treatment unit 102 to the chest 502, Subjects 500 provides a support structure 128 that makes the airway phototherapy unit 102 more comfortable to wear.

[0068] The configured illumination unit 108 is positioned within the airway light treatment unit 102 to target a specific location. In a preferred embodiment, the configured illumination unit 108 is positioned to direct light energy to at least a portion of an in vivo target selected from the group consisting of the thymus, the sternal bone marrow, and the lungs.

[0069] As can be seen in Figures 1, 3 and 4, the preferred system of the present invention optionally includes an intranasal phototherapy unit 200 including a nose clip 202. The nose clip 202 includes an illumination lens 204 configured to Subjects 500. The configured illumination lens 204 includes a portable hollow casing having a fixed dimension, a sized interior spatial volume, and an exterior surface configuration suitable for application inside the nostril.

[0070] The portable casing comprises (i) a light energy transmitting material forming at least a portion of a configured exterior surface for said hollow casing, and (ii) at least one light generating unit that is entirely contained and contained within said interior spatial volume of said hollow casing and is capable of generating light energy of at least one preselected wavelength selected from the group consisting of near infrared light wavelengths and visible red light wavelengths, at a predetermined energy intensity for a preset duration, and at a predetermined pulse frequency sufficient collectively to penetrate nasal tissue on demand and advance into blood vessels.

[0071] The first connector 300 may be in electrical communication with the configured illumination unit 108 of the airway phototherapy unit 102. The second connector 400 may be in electrical communication with the configured illumination lens 204 of the nasal phototherapy unit 200. This allows direct current to be delivered on demand from a power source, such as a battery pack 600 or a power plug 700 plugged into an electrical outlet, through the controller assembly 150 to one or more light-generating units in the configured illumination unit 108 as well as to one or more light-generating units of the configured illumination lens 204 in the nasal phototherapy unit 200.

[0072] Experimental scope A 30-day randomized study was conducted to evaluate the efficacy of a preferred system of the present invention in treating respiratory symptoms of COVID-19.

[0073] Research Subjects A total of 280 subjects aged 18-65 years were involved in the study. All subjects had tested positive for COVID-19 infection and had moderate to severe symptoms. Subjects were randomized in a 1:1 ratio to receive either treatment with the present invention or standard of care (SOC).

[0074] None of the subjects were hospitalized or required supplemental oxygen or positive pressure support. Additionally, none of the subjects were pregnant, had been diagnosed with Chronic Obstructive Pulmonary Disease (COPD), or had tested positive for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or Human Immunodeficiency Virus (HIV).

[0075] Subject Treatment For the first five days, subjects were treated with the system of the present invention for 20 minutes, twice a day, separated by at least 6 hours between each treatment. Thereafter, subjects were treated once a day for 20 minutes.

[0076] The NIR LED module of the preferred embodiment of the present invention was positioned above the manubrium of the sternum to target the upper sternum. Applicator was positioned.

[0077] Subjects were asked to self-report their symptoms by completing the Wisconsin Upper Respiratory Symptom Survey (WURSS-44). Oxygen saturation levels were measured at rest.

[0078] result Seventy-three subjects were randomized to receive either the treatment group or standard of care. An independent statistical analysis reported that the study was highly promising and was strongly recommended for full completion with the planned 280 subjects.

[0079] The scope of the claims should not be limited to the preferred embodiments set forth in the examples, but should be accorded the broadest interpretation consistent with the specification as a whole.

Claims

1. A system for improving immunity and treatment of a respiratory tract infection in a subject, comprising: A configured irradiation unit comprising a portable hollow casing having fixed dimensions, a sized internal spatial volume, and an external surface configuration suitable for application to a chest, the portable hollow casing of the configured irradiation unit comprising: (i) a light energy transmitting material forming at least a portion of the configured exterior surface for the hollow casing of the configured illumination unit; and (ii) at least one light-generating unit housed and contained within the interior spatial volume of the hollow casing of the configured illumination unit and capable of generating light energy of at least one preselected wavelength selected from the group consisting of near-infrared light wavelengths and visible red light wavelengths at a predetermined energy intensity for a preset duration and at a predetermined pulse frequency sufficient to collectively penetrate the skin on demand and travel to at least a portion of an in vivo target selected from the group consisting of the thymus, sternal bone marrow, and lungs. It is composed of Thereby, the configured irradiation unit can emit light energy after being applied to the breast, so as to achieve that the emitted light energy passes through the skin and into the at least a portion of the in vivo target. An irradiation unit configured as above; a frame adapted to support the configured illumination unit and to position at will the exterior surface of the configured illumination unit in a fixed position and desired illumination direction on the chest; a handheld controller assembly capable of controlling on-demand delivery of light energy from said configured illumination unit into at least a portion of said thymus, said sternal bone marrow, and / or said lungs in vivo, said handheld controller assembly comprising: (a) an on-demand source of direct current; (b) a central processing unit for controlling and directing such flow of direct current; (c) at least one connector in electrical communication with the power source for carrying direct current on demand to a central processing unit; and (d) at least one connector in electrical communication with the configured illumination unit for carrying direct current from the central processing unit to the light-generating unit on demand; a portable controller assembly including: A system comprising:

2. An illumination lens configured as follows: A portable hollow casing having a fixed dimension, a sized interior spatial volume, and an exterior surface configuration suitable for in vivo insertion within a nasal cavity of a nostril without causing substantial impairment to the subject's ability to breathe and without penetrating the nasal tissue of the living body, the portable hollow casing of the configured illumination lens comprising: (i) an optical energy transmitting material forming at least a portion of the configured exterior surface for the hollow casing of the configured illumination lens; (ii) at least one light generating unit housed and contained within the interior spatial volume of the hollow casing of the configured illumination lens, capable of generating light energy of at least one preselected wavelength selected from the group consisting of near infrared light wavelengths and visible red light wavelengths, at a predetermined energy intensity for a preset duration, and at a predetermined pulse frequency sufficient collectively to penetrate the nasal tissue and travel into a blood vessel on demand; It is composed of Thereby, the configured illumination lens can emit light energy in any desired direction inside the nasal cavity after being inserted into the living body, and the emitted light energy can be achieved to travel from the nasal cavity into at least a portion of the blood vessel in the living body. an illumination lens configured to include a portable hollow casing; an applicator means adapted to support said configured illuminated lens and to position at will said exterior surface of said configured illuminated lens in a fixed position and desired illumination orientation within said nostril adjacent the lining of said nasal cavity of said subject; Further equipped with the portable controller assembly can further control on-demand delivery of light energy from the configured illumination lens. The system of claim 1 .

3. The system of claim 1 or 2, wherein the light energy has a wavelength of about 633 nm to 810 nm.

4. The system of any one of claims 1 to 3, wherein the respiratory tract infection is COVID-19.

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