Photobiomodulation system and method for improving immunity and treating respiratory infections

Abstract

A self-administrable system for boosting immunity and treating respiratory infections in a subject, the system comprising: a configured illumination unit for delivering light energy to at least a portion of an in vivo target selected from the group consisting of thymus, sternum bone marrow, and lungs.

Description

Invention Field

[0001] This invention relates to photobiological regulation, and more particularly to photobiological regulation systems and methods for treating respiratory infections. Background Technology

[0002] Respiratory infection

[0003] Respiratory tract infection (RTI) is an infectious disease involving the respiratory tract. This type of infection can be classified as upper respiratory tract infection (URI) or lower respiratory tract infection (LRI).

[0004] The upper respiratory tract is generally considered to be the airway above the glottis or vocal cords. This part 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 an upper respiratory tract infection (URI) may include cough, sore throat, runny nose, nasal congestion, headache, low-grade fever, facial pressure, and sneezing.

[0005] The lower respiratory tract consists of the trachea (air ducts), bronchi, bronchioles, and lungs. Lower respiratory tract infections are generally more serious than upper respiratory tract infections. Lower respiratory tract infections (LRIs) are the leading cause of death among all infectious diseases. The two most common LRIs are bronchitis and pneumonia.

[0006] COVID-19

[0007] COVID-19 is a notorious respiratory infection that led to the global pandemic that began in 2019. By early 2021, several vaccines with varying efficacy had been developed. However, numerous challenges remain in vaccine rollout. Many countries, including high-income nations, are grappling with vaccine shortages, even shortages of vaccines to vaccinate the most vulnerable and at-risk members of their populations.

[0008] Furthermore, due to their high mutation rate, numerous viral versions can exist. This makes viruses perpetually moving targets for comprehensive therapeutic interventions. For example, as a result of mutations, the dominant genotype of SARS-CoV-2 in this pandemic is significantly different from other viruses, such as those that cause the common cold, including four other types of coronaviruses (OC43, HKU1, NL63, and 229E), and various influenza variants. This is why treatments effective against well-known viruses are often ineffective against novel viruses such as SARS-CoV-2. The same problem arises with the emergence of new variants of SARS-CoV-2.

[0009] Even with the development of vaccines against COVID-19, variants have emerged. These include variants from the UK and South Africa, which some experts fear are more transmissible and could lead to higher mortality rates. It is uncertain whether current vaccines are effective against these new variants. Therefore, there are proposals for intervention against potentially unknown coronavirus variants.

[0010] Photobiological regulation (PBM)

[0011] Photobiological modulation (PBM), also known as low-intensity phototherapy (LLLT), is a biostimulation technique that delivers photons (primarily red and near-infrared wavelengths) to living tissue to modulate its function. It can even be expected to enhance the immune system. Growth factors expressed during PBM activity accelerate tissue healing.

[0012] The biochemical mechanisms of PBM interactions include increased activity of ion channels such as Na+ / K+ ATPases, and indirect effects include regulation of important second messengers such as calcium, cyclic adenosine monophosphate (cAMP), and reactive oxygen species (ROS)—all of which lead to different biological cascades. These cascades result in effects such as maintaining homeostasis and activating protective antioxidants and proliferative gene factors, as well as systemic responses such as cerebral blood flow, which is lacking in neurocognitive disorders.

[0013] The most thoroughly studied mechanism of action of PBM is its fundamental impact on mitochondrial function. PBM has been shown 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 photoreceptor and converter. CCO specifically accepts and converts red light (620–700 nm) and near-infrared light (780–1400 nm), wavelengths that can be processed by PBM. This process increases the production of ATP, as well as cyclic adenosine monophosphate (cAMP) and reactive oxygen species (ROS). The increase in ATP increases the activity of ion channels regulating cAMP and calcium, thereby stimulating multiple biological cascades and activating up to 110 transcriptional genes, leading to prolonged healing and recovery activities and extended mitochondrial energy production. One of the most significant responses to PBM is the activation of the sodium pump and Na+ / K+ ATPase, resulting in greater membrane stability and depolarization resistance.

[0014] Using non-invasive therapies (such as PBM) to treat respiratory infections (such as COVID-19) would be advantageous. Summary of the Invention

[0015] In one aspect, the present invention provides a system for enhancing immunity and treating respiratory infections in a subject, the system comprising:

[0016] The configured irradiation unit includes a portable hollow shell having a fixed size, a specific internal volume, and an outer surface configuration suitable for application to the chest. The portable hollow shell of the configured irradiation unit comprises:

[0017] (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the hollow shell of the configured irradiation unit; and

[0018] (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the hollow housing of the configured irradiation unit, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, having a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate the skin and reach at least a portion of an in vivo target, said in vivo target being selected from the group consisting of the thymus, sternal bone marrow, and lungs.

[0019] The irradiation unit thus configured is able to emit light energy after being applied to the chest and achieve the passage of the emitted light energy through the skin to at least a portion of the target in the body;

[0020] A frame adapted to support the configured irradiation unit and to arbitrarily place the light-transmitting outer surface of the configured irradiation unit on the chest in a fixed position and a desired irradiation direction;

[0021] A portable controller assembly capable of controlling the on-demand delivery of light energy from the configured irradiation unit to at least a portion of the thymus, sternal bone marrow, and / or lungs within the body, the controller assembly comprising:

[0022] (a) A power supply with on-demand DC current.

[0023] (b) A central processing unit for controlling and directing the flow of such direct current.

[0024] (c) At least one connector in electrical communication with the power supply for delivering DC current to the central processing unit on demand, and

[0025] (d) At least one connector that is in electrical communication with the irradiation unit of the configuration for delivering direct current from the central processing unit to the light generating unit on demand.

[0026] In another aspect, the present invention provides a method for enhancing immunity and treating respiratory infections in subjects, the method comprising the following steps:

[0027] A. Obtaining a light energy emitting device, the light energy emitting device comprising:

[0028] The configured irradiation unit includes a portable hollow shell having a fixed size, a specific internal volume, and an outer surface configuration suitable for application to the chest. The portable hollow shell of the configured irradiation unit comprises:

[0029] (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the hollow shell of the configured irradiation unit; and

[0030] (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the hollow housing of the configured irradiation unit, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, having a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate the skin and reach at least a portion of an in vivo target, said in vivo target being selected from the group consisting of the thymus, sternal bone marrow, and lungs.

[0031] The irradiation unit thus configured is able to emit light energy after being applied to the chest and achieve the passage of the emitted light energy through the skin to at least a portion of the target in the body;

[0032] A frame adapted to support the configured irradiation unit and to arbitrarily place the light-transmitting outer surface of the configured irradiation unit on the chest in a fixed position and a desired irradiation direction;

[0033] A portable controller assembly capable of controlling the on-demand delivery of light energy from the configured irradiation unit to at least a portion of the thymus, sternal bone marrow, and / or lungs within the body, the controller assembly comprising:

[0034] (a) A power supply with on-demand DC current.

[0035] (b) A central processing unit for controlling and directing the flow of such direct current.

[0036] (c) At least one connector in electrical communication with the power supply for delivering DC current to the central processing unit on demand, and

[0037] (d) At least one connector electrically communicating with the configured irradiation unit for delivering direct current from the central processing unit to the light generating unit on demand; and

[0038] B. The light-generating unit of the positioned irradiation unit generates light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, which is in a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency that is commonly sufficient to penetrate the skin of the subject and reach at least a portion of the target in the body. Attached Figure Description

[0039] The invention can be better understood and more easily comprehended by referring to the accompanying drawings, in which:

[0040] Figure 1 This is a perspective view of a preferred system of the present invention;

[0041] Figure 2 This is another perspective view of the preferred system of the present invention;

[0042] Figure 3 This is a side view of a preferred system of the present invention applied to a subject; and

[0043] Figure 4 This is a front view of the preferred system of the present invention applied to a subject.

[0044] Detailed description of the invention and preferred embodiments

[0045] Using PBM to combat viral infection

[0046] The human body has repeatedly demonstrated the ability to adapt to ever-changing microbes and viruses. The ability to overcome these moving targets depends heavily on the state of the immune system. Therefore, it is wise to invest in methods that support and enhance the body's natural intelligence in its immune system. The inventors recognized that the PBM model could be such a solution because it supports the body's natural intelligence in restoring functional homeostasis and simultaneously enhances the immune response to infections such as COVID-19.

[0047] The inventors propose that PBM can treat viral infections by enhancing the immune system. Furthermore, PBM reduces inflammation and excessive activation of inflammatory cytokines, which are characteristic of COVID-19 cases. Growth factors expressed during PBM activity accelerate the healing of tissues damaged in severe infections and inflammatory responses.

[0048] Preferred system / device components

[0049] The system and apparatus of the present invention preferably include at least the following components:

[0050] (1) Portable hollow shell;

[0051] (2) One or more light-generating units are housed and contained within the internal space volume of the hollow shell;

[0052] (3) Current source;

[0053] (4) Process controller components; and

[0054] (5) Optional smartphone, tablet or other computing device.

[0055] Preferably, these components can be electrically connected together by at least one connector for transmitting DC current from the current source to the controller assembly and at least one connector for transmitting DC current from the controller assembly to the light generating unit.

[0056] 1. Portable hollow shell

[0057] The present invention includes at least one portable hollow housing having a fixed size, a specific internal volume, and an external surface configuration suitable for application to a subject. The portable housing is intended to serve two purposes and objectives: (i) as a containment chamber configured for easy application to a subject; and (ii) as a molded lens that reflects and guides emitted light to the subject.

[0058] Preferably, the portable housing may be constructed and formed of a light-transmitting material on at least a portion of its outer surface, and will cover a volumetric area intended to house and accommodate at least one light-generating unit. By definition, such light-transmitting materials include and cover transparent, translucent, and opaque substances. However, in most cases, a completely clear and transparent material is preferred.

[0059] 2. One or more light generating units

[0060] The light generating unit will be able to deliver therapeutic light at wavelengths including, but not limited to, those in the following categories: (i) visible red light wavelengths in the visible color spectrum range of approximately 620–780 nm; and (ii) near-infrared light wavelengths in the invisible spectrum range of approximately 780–1400 nm. Additionally, the generated light energy waves and particles may alternatively be: (i) coherent (e.g., in a laser) or incoherent (e.g., in a non-laser light-emitting diode (LED)); (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 or non-polarized; and (vi) having regular or irregular flux.

[0061] Any conventionally known device for generating electromagnetic radiation or article for propagating radiant energy can be used in the device of the present invention. In most embodiments, it is intended and desirable to use a low-intensity laser unit or LED as one or more light-generating units for irradiation purposes.

[0062] 3. Current source

[0063] Preferably, portable and rechargeable on-demand DC current sources are present as part of the apparatus and system of the present invention. The therapeutic treatment systems and methods provided by the present invention are designed to deliver specific energy doses (measured in joules), which are functions of power (in watts) and time (in seconds), and are considered effective for each therapeutic treatment.

[0064] The power source will typically deliver energy in the form of direct current. For example, sufficient current can be repeatedly delivered from a single battery source or from a combination of several dry cell batteries connected in series or parallel. In some other desired embodiments, the power source will take the form of a rechargeable portable power source, a DC battery cell (chargeable from a standard household AC outlet), or as alternating current (AC) via a power adapter. It is desired and intended that several alternative embodiments exist, each with different combinations of these components and suitable for different configurations of power, energy dosage, and treatment duration.

[0065] Regarding placement, in some preferred embodiments, the power source is a separate entity fully contained within the internal scope of the controller assembly. However, in other preferred embodiments, the current source can be a complete, separate, and self-contained unit, such as a portable and rechargeable power source, that is electrically communicated with the controller assembly via cables and connector modules. In alternative embodiments, the current source is obtained by plugging the system and devices into the local power grid via a power adapter.

[0066] 4. Process controller components

[0067] The process controller assembly is a portable unit component with at least three structural features:

[0068] (i) A receiving circuit, the receiving circuit being configured to receive such current when such current is transmitted from a current source to a controller component;

[0069] (ii) a central processing unit (CPU) for controlling and directing the flow of such current received by the controller components over time; and

[0070] (iii) Delivery circuitry for delivering direct current from the controller assembly to one or more light generating units.

[0071] It is intended and expected that the process controller assembly will be electrically connected to other major components of the device and therefore will typically also have:

[0072] (a) At least one connector for transferring DC current from a current source to a controller assembly; and

[0073] (b) At least one connector for delivering DC current from the controller assembly to one or more light generating units.

[0074] These connectors are typically formed as insulated copper wire cables and jack modules, which allow for quick and easy connection and electrical communication with both a current source and one or more light-generating units.

[0075] It is intended and expected that any conventionally known and interchangeable cables and connectors will be used to connect the controller assembly to the illumination lens. This also provides the user with the clear advantage and benefit of choosing to replace one configuration of illumination lens (capable of transmitting light of a first wavelength) with another illumination lens (capable of transmitting light of a second different wavelength), thereby allowing the use of different lasers and alternative light-emitting diodes capable of delivering visible and invisible light energy of different wavelengths with a single controller assembly.

[0076] In some preferred embodiments, the current source is located inside the controller assembly and contained within the internal space volume of the controller assembly, and is embodied as a battery (dry cell or rechargeable cell). In this case, the controller assembly also has a socket suitable for connecting insulated copper wire cables and modular jack connectors, the other end of which is connected to a light generating unit arranged within a hollow housing.

[0077] The central processing unit (“CPU”) of the controller assembly is preferably capable of adjusting the optical energy relative to a number of different parameters, including but not limited to: wavelength, coherence / synchronization, energy (joules (J)), power (watts (W) or milliwatts (mW)) or irradiance (W / cm²). 2 ), radiation exposure (J / cm) 2 Exposure time (seconds), pulse mode (continuous or pulsed), frequency (Hertz (Hz)), duty cycle (percentage), fractionation plan (number of patient treatment periods), beam size (beam area occupied) and beam penetration (delivery) distance.

[0078] Without a current source, the process controller assembly will not operate. In addition to preferably shutting down the unit after a predetermined time, the controller assembly is also the circuitry that provides power to properly and efficiently drive one or more light-generating units. The controller also ensures that the power delivered to the one or more light-generating units is consistent. Therefore, when the power source is a power bank or battery, it is best to monitor the battery strength and shut down the unit if the power bank or battery cannot provide sufficient power to properly drive the circuitry.

[0079] In a preferred embodiment, the controller is part of the same system that houses one or more light-generating units. Alternatively, the controller may be detached from this part but connected via cable for communication.

[0080] 5. Smartphones, tablets, or other computing devices

[0081] In an alternative implementation, the functionality of the controller component is controlled, in whole or in part, by a smartphone, smartwatch, tablet, laptop, desktop computer, or any suitable computing device. For example, the smartphone may run on one of the more popular mobile platforms. One or more light-generating units can be connected to the smartphone via cable or wirelessly. The smartphone comes with a downloadable software application that largely replicates the software functionality of the controller component. A modified accessory containing interface processing software in the computer chip provides a physical connection between the controller and the proprietary smartphone platform. The software application will also contain additional software controls and a graphical interface. Alternatives to the smartphone include smartwatches, tablets, laptops, desktop computers, or any suitable computing device with the software application downloaded to them.

[0082] In another alternative implementation, the controller component works in conjunction with a smartphone, smartwatch, tablet, laptop, desktop computer, or any suitable computing device. Specifically, the computing device has software applications downloaded thereon that can: (i) turn the controller component on and off; and / or (ii) send instructions to the controller component to adjust the light energy parameters of each individual light-generating unit, including but not limited to wavelength, coherence / synchronization, energy (joules (J)), power (watts (W) or milliwatts (mW)) or irradiance (W / cm²). 2 ), radiation exposure or dose or energy density (J / cm³) 2 Exposure time (seconds), pulse mode (continuous or pulsed), frequency (Hertz (Hz)), duty cycle (percentage), fractionation plan (number of patient treatment periods), beam size (beam area occupied) and beam penetration (delivery) distance.

[0083] Furthermore, the computing device can serve as a system interface through which the user inputs commands to turn the controller components on and off and / or adjust the light energy parameters of each individual light-generating unit. Commands can be input from any known input device, such as a touchscreen, mouse, keypad, keyboard, microphone, camera, or camcorder. Once the user inputs the command into the system interface, the command is sent to the controller components, which then adjust the parameters of the light energy delivered by the light-generating units.

[0084] In these implementations, any conventionally known and interchangeable cables and connectors can be used to connect the computing device to the controller assembly. Alternatively, the computing device can communicate wirelessly with the controller assembly. Any connection between these components is made using appropriate wired or wireless communication methods such as BLUETOOTH. TM Protocols such as 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.

[0085] Two specific components of the preferred system of the present invention can play a role in the treatment of RTIs (such as COVID-19):

[0086] 1. Intranasal LED devices for use in the nasal cavity; and

[0087] 2. LED module positioned on the sternum.

[0088] Two specific components of the preferred system of the present invention can also contribute additional beneficial systemic effects, which is a characteristic of PBM.

[0089] Mechanism of action

[0090] The system of this invention delivers light of a specific wavelength, power, and duration to the body. The body responds by utilizing energy to transform numerous interacting elements in order to restore functional homeostasis. A beneficial consequence is the regulation of the immune system. PBMs using the system of this invention enhance weakened immune systems and, in the case of healthy individuals, provide preventative benefits.

[0091] The fundamental mechanism of action of PBM is based on directing photons to mitochondria at the cellular level. PBM has a regulatory effect on the mitochondrial respiratory chain, in which the transient release of non-cytotoxic levels of reactive oxygen species (ROS) has a positive effect. PBM also has a regulatory effect through crosstalk with nuclear factor κ-light chain enhancer (NF-κB), which is used to control various diseases, including immune-related conditions. In immunocompromised systems, the active chain leads to an increase in the production of appropriate levels of leukocytes while controlling inflammation. Appropriate doses of PBM directed to mitochondria can positively modulate the immune system.

[0092] Its role in COVID-19

[0093] Regarding COVID-19, the coronavirus spike protein of the SARS-CoV membrane has a high tendency to absorb light from ultraviolet to infrared. This process can alter the viral envelope, thereby weakening it. This makes the virus particularly compliant with the further action of the PBM in the red and NIR spectra used in the system of this invention.

[0094] Another relevant component released during PBM is nitric oxide (NO). It is generally associated with vasodilation and improved blood circulation. However, in the context of the coronavirus pandemic, its potential value in inhibiting coronavirus replication is even more important.

[0095] Given the effects of PBM on the mitochondrial electron transport chain, such as its influence on the enzyme cytochrome c oxidase (CCO), the inventors proposed an inhibitory effect on coronavirus replication. When photons from the PBM process dissociate nitric oxide (NO) from CCO, the function of CCO as a photoreceptor is enhanced. NO can then inhibit coronavirus replication.

[0096] Preferred target of the system / device of the present invention

[0097] A. Thymus

[0098] In PBM, low levels of red and NIR light interact with cells, leading to changes at the molecular, cellular, and tissue levels. In addition to restoring immune function, PBM also induces stem cell development, which evolves into embryonic cells for tissue repair and produces white blood cells to support the immune system.

[0099] Applying controlled doses of PBM to the thymus can improve T lymphocyte maturation. Although the thymus shrinks with age, PBM activates the remaining gland and surrounding bone marrow to promote mesenchymal stem cell production. The overall effect helps strengthen the immune system to fight viral infections.

[0100] The system of the present invention has an LED module positioned above the thymus to stimulate the production of T lymphocytes and surrounding bone tissue.

[0101] B. Upper and lower respiratory tracts

[0102] Some viral respiratory infections, such as COVID-19, affect both the upper respiratory tract (nasal cavity, pharynx, larynx) and the lower respiratory tract (trachea, main bronchi, lungs). One reason for the potency of COVID-19 is its ability to migrate to the lungs and enter the host's type II alveolar cells, the most abundant type of alveoli for gas exchange. This entry is facilitated by the enzyme ACE2, which is linked by its "coronal" spike. As alveolar damage progresses, respiratory failure and death can follow.

[0103] This invention may preferably include direct irradiation of the lower respiratory tract, particularly the lungs, where most COVID-19 secondary pathology occurs in symptomatic patients. One consequence of PBM-associated mitochondrial activity is the release of nitric oxide (NO) dissociated from the respiratory chain. The role of NO in viral infections is complex and can be protective or harmful. However, in our examination of COVID-19 pathology, we found that NO has a beneficial effect in inhibiting the SARS-CoV replication cycle.

[0104] In this invention, which targets the lungs, the PBM is preferably directed at the chest region, more preferably around the sternum. This is the same preferred location where the LED module targets the thymus. Therefore, this location allows for the dual effect of irradiating both the thymus and the lungs. The LED module of the system of the invention used in this region preferably emits light at approximately 810 nm. This wavelength was chosen based on its penetration depth into mammalian tissue while minimizing water absorption.

[0105] C. Nasal cavity

[0106] The nasal cavity is preferably chosen for LED placement due to the dense capillary network shielded by a very thin membrane. This allows light from the low-power LED system of the present invention to reach the circulatory system and desired tissues relatively easily in this area.

[0107] PBM has a systemic effect mediated by ubiquitous circulating, cell-free, respiratory mitochondria. This is in addition to the mitochondria embedded within human eukaryotic cells. Therefore, the positive effects of therapeutic light are delivered throughout the body simply by illuminating the capillaries in the nasal cavity where these circulating mitochondria are present. This effect circulates and spreads throughout the body via major blood vessels (approximately three times per minute).

[0108] A study using red laser fiber to treat vasomotor rhinitis showed a significant increase in T lymphocytes. A complex and cascading mechanism, starting with circulating mitochondria freely floating in the blood vessels around the nasal cavity, is a possible factor behind this result. PBM via the nasal cavity using the system of this invention can promote the production of protective leukocytes, including T lymphocytes present throughout the body.

[0109] The intranasal applicator of the system of the present invention is such that its LED preferably delivers 633nm red light at a safe power density of 6.5mW / cm2.

[0110] Some have suggested that ultraviolet (UV)C may help eliminate viruses through direct irradiation, but prolonged exposure carries a carcinogenic risk, therefore further research is needed on the optimal wavelength for use in the nasal cavity.

[0111] In summary, applying PBM to the nasal cavity and thymus using light in the red and NIR ranges activates the body's immune response system throughout the body. These wavelengths also fall within and near the peak of the effective spectrum of PBM. For this effect, the system of the present invention has an intranasal applicator to preferably deliver a 633 nm wavelength. The estimated penetration depth is close to optimal for penetrating and irradiating the vascular network beneath the membrane surrounding the nasal cavity.

[0112] Other applications of the system / device of the present invention

[0113] Cytokine storm syndrome

[0114] Mounting evidence suggests that a subgroup of severely ill COVID-19 patients may suffer from cytokine storm syndrome. A cytokine storm is the overproduction of immune cells and their activating cytokines, often associated with an influx of activated immune cells into the lungs. The resulting lung inflammation and fluid buildup can lead to respiratory distress and may be contaminated with secondary bacterial pneumonia, typically increasing mortality in patients.

[0115] Managing lung inflammation and the cytokines at play is crucial. PBMs can increase immune activation by promoting the NF-κB protein in normal cells. PBMs may also have anti-inflammatory effects in the presence of inflammatory markers. The anti-inflammatory properties of PBMs are expected to quell potential cytokine storms in patients.

[0116] Post-infectious sepsis

[0117] Because a weakened immune system overworks, lung damage from the infection can lead to a subsequent risk of sepsis. Statistics show that half of the survivors of this infection develop further infections, kidney failure, or cardiovascular problems approximately three months after onset.

[0118] In addition, many sepsis patients suffer severe, long-term functional, cognitive, or psychological consequences, such as paralysis, depression, or anxiety. In 2017, the global sepsis burden was 49 million cases and 11 million deaths.

[0119] In an animal study, the results showed that PBM is a potentially effective, inexpensive, and non-invasive treatment for sepsis.

[0120] Disease prevention

[0121] PBM has been shown to modulate the body's own immune response both locally and systemically. The fact that PBM enhances the immune system makes it a reliable method for preventing diseases, including viral infections.

[0122] Preferred embodiments of the system of the present invention

[0123] like Figures 1 to 4 As shown, the present invention provides a preferred embodiment of a device 100 having a respiratory tract phototherapy unit 102. Optionally, as Figure 1 and 3 As can be seen in section 4, there is also an intranasal unit 200.

[0124] The controller assembly 150 can serve as the power supply and central processing unit for both the respiratory phototherapy unit 102 and the intranasal unit 200. Figures 1 to 4 In the preferred embodiment shown, the controller assembly 150 is located on the respiratory tract phototherapy unit 102. In an alternative embodiment, the controller assembly 150 is a separate unit capable of communicating with both the respiratory tract phototherapy unit 102 and the intranasal unit 200.

[0125] Reference Figures 1 to 4 The respiratory phototherapy unit 102 includes one or more configured irradiation units 108, each of which includes a portable hollow housing having a fixed size, a specific internal volume, and an external surface configuration suitable for application to the chest 502 of a subject 500.

[0126] The portable housing includes: (i) a light energy transmission material forming at least a portion of the outer surface of the configuration of the hollow housing; and (ii) at least one light generating unit wholly housed and contained within the internal space volume of the hollow housing, and capable of generating light energy at least one preselected wavelength selected from the group consisting of near-infrared red light wavelengths and visible red light wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate the chest 502 and be transmitted into the body as needed.

[0127] A frame 118 is provided in the respiratory tract phototherapy unit 102 to support the configured irradiation unit 108 and to adapt the respiratory tract phototherapy unit 102 to allow the outer surface of the light transmission of the configured irradiation unit 108 to be freely placed on the chest 502 in a fixed position and with a desired irradiation direction. Preferably, a support structure 128 is provided to help fix the respiratory tract phototherapy unit 102 to the chest 502 and to make the respiratory tract phototherapy unit 102 more comfortable for the subject 500 to wear.

[0128] The configured irradiation unit 108 is positioned within the respiratory phototherapy unit 102 so that it can target a specific location. In a preferred embodiment, the configured irradiation 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, sternal bone marrow, and lungs.

[0129] As in Figure 1 and 3 As can be seen in sections 4 and 4, the preferred system of the present invention optionally includes an intranasal phototherapy unit 200, which includes a nose clip 202. The nose clip 202 holds a configured irradiation lens 204 within one of the nostrils of a subject 500. The configured irradiation lens 204 includes a portable hollow housing having fixed dimensions, a specific internal volume, and an external surface configuration suitable for application inside the nostril.

[0130] The portable housing includes: (i) a light energy transmission material forming at least a portion of the outer surface of the configuration of the hollow housing, and (ii) at least one light generating unit wholly housed and contained within the internal space volume of the hollow housing, and capable of generating light energy at least one preselected wavelength selected from the group consisting of near-infrared red light wavelengths and visible red light wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate nasal tissue and reach blood vessels as needed.

[0131] The first connector 300 can electrically communicate with the irradiation unit 108 configured in the respiratory phototherapy unit 102. The second connector 400 can electrically communicate with the irradiation lens 204 configured in the intranasal 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 a power outlet) via the controller assembly 150 to one or more light generating units in the configured irradiation units 108 and one or more light generating units in the configured irradiation lens 204 in the intranasal phototherapy unit 200.

[0132] Experimental Section

[0133] A 30-day randomized study was conducted to evaluate the efficacy of the preferred system of the present invention in treating respiratory symptoms of COVID-19.

[0134] Study participants

[0135] A total of 280 participants aged 18 to 65 years participated in the study. All participants tested positive for COVID-19 infection, with moderate to severe symptoms. Participants were randomized 1:1 to either receive the treatment described herein or standard of care (SOC).

[0136] No participants were hospitalized or required supplemental oxygen or positive pressure support. Furthermore, no participants were pregnant, diagnosed with chronic obstructive pulmonary disease (COPD), or tested positive for hepatitis C virus (HCV), hepatitis B virus (HBV), or human immunodeficiency virus (HIV).

[0137] Treatment of subjects

[0138] The system of the present invention was applied to the subject for 20 minutes, twice a day for the first 5 days, with each application at least 6 hours apart. Subsequently, the subject was treated once a day for 20 minutes.

[0139] In the preferred system of the present invention, the NIR LED module is positioned above the manubrium of the sternum, thereby using the upper sternum as a target. The intranasal applicator is then positioned inside the subject's left or right nostril.

[0140] Participants were asked to report their symptoms by completing the Wisconsin Upper Respiratory Symptom Questionnaire (WURSS-44). Resting oxygen saturation levels were measured.

[0141] result

[0142] Seventy-three participants were randomly assigned to either the treatment group or the standard care group. Independent statistical analysis reported that the study was highly promising and strongly recommended that the study be completed with the planned 280 participants.

[0143] The scope of the claims should not be limited to the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the entire description.

Claims

1. A photobiological modulation system for treating respiratory infections and enhancing immunity in subjects, the system comprising: The configured irradiation unit includes a portable hollow shell having fixed dimensions, internal volume, and outer surface configuration suitable for application to the chest. The portable hollow shell of the configured irradiation unit comprises: (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the configured portable hollow shell of the irradiation unit; and (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the portable hollow housing of the configured irradiation unit, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency commonly sufficient to penetrate the skin and reach at least a portion of a target within the body, said target being selected from the group consisting of the thymus and optionally the sternal bone marrow and optionally the lungs. The irradiation unit thus configured is able to emit light energy after being applied to the chest and to deliver the emitted light energy through the skin to at least a portion of the target in the body; A frame adapted to support the configured irradiation unit and the outer surface that transmits light from the configured irradiation unit is arbitrarily placed on the chest in a fixed position and a desired irradiation direction and passes through the skin into at least a portion of the in vivo target; A portable controller assembly capable of controlling the on-demand delivery of light energy from the configured irradiation unit to at least a portion of the thymus and optionally the sternal bone marrow and / or optionally the lungs within the body, the controller assembly comprising: (a) A power supply with on-demand DC current. (b) A central processing unit for controlling and directing the flow of such direct current. (c) At least one connector in electrical communication with the power supply for delivering DC current to the central processing unit on demand, and (d) At least one connector electrically communicating with the irradiation unit of the configuration, for delivering direct current from the central processing unit to the light generating unit on demand. The system also includes: The configured illumination lens includes: A portable hollow shell having fixed dimensions, internal volume, and external surface configuration, suitable for insertion into the nasal cavity of a subject without causing substantial impairment to the subject's breathing ability and without intruding into the nasal tissue of a living subject, the portable hollow shell comprising an irradiation lens: (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the configuration of the portable hollow housing of the configured illumination lens. (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the portable hollow housing of the configured illumination lens, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate the nasal tissue and reach the blood vessels, to promote the production of T lymphocytes by illuminating freely floating circulating mitochondria in the blood vessels surrounding the nasal cavity. The irradiation lens thus configured is capable of emitting light energy in any desired direction within the nasal cavity after insertion into the body, and of transmitting the emitted light energy from the nasal cavity to at least a portion of the blood vessels within the body; A self-application device adapted to support the configured illumination lens and the outer surface of the configured illumination lens for light transmission is arbitrarily placed in the lining of the nostril adjacent to the subject's nasal cavity in a fixed position and a desired illumination direction. The portable controller component is also capable of controlling the on-demand delivery of light energy from the configured illumination lens.

2. The system according to claim 1, wherein the wavelength of the light energy is from 633 nm to 810 nm.

3. The system according to claim 1 or 2, wherein the respiratory infection is COVID-19.

4. A computer-readable medium containing instructions that, when executed by a computer, cause a photobiological regulatory system to perform a method for treating a respiratory infection and enhancing immunity in a subject, the method comprising the steps of: A. The function of controlling a light energy emitting device, wherein the light energy emitting device includes: The configured irradiation unit includes a portable hollow shell having fixed dimensions, internal volume, and outer surface configuration suitable for application to the chest. The portable hollow shell of the configured irradiation unit comprises: (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the configured portable hollow shell of the irradiation unit; and (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the portable hollow housing of the configured irradiation unit, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency commonly sufficient to penetrate the skin and reach at least a portion of a target within the body, said target being selected from the group consisting of the thymus and optionally the sternal bone marrow and optionally the lungs. The irradiation unit thus configured is able to emit light energy after being applied to the chest and achieve that the emitted light energy passes through the skin to at least a portion of the target inside the body; A frame adapted to support the configured irradiation unit and the outer surface that transmits light from the configured irradiation unit is arbitrarily placed on the chest in a fixed position and a desired irradiation direction and passes through the skin into at least a portion of the in vivo target; The instructions are sent to a portable controller assembly capable of controlling the on-demand delivery of light energy from the configured irradiation unit to at least a portion of the thymus and optionally the sternal bone marrow and / or optionally the lungs within the body, the controller assembly comprising: (a) A power supply with on-demand DC current. (b) A central processing unit for controlling and directing the flow of such direct current. (c) At least one connector in electrical communication with the power supply for delivering DC current to the central processing unit on demand, and (d) At least one connector electrically communicating with the configured irradiation unit for delivering direct current from the central processing unit to the light generating unit on demand; and B. The light-generating unit of the positioned irradiation unit generates light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, which is in a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency that is commonly sufficient to penetrate the skin of the subject and reach at least a portion of the target within the body. The light energy emitting device further includes: The configured illumination lens includes: A portable hollow shell having fixed dimensions, internal volume, and external surface configuration, suitable for insertion into the nasal cavity of a subject without causing substantial impairment to the subject's breathing ability and without intruding into the nasal tissue of a living subject, the portable hollow shell comprising an irradiation lens: (i) a light energy transmission material, said light energy transmission material forming at least a portion of the outer surface of the configuration of the portable hollow housing of the configured illumination lens. (ii) At least one light-generating unit, said light-generating unit being housed and contained within the internal space volume of the portable hollow housing of the configured illumination lens, and capable of generating light energy at at least one preselected wavelength selected from the group consisting of near-infrared and visible red light wavelengths, at a predetermined energy intensity, a predetermined duration, and a predetermined pulse frequency sufficient to penetrate the nasal tissue and reach the blood vessels, to promote the production of T lymphocytes by illuminating freely floating circulating mitochondria in the blood vessels surrounding the nasal cavity. The irradiation lens thus configured is capable of emitting light energy in any desired direction within the nasal cavity after insertion into the body, and of transmitting the emitted light energy from the nasal cavity to at least a portion of the blood vessels within the body; A self-applying device adapted to support the configured illumination lens and the outer surface of the configured illumination lens for light transmission, which is arbitrarily placed in the lining of the nostril adjacent to the subject's nasal cavity in a fixed position and a desired illumination direction. The portable controller component is also capable of controlling the on-demand delivery of light energy from the configured illumination lens.

5. The computer-readable medium of claim 4, wherein the wavelength of the light energy is from 633 nm to 810 nm.

6. The computer-readable medium of claim 4 or 5, wherein the respiratory infection is COVID-19.

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