Light therapy device for treating Alzheimer's disease

Abstract

This application relates to a light therapy device for treating Alzheimer's disease. [Solution] This device includes a cover that comfortably accommodates the patient's head, an array of near-infrared irradiation units arranged on the cover and configured to radiate near-infrared rays of a single wavelength with an average power density greater than 40 mW / cm2 to the head, and a cooling mechanism configured to introduce and send cool air into the cover and then blow it onto the patient's head through a cool air transport passage between the cover and the patient's head, thereby dissipating heat from the patient's head. This device can provide effective treatment for patients with Alzheimer's disease, adapt to the specific psychological and physiological needs of patients with various disease histories, improve patient compliance with treatment, and ensure good therapeutic effects for Alzheimer's disease.

Description

[Technical Field]

[0001] This application relates to the field of medical devices, and more particularly to phototherapy devices for treating Alzheimer's disease. [Background technology]

[0002] Epidemiological studies have shown that the incidence of brain function-related diseases in modern society is on the rise, and among them, Alzheimer's disease (AD) is currently one of the most common brain function-related diseases.

[0003] AD is common in people over 65 years old, and its onset is slow or hidden, worsening over time. It mainly manifests as cognitive decline, language impairment, emotional instability, psychiatric symptoms, and behavioral disorders, gradually reducing daily living ability and ultimately leading to loss of physical function and death. Currently, the cause of AD is unclear, and with the progress of global population aging, the number of AD patients continues to increase, placing a heavy burden on families and society.

[0004] There are currently no clinically effective drug treatments for AD. Over the years, a large amount of research has been conducted in China and abroad on AD treatments using physical electromagnetic stimulation, such as transcranial direct current stimulation and transcranial magnetic therapy. However, these electromagnetic treatments can only reach the cerebral cortex and are not good at stimulating deeper brain regions. In recent years, cutting-edge research on AD treatments using near-infrared rays has been conducted in China and abroad, and some research results have been achieved. However, most of the research has been conducted in vivo on mice, and clinical results in human subjects are currently limited.

[0005] In conventional phototherapy devices for treating Alzheimer's disease, the average optical power density of near-infrared light is low, and the energy deposition on brain tissue after the near-infrared light passes through the skull is low, making it difficult to achieve good phototherapy effects. Furthermore, because the near-infrared light therapy module is installed separately, the near-infrared light cannot irradiate the entire brain, resulting in poor phototherapy effects and a high risk of near-infrared light leakage, which can cause safety issues.

[0006] Furthermore, although the housing of conventional phototherapy devices for treating AD with near-infrared light usually conforms to the shape of the patient's head, AD patients not only exhibit a decline in memory ability, but also emotional agitation, excessive anxiety, lack of security, suspiciousness, and a tendency to become agitated. For example, if AD patients' heads are squeezed or they are asked to keep their heads still during treatment, this can lead to strong resistance to phototherapy, poor acceptance and cooperation, and thereby affect the effectiveness of phototherapy. Summary of the Invention [Problem to be solved by the invention]

[0007] In order to solve the above problems in the prior art, the present application provides a light therapy device for treating Alzheimer's disease that can provide effective treatment to Alzheimer's disease patients, adapt to the specific psychological and physiological needs of Alzheimer's disease patients with various disease histories, improve patient compliance with treatment, and ensure good therapeutic effects on Alzheimer's disease. [Means for solving the problem]

[0008] According to a first aspect of the present application, there is provided a light therapy device for treating Alzheimer's disease. The light therapy device includes a cover that comfortably accommodates a patient's head so that the head can rotate within a preset angular range and move up and down within a preset distance range during treatment. The light therapy device also includes an array of near-infrared irradiation units disposed in the cover and configured to radiate near-infrared rays to the patient's head at an average power density of greater than 40 mW / cm2. The light therapy device further includes a cooling mechanism configured to introduce and send cool air into the cover, and blow it onto the patient's head through a cool air transport passage between the cover and the patient's head, thereby dissipating heat from the patient's head. [Effects of the Invention]

[0009] The phototherapy device for treating Alzheimer's disease according to each embodiment of the present application can be used to provide effective treatment to patients with Alzheimer's disease, can be adapted to patients with various disease histories, can provide a comfortable environment for patients with Alzheimer's disease during treatment, can accommodate physiological needs of patients with Alzheimer's disease, such as their inability to tolerate elevated temperatures and their need for high irradiation power, can improve patients' compliance with treatment, and can meet special psychological needs, such as emotional agitation, excessive anxiety, and psychological disorders caused by exposure to closed or crowded spaces, thereby ensuring good therapeutic effects on Alzheimer's disease. [Brief explanation of the drawings]

[0010] In the drawings, which are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The drawings generally illustrate various embodiments by way of example, not limitation, and serve to explain the disclosed embodiments together with the specification and claims. Where appropriate, the same reference numerals will be used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and are not intended to be all or exclusive embodiments of the present apparatus or methods. [Figure 1(a)] 1 is a schematic diagram of the configuration of a phototherapy device for treating Alzheimer's disease according to an embodiment of the present application. [Figure 1(b)] 1 is a schematic diagram illustrating the configuration of an array of near-infrared irradiation units in a head cap of a phototherapy device for treating Alzheimer's disease. [Figure 2] 1 is a schematic diagram showing the distribution of each brain region in the whole brain of a patient according to an embodiment of the present application. [Figure 3(a)] FIG. 1 is a comparative diagram of energy deposition in the dorsolateral prefrontal cortex (dlPFC) when near-infrared rays of various wavelengths are irradiated on humans of different ages according to an embodiment of the present application. [Figure 3(b)] FIG. 1 is a comparative diagram of energy deposition in the ventromedial prefrontal cortex (vmPFC) when near-infrared rays of various wavelengths are irradiated on humans of different ages according to an embodiment of the present application. [Figure 4] 1 is a graph showing the absorption curves of near-infrared light of different wavelengths in water, deoxygenated hemoglobin, and oxygenated hemoglobin according to an embodiment of the present application. FIG. [Figure 5] 1 is a schematic diagram of a phototherapy device for treating Alzheimer's disease according to an embodiment of the present application in a state where a head cap is worn. [Figure 6] 1 is a perspective view of a head cap of a light therapy device for treating Alzheimer's disease according to an embodiment of the present application. FIG. [Figure 7] This is a diagram of an arrangement of near-infrared LEDs on a light panel as an example of a near-infrared irradiation unit in a phototherapy device for treating Alzheimer's disease. [Figure 8] 1 is a schematic diagram illustrating the overall configuration of a phototherapy device for treating Alzheimer's disease according to an embodiment of the present application. [Figure 9] 1 is a graph comparing in vivo experimental data of a water maze experiment between AD mice that received light therapy and control AD mice after phototherapy of 5-month-old AD mice using a phototherapy device according to an embodiment of the present application. [Figure 10] 10 shows pathological sections of the cerebral cortex and hippocampal CA1 regions of AD mice that received light therapy and control AD mice after 5-month-old AD mice were treated with light therapy using a light therapy device according to an embodiment of the present application, and the distribution of β-amyloid protein (Aβ) (shown as particles in FIG. 10) is shown. [Figure 11] 1 is a graph comparing the scores of the Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cog) of AD patients who received light therapy and a control group of AD patients after light therapy was performed on the AD patients using a light therapy device according to an embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0011] In order to allow those skilled in the art to better understand the technical solution of the present application, the present application will be described in detail below with reference to the drawings and specific embodiments. The examples of the present application will be described in more detail below with reference to the drawings and specific examples, but are not intended to limit the present application. The steps described herein do not necessarily have a sequential relationship, and the order in which they are described as examples herein should not be considered restrictive. Those skilled in the art should be aware that the order can be adjusted as long as it does not destroy the logic between them and make it impossible to realize the entire process.

[0012] The terms "first," "second," and similar terms used in this application do not denote any order, number, or importance, but are merely used for distinction. Similar terms such as "comprise" or "comprise" mean that the element before the term encompasses the elements listed thereafter, and do not exclude the possibility of including other elements. The term "head" used in this application refers to the organs of the human body above the neck (cervical vertebrae), including the brain and extracerebral tissues such as the skull, skin, and hair. The term "brain" used in this application refers to the organs remaining after removal of extracerebral tissues, and is intended to primarily refer to the cerebrum, but may include, but is not limited to, the cerebrum, cerebellum, brainstem, etc. The term "whole brain" used in this application is intended to distinguish it from individual brain regions, such as the frontal lobe and temporal lobe, and is not limited to any individual region of the "brain." "Whole brain" includes at least the frontal, temporal, parietal, and occipital lobes, and in some cases may (but need not) further include the hippocampus, amygdala, etc., and in other cases may (but need not) further include the cerebellum, brainstem, etc.

[0013] The applicant's research team has conducted in-depth research on near-infrared treatment of AD and phototherapy devices, and has carried out a large number of simulation experiments and clinical experiments to demonstrate the theoretical and practical feasibility of AD phototherapy devices. In addition, in clinical experiments on AD patients with various disease histories, the team has also conducted in-depth research, focusing on the special psychological and physiological needs of these patients. This application proposes a phototherapy device for treating Alzheimer's disease, which can not only significantly improve patients' treatment compliance, but also ensure good therapeutic effects on AD.

[0014] FIG. 1(a) is a schematic diagram of a phototherapy device for treating Alzheimer's disease according to an embodiment of the present application. As shown in FIG. 1(a), this phototherapy device includes a cover 1 that comfortably accommodates a patient's head, allowing the head to rotate within a preset angular range and move up and down within a preset distance during treatment. Instead of conforming to the shape of the patient's head, a gap of several centimeters, preferably 1-2 cm, is provided between the cover 1 and the patient's head, allowing the patient to move their head within the preset angular range and distance according to their own will. The open-type cover 1 design provides a non-restrictive feel to the patient's head, making it particularly friendly for elderly people who are emotionally agitated, anxious, or resistant or even afraid of confined or crowded spaces, thereby significantly improving treatment compliance among AD patients.

[0015] Specifically, the light therapy device can be used to treat patients with AD who experience psychological discomfort in confined or crowded spaces. Such psychological discomfort in confined or crowded spaces may be due to the patient's age or the AD they have. This design of the cover 1 can also be widely applied to the behavioral characteristics of patients with different AD histories. For example, early-stage AD patients may experience impaired judgment, suspiciousness, and irritability. Wearing the cover 1, which offers sufficient freedom and openness, can make the patient more accepting and less likely to become irritable, allowing them to cooperate with the ongoing progress of light therapy. For example, mid-stage AD patients may experience extreme emotional fluctuations, excessive anxiety, and frequent walking, which may cause some patients' heads to frequently and unconsciously shake slightly. This open-type cover 1 allows such unconscious, small shaking of the patient's head without causing any vibrations in the cover 1 itself. Therefore, there is no need to forcibly stop such small shaking, which improves patient comfort, reduces the workload of medical personnel, and prevents such shaking of the patient's head from being transmitted to the cover 1 and affecting the effectiveness of the light therapy. Therefore, the light therapy device can be used to treat Alzheimer's disease patients who are emotionally upset or anxious.

[0016] With its open and spacious design, Cover 1 makes AD patients with various disease histories more likely to undergo treatment and can tolerate a single irradiation for a longer period of time, for example, 20 minutes, 30 minutes, or even longer each time, further improving the treatment effect.

[0017] The phototherapy device further includes an array of near-infrared irradiation units 2 disposed on the cover 1. The array of near-infrared irradiation units 2 is disposed corresponding to each brain region of the head. As an example, as shown in FIG. 1(b), each of the near-infrared irradiation units 2 includes a plurality of near-infrared light-emitting diodes 2a. In some embodiments, each of the near-infrared irradiation units 2 may include a single near-infrared light-emitting diode 2a. The array of near-infrared irradiation units 2 is configured to radiate near-infrared rays to the patient's head at an average power density of greater than 40 mW / cm2. As will be understood, the term "average power density" used in this application refers to the energy size of near-infrared rays irradiated per unit area per unit time.

[0018] The inventors have found through research that, for example, for elderly patients aged 65 or older suffering from AD, a higher power density needs to be provided to ensure sufficient light energy reaches the brain to effectively treat AD. In the optical therapy device of the embodiment of the present application, the array of near-infrared irradiation units 2 is configured to emit near-infrared rays with a power density greater than 40 mW / cm2 to the patient's head so that sufficient light energy reaches the brain. Furthermore, in the optical therapy device of the embodiment of the present application, the cover 1 does not adopt a fitting design but adopts a loose design that allows the head to move freely within the storage space. The gap between the cover 1 and the head also causes scattering of near-infrared rays. The scattering and superposition of near-infrared rays allows high power density at the location of each brain region, further meeting the need for increased power density and further meeting the requirement for high power density in the whole brain.

[0019] Through simulation and clinical experiments, the inventors have found that the phototherapy device of the present application employs a spacious design and an average power density greater than 40 mW / cm², ensuring sufficient light energy entering the brain tissue and achieving good therapeutic effects, even for elderly patients with AD. Specifically, the average power density may be 40 mW / cm² to 150 mW / cm², such as 60 mW / cm², 70 mW / cm², 80 mW / cm², 90 mW / cm², 100 mW / cm², or 120 mW / cm². For some specific brain regions, such as the frontal lobe and temporal lobe, the average power density of near-infrared light may be 50 mW / cm² or more to 250 mW / cm², preferably 70 mW / cm² or more.

[0020] At average power densities greater than 40 mW / cm², conventional fan-type cooling mechanisms are inadequate. Even with high airflow, AD patients experience discomfort around the scalp, even intolerable heat, making sustained treatment unbearable. Furthermore, excessive airflow can cause discomfort in the patient's head. For some types of irradiation treatment, such as whole-brain irradiation, or targeted treatment of specific brain regions, such as the frontal and temporal lobes, the required average power density may be higher, reaching 70 mW / cm² or even 150 mW / cm². For external irradiation of cortical cells with near-infrared radiation, the array of near-infrared radiation irradiation units 2 may be configured to radiate near-infrared radiation at an average power density of less than 250 mW / cm² to the patient's head. This range of average power densities has been shown to avoid the risk of thermal injury and to prevent inhibitory effects and mitochondrial damage.

[0021] In some embodiments, the average power density required for the near-infrared radiation employed can be determined and adjusted based on patient attributes, for example, the average power density is determined based on the optical transparency of the patient's extracerebral tissue, such that the average power density for a patient with low optical transparency of extracerebral tissue is higher than the average power density for a patient with high optical transparency of extracerebral tissue.

[0022] Specifically, AD patients have lower sensitivity to temperature and pain, meaning that they may have experienced greater pain and potentially greater tissue or organ damage before discovering and reporting the damage. Furthermore, a large proportion of AD patients are aged 65 or older, and older patients are more susceptible to cold than younger patients. Therefore, when treating AD patients with high average power density or even total power, it is important to take into account the characteristics of AD patient sensitivity, particularly to temperature and pain, to provide them with a treatment environment that is comfortable and does not cause pain or thermal damage, contributing to extending treatment times and thereby achieving better treatment outcomes.

[0023] 2 is a schematic diagram showing the distribution of each brain region of the cerebral cortex of the whole brain of a patient according to an embodiment of the present application. As shown in FIG. 2, each brain region of the cerebral cortex mainly includes the frontal lobe, temporal lobe, parietal lobe, occipital lobe, and cerebellum.

[0024] The inventors have discovered that, in the treatment of diseases such as AD, an array of near-infrared irradiation units can irradiate the entire brain region of a patient's head with near-infrared rays, particularly at least the frontal lobe, temporal lobe, and hippocampus, achieving better therapeutic effects than irradiating only certain brain regions. Specifically, as shown in FIG. 2, the hippocampus is located between the thalamus and medial temporal lobe, belongs to the limbic system, and is responsible for short-term memory, long-term memory, and spatial orientation. Hippocampal atrophy is closely associated with Alzheimer's disease. As AD progresses, the lesions spread further to the frontal and temporal lobes, gradually shrinking the cerebrum, leading to further memory loss and loss of self-control. The functions of the temporal lobe mainly include auditory perception, language reception, visual memory, declarative (true) memory, and emotional control. Specifically, patients with right temporal lobe lesions often lose the ability to understand non-verbal auditory stimuli (such as music), while left temporal lobe lesions affect the patient's ability to perceive, remember, and produce language. The frontal lobe is the physiological basis for the most complex psychological activities in humans, and is responsible for planning, regulating, and controlling human psychological activities. It plays an important role in higher-level, intentional human behavior, and is closely related to higher-level cognitive functions such as attention, memory, and problem-solving, as well as personality development.

[0025] By covering the entire brain with the cover 1 and emitting near-infrared light to the entire brain region of the patient's head, including at least the frontal lobe, temporal lobe, and hippocampus, the array of near-infrared light emitting units 2 can provide comprehensive and thorough phototherapy to the cortical region involved in the lesion, resulting in better therapeutic effects (as will be demonstrated later using clinical experiments and clinical data). In some embodiments, the array of near-infrared light emitting units 2 is configured to emit near-infrared light to the frontal lobe and temporal lobe at a higher average power density than to other brain regions, thereby improving the therapeutic effects on the focused frontal lobe and temporal lobe.

[0026] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared rays to brain network nodes, which may include at least one of the medial prefrontal cortex, medial temporal lobe, dentate cortex, precuneus, and inferior parietal lobe. Studies have shown that there is a certain correlation between the functional connections between each brain network node in the medial prefrontal cortex, medial temporal lobe, dentate cortex, precuneus, and inferior parietal lobe and the development of AD. For example, when brain network connections were constructed in AD patients, it was found that the functional connection strength between brain network nodes such as the hippocampus located in the medial temporal lobe and the medial prefrontal cortex and precuneus was significantly weaker than that in normal subjects. Furthermore, the results of functional connection strength in the brain networks of some AD patients showed that the hippocampus had lost connections with some brain network nodes. The array of near-infrared irradiation units 2 is configured to radiate near-infrared rays to the brain network nodes, thereby strengthening the functional connectivity between these brain network nodes, improving the collaborative operations and information transmission capabilities between brain regions, and improving memory ability, cognitive function, etc. Specifically, a brain network is constructed based on brain function imaging and / or brain structural imaging of the patient's head, and each node of the brain network is determined, for example, by MRI images. The brain network may include multiple nodes, each of which corresponds to a different brain region, or one brain region may have multiple nodes. There is a functional connection between pairs of nodes, and the functional connection strength between pairs of nodes can be used to characterize the collaborative operations and information transmission between brain regions.

[0027] In one specific embodiment, the brain network node includes at least the hippocampus located in the medial temporal lobe, and the array of near-infrared irradiation units 2 is configured to irradiate near-infrared rays to the hippocampus and to brain network nodes whose functional connection strength with the hippocampus is weaker than a predetermined level. In this way, localized irradiation of the brain network nodes with functional imbalance (i.e., whose functional connection is weaker than a predetermined level, e.g., whose functional connection is weaker than a normal level or whose functional connection has been lost) is focused on. For example, irradiating the brain network nodes with near-infrared rays at an average power density greater than 70 mW / cm2 not only strengthens the functional connection strength between the hippocampus and other brain network nodes, but also contributes to the recovery of functional connections between the hippocampus and other brain network nodes, thereby achieving a good therapeutic effect on AD. By irradiating near-infrared rays only to these brain network node regions, heat generation can be further reduced, reducing the need for a cooling mechanism, making it easier to create a more comfortable environment for the patient's head and improving comfort.

[0028] In some embodiments, the array of near-infrared irradiation units 2 is configured to radiate near-infrared rays to these brain network nodes, including the medial prefrontal cortex, the hippocampus located in the medial temporal lobe, the anterior dentate cortex, the precuneus, and the inferior parietal lobe, together, thus strengthening the functional connectivity between each node in this brain network and achieving better therapeutic effects on AD.

[0029] As can be seen, when the array of near-infrared irradiation units 2 is used to precisely target and locally irradiate nodes in a brain network, one of the nodes in a pair of nodes with an imbalanced functional connection may be irradiated, or the pair (i.e., both nodes) may be irradiated simultaneously. In particular, when one of the nodes in a pair is located deep in the cerebrum and difficult to irradiate, such as the hippocampus located deep in the cerebrum, the other node in the pair that is more easily irradiated may be irradiated, thereby indirectly affecting the other node located deep in the cerebrum and achieving a certain phototherapeutic effect. The present application does not specifically limit the irradiating method for brain network nodes.

[0030] In some embodiments, the array of near-infrared irradiation units 2 is configured to irradiate the patient's head with near-infrared rays having a certain range of center wavelengths, where the mean energy deposition of near-infrared rays with center wavelengths in this range and the absorption coefficients of deoxygenated hemoglobin (Hb) and oxygenated hemoglobin (HbO2) are both good. Preferably, the array of near-infrared irradiation units 2 is configured to irradiate the patient's head with near-infrared rays having a center wavelength of 800 to 820 nm, as will be described in detail below with reference to Figures 3(a), 3(b), and 4. Preferably, the array of near-infrared irradiation units 2 is configured to irradiate the patient's head with near-infrared rays having a single wavelength and a center wavelength of 810 nm.

[0031] To effectively solve the above-mentioned problems, the phototherapy device according to the embodiment of the present application further includes a cooling mechanism 4 for sufficiently dissipating heat from the patient's head. Specifically, the cooling mechanism 4 is configured to introduce cool air into the cover 1, and then blow it onto the patient's head through a cool air transport passage between the cover 1 and the patient's head, thereby dissipating heat from the patient's head. The temperature of the cool air introduced by the cooling mechanism 4 is lower than the surface temperature of the patient's head.

[0032] 1(a), the cooling mechanism 4 may include a cooling device 3 or may be connected to the cooling device 3, and the cover 1 is provided with a cold air transport chamber 5 for receiving the cold air generated by the cooling device 3, and a cold air transport passage 7 is directly formed between the inner wall of the cold air transport chamber 5 and the patient's head. The cold air transport chamber 5 may be provided in various forms. For example, the cold air transport chamber 5, a near-infrared irradiation unit storage chamber (not shown), etc. may be separately provided in the internal open space of the cover 1. The cold air transport chamber 5 may be integrated with other chambers in the cover 1, provided in a different layer, or provided alternately and independently; this is not specifically limited herein.

[0033] In some embodiments, the speed of the cool air blown onto the patient's head through the cool air transport passage 7 is 0.5 to 3.5 m / s, which is comfortable for the patient while ensuring heat dissipation. Preferably, the speed is 1 to 2.5 m / s. When the array of near-infrared irradiation units 2 radiates near-infrared rays onto the patient's head (e.g., the entire brain region) using this temperature-lowering mechanism 4, the total power of the near-infrared rays is greater than 3 W. In special phototherapy treatments with higher total power requirements, the total power can reach 10 W or more. With this average power density and total power, the temperature-lowering mechanism 4 can still sufficiently heat the patient's head, maintaining a temperature near the patient's scalp between 23°C and 43°C. Preferably, the temperature near the patient's scalp is maintained between 25°C and 40°C, which is close to body temperature and provides a comfortable temperature environment for humans. This temperature environment is also comfortable for elderly people who have low sensitivity to temperature and pain and are sensitive to cold, and allows for continuous treatment without causing thermal damage. By combining this cooling mechanism 4 with the cover 1, which has the aforementioned spacious design, patients with various medical histories will be more willing to undergo continuous irradiation treatment, and will be able to tolerate a single irradiation for a longer period of time (the longer the period, the higher the heat generated near the scalp), further improving the therapeutic effect.

[0034] For example, as shown in Figure 1(a), the cold air transport passage 7 may be formed by the vent hole 6 inside the cold air transport chamber 5 and the gap between the cover 1 and the patient's head, but this is merely an example, and cold air may be transported toward the patient's head by pulling out a cold air transport pipe from the cold air transport chamber 5, which will not be described further here. The configuration of the temperature-reducing mechanism 4 allows the cover 1 to cover the head in all directions, thereby avoiding light leakage and reducing safety risks caused by infrared light leakage, and delivering sufficient light energy to the entire brain to ensure therapeutic effects while still ensuring a good and comfortable heat dissipation effect.

[0035] The above-mentioned structural features are explained and described in detail in the priority Chinese application (application number 202210886242X), the relevant contents of which are all incorporated herein by way of example.

[0036] FIG. 5 is a schematic diagram of a head cap of a phototherapy device for treating Alzheimer's disease according to an embodiment of the present application in a worn state. As shown in FIG. 5, the cover 1 has a fixed configuration and size that comfortably accommodates the patient's head, allowing for lateral movement of the patient's head within 1 to 2 cm during treatment. In some embodiments, the cover 1 is configured to cover at least the entire brain. Specifically, the configuration of the cover 1 leaves a certain amount of room so that even if the patient rotates within a predetermined angle range or moves up and down within a predetermined distance range, the cover 1 can still cover the entire brain. If necessary, each brain region of the entire brain can be irradiated using an array of near-infrared irradiation units 2 (see FIGS. 1(a) and 1(b)). Furthermore, the open and roomy design of the cover 1 allows a fixed configuration and size to be used for patients with some degree of individual variation in head shape and size, rather than necessarily customizing the cover 1 to precisely fit each individual patient's head shape and size, thereby allowing the cover 1 to be standardized and manufactured, resulting in lower manufacturing costs, a wider range of patients for whom the phototherapy device is applicable, and reduced purchase and repair costs for facilities where the phototherapy device is used, such as hospitals, communities, and homes. Specifically, the fixed configuration and size means that the cover 1 does not need to have moving parts and may even be molded as a single unit, thereby extending the life of the cover 1 and simplifying its configuration.

[0037] FIG. 6 is a perspective view of a head cap of a light therapy device for treating Alzheimer's disease according to an embodiment of the present application. As shown in FIG. 6, the cover 1 may have a left protruding ear portion and a right protruding ear portion 8. The left protruding ear portion is obscured and not shown in FIG. 6, and the left protruding ear portion and the right protruding ear portion are uniformly designated by the reference numeral 8 in this specification. The left protruding ear portion and the right protruding ear portion 8 may be configured to extend downward to below the ears of the patient so as to cover the patient's left and right temporal lobes, respectively. As shown in FIG. 1(b), when this light therapy device is normally worn by a patient, the distribution of the near-infrared irradiation units 2 shown in A approximately corresponds to the frontal lobe area, and the distribution of the near-infrared irradiation units 2 shown in B approximately corresponds to the temporal lobe area. A near-infrared irradiation unit 2 (as shown in FIG. 1(b)) is arranged in each of the left protruding ear portion and the right protruding ear portion 8 so as to radiate near-infrared rays to the covered temporal lobe area. Referring to the brain region distribution shown in FIG. 2, the temporal lobe extends toward the ears, and this extension is covered by the left and right protruding ears 8, allowing it to be sufficiently irradiated with near-infrared light.

[0038] In some embodiments, the left protruding ear and the right protruding ear 8 may be configured so that when the head rotates within a preset angle range and moves up and down within a preset distance range during treatment, the near-infrared irradiation units 2 (as shown in FIG. 1( b)) disposed on the left protruding ear and the right protruding ear 8 can still irradiate the patient's temporal lobe. Specifically, the left protruding ear and the right protruding ear 8 may be designed to extend to the corresponding peripheral region of the head of the temporal lobe, leaving a margin associated with the preset angle range and the preset distance range relative to the temporal lobe. In this way, even if the patient tries to rotate or move due to an inclination to move or uncontrollable vibration, the temporal lobe can always be sufficiently irradiated, thereby ensuring the therapeutic effect.

[0039] The left and right protruding ear portions 8 may extend toward the patient's ears, and in some embodiments, may extend downward to below the patient's ears. In this manner, near-infrared light emitted by the near-infrared light irradiation units 2 disposed in the left and right protruding ear portions 8 can reach and irradiate not only the left and right temporal lobes but also the hippocampus via the ear canal. However, the light travels far from the ears along the ear canal to reach the hippocampus, and the light travels farther through the ear canal than the light travels from the frontal lobe to the hippocampus. Furthermore, the attenuation of near-infrared light in the ear canal is far less than that of near-infrared light in the skull. This allows near-infrared light to be sufficiently irradiated even to the hippocampus, which is located deep within the brain. The hippocampus is closely related to the development of AD. By allowing sufficient near-infrared energy to reach the frontal and temporal lobes as well as the hippocampus, it is possible to significantly improve the function of brain mitochondria and ATP levels, promote the degradation of amyloid beta protein (Aβ), reduce Aβ accumulation, reduce damage to nerve cells, improve the repair and regeneration ability of neural tissue, improve cognitive ability, and make the phototherapy effects on AD more pronounced.

[0040] In some embodiments, the cover 1 includes a forehead portion 9, and a curved attachment portion 10 is provided between the forehead portion 9 and the left and right protruding ear portions 8, such that the lower edges of the left protruding ear portion 8, the forehead portion 9, and the right protruding ear portion 8 are connected together by a curve, thereby completely covering the patient's left and right temporal lobes. As shown in the brain region distribution diagram of FIG. 2, a portion of the temporal lobe is located near the temples, and the curved attachment portion 10 can cover this portion and provide sufficient near-infrared radiation. The inventors discovered that as AD progresses, lesions spread to various parts of the temporal lobe, and that providing sufficient near-infrared radiation to each portion can achieve more effective treatment. In some cases, the specific location of the temporal lobe affected by the lesion cannot be identified without functional brain imaging. However, the cost of obtaining functional brain imaging is high for the patient, and each patient's head has a different shape and size. When actually wearing the optical therapy device, the optical therapy device is attached to the patient's head, making it difficult for medical personnel, the patient, or other caregivers to accurately determine the location of each brain area from the external surface of the head. Therefore, the combined design of the left and right protruding ears 8 and the curved attachment part 10 can completely cover each area affected by the lesion, thereby providing more effective treatment and reducing the workload of caregivers and patients by eliminating the need to distribute their attention excessively.

[0041] In some embodiments, the lower edge of the front of the cover 1 has a gentle curve, with the middle portion of the lower edge extending downward relative to both sides to guide the user to place the lower edge on the brow bone. This curve, with a low center and slightly higher sides, matches the structure of the brow bone, and users naturally draw the curved lower edge toward the brow bone according to their daily habits (e.g., wearing glasses), thereby irradiating the entire forehead and allowing the doctor or patient to intuitively confirm that the wearing position is appropriate. In the case of a cover 1 with a relaxed design, this curve, with a low center and slightly higher sides, also guides the user to actively bring the forehead closer to the cover 1 when wearing it. Because the frontal lobe is a primary treatment area and irradiation effectiveness must be ensured, this wearing position, which is close enough to the forehead, is appropriate. By bringing the curved lower edge close to the brow bone, both the patient and the doctor can confirm that the appropriate wearing position has been achieved, and the patient can consciously maintain the appropriate wearing position.

[0042] Returning to FIG. 1(b), the irradiation parameters of at least some of the near-infrared irradiation units 2 may be independently adjustable, including at least the average power density. For example, the irradiation parameters of each near-infrared irradiation unit 2 may be independently controlled. That is, the irradiation parameters are adjusted for each near-infrared irradiation unit 2. The near-infrared irradiation unit 2 may include a set of multiple near-infrared light-emitting diodes 2a, thereby controlling the irradiation parameters of all the near-infrared light-emitting diodes 2a flexibly and efficiently. The irradiation parameters may include, in addition to the average power density, pulse frequency, waveform, duty cycle, etc. In another embodiment, the irradiation parameters of each of the two near-infrared irradiation units 2 may be independently controlled, which can be determined according to actual irradiation needs. In some embodiments, the pulse frequencies of at least some of the near-infrared irradiation units 2 may be independently adjustable, allowing different pulse frequencies to be set for different brain regions, thereby achieving more precisely targeted treatment for each brain region.

[0043] In some embodiments, the array of near-infrared irradiation units 2 is configured to irradiate the patient's head with near-infrared light having a central wavelength of 800-820 nm. Research has found that using a single wavelength of near-infrared light having a central wavelength of 800-820 nm is more suitable and effective.

[0044] 3(a) is a comparative diagram of the energy deposition status in the dorsolateral prefrontal cortex (dlPFC) when humans of various ages are irradiated with near-infrared light of various wavelengths according to an embodiment of the present application, and FIG. 3(b) is a comparative diagram of the energy deposition status in the ventromedial prefrontal cortex (vmPFC) when humans of various ages are irradiated with near-infrared light of various wavelengths according to an embodiment of the present application. As shown in FIG. 3(a) and FIG. 3(b), for the energy deposition status in the two cortical regions of the dlPFC and vmPFC across various age ranges, the central wavelength of 810 nm is superior to the energy deposition status of 670 nm, 850 nm, 980 nm, and 1064 nm, followed by the central wavelengths of 1064 nm and 850 nm. Simulation experiments have verified that the energy deposition conditions of single wavelength near-infrared rays with other wavelength values in the central wavelength range of 800 to 820 nm are all superior to the energy deposition conditions of 670 nm, 850 nm, 980 nm, and 1064 nm.

[0045] The near-infrared irradiation unit 2 in the examples of the present application irradiates near-infrared radiation with a single wavelength having a central wavelength of 800-820 nm, and the central wavelength is neither in the wavelength range surrounding 670 nm (e.g., 630-750 nm) nor in the wavelength range surrounding 980 nm (e.g., 900-1020 nm), thereby achieving optimal energy deposition conditions. Furthermore, the near-infrared radiation irradiated by the near-infrared irradiation unit 2 in the examples of the present application does not depend on dual or multiple wavelengths, and a single wavelength with a central wavelength of approximately 810 nm can achieve good therapeutic effects if the power density is appropriate, as demonstrated by animal experiment data and clinical data provided below.

[0046] Figure 4 is a graph showing the absorption curves of near-infrared rays of different wavelengths in water, deoxygenated hemoglobin, and oxygenated hemoglobin protein according to an embodiment of the present application. As shown in Figure 4, when a wavelength of 950 nm to 1000 nm is used, the absorptance of near-infrared rays in water is high, but the absorptance of deoxygenated hemoglobin is low, and is much lower than the absorptance of near-infrared rays at a wavelength of about 810 nm in deoxygenated hemoglobin. As can be seen from Figure 4, the absorptances of near-infrared rays in the wavelength range of 800 to 820 nm in deoxygenated hemoglobin and oxygenated hemoglobin are balanced and both are significantly higher than the absorptance in water. When irradiating the same treatment target area with near-infrared rays of the same power density, irradiating with only a single wavelength of about 810 nm has a better absorption effect in oxygenated hemoglobin and deoxygenated hemoglobin, a better therapeutic effect, a lower array cost for the single-wavelength near-infrared irradiation unit 2, and easier control than using two wavelengths, for example, 760 nm to 860 nm and 950 to 1000 nm.

[0047] The near-infrared light may include pulsed light. A good irradiation effect can be achieved by using pulsed light of a single frequency within an appropriate frequency range, which may be the alpha wave frequency band (e.g., 10 Hz) or the gamma wave frequency band (e.g., 40 Hz). In some embodiments, irradiation may be performed using pulsed light containing at least two frequency components within a certain frequency range, and in some cases, the irradiation effect is better than that of pulsed light using a typical single frequency. In some embodiments, the pulsed light includes a pulse wave component of a first pulse frequency and / or a pulse wave component of a second pulse frequency, wherein the first pulse frequency is 7 Hz to 13 Hz and the second pulse frequency is 30 Hz to 100 Hz. Preferably, the first pulse frequency is 10 Hz and the second pulse frequency is 40 Hz. The present invention has discovered that the use of appropriate frequencies, such as, but not limited to, the alpha wave frequency band and the gamma wave frequency band, can provide a better irradiation effect than other frequencies. The pulsed light includes α waves and γ waves as pulsed wave components of a first pulse frequency and a second pulse frequency, respectively, and is formed in one of the following forms. For example, the waveform of the pulsed light emitted by each near-infrared light-emitting diode 2a may be formed by synchronously mixing α waves and γ waves. That is, each near-infrared light-emitting diode 2a directly emits a waveform of synchronously mixing α waves and γ waves, thereby realizing a hybrid waveform (pulsed light containing a mixture of the two frequency bands of α waves and γ waves) in which the time is synchronized and the waves are spatially superimposed. Alternatively, for example, the waveform of the pulsed light emitted by each near-infrared light-emitting diode 2a may be formed by time-division combining α waves and γ waves. That is, the same near-infrared light-emitting diode 2a can be turned on at different time periods to alternately irradiate α waves and γ waves, which is simply a hybrid mode in which the waves are spatially superimposed. In some embodiments, each near-infrared light emitting diode 2a in the first set of near-infrared light emitting diodes 2a is controlled to emit pulsed light of alpha waves, and each near-infrared light emitting diode 2a in the second set of near-infrared light emitting diodes 2a is controlled to emit pulsed light of gamma waves in synchronization therewith, that is, the near-infrared light emitting diodes 2a in the first set and the second set can be turned on at the same time period.Specifically, near-infrared light-emitting diodes 2a corresponding to different brain regions can be turned on at the same time, which is a hybrid mode in which the light is simply superimposed in time, and in this way pulsed light of frequencies and waveforms specific to different brain regions can be provided.

[0048] It should be noted that, although a loose, open-type head cap is used as the carrier for irradiating multi-frequency pulsed light in this application, the application is not limited to this, and other head caps, such as a head cap that fits to the head, or a non-head cap type wearable device, such as, but not limited to, glasses, or a wearable device that is embedded through the ear canal or nasal cavity, may also be used as the carrier for irradiating multi-frequency pulsed light to the patient's brain.

[0049] In some embodiments, the pulse frequency of the near-infrared irradiation unit 2 is adjustable, with an adjustable range of 0 Hz to 100 Hz, for example, near-infrared irradiation with a pulse frequency of 8 Hz, 10 Hz, 30 Hz, 40 Hz, etc. In this way, when performing phototherapy using a phototherapy device, the user can determine a clearly targeted and appropriate pulse frequency based on the degree of disease, target brain region, etc., to achieve better phototherapy effects.

[0050] The present application further provides a head cap for a phototherapy device for treating Alzheimer's disease. As shown in FIGS. 1(a) and 1(b), the head cap includes a cover 1 that loosely accommodates a patient's head so that the head can rotate within a preset angle range and move up and down within a preset distance range during treatment. The head cap further includes an array of near-infrared irradiation units 2 disposed on the cover 1 and configured to irradiate near-infrared rays toward the patient's head. In some embodiments, each of the near-infrared irradiation units 2 may include a plurality of near-infrared light-emitting diodes 2a. The implementation of the array of near-infrared irradiation units 2 described in each embodiment of the present application can be incorporated therein.

[0051] This head cap may further include a cold air transport chamber 5 arranged adjacent to the array of near-infrared irradiation units 2 on the cover 1, and a cold air transport passage 7 communicating from the cold air transport chamber 5 to the patient's head, and cold air generated by a cooling device 3 outside the head cap is sent into the cold air transport chamber 5 and blown onto the patient's head through the cold air transport passage 7 to dissipate heat from the patient's head.

[0052] Returning to FIG. 1(b), a specific embodiment relating to the near-infrared irradiation unit 2 and the temperature lowering mechanism 4 in the head cap of the phototherapy device for treating Alzheimer's disease will now be described by way of example.

[0053] As shown in Fig. 1(b), the head cap may include a cover 1 that loosely accommodates the patient's head so that the head can rotate within a preset angle range and move up and down within a preset distance range during treatment. In each embodiment of the present application, all of the realization forms of the cover 1 described in conjunction with the phototherapy device can be incorporated therein. No further description will be given here.

[0054] This head cap is provided with a temperature-reducing member for use in cooperation with an external cooling device 3 and a cold air transport duct 12, thereby forming a temperature-reducing mechanism 4 that can sufficiently dissipate heat from the patient's head. Specifically, as shown in Fig. 1(b), a cold air transport chamber 5 and a cold air transport passage 7 that communicates from the cold air transport chamber 5 to the patient's head are provided adjacent to the array of near-infrared irradiation units 2 in the cover 1, and cold air generated by the cooling device 3 outside the head cap is sent into the cold air transport chamber 5 (for example, via the cold air transport duct 12) and blown onto the patient's head via the cold air transport passage 7, thereby dissipating heat from the patient's head.

[0055] 1(a) and 1(b), the cover 1 includes an outer layer 12a and a light-transmitting cover 13 as an inner layer, and a cool air transport chamber 5 is formed between the outer layer 12a and the light-transmitting cover 13. The light-transmitting cover 13 has a plurality of vent holes 6 that, together with the gap between the light-transmitting cover 13 and the patient's head, form a cool air transport passage 7. As can be seen from the above, the vent holes 6 may be arranged in groups to more evenly distribute the cool air blown onto the head from the periphery, thereby making the Alzheimer's disease patient feel comfortable and cooperating with treatment.

[0056] The near-infrared irradiation unit 2 may be implemented in various forms, for example, as a light panel 2b (as shown in FIG. 1(b)) carrying a plurality of near-infrared light-emitting diodes 2a. The plurality of air vents 6 may be distributed in groups (as shown in FIG. 1(a)), and may be implemented as a multi-point array, with each group of air vents 6 corresponding to a respective light panel 2b. The gap directly opposite the light panel 2b experiences significant temperature rise. Each group of air vents 6 corresponding to each light panel 2b can deliver cool air in a targeted manner, effectively reducing the heat in this gap. The cool air can be discharged slowly and evenly from each air vent 6, uniformly dissipating heat from the scalp and further improving patient comfort.

[0057] The outer layer 12a of the cover 1 at least partially houses the circuit 15 and includes a hot air extraction chamber 14 connected to the outside via an air inlet 16 (as shown in FIG. 5 ) and an air outlet 17. The air introduced through the air inlet 16 carries the heat generated by the circuit 15 and releases it to the outside via the air outlet 17. The inventors discovered that when the array of near-infrared irradiation units 2 is configured to have an average power density greater than 40 mW / cm², the heat generated by the circuit 15 also becomes very high, and the local heat generated by the circuit 15 at any given time becomes significantly higher than the heat generated by the photothermal conversion of the near-infrared light-emitting diodes 2a. Therefore, the hot air extraction chambers 14 are provided to efficiently discharge the heat, thereby conducting the local heat generated by the circuit 15 to the near-infrared light-emitting diodes 2a and further to the head side in large quantities, thereby improving heat dissipation efficiency. In some embodiments, a thermally conductive sheet may be disposed on the outside of the circuit 15 to guide the transport and release of heat to the outside.

[0058] In some embodiments, the hot air extraction chamber 14 and the cold air transport chamber 5 are independent of each other, thus avoiding the heat generated by the circuit 15 from spreading to the cold air transport cavity 5 and adversely affecting the heat dissipation effect of the gap between the head and the light-transmitting cover 13.

[0059] In some embodiments, the cover 1 may further include a spacer 18 for separating the chambers within the cover 1 into a first chamber and a second chamber, the first chamber being used to house the near-infrared irradiation unit 2 and the second chamber being used at least partially as a cold air transport chamber 5, and the wall of the second chamber facing the head is optically transparent.

[0060] For example, as shown in FIGS. 1(a) and 1(b), a spacer 18 is positioned outside the cool air transport chamber 5, and each light panel 2b is positioned outside the spacer 18. The spacer 18 completely separates the hot air extraction chamber 14 from the cool air transport chamber 5, preventing the transported cool air from entering the hot air extraction chamber 14. The cool air can then more effectively penetrate the gap between the head and the light-transmitting cover 13, improving the heat dissipation effect through the gap. Furthermore, by placing the light panel 2b inside the hot air extraction chamber 14, the light panel 2b can be spaced somewhat apart from the head, thereby reducing the impact of heat generated by the light panel 2b on the head temperature and ensuring a certain level of safety. To ensure that near-infrared rays emitted by the light panel 2b are directly irradiated on the scalp, the spacer 18 is made of a transparent material similar to the light-transmitting cover 13, thereby reducing near-infrared ray loss and guiding the near-infrared ray to the scalp as much as possible.

[0061] However, the configuration and number of the spacers 18 are not limited to this. The spacers 18 may include a set of curved members for forming a plurality of individual first chambers, and the spaces between the first chambers and between the chambers of the cover 1 can be used as second chambers for transporting cool air. This will not be described further here.

[0062] In some embodiments, the hot air extraction chamber 14 and the cold air transport chamber 5 may be connected, for example, by piping. Specifically, by installing the piping with a small inner diameter, a large amount of cold air in the cold air transport chamber 5 can be used to dissipate heat from the patient's head, and a small amount of cold air can enter the hot air extraction chamber 14 through the piping to cool the circuit 15.

[0063] In some optional embodiments, the top of the light-transmitting cover 13 is arched, and the curvature of the arch is smaller than a preset curvature so that the introduced cool air is gently dispersed to the surroundings by the action of the arched top of the light-transmitting cover 13.

[0064] The curvature of the arch can be as small as possible, so that a large amount of the incoming cold air can be blown directly onto the top of the light-transmitting cover 13, and the action of the top of the light-transmitting cover 13 can reduce the flow rate of the cold air, and the cold air can be dispersed around the top of the light-transmitting cover 13, allowing the cold air to be discharged slowly and evenly from each air vent 6, improving the comfort of the patient.

[0065] In some embodiments, adjacent near-infrared irradiation units 2 in the array of near-infrared irradiation units 2 have a first preset distance between them. For example, as shown in FIG. 1(b), the first preset distance between adjacent near-infrared irradiation units 2 is d, and adjacent near-infrared irradiation units 2 in the array cooperate with a preset divergence angle to radiate near-infrared light toward the patient's head. When the patient's head remains stationary within the cover 1 or moves within the gap, the radiated near-infrared light covers the target brain region and has an average power density greater than 40 mW / cm2, ensuring sufficient light energy entering the brain tissue in the target brain region and ensuring a good therapeutic effect. For example, when the optical therapy device is used to treat AD, the target brain region may be the entire head region, i.e., the near-infrared light covers the entire head without excluding any brain regions.

[0066] Wherein, the first preset distance and the preset divergence angle may be manually set or may be system default values. In this embodiment, by combining and setting the movable gap, the divergence angle, and the first preset distance between adjacent near-infrared irradiation units 2, the emitted near-infrared light forms an infrared light superposition on the scalp after passing through the movable gap, which can not only closely cover the target brain region but also ensure a sufficient average power density through the superposition.

[0067] The therapeutic effect for AD can be improved by combining the movable gap, the divergence angle, and the first preset distance. In some embodiments, the combined settings of the movable gap, the divergence angle, and the movable gap for different brain regions can be varied according to related factors, such as the curvature of the cover 1 and the average power density needs of different brain regions. For example, the curvature of the cover 1 corresponding to the frontal lobe and the temporal lobe is small. In this case, the first preset distance between adjacent near-infrared irradiation units 2 in the region of the cover 1 corresponding to the frontal lobe and the temporal lobe can be set smaller than the first preset distance between adjacent near-infrared irradiation units 2 in other regions of the cover 1 (e.g., the parietal lobe). If the movable gap is too large, it may be difficult for the near-infrared rays emitted by the adjacent near-infrared irradiation units 2 to form an appropriate overlap of infrared light on the scalp after passing through the movable gap. For example, even if overlapping occurs, the average power density may still be insufficient due to the large divergence angle. For example, if it is desired to intensify the therapeutic effect on the frontal lobe and temporal lobe and apply a higher average power density to the frontal lobe and temporal lobe, the movable gap between the cover 1 corresponding to the frontal lobe and temporal lobe and the head can be set smaller than the movable gap corresponding to other brain regions, or the shape of the cover 1 can be used to guide the patient's head closer to the frontal lobe and temporal lobe. Also, for example, the first preset distance between adjacent near-infrared irradiation units 2 in the areas of the cover 1 corresponding to the frontal lobe and temporal lobe can be further reduced to improve the therapeutic effect on the frontal lobe and temporal lobe.

[0068] By combining and setting the movable gap, the first preset distance, and the preset divergence angle, when the AD patient's head moves maximally within the cover 1 (for example, approaching the cover 1 in a certain direction), the target brain region can still be closely covered, and the superposition ensures that the average power density is greater than 40mW / cm2, thereby ensuring the therapeutic effect on AD.

[0069] In some embodiments, the array of near-infrared irradiation units 2 on the cover 1 and the head have a second predetermined distance such that the projection areas on the head of near-infrared rays emitted at the predetermined divergence angles by adjacent near-infrared irradiation units 2 at least partially overlap, so that all target brain regions on the head can be irradiated with near-infrared rays. Meanwhile, the cover 1 does not adopt a fitting design but a loose design that allows the head to move freely within the storage space, and the gap between the array of near-infrared irradiation units 2 on the cover 1 and the head also causes scattering of near-infrared rays.

[0070] The inventors have found through research that if the distance between the array of near-infrared irradiation units 2 and the head is too small, the patient's head will have little room to move, which will be uncomfortable for the AD patient and hinder their cooperation with treatment. Furthermore, if the distance between the array of near-infrared irradiation units 2 and the head is too small, the near-infrared rays will not be sufficiently scattered, resulting in a small overlap of the near-infrared rays emitted by adjacent near-infrared irradiation units 2 on the head, and some parts of the head will not be exposed to the near-infrared rays, resulting in a reduced therapeutic effect. Alternatively, if the required density of near-infrared irradiation units 2 is too high, excessive heat will be generated, affecting the patient's comfort, significantly reducing the service life of the near-infrared irradiation units 2, and increasing manufacturing costs and control difficulties. Conversely, if the distance between the array of near-infrared irradiation units 2 and the head is too large, the infrared light will be excessively dispersed, resulting in an unbalanced distribution of the average power density, or the average power density after overlapping will still be insufficient, resulting in an insufficient therapeutic effect. By controlling the second preset distance between the array of near-infrared irradiation units 2 and the head, near-infrared rays with sufficient average power density and uniform distribution can be irradiated to each part of the head. The required divergence angle range of the near-infrared irradiation units 2 matches the radiation angle range of typical near-infrared LEDs (e.g., 100 to 135 degrees). The required arrangement density and pitch of the near-infrared irradiation units 2 are also appropriate, which advantageously controls manufacturing difficulty and cost. Preferably, the second preset distance between the array of near-infrared irradiation units 2 and the head is set to 2.5 to 4 cm, and the gap allowing lateral movement of the patient's head during treatment is controlled to 1 to 2 cm. The inventors investigated and analyzed patients' psychology in clinical experiments and demonstrated that this is a psychologically comfortable range for patients, allowing sufficient freedom of movement without causing anxiety and worry to patients that the gap is too wide to accurately position their head.

[0071] In some embodiments, the near-infrared irradiation unit 2 may be implemented as a light panel 2b (as shown in FIG. 1(b)) carrying multiple near-infrared LEDs 2a. By providing the near-infrared LEDs 2a on the light panel 2b, the divergence angles of the near-infrared LEDs 2a and the pitch between the light panels 2b can be fully utilized to achieve overlapping of the near-infrared rays emitted by adjacent near-infrared LEDs 2a. Optionally, the pitch between two adjacent near-infrared LEDs 2a is 12-13 mm. The near-infrared LEDs 2a have an appropriate divergence angle, and the combination of the movable gap and the first preset distance can be achieved to improve the therapeutic effect. In treating AD, radiating near-infrared rays to the frontal lobe, temporal lobe, and hippocampus can achieve better therapeutic effects. For targeted areas such as the frontal lobe and temporal lobe, a high average power density is required, for example, 70 mW / cm² or more, even up to 150 mW / cm².

[0072] In some embodiments, in the corresponding regions of the frontal lobe and temporal lobe, as shown in FIG. 7, the distance between two adjacent light panels 2b has a first preset pitch d1, and the projection areas on the head of the near-infrared rays emitted by each of the near-infrared LEDs 2a (e.g., LED 2a-1 in FIG. 7) on one of the light panels 2b (e.g., the right light panel 2b in FIG. 7) all cover the projection areas on the head of the first preset pitch d1, thereby further improving the average power density in the corresponding brain regions of the frontal lobe and temporal lobe, allowing sufficient light energy to enter the brain regions, and thereby improving the therapeutic effect on the targeted frontal lobe and temporal lobe.

[0073] For example, the first preset pitch may be set slightly smaller than the first preset distance between the light panels 2b corresponding to other brain regions so that the distribution density of the near-infrared irradiation units 2 in the corresponding regions of the frontal lobe and temporal lobe is higher than the distribution density in the corresponding regions of other brain regions. The first preset pitch may also be equal to the first preset distance. For example, even in the corresponding regions of the frontal lobe and temporal lobe, the corresponding regions of the frontal lobe and temporal lobe have different curvatures, so that the first preset pitch may be exactly equal to the first preset distance. By further limiting the first preset pitch between two adjacent near-infrared irradiation units 2 in the corresponding regions of the frontal lobe and temporal lobe, rather than setting the first preset distance, the average power density applied to the corresponding regions of the frontal lobe and temporal lobe can be further improved, thereby drawing attention to the corresponding regions of the frontal lobe and temporal lobe.

[0074] In one specific embodiment, the near-infrared irradiation unit 2 is provided with a plurality of LEDs 2a. A movable gap is provided between the array of the near-infrared irradiation unit 2 and the head, allowing the near-infrared rays emitted by the LEDs 2a on each light panel 2b to be scattered through the movable gap and projected onto the head. In some embodiments, the first preset pitch d1 is 15 to 20 mm. An example will be described in which the first preset pitch is 15 mm. When the first preset pitch is 15 mm, the projection area on the head of the near-infrared rays emitted by the LED 2a furthest from the edge of one of the adjacent light panels 2b can cover the projection area on the head at the first preset pitch d1 (such as area C in FIG. 7). This ensures that the projection areas on the head of the near-infrared rays emitted by each LED 2a cover the projection area on the head at the first preset pitch, further improving the average power density in the corresponding regions of the frontal lobe and temporal lobe, thereby improving the therapeutic effect of AD.

[0075] Preferably, the first preset pitch d1 is 15 to 20 mm, the second preset distance d2 between each light panel 2b and the head is 2.5 to 4 cm, the preset divergence angle is 100 to 135 degrees, for example, 100 degrees, 120 degrees, 130 degrees, etc., and the deviation between the average power density of the near-infrared rays in the projection area of the head at the first preset pitch and the average power density at other positions on the head is less than 20%, preferably less than 10%, so that when the emitted near-infrared rays cover the target brain area and the average power density is greater than 40 mW / cm2, focused irradiation of the corresponding areas of the frontal lobe and temporal lobe can be achieved, and the corresponding areas of the frontal lobe and temporal lobe can have a higher and sufficiently uniformly distributed average power density. Specifically, for example, if the deviation between the average power density in the projection area of the near-infrared light at the first preset pitch on the head and the average power density at other locations on the head exceeds 20%, the average power density in the projection area of the near-infrared light at the first preset pitch on the head may be slightly higher or lower, and accordingly, the average power density at other locations may be slightly lower or higher, resulting in an uneven average power density distribution. Moreover, areas on the scalp with a slightly higher average power density may be overheated (which may force treatment to be discontinued), while areas with a slightly lower average power density may be ineffective, thereby reducing the overall therapeutic effect on AD patients. In one preferred embodiment of the present application, the first preset pitch is set to 15 to 20 mm, the second preset distance between each light panel 2b and the head is set to 2.5 to 4 cm, and the preset divergence angle is set to 100 to 135 degrees, for example 120 degrees. By taking into consideration the mutual influences of the first preset pitch, the second preset distance between each light panel and the head, and the preset divergence angle in combination, it is possible to ensure that the entire head is uniformly covered with near-infrared rays and has a high average power density.

[0076] FIG. 8 is a schematic diagram of the overall configuration of a light therapy device for treating Alzheimer's disease according to an embodiment of the present application. As shown in FIG. 8, the light therapy device may further include a user terminal 19, which may be configured to allow a user to perform an interaction operation. The user terminal 19 may include a computer storage medium storing computer-executable instructions, which, when executed by a processor, can realize various interaction steps with the user. The storage medium may include read-only memory (ROM), flash, random access memory (RAM), dynamic random access memory (DRAM), such as synchronous DRAM (SDRAM) or Rambus DRAM, static memory (e.g., flash, static random access memory), etc., and the computer-executable instructions may be stored in any format.

[0077] In some embodiments, the user terminal 19 may be configured to acquire physiological parameters of the patient, including age, optical transparency of extracerebral tissues, and biochemical parameters related to Alzheimer's disease, and to generate and display to the user a suggested infrared light treatment plan for the patient based on the acquired physiological parameters of the patient.

[0078] In some embodiments, the user terminal 19 is further configured to receive a user confirmation operation for the proposed infrared light treatment plan, and after receiving the confirmation operation, each near-infrared irradiation unit 2 (as shown in Figures 1(a) and 1(b)) performs irradiation based on the confirmed infrared light treatment plan.

[0079] Specifically, a controller (not shown) for controlling irradiation may be located in the user terminal 19 or the head cap, and the user terminal 19 issues execution commands, including confirmation of the infrared light treatment plan, to the controller in the head cap. The controller can be realized by various processors, including one or more general-purpose processors, such as a microprocessor, a central processing unit (CPU), a graphics processing unit (GPU), etc. More specifically, the processor may be a complex instruction set computing (CISC) microprocessor, a reduced instruction set computing (RISC) microprocessor, a very long instruction word (VLIW) microprocessor, a processor that executes other instruction sets, or a processor that executes a combination of real instruction sets. The processor may also be one or more application-specific processing devices, such as an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a digital signal processor (DSP), a system-on-chip (SoC), etc. Preferably, most of the calculations and processing are integrated into the user terminal 19 to reduce the computational load and software / hardware costs of the head cap.

[0080] In some embodiments, the light therapy device further includes a holder 20, and as shown in FIG. 8, the cover 1 is connected to the holder 20 via an elastic member 21, which provides a certain degree of movement for the patient's head during treatment, allowing the patient's head to move more freely, further improving comfort and enhancing the patient's user experience.

[0081] The inventors conducted in vivo experiments using phototherapy on 5-month-old AD mice. The single-wavelength near-infrared light used was centered at 800-820 nm, pulsed at 10 Hz, and irradiated once daily for 10 minutes each time for 5 weeks. The AD mice receiving phototherapy (also referred to as the experimental group) and the control group (also referred to as the control group) showed significant improvement in water maze tests. As shown in Figure 9, the experimental group significantly reduced the distance traveled to find the platform and the escape latency by 36% compared to the control group. Furthermore, the distribution of Aβ protein sampled and analyzed from brain tissue from both the cortical and hippocampal CA1 regions of the experimental group was significantly lower than that of the control group, as shown in Figure 10. Research has shown that the extracellular deposition of amyloid beta (Aβ) protein, generated by the degradation of amyloid precursor protein (APP), is an important factor in the pathogenesis of AD, and that widespread Aβ plaque deposition in the cerebral cortex, intertwined with neuronal fibers due to tau protein lesions in the cortex, is a prominent pathological feature of AD. Therefore, in the experimental group, the significant reduction in Aβ plaque deposition after treatment with near-infrared light indicated a favorable therapeutic effect against AD.

[0082] The inventors conducted clinical trials of phototherapy on AD patients using a phototherapy device according to the embodiments of the present application, using near-infrared light with a single wavelength of 810 nm at an average power density of more than 40 mW / cm², 5-7 times per week for 30 minutes each, for a period of 4 months. The average power density of the frontal and temporal lobes, which are the focus areas, is preferably about 90-120 mW / cm², and the average light power density of most areas is 100 mW / cm² or more, and preferably the average power density of the parietal and occipital lobes is greater than 60 mW / cm².

[0083] The results of the mid-term clinical trial are shown in Figure 11, which is a graph comparing the scores of the Alzheimer's Disease Assessment Scale-cognitive section (ADAS-cognitive) of AD patients in the treatment group who received light therapy and AD patients in the control group after light therapy was performed on AD patients using a light therapy device according to an embodiment of the present application.

[0084] As can be seen from the above, after two months of near-infrared treatment, the treatment group's total score on the ADAS-cog scale decreased by an average of 6.7 points from baseline, showing a statistically significant difference, while the control group, which did not receive near-infrared treatment, saw an increase of 3 points in the total score on the ADAS-cog scale after two months. The ADAS-cog score results demonstrated the favorable therapeutic effect of the phototherapy device according to the examples of the present application on AD.

[0085] In addition to the ADAS-Cog score, this clinical trial also analyzed the MMSE score. The MMSE score was a total of 30, with lower scores indicating more severe cognitive impairment. The baseline MMSE score for AD patients receiving light therapy was 11.67 points, and the MMSE score after two months was 14.83 points, an average increase of 3.12 points from baseline, indicating that the cognitive function of AD patients improved after light therapy. The MMSE score also demonstrated the favorable therapeutic effect of the light therapy device according to the embodiments of the present application on AD.

[0086] In some embodiments, the light therapy device for treating Alzheimer's disease according to the present application can also be used to treat psychiatric disorders such as depression, autism, and bipolar affective disorder.

[0087] The inventors have demonstrated through clinical experimental studies that treating mental disorders such as depression with a higher average power density results in better therapeutic effects while ensuring safety and patient comfort. When treating depression, the average power density of near-infrared light radiated to at least the frontal lobe of the head is preferably 80 mW / cm to 250 mW / cm. In another embodiment, near-infrared light with an average power density of 80 mW / cm to 250 mW / cm may be radiated simultaneously to the frontal lobe and temporal lobe to achieve better phototherapeutic effects for depression.

[0088] In some embodiments, when treating depression, the array of near-infrared irradiation units 2 is configured to irradiate near-infrared rays to at least some nodes of a brain network, the brain network including at least one of a default network, a salience network, and a central executive network. As can be understood, the brain network may include multiple nodes, each of which corresponds to a different brain region, or one brain region may have multiple nodes, and functional connections exist between pairs of nodes, and the strength of the functional connections between the pairs of nodes can be used to characterize the cooperation, communication, etc. between brain regions.

[0089] In the case of autistic patients of various age groups, abnormalities in the structure, function, and connectivity of the frontal lobe, temporal lobe, hippocampus, amygdala, and thorium corpus often occur to varying degrees. Similar to the treatment of depression, a high average power density is required for the treatment of autism. To achieve a good therapeutic effect, a higher average power density is required for irradiation of brain regions associated with autism. Therefore, when treating autism with the phototherapy device of the present application, the average power density of near-infrared rays emitted by the array of near-infrared irradiation units corresponding to brain regions associated with autism can be set to 100 mW / cm2 to 250 mW / cm2. When phototherapy is performed on such autistic patients with the phototherapy device, the average power density of near-infrared rays emitted by the array of near-infrared irradiation units corresponding to one or more brain regions selected from the frontal lobe, temporal lobe, hippocampus, amygdala, and thorium corpus can be set to 100 mW / cm2 to 250 mW / cm2. In some embodiments, treating autism with a light therapy device may also provide targeted, localized treatment of autism based on brain networks associated with autism.

[0090] When treating bipolar affective disorder, the average power density of near-infrared light emitted by the array of near-infrared irradiation units corresponding to the brain regions associated with bipolar affective disorder is 100 mW / cm to 250 mW / cm, and the brain regions associated with bipolar affective disorder may include the frontal lobe and limbic brain regions, such as the ventrolateral prefrontal cortex, dorsolateral prefrontal cortex, and intraparietal sulcus. As can be seen, bipolar affective disorder differs from other psychiatric disorders in that it has different stages, including depression and mania, and different abnormalities in the brain network occur in different stages. Therefore, by specifically targeting the abnormalities in the brain network at different stages and administering light irradiation therapy, more accurate treatment of bipolar affective disorder can be achieved.

[0091] As can be understood, in the above-mentioned case of using a brain network to perform precise phototherapy for mental disorders such as depression, autism, bipolar affective disorder, etc., the near-infrared irradiation parameters can be specifically set according to the disease type, the degree of morbidity, the functional connection status between brain network nodes, etc., and the present application is not specifically limited thereto, and the irradiation parameters may include a central wavelength, an average power density, a pulse frequency, etc.

[0092] In some embodiments, the above configuration of left and right prominent ears 8 can be used to treat AD as well as other disorders associated with the frontal and temporal lobes, such as depression.

[0093] It should be noted that although exemplary embodiments have been described herein, the scope of the present invention includes any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., cross-sectional designs of various embodiments), adaptations, or variations based on the present application. Claim elements are to be broadly construed based on the language employed in the claims and are not limited to the examples described in the specification or during the practice of this application, which examples are to be construed as non-exclusive. Accordingly, the specification and examples are intended to be considered merely as examples, with the true scope and spirit being indicated by the following claims and the full scope of their equivalents.

[0094] The above description is intended to be illustrative, not limiting. For example, the above examples (or one or more versions thereof) may be used in combination with each other. For example, one skilled in the art may use other embodiments upon reading the above description. Additionally, in the above Detailed Description, various features may be grouped together to simplify the application. This should not be interpreted as an intention that no disclosed feature is required in any claim, even if protection is not claimed. Rather, subject matter of the application may comprise less than all features of a particular embodiment disclosed. The following claims are hereby incorporated into the Detailed Description herein as an example or embodiment. It is contemplated that each claim stands alone as a stand-alone embodiment, and that these embodiments may be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which those claims are entitled.

[0095] The above embodiments are merely illustrative examples of the present application and are not intended to limit the present invention, and the protection scope of the present invention is limited by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present invention within the substance and protection scope of the present application, and such modifications or equivalent substitutions should also be considered to be within the protection scope of the present invention.

Claims

1. A phototherapy device for treating Alzheimer's disease, comprising: a cover that comfortably accommodates the patient's head so that the head can rotate within a preset angular range and move up and down within a preset distance range during treatment; an array of near-infrared irradiation units disposed on the cover and configured to radiate near-infrared rays at an average power density of greater than 40 mW / cm to the patient's head; and a cooling mechanism configured to introduce and send cool air into the cover, and to blow the cool air onto the patient's head through a cool air transport passage between the cover and the patient's head, thereby dissipating heat from the patient's head. A phototherapy device for treating Alzheimer's disease.

2. the temperature-reducing mechanism includes a cooling device or is connected to a cooling device; the cover is provided with a cold air transport chamber for receiving the cold air generated by the cooling device; The cold air transport passage is formed directly between the inner wall of the cold air transport chamber and the patient's head.

2. The phototherapy device according to claim 1.

3. The array of near-infrared irradiation units is configured to irradiate the patient's head with near-infrared light having a central wavelength of 800 to 820 nm.

3. The phototherapy device according to claim 1 or 2.

4. The array of near-infrared irradiation units is configured to irradiate near-infrared light at a single wavelength and having a central wavelength of 810 nm onto the patient's head.

3. The phototherapy device according to claim 1 or 2.

5. the near-infrared light is pulsed light, The irradiation parameters of the near-infrared irradiation unit further include a pulse frequency; the pulsed light includes a pulse wave component of a first pulse frequency and / or a pulse wave component of a second pulse frequency, the first pulse frequency is 7 Hz to 13 Hz; The second pulse frequency is 30 Hz to 100 Hz.

3. The phototherapy device according to claim 1 or 2.

6. the first pulse frequency is 10 Hz; The second pulse frequency is 40 Hz.

6. The phototherapy device according to claim 5.

7. each of the near-infrared irradiation units includes a plurality of near-infrared light emitting diodes; The pulsed light includes pulse wave components having an alpha wave frequency and a gamma wave frequency as a first pulse frequency and a second pulse frequency, respectively, and is formed by any one of the following: The waveform of the pulsed light emitted by each of the near-infrared light emitting diodes is a synchronous mixture of alpha waves and gamma waves; The waveform of the pulsed light emitted by each of the near-infrared light emitting diodes is a time-division combination of alpha waves and gamma waves; each of the near-infrared light emitting diodes in the first set of near-infrared light emitting diodes emits pulsed light of alpha waves, each of the near-infrared light emitting diodes in the second set of near-infrared light emitting diodes emits pulsed light of gamma waves, and the two sets of near-infrared light emitting diodes synchronously emit pulsed light; 6. The phototherapy device according to claim 5.

8. The wind speed at which the cool air is blown onto the patient's head through the cool air transport passage is 0.5 to 3.5 m / s.

3. The phototherapy device according to claim 1 or 2.

9. Irradiation parameters, including average power density, of at least some of the near-infrared irradiation units are independently adjustable; 3. The phototherapy device according to claim 1 or 2.

10. and a user terminal configured to acquire physiological parameters of the patient, including age, optical transparency of extracerebral tissue, and biochemical parameters related to Alzheimer's disease, and to generate and display to a user a proposed infrared light treatment plan for the patient based on the acquired physiological parameters of the patient.

3. The phototherapy device according to claim 1 or 2.

11. The cover is configured to cover at least the entire brain.

3. The phototherapy device according to claim 1 or 2.

12. The array of near-infrared irradiation units is configured to irradiate the near-infrared light to the frontal lobe and the temporal lobe at a higher average power density than to other brain regions.

3. The phototherapy device according to claim 1 or 2.

13. The average power density of the near-infrared rays radiated to the frontal lobe and the temporal lobe is 50 mW / cm or more to 250 mW / cm.

13. The phototherapy device according to claim 12.

14. When the array of near-infrared irradiation units radiates the near-infrared rays to the whole brain region of the patient's head together, the total power of the near-infrared rays is greater than 3 W and can reach 10 W or more.

3. The phototherapy device according to claim 1 or 2.

15. the array of near-infrared irradiation units is configured to emit near-infrared rays to nodes of a brain network; The nodes of the brain network include at least one of the medial prefrontal cortex, the medial temporal lobe, the dentate cortex, the precuneus, and the inferior parietal lobe; 3. The phototherapy device according to claim 1 or 2.

16. The node of the brain network includes at least the hippocampus located in the medial temporal lobe, the array of near-infrared irradiation units is configured to irradiate near-infrared light to the hippocampus and to nodes of the brain network whose functional connection strength with the hippocampus is weaker than a predetermined level; 16. The phototherapy device according to claim 15.

17. The cover has a left protruding ear and a right protruding ear, the left protruding ear portion and the right protruding ear portion are configured to extend downward to below the patient's ears so as to cover the patient's left and right temporal lobes, respectively; A near-infrared irradiation unit is disposed on each of the left protruding ear portion and the right protruding ear portion so as to irradiate the near-infrared rays to the covered temporal lobe region.

3. The phototherapy device according to claim 1 or 2.

18. The cover includes a forehead portion, and curved joints are provided between the forehead portion and the left and right protruding ear portions so that lower edges of the left protruding ear portion, the forehead portion, and the right protruding ear portion are integrally connected by curved lines, thereby completely covering the patient's left and right temporal lobes.

18. The phototherapy device according to claim 17.

19. the cover further includes a spacer for separating a chamber within the cover into a first chamber and a second chamber; the first chamber is used to accommodate a near-infrared irradiation unit; The second chamber is at least partially used as a cold air transport chamber, and the wall of the second chamber facing the head is light-transmitting.

3. The phototherapy device according to claim 2.

20. The cover includes an outer layer and a light-transmitting cover as an inner layer, a cold air transport chamber is formed between the outer layer and the light-transmitting cover; The light-transmitting cover has a plurality of ventilation holes for forming the cool air passage together with a gap between the light-transmitting cover and the patient's head.

3. The phototherapy device according to claim 1 or 2.

21. the outer layer of the cover includes a hot air extraction chamber that at least partially houses the circuit and is in communication with the outside through an air intake port and an air exhaust port, whereby air introduced through the air intake port carries heat generated by the circuit and releases it to the outside through the air exhaust port; 21. The phototherapy device of claim 20.

22. The top of the light-transmitting cover is arched, and the curvature of the arch is smaller than a preset curvature so that the introduced cool air is gently dispersed to the surroundings by the action of the arched top.

21. The phototherapy device of claim 20.

23. The array of near-infrared irradiation units has a first preset distance between adjacent near-infrared irradiation units, and the adjacent near-infrared irradiation units cooperate with each other at a preset divergence angle to radiate near-infrared rays to the patient's head, so that when the patient's head is kept stationary within the cover or moves within the gap, the radiated near-infrared rays cover a target brain region.

3. The phototherapy device according to claim 1 or 2.

24. a second preset distance is provided between the array of near-infrared irradiation units and the head such that projected areas on the head of near-infrared rays emitted at preset divergence angles by adjacent near-infrared irradiation units at least partially overlap each other; 3. The phototherapy device according to claim 1 or 2.

25. the near-infrared irradiation unit is a light panel carrying a plurality of near-infrared LEDs, In the corresponding regions of the frontal lobe and the temporal lobe, two adjacent near-infrared irradiation units have a first preset pitch between them so that the projection areas on the head of near-infrared rays emitted by each of the near-infrared LEDs of one of the near-infrared irradiation units all cover the projection areas on the head of the first preset pitch.

25. The phototherapy device of claim 24.

26. The first preset pitch is 15-20 mm, the second preset distance between each light panel and the head is 2.5-4 cm, and the preset divergence angle is 100-135 degrees, so that the deviation of the average power density of the near-infrared light in the projection area of the first preset pitch of the head from the average power density at other positions on the head is less than 20%; 26. The phototherapy device of claim 25.

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