Light treatment equipment for treating Alzheimer's disease

Abstract

The invention relates to a light treatment device for treating Alzheimer's disease. The device comprises: a cover body which accommodates the head of a patient in a loose manner; the array of near-infrared irradiation units is arranged in the cover body, and the array is constructed to emit single-wavelength near-infrared light with the average power density larger than 40 mw / cm < 2 > to the head part; and the cooling mechanism is configured to introduce cold air and send the cold air into the cover body, and the cold air is blown to the head of the patient through a cold air transmission channel between the cover body and the head of the patient so as to cool the head of the patient. The equipment can effectively treat the Alzheimer's disease patients, adapts to special psychological needs and physiological needs of the patients in various disease courses, improves the treatment compliance of the patients, and ensures a good treatment effect on the Alzheimer's disease.

Description

[0001] This application is a divisional application of Chinese invention patent application No. 202380053768.2, filed on July 26, 2023, entitled "A phototherapy device for treating Alzheimer's disease". Technical Field

[0002] This application relates to the field of medical devices, and more specifically, to a light therapy device for treating Alzheimer's disease. Background Technology

[0003] Epidemiological surveys show that the incidence of brain function-related diseases in modern society is on the rise, among which Alzheimer's disease (AD) is one of the most common brain function-related diseases.

[0004] Alzheimer's disease (AD) is most common in people over 65 years of age. Its onset is slow or insidious, gradually worsening over time. The main symptoms include cognitive decline, language impairment, emotional instability, psychiatric symptoms and behavioral disturbances, and a gradual decline in daily living abilities, ultimately leading to loss of bodily function and death. Currently, the cause of AD is unclear. With the aging of the global population, the number of AD patients is increasing, placing a heavy burden on families and society.

[0005] Currently, there is no effective drug treatment for Alzheimer's disease (AD) in clinical practice. For many years, extensive research has been conducted both domestically and internationally on the use of physical electromagnetic stimulation to treat AD, such as transcranial direct current stimulation and transcranial magnetic stimulation. However, these electromagnetic therapies can only reach the cerebral cortex and are ineffective in stimulating deeper brain regions. In recent years, cutting-edge research has also been conducted both domestically and internationally on the use of near-infrared light to treat AD. Although some research results have been achieved, most are based on in vivo experiments on mice, and clinical results using human subjects are scarce.

[0006] In existing phototherapy devices for treating Alzheimer's disease, the average power density of near-infrared light is low, and the energy deposition on brain tissue after near-infrared light penetrates the skull is less, making it difficult to achieve a good phototherapy effect. The near-infrared treatment module is set up separately, which means that near-infrared light cannot irradiate the whole brain, resulting in poor phototherapy effect and easy leakage of near-infrared light, causing safety problems.

[0007] Furthermore, the housings of existing phototherapy devices that use near-infrared light to treat AD are usually adapted to the shape of the patient's head. In addition to memory loss, AD patients also exhibit emotional agitation, anxiety, insecurity, suspicion, and irritability. If the patient's head is constricted or they are required to keep their head still during treatment, it can lead to strong resistance to phototherapy, poor acceptance and cooperation, and thus affect the effectiveness of the phototherapy. Summary of the Invention

[0008] This application is provided to address the aforementioned problems existing in the prior art. There is a need for a light therapy device for treating Alzheimer's disease, which can effectively treat Alzheimer's patients, adapt to the specific psychological and physiological needs of Alzheimer's patients at various stages of the disease, improve patient treatment compliance, and ensure good treatment results for Alzheimer's disease.

[0009] According to a first aspect of this application, a phototherapy device for treating Alzheimer's disease is provided. The phototherapy device includes a housing that loosely accommodates the patient's head, allowing the head to rotate within a preset angle range and move up and down within a preset distance during treatment. The phototherapy device includes an array of near-infrared irradiation units disposed within the housing, the array of near-infrared irradiation units being configured to emit an average power density greater than 40 mW / cm² towards the patient's head. 2 The near-infrared light is emitted. The phototherapy device also includes a cooling mechanism configured to introduce cold air and deliver it into the cover, blowing it towards the patient's head via a cold air transmission path between the cover and the patient's head to dissipate heat from the patient's head.

[0010] The phototherapy device for treating Alzheimer's disease according to various embodiments of this application can effectively treat Alzheimer's patients, is suitable for Alzheimer's patients at various stages of the disease, and allows Alzheimer's patients to be in a relatively comfortable environment during treatment. It is particularly suitable for the physiological needs of Alzheimer's patients, such as intolerance to increased temperature and the need for higher irradiation power, thereby improving patient compliance. It can also meet special psychological needs such as emotional agitation, anxiety, and psychological barriers in enclosed and crowded spaces, ensuring good treatment results for Alzheimer's disease. Attached Figure Description

[0011] In drawings that 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 rather than limitation and are used, together with the description and claims, to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method.

[0012] Figure 1(a) shows a schematic diagram of the structure of a phototherapy device for treating Alzheimer's disease according to an embodiment of this application; Figure 1(b) shows a schematic diagram of the structure of the array of near-infrared irradiation units in the headgear of a phototherapy device for treating Alzheimer's disease; Figure 2A schematic diagram showing the distribution of various brain regions in the whole brain of a patient according to an embodiment of this application; Figure 3(a) shows a comparison of energy deposition in the dorsolateral prefrontal cortex (dlPFC) of people of different ages under near-infrared light of various wavelengths according to embodiments of the present application. Figure 3(b) shows a comparison of energy deposition in the ventromedial prefrontal cortex (vmPFC) of people of different ages under near-infrared light irradiation of various wavelengths according to embodiments of the present application. Figure 4 The diagram illustrates the absorption curves of near-infrared light of different wavelengths in water, deoxyhemoglobin, and oxyhemoglobin according to embodiments of this application. Figure 5 A schematic diagram showing the headgear of a light therapy device for treating Alzheimer's disease according to an embodiment of this application in the wearing state; Figure 6 A perspective view of a headgear for a phototherapy device for treating Alzheimer's disease according to an embodiment of this application is shown; Figure 7 A diagram showing the arrangement of near-infrared LEDs on a lamp panel, serving as a near-infrared irradiation unit in a phototherapy device for treating Alzheimer's disease. Figure 8 This diagram illustrates the overall structure of a phototherapy device for treating Alzheimer's disease according to an embodiment of this application. Figure 9 A graph showing a comparison of in vivo experimental data of the water maze test between AD mice receiving phototherapy and control AD ​​mice after phototherapy was performed on 5-month-old AD mice using the phototherapy device according to an embodiment of this application. Figure 10 This image shows pathological sections of the cerebral cortex and hippocampal CA1 region of 5-month-old AD mice after phototherapy using the phototherapy device according to an embodiment of this application, comparing the treated AD mice with control AD ​​mice. The sections show β-amyloid protein (Aβ). Figure 10 The distribution of particles is shown in the figure; and Figure 11 A chart showing a comparison of the Alzheimer's Disease Assessment Scale Cognitive Scale (ADAS-cog) scores of AD patients who received phototherapy and control AD ​​patients after phototherapy was performed using the phototherapy device according to an embodiment of this application. Detailed Implementation

[0013] To enable those skilled in the art to better understand the technical solutions of this application, the application will be described in detail below with reference to the accompanying drawings and specific embodiments. The embodiments of this application will be further described in detail below with reference to the accompanying drawings and specific examples, but this is not intended to limit the application. If there is no necessary sequential relationship between the various steps described herein, the order in which they are described as examples should not be considered a limitation. Those skilled in the art should understand that the order can be adjusted, as long as it does not disrupt the logical coherence between them and render the entire process impossible.

[0014] The terms "first," "second," and similar words used in this application do not indicate any order, quantity, or importance, but are merely used for distinction. Words such as "including" or "comprising" mean that the element preceding the word encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well. The term "head" used in this application refers to organs above the neck (cervical vertebrae), including the brain and extracranial tissues such as the skull, skin, and hair. The term "brain" used in this application refers to the organs remaining after removing extracranial tissues, primarily intended to refer to the cerebrum, but not limited to it, and may also include the cerebrum, cerebellum, and brainstem. The term "whole brain" used in this application is intended to distinguish it from separate brain regions such as the frontal lobe and temporal lobe, but is not limited to all regions of the "brain." "Whole brain" includes at least the frontal lobe, temporal lobe, parietal lobe, and occipital lobe, and in some cases (but not necessarily) may further include the hippocampus and amygdala, and in other cases (but not necessarily) may further include the cerebellum and brainstem.

[0015] Our research team has conducted in-depth research on near-infrared light therapy for Alzheimer's disease and related phototherapy devices. Extensive simulation and clinical trials have demonstrated the theoretical and practical feasibility of AD phototherapy devices. Furthermore, in clinical trials targeting AD patients at various disease stages, we have focused on and deeply studied the specific psychological and physiological needs of these patients. This application proposes a phototherapy device for treating Alzheimer's disease that significantly improves patient compliance and ensures effective treatment of AD.

[0016] Figure 1(a) shows a schematic diagram of the construction of a phototherapy device for treating Alzheimer's disease according to an embodiment of this application. As shown in Figure 1(a), the phototherapy device includes a cover 1 that loosely accommodates the patient's head, allowing the head to rotate within a preset angle range and move up and down within a preset distance range during treatment. Unlike a device adapted to the shape of the patient's head, a small gap of a few centimeters is reserved between the cover 1 and the patient's head, preferably 1-2 cm, allowing the patient to move their head within the preset angle and distance range as desired. This open design of the cover 1 provides no restriction on the patient's head and is particularly friendly to elderly people who are emotionally agitated, anxious, resistant, or even fearful of enclosed or crowded spaces, thereby significantly improving the treatment compliance of AD patients.

[0017] Specifically, the phototherapy device can be used to treat patients with Alzheimer's disease (AD) who have psychological barriers to enclosed or crowded spaces. These psychological barriers can be due to the patient's age or the nature of their AD. The design of the cover 1 is also widely applicable to the behavioral characteristics of patients at different stages of AD. For example, early-stage AD patients often experience impaired judgment, are suspicious, and easily irritated. The cover 1, with its ample freedom and openness, is easily accepted by patients and less likely to cause irritation, allowing them to cooperate with the continuous phototherapy. Similarly, mid-stage AD patients often experience severe mood swings, restlessness, and frequent pacing. Some patients may unconsciously shake their heads frequently. The open design of the cover 1 allows these unconscious head movements without causing the cover 1 itself to vibrate. Therefore, there is no need to forcibly stop these movements, increasing patient comfort and reducing the workload of medical staff. At the same time, it prevents these head movements from being transmitted to the cover 1 and affecting the phototherapy effect. Therefore, the light therapy device can be used to treat Alzheimer's patients with agitation and anxiety.

[0018] The open and relaxed design of the mask 1 makes AD patients at various stages more willing to accept treatment, and allows for longer durations of single irradiation sessions, such as 20 minutes, 30 minutes, or even longer, thereby further improving treatment effectiveness.

[0019] The phototherapy device further includes an array of near-infrared irradiation units 2 disposed within the housing 1. The array of near-infrared irradiation units 2 is arranged corresponding to various brain regions of the head. As an example, as shown in FIG1(b), each near-infrared irradiation unit 2 includes multiple near-infrared light-emitting diodes 2a. In some embodiments, each near-infrared irradiation unit 2 may include a single near-infrared light-emitting diode 2a. The array of near-infrared irradiation units 2 is configured to emit an average power density greater than 40 mW / cm² towards the patient's head. 2 Near-infrared light. It is understood that the term "average power density" as used in this application refers to the amount of energy of near-infrared light irradiating a unit area per unit time.

[0020] The inventors discovered that for elderly patients with Alzheimer's disease (AD), such as those over 65 years of age, a higher power density is required to ensure sufficient light energy reaches the brain for effective treatment. In the phototherapy device of this application embodiment, the array of near-infrared irradiation units 2 is configured to emit a power density greater than 40 mW / cm² towards the patient's head. 2 The near-infrared light provides sufficient light energy to enter the brain. Furthermore, in the phototherapy device of this application embodiment, the cover 1 is not designed to fit the head, but rather a loose design that allows the head to move freely within the accommodating space. The gap between the cover 1 and the head also causes near-infrared light scattering. The superposition of near-infrared light scattering results in high power density at various brain regions, further satisfying the need for increased power density, and thus meeting the requirement for high power density throughout the entire brain.

[0021] Through simulation and clinical trials, the inventors discovered that for the light therapy device with a loosely designed shield 1 in this application, a power output greater than 40mW / cm² is achieved. 2 The average power density ensures sufficient light energy to reach the brain tissue, even for elderly patients with Alzheimer's disease (AD), guaranteeing a good therapeutic effect. Specifically, the average power density used is 40 mW / cm². 2 -150 mW / cm 2 For example, 60 mW / cm 2 70 mW / cm 2 80 mW / cm 2 90 mW / cm 2 100 mW / cm 2 120 mW / cm 2 For certain brain regions, such as the frontal and temporal lobes, the average power density of near-infrared light can reach 50 mW / cm². 2 Up to 250 mW / cm 2 70 mW / cm is preferred 2 above.

[0022] Greater than 40mW / cm 2 For the average power density required, conventional fan-type cooling mechanisms are unsuitable. Even with increased airflow, AD patients still experience discomfort or even unbearable burning sensations near their scalp, making it impossible to tolerate continuous treatment. Furthermore, excessive airflow can cause discomfort to the patient's head. For certain types of irradiation therapy, such as whole-brain irradiation or targeted therapy for specific brain regions like the frontal and temporal lobes, a higher average power density may be required, such as 70 mW / cm². 2 Above, even 150 mW / cm 2 It was confirmed by irradiating cortical cells in vitro with near-infrared light that the array of near-infrared irradiation units 2 can be configured to emit an average power density of less than 250 mW / cm² towards the patient's head. 2 The near-infrared light, with its average power density in this range, avoids the risk of thermal damage, as well as inhibition and mitochondrial damage.

[0023] In some embodiments, the average power density required for the near-infrared light used can be determined and adjusted based on the patient's attributes. For example, the average power density can be determined based on the translucency of the patient's extracranial tissues, such that the average power density is higher for patients with low translucency of extracranial tissues than for patients with high translucency of extracranial tissues.

[0024] Specifically, Alzheimer's disease (AD) patients have lower sensitivity to temperature and pain. This means that AD patients may experience greater pain and potentially more extensive tissue or organ damage before lesions are detected and reported. Furthermore, a large proportion of AD patients are over 65 years old, and the elderly are more susceptible to cold than younger people. Therefore, when using higher average power density or even total power to treat AD patients, it is especially important to fully consider the patient population's sensitivity to temperature and pain, providing them with a comfortable treatment environment that does not cause pain or even thermal damage. This helps prolong treatment time and thus achieve better therapeutic outcomes.

[0025] Figure 2 This diagram illustrates the distribution of various brain regions in the cerebral cortex of a patient according to an embodiment of this application. Figure 2 As shown, the main brain regions of the cerebral cortex include the frontal lobe, temporal lobe, parietal lobe, occipital lobe, and cerebellum.

[0026] The inventors discovered that in treating conditions such as Alzheimer's disease (AD), emitting near-infrared light from an array of near-infrared irradiation units onto all brain regions of the patient's head, particularly at least the frontal lobe, temporal lobe, and hippocampus, yields better therapeutic results compared to irradiating only specific brain regions. Specifically, for example... Figure 2 As shown, the hippocampus, located between the thalamus and the medial temporal lobe, is part of the limbic system and plays a role in short-term memory, long-term memory, and spatial orientation. Hippocampal atrophy is closely related to Alzheimer's disease. As AD progresses, the lesions spread to the frontal and temporal lobes, causing the brain to gradually atrophy, leading to further memory loss and loss of self-care abilities. The temporal lobe's functions mainly include auditory perception, language reception, visual memory, declarative (real) memory, and emotional control. Specifically, patients with right temporal lobe lesions often lose the ability to understand nonverbal auditory stimuli (such as music), while left temporal lobe lesions affect the patient's perception, memory, and organization of language. The frontal lobe is the physiological basis of the most complex psychological activities in humans, responsible for planning, regulating, and controlling psychological activities. It plays an important role in higher-level, purposeful behavior, and is closely related to higher cognitive functions such as attention, memory, and problem-solving, as well as personality development.

[0027] By covering the entire brain with the shield 1, the array of near-infrared irradiation units 2 emits near-infrared light to all brain regions of the patient's head, including at least the frontal lobe, temporal lobe, and hippocampus, providing comprehensive and thorough phototherapy to the cortical regions involved in the lesion, thereby achieving better treatment results (which will be confirmed below with clinical trials and clinical data). In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light to the frontal and temporal lobes with a higher average power density than other brain regions, thereby enhancing the treatment effect on the frontal and temporal lobes where the focus is concentrated.

[0028] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light to brain network nodes, which may include at least one of the medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe. Studies have shown that the functional connectivity between brain network nodes in the medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe is correlated with the progression of Alzheimer's disease (AD). For example, brain network connectivity studies of AD patients have revealed that, compared to healthy individuals, the functional connectivity between the hippocampus in the medial temporal lobe and nodes in the medial prefrontal cortex and precuneus is significantly weakened. In some AD patients, the functional connectivity results even show that the hippocampus has lost connections with certain brain network nodes. Configuring the array of near-infrared irradiation units 2 to emit near-infrared light to these brain network nodes can enhance the functional connectivity between these nodes, improve inter-brain collaboration and information transmission capabilities, and improve memory and cognitive functions. Specifically, brain networks and individual nodes can be constructed and identified based on brain functional imaging and / or brain structural imaging of the patient's head. For example, brain networks can be established using MRI images. A brain network can include multiple nodes with brain regions as nodes, each node corresponding to a different brain region. Alternatively, multiple nodes can be set on a single brain region, with functional connections between node pairs. The strength of the functional connections between node pairs can be used to characterize the collaborative work and information transmission between brain regions.

[0029] In one specific embodiment, the brain network nodes include at least the hippocampus located in the medial temporal lobe. The array of near-infrared irradiation units 2 is configured to emit near-infrared light towards the hippocampus and brain network nodes whose functional connectivity with the hippocampus is weaker than a predetermined level. Thus, targeted local irradiation is performed on nodes in the brain network nodes with functional connectivity imbalances (i.e., functional connectivity weaker than a predetermined level, such as weaker than normal or loss of functional connectivity), for example, using an average power density greater than 70 mW / cm². 2 Irradiation with near-infrared light can not only enhance the functional connection between the hippocampus and other brain network nodes, but also help restore the functional connection between the hippocampus and other brain network nodes, achieving a good therapeutic effect on AD. Targeting these brain network node areas with near-infrared light can also reduce heat generation, reduce the requirements for cooling mechanisms, and make it easier to put the patient's head in a more comfortable environment, thus improving comfort.

[0030] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light together to brain network nodes including the medial prefrontal cortex, the hippocampus located in the medial temporal lobe, the anterior cingulate cortex, the precuneus, and the inferior parietal lobe. This can enhance the functional connectivity between the nodes in the brain network and achieve better treatment results for AD.

[0031] It is understandable that when using the array of near-infrared irradiation units 2 to target and irradiate nodes of the brain network, for a pair of nodes with functional connectivity imbalance, one node can be irradiated, or the pair of nodes (i.e., both nodes) can be irradiated simultaneously. In particular, when one node in a pair of nodes is located deep in the brain and is difficult to irradiate, such as the hippocampus located deep in the brain, the other node in the pair that is easier to irradiate can be irradiated. This can also indirectly affect the other node located deep in the brain and achieve a certain phototherapy effect. This application does not make specific limitations on the irradiation method of brain network nodes.

[0032] In some embodiments, the array of the near-infrared irradiation unit 2 can be configured to emit near-infrared light with a center wavelength within a certain range toward the patient's head. The average energy deposition and absorption coefficients of the near-infrared light with a center wavelength within this range are both good. Preferably, the array of the near-infrared irradiation unit 2 can be configured to emit near-infrared light with a center wavelength of 800-820 nm toward the patient's head, as will be discussed in conjunction with Figures 3(a), 3(b), and... Figure 4 A detailed explanation follows. Preferably, the array of the near-infrared irradiation unit 2 is configured to emit single-wavelength near-infrared light with a center wavelength of 810 nm toward the patient's head.

[0033] The phototherapy device according to an embodiment of this application further includes a cooling mechanism 4 to adequately dissipate heat from the patient's head, thus effectively solving the aforementioned problems. Specifically, the cooling mechanism 4 is configured to introduce cold air and deliver it into the cover 1, blowing it towards the patient's head via a cold air transmission path between the cover 1 and the patient's head to dissipate heat from the patient's head. The temperature of the cold air introduced by the cooling mechanism 4 is lower than the surface temperature of the patient's head.

[0034] In some embodiments, as shown in FIG1(a), the cooling mechanism 4 may include a refrigerator 3 or may be connected to a refrigerator 3. The cover 1 is provided with a cold air transmission cavity 5 to receive cold air generated by the refrigerator 3. The inner wall of the cold air transmission cavity 5 directly forms a cold air transmission passage 7 between itself and the patient's head. The cold air transmission cavity 5 can be set in various ways. For example, the cold air transmission cavity 5 and the near-infrared irradiation unit accommodating cavity (not shown) can be set separately in the internal open space of the cover 1. The cold air transmission cavity 5 can be integrated with other chambers in the cover 1, set in layers, or set independently and alternately. No specific limitation is made here.

[0035] In some embodiments, the airflow velocity of the cold air blowing towards the patient's head via the cold air transmission passage 7 is 0.5-3.5 m / s. This velocity is comfortable for the patient while ensuring effective heat dissipation. Preferably, the velocity is 1-2.5 m / s. Using this cooling mechanism 4, when the array of near-infrared irradiation units 2 emits near-infrared light simultaneously towards the patient's head (e.g., all brain regions), the total power of the near-infrared light is greater than 3W. For some special phototherapy programs with higher power requirements, the total power can reach over 10W. Even with this average power density and total power, the cooling mechanism 4 can still effectively dissipate heat from the patient's head, resulting in a scalp temperature of 23 to 43 degrees Celsius. Preferably, the scalp temperature is 25 to 40 degrees Celsius, close to body temperature. This temperature environment is comfortable for the human body, even for elderly people with low sensitivity to temperature and pain who are sensitive to cold, without causing heat damage, allowing them to continue receiving treatment. With the cooling mechanism 4 combined with the loosely designed cover 1 described earlier, patients with various disease stages are more willing to accept continuous irradiation treatment, and a single irradiation session can be sustained for a longer period of time (the longer the time, the higher the heat production near the scalp), thereby further improving the treatment effect.

[0036] As an example, the cold air transmission path 7 can be formed through the vent 6 on the inner side of the cold air transmission cavity 5 and the gap between the cover 1 and the patient's head, as shown in Figure 1(a). However, this is only an example; a cold air delivery pipe can also be led out from the cold air transmission cavity 5 and delivered towards the patient's head, which will not be elaborated here. The structure of the cooling mechanism 4 ensures that the cover 1 covers the head from all directions, which avoids light leakage, reduces the safety risks caused by infrared light leakage, and ensures that sufficient light energy is transmitted to the whole brain to ensure the therapeutic effect, while still ensuring good and comfortable heat dissipation.

[0037] The aforementioned structural features are described in detail in the Chinese application (application number 202210886242X), which is a priority application, and the relevant content is incorporated herein as an example.

[0038] Figure 5 A schematic diagram showing a headgear for treating Alzheimer's disease according to an embodiment of this application in a worn state. Figure 5As shown, the cover 1 has a fixed structure and size to loosely accommodate the patient's head, allowing for lateral movement of the patient's head of 1-2 cm during treatment. In some embodiments, the cover 1 is configured to at least cover the entire brain. Specifically, the cover 1 is constructed with a certain margin so that the cover 1 can still cover the entire brain when the patient rotates within a preset angle range or moves up and down within a preset distance range, allowing the array of near-infrared irradiation units 2 (see Figures 1(a) and 1(b)) to irradiate various brain regions if necessary. Furthermore, the loose and open design of the cover 1 allows for the use of a fixed structure and size for patients with varying degrees of head shape and size, without the need for custom-made cover 1s that are strictly adapted to each patient's head shape and size. This enables standardized manufacturing of the cover 1, resulting in lower manufacturing costs, a wider range of patients to whom the phototherapy device can be applied, and reduced costs associated with the purchase and maintenance of facilities in locations such as hospitals, communities, and homes. Specifically, the so-called fixed structure and size means that the cover 1 does not need to have moving components, and can even be molded as a whole, thereby increasing the service life of the cover 1 and simplifying the structure of the cover 1.

[0039] Figure 6 A perspective view of a headgear for a light therapy device for treating Alzheimer's disease according to an embodiment of this application is shown. Figure 6 As shown, the cover 1 can have a left protruding ear and a right protruding ear 8, the left protruding ear being... Figure 6 The left and right convex auricles are obscured and not shown; in this document, they are uniformly referred to as 8 in the accompanying drawings. The left and right convex auricles 8 can be configured to extend downwards below the patient's ear to cover the left and right temporal lobes of the patient, respectively. As shown in Figure 1(b), when the phototherapy device is worn by the patient as standard, the distribution of near-infrared irradiation units 2 shown in A roughly corresponds to the frontal lobe region, and the distribution of near-infrared irradiation units 2 shown in B roughly corresponds to the temporal lobe region. Near-infrared irradiation units 2 are evenly distributed on both the left and right convex auricles 8 (as shown in Figure 1(b)) to emit near-infrared light to the covered temporal lobe region. See also... Figure 2 The brain region distribution shown indicates that the temporal lobe extends towards the ear, and this extension is covered by the left and right lateral convex ear 8 and receives sufficient near-infrared light illumination.

[0040] In some embodiments, the left and right convex auricles 8 can be configured such that, even 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 Figure 1(b)) deployed on the left and right convex auricles 8 can still irradiate the patient's temporal lobe. Specifically, the left and right convex auricles 8 can be designed to extend to the surrounding area of ​​the head corresponding to the temporal lobe, retaining a margin relative to the temporal lobe associated with the preset angle and distance ranges. Thus, even if the patient needs to rotate or move due to a desire to move or uncontrollable tremors, their temporal lobe can always be adequately irradiated, thereby ensuring the treatment effect.

[0041] The left and right convex ear portions 8 can extend towards the patient's ear, and in some embodiments, can extend downwards below the patient's ear. Thus, the near-infrared light emitted by the near-infrared irradiation units 2 arranged on the left and right convex ear portions 8 can not only comprehensively irradiate the left and right temporal lobes, but also irradiate the hippocampus through the ear canal. Note that the light transmission distance from the ear along the ear canal to the hippocampus is much shorter than the light transmission distance from the frontal lobe to the hippocampus, and the attenuation of near-infrared light in the ear canal is much less than that in the skull. Therefore, the hippocampus, located deep in the brain, can also receive sufficient near-infrared light irradiation. The hippocampus is closely related to the development of Alzheimer's disease (AD). By ensuring that sufficient near-infrared light energy reaches the hippocampus while simultaneously reaching the frontal and temporal lobes, it is possible to significantly improve the function of brain mitochondria and ATP levels, promote the breakdown of β-amyloid protein (Aβ), reduce Aβ deposition, reduce damage to nerve cells, improve the repair and regeneration capacity of nerve tissue, and improve cognitive abilities, making the phototherapy effect on AD more significant.

[0042] In some embodiments, the cover 1 includes a forehead portion 9, and has a curved connecting portion 10 between the forehead portion 9 and the left and right protruding ear portions 8, so that the lower edges of the left protruding ear portion 8, the forehead portion 9, and the right protruding ear portion 8 are connected by a curve to form a single unit, thereby completely covering the left and right temporal lobes of the patient. Figure 2The brain region distribution shown includes a portion of the temporal lobe near the temple. The curved connector 10 can cover this portion and provide sufficient near-infrared light illumination. The inventors discovered that as Alzheimer's disease (AD) progresses, lesions spread to various parts of the temporal lobe. Providing thorough and sufficient near-infrared light illumination to each part can achieve a more effective treatment. Sometimes, without brain functional imaging, it is impossible to determine the specific location of the lesion in the temporal lobe. However, obtaining brain functional imaging is expensive for patients. Furthermore, each patient has a different head shape and size, and when actually wearing the light therapy device, since the device is worn on the patient's head, it is difficult for medical staff, patients, or other caregivers to accurately determine the location of each brain region from the external head surface. Therefore, the combined design of the left and right convex ear portions 8 and the curved connector 10 can completely cover all areas affected by the lesion, thus achieving a more effective treatment without distracting caregivers or the patient, reducing their workload.

[0043] In some embodiments, the lower edge of the front portion of the cover 1 is gently curved, with the middle portion extending downwards relative to the sides to guide the user to place the lower edge on the brow bone. This curve, lower in the middle and slightly higher on the sides, matches the shape of the brow bone. Based on daily habits (such as the habit of wearing glasses), the user will naturally pull this curved lower edge closer to the brow bone, thus ensuring that the entire forehead is irradiated. This also allows the doctor or patient to visually confirm that the wearing position is appropriate. For a loosely designed cover 1, this curve, lower in the middle and slightly higher on the sides, will also guide the user's forehead to actively approach the cover 1 during wear. This wearing position, close enough to the forehead, is appropriate because the frontal lobe is a key treatment area that needs to ensure irradiation effectiveness. By placing the lower edge of the curve close to the brow bone, both the patient and the doctor can confirm that the wearing position is appropriate, and the patient will consciously maintain this appropriate wearing position.

[0044] Returning to Figure 1(b), the irradiation parameters of at least some of the near-infrared irradiation units 2 can be independently adjusted. These irradiation parameters include at least the average power density. For example, the irradiation parameters of each near-infrared irradiation unit 2 can be independently controlled; that is, the irradiation parameters are adjusted on a per-unit basis (near-infrared irradiation unit 2). A near-infrared irradiation unit 2 can include a group of multiple near-infrared light-emitting diodes 2a, thus allowing for flexible and efficient control of the irradiation parameters of all near-infrared light-emitting diodes 2a. In addition to the average power density, the irradiation parameters may also include pulse frequency, waveform, duty cycle, etc. In other embodiments, the irradiation parameters of every two near-infrared irradiation units 2 can be independently controlled, depending on the actual irradiation requirements. In some embodiments, the pulse frequency of at least some of the near-infrared irradiation units 2 can be independently adjusted. Thus, by setting different pulse frequencies for different brain regions, targeted treatment of each brain region can be achieved.

[0045] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light with a center wavelength of 800-820 nm toward the patient's head. Studies have found that using a single wavelength of near-infrared light with a center wavelength of 800-820 nm is more suitable and effective.

[0046] Figure 3(a) shows a comparison of energy deposition in the dorsolateral prefrontal cortex (dlPFC) of individuals of different ages irradiated with near-infrared light of various wavelengths according to embodiments of this application. Figure 3(b) shows a comparison of energy deposition in the ventromedial prefrontal cortex (vmPFC) of individuals of different ages irradiated with near-infrared light of various wavelengths according to embodiments of this application. As shown in Figures 3(a) and 3(b), for energy deposition in both the dlPFC and vmPFC cortical regions of different age ranges, the center wavelength of 810 nm is superior to that of 670 nm, 850 nm, 980 nm, and 1064 nm, with 1064 nm and 850 nm being the next best. Simulation experiments verify that the energy deposition of other wavelengths of near-infrared light with center wavelengths in the range of 800-820 nm is also superior to that of 670 nm, 850 nm, 980 nm, and 1064 nm.

[0047] The near-infrared irradiation unit 2 in this embodiment uses a single-wavelength near-infrared light with a center wavelength of 800-820 nm for irradiation. Its center wavelength is neither in the peripheral wavelength range of 670 nm (e.g., 630-750 nm) nor in the peripheral wavelength range of 980 nm (e.g., 900-1020 nm), thereby achieving optimized energy deposition. Furthermore, the near-infrared light irradiated by the near-infrared irradiation unit 2 in this embodiment does not depend on dual-wavelength or multi-wavelength irradiation. A single wavelength with a center wavelength of approximately 810 nm can achieve good therapeutic effects as long as the power density is appropriate, as confirmed by animal experimental data and clinical data provided below.

[0048] Figure 4 The diagram illustrates the absorption curves of near-infrared light of different wavelengths in water, deoxyhemoglobin, and oxyhemoglobin proteins according to embodiments of this application. Figure 4 As shown, when using wavelengths of 950nm-1000nm, near-infrared light has a high absorption rate in water, but a very low absorption rate in deoxyhemoglobin, far lower than the absorption rate of near-infrared light with a wavelength of around 810 nm in deoxyhemoglobin. Figure 4 As can be seen, the absorption rate of near-infrared light in the wavelength range of 800-820nm is relatively balanced in both deoxygenated and oxyhemoglobin, and is significantly higher than that in water. For the same therapeutic target area, if near-infrared light of the same power density is used for irradiation, it is obviously better to use a single wavelength of around 810nm than to use dual wavelengths such as 760nm-860nm and 950-1000nm. The absorption effect of oxyhemoglobin and deoxygenated hemoglobin is better, and the therapeutic effect is also better. The array of single-wavelength near-infrared irradiation unit 2 is also cheaper and easier to control.

[0049] Near-infrared light can include pulsed light. Using pulsed light of a single frequency within an appropriate frequency range provides good illumination, where the frequency range can be the alpha wave band (e.g., 10 Hz) or the gamma wave band (e.g., 40 Hz). In some embodiments, illumination can be performed using pulsed light containing at least two frequency components within a certain frequency range, and in some cases, the illumination effect is superior to that using conventional single-frequency pulsed light. 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, where the first pulse frequency is 7 Hz-13 Hz and the second pulse frequency is 30 Hz-100 Hz. Preferably, the first pulse frequency is 10 Hz and the second pulse frequency is 40 Hz. The present invention has found that using appropriate frequencies, such as, but not limited to, the alpha wave band and the gamma wave band, provides better illumination effects than other frequencies. The pulsed light includes alpha waves and gamma waves as pulse wave components of the first pulse frequency and the second pulse frequency, respectively, and is formed in any of the following ways. For example, alpha waves and gamma waves can be synchronously aliased to form the waveform of the pulsed light emitted by each near-infrared light-emitting diode 2a. In other words, each near-infrared LED 2a directly emits a waveform composed of synchronously superimposed alpha and gamma waves, thereby achieving a time-synchronized and spatially overlapping mixed waveform (pulsed light composed of superimposed alpha and gamma wave frequency bands). For example, alpha and gamma waves can be time-divisionally combined to form the waveform of the pulsed light emitted by each near-infrared LED 2a. That is, the same near-infrared LED 2a can be lit at different time periods to alternately irradiate alpha and gamma waves; this is a purely spatially overlapping mixing mode. In some embodiments, each near-infrared LED 2a in the first group can be controlled to emit alpha pulses, and each near-infrared LED 2a in the second group can synchronously emit gamma pulses; that is, the first and second groups of near-infrared LEDs 2a can be lit simultaneously within the same time period. Specifically, near-infrared LEDs 2a corresponding to different brain regions can be lit within the same time period; this is a mixing mode with only temporal overlap, thus providing pulsed light of specific frequencies and waveforms to different brain regions.

[0050] Please note that in this application, a loose, open-style headgear is used as a carrier for irradiating multi-frequency pulsed light. However, this application is not limited to this. Other headgear structures, such as headgear that fits the head, or non-headgear-type wearing devices, such as, but not limited to, glasses, or wearing devices built into the ear canal or nasal cavity, can also be used as carriers to irradiate multi-frequency pulsed light onto the patient's brain.

[0051] In some embodiments, the pulse frequency of the near-infrared irradiation unit 2 is adjustable, wherein the adjustable range is 0Hz-100Hz. For example, near-infrared light with pulse frequencies of 8Hz, 10Hz, 30Hz, 40Hz, etc. can be used for irradiation. In this way, when using the phototherapy device to perform phototherapy, the user can determine a more suitable pulse frequency according to the degree of disease, target brain region, etc., in order to achieve a better phototherapy effect.

[0052] This application also provides a headgear for a phototherapy device used to treat Alzheimer's disease. As shown in Figures 1(a) and 1(b), the headgear includes a cover 1 that loosely accommodates the patient's head, allowing the head to rotate within a preset angle range and move up and down within a preset distance during treatment. The headgear also includes an array of near-infrared irradiation units 2 disposed within the cover 1, the array of near-infrared irradiation units 2 being configured to emit near-infrared light toward the patient's head. In some embodiments, each near-infrared irradiation unit 2 may include a plurality of near-infrared light-emitting diodes 2a. Implementations of the array of near-infrared irradiation units 2 described in various embodiments of this application can be incorporated herein.

[0053] The headgear may also include a cold air transmission cavity 5 arranged in an array adjacent to the near-infrared irradiation unit 2 in the cover 1, and a cold air transmission passage 7 leading from the cold air transmission cavity 5 to the patient's head, so that cold air generated by the refrigerator 3 outside the headgear is sent into the cold air transmission cavity 5 and blown to the patient's head through the cold air transmission passage 7 to dissipate heat from the patient's head.

[0054] Now, returning to Figure 1(b), an example is given illustrating the specific implementation of the near-infrared irradiation unit 2 and the cooling mechanism 4 in the headgear of the phototherapy device used to treat Alzheimer's disease.

[0055] As shown in Figure 1(b), the headgear may include a cover 1, which loosely accommodates the patient's head, allowing the head to rotate within a preset angle range and move up and down within a preset distance range during treatment. The implementation of the cover 1 described in conjunction with the phototherapy device in various embodiments of this application can be incorporated herein, and will not be elaborated upon here.

[0056] The headgear also includes a cooling component for use in conjunction with an external refrigerator 3 and a cold air delivery pipe 12, forming a cooling mechanism 4 capable of adequately dissipating heat from the patient's head. Specifically, as shown in Figure 1(b), the array adjacent to the near-infrared irradiation unit 2 in the cover 1 is provided with a cold air delivery cavity 5 and a cold air delivery passage 7 leading from the cold air delivery cavity 5 to the patient's head, so that cold air generated by the refrigerator 3 outside the headgear (e.g., via the cold air delivery pipe 12) is sent into the cold air delivery cavity 5 and blown onto the patient's head via the cold air delivery passage 7 to dissipate heat from the patient's head.

[0057] Referring to Figures 1(a) and 1(b), the cover 1 includes an outer layer 12a and a light-transmitting cover 13 as an inner layer. A cold air transmission cavity 5 is formed between the outer layer 12a and the light-transmitting cover 13. The light-transmitting cover 13 has multiple ventilation holes 6, so that each ventilation hole 6, together with the gap between the light-transmitting cover 13 and the patient's head, forms a cold air transmission path 7. It can be seen that the ventilation holes 6 can be grouped to distribute the cold air blowing towards the head more evenly from all sides, making Alzheimer's patients feel comfortable and cooperate with treatment.

[0058] The near-infrared irradiation unit 2 can be implemented in various ways. For example, it can be a lamp plate 2b carrying multiple near-infrared light-emitting diodes 2a (as shown in Figure 1(b)). The multiple ventilation holes 6 are distributed in groups (as shown in Figure 1(a)) and can be implemented as a multi-point array, so that each group of ventilation holes 6 corresponds to each lamp plate 2b. The gaps directly opposite the lamp plate 2b are where the temperature rises significantly. Each group of ventilation holes 6 corresponding to each lamp plate 2b can deliver cool air in a targeted manner to efficiently reduce the heat in these gaps. Moreover, the cool air can be discharged smoothly and evenly from each ventilation hole 6, dissipating heat evenly to the scalp and further improving patient comfort.

[0059] The outer layer 12a of the cover 1 includes a hot air extraction cavity 14, which at least partially houses the circuitry 15 and is located via an air inlet 16 (e.g., Figure 5 As shown, the air inlet 16 and outlet 17 are connected to the outside, so that the air introduced through the air inlet 16 carries the heat generated by the circuit 15 and is discharged to the outside through the air outlet 17. The inventors noted that the array of near-infrared irradiation units 2 is configured with an average power density greater than 40 mW / cm². 2In some cases, the heat generated by circuit 15 can be very high, and sometimes the local heat generated by circuit 15 is significantly higher than the heat generated by the photothermal conversion of near-infrared LED 2a. Therefore, a heat extraction cavity 14 is provided to efficiently remove heat, thereby preventing a large amount of local heat generated by circuit 15 from being conducted to the near-infrared LED 2a side or even the head side, thus improving heat dissipation efficiency. In some embodiments, a heat-conducting plate can be provided on the outside of circuit 15 to guide heat to be transferred and discharged to the outside.

[0060] In some embodiments, the hot air extraction cavity 14 and the cold air transmission cavity 5 are independent of each other. This prevents the heat generated by the circuit 15 from spreading to the cold air transmission cavity 5, thereby adversely affecting the heat dissipation effect on the gap between the head and the light-transmitting cover 13.

[0061] In some embodiments, the cover 1 may further include a spacer 18 for dividing the chamber within the cover 1 into a first chamber and a second chamber, the first chamber for accommodating the near-infrared irradiation unit 2, the second chamber for at least partially serving as a cold air transmission cavity 5, and the wall of the second chamber facing the head being transparent.

[0062] As an example, as shown in Figures 1(a) and 1(b), the spacer 18 is located outside the cold air transmission cavity 5, and each lamp plate 2b is located outside the spacer 18. The spacer 18 completely separates the hot air extraction cavity 14 from the cold air transmission cavity 5, thus preventing the transmitted cold air from entering the hot air extraction cavity 14, allowing the cold air to act more effectively on the gap between the head and the light-transmitting cover 13, improving the heat dissipation effect on the gap. In addition, placing the lamp plate 2b inside the hot air extraction cavity 14 can, to a certain extent, keep the lamp plate 2b away from the head, thereby reducing the impact of the heat generated by the lamp plate 2b on the head temperature and ensuring a certain level of safety. To ensure that the near-infrared light emitted by the lamp plate 2b can directly irradiate the scalp, similar to the light-transmitting cover 13, the spacer 18 is also made of a transparent material to reduce the loss of near-infrared light, so that the near-infrared light can be directed to the scalp as much as possible.

[0063] Note that the construction and number of spacers 18 are not limited thereto. Spacers 18 may also include a set of curved members to form a plurality of discrete first chambers, and the space between the first chambers and between them and the inner cavity of the cover 1 can be used as a second chamber to transfer cold air, which will not be elaborated here.

[0064] In some embodiments, the hot air extraction chamber 14 and the cold air transmission chamber 5 can also be connected. For example, a pipe can be used to achieve the connection. Specifically, the inner diameter of the pipe can be set to be relatively small, so that more cold air in the cold air transmission chamber 5 is 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 pipe to cool the circuit 15.

[0065] In some alternative embodiments, the top of the light-transmitting cover 13 is arched, and the curvature of the arch is less than a preset curvature, so that the introduced cold air is gently dispersed in all directions under the action of the arched top of the light-transmitting cover 13.

[0066] The curvature of the arch can be as small as possible, so that a large amount of cold air can blow directly towards the top of the light-transmitting cover 13, and the cold air flow rate can be reduced under the action of the top of the light-transmitting cover 13, and the cold air can be dispersed around the top of the light-transmitting cover 13, so that the cold air can be discharged smoothly and evenly from each vent 6, improving the patient's comfort.

[0067] 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. As an example, as shown in FIG1(b), the first preset distance between adjacent near-infrared irradiation units 2 is d. The adjacent near-infrared irradiation units 2 in the array coordinately emit near-infrared light toward the patient's head at a preset divergence angle, such that when the patient's head remains stationary within the cover 1 or moves within the movable gap, the emitted near-infrared light covers the target brain region and has an average power density greater than 40 mW / cm². 2 This ensures that sufficient light energy enters the target brain tissue, ensuring good treatment results. For example, when the light therapy device is used to treat AD, the target brain area can be the entire brain area of ​​the head, that is, the near-infrared light covers the entire head without missing any brain area.

[0068] The first preset distance and the preset divergence angle can be manually set or be system default values. In this embodiment, the movable gap, the divergence angle, and the first preset distance between the adjacent near-infrared irradiation unit 2 are configured in a coordinated manner so that the emitted near-infrared light overlaps at the scalp after passing through the movable gap. This not only provides tight coverage of the target brain region but also ensures sufficient average power density through the overlap.

[0069] Coordinating the configuration of the movable gap, divergence angle, and first preset distance can improve the therapeutic effect on AD. In some embodiments, regarding the coordinating configuration, the first preset distance, divergence angle, and movable gap for different brain regions can vary according to factors such as the curvature of the cover 1 and the average power density requirements of different brain regions. For example, if the curvature of the regions of cover 1 corresponding to the frontal and temporal lobes is small, the first preset distance between adjacent near-infrared irradiation units 2 in these regions can be set to be smaller than the first preset distance between adjacent near-infrared irradiation units 2 in other regions of cover 1 (e.g., the parietal lobe). If the movable gap is too large, it is difficult to achieve proper overlap of near-infrared light emitted by adjacent near-infrared irradiation units 2 at the scalp after passing through the movable gap; for example, even if overlap occurs, insufficient average power density may result due to a large divergence angle. For example, to enhance the therapeutic effect on the frontal and temporal lobes, and to apply a higher average power density to these lobes, the movable gap between the corresponding shield 1 and the head can be set smaller than the movable gaps for other brain regions. Alternatively, the shape of the shield 1 can be used to guide the patient to bring their head closer to the frontal and temporal lobes. Furthermore, the first preset distance between adjacent near-infrared irradiation units 2 in the region of the shield 1 corresponding to the frontal and temporal lobes can be reduced to enhance the therapeutic effect on these lobes.

[0070] By coordinating the configuration of the movable gap, the first preset distance, and the preset divergence angle, the target brain region is still tightly covered even when the AD patient's head moves to its maximum extent within the cover 1 (e.g., close to the cover 1 in a certain direction). Simultaneously, the overlapping mechanism ensures an average power density greater than 40 mW / cm². 2 This ensures the effectiveness of AD treatment.

[0071] In some embodiments, the array of near-infrared irradiation units 2 in the cover 1 has a second preset distance from the head, such that the near-infrared light emitted by adjacent near-infrared irradiation units 2 at a preset divergence angle at least partially overlaps in the projection area of ​​the head, ensuring that the target brain region of the head is irradiated by near-infrared light. The cover 1 is not designed to fit the head, but rather a loose design that allows the head to move freely within the accommodating space. The gap between the array of near-infrared irradiation units 2 in the cover 1 and the head also causes near-infrared light scattering.

[0072] The inventors discovered through research that when the distance between the array of near-infrared irradiation units 2 and the head is too small, on the one hand, the patient's head has limited space for movement, resulting in poor comfort for AD patients and hindering their cooperation with treatment. On the other hand, if the distance between the array of near-infrared irradiation units 2 and the head is too small, the near-infrared light is not sufficiently scattered, resulting in less overlap of the near-infrared light emitted by adjacent near-infrared irradiation units 2 in the projection area of ​​the head, causing some parts of the head to be unirradiated by near-infrared light, thus reducing the treatment effect; or requiring the near-infrared irradiation units 2 to have an excessively high arrangement density, which leads to excessive heat generation, affecting patient comfort and significantly reducing the lifespan of the near-infrared irradiation units 2, while increasing manufacturing costs and control difficulty. Conversely, if the distance between the array of near-infrared irradiation units 2 and the head is too large, it will cause excessive divergence of infrared light, resulting in poor uniformity of the average power density distribution, or the average power density after superposition is still insufficient, still failing to achieve a good treatment effect. By controlling the second preset distance between the array of near-infrared irradiation units 2 and the head, all parts of the head can be irradiated with near-infrared light of sufficient average power density and relatively uniform distribution. The required divergence angle range of the near-infrared irradiation units 2 conforms to the emission angle range of conventional near-infrared LEDs (e.g., 100-135 degrees), and the required arrangement density and spacing of the near-infrared irradiation units 2 are also appropriate, thus effectively controlling the manufacturing difficulty and cost. Preferably, by setting the second preset distance between the array of near-infrared irradiation units 2 and the head to 2.5-4cm, the lateral movable gap of the patient's head during treatment is controlled to 1-2cm. Through clinical trials and psychological investigations of patients, the inventors have confirmed that this is a psychologically comfortable range for patients, allowing them sufficient freedom of movement without causing anxiety or worry about inaccurate head positioning due to excessive openness.

[0073] In some embodiments, the near-infrared irradiation unit 2 can be implemented as a lamp plate 2b carrying multiple near-infrared LEDs 2a (as shown in Figure 1(b)). By arranging the lamp plate 2b with near-infrared LEDs 2a, the divergence angle of the near-infrared LEDs 2a and the spacing between the lamp plates 2b can be fully utilized to achieve overlap of near-infrared light emitted by adjacent near-infrared LEDs 2a. Optionally, the spacing between two adjacent near-infrared LEDs 2a is 12-13 mm. Moreover, the near-infrared LEDs 2a have appropriate divergence angles, enabling synergistic configuration with the movable gap and a first preset distance to improve the therapeutic effect. In treating AD, emitting near-infrared light simultaneously to the frontal lobe, temporal lobe, and hippocampus can achieve better therapeutic effects. For key areas of focus such as the frontal and temporal lobes, a higher average power density is required, for example, reaching 70 mW / cm². 2Above, even 150 mW / cm 2 .

[0074] In some embodiments, in corresponding regions of the frontal and temporal lobes, such as Figure 7 As shown, there is a first preset distance d1 between two adjacent light panels 2b, such that one of the light panels 2b (e.g., Figure 7 Each near-infrared LED 2a (e.g., on the right-hand side of the light panel 2b) on the light panel 2b Figure 7 The near-infrared light emitted by LED 2a-1 in the head covers the projection area of ​​the first preset spacing d1 on the head, thereby further increasing the average power density of the corresponding brain regions of the frontal and temporal lobes, so that sufficient light energy can enter the brain regions, thereby enhancing the therapeutic effect on the frontal and temporal lobes that are the focus of attention.

[0075] For example, the first preset spacing can be set slightly smaller than the first preset distance between the lamp 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 and temporal lobes is higher than the distribution density in the corresponding regions of other brain regions. Furthermore, the first preset spacing may also be equal to the first preset distance. For example, even in the corresponding regions of the frontal and temporal lobes, due to the different curvatures of the corresponding regions, there may be a situation where the first preset spacing is exactly equal to the first preset distance. Compared to setting a first preset distance, further defining the first preset spacing between two adjacent near-infrared irradiation units 2 in the corresponding regions of the frontal and temporal lobes can further increase the average power density applied to the corresponding regions of the frontal and temporal lobes and highlight the degree of attention paid to the corresponding regions of the frontal and temporal lobes.

[0076] In one specific embodiment, multiple LEDs 2a are arranged in the near-infrared irradiation unit 2. A movable gap exists between the array of the near-infrared irradiation unit 2 and the head. Therefore, the near-infrared light emitted by the LEDs 2a on each lamp panel 2b is scattered through the movable gap and projected onto the head. In some embodiments, the first preset spacing d1 is 15-20 mm. An example of a first preset spacing of 15 mm is provided. With a first preset spacing of 15 mm, the near-infrared light emitted by the LED 2a furthest from the edge of the other lamp panel 2b in one adjacent lamp panel 2b can also cover the projection area of ​​the head at the first preset spacing d1 (e.g., ...). Figure 7 In the C region of the head, it is possible to ensure that the near-infrared light emitted by each LED 2a covers the projection area of ​​the head at the first preset spacing, thereby increasing the average power density in the corresponding areas of the frontal and temporal lobes and improving the treatment effect of AD.

[0077] Preferably, the first preset spacing d1 is 15-20mm, the second preset distance d2 between each lamp panel 2b and the head is 2.5-4cm, and the preset divergence angle is 100-135 degrees, for example, 100 degrees, 120 degrees, 130 degrees, etc., so that the average power density of near-infrared light at the projection area of ​​the first preset spacing on the head deviates from the average power density at other locations on the head by less than 20%, preferably less than 10%, thereby ensuring that the emitted near-infrared light covers the target brain region and the average power density is greater than 40mW / cm². 2 In this case, targeted irradiation of the corresponding areas of the frontal and temporal lobes is achieved, ensuring a higher and sufficiently uniform average power density in these areas. Specifically, for example, if the average power density of near-infrared light at the projection area of ​​the first preset distance on the head deviates by more than 20% from the average power density at other locations on the head, it may be that the average power density at the projection area of ​​the first preset distance on the head is too high or too low, correspondingly resulting in a lower or higher average power density at other locations, leading to uneven distribution of average power density. Furthermore, this can cause overheating in areas of the scalp with higher average power density (potentially necessitating treatment interruption), while areas with lower average power density may not receive sufficient treatment, thus reducing the overall treatment effect for AD patients. In a preferred embodiment of this application, the first preset spacing is configured to be 15-20mm, the second preset distance between each lamp panel 2b and the head is 2.5-4cm, and the preset divergence angle is 100-135 degrees, for example, the divergence angle can be 120 degrees. By taking into account the mutual influence between the first preset spacing, the second preset distance between each lamp panel and the head, and the preset divergence angle, it can be ensured that the entire head is uniformly covered by near-infrared light and has a high average power density.

[0078] Figure 8 A schematic diagram of the overall structure of a light therapy device for treating Alzheimer's disease according to an embodiment of this application is shown. Figure 8 As shown, the phototherapy device may further include a user terminal 19, which can be configured for interactive operation by a user. A computer storage medium can be configured in the user terminal 19, storing computer-executable instructions that, when executed by a processor, enable various interactive steps with the user. The storage medium may include read-only memory (ROM), flash memory, random access memory (RAM), dynamic random access memory (DRAM) such as synchronous DRAM (SDRAM) or Rambus DRAM, static memory (e.g., flash memory, static random access memory), etc., on which computer-executable instructions can be stored in any format.

[0079] In some embodiments, the user terminal 19 may be configured to: acquire the patient's physiological parameters, including age, translucency of extracerebral tissues, and biochemical parameters related to Alzheimer's disease; generate a suggested infrared light therapy plan for the patient based on the acquired physiological parameters, and display it to the user.

[0080] In some embodiments, the user terminal 19 is further configured to receive a user's confirmation operation for the suggested infrared light therapy scheme; after receiving the confirmation operation, each near-infrared irradiation unit 2 (as shown in Figures 1(a) and 1(b)) performs irradiation according to the confirmed infrared light therapy scheme.

[0081] Specifically, the controller (not shown) for controlling the irradiation can be located on the user terminal 19 or at the headgear, with the user terminal 19 issuing execution instructions containing confirmation of the infrared light therapy plan to the controller at the headgear. The controller can be implemented using various processors, including processing devices comprising one or more general-purpose processing units, such as microprocessors, central processing units (CPUs), graphics processing units (GPUs), etc. More specifically, the processor can be a Complex Instruction Set Computing (CISC) microprocessor, a Reduced Instruction Set Computing (RISC) microprocessor, a Very Long Instruction Word (VLIW) microprocessor, a processor running other instruction sets, or a processor running a combination of instruction sets. The processor can also be one or more special-purpose processing units, such as application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), system-on-a-chip (SoCs), etc. Preferably, most of the computation and processing are concentrated at the user terminal 19, reducing the computational load and hardware / software costs of the headgear.

[0082] In some embodiments, the light therapy device further includes a support 20, such as Figure 8 As shown, the cover 1 is connected to the support 20 through the elastic element 21. During the treatment, the elastic element 21 provides a certain amount of mobility for the patient's head, making the patient's head move more freely, which can further improve comfort and enhance the patient's user experience.

[0083] The inventors conducted in vivo phototherapy experiments on 5-month-old Alzheimer's disease (AD) mice. The single-wavelength near-infrared light used had a center wavelength of 800-820 nm, a pulse frequency of 10 Hz, and was administered once daily for 10 minutes each time, for 5 weeks. The AD mice receiving phototherapy (also known as the experimental group) and the control group (also known as the control group) showed significant improvement in the water maze test, such as... Figure 9As shown, the experimental group had a significantly shorter voyage distance to the platform compared to the control group, and the escape latency was reduced by 36% compared to the control group. Furthermore, the distribution of Aβ protein in the brain tissue of the experimental group, including both the cortical region and the CA1 region of the hippocampus, was significantly lower than that in the control group. Figure 10 As shown in the image, the study suggests that the extracellular accumulation of amyloid β (Aβ) protein, produced by the cleavage of amyloid precursor protein (APP), is a crucial factor in the pathogenesis of Alzheimer's disease (AD). Furthermore, widespread Aβ plaque deposition in the cerebral cortex, along with neurofibrillary tangles induced by tau protein lesions in the cortex, are significant pathological markers of AD. Therefore, the significant reduction in Aβ plaque deposition in the experimental group after the aforementioned near-infrared light irradiation treatment indicates a good therapeutic effect on AD.

[0084] The inventors conducted clinical trials of phototherapy on AD patients using the phototherapy device according to the embodiments of this application, using single-wavelength near-infrared light with a center wavelength of 810nm and an average power density greater than 40 mW / cm². 2 The irradiation frequency was 5-7 times per week, with each session lasting 30 minutes, for a period of 4 months. Preferably, the average power density in the key areas of the frontal and temporal lobes was approximately 90-120 mW / cm². 2 In most of these areas, the average light power density is around 100 mW / cm². 2 Preferably, the average power density of the apical and occipital lobes is greater than 60 mW / cm². 2 .

[0085] Interim clinical trial results as follows Figure 11 As shown, Figure 11 A chart showing a comparison of the Alzheimer's Disease Assessment Scale Cognitive Scale (ADAS-cog) scores of AD patients in the treatment group and the control group after phototherapy was performed on AD patients using the phototherapy device according to an embodiment of this application.

[0086] As can be seen, after two months of near-infrared light therapy, the total ADAS-cog score of the treatment group decreased by an average of 6.7 points from baseline, which was statistically significant. In contrast, the total ADAS-cog score of the control group that did not receive near-infrared light therapy increased by 3 points after two months. The ADAS-cog score results confirm the good therapeutic effect of the light therapy device according to the embodiments of this application on AD.

[0087] In addition to the ADAS-cog score, this clinical trial also analyzed the MMSE score. The MMSE score has a total score of 30, with lower scores indicating more severe cognitive impairment. The baseline MMSE score of AD patients receiving phototherapy was 11.67, and after 2 months, the MMSE score was 14.83, an average increase of 3.12 points from baseline, indicating that cognitive function improved after phototherapy. The MMSE score also confirms the good therapeutic effect of the phototherapy device according to the embodiments of this application on AD.

[0088] In some embodiments, the light therapy device for treating Alzheimer's disease according to this application can also be used to treat mental illnesses such as depression, autism, and bipolar disorder.

[0089] The inventors have demonstrated through clinical trials that, while ensuring safety and patient comfort, using a higher average power density to treat mental illnesses such as depression can lead to better therapeutic effects. In treating depression, an average power density of 80 mW / cm² for near-infrared light emitted at least towards the frontal lobe of the head is preferred. 2 -250mW / cm 2 In another embodiment, an average power density of 80 mW / cm² can also be emitted simultaneously to both the frontal and temporal lobes. 2 -250mW / cm 2 Near-infrared light is used to achieve better phototherapy effects for depression.

[0090] In some embodiments, in the treatment of depression, the array of near-infrared irradiation units 2 is configured to emit near-infrared light to at least some nodes of a brain network, said brain network including at least one of a default network, a salience network, and a central executive network. It is understood that the brain network may include multiple nodes with brain regions as nodes, each node corresponding to a different brain region; alternatively, multiple nodes may be set on a single brain region, with functional connections between node pairs. The strength of these functional connections can be used to characterize inter-brain region collaboration, information transmission, etc.

[0091] For individuals with autism, structural, functional, and connectivity abnormalities often exist to varying degrees in the frontal lobe, temporal lobe, hippocampus, amygdala, and corpus callosum at different ages. Similar to the treatment of depression, autism treatment requires a high average power density; to achieve better therapeutic effects, even higher average power densities are needed to irradiate the brain regions associated with autism. Therefore, the phototherapy device of this application, in the treatment of autism, can achieve an average power density of 100 mW / cm² for the near-infrared light emitted by the array of near-infrared irradiation units corresponding to the autism-associated brain regions. 2 -250mW / cm2 When phototherapy is used to treat autistic patients, the average power density of the near-infrared light emitted by the array of near-infrared irradiation units corresponding to one or more brain regions, including the frontal lobe, temporal lobe, hippocampus, amygdala, and corpus callosum, can be 100 mW / cm². 2 -250mW / cm 2 In some embodiments, when using light therapy devices to treat autism, targeted treatment of local autism targets can also be performed based on brain networks associated with autism.

[0092] In the treatment of bipolar disorder, the average power density of near-infrared light emitted by the array of near-infrared irradiation units corresponding to brain regions associated with bipolar disorder was 100 mW / cm². 2 -250mW / cm 2 Brain regions associated with bipolar disorder can include the frontal lobe and limbic regions, such as the ventrolateral prefrontal cortex, dorsolateral prefrontal cortex, and internal parietal sulcus. Understandably, unlike other mental illnesses, bipolar disorder has different phases, including depressive and manic phases, and the abnormalities in the brain network differ depending on the phase. Targeted light therapy based on the abnormalities in the brain network at different phases can achieve more precise treatment for bipolar disorder.

[0093] It is understandable that when using brain networks to perform precise phototherapy for mental illnesses such as depression, autism, and bipolar disorder, the irradiation parameters of near-infrared light can be specifically set according to the type of disease, the degree of disease, and the functional connectivity between brain network nodes. This application does not make specific limitations on this. The irradiation parameters may include center wavelength, average power density, pulse frequency, etc.

[0094] In some embodiments, the above-described construction of the left and right convex auricles 8 can be used not only to treat AD, but also to treat other diseases related to the frontal and temporal lobes, such as depression.

[0095] Furthermore, although exemplary embodiments have been described herein, their scope includes any and all embodiments based on this application that have equivalent elements, modifications, omissions, combinations (e.g., schemes involving intersections of various embodiments), adaptations, or alterations. Elements in the claims will be interpreted broadly based on the language used in the claims and are not limited to the examples described in this specification or during the implementation of this application, which will be interpreted as non-exclusive. Therefore, this specification and examples are intended to be considered illustrative only, and the true scope and spirit are indicated by the following claims and the full scope of their equivalents.

[0096] The above description is intended to be illustrative and not restrictive. For example, the above examples (or one or more of them) can be used in combination with each other. Other embodiments may be used by those skilled in the art upon reading the above description. Furthermore, in the above detailed description, various features may be grouped together to simplify the application. This should not be construed as an intention that a disclosed feature not claimed is necessary for any claim. Rather, the subject matter of this application may be less than all the features of a particular disclosed embodiment. Thus, the following claims are incorporated herein by reference as examples or embodiments, wherein each claim is independently considered as a separate embodiment, and these embodiments are contemplated as being possible in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0097] The above embodiments are merely exemplary embodiments of this application and are not intended to limit the present invention. The scope of protection of the present invention is defined by the claims. Those skilled in the art can make various modifications or equivalent substitutions to the present invention within the spirit and scope of this application, and such modifications or equivalent substitutions should also be considered to fall within the scope of protection of the present invention.

Claims

1. A phototherapy device for treating Alzheimer's disease, characterized in that, include: The carrier is used to carry the near-infrared illumination unit; The array of near-infrared irradiation units corresponding to each brain region is configured such that it irradiates the target brain region with near-infrared light at a specific frequency, thereby acting on the target brain region, and the average power density of the emitted near-infrared light is greater than 40 mW / cm². 2 The total power of the near-infrared light is greater than 3W, and can reach more than 10W. The target brain regions it acts on can include the default mode network, the salience network, and the central executive network.

2. The phototherapy device according to claim 1, characterized in that, The specific method of irradiating near-infrared light at a specific frequency to different target brain regions to act on the target brain regions specifically includes: irradiating at least a portion of the nodes of the brain network that is the target brain region with near-infrared light at a specific frequency to act on the brain network that is the target brain region.

3. The phototherapy device according to claim 2, characterized in that, Irradiating at least a portion of the nodes of the brain network that is the target brain region with near-infrared light at a specific frequency specifically includes irradiating nodes that are more easily irradiated in the brain network that is the target brain region, thereby acting on nodes located deep in the brain network that is the target brain region, including the cingulate cortex.

4. The phototherapy device according to claim 2, characterized in that, At least some of the near-infrared irradiation units are independently adjusted to form different target brain regions, and near-infrared light is irradiated at specific frequencies for different target brain regions to act on the target brain regions. When the default network, the salience network and the central executive network are used as the target brain regions, the frequency of the alpha wave band and / or the frequency of the gamma wave band are used as the specific frequencies.

5. The phototherapy device according to claim 2, characterized in that, The illumination parameters of at least some of the near-infrared irradiation units can be adjusted independently, and the illumination parameters include at least one of the following: average power density, pulse frequency of emitted pulse light, waveform, and duty cycle.

6. The phototherapy device according to claim 5, characterized in that, The adjustable range of the pulse frequency is 0Hz-100Hz.

7. The phototherapy device according to claim 1, characterized in that, The near-infrared irradiation units are arranged in at least one of the following ways for each brain region: The near-infrared irradiation units are multiple and are distributed in multiple layers along the circumferential direction for each brain region. The array of near-infrared irradiation units irradiates near-infrared light onto at least one of the temporal lobe near the temple, the frontal lobe on the brow bone, and the temporal lobe around the ear. The near-infrared irradiation units are multiple and multi-layered, with the middle layer distributed circumferentially, and the gap between adjacent near-infrared irradiation units in the circumferential direction is smaller than the width of the near-infrared irradiation unit.

8. The phototherapy device according to claim 1, characterized in that, Irradiating near-infrared light at specific frequencies onto different target brain regions to act on the target brain regions, specifically including acting on the brain network that is the target brain region in at least one of the following ways: In cases where the nodes of the brain network serving as the target brain region include the medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe, near-infrared light is irradiated onto nodes that are more easily irradiated, and / or other nodes that are more easily irradiated and have functional connections with nodes located deep in the brain, using the frequency of the alpha wave band as the specific frequency. In cases where the nodes include multiple nodes distributed in various brain regions such as the frontal lobe, temporal lobe, parietal lobe, and occipital lobe, or multiple nodes distributed in various brain regions such as the frontal lobe, temporal lobe, and hippocampus, near-infrared light is irradiated onto nodes that are more easily irradiated, and / or other nodes that are more easily irradiated and have functional connections with nodes located deep in the brain, using the frequency of the γ-wave band as a specific frequency.

9. The phototherapy device according to claim 1, characterized in that, The target brain region also includes nodes or node pairs with functional connectivity imbalances in the brain network, the functional connectivity strength of which is constructed and determined based on brain functional imaging of the patient's head.

10. The phototherapy device according to claim 9, characterized in that, In cases where a node in a pair of nodes with functional connectivity imbalances in a brain network is difficult to illuminate, the near-infrared irradiation unit irradiates the node in that pair that is easier to illuminate.

11. The phototherapy device according to claim 9, characterized in that, The target brain region includes at least the hippocampus, and the near-infrared irradiation unit is configured such that nodes in the brain network with a functional connection strength to the hippocampus that is weaker than a predetermined level emit near-infrared light.

12. The phototherapy device according to any one of claims 1-11, characterized in that, The near-infrared irradiation unit is configured to emit a pulse light component at a first pulse frequency and / or a pulse light component at a second pulse frequency, wherein the first pulse frequency is in the α-wave band and the second pulse frequency is in the γ-wave band.

13. The phototherapy device according to claim 12, characterized in that, The first pulse frequency is 10Hz, and the second pulse frequency is 40Hz.

14. The phototherapy device according to claim 12, characterized in that, The pulse light components of the first pulse frequency and the second pulse frequency are formed by any of the following methods: The waveform of the emitted pulsed light is composed of synchronous superposition of alpha and gamma waves; The waveform of the emitted pulsed light is composed of a time-division multiplexing of alpha and gamma waves; The near-infrared irradiation unit is at least one and includes multiple near-infrared light-emitting diodes. Each near-infrared light-emitting diode in the first group emits alpha wave pulse light, and each near-infrared light-emitting diode in the second group emits gamma wave pulse light. The two groups of near-infrared light-emitting diodes emit pulse light synchronously.

15. The phototherapy device according to any one of claims 1-11, characterized in that, The phototherapy device also includes a cooling mechanism configured to dissipate heat from the patient's head, so that the temperature near the patient's scalp is between 23 and 43 degrees Celsius.

16. The phototherapy device according to claim 15, characterized in that, The carrier includes a cover that loosely accommodates the patient's head; The cooling mechanism is further configured to: introduce cold air and send it into the cover, and blow it toward the patient's head through the cold air transmission passage between the cover and the patient's head, so as to dissipate heat from the patient's head.

17. The phototherapy device according to claim 16, characterized in that, The cooling mechanism includes a refrigerator or can be connected to a refrigerator. The cover is provided with a cold air transmission cavity to receive cold air generated by the refrigerator. The inner wall of the cold air transmission cavity forms the cold air transmission path between the patient's head and the cold air transmission cavity.

18. The phototherapy device according to claim 16, characterized in that, The airflow velocity from the cold air to the patient's head via the cold air transmission channel is 0.5-3.5 m / s.

19. The phototherapy device according to any one of claims 1-11, characterized in that, The array of near-infrared irradiation units is configured to emit near-infrared light into the frontal and temporal lobes at a higher average power density than other brain regions, with the average power density of the near-infrared light emitted into the frontal and temporal lobes being 50 mW / cm². 2 Up to 250 mW / cm 2 .

20. The phototherapy device according to claim 16, characterized in that, The cover also includes a spacer for dividing the chambers within the cover into a first chamber and a second chamber. The first chamber is used to house a near-infrared irradiation unit, and the second chamber serves at least partially as a cold air delivery cavity. The wall of the second chamber facing the patient's head is translucent; and / or The cover includes an outer layer and a light-transmitting cover as an inner layer. A cold air transmission cavity is formed between the outer layer and the light-transmitting cover. The light-transmitting cover has multiple ventilation holes, so that each ventilation hole, together with the gap between the light-transmitting cover and the patient's head, constitutes the cold air transmission path. and / or The outer layer of the cover includes a heat extraction cavity, which at least partially houses the circuitry and is connected to the outside via an air inlet and an air outlet, such that air introduced through the air inlet carries the heat generated by the circuitry and is discharged to the outside via the air outlet.

21. The phototherapy device according to claim 16, characterized in that, The cover includes an outer layer and a light-transmitting cover as an inner layer. The top of the light-transmitting cover is arched, and the curvature of the arch is less than a preset curvature, so that the introduced cold air can be gently dispersed in all directions under the action of the top of the arch.

22. The phototherapy device according to claim 16, characterized in that, The adjacent near-infrared irradiation units in the array of near-infrared irradiation units have a first preset distance between them. The adjacent near-infrared irradiation units coordinate to emit near-infrared light toward the patient's head at a preset divergence angle, so that the emitted near-infrared light covers the target brain region when the patient's head remains stationary within the cover or moves within the movable gap.

23. The phototherapy device according to any one of claims 1-11, characterized in that, The near-infrared irradiation unit is a lamp board carrying multiple near-infrared LEDs. In the corresponding region of the frontal lobe, there is a first preset distance between two adjacent near-infrared irradiation units, such that: the near-infrared light emitted by each near-infrared LED of one of the near-infrared irradiation units covers the projection area of ​​the patient's head at the first preset distance in the projection area of ​​the head.

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