Headgear for a light therapy device for the treatment of Alzheimer's disease

Abstract

The application relates to a head cap of a light treatment device for treating Alzheimer's disease. The head cap comprises: a cover body which loosely accommodates a patient's head so that the patient's head has a movable gap during treatment; and an array of near-infrared irradiation units arranged in the cover body, adjacent near-infrared irradiation units in the array having a first preset distance, and adjacent near-infrared irradiation units cooperatively emitting near-infrared light to the patient's head at a preset divergence angle, so that, when the patient's head remains stationary in the cover body or moves in the movable gap, the emitted near-infrared light covers the whole head and the average power density is greater than 40 mW / cm 2 The head cap can enable the patient's head to move in a loose space during treatment, improve the patient's treatment compliance, and, when the patient's head moves, irradiate each brain area of the AD patient, thereby ensuring the treatment effect on the AD.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical equipment, more particularly, to a head cap of a light therapy device for treating Alzheimer's disease. BACKGROUND

[0002] Alzheimer's disease (AD) is more common in people over 65 years old, with slow or occult onset, and worsening over time, mainly manifested as cognitive decline, language dysfunction, emotional instability, mental symptoms and behavioral disorders, and gradual decline in daily living skills, eventually losing physical function and leading to death. At present, the cause of AD is unclear, and with the development of global population aging, the number of AD patients is increasing, which has brought a heavy burden to families and society.

[0003] There is currently no effective drug treatment method for AD in clinical practice. For many years, a large number of studies have been conducted at home and abroad to treat AD using physical electromagnetic stimulation, such as transcranial direct current stimulation, transcranial magnetic therapy, etc., but these electromagnetic treatments can only reach the cerebral cortex and are not good for stimulating deep brain areas. In recent years, there have also been frontier researches on treating AD with near-infrared light at home and abroad, but although there are some research results, most of them are in vivo experiments on mice, and there are few clinical results with human subjects.

[0004] The head cap of the treatment device in the prior art emits near-infrared light with low average power density, and the energy deposition of the near-infrared light on the brain tissue after penetrating the skull is less, making it difficult to achieve good light therapy effect, and the separate arrangement of the near-infrared treatment module cannot irradiate the whole brain, thereby resulting in poor light therapy effect. SUMMARY

[0005] The present application is provided to solve the above problems in the prior art. There is a need for a head cap of a light therapy device for treating Alzheimer's disease, which can allow the patient's head to move in a relaxed space during treatment, and still be able to emit near-infrared light with sufficient average power density to the whole head of the AD patient under the condition of the patient's head movement, so that each brain area of the AD patient can be irradiated, thereby improving the patient's treatment compliance while ensuring good treatment effect for AD.

[0006] According to a first aspect of the present application, a headgear of a light therapy device for treating Alzheimer's disease is provided. The headgear comprises a cover body configured to loosely accommodate a patient's head such that the patient's head has a movable clearance during a treatment. An array of near-infrared irradiation units is disposed in the cover body, adjacent near-infrared irradiation units in the array have a first preset distance, and the adjacent near-infrared irradiation units cooperatively emit near-infrared light to the patient's head at a preset divergence angle, such that the emitted near-infrared light covers the whole head and has an average power density greater than 40 mW / cm 2 .

[0007] Compared with the prior art, the headgear of the light therapy device for treating Alzheimer's disease according to the embodiments of the present application has the following beneficial effects:

[0008] The headgear of the light therapy device for treating Alzheimer's disease according to the embodiments of the present application can allow the patient's head to move in a loose space during the treatment, adapt to the special psychological needs of AD patients at various stages of the disease, such as psychological barriers to closed and crowded spaces, and improve the treatment compliance of the patient. Moreover, through the cooperation of the movable clearance in the cover body space, the preset divergence angle of the adjacent near-infrared irradiation units, and the preset distance between them, it is ensured that the near-infrared light emitted by the adjacent near-infrared irradiation units at the preset divergence angle forms an overlap at the scalp, which not only can cover the whole head without missing any brain area, but also can ensure sufficient average power density through the overlap, thereby ensuring the treatment effect on AD.

[0009] The above description is only a summary of the technical solutions of the present application. In order to enable a clearer understanding of the technical means of the present application, the technical solutions can be implemented in accordance with the content of the specification, and in order to enable the above and other purposes, features and advantages of the present application to be more apparent and easy to understand, the following specific embodiments of the present application are described. BRIEF DESCRIPTION OF DRAWINGS

[0010] In the drawings, which are not necessarily drawn to scale, like numerals can describe similar components in different views. The drawings are intended to illustrate various embodiments in accordance with the present disclosure, and are not intended to limit the present disclosure in any way. Wherever possible, the same reference numbers will be used throughout the drawings to depict the same or like parts. Such embodiments are illustrative rather than limiting in nature, and are not intended to be exhaustive or exclusive.

[0011] FIG. 1(a) shows a schematic diagram of the configuration of a light therapy device for treating Alzheimer's disease equipped with a headgear according to an embodiment of the present application;

[0012] Fig. 1(b) shows a schematic diagram of the configuration of an array of near-infrared irradiation units in a headgear of a light therapy device for treating Alzheimer's disease;

[0013] Figure 2 Fig. 6 shows a comparison chart of the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) scores of AD patients who received light therapy and control AD patients after the AD patients were subjected to light therapy using a light therapy device according to an embodiment of the present application;

[0014] Figure 3 Fig. 7 shows a schematic diagram of the distribution of various brain regions of the whole brain of a patient according to an embodiment of the present application;

[0015] Figure 4 Fig. 8 shows pathological section images of the cerebral cortex region and the hippocampus CA1 region of AD mice who received light therapy and control AD mice after the 5-month-old AD mice were subjected to light therapy using a light therapy device according to an embodiment of the present application, wherein the distribution of amyloid (A β -amyloid (A β )( Figure 4 is shown as granules);

[0016] Figure 5 Fig. 9 shows a layout diagram of the arrangement of near-infrared LEDs on a light panel that is an example of a near-infrared irradiation unit in a headgear of a light therapy device for treating Alzheimer's disease;

[0017] Figure 6 Fig. 10 shows a schematic diagram of a headgear of a light therapy device for treating Alzheimer's disease according to an embodiment of the present application in a worn state;

[0018] Figure 7 Fig. 11 shows a perspective view of a headgear of a light therapy device for treating Alzheimer's disease according to an embodiment of the present application; and

[0019] Figure 8 Fig. 12 shows a schematic diagram of the overall configuration of a light therapy device for treating Alzheimer's disease equipped with a headgear according to an embodiment of the present application. DETAILED DESCRIPTION

[0020] For those skilled in the art to better understand the technical solutions of the present application, the present application will be described in detail below in combination with the drawings and specific embodiments. The embodiments of the present application will be described in further detail below in combination with the drawings and specific embodiments, but should not be considered as limiting the present application. The order in which each step is described herein as an example should not be considered as limiting, and those skilled in the art should know that the order can be adjusted, as long as the logic between them is not destroyed and the entire process cannot be implemented.

[0021] The terms "first", "second", and similar terms used in the present application do not denote any order, quantity, or importance, but are only used to distinguish between the terms. The terms "include", "contain", and similar terms mean that the elements before the terms encompass the elements listed after the terms, and do not exclude the possibility of also encompassing other elements. The term "head" used in the present application means the organs above the human neck (cervical vertebra), including the brain and extracerebral tissues such as the skull, skin, and hair. The term "brain" used in the present application means the organs left after removing extracerebral tissues, and is intended to mean the brain, but is not limited thereto, and can also include the cerebellum, brainstem, etc. The term "whole brain" used in the present application is intended to be distinguished from discrete brain regions such as the frontal lobe, temporal lobe, but is not limited to the exhaustive regions of the "brain". The "whole brain" at least includes the frontal lobe, temporal lobe, parietal lobe, and occipital lobe, and in some cases can further include (but not necessarily) the hippocampus, amygdala, etc., and in other cases can further include (but not necessarily) the cerebellum, brainstem, etc. It can be understood that the term "average power density" used in the present application means the amount of energy of near-infrared light irradiated per unit area per unit time.

[0022] The research team of the present applicant has conducted in-depth research on the treatment of AD by near-infrared light and light therapy devices, and has conducted a large number of simulation experiments and clinical experiments, not only demonstrating the theoretical and factual feasibility of the AD light therapy device, but also paying attention to and conducting in-depth research on the special psychological and physiological needs of AD patients with various courses in clinical experiments. The present application proposes a head cap for a light therapy device for treating Alzheimer's disease, which not only ensures that each brain region has sufficient average power density to ensure good treatment effect on AD, but also significantly improves the treatment compliance of patients.

[0023] Fig. 1(a) shows a schematic diagram of the configuration of a headgear for a light therapy device for treating Alzheimer's disease equipped with a headgear according to embodiments of the present application, and Fig. 1(b) shows a schematic diagram of the configuration of an array of near-infrared irradiation units in the headgear for the light therapy device for treating Alzheimer's disease. As shown in Figs. 1(a) and 1(b), the headgear for the light therapy device for treating Alzheimer's disease comprises a shell 1 that loosely accommodates the patient's head such that there is a movable clearance for the patient's head during the treatment. Unlike a headgear that is fitted to the shape of the patient's head, the shell 1 leaves a clearance between itself and the patient's head for the patient's head to move, so that the patient can move his or her head in the clearance as he or she wishes or involuntarily due to the disease progression. This loosely open design of the shell 1 does not constrain the patient's head and is particularly friendly to the elderly who are emotionally agitated, anxious, resistant or even fearful of closed or crowded spaces, thereby significantly improving the treatment compliance of AD patients. In particular, the headgear for the light therapy device can be used for continuous wearing by a patient suffering from Alzheimer's disease and having a psychological barrier to closed or crowded spaces during the treatment. This psychological barrier to closed or crowded spaces can be caused by the patient's age or a psychological disease other than AD, or caused by the AD itself. This design of the shell 1 can also be widely applicable to the behavioral characteristics of patients at different stages of AD. For example, for early-stage AD patients, the judgment ability is decreased and they are often suspicious and easily irritated. The wearing of this shell 1 with sufficient freedom and openness is easily accepted by the patients and is less likely to cause irritation, so that the patients can cooperate with the continuous light therapy. For example, for mid-stage AD patients, the mood fluctuates dramatically, and they are impatient and restless, and the head of some patients will frequently and involuntarily sway slightly. This open shell 1 allows the patient's head to involuntarily sway slightly without causing the shell 1 to shake. Therefore, it is not necessary to forcibly stop this slight swaying, which increases the comfort of the patient and reduces the workload of the medical staff, while avoiding the transmission of the swaying of the patient's head to the shell 1, which affects the light therapy effect. Therefore, in other embodiments, the headgear for the light therapy device can be used for continuous wearing by an Alzheimer's disease patient who is emotionally agitated and anxious during the treatment.

[0024] This design of the shell 1 that is closed at the bottom but loosely open allows the patients at various stages of AD to be more willing to accept the treatment, and the single irradiation can be maintained for a longer time, for example, 20 minutes, 30 minutes or even longer for each irradiation, thereby further improving the treatment effect; and avoiding the leakage of near-infrared light in various directions during the irradiation of the whole head, thereby further improving the safety of the treatment.

[0025] The headgear further comprises an array of near-infrared irradiation units 2 arranged in the cover 1, and the first preset distance is between adjacent near-infrared irradiation units 2 in the array. As an example, as shown in FIG. 1(b), the first preset distance between adjacent near-infrared irradiation units 2 is d. Adjacent near-infrared irradiation units 2 in the array emit near-infrared light to the patient's head at a preset divergence angle, so that the emitted near-infrared light covers the whole head and the average power density is greater than 40 mW / cm 2 For the elderly with AD, it is also possible to ensure that sufficient light energy enters the brain tissue of the whole head, ensuring good treatment effect. Figure 2 A comparison chart of Alzheimer's Disease Assessment Scale Cognitive Scale (ADAS-cog) scores of AD patients receiving phototherapy and control group AD patients after phototherapy using the light therapy device according to the embodiment of the present application is shown, wherein the light therapy device adopts the loose design headgear 1 according to the above embodiment of the present application. It can be seen that after 2 months of near-infrared light treatment, the total score of ADAS-cog scale of the treatment group decreased by an average of 6.7 points compared with the baseline, with a significant statistical difference. The total score of ADAS-cog scale of the control group without receiving near-infrared light treatment increased by 3 points after 2 months, which confirms the good treatment effect of the light therapy device according to the embodiment of the present application on AD from the ADAS-cog score results.

[0026] In addition to the ADAS-cog score, the MMSE score was also analyzed in this clinical experiment, and the total score of MMSE score is 30, and the lower the score, the more serious the cognitive impairment. The baseline data of MMSE score of the treatment group receiving light therapy is 11.67 points, and the MMSE score after 2 months is 14.83 points, which is an average increase of 3.12 points compared with the baseline, indicating that the cognitive function of AD patients has improved after light therapy. The good treatment effect of the light therapy device according to the embodiment of the present application on AD is also confirmed from the MMSE score.

[0027] The first preset distance and the preset divergence angle can be artificially set or system default values. In this embodiment, the movable gap, the divergence angle and the first preset distance between adjacent near-infrared irradiation units 2 are cooperatively configured to form overlapping of infrared light at the scalp after passing through the movable gap, which not only can tightly cover the whole head without missing any brain area, but also can ensure sufficient average power density through overlapping.

[0028] The synergic configuration of the movable gap, the divergence angle and the first preset distance can improve the therapeutic effect on AD. In some embodiments, in terms of the synergic configuration, the first preset distance, the divergence angle and the movable gap of different brain regions can vary according to the curvature of the cap 1, the requirement of different brain regions for the average power density and other related factors. For example, the region of the cap 1 corresponding to the frontal lobe and the temporal lobe has a small curvature, and at this time, the first preset distance between the adjacent near-infrared irradiation units 2 in the region of the cap 1 corresponding to the frontal lobe and the temporal lobe can be set to be smaller than the first preset distance between the adjacent near-infrared irradiation units 2 in other regions (for example, the parietal lobe) of the cap 1. If the movable gap is too large, it is difficult to achieve the appropriate overlap of the near-infrared light emitted by the adjacent near-infrared irradiation units 2 after passing through the movable gap at the scalp, and for example, even if the overlap is caused by the too large divergence angle, it will lead to insufficient average power density. For another example, if it is desired to strengthen the therapeutic effect on the frontal lobe and the temporal lobe, it is desired to apply a higher average power density to the frontal lobe and the temporal lobe, and at this time, the movable gap between the cap 1 corresponding to the frontal lobe and the temporal lobe and the head can be set to be smaller than the movable gap corresponding to other brain regions, or the shape of the cap 1 is used to guide the patient to place the head close to the frontal lobe and the temporal lobe. For another example, the first preset distance between the adjacent near-infrared irradiation units 2 in the region of the cap 1 corresponding to the frontal lobe and the temporal lobe can also be reduced to strengthen the therapeutic effect on the frontal lobe and the temporal lobe.

[0029] By synergic configuration of the movable gap, the first preset distance and the preset divergence angle, when the patient's head is maximally active in the cap 1 (for example, close to the cap in a certain direction), the whole head is still tightly covered without missing any brain region, and at the same time, the overlap can also ensure that the average power density is greater than 40 mW / cm 2 , thereby ensuring the therapeutic effect on AD.

[0030] In some embodiments, the array of near-infrared irradiation units 2 in the cover 1 has a second preset distance from the head, so 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, so that each part of the head can be irradiated by near-infrared light. Wherein, the cover 1 does not adopt an adaptive design, but adopts a loose design in which the head can move freely in the accommodation space, and the gap between the array of near-infrared irradiation units 2 in the cover 1 and the head also causes scattering of the near-infrared light. The inventors have found 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 a small movable space, which is less comfortable for AD patients and is not conducive to the cooperation of AD patients. On the other hand, if the distance between the array of near-infrared irradiation units 2 and the head is small, the near-infrared light cannot be fully 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, so that some parts of the head cannot be irradiated by near-infrared light, thereby reducing the treatment effect; or requiring a high arrangement density of near-infrared irradiation units 2, which can cause excessive heat generation, affect the comfort of the patient, and greatly reduce the service life of the near-infrared irradiation units 2, increase the manufacturing cost 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 the infrared light, resulting in poor distribution balance of the average power density, or insufficient average power density after superposition, still unable to obtain a good treatment effect. By controlling the second preset distance between the array of near-infrared irradiation units 2 and the head, each part of the head can be irradiated by near-infrared light with sufficient and relatively uniform average power density, the required divergence angle range of the near-infrared irradiation units 2 conforms to the emission angle range of the conventional near-infrared LED (for example, 100-135 degrees), and the required arrangement density and spacing of the near-infrared irradiation units 2 are also appropriate, so that the manufacturing difficulty and cost are beneficially controlled. Preferably, the second preset distance between the array of near-infrared irradiation units 2 and the head is set to 2.5-4 cm, and the transverse movable gap during treatment is controlled to be 1-2 cm. The inventors have confirmed through clinical experiments and investigation and analysis of the psychology of patients that this is a range that is more comfortable psychologically for patients, which can give patients sufficient freedom of movement, and also does not make the patient too worried and worried about the inaccuracy of the head position.

[0031] Figure 3 A distribution diagram of various brain regions of the whole brain of a patient according to an embodiment of the present application is shown. As Figure 3As shown, the main brain regions of the cerebral cortex include the frontal lobe, temporal lobe, parietal lobe, occipital lobe, and cerebellum. The inventors discovered that, in treating Alzheimer's disease (AD), emitting near-infrared light from the array of near-infrared irradiation units 2 onto the entire brain of the patient's head, such as at least the frontal lobe, temporal lobe, parietal lobe, and occipital lobe, and especially at least the frontal lobe, temporal lobe, and hippocampus, achieves better therapeutic effects compared to irradiating only certain brain regions.

[0032] Specifically, such as Figure 3 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 further 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.

[0033] By constructing the cover 1 to cover the entire brain, the array of near-infrared irradiation units 2 can emit near-infrared light to all brain regions of the patient's head, such as at least the frontal lobe, temporal lobe, parietal lobe, and occipital lobe, and especially the hippocampus, to provide comprehensive and thorough phototherapy to the cortical regions involved in the lesion, thereby achieving better treatment results (as confirmed by clinical trials and clinical data above).

[0034] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light to brain network nodes including at least one of the medial prefrontal cortex, the medial temporal lobe, the cingulate cortex, the precuneus, and the inferior parietal lobe. Studies have shown that the functional connectivity between each of the medial prefrontal cortex, the medial temporal lobe, the cingulate cortex, the precuneus, and the inferior parietal lobe is related to the development of AD. For example, a brain network is constructed for AD patients, and it is found that the functional connectivity between the hippocampus in the medial temporal lobe and the medial prefrontal cortex, the precuneus, and other brain network nodes is significantly weakened compared to normal people. In some AD patients, the functional connectivity of the brain network shows that the hippocampus has lost connectivity with certain brain network nodes. The array of near-infrared irradiation units 2 is configured to emit near-infrared light to the above brain network nodes, which can enhance the brain functional connectivity between these brain network nodes, thereby improving memory, cognitive function, etc. Specifically, the brain network and the brain network nodes can be constructed based on brain function imaging and / or brain structure imaging of the patient's head. For example, a brain network can be established through MRI images, which can include multiple nodes with brain regions as nodes. Each node corresponds to a different brain region, or multiple nodes can be provided on one brain region. The nodes have functional connectivity between each other, and the functional connectivity between the nodes can be used to represent the cooperation and information transmission between brain regions.

[0035] In a specific embodiment, the brain network nodes include at least the hippocampus in the medial temporal lobe, and the array of near-infrared irradiation units 2 is configured to emit near-infrared light to the hippocampus and brain network nodes whose functional connectivity with the hippocampus is weaker than a predetermined level. In this way, the nodes with unbalanced functional connectivity (i.e., functional connectivity weaker than a predetermined level, such as weaker than a normal level or lost functional connectivity) in the brain network nodes are irradiated locally and intensively. For example, near-infrared light with an average average power density greater than 70 mW / cm 2 In this way, the functional connectivity between the hippocampus and other brain network nodes can be enhanced, and even the functional connectivity between the hippocampus and other brain network nodes can be restored, achieving a good therapeutic effect on AD. Emitting near-infrared light only to these brain network nodes can reduce heat production, reduce the requirement for cooling mechanisms, and enable the patient's head to be in a more comfortable environment, providing comfort.

[0036] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit near-infrared light to the brain network nodes including the medial prefrontal cortex, the hippocampus in the medial temporal lobe, the anterior cingulate cortex, the precuneus, and the inferior parietal lobe together. In this way, the functional connectivity between each node in the brain network can be enhanced, achieving a better therapeutic effect on AD.

[0037] In some embodiments, the average power density of the near-infrared light in the frontal and temporal lobes of the array of near-infrared irradiation units 2 is 50 mW / cm 2 up to 150 mW / cm 2 , for example, 90 mW / cm 2 , 100 mW / cm 2 , 120 mW / cm 2 , etc. In some embodiments, for non-focus irradiation regions, such as the parietal and occipital lobes, the average power density of the near-infrared light in these non-focus regions can be 50 mW / cm 2 up to 70 mW / cm 2 . The average power density of the near-infrared light in the frontal and temporal lobes is higher than that in other regions, so that the frontal and temporal lobes can be focused on for irradiation, thereby improving the therapeutic effect on AD. Accordingly, the distribution density of the near-infrared irradiation units 2 in the corresponding regions of the frontal and temporal lobes can be higher than that in the corresponding regions of other brain regions, so that the average power density of the near-infrared light in the corresponding regions of the frontal and temporal lobes can be increased to 50 mW / cm 2 up to 150 mW / cm 2 , so as to enhance the therapeutic effect on the focus of the frontal and temporal lobes.

[0038] The inventors conducted in vivo experiments on 5-month-old AD mice using light therapy. The center wavelength of the single-wavelength near-infrared light used was 800-820 nm, the pulse frequency was 10 Hz, the irradiation frequency was once a day, each duration was 10 minutes, and the duration was 5 weeks. The experimental results show that the AD mice receiving light therapy (also referred to as the experimental group) and the control group AD mice (also referred to as the control group) performed significantly better in the water maze experiment. The experimental group significantly shortened the navigation distance to find the platform compared to the control group. The experimental group shortened the escape latency by 36% compared to the control group. The inventors also analyzed the distribution of Aβ protein in the brain tissue of the mice after sampling, as shown in Figure 4 , the experimental group mice, including both the cortical region and the hippocampal CA1 region, showed significantly less Aβ protein in the cortical region and the hippocampal CA1 region than the control group mice. The accumulation of amyloid β (Aβ) peptide produced by the cleavage of amyloid precursor protein (APP) in the extracellular space is an important factor in the pathogenesis of AD. Moreover, extensive Aβ plaque deposition in the cerebral cortex, together with neurofibrillary tangles caused by tau protein lesions in the cortex, is a significant pathological marker of AD. Therefore, the significant reduction in Aβ plaque deposition in the experimental group after the above-mentioned near-infrared light irradiation treatment indicates a good therapeutic effect on AD.

[0039] In other embodiments, the average power density of 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.

[0040] 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. 2 Above, even 150mW / cm 2 .

[0041] In some embodiments, in corresponding regions of the frontal and temporal lobes, such as Figure 5 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 5 Each near-infrared LED 2a (e.g., on the right-hand side of the light panel 2b) on the light panel 2b Figure 5 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.

[0042] 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.

[0043] In some embodiments, the near-infrared irradiation unit 2 is a lamp board 2b carrying one or more near-infrared LEDs 2a. The near-infrared LEDs 2a and the near-infrared lamp board 2b can be distributed on the lamp board 2b in any array such as 1×1, 2×2, 3×3, 4×4, 5×5, etc.

[0044] 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 5 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.

[0045] 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 deviation between the average power density of the near-infrared light at the projection area of ​​the first preset spacing on the head and the average power density at other positions on the head is less than 20%, preferably less than 10%, thereby ensuring that the emitted near-infrared light covers the entire head and the average power density is greater than 40mW / cm². 2In the case that the average power density of the near-infrared light at the first preset interval of the head is higher than the average power density at other positions of the head by more than 20%, the average power density of the near-infrared light at the first preset interval of the head is either too high or too low, and correspondingly, the average power density at other positions of the head is too low or too high, resulting in uneven distribution of the average power density. Moreover, the place where the average power density is too high on the scalp will overheat (thereby possibly having to suspend the treatment), and the place where the average power density is too low will not have sufficient treatment effect, thereby reducing the overall treatment effect on the patient's AD. In the embodiments of the present application, the first preset interval is 15-20 mm, the second preset distance between each lamp panel 2b and the head is 2.5-4 cm, and the preset divergence angle is 100-135 degrees, for example, the divergence angle can be 120 degrees. By considering the mutual influence among the first preset interval, the second preset distance between each lamp panel and the head, and the preset divergence angle, the whole head can be uniformly covered by the near-infrared light and have a relatively high average power density.

[0046] Preferably, as shown in FIG. 1(b), the near-infrared irradiation unit 2 is a lamp panel 2b carrying a plurality of near-infrared LEDs 2a, wherein the near-infrared LEDs 2a are distributed on the lamp panel 2b in a 3x3 array. The inventors have found that if the near-infrared LEDs 2a are distributed on the lamp panel 2b in a 2x2 array, according to the performance parameters of conventional near-infrared LEDs 2a and safety requirements, when the requirement of high average power density of the corresponding regions of the temporal lobe and frontal lobe is required, not only will the photoelectric conversion efficiency decrease sharply, but also the lamp panel 2b will generate excessive heat, which puts higher requirements on the cooling equipment and makes it difficult to achieve high safety and comfort for the patient during treatment. If the near-infrared LEDs 2a are distributed on the lamp panel 2b in a 4x4 array, on the one hand, it will reduce the coverage area of the near-infrared light emitted by the near-infrared LEDs 2a on the head, making it difficult to meet the requirement of uniform and high average power density, and on the other hand, it will also increase the manufacturing difficulty of arranging conventional size near-infrared LEDs 2a on the transparent partition plate 18 with curvature. In the preferred embodiments of the present application, the near-infrared LEDs 2a are distributed on the lamp panel 2b in a 3x3 array, which not only ensures that the near-infrared light emitted by the near-infrared LEDs 2a covers the whole head and meets the requirement of high average power density of the frontal and temporal regions, but also enables the average power density of each brain region to be distributed uniformly to a certain extent, and does not generate excessive heat, thereby achieving the effect of uniform cooling of the whole head through appropriate cooling methods (which will be described in detail below).

[0047] In some embodiments, the near-infrared LEDs 2a are evenly distributed on the lamp panel 2b, and at least some of the LEDs 2a are arranged near the outer edge of each lamp panel 2b to make full use of the space of the lamp panel 2b and to obtain a larger near-infrared light projection area. As shown in Figure 1(b), eight near-infrared LEDs 2a are arranged in a 3×3 array near the outer edge of the lamp panel 2b. Further, the size of the lamp panel 2b is 25-35mm × 25-35mm, and the spacing between two adjacent near-infrared LEDs 2a is 12-15mm. This structure also helps that the near-infrared light emitted by each near-infrared LED 2a of the lamp panel 2b covers the projection area of ​​the head at the first preset spacing, and helps that all parts of the head can be illuminated by near-infrared light.

[0048] Figure 6 A schematic diagram showing a headgear for treating Alzheimer's disease according to an embodiment of this application in a worn state. Figure 6 As shown, the cover 1 has a fixed structure and size, so that the lateral movable gap of the patient's head is 1-2cm during the treatment. The beneficial psychological effect of this range of movable gap on the patient has been specifically explained above and will not be repeated here. The fixed structure and size mean that the cover 1 can be mass-produced and is suitable for a wide range of users with individual differences in head size.

[0049] In some embodiments, the cover 1 is configured to at least cover the entire brain. Specifically, there is a movable gap between the cover 1 and the head, so that the cover 1 can still cover the entire brain when the patient moves up and down within the movable gap, allowing the array of near-infrared irradiation units 2 (see Figures 1(a) and 1(b)) to irradiate various brain regions of the entire brain if needed. Furthermore, the loose and open design of the cover 1 allows for a fixed structure and size for patients with varying degrees of individual differences in head shape and size, without the need for a custom-made cover 1 that is strictly fitted to the individual patient's head shape and size. This enables the cover 1 to be manufactured in a standardized manner, resulting in lower manufacturing costs, a wider range of patients to whom the phototherapy device can be applied, and reduced procurement and maintenance costs for medical facilities such as hospitals and diagnostic centers. Specifically, the so-called fixed structure and size means that the cover 1 may not have moving components and may even be molded as a single piece, thereby increasing the service life of the cover 1 and simplifying its structure.

[0050] Figure 7 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 7 As shown, the cover 1 can have a left protruding ear and a right protruding ear 8, the left protruding ear being... Figure 7The left and right ear lugs 8 are configured to cover the temporal lobes of the patient, as shown in Fig. 1(b). The distribution of the near-infrared irradiation units 2 shown in Fig. 1(b) roughly corresponds to the regions of the temporal lobes. The left and right ear lugs 8 are each provided with near-infrared irradiation units 2 (as shown in Fig. 1(b)) to irradiate the covered regions of the temporal lobes with near-infrared light. Referring to Figure 3 The temporal lobes extend towards the ears, and the extensions can be covered by the left and right ear lugs 8 and irradiated with sufficient near-infrared light.

[0051] In some embodiments, the left and right ear lugs 8 are configured such that the near-infrared irradiation units 2 (as shown in Fig. 1(b)) provided on the left and right ear lugs 8 can still irradiate the temporal lobes of the patient when the head of the patient rotates within a predetermined angular range and moves up and down within a third predetermined distance range during the treatment. Specifically, the left and right ear lugs 8 can be designed to extend to the peripheral regions of the head corresponding to the temporal lobes, with a margin relative to the temporal lobes associated with the predetermined angular range and the third predetermined distance range. In this way, the temporal lobes of the patient can always be sufficiently irradiated even when the patient rotates or moves due to voluntary movement or uncontrollable tremor, thereby ensuring the treatment effect.

[0052] In some embodiments, the left and right ear lugs 8 are configured to extend below the ears of the patient, and at least one near-infrared irradiation unit 2 (as shown in Fig. 1(b)) is provided in the cover 1 corresponding to the region below the ears of the patient, so that the near-infrared light emitted by the near-infrared irradiation unit 2 is irradiated to the hippocampus via the ear canal. Note that the hippocampus can be reached by extending along the ear canal from the ear, and the light transmission distance to the hippocampus via the ear canal is much smaller than the light transmission distance from the frontal lobe to the hippocampus, and the attenuation of the ear canal to near-infrared light is much smaller than the attenuation of the skull to near-infrared light. In this way, the hippocampus located in the deep brain can also be sufficiently irradiated with near-infrared light. The hippocampus is closely related to the development of AD, and by allowing sufficient near-infrared light energy to reach the frontal lobe and the temporal lobe, the hippocampus can also be reached, which can significantly improve the function of brain mitochondria and the level of ATP, promote the decomposition of amyloid beta (Aβ), reduce the deposition of Aβ, reduce the damage to nerve cells, improve the repair and regeneration ability of nerve tissue, improve cognitive ability, and make the phototherapy effect on AD more significant.

[0053] In some embodiments, the cover 1 comprises a forehead portion 9, and has a curved connection portion 10 between the forehead portion 9 and the left and right ear lobe portions 8, so that the lower edges of the left and right ear lobe portions 8, the forehead portion 9 and the right ear lobe portion 8 are connected in a curve to form an integral whole, so as to completely cover the left and right temporal lobes of the patient. As shown in the brain region distribution, Figure 3 With the curved connection portion 10, the part of the temporal lobe near the temple can be covered and sufficient near-infrared light irradiation can be provided. The inventors have found that as AD progresses, the lesions spread to various parts of the temporal lobe, and providing careful and sufficient near-infrared light irradiation to each part can achieve a more effective treatment effect. Sometimes, the specific part of the temporal lobe affected by the lesion cannot be determined without brain function imaging, and the cost of obtaining brain function imaging is high for the patient. In addition, the head shape, size, etc. of each patient are different, and when the light treatment device is actually worn, it is difficult for medical staff, patients or other accompanying personnel to accurately determine the position of each brain region from the surface of the head located externally. Therefore, through the combined design of the left and right ear lobe portions 8 together with the curved connection portion 10, each part affected by the lesion can be completely covered, thereby achieving a more effective treatment effect, and without the need to distract the attention of the accompanying personnel or the patient himself / herself, the work burden can be reduced.

[0054] Further, the lower edge of the front portion of the cover 1 is gently curved, and the middle portion of the lower edge extends downward relative to the two side portions, for guiding the user to wear the lower edge to the supraorbital ridge. This curve shape with the middle lower and the two sides slightly higher matches the configuration of the supraorbital ridge, and according to daily habits (such as the habit of wearing glasses), the user will naturally pull the lower edge of this curve shape close to the supraorbital ridge, so that the entire forehead can be irradiated, and the doctor or patient can visually confirm that the wearing position is appropriate.

[0055] In some embodiments, the array of near-infrared irradiation units 2 is configured to emit single-wavelength near-infrared light with a central wavelength of 800-820 nm (for example, 810 nm) to the head of the patient, so as to improve the energy deposition on the brain tissue after penetrating the skull with the near-infrared light, and achieve a good light treatment effect. At the same time, using single-wavelength near-infrared light with a wavelength of 800-820 nm for irradiation, the absorption effect of oxyhemoglobin and deoxyhemoglobin is better, and the treatment effect is also better.

[0056] The near-infrared light can include pulsed light. Using pulsed light of a single frequency in a proper frequency range has a good irradiation effect, which can be in the frequency band of alpha waves (e.g., 10 Hz) or the frequency band of gamma waves (e.g., 40 Hz). In some embodiments, pulsed light containing at least two frequency components in a certain frequency range can be used to perform irradiation, which in some cases has a better irradiation effect than using pulsed light of a conventional single frequency. In some embodiments, the pulsed light includes a pulsed wave component of a first pulse frequency and / or a pulsed wave component of a second pulse frequency, the first pulse frequency being 7 Hz-13 Hz, and the second pulse frequency being 30 Hz-100 Hz. Preferably, the first pulse frequency is 10 Hz, and the second pulse frequency is 40 Hz. The present application finds that using a proper frequency, such as but not limited to the frequency band of alpha waves and the frequency band of gamma waves, has a better irradiation effect than other frequencies. The pulsed light includes alpha waves and gamma waves as the pulsed wave component of the first pulse frequency and the pulsed wave component of the second pulse frequency, respectively, and is formed by any of the following ways. For example, the alpha waves and the gamma waves can be synchronously superimposed to form the waveform of the pulsed light emitted by each near-infrared LED 2a. That is, each near-infrared LED 2a directly emits a waveform formed by the synchronous superposition of the alpha waves and the gamma waves, thereby realizing a mixed waveform (pulsed light formed by the superposition of the two frequency bands of alpha waves and gamma waves) that is time-synchronous and spatially coincident. For another example, the alpha waves and the gamma waves can be combined in time to form the waveform of the pulsed light emitted by each near-infrared LED 2a. That is, for the same near-infrared LED 2a, it can be lit in different time periods to alternately irradiate the alpha waves and the gamma waves, which is a mixed mode of pure spatial coincidence. In some embodiments, each of the first group of near-infrared LEDs 2a emits pulsed light of alpha waves, and each of the second group of near-infrared LEDs 2a synchronously emits pulsed light of gamma waves, that is, the near-infrared LEDs 2a of the first group and the second group are simultaneously lit in the same time period. Specifically, the near-infrared LEDs 2a corresponding to different brain regions can be lit in the same time period, which is a mixed mode of only time coincidence, so that pulsed light of specific frequency and waveform can be provided to different brain regions.

[0057] In some embodiments, the pulse frequency of the near-infrared irradiation unit 2 is adjustable, wherein the adjustable range is 0 Hz-100 Hz, for example, the near-infrared light with a pulse frequency of 8 Hz, 10 Hz, 30 Hz, 40 Hz, etc. is used for irradiation, etc., so that when the user uses the light treatment device to perform light treatment, the user can determine a more appropriate pulse frequency according to the degree of illness, the target brain region, etc. to achieve a better light treatment effect.

[0058] Returning to Fig. 1(a), as shown in Fig. 1(a), the headgear further comprises a cooling mechanism 4 configured to cool the patient's head such that the temperature near the patient's scalp is between 23 and 43 degrees Celsius. A cold air delivery lumen 5 is provided in the shell 1 adjacent to the array of near-infrared irradiation units 2 and a pathway 7 leading from the cold air delivery lumen 5 to the patient's head, and is configured to deliver cold air into the cold air delivery lumen 5 and blow the cold air towards the patient's head via the pathway 7 to cool the patient's head. The cold air delivered by the cold air delivery lumen 5 can be delivered by directly introducing air from the environment into the cold air delivery lumen 5 or by using a refrigerator 3 to deliver cold air into the cold air delivery lumen 5, and the specific way of delivering cold air into the cold air delivery lumen 5 is not limited.

[0059] The cooling mechanism 4 using a refrigerator 3 to cool the patient's head is used as an example in the embodiments of the present application, i.e. as shown in Fig. 1(a), cold air generated by the refrigerator 3 is delivered into the cold air delivery lumen 5 and gently blown towards the patient's head via the pathway 7 to cool the patient's head. In some embodiments, the wind speed of the cold air blown towards the patient's head via the pathway 7 is between 0.5 and 3.5 m / s, which is comfortable for the patient and can ensure the cooling effect. With such a cooling mechanism 4, when the array of near-infrared irradiation units 2 emits the near-infrared light together towards the patient's head (e.g. the whole brain), the total power of the near-infrared light is greater than 3 W, and even for some special light treatment programs with higher requirements for total power, the total power can be more than 10 W. Under such average power density and total power, the cooling mechanism 4 can still sufficiently cool the patient's head such that the temperature near the patient's scalp is between 23 and 43 degrees Celsius. Preferably, the temperature near the patient's scalp is between 25 and 40 degrees Celsius, which is close to the body temperature and the human body is more comfortable in such an environment, even for the elderly who are less sensitive to temperature and pain and are afraid of cold, they will also feel more comfortable and will not cause thermal damage, so that they can continuously receive treatment. By using such a cooling structure 4 in combination with the previously described loosely designed shell 1, AD patients of various disease courses are more willing to receive continuous irradiation treatment, and single irradiation can also be sustained for a longer time (the longer the time, the more heat is generated near the scalp), thereby further improving the treatment effect.

[0060] As an example, the pathway 7 can be constructed 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 drawn 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 near-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.

[0061] Referring to Figures 1(a) and 1(b), the cover 1 includes an outer layer 12a and a transparent cover 13 as an inner layer. A cold air transmission cavity 5 is formed between the outer layer 12a and the transparent cover 13. The transparent cover 13 has multiple ventilation holes 6, so that each ventilation hole 6, together with the gap between the transparent cover 13 and the patient's head, forms a passage 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 elderly AD patients feel comfortable and cooperate with treatment.

[0062] In some embodiments, the near-infrared irradiation unit 2 is a lamp plate 2b carrying multiple near-infrared LEDs 2a (as shown in Figure 1(b)). The multiple vent 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 vent holes 6 corresponds to each lamp plate 2b. The gap portion directly opposite the lamp plate 2b is where the temperature rises significantly. The groups of vent holes 6 corresponding to each lamp plate 2b can specifically deliver cool air to efficiently reduce the heat in this gap portion. Further, the lamp plate 2b includes a circuit 15, which is housed in the outer layer 12a of the cover 1. The outer layer 12a includes a hot air extraction cavity 14, which is connected to an air inlet 16 (e.g., ...). Figure 6 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. 2 In some cases, the heat generated by circuit 15 is very high. Sometimes the local heat generated by circuit 15 is significantly higher than that generated by near-infrared LED 2a. Therefore, a heat extraction cavity 14 is set 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.

[0063] In some embodiments, the circuit 15 is arranged on the side of the lamp board 2b opposite to the LED 2a, and this side is provided with a heat sink (shown in FIG. 1(b), behind the lamp board). The heat sink is used to guide heat away from the cold air transmission cavity 5 and avoid it from being transferred to the head, so as to further improve the heat dissipation effect.

[0064] 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 transparent cover 13.

[0065] As shown in Figures 1(a) and 1(b), the cold air transmission cavity 5 has a transparent partition 18 on its outer side, and each lamp plate 2b is located outside the transparent partition 18. The transparent partition 18 can completely separate 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 transparent cover 13, improving the heat dissipation effect on the gap.

[0066] Figure 8 A schematic diagram of the overall structure of a phototherapy device for treating Alzheimer's disease, equipped with a headgear 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.

[0067] 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.

[0068] 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.

[0069] 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 treatment 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.

[0070] 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 full scope of the following claims and their equivalents.

[0071] 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 can be used by those skilled in the art when 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 the 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 an independent, 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.

[0072] The above examples are only exemplary embodiments of the present application, and are not intended to limit the present application, and the protection scope of the present application is defined by the claims. Those skilled in the art can make various modifications or equivalent replacements to the present application within the spirit and protection scope of the present application, and such modifications or equivalent replacements are also considered to fall within the protection scope of the present application.

Claims

1. A headgear of a light therapy device for treating Alzheimer's disease, characterized in that, a cover body, an inner side of the cover body being provided with a transparent cover to loosely accommodate a head of a patient with a movable gap between the transparent cover and the head of the patient during a treatment process; an array of near-infrared irradiation units fixed in the cover body, the near-infrared irradiation units being light panels carrying a plurality of near-infrared LEDs, in corresponding regions of the frontal lobe, adjacent near-infrared irradiation units in the array have a first preset distance, adjacent near-infrared irradiation units emit near-infrared light to the head of the patient with a preset divergence angle, so that in the case that the head of the patient remains stationary or moves up and down within a third preset distance range in the cover body, the near-infrared light emitted by each near-infrared LED of each light panel covers a projection area of the head of the first preset distance on the head of the head after passing through the movable gap, Thereby, the near infrared light emitted via the transparent cover covers the full head and the average power density in the corresponding region of the frontal lobe is greater than 40 mW / cm 2 and less than 150 mW / cm 2 .

2. The headgear of claim 1, wherein the array of near-infrared irradiation units in the cover body and the head have a second preset distance, so that the near-infrared light emitted by adjacent near-infrared irradiation units with a preset divergence angle at least partially overlaps in the projection area of the head, so that each part of the head can be irradiated by near-infrared light.

3. The headgear of claim 1 or 2, wherein, The distribution density of the near-infrared irradiation units in the corresponding regions of the frontal lobe and the temporal lobe is higher than that in the corresponding regions of other brain regions.

4. The headgear of claim 2, wherein In the corresponding regions of the temporal lobe, the first preset distance between adjacent two near-infrared irradiation units is 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 head of the first preset distance on the head.

5. The headgear of claim 4, wherein, The first preset distance is 15-20mm, the second preset distance between each light panel and the head is 2.5-4cm, and the preset divergence angle is 100-135 degrees, so that the average power density of the near-infrared light at the projection area of the head of the first preset distance and the average power density at other positions of the head deviate by less than 20%.

6. The headgear of claim 1 or 2, wherein, The average power density of the near-infrared light at the corresponding regions of the frontal lobe and temporal lobe of the array of near-infrared irradiation units is 50 mW / cm 2 to 150 mW / cm 2 .

7. The headgear according to any one of claims 1, 2 and 4, wherein, The near-infrared LEDs are arranged in a 2x2 array on the light panel.

8. The headgear according to any one of claims 1, 2 and 4, wherein, The near-infrared LEDs are arranged in a 4x4 array on the light panel.

9. The headgear according to any one of claims 1, 2 and 4, wherein, The near-infrared LEDs are arranged in a 3x3 array on the light panel.

10. The headgear of claim 9, wherein, The size of the light panel is 25-35mm x 25-35mm.

11. The headgear of claim 9, wherein, Each near-infrared LED is uniformly distributed on the light panel, and at least some of the LEDs are arranged near the outer edge of each light panel.

12. The headgear of claim 1, wherein The cover body has a fixed structure and size, so that the transverse movable gap of the patient's head during the treatment process is 1-2cm.

13. The headgear of claim 1 or 2, wherein, The cover body is configured to cover at least the whole brain.

14. The headgear of claim 13, wherein, The cover body has a left ear part and a right ear part to cover the left and right temporal lobes of the patient respectively, and each of the left ear part and the right ear part is provided with near-infrared irradiation units to emit the near-infrared light to the covered temporal lobe region.

15. The headgear of claim 14, wherein, The left ear part and the right ear part are configured to extend downward below the ears of the patient, and At least one near-infrared irradiation unit is arranged in the cover corresponding to the patient's ear below to enable the near-infrared light emitted by the near-infrared irradiation unit to irradiate the hippocampus via the ear canal.

16. The headgear of claim 15, wherein, The cover comprises a forehead portion and has a curved connection portion between the forehead portion and the left and right ear portions, so that the lower edges of the left and right ear portions, the forehead portion and the right ear portion are connected in a curve to form an integrated whole, thereby completely covering the left and right temporal lobes of the patient.

17. The headgear of claim 15, wherein, The left and right ear portions are configured such that, during the treatment, when the head rotates within a predetermined angle range and moves up and down within a third predetermined distance range, the near-infrared irradiation units arranged on the left and right ear portions can still irradiate the temporal lobes of the patient.

18. The headgear of claim 1, wherein, The array of near-infrared irradiation units is configured to emit single-wavelength near-infrared light with a central wavelength of 810 nm to the patient's head.

19. The headgear of claim 1, wherein, The headgear is used for continuous wearing by an Alzheimer's patient with emotional agitation and anxiety during the treatment.

20. The headgear of claim 1, wherein, The headgear is used for continuous wearing by a patient with Alzheimer's disease and psychological barriers to closed or crowded spaces during the treatment.

21. The headgear of claim 1 or 2, wherein, The headgear further comprises a cooling mechanism, which comprises a cold air transmission inner cavity arranged adjacent to the array of near-infrared irradiation units in the cover and a passage from the cold air transmission inner cavity to the patient's head, and is configured to send cold air into the cold air transmission inner cavity and blow it towards the patient's head via the passage, so as to dissipate heat from the patient's head and keep the temperature near the patient's scalp at 23-43 degrees.

22. The headgear of Claim 21, wherein, The near-infrared irradiation unit is a lamp panel carrying a plurality of near-infrared LEDs, the lamp panel comprising a circuit, being accommodated in an outer layer of the cover, the outer layer being provided with a hot air extraction inner cavity, the hot air extraction inner cavity being in communication with the outside world via an air inlet and an air outlet, so that the air introduced via the air inlet carries the heat generated by the circuit and is discharged to the outside world via the air outlet.

23. The headgear of Claim 22, wherein, The circuit is arranged on the side of the lamp panel opposite to the LEDs, and this side is provided with a heat sink for guiding heat away from the cold air transmission inner cavity.

24. The headgear of Claim 22, wherein, The hot air extraction inner cavity and the cold air transmission inner cavity are independent of each other.

25. The headgear of Claim 21, wherein, The wind speed of the cold air blown towards the patient's head via the passage is 0.5-3.5 m / s.

26. The headgear of claim 1, wherein, The near-infrared light is pulsed light, and the irradiation parameters of the near-infrared irradiation unit further comprise a pulse frequency, the pulsed light comprising a pulse wave component with a first pulse frequency and / or a pulse wave component with a second pulse frequency, the first pulse frequency being 7-13 Hz, and the second pulse frequency being 30-100 Hz.

27. The headgear of Claim 26, wherein, The first pulse frequency is 10 Hz, and the second pulse frequency is 40 Hz.

28. The headgear of Claim 26, wherein, Each near-infrared irradiation unit comprises a plurality of near-infrared LEDs, the pulsed light comprises a pulse wave component with an alpha wave frequency and a pulse wave component with a gamma wave frequency as the first pulse frequency and the second pulse frequency, respectively, and is formed by any one of the following ways: The waveform of the pulsed light emitted by each near-infrared LED is formed by synchronous aliasing of alpha waves and gamma waves; The waveform of the pulsed light emitted by each near-infrared LED is composed of an alpha wave and a gamma wave in time division; Each near-infrared LED in the first group of near-infrared LEDs emits pulsed light of an alpha wave, and each near-infrared LED in the second group of near-infrared LEDs emits pulsed light of a gamma wave, and the two groups of near-infrared LEDs emit pulsed light synchronously.

29. The headgear of claim 1 or 2, wherein, The array of the near-infrared irradiation units is configured to emit near-infrared light to brain network nodes, the brain network nodes at least including at least one of a medial prefrontal cortex, a medial temporal lobe, a cingulate cortex, a precuneus, and an inferior parietal lobe.

30. The headgear of Claim 29, wherein, The brain network nodes at least include a hippocampus located in the medial temporal lobe, and the array of the near-infrared irradiation units is configured to emit near-infrared light to the hippocampus and brain network nodes whose functional connection strength with the hippocampus is weaker than a predetermined level among the brain network nodes.

31. The headgear of Claim 29, wherein, The array of the near-infrared irradiation units is configured to emit near-infrared light to brain network nodes including a medial prefrontal cortex, a hippocampus located in a medial temporal lobe, an anterior cingulate cortex, a precuneus, and an inferior parietal lobe together.

32. The headgear of claim 1, wherein The near-infrared light is pulsed light, and the irradiation parameters of the near-infrared irradiation units further include an adjustable pulse frequency, and the adjustable range of the pulse frequency is 0Hz-100Hz.

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