Near-infrared light treatment device for inhibiting or preventing alzheimer's disease

Abstract

This application relates to a near-infrared light therapy device for inhibiting or preventing Alzheimer's disease, comprising a main body and an array of near-infrared irradiation units. The main body is configured to have a receiving space for accommodating a subject's head. The array of near-infrared irradiation units is arranged on a supporting structure and configured to emit near-infrared light into the receiving space. When the subject's head is located in the receiving space, the array of near-infrared irradiation units is configured such that the time-averaged total irradiation power over a preset irradiation range within the receiving space reaches 27.5W or more, 31W or more, 40W or more, 60W or more, or 70W or more, and the average light power density does not exceed 230 mW / cm². 2 The preset irradiation range is defined by at least the anterior upper part of the skull, the top of the skull, the left side of the skull, and the right side of the skull. The phototherapy effect was tested on individual AD patients, who also reported that their previous cognitive impairment was alleviated to some extent.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a near-infrared light therapy device for inhibiting or preventing Alzheimer's disease. Background Technology

[0002] With the aging of the global population, Alzheimer's disease (AD), which commonly occurs in the elderly, has become a serious problem. Epidemiological surveys show that the prevalence rate increases with age in people over 60. In addition to medication combined with conventional treatment, photobiological modulation (PBM) has been explored in recent years to treat AD. This involves irradiating the brain with appropriate doses of transcranial light (infrared or near-infrared light) within a specific wavelength range to achieve neuromodulation. This wavelength of light has gentle energy and good penetration, and many studies have demonstrated the effectiveness of PBM in treating AD.

[0003] However, many existing photobiological modulation devices rely on direct irradiation of the eyes or irradiation via the nasal cavity. Their therapeutic effect largely depends on irradiating the olfactory bulb through these sites, thereby delivering the therapeutic dose of near-infrared light to the frontal lobe. However, the majority of AD patients are elderly, and the inventors found during their research and clinical trials that most elderly Chinese people have significant resistance to eye irradiation and nasal irradiation, making it difficult to implement. Moreover, irradiation of the eyes also carries uncontrollable risks and damage, including but not limited to infrared cataracts, retinal and choroidal damage, photosensitive cell damage, and corneal damage.

[0004] Currently, manufacturers and researchers of near-infrared light therapy equipment, as mentioned above, typically only measure and list the light power density at different locations, lacking attention to the total power. Furthermore, US8308784B2 explicitly states that "for a selected wavelength, the light energy delivered to the tissue by the power density (light intensity or power per unit area, W / cm2) or energy density (energy per unit area, in J / cm2, or power density multiplied by exposure time) is an important factor in determining the relative efficacy of phototherapy, while efficacy is not directly related to the total power or total energy delivered to the tissue" (see paragraph

[0192] of its specification).

[0005] In summary, existing technologies have deficiencies in the construction and irradiation configuration of near-infrared light therapy devices, which hinders the promotion and development of near-infrared light therapy devices and even near-infrared light therapy methods. Utility Model Content

[0006] This application provides a near-infrared light therapy device for inhibiting or preventing Alzheimer's disease. This near-infrared light therapy device does not rely on nasal or ocular irradiation, has a simple structure, and is suitable for providing optimized irradiation configuration, enabling optimized treatment effects for AD patients from MCI to dementia stages.

[0007] According to a first aspect of this application, a near-infrared light therapy device is provided. The near-infrared light therapy device includes: a main body configured to have a receiving space for accommodating a subject's head; and an array of near-infrared irradiation units disposed on a supporting mechanism and configured to emit near-infrared light into the receiving space. When the subject's head is located within the receiving space, the array of near-infrared irradiation units is configured such that the emitted near-infrared light has a time-averaged total irradiance power and a spatiotemporal average optical power density such that the time-averaged total irradiance power irradiating a predetermined irradiation range within the receiving space reaches 27.5W or more, 31W or more, 40W or more, 60W or more, or 70W or more, and the spatiotemporal average optical power density irradiating the predetermined irradiation range does not exceed 230 mW / cm². The predetermined irradiation range is defined by at least the anterior upper part of the skull, the top of the skull, the left side of the skull, and the right side of the skull, all located on the surface of the skullcap of the subject's head located within the receiving space.

[0008] For example, the main body includes a light-transmitting inner shell, which forms at least a front, a top, a left side and a right side, and encloses an accommodating space. Near-infrared light emitted by the array of near-infrared irradiation units is emitted through the light-transmitting inner shell and irradiates the accommodating space.

[0009] For example, the array of at least the near-infrared irradiation units is configured such that the time-averaged light power density of the irradiated surface of the transparent inner shell is 50-100 mw / cm2 at the top and 100±20 mw / cm2 at the front, left, and right sides.

[0010] For example, the spatiotemporal average optical power density of the top of the light-transmitting inner shell is not higher than the spatiotemporal average optical power density of the front, left, and right sides, respectively.

[0011] For example, the near-infrared irradiation unit corresponding to the top of the light-transmitting inner shell is arranged along the dome-shaped curved surface, and the first average distance between the top of the light-transmitting inner shell and its corresponding near-infrared irradiation unit is greater than the second average distance between the left and right sides of the light-transmitting inner shell and their corresponding near-infrared irradiation units.

[0012] For example, at least the array of near-infrared irradiation units is configured such that the time-averaged optical power density emitted from all points on the inner wall of the light-transmitting inner shell is above 20 mW / cm2.

[0013] For example, the main body is a cover structure, the supporting mechanism is located on the side of the light-transmitting inner shell away from the accommodating space, and each of the near-infrared irradiation units in the first group of near-infrared irradiation units has a preset emission angle and a preset interval and drop configuration, so that multiple near-infrared light convergence areas are formed on the top of the light-transmitting inner shell.

[0014] For example, the array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer. The bottom layer of near-infrared irradiation units includes a first group and a second group separated in the circumferential direction, with the first group and the second group respectively corresponding to the left ear and the right ear.

[0015] For example, the main body is a cover, which, when the head of the object is in place in the receiving space, is located at the tragus on both sides below the cover, above the brow bone on the front side and extends flat to both sides for a first predetermined distance, and within a second predetermined distance above or below the external occipital protuberance on the back side.

[0016] For example, the array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer, with the near-infrared irradiation unit in the lower middle layer adjacent to the brow bone of the object's head when the object's head is in place in the receiving space.

[0017] For example, the array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer. When the object's head is in place in the receiving space, the middle layer is arranged circumferentially and covers a second predetermined distance in the longitudinal direction, so that the near-infrared irradiation units in front of and on the left and right sides correspond to the frontal lobe and the left and right temporal lobes of the object's head, respectively, when the object's head is in place in the receiving space.

[0018] The applicant tested the light therapy effect on individual AD patients (volunteers) in several nursing homes and confirmed that no patients had adverse reactions under the total power range formed by the array configuration of the near-infrared irradiation unit of this near-infrared light therapy device. AD patients also reported that their previous cognitive impairments, such as recent memory loss, muscle stiffness, and weakened spatial ability, had been alleviated to some extent.

[0019] This utility model description introduces a series of simplified concepts, which will be further explained in detail in the detailed description section. This utility model description is not intended to limit the key features and essential technical features of the claimed technical solution, nor is it intended to determine the scope of protection of the claimed technical solution.

[0020] The advantages and features of this application are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0021] The following drawings, which are incorporated herein by reference and are used to understand this application, illustrate embodiments of the invention and their descriptions to explain the principles of the invention. In the drawings,

[0022] Figure 1 This is a schematic diagram of a near-infrared light therapy device according to the first embodiment of this application;

[0023] Figure 2 This is a longitudinal cross-sectional structural diagram of the near-infrared light therapy device according to the second embodiment of this application;

[0024] Figure 3 This is a schematic diagram of the middle shell and the transparent inner shell of the near-infrared light therapy device according to the first or second embodiment of this application;

[0025] Figures 4(a)-4(f) illustrate the characteristic parameters of the head of a therapist or a group of therapists according to the third embodiment of this application;

[0026] Figure 5(a) shows a front view of the head of an object according to the fourth embodiment of the present application, showing the electrode positions of the 10-10 international standard lead system, the general boundary line of the reference scalp, and the boundary lines between the upper front part of the skull, the left side of the skull, and the right side of the skull.

[0027] Figure 5(b) shows a left-side view of the head of an object according to the fourth embodiment of this application, showing the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference scalp, and the boundary lines between the upper front part of the skull, the left side of the skull, the top of the skull, and the back of the skull.

[0028] Figure 5(c) shows a right-side view of the head of an object according to the fourth embodiment of this application, showing the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference scalp, and the boundary lines between the upper front part of the skull, the right side of the skull, the top of the skull, and the back part of the skull.

[0029] Figure 5(d) shows a top view of the head of an object according to the fourth embodiment of this application, showing the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference scalp, and the boundary lines between the upper front part of the skull, the top of the skull, the left side of the skull, the right side of the skull, and the back of the skull.

[0030] Figure 5(e) shows a rear view of the head of an object according to the fourth embodiment of this application, showing the electrode positions of the 10-10 international standard lead system, the overall boundary line of the reference scalp, and the boundary lines between the top of the skull, the left side of the skull, the right side of the skull, and the back of the skull.

[0031] Figure 6 This diagram illustrates the spatial locations of the Default Mode Network (DMN), Central Executive Network (ECN, also known as the Executive Control Network), Spokesperson Network (SN), Sensorimotor Network (SMN), Dorsal Attention Network (DAN), and Visual Network (VN) in the brain. Detailed Implementation

[0032] In the following description, numerous details are provided to enable a thorough understanding of this application. However, those skilled in the art will appreciate that the following description illustrates only preferred embodiments of the application in some examples, and the present invention can be practiced without one or more of these details. Furthermore, to avoid confusion with the present invention, some technical features well-known in the art have not been described in detail.

[0033] Unless otherwise defined, the technical or scientific terms used in this application shall have the ordinary meaning understood by one of ordinary skill in the art to which this application pertains. The terms "first," "second," and similar terms used in this application do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0034] The term "inhibition or prevention of Alzheimer's disease" in this application refers to its ability to prevent, reduce, alleviate, inhibit, terminate, or even reverse the progression of Alzheimer's disease. The progression of Alzheimer's disease includes both the appearance of clinical symptoms of AD and its subsequent development, as well as the occurrence of pathological or physiological phenomena associated with AD and with a certain probability of developing into AD, even before obvious clinical symptoms are present. In other words, the statement "inhibition or prevention of Alzheimer's disease" in this application includes treating Alzheimer's disease that has already occurred, as well as preventing the onset of Alzheimer's disease or reducing its probability.

[0035] Unless otherwise specified, the term "cranioides" in this application is intended to encompass "cranioides" as defined in various ways in the fields of anthropology and medicine. For example, "cranioides" can be defined using the boundary established by Friess et al. (2002) when measuring the area of ​​the cranioides. Alternatively, the boundary can be defined as the portion of the head above the plane formed by the glabella and the upper edges of the external auditory meatuses on both sides. Furthermore, "cranioides" can also refer to the portion of the head surface enclosed by a general boundary line, which, according to the 10-10 international standard lead system, is defined as starting from the glabella, passing through the preauricular points on both sides, circling backward around the occipital protuberance, and converging between the electrode positions O1, OZ, and O2 of the 10-10 international standard lead system.

[0036] In this application, the term "acting on the scalp of the subject's head" refers to the thin outer irradiation surface immediately adjacent to the hair (or scalp where there is no hair) of the subject's scalp. Near-infrared light irradiating this thin outer irradiation surface means that the irradiation energy of the near-infrared light is transferred to the scalp of the head, which includes the hair, scalp, skull, and brain tissue. Furthermore, after absorption by the hair and attenuation by the scalp and skull, the remaining energy capable of acting on the cortex or even deeper parts of the brain tissue is related to attenuation along the transmission path.

[0037] The inventors discovered that the therapeutic efficacy of near-infrared light therapy devices for atopic dermatitis (AD) is directly related to the total power or energy delivered to the tissue. In this application, the term "time-average optical power density" refers to the optical power density averaged over time. For example, the "time-average optical power density" of a target site refers to the optical power density at that target site averaged over time. Similarly, the "time-average optical power density" of a target portion refers to the "time-average optical power density" of representative positions on that target portion. Specifically, a "time-average optical power density" of 30-60 mW / cm² for the target portion means that the time-average optical power density at various representative positions on the target portion, such as, but not limited to, the position corresponding to the center of the lamp panel, fluctuates within the range of 30-60 mW / cm².

[0038] The so-called "spatiotemporal average optical power density" of the target region is intended to represent the time-averaged optical power density relative to the surface area of ​​the target region, that is, the optical power density after performing averaging operations relative to both surface area and time.

[0039] The term “time-averaged total irradiance” in this application is distinct from peak irradiance and is intended to represent the total irradiance level obtained by averaging the total irradiance energy accumulated over a period of time.

[0040] According to a first aspect of this application, a near-infrared light therapy device for inhibiting or preventing Alzheimer's disease is provided. The near-infrared light therapy device may include a main body and an array of near-infrared irradiation units. The main body is configured to have a receiving space for accommodating a subject's head. The near-infrared light therapy device may further include a support mechanism, on which the array of near-infrared irradiation units is disposed. The support mechanism may be independent of the main body. Figures 1-3 In the illustrated embodiment, the supporting mechanism can be a middle shell 200 disposed within the main body 100. In other embodiments, the supporting mechanism can be disposed on the outside of the main body 100. In still other embodiments, the supporting mechanism can be disposed within the main body 100. In yet another embodiment, the main body 100 can be provided with structures such as openings for mounting the infrared irradiation unit 300, so that the supporting mechanism is formed by the main body 100 itself.

[0041] In some embodiments, the support mechanism can also be implemented as a skeleton structure that fits closely to the head of the AD patient, so that the infrared irradiation unit 300 or its subarray can be mounted as a module on the skeleton structure. In still other embodiments, the support mechanism can also be implemented as a non-headgear-type support frame further away from the head of the AD patient, using various structures such as arc shape, cone shape, spatial grid shape, etc., as long as it supports the array of near-infrared irradiation units 300, which will not be described in detail here.

[0042] The array configuration of the near-infrared irradiation unit 300 is such that the emitted near-infrared light has a time-averaged total irradiance power and a spatiotemporal average optical power density of 27.5W or more, 31W or more, 40W or more, 60W or more, or 70W or more, irradiating a preset irradiation range within the containment space, and the spatiotemporal average optical power density irradiating the preset irradiation range does not exceed 230mW / cm2. The preset irradiation range is defined by at least the anterior upper part of the skull, the top of the skull, together with the left and right sides of the skull, on the surface of the skullcap of the object's head located in the containment space.

[0043] Regarding the array of near-infrared irradiation units 300, the emitted near-infrared light is relatively uniformly dispersed on the head of the object, and a high time-averaged optical power density can be formed at the overlapping areas. On the other hand, the near-infrared light irradiating the head of the object attenuates and disperses during transmission, ensuring that the spatiotemporal average optical power density does not exceed 230mW / cm2. This ensures that there are no areas with excessively high spatiotemporal average optical power density on the head of the object, thereby avoiding the risk of thermal damage.

[0044] Please note that the phrase "the object's head is positioned within the receiving space" in this document means that the object's head is in a standard treatment position within the receiving space, or within an allowable deviation from the standard treatment position. For example, in the standard treatment position, the object's head's center of gravity can be aligned with the center of the receiving space, and the front-to-back axes can be aligned with each other. Alternatively, in the standard treatment position, the object's head can be centered within the receiving space, with approximately equidistant front-to-back distances from the front and back walls of the receiving space, and approximately equidistant left-to-right distances from the left and right walls of the receiving space.

[0045] Because different patients have different head sizes, the preset irradiation range can be defined by using the surfaces of the smallest head segments as one boundary of the preset irradiation range, and the surfaces of the largest head segments as the other boundary. Therefore, this preset irradiation range can cover patients of any head size. The specific head size of each patient is determined by the following parameters:

[0046] The majority of AD patients are over 60 years old. For this age group, the following head parameters can be used: head width 140-166 mm, head length 170-196 mm, head circumference 525-583 mm, morphological face length 104-130 mm, head sagittal arc 304-372 mm, intertragic arc 320-375 mm, and head height 206-253 mm. These parameters are schematically shown in Figures 4(a)-4(d).

[0047] Specifically, the parameter range falls within the intersection of the distribution ranges of P1, P5, P10, P50, P90, P95, and P99 for women and men in this age group, thus providing good representativeness for both men and women in this age group. Furthermore, the cephalo-facial index of this parameter is 82%, which aligns with the cephalo-facial index range of the dominant head shape (Brachycephaly) in Chinese (and even East Asian) populations.

[0048] Specifically, the anterior superior part of the skull surface is mainly associated with the frontal lobe, the cranial vertex is mainly associated with the parietal lobe, and the left and right sides of the skull surface are mainly associated with the left and right temporal lobes. However, it is important to understand that this association is not merely spatial, but rather a connection in the brain's functional networks. Sufficient irradiation of the anterior superior part of the skull with near-infrared light can achieve neuromodulation of the frontal lobe, and the same applies to other parts. The inventors have discovered that by directly applying a time-averaged total irradiation power of 27.5W or higher to the skull of the subject, with the irradiation spatial range covering at least the anterior superior part, the cranial vertex, along with the left and right sides of the skull, sufficient energy of near-infrared light can be irradiated to the core network nodes and brain regions of the Default Mode Network (DMN), Central Executive Network (ECN, also known as the executive control network), Seminarization Network (SN), Sensorimotor Network (SMN), and Dorsal Attention Network (DAN), thereby effectively inhibiting or interrupting the propagation of neurodegenerative diseases caused by Aβ plaques and Tau protein abnormalities along the brain's functional networks. The inventors have creatively discovered that focusing solely on the average irradiation power per unit area (i.e., the light power density per unit area, mW / cm²) or solely on the irradiation energy (J / cm²) "filled" per unit area does not guarantee a robust therapeutic effect against Alzheimer's disease (AD) affecting the entire brain. Specifically, AD is a global brain disease where lesions spread from certain regions along functional connectivity areas of the brain's functional networks rather than along spatially related, less connected sites. Furthermore, AD lesions induce specific responses in specific cell populations (e.g., but not limited to, astrocytes, microglia, oligodendrocytes, neurons, vascular cells, peripheral glial cells, extracellular matrix, etc.). By applying a sufficiently long-term averaged total irradiation power to these cell populations, they not only exhibit altered responses that inhibit AD but also disseminate these altered responses along functional connectivity areas to other cell populations. Please note that the location and extent of the anterior upper part of the skull, the top of the skull, together with the left and right sides of the skull in this application correspond precisely to or target the core network nodes and brain regions of the aforementioned brain networks. By irradiating the core network nodes and brain regions of the aforementioned networks with sufficient time-averaged total irradiation power, the propagation path along the functional connectivity region is smoother, and the propagation and transmission of the inhibitory response is more efficient, thereby achieving an optimized AD inhibition effect throughout the whole brain.If we compare the process of irradiating a subject's head with near-infrared light to a battery charging process, such as a "photocharging" process, the near-infrared light therapy device of this application can increase the "photocharging capacity" of the subject's brain, deepen the "photocharging depth," and increase the "photocharging speed." Therefore, its subsequent "endurance" (that is, the time during which it can continuously trigger biochemical reactions, maintain the therapeutic effect, and even continuously accumulate the therapeutic effect after being charged with light energy) is also superior. This has been confirmed in the applicant's tests on individual AD volunteers in multiple nursing homes, and these tests have utilized this technology. Figures 1-3 The near-infrared light therapy device shown will be described further below.

[0049] Please note that, in order to achieve a predetermined irradiation range covering at least the upper front part, the top of the skull, and the left and right sides of the skull of the object's head, a three-dimensional, surrounding array of near-infrared irradiation units can be configured. Furthermore, to achieve the time-averaged total irradiation power and spatiotemporal average optical power density of the predetermined irradiation range—specifically, the time-averaged total irradiation power irradiated onto the predetermined irradiation range within the accommodating space must reach 27.5W or more, 31W or more, or 40W or more, or 60W or more, or 70W or more, and the spatiotemporal average optical power density irradiated onto the predetermined irradiation range must not exceed 230mW / cm²—the operating parameters of the near-infrared irradiation unit array can be controlled. The control of the near-infrared irradiation units can be implemented via devices such as an MCU and a drive circuit, which are readily available to those skilled in the art and will not be elaborated upon here. Taking a lamp panel composed of a set of LED devices as an example of a near-infrared irradiation unit, by selecting LED devices with appropriate configuration, such as an average time-averaged light power density of 70-120mW / cm2 at the emission surface, and combining them with an appropriate number of lamp panels arranged in a three-dimensional surround, the average time-averaged total irradiance power and the average spatiotemporal light power density of the preset irradiation range can be achieved.

[0050] In some embodiments, the average total irradiation power of the emitted near-infrared light irradiating the head of the subject is 23-140W, or 29-120W, or 31-100W. In some embodiments, the average total irradiation power can also be adapted according to the course of AD. The applicant tested the phototherapy effect on individual AD patients in several nursing homes, confirming that no adverse reactions occurred at this range of total power. AD patients also reported some relief from previous cognitive impairments, such as recent memory loss, muscle stiffness, and weakened spatial abilities.

[0051] Figures 1-3The structure illustrates an example of a light-transmitting inner shell 400 within the enclosure. As an example, the light-transmitting inner shell 400 can be a single, integral design, but is not limited to this. The light-transmitting inner shell 400 may also include multiple light-transmitting units, which can be correspondingly arranged with a single or group of near-infrared irradiation units to form an independent near-infrared irradiation assembly with a light-transmitting insulating surface; details are omitted here.

[0052] For example, the inner shell is made of a light-transmitting material to form a light-transmitting inner shell 400. The light-transmitting inner shell 400 has at least a front, a top, a left side, and a right side, and encloses an accommodating space. Near-infrared light emitted by the array of near-infrared irradiation units 300 exits through the light-transmitting inner shell 400 and irradiates the accommodating space. Using this light-transmitting inner shell 400, the head of the object can be protected from direct contact with the near-infrared irradiation units 300. Specifically, the upper front part corresponds to the upper front part of the skull, the top part corresponds to the top of the skull, the rear part corresponds to the back of the skull, the left side corresponds to the left side of the skull, and the right side corresponds to the right side of the skull. The near-infrared light emitted from the top, upper front, rear, left, and right sides of the light-transmitting inner shell 400 forms a flawless irradiated surface on the surface of the skullcap of the object's head. In this way, the near-infrared beam emitted from the array of near-infrared irradiation units 300 and exited through the light-transmitting inner shell 400 has no irradiation dead angles and can provide comprehensive radiation to all parts of the scalp of the subject's head. This not only applies transcranially to the core sites of lesions in the default mode network (DMN), central executive network (ECN, also known as executive control network), salience network (SN), sensorimotor network (SMN), and dorsal attention network (DAN), but also ensures that sufficient radiation is applied to the sites on the functional connectivity pathways between these core sites.

[0053] For example, the light-transmitting inner shell 400 can be an integral shell, and the inner walls of the light-transmitting inner shell 400 emit near-infrared light.

[0054] For example, the near-infrared irradiation unit 300 corresponding to the top of the translucent inner shell 400 is arranged along a dome-shaped curved surface. Since the top of the skull is curved, arranging the near-infrared irradiation unit 300 on a corresponding curved surface allows the emitted near-infrared light to generally point towards the top of the object's skull. Furthermore, the near-infrared irradiation units 300 can be arranged more densely on the curved surface. This improves the efficiency of the near-infrared irradiation units 300 and increases the light power density at the top of the skull. In some embodiments, although the near-infrared irradiation unit 300 is arranged on a curved surface, the irradiation direction of the near-infrared light can be vertical, and the distance between it and the object's head is sufficient to ensure that the near-infrared light, due to its divergence during propagation, covers the entire top of the object's skull upon reaching it, or irradiates the top of the object's skull after reflection and refraction. The first average distance between the top of the translucent inner shell 400 and its corresponding near-infrared irradiation unit 300 is greater than the second average distance between the left and right sides of the translucent inner shell 400 and their corresponding near-infrared irradiation units 300. Specifically, the inventors creatively discovered that when the subject's head is positioned, a space of at least several centimeters, or even close to 10 centimeters, is reserved on the skull to reduce the pressure felt during phototherapy. However, the near-infrared light emitted by multiple LEDs can overlap on the surface of the subject's head after propagating through this interval. Similarly, the near-infrared beams emitted by each near-infrared irradiation unit 300 can also overlap on the surface of the subject's head after propagating through this interval. Note that the multi-layered circumferential distribution of the multiple near-infrared irradiation units 300 is merely an example of an array of near-infrared irradiation units 300. The array of near-infrared irradiation units 300 can also employ LEDs, laser diodes, or optical fibers transmitting near-infrared light from the outside, which will not be elaborated upon here.

[0055] For AD patients, when their head is within the space of the near-infrared light therapy device, if they are too close to the near-infrared irradiation unit 300 at the top of the device, it may not only cause a significant increase in light power density in certain areas leading to discomfort, but it may also prevent the near-infrared light from multiple adjacent near-infrared irradiation units 300 from overlapping properly, resulting in blind spots in the treatment. The placement of the transparent inner cover ensures that even when the patient's head is against the inner cover, the distance between the patient and the near-infrared irradiation unit 300 remains at a safe distance, allowing the near-infrared light from the multiple units 300 at the top to overlap on the patient's skull without creating blind spots. In contrast, because the left and right sides of the patient's skull (described in detail below) are relatively flat, it is difficult to construct the near-infrared irradiation unit 300 so that its emitted near-infrared light overlaps. Therefore, by reducing the distance between the unit and the patient's head, the near-infrared light irradiating the patient's head can achieve sufficient light power density.

[0056] The eye is not a target area for near-infrared light therapy, and leaked near-infrared light irradiation can lead to uncontrollable risks and damage, including but not limited to infrared cataracts, retinal and choroidal damage, photosensitive cell damage, and corneal damage. Therefore, the main body 100 and the supporting mechanism not only support the near-infrared irradiation unit 300 but also prevent near-infrared light leakage. In some preferred embodiments, the near-infrared light therapy device may include a reflective layer that reflects near-infrared light deviating from the subject's head back towards the subject's head. The relatively small distance between the sidewalls of the receiving space and the subject's head allows the main body 100 and the supporting mechanism to be closer to the subject's head, reducing near-infrared light leakage. Near-infrared light from the top wall of the receiving space to the subject's head is blocked and / or reflected, preventing leakage.

[0057] For example, the main body 100 is a cover. When the head of the object is positioned in the receiving space, the lower part of the cover is located at the tragus or its periphery on both sides (e.g., 0.5-3 cm from the tragus), within a second predetermined distance above or below the external occipital protuberance on the posterior side, and above the brow bone on the anterior side extending flatly to both sides for a first predetermined distance, within a second predetermined distance above or below the external occipital protuberance on the posterior side. In some embodiments, the second predetermined distance is 1-2 cm, that is, the cover is located within a range of 1-2 cm above the external occipital protuberance and 1-2 cm below the external occipital protuberance on the posterior side. Due to the different head shapes of the objects used, the subjective influence of the wearer is significant, making it difficult to ensure that the lower edge of the cover is perfectly aligned with these positions. Figures 1-3 Taking the near-infrared light therapy device shown as an example, during wear and treatment, the brow bone of the subject's head can be aligned with the front edge of the device, and the subject's head should be positioned at the center within the device. This ensures that the front-to-back distance from the irradiation surface of the inner shell is approximately the same, and the left-to-right distance from the irradiation surface is also approximately the same. Therefore, positioning in the height direction is relatively easy. If the second average distance between the left and right sides of the translucent inner shell 400 and its corresponding near-infrared irradiation unit 300 is large, it may increase the difficulty of positioning during wear and treatment. Figures 1-3 In embodiments other than the near-infrared light therapy device shown, the second average distance between the left and right sides of the light-transmitting inner shell 400 and its corresponding near-infrared irradiation unit 300 is relatively large, which may make it difficult for the patient to confirm whether the left and right distances from the left and right walls of the receiving space are consistent, and will also increase the difficulty of positioning during wearing and treatment.

[0058] For example, the spatiotemporal average optical power density of the top of the translucent inner shell 400 is not higher than the spatiotemporal average optical power density of the front, left, and right sides, respectively. As described above, near-infrared light shines through the top of the translucent inner shell 400 onto the top of the subject's skull. The overall optical power density of the subject's head is relatively uniform, while the near-infrared light at the top of the skull comes not only from the near-infrared irradiation unit 300 at the top of the near-infrared light therapy device but also partially from other near-infrared irradiation units 300. Therefore, the spatiotemporal average optical power density emitted from the top of the inner surface of the translucent inner shell 400 can be relatively low because, relative to the top of the skull, the near-infrared light from other near-infrared irradiation units 300 overlaps less on the irradiation surface of the translucent inner shell 400. Note that the "irradiation surface of the translucent inner shell" mentioned below refers to the surface formed by the inner surface of the translucent inner shell 400, and the optical power density on this irradiation surface can be measured by attaching a sensor to this surface.

[0059] The optical power density of near-infrared light irradiating the transparent inner shell 400 and penetrating therein is affected by many factors. Specifically, for example, the maximum luminous power of the light-emitting elements in the array of near-infrared irradiation units 300 will affect the upper limit of the optical power density of the irradiated surface of the transparent inner shell 400. The array arrangement of the near-infrared irradiation units 300, the current provided by the controller, and the reflection of near-infrared light within the near-infrared light therapy device may also have an impact.

[0060] In one specific embodiment, at least the array of near-infrared irradiation units 300 is configured such that the spatiotemporal average optical power density of the irradiated surface of the light-transmitting inner shell 400 is 50-100 mw / cm2 at the top and 100±20 mw / cm2 at the front, left, and right sides.

[0061] For example, at least the array of near-infrared irradiation units 300 is configured such that the time-averaged optical power density emitted from all points on the inner wall of the light-transmitting inner shell 400 is above 20 mW / cm². That is, there are no locations on its inner wall with excessively low time-averaged optical power density.

[0062] In some embodiments, when multiple near-infrared irradiation units 300 are distributed on a spatial curved surface covering the head of the object with predetermined gaps, the time-averaged optical power density (or the spatiotemporal average optical power density) irradiated to representative positions of the top and upper anterior parts of the skull is higher than that irradiated to representative positions of the left and right sides of the skull (or the spatiotemporal average optical power density irradiated to the left and right sides of the skull). This is particularly applicable to... Figures 1-3The diagram illustrates an array of 300 near-infrared irradiation units at multiple heights, along with a spacious near-infrared light therapy device design. Specifically, while this design is highly acceptable to AD patients who dislike constraints, it can easily lead to obstruction of the left and right sides of the skull, or a weak superposition effect, resulting in lower light power density. By maximizing the light power density distribution in the top of the skull (where near-infrared light can be fully concentrated) and the sparsely haired, unobstructed anterior superior skull, leveraging their largest surface areas, a greater overall power can be provided to the anterior superior skull, top of the skull, left side of the skull, and the right side of the skull. Furthermore, the anterior superior skull and top of the skull correspond to a considerable number of core sites and regions of brain functional networks, thus achieving efficient "photocharging" of these core sites and regions prone to AD lesions. The applied near-infrared irradiation energy propagates more smoothly along the functional connectivity areas, resulting in more efficient dissemination and transmission of inhibitory responses, thereby achieving optimized AD suppression throughout the entire brain.

[0063] In embodiments where the main body 100 is a cover structure, the supporting mechanism is located on the side of the light-transmitting inner shell 400 away from the receiving space. This minimizes the possibility of direct contact between the object's head and the high-temperature near-infrared irradiation unit 300 on the supporting mechanism when the object's head is received in the receiving space, thus enhancing safety. In some embodiments, a cooling air cavity for introducing cooling air into the receiving space can also be formed between the supporting mechanism and the light-transmitting inner shell 400. Each near-infrared irradiation unit 300 in the first group of near-infrared irradiation units 300 has a preset emission angle and a preset spacing and drop configuration, resulting in multiple near-infrared light convergence areas formed on the top of the light-transmitting inner shell 400. The first group of near-infrared irradiation units 300 may include the aforementioned near-infrared irradiation unit 300 disposed on the top of the supporting mechanism. This unit can be disposed on a curved surface, and the near-infrared light emitted by the near-infrared irradiation unit 300 at a higher position overlaps with the near-infrared light emitted by the near-infrared irradiation unit 300 at a higher position when it irradiates the irradiation surface of the light-transmitting inner shell 400. Furthermore, the overlapping near-infrared light can pass through the light-transmitting inner shell 400 and illuminate the top of the subject's skull. In some embodiments, the light-transmitting inner shell 400 has certain optical properties that can modify the light path or homogenize the near-infrared light, thereby improving the therapeutic effect.

[0064] contrast Figures 1-3 As shown in Figure 5(d), the area on the skull includes both the top of the skull and part of the upper front of the skull, and this area is not obstructed by other parts of the head. For black or dark hair, a light guide comb can be used to part and bundle the hair on the skull to further improve light transmittance.

[0065] For example, the array of near-infrared irradiation units 300 includes a top layer, a middle layer, and a bottom layer. The bottom layer of near-infrared irradiation units 300 includes a first group and a second group separated circumferentially, with the first group and the second group corresponding to the left and right ears, respectively. This differs from designs that completely enclose the head and neck area within a housing, such as... Figures 1-3 The near-infrared light therapy device shown adopts a "cap"-like structure rather than a "helmet"-like structure. Specifically, the subject's vision is not obstructed, and there is sufficient distance between the head and the inner wall, like wearing a cap rather than being enclosed in the near-infrared light therapy device, reducing the subject's psychological stress. The near-infrared irradiation units 300 located at the left and right ears emit near-infrared light that can treat areas such as the temporal lobe through the ear canal, achieving good therapeutic effects.

[0066] For example, when the object's head is positioned in the receiving space, the near-infrared irradiation unit 300 in the lower middle layer is located adjacent to the brow bone of the object's head. As mentioned above, there is no hair obstructing the area above the brow bone after combing, and placing the near-infrared irradiation unit 300 there adjacent to the hair results in less heat being absorbed by the hair and less discomfort at the same light power density.

[0067] For example, when the object's head is in place in the receiving space, the middle layer is arranged circumferentially and covers a third predetermined distance in the longitudinal direction, so that the near-infrared irradiation units 300 on the front and left and right sides of the object's head correspond to the frontal lobe and left and right temporal lobes of the object's head, respectively, when the object's head is in place in the receiving space.

[0068] Figures 1-3 This near-infrared light therapy device is also an application example of an array of near-infrared irradiation units 300 at multiple heights in a surrounding configuration. Specifically, the supporting mechanism includes a housing disposed in the air, the housing being shaped to form a cavity, and the housing supporting at least three sets of near-infrared irradiation units 300 at different heights, with each set of near-infrared irradiation units 300 arranged circumferentially at their corresponding heights. This circumferentially spaced arrangement allows for a stable treatment effect when the subject's head is rotated in place, and also maintains a balanced and stable treatment effect on different circumferential positions and areas of the head.

[0069] In some embodiments, the anterior superior cranial portion 500a, the top of the cranial portion 500b, the left side of the cranial portion 500c, the right side of the cranial portion 500d, and the posterior cranial portion 500e can be defined based on their boundary lines. Referring to Figures 5(a)-5(e), the anterior superior cranial portion 500a is located within a first region enclosed by the first boundary line 502b and the total boundary line 501. According to the 10-10 standard lead system, the first boundary line 502b passes sequentially between the following electrode positions: between F7 and FT7, between F5 and FC5, between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between F6 and FC6, and between F8 and FT8. Within the second region enclosed by the second boundary line 502c, the top of the skull 500b passes sequentially between the following electrode positions according to the 10-10 standard lead system: between FC3 and C3, between FC1 and C1, between FCZ and CZ, between FC2 and C2, between FC4 and C4, between C6 and C4, between CP6 and CP4, between P6 and P4, between PO4 and P4, between PO4 and P2, between POZ and P2, between POZ and PZ, between POZ and P1, between PO3 and P1, between PO3 and P3, between P5 and P3, between CP5 and CP3, and between C5 and C3. In the left cranial region 500c, within the third region enclosed by the third boundary line 502d and the total boundary line 501, according to the 10-10 standard lead system, the third boundary line 502d passes sequentially between the following electrode positions: between FT7 and F7, between FC5 and F5, between FC5 and FC3, between C5 and C3, between CP5 and CP3, between P5 and P3, between P5 and PO5, and between P7 and PO7. In the right cranial region 500d, within the fourth region enclosed by the fourth boundary line 502e and the total boundary line 501, according to the 10-10 standard lead system, the fourth boundary line 502e passes sequentially between the following electrode positions: between FT8 and F8, between FC6 and F6, between FC6 and FC4, between C6 and C4, between CP6 and CP4, between P6 and P4, between P6 and PO6, and between P8 and PO8. Within the fifth region enclosed by the fifth boundary line 502a and the total boundary line 501 in the posterior cranial region 500e, according to the 10-10 standard lead system, the fifth boundary line 502a sequentially passes between the following electrode positions: between P7 and PO7, between P5 and PO5, between P3 and PO3, between P1 and POZ, between PZ and POZ, between P2 and POZ, between P4 and PO4, between P6 and PO6, and between P8 and PO8. The term "passing between electrode positions A and B" in this application is intended to refer to the intermediate point on the line connecting electrode positions A and B.For example, the intermediate point can be the midpoint of the line connecting the electrode positions, or it can be any other point on the line, such as a point located at a distance of 1:2 from electrode positions A and B. In some embodiments, for the same boundary line, such as the fifth boundary line 502a, the points that pass between the paired electrode positions can be located at different proportions on the line connecting the electrode positions, so that the boundary line formed by the sequential connection is smooth.

[0070] In some embodiments, the anterior upper part 500a, the top of the skull 500b, the left side of the skull 500c, the right side of the skull 500d, and the posterior part of the skull 500e can also be defined based on the electrode positions they contain. Referring to Figures 5(a)-5(e), the anterior upper part 500a forms a region including electrode positions FP2, FPZ, FP1, AF3, AF4, AF7, AF8, AFZ, FZ, F1, F2, F3, F4, F5, F6, F7, F8, FC1, FC2, FC3, FC4, and FCZ. The top of the skull 500b forms a region including electrode positions CZ, C1, C2, C3, C4, CPZ, CP1, CP2, CP3, CP4, PZ, P1, P2, P3, and P4. The left cranial portion 500c forms a region including electrode positions FT7, FC5, T7, C5, TP7, CP5, P7, and P5, while the right cranial portion 500d forms a region including electrode positions FT8, FC6, T8, C6, TP8, CP6, P8, and P6. The posterior cranial portion 500e forms a region including electrode positions PO7, PO5, PO3, PO2, PO4, PO6, PO8, O1, O2, and O2.

[0071] Figure 6 This diagram illustrates the spatial locations of the Default Mode Network (DMN), Central Executive Network (ECN, also known as the Executive Control Network), Spokesperson Network (SN), Sensorimotor Network (SMN), Dorsal Attention Network (DAN), and Visual Network (VN) in the brain. Figure 6As shown, the sites in the anterior part of the DMN include the medial prefrontal cortex, anterior cingulate cortex, dorsal prefrontal cortex, and lateral temporal lobe, while the sites in the posterior part include the medial temporal lobe, hippocampus, angular gyrus, inferior parietal lobule, posterior cingulate cortex, and ventral prefrontal cortex. More than a decade before the onset of identifiable cognitive states, β-amyloid (Aβ) begins to significantly deposit in the DMN, spreading along functional connectivity regions rather than along spatially related, less connected sites. In patients with dementia and MCI, brain functional networks are frequently damaged in the posterior cingulate cortex, medial temporal lobe (especially the hippocampal nodes), and posterior parietal lobe. In MCI patients, Aβ deposition initially occurs in the posterior cingulate cortex, prefrontal lobe, precuneus, and parietal-temporal lobes, leading to reduced and weakened functional connectivity in other brain regions within these areas. These lesion sites are well covered by the anterior superior cranial region (500a), cranial parietal region (500b), left cranial region (500c), and right cranial region (500d).

[0072] The salience network (SN), also known as the ventral attention network, together with the dorsal attention network (DAN), constitutes the attention network (AN). The salience network is mainly distributed in the anterior cingulate cortex, frontal insula cortex, and ventral prefrontal cortex. Abnormal increases in its internal function are related to damage to its functional network, leading to hyperactivity symptoms, especially in dementia patients, such as, but not limited to, irritability, abnormal motor behavior (restless pacing), anger, and aggressive behavior. In fact, weakened functional connectivity in the DMN can compensate by increasing SN-related functional connectivity; for example, enhanced SN connectivity in the right anterior genicular cingulate cortex. The DAN is mainly distributed in the intraparietal sulcus and oculomotor area of ​​the frontal lobe. Reduced functional connectivity between the DAN and SN is also closely associated with attention deficits in AD patients. Specifically, both the DAN and SN are damaged in AD patients, while in MCI patients, DAN function is impaired while the internal functional connectivity of the SN is somewhat preserved. See also Figure 6 The anterior superior cranial region 500a, cranial top 500b, left cranial region 500c, and right cranial region 500d fully cover the frontal lobe, especially adjacent to the temporal lobe, as well as the parietal lobe, thus fully covering the important sites of lesions in SN and DAN in AD patients.

[0073] The central executive network (ECN, also known as the executive control network) is mainly distributed in the dorsolateral prefrontal cortex, ventral prefrontal cortex, medial prefrontal cortex, and parietal cortex, etc. See [link to relevant documentation]. Figure 6In the early stages of Alzheimer's disease (AD), the functional connectivity patterns of the ECN (external coronary neural network) have already changed. For example, functional connectivity between the left frontal cortex and other brain regions is reduced, as is functional connectivity in the left parietal cortex, which is associated with visuospatial impairment. For instance, in patients during the dementia stage and MCI (Minimal Cognitive Impairment), functional connectivity in the right frontal lobe and superior frontal gyrus of the ECN is significantly reduced, which is associated with cognitive decline. Not only is internal functional connectivity within the ECN reduced, but functional connectivity between the ECN and the DMN (Digital Superior Brain Narrowing) is also reduced, leading to the spread of impaired executive control. The anterior superior cranial region (500a), cranial vertex (500b), left cranial region (500c), and right cranial region (500d) adequately cover these lesion sites.

[0074] The sensorimotor network (SMN) is responsible for body perception and movement, and mainly includes the precentral gyrus and postcentral gyrus. See [link to relevant documentation]. Figure 6 The SMN is mainly distributed in the adjacent areas before and after the central sulcus, extending laterally to the temporal lobe along the central sulcus. Impaired functional connectivity of the SMN leads to motor dysfunction in AD patients. Furthermore, in patients in the dementia and MCI stages, reduced functional connectivity between the SMN and DAN is closely associated with attention deficit; as AD progresses, the internal functional connectivity of the SMN deteriorates further, as does its functional connectivity with the DAN. The anterior superior cranial region 500a and the apical cranial region 500b tightly cover the adjacent areas before and after the central sulcus, and together with the left lateral cranial region 500c and the right lateral cranial region 500d, they extend longitudinally to the temporal lobe, fully covering these lesion sites.

[0075] Unlike near-infrared light therapy devices that lack coverage at the top of the skull and only focus on the DMN, the near-infrared light therapy device of this application ensures that sufficient time-averaged irradiation power is comprehensively applied to the core sites of lesions in the Default Mode Network (DMN), Central Executive Network (ECN, also known as the executive control network), Seminarization Network (SN), Sensorimotor Network (SMN), and Dorsal Attention Network (DAN). Furthermore, the near-infrared light therapy device of this application uses a 10-10 standard lead system to precisely divide the upper anterior cranial region (500a), top cranial region (500b), left cranial region (500c), and right cranial region (500d), ensuring precise localization of sites at brain region junctions within these networks, as well as sites connecting different functional networks, thereby reducing the loss or omission of sites of action within the networks. Therefore, the near-infrared light irradiation applied by the near-infrared light therapy device of this application has a smoother propagation path along functional connectivity areas, and the propagation and transmission of inhibitory responses are more efficient, thus achieving optimized AD inhibition effects across the entire brain. If the process of irradiating a subject's head with near-infrared light is analogous to a battery charging process, such as a "photocharging" process, then the near-infrared light therapy device of this application, because it fully "photocharges" the core sites of DMN, ECN, SN, SMN, and DAN where AD lesions occur, can achieve a larger "photocharging capacity," a deeper "photocharging depth," and a faster "photocharging speed" in the subject's brain. This results in better subsequent "endurance," meaning that the biochemical reactions are continuously triggered even after phototherapy is interrupted, leading to sustained and cumulative benefits. This effect has also been verified by clinical trial results from multiple AD patient volunteers. It should be noted that the terminology used herein is for describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, unless the context clearly indicates otherwise, the singular form is intended to include the plural form as well. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, parts, components, and / or combinations thereof.

[0076] This application has been described through the above embodiments. However, it should be understood that the above embodiments are for illustrative purposes only and are not intended to limit the present invention to the described embodiments. Furthermore, those skilled in the art will understand that the present invention is not limited to the above embodiments, and many more variations and modifications can be made based on the teachings of the present invention, all of which fall within the scope of protection claimed by the present invention. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A near-infrared light therapy device for inhibiting or preventing Alzheimer's disease, characterized in that, include: The main body is configured to have a receiving space for accommodating the head of an object; as well as An array of near-infrared irradiation units is arranged on a supporting structure and configured to emit near-infrared light into the accommodating space. The array of near-infrared irradiation units is configured such that the time-averaged total irradiation power irradiating a predetermined irradiation range within the accommodating space reaches 27.5W or more, 31W or more, 40W or more, 60W or more, or 70W or more, and the spatiotemporal average optical power density irradiating the predetermined irradiation range does not exceed 230 mW / cm². 2 The preset irradiation range is defined by at least the anterior upper part of the skull, the top of the skull, together with the left and right sides of the skull, on the surface of the skull cap of the object located in the containment space.

2. The near-infrared light therapy device according to claim 1, characterized in that, The main body includes a light-transmitting inner shell, which forms at least a front, a top, a left side, and a right side, and encloses the receiving space. Near-infrared light emitted by the array of near-infrared irradiation units is emitted through the light-transmitting inner shell and irradiates the receiving space.

3. The near-infrared light therapy device according to claim 2, characterized in that, The array of at least the near-infrared irradiation units is configured such that the time-averaged optical power density of the irradiated surface of the transparent inner shell is 50-100 mW / cm² at the top. 2 The front portion, the left side portion, and the right side portion have a strength of 100±20 mW / cm. 2 .

4. The near-infrared light therapy device according to claim 2, characterized in that, The spatiotemporal average optical power density at the top of the light-transmitting inner shell is not higher than the spatiotemporal average optical power density of the front, left, and right sides, respectively.

5. The near-infrared light therapy device according to claim 2, characterized in that... The near-infrared irradiation unit corresponding to the top of the light-transmitting inner shell is arranged along the dome-shaped curved surface. The first average distance between the top of the light-transmitting inner shell and its corresponding near-infrared irradiation unit is greater than the second average distance between the left and right sides of the light-transmitting inner shell and their corresponding near-infrared irradiation units.

6. The near-infrared light therapy device according to claim 2, characterized in that, The array of near-infrared irradiation units is configured such that the time-averaged optical power density emitted from all points on the inner wall of the transparent inner shell is 20 mW / cm². 2 above.

7. The near-infrared light therapy device according to claim 2, characterized in that, The main body is a cover structure, and the supporting mechanism is located on the side of the light-transmitting inner shell away from the accommodating space. Each near-infrared irradiation unit in the first group of near-infrared irradiation units has a preset emission angle and a preset interval and drop configuration, so that multiple near-infrared light convergence areas are formed on the top of the light-transmitting inner shell.

8. The near-infrared light therapy device according to any one of claims 1-7, characterized in that, The array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer. The bottom layer of near-infrared irradiation units includes a first group and a second group separated in the circumferential direction. The first group and the second group are respectively set for the left ear and the right ear.

9. The near-infrared light therapy device according to any one of claims 1-7, characterized in that, The main body is a cover. When the head of the object is in place in the receiving space, the lower part of the cover is located at the tragus or its periphery on both sides, the front side is located above the brow bone and extends flat to both sides for a first predetermined distance, and the rear side is located within a second predetermined distance above or below the external occipital protuberance.

10. The near-infrared light therapy device according to any one of claims 1-7, characterized in that, The array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer. When the object's head is in place in the receiving space, the near-infrared irradiation unit in the lower middle layer is adjacent to the brow bone of the object's head.

11. The near-infrared light therapy device according to any one of claims 1-7, characterized in that, The array of near-infrared irradiation units includes a top layer, a middle layer, and a bottom layer. When the object's head is in place in the receiving space, the middle layer is arranged circumferentially and covers a third predetermined distance in the longitudinal direction, so that the near-infrared irradiation units in front of and on the left and right sides correspond to the frontal lobe and the left and right temporal lobes of the object's head, respectively, when the object's head is in place in the receiving space.

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