CN111420293A - Device for treating brain diseases based on semiconductor laser external irradiation technology - Google Patents

Abstract

The invention relates to a device for treating brain diseases, in particular to a device for treating brain diseases based on semiconductor laser external irradiation technology, which solves the problem that the irradiation light emitted by the existing treatment device cannot irradiate the deep brain cells of the skull, and the illumination does not Uniform, bulky helmet, impossible to implement. The device includes a helmet, a semiconductor laser generator, at least one energy-transmitting optical fiber, a power supply and a main control box; its special features are: the helmet includes an outer layer of the helmet and at least one scattering optical fiber arranged inside the outer layer of the helmet; The optical fiber is connected with the scattering fiber; the semiconductor laser generator is used to generate laser light with a wavelength of 600-1400nm; the semiconductor laser generator is connected with all the energy-transmitting fibers separately, and is used to output the average power of the total 5W-200W laser to all the scattering fibers or make the The average laser power density of the scattering fibers irradiated on the skin surface was between 30‑500 mW/cm ² .

Description

Device for treating brain diseases based on semiconductor laser external irradiation technology

technical field

The invention relates to a device for treating brain diseases, in particular to a device for treating brain diseases based on semiconductor laser external irradiation technology.

Background technique

The use of low-level laser therapy (or Low-level lighttherapy, LLLT) to treat tissue pain within 30 cm of the human skin has been around for decades. So far, researchers around the world have completed more than 500 various clinical trials and more than 4,000 laboratory animal studies, confirming that red and infrared light with wavelengths of 600nm-1400nm can relieve pain and reduce pain. It plays an effective role in inflammation, regulating immune response, promoting wound healing, stimulating human acupuncture points, and promoting hair growth. Its biophysical principle is: using quasi-monochromatic light of low and medium power density (mW/cm ² ) and large energy density (J/cm ² ) in red to near-infrared wavelengths with narrow-band spectrum to non-destructive and non-thermal photobiomodulation (PBM) at the cellular level. PBM uses low-medium-intensity narrow-band light to non-invasively or non-invasively irradiate human tissues, and modulate a series of biochemical effects at the cellular level, including increasing the activity of cytochrome oxidase, cellular oxygen consumption, nitric oxide production and other major therapeutic effects , as well as subsequent therapeutic effects such as promoting vasodilation in the light-irradiated area, improving blood flow, and increasing the speed of cellular and neurorehabilitation. The light sources used in PBM are narrow-band light sources, including lasers, LEDs, and light bulbs with narrow-band filters.

It is currently recognized that the mechanism of PBM is closely related to the key protein of cytochrome c oxidase (CCO). This protein is located at the end of the cell mitochondria and is an endogenous neuron photoreceptor. It is part of the mitochondrial respiratory chain in the cell and is responsible for catalyzing the reduction of oxygen molecules in glucose metabolism into water molecules, and is coupled with the proton pump function. Cytochrome oxidase is present in all human cells and is more abundant in neurons with high energy demands. CCOs are the main photoacceptors that absorb light in the red to near-infrared region of the spectrum. When COO is stimulated by light, it not only increases the activity of electron transport chain in mitochondria, but also regulates the synthesis of nitric oxide (Nitric Oxide Synthesis, NOS). NOS can catalyze arginine (Arginine) in cells to produce nitric oxide (NO). NO is a highly lipophilic gas, which melts with Soluble Guanylyl Cyclase (sGC), converts Guanosine Triphosphate (GTP) into Cyclic Guanosine Monophosphate (cGMP), increases Expression of cGMP in cells. A study by Poyton et al. (2011) suggested that NO may be produced by PBM in two ways: 1) NO may be transiently released from the cytochrome oxidase catalytic site when light stimulates cytochrome oxidase; 2) when oxygen When levels drop, ie, hypoxia-inducible factor (HIF-1α) increases, cytochrome oxidase activity itself may generate NO. The role of cytochrome oxidase is to catalyze the formation of water at high oxygen levels and NO formation from nitrate at low oxygen levels. Therefore, under light stimulation, the increase of NO in turn increases the expression of cGMP in cells, and the increase of cGMP expression can cause vasodilation and increase blood flow. It is generally believed that hypoxic injury or death of body cells will cause nerve cells to produce excessive NO and inhibit the enzymatic activity of CCO. However, photons of red and near-infrared light can separate excess NO, restore physiological levels of NO, and make mitochondrial The membrane is better able to metabolize oxygen and glucose, resulting in more adenosine triphosphate (ATP). ATP is the main source of cellular energy in regulating cellular processes.

CCO is a terminal enzyme located in the electron transport chain in the outer mitochondrial membrane. The electron transport chain facilitates the transfer of electrons across the inner mitochondrial membrane through a series of redox reactions. The end result of these electron transfer steps is the creation of a proton gradient across the mitochondrial membrane, which drives the activity of ATP Synthesis. ATP synthase produces ATP from adenosine diphosphate (ADP). CCO mediates the transfer of electrons from cytochrome c to molecular oxygen. CCO is a complex protein composed of 13 distinct polypeptide subunits that also contains two heme centers and two copper centers. Both the heme center and the copper center can be oxidized or reduced, resulting in sixteen different oxidation states. Each oxidation state has a slightly different absorption spectrum, but CCO is almost unique among biomolecules with significant absorption in the red and near-infrared spectra. According to the current study, more than 50% of the absorption of red and near-infrared light by biological tissues can be attributed to CCO. During PBM, light not only increased mitochondrial membrane potential (ΔΨ) and proton gradient (ΔpH). Mitochondrial optical properties were also altered, increased ADP/ATP exchange, ribonucleic acid (RNA) and protein synthesis in mitochondria, and increased oxygen consumption. Several studies have found that the effect of PBM on mitochondria in different tissues is wavelength-specific. As far as brain nerve tissue is concerned, CCO has strong absorption of light at wavelengths of 665 nm and 810 nm.

In the 1990s, Kaelin, Ratcliffe and Semenza, winners of the 2019 Nobel Prize in Physiology or Medicine, discovered that cells sense and adapt to oxygen through the interaction of VHL, hypoxia-inducible factor (HIF-1α), and hydroxyl (OH). supply. In 2012, Taiwanese scholar Yueh-Ling Hsieh found that low-power laser irradiation can modulate the activity of HIF-1a, improve tissue hypoxia/ischemia and nerve bundle inflammation, and promote nerve regeneration. Harvard scholar Hamblin also mentioned the down-regulation of HIF-1a levels by PBM in 2013. When oxygen levels are high, cells contain little HIF-1α. However, when oxygen levels are low, the amount of HIF-1α increases. Downregulation of HIF-1a levels by BPM indicates increased oxygen levels in cells.

Since brain cell activity requires a lot of energy, cytochrome oxidase is more abundant in neuronal cells in the brain. Since cytochrome oxidase plays an important role in cellular respiration, the expression of cytochrome oxidase is therefore also a sensitive marker of neuronal activity. Photons in the action of PBM can not only accelerate the catalytic activity and oxygen consumption rate of cytochrome oxidase, increase the production of ATP in the brain, but also induce a large number of secondary cellular effects. These subsequent secondary effects include activating gene expression in cells, increasing the metabolic capacity of neurons, and improving cell survival.

PBM enhances the activity of the electron transport chain in brain cells and also regulates NOS. NOS is normally activated by glutamatergic receptors (AMPAR and NMDAR) to generate NO, which acts as a second messenger to regulate cytochrome oxidase activity, which further regulates cellular respiration. A study by Uozumi et al. (2010) noted a peak increase in NO followed by a subsequent decrease after 5 min of PBM irradiation. With increased cerebral blood flow, local increases in NO lead to vasodilation and hemodynamic responses.

There are many kinds of brain diseases, including neuronal degeneration brain diseases, sequelae of traumatic encephalopathy, sequelae of vascular encephalopathy, sequelae of infectious encephalopathy, metabolic encephalopathy, mental and psychological encephalopathy and other diseases. Some brain diseases have known causes or known partial causes, such as vascular brain diseases i.e. cerebral infarction, cerebral hemorrhage, hypoxic brain injury, atherosclerotic stroke, embolic stroke, ischemic stroke, acute traumatic Brain injury, chronic traumatic brain injury, neurodegenerative diseases, depression, Parkinson's disease, etc., there are many still unknown real causes, such as Alzheimer's disease (Alzheimer's Disease, AD). Many brain diseases can lead to dementia. Dementia can be roughly divided into congenital dementia and acquired dementia. Including senile dementia, brain damage dementia, etc. are all acquired dementia caused by degenerative brain diseases. AD patients are generally accompanied by different degrees of senile dementia. The current study found that PBM has some degree of benefit in brain diseases other than congenital dementia.

Alzheimer's disease is a common, chronic progressive neurodegenerative disease that gradually leads to dementia. , slow thinking, decreased attention and emotional disturbances are characterized. Its etiology and pathogenesis are complex, with many genetic and environmental risk factors, including mental stress and insulin resistance. Typical pathological manifestations are amyloid deposition, neurofibrillary tangles, neuronal reduction, axonal and synaptic abnormalities, and granular vacuolar degeneration. Expression of many genes and upregulation of multiple pathogenic pathway factors lead to amyloid beta peptide (Aβ) deposition, tau hyperphosphorylated tangles, inflammation, reactive oxidative stress, reactive oxygen species (ROS), mitochondrial disease, insulin resistance, Defective methylation, and downregulation of neuroprotective factors. Although AD pathology is well recognized as β-amyloid plaques and tau tangles, many related etiologies remain unclear and require extensive research.

Aside from cancer, AD and Alzheimer's may be one of the most worrisome health problems facing the world today. With the aging of the social population, the incidence of AD is gradually increasing. According to the "World Alzheimer Report 2018", there were nearly 50 million AD patients worldwide in 2018, and it is expected to increase to 152 million by 2050. Public information shows that there are about 10 million Alzheimer's patients in my country, which is the country with the largest number of patients in the world. With the accelerated aging of the population, it is estimated that there will be 40 million patients in my country by 2050. There are currently very few drugs that can be effectively used to treat AD and dementia. Numerous clinical trials of tested drugs over the past few decades have failed to reverse, improve, or even stabilize the progressive decline of cognitive function in people with dementia.

Gonzalez-Lima et al. (1998) and Valla et al. (2001) demonstrated that cognitive impairment and neurodegeneration associated with dementia manifest local brain metabolic deficits early in the disease. For example, in patients at risk for AD, an early drop in metabolic activity in the brain, especially cytochrome oxidase activity, can be detected. Likewise, phenotypic expression in disorders such as major depression and post-traumatic stress disorder is associated with decreased metabolic capacity in frontal forebrain regions. PBM is expected to enhance the metabolic capacity of those regions showing functional deficits, thereby increasing the functional connectivity of brain neural networks.

Many studies have found that mitochondrial dysfunction, insufficient ATP supply, and oxidative stress are contributing factors to nearly all forms of brain disease. Many neurological diseases, including major depressive disorder, traumatic brain injury, Parkinson's disease and AD are related to these factors.

In terms of molecular studies of PBM, Lu et al. (2017) confirmed that PBM can improve mitochondrial dynamics, increase mitochondrial membrane potential, reduce oxidized mitochondrial DNA, inhibit apoptosis, increase mitochondrial antioxidant expression, increase CCO activity and ATP levels, inhibition of Aβ-induced reactive gliosis, inflammation and tau hyperphosphorylation. Lee (2017) et al proposed that NO release due to PBM was responsible for the increased cerebral blood flow. NO is a major neuronal signaling molecule that, among other functions, has the ability to trigger vasodilation. To do this, it first stimulates soluble guanylate cyclase to form cyclic GMP (cGMP); then, cGMP activates protein kinase G, leading to reuptake of ^Ca and opening of calcium-activated potassium channels. Decreased Ca ²⁺ concentration prevents myosin light chain kinase from phosphorylating myosin molecules, thereby relaxing the smooth muscle cells in the walls of blood vessels and lymphatic vessels. This vasodilation then increases blood circulation, which in turn improves the oxygenation process of the brain.

Oxidative stress occurs when there is an imbalance between the production of reactive oxygen species (ROS) and the body's ability to resist, and when ROS are in excess, they become harmful through antioxidants. Many studies have found that oxidative stress is associated with various neurological diseases, such as severe depression and traumatic brain injury, cardiovascular disease and AD. PBM can regulate the balance of ROS at the cellular level and alleviate the disease.

PBM can improve metabolic function at the cellular level by increasing intracellular ATP production. Numerous studies have shown that PBM can protect nerves at the cellular level, protect cells from damage, promote their survival, prolong lifespan, and reverse apoptotic signaling. A study by Oron et al. (2006) found that transcranial PBM (tPBM) stimulates nerve cell growth. At the tissue level, some research experiments have confirmed that tPBM improves cerebral blood flow and oxygenation process, and also exhibits certain anti-inflammatory effects.

Similar to the results achieved by physical exercise, tPBM can promote the regeneration and relaxation of microvessels in the brain and improve blood circulation. These improvements in blood flow function can effectively reduce the probability of microvascular rupture in the brain of elderly patients, reduce the death rate of brain cells caused by microvascular rupture, reduce the probability of dementia and delay the occurrence of dementia.

PBMs (LLLTs) have long used red or near-infrared light for wound healing, pain relief, treatment of inflammation, and prevention of tissue death. In recent years, there have been many high-level studies abroad using red or near-infrared light to non-invasively irradiate the head (tPBM) to treat a variety of brain diseases through animal experiments, human clinical trials, and other methods. Ando et al. (2011) and Salehpour et al. (2017) treated experimental animals (mice or rats) with some brain diseases with tPBM and found increased levels of ATP in the brains of these experimental animals. De Taboada et al. (2011) used an 810 nm laser to irradiate the heads of transgenic mice with amyloid beta precursor protein (AβPP) at different irradiation doses (three times a week for 6 months) and found that Aβ in the mouse brains The number of plaques was significantly reduced. PBM resulted in dose-dependent reductions in amyloid burden, soluble AβPPα, and markers of encephalitis. Both ATP levels and mitochondrial function were elevated; the mice also improved cognitive function as measured by the Morris water maze.

Hamblin (2016), Hennessy and Hamblin (2016), Thunshelle and Hamblin (2016) used tPBM modalities to treat a variety of brain disorders, including sudden illness (stroke, traumatic brain injury, TBI, cerebrovascular ischemia) , neurodegenerative (Alzheimer's, Parkinson's, dementia) or psychotic (depression, anxiety, post-traumatic stress disorder), confirming that tPBM is not only effective, but there is no observable side effects.

Saltmarche et al. (2017) reported a small human clinical trial of tPBM in AD. The clinical trial enrolled 5 patients diagnosed with mild to moderately severe dementia (Mini-Mental State Exam, MMSE, score 10-24). The study used Vielight's Neuro alpha (810nm, 10Hz pulsed LED) PBM therapy device, combined with transcranial and intranasal PBM to treat the brain's default network cortical nodules (bilateral medial prefrontal cortex, anterior neurite/posterior cingulate) gyrus, angular gyrus and hippocampus). During the 12-week treatment period, each patient was treated with transcranial tPBM/intranasal PBM in the office weekly and intranasal PBM daily at home. The 12-week follow-up was followed by a 4-week follow-up without any treatment. At 12 weeks, all patients were found to have significantly enhanced cognitive function (MMSE and ADAS-cog), improved sleep, and reduced restlessness, anxiety, and wandering mood. No adverse side effects were found. However, during the 4-week follow-up period, these improved effects were observed to decline rapidly again. This suggests that for sustained improvement and remission of dementia, patients need weekly or even daily treatment with transcranial tPBM.

Using the safety and effectiveness of PBM in the treatment of brain diseases, there are many related products and patents at home and abroad. The more representative products in foreign countries include the use of LED light source for transcranial and intranasal PBM irradiation by Vielight Company of Canada; the transcranial irradiation of LED light source helmet from Photomedex Company of the United States; the transcranial irradiation of LED light source helmet from THOR Photomedicine Company of the United Kingdom; Cognitolite Company of Ireland LED light source for helmet transcranial irradiation, etc. Domestic products include Tianjin Leiyi Laser Technology Co., Ltd. that uses lasers to irradiate brain acupuncture points, or other companies that use lasers to irradiate into the head through the ears and other products. The light sources in the above products are all low-power light sources with optical power less than 5W.

US Patent No. US8,535,361B2, US Patent Application No. US2014/0358199A1, US2018/0256917A9 are inventions of Dr. Lew Lim of Vielight Company. In these three patents, Dr. Lim discloses a device that uses a battery-operated light source of no more than 20 mW placed in a nostril. The intranasal irradiation device can irradiate light from the nasal cavity to the brain parts such as the hippocampus through the thin skull. The advantage of these three US patented inventions is that the design is lightweight and can use less expensive LEDs as light sources. But its shortcomings are also obvious. The low power of the LED light source cannot effectively penetrate the skull, and effectively irradiate the brain cells deep in the skull to achieve the desired effect. According to Henderson et al. (2019), the depth of transnasal LED illumination generally does not exceed 2 cm.

Luis De Taboada et al. and his company Photothera have applied for and obtained several invention patents in the United States and Europe, including US Patent Nos. US7,303,578B2, US7,309,348B2, US7,575,589B2, US8,308,784B2, US10,188,872B2 , US10,357,662B2 and European Patent Application No. EP2,489,403A2 and so on. In these patents, De Taboada et al. respectively disclose the use of red to near-infrared lasers to irradiate the head for the treatment of brain diseases. The irradiation helmets are broadly classified into three types. The first is to use one or more fiber-coupled lasers through a A complex transmitter head with optical lenses is fixed on a helmet with multiple holes to illuminate the head. The second is to irradiate the head with multiple semiconductor lasers fixed on a specific helmet. The third is to direct the laser through an optical fiber into a device with multiple fibers, called a light blanket, to illuminate the head. Among them, the first and second designs require a very complex set of optical, mechanical, heat dissipation and electronic control devices because the laser directly irradiates the head, and there is no laser safety automatic protection device. patient treatment. In the third type, although the optical fiber is used to guide the laser into the light blanket, the helmet becomes lighter, but due to: 1) There is no light feedback detection and interlocking device, when the optical fiber is accidentally broken during use or due to a local laser irradiation When the laser power is too high, the helmet will cause injury to the patient; 2) Using continuous emission (CW) laser, when the laser power is high, it will cause damage to the external tissues of the head, such as hair, scalp, etc., when the laser power is too low, it will not be able to The laser is irradiated to the deeper areas of the brain; 3) In the case of infrared irradiation, there is no indicator light and no intelligent electronic control device, so an untrained person cannot treat the patient. In conclusion, the inventions disclosed in the series of patents by Luis De Taboada et al have many design flaws, high cost, insecurity and technical problems that are difficult to implement.

In a series of patent applications such as US20170304584A1, US20190105509A1, US20190126062A1, US20190240443A1, Li-HueiTsai et al. of the Massachusetts Institute of Technology disclosed the use of low light with 10-100Hz to stimulate the eyes and head, and 10-100Hz sound to stimulate Ear, 10-100Hz mechanical vibration stimulates the brain to treat AD and dementia. The invention is based on the principle of optical signal or electromagnetic wave signal, acoustic signal or mechanical vibration signal to stimulate and resonate brain waves, which belongs to the theory and mechanism of optogenetics, not based on the biomedical principle of PBM energy using a certain energy (including Promote nerve cell repair, regeneration, increase cerebral blood flow and cerebral blood oxygen content, etc.) to treat AD, dementia and other brain diseases.

The name of the invention is "a therapeutic device for using LED light to stimulate acupoints on the head", and the Chinese patent with the authorization announcement number CN201768276U discloses a near-infrared LED light aimed at the corresponding acupoints on the patient's head, and the LED light can penetrate The scalp and skull reach damaged brain cells for therapeutic purposes through a combination of acupoint stimulation and photobiomodulation. This patent is similar to the above-mentioned other methods of using LED treatment. The advantages are simple design and low cost, but the disadvantage is that the low power of the LED light source cannot effectively penetrate the skull, and effectively irradiate the deep brain cells in the skull to achieve the desired effect. Effect. As mentioned above, this is because of the low brightness and low optical power of any LED compared to a laser, which does not allow enough photons to reach brain tissue deeper than 2cm. If multiple LED arrays are used, heat sinks, such as fans, are necessary for the LED arrays, making the entire helmet bulky. In addition, multiple LED arrays can only increase the irradiation area, but cannot increase the irradiation depth.

The name of the invention is "Near-Infrared Light Therapy Apparatus for Treating Brain Diseases", and the Chinese Patent Application Publication No. CN 104162233A discloses a near-infrared light therapy apparatus. A plurality of near-infrared LED light sources are fixed on a helmet-shaped hemispherical surface. On the stand, the main light distribution design principle is similar to the first or second design of Luis De Taboada et al. However, in terms of light source, the invention also uses LEDs. Even if the LEDs work in flashing mode, the peak power of the light is very low, and it cannot irradiate tissues deeper than 2cm in the brain. Because of its close-fitting design, if the LED is replaced by a semiconductor laser, the laser spot on the hair or scalp will be too small, and the laser power density will be too large, which will damage the hair or scalp.

The name of the invention is "a wearable optoelectronic integrated autism treatment device", and the Chinese patent application publication number CN109432607A discloses an LED with multiple wavelengths from red light to near-infrared to illuminate the brain, and combined with 2Hz or 40Hz pulsed electrical stimulation together to treat brain disorders such as autism. The name of the invention is "a kind of red light helmet", and the Chinese patent with the authorization announcement number CN 204890973U describes another kind of helmet, which uses a plurality of red LEDs to illuminate the brain. The application publication number CN 109432607A and the authorization publication number CN 204890973U both use LED as the light source. As mentioned above, the design using LED has the advantages of simple design and low cost, but also has the disadvantage of using LED illumination, that is, it cannot illuminate the deep brain in the skull. The cells are effectively irradiated to achieve the desired effect.

The name of the invention is "a new type of earphone-type laser health care device with multiple working wavelengths", and the Chinese patent application publication number CN106730404A discloses a multi-wavelength laser transmitted through optical fiber to irradiate ear tissue and flow through the ear. Brain blood for specific therapeutic purposes. The invention is similar to the technique of irradiation through the nasal cavity. The area that can be irradiated through the ear is limited, so the area and volume of the brain that can reach the effective irradiation area are also limited, and it is difficult to achieve the desired therapeutic effect. The laser irradiation to the ear is similar to the laser irradiation to the nasal cavity, and the laser power should not be too high, otherwise it will cause thermal damage to the irradiation site.

The name of the invention is "an intelligent photodynamic hair growth helmet", and the Chinese patent application publication number CN 110141797A discloses a helmet that uses PBM or LLLT to treat hair loss and stimulate hair growth. In order to avoid the hair covering the scalp in the prior art, the invention uses a plurality of needle-shaped light guide channels to bypass the hair and direct light to the scalp. Since the laser used to treat hair loss is a low-power continuous mode (CW) laser, the power emitted by a single laser is generally less than 20mW, which cannot effectively penetrate more than the brain tissue, so it cannot be effectively used for the treatment of brain diseases.

The name of the invention is "a hair growth device", and the Chinese patent application publication number CN 108114378A discloses a kind of use of multiple low-power lasers, such as multiple 5mW 620-700nm red lasers, irradiated on the scalp to generate 1 -20mW/cm ² irradiation power density, and a flexible and adaptive helmet hair growth device that can be output in a pulsed manner to enhance hair development. The disadvantage of this invention is that because the laser light source is fixed on the flexible helmet, and the flexible helmet limits the heat dissipation of each laser light source, only a small power laser source, such as a 5mW laser source, can only be used, even in the case of pulses. Only a laser irradiation power density of not more than 20mW/ ^cm2 can be produced on the scalp. This power density produces a PBM effect on the scalp portion, but is not sufficient to penetrate the cranium for effective effect on deep brain cells. The current research results show that even if an LED light source is used, an optical power density of at least tens of milliwatts per square centimeter should be generated in the scalp. For example, the power density index of Vielight's clinically proven product Neuro Alpha is 25–150mW/cm ² .

The name of the invention is "a wearable optoelectronic integrated autism treatment instrument", and the Chinese patent application publication number CN109432607A discloses a method of using red and near-infrared LED light to irradiate autism-related brain regions to treat autism. Devices for autism. The device is similar to Dr. Lew Lim's patent, but emphasizes the specificity of the irradiated area.

The name of the invention is "acupoint positioning cover for laser treatment of brain diseases", and the authorization announcement number is CN

The Chinese patent of 204121616U discloses an acupoint positioning cover for laser treatment of brain diseases. This positioning cover is similar to the helmet described in the series of patents by Luis De Taboada et al, in that the helmet has holes for fixing the light source. The name of the invention is "helmet-type therapeutic apparatus", and the Chinese patent application publication number CN 107998516A discloses a device based on acupoint irradiation combined with magnetic therapy. The design of the device is not suitable for PBM treatment of deep cellular tissues in the brain.

The name of the invention is "Hand-held low-level laser instrument and low-level laser beam generating method", and the Chinese patent application publication number CN108325090A discloses a hand-held low-level laser instrument and a low-level laser beam generating method. The name of the invention is "Handheld Low-Level Laser Therapy Device", and the Chinese Patent Application Publication No. CN 102573991A describes another handheld low-level laser therapy device. In both inventions, the treatment laser beam is shaped by one or more correction lenses to achieve the irradiation parameters required for treatment, and the operator needs to treat the patient in a hand-held manner.

Since Professor Raichle of Washington University in St. Louis discovered The Brain's Default Mode Network in 2001, there have been 3,000 academic studies around the world discussing the role of the Brain's Default Mode Network in neuroscience, cognitive science, brain disease research, neurophysiology and cytology. Apply and Contribute. The brain default network consists of the medial prefrontal cortex, posterior inferior parietal cortex, retrosplenial cortex, hippocampus, parahippocampal gyrus, posterior cingulate cortex, and adjacent brain organs such as the anterior process nerve and the horny gyrus. For normal adults, most of these organs are at least 3 cm below the scalp, with the hippocampus and parahippocampal gyrus in the midbrain exceeding 5 cm. However, the existing treatment devices based on continuous light irradiation of the brain cannot effectively penetrate the brain tissue above 5 cm.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a device for treating brain diseases based on semiconductor laser external irradiation technology, in order to solve the problem that the irradiation light emitted by the existing treatment device cannot effectively penetrate the skull, and the brain cells in the deep layer of the skull can be irradiated. Uniform and complex structure, so that the helmet is cumbersome and impossible to implement, and how to realize the technical problem of irradiation treatment of brain cells deep in the skull without adverse effects due to excessive temperature. The present invention fully considers that the balanced high peak power density red to near-infrared laser can effectively irradiate the deep brain tissue exceeding 7cm and avoid the adverse effect of high average power density on brain heating, and proposes a combination of low laser average power irradiation. Superficial brain tissue, and a design for PBM treatment of deeper brain tissue at higher peak powers of the pulsed laser.

The technical scheme adopted in the present invention is a device for treating brain diseases based on semiconductor laser external irradiation technology, comprising a helmet, a semiconductor laser generator, at least one energy-transmitting optical fiber, a power supply and a main control box; the special feature is that :

The helmet includes a helmet outer layer and at least one scattering optical fiber disposed inside the helmet outer layer;

the energy transmission fiber is connected with the scattering fiber;

The semiconductor laser generator is used to generate laser light with a wavelength of 600nm-1400nm;

The semiconductor laser generator is connected to all the energy-transmitting fibers respectively, and is used for outputting a laser with a total average power of 5W-200W to all the scattering fibers, or the average laser power density of the scattering fibers irradiated on the skin surface is 30-500mW/cm between ² .

Further, the helmet also includes a light-emitting body arranged on the inner side of the outer layer of the helmet;

The scattering optical fiber is arranged on the light exit body.

Further, the light-emitting body is a three-dimensional structure, and one side close to the skin is a light-emitting surface, and the other surfaces are light-reflecting surfaces;

The scattering optical fiber is a high scattering optical fiber;

The scattering optical fiber is arranged in the light exit body.

The high-scattering optical fiber of the present invention refers to a scattering optical fiber with a scattering length of less than 0.3 m or more, such as 5 mm, 10 mm, 100 mm, etc.; the core diameter of the high-scattering optical fiber is between 0.2 mm and 2.0 mm; The scattering mechanism can be a certain surface treatment on the side of the optical fiber cylinder, such as etching with hydrofluoric acid or sanding with sandpaper, so that the scattering length can reach the required length.

Further, the structure of the high-scattering optical fiber includes an unclad optical fiber core and a surface of the unclad optical fiber that has been corroded or frosted.

Further, the light-emitting body is a flexible pad;

The scattering optical fiber is a low scattering optical fiber;

The scattering optical fibers are arranged on the inner side of the flexible pad.

The low-scattering optical fiber of the present invention refers to a scattering optical fiber with a scattering length greater than 0.3 m or more, such as scattering lengths of 0.5 m, 1 m, and 5 m. The scattering length means that after the laser energy passes through a certain length of optical fiber, its energy attenuates by 90% of the incident energy. A scattering fiber with a scattering length of 1m can scatter 90% of its incident energy over a length of 1m, that is, only 10% of the energy remains, and 99% of the incident energy over a length of 2m, that is, only 1% of the energy remains. The diameter of the core of the low-scattering optical fiber is between 0.1 mm and 0.3 mm; the scattering mechanism of the core of the low-scattering optical fiber can be that a scattering center is doped in the core, or a certain surface treatment is performed on the side of the optical fiber cylinder , so that a certain amount of light leaks out from the side during the internal reflection of the optical fiber; the scattering center is a tiny bubble with a diameter of less than 0.1um or a scattering particle with a diameter smaller than the wavelength of the conducting laser.

Further, the light-emitting body is a three-dimensional structure, and one side close to the skin is a light-emitting surface, and the other surfaces are light-reflecting surfaces;

The scattering optical fiber is a low scattering optical fiber;

The scattering optical fiber is arranged in the light exit body.

Further, the low scattering optical fiber includes a scattering optical fiber core and an organic material cladding layer of the low scattering optical fiber.

Further, the helmet and the semiconductor laser generator are separate structures.

Further, the wavelength of the laser light generated by the semiconductor laser generator is 800nm-1000nm.

Further, the wavelength of the laser light generated by the semiconductor laser generator is 635±10nm or 810±10nm or 980±10nm.

Further, it also includes a detection feedback unit arranged in the helmet and a switch element for controlling the work of the semiconductor laser generator;

The helmet also includes a helmet inner layer;

The scattering optical fiber is located between the outer layer of the helmet and the inner layer of the helmet; the inner layer of the helmet is made of transparent material;

The detection and feedback unit is used to detect the working condition of the scattering optical fiber, the temperature in the helmet and/or the posture of the head of the irradiated person, and feed it back to the power supply and the main control box;

The switch element includes an interlocking power switch and a signal sensor; the signal sensor is a clip-on interlock of the helmet fixing belt and/or a pressure sensor in the helmet for sensing the pressure of the helmet and the top of the head.

Further, it also includes a working state indicating unit;

The working state indicating unit is a visible light semiconductor laser tube arranged in a semiconductor laser generator or an LED lamp arranged in a helmet;

The helmet also includes a flexible shading strip disposed inside the rim of the helmet.

Further, the scattering optical fiber is fixed in the light-emitting body by pouring high-refractive-index glue or transparent glue;

or,

The scattering optical fiber is fixed in the light-emitting body by means of fixed point bonding, or snapping, or thread stitching, and the medium for transmitting the laser light inside the light-emitting body is air.

The beneficial effects of the present invention are:

(1) In the treatment device of the present invention, the wavelength of laser light generated by the semiconductor laser generator is 600nm-1400nm; the average power output from the semiconductor laser generator to all scattering fibers is between 5W-200W in total or the peak value of the scattering fibers irradiated on the skin surface The laser power density is between 30-500mW/cm ² ; in this way, the emitted laser can effectively penetrate the skull and irradiate the brain cells in the deep layer of the skull; The laser is evenly scattered, so that the laser is evenly irradiated on the patient's head, and the helmet structure is also very simple due to the use of a scattering optical fiber in the present invention; Penetrating the skull and irradiating the brain cells in the deep layer of the skull is a technical problem that the light is uneven and the structure is complex, so that the helmet is bulky and cannot be implemented.

(2) The present invention transmits the laser energy through the optical fiber, which can effectively avoid the very complicated design for dissipating the laser light at the helmet part.

(3) In the present invention, the light-emitting body is preferably a flexible pad, which can be bent, and can output laser energy to the light-emitting surface evenly from the input laser. The energy distribution covers the entire head and focuses on the acupoint area.

(4) The modular design of the light-emitting body can place the light-emitting body with a specific wavelength and specific power characteristics in the area that needs to be irradiated to achieve personalized treatment.

(5) Using a fiber-coupled semiconductor laser, the laser can have a single wavelength or multiple wavelengths, which can be selected according to the needs of treatment.

(6) In the present invention, the helmet and the semiconductor laser generator preferably have a separate structure, so that the helmet is simple in structure, easy to implement, light in weight, and convenient to wear.

(7) The present invention preferably uses pulsed light to stimulate the deep part of the brain through tPBM to treat the deep part of the brain. At the same time, the pulsed laser with high peak power and low average power can also effectively reduce the heating of the patient's head by the laser.

(8) Preferably, the semiconductor laser generator of the present invention further includes a visible light semiconductor laser tube, so as to ensure that the therapeutic helmet meets the safety requirements for laser use.

(9) All laser energy input into the helmet by the present invention is fed back and detected to ensure that the laser energy irradiated to each area of the patient's head meets the required dose, and can automatically shut down any accident during the laser input process.

(10) In the present invention, there is preferably a temperature sensor in the helmet, so that the patient will not suffer from head discomfort due to laser heating.

(11) The present invention can manually set the laser irradiation parameters, and can also automatically set the laser irradiation parameters through the intelligent PBM parameter automatic output device.

Description of drawings

Fig. 1 is the structural representation of helmet embodiment 1 in the present invention;

Fig. 2 is the structural representation of helmet embodiment 2 in the present invention;

Figure 3 is a schematic diagram of the main areas of the brain and the division of labor;

Figure 4 is a schematic diagram of the mechanism of action of PBM is that red and near-infrared light can lead to a cascade of intracellular pleiotropic effects;

5 is a schematic structural diagram of scattering input laser light into a rectangular area based on a low-scattering optical fiber;

FIG. 6 is another structural schematic diagram of scattering the input laser into a rectangular area based on a low-scattering optical fiber;

7 is a schematic diagram of the structure of a light-emitting body that glues together a high-refractive-index glue or a transparent glue and a low-scattering optical fiber;

8 is a schematic diagram of the structure of a light-emitting body based on a high-scattering optical fiber that scatters the input laser into a rectangular area and pours high-refractive-index glue or transparent glue;

9 is a schematic diagram of the structure of a light-emitting body based on a high-scattering optical fiber that scatters multiple input lasers into a rectangular area and pours high-refractive-index glue or transparent glue;

Fig. 10 is a light-emitting body design that can use high-scattering optical fiber or low-scattering optical fiber, and scatter the input laser into a rectangular area, and the laser transmission medium in this area except the optical fiber is air.

FIG. 11 is a schematic structural diagram of a cross-section of an energy-transmitting optical fiber;

12 is a schematic structural diagram of a cross-section of a low-scattering optical fiber;

13 is a schematic structural diagram of a cross-section of a high-scattering optical fiber;

14 is a schematic structural diagram of adding a spherical diverging head to the light-emitting surface of an ordinary optical fiber, so that the output light of the optical fiber is output with a larger divergence angle;

15 is a schematic cross-sectional structure diagram of a high-refractive-index glue or transparent glue and a low-scattering optical fiber glued together;

16 is a schematic cross-sectional structure diagram of a high-refractive-index glue or a transparent glue and a high-scattering optical fiber or an unclad optical fiber glued together;

17 is a schematic diagram of the optical-mechanical structure of the inner layer of a helmet based on an optical fiber light-emitting body;

18 is a schematic structural diagram of the energy-transmitting optical fiber and the scattering optical fiber being connected by optical fiber fusion welding;

Figure 19 is a schematic structural diagram of the energy transmission optical fiber and the scattering optical fiber being connected by a flange;

Fig. 20 is the A-A sectional view of Fig. 19;

Fig. 21 is the B-B sectional view of Fig. 19;

22 is a schematic structural diagram of a semiconductor laser generator including a visible light semiconductor laser tube connected to a power supply and a main control box;

23 is a schematic structural diagram of a semiconductor laser generator including two semiconductor laser tubes connected to a power supply and a main control box;

24 is a schematic structural diagram of a semiconductor laser generator including a plurality of semiconductor laser tubes connected to a power supply and a main control box;

25 is a schematic structural diagram of a semiconductor laser generator including a plurality of semiconductor laser tubes and a plurality of fiber couplers being connected to a power supply and a main control box;

Figure 26 is a graph of Arndt-Schulz dose curve for laser PBM treatment;

Fig. 27 is a laser waveform diagram when the embodiment of the present invention works in a continuous light output mode;

Fig. 28 is a laser waveform diagram when the embodiment of the present invention works in a chopping light output mode;

FIG. 29 is a laser waveform diagram when the embodiment of the present invention works in a square wave light output mode and an intermittent light output mode;

FIG. 30 is a laser waveform diagram when the embodiment of the present invention works in an arbitrary pulse light output mode and an intermittent light output mode;

31 is a schematic structural diagram of a plurality of semiconductor lasers connected to a plurality of light-emitting bodies in a helmet through a plurality of optical fibers;

32 is an electrical schematic diagram of a main control box according to an embodiment of the present invention;

The description of each label in the figure is as follows:

100- Helmet, 106- Soft or hard reflective material or reflective film, 110- Helmet strap, 115- Helmet strap Snap-on interlock, 116- Helmet interlock cable, 120- Evenly scattered light , 125-pressure sensor, 126-pressure sensor connection line, 130-temperature sensor, 135-helmet temperature sensor connection line, 160-helmet inner layer, 170-flexible shading tape, 180-helmet and power supply and main control box light path and Circuit bus, 200-light-exiting body, 201-high refractive index glue or transparent glue, 202-light-exiting surface, 203-light reflecting surface, 205-input laser connector, 206-air, 210-energy transmission fiber, 211-high scattering Fiber, 220-low scattering fiber, 225-output laser connector, 230-light output body feedback output fiber, 251-photodetector, 252-photodetector output cable, 261-normal fiber core, 262-normal fiber package Cladding, 263-Ordinary fiber coating, 271-scattering fiber core, 273-low-scattering fiber organic material cladding, 281-unclad fiber core, 283-corroded or frosted without cladding Surface of cladding fiber, 290-optical beam expander ball, 300-semiconductor laser generator, 305-semiconductor laser base and heat sink, 306-visible light semiconductor laser base and heat sink, 310-semiconductor laser tube, 312-visible light semiconductor Laser tube, 313-visible light semiconductor laser collimator, 315-fast-axis collimator, 316-slow-axis collimator, 317-collimator, 318-visible light collimator, 320-beam reflector, 325-polarization Optical beam splitter, 326-wavelength combiner, 330-focusing mirror, 340-fiber coupler, 350-air cooling device for semiconductor laser generator, 400-power supply and main control box, 405-electronic control main control system and Semiconductor laser generator wiring, 410-Electronic control main control system, 420-Medical DC power supply, 421-AC AC power supply wiring, 422-AC AC power supply, 425-Electronic control main control system and medical DC power supply wiring, 430-Internet of things module and external communication module, 435-connection of electronic control main control system and Internet of things module and external communication module, 440-semiconductor laser constant current power supply, 441-semiconductor laser constant current power supply and electronic control main control system Wiring, 445-connection of electronic control main control system and man-machine control interface, 450-photoelectric detector or photoelectric signal receiver, 455-connection line of photoelectric detector and embedded electronic control main control system, 460-interlock Power switch, 465-interlock power switch connection, 480- intelligent PBM parameter automatic output device, 485- intelligent PBM parameter automatic output device and electronic control main control system connection, 500- man-machine control interface, 510- manual control Interface, 600-pulse waveform input.

Detailed ways

The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

Some detailed examples are provided below to illustrate various embodiments of the present invention and for the purpose of describing the main technical features, embodiments and technical advantages of the present invention. The core technical content of the present invention includes but is not limited to the examples provided below. After understanding the main content of the present invention, those skilled in the art can make many changes to the present invention without departing from the scope or core technology of the present invention, but all belong to the content of the present invention.

The core technical content of the present invention is to use a semiconductor laser tube with a wavelength of 600nm-1400nm. After optical fiber coupling, the semiconductor laser is input into a helmet specially used for the treatment of brain diseases through an energy transmission fiber. PBM) principle for the treatment of brain diseases. In order to effectively irradiate the red or near-infrared laser to the cells of the deep brain system including the hippocampus, the average laser power density of the laser of the present invention irradiated on the skin surface is between 30-500mW/ ^cm2 , and the peak laser power density Between 1–500W/ ^cm2 . Brain diseases that can be treated by the device based on the present invention include, but are not limited to, stroke, traumatic brain injury (TBI), cerebrovascular ischemia, Alzheimer's disease, dementia, depression, anxiety, and post-traumatic stress disorder It can also help users increase cerebral blood flow, promote the generation of brain cells, brain micro-nerves, and brain micro-vessels, so as to improve their brain health and improve their concentration and cognitive ability.

The device for treating brain diseases based on the semiconductor laser external irradiation technology of the present invention includes a helmet 100 , a semiconductor laser generator 300 , at least one energy-transmitting optical fiber 210 , and a power supply and a main control box 400 . The helmet 100 described above includes a helmet outer layer and at least one scattering optical fiber disposed inside the helmet outer layer. Referring to FIGS. 1 and 2 , in this embodiment, preferably, the helmet 100 further includes a light-emitting body 200 disposed on the inner side of the outer layer of the helmet; the scattering optical fiber is provided on the light-emitting body 200 . And preferably, the helmet 100 further includes a helmet inner layer 160; the light-emitting body 200 is located between the helmet outer layer and the helmet inner layer 160; the helmet inner layer 160 is made of a transparent material; Root scattering optical fiber; the above-mentioned semiconductor laser generator 300 is used to generate laser light with a wavelength of 600nm-1400nm; preferably, the wavelength of the laser light generated by the semiconductor laser generator 300 is 800nm-1000nm; when the semiconductor laser generator 300 generates laser light with a wavelength of 635± 10nm or 810±10nm or 980±10nm, the treatment effect is better. The above-mentioned semiconductor laser generator 300 is connected to all the energy transmission fibers 210 respectively, and is used for outputting lasers with a total average power of 5W-200W to all the scattering fibers, or the average laser power density of the scattering fibers irradiated on the skin surface is 30-500mW/ between cm ² .

FIG. 1 is a schematic structural diagram of Embodiment 1 of the helmet in the present invention. The helmet 100 is a helmet made of a rigid or semi-rigid material, including an outer helmet layer and an inner helmet layer 160 . One or more light-emitting bodies 200 that emit laser light are disposed between the outer helmet layer and the inner helmet layer 160, such as where the helmet 100 is located on the sides and top of the head. The helmet 100 is fixed on the patient's head by the helmet fixing strap 110, and the two pieces of the helmet fixing strap 110 are connected together by the helmet fixing strap snap-type interlock 115, or the helmet fixing strap 110 is directly connected with the helmet, and The helmet strap snap-on interlock 115 may also serve as the switch element described above. The optical fibers and wires in the helmet 100 connected to the light body 200, the connection of the helmet fixing belt clip-type interlock 115, the temperature sensor connection in the helmet 100 and other optical fibers and wires pass through the helmet and the power supply and the main control box optical path and circuit bus 180 and The power supply is connected to the main control box 400 . In order to prevent the treatment light from leaking out of the helmet 100 and irradiating the eyes of the patient or the operator, and to ensure the laser safety of the brain disease treatment device, a flexible light-shielding belt 170 is installed on the inner side of the edge of the helmet 100, and the flexible light-shielding belt 170 is made of black knitted material make. The flexible light shielding strip 170 can not only prevent laser leakage in the helmet 100 , but also improve the comfort of the patient using the helmet 100 .

FIG. 2 is a schematic structural diagram of Embodiment 2 of the helmet in the present invention. Unlike FIG. 1 , FIG. 2 contains two laser-emitting light extraction bodies 200 for illuminating the brain through the ear and the face. The advantage of irradiating the brain through the face is that it avoids the absorption of the laser by the hair and the discomfort of placing the laser light in the mouth.

Figure 3 is a schematic diagram of the main areas of the brain and the division of labor. By setting the power supply and the main control box 400, and selectively opening the light exit body 200 above the treatment area in the helmet 100, tPBM can be performed on the treatment area in a targeted manner.

Figure 4 is a schematic diagram of the mechanism of action of PBM is that red and near-infrared light can lead to a cascade of intracellular pleiotropic effects. During the PBM process, due to the unique spectral properties of cytochrome c oxidase, photons are absorbed by cytochrome c oxidase, the photon energy catalyzes a series of redox reactions, and the electron transport chain promotes the transfer of electrons across the inner mitochondrial membrane . The specific steps are an increase in the ratio of NAD-NADH and an increase in mitochondrial membrane potential (ΔΨ), which in turn leads to an increase in the content of ATP and free radicals (ROS). At the same time, the enhanced activity of the electron transport chain regulates NO synthesis (NOS) in cytochrome oxidase. Calcium ion release then occurs and cyclic guanosine phosphate (cGMP) expression increases in cells, ultimately leading to vasodilation and increased blood flow. Secondary consequences are increased cellular energy metabolism, and decreased apoptosis and inflammation.

FIG. 5 is a schematic diagram of a structure that scatters input laser light into a rectangular area based on a low-scattering fiber. In this structure, the light-emitting body 200 is a flexible pad, and this area is a surface light-emitting body. The energy transfer fiber 210 is connected to the low scattering fiber 220 through the input laser connector 205 . The input laser connector 205 can be used to weld the energy-transmitting optical fiber 210 and the low-scattering optical fiber 220 together by means of optical fiber fusion welding, or can be connected together by other optical fiber-to-fiber optical coupling methods. In order to make the light-emitting surface of the light-emitting body 200 as uniform as possible, the low-scattering optical fibers 220 are fixed in the light-emitting body 200 in a uniform distribution manner. For example, the low-scattering optical fibers 220 shown in FIG. , and the adjacent U-shapes have the same size and opposite opening directions; or as shown in FIG. 6 , the nested and evenly arranged concentric rectangles are wound into a tapered shape from the outside to the inside, etc. The output end of the low-scattering optical fiber 220 is connected to the light-exiting body feedback output optical fiber 230 through the output laser connector 225 . At least 80% of the laser energy in the energy-transmitting fiber 210 is scattered out by the low-scattering fiber 220 in the light-emitting body 200 . The remaining laser energy is output to the outside of the light output body 200 through the light output body feedback output fiber 230 . Although FIGS. 5 to 10 take the geometric shape of a rectangle or a cuboid as an example, on the basis of not violating this design principle, the geometric shape of the light-emitting body 200 is not limited to a rectangle or a cuboid. other shapes. FIG. 6 is a schematic diagram of another structure that scatters the input laser light into a rectangular area based on a low-scattering fiber.

FIG. 7 is a schematic diagram of the structure of a light emitting body that glues together a high-refractive-index glue or a transparent glue and a low-scattering optical fiber. The light emitting body 200 is a three-dimensional structure. In this embodiment, taking a rectangular parallelepiped as an example, the light emitting body 200 close to the inner layer 160 of the helmet is the light emitting surface 202, and the other surface is the light reflecting surface 203; a low-scattering optical fiber 220 emits light On the plane parallel to the light-emitting surface 202 in the body 200, it is wound into a U-shape that is connected end to end, and the adjacent U-shapes have the same size and opposite opening directions; A plurality of concentric rectangles of cloth; the low-scattering optical fiber 220 is fixed in the light-emitting body 200 by high-refractive-index glue or transparent glue 201 . The laser light scattered by the low-scattering optical fiber 220 is output from the surface of the light-emitting surface 202 of the light-emitting body 200 . The surface of the light-emitting surface 202 may be a smooth surface or a frosted surface to increase the uniformity of scattering. The light reflecting surface 203 can be affixed with a reflective material or a reflective coating, the reflective material can be smooth aluminum, copper or other metal materials, and the reflective coating can be a metal film or a dielectric film, and the laser cannot pass through. The above-mentioned low-scattering optical fiber 220 refers to a scattering optical fiber with a scattering length greater than 0.3m or more, such as 0.5m, 1m, 5m and other scattering lengths.

FIG. 8 is a schematic diagram of the structure of a light-exiting body based on a high-scattering optical fiber that scatters the input laser into a cuboid area and pours high-refractive-index glue or transparent glue. The energy-transmitting optical fiber 210 and the high-scattering optical fiber 211 can be connected outside the light-emitting body 200 or inside the light-emitting body 200 . The high-scattering optical fiber 211 may also be subjected to surface grinding or corrosion treatment on the energy-transmitting optical fiber 210, so as to have optical properties with high scattering rate. Since the scattering length of the high-scattering fiber 211 is short, more than 90% of the laser power will generally be scattered at a length of less than 20 cm. Therefore, in the design shown in FIG. 8, the output fiber is not used for feedback, and a photodetector 251 is used instead to detect the light The working condition of the laser is outputted to the outside of the light-emitting body 200 by the output connection line 252 of the photodetector.

In many cases, the design of Fig. 8 is still unable to meet the requirements of luminous uniformity. The improved design Fig. 9 shows a multi-channel input laser based on a high-scattering fiber that scatters multiple input lasers into a rectangular area, and injects high Schematic diagram of the structure of the light-emitting body of the refractive index glue or transparent glue. The above-mentioned light-emitting body 200 is a three-dimensional structure. In this embodiment, taking a rectangular parallelepiped as an example, the side of the light-emitting body 200 close to the helmet inner layer 160 is the light-emitting surface 202, and the other surfaces are the light-reflecting surface 203; the laser is output from the light-emitting surface 202, and the light The reflecting surface 203 is pasted with a metal laser reflecting film, so that the laser light cannot pass through. Each light-emitting body 200 is provided with a plurality of scattering fibers, and the scattering fibers are high-scattering fibers 211; the plurality of high-scattering fibers 211 are divided into two groups, and the laser light is input to the light-emitting body from the two opposite light reflecting surfaces 203 of the light-emitting body 200 respectively. In 200, two adjacent high-scattering optical fibers 211 belong to different groups, and multiple high-scattering optical fibers 211 are evenly arranged and located on the same plane; A photodetector 251 is used to detect the working condition of the input laser light in the light body 200 , and the output connection line 252 of the photodetector is outputted to the outside of the light output body 200 .

Figure 10 is a schematic structural diagram of a light-emitting body design that can use high-scattering optical fiber or low-scattering optical fiber, and scatter the input laser into a cuboid area, where the laser transmission medium other than the optical fiber is air. The difference between this design and the above-mentioned light-emitting body design using transparent glue is that other methods are used to fix the optical fiber, such as several fixed points bonding, or snapping, or thread stitching, etc. to fix the low-scattering optical fiber 220 or the high-scattering optical fiber 211. inside the light-emitting body 200 . The remaining space in the light exit body 200 is air 206 . The light-emitting surface 202 of the light-emitting body 200 is made of a transparent material, and the surface outputs laser light. The light-emitting body 200 has four side surfaces and a bottom surface that does not output laser light, and is a light-reflecting surface 203 . The light reflecting surface 203 can be pasted with a reflective material or a reflective coating, the reflective material can be smooth aluminum, copper or other metal materials, and the reflective coating can be a metal film or a dielectric film. The above-mentioned high scattering optical fiber 211 refers to a scattering optical fiber whose scattering length is less than 0.3 m or more, such as 5 mm, 10 mm, 100 mm, and the like.

FIG. 11 is a schematic structural diagram of a cross-section of an energy-transmitting optical fiber. The energy-transmitting optical fiber 210 includes a common optical fiber core 261, an optical fiber cladding layer 262, and an optical fiber coating layer 263. The above-mentioned low-scattering optical fiber 220 is a plastic cladding layer or a cladding-layer scattering optical fiber, and its cross-sectional structural schematic diagram is shown in FIG. The high-scattering fiber 211 uses an uncoated fiber to undergo hydrofluoric acid corrosion or sanding treatment on the surface of the fiber to make the surface of the uncoated fiber rough to achieve the purpose of scattering the laser light in the fiber. As shown in Figure 13, the high-scattering fiber 211 The structure includes an unclad fiber core 281 and an unclad fiber surface 283 that has been etched or sanded. In the light-emitting body 200, not only the scattering method can be used to homogenize the laser distribution, such as the use of the low-scattering fiber 220 or the high-scattering fiber 211, but also the optical fast beam expansion method can be used to make the light spot become larger in a short distance, as shown in Figure 14 , using a method of connecting an optical beam expander 290 (beam expander) at the output end of the energy transmission fiber 210 or other optical methods to increase the spot area.

In order to illustrate the cross-sectional result of the light-emitting body 200, FIG. 15 is a schematic cross-sectional structure diagram of a high-refractive-index glue or transparent glue and a low-scattering optical fiber glued together. The low-scattering fiber 220 is fixed within it by a high-refractive-index glue or transparent glue 201 . The laser light in the scattering fiber core 271 is scattered into the high-refractive index glue or transparent glue 201 through the low-scattering optical fiber organic material coating layer 273 , and finally output to the outside of the light-emitting body 200 through the light-emitting surface 202 . FIG. 16 is a schematic cross-sectional structure diagram of a high-refractive-index glue or transparent glue and a high-scattering optical fiber or an unclad optical fiber glued together. The high scattering optical fiber 211 is fixed within it by the high refractive index glue or transparent glue 201 . The surface of the light-emitting surface 202 may be a smooth surface or a frosted surface to increase the uniformity of scattering. In order to reduce the loss of light energy, the light reflection surface 203 can be affixed with a reflective material or a reflective coating, the reflective material can be smooth aluminum, copper or other metal materials, and the reflective coating can be a metal film or a dielectric film.

FIG. 17 is a schematic diagram of an optical-mechanical structure of the inner layer of a helmet based on an optical fiber light-emitting body. The outer layer of the helmet includes a first outer layer and a second outer layer arranged in turn from the outside to the inside; the first outer layer is made of a rigid or semi-rigid material, and the second outer layer is a soft or rigid reflective material or reflective material. The film 106, the light reflecting surface 203 opposite to the light emitting surface 202 and the second outer layer are fixedly connected, and the light emitting surface 202 faces the inner layer 160 of the helmet. The light emitted from the low-scattering optical fiber 220 can be directly or passed through a soft or hard reflective material or reflective film 106 to be irradiated on the helmet inner layer 160, and finally the uniformly scattered light 120 can be irradiated on the treated part of the patient.

The output fiber of the fiber-coupled red or near-infrared semiconductor laser generator 300 is the energy transmission fiber 210 . The energy-transmitting optical fiber 210 and the low-scattering optical fiber 220 are connected, and the connection method may be a fusion welding method of optical fibers, or an optical fiber-fiber optical coupling method. FIG. 18 is a schematic structural diagram of connecting the energy-transmitting optical fiber and the scattering optical fiber by means of optical fiber fusion welding. Specifically: Using the fusion taper and beam combining technology, N (N≥1) low-scattering optical fibers 220 are stripped of their outer coating layers, and about 30mm of bare fibers are leaked out. For the tapered waveguide, several low-scattering optical fibers 220 are sintered at high temperature and tapered, and the cross-section is smaller than or equal to the cross-section of the energy-transmitting optical fibers 210 , and then fused with the energy-transmitting optical fibers 210 to prepare. Fig. 19 is a schematic diagram of the structure of connecting the energy-transmitting optical fiber and the scattering optical fiber through a flange. Specifically, the optical fiber bundles formed by N (N≥1) low-scattering optical fibers 220 are arranged according to the geometric structure, and the optical fiber bundles are bundled, polished and ground according to the number of mechanical, chemical and other means, and finally passed through a high-precision flange. (ie, the input laser connector 205 ) is connected to the energy transmission fiber 210 , and the cross section of the core diameter of the energy transmission fiber 210 is larger than the cross-section of the ground and polished low-scattering fibers 220 , which can realize the transmission of light energy. FIG. 20 is a cross-sectional view taken along line A-A of FIG. 19 . FIG. 21 is a cross-sectional view taken along line B-B of FIG. 19 .

FIG. 22 is a schematic structural diagram of a semiconductor laser generator including a visible light semiconductor laser tube connected to a power supply and a main control box. The semiconductor laser generator 300 couples the energy emitted by the semiconductor laser into the energy transmission fiber 210 by core components such as a semiconductor laser tube 310 with a wavelength of 600-1400 nm and an optical element. The semiconductor laser tube 310 can output an average laser power of 0.1W-100W, and can also output a pulsed laser peak power of 0.5-500W. Specifically, the semiconductor laser tube 310 is fixed on the semiconductor laser base and the heat sink 305. In order to effectively achieve the purpose of heat dissipation, the semiconductor laser base and the heat sink 305 are fixed to the air cooling device of the semiconductor laser generator in a thermally conductive manner. device 350. The laser beam emitted by the semiconductor laser tube 310 is focused on an optical fiber coupler 340 that can fix the optical fiber through the fast-axis collimating mirror 315, the slow-axis collimating mirror 316, the beam reflector 320, the focusing mirror 330 and other optical elements, and finally the semiconductor The laser energy of the laser tube 310 is input into the energy transmission fiber 210 . Considering that the wavelength of the semiconductor laser tube 310 can be invisible infrared light, such as laser light with a wavelength above 800 nm, the semiconductor laser generator 300 can also include a visible light semiconductor laser as the working state indicating unit of the device of the present invention. Specifically, a visible light semiconductor laser tube 312 with a wavelength of 400nm-700nm is fixed on the visible light semiconductor laser base and the heat sink 306, and its emission beam is irradiated on the beam reflector 320 through the visible light semiconductor laser collimating mirror 313. The beam reflector 320 is a wavelength combiner, which can not do any coating on the emission wavelength of the visible light semiconductor laser tube 312, or can be coated with an anti-reflection coating to reduce the laser energy loss of the visible light semiconductor laser tube 312. For example, in the beam reflector 320 Both sides are coated with a high antireflection film for the wavelength emitted by the visible light semiconductor laser tube 312 , and the side facing the semiconductor laser tube 310 is coated with a high reflection film for the wavelength emitted by the semiconductor laser tube 310 . The combined laser beam enters the fiber coupler 340 through the focusing mirror 330 and is coupled to the energy transmission fiber 210 . When the visible light semiconductor laser tube 312 is installed, the energy transmission fiber 210 will contain invisible near-infrared light laser and visible light laser for indication. The semiconductor laser generator 300 is connected to the power supply and the main control box 400 through the electronic control main control system and the semiconductor laser generator connection line 405 . The power supply and main control box 400 provides the required power and electronic control for the semiconductor laser generator 300 . In this embodiment, preferably, the output laser power of the visible light semiconductor laser tube 312 is in the range of 1-200 mW, and the wavelength of the visible light laser beam emitted is 450±20nm or 520±20nm or 635±20nm; the above-mentioned semiconductor laser tube 310 Output 0.1W-100W average laser power, or pulse output 0.5-500W laser peak power; the physical structure of the above-mentioned semiconductor laser tube 310 is a single-tube semiconductor laser with a single light-emitting point or a bar semiconductor laser with more than two light-emitting points . In addition to the above-mentioned use of the visible light semiconductor laser tube 312 as the working state indicating unit, LED lights can also be provided in the helmet 100 as the working state indicating unit of the device of the present invention.

FIG. 23 is a schematic diagram of the structure of a semiconductor laser generator including two semiconductor laser tubes connected to a power supply and a main control box. Two semiconductor laser tubes 310 are used for increasing the therapeutic laser output energy of the semiconductor laser generator 300 or outputting different therapeutic laser wavelengths. The two 600-1400nm wavelength semiconductor laser tubes 310 can have the same wavelength or different wavelengths. The two semiconductor laser tubes 310 are respectively fixed on the two semiconductor laser bases and the heat sink 305 with the polarization directions perpendicular to each other, and then pass through the respective collimating mirrors 317 and are combined by the polarization beam splitter 325 (PBS). There is one beam, and the combined laser beam enters the fiber coupler 340 through the focusing mirror 330 , and is finally coupled into the energy transmission fiber 210 . The collimating mirror 317 in FIG. 23 may be a single lens, such as an aspherical lens, or may be a combination of the fast-axis collimating mirror 315 and the slow-axis collimating mirror 316 as in FIG. 22 . Similarly, the combination of the fast-axis collimating mirror 315 and the slow-axis collimating mirror 316 in FIG. 22 can also be replaced by a single collimating mirror 317 in FIG. 23 .

FIG. 24 is a schematic structural diagram of a semiconductor laser generator including a plurality of semiconductor laser tubes connected to a power supply and a main control box. The semiconductor laser generator 300 includes more than two semiconductor laser tubes 310, and the wavelengths of laser light emitted by the plurality of semiconductor laser tubes 310 are different. The light beams emitted by the plurality of semiconductor laser tubes 310 are collimated by the plurality of collimating mirrors 317 in a one-to-one correspondence, and then are respectively combined by the polarizing beam splitter 325 (PBS) and the plurality of wavelength combiners 326, and are incident on the opposite The laser light of different wavelengths emitted by the plurality of semiconductor laser tubes 310 has an antireflection effect on the focusing mirror 330 coated with the antireflection film, and finally the laser light emitted by the plurality of semiconductor laser tubes 310 is coupled into the energy transmission fiber 210 .

FIG. 25 is a schematic structural diagram of a semiconductor laser generator including a plurality of semiconductor laser tubes and a plurality of optical fiber couplers connected to a power supply and a main control box. The semiconductor laser generator 300 includes more than two semiconductor laser tubes 310 . The wavelengths of the laser light emitted by the plurality of semiconductor laser tubes 310 may be the same or different. The laser beams emitted by the plurality of semiconductor laser tubes 310 are respectively collimated by a combination of multiple groups of fast-axis collimating mirrors 315 and slow-axis collimating mirrors 316, or collimated by a plurality of collimating mirrors 317 (not shown in FIG. 25 ). shown), and then reflected by the plurality of beam mirrors 320 to the corresponding focusing mirrors 330, respectively, and finally output by the plurality of energy transmission fibers 210 in a one-to-one correspondence.

Figure 26 is a graph of the Arndt-Schulz dose curve for laser PBM treatment. The Arndt-Schulz dose curve is a generalized dose curve that is often used for drug therapy in the treatment of disease. Many PBM scholars have found that this dose curve is also suitable for PBM treatment. The light irradiation dose is usually measured in units of laser energy (joules) per unit area (cm ² ), ie J/cm ² . When the light irradiation dose is too small, the photo-stimulating effect of PBM on brain tissue is not obvious, but when the light irradiation dose is too large, PBM not only does not have photostimulation on brain tissue, but has photo-inhibition, which cannot achieve the therapeutic effect. The method of calculating the light irradiation dose is to multiply the light power density irradiated by the light irradiation time. Therefore, the optical power density of the therapeutic light emitted by the light-emitting body 200 on the skin surface should be moderate, which is generally tens to hundreds of milliwatts per square centimeter in the treatment of brain diseases, so that the light in the brain can be treated within a certain period of time. The irradiation dose is within the optimal region in Figure 26.

The human brain is a complex organ with multiple layers and multiple organisms. The thickness of the skull varies in different regions, the brain organs in different regions of the head are different, and the distances of different brain organs from the nearest epidermal tissue are also different. Different brain tissues have different biological structures, which also lead to differences in the absorption characteristics of different wavelengths of laser light. Such complex brain tissue morphology, tissue structure and cell characteristics lead to the semiconductor laser treatment device for brain diseases should have a relatively large laser energy output range to meet the required PBM light irradiation dose. The penetration depth of laser in human tissue is mainly determined by two factors, namely laser wavelength and laser peak power density. As mentioned above, red to near-infrared light can be transmitted through the skin, skull and other organs into the human brain tissue, but the penetration depth of different wavelengths is different in different regions, and some studies have shown that light with wavelengths around 810nm penetration depth is deep. Laser peak power density is another parameter related to penetration depth. With a fixed wavelength, the higher the laser peak power density, the deeper the laser penetrates in biological tissue, and vice versa. In order to achieve the expected PBM treatment effect, the semiconductor laser treatment device for brain diseases can work in the continuous light output mode, and its laser output waveform is shown in Figure 27. Continuous light output mode is effective for superficial brain tissue. The advantage of this light output mode is that the brain tissue that can be reached by continuous light is mainly the part closer to the light source, while the deep brain tissue is not affected due to the low peak power density. But for deep brain tissues that require PBM treatment, such as the hippocampus, the continuous light-emitting pattern is not sufficient. If the laser power density in continuous light mode is too high, laser photons can indeed reach the hippocampus, but other brain tissues in the photon path will fall into the inhibition zone of the Arndt-Schulz dose curve due to the high light exposure dose. At the same time, the high average laser power can also heat the subject's head and cause discomfort. In order to avoid these unfavorable factors, the semiconductor laser treatment device for treating brain diseases can output laser light in chopping mode, and its output waveform is as shown in FIG. 28 . In the waveform of Fig. 28, the peak power of the laser light is higher than the average power. The peak power of the laser is determined by the current peak amount (Ampere, A) input to the semiconductor laser generator 300, and the average power of the laser is determined by the duty ratio of the chopper waveform. When the duty ratio is small, the high peak current can generate high peak power in the semiconductor laser generator 300 while achieving the effect of low average power. In this case, the red and near-infrared photons can reach deep brain tissue while avoiding the heating of the head by the high average power laser. Figure 29 is the laser waveform diagram when working in the square wave light output mode and the intermittent light output mode, which is another laser output waveform with high peak power and low average power. In addition to the chopper mode, Fig. 30 is the laser waveform diagram when working in the arbitrary pulse light output mode and the intermittent light output mode. This arbitrary pulse mode can be a preset pulse waveform, such as imitating the waveform and frequency of a certain brain wave, or directly input the brain wave waveform of the irradiated person to the power supply and the main control box 400 through the pulse waveform input terminal 600, and Finally, the desired laser output waveform is generated in the semiconductor laser generator 300 and the light exit body 200 .

As shown in FIGS. 1 and 2 , the helmet 100 may contain one or more light emitting bodies 200 . FIG. 31 is a schematic structural diagram of a plurality of semiconductor lasers connected to a plurality of light-emitting bodies in a helmet through a plurality of optical fibers, respectively. The input ends of the plurality of semiconductor laser generators 300 are respectively connected to the power supply and the main control box 400 through a plurality of electronic control main control systems and the semiconductor laser generator connection lines 405, and the output ends of the plurality of semiconductor laser generators are respectively connected to the laser through a plurality of energy transmission fibers 210. The energy is respectively transmitted to the plurality of light-emitting bodies 200 in the helmet 100 . In order to ensure the safety of the laser and the safety of the helmet user, each of the plurality of light-emitting bodies 200 in the helmet 100 has a light-emitting body feedback output optical fiber 230 , which is connected to the power supply and the main control box 400 . When the output optical fiber 230 of the light-emitting body is not used for feedback, the detection feedback unit may be a photoelectric detection signal output from the light-emitting body 200 . The helmet 100 is also provided with one or several temperature sensors 130, which are connected to the power supply and the main control box 400 through the temperature sensor connecting wire 135 in the helmet. The helmet 100 is fixed on the head of the irradiated person by the helmet fixing strap 110 and the helmet fixing strap snap-on interlock 115, and the helmet-fixed strap snap-on interlock 115 is connected to the power supply and the main control through the helmet interlock connecting line 116 in box 400. In order to further ensure the safety of the laser, a pressure sensor 125 for sensing the pressure of the helmet 100 and the top of the head is placed inside the helmet 100 . When the head of the irradiated person is upright, the natural gravity will close the switch of the pressure sensor 125 , and the closed electrical signal is connected to the power supply and the main control box 400 through the pressure sensor connection line 126 . The semiconductor laser generator 300 can emit laser light only after the power supply and the main control box 400 receive the switch closing signal of the pressure sensor 125 .

FIG. 32 is an electrical schematic diagram of the main control box according to the embodiment of the present invention. The power supply and main control box 400 contains an electronic control main control system 410 . The electronic control main control system 410 is composed of one or more central processing units (CPUs), electronic components for controlling the laser generators, and hardware and software related to the embedded control system. The power supply of the electronic control main control system 410 is provided by the medical DC power supply 420 . The medical DC power supply 420 can be built-in or external, and is connected through the electronic control main control system 410 and the connection line 425 of the medical DC power supply. The medical DC power supply 420 and the AC AC power supply 422 are connected through the AC AC power supply connection line 421 . The electronic control main control system 410 controls one or more semiconductor laser constant current power supplies 440 through the semiconductor laser constant current power supply and the electronic control main control system connection 441. The semiconductor laser constant current power supply 440 supplies power to the corresponding semiconductor laser generator 300 through the electronic control main control system and the semiconductor laser generator connection 405, and finally the output laser of the semiconductor laser generator 300 is input into the helmet 100 through the energy transmission fiber 210. inside the light-emitting body 200.

Each light-emitting body 200 in the helmet 100 also has its own light-emitting body feedback output fiber 230, which is connected to one or more photodetectors or photoelectric signal receivers 450 located in the power supply and the main control box 400 to monitor the laser light of each light-emitting body 200. output. The photodetector or photoelectric signal receiver 450 may be one or more photodiodes. The output signal of the photodiode is input to the electronic control main control system 410 through the photodetector and the embedded electronic control main control system connecting line 455 . The electronic control main control system 410 determines the working state of each light-emitting body 200 after analyzing the laser intensity of each light-emitting body 200 .

In order to ensure the laser safety of the semiconductor laser treatment device for treating brain diseases, the helmet 100 is provided with a helmet fixing belt buckle-type interlock 115 and/or a pressure sensor 125 . The output signals are all switching electrical signals, which are respectively connected to the interlock power switch 460 by the helmet interlock connecting wire 116 and/or the pressure sensor connecting wire 126 . The interlocking power switch 460 controls the on and off of the semiconductor laser constant current power supply 440 through the interlocking power switch connection line 465 , and then controls the laser output of the semiconductor laser generator 300 . The interlocking power switch 460 may be provided inside the power supply and the main control box 400, or may be provided outside. The temperature sensor 130 in the helmet 100 is connected to the electronic control main control system 410 through the temperature sensor connecting wire 135 in the helmet. After the temperature detected by the temperature sensor 130 exceeds 41 degrees Celsius, the electronic control main control system 410 automatically reduces the average laser power emitted by the semiconductor laser generator 300 . The method of reducing power is to reduce the current or reduce the duty cycle in the case of chopping and pulse.

The power supply and main control box 400 may also contain an Internet of Things module and an external communication module 430, and is connected to the electronic control main control system 410 through a connection 435 between the electronic control main control system and the Internet of Things module and the external communication module. The purpose of the Internet of Things module and the external communication module 430 is to allow the semiconductor laser treatment device for treating brain diseases to receive the input of treatment parameters from the treating doctor, and also to output its working status and usage history to a central computer, so that the central computer can Analyze the usage of each semiconductor laser treatment device for brain diseases, provide treatment doctors with the usage of each user, or provide big data analysis. The Internet of Things module and the external communication module 430 can be connected to the local area network through a network cable, or can be connected to the local area network through wireless means such as WiFi or Bluetooth.

The operator of the semiconductor laser treatment device for treating brain diseases can control the power supply and the operation of the main control box 400 through the man-machine control interface 500 . The man-machine control interface 500 can be connected to the control power supply and the main control box 400 by wire using the connection 445 of the electronic control main control system and the man-machine control interface, or it can be connected to the control power supply and the main control box by wireless means such as WiFi or Bluetooth. 400 connections. The operator can use the manual control interface 510 to set the man-machine control interface 500 to set the treatment parameters, and can also use the intelligent PBM parameter automatic exporter 480 to allow the doctor to set the treatment parameters in different places through the Internet.

The semiconductor laser treatment device for treating brain diseases can also be connected with one or more external devices, such as a pulse waveform input terminal 600 . The input pulse waveform can be a waveform and frequency that mimics a certain brain wave, such as 8-14Hz Alpha wave, 12.5-28Hz Beta wave, or 25-100Hz (usually 40Hz) Gamma wave, or directly irradiate the subject The brainwave waveform is input to the power supply and the main control box 400 through the pulse waveform input terminal 600 , and finally the expected laser output waveform is generated in the semiconductor laser generator 300 and the light-emitting body 200 .

Claims (13)

1. A device for treating brain diseases based on semiconductor laser external irradiation technology comprises a helmet (100), a semiconductor laser generator (300), at least one energy transmission optical fiber (210) and a power supply and main control box (400); the method is characterized in that:

the helmet (100) comprises a helmet outer layer and at least one scattering optical fiber arranged on the inner side of the helmet outer layer;

the energy transmission optical fiber (210) is connected with a scattering optical fiber;

the semiconductor laser generator (300) is used for generating laser with the wavelength of 600nm-1400 nm;

the semiconductor laser generator (300) is respectively connected with all the energy transmission optical fibers (210) and is used for outputting laser with the average power of 5W-200W in total to all the scattering optical fibers or enabling the scattering optical fibers to irradiate the average laser power density on the skin surface to be 30-500mW/cm²In the meantime.

2. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 1, characterized in that:

the helmet (100) further comprises a light-emitting body (200) arranged on the inner side of the outer layer of the helmet;

the scattering optical fiber is disposed on the light-emitting body (200).

3. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 2, characterized in that:

the light-emitting body (200) is of a three-dimensional structure, one surface close to the skin is a light-emitting surface (202), and the other surfaces are light-reflecting surfaces (203);

the scattering optical fiber is a high scattering optical fiber (211);

the scattering optical fiber is disposed within the light-exiting body (200).

4. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 3, characterized in that:

the structure of the high-scattering optical fiber (211) comprises an uncoated optical fiber core (281) and an uncoated optical fiber surface (283) which is corroded or frosted.

5. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 2, characterized in that:

the light-emitting body (200) is a flexible pad;

the scattering optical fiber is a low scattering optical fiber (220);

the scattering optical fiber is arranged on the inner side face of the flexible pad.

6. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 2, characterized in that:

the light-emitting body (200) is of a three-dimensional structure, one surface close to the skin is a light-emitting surface (202), and the other surfaces are light-reflecting surfaces (203);

the scattering optical fiber is a low scattering optical fiber (220);

the scattering optical fiber is disposed within the light-exiting body (200).

7. The device for treating brain diseases based on semiconductor laser external irradiation technology according to claim 5 or 6, characterized in that:

the low-scattering optical fiber (220) comprises a scattering optical fiber core (271) and a low-scattering optical fiber organic material cladding (273).

8. The device for treating brain diseases based on semiconductor laser external irradiation technology according to any one of claims 1 to 6, characterized in that:

the helmet (100) and the semiconductor laser generator (300) are of a split structure.

9. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 8, characterized in that: the wavelength of the laser generated by the semiconductor laser generator (300) is 800nm-1000 nm.

10. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 8, characterized in that: the wavelength of the laser generated by the semiconductor laser generator (300) is 635 +/-10 nm, 810 +/-10 nm or 980 +/-10 nm.

11. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 8, characterized in that:

the helmet also comprises a detection feedback unit arranged in the helmet (100) and a switching element for controlling the semiconductor laser generator (300) to work;

the helmet (100) further comprises a helmet inner layer (160);

the scattering optical fiber is positioned between the helmet outer layer and the helmet inner layer (160); the helmet inner layer (160) is made of a transparent material;

the detection feedback unit is used for detecting the working condition of the scattering optical fiber, the temperature in the helmet (100) and/or the posture of the head of the irradiated person and feeding back to the power supply and the main control box (400);

the switching elements include an interlock power switch (460) and a signal sensor; the signal sensor is a helmet fixing belt buckle type interlock (115) and/or a pressure sensor (125) used for sensing the pressure between the helmet (100) and the head in the helmet (100).

12. The device for treating brain diseases based on the semiconductor laser external irradiation technology according to claim 8, characterized in that:

the device also comprises a working state indicating unit;

the working state indicating unit is a visible light semiconductor laser tube (312) arranged in a semiconductor laser generator (300) or an L ED lamp arranged in a helmet (100);

the helmet (100) further comprises a flexible shade strip (170) disposed inside the helmet rim.

13. The device for treating brain diseases based on semiconductor laser external irradiation technology according to claim 3, 4 or 6, characterized in that:

the scattering optical fiber is fixed in the light outlet body (200) by pouring high-refractive-index glue or transparent glue (201);

or,

the scattering optical fiber is fixed in the light-emitting body (200) through a fixing point adhesion, or a buckling or a thread sewing mode, and a medium for transmitting laser inside the light-emitting body (200) is air (206).

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