CN111420293A

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

Info

Publication number: CN111420293A
Application number: CN202010294500.6A
Authority: CN
Inventors: 穆力越; 杨冰; 贺大林; 鲁怀安; 魏周文; 孟涛; 刘启; 刘琦; 陈荣
Original assignee: Xi'an Blue Top Medical Electronic Technology Co ltd
Current assignee: Xi'an Blue Top Medical Electronic Technology Co ltd
Priority date: 2020-04-15
Filing date: 2020-04-15
Publication date: 2020-07-17

Abstract

The invention relates to a device for treating brain diseases, in particular to a device for treating brain diseases based on a semiconductor laser external irradiation technology, which solves the problems that irradiation light emitted by the existing treatment device cannot irradiate and treat deep brain cells of a skull, the irradiation is uneven, a helmet is heavy and cannot be implemented. The device comprises a helmet, a semiconductor laser generator, at least one energy transmission optical fiber, a power supply and a main control box; it is characterized in that: the helmet 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 is connected with the scattering optical fiber; the semiconductor laser generator is used for generating laser with the wavelength of 600-1400 nm; the semiconductor laser generator is connected with all the energy transmission optical fibers respectively 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.

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 a semiconductor laser external irradiation technology.

Background

The use of low power laser irradiation to treat (L ow-level laser therapy, or L ow-level light therapy, LLL T) tissue pain within 30cm of human skin has been known for decades and researchers around the world have completed over 500 various clinical trials and more than 4000 laboratory animal studies to date, demonstrating that such red and infrared light at 600nm to 1400nm can be effective in relieving pain, reducing inflammation, modulating immune responses, promoting wound healing, stimulating acupuncture points in the human body, promoting hair growth, etc²) And a large energy density (J/cm)²) The quasi-monochromatic light used by the PBM is a narrow-band light source, and comprises laser, L ED, a bulb with a narrow-band optical filter and the like.

It is currently accepted that the mechanism of PBM is closely related to the key protein of Cytochrome C Oxidase (CCO), which is located at the end of the mitochondria of cells, is an endogenous neuronal photoreceptor, which is part of the mitochondrial respiratory chain in cells, responsible for catalyzing the reduction of oxygen molecules in glucose metabolism to water molecules and is coupled to proton pump function cytochrome oxidase is present in all human cells and is more abundant in neurons with high energy requirements CCO is the main photoreceptor that absorbs light in the red to near infrared region of the spectrum, when COO is stimulated by light, it not only increases the electron transport chain activity in the mitochondria of cells, but also regulates the Synthesis of Nitric Oxide (Nitrice Oxide Synthesis, NOS), NOS catalyzes Arginine (Arginine) in cells, produces Nitric Oxide (NO) as a highly lipophilic gas, and when RGE (Soluble Guanylyl Cyclase, Guanosine, which is fused with Soluble Guanylyl Cyclase (Guanosine, or other enzymes, which may be able to increase the production of cytochrome c, thus, when intracellular cytochrome c oxidase, ATP, and ATP, which are expressed at a physiological, which may be capable of catalyzing the transient increase the production of intracellular energy, and thus, increase the production of cellular hypoxia, increase the cellular oxygen-production of intracellular cytochrome c, which, may cause the cellular hypoxia-oxidase, increase the production of intracellular cytochrome, and increase the cellular oxygen-oxidase, thus, the cellular oxygen-production of intracellular cytochrome-oxidase, the cellular oxygen-production of intracellular cytochrome, which may be able to increase, and increase the cellular hypoxia-oxidative cell, and cell-oxidative cell, which may cause cell-oxidative cell-.

CCO is a terminal enzyme located in the electron transport chain of the outer mitochondrial membrane. Through a series of redox reactions, electron transport chains facilitate the transfer of electrons across the inner mitochondrial membrane. The end result of these electron transfer steps is the generation of a proton gradient across the mitochondrial membrane, driving the activity of ATP synthase (ATP Synthesis). ATP synthase produces ATP from Adenosine Diphosphate (ADP). CCO mediates electron transfer from cytochrome c to molecular oxygen. CCO is a complex protein consisting of 13 different polypeptide subunits, also containing two heme centers and two copper centers. Both the heme center and the copper center can be oxidized or reduced, yielding sixteen different oxidation states. Each oxidation state has a slightly different absorption spectrum, but CCO is almost the only one in biomolecules with significant absorption in the red and near infrared spectra. According to current studies, absorption of red and near infrared light by biological tissues of more than 50% can be attributed to CCO. During PBM, light not only increases mitochondrial membrane potential (Δ Ψ) and proton gradient (Δ pH). It also changes the optical properties of mitochondria, increases ADP/ATP exchange, ribonucleic acid (RNA) and protein synthesis in mitochondria, and increases oxygen consumption. A plurality of researches find that PBM has certain wavelength specificity on the influence of mitochondria of different tissues, and CCO has stronger light absorption at 665nm and 810nm in terms of brain nervous tissues.

In 2019, Nobel physiologically or medically awarded leading Kaelin, Ratcliffe and Semenza et al discovered in the 90's last century that cells were perceived and adapted to the supply of oxygen through the interaction of VH L, hypoxia inducible factor (HIF-1 α), and hydroxyl (OH). Thieh-L in Taiwan, 2012, discovered that low power laser irradiation could modulate HIF-1a activity, improve tissue hypoxia/ischemia and nerve bundle inflammation, and promote nerve regeneration.

Since brain cells require a large amount of energy for their activities, cytochrome oxidase is more abundant in brain neuronal cells. 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 from the action of PBM not only accelerate the catalytic activity and oxygen consumption rate of cytochrome oxidase, increasing ATP production in the brain, but also induce a number of secondary cellular effects. These subsequent secondary effects include activation of gene expression in cells, increased metabolic capacity of neurons, and increased cell survival.

PBM can enhance the activity of the electron transport chain in brain cells while also modulating NOS. NOS is typically activated by glutamatergic receptors (AMPAR and NMDAR) to produce NO, which acts as a second messenger regulating cytochrome oxidase activity, further regulating cellular respiration. A study by Uozumi et al (2010) indicated that after 5 minutes of PBM irradiation treatment, there was a peak increase in NO followed by a decrease. As cerebral blood flow increases, a local increase in NO leads to vasodilation and hemodynamic response.

There are many kinds of brain diseases, including neuron degeneration brain diseases, traumatic encephalopathy sequelae, vascular encephalopathy sequelae, infectious encephalopathy sequelae, metabolic encephalopathy, psychopsychological encephalopathy, etc. Some brain diseases are 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., and there are many diseases for which the true cause is not known at present, such as Alzheimer's Disease (AD). Many brain diseases can lead to dementia. Dementia can be broadly classified into congenital dementia and acquired dementia. Including senile dementia, brain injury dementia and the like, which belong to acquired dementia caused by degenerative brain diseases. AD patients are generally accompanied by senile dementia of different strengths. Current research has found that PBM is beneficial to some extent in brain diseases other than congenital dementia.

Alzheimer's disease is a common, chronic progressive neurodegenerative disease, gradually leading to dementia, is a degenerative lesion of the nervous system, which is mostly developed in the elderly, and is clinically characterized by progressive hypomnesis, language disorders, impairment of visual spatial function, thought retardation, attention deficit, and affective disorders, etc. its etiology and pathogenesis are complex, with many genetic and environmental risk factors, including mental stress and insulin resistance.

In addition to cancer, AD and senile dementia may be one of the most alarming health problems facing the world today. With the gradual increase of the aging population of the society, the incidence rate of AD is in a gradually rising trend. According to statistics of World Alzheimer Report2018, nearly 5000 million AD patients exist in the World in 2018, and the number of the AD patients is estimated to increase to 1.52 hundred million people by 2050. The published data shows that about 1000 million people suffer from Alzheimer disease in China, and the number of the Alzheimer disease is the most serious country in the world. With the aging of population accelerating, it is expected that the number of patients in China will reach 4000 million in 2050 years. There are very few drugs that can be effectively used to treat AD and dementia at present. Over the past few decades, numerous clinical trials of the drug tested have failed to reverse, improve, and even stabilize the progressively declining cognitive function of dementia patients.

Gonzalez-L ima et al (1998) and Valla et al (2001) demonstrated that cognitive impairment and neurodegeneration associated with dementia manifest local deficits in brain metabolism early in the disease, for example, in patients at risk for AD, early decline in brain metabolic activity, especially decline in cytochrome oxidase activity, can be detected.

Many studies have found that mitochondrial dysfunction, insufficient ATP supply and oxidative stress are contributing factors to almost all forms of brain disease. Several neurological disorders, including major depressive disorder, brain trauma, Parkinson's disease, and AD are associated with these several factors.

In the field of molecular studies of PBM, L u et al (2017) demonstrated that PBM can improve mitochondrial dynamics, increase mitochondrial membrane potential, reduce oxidized mitochondrial DNA, inhibit apoptosis, increase expression of mitochondrial antioxidants, increase CCO activity and ATP levels, inhibit A β -induced reactive gliosis, inflammation and tau hyperphosphorylation L ee (2017) et al suggested that NO is a major neuronal signaling molecule and has the ability to trigger vasodilation among other functions since it first stimulates soluble guanylate cyclase to form cGMP (cGMP), and then cGMP activates protein kinase G, resulting in Ca activation²⁺And calcium activates the opening of potassium channels. Ca²⁺The decreased concentration prevents the myosin light chain kinase from phosphorylating myosin molecules, thereby relaxing smooth muscle cells of the vascular and lymphatic walls. This vasodilation then promotes 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 resistance, and when reactive oxygen species are excessive, they become harmful through antioxidants. Many studies have found that oxidative stress is associated with various neurological disorders, such as major depression and traumatic brain injury, cardiovascular disease and AD. PBM can regulate the balance of ROS at the cellular level, alleviating the condition.

PBMs can achieve improved metabolic function at the cellular level by increasing intracellular ATP production. There is a great deal of research evidence that PBM can protect nerves at the cellular level, protect cells from damage, promote their survival, prolong life span, and reverse apoptotic signals. One study by Oron et al (2006) found that transcranial pbm (tpbm) stimulated nerve cell growth. At the tissue level, several studies have demonstrated that tPBM enhances cerebral blood flow and oxygenation processes and also exhibits certain anti-inflammatory effects.

Similar to the results achieved by physical exercise, tPBM promotes the regeneration and relaxation of microvasculature in the brain, improving blood circulation. These improvements in blood flow functionality can effectively reduce the probability of microvascular rupture in the brain of elderly patients, reduce the mortality of brain cells due to microvascular rupture, reduce the probability of dementia and delay the onset of dementia.

In recent years, there have been many studies abroad in which red or near-infrared light is non-invasively irradiated to the head (tPBM) to treat various brain diseases by means of animal experiments, human clinical trials, etc. tPBM (LLL T) has been used to treat brain diseases by irradiating red or near-infrared light to the head (tPBM) in such a manner that the red or near-infrared light is used to treat the brain diseases, and Ando et al (2011) and Salehpour et al (2017) have been used to treat brain diseases by tPBM in such a manner that the ATP content in the brain of some experimental animals is increased.

Hamblin (2016), Hennessy and Hamblin (2016), Thunshelle and Hamblin (2016) used the tPBM approach to treat a variety of brain diseases, including sudden disorders (stroke, traumatic brain injury, TBI, cerebral vascular ischemia), neurodegenerative disorders (Alzheimer's disease, Parkinson's disease, dementia) or psychiatric disorders (depression, anxiety, post-traumatic stress disorder), confirming that tPBM is not only effective, but also does not have any observable side effects.

This study used Neuro alpha (810nm, 10Hz pulse L ED) PBM therapy instrument from Vielight corporation, in combination with transcranial and intranasal PBM to treat default network cortical nodules of the brain (bilateral medial prefrontal cortex, anterior/posterior cingulate cortex, horn gyrus and hippocampus), in 12 weeks of treatment, each patient was treated with transcranial tPBM/intraluminal PBM weekly in the consulting room, and with intranasal PBM daily at home, followed immediately 4 weeks of follow-up followed by 4 weeks of follow-up without any treatment during follow-up, at 12 weeks, all patients were found to have significantly enhanced cognitive function (MMSE-cog), improved sleep and improved sleep, and reduced anxiety, and even decreased mood was observed for patients at 4 weeks of follow-up.

Representative products abroad are products which are irradiated by L ED light source through skull and nose PBM, manufactured by U.S. photomdex, manufactured by VIELight, Canada, manufactured by the company L ED light source helmet through skull, manufactured by the company THOR Photomedicine, manufactured by the company British, manufactured by the company L ED light source helmet through skull, manufactured by the company L ED light source helmet through skull, manufactured by the company Irish Cognitolite, manufactured by the company Tianjin Leyi laser technology, manufactured by the company Limited, manufactured by the company Tianjin, manufactured by the company using laser to irradiate the acupoints of the brain, or manufactured by other companies using laser to irradiate the head through the ear, and the light source in the products is low-power light source with the light power less than 5W.

U.S. Pat. No. US8,535,361B2, U.S. patent application Nos. US2014/0358199A1, US2018/0256917A9 are all inventions of doctor Vielight L ew L im, of which doctor L im discloses a device using a battery-driven light source of no more than 20mW placed in a nostril for illuminating light from the intranasal cavity through the thinner skull to the brain region such as the hippocampus.

L uis De Taboada et al, and Phototera corporation, have filed several patents in the United states and Europe, including U.S. Pat. No. 7,303,578B2, U.S. Pat. No. 7,309,348B2, U.S. Pat. No. 7,575,589B2, U.S. Pat. No. 8,308,784B2, U.S. Pat. No. 10,188,872B2, U.S. Pat. No. 10,357,662B2 and European patent application No. EP2,489,403A2, among which De Taboada et al, disclose the use of red to near infrared laser radiation to treat head disorders, respectively, which irradiate helmet devices are largely divided into three types, the first type, in which one or more fiber-coupled lasers are secured to a helmet having a plurality of optical lenses through a complex head-emitting head-mounted with optical lenses, to irradiate the head-mounted semiconductor lasers through a specific helmet-mounted fiber-mounted head-mounted to the helmet, the helmet-mounted laser-mounted to the helmet, to the head-mounted, a high-mounted, highly-optical fiber-mounted, highly-fiber-head-light-fiber-light.

Massachusetts institute of technology L i-Hueissai et al disclose in a series of patent applications, US20170304584A1, US20190105509A1, US20190126062A1, US20190240443A1, etc., the use of weak light having 10-100Hz for stimulating eyes and head, sound having 10-100Hz for stimulating ears, and mechanical vibration having 10-100Hz for stimulating brain for treating AD and dementia, the invention is based on the principle of optical or electromagnetic wave signals, acoustic or mechanical vibration signals stimulating and resonating waves, belonging to the theory and mechanism of Optogenetics (Optogenetics), rather than the PBM energy biomedical principle of using certain energy (including promotion of nerve cell repair, regeneration, improvement of cerebral blood flow and cerebral blood oxygen content, etc.) for treating AD, dementia and other brain diseases.

The invention relates to a therapeutic device for stimulating head acupuncture points by using L ED light, and Chinese patent with an authorized publication number of CN201768276U discloses a therapeutic device which aims at corresponding acupuncture points of the head of a patient by using near infrared L ED lamps, and L ED light can penetrate through the scalp and skull to reach injured brain cells, so that the therapeutic purpose is achieved by the combined action of acupuncture point stimulation and photobiological regulation.

The invention discloses a near infrared light therapeutic apparatus for treating brain diseases, which is named as 'a near infrared light therapeutic apparatus for treating brain diseases', and is applied to Chinese patent with publication number CN 104162233A, wherein a plurality of near infrared L ED light sources are fixed on a helmet-shaped hemispherical support, the main light distribution design principle is similar to the first or second design of L uis De Taboada and the like, but in the aspect of the light sources, L ED is also used, even though L ED works in a flicker mode, the peak power of light is very low, and the light cannot irradiate tissues with the depth of more than 2cm in the brain, because the design belongs to a close fit type design, if L ED is changed into semiconductor laser, the laser spots on the hair or scalp are too small, the laser power density is too large, and the hair is damaged or the scalp is damaged.

The invention discloses a wearable photoelectric integrated autism therapeutic apparatus, which is a Chinese patent with the application publication number CN109432607A, and discloses a red light helmet, wherein L ED with multiple wavelengths from red light to near infrared is used for irradiating a brain, and the brain is treated by combining 2Hz or 40Hz pulse current stimulation, such as autism.

The invention discloses a brand-new earphone type laser health care therapeutic instrument with multiple working wavelengths, and Chinese patent with application publication number CN106730404A, and discloses a method for irradiating ear tissues and brain blood flowing through ears by multi-wavelength laser transmitted by optical fibers so as to achieve the specific therapeutic purpose. The invention is similar to the technology of nasal cavity irradiation, the area irradiated by the ear is limited, therefore, the brain area and volume of the effective irradiation area are limited, and the expected treatment effect is difficult to achieve. The ear irradiation laser and the nasal cavity irradiation laser are similar, and the laser power cannot be too high, so that thermal damage can be caused to the irradiation part.

The invention discloses an intelligent photodynamic hair growth helmet, and Chinese patent with application publication number CN 110141797A discloses a helmet for treating alopecia and stimulating hair growth by PBM or LLL T, in order to avoid covering scalp by hair in the prior art, the invention uses a plurality of needle-shaped light guide channels to bypass the hair and directly irradiate the light to the scalp, and because the laser for treating alopecia is low-power continuous mode (CW) laser, the power emitted by a single laser is generally less than 20mW and cannot effectively penetrate through brain tissues, the laser cannot be effectively used for treating brain diseases.

The invention relates to a hair-growing device, and the Chinese patent with the application publication number of CN 108114378A discloses a hair-growing device which uses a plurality of small-power lasers, such as a plurality of red lasers with the wavelength of 700nm and the power of 620 mW and the power of 700nm, to irradiate on the scalp to generate 1-20mW/cm²The irradiation power density of the helmet, and the flexible self-adaptive helmet hair-growing device can be output in a pulse mode so as to enhance the development of hair. The disadvantage of this invention is that since the laser sources are fixed to a flexible helmet which limits the heat dissipation of each laser source, only a very low power laser source, for example a 5mW laser source, can be used, even in the case of pulses, producing no more than 20mW/cm on the scalp²Current research results indicate that even with L ED light sources, an optical power density of at least tens of milliwatts per square centimeter should be produced at the scalp site, as clinically validated by Vielight, Neuro Alpha is 25-150 mW/cm²。

The invention discloses a wearable photoelectric integrated autism therapy instrument, and Chinese patent with application publication No. CN109432607A discloses a device for directionally irradiating a brain region related to autism by using red and near-infrared L ED light to treat autism, wherein the device is similar to the patent of doctor L ew L im, and only the specificity of an irradiation region is emphasized.

The invention relates to an acupuncture point positioning cover for laser therapy of brain diseases, and the name of the invention is CN

204121616U, which is similar to the helmets described in L uis De Taboada et al, where a plurality of holes are left for fixing a light source, is called a "helmet-type therapeutic apparatus", which is a Chinese patent with publication number CN 107998516A and discloses a device based on point irradiation combined with magnetic therapy.

The invention discloses a handheld low-level laser and a low-level laser beam generation method, and discloses a handheld low-level laser and a low-level laser beam generation method in Chinese patent with the application publication number of CN 108325090A. The invention relates to a handheld low-level laser treatment device, and discloses another handheld low-level laser treatment device in Chinese patent with publication number CN 102573991A. Both of these inventions beam-shape the treatment laser through one or more corrective lenses to achieve the desired irradiation parameters for treatment, and the operator needs to treat the patient in a hand-held manner.

Since the discovery of the brain Default Network (the brain's Default model Network) in 2001 taught by Raichle, university of st louisis washington, usa, 3000 academic studies have discussed the application and contribution of the brain Default Network in neuroscience, cognitive science, brain disease research, neurophysiology and cytology worldwide. The default network of the brain consists of brain organs such as medial prefrontal cortex, posterior parietal subcortical, splenic posterior cortex, hippocampus, hippocampal juxtapose, cingulate posterior cortex, and adjacent anterior process nerves and horny gyrus. For normal adults, these organs are mostly at a depth of at least 3cm below the scalp, with both the hippocampus and the hippocampal paradox located in the midbrain exceeding a depth of 5 cm. However, the existing therapeutic device based on continuous light irradiation of brain can not effectively penetrate the brain tissue above 5 cm.

Disclosure of Invention

The invention aims to provide a device for treating brain diseases based on a semiconductor laser external irradiation technology, which aims to solve the technical problems that irradiation light emitted by the existing treatment device cannot effectively penetrate through a skull to carry out irradiation treatment on brain cells at the deep layer of the skull, the helmet is heavy and cannot be implemented due to uneven illumination and complex structure, and the irradiation treatment on the brain cells at the deep layer of the skull cannot be realized, and adverse effects cannot be caused due to overhigh temperature. The invention provides a design for irradiating a shallower brain tissue by combining low average power of laser and carrying out PBM treatment on the deeper brain tissue under the condition of higher peak power of pulse laser, fully considering that the balanced high peak power density red to near infrared laser can effectively irradiate the deep brain tissue of more than 7cm and avoid the adverse effect of high average power density on brain heating.

The invention adopts the technical scheme that a device for treating brain diseases based on a semiconductor laser external irradiation technology comprises a helmet, a semiconductor laser generator, at least one energy transmission optical fiber, a power supply and a main control box; it is characterized in that:

the helmet 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 is connected with the scattering optical fiber;

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

the semiconductor laser generator is respectively connected with all the energy transmission optical fibers and is used for outputting laser with the average power of 5W-200W 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.

Further, the helmet also comprises 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-emitting body.

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

the scattering optical fiber is a high scattering optical fiber;

the scattering optical fiber is arranged in the light emergent body.

The high-scattering optical fiber of the invention refers to a scattering optical fiber with a scattering length of less than 0.3m, such as 5mm, 10mm, 100mm and the like; the diameter of the fiber core of the high-scattering optical fiber is between 0.2mm and 2.0 mm; the scattering mechanism of the high-scattering optical fiber can be that the side surface of the optical fiber cylinder is subjected to certain surface treatment, such as hydrofluoric acid corrosion or sanding treatment by using sand paper, so that the scattering length reaches the required length.

Further, the structure of the high-scattering optical fiber comprises an uncoated optical fiber core and an uncoated optical fiber surface which is 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 fiber is arranged on the inner side face of the flexible pad.

The low scattering optical fiber of the present invention means a scattering optical fiber having a scattering length of more than 0.3m, for example, a scattering length of 0.5m, 1m, 5m, or the like. The scattering length refers to the energy attenuation of 90% of the incident energy after the laser energy passes through a length of optical fiber. A scattering fiber with a scattering length of 1m can scatter 90% of its incident energy over a length of 1m, i.e. only 10% of the energy remains, and can scatter 99% of the incident energy over a length of 2m, i.e. only 1% of the energy remains. The diameter of the fiber core of the low-scattering optical fiber is between 0.1mm and 0.3 mm; the scattering mechanism of the fiber core of the low-scattering optical fiber can be that a scattering center is doped in the fiber core, or the side surface of the cylindrical body of the optical fiber is subjected to certain surface treatment, so that certain light leaks out from the side surface in the internal reflection process of the optical fiber; the scattering centers are small bubbles with a diameter less than 0.1um or scattering particles smaller than the wavelength of the guided laser.

the scattering optical fiber is a low scattering optical fiber;

the scattering optical fiber is arranged in the light emergent body.

Further, the low-scattering optical fiber comprises a scattering optical fiber core and a low-scattering optical fiber organic material coating layer.

Further, the helmet and the semiconductor laser generator are of a split structure.

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

Further, the wavelength of the laser generated by the semiconductor laser generator is 635 +/-10 nm or 810 +/-10 nm or 980 +/-10 nm.

Further, the helmet also comprises a detection feedback unit arranged in the helmet and a switching element for controlling the semiconductor laser generator to work;

the helmet further comprises a helmet inner layer;

the scattering optical fiber is positioned between the helmet outer layer and the helmet inner layer; the inner layer of the helmet is made of transparent materials;

the detection feedback unit is used for detecting 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 feeding back to the power supply and the main control box;

the switching element comprises an interlocking power switch and a signal sensor; the signal sensor is a helmet fixing belt buckle type interlocking device and/or a pressure sensor used for sensing helmet and head top pressure in the helmet.

Further, the device also comprises 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 L ED lamp arranged in a helmet;

the helmet also comprises a flexible shading belt arranged on the inner side of the helmet edge.

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

alternatively, the first and second electrodes may be,

the scattering optical fiber is fixed in the light emitting body in a fixing point bonding or buckling or thread sewing mode, and a medium for transmitting laser inside the light emitting body is air.

The invention has the beneficial effects that:

(1) the treatment device of the invention has the advantages that the wavelength of the laser generated by the semiconductor laser generator is 600nm-1400 nm; the semiconductor laser generator outputs average power of 5-200W to all scattering optical fibers or the peak laser power density of 30-500mW/cm²To (c) to (d); thus, the emitted laser can effectively penetrate the skull to carry out irradiation treatment on brain cells in the deep layer of the skull; in addition, the inventionThe scattering optical fiber arranged on the inner side of the outer layer of the helmet uniformly scatters the laser, so that the laser uniformly irradiates the head of a patient; therefore, the invention solves the technical problems that the irradiation light emitted by the existing treatment device can not effectively penetrate through the skull to irradiate and treat brain cells at the deep layer of the skull, and the helmet is heavy and cannot be implemented due to uneven illumination and complex structure.

(2) The invention transmits laser energy through the optical fiber, and can effectively avoid the very complicated design for laser of the heat dissipation helmet part.

(3) The light emitting body is preferably a flexible pad which can be bent, input laser can be uniformly output to the light emitting surface to output laser energy, the energy is distributed to cover the whole head, and the head is mainly covered in an acupuncture point area.

(4) The modular light-emitting body design can place the light-emitting body with specific wavelength and specific power characteristic in the area to be irradiated, thereby realizing personalized treatment.

(5) The laser can be single wavelength or multiple wavelengths, and can be selected according to treatment needs.

(6) According to the invention, the helmet and the semiconductor laser generator are preferably in a split structure, so that the helmet is simple in structure, easy to implement, light in weight and convenient to wear.

(7) The invention preferably adopts a pulse light mode, stimulates the deep part of the brain through the tPBM to treat the deep part of the brain, and simultaneously, the pulse laser with high peak power and low average power can effectively reduce the heating of the laser to the head of a patient.

(8) The semiconductor laser generator preferably further comprises a visible light semiconductor laser tube, so that the treatment helmet meets the safety requirements of laser use.

(9) The present invention provides feedback detection of all laser energy input into the helmet to ensure that the laser energy delivered to various areas of the patient's head meets the required dose and to ensure that any accidental shutdown can be automatically initiated during the laser input process.

(10) The present invention preferably has a temperature sensor in the helmet that will not cause discomfort to the patient due to laser heating.

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

Drawings

FIG. 1 is a schematic structural view of a helmet according to an embodiment 1 of the present invention;

FIG. 2 is a schematic structural view of a helmet according to an embodiment 2 of the present invention;

FIG. 3 is a schematic diagram of the main brain area and its division of labor;

FIG. 4 is a schematic diagram of the process by which the mechanism of action of PBM is that red and near infrared light can lead to a cascade of intracellular pleiotropic effects;

FIG. 5 is a schematic diagram of a low-dispersion fiber-based structure for scattering input laser light into a rectangular area;

FIG. 6 is a schematic diagram of another structure based on low-dispersion optical fiber for scattering input laser light into a rectangular area;

FIG. 7 is a schematic diagram of an optical structure for bonding a high refractive index glue or transparent glue and low scattering optical fibers together;

FIG. 8 is a schematic diagram of a light-emitting structure based on a high-scattering optical fiber for scattering input laser light into a rectangular region and injecting high-refractive-index glue or transparent glue;

FIG. 9 is a schematic diagram of a light-emitting structure based on a high-scattering optical fiber for scattering multiple paths of input laser light into a rectangular region and injecting high-refractive-index glue or transparent glue;

FIG. 10 is a schematic diagram of a light-emitting body design that can use high-scattering optical fiber or low-scattering optical fiber and scatter the input laser light into a rectangular region, in which the laser transmission medium except the optical fiber is air;

FIG. 11 is a schematic structural view of a cross section of an energy transmitting fiber;

FIG. 12 is a cross-sectional structural view of a low-scattering optical fiber;

FIG. 13 is a schematic structural view of a cross section of a high-scattering optical fiber;

FIG. 14 is a schematic structural diagram of a conventional optical fiber with a spherical scattering head on its light-emitting surface to output light at a larger angle of divergence;

FIG. 15 is a schematic cross-sectional view of a high refractive index glue or clear glue and low scattering optical fibers glued together;

FIG. 16 is a schematic cross-sectional view of a high refractive index glue or transparent glue and a high scattering optical fiber or uncoated optical fiber glued together;

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

FIG. 18 is a schematic view of an energy transmitting fiber and a scattering fiber connected by fusion welding;

FIG. 19 is a schematic structural view of an energy transmitting fiber and a scattering fiber connected by a flange;

FIG. 20 is a cross-sectional view A-A of FIG. 19;

FIG. 21 is a cross-sectional view B-B of FIG. 19;

FIG. 22 is a schematic view showing a configuration in which a semiconductor laser generator including a visible light semiconductor laser tube is connected to a power supply and a main control box;

FIG. 23 is a schematic view showing a structure in which a semiconductor laser generator including two semiconductor laser tubes is connected to a power supply and a main control box;

FIG. 24 is a schematic view showing a configuration in which a semiconductor laser generator including a plurality of semiconductor laser tubes is connected to a power supply and a main control box;

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

FIG. 26 is a graph of the dose profile of laser PBM treatment for Arndt-Schulz;

FIG. 27 is a laser waveform diagram of an embodiment of the present invention operating in a continuous light extraction mode;

FIG. 28 is a laser waveform diagram of an embodiment of the present invention operating in a chopped light extraction mode;

FIG. 29 is a laser waveform diagram of the embodiment of the present invention operating in the square wave light emitting mode and the intermittent light emitting mode;

FIG. 30 is a laser waveform diagram for operation in any of the pulsed light extraction mode and the intermittent light extraction mode in accordance with embodiments of the present invention;

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

FIG. 32 is an electrical schematic of the main control box of an embodiment of the present invention;

the reference numerals in the drawings are explained as follows:

100-helmet, 106-soft or hard reflective material or film, 110-helmet fastening band, 115-helmet fastening band snap-on interlock, 116-helmet interlock connection, 120-uniformly scattered light, 125-pressure sensor, 126-pressure sensor connection, 130-temperature sensor, 135-helmet internal temperature sensor connection, 160-helmet internal layer, 170-flexible shading band, 180-helmet and power and main control box light path and circuit bus, 200-light outlet body, 201-high refractive index glue or transparent glue, 202-light outlet surface, 203-light reflection surface, 205-input laser connector, 206-air, 210-energy transmission fiber, 211-high scattering fiber, 220-low scattering fiber, 225-output laser connector, 230-optical feedback output fiber, 251-photodetector, 252-photodetector output connection, 261-common fiber core, 262-common fiber cladding, 263-common fiber coating, 271-scattering fiber core, 273-low scattering fiber organic material cladding, 281-non-cladding fiber core, 283-corroded or frosted non-cladding fiber surface, 290-optical beam expansion ball, 300-semiconductor laser generator, 305-semiconductor laser base and heat sink, 306-visible semiconductor laser base and heat sink, 310-semiconductor laser tube, 312-visible semiconductor laser tube, 313-visible semiconductor laser collimator, 315-fast axis collimator, 316-slow axis collimator, 317-a collimating mirror, 318-a visible light collimating mirror, 320-a beam reflecting mirror, 325-a polarized light beam splitter, 326-a wavelength beam combiner, 330-a focusing mirror, 340-a fiber coupler, 350-an air cooling device of a semiconductor laser generator, 400-a power supply and main control box, 405-a connection line of an electronic control main control system and the semiconductor laser generator, 410-an electronic control main control system, 420-a medical direct current power supply, 421-an AC power supply connection line, 422-an AC power supply, 425-a connection line of the electronic control main control system and the medical direct current power supply, 430-a connection line of an Internet of things module and an external communication module, 435-a connection line of the electronic control main control system and the Internet of things module and the external communication module, 440-a semiconductor laser constant current power supply, 441-a connection line of the semiconductor laser constant current power supply and the electronic control main control system, 445-the connection of the electronic control main control system and the human-computer control interface, 450-the connection of the photoelectric detector or the photoelectric signal receiver, 455-the connection of the photoelectric detector and the embedded electronic control main control system, 460-the interlocking power switch, 465-the interlocking power switch connection, 480-the connection of the intelligent PBM parameter automatic output device, 485-the connection of the intelligent PBM parameter automatic output device and the electronic control main control system, 500-the human-computer control interface, 510-the manual control interface and 600-the input end of the pulse waveform.

Detailed Description

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

The following detailed description is provided to illustrate various embodiments of the present invention for the purpose of describing the principal technical features, embodiments and technical advantages thereof. The core technical content of the present invention includes but is not limited to the examples provided below. Those skilled in the art, having the benefit of the teachings of this invention, may effect numerous modifications thereto without departing from the scope or spirit of the invention in its aspects.

The core technical content of the invention is that a semiconductor laser tube with the wavelength of 600nm-1400nm is used, the semiconductor laser is input into a helmet special for treating the brain diseases through an energy transmission optical fiber after being coupled by an optical fiber, and the brain diseases are treated by utilizing the principle of photobiological modulation (PBM). In order to efficiently irradiate red or near-infrared laser to cells of the deep brain system including hippocampus, the average laser power density of the laser irradiated on the skin surface of the present invention is 30-500mW/cm²The peak laser power density is 1-500W/cm²In the meantime. Devices according to the inventionBut the brain diseases which can be treated include but are not limited to the treatment or rehabilitation treatment of diseases such as stroke, traumatic brain injury TBI, cerebral vascular ischemia, Alzheimer's disease, dementia, depression, anxiety, post-traumatic stress disorder and the like, and can also help users to improve the cerebral blood flow and promote the generation of brain cells, brain microgrooves and brain microvascular so as to improve the brain health and improve the attention and cognitive ability.

The device for treating brain diseases based on the 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 helmet 100 includes a helmet outer layer and at least one scattering optical fiber disposed inside the helmet outer layer. Referring to fig. 1 and 2, in the present embodiment, preferably, the helmet 100 further includes a light-emitting body 200 disposed inside the outer layer of the helmet; the scattering fiber is disposed on the light-emitting body 200. And preferably the helmet 100 further comprises 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 transparent material; at least one scattering optical fiber is disposed on each light-emitting body 200; the semiconductor laser generator 300 is used for generating laser with the wavelength of 600nm-1400 nm; preferably, the semiconductor laser generator 300 generates laser light with a wavelength of 800nm to 1000 nm; when the wavelength of the laser generated by the semiconductor laser generator 300 is 635 +/-10 nm, 810 +/-10 nm or 980 +/-10 nm, the treatment effect is better. The semiconductor laser generator 300 is connected to all the energy transmission fibers 210, and is used for outputting laser with average power of 5-200W to all the scattering fibers, or enabling the scattering fibers to irradiate the skin surface with average laser power density of 30-500mW/cm²In the meantime.

Fig. 1 is a schematic structural view of a helmet according to an embodiment 1 of the present invention. Helmet 100 is a hard or semi-hard helmet comprising an outer helmet layer and an inner helmet layer 160. One or more light emitting bodies 200 for emitting laser light are disposed between the helmet outer layer and the helmet inner layer 160, for example, at positions on both sides of the head and at the top of the head of the helmet 100. The helmet 100 is fixed on the head of a patient by the helmet fixing band 110, and two pieces of helmet fixing band 110 are connected together by the helmet fixing band snap-type interlock 115, or the helmet fixing band 110 is directly connected with the helmet, and the helmet fixing band snap-type interlock 115 can also serve as the above-mentioned switching element. Optical fibers and wires in the helmet 100, such as optical fibers connected to the light-emitting body 200, connection wires of the helmet fixing band snap-in interlock 115, connection wires of the temperature sensor in the helmet 100, and the like, are connected to the power supply and main control box 400 through the helmet and power supply and main control box optical path and circuit bus 180. In order to prevent therapeutic light from leaking out of the helmet 100 and irradiating the eyes of a patient or an operator, and to ensure laser safety of the device for treating a brain disease, a flexible light-shielding tape 170 is installed inside the edge of the helmet 100, and the flexible light-shielding tape 170 is made of a black knitted material. The flexible masking strip 170 not only prevents laser leakage from the helmet 100, but also improves the comfort of the patient using the helmet 100.

Fig. 2 is a schematic structural view of a helmet in accordance with an embodiment 2 of the present invention. In contrast to fig. 1, fig. 2 contains two laser emitting emitters 200 for illuminating the brain through the ear and face. The advantage of illuminating the brain through the face is that absorption of laser light by the hair is avoided, and discomfort of placing the laser light emitter into the oral cavity is avoided.

Fig. 3 is a schematic diagram of the main brain area and its division of labor. By providing the power supply and the main control box 400, the light emitting body 200 above the treatment region in the helmet 100 is selectively turned on, and tPBM can be performed on the treatment region in a targeted manner.

FIG. 4 is a schematic diagram of the process by which the mechanism of action of PBM is that red and near infrared light can lead to a cascade of intracellular pleiotropic effects. In the PBM process, photons are absorbed by cytochrome c oxidase due to its unique spectral properties, photon energy catalyzes a series of redox reactions, and electron transport chains facilitate the transfer of electrons across the inner mitochondrial membrane. The specific steps are that NAD-NADH proportion is increased and mitochondrial membrane potential (delta psi) is increased, which in turn leads to increased ATP and free Radical (ROS) content. While the enhancement of the activity of the electron transport chain regulates NO synthesis (NOS) in cytochrome oxidase. Then calcium ion release occurs, and the expression of cGMP in cells is increased, finally causing vasodilatation and increasing blood flow. Secondary consequences are increased cellular energy metabolism, decreased apoptosis and decreased inflammation.

Fig. 5 is a schematic diagram of a structure for scattering input laser light into a rectangular region based on a low-scattering optical fiber. In this structure, the light emitter 200 is a flexible pad, and the area is a planar light emitter. The energy transmitting fiber 210 is connected to the low dispersion fiber 220 through the input laser connector 205. The input laser connector 205 may be a fiber fusion splice that joins the energy transmitting fiber 210 and the low dispersion fiber 220 together, or may be a fiber-to-fiber optical coupling that joins them together. In order to make the light emitting surface of the light emitting body 200 as uniform as possible, the low scattering fibers 220 are fixed in the light emitting body 200 in a uniformly distributed manner, for example, the low scattering fibers 220 shown in fig. 5 are wound on the plane of the light emitting body 200 into U-shapes connected end to end, and the adjacent U-shapes have the same size and opposite opening directions; or a plurality of nested and evenly arranged concentric rectangles wound to taper in outside-in dimension as shown in fig. 6, etc. The output end of the low-dispersion fiber 220 is connected to an optical output feedback fiber 230 via an 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 inside the light body 200. The remaining laser energy is output out of the light emitter 200 through the light emitter feedback output fiber 230. Although fig. 5-10 are all examples of rectangular or rectangular parallelepiped geometries, the geometry of the light emitter 200 is not limited to rectangular or rectangular, such as other shapes that conform to the topography of a human body, without departing from the design principles. Fig. 6 is a schematic diagram of another structure based on a low-scattering optical fiber for scattering input laser light into a rectangular area.

Fig. 7 is a schematic diagram of a light-emitting body structure formed by gluing a high refractive index glue or a transparent glue and low scattering optical fibers together. The light-emitting body 200 is a three-dimensional structure, in this embodiment, a cuboid is taken as an example, one surface of the light-emitting body 200 close to the helmet inner layer 160 is a light-emitting surface 202, and the rest surfaces are light-reflecting surfaces 203; a low-scattering optical fiber 220 is wound into U-shapes connected end to end on a plane parallel to the light-emitting surface 202 in the light-emitting body 200, and the adjacent U-shapes have the same size and opposite opening directions; or the rectangular plate is wound into a plurality of concentric rectangles which are gradually reduced in size from outside to inside, nested and uniformly arranged; the low scattering fiber 220 is fixed within the light exiting body 200 by a 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 may be adhered with a reflecting material or a reflecting coating, the reflecting material may be smooth aluminum, copper or other metal material, and the reflecting coating may be a metal film or a dielectric film, which is not penetrated by laser. The low scattering fiber 220 is a scattering fiber having a scattering length of more than 0.3m, for example, a scattering length of 0.5m, 1m, 5m, or the like.

Fig. 8 is a schematic diagram of a light-emitting body structure based on a high-scattering optical fiber, which scatters input laser light into a rectangular region and injects high-refractive-index glue or transparent glue. The energy-transmitting fiber 210 and the high-scattering fiber 211 may be connected outside the light-emitting body 200 or inside the light-emitting body 200. The high scattering optical fiber 211 may also be surface ground or etched into the energy delivery fiber 210 to provide optical properties with high scattering power. Since the scattering length of the high scattering fiber 211 is short, typically more than 90% of the laser power will be scattered at a length less than 20cm, the design of fig. 8 is not used for feeding back the output fiber, but instead the photodetector 251 detects the laser operation in the light-emitting body and outputs the laser operation out of the light-emitting body 200 through the photodetector output line 252.

In many cases, the design of fig. 8 still cannot meet the requirement for the uniformity of light emission, and the improved design fig. 9 is a schematic diagram of a light-emitting body structure for scattering multiple paths of input laser light into a rectangular region based on a high-scattering optical fiber and pouring high-refractive-index glue or transparent glue. The light-emitting body 200 is a three-dimensional structure, in this embodiment, a cuboid is taken as an example, one surface of the light-emitting body 200 close to the helmet inner layer 160 is a light-emitting surface 202, and the rest surfaces are light-reflecting surfaces 203; the laser light is output from the light output surface 202, and the light reflection surface 203 is adhered with a metal laser reflection film through which the laser light cannot pass. A plurality of scattering optical fibers are arranged in each light outlet body 200, and each scattering optical fiber is a high-scattering optical fiber 211; the plurality of high scattering optical fibers 211 are divided into two groups, laser is input into the light-emitting body 200 from two opposite light reflecting surfaces 203 of the light-emitting body 200 respectively, two adjacent high scattering optical fibers 211 belong to different groups, and the plurality of high scattering optical fibers 211 are uniformly arranged and are positioned on the same plane; a high refractive index glue or transparent glue 201 is poured to fix the high scattering optical fiber 211. The operation of the laser light input into the light emitting body 200 is detected by one photodetector 251, and the detected laser light is output to the outside of the light emitting body 200 through a photodetector output line 252.

Fig. 10 is a schematic structural diagram of an optical body design that can use a high-scattering optical fiber or a low-scattering optical fiber and scatter input laser light into a rectangular parallelepiped region, in which the laser transmission medium except for the optical fiber is air. Different from the above-mentioned light-emitting body design using transparent adhesive, the design uses other means to fix the optical fiber, such as adhering a plurality of fixing points, or fastening, or sewing, etc. to fix the low-scattering optical fiber 220 or the high-scattering optical fiber 211 in the light-emitting body 200. The remaining space within the light emitter 200 is air 206. The light emitting surface 202 of the light emitter 200 is made of a transparent material, and the surface thereof outputs laser light. The light emitting body 200 has four side surfaces and a bottom surface, which is a light reflecting surface 203 and does not output laser light. The light reflecting surface 203 may be adhered with a reflecting material or a reflecting coating, the reflecting material may be smooth aluminum, copper or other metal material, and the reflecting coating may be a metal film or a dielectric film. The high-scattering optical fiber 211 is a scattering optical fiber having a scattering length of less than 0.3m or more, for example, 5mm, 10mm, 100mm, or the like.

Fig. 11 is a structural diagram of a cross section of an energy transmission fiber. The energy transmitting fiber 210 includes a conventional fiber core 261, a fiber cladding 262, and a fiber coating 263. The low-scattering optical fiber 220 is a plastic clad or clad scattering optical fiber, and the cross-sectional structure thereof is schematically shown in fig. 12, and is composed of a scattering optical fiber core 271 and a low-scattering optical fiber organic material clad 273. In the high-scattering optical fiber 211, the surface of the optical fiber is etched or polished with hydrofluoric acid to make the surface of the uncoated optical fiber rough for the purpose of scattering laser in the optical fiber, as shown in fig. 13, the structure of the high-scattering optical fiber 211 includes an uncoated optical fiber core 281 and an uncoated optical fiber surface 283 that is etched or polished. The light-emitting body 200 can not only homogenize the laser distribution by using a scattering method, such as using a low-scattering optical fiber 220 or a high-scattering optical fiber 211, but also can make the light spot become large in a short distance by using an optical rapid beam expanding method, such as a method of connecting an optical beam expanding ball 290 (beam expander) to the output end of the energy transmission optical fiber 210 or other optical methods, such as a method of increasing the area of the light spot, as shown in fig. 14.

To illustrate the cross-sectional results of the light exiting body 200, fig. 15 is a schematic cross-sectional structure of a high refractive index glue or transparent glue and a low scattering optical fiber glue together. The low scattering fibers 220 are secured therein by a high index of refraction glue or transparent glue 201. The laser in the scattering fiber core 271 is scattered into the high refractive index glue or transparent glue 201 through the low scattering fiber organic material cladding 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 view of a high refractive index glue or transparent glue and a high scattering optical fiber or an uncoated optical fiber glued together. The highly scattering optical fiber 211 is fixed therein by a 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 reflecting surface 203 may be adhered with a reflective material, such as smooth aluminum, copper or other metal material, or a reflective coating, such as a metal film or a dielectric film.

Fig. 17 is a schematic view of an optical mechanical structure of an inner layer of a helmet based on an optical fiber light-emitting body. The outer layer of the helmet comprises a first outer layer and a second outer layer which are sequentially arranged from outside to inside; the first outer layer is made of hard or semi-hard material, the second outer layer is made of soft or hard reflecting material or reflecting film 106, the light reflecting surface 203 opposite to the light emitting surface 202 is fixedly connected with the second outer layer, and the light emitting surface 202 faces the helmet inner layer 160. The emitted light from the low-scattering optical fiber 220 can be directly irradiated on the helmet inner layer 160 or through the soft or hard reflective material or the reflective film 106, and finally the uniformly scattered light 120 is 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 transmission fiber 210 is connected with the low-scattering fiber 220 by fiber fusion welding or fiber-to-fiber optical coupling. Fig. 18 is a schematic structural view showing a structure in which an energy transmitting optical fiber and a scattering optical fiber are connected by fusion-bonding. The method specifically comprises the following steps: the method is characterized in that a fused biconical beam combining technology is adopted, the outer coating layer of N (N is more than or equal to 1) low-scattering optical fibers 220 is stripped, about 30mm bare fibers are leaked out, then the bare fibers are sintered and drawn into a biconical waveguide at high temperature under the condition of light transmission energy detection, the cross section of the tapered low-scattering optical fibers 220 after high-temperature sintering is smaller than or equal to that of the energy transmission optical fibers 210, and the tapered low-scattering optical fibers are mutually welded with the energy transmission optical fibers 210 to prepare the optical fiber composite material. Fig. 19 is a schematic structural view of a flange connection between an energy transmission fiber and a scattering fiber. The method specifically comprises the following steps: the optical fiber bundle formed by N (N is more than or equal to 1) low-scattering optical fibers 220 is arranged according to a geometric structure, the optical fiber bundle is bundled, polished and ground according to the number by means of machinery, chemistry and the like, and finally the optical fiber bundle is connected with an energy transmission optical fiber 210 through a high-precision flange (namely an input laser connector 205), and the cross section of the core diameter of the energy transmission optical fiber 210 is larger than the cross section of the ground and polished low-scattering optical fibers 220, so that the transmission of optical energy can be realized. Fig. 20 is a sectional view a-a of fig. 19. Fig. 21 is a sectional view taken along line B-B of fig. 19.

FIG. 22 is a schematic diagram of a semiconductor laser generator including a visible light semiconductor laser diode connected to a power supply and a main control box, the semiconductor laser generator 300 is composed of a semiconductor laser diode 310 with a wavelength of 600-1400nm, optical components and other core components for coupling the energy emitted by the semiconductor laser into a power transmission fiber 210. the semiconductor laser diode 310 can output a laser average power of 0.1W-100W and also pulse output a laser peak power of 0.5-500W. specifically, the semiconductor laser diode 310 is fixed to a semiconductor laser base and a heat sink 305. for effective heat dissipation, the semiconductor laser base and the heat sink 305 are fixed to an air cooling device 350 of the semiconductor laser generator by heat conduction, the laser beam emitted by the semiconductor laser diode 310 is focused on a fiber coupler 340 capable of fixing an optical fiber by an optical element such as a fast axis collimating mirror 315, a slow axis collimating mirror 316, a beam mirror 320, a focusing mirror 330 and the laser energy of a semiconductor laser beam, and finally the laser energy emitted by the semiconductor laser diode 310 is input into the power transmission fiber 210 by the semiconductor laser diode 310, the semiconductor laser diode 310 is preferably, the semiconductor laser diode 310, the semiconductor laser generator is fixed to a visible light emitting laser light 20, the semiconductor laser light emitting light, the semiconductor laser diode 300 is preferably, the semiconductor laser diode 100-100 laser light emitting diode 300, the semiconductor laser diode 100 laser diode 310 and the semiconductor laser diode 100, the semiconductor laser diode 100 is preferably, the semiconductor laser diode 100 laser light emitting a laser light emitting a laser light emitting diode 100 laser light emitting a laser light emitting diode 100 laser light emitting diode 100 laser light emitting a laser light emitting diode 100 laser light emitting a laser light emitting diode 100 laser light emitting diode 100 laser light emitting.

Fig. 23 is a schematic view showing a structure in which a semiconductor laser generator including two semiconductor laser tubes is connected to a power supply and a main control box. Two semiconductor laser tubes 310 are used for increasing the treatment laser output power or outputting different treatment laser wavelengths of the semiconductor laser generator 300. The two semiconductor laser tubes 310 with the wavelength of 600-1400nm may 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 dissipation device 305 in the polarization directions perpendicular to each other, pass through respective collimating lenses 317, and are combined into one by a polarization beam splitter 325(PBS), and the combined laser enters the optical fiber coupler 340 through a focusing lens 330, and finally is coupled into the energy transmission optical fiber 210. The collimating mirror 317 in fig. 23 may be a single lens, such as an aspheric lens, or may be a combination of a fast axis collimating mirror 315 and a slow axis collimating mirror 316 similar to that in fig. 22. Similarly, the combination of the fast axis collimator 315 and the slow axis collimator 316 shown in fig. 22 can be replaced by a single collimator 317 shown in fig. 23.

FIG. 24 is a schematic view showing a structure in which a semiconductor laser generator including a plurality of semiconductor laser tubes is connected to a power supply and a main control box. The semiconductor laser generator 300 includes more than 2 semiconductor laser tubes 310, and the semiconductor laser tubes 310 emit laser light having different wavelengths. The light beams emitted by the semiconductor laser tubes 310 are collimated by the collimating mirrors 317 in a one-to-one correspondence manner, then combined by the polarization beam splitter 325(PBS) and the wavelength beam combiners 326, and incident on the antireflection film-coated focusing mirror 330 which has an antireflection effect on the laser beams with different wavelengths emitted by the semiconductor laser tubes 310, and finally the laser beams emitted by the semiconductor laser tubes 310 are coupled into the energy transmission optical fiber 210.

Fig. 25 is a schematic diagram of a semiconductor laser generator including a plurality of semiconductor laser tubes and a plurality of fiber couplers connected to a power supply and a main control box. More than 2 semiconductor laser tubes 310 are contained in the semiconductor laser generator 300. The wavelengths of the laser light emitted from 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 collimated by the plurality of sets of fast axis collimating mirrors 315 and slow axis collimating mirrors 316, respectively, or by the plurality of collimating mirrors 317 (not shown in fig. 25), and then reflected by the plurality of beam reflecting mirrors 320 to the corresponding focusing mirrors 330, respectively, and finally output by the plurality of energy transmitting fibers 210, respectively, in a one-to-one correspondence manner.

FIG. 26 is a graph of the dose profile of laser PBM treatment for Arndt-Schulz. The Arndt-Schulz dose curve is a universal dose curve and is commonly used for drug therapy in the treatment of diseases. Through many studies by researchers of PBM researchers, the dose curve is also suitable for PBM treatment. The dose of light irradiation is generally expressed in unit area (cm)²) In units of laser energy (joules), i.e. J/cm². When the light irradiation dose is too small, the light stimulation treatment effect of the PBM on the brain tissue is not obvious, but when the light irradiation dose is too large, the PBM has no light stimulation but has light inhibition on the brain tissue, and the treatment effect cannot be achieved. The light irradiation dose is calculated by multiplying the power density of the irradiated light by the light irradiation time. Therefore, the light power density of the therapeutic light emitted from the light-emitting body 200 on the skin surface should be moderate, typically several tens to several hundreds of milliwatts per square centimeter in the treatment of brain diseases, so that the light irradiation dose to the brain reaches the optimal region in fig. 26 within a certain time.

The human brain is a complex organ with multiple layers and multiple organisms. The thickness of the skull in different areas is different, the brain organs in different areas of the head are different, and the distance from different brain organs to the nearest epidermal tissue is also different. Different brain tissue biological structures also result in differences in absorption characteristics for different wavelengths of laser light. Such complex brain tissue morphology, tissue structure and cellular characteristics lead to the fact that semiconductor laser therapy brain disease treatment devices should have a relatively large laser energy output range to meet the required PBM light irradiation dose. The penetration depth of laser light in human tissue is mainly determined by two factors, namely the laser wavelength and the laser peak power density. As described above, red to near infrared light can be transmitted into human brain tissue through skin, skull, etc., but the penetration depth of light with different wavelengths is different in different regions, and studies have shown that the penetration depth of light with a wavelength around 810nm 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 penetration depth of the laser in the biological tissue and vice versa. In order to achieve the desired PBM treatment effect, the semiconductor laser treatment device for brain diseases can be operated in a continuous light-emitting mode, and the laser output waveform thereof is shown in fig. 27. The continuous light pattern is effective for superficial brain tissue. The advantage of the light emitting mode is that the brain tissue reached by the continuous light is mainly the part closer to the light source, and the deep brain tissue is not affected due to the low peak power density. However, for deep brain tissue requiring PBM treatment, such as the hippocampus, the continuous light extraction pattern is not sufficient. If the laser power density in the continuous light-emitting mode is too high, the laser photons can reach the hippocampus, but other brain tissues in the photon path can cause the treatment effect to fall into the inhibition zone of the Arndt-Schulz dose curve due to high light irradiation dose. At the same time, a high average laser power may also heat the head of the person to be irradiated, causing discomfort. In order to avoid these disadvantages, the semiconductor laser therapy device for treating brain diseases may output laser light in a chopping light-emitting mode, and the output waveform thereof 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 light is determined by the peak amount of current (amperes, a) input to the semiconductor laser generator 300, and the average power of the laser light is determined by the duty cycle of the chopped waveform. When the duty ratio is small, the high peak current may generate high peak power in the semiconductor laser generator 300 while achieving a low average power. In this case, the red and near infrared photons can reach deep brain tissue while avoiding heating of the head by the high average power laser. Fig. 29 is a laser waveform diagram when operating in the square wave light extraction mode and the intermittent light extraction mode, and is another laser output waveform with high peak power and low average power. Fig. 30 is a laser waveform diagram in operation in any of the pulse light emission mode and the intermittent light emission mode, except for the chopper mode. Such an arbitrary pulse pattern may be a preset pulse waveform such as a waveform and frequency imitating a certain brain wave, or a brain wave waveform of the person to be irradiated may be directly inputted to the power supply and main control box 400 through the pulse waveform input terminal 600, and a desired laser output waveform may be finally generated in the semiconductor laser generator 300 and the light emitting body 200.

As shown in fig. 1 and 2, one or more light emitters 200 may be included in the helmet 100. Fig. 31 is a schematic structural diagram of a plurality of semiconductor lasers respectively connected to a plurality of light-emitting bodies in a helmet through a plurality of optical fibers. The input ends of the plurality of semiconductor laser generators 300 are respectively connected with the power supply and main control box 400 through a plurality of electronic control main control systems and semiconductor laser generator connecting wires 405, and the output ends thereof respectively transmit laser energy to the plurality of light emitting bodies 200 in the helmet 100 through a plurality of energy transmission optical fibers 210. In order to ensure the safety of 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 and is connected to the power supply and the main control box 400. When the light exiting body feedback output fiber 230 is not used, the detection feedback unit may be a photo-detection signal output in the light exiting body 200. One or more temperature sensors 130 are disposed in the helmet 100 and connected to the power supply and main control box 400 through the helmet temperature sensor connecting wires 135. The helmet 100 is fixed on the head of the person to be irradiated by the helmet fixing band 110 and the helmet fixing band snap-in interlock 115, and the helmet fixing band snap-in interlock 115 is connected to the power supply and the inside of the main control box 400 through the helmet interlock connection line 116. In order to further ensure the safety of the laser, a pressure sensor 125 for sensing the pressure between the helmet 100 and the head is disposed inside the helmet 100. In the case where the head of the person to be irradiated stands upright, the switch of the pressure sensor 125 is closed by natural gravity, and the closing electric 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 main control box 400 receives a switch closing signal of the pressure sensor 125.

FIG. 32 is an electrical schematic diagram of the main control box of an embodiment of the present invention. The power 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 master control system 410 is provided by a medical direct current power supply 420. The medical dc power supply 420 may be internal or external, and is connected to the connection 425 of the medical dc power supply through the electronic control main control system 410. The medical dc power supply 420 and the AC power supply 422 are connected by an AC power supply line 421. The electronic control master system 410 controls one or more semiconductor laser constant current power supplies 440 through a semiconductor laser constant current power supply and electronic control master 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 connecting line 405, and finally the output laser of the semiconductor laser generator 300 is input into the corresponding light emitting body 200 in the helmet 100 through the energy transmission optical fiber 210.

Each light-emitting body 200 in the helmet 100 further has a respective light-emitting body feedback output optical fiber 230, which is connected to one or more photodetectors or photoelectric signal receivers 450 in the power supply and main control box 400, for monitoring the laser output condition of each light-emitting body 200. The photodetector or photo-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 connection line 455. The electronic control main control system 410 analyzes the laser intensity of each light-emitting body 200 and then determines the operating state of each light-emitting body 200.

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

The power and main control box 400 may further include 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 internet of things module and the external communication module 430 are designed to allow the semiconductor laser therapy device for brain diseases to receive input of therapy parameters from a treating doctor, and also to output the working conditions and usage history thereof to a central computer, so that the central computer can analyze the usage of each semiconductor laser therapy device for brain diseases, provide the treating doctor with the usage of each user, or provide big data analysis. The internet of things module and the external communication module 430 may be connected to the lan through a network cable, or may be connected to the lan through WiFi or bluetooth or other wireless methods.

An operator of the semiconductor laser therapy brain disease treatment apparatus can control the operation of the power supply and the main control box 400 through the man-machine control interface 500. The human-machine control interface 500 can be connected with the control power supply and the main control box 400 by a wire 445 of the electronic control main control system and the human-machine control interface, or can be connected with the control power supply and the main control box 400 by a wireless mode such as WiFi or Bluetooth. The operator can use the manual control interface 510 to set the human-machine control interface 500 to set the treatment parameters, and can also use the intelligent PBM parameter automatic output device 480 to let the doctor set the treatment parameters at different places through the Internet.

The semiconductor laser therapy device for brain diseases can also be connected with one or more external devices, such as a pulse waveform input 600. The inputted pulse waveform may be a waveform and frequency imitating a certain brain wave, such as an Alpha wave of 8-14Hz, a Beta wave of 12.5-28Hz, or a Gamma wave of 25-100Hz (usually 40Hz), or directly inputting the waveform of the brain wave of the person to be irradiated to the power supply and main control box 400 through the pulse waveform input terminal 600, and finally generating a desired laser output waveform in the semiconductor laser generator 300 and the light emitting body 200.

Claims

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);

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

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);

alternatively, the first and second electrodes may be,

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).