Laser irradiation device for treating peripheral artery occlusion diseases

Abstract

The utility model provides a laser irradiation device for treating peripheral artery occlusion diseases, which comprises a fixing frame, the fixing frame comprises a fixing component and a support, the fixing component is arranged at the top of the support, a plurality of first laser diodes are arranged on the inner side of the fixing component and used for emitting laser with the wavelength ranging from 620 nm to 700 nm, and the first laser diodes are used for emitting laser with the wavelength ranging from 620 nm to 700nm; the second laser diodes are used for emitting laser with the wavelength ranging from 900 nm to 1100 nm; the power supply is arranged on the fixed frame and is used for supplying power to the plurality of laser diodes; the foot stool is arranged at the bottom of the bracket and is used for supporting the fixing frame; wherein the plurality of laser diodes are used for emitting laser light of different wavelengths to irradiate an affected part of a patient suffering from the peripheral artery occlusion disease.

Description

Technical Field

[0001] The utility model provides a foot medical laser irradiation device with two or more laser sources, in particular to a medical laser irradiation device for treating peripheral arterial occlusive diseases. Background Art

[0002] Peripheral Arterial Occlusive Disease (PAO) has rapidly increased in recent years, posing a significant burden on public health. One of the main causes is diabetes, with foot ulcers being the most prominent symptom. The global average prevalence of foot ailments among diabetic patients is 6.4%. Diabetic foot ulcers have a poor prognosis and are a leading cause of disability and death among diabetic patients. The annual mortality rate for patients with DFUs is as high as 11%. Common conditions include infection, gangrene, and cellulitis. Severe cases necessitate amputation, with a mortality rate as high as 22%. Most amputees lose their economic productivity and mobility, becoming dependent on care from others. This is a heavy blow to both the patient and their family.

[0003] One mechanism that makes diabetic foot ulcers difficult to treat is glycation of the phosphatidylserine receptor on macrophages, which hinders their recognition of apoptotic cells, leading to an increase in pro-inflammatory substances and making inflammation difficult to resolve. Another mechanism is the production of advanced glycation end products and inflammatory mediators, which hinder the apoptosis of fibroblasts and vascular cells and the formation of granulation tissue. These two mechanisms indicate that the optimal approach to treating diabetic foot ulcers is to simultaneously reduce inflammation, dilate vasodilation, and promote tissue and vascular proliferation to increase blood flow for effective treatment.

[0004] Previous patents have used light sources with multiple wavelengths for phototherapy of various disease areas. For example, WO2014 / 146029A1 uses light sources with wavelengths of 350-480nm and 590-960nm to relieve muscle and joint inflammation and pain, alleviate acne and fungal infections, increase bone density, and promote plant growth.

[0005] US10525275B2 (and US11524173B2) utilize a dual-wavelength incoherent light source (a 400-420nm blue LED and a 620-640nm long-wavelength light source generated by irradiating a fluorescent agent) to regulate nitric oxide (NO) production in the body. The shorter wavelength light increases NO production within cells, while the longer wavelength light promotes NO transport outside the cells and promotes hair growth. Extracellular NO promotes vasoconstriction, increasing blood flow.

[0006] JP2013146529A uses blue, yellow and red LEDs to promote collagen synthesis, inhibit bacterial growth and inhibit melanin formation.

[0007] CN205339869U uses blue light (400-490nm), red light (600-690nm) and infrared light (780-970nm) lasers or LEDs to treat skin ulcers, burns, and traumatic injuries. However, because the treatment requires hand-held contact, it is prone to cross-infection.

[0008] The medical community has long confirmed the safety and efficacy of laser light therapy for pain relief, but there are not many clinical reports on diabetic foot ulcers. Although these clinical reports show that patients who receive light therapy have better results than those who do not, the number of participants is still too small, and the dose (light intensity, time) and wavelength are inconsistent, making it difficult to evaluate and even more difficult to standardize. Therefore, there has not yet been enough data to form a medical practice guideline. Currently, the application of laser light therapy for diabetic foot ulcers is limited to medical research and has not yet been implemented on a large scale. There are three reasons for this: (1) Diabetic patients are already in poor health, and foot ulcers are already very serious when they appear. It is not easy to delay the deterioration of the ulcer, and it is even more difficult to reduce its area. It is rare for the ulcer to heal completely; (2) In the past, laser energy was low and the area was small, and the treatment beam diameter was very small (the area was less than 0.3 cm). 2 , to irradiate an affected area (about 10cm 2 ), an affected area needs to be treated dozens of times, which takes a long time for both medical staff and patients, and they often lose patience; (3) In the past, lasers were of a single wavelength (mostly short-wavelength red light), which only reached the surface of the skin and could not penetrate deep into the tissue, making it difficult to significantly increase blood perfusion.

[0009] Previous studies have shown that in clinical practice, doctors must consider variables such as the patient's skin color, thickness, and severity of the ulcer to determine the power density, energy density, and number of irradiations within a treatment course that the patient should receive. Therefore, it is necessary to adjust the power density and irradiation time. Utility Model Content

[0010] The technical problem to be solved by the utility model is a multi-wavelength medical laser device for treating peripheral arterial occlusive diseases.

[0011] To solve the above problems, the present invention provides a laser device that irradiates the affected area with multiple wavelengths. The different wavelengths have different mechanisms of action and depths of penetration into the body. The simultaneous action of different wavelengths can achieve complementary effects, and the therapeutic effect is better than that of a single wavelength.

[0012] Existing phototherapy devices include red light and near-infrared lasers. In the early years, the difference between the two was unknown. Recent advances in molecular biology have revealed that their mechanisms of action are quite different. Red light acts on cytochrome C oxidase (CCO) on the mitochondrial membrane within cells. Exposure to red light increases the release of reactive oxygen species (ROS) and nitric oxide (NO), increasing ATP synthesis and causing mitochondria to release more calcium ions (Ca). 2+ ), potassium ion (K + ) to the cytoplasm. Near-infrared light acts on the ion channels on the mitochondrial membrane. Water molecules are adsorbed around them, and their absorption spectrum is different from that of free water molecules. They absorb near-infrared light around 1000nm, locally heating the ion selective channels and promoting their wide opening, allowing calcium ions (Ca 2+ ) are released into the cytoplasm in large quantities, causing a series of reactions.

[0013] The key mechanism of red and infrared light increasing blood flow lies in nitric oxide (NO) and calcium ions (Ca 2+ Nitric oxide is a major neuronal signaling molecule with the ability to trigger vasodilation. Nitric oxide first stimulates soluble guanylate cyclase to form cyclic guanosine monophosphate (cGMP, an intracellular signaling molecule). cGMP then activates protein kinase G, leading to calcium reabsorption and the opening of calcium-activated potassium channels. The subsequent decrease in calcium concentration prevents myosin light-chain kinase from phosphorylating myosin molecules, causing the smooth muscle cells lining blood and lymphatic vessels to relax, thereby increasing blood and lymph flow.

[0014] The increase in intracellular ATP and nitric oxide (NO) regulates inflammation-related transcription factors, thereby significantly reducing inflammation, such as nuclear factor-κB (NF-κB), prostaglandin E2, tumor necrosis factor-α (TNF-α), cyclooxygenase-2, and interleukin-1β (IL-1β).

[0015] The benefits of light therapy extend beyond vasodilation, increased blood flow, and anti-inflammatory effects. It also enhances the proliferation of fibroblasts, keratinocytes, endothelial cells, and lymphocytes. Light stimulation of mitochondria activates signaling pathways and upregulates transcription factors, ultimately leading to an increase in growth factors. Light therapy can enhance neovascularization, promote angiogenesis, and increase collagen synthesis, thereby promoting the treatment of diabetic foot ulcers.

[0016] For chronic diseases such as diabetic foot ulcers, it is necessary to first promote anti-inflammation, then re-epithelialization, and then connective tissue remodeling before a complete cure can be achieved. In recent years, it has been discovered that the canonical Wnt / β-catenin signaling pathway plays a key role in this, and this pathway is easily modulated by red light and near-infrared light. This pathway can explain why red light and near-infrared light are helpful in treating diabetic foot ulcers. However, the effects of existing methods are still not perfect. The present invention believes that the reason is that existing methods fail to penetrate deeply into the skin. The present invention uses multiple wavelengths and large-area irradiation to make the light penetrate deeper.

[0017] It's known that, in general, longer wavelengths penetrate deeper into the human body. Once light enters the body, it's absorbed and scattered. The primary absorbing substances in the human body are melanin, hemoglobin, and water molecules. Relatively speaking, light with a wavelength between 600 and 1300 nm is less easily absorbed, forming an optical window within the human body for light to enter. Specifically, red light with a wavelength of 660 nm and near-infrared laser light with a wavelength of 980 nm are less easily absorbed by melanin, hemoglobin (including oxygenated hemoglobin (HbO2) and unoxygenated hemoglobin (Hb), which have different absorption spectra), and water molecules. Therefore, these two wavelengths are more likely to penetrate deeper into the body through scattering. Approximately 95% of human arterial blood is oxygenated hemoglobin. After entering the capillaries and exchanging oxygen for carbon dioxide, only about 70% of the hemoglobin remains oxygenated by the time it reaches the veins. On average, however, a significant portion of the hemoglobin remains oxygenated. Oxygenated hemoglobin has a low absorbance range between 650 and 700 nm, allowing light waves in this region to penetrate tissue more easily. Furthermore, subcutaneous fat has a low absorbance range at 980 nm, allowing 980 nm light to penetrate subcutaneous fat more easily and reach the blood vessels beneath it. Because the epidermis, dermis, and subcutaneous tissue (which are rich in fat) have relatively low absorbance for 660 nm red light and 980 nm near-infrared light, coupled with their strong scattering properties, 660 nm red light and 980 nm near-infrared light are more easily scattered and less absorbed than other wavelengths in the 600 to 1300 nm range. Consequently, these wavelengths penetrate deeper into the body, resulting in greater therapeutic efficacy. Considering the anatomy and hemodynamics of the skin, the primary resistance to blood flow occurs in the arterioles, not the microvessels. Arterioles have three layers: the innermost layer, the tunica intima, contains endothelial cells and the internal elastic lamina; the outermost layer, the tunica externa, contains elastic fibers and collagen fibers; and between the intima and adventitia is the tunica media, which contains smooth muscle and elastic fibers and is the primary regulator of blood flow. Arterioles are concentrated in the subcutaneous tissue and deeper within the skin, while the superficial dermis contains only microvessels. Using only 660nm red light would only dilate the microvessels, not the deeper arterioles, resulting in a less effective overall treatment. However, if 660nm red light and 980nm near-infrared light could be applied simultaneously to the same area, dilating both superficial and deep blood vessels, the effect would be even more pronounced.

[0018] Furthermore, the present invention utilizes multiple laser sources in a large-area array, replacing existing small-area light sources, allowing therapeutic light to penetrate deeper into the human body. Surgical lasers rely on the coherence of a large number of photons to generate constructive interference, enabling them to cut tissue or coagulate blood. Consequently, their power is very high. Furthermore, photons scattered by tissue after entering the body have lost their coherence and cannot generate constructive interference, thus failing to contribute to cutting or coagulation. Lasers used to treat peripheral arterial occlusive disease do not need to be as powerful as ablative lasers such as surgical lasers. Furthermore, although photons scattered by tissue are incoherent, they do not hinder mitochondrial stimulation. As previously mentioned, human tissue exhibits low absorption and high scattering properties for 660nm red light and 980nm near-infrared light. This multiple scattering allows the laser to penetrate deeper into the tissue, dilating deep blood vessels. Previous literature has used computer simulations to calculate the relationship between different irradiation areas (represented by beam diameter) and penetration depth, taking into account the absorption levels of people with different skin tones. The results indicate that the larger the irradiation area, the deeper the laser penetrates.

[0019] Regarding the appropriate light intensity, previous literature suggests that the power density (irradiance) is only 0.016W / cm 2 Therefore, some literature suggests that the energy density of a single irradiation (radiance exposure, the integral of power density over time) should be between 3 and 7 J / cm 2 The use of excessive power or for too long a time still raises questions about efficacy or safety. Therefore, the internationally accepted laser safety standard (IEC 60825-1:2014) stipulates that the upper limit of non-ablative therapeutic lasers in the red to near-infrared range is 0.2W / cm 2 In order to avoid human error and forget to turn off the power so that the irradiation time is too long, it is best to have an automatic timer switch to turn off the power.

[0020] The utility model provides a laser irradiation device for treating peripheral arterial occlusive diseases, which comprises: a fixing frame, which comprises a fixing member and a bracket, the fixing member is arranged on the top of the bracket, wherein the inner area of the fixing member is greater than 25cm 2 , and a plurality of first laser diodes are arranged on the inner side of the fixing member, which are used to emit lasers with a wavelength between 620 and 700 nm, and a plurality of second laser diodes are arranged on the inner side of the fixing member, which are used to emit lasers with a wavelength between 900 and 1100 nm; a power supply is arranged on the fixing frame, which is used to supply power to the plurality of laser diodes; and a tripod is arranged at the bottom of the bracket, which is used to support the fixing frame; wherein the plurality of laser diodes are used to emit lasers of different wavelengths to irradiate the affected part of a patient with peripheral arterial occlusive disease.

[0021] In the present invention, the area of the plurality of laser diodes disposed on the inner side of the fixing member is greater than 25 cm 2 In a specific embodiment, the area of the plurality of laser diodes disposed on the inner side of the fixing member ranges from 25 to 800 cm 2 In a preferred embodiment, the area of the plurality of laser diodes disposed on the inner side of the fixing member ranges from 25 to 600 cm 2 In a more preferred embodiment, the area of the plurality of laser diodes disposed on the inner side of the fixing member ranges from 25 to 400 cm 2 .

[0022] In another embodiment, the fixing member is made of aluminum, copper, or aluminum nitride.

[0023] In a specific embodiment, the laser irradiation device further includes a heat dissipation component disposed outside the fixing component for dissipating heat generated by the plurality of laser diodes.

[0024] In another embodiment, the plurality of first laser diodes and the plurality of second laser diodes each number at least 8. In a preferred embodiment, the plurality of first laser diodes and the plurality of second laser diodes each number at least 15. In a more preferred embodiment, the plurality of first laser diodes and the plurality of second laser diodes each number at least 20.

[0025] In one embodiment, the plurality of laser diodes on the inner side of the fixation member are located at a distance greater than 5 cm from the affected part of the patient. In a more preferred embodiment, the plurality of laser diodes on the inner side of the fixation member are located at a distance greater than 7 cm from the affected part of the patient. In a more preferred embodiment, the plurality of laser diodes on the inner side of the fixation member are located at a distance greater than 10 cm from the affected part of the patient.

[0026] In another specific embodiment, the inner side of the fixing member is flat or curved.

[0027] In one embodiment, the plurality of first laser diodes and the plurality of second laser diode light sources are mounted on the inner side of the fixing member in a staggered manner so that the maximum and minimum brightness on the illuminated surface are within ±30% of the average brightness. In a preferred embodiment, the plurality of first laser diodes and the plurality of second laser diode light sources are mounted on the inner side of the fixing member in a staggered manner so that the maximum and minimum brightness on the illuminated surface are within ±40% of the average brightness. In an even more preferred embodiment, the plurality of first laser diodes and the plurality of second laser diode light sources are mounted on the inner side of the fixing member in a staggered manner so that the maximum and minimum brightness on the illuminated surface are within ±50% of the average brightness.

[0028] In another specific embodiment, the power supply is further connected to a timing device so that the power supply is automatically turned off at a set time.

[0029] In a specific embodiment, the laser irradiation device further comprises a programmable digital controller for controlling the power supply so that the optical power density of the laser light emitted by the plurality of laser diodes irradiating the affected part of the patient is in the range of 8 to 200 mW / cm 2 In a preferred embodiment, the optical power density ranges from 10 to 100 mW / cm 2 In a more preferred embodiment, the optical power density ranges from 20 to 50 mW / cm 2 In the present invention, the power supply is connected to the plurality of laser diodes. The programmable digital controller can control the power of the plurality of laser diodes.

[0030] In another embodiment, the power supply supplies power in an interleaved manner with an interleaving frequency in the range of 40 to 1000 Hz. In a preferred embodiment, the power supply supplies power in an interleaved manner with an interleaving frequency in the range of 60 to 800 Hz. In a more preferred embodiment, the power supply supplies power in an interleaved manner with an interleaving frequency in the range of 100 to 500 Hz.

[0031] In a specific embodiment, an infrared temperature sensor is installed on the fixing frame to sense the temperature of the irradiated human skin.

[0032] The utility model provides a method for treating peripheral arterial occlusive disease, comprising: using the above-mentioned laser irradiation device to emit multiple lasers to irradiate the affected part of an individual suffering from peripheral arterial occlusive disease, wherein the lasers include a first laser and a second laser, the wavelength of the first laser is 620 to 700 nm, the wavelength of the second laser is 900 to 1100 nm, and the optical power density of the first laser and the second laser irradiated on the affected part of the individual is in the range of 8 to 200 mW / cm 2 .

[0033] In one embodiment, the peripheral arterial occlusive disease comprises diabetes mellitus.

[0034] In another embodiment, the affected part is a damaged part caused by peripheral arterial occlusion. In a preferred embodiment, the affected part is a foot ulcer caused by diabetes.

[0035] In one embodiment, the laser is irradiated at a distance of 5 cm or more from the subject. In a preferred embodiment, the laser is irradiated at a distance of 7 cm or more from the subject. In a more preferred embodiment, the laser is irradiated at a distance of 10 cm or more from the subject.

[0036] In another embodiment, the optical power of the plurality of lasers ranges from 10 to 100 mW / cm 2 In a preferred embodiment, the optical power of the plurality of lasers ranges from 20 to 50 mW / cm 2 .

[0037] In one embodiment, the first laser and the second laser are alternately emitted at a frequency of 40 to 1000 Hz. In a preferred embodiment, the first laser and the second laser are alternately emitted at a frequency of 60 to 800 Hz. In a preferred embodiment, the first laser and the second laser are alternately emitted at a frequency of 100 to 500 Hz.

[0038] In another embodiment, the irradiation time of the multiple lasers is 10-100 minutes. In a preferred embodiment, the irradiation time of the multiple lasers is 20-50 minutes. In a more preferred embodiment, the irradiation time of the multiple lasers is 30-40 minutes.

[0039] In one embodiment, the plurality of lasers are irradiated at least once a week. In a preferred embodiment, the plurality of lasers are irradiated at least twice a week.

[0040] In one embodiment, the multiple lasers are irradiated for at least one week. In a preferred embodiment, the multiple lasers are irradiated for at least two weeks. In a more preferred embodiment, the multiple lasers are irradiated for at least one month. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This is an example diagram of the laser irradiation device of the present invention being used to treat peripheral arterial occlusive disease.

[0042] Figure 2 The utility model discloses a structural design of a laser irradiation device.

[0043] Figure 3 It is a timing diagram of the alternating emission of red light and near-infrared light.

[0044] Figure 4 This is an irradiation method in which pyramidal laser light sources are spaced appropriately apart to achieve uniform irradiation intensity.

[0045] Explanation of symbols

[0046] 100: Laser irradiation device

[0047] 101: Affected area

[0048] 110: Fixed bracket

[0049] 111: Fixed components

[0050] 112: Bracket

[0051] 113: The first laser diode

[0052] 114: The second laser diode

[0053] 115: Infrared temperature sensor

[0054] 120: Heat dissipation components

[0055] 130: Power supply

[0056] 131: Timing device

[0057] 132: Programmable Digital Controller

[0058] 140: Tripod DETAILED DESCRIPTION

[0059] Figure 1This figure illustrates an exemplary embodiment of the laser irradiation device of the present invention for treating peripheral arterial occlusive disease. The laser irradiation device 100 comprises a mounting frame 110, comprising a fixing member 111 and a support 112. The fixing member 111 is mounted on top of the support 112. Multiple laser diodes are mounted inside the fixing member 111, and these laser diodes are configured to emit laser light of varying wavelengths to irradiate an affected area 101 of a patient suffering from peripheral arterial occlusive disease. A heat dissipation member 120 is mounted outside the fixing member 111 to dissipate heat generated by the laser diodes. A power supply 130 is mounted on the support 112 to supply power to the laser diodes. A tripod 140 is mounted on the bottom of the support 112 to support the mounting frame.

[0060] In addition, the power supply 130 is further connected to a timing device 131. The function of the timing device 131 is to allow the power supply 130 to automatically shut down at a set time.

[0061] The power supply 130 is also connected to a programmable digital controller 132. The programmable digital controller 132 is used to control the power supply 130 and thereby adjust the optical power emitted by the plurality of laser diodes.

[0062] Figure 2 The structural design of the laser irradiation device of the present invention. The area inside the fixing member 111 of the laser irradiation device should be greater than 25cm 2 , used to support multiple laser diodes. Furthermore, these multiple laser diodes are divided into a first type of laser diode 113 and a second type of laser diode 114. The first type of laser diode 113 can emit laser light with a wavelength between 620 and 700 nm, and the second type of laser diode 114 can emit laser light with a wavelength between 900 and 1100 nm. Therefore, a heat dissipation member 120 is provided on the outside of the fixing member 111 to dissipate the heat generated by the multiple laser diodes.

[0063] In addition, an infrared temperature sensor 115 is further provided inside the fixing member 111 for sensing the skin temperature of the patient.

[0064] The multiple laser diodes are connected to a power supply 130, which supplies power to the multiple laser diodes. The power supply 130 is further connected to a timer 131, which automatically shuts off the power supply 130 at a set time. Furthermore, the power supply 130 is connected to a programmable digital controller 132. The programmable digital controller 132 controls the power supply 130, thereby regulating the optical power emitted by the multiple laser diodes. Furthermore, a tripod 140 supports the fixed frame.

[0065] Example 1: Laser sources of different wavelengths emit light alternately to facilitate heat dissipation

[0066] In existing technologies, heat dissipation is the main bottleneck of laser diode luminous power. The maximum power of the laser is limited by its heat dissipation energy. Once excessive heat cannot be removed, the laser diode will be irreversibly damaged. The utility model can make laser sources of different wavelengths (i.e., red light and near-infrared light) emit light alternately, which can effectively dissipate heat from the laser diode and reduce the probability of damage. Figure 3 As shown, the light emission waveforms of the first laser diode (red light) 113 and the second laser diode (near infrared light) 114 can be pulse waves ( Figure 3 left), or a sine wave ( Figure 3 right), glowing alternately with each other.

[0067] Considering the human eye's persistence of vision, interleaving should ideally be faster than 40Hz to avoid flickering and discomfort. Furthermore, considering the laser diode structure, the heat is generated within the diode's resonant cavity, which measures tens of microns in length, width, and height. For such a small volume, a hundredth of a second of free time for heat dissipation can have a significant effect. However, if it's faster than one thousandth of a second, it won't be enough to dissipate heat. Therefore, the interleaving frequency should ideally be faster than 40Hz, but not exceed 1kHz. Furthermore, to ensure optimal heat dissipation, the mounting structure for the laser source should be made of a material with good thermal conductivity, such as aluminum, copper, or aluminum nitride. The mounting bracket can also be connected to other heat dissipation devices, such as a thermocouple cooler (TE cooler), as well as heat sink fins and fans, to facilitate heat dissipation.

[0068] Example 2: Installing a non-contact infrared sensor between the laser source array to sense the human body surface temperature

[0069] It is known that the thermal effect of 660nm and 980nm on human tissue is not significant. For normal people, even within the upper limit of 200mW / cm2 set by IEC 60825-1, the 2 , without causing harm or discomfort due to overheating. However, for patients with peripheral arterial occlusion who have poor peripheral blood circulation and near-neural dysfunction, the possibility of overheating and injury from light therapy cannot be completely ruled out. Therefore, a better way to prevent this is to install a non-contact infrared sensor, such as the TMP006 produced by Texas Instruments, between the laser source arrays, such as Figure 2Because the TMP006 is highly sensitive to infrared light with a wavelength between 4 and 16 μm and is virtually unresponsive to wavelengths of 660 and 980 nm, it is immune to interference from its own lasers. Furthermore, the thermopile within the TMP006 receives infrared light within a roughly 90-degree cone, making it less susceptible to interference from nearby laser sources. It only receives infrared light from the human body, enabling accurate, non-contact measurement of human body temperature.

[0070] Example 3: Laser sources are staggered to form an irradiation surface with uniform brightness

[0071] 42 red laser diodes form 7 red light modules, and 30 infrared laser diodes form 5 infrared light modules. Figure 2 As shown. The laser light emitted by the laser diode is not collimated light, but a Gaussian beam with a cone-shaped diffusion. The horizontal diffusion angle of a common laser diode is about 10 degrees, and the vertical diffusion angle is about 20 degrees. A single laser diode, based on its divergence angle, will form an elliptical bright area on the irradiation surface at a distance of 20 cm from the chip, with a major axis of 7.05 cm and a minor axis of 3.5 cm. Figure 4 As shown, two laser sources 113 of the first type are installed 3.52 cm apart, with a second laser source 114 positioned between them. This allows the Gaussian beams of each laser source to complement each other, thus creating a continuous bright area on the irradiation surface, with both the strongest and weakest brightnesses within ±30% of the average brightness. Both laser sources illuminate the same area. To achieve this complementarity and create a uniformly bright irradiated surface, the preferred embodiment is to have more than eight laser diodes of each type. This arrangement provides a sufficiently large irradiation area, allowing the therapeutic light to penetrate deeper into the body and achieve greater effectiveness. If a larger irradiation area is desired, handheld operation is impossible. A preferred embodiment uses a tripod that supports the mounting bracket for the laser sources, eliminating the need for handheld operation by the operator and allowing the bracket to remain at a distance from the patient, preventing cross-infection.

[0072] Implementation Results 1

[0073] The present invention uses skin perfusion pressure (SPP) to test whether the blood flow of the previously blocked external artery increases after light therapy. SPP measurement has been shown to be helpful in evaluating critical limb ischemia (CLI) of peripheral arterial occlusive disease and is also the best indicator for determining amputation. The SPP of a normal person is greater than 50 mmHg. If it is less than 30 mmHg, amputation is likely to be necessary. The present invention uses the VMS-LDF1 laser Doppler skin perfusion sphygmomanometer from the British moor factory for testing. The subjects of Case 1 and Case 2 were patients with severe diabetes who were admitted to the plastic surgery ward of a medical center in northern Taiwan, China. Their foot ulcers received dual-wavelength (660 nm and 980 nm) light therapy for a total of five times over a two-week period, each session lasting 30 minutes, with an average light power of 40 mW / cm 2 , the laser array area is about 600cm 2 .

[0074] Case 1: SPP was 41.4 mmHg before treatment and 58.6 mmHg after treatment.

[0075] Case 2: SPP was 34.9 mmHg before treatment and 48.4 mmHg after treatment.

[0076] Implementation Results 2

[0077] The present invention also uses Image J software developed by the National Institutes of Health to calculate the area of foot ulcers. The subjects were severe diabetic patients admitted to the Department of Plastic Surgery of a medical center in southern Taiwan, China. Case 3 was an inpatient and Case 4 was an outpatient. The dates before and after treatment and the area of the affected area at that time (cm 2 ) information is shown in Tables 1 and 2.

[0078] Table 1. Treatment date and affected area of Case 3 (hospitalized patient)

[0079]

[0080] Table 2. Treatment date and affected area of Case 4 (outpatient)

Claims

1. A laser irradiation device for treating peripheral arterial occlusive disease, characterized in that: Include: A fixing frame comprising a fixing member and a bracket, wherein the fixing member is arranged on the top of the bracket, wherein the inner area of the fixing member is greater than 25 cm 2 , and a plurality of first laser diodes for emitting laser light with a wavelength between 620 and 700 nm, and a plurality of second laser diodes for emitting laser light with a wavelength between 900 and 1100 nm are disposed on the inner side of the fixing member; a power supply, disposed on the fixing frame, for supplying power to the plurality of laser diodes; and A tripod, provided at the bottom of the bracket, for supporting the fixing frame; The plurality of first laser diodes and the plurality of second laser diodes are used to emit lasers of different wavelengths to irradiate and treat affected areas of patients suffering from peripheral arterial occlusive disease.

2. The laser irradiation device according to claim 1, wherein The laser irradiation device further includes a heat dissipation component disposed outside the fixing component and configured to dissipate heat generated by the plurality of laser diodes.

3. The laser irradiation device according to claim 1, wherein The number of the plurality of first type laser diodes and the number of the plurality of second type laser diodes are at least 8 each.

4. The laser irradiation device according to claim 1, wherein The plurality of laser diodes on the inner side of the fixing member are located at a distance greater than 5 cm from the affected part of the patient.

5. The laser irradiation device according to claim 1, wherein The inner side of the fixing member is in a flat or curved shape.

6. The laser irradiation device according to claim 1, wherein The plurality of first laser diodes and the plurality of second laser diode light sources are respectively installed on the inner side of the fixing component in a staggered manner so that the strongest and weakest brightness on the irradiated surface are within ±30% of the average brightness.

7. The laser irradiation device according to claim 1, wherein The power supply is further connected to a timing device so that the power supply is automatically turned off at a set time.

8. The laser irradiation device according to claim 1, wherein The laser irradiation device further comprises a programmable digital controller for controlling the power supply so that the optical power density of the laser light emitted by the plurality of laser diodes irradiating the affected part of the patient is in the range of 8 to 200 mW / cm 2 .

9. The laser irradiation device according to claim 1, wherein The power supply supplies power in an interleaved manner with an interleaving frequency ranging from 40 to 1000 Hz.

10. The laser irradiation device according to claim 1, wherein The laser irradiation device further includes an infrared temperature sensor installed on the fixing component for sensing the skin temperature of the patient.

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