Irradiation device and method for photodynamic therapy for reducing pain

Abstract

The invention relates to the technical field of medical instruments, and provides a photodynamic therapy irradiation device and method for relieving pain, the photodynamic therapy irradiation device comprises a case and a movable arm arranged at the top of the case, one end of the movable arm is provided with an illumination lamp, and the surface of the case is further provided with a man-machine interaction panel and a power supply control switch. The device further comprises a heat dissipation cooling structure arranged at the top of the illumination lamp and an air blowing structure arranged on one side of the illumination lamp, a linkage adjusting structure capable of adjusting the illumination range and the air blowing range at the same time is arranged between the air blowing structure and the illumination lamp, and an illumination control unit is arranged in the machine box. According to the illumination device, the illumination power and the illumination time are adjusted in a two-step illumination mode, the air blowing mechanism is matched to blow out cold air during photodynamic therapy, heat damage is reduced, and experimental results show that compared with a traditional illumination device and a traditional illumination method, the illumination device can greatly relieve pain of a patient during therapy.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an irradiation device and method for photodynamic therapy for reducing pain. Background Art

[0002] Acid photodynamic therapy (PDT) is a multidisciplinary treatment method involving physics, chemistry, and pharmacology. In PDT, photosensitizers work together with photodynamics and selectively accumulate in target cells after entering the human body. After the photodynamics are activated, the photosensitizers are activated, photochemical reactions occur, and target cells are destroyed, thereby achieving the purpose of treating the disease. However, the reactive oxygen species produced during PDT may also stimulate normal nerve endings, causing burning pain during treatment, which has become one of the important challenges limiting its further promotion and optimization.

[0003] In PDT, the mechanism of pain generation is mainly attributed to the generation of reactive oxygen species. The photosensitizer protoporphyrin IX (PpIX) is activated under the irradiation of light of a specific wavelength, and the generated ROS can not only remove the lesion cells, but also directly stimulate nerve endings or cause local inflammation to produce pain. 92% of patients feel pain during PDT treatment, and 54% of patients will interrupt the treatment because they cannot tolerate the pain.

[0004] Therefore, in order to reduce the pain of patients during photodynamic therapy, a photodynamic therapy irradiation device and method for reducing pain are proposed. Summary of the invention

[0005] In view of the deficiencies of the prior art, the present invention provides an irradiation device and method for photodynamic therapy for reducing pain, which solves the problem of strong pain generated during the irradiation process of current acid photodynamic therapy.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions: an irradiation device for photodynamic therapy for reducing pain, comprising a chassis and a movable arm arranged on the top of the chassis, a light lamp is arranged at one end of the movable arm, a human-machine interaction panel and a power control switch are also arranged on the surface of the chassis, the device also comprises a heat dissipation and cooling structure arranged on the top of the light lamp and a blowing structure arranged on one side of the light lamp, a linkage adjustment structure capable of simultaneously adjusting the illumination range and the blowing range is arranged between the blowing structure and the light lamp, an irradiation control unit is arranged inside the chassis, the irradiation control unit is connected to the light lamp and the human-machine interaction panel through a circuit, a timing buzzer is included inside the irradiation control unit, the timing buzzer is connected to the programmable circuit of the irradiation control unit, and is used to time the two-step illumination;

[0007] The heat dissipation and cooling structure includes a cooling box, and a semiconductor refrigeration component and a blowing and heat dissipation component are arranged inside the cooling box. The semiconductor refrigeration component is used to reduce the temperature inside the cooling box, and the blowing and heat dissipation component is used to supply air to the blowing structure and dissipate heat to the semiconductor refrigeration component and the lighting lamp. The blowing and heat dissipation component is independently controlled by an external speed regulator.

[0008] The linkage adjustment structure comprises a first adjuster fixed at the bottom end of the illumination lamp and a second adjuster fixed at one end of a blowing head in the blowing structure, the first adjuster and the second adjuster are connected via a linkage assembly, and the blowing head is arranged in an inclined manner;

[0009] During treatment, the illumination time and illumination parameters were adjusted through the human-computer interaction panel, with the illumination time set at 5 minutes and 18 minutes, and the illumination power set at 40 mW / cm2 and 100 mW / cm2.

[0010] Preferably, the emission wavelength of the illumination lamp is 620-640 nanometers, and the power range is 20-100 milliwatts per square centimeter.

[0011] Preferably, the first regulator and the second regulator have the same structure and both include a shell, the interior of the shell is connected to an annular mounting seat via a connecting rod, the interior of the annular mounting seat is rotatably connected to an annular internal gear, the annular internal gear is meshed with four gears, the four gears are rotatably connected to the annular mounting seat, one side of the four gears are meshed with a rack, a spring is fixed between one end of the rack and the shell, wherein a first shielding adjustment plate is fixed to one end of two symmetrical racks, and a second shielding adjustment plate is fixed to one end of the other two symmetrical racks via a raising block.

[0012] Preferably, the linkage assembly includes a fixed connecting piece, a cavity is arranged inside the fixed connecting piece, a linkage assembly is arranged inside the cavity, the linkage assembly includes a rotating shaft rotatably connected inside the cavity, a large winding disk and a small winding disk are fixed to the outer surface of the rotating shaft, the surfaces of the large winding disk and the small winding disk are both wrapped with pull ropes, and the two pull ropes are respectively connected to the racks in the first adjuster and the second adjuster close to the fixed connecting piece.

[0013] Preferably, a worm wheel is also connected to the top of the rotating shaft, one side of the worm wheel is meshingly connected to a worm via a rotating rod, and one end of the rotating rod extends to the outside of the fixed connecting member and is connected to a rotating handle.

[0014] Preferably, the cooling box is provided with a cooling chamber, a heat dissipation chamber and a transmission chamber, the semiconductor refrigeration assembly comprises a semiconductor refrigeration sheet embedded between the cooling chamber and the heat dissipation chamber, the hot end of the semiconductor refrigeration sheet is connected to a heat sink, and the cold end is connected to a cold conduction plate and a plurality of cold conduction rods;

[0015] The blowing structure also includes an air guide pipe, and two ends of the air guide pipe are respectively connected to the blowing head and the cooling box.

[0016] Preferably, the blowing and heat dissipation assembly includes a first heat dissipation fan blade arranged inside the heat dissipation cavity, a blowing fan blade arranged inside the cooling cavity, and a second heat dissipation fan blade arranged inside the lighting lamp, a driving motor is installed inside the transmission cavity, the driving end of the driving motor is connected to the first heat dissipation fan blade, a rotating rod is rotatably connected between the cooling cavity and the transmission cavity, the rotating rod and the driving motor are transmitted through a transmission belt, the blowing fan blade is installed on the outer surface of the rotating rod, and the rotating rod and the second heat dissipation fan blade are connected through a bevel gear assembly.

[0017] Preferably, the movable arm is rotatably connected to the top of the chassis, an installation groove is opened inside the chassis, and a telescopic cylinder is rotatably installed inside the installation groove, the telescopic end of the telescopic cylinder is rotatably connected to the bottom of the movable arm, a turntable is installed at the front end of the movable arm, the bottom of the turntable is connected to a rotating part, and the rotating part is rotatably connected to the top of the cooling box.

[0018] The photodynamic therapy irradiation method for reducing pain includes the following specific steps:

[0019] S1. Before treatment, clean and disinfect the lesion area to be treated;

[0020] S2. Apply 20% fresh ALA solution to the lesion area, with the coverage area exceeding the edge of the lesion by about 1 cm, and use a special light-shielding material to cover the drug and seal it for 2-3 hours;

[0021] S3. After the sealing time is over, remove the light-shielding material and residual drugs, let the patient lie under the lighting device, and adjust the position of the light to keep it in a fixed position of 10 cm from the skin;

[0022] S4. According to the location and size of the lesion, the linkage adjustment structure is rotated to adjust the size of the illumination range to avoid excessive illumination on healthy skin. During the adjustment, the air outlet range of the hair dryer 8 can be adjusted in linkage to ensure that it blows within the illumination range;

[0023] S5. Implement two-step photodynamic therapy. First, irradiate at a power of 40 mW / cm2 for 5 minutes, and adjust the speed of the drive motor 551 to a low speed. Then adjust the power to 100 mW / cm2 and irradiate for another 18 minutes. At the same time, adjust the speed of the drive motor 551 to a medium-high speed. During the irradiation process, continuously blow cold air to further relieve pain.

[0024] The present invention provides a photodynamic therapy irradiation device and method for reducing pain.

[0025] Beneficial effects:

[0026] 1. The illumination device of the present invention adjusts the illumination power and illumination time by dividing the illumination into two steps, and cooperates with the blower mechanism to blow out cold air during photodynamic therapy to reduce thermal damage. Experimental results show that compared with traditional illumination devices and illumination methods, it can greatly reduce the pain of patients during treatment.

[0027] 2. The present invention sets the first regulator, the second regulator and the linkage component. The first regulator and the second regulator can adjust the size of the light port and the air outlet according to the skin area of ​​the patient that needs photodynamic therapy, so as to avoid excessive irradiation and blowing on the skin that does not need treatment. The setting of the linkage component can realize the simultaneous proportional adjustment of the size of the light port and the air outlet, which is more convenient to operate.

[0028] 3. The present invention arranges semiconductor refrigeration components and air blowing and heat dissipation components. The semiconductor refrigeration components can reduce the temperature of the blown air. The air blowing and heat dissipation components can simultaneously work together to achieve heat dissipation of the illumination lamp and the semiconductor refrigeration sheet, as well as blowing out the cold air. During treatment, it can be used in conjunction with two illuminations. The heat dissipation effect and the temperature and volume of the blown cold air can be matched with the two illumination powers by only adjusting the speed of the driving motor. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 A first-view stereoscopic image of the photodynamic therapy irradiation device for reducing pain according to the present invention;

[0030] Figure 2 A second perspective stereoscopic image of the photodynamic therapy irradiation device for reducing pain according to the present invention;

[0031] Figure 3 It is a partial stereoscopic diagram of the irradiation device for photodynamic therapy for reducing pain according to the present invention;

[0032] Figure 4 It is an enlarged view of point A in the irradiation device for photodynamic therapy for reducing pain of the present invention;

[0033] Figure 5 It is a front and back stereoscopic view of a first regulator in the irradiation device for photodynamic therapy for reducing pain of the present invention;

[0034] Figure 6 The invention is a photodynamic therapy irradiation device for reducing pain Figure 5 A three-dimensional diagram without the housing and the spring;

[0035] Figure 7The invention is a photodynamic therapy irradiation device for reducing pain Figure 6 A three-dimensional image in which one of the blocking adjustment plates is removed;

[0036] Figure 8 It is an enlarged view of point B in the irradiation device for photodynamic therapy for reducing pain of the present invention;

[0037] Fig. 9 This is a diagram of the internal structure of the cooling chamber belt in the irradiation device for photodynamic therapy for reducing pain of the present invention;

[0038] Fig.10 It is a test flow chart of the experimental example of the present invention;

[0039] Fig.11 This is the ALA-PDT pain trend diagram of acne patients in the experimental example of the present invention;

[0040] Fig.12 This is the ALA-PDT pain trend diagram of AK patients in the experimental example of the present invention.

[0041] Among them, 1. chassis; 2. human-computer interaction panel; 3. movable arm; 4. rotating part; 5. cooling box; 51. cooling chamber; 52. heat dissipation chamber; 53. transmission chamber; 54. semiconductor refrigeration component; 541. semiconductor refrigeration plate; 542. heat sink; 543. cold plate; 544. cold rod; 55. blowing and heat dissipation component; 551. driving motor; 552. transmission belt; 553. first heat dissipation fan blade; 554. blowing fan blade; 555. rotating rod; 556. bevel gear assembly; 6. lighting lamp; 7. first regulator; 71. housing ; 72. annular mounting seat; 721. notch; 73. spring; 74. first shielding adjustment plate; 75. second shielding adjustment plate; 76. rack; 761. slider; 77. gear; 78. annular internal gear; 79. padding block; 8. hair dryer head; 9. second regulator; 10. fixed connector; 11. air duct; 12. telescopic cylinder; 13. linkage assembly; 131. rotating shaft; 132. worm gear; 133. large winding reel; 134. rotating handle; 135. small winding reel; 136. pull rope; 137. worm; 138. rotating rod. DETAILED DESCRIPTION

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] Embodiment 1:

[0044] like Figure 1-Figure 2 and Fig. 9 As shown, an embodiment of the present invention provides an irradiation device for photodynamic therapy for reducing pain, including a chassis 1 and a movable arm 3 arranged on the top of the chassis 1, an illumination lamp 6 is arranged at one end of the movable arm 3, and a human-machine interaction panel 2 and a power control switch are also arranged on the surface of the chassis 1. Specifically, the movable arm 3 is rotatably connected to the top of the chassis 1, a mounting groove is provided inside the chassis 1, and a telescopic cylinder 12 is rotatably installed inside the mounting groove, and the telescopic end of the telescopic cylinder 12 is rotatably connected to the bottom of the movable arm 3, a turntable is installed at the front end of the movable arm 3, a rotating member 4 is connected to the bottom of the turntable, and the rotating member 4 is rotatably connected to the top of the cooling box 5. The height of the illumination lamp 6 at one end of the movable arm 3 can be adjusted by telescoping the telescopic cylinder 12, and the specific position and direction of the illumination lamp 6 can be adjusted by the turntable and the rotating member 4.

[0045] The device also includes a heat dissipation and cooling structure arranged on the top of the lighting lamp 6 and a blowing structure arranged on one side of the lighting lamp 6. A linkage adjustment structure that can simultaneously adjust the lighting range and the blowing range is arranged between the blowing structure and the lighting lamp 6. An irradiation control unit is arranged inside the chassis 1. The irradiation control unit is connected to the lighting lamp 6 and the human-computer interaction panel 2 through a circuit. The irradiation control unit contains a timing buzzer, which is connected to the programmable circuit of the irradiation control unit for timing the two-step illumination.

[0046] The heat dissipation and cooling structure includes a cooling box 5, and the cooling box 5 is provided with a semiconductor refrigeration component 54 and a blowing and heat dissipation component 55. The semiconductor refrigeration component 54 is used to reduce the temperature inside the cooling box 5, and the blowing and heat dissipation component 55 is used to supply air to the blowing structure and dissipate heat to the semiconductor refrigeration component 54 and the illumination lamp 6. Blowing out the cold air of the semiconductor refrigeration component 54 can reduce the temperature of the skin surface during illumination, thereby reducing thermal damage and pain. During treatment, the illumination time and illumination parameters are adjusted through the human-computer interaction panel 2, and the illumination time is set to 5 minutes and 18 minutes for two times, and the illumination power is set to 40 milliwatts / square centimeter and 100 milliwatts / square centimeter for two times. The emission wavelength of the illumination lamp 6 is 620-640 nanometers, and the power range is 20-100 milliwatts / square centimeter. By adopting a two-step illumination method and accurately controlling the illumination power and time, the patient's pain can be reduced, and the blowing of cold air can reduce thermal damage and pain.

[0047] Specifically, the interior of the cooling box 5 is provided with a cooling chamber 51, a heat dissipation chamber 52 and a transmission chamber 53. The semiconductor refrigeration component 54 includes a semiconductor refrigeration plate 541 embedded between the cooling chamber 51 and the heat dissipation chamber 52. The hot end of the semiconductor refrigeration plate 541 is connected to the heat dissipation plate 542, and the cold end is connected to a cold conduction plate 543 and a plurality of cold conduction rods 544, which can absorb the heat of the hot end of the semiconductor refrigeration plate 541, thereby reducing the temperature of the cold end of the semiconductor refrigeration plate 541. Under the action of the cold end, the air around the cold conduction plate 543 and the plurality of cold conduction rods 544 becomes cold, and a sufficiently large gap is left between the plurality of cold conduction rods 544, so that it will not affect the blowing of cold air from the cooling chamber 51. The blowing structure also includes an air guide duct 11, and the two ends of the air guide duct 11 are respectively connected to the blowing head 8 and the cooling box 5, specifically connected to the cooling chamber 51 of the cooling box 5.

[0048] The blowing and heat dissipation assembly 55 includes a first heat dissipation fan blade 553 arranged inside the heat dissipation cavity 52, a blowing fan blade 554 arranged inside the cooling cavity 51, and a second heat dissipation fan blade arranged inside the illumination lamp 6. A driving motor 551 is installed inside the transmission cavity 53. The driving end of the driving motor 551 is connected to the first heat dissipation fan blade 553, which can drive the first heat dissipation fan blade 533 to rotate. The first heat dissipation fan blade 533 blows air toward the heat sink 542, which can improve the heat dissipation efficiency of the first heat sink 542, thereby improving the semi-circular heat dissipation efficiency. In order to achieve the cooling effect of the conductive refrigeration plate 541, a rotating rod 555 is rotatably connected between the cooling chamber 51 and the transmission chamber 53. The rotating rod 555 and the driving motor 551 are transmitted through a transmission belt 552. The blowing fan blades 554 are installed on the outer surface of the rotating rod 555 to facilitate blowing the cold air out from the inside of the cooling chamber 51. The rotating rod 555 and the second heat dissipation fan blades are connected through a bevel gear assembly 556, which can jointly drive the lighting lamp 6 for heat dissipation. The blowing and heat dissipation components 55 are independently controlled by an external speed regulator.

[0049] The semiconductor refrigeration sheet 541 adjusts the cooling capacity by changing the magnitude of the current. When the magnitude of the current is stable, the better the heat dissipation effect is, the better the cooling effect of the semiconductor refrigeration sheet 541 is. The cooling effect can be improved by connecting multiple semiconductor refrigeration sheets 541 in parallel or in series. Therefore, the number of semiconductor refrigeration sheets 541 can be adjusted according to the temperature range that needs to be lowered. According to the test, the number of semiconductor refrigeration sheets 541 can be adjusted according to the heat generated by the semiconductor refrigeration sheets 541. The total heat that needs to be dissipated at the hot end can be calculated according to the formula, so as to select a suitable heat sink 542, a suitable heat dissipation fan blade and determine the speed range of the heat dissipation fan blade. In the irradiation treatment, the treatment is carried out in two steps. At 0-5 minutes, the power of the light lamp 6 is 40 mW / cm2. The thermal damage is relatively low, and the heat generated by the light lamp 6 itself is also low. The light lamp 6 itself does not require high-intensity heat dissipation. Therefore, in the first time period (0-5 minutes), the speed of the driving motor 551 is adjusted to be within the low speed range (300-600RPM), thereby linking the speed of the second heat dissipation fan blade in the light lamp 6 and the cooling effect of the semiconductor refrigeration plate 541, as well as the amount of air blown out by the hair dryer 8 to keep it adapted to the 0-5 minute light photography. There is no need to adopt complex control technology and algorithms, and it is easy to use. Similarly, in the second time period, the driving motor 551 is adjusted to be within the medium and high speed range (800-1300RPM). A temperature sensor is also installed inside the cooling chamber 51 to monitor the temperature in real time.

[0050] Embodiment 2:

[0051] Since the range of skin damage of patients is different, the required range of illumination and cooling is also different. In order to ensure that the range of illumination and cooling can be more accurately controlled within the required range, the irradiation device is further designed:

[0052] like Figure 1-Figure 8As shown, the linkage adjustment structure includes a first adjuster 7 fixed at the bottom end of the illumination lamp 6 and a second adjuster 9 fixed at one end of a blow head 8 in the blowing structure. The first adjuster 7 and the second adjuster 9 are connected by a linkage assembly 13. The blow head 8 is tilted. Specifically, the tilt angle of the blow head 8 is maintained at a position where the wind blown out of the blow head 8 can accurately irradiate the position when the illumination lamp 6 is 10 cm away from the patient's skin. The first adjuster 9 and the second adjuster 7 can respectively adjust the illumination range of the illumination lamp 6 and the blowing range of the blow head 8. When the illumination range is small, the illumination range can be adjusted mechanically to avoid excessive illumination of normal skin. At the same time, there is no need to control the lamp beads inside the illumination lamp 6 by multiple modules. When the illumination range becomes smaller, the area that needs to be cooled will naturally become smaller. Therefore, when adjusting the illumination range, the air outlet range of the blow head 8 can be naturally linked to be adjusted proportionally, which can well prevent the cold wind from blowing outside the unilluminated area and avoid the problem of external skin discomfort caused by the low temperature of the cold wind.

[0053] like Figure 5-Figure 8 As shown, specifically, the first regulator 7 and the second regulator 9 have the same structure, both including a shell 71, the interior of the shell 71 is connected to an annular mounting seat 72 through a connecting rod, the interior of the annular mounting seat 72 is rotatably connected to an annular internal gear 78, so that the annular internal gear 78 can rotate inside the annular mounting seat 72, the annular internal gear 78 is meshingly connected to four gears 77, the four gears 77 are rotatably connected to the annular mounting seat 72, one side of the four gears 77 are meshingly connected to a rack 76, one end of the rack 76 is fixed with a spring 73 between the shell 71, wherein one end of two symmetrical racks 76 is fixed with a first shielding adjustment plate 74, and one end of the other two symmetrical racks 76 is fixed with a second shielding adjustment plate 75 through a padding protrusion 79, so that the first shielding adjustment plate 74 and the second shielding adjustment plate 75 can overlap, and the shape of the first shielding adjustment plate 74 and the second shielding adjustment plate 75 can be as follows Figure 5 The shape of the light port formed in this way is rectangular, or the edge can be set in an arc shape, so that the size of the light port formed is smoother, and a notch 721 (such as Figure 8 ), the notch 721 is arranged in a dovetail shape, and a slider 761 matching the notch 721 is arranged at the bottom of the rack 76, so that the rack 76 can slide on the surface of the annular mounting seat 72 without falling off the annular mounting seat 72.

[0054] The linkage assembly 13 includes a fixed connecting member 10, a cavity is arranged inside the fixed connecting member 10, and a linkage assembly 13 is arranged inside the cavity. The linkage assembly 13 includes a rotating shaft 131 rotatably connected inside the cavity, a large winding disk 133 and a small winding disk 135 are fixed to the outer surface of the rotating shaft 131, and the surfaces of the large winding disk 133 and the small winding disk 135 are both wrapped with a pull rope 136, and the two pull ropes 136 are respectively connected to the rack 76 close to the fixed connecting member 10 in the first adjuster 7 and the second adjuster 9. When the rotating shaft 131 rotates, the large winding disk 133 and the small winding disk 135 rotate to reel in the pull rope 136, thereby pulling the rack 76 to adjust the size of the irradiation port.

[0055] A worm gear 132 is also connected to the top of the rotating shaft 131, and one side of the worm gear 132 is meshedly connected to a worm 137 through a rotating rod 138. One end of the rotating rod 138 extends to the outside of the fixed connecting member 10 and is connected to a rotating handle 134. The worm gear is self-locking, so the irradiation port adjustment will not be unstable due to the force of the spring 73.

[0056] In addition, the adjustment opening sizes of the first adjuster 7 and the second adjuster 9 can be set at the position of the rotating handle 134 when the rotating handle 134 is rotated to different positions, so that the irradiation area can be rotated to the desired size.

[0057] When using it, first determine the size of the irradiation port. Figure 5 As shown, when it is necessary to expand the range of illumination, first rotate the rotating handle 134. The rotation of the rotating handle 134 drives the rotating shaft 131 to rotate under the action of the worm gear. When the rotating shaft 131 rotates, the large winding disk 133 and the small winding disk 135 rotate to wind up the pull rope 136, thereby pulling the rack 76 connected to the pull rope 136 to move in the direction of the spring 73. When the rack 76 moves, it drives the gear 77 to rotate, thereby driving the annular internal gear 78 to rotate, and then the annular internal gear 78 drives other gears 77 to rotate, so that other gears 77 in turn drive other racks 76 to move, so that the four racks 76 drive the first shielding adjustment plate 74 and the second shielding adjustment plate 75 to move synchronously and adjust the position, thereby realizing the adjustment of the first regulator 7 and the second regulator 9, that is, realizing the adjustment of the illumination port and the air outlet.

[0058] Embodiment 3:

[0059] The photodynamic therapy irradiation method for reducing pain includes the following specific steps:

[0060] S1. Before treatment, the affected area to be treated should be cleaned and disinfected. Specifically, for patients with acne, a sterile acne needle should be used to gently puncture the affected area and clean the secretions or purulent substances therein. For patients with actinic keratosis, gentle physical exfoliation (such as using sterile gauze or a scraper to gently remove excessive keratinization on the surface) can be used to make it easier for the drug to penetrate into the deep layer of the skin lesions.

[0061] S2. Apply 20% fresh ALA solution to the lesions. The photosensitizer used is 5-ALA, with a specification of 118 mg per bottle, produced by Shanghai Fudan Zhangjiang Biopharmaceutical Co., Ltd. The coverage area needs to exceed the edge of the lesion by about 1 cm, and a special light-shielding material is used to cover the drug and seal it for 2-3 hours;

[0062] S3. After the sealing time is over, remove the shading material and the residual medicine, let the patient lie under the lighting device, and adjust the position of the lighting lamp 6 to keep it at a fixed position of 10 cm from the skin;

[0063] S4. According to the location and size of the lesion, the linkage adjustment structure is rotated to adjust the size of the illumination range to avoid excessive illumination on healthy skin. During the adjustment, the air outlet range of the hair dryer 8 can be adjusted in linkage to ensure that it blows within the illumination range;

[0064] S5. Implement two-step photodynamic therapy. First, irradiate at a power of 40 mW / cm2 for 5 minutes, then adjust to 100 mW / cm2 for another 18 minutes to relieve the patient's pain during irradiation. During the irradiation process, continuously blow cold air to further relieve the pain. The temperature of the cold air is maintained at 0-10℃. This range can effectively reduce the epidermal temperature by 8-13℃, reduce thermal damage and pain, and avoid the risk of frostbite.

[0065] Experimental example:

[0066] This study was conducted in the Department of Dermatology, Affiliated Hospital of Xuzhou Medical University in May 2023, and a total of 26 patients diagnosed with acne and 26 patients diagnosed with actinic keratosis (AK) were included. Patients were randomly assigned to the experimental group (two-step photodynamic therapy) and the control group (conventional photodynamic therapy) using a computer-generated random list. The study adopted a double-blind design for patients and assessors, and the patients and researchers who performed pain and efficacy assessments were unaware of the group allocation. All patients met the indications for ALA-PDT treatment and signed informed consent before treatment.

[0067] Table 1: Basic information of acne patients

[0068]

[0069]

[0070] Table 2: Basic information of AK patients

[0071]

[0072] The experimental materials and equipment used in this study included photosensitizers and light devices to ensure standardization and reproducibility of treatment. The photosensitizer used was 5-ALA, with a specification of 118 mg per bottle, produced by Shanghai Fudan Zhangjiang Biopharmaceutical Co., Ltd. For different patients, according to the size and location of the lesions, fresh 20% ALA solution was prepared and used for wet compresses to ensure that the photosensitizer could fully penetrate into the lesion area.

[0073] The illumination device adopts the device of the present invention, emitting red light with a wavelength of 630±5 nanometers and a power range of 20 to 100 milliwatts per square centimeter. The device can vertically illuminate the lesion area to ensure a uniform illumination effect. The light source is kept at a fixed distance of 10 centimeters from the skin surface to avoid interference with the treatment effect caused by local overheating or uneven illumination.

[0074] like Fig.10 The control group used conventional PDT, using red light with a power of 100 mW / cm2 for continuous irradiation for 20 minutes; the experimental group used a two-step photodynamic therapy scheme, first irradiating with a power of 40 mW / cm2 for 5 minutes, and then adjusting to 100 mW / cm2 for another 18 minutes, with a total treatment time of 23 minutes. During the entire illumination process, ensure that the light source maintains a fixed distance of 10 cm from the skin surface to provide uniform and safe light energy distribution, and blow out cold air continuously during illumination. During the treatment, the patient's pain perception at 6, 12, 18, 24 and 30 minutes was recorded using the NRS pain score. Before and after treatment, the changes in skin lesions were recorded using naked eye observation and Wood lamp examination, and the area of ​​lesions was measured to calculate the proportion of area changes before and after treatment.

[0075] After the treatment, patients need to avoid direct exposure to strong light to prevent adverse reactions such as skin pigmentation. The research team used a camera to take photos of the lesions multiple times before, during and after treatment and during follow-up to keep the light source, angle and equipment consistent in order to accurately evaluate the treatment effect. In addition, the treatment interval for each patient was two weeks, with a total of three treatments, and the pain score, lesion changes and possible adverse reactions during each treatment were recorded. According to the percentage reduction in the area of ​​lesions after treatment, the efficacy was divided into four levels: 76%-100% was ineffective, 51%-75% was effective, 26%-50% was effective, and 1%-25% was mild. Finally, all the data were collected and statistically analyzed to verify the comprehensive performance of dual-step PDT in treatment effect and pain management.

[0076] The pain level was assessed using a numerical rating scale (NRS). NRS is a commonly used subjective pain assessment tool, in which patients are required to rate themselves on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the most severe pain. In this study, NRS pain scores were recorded at different time points during the treatment process (6 minutes, 12 minutes, 18 minutes, 24 minutes after the start of treatment, and 30 minutes after the end of treatment). The NRS score at each time point was the patient's peak pain score at that time, which was used as an indicator of pain intensity at that time point.

[0077] Statistical description of NRS pain scores in the acne group:

[0078] In this study, a total of 26 acne patients participated, including 12 in the experimental group (receiving two-step photodynamic therapy) and 14 in the control group (receiving traditional photodynamic therapy). We recorded and counted the patients' pain levels in detail during the treatment. Specifically, the pain NRS scores of the two groups of patients were evaluated at the 6th, 12th, 18th, and 24th minutes after the start of treatment, and 30 minutes after the end of treatment. The results showed that the average NRS scores of the patients in the experimental group were lower than those in the control group at each time point. The pain scores of the patients in the experimental group showed a lower level during the treatment, and the peak pain occurred later and lasted for a shorter time. The pain scores of the patients in the control group were higher, the peak pain occurred earlier, and the duration was longer.

[0079] Fig.11 The figure shows the comparison of mean NRS pain scores between the two-step irradiation group and the conventional irradiation group during PDT treatment in patients with acne. The pain scores of both groups peaked at 6 minutes and gradually decreased over time, with the two-step group having significantly lower pain scores. Error bars represent standard deviations.

[0080] Statistical description of NRS pain scores in the AK group:

[0081] Fig.12 The pain trend of ALA-PDT in AK patients is shown. A, B and C represent the pain trend of the first, second and third treatments, respectively. We recorded the peak NRS at 6, 12, 18 and 24 minutes during and 30 minutes after each treatment. Error bars and statistical P values ​​are directly displayed on the graph. At each recorded time point, the peak pain of the experimental group was lower than that of the control group.

[0082] After three treatments, the lesion areas of the two groups of patients were evaluated. In the experimental group, 84.0% (21 / 25) of the patients were cured, 12.0% (3 / 25) of the patients had improved symptoms, and 4.0% (1 / 25) of the patients had no effect. In the control group, 74.1% (20 / 27) of the patients were cured, 11.1% (3 / 27) of the patients had improved symptoms, and 14.8% (4 / 27) of the patients had no effect. There was no statistically significant difference in the efficacy between the two groups (χ2=1.750, p=0.417), indicating that the two-step photodynamic illumination method of the present invention is equivalent to the illumination method in traditional therapy in terms of therapeutic effect, and is more conducive to reducing the patient's pain than the traditional illumination method.

[0083] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A photodynamic therapy irradiation device for reducing pain, comprising a case (1) and a movable arm (3) arranged on the top of the case (1), one end of the movable arm (3) being provided with a light (6), and a human-machine interaction panel (2) and a power control switch being further provided on the surface of the case (1), characterized in that: The device also includes a heat dissipation and cooling structure arranged on the top of the illumination lamp (6) and an air blowing structure arranged on one side of the illumination lamp (6); a linkage adjustment structure capable of simultaneously adjusting the illumination range and the air blowing range is arranged between the air blowing structure and the illumination lamp (6); an illumination control unit is arranged inside the chassis (1); the illumination control unit is connected to the illumination lamp (6) and the human-machine interaction panel (2) through a circuit; a timing buzzer is included inside the illumination control unit; the timing buzzer is connected to the programmable circuit of the illumination control unit and is used to time the two-step illumination; The heat dissipation and cooling structure comprises a cooling box (5), wherein a semiconductor refrigeration component (54) and a blowing and heat dissipation component (55) are arranged inside the cooling box (5), wherein the semiconductor refrigeration component (54) is used to reduce the temperature inside the cooling box (5), and the blowing and heat dissipation component (55) is used to supply air to the blowing structure and to dissipate heat from the semiconductor refrigeration component (54) and the illumination lamp (6), and the blowing and heat dissipation component (55) is independently controlled by an external speed regulator; The linkage adjustment structure comprises a first adjuster (7) fixed at the bottom end of the illumination lamp (6) and a second adjuster (9) fixed at one end of a blowing head (8) in the blowing structure, the first adjuster (7) and the second adjuster (9) being connected via a linkage assembly (13), and the blowing head (8) is arranged in an inclined manner; During treatment, the illumination time and illumination parameters are adjusted through the human-computer interaction panel (2), and the illumination time is set at 5 minutes and 18 minutes for two times, and the illumination power is set at 40 mW / cm2 and 100 mW / cm2 for two times.

2. The photodynamic therapy irradiation device for reducing pain according to claim 1, characterized in that: The emission wavelength of the illumination lamp (6) is 620-640 nanometers, and the power range is 20-100 milliwatts per square centimeter.

3. The photodynamic therapy irradiation device for reducing pain according to claim 1, characterized in that: The first regulator (7) and the second regulator (9) have the same structure and both comprise a housing (71). The interior of the housing (71) is connected to an annular mounting seat (72) via a connecting rod. The interior of the annular mounting seat (72) is rotatably connected to an annular internal gear (78). The annular internal gear (78) is meshedly connected to four gears (77). The four gears (77) are rotatably connected to the annular mounting seat (72). One side of the four gears (77) is meshedly connected to a rack (76). A spring (73) is fixed between one end of the rack (76) and the housing (71). One end of two symmetrical racks (76) is fixed to a first shielding adjustment plate (74), and one end of the other two symmetrical racks (76) is fixed to a second shielding adjustment plate (75) via a padding protrusion (79).

4. The photodynamic therapy irradiation device for reducing pain according to claim 3, characterized in that: The linkage assembly (13) comprises a fixed connection member (10), a cavity is arranged inside the fixed connection member (10), a linkage assembly (13) is arranged inside the cavity, the linkage assembly (13) comprises a rotating shaft (131) rotatably connected inside the cavity, a large winding disk (133) and a small winding disk (135) are fixed on the outer surface of the rotating shaft (131), and the surfaces of the large winding disk (133) and the small winding disk (135) are both wound with a pull rope (136), and the two pull ropes (136) are respectively connected to the racks (76) in the first adjuster (7) and the second adjuster (9) close to the fixed connection member (10).

5. The photodynamic therapy irradiation device for reducing pain according to claim 4, characterized in that: The top of the rotating shaft (131) is also connected to a worm wheel (132), one side of the worm wheel (132) is meshedly connected to a worm (137) via a rotating rod (138), one end of the rotating rod (138) extends to the outside of the fixed connecting member (10) and is connected to a rotating handle (134).

6. The photodynamic therapy irradiation device for reducing pain according to claim 1, characterized in that: The cooling box (5) is provided with a cooling chamber (51), a heat dissipation chamber (52) and a transmission chamber (53) inside, the semiconductor refrigeration assembly (54) comprises a semiconductor refrigeration plate (541) embedded between the cooling chamber (51) and the heat dissipation chamber (52), the hot end of the semiconductor refrigeration plate (541) is connected to a heat dissipation plate (542), and the cold end is connected to a cold conduction plate (543) and a plurality of cold conduction rods (544); The blowing structure further comprises an air guide pipe (11), and two ends of the air guide pipe (11) are respectively connected to the blowing head (8) and the cooling box (5).

7. The photodynamic therapy irradiation device for reducing pain according to claim 6, characterized in that: The blowing and heat dissipation component (55) comprises a first heat dissipation fan blade (553) arranged inside the heat dissipation cavity (52), a blowing fan blade (554) arranged inside the cooling cavity (51), and a second heat dissipation fan blade arranged inside the illumination lamp (6); a driving motor (551) is installed inside the transmission cavity (53); a driving end of the driving motor (551) is connected to the first heat dissipation fan blade (553); a rotating rod (555) is rotatably connected between the cooling cavity (51) and the transmission cavity (53); the rotating rod (555) and the driving motor (551) are transmitted via a transmission belt (552); the blowing fan blade (554) is installed on the outer surface of the rotating rod (555); and the rotating rod (555) and the second heat dissipation fan blade are connected via a bevel gear component (556).

8. The photodynamic therapy irradiation device for reducing pain according to claim 1, characterized in that: The movable arm (3) is rotatably connected to the top of the chassis (1); a mounting groove is provided inside the chassis (1), and a telescopic cylinder (12) is rotatably installed inside the mounting groove; the telescopic end of the telescopic cylinder (12) is rotatably connected to the bottom of the movable arm (3); a turntable is installed at the front end of the movable arm (3); a rotating member (4) is connected to the bottom of the turntable; and the rotating member (4) is rotatably connected to the top of the cooling box (5).

9. A method for photodynamic therapy irradiation for reducing pain, according to the device for photodynamic therapy irradiation for reducing pain according to any one of claims 1 to 8, characterized in that: The specific steps are as follows: S1. Before treatment, clean and disinfect the lesion area to be treated; S2. Apply 20% fresh ALA solution to the lesion area, with the coverage area exceeding the edge of the lesion by about 1 cm, and use a special light-shielding material to cover the drug and seal it for 2-3 hours; S3. After the sealing time is over, remove the light-shielding material and the remaining medicine, let the patient lie under the lighting device, and adjust the position of the lighting lamp (6) so that it remains at a fixed position of 10 cm from the skin; S4. According to the location and size of the lesion, the linkage adjustment structure is rotated to adjust the size of the illumination range to avoid excessive illumination on healthy skin. During the adjustment, the air outlet range of the hair dryer 8 can be adjusted in linkage to ensure that it blows within the illumination range; S5. Implement two-step photodynamic therapy, first irradiate with a power of 40 mW / cm2 for 5 minutes, and adjust the speed of the drive motor (551) to a low speed gear, then adjust the power to 100 mW / cm2 and irradiate for another 18 minutes, and adjust the speed of the drive motor (551) to a medium-high speed gear. During the irradiation process, continuously blow cold air to further relieve pain.

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