WO2022105848A1 - Laser thermoplasty treatment device for bronchial asthma - Google Patents

Laser thermoplasty treatment device for bronchial asthma Download PDF

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Publication number
WO2022105848A1
WO2022105848A1 PCT/CN2021/131616 CN2021131616W WO2022105848A1 WO 2022105848 A1 WO2022105848 A1 WO 2022105848A1 CN 2021131616 W CN2021131616 W CN 2021131616W WO 2022105848 A1 WO2022105848 A1 WO 2022105848A1
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laser
laser light
light source
balloon
optical
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PCT/CN2021/131616
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French (fr)
Chinese (zh)
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毕勇
孙礼朋
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毕勇
孙礼朋
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00214Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00541Lung or bronchi
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00714Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature

Definitions

  • the present application relates to the technical field of medical devices. More specifically, it relates to a laser-based laser thermoforming device for bronchial asthma.
  • radiofrequency thermoforming devices for bronchial asthma as an example:
  • Bronchial asthma is a common chronic airway inflammatory disease characterized by reversible airflow limitation. According to statistics, 300 million people worldwide are sick, and more than 10 million people are sick in China. The etiology and pathogenesis of bronchial asthma are very complex and have not yet been fully elucidated. At present, asthma patients often use hormones, ⁇ 2-receptor agonists, leukotriene modifiers, etc. to control their disease, but 5%-10% of patients cannot be relieved by conventional treatment. Although such patients use a large amount of inhaled hormones, even oral administration Hormones are still not well controlled, and there are still acute exacerbations, namely severe asthma (severe asthma).
  • ASM airway smooth muscle
  • BT bronchial thermoplasty
  • existing technical solutions mainly use the method of radiofrequency ablation (RFA), which is called radiofrequency thermoplasty.
  • RFA radiofrequency ablation
  • Electromagnetic waves through radio frequency, make the charged ions in the tissue oscillate to generate heat, transfer heat to the airway smooth muscle, and reduce the contractility and hyperresponsiveness of the airway smooth muscle (reduce the number of airway smooth muscle) by means of temperature regulation treatment.
  • the cells of hypertrophic smooth muscle coagulate and necrosis, and finally achieve the purpose of ablating the airway smooth muscle layer, reducing airway reactivity, and partially reversing the remodeling of airway structure.
  • the existing RF thermoplasty solutions mainly have the following problems:
  • radiofrequency thermoplasty is a direct contact treatment method.
  • the radiofrequency electrode is in close contact with the inner wall of the human trachea after being electrified and heated, which can easily damage the tracheal intima, resulting in infection or scarring and easy generation. Granulation, which poses additional risks and side effects to the patient.
  • the use of radiofrequency thermoplasty to treat severe asthma has a long treatment cycle, which virtually increases the physical pain and economic burden of the patient.
  • the whole lung treatment process is divided into three stages: the right lower lobe, the left lower lobe, and the left and right upper lobes, and each stage is treated 3 weeks apart.
  • electrodes are used to introduce AC electromagnetic waves into the airway smooth muscle to stimulate the charged ions in the tissue to oscillate and generate heat, so as to achieve the purpose of thermal ablation of the smooth muscle tissue.
  • the treatment time of each stage lasts 30 minutes or longer, and the treatment cycle is too long and the efficiency is low.
  • Radiofrequency thermoplasty is constrained by the structure of the inner wall of the airway, and the treatment area is limited.
  • Radiofrequency thermoplasty is an energy coupling method that uses four electrode contacts to contact the inner wall of the trachea. When the airway smooth muscle is severely contracted or has an irregular shape, the four electrodes may not be in complete contact with the inner wall of the airway, resulting in inability to Effective use of thermoplasty for surgical treatment.
  • the purpose of the present application is to provide a laser thermoforming treatment device for bronchial asthma to solve at least one of the problems existing in the prior art.
  • a first aspect of the present application provides a laser thermoforming treatment device for bronchial asthma, comprising: a laser light source, a catheter, and a balloon disposed at one end of the catheter, and an optical fiber is disposed in the catheter; a first end of the optical fiber As a laser input end, it is connected to the laser light source; the second end of the optical fiber is located in the balloon and serves as a laser output end, used for irradiating the biological tissue with the laser light emitted by the laser light source.
  • the device further includes an optical shaping module disposed between the laser light source and the optical fiber, for shaping the laser light emitted by the laser light source so that the irradiation spot of the laser light is Ring-shaped or multi-lobed.
  • the optical shaping module includes a first optical device arranged in sequence along the optical path for compressing the irradiation spot size of the laser light, and for shaping the irradiation spot of the laser into an annular or multi-lobed shape.
  • the second optical device and the third optical device for coupling laser light wherein the first optical device is a stepped mirror or a rhombus prism group, the second optical device is a conical mirror, and the third optical device is a conical lens or a pyramid lens.
  • the device further includes a temperature sensor for sensing the temperature in the vicinity of the biological tissue.
  • the device further includes an image capturer for capturing an image of the front of the balloon.
  • the wavelength range of the laser light emitted by the laser light source is 380 nm ⁇ 2100 nm.
  • the temperature sensor is a thermocouple temperature sensor or a platinum resistance temperature sensor.
  • the apparatus further includes a control module, configured to adjust the output power of the laser light source according to the temperature sensed by the temperature sensor.
  • the apparatus further includes a display module, configured to display the temperature sensed by the temperature sensor, the image collected by the image collector, the output power of the laser light source, and the duration of the laser irradiation. at least one of.
  • the device further includes a manipulation handle device for manipulating the movement of the balloon.
  • the "laser thermoplasty" adopted in the technical solution of the present invention has many advantages such as high safety, high accuracy, high efficiency, low cost, and the like.
  • FIG. 1 shows a schematic diagram of a laser thermoforming device for bronchial asthma provided by an embodiment of the present application.
  • Figure 2 shows a schematic diagram of an optical shaping module.
  • 3-a shows a schematic diagram of a ring-shaped light spot
  • 3-b shows a schematic diagram of a multi-lobed light spot.
  • Figure 4 shows a schematic diagram showing the entry of a balloon from the oral cavity into the airways of the lungs.
  • Figure 5 Schematic diagram of laser irradiation of airway smooth muscle in the airway of the lung.
  • an embodiment of the present application provides a laser-based thermoforming device. forming device.
  • the laser thermoforming treatment device for bronchial asthma includes: a laser light source 10, a catheter 20, and a balloon 30 arranged at one end of the catheter 20.
  • An optical fiber is arranged in the catheter 20; The second end of the optical fiber is located in the balloon 30 and serves as a laser output end, which is used to make the laser emitted from the laser light source 10 irradiate the biological tissue, so as to realize thermal ablation of the biological tissue through thermal effect. .
  • the laser thermoforming device for bronchial asthma provided in this embodiment further includes a control module 40 for controlling the laser light source 10 to emit laser light.
  • the balloon 30 may be made of silicone, polyurethane, nitinol material or other superelastic material, and has a conical or cylindrical shape.
  • the light-emitting device in the laser light source 10 can be a semiconductor laser, an all-solid-state laser, a fiber laser, a gas laser, etc., preferably a semiconductor laser; the average output power of the laser light source 10 is adjustable, and the adjustment range of the average power can be set to 0-20W ;
  • the modulation mode of the control module 40 for the laser light source 10 can be current value adjustment (the current adjustment accuracy is, for example, 0.1A), or PWM modulation; the laser light emitted by the laser light source 10 can be a continuous laser or a discontinuous laser;
  • the laser light emitted by the light source 10 may be visible light or infrared light (including near-infrared light and mid-infrared light), and the wavelength range of the laser light emitted by the laser light source 10 is 380 nm ⁇ 2
  • the laser thermoforming device for bronchial asthma provided in this embodiment is used to thermally ablate the proliferated airway smooth muscle to treat bronchial asthma. That is, the above-mentioned biological tissue is airway smooth muscle.
  • the balloon 30 enters the airway tube through the patient's nasal cavity or oral cavity and reaches the position of the airway smooth muscle, the laser light emitted by the laser light source 10 is transmitted through the optical fiber in the catheter 20 to illuminate the airway smooth muscle. , to achieve thermal ablation of airway smooth muscle through thermal effect, thereby treating bronchial asthma.
  • the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes a manipulation device 50 for manipulating the movement of the balloon 30 .
  • the balloon 30 is disposed at the top of the catheter 20, and the catheter 20 is a hollow thin tube (typically a bronchoscope) with a degree of bending.
  • the optical fibers also follow the balloon 30 into the airway.
  • the laser output end of the optical fiber is not only located in the balloon 30 , but also can be arranged such that the optical fiber passes through the balloon 30 so that the laser output end of the optical fiber is located in front of the balloon 30 .
  • the control device 50 is, for example, a handle or a joystick, or a touch module implemented by a touch screen, which can control the movement of the balloon 30 and the catheter 20, including the movement distance (forward distance, backward distance), movement direction (turning distance). )Wait.
  • the manipulation device 50 can also control the opening or closing of the balloon 30.
  • the manipulation device 50 can control the closing of the balloon 30 during the process of controlling the movement of the balloon 30 and the catheter 20, and when the balloon 30 reaches a predetermined position, that is, when the laser output end of the optical fiber is facing the airway smooth muscle to be ablated, the balloon 30 is controlled. Open to expose the laser output end of the fiber.
  • the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes a temperature sensor for sensing the temperature near the biological tissue. Therefore, the thermal ablation effect can be determined according to the temperature near the biological tissue sensed by the temperature sensor, which provides a basis for controlling the temperature of thermal ablation by manually or automatically controlling the output power of the laser light source 10 .
  • the temperature sensor can be a thermocouple temperature sensor, a platinum resistance temperature sensor, and a thermistor temperature sensor. Among them, a thermocouple temperature sensor or a platinum resistance temperature sensor is preferably used, which has the advantages of high precision and high stability, and the precision is 0.1 °C or so.
  • the temperature sensor is used to sense the temperature near the airway smooth muscle to be ablated.
  • the set target temperature for thermal ablation through thermal effect is between 55°C and 65°C, and a thermocouple is used.
  • a temperature sensor or platinum resistance temperature sensor can meet requirements such as accuracy. It can be understood that the temperature sensor may be positioned close to the laser output end of the optical fiber. In addition, for the case where the laser output end of the optical fiber is located in the balloon 30, the temperature sensor can also be arranged outside the front of the balloon 30, so that the temperature sensor is closer to the airway smooth muscle to be ablated.
  • control module 40 is configured to adjust the output power of the laser light source 10 according to the temperature sensed by the temperature sensor. Therefore, the control module 40 can sense the temperature near the biological tissue through the temperature sensor, and perform closed-loop control of the output power of the laser light source 10, so as to perform thermal ablation of the biological tissue more accurately and controllably, and improve the safety and effectiveness of the treatment. sex, to ensure the therapeutic effect.
  • the laser thermoforming device for bronchial asthma provided in this embodiment further includes an image acquisition device for acquiring an image of the front of the balloon 30 .
  • the image collector may be an endoscopic camera or a miniature camera. As a result, an endoscopic view can be provided, enabling more precise movements and viewing thermal ablation effects on biological tissue.
  • the image acquisition device is a CMOS device, which can be disposed outside the front of the balloon 30 .
  • the image collected by the image collector can be used to provide a real-time picture of the moving position in the process of controlling the movement of the balloon 30 and the catheter 20 through the manipulation device 50, so as to assist the manipulation and achieve more accurate movement of the balloon 30 to the position of the catheter 20.
  • the position of the airway smooth muscle to be ablated so that the laser output end of the optical fiber can be more accurately aligned with the airway smooth muscle to be ablated; on the other hand, users such as doctors can also view the airway according to the images collected by the image collector.
  • the thermal ablation effect of smooth muscle can be used to determine whether to increase/decrease the output power of the laser light source, prolong the laser irradiation time, etc., so as to ensure the therapeutic effect.
  • control module 40 may control the laser light source 10 through signals or instructions in response to an input control command or based on preset control parameters, so as to adjust the driving current of the laser light source 10 to control the laser light source 10 to emit laser light
  • the control module 40 can be equipped with operating devices such as emergency stop switch and foot switch controller;
  • the change of the above-mentioned temperature value automatically adjusts the driving current value of the laser light source 10 or the duty cycle of the PWM control signal, thereby controlling the output power of the laser light source 10 to achieve stable control of the temperature of the inner wall of the bronchus irradiated by the laser (for example, set
  • the predetermined target temperature is between 55°C and 65°C
  • the output power of the laser light source 10 is controlled by comparing the temperature value sensed by the temperature sensor with the target temperature, so that the temperature of the thermal ablation position is controlled at 55°C-65°C between, that is, the temperature of the airway smooth muscle at the place where the laser is irradiated reaches the
  • the temperature sensor and the image collector may be connected to the control module 40 through cables, respectively, and the two cables may be respectively disposed in the conduit 20 .
  • the catheter 20 is provided with an optical fiber, a connection cable for the temperature sensor, and a connection cable for the image acquisition device.
  • the laser output end of the optical fiber can be set at the opening of the balloon 30 After the balloon 30 is opened, the laser output end of the optical fiber is located in the center of the bronchial airway, which is convenient to achieve centering, wherein the laser output end of the optical fiber and the balloon 30 can adopt an integrated design.
  • the laser thermoforming treatment device for bronchial asthma further includes a display module 60 for displaying the temperature sensed by the temperature sensor, the image collected by the image collector, the output power of the laser light source 10, the laser At least one of the irradiation durations may also display other information such as the drive current value of the laser light source 10 .
  • information such as the temperature sensed by the above temperature sensor, the image collected by the image collector, the output power of the laser light source 10, and the duration of laser irradiation can also be stored in the memory.
  • control module 40, the manipulation module 50 and the display module 60 can be integrated into a terminal device, wherein the manipulation module 50 and the display module 60 can be integrated into the touch screen of the terminal device, and the control module 40 can be used to control the When the laser light source 10 is turned on/off, or parameters such as the output power of the laser light source 10 are controlled, the touch screen can also be used for input.
  • the terminal device can be various electronic devices, including but not limited to personal computers, tablet computers, medical instruments and so on.
  • the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes an optical shaping module 70 disposed between the laser light source 10 and the optical fiber 80 , and is used for aligning the laser light source. 10.
  • the outgoing laser light is shaped so that the irradiation spot of the laser light is annular or multi-lobed. As a result, the uniformity of the laser light irradiated on the biological tissue can be improved, and the therapeutic effect can be ensured.
  • the optical shaping module 70 includes a rhombus prism group 701 arranged in sequence along the optical path for compressing the size of the irradiation spot of the laser light, and for shaping the irradiation spot of the laser into an annular or multi-lobed shape.
  • the rhombus prism group 701 is, for example, a pair of glued rhombus prisms as shown in FIG. 2 .
  • the spot size is compressed, and the laser light with the compressed spot size passes through the rhombus prism group 701 .
  • the conical mirror 702 becomes the laser light of the annular spot, and the laser light of the annular spot is coupled into the optical fiber 80 after passing through the lens group 703 .
  • the materials of the optical devices of the rhombus prism group 701 , the conical mirror 702 and the lens group 703 may be optical glass, optical resin material, or the like.
  • Lens group 703 may include conical lenses or pyramid lenses.
  • the rhombic prism group 701 can also be replaced by a stepped mirror, that is, the stepped mirror is used to compress the irradiation spot size of the laser light.
  • the workflow of the laser thermoforming treatment device for bronchial asthma provided in this embodiment is, for example: through the catheter 20, the optical fiber is put into the bronchi of the patient, the operation device 40 controls the balloon 30, and the laser light source 10 is emitted
  • the laser light shaped by the optical shaping module 70 is transmitted to the affected part of the bronchus through the optical fiber to achieve centering, and the formed annular light spot or multi-lobed light spot is used to irradiate the inner wall of the bronchus and generate a thermal effect, thereby coagulating the hyperplasia and hypertrophy smooth muscle cells.
  • the laser shaped by the optical shaping module 70 forms a ring-shaped light spot or a multi-lobed light spot with uniform energy distribution and no gap, which can completely irradiate and cover the inner wall of the bronchus, and will not be unable to be treated due to severe contraction or deformation of the airway smooth muscle.
  • the laser has the advantages of high energy, good directionality, high efficiency, and significant thermal effect when interacting with biological tissues, and can rapidly heat up in a short time. Laser thermoforming avoids contact with biological tissue, does not cause damage and side effects caused by contact, and is safer.
  • the operation method of the laser thermoforming device for bronchial asthma is, for example: inserting the catheter 20 ⁇ turning on the low-power mode of the laser light source 10 and guiding the balloon 30 and the laser output end of the optical fiber On the affected area ⁇ turn on the treatment mode of the laser light source 10 ⁇ output the annular light spot to irradiate the affected area (airway smooth muscle), and operate continuously to treat the entire bronchus.
  • the local treatment temperature is between 55°C and 65°C, and each treatment part (affected part) is maintained for about 10 seconds; the patient moves from the distal affected part to the proximal affected part, and the above operations are repeated until the entire treatment process or operation is over.
  • the process includes: after the patient is anesthetized, lie down on the operating table, the balloon 30 and the catheter 20 enter the airway tube through the nasal cavity or the oral cavity, as shown in FIG. 4 , the balloon 30 is closed at this time;
  • the module 50 controls the movement of the balloon 30, collects images in the airway in real time through the image collector and transmits them to the control module 40, and is displayed by the display module 60; after reaching the designated patient, the balloon 30 is opened through the operation module 50, and the display is displayed.
  • the module 60 displays the setting interface; the ablation temperature is set at 65 degrees Celsius and the duration is 10s, the control module 40 controls the laser light source 10 to emit laser light, which is shaped by the optical shaping module 70 and output from the laser output end of the optical fiber, as shown in FIG.
  • the light spot on the airway wall tissue is an annular light spot.
  • the control module 40 adjusts the driving current value of the laser light source 10 according to the change of the temperature value sensed by the temperature sensor, so as to achieve stable temperature control in the human body, and the display module 60 displays the image of the irradiated tissue collected by the image collector in real time, so as to achieve disease control. Thermal ablation of affected tissue.
  • the balloon 30 is moved, so that the formed annular light spot reaches the next patient position, and the treatment is continued.
  • the driving current of the laser light source 10 is adjusted to 0A by the control module 40 to turn off the laser light source 10; the balloon 30 is closed by the operation module 50, and the catheter 20 is pulled out to complete the treatment.
  • the local treatment temperature is controlled between 55°C and 65°C, and the treatment time for each part lasts about 10s. It can be performed one by one from far to near from the airway patient with a diameter of more than 3 mm to avoid repeated or missed treatment. Compared with radiofrequency thermoplasty, this embodiment greatly shortens the treatment time, which can reduce the pain and burden of the patient.
  • the laser thermoforming treatment device for bronchial asthma utilizes the advantages of high efficiency, miniaturization, low cost, non-contact, and significant thermal effect in interaction with biological tissues, using laser as an energy source.
  • thermoplasty to treat bronchial asthma and other diseases.
  • using the integration of catheter, balloon and optical fiber, as well as high-precision temperature sensing and feedback control system a convenient, precise and controllable, safe and effective "laser thermoplasty" for the treatment of bronchial asthma is realized and other disease devices.
  • the first aspect non-contact treatment, has high safety:
  • the "laser thermoplasty" used in this embodiment uses a laser as an energy source to couple the laser light emitted by the laser light source into a conducting fiber.
  • the fiber enters the trachea along with the catheter and the balloon, and the laser output from the laser output end of the fiber forms a ring. It can irradiate the inner wall of the bronchus, so that the contracted smooth muscle tissue absorbs light energy and is heated, so that the smooth muscle cells coagulate and necrosis, so as to achieve the purpose of treatment. In this process, the contact between the therapeutic instrument and the human tissue is avoided, the damage and side effects caused by the contact will not be caused, and the safety is high.
  • the second aspect the treatment efficiency is high and the time is short:
  • Laser has the advantages of high energy and good directionality, and has a significant thermal effect when interacting with smooth muscle tissue. It can heat up rapidly in a short time, and the treatment efficiency is high.
  • the laser thermoforming device for bronchial asthma provided in this example (referred to as laser thermoforming in Table 2) and the existing radio frequency thermoforming device (referred to as radio frequency thermoforming in Table 2) are shown in Table 2.
  • the effect of molding) is compared to show:
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection, It can also be an electrical connection; it can be a direct connection, an indirect connection through an intermediate medium, or an internal connection between two components.
  • installed should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection, It can also be an electrical connection; it can be a direct connection, an indirect connection through an intermediate medium, or an internal connection between two components.

Abstract

A laser thermoplasty treatment device for bronchial asthma, comprising: a laser source (10), a catheter (20) and a balloon (30) arranged at one end of the catheter (20). An optical fiber is provided in the catheter (20). A first end of the optical fiber is used as a laser input end to connect to the laser source (10). A second end of the optical fiber is positioned in the balloon (30) and is used as a laser output end for irradiating the laser light emitted by the laser source (10) into biological tissue. In the process of thermal ablation of biological tissue by means of thermal effect, the present laser thermoplasty treatment device has advantages such as high safety, high accuracy, high efficiency, and low cost.

Description

一种支气管哮喘的激光热成形治疗装置A laser thermoforming treatment device for bronchial asthma 技术领域technical field
本申请涉及医疗器械技术领域。更具体地,涉及一种基于激光的支气管哮喘的激光热成形治疗装置。The present application relates to the technical field of medical devices. More specifically, it relates to a laser-based laser thermoforming device for bronchial asthma.
背景技术Background technique
目前,一些疾病的治疗需要利用射频热成形术,以利用射频热成型装置支气管哮喘为例:At present, the treatment of some diseases requires the use of radiofrequency thermoplasty. Take the use of radiofrequency thermoforming devices for bronchial asthma as an example:
支气管哮喘(Asthma)是一种以可逆性气流受限为特征的常见慢性气道炎症性疾病。根据统计,全球有3亿人群患病,在中国约一千万以上人群患病。支气管哮喘的病因和发病机制非常复杂,至今尚未完全阐明。目前哮喘患者多用激素、β2受体激动剂、白三烯调节剂等联合控制病情,但尚有5%-10%的患者经过常规治疗不能得到缓解,这类患者尽管使用大量吸入激素,甚至口服激素仍然不能获得较好控制,仍有急性加重,即重症哮喘(severe asthma)患者。Bronchial asthma (Asthma) is a common chronic airway inflammatory disease characterized by reversible airflow limitation. According to statistics, 300 million people worldwide are sick, and more than 10 million people are sick in China. The etiology and pathogenesis of bronchial asthma are very complex and have not yet been fully elucidated. At present, asthma patients often use hormones, β2-receptor agonists, leukotriene modifiers, etc. to control their disease, but 5%-10% of patients cannot be relieved by conventional treatment. Although such patients use a large amount of inhaled hormones, even oral administration Hormones are still not well controlled, and there are still acute exacerbations, namely severe asthma (severe asthma).
气道平滑肌(airway smooth muscle,ASM)在哮喘发病机制中的作用越来越受到重视。ASM增生导致气道狭窄是哮喘的主要发病机制之一。如果肺部经常受到刺激,ASM数量和体积均会发生变化,导致ASM层变厚和气道狭窄。The role of airway smooth muscle (ASM) in the pathogenesis of asthma has received increasing attention. Airway narrowing due to ASM hyperplasia is one of the main pathogenesis of asthma. If the lungs are frequently irritated, both the number and volume of ASMs can change, resulting in a thickening of the ASM layer and narrowing of the airways.
支气管热成形术(bronchial thermoplasty,BT)原理主要是能在指定部位精确地控制能量释放,在达到所需温度和作用时间后,实现去除ASM的增生,恢复气道通畅的目的。现有的技术方案(如美国Asthmatx公司研发的AlairTM系统)主要是利用了射频消融术(radiofrequency ablation,RFA)的方法,称为射频热成形术,具体方案为通过电极在气道平滑肌中导入交流电磁波,通过射频使组织中带电离子震荡产热,向气道平滑肌传递热量,以温度调控治疗方式来降低气道平滑肌的收缩性和高反应性(减少气道平滑肌的数量),从而使增生、肥厚的平滑肌的细胞发生凝固、坏死,最终达到消融气道平滑肌层、降低气道反应性、并部分逆转气道结构重塑的目的。The principle of bronchial thermoplasty (BT) is mainly to precisely control the release of energy at the designated site, and to achieve the purpose of removing the hyperplasia of ASM and restoring the patency of the airway after reaching the required temperature and action time. Existing technical solutions (such as the AlairTM system developed by Asthmatx in the United States) mainly use the method of radiofrequency ablation (RFA), which is called radiofrequency thermoplasty. Electromagnetic waves, through radio frequency, make the charged ions in the tissue oscillate to generate heat, transfer heat to the airway smooth muscle, and reduce the contractility and hyperresponsiveness of the airway smooth muscle (reduce the number of airway smooth muscle) by means of temperature regulation treatment. The cells of hypertrophic smooth muscle coagulate and necrosis, and finally achieve the purpose of ablating the airway smooth muscle layer, reducing airway reactivity, and partially reversing the remodeling of airway structure.
现有的射频热成形术方案主要存在以下几个问题:The existing RF thermoplasty solutions mainly have the following problems:
第一、射频热成形术是一种直接接触式的治疗手段,在手术操作过程中,射频电极通电发热后与人体气管内壁密切接触,极易损伤气管内膜,导致感染或疤痕产生并易生成肉芽,给病人带来额外的风险和副作用。First, radiofrequency thermoplasty is a direct contact treatment method. During the surgical operation, the radiofrequency electrode is in close contact with the inner wall of the human trachea after being electrified and heated, which can easily damage the tracheal intima, resulting in infection or scarring and easy generation. Granulation, which poses additional risks and side effects to the patient.
第二、采用射频热成形术治疗重症哮喘治疗周期长,无形中增添了患者的身体痛苦和经济负担。整个肺部的治疗过程分为右肺下叶、左肺下叶和左右肺上叶三个阶段,每个阶段相隔3周治疗。每次治疗,利用电极在气道平滑肌中导入交流电磁波,激发组织中带电离子震荡发热,达到平滑肌组织热消融的目的。每一阶段治疗时间持续30分钟或更长时间,治疗周期过长、效率较低。Second, the use of radiofrequency thermoplasty to treat severe asthma has a long treatment cycle, which virtually increases the physical pain and economic burden of the patient. The whole lung treatment process is divided into three stages: the right lower lobe, the left lower lobe, and the left and right upper lobes, and each stage is treated 3 weeks apart. In each treatment, electrodes are used to introduce AC electromagnetic waves into the airway smooth muscle to stimulate the charged ions in the tissue to oscillate and generate heat, so as to achieve the purpose of thermal ablation of the smooth muscle tissue. The treatment time of each stage lasts 30 minutes or longer, and the treatment cycle is too long and the efficiency is low.
第三、射频热成形术受到气道内壁结构的约束,治疗区域受限。射频热成形术是利用四个电极触点接触气管内壁的能量耦合方式,在气道平滑肌严重收缩或者形状不规则的情况下,四个电极很有可能无法完全与气道内壁接触,从而导致无法有效使用热成形术进行手术治疗。Third, radiofrequency thermoplasty is constrained by the structure of the inner wall of the airway, and the treatment area is limited. Radiofrequency thermoplasty is an energy coupling method that uses four electrode contacts to contact the inner wall of the trachea. When the airway smooth muscle is severely contracted or has an irregular shape, the four electrodes may not be in complete contact with the inner wall of the airway, resulting in inability to Effective use of thermoplasty for surgical treatment.
第四、射频热成形术中的电极作为一次性使用的医用耗材,价格较高。Fourth, the electrodes in radiofrequency thermoplasty, as disposable medical consumables, are expensive.
发明内容SUMMARY OF THE INVENTION
本申请的目的在于提供一种支气管哮喘的激光热成形治疗装置,以解决现有技术存在的问题中的至少一个。The purpose of the present application is to provide a laser thermoforming treatment device for bronchial asthma to solve at least one of the problems existing in the prior art.
为达到上述目的,本申请采用下述技术方案:In order to achieve the above object, the application adopts the following technical solutions:
本申请第一方面提供了一种支气管哮喘的激光热成形治疗装置,包括:激光光源、导管和设置于所述导管一端的球囊,所述导管内设置有光纤;所述光纤的第一端作为激光输入端,连接所述激光光源;所述光纤的第二端位于所述球囊中,作为激光输出端,用于使所述激光光源出射的激光照射生物组织。A first aspect of the present application provides a laser thermoforming treatment device for bronchial asthma, comprising: a laser light source, a catheter, and a balloon disposed at one end of the catheter, and an optical fiber is disposed in the catheter; a first end of the optical fiber As a laser input end, it is connected to the laser light source; the second end of the optical fiber is located in the balloon and serves as a laser output end, used for irradiating the biological tissue with the laser light emitted by the laser light source.
在一种可能的实现方式中,该装置还包括设置于所述激光光源与所述光纤之间的光学整形模块,用于对所述激光光源出射的激光进行整形以使得所述激光的照射光斑呈环状或多瓣状。In a possible implementation manner, the device further includes an optical shaping module disposed between the laser light source and the optical fiber, for shaping the laser light emitted by the laser light source so that the irradiation spot of the laser light is Ring-shaped or multi-lobed.
在一种可能的实现方式中,所述光学整形模块包括沿光路依次设置的用于压缩激光的照射光斑尺寸第一光学器件、用于将激光的照射光斑整形为呈环状或多瓣状的第二光学器件及用于耦合激光的第三光学器件,其中,第一光学器件为阶梯反射镜或斜方棱镜组,第二光学器件为锥形镜,第三光学器件为锥形透镜或金字塔透镜。In a possible implementation manner, the optical shaping module includes a first optical device arranged in sequence along the optical path for compressing the irradiation spot size of the laser light, and for shaping the irradiation spot of the laser into an annular or multi-lobed shape. The second optical device and the third optical device for coupling laser light, wherein the first optical device is a stepped mirror or a rhombus prism group, the second optical device is a conical mirror, and the third optical device is a conical lens or a pyramid lens.
在一种可能的实现方式中,该装置还包括用于感测所述生物组织附近温度的温度传感器。In a possible implementation, the device further includes a temperature sensor for sensing the temperature in the vicinity of the biological tissue.
在一种可能的实现方式中,该装置还包括用于采集所述球囊的前方图像的图像采集器。In a possible implementation, the device further includes an image capturer for capturing an image of the front of the balloon.
在一种可能的实现方式中,所述激光光源出射的激光的波长范围为380nm~2100nm。In a possible implementation manner, the wavelength range of the laser light emitted by the laser light source is 380 nm˜2100 nm.
在一种可能的实现方式中,所述温度传感器为热电偶温度传感器或铂电阻温度传感器。In a possible implementation manner, the temperature sensor is a thermocouple temperature sensor or a platinum resistance temperature sensor.
在一种可能的实现方式中,该装置还包括控制模块,用于根据所述温度传感器感测的温度,调节所述激光光源的输出功率。In a possible implementation manner, the apparatus further includes a control module, configured to adjust the output power of the laser light source according to the temperature sensed by the temperature sensor.
在一种可能的实现方式中,该装置还包括显示模块,用于显示所述温度传感器感测的温度、所述图像采集器采集的图像、所述激光光源的输出功率、激光照射的时长中的至少之一。In a possible implementation manner, the apparatus further includes a display module, configured to display the temperature sensed by the temperature sensor, the image collected by the image collector, the output power of the laser light source, and the duration of the laser irradiation. at least one of.
在一种可能的实现方式中,该装置还包括用于操控所述球囊移动的操控手柄装置。In a possible implementation manner, the device further includes a manipulation handle device for manipulating the movement of the balloon.
本发明的有益效果如下:The beneficial effects of the present invention are as follows:
本发明所述技术方案采用的“激光热成形术”,相比于现有的射频热成形术而言,具有高安全性、高精确性、高效率、低成本等诸多优势。Compared with the existing radio frequency thermoplasty, the "laser thermoplasty" adopted in the technical solution of the present invention has many advantages such as high safety, high accuracy, high efficiency, low cost, and the like.
附图说明Description of drawings
下面结合附图对本申请的具体实施方式作进一步详细的说明。The specific embodiments of the present application will be described in further detail below with reference to the accompanying drawings.
图1示出本申请实施例提供的支气管哮喘的激光热成形治疗装置的示意图。FIG. 1 shows a schematic diagram of a laser thermoforming device for bronchial asthma provided by an embodiment of the present application.
图2示出光学整形模块的示意图。Figure 2 shows a schematic diagram of an optical shaping module.
图3中,3-a示出环状光斑的示意图,3-b示出多瓣状光斑的示意图。In FIG. 3 , 3-a shows a schematic diagram of a ring-shaped light spot, and 3-b shows a schematic diagram of a multi-lobed light spot.
图4示出示出球囊从口腔进入肺部气道的示意图。Figure 4 shows a schematic diagram showing the entry of a balloon from the oral cavity into the airways of the lungs.
图5中激光照射肺部气道中的气道平滑肌的示意图。Figure 5. Schematic diagram of laser irradiation of airway smooth muscle in the airway of the lung.
具体实施方式Detailed ways
为了更清楚地说明本申请,下面结合实施例和附图对本申请做进一步的说明。附图中相似的部件以相同的附图标记进行表示。本领域技术人员应当理解,下面所具体描述的内容是说明性的而非限制性的,不应以此限制本申请的保护范围。In order to illustrate the present application more clearly, the present application will be further described below with reference to the embodiments and the accompanying drawings. Similar parts in the figures are denoted by the same reference numerals. Those skilled in the art should understand that the content specifically described below is illustrative rather than restrictive, and should not limit the protection scope of the present application.
为了解决现有的射频热成形装置存在的安全性较低、治疗周期长、效率较低、有效性和精度较低、成本较高等问题,本申请的一个实施例提供了一种基于激光的热成形装置。In order to solve the problems of low safety, long treatment period, low efficiency, low effectiveness and precision, and high cost of existing radio frequency thermoforming devices, an embodiment of the present application provides a laser-based thermoforming device. forming device.
如图1所示,本实施例提供的支气管哮喘的激光热成形治疗装置,包括: 激光光源10、导管20和设置于导管20一端的球囊30,导管20内设置有光纤;光纤的第一端作为激光输入端,连接激光光源10;光纤的第二端位于球囊30中,作为激光输出端,用于使激光光源10出射的激光照射生物组织,以通过热效应实现对生物组织的热消融。As shown in FIG. 1 , the laser thermoforming treatment device for bronchial asthma provided in this embodiment includes: a laser light source 10, a catheter 20, and a balloon 30 arranged at one end of the catheter 20. An optical fiber is arranged in the catheter 20; The second end of the optical fiber is located in the balloon 30 and serves as a laser output end, which is used to make the laser emitted from the laser light source 10 irradiate the biological tissue, so as to realize thermal ablation of the biological tissue through thermal effect. .
在一些实施例中,本实施例提供的支气管哮喘的激光热成形治疗装置还包括用于控制激光光源10出射激光的控制模块40。In some embodiments, the laser thermoforming device for bronchial asthma provided in this embodiment further includes a control module 40 for controlling the laser light source 10 to emit laser light.
在一个具体示例中,球囊30可由硅胶、聚氨酯、镍钛合金材料或其他超弹性材料制成,呈圆锥形或圆柱形。激光光源10中的出光器件可以为半导体激光器、全固态激光器、光纤激光器、气体激光器等,优选为半导体激光器;激光光源10的平均输出功率可调,其平均功率的调节区间可设置为0~20W;控制模块40对于激光光源10的调制方式可以是电流值调节(电流调节精度例如为0.1A),也可以是PWM调制;激光光源10出射的激光可以是连续激光,也可以是非连续激光;激光光源10出射的激光可以是可见光也可以是红外光(包括近红外光和中红外光),激光光源10出射的激光的波长范围为380nm~2100nm。光纤可以为石英光纤、玻璃光纤等;光纤的芯径范围为50微米~500微米;光纤端面可以为平面、圆锥面或多棱锥面等。In one specific example, the balloon 30 may be made of silicone, polyurethane, nitinol material or other superelastic material, and has a conical or cylindrical shape. The light-emitting device in the laser light source 10 can be a semiconductor laser, an all-solid-state laser, a fiber laser, a gas laser, etc., preferably a semiconductor laser; the average output power of the laser light source 10 is adjustable, and the adjustment range of the average power can be set to 0-20W ; The modulation mode of the control module 40 for the laser light source 10 can be current value adjustment (the current adjustment accuracy is, for example, 0.1A), or PWM modulation; the laser light emitted by the laser light source 10 can be a continuous laser or a discontinuous laser; The laser light emitted by the light source 10 may be visible light or infrared light (including near-infrared light and mid-infrared light), and the wavelength range of the laser light emitted by the laser light source 10 is 380 nm˜2100 nm. The optical fiber can be a silica optical fiber, a glass optical fiber, etc.; the core diameter of the optical fiber ranges from 50 microns to 500 microns;
接续前述示例,本实施例提供的支气管哮喘的激光热成形治疗装置用于对增生的气道平滑肌进行热消融,以治疗支气管哮喘。即,上述生物组织为气道平滑肌,球囊30通过患者的鼻腔或口腔进入气道管内而到达气道平滑肌位置时,激光光源10出射的激光经过导管20内的光纤的传输,照射气道平滑肌,以通过热效应实现对气道平滑肌的热消融,从而治疗支气管哮喘。Continuing from the foregoing example, the laser thermoforming device for bronchial asthma provided in this embodiment is used to thermally ablate the proliferated airway smooth muscle to treat bronchial asthma. That is, the above-mentioned biological tissue is airway smooth muscle. When the balloon 30 enters the airway tube through the patient's nasal cavity or oral cavity and reaches the position of the airway smooth muscle, the laser light emitted by the laser light source 10 is transmitted through the optical fiber in the catheter 20 to illuminate the airway smooth muscle. , to achieve thermal ablation of airway smooth muscle through thermal effect, thereby treating bronchial asthma.
在一些实施例中,本实施例提供的支气管哮喘的激光热成形治疗装置还包括用于操控球囊30移动的操控装置50。In some embodiments, the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes a manipulation device 50 for manipulating the movement of the balloon 30 .
接续前述示例,球囊30设置于导管20顶端,导管20为具有弯折度的中空细管(典型的为支气管镜),在操控装置50操控球囊30进入气道时,导管20及其中的光纤也随着球囊30进入气道。其中,光纤的激光输出端除了位于球囊30之中外,也可设置为光纤穿过球囊30而使得光纤的激光输出端位于球囊30的前方。操控装置50例如为手柄或操控杆,也可以是由触控屏实现的触控模块,其可控制球囊30及导管20的移动,包括移动距离(前进距离、后退距离)、移动方向(转弯)等。除了控制球囊30及导管20的移动外,操控装置50还可控制球囊30的张开或闭合,例如,为了进一步提升安全性,可在光纤的激光输出端位于球囊30之中时,操控装置50可在控制球囊30及导管20的移动的过程中控制球囊30闭合,在球囊30到达预定 位置,即使得光纤的激光输出端正对待消融的气道平滑肌时,控制球囊30张开以露出光纤的激光输出端。Continuing the previous example, the balloon 30 is disposed at the top of the catheter 20, and the catheter 20 is a hollow thin tube (typically a bronchoscope) with a degree of bending. The optical fibers also follow the balloon 30 into the airway. The laser output end of the optical fiber is not only located in the balloon 30 , but also can be arranged such that the optical fiber passes through the balloon 30 so that the laser output end of the optical fiber is located in front of the balloon 30 . The control device 50 is, for example, a handle or a joystick, or a touch module implemented by a touch screen, which can control the movement of the balloon 30 and the catheter 20, including the movement distance (forward distance, backward distance), movement direction (turning distance). )Wait. In addition to controlling the movement of the balloon 30 and the catheter 20, the manipulation device 50 can also control the opening or closing of the balloon 30. For example, in order to further improve safety, when the laser output end of the optical fiber is located in the balloon 30, The manipulation device 50 can control the closing of the balloon 30 during the process of controlling the movement of the balloon 30 and the catheter 20, and when the balloon 30 reaches a predetermined position, that is, when the laser output end of the optical fiber is facing the airway smooth muscle to be ablated, the balloon 30 is controlled. Open to expose the laser output end of the fiber.
在一些实施例中,本实施例提供的支气管哮喘的激光热成形治疗装置还包括用于感测生物组织附近温度的温度传感器。由此,可根据温度传感器感测得到的生物组织附近的温度,判断热消融效果,为通过手动或自动控制激光光源10的输出功率以控制热消融的温度提供基础。进一步,温度传感器可采用热电偶温度传感器、铂电阻温度传感器、热敏电阻温度传感器,其中,优选采用热电偶温度传感器或铂电阻温度传感器,其具有高精度和高稳定性等优点,精度为0.1℃左右。接续前述示例,温度传感器用于感测待消融的气道平滑肌附近温度,对于待消融的气道平滑肌,通过热效应实现热消融的设定的目标温度为55℃~65℃之间,采用热电偶温度传感器或铂电阻温度传感器可满足精度等要求。可理解的是,温度传感器可设置于靠近光纤的激光输出端的位置。另外,对于光纤的激光输出端的位于球囊30中的情况,温度传感器也可设置于球囊30的前部外侧,以使得温度传感器更加靠近待消融的气道平滑肌。In some embodiments, the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes a temperature sensor for sensing the temperature near the biological tissue. Therefore, the thermal ablation effect can be determined according to the temperature near the biological tissue sensed by the temperature sensor, which provides a basis for controlling the temperature of thermal ablation by manually or automatically controlling the output power of the laser light source 10 . Further, the temperature sensor can be a thermocouple temperature sensor, a platinum resistance temperature sensor, and a thermistor temperature sensor. Among them, a thermocouple temperature sensor or a platinum resistance temperature sensor is preferably used, which has the advantages of high precision and high stability, and the precision is 0.1 ℃ or so. Continuing from the previous example, the temperature sensor is used to sense the temperature near the airway smooth muscle to be ablated. For the airway smooth muscle to be ablated, the set target temperature for thermal ablation through thermal effect is between 55°C and 65°C, and a thermocouple is used. A temperature sensor or platinum resistance temperature sensor can meet requirements such as accuracy. It can be understood that the temperature sensor may be positioned close to the laser output end of the optical fiber. In addition, for the case where the laser output end of the optical fiber is located in the balloon 30, the temperature sensor can also be arranged outside the front of the balloon 30, so that the temperature sensor is closer to the airway smooth muscle to be ablated.
在一些实施例中,控制模块40,用于根据温度传感器感测的温度,调节激光光源10的输出功率。由此,控制模块40可通过温度传感器感测生物组织附近温度,进行对激光光源10的输出功率的闭环控制,从而更加精确可控地进行对于生物组织的热消融,提升治疗的安全性和有效性,保证治疗效果。In some embodiments, the control module 40 is configured to adjust the output power of the laser light source 10 according to the temperature sensed by the temperature sensor. Therefore, the control module 40 can sense the temperature near the biological tissue through the temperature sensor, and perform closed-loop control of the output power of the laser light source 10, so as to perform thermal ablation of the biological tissue more accurately and controllably, and improve the safety and effectiveness of the treatment. sex, to ensure the therapeutic effect.
在一些实施例中,本实施例提供的支气管哮喘的激光热成形治疗装置还包括用于采集球囊30的前方图像的图像采集器。进一步,图像采集器可以是内窥镜相机或微型相机。由此,可提供内窥画面,实现更精确的移动并可查看对生物组织的热消融效果。接续前述示例,图像采集器为CMOS器件,可设置于球囊30的前部外侧。图像采集器采集的图像,一方面可以用于在通过操控装置50控制球囊30及导管20的移动的过程中实时提供移动位置的画面,以辅助操控,实现更精确的使球囊30移动至待消融的气道平滑肌的位置,进而使得光纤的激光输出端可以更精确得对准待消融的气道平滑肌;另一方面,例如医生等用户还可根据图像采集器采集的图像,查看气道平滑肌的热消融效果,以判断是否要执行加大/减小激光光源的输出功率、延长激光照射时长等操作,从而保证治疗效果。In some embodiments, the laser thermoforming device for bronchial asthma provided in this embodiment further includes an image acquisition device for acquiring an image of the front of the balloon 30 . Further, the image collector may be an endoscopic camera or a miniature camera. As a result, an endoscopic view can be provided, enabling more precise movements and viewing thermal ablation effects on biological tissue. Continuing from the previous example, the image acquisition device is a CMOS device, which can be disposed outside the front of the balloon 30 . On the one hand, the image collected by the image collector can be used to provide a real-time picture of the moving position in the process of controlling the movement of the balloon 30 and the catheter 20 through the manipulation device 50, so as to assist the manipulation and achieve more accurate movement of the balloon 30 to the position of the catheter 20. The position of the airway smooth muscle to be ablated, so that the laser output end of the optical fiber can be more accurately aligned with the airway smooth muscle to be ablated; on the other hand, users such as doctors can also view the airway according to the images collected by the image collector. The thermal ablation effect of smooth muscle can be used to determine whether to increase/decrease the output power of the laser light source, prolong the laser irradiation time, etc., so as to ensure the therapeutic effect.
结合前述示例,控制模块40可响应于输入的控制命令或者基于预设的控制参数,通过信号或者指令控制激光光源10,从而实现对激光光源10的 驱动电流调节,以控制激光光源10出射激光,控制模块40可配备有紧急停止开关和脚踏开关控制器等操作器件;控制模块40还可根据温度传感器实时感测的待消融的气道平滑肌附近的温度值,实现高精度的温度监测,根据上述温度值的变化自动调节激光光源10的驱动电流值或PWM控制信号的占空比,从而控制激光光源10的输出功率,以实现对被激光辐照的支气管内壁的温度的稳定控制(例如设定的目标温度为55℃~65℃之间,通过温度传感器感测的温度值与目标温度的比对,控制激光光源10的输出功率,实现将热消融位置的温度控制在55℃-65℃之间,即激光照射处的气道平滑肌的温度达到最佳治疗温度值);还可根据接收的图像采集器采集的气管内的内窥镜图像,实现对支气管内的气道平滑肌的热消融状态的实时监控。With reference to the foregoing examples, the control module 40 may control the laser light source 10 through signals or instructions in response to an input control command or based on preset control parameters, so as to adjust the driving current of the laser light source 10 to control the laser light source 10 to emit laser light, The control module 40 can be equipped with operating devices such as emergency stop switch and foot switch controller; The change of the above-mentioned temperature value automatically adjusts the driving current value of the laser light source 10 or the duty cycle of the PWM control signal, thereby controlling the output power of the laser light source 10 to achieve stable control of the temperature of the inner wall of the bronchus irradiated by the laser (for example, set The predetermined target temperature is between 55°C and 65°C, and the output power of the laser light source 10 is controlled by comparing the temperature value sensed by the temperature sensor with the target temperature, so that the temperature of the thermal ablation position is controlled at 55°C-65°C between, that is, the temperature of the airway smooth muscle at the place where the laser is irradiated reaches the optimal therapeutic temperature value); the thermal ablation of the airway smooth muscle in the bronchus can also be realized according to the received endoscopic image of the trachea collected by the image collector. Real-time monitoring of status.
在一个具体示例中,温度传感器和图像采集器可分别通过线缆连接控制模块40,这两个线缆可分别设置在导管20内。例如,导管20内设置有光纤、温度传感器的连接线缆和图像采集器的连接线缆,需要说明的是,此种情况下,结合前述示例,可设置光纤的激光输出端位于球囊30开口的中心,球囊30张开后使光纤的激光输出端处于支气管气道中央,便于实现定中,其中,光纤的激光输出端与球囊30可采用一体化设计。In a specific example, the temperature sensor and the image collector may be connected to the control module 40 through cables, respectively, and the two cables may be respectively disposed in the conduit 20 . For example, the catheter 20 is provided with an optical fiber, a connection cable for the temperature sensor, and a connection cable for the image acquisition device. It should be noted that, in this case, in combination with the foregoing examples, the laser output end of the optical fiber can be set at the opening of the balloon 30 After the balloon 30 is opened, the laser output end of the optical fiber is located in the center of the bronchial airway, which is convenient to achieve centering, wherein the laser output end of the optical fiber and the balloon 30 can adopt an integrated design.
在一些实施例中,本实施例提供的支气管哮喘的激光热成形治疗装置还包括显示模块60,用于显示温度传感器感测的温度、图像采集器采集的图像、激光光源10的输出功率、激光照射的时长中的至少之一,还可显示激光光源10的驱动电流值等其他信息。另外,上述温度传感器感测的温度、图像采集器采集的图像、激光光源10的输出功率、激光照射的时长等信息还可存储于存储器中。In some embodiments, the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes a display module 60 for displaying the temperature sensed by the temperature sensor, the image collected by the image collector, the output power of the laser light source 10, the laser At least one of the irradiation durations may also display other information such as the drive current value of the laser light source 10 . In addition, information such as the temperature sensed by the above temperature sensor, the image collected by the image collector, the output power of the laser light source 10, and the duration of laser irradiation can also be stored in the memory.
在一个具体示例中,控制模块40、操控模块50和显示模块60可集成在一终端设备实现,其中,操控模块50和显示模块60可集成于终端设备的触控屏实现,利用控制模块40控制激光光源10开启/关闭,或控制激光光源10的输出功率等参数时也可通过触控屏输入。终端设备可以是各种电子设备,包括但不限于个人电脑、平板电脑、诊疗仪等等。In a specific example, the control module 40, the manipulation module 50 and the display module 60 can be integrated into a terminal device, wherein the manipulation module 50 and the display module 60 can be integrated into the touch screen of the terminal device, and the control module 40 can be used to control the When the laser light source 10 is turned on/off, or parameters such as the output power of the laser light source 10 are controlled, the touch screen can also be used for input. The terminal device can be various electronic devices, including but not limited to personal computers, tablet computers, medical instruments and so on.
在一些实施例中,如图1和2所示,本实施例提供的支气管哮喘的激光热成形治疗装置还包括设置于激光光源10与光纤80之间的光学整形模块70,用于对激光光源10出射的激光进行整形以使得激光的照射光斑呈环状或多瓣状。由此,可提升照射在生物组织上的激光的均匀性,保证治疗效果。In some embodiments, as shown in FIGS. 1 and 2 , the laser thermoforming treatment device for bronchial asthma provided in this embodiment further includes an optical shaping module 70 disposed between the laser light source 10 and the optical fiber 80 , and is used for aligning the laser light source. 10. The outgoing laser light is shaped so that the irradiation spot of the laser light is annular or multi-lobed. As a result, the uniformity of the laser light irradiated on the biological tissue can be improved, and the therapeutic effect can be ensured.
进一步,如图2所示,光学整形模块70包括沿光路依次设置的用于压缩激光的照射光斑尺寸的斜方棱镜组701、用于将激光的照射光斑整形为呈 环状或多瓣状的锥形镜702及用于耦合激光的透镜组703,其中,环状光斑如图3中3-a所示,多瓣状光斑如图3中3-b所示。在一个具体示例中,斜方棱镜组701例如图2所示的一对胶合的斜方棱镜,激光光源10出射的激光经过斜方棱镜组701后光斑尺寸被压缩,被压缩光斑尺寸的激光经过锥形镜702后变为环形光斑的激光,环形光斑的激光经过透镜组703后耦合进入光纤80。其中,斜方棱镜组701、锥形镜702和透镜组703的光学器件的材料可以为光学玻璃、光学树脂材料等。透镜组703可包括锥形透镜或金字塔透镜。Further, as shown in FIG. 2 , the optical shaping module 70 includes a rhombus prism group 701 arranged in sequence along the optical path for compressing the size of the irradiation spot of the laser light, and for shaping the irradiation spot of the laser into an annular or multi-lobed shape. The conical mirror 702 and the lens group 703 for coupling laser light, wherein the annular light spot is shown as 3-a in FIG. 3 , and the multi-lobed light spot is shown as 3-b in FIG. 3 . In a specific example, the rhombus prism group 701 is, for example, a pair of glued rhombus prisms as shown in FIG. 2 . After the laser light emitted from the laser light source 10 passes through the rhombus prism group 701 , the spot size is compressed, and the laser light with the compressed spot size passes through the rhombus prism group 701 . The conical mirror 702 becomes the laser light of the annular spot, and the laser light of the annular spot is coupled into the optical fiber 80 after passing through the lens group 703 . The materials of the optical devices of the rhombus prism group 701 , the conical mirror 702 and the lens group 703 may be optical glass, optical resin material, or the like. Lens group 703 may include conical lenses or pyramid lenses.
另外,斜方棱镜组701也可利用阶梯反射镜替代,即,利用阶梯反射镜进行压缩激光的照射光斑尺寸。In addition, the rhombic prism group 701 can also be replaced by a stepped mirror, that is, the stepped mirror is used to compress the irradiation spot size of the laser light.
接续前述示例,本实施例提供的支气管哮喘的激光热成形治疗装置的工作流程例如:通过导管20,将光纤放入患者支气管内,操作装置40通过操控球囊30,将激光光源10出射的并经光学整形模块70整形后的激光通过光纤传导至支气管患处并实现定中,利用形成的环状光斑或多瓣状光斑对支气管内壁进行照射并产生热效应,从而使增生、肥厚的平滑肌细胞发生凝固、坏死,达到消融气道平滑肌层、降低气道反应性目的,从而达到治疗支气管哮喘的效果。其中,经光学整形模块70整形后的激光形成的是能量均匀分布、无间隙的环状光斑或多瓣形光斑,可完全照射覆盖支气管内壁,不会因为气道平滑肌严重收缩或形变导致无法治疗的情况;激光具有能量高、方向性好、效率高,与生物组织相互作用有显著的热效应等优点,可以在短时间内快速升温。激光的热成形避免了与生物组织接触,不会带来因接触造成的损伤和副作用,安全性更高。Continuing the previous example, the workflow of the laser thermoforming treatment device for bronchial asthma provided in this embodiment is, for example: through the catheter 20, the optical fiber is put into the bronchi of the patient, the operation device 40 controls the balloon 30, and the laser light source 10 is emitted The laser light shaped by the optical shaping module 70 is transmitted to the affected part of the bronchus through the optical fiber to achieve centering, and the formed annular light spot or multi-lobed light spot is used to irradiate the inner wall of the bronchus and generate a thermal effect, thereby coagulating the hyperplasia and hypertrophy smooth muscle cells. , necrosis, to achieve the purpose of ablating the airway smooth muscle layer, reducing airway reactivity, so as to achieve the effect of treating bronchial asthma. Among them, the laser shaped by the optical shaping module 70 forms a ring-shaped light spot or a multi-lobed light spot with uniform energy distribution and no gap, which can completely irradiate and cover the inner wall of the bronchus, and will not be unable to be treated due to severe contraction or deformation of the airway smooth muscle. The laser has the advantages of high energy, good directionality, high efficiency, and significant thermal effect when interacting with biological tissues, and can rapidly heat up in a short time. Laser thermoforming avoids contact with biological tissue, does not cause damage and side effects caused by contact, and is safer.
在另一种描述中,本实施例提供的支气管哮喘的激光热成形治疗装置的操作方法例如:置入导管20→开启激光光源10的低功率模式并引导球囊30和光纤的激光输出端置于患处→开启激光光源10的治疗模式→输出环状光斑照射患处(气道平滑肌),连续操作以对整个支气管进行治疗。其中,局部治疗温度55℃~65℃之间,每一治疗部位(患处)维持时间10秒左右;由远端患处向近端患处移动,重复上面的操作,直至整个治疗过程或者说手术结束。更具体的说,流程包括:患者麻醉后,平躺于手术台,球囊30及导管20通过鼻腔或口腔进入气道管内,如图4所示,此时球囊30是闭合的;通过操作模块50控制球囊30的移动,通过图像采集器实时采集气道内图像并传送至控制模块40,且由显示模块60显示;到达指定病患处后,通过操作模块50球囊30张开,显示模块60显示设置界面;设定消融温度65摄氏 度及时长10s,控制模块40控制激光光源10出射激光,经光学整形模块70整形后由光纤的激光输出端输出,如图5所示,激光照射到气道管壁组织上的光斑为环形光斑。控制模块40根据温度传感器感测的温度值变化调节激光光源10的驱动电流值,达到人体内稳定的温度控制,并且显示模块60显示图像采集器实时采集的被照射的组织的图像,实现对病患组织的热消融。通过操作模块50,移动球囊30,从而使形成的环状光斑到达下一个病患位置,继续进行治疗。In another description, the operation method of the laser thermoforming device for bronchial asthma provided by this embodiment is, for example: inserting the catheter 20 → turning on the low-power mode of the laser light source 10 and guiding the balloon 30 and the laser output end of the optical fiber On the affected area → turn on the treatment mode of the laser light source 10 → output the annular light spot to irradiate the affected area (airway smooth muscle), and operate continuously to treat the entire bronchus. Among them, the local treatment temperature is between 55°C and 65°C, and each treatment part (affected part) is maintained for about 10 seconds; the patient moves from the distal affected part to the proximal affected part, and the above operations are repeated until the entire treatment process or operation is over. More specifically, the process includes: after the patient is anesthetized, lie down on the operating table, the balloon 30 and the catheter 20 enter the airway tube through the nasal cavity or the oral cavity, as shown in FIG. 4 , the balloon 30 is closed at this time; The module 50 controls the movement of the balloon 30, collects images in the airway in real time through the image collector and transmits them to the control module 40, and is displayed by the display module 60; after reaching the designated patient, the balloon 30 is opened through the operation module 50, and the display is displayed. The module 60 displays the setting interface; the ablation temperature is set at 65 degrees Celsius and the duration is 10s, the control module 40 controls the laser light source 10 to emit laser light, which is shaped by the optical shaping module 70 and output from the laser output end of the optical fiber, as shown in FIG. The light spot on the airway wall tissue is an annular light spot. The control module 40 adjusts the driving current value of the laser light source 10 according to the change of the temperature value sensed by the temperature sensor, so as to achieve stable temperature control in the human body, and the display module 60 displays the image of the irradiated tissue collected by the image collector in real time, so as to achieve disease control. Thermal ablation of affected tissue. By operating the module 50, the balloon 30 is moved, so that the formed annular light spot reaches the next patient position, and the treatment is continued.
治疗结束后,通过控制模块40将激光光源10的驱动电流调至0A,以关闭激光光源10;通过操作模块50闭合球囊30,抽出导管20,完成治疗。After the treatment, the driving current of the laser light source 10 is adjusted to 0A by the control module 40 to turn off the laser light source 10; the balloon 30 is closed by the operation module 50, and the catheter 20 is pulled out to complete the treatment.
采用基于蓝光半导体激光器的激光光源的具体实验数据例如表1所示:The specific experimental data of the laser light source based on blue semiconductor laser is shown in Table 1:
表1Table 1
Figure PCTCN2021131616-appb-000001
Figure PCTCN2021131616-appb-000001
基于上述实验数据,可以看出,在使用442nm蓝光半导体激光器照射气管组织时,当功率密度为8.92W/cm 2时,气管组织由初始温度升温至50℃左右需要6s,升温至60℃左右需要10s。 Based on the above experimental data, it can be seen that when 442nm blue light semiconductor laser is used to irradiate tracheal tissue, when the power density is 8.92W/cm 2 , it takes 6s for the tracheal tissue to heat up from the initial temperature to about 50°C, and it takes 6s to heat up to about 60°C. 10s.
在实际治疗过程中,将局部治疗温度控制于55℃~65℃之间,每一部位治疗时间持续10s左右,可从直径3mm以上的气道病患位置由远至近逐一进行,以避免重复或遗漏治疗。与射频热成形术相比,本实施例大幅度缩小了治疗时间,可减轻患者的痛苦和负担。In the actual treatment process, the local treatment temperature is controlled between 55°C and 65°C, and the treatment time for each part lasts about 10s. It can be performed one by one from far to near from the airway patient with a diameter of more than 3 mm to avoid repeated or missed treatment. Compared with radiofrequency thermoplasty, this embodiment greatly shortens the treatment time, which can reduce the pain and burden of the patient.
综上,本实施例提供的支气管哮喘的激光热成形治疗装置,利用激光具有高效率、小型化、低成本、非接触、且与生物组织相互作用有显著的热效应等优点,采用激光作为能量源的热成形术来治疗支气管哮喘等疾病。同时,采用导管、球囊和光纤一体化的方式,以及高精度的温度感测与反馈控制系统,实现了一种操作方便、精确可控、安全有效的“激光热成形术”的治疗支气管哮喘等疾病的装置。To sum up, the laser thermoforming treatment device for bronchial asthma provided in this embodiment utilizes the advantages of high efficiency, miniaturization, low cost, non-contact, and significant thermal effect in interaction with biological tissues, using laser as an energy source. thermoplasty to treat bronchial asthma and other diseases. At the same time, using the integration of catheter, balloon and optical fiber, as well as high-precision temperature sensing and feedback control system, a convenient, precise and controllable, safe and effective "laser thermoplasty" for the treatment of bronchial asthma is realized and other disease devices.
接续前述示例,在用于对增生的气道平滑肌进行热消融时,相比于现有的射频热成形装置,本实施例提供的支气管哮喘的激光热成形治疗装置最突出的优势体现在以下两方面:Continuing from the previous example, when used for thermal ablation of hyperplastic airway smooth muscle, compared with the existing radiofrequency thermoforming device, the most prominent advantages of the laser thermoforming device for bronchial asthma provided in this embodiment are reflected in the following two: aspect:
第一方面、非接触治疗,安全性高:The first aspect, non-contact treatment, has high safety:
本实施例采用的“激光热成形术”是用激光作为能量源,将激光光源出 射的激光耦合入传导光纤,光纤随着导管和球囊进入气管中,光纤的激光输出端出射的激光形成环状光斑或多瓣光斑,实现对支气管内壁的辐照,使得收缩的平滑肌组织吸收光能受热,使平滑肌细胞发生凝固、坏死,达到治疗的目的。这个过程中避免了治疗仪器与人体组织接触,不会带来因接触造成的损伤和副作用,安全性高。The "laser thermoplasty" used in this embodiment uses a laser as an energy source to couple the laser light emitted by the laser light source into a conducting fiber. The fiber enters the trachea along with the catheter and the balloon, and the laser output from the laser output end of the fiber forms a ring. It can irradiate the inner wall of the bronchus, so that the contracted smooth muscle tissue absorbs light energy and is heated, so that the smooth muscle cells coagulate and necrosis, so as to achieve the purpose of treatment. In this process, the contact between the therapeutic instrument and the human tissue is avoided, the damage and side effects caused by the contact will not be caused, and the safety is high.
第二方面、治疗效率高、用时短:The second aspect, the treatment efficiency is high and the time is short:
激光具有能量高、方向性好的等优点,与平滑肌组织相互作用有显著的热效应,可以在短时间内快速升温,治疗效率高。Laser has the advantages of high energy and good directionality, and has a significant thermal effect when interacting with smooth muscle tissue. It can heat up rapidly in a short time, and the treatment efficiency is high.
为了更清楚直观的说明,以表2对本实施例提供的支气管哮喘的激光热成形治疗装置(表2中称为激光热成型术)与现有的射频热成形装置(表2中称为射频热成型术)的效果对比进行展示:For a more clear and intuitive description, the laser thermoforming device for bronchial asthma provided in this example (referred to as laser thermoforming in Table 2) and the existing radio frequency thermoforming device (referred to as radio frequency thermoforming in Table 2) are shown in Table 2. The effect of molding) is compared to show:
表2Table 2
Figure PCTCN2021131616-appb-000002
Figure PCTCN2021131616-appb-000002
在本申请的描述中,需要说明的是,术语“上”、“下”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本申请和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本申请的限制。除非另有明确的规定和限定,术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本申请中的具体含义。In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the application and simplifying the description, Rather than indicating or implying that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, it should not be construed as a limitation on the application. Unless otherwise expressly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection, It can also be an electrical connection; it can be a direct connection, an indirect connection through an intermediate medium, or an internal connection between two components. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific situations.
还需要说明的是,在本申请的描述中,诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来,而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且,术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含,从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素,而且 还包括没有明确列出的其他要素,或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下,由语句“包括一个……”限定的要素,并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。It should also be noted that, in the description of this application, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply these There is no such actual relationship or sequence between entities or operations. Moreover, the terms "comprising", "comprising" or any other variation thereof are intended to encompass a non-exclusive inclusion such that a process, method, article or device that includes a list of elements includes not only those elements, but also includes not explicitly listed or other elements inherent to such a process, method, article or apparatus. Without further limitation, an element qualified by the phrase "comprising a..." does not preclude the presence of additional identical elements in a process, method, article or apparatus that includes the element.
显然,本申请的上述实施例仅仅是为清楚地说明本申请所作的举例,而并非是对本申请的实施方式的限定,对于本领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动,这里无法对所有的实施方式予以穷举,凡是属于本申请的技术方案所引伸出的显而易见的变化或变动仍处于本申请的保护范围之列。Obviously, the above-mentioned embodiments of the present application are only examples for clearly illustrating the present application, rather than limiting the implementation of the present application. Changes or changes in other different forms cannot be exhausted here, and all obvious changes or changes derived from the technical solutions of the present application are still within the scope of protection of the present application.

Claims (10)

  1. 一种支气管哮喘的激光热成形治疗装置,其特征在于,包括:激光光源、导管和设置于所述导管一端的球囊,所述导管内设置有光纤;所述光纤的第一端作为激光输入端,连接所述激光光源;所述光纤的第二端位于所述球囊中,作为激光输出端,用于使所述激光光源出射的激光照射生物组织。A laser thermoforming treatment device for bronchial asthma, characterized in that it comprises: a laser light source, a catheter and a balloon arranged at one end of the catheter, an optical fiber is arranged in the catheter; the first end of the optical fiber is used as a laser input The second end of the optical fiber is located in the balloon, and serves as a laser output end, used for irradiating the biological tissue with the laser light emitted by the laser light source.
  2. 根据权利要求1所述的装置,其特征在于,该装置还包括设置于所述激光光源与所述光纤之间的光学整形模块,用于对所述激光光源出射的激光进行整形以使得所述激光的照射光斑呈环状或多瓣状。The device according to claim 1, characterized in that, the device further comprises an optical shaping module arranged between the laser light source and the optical fiber, for shaping the laser light emitted by the laser light source to make the The irradiation spot of the laser is annular or multi-lobed.
  3. 根据权利要求2所述的装置,其特征在于,所述光学整形模块包括沿光路依次设置的用于压缩激光的照射光斑尺寸第一光学器件、用于将激光的照射光斑整形为呈环状或多瓣状的第二光学器件及用于耦合激光的第三光学器件,其中,第一光学器件为阶梯反射镜或斜方棱镜组,第二光学器件为锥形镜,第三光学器件为锥形透镜或金字塔透镜。The device according to claim 2, wherein the optical shaping module comprises a first optical device arranged in sequence along the optical path for compressing the irradiation spot size of the laser light, and for shaping the irradiation spot of the laser into a ring or A multilobe second optical device and a third optical device for coupling laser light, wherein the first optical device is a stepped mirror or a rhombus prism group, the second optical device is a conical mirror, and the third optical device is a cone shape lens or pyramid lens.
  4. 根据权利要求1所述的装置,其特征在于,该装置还包括用于感测所述生物组织附近温度的温度传感器。The apparatus of claim 1, further comprising a temperature sensor for sensing a temperature near the biological tissue.
  5. 根据权利要求1所述的装置,其特征在于,该装置还包括用于采集所述球囊的前方图像的图像采集器。The device of claim 1, further comprising an image capturer for capturing an image of the front of the balloon.
  6. 根据权利要求1所述的装置,其特征在于,所述激光光源出射的激光的波长范围为380nm~2100nm。The device according to claim 1, wherein the wavelength range of the laser light emitted by the laser light source is 380 nm to 2100 nm.
  7. 根据权利要求4所述的装置,其特征在于,所述温度传感器为热电偶温度传感器或铂电阻温度传感器。The device according to claim 4, wherein the temperature sensor is a thermocouple temperature sensor or a platinum resistance temperature sensor.
  8. 根据权利要求4所述的装置,其特征在于,该装置还包括控制模块,用于根据所述温度传感器感测的温度,调节所述激光光源的输出功率。The device according to claim 4, characterized in that, the device further comprises a control module for adjusting the output power of the laser light source according to the temperature sensed by the temperature sensor.
  9. 根据权利要求1-8中任一项所述的装置,其特征在于,该装置还包括显示模块,用于显示所述温度传感器感测的温度、所述图像采集器采集的图像、所述激光光源的输出功率、激光照射的时长中的至少之一。The device according to any one of claims 1-8, characterized in that, the device further comprises a display module for displaying the temperature sensed by the temperature sensor, the image collected by the image collector, the laser At least one of the output power of the light source and the duration of laser irradiation.
  10. 根据权利要求1所述的装置,其特征在于,该装置还包括用于操控所述球囊移动的操控手柄装置。The device of claim 1, further comprising a manipulation handle device for manipulating the movement of the balloon.
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