WO2018021780A1 - Dispositif de traitement ophtalmique et son procédé de commande - Google Patents

Dispositif de traitement ophtalmique et son procédé de commande Download PDF

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Publication number
WO2018021780A1
WO2018021780A1 PCT/KR2017/007957 KR2017007957W WO2018021780A1 WO 2018021780 A1 WO2018021780 A1 WO 2018021780A1 KR 2017007957 W KR2017007957 W KR 2017007957W WO 2018021780 A1 WO2018021780 A1 WO 2018021780A1
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Prior art keywords
treatment
light
monitoring unit
target position
ophthalmic
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PCT/KR2017/007957
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English (en)
Korean (ko)
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하태호
김종민
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주식회사 루트로닉
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Publication of WO2018021780A1 publication Critical patent/WO2018021780A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/067—Radiation therapy using light using laser light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00844—Feedback systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00855—Calibration of the laser system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00872—Cornea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
    • A61F2009/00891—Glaucoma
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0626—Monitoring, verifying, controlling systems and methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N2005/0635—Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643—Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645—Applicators worn by the patient
    • A61N2005/0647—Applicators worn by the patient the applicator adapted to be worn on the head
    • A61N2005/0648—Applicators worn by the patient the applicator adapted to be worn on the head the light being directed to the eyes

Definitions

  • the present invention relates to an ophthalmic treatment apparatus and a control method thereof, and more particularly, to an ophthalmic treatment apparatus and a control method thereof for detecting the state of the target position during the treatment to control the treatment.
  • Such a treatment device delivers energy to a target location through light to induce a change in the state of the tissue to proceed with treatment.
  • damage occurs not only to the target tissue but also to adjacent tissues, and in particular, may cause damage to eyesight when treating an ocular lesion. Therefore, it is necessary to monitor the treatment status while the treatment is in progress, but there is a limit in detecting minute changes in tissues.
  • the present invention is to solve the above problems, and to provide an optical therapy apparatus and a driving method thereof that can monitor in real time the change of the state inside the tissue of the treatment area during treatment and proceed with the treatment based on this.
  • the setting unit is formed to set the treatment mode, the treatment light irradiation unit for performing treatment by irradiating the treatment light to the target position of the fundus a plurality of times, the treatment light is irradiated And a monitoring unit for monitoring state information of the target location by the treatment light, and whether the treatment intensity according to the treatment mode is reached using the information monitored by the monitoring unit, and based on the treatment light
  • a monitoring unit for monitoring state information of the target location by the treatment light, and whether the treatment intensity according to the treatment mode is reached using the information monitored by the monitoring unit, and based on the treatment light
  • the controller adjusts the parameter of the treatment light when it is determined that the information detected by the monitoring unit does not reach the set treatment intensity, and when it is determined that the set treatment intensity has been reached, the treatment light to the target position. Can be controlled to terminate the survey.
  • the treatment light is irradiated to have a spot size that can deliver energy to a plurality of RPE cells located in the target region, the plurality of RPE cells are a portion of the RPE cells as the treatment is irradiated with a plurality of treatment light
  • the therapeutic light may have a spot size for delivering energy to at least 50 or more RPE cells.
  • the treatment light may have a spot size of 50 ⁇ m or more in the fundus.
  • the monitoring unit may be configured to detect an amount of RPE cells whose state changes by treatment among a plurality of RPE cells disposed at a target location to which the treatment light is irradiated, and monitor the treatment intensity progressed at the target location. .
  • the monitoring unit may be configured using an optoacoustic sensor or a reflectometry sensor.
  • the monitoring unit may include a first monitoring unit composed of an optoacoustic sensor and a second monitoring unit composed of a reflectometry sensor, wherein the first monitoring unit and the second monitoring unit
  • the control may be controlled to terminate the irradiation of the treatment light to the target position.
  • the setting unit is configured to display a plurality of treatment intensities having different values, the user is configured to set the treatment mode by selecting the treatment intensity, or configured to display a plurality of treatment lesions, the user selects the treatment lesion to treat It can be configured to set the mode.
  • the above object of the present invention is to select a treatment intensity through a setting unit, irradiating the treatment light to a target position where a plurality of RPE cells are arranged, state change information of the RPE cells arranged at the target position through a monitoring unit Monitoring the; determining whether the set treatment intensity has been reached based on the monitored information; and if it is determined that the set treatment intensity has not been reached, the energy transmitted per unit area of the target location increases. It can also be achieved by a control method of an ophthalmic treatment device comprising adjusting the treatment light parameters.
  • the present invention provides a treatment light irradiation unit for irradiating the treatment light to a target position located in the fundus a plurality of times, the state information of the target position while the treatment light is irradiated
  • the first monitoring unit for measuring the second monitoring unit
  • the second monitoring unit for measuring the state information of the target position in a second manner different from the first method while the treatment light is irradiated
  • the ophthalmic treatment apparatus may include a controller configured to adjust a parameter of the treatment light or determine whether the treatment light is irradiated based on the information measured by the unit.
  • the first monitoring unit may measure information on the treatment progress state or the treatment end time for the target location
  • the second monitoring unit may measure information on whether an abnormality occurs during the treatment.
  • the present invention by delivering energy to a plurality of RPE cells located in the target region and progressing the treatment, there is an advantage that the treatment intensity can be effectively controlled.
  • FIG. 1 is a schematic diagram schematically showing an ophthalmic treatment device according to a first embodiment of the present invention
  • FIG. 2 is an enlarged cross-sectional view of region A of FIG. 1;
  • FIG. 3 is a block diagram schematically showing the configuration of a second monitoring unit
  • FIG. 4 is a view showing a state in which the treatment light is irradiated to the fundus
  • FIG. 5 is a graph showing the irradiation pattern of the treatment light and the measurement signal according to the monitoring unit
  • FIG. 6 is a view illustrating an example displayed through a display of a setting unit
  • FIG. 8 is a flow chart showing a control method of the ophthalmic treatment device of FIG.
  • FIG. 9 is a flowchart illustrating a control method of an ophthalmic treatment device according to a second embodiment of the present invention.
  • 10 to 12 is a graph showing the irradiation pattern of the treatment light according to the control method of FIG.
  • 13 to 15 are graphs showing another example of adjusting the treatment light parameter
  • 16 is a cross-sectional view showing the treatment of the anterior segment lesions using the present invention.
  • the ophthalmic treatment device described below is described as a device for treating an ocular fundus lesion, but the present invention may be applied to a treatment device for treating a lesion other than the ocular fundus lesion.
  • a treatment device for treating an anterior eye lesion such as glaucoma treatment
  • a treatment device for treating a lesion of skin tissue may be applied to a treatment device for treating a lesion of skin tissue.
  • the present invention is not limited to the ophthalmic treatment device described below, and it can be found that the present invention can be widely applied to a treatment device for optically treating other lesions.
  • the ophthalmic treatment apparatus 1 includes a treatment light generator 10 for generating a treatment beam and an aiming light generator for generating an aiming beam ( 20) and a beam delivery unit 30 forming a progress path of the treatment light and the aiming light.
  • the monitoring unit 40 for detecting the tissue state information of the target location to which the treatment light is irradiated, and a control unit 60 for controlling various components based on the information detected from the monitoring unit.
  • the treatment light generator 10 may include a treatment light source and various optical elements for processing characteristics of light generated by the treatment light source.
  • the treatment light is composed of a laser, and the treatment light source may include a laser medium or a laser diode such as Nd: YAG, Ho: YAG, etc. capable of oscillating the laser.
  • the therapeutic light source is configured to irradiate a laser whose lesion or energy has a suitable wavelength, pulse width, and output, taking into account the characteristics of the tissue at the target location.
  • various electric circuits for generating a laser, an optical filter, and various elements such as a shutter may be included.
  • the aiming light generator 20 generates an aiming beam irradiated to the treatment area.
  • Aim light is a configuration that displays the location so that the operator can determine the location to which the treatment light is irradiated before or while the treatment light is irradiated.
  • the aiming light has a wavelength of a visible light band, and the operator may identify the treatment area by the aiming light reflected from the treatment area.
  • the aiming light generator 20 irradiates the aiming light in the form of a single spot and may irradiate the target light through the same path as the irradiation path of the treatment light. Alternatively, it is also possible to irradiate in the form of a pattern composed of a plurality of spots so as to display a plurality of positions to which the treatment light is irradiated. In addition to this, the collimated light may be irradiated in the form of a lattice or boundary line to indicate an area to which the treatment light is irradiated.
  • the collimator may be omitted.
  • the beam delivery unit 30 is composed of a plurality of optical elements, and constitutes an optical path through which the treatment light travels.
  • the aiming light and the probe beam of the second monitoring unit to be described later may also travel along the beam delivery unit.
  • the optical path of the aiming light and / or the detection light is configured to share at least a part of the optical path of the treatment light, but may be configured to form a separate light path if necessary.
  • the beam delivery unit 30 includes a plurality of beam combiners 31.
  • the treatment light, the aiming light, and the detection light may be irradiated to the treatment area through the beam delivery unit 30 as shown in FIG. 1.
  • the aiming light and the detection light reflected from the treatment area may progress in the direction in which the operator's eyes are located through the beam delivery unit 30, or may be incident again to the second monitoring unit 42.
  • the beam delivery part 30 includes the scanner 32 which changes the position to which light is irradiated.
  • the scanner 32 includes at least one reflective mirror and a driver to rotate the mirror, and the light may change the irradiation position while the rotation position of the reflective mirror on which the light is reflected is changed.
  • the beam delivery unit may further include optical elements such as a plurality of optical lenses and optical filters for focusing or dispersing light.
  • the alternative unit 70 is a configuration in which the eye of the patient to be treated is located, and includes a contact lens in contact with the eye of the patient. Furthermore, it may be configured to include a suction device for inhaling and fixing the eyes of the patient so that the eyes of the patient can be fixed during the procedure.
  • the treatment light irradiator includes the treatment light generator 10 and the beam delivery unit 30, and the treatment light generated by the treatment light generator 10 includes the beam delivery unit 30 and the alternative unit 70. Irradiated to the treatment area of the fundus.
  • the aiming light irradiation unit includes the aiming light generating unit 20 and the beam delivery unit 30, and the aiming light generated by the aiming light generating unit is also provided through the beam delivery unit 30 and the alternative unit 70. Irradiated to the treatment area of the fundus.
  • FIG. 2 is an enlarged cross-sectional view of region A of FIG. 1.
  • 2A is a diagram showing retinal tissue of a patient corresponding to a treatment area.
  • Such retinal tissues are generally internal limiting layer, nerve fiber layer, ganglion cell layer, inner plexiform layer, inner nuclear layer, outer reticular It consists of ten layers of outer plexiform layer, outer nuclear layer, external limiting layer, photoreceptor layer, and RPE layer (retinal pigment epithelial layer) (from retinal surface) Medial depth direction).
  • the RPE cell layer forms a boundary layer in the rear direction among the ten layers above, and is formed in a tight junction structure.
  • a Bruch's membrane is located below the RPE layer.
  • the RPE layer receives nutrients and oxygen from blood vessels located in the choroid to supply nutrients to the photoreceptor, and discharges waste products generated from the photoreceptor through the Bruch membrane.
  • the ophthalmic treatment device irradiates therapeutic light to the RPE cell layer to transfer energy, and induces new RPE cells to regenerate and proceed with treatment.
  • the treatment light generated by the treatment light generator 10 has a wavelength in the visible or near infrared region. Light of this wavelength is transmitted to the cell layer (first to ninth cell layers) located in front of the retina with little absorption, and then absorbed by melanosomes inside the RPE cells of the RPE cell layer.
  • the RPE cells change state with increasing temperature, whereby the changed RPE cells are replaced with healthy RPE cells. It is interpreted that as the temperature rises, micro bubbles are generated on the surface of the melanosome, and the RPE cells are selectively necrotic as the micro bubbles are gradually grown.
  • the ophthalmic treatment device of FIG. 1 includes a monitoring unit 40, and monitors the change in the state of the tissue during treatment through the monitoring unit to check the progress of the treatment in real time.
  • the monitoring unit 40 of the present embodiment may include a plurality of monitoring units 41 and 42 that independently perform the monitoring operation.
  • the monitoring unit 40 may include a first monitoring unit 41 and a second monitoring unit 42.
  • the first monitoring unit 41 may measure state information of the target location in a first manner
  • the second monitoring unit 42 may measure state information of the target location in a second manner. That is, the first monitoring unit 41 and the second monitoring unit 42 can compensate for the shortcomings of the respective measuring methods by monitoring the state information of the target position in different ways.
  • the first monitoring unit 41 may be configured by using an optoacoustic sensor.
  • Optoacoustic sensors are devices that measure acoustic signals generated by light absorption.
  • RPE cells at the target site absorb the treatment light and change state, and an acoustic signal is generated during this process. This acoustic signal is determined to occur in the process of generating microbubbles as the temperature of the RPE cells rises.
  • the first monitoring unit 41 measures this to measure the state change of the target position and the treatment progress.
  • the first monitoring unit 41 of the present embodiment may be installed in the contact lens of the alternative unit 70 to measure an acoustic signal transmitted from the patient's eye while in contact with the patient's eye.
  • the first monitoring unit is configured as a separate device from the contact lens, and may be installed to be in contact with the eye of the patient or an area adjacent to the eye.
  • the second monitoring unit 42 may be configured as a reflectometry sensor.
  • the second monitoring unit 42 may receive the reflected light reflected at the target location and analyze the reflected light to determine state information of the target location included in the reflected light. Thereby, it is possible to measure whether the state of the target position changes and the progress of treatment.
  • the second monitoring unit 42 of the present embodiment receives the light to which the treatment light irradiated to the target position is reflected. As shown in FIG. 2, a part of the treatment light irradiated to the target position is absorbed at the target position, and part is reflected and received by the sensor of the second monitoring unit 42 through the beam combiner 31.
  • the second monitoring unit 42 analyzes the parameter of the received reflected light and monitors state information of the target position. For example, as the microbubbles are generated in the RPE cells by the treatment light, the signal by the reflected light increases the frequency component of the 5 ⁇ 50MHz band, the second monitoring unit 42 is based on the state of the target position Measure changes and progress of treatment. However, various parameters may be used in addition to the frequency components included in the reflected light.
  • the second monitoring unit 42 monitors using the reflected treatment light, there is an advantage in that the change in the target position by each treatment light can be monitored in real time.
  • this is an example, and instead of receiving the treatment light, it is also possible to irradiate a separate detection light for monitoring to the target position, and to receive the detection light reflected from the target position to perform the monitoring.
  • the first monitoring unit of the present embodiment is composed of a photoacoustic sensor, and the second monitoring unit is configured using a reflectometer sensor.
  • the first monitoring unit or the second monitoring unit may be configured as an interferometry sensor instead of a reflectometry sensor.
  • FIG. 3 is a block diagram schematically illustrating a configuration of a second monitoring unit according to another example.
  • the second monitoring unit is configured as an interferometer sensor such as an OCT device
  • the second monitoring unit may use the interference information of the reflected light reflected from the target position.
  • various tomographic information including the temperature information of a target position, a state change, and a progress of treatment can be acquired.
  • the conventional OCT apparatus acquires a tomography image of a predetermined area while moving the irradiation position in the horizontal direction (relative to the retina plane of the fundus)
  • the second monitoring unit 142 of FIG While the process, tomographic information of the target position is acquired a plurality of times or continuously.
  • the interference information detected by the second monitoring unit 142 may change, and the change of the state of the target location may be detected by using the change.
  • the second monitoring unit 142 configured as an interferometer sensor includes a detection light source 143, a light splitter 144, a reference light reflector 145, and a detector 146. It is configured to include).
  • the detection light source 143 may be a light source for generating a low coherent beam in the case of the SD OCT, and may use a swept source light source capable of changing the wavelength of light in the case of the SS OCT.
  • the light emitted from the detection light source 143 passes through the light splitter 144 and is split into two lights, the detection light and the reference light.
  • the reference light travels along the first path P1 to reach the reference light reflector 145 and is then reflected by the reference light reflector 145.
  • the detection light travels along the second path P2, is irradiated to the target position through the beam delivery unit 30, and then is reflected at the target position.
  • the reflected detection light and the reference light are combined in the light splitter 144 again and proceed to the detector 146.
  • the detector 146 detects the state information of the target location by using the interference information by the received detection light and the reference light.
  • the detector 146 may be configured using an array detector in case of SD OCT, and may be configured using a photo diode in case of SS OCT.
  • the second monitoring unit 142 of FIG. 3 uses the interference information of the detection light by the interferometer to include a tissue including a temperature rise at a target location, a thickness change of a tissue, a change in refractive index, a movement of a tissue, and an abnormality occurrence. It is possible to grasp the microscopic state change.
  • FIG. 3 an example in which the second monitoring unit is replaced with the interferometer sensor has been described.
  • the monitoring unit may be configured by using the interferometer sensor and the reflectometer sensor by replacing the first monitoring sensor with the interferometer sensor.
  • the first monitoring unit 41 and the second monitoring unit 42 each measure a change in state of the target position in different ways, and transmit this information to the control unit 60.
  • the controller 60 may control the operation content of the treatment apparatus based on the information measured by the first monitoring unit 41 and the second monitoring unit 42.
  • the controller 60 is configured to control the operation of various components including the treatment light generator 10, the aiming light generator 20, and the beam delivery unit 30. Thereby, the treatment position, treatment time, parameters of treatment light, etc. can be variously controlled. In performing such control, the controller 60 controls various components in consideration of the information monitored by the above-described monitoring unit 40.
  • the controller 60 controls to irradiate the treatment light to the same target position a plurality of times while the treatment is performed for one target position. During this process, if it is detected that the treatment is not progressed at the treatment intensity set through the monitoring unit 40, the controller controls the treatment light irradiation unit to adjust the treatment light parameters. At this time, the parameter of the treatment light is adjusted to increase the energy delivered per unit area of the target position. For example, the controller 60 may control to sequentially increase the output of the treatment light until the treatment is finished. On the other hand, if it is detected through the monitoring unit that the treatment progresses to the set treatment intensity, the control unit 60 may terminate the treatment of the target position by terminating the irradiation of the treatment light to the target position. The control contents of the controller will be described in more detail below.
  • the controller 60 may utilize the information measured by the first monitoring unit 41 and the second monitoring unit 42 in various ways. For example, when the information measured by the first monitoring unit and the second monitoring unit both satisfy the first condition, it may be determined that the state of the target location has reached the first condition and perform the corresponding control. have. Alternatively, the state information of the target location is determined based on the information measured by either the first monitoring unit or the second monitoring unit, and when it is determined that the reliability of the target information is unsatisfactory due to an unexpected event, It is also possible to configure the status information by using the information measured in the other.
  • the controller 60 of the present embodiment determines that the treatment of the target position is finished and treats the corresponding position.
  • the irradiation of light is terminated.
  • a state in which microbubbles or the like change in state generates a sound wave signal, or a light path changes or scattered light occurs due to cell expansion or damage.
  • the sound wave signal strength may be weak, or the optical change may be minute (for example, when there is substantially no change in the optical path or the size of the reflected scattered light).
  • the present embodiment can detect a change of state in different ways to determine when to end treatment, thereby preventing excessive energy from being delivered to the target location and damaging the tissue.
  • Figure 4 is a view showing a state that the treatment light is irradiated to the fundus.
  • the size of the spot of the treatment light irradiated to the target position may be formed such that the plurality of RPE cells C is located inside the boundary S of the spot based on the RPE cell layer. Therefore, while the treatment is performed for one target position, energy is delivered to the plurality of RPE cells positioned at the target position, and the treatment proceeds, and the monitoring unit 40 detects the state change of the plurality of RPE cells. The progress of the treatment can be monitored.
  • RPE cells exposed to therapeutic light either retain existing RPE cells if not enough energy is delivered, or regenerate into new RPE cells with state changes when sufficient energy is delivered.
  • one RPE cell follows one of two processes when irradiating the therapeutic light, and thus, when the spot size of the therapeutic light is focused on only one RPE cell, it is difficult to control the treatment intensity.
  • the treatment intensity can be adjusted by controlling the amount of RPE cells whose state changes by treatment among the plurality of RPE cells. . Therefore, according to the present embodiment, it is possible to proceed the treatment at the optimal treatment intensity according to the lesion, the treatment position, and the condition of the patient.
  • the spot size of the treatment light delivers energy to only one RPE cell, it is possible to adjust the treatment intensity in a manner that adjusts the interval of target positions to which the treatment light is irradiated.
  • the treatment time increases.
  • the size of RPE cells varies depending on the position of the retina (for example, the diameter of RPE cells at the center of the fundus is 10-15 ⁇ m, and the diameter of RPE cells at the periphery of the fundus is 50 ⁇ m or more).
  • additional considerations need to be taken into consideration, such as adjusting an interval between target positions according to the position of the treatment area.
  • the spot size (S) of the treatment light can be configured such that 10 to 1000 RPE cells (C) are located inside the boundary of the spot, based on the area irradiated to the RPE cells, preferably 50 to 500 Can be configured to position RPE cells (C).
  • the spot size S of the treatment light may be configured to have a diameter of 50 ⁇ m to 1000 ⁇ m.
  • the spot size of the treatment light can be configured to have a diameter of 100 ⁇ m to 400 ⁇ m. Furthermore, the spot size may be adjusted according to the position of the treatment area. For example, when the treatment area is located inside the fundus, the diameter of the spot may be controlled to 150 to 200 ⁇ m, and when the treatment area is located to the periphery of the fundus, the diameter of the spot may be controlled to 250 to 350 ⁇ m.
  • the monitoring unit 40 monitors the progress of treatment at the target position in real time.
  • the monitoring unit 40 monitors the progress of the treatment by detecting the amount or the ratio of the RPE cells in which the state change among the plurality of RPE cells in the region, and the control unit 60 proceeds to the target location based on the treatment intensity Can be determined.
  • the treatment light irradiation unit irradiates the treatment light to the target position a plurality of times, each treatment light is irradiated so that the output is sequentially increased.
  • the signal measured by the monitoring unit may appear as a graph shown in the lower side of FIG. 5 (showing a signal measured by the first monitoring unit of the monitoring unit for convenience of description).
  • the monitoring unit 40 detects a measured value equal to or less than the effective value.
  • the measured value detected in this section is the noise value detected in the steady state. Therefore, the controller 60 determines that the state change of the RPE cells does not occur while the measured value below the effective value is detected.
  • the monitoring unit 40 detects a measured value of more than an effective value, and the control unit 60 determines that some RPE cells of the target position have started to change state. .
  • the sixth treatment light T6 and the seventh treatment light T7 are irradiated, the value measured by the monitoring unit 40 also gradually increases, and the control unit 60 gradually changes the state of the RPE cells. I think it will increase.
  • the treatment intensity may be determined by the amount or ratio of the RPE cells whose state is changed among the plurality of RPE cells located at the target position.
  • the controller 60 may determine the treatment intensity by matching the data measured by the monitoring unit 40 with the previously stored data by referring to the data previously stored in the memory. As such, the controller 60 may determine in real time the progress of the treatment proceeding to the target position while the treatment light is irradiated. When the value measured by the monitoring unit 40 exceeds the value corresponding to the preset treatment intensity (measured value by T7 of FIG. 5), it is determined that the treatment is performed at the target set intensity at the corresponding position. End the treatment for that location.
  • the ophthalmic treatment device 1 may further include a setting unit 80 for the user to select a treatment mode.
  • the setting unit 80 includes a display and an operation button that can be operated by the user.
  • Each of the selected treatment modes includes information on treatment intensity, and may also include information on various parameters such as the irradiation pattern of the treatment light. Therefore, when the user selects the treatment mode through the setting unit 80, the controller 60 controls each component to proceed with the corresponding treatment based on this.
  • the setting unit 80 of FIG. 6 is a treatment mode and is configured to select treatment intensity for each target position.
  • the treatment intensity may be expressed as the ratio of RPE cells whose status changes by treatment among a plurality of RPE cells located at a target position.
  • ASV 20 (auto-set value 20) refers to the therapeutic intensity at which about 20% of the RPE cells change state among the RPE cells at the corresponding position
  • ASV 50 refers to the therapeutic intensity at which about 50% of the RPE cells change state. Means.
  • FIG. 7 illustrates another example displayed through the display of the setting unit.
  • the name of the lesion to be treated is displayed as a treatment mode.
  • fundus fundus lesions such as central serous chorioretinopathy (CSC), diabetic macular edema (DME), and dry age-related macular degeneration (Dry AMD).
  • CSC central serous chorioretinopathy
  • DME diabetic macular edema
  • Dry AMD dry age-related macular degeneration
  • the treatment mode of FIG. 7 may also include information about different treatment intensities. For example, as a result of clinical trials, CSCs showed that RPE cells were relatively healthy and could be treated with low therapeutic intensity, while DME had poor condition of RPE cells and had to be treated with high therapeutic intensity. Dry AMD has been shown to be curable with higher therapeutic strength than CSC and lower than DME. Therefore, when the user selects a treatment mode using the treatment lesion, the treatment is set to proceed according to the treatment intensity suitable for the lesion.
  • the treatment intensity when the CSC mode is selected, the treatment intensity may be set in the range of ASV 20 to 40, when the Dry AMD mode is selected, the treatment intensity may be set in the range of ASV 40 to 60, and the DME mode When is selected the treatment intensity can be set in the range of ASV 60 to 80.
  • the level of treatment intensity for each lesion is divided into high, medium, and low to further increase the treatment intensity within the range of treatment intensity according to each lesion. Can be set finely.
  • the ophthalmic treatment device 1 of the present embodiment is configured to irradiate the plurality of RPE cells with the spot size of the treatment light, and may proceed with treatment at various treatment intensities according to the user's selection.
  • the monitoring unit 40 may monitor the state information of the target location in different ways by using the plurality of monitoring units 41 and 42, thereby enabling safe and optimized treatment.
  • FIG. 8 is a flow chart illustrating a control method of the ophthalmic treatment device of FIG.
  • the control method of the ophthalmic treatment apparatus 1 described above will be described in detail.
  • the front part of the patient is fixed to the alternative part 70 and the treatment is performed.
  • the treatment is performed by irradiating the treatment light to a plurality of target positions distributed in the treatment area to proceed with the treatment.
  • the treatment is performed by irradiating a plurality of treatment lights to one target position, and when treatment of the target position is completed, the treatment is performed by changing the treatment light irradiation position to the next target position.
  • FIG. 8 for convenience of description, the process of treating the initial target position will be described.
  • the user selects the treatment mode through the setting unit 80 (S10), and the information about the selected treatment mode is transmitted to the controller 60.
  • the control unit 60 irradiates the treatment light by driving the treatment light irradiation unit based on the selected treatment mode (S20).
  • the monitoring unit 40 monitors the state information of the target location.
  • the first monitoring unit 41 and the second monitoring unit 42 each independently monitor the status information of the target position.
  • the control unit 60 determines whether the treatment has proceeded at the set treatment intensity based on the information monitored by the first monitoring unit 41 (S30). In addition, based on the information monitored by the second monitoring unit 42, it is determined whether or not the treatment has proceeded at the set treatment intensity (S40).
  • S30 the determination step S30 using the first monitoring unit and the determination step S40 using the second monitoring unit are performed sequentially, but are not limited thereto.
  • the two steps S30 and S40 may be simultaneously performed in cycles corresponding to the irradiation period of the treatment light, or may be continuously performed while the treatment is in progress.
  • the controller 60 determines that the treatment of the target position is not completed. Determine and adjust the parameters of the treatment light (S50).
  • the treatment light parameter is adjusted to sequentially increase the energy transmitted per unit area of the target position by the treatment light, for example, it is possible to increase the size of the output of the treatment light among the parameters. Thereafter, the controller 60 irradiates the treatment light having the adjusted parameter to the target position, and repeats the above-described steps.
  • the control unit 60 determines that treatment of the corresponding target position is performed. Judging by completion. Therefore, the irradiation of the treatment light to the target position is terminated (S60), the irradiation position of the treatment light is changed to another target position, and the aforementioned steps (S20 to S70) are repeated to proceed with the treatment.
  • FIGS. 9 to 12 an ophthalmic treatment apparatus and a control method thereof according to a second embodiment of the present invention will be described with reference to FIGS. 9 to 12.
  • the same or similar configuration and steps as the first embodiment described above are replaced with the drawings and the description of the first embodiment to avoid duplication of description.
  • the monitoring unit of the first embodiment described above used both the first monitoring unit and the second monitoring unit for the purpose of monitoring the progress of treatment.
  • the information measured in each monitoring unit can be used for control of different purposes.
  • the first monitoring unit 41 is configured to receive a sound wave signal generated from the target position, convert it into an electrical signal, and transmit the converted signal to the control unit 60. It has a relatively quick advantage.
  • the information detected by the first monitoring unit 41 may also include a signal due to a separate event occurring at a location other than the target location, which has a disadvantage of relatively low accuracy.
  • the second monitoring unit 42 since the second monitoring unit 42 uses the reflected light reflected from the target position, the second monitoring unit 42 has an advantage of accurately determining the state information of the target position compared to the first monitoring unit.
  • the second monitoring unit 41 undergoes various calculation processes to detect the parameter change of the reflected light, the operation speed is slower than that of the first monitoring unit (in particular, as shown in FIG.
  • the processing speed is relatively delayed because the interference signal is analyzed through complex calculation process such as Fourier transform.
  • the ophthalmic treatment device of the present embodiment in consideration of the rapid calculation speed of the first monitoring unit 41, the information detected by the first monitoring unit 41, the treatment progress state or the treatment end point for the target position Can be used to determine In addition, in consideration of the accuracy of the second monitoring unit 42, the information detected by the second monitoring unit 42 may be used to determine whether an odd event occurs during treatment.
  • the controller 60 may proceed with the treatment based on the information measured by the first monitoring unit 41 (for example, whether microbubbles have started to occur among the RPE cells at the target location, and among the RPE cells at the target location). The percentage of RPE cells in which microbubbles have occurred, etc.) and the end of treatment.
  • the end point of treatment may be determined based on whether a value measured by the first monitoring unit (hereinafter, referred to as a first measurement value) reaches a predetermined first reference value (a value corresponding to the set treatment intensity). If it is determined that the treatment is completed, the controller may stop irradiating the treatment light to the corresponding target position and change the irradiation position of the treatment light to another target position to proceed with the treatment.
  • the first monitoring unit may grasp the change in the state of the target position by each treatment light in real time through a quick calculation and use it for control.
  • the second monitoring unit 42 may continuously monitor whether or not an abnormality occurs at the target position while the treatment is in progress.
  • the abnormal occurrence may include various events.
  • abnormalities may occur in retinal surface tissues, and the like.
  • the second monitoring unit 42 can obtain highly accurate information on the target position (particularly, when the second monitoring unit is configured as an interferometer sensor as shown in FIG. 3, the tissue of another depth as well as the RPE cell layer of the target position can be obtained. To identify events that occur in. Therefore, the controller 60 uses the information measured by the second monitoring unit 42 to determine whether the measured value (hereinafter, the second measured value) is greater than the second reference value (the value corresponding to the occurrence of the abnormality). It can be judged that it occurred.
  • the second measured value the measured value
  • the second reference value the value corresponding to the occurrence of the abnormality
  • the second measured value may be variously processed values from the information obtained by the second monitoring unit.
  • the second reference value may be a value itself obtained by the second monitoring unit.
  • the second monitoring unit may be a difference value from the previously measured value.
  • the controller 60 may control to immediately stop the treatment light irradiation irrespective of the information measured by the first monitoring unit 41. have. In addition, this may be displayed to the outside through a separate indicating unit 90 (see FIG. 1) to inform the user of an abnormality.
  • FIG. 9 is a flowchart illustrating a control method of an ophthalmic treatment device according to a second embodiment of the present invention.
  • the control method of the ophthalmic treatment apparatus 1 described above will be described in detail.
  • the treatment mode is selected (S110) and the treatment light is irradiated to the target position (S120).
  • the first monitoring unit 41 and the second monitoring unit 42 monitor state information of the target location (S130).
  • the monitoring step S130 is shown to be performed after the treatment light step S120, but is not limited to this order, and may be continuously performed while the treatment is in progress.
  • the controller 60 determines that the treatment of the target position is not completed and adjusts the parameter of the treatment light ( S140). For example, the size of the output of the treatment light among the parameters may be increased. Thereafter, the controller 60 controls the treatment light irradiation unit to irradiate the treatment light having the adjusted parameter to the target position (S120). Then, while the first measured value is lower than the first reference value, steps S120 to S140 are repeatedly performed, whereby the treatment light is irradiated to the target position a plurality of times.
  • the controller 60 determines that the treatment of the corresponding target position is completed. Therefore, the irradiation of the treatment light to the target position is terminated (S150), the treatment light irradiation position is changed to another target position, and the above-described steps are repeated to proceed with the treatment.
  • the second monitoring unit 42 continuously monitors whether or not an abnormality occurs, and when the second measurement value measured by the second monitoring unit 42 is smaller than the second reference value, and according to S120 to S160. Perform the steps.
  • the controller 60 determines that an abnormality has occurred and stops the treatment of the target position by immediately stopping the treatment light irradiation ( S170). This step is performed immediately after detecting whether an abnormality occurs, regardless of whether the first measured value is higher or lower than the first reference value. Then, the controller 60 displays the fact that the abnormality occurred to the user through the notification unit 90 (S180).
  • 10 to 12 are graphs showing the irradiation pattern of the treatment light according to the control method of FIG.
  • FIG. 10 it is detected that microbubbles are generated in RPE cells at a target position when the fifth treatment light is irradiated (ASV 0). Whether the fine bubbles are generated is determined based on the first measurement value measured by the first monitoring unit. As described above, when the first measured value is less than or equal to the effective value, it is determined that there is no change of state in which bubbles are generated in the RPE cells.
  • the controller 60 may determine, in real time, the specific gravity of the RPE cells in which the state change occurs in the RPE cells at the target location based on the first measured value measured in real time.
  • the controller 60 determines that the treatment is completed at the corresponding target position and stops irradiation of the treatment light. have.
  • FIG. 10 illustrates a case where an abnormal occurrence is not detected during treatment
  • FIG. 11 illustrates a case where an abnormal occurrence is detected during treatment.
  • FIG. 11 illustrates a case where an abnormal occurrence is detected through the second monitoring unit 42 at the time when the seventh treatment light is irradiated. In this case, the control unit immediately stops the treatment light irradiation and terminates the treatment at the time when the abnormality is detected.
  • Figures 10 and 11 in adjusting the parameters of the treatment light the output of the treatment light is adjusted to be ramped to the same magnitude.
  • this is an example.
  • FIG. 12 when bubbles are detected and the end point of treatment is determined to be close, it is possible to adjust the size of the output of the treatment light to be smaller than before the fine bubbles are detected.
  • 5 and 10 to 12 illustrate a method of increasing the output of the treatment light in controlling the parameter of the treatment light.
  • this is one example, and it is also possible to adjust other parameters other than the output so that the amount of energy delivered per unit area by the treatment light can be increased.
  • 13 to 15 are graphs showing another example of adjusting the treatment light parameter.
  • the treatment light generator generates treatment light having the same pulse duration time, but may adjust the parameter in such a manner as to gradually reduce the off time between the treatment lights.
  • a treatment light pulse having the same output may be generated, but the parameter may be adjusted so that the pulse duration of each treatment light gradually increases.
  • the treatment light is irradiated so that each treatment light includes a plurality of unit pulses Pu, and the parameter may be adjusted to sequentially increase the number of unit pulses constituting each treatment light. .
  • the present invention may be configured to be applicable to various ocular diseases by using as a target position various tissues in the eye as well as fundus lesions.
  • the present invention may be applied to a treatment apparatus for treating glaucoma in the anterior eye and a control method thereof, which will be described below with reference to FIG. 16.
  • Glaucoma is a lesion in which the optic nerve is damaged by an increase in intraocular pressure, and treatment is performed in such a manner as to maintain a proper intraocular pressure by securing a path through which intraocular fluid is discharged.
  • the ophthalmic treatment device according to the present invention can improve the characteristics of the fluid discharged by irradiating the treatment light on the trabecualr meshwork (TM) tissue located under the rimbus of the anterior eye. .
  • the ophthalmic treatment device proceeds to treatment using a treatment light of a wavelength selectively absorbed by the melanosome, similarly to the device for treating the ocular fundus lesion.
  • the trabecualr meshwork cell (TM cell) constituting the fibrotic tissue includes pigment components such as melanosomes, like RPE cells. Therefore, as the treatment light is irradiated, energy is transmitted to the cells of the fibrous stem tissue, thereby thermally damaging the fibrous stem cells and securing a discharge path of the fluid to maintain the intraocular pressure normally.
  • the ophthalmic treatment apparatus for treating the ocular fundus lesion is delivered to the plurality of RPE cells arranged at the target position using the retina as a target position, and the treatment is performed.
  • the treatment is performed by transferring energy to a plurality of fibrous stem cells arranged at the target position using the fibrous stem tissue as a target position.
  • the alternative portion 70 of the ophthalmic treatment device comprises a contact lens including a reflective member.
  • the paths of various light including the treatment light are irradiated to the fibrous stem tissue that is the target position through the reflective member, and the reflected light reflected from the target position can also enter the beam delivery portion of the ophthalmic treatment apparatus through the reflective member 71. have.
  • various control contents including the configuration and operation of the ophthalmic treatment device described in the above embodiments may be applied to the ophthalmic treatment device of FIG. 16. Therefore, during the treatment of glaucoma, the treatment intensity can be effectively controlled while irradiating the treatment light to a plurality of fibrotic stem cells, and the optimal treatment can be proceeded, and the monitoring unit monitors the status information in different ways to effectively check the status information. At the same time, it is possible to realize the advantage of stopping in an emergency.
  • the ophthalmic treatment device comprising two monitoring units and a control method thereof have been described in detail.
  • the above-described embodiment is a simplified description of the invention for the convenience of description, and of course, it can be modified in various ways.

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Abstract

La présente invention concerne un dispositif de traitement ophtalmique et son procédé de commande, le dispositif de traitement ophtalmique comprenant : une unité de réglage formée pour établir un mode de traitement ; une unité d'irradiation de lumière de traitement pour irradier un emplacement cible du fond de l'œil une pluralité de fois avec une lumière de traitement pour effectuer un traitement ; une unité de surveillance avec laquelle des informations d'état de l'emplacement cible sont surveillées au moyen de la lumière de traitement, pendant que la lumière de traitement est irradiée ; une unité de commande pour déterminer si une intensité de traitement selon le mode de traitement est atteinte à l'aide des informations surveillées par l'intermédiaire de l'unité de surveillance et, sur la base de cette détermination, pour commander un fonctionnement de l'unité d'irradiation de la lumière de traitement.
PCT/KR2017/007957 2016-07-27 2017-07-24 Dispositif de traitement ophtalmique et son procédé de commande WO2018021780A1 (fr)

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WO2021048723A1 (fr) * 2019-09-12 2021-03-18 Belkin Laser Ltd. Stimulation laser sélective de cellules souches cornéennes
WO2022130137A1 (fr) * 2020-12-16 2022-06-23 Alcon Inc. Réglage d'impulsions laser pour compenser des objets interférents
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KR102191632B1 (ko) * 2019-02-08 2020-12-16 주식회사 루트로닉 안과용 치료장치 및 이의 제어방법
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KR102577406B1 (ko) * 2021-02-25 2023-09-12 부산대학교 산학협력단 적응광학 기반의 초고해상도 인공시각 장치 및 그 동작 방법

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