WO2019203373A1 - Appareil de traitement ophtalmique et son procédé de commande - Google Patents

Appareil de traitement ophtalmique et son procédé de commande Download PDF

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Publication number
WO2019203373A1
WO2019203373A1 PCT/KR2018/004511 KR2018004511W WO2019203373A1 WO 2019203373 A1 WO2019203373 A1 WO 2019203373A1 KR 2018004511 W KR2018004511 W KR 2018004511W WO 2019203373 A1 WO2019203373 A1 WO 2019203373A1
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Prior art keywords
treatment
intensity
treatment light
light
irradiated
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PCT/KR2018/004511
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English (en)
Korean (ko)
Inventor
김종민
노영정
박영근
장동진
Original Assignee
주식회사 루트로닉
가톨릭대학교 산학협력단
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Publication of WO2019203373A1 publication Critical patent/WO2019203373A1/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/12Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for looking at the eye fundus, e.g. ophthalmoscopes
    • A61B3/1241Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for looking at the eye fundus, e.g. ophthalmoscopes specially adapted for observation of ocular blood flow, e.g. by fluorescein angiography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F2009/00844Feedback systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F9/00Methods 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
    • A61F9/007Methods or devices for eye surgery
    • A61F9/008Methods or devices for eye surgery using laser
    • A61F2009/00878Planning

Definitions

  • the present invention relates to an ophthalmic treatment device and a control method thereof, and more particularly, to an ophthalmic treatment device and a control method thereof for detecting the condition of the target tissue during the treatment process to control the treatment.
  • This treatment device irradiates the laser to the target tissue to deliver energy, thereby inducing a change in the state of the tissue.
  • damage may occur to adjacent tissues, and in particular, when treating an ophthalmic lesion, visual damage may occur, which may be fatal.
  • the treatment is not made properly. Therefore, there is a need for a technique for precisely monitoring the condition of the target tissue during treatment so as to prevent unnecessary damage and proceed with appropriate treatment.
  • An object of the present invention is to provide an ophthalmic treatment apparatus and a control method thereof that can monitor a change in the state of a treatment area in real time during treatment and proceed with the treatment based on this.
  • the treatment light irradiation unit for irradiating the treatment light having a pattern consisting of a plurality of micro pulses of increasing intensity sequentially to the treatment position of the eye tissue, while the treatment light is irradiated
  • the monitoring unit for monitoring the state information of the treatment position by the treatment light, the irradiation of the treatment light to the treatment position is automatically stopped when it is detected that a target state change has occurred in the treatment position based on the monitored state information.
  • An ophthalmic treatment comprising a control unit configured to control the control unit, a guide unit for guiding a user to determine whether the treatment intensity is suitable based on a time point at which a state change of the treatment position is detected, and a setting unit for adjusting the treatment intensity by the user.
  • a control unit configured to control the control unit
  • a guide unit for guiding a user to determine whether the treatment intensity is suitable based on a time point at which a state change of the treatment position is detected
  • a setting unit for adjusting the treatment intensity by the user.
  • the guide unit may guide the user whether the treatment intensity is appropriate based on the number of micro pulses previously irradiated until the treatment light irradiation is automatically stopped.
  • the treatment light is set to emit micro pulses N times at one treatment position
  • the guide unit may increase the treatment intensity if the micro pulses irradiated until the treatment light is automatically stopped are n1 or more times n2 or less. If it is indicated as appropriate and the micropulse irradiated until the treatment light is automatically stopped is less than n1 times, the guide portion indicates that the treatment intensity is excessive and the irradiated micropulse is detected until the treatment light is automatically stopped. When n2 times is exceeded, the guide part may indicate that the treatment strength is weak.
  • the setting unit is configured to allow the user to adjust the intensity of the micro pulse having the maximum intensity, if the intensity of the micro pulse having the maximum intensity is adjusted, the intensity of the remaining micro pulses is also adjusted in a predetermined manner so that the treatment intensity is It can be configured to be adjusted.
  • the initial intensity of the micro pulse having the maximum intensity may be a minimum intensity value at which leakage is observed in the RPE region through fluorescein angiography when the micro pulse is irradiated to the test region.
  • the monitoring unit may include a first monitoring unit and a second monitoring unit configured to detect a state change of the treatment position in a different manner from each other, and wherein the control unit is configured to monitor the first monitoring unit and the second monitoring while the treatment light is irradiated. If any one of the units is detected a change in the state of the treatment position may be controlled to automatically stop the treatment light.
  • the controller may be configured to automatically adjust the treatment intensity to correspond to the appropriate treatment intensity based on the judgment of the guide.
  • the object of the present invention irradiating the treatment light consisting of a plurality of micro pulses of increasing intensity sequentially through the treatment light irradiation to the treatment position of the eye tissue, the treatment light is irradiated through the monitoring unit Monitoring the change of state of the treatment position during the treatment, automatically stopping the treatment light when a change of state of the treatment position occurs while the treatment light is irradiated, based on a time point at which the change of state of the treatment position is detected. It may also be achieved by a control method of an ophthalmic treatment device comprising the step of guiding the user through the guide unit whether the treatment intensity is suitable.
  • the object of the present invention described above is to set a treatment intensity by irradiating test pulses having different intensities to the test area of the eye tissue, consisting of a plurality of micro-pulse sequentially increasing the intensity based on the set treatment intensity Irradiating a treatment light to a treatment position of an eye tissue, monitoring a change in state of the treatment position while the treatment light is irradiated to the treatment position, and automatically stopping the treatment light when a change in state of the treatment position is detected.
  • the treatment intensity information guided on the basis of the step of the step and the change in the state of the treatment position is detected it can also be achieved by a treatment method using an ophthalmic treatment device comprising the step of adjusting the treatment intensity.
  • the setting of the treatment intensity may include irradiating a plurality of test pulses having different intensities to the test regions at different positions, and irradiating the plurality of test pulses using fluorescein angiography. And determining the treatment intensity using the lowest value of the intensities of the test pulses irradiated to the leaked position.
  • the present invention even if the tissue characteristics for each treatment location is different, it is possible to confirm the suitability of the treatment intensity in real time, thereby minimizing the occurrence of undesirable damage or insufficient treatment.
  • FIG. 1 is a schematic diagram schematically showing an ophthalmic treatment device according to an embodiment of the present invention
  • FIG. 2 is a block diagram schematically showing the components of the ophthalmic treatment device of FIG.
  • FIG. 3 is an enlarged cross-sectional view of region A of FIG. 2;
  • FIG. 5 is a view showing an image of a fundus of a patient
  • FIG. 6 is a graph showing a treatment light irradiation pattern irradiated to one treatment position and a monitoring value detected
  • FIG. 7 is a graph for explaining a criterion for determining the treatment intensity of the guide unit of FIG.
  • FIG. 8 to 10 are views illustrating various display examples of the guide part of FIG. 2;
  • FIG. 11 is a flowchart illustrating a control method of an ophthalmic treatment apparatus according to the present embodiment
  • FIG. 12 is a flowchart illustrating the initial treatment intensity setting step of FIG. 11 in more detail.
  • the ophthalmic treatment device described below will be described with reference to a device for treating an ocular fundus lesion, but the present invention can be applied to a treatment device for treating ophthalmic lesions other than the ocular fundus lesion.
  • a treatment device for treating ophthalmic lesions other than the ocular fundus lesion.
  • it may be applied to a device for treating anterior eye lesions, such as glaucoma, or may be applied to a device for treating lesions occurring in the lens, such as cataracts.
  • the present invention is found to be widely used in the treatment device for treating lesions of other medical subjects such as skin lesions as well as ophthalmic lesions.
  • the term 'treatment area' may mean an area requiring treatment, and an area as a predetermined area or a predetermined length section.
  • the "treatment position" is a position where treatment is performed in the treatment area, and may mean a position as a spot located at a specific coordinate.
  • the 'target tissue' refers to the tissue to be treated. When a plurality of tissues form a layered structure according to the depth at a specific treatment position, the target tissue may be a tissue located at all or part of the depth section.
  • treatment may be performed by sequentially irradiating light to a plurality of 'treatment locations' located in the treatment area.
  • the 'test area' is an area to which the test light is irradiated to set a parameter of the treatment light.
  • This test area refers to an area where a lesion is located and is separated from a treatment area requiring treatment.
  • the ophthalmic treatment apparatus is a device for performing treatment by irradiating the treatment light on the fundus, and includes a slit lamp 10 and an interface unit 20 as shown in FIG. 1.
  • the slit lamp 10 is a device for the user to observe the patient's eyes and proceed with treatment.
  • One side of the main body of the slit lamp 10 is provided with an object part 180 for fixing the position of the eye of the patient.
  • the other side is provided with an eyepiece part 170 on which the user's eye is located to observe the eye of the patient.
  • various components for performing the treatment operation are provided in the slit lamp 10, which will be described in more detail below.
  • the operation unit 30 for controlling the operation of the treatment device may be provided outside the slit lamp.
  • the operation unit 30 is configured using a structure such as a keyboard, a joystick, a pedal, and the user can manipulate the operation unit 30 to manipulate the viewing direction of the slit lamp or the treatment operation of the treatment apparatus.
  • the interface unit 20 is provided at a position adjacent to the slit lamp 10 and is configured to display various types of information necessary for the user during the treatment, or to allow the user to input / set commands and information. As shown in FIG. 1, the interface unit 20 includes a display device such as a monitor. The display device may be configured to input information through a touch screen function of the display device, or may include a separate input device such as a keyboard or a mouse.
  • FIG. 2 is a block diagram schematically illustrating internal components of the ophthalmic treatment device of FIG. 1.
  • the slit lamp 10 includes a treatment light irradiation unit for generating treatment light and irradiating the treatment light to the fundus.
  • the treatment light irradiator includes a treatment light generator 110 for generating a treatment beam and a beam delivery unit 130 for delivering the treatment light generated by the treatment light generator to the fundus.
  • it may further include a collimation light generating unit 120 for indicating a position to which the treatment light is irradiated.
  • the apparatus further includes an imaging unit 140 for photographing a patient's fundus image, a monitoring unit 150 for sensing state change information of the tissue caused by the treatment light, and a controller 160 for controlling various components. can do.
  • the treatment light generator 110 includes a treatment light source (not shown) and various optical elements (not shown) for modulating the characteristics of light generated by the treatment light source.
  • the treatment light source of the present embodiment includes a laser medium or a laser diode such as Nd: YLF, Nd: YAG, Ho: YAG, and the like, to generate a laser as the treatment light.
  • the treatment light generating unit of the present embodiment is configured to include a laser medium of Nd: YLF, and uses a laser having a wavelength of 527 nm as the treatment light.
  • Such treatment light may be composed of a plurality of micro pulses irradiated with a predetermined time gap. However, specific details of the treatment light pattern will be described below.
  • the beam delivery unit 130 includes a plurality of optical elements to form an optical path through which the treatment light travels. Therefore, the treatment light generated by the treatment light generator 110 travels along the beam delivery unit 130 and is irradiated in the fundus direction.
  • the beam delivery unit 130 may form an optical path through which aiming light and / or photographing light, which will be described later, in addition to the treatment light.
  • the beam delivery unit 130 includes at least one beam combiner 131 such that the aiming light and / or the imaging light are joined on the optical path, and the fundus direction Can be investigated.
  • the collimated light and / or the photographed light reflected by the fundus may travel in the reverse direction through the beam delivery unit 130 to proceed to the eyepiece 170 or may be received by the imaging unit 140.
  • the present invention is not limited thereto, and the aiming light and / or the photographing light may be implemented by forming or omitting a separate light path that is separated from the irradiation path of the treatment light.
  • the beam delivery unit 130 includes a scanner 132 for changing the position at which light is irradiated.
  • the scanner 132 includes at least one reflective member and a driving unit for rotating the scanner 132.
  • the scanner 132 may change the irradiation position of the light reflected by the reflecting member while rotating the reflecting member.
  • the beam delivery unit 130 may further include an optical element such as a plurality of optical lenses and an optical filter for focusing or dispersing light.
  • the beam delivery unit 130 may adjust various parameters including the spot size at which the treatment light is irradiated onto the treatment area by using these optical elements.
  • the alternative unit 180 is a configuration in which the eye of the patient to be treated is positioned, and includes an objective lens or a contact lens in contact with the eye of the patient. Furthermore, the alternative may further include a suction device for sucking and fixing the anterior part of the patient so as to fix the eye of the patient.
  • the aiming light generation unit 120 generates an aiming light (aiming beam).
  • the aiming light is configured to be irradiated to the treatment position to which the treatment light is irradiated and to indicate the position so that the operator can identify the position to which the treatment light is to be irradiated before or during the treatment light.
  • the aiming light generated by the aiming light generating unit 120 is reflected after being irradiated to the treatment area of the fundus through the beam delivery unit 130.
  • the aiming light has a wavelength of the visible light band, the user can confirm the position of the aiming light by checking it through the eyepiece.
  • the collimation light generating unit may be omitted.
  • the imaging unit 140 is configured to obtain an image of the treatment area of the patient.
  • the imaging unit 140 includes an imaging device, and acquires a fundus image by receiving photographed light emitted from a photographing light source (not shown) reflected from the fundus.
  • the imaging unit 140 according to the present exemplary embodiment is configured to acquire a fundus image including the entire treatment area.
  • the irradiation position of the photographing light may be configured to be changed through the scanner, such as the treatment light, and may be configured to acquire an image of an area adjacent to the treatment light irradiation position.
  • an ophthalmic treatment apparatus including an imaging unit is described, but the present invention is not limited thereto, and a configuration corresponding to the imaging unit may be omitted.
  • the monitoring unit 150 is configured to detect the state change information of the target tissue located at the treatment position by the treatment light when the treatment light irradiation.
  • the monitoring unit may be configured using at least one of various devices such as an optical acoustic sensor, a reflectometry sensor, a temperature sensor, an optical detector, an optical coherence tomography (OCT), and an ultrasonic sensor. Therefore, while the treatment light is irradiated to the treatment position, the state change information of the treatment position may be detected in real time, and whether the target state change has occurred therefrom.
  • the monitoring unit 150 of the present embodiment may include a plurality of monitoring units that independently perform the monitoring operation.
  • the monitoring unit 150 may include a first monitoring unit and a second monitoring unit measuring a change in the state of the treatment location in different ways. As such, the monitoring unit configures two monitoring units to perform monitoring, thereby making it possible to compensate for the disadvantages of the respective measurement methods.
  • the first monitoring unit (not shown) is composed of an optoacoustic sensor for measuring optoacoustic.
  • the photoacoustic sensor is provided in the eyepiece 170 in contact with the eye of the patient, and detects the state change of the tissue by measuring the photoacoustic signal generated when the state of the target tissue at the treatment position is made when the treatment light irradiation.
  • the second monitoring unit (not shown) is composed of a reflectometer sensor. The second monitoring unit receives the reflected treatment light irradiated to the treatment position, analyzes the parameter of the received light, and monitors state information of the treatment position.
  • the second monitoring unit does not receive the reflected treatment light, but has a separate detection light source to irradiate the detection light to the treatment position during the treatment, and to analyze the reflected detection light to monitor the change of the state of the treatment position. It is also possible to configure. As described above, in the present embodiment, the monitoring unit is configured by using the photoacoustic sensor and the reflectometer sensor, but this is an example and various sensors may be used in combination.
  • the controller 160 is configured to control various components including the treatment light generator 110, the aiming light generator 120, the beam delivery unit 130, the imaging unit 140, and the like. Control various components based on the content to be operated through the) or the content input or set through the interface unit 20. In addition, based on the information detected by the monitoring unit during the treatment, the aforementioned various components may be controlled to adjust / stop the treatment operation. In addition, the controller 160 receives image information captured by the imaging unit 140, information detected by the monitoring unit 150, and the like, processes and calculates the information, and delivers the information to other components.
  • the interface unit 20 includes a display unit 210 and an input unit 220.
  • the display unit 210 is a component for displaying and transmitting various types of information to the user
  • the input unit 220 is a component that allows the user to input and transmit information and commands to the device.
  • the display unit 210 is configured as a display device capable of displaying various information including an image.
  • the fundus image photographed by the above-described imaging unit 140 or the fundus image previously photographed by a separate fundus camera is transmitted through the controller 160 to be displayed on the display unit 210, and the user is displayed on the display unit 210.
  • the patient's fundus image can be checked.
  • the fundus image may be used in various ways to confirm the location of the lesion before treatment, to set the irradiation position of the treatment light, or to confirm the treatment result.
  • various information may be displayed to the user through the display unit.
  • the input unit 220 is a component in which the user transmits various information or commands to the treatment apparatus. Accordingly, the user may input patient information and treatment information through the input unit 220, instruct a treatment operation, and select a desired one from various options provided by the treatment apparatus. For example, the user may set the treatment area on the fundus image displayed on the display unit 210 using the input unit 220, select one of the treatment modes proposed by the treatment device, or store the treatment stored in the treatment device. It is also possible to select any one of the position patterns irradiated with light.
  • the input unit 220 may be configured to input various information by using a separate input device such as a keyboard or a mouse, or by using a touch screen function of a display forming the display unit 210.
  • the guide unit 230 provides guide information for the user to refer to while performing a treatment operation based on the state change information detected by the monitoring unit 150 during the treatment.
  • the guide unit 230 may display to the user whether the intensity of the treatment light irradiated to the corresponding position during the treatment is appropriate.
  • the user may adjust the treatment light intensity by referring to the information on whether the treatment light intensity is provided by the guide unit 230.
  • the treatment light intensity may mean a pulse energy value of the treatment light.
  • the suitability of the treatment light intensity may be determined in consideration of whether a target tissue state change is caused at the corresponding position, safety in consideration of tissue specificity, and possibility of incomplete treatment.
  • Guide unit 230 of the present embodiment is configured to be displayed to the user through the display device of the interface unit 20.
  • it may be configured to be displayed through a separate display provided inside the slit lamp so that the user can check through the eyepiece 170 during treatment.
  • specific guide content of these guide units will be described separately below.
  • the ophthalmic treatment device further includes a setting unit 240 that can set the irradiation intensity of the treatment light.
  • the setting unit 240 may be a component provided in the interface unit 20.
  • the user may set the intensity of the treatment light through the setting unit 240 in consideration of patient information, lesion location and condition.
  • the setting unit 240 and the input unit 220 are shown to be separate components, but the setting unit 240 and the input unit 220 are shown separately based on the contents input to the apparatus. It is also possible.
  • 3 is an enlarged cross-sectional view of region A of FIG. 2.
  • 3A illustrates fundus tissue, particularly retinal tissue, of a patient corresponding to a treatment area.
  • retinal tissues generally have an internal limiting layer, a nerve fiber layer, a ganglion cell layer, an inner plexiform layer, an inner nuclear layer, and an outer reticular layer. It consists of 10 layers (outer plexiform layer, outer nuclear layer, external limiting layer, photoreceptor layer, and RPE layer (retinal pigment epithelial layer) (inner depth from retinal surface) 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, and supplies nutrients to the photoreceptor, and discharges waste products generated from the photoreceptor through the Bruch membrane.
  • the ophthalmic treatment device proceeds the treatment of inducing the activation of new RPE cells by delivering energy to the RPE cell layer by selectively irradiating the therapeutic light.
  • the treatment light has a wavelength in the visible or near infrared region.
  • This therapeutic light is transmitted to the cell layer (first cell layer to the ninth cell layer) located in front of the retina with little absorption, and then absorbed by the melanosomes present inside the RPE cells.
  • the target state change is a state in which the temperature of the RPE cells rises and a predetermined level of microbubbles are generated on the surface of the melanosome, in which case the RPE cells are selectively necrotic to induce new RPE cells. I judge it.
  • the present invention controls the treatment contents by monitoring the state information of the treatment position while the treatment light is irradiated to one treatment position, and further, the guide unit 230 continuously receives information on whether the intensity of the treatment light is appropriate. Display to the user so that the user can adjust and treat the treatment light intensity.
  • FIG. 4 is a diagram illustrating an irradiation pattern of treatment light.
  • one treatment light is configured in a pattern in which N micro pulses P irradiated at predetermined periods are combined and set to irradiate N micro pulses at one treatment position.
  • Each of the micro pulses P has a form in which pulse energy, that is, intensity, increases sequentially in the order of irradiation.
  • the intensity of each micro pulse may be in the range of 50 ⁇ J to 200J.
  • the treatment light is configured to consist of 15 micro pulses.
  • Each micro pulse is irradiated at a period of 100 Hz, and the duration of each micro pulse may be 1.7 ms.
  • the intensity of the first micropulse corresponds to 50% of the intensity of the fifteenth micropulse, and each micropulse may be configured to increase evenly by about 3.57% of the fifteenth micropulse intensity.
  • the intensity of the treatment light may refer to the intensity distribution of the micro pulses constituting the treatment light.
  • the intensity setting of the treatment light can be set in various ways, and in this embodiment, the intensity of the treatment light is set by setting the intensity of the fifteenth micro pulse P15 having the maximum intensity.
  • the intensity of the initial treatment light can be set based on the user's experience or information previously stored in the in-device database.
  • the intensity of the treatment light may be determined by performing a test step of irradiating the test light to a separate test area before treatment so that the patient-specific treatment may be performed.
  • the test area C for performing the test step may be selected as an area separate from the treatment area B in which the lesion is located.
  • the test area C is an area where no lesion is located, and may select a location adjacent to the treatment area.
  • the test light is irradiated to the plurality of test positions T0 located in the test area. Since the test step is for selecting the intensity of the treatment light, the test light may use light irradiated through the treatment light irradiation unit.
  • the test light irradiated to each test position is irradiated with different output intensities.
  • the position where the test light is irradiated is confirmed by fluorescein angiography.
  • the leakage observed by fundus fluorescein angiography is due to a change in the state of RPE cells (steps that change beyond the level at which microblasts occur). Therefore, the intensity of the micro pulse P15 having the maximum intensity among the treatment light patterns may be set using the lowest intensity value among the test lights causing leakage in the RPE layer.
  • the intensity of the fifteenth micro pulse is set, the intensity of the remaining micro pulses is also set automatically according to the above-described ratio, thereby setting the intensity of all the treated light. Then, the treatment proceeds while the treatment light is irradiated to the treatment position at the intensity set as described above.
  • FIG. 6 is a graph showing a treatment light irradiation pattern irradiated to one treatment position and a monitored monitoring value. As shown in FIG. 6, while the plurality of micro pulses P are in progress to one treatment position, the monitoring unit 150 detects a state change of the treatment position. In addition, when a signal of more than the reference value V1 is detected from the monitoring unit 150 to detect that a target state change of the target tissue has occurred, the controller 160 automatically stops the treatment light irradiation and ends.
  • the micropulse does not proceed N times in every treatment position. If it is determined that the treatment is completed by monitoring the condition of the tissue in real time, the treatment for the position is terminated without irradiating the remaining micro pulses. Thereby, it is possible to prevent unnecessary tissue damage.
  • the change in state of the target tissue tends to depend on whether micropulses of sufficient intensity are irradiated, rather than the cumulative amount of energy delivered by the plurality of micropulses. Therefore, in the case of the irradiation pattern of the treatment light and the automatic stop method according to the present embodiment, it is possible to proceed with the treatment using the micro pulse of the minimum intensity causing the state change of the tissue.
  • FIG. 6 shows only signals detected by one monitoring unit of the monitoring unit. However, this is for convenience of description, when using two monitoring units at the same time as in the present embodiment, if any one of the first, second monitoring unit detects a change in the position of the treatment position and determines that a change in state It is also possible to configure the algorithm to automatically terminate the treatment light.
  • the treatment proceeds at a plurality of treatment locations within the treatment area.
  • the treatment light intensity required to reach a change in the state of the tissue may be different. Therefore, even if irradiated with the treatment light of the same intensity, the condition change can be sensed after the micro pulses are irradiated twice at some positions, and the treatment light irradiation can be terminated, and at some positions, the micro pulses are irradiated with all 15 times (automatic The state change may not be detected even if it is not stopped.
  • the treatment light intensity is set higher than that of the corresponding tissue characteristics, and there is a possibility that overtreatment occurs at a specific position.
  • the treatment light intensity is set lower than that of the corresponding tissue characteristic, so that treatment may not be performed properly at a specific position.
  • the guide unit 230 determines whether the set treatment light intensity is appropriate based on the time point at which the state change of the treatment position is detected while the treatment for one treatment position is in progress. Provide information to the user.
  • the time point may mean the number of micro pulses (n, the number of micro pulses irradiated to the treatment position) irradiated until the time when the state change of the tissue is automatically stopped.
  • the guide unit 230 is It may be determined that the treatment light intensity is excessively set in an appropriate range. In this case, an automatic stop may occur by the first micropulse at another adjacent position, since excessive damage may also be caused by the intensity of the first micropulse.
  • the guide unit 230 may determine that the treatment light intensity is set to fall within an appropriate range. have. In this case, the automatic stop may not be made while all N micropulses are irradiated at other adjacent positions, because the treatment is not properly performed.
  • n1 and n2 may be set in consideration of the margin of safety and the possibility of incomplete treatment.
  • n1 may be a value of 20% or more of N
  • n2 may be a value of 80% or less of N (n1, n2 ⁇ N).
  • the treatment light irradiation is terminated after three or less micropulses are irradiated, it is determined that the set treatment light intensity is excessive, and when the treatment light irradiation is finished after 13 or more micro pulses are irradiated, the set treatment light intensity is weak. You can judge.
  • the guide unit 230 determines whether the treatment light intensity setting is appropriate based on the treatment progressed at each treatment position, and guides it to the user.
  • the guide unit 230 may be configured in various ways to indicate whether the treatment light intensity is suitable for the user.
  • 8 to 10 are views illustrating various display examples of the guide unit of FIG. 2, and various examples of the guide unit will be described below with reference to FIGS. 8 to 10.
  • the guide unit may be configured to selectively display or alternatively light three arrow icons representing different directions.
  • the arrow displayed downward is selectively displayed / lighted so that the user can adjust the treatment light intensity low.
  • the user selectively displays / lights the arrow displayed upward in order to increase the treatment light intensity.
  • the horizontal arrow is selectively displayed / lit.
  • an icon in the form of an arrow is displayed to the user, but this is an example and may be displayed using various shapes, colors, and characters.
  • such a display may be displayed through the display unit 210 of the interface unit, and may be displayed using a display element provided inside the slit lamp so that the user can check it while using the slit lamp 10. It is possible.
  • the guide unit may indicate whether the treatment light intensity of each treatment position is appropriate on the fundus image. That is, as shown in FIG. 9, the treatment position of the fundus image displayed on the display unit 210 may be displayed, and spots of each treatment position may be differently displayed according to excessive treatment intensity, proper treatment intensity, and insufficient treatment intensity. . For example, spots may be displayed differently using colors, shades, shapes, or the like, or it is possible to display the treatment light intensity in a manner of describing a numerical value adjacent to the spots.
  • the guide unit may directly display a phrase suggesting treatment light intensity control to the user.
  • the treatment operation may be guided by directly suggesting to the user to lower the treatment light intensity.
  • the display example of the guide unit described with reference to FIGS. 8 to 10 may alternatively be implemented. Alternatively, the guide unit may be simultaneously displayed using a separate window. Meanwhile, in the above-described example, it is described that the determination of the suitability of the treatment light intensity for one treatment position is indicated. However, the determination that the set treatment light intensity is excessive or insufficient appears to be above a certain specific gravity. For example, it can be controlled to be displayed to the user only when it appears continuously.
  • the user is provided with information on whether the treatment light intensity is suitable while the treatment is in progress from the guide unit 230, if it is determined that it is necessary to adjust the treatment light intensity through the setting unit 240 to proceed with the treatment Can be. If the indication that the treatment light intensity set by the guide unit 230 is excessive is repeated, the user may adjust the intensity of the maximum micro pulse by 10 ⁇ J through the setting unit 240. Alternatively, when the indication that the set treatment light intensity is weak is repeated, the user may adjust the intensity of the maximum micro pulse by 10 ⁇ J through the setting unit 240.
  • control unit itself may be configured to automatically adjust and control the treatment light intensity based on the information determined by the guide unit.
  • FIG. 11 is a flowchart illustrating a control method of an ophthalmic treatment apparatus according to the present embodiment
  • FIG. 12 is a flowchart illustrating the initial treatment light intensity setting step of FIG. 11 in more detail.
  • the treatment area of the fundus is determined, and various modes necessary for treatment and input of information are performed.
  • the step of setting the initial treatment light intensity may be set using the result of irradiating the test light to a test region which is separated from the treatment region.
  • the test light is irradiated to the test area C of the fundus, which is distinguished from the treatment area B.
  • FIG. 11 the test light is irradiated to each of 5 to 18 test positions T0 in the test region in the form of a single micro pulse, and the intensity of the micro pulses irradiated to each position is set differently.
  • the test light may use the light generated from the treatment light generator 110 (S11).
  • the initial treatment light intensity is set by setting the intensity to the intensity of the micro pulse (the 15th pulse) having the maximum intensity among the treatment lights (S13).
  • the treatment light is irradiated to the first treatment position positioned in the treatment region at the set intensity (S20).
  • the treatment light is composed of N (15) micro pulses of sequentially increasing intensity.
  • the monitoring unit 150 detects a signal generated from the treatment position, and detects whether the target tissue state changes (S30).
  • the algorithm for detecting the change in the tissue state in the monitoring unit 150 is replaced with the above-described parts.
  • the treatment light irradiation step (S20) and the step (S30) of detecting the state change is shown as being a step that proceeds sequentially, but this is for convenience of description, the two steps are the treatment for the treatment location It runs in parallel at the same time until it is finished.
  • the controller 160 automatically stops the treatment light irradiation without irradiating the remaining micro pulses to the first treatment position. End the treatment (S40).
  • the set N micro pulses are irradiated, and then the treatment for the first treatment position is terminated.
  • the user performs the step of adjusting the treatment light intensity by referring to the information guided by the guide unit 230 (S60). For example, when the treatment light intensity irradiated to the first treatment position is guided to be excessive, the treatment light intensity, ie, the intensity of the maximum micro pulse, may be adjusted to lower the guide, and the treatment light intensity irradiated to the first treatment position is insufficient. Treatment light intensity can be increased. However, this step is not necessarily a step to be performed, and if the therapeutic light intensity is guided to an appropriate level or if the user determines that the therapeutic light intensity is guided to be excessive or insufficient, the treatment light will not be affected. The following steps can be performed without adjusting the intensity.
  • the steps corresponding to S20 to S60 can be repeated at the treatment position. Thereafter, the treatment may proceed in the same manner with respect to the third and fourth treatment positions. At this time, in each treatment position, the treatment can be performed with the adjusted treatment light intensity reflecting the treatment result of the previously treated position, so that it is possible to proceed with the appropriate treatment.
  • the treatment light automatically stops and proceeds to the optimal treatment, while continually guiding the optimal treatment light intensity considering the characteristics of the tissue
  • the therapeutic effect can be improved by improving safety and preventing the treatment from being omitted.
  • the damage information of the tissue according to the irradiation of each treatment light is guided so that the user can perform the treatment with reference thereto, thereby minimizing the difference in treatment result according to the user's skill level.

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Abstract

La présente invention concerne un appareil de traitement ophtalmique et son procédé de commande. Plus précisément, la présente invention concerne un appareil de traitement ophtalmique et son procédé de commande, l'appareil de traitement ophtalmique comprenant : une unité d'irradiation de lumière de traitement pour irradier une position de traitement d'un tissu intraoculaire avec une lumière de traitement ayant un motif composé d'une pluralité d'impulsions dont l'intensité augmente séquentiellement ; une unité de surveillance pour surveiller des informations d'état de la position de traitement par la lumière de traitement pendant l'irradiation avec la lumière de traitement ; une unité de commande pour commander l'arrêt automatique de l'irradiation de la position de traitement avec la lumière de traitement lorsqu'un changement souhaité dans l'état de la position de traitement est détecté sur la base des informations d'état surveillées ; une unité de guidage pour guider un utilisateur si l'intensité de la lumière de traitement est appropriée sur la base d'un moment où le changement de l'état de la position de traitement est détecté ; et une unité de réglage dans laquelle un utilisateur peut régler l'intensité de la lumière de traitement.
PCT/KR2018/004511 2018-04-18 2018-04-18 Appareil de traitement ophtalmique et son procédé de commande WO2019203373A1 (fr)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2008183247A (ja) * 2007-01-30 2008-08-14 Nidek Co Ltd 眼科用レーザ治療装置
US20140135753A1 (en) * 2002-09-18 2014-05-15 Ellex Medical Pty Ltd Ophthalmic laser system
JP2016154790A (ja) * 2015-02-26 2016-09-01 株式会社ニデック 眼科用レーザ治療装置

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WO2010085650A2 (fr) * 2009-01-23 2010-07-29 The General Hospital Corporation Détermination de la dose nécessaire à l'induction d'une microcavitation dans l'épithélium pigmentaire rétinien (epr)
KR101421653B1 (ko) 2012-07-13 2014-07-23 주식회사 루트로닉 안과용 치료장치 및 이의 빔 제어방법

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US20140135753A1 (en) * 2002-09-18 2014-05-15 Ellex Medical Pty Ltd Ophthalmic laser system
US20150157506A1 (en) * 2002-09-18 2015-06-11 Ellex Medical Pty Ltd Ophthalmic Laser System
JP2008183247A (ja) * 2007-01-30 2008-08-14 Nidek Co Ltd 眼科用レーザ治療装置
JP2016154790A (ja) * 2015-02-26 2016-09-01 株式会社ニデック 眼科用レーザ治療装置

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