WO2020215359A1 - Intelligent fundus laser surgery treatment apparatus and system, and system implementation method - Google Patents

Intelligent fundus laser surgery treatment apparatus and system, and system implementation method Download PDF

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Publication number
WO2020215359A1
WO2020215359A1 PCT/CN2019/085498 CN2019085498W WO2020215359A1 WO 2020215359 A1 WO2020215359 A1 WO 2020215359A1 CN 2019085498 W CN2019085498 W CN 2019085498W WO 2020215359 A1 WO2020215359 A1 WO 2020215359A1
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fundus
laser
module
imaging
treatment
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PCT/CN2019/085498
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French (fr)
Chinese (zh)
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张�杰
张金莲
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南京博视医疗科技有限公司
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Publication of WO2020215359A1 publication Critical patent/WO2020215359A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/12—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for looking at the eye fundus, e.g. ophthalmoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14—Arrangements specially adapted for eye photography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/14—Arrangements specially adapted for eye photography
    • A61B3/15—Arrangements specially adapted for eye photography with means for aligning, spacing or blocking spurious reflection ; with means for relaxing
    • 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

Definitions

  • the invention relates to fundus laser treatment technology, in particular to an intelligent fundus laser surgery treatment device, system and implementation method thereof.
  • Diabetic retinopathy is the first blinding disease among working-age people.
  • the main causes of visual impairment and blindness in patients with DR are proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME), and laser photocoagulation is the main treatment method for patients with diabetic retinopathy (DR).
  • PDR proliferative diabetic retinopathy
  • DME diabetic macular edema
  • laser photocoagulation is the main treatment method for patients with diabetic retinopathy (DR).
  • the current fundus laser treatment technology for patients with diabetic retinopathy (DR), macular degeneration and other ophthalmic diseases mainly relies on doctors to manually operate lasers for fixed-point strikes, or use two-dimensional galvanometers for array-shaped laser strikes. treatment.
  • these technologies are often not precise enough, and the treatment measures are based on mechanical contact. It is common that the operation time is longer and the experience of clinicians and patients is poor (such as aggravating DME, causing permanent central vision damage, laser scars and other side effects. Cause the patient's peripheral vision decline, visual field reduction, and scotopic vision deficiency).
  • the existing methods of manual fundus laser surgery or fractional laser strike with scanning galvanometer cannot realize automatic and intelligent laser fundus surgery. Moreover, it is impossible to view and check the treatment effect in real time, so the efficiency is not high.
  • the latest advanced laser fundus surgery such as the technology used in the Navilas system navigation laser fundus therapy instrument, can combine in vivo fundus imaging, fluorescein fundus angiography and retinal laser photocoagulation, which can be obtained by clinicians on a computer screen Retina image, and then use the computer to execute the pre-designed laser range and pattern of the retina for treatment.
  • This fundus laser treatment technology provides retinal laser navigation through computer images and target assistance systems. Specifically, it uses a fundus camera for navigation and an external laser source for treatment to achieve laser surgery. It has relatively high accuracy and theoretically Reproducibility of retina less than 60-100 ⁇ m.
  • the imaging method of the fundus treatment instrument is single, that is, only a fundus camera, which cannot provide high-precision human eye tracking and high-precision laser treatment measures, and therefore has obvious limitations.
  • the main purpose of the present invention is to provide an intelligent fundus laser surgery treatment device, system and implementation method thereof, aiming to solve the pain points of existing laser surgery treatment, simplify the operation of clinicians, improve patient experience, and optimize the treatment effect. Improve the accuracy and efficiency of treatment, while reducing the risk of surgical treatment.
  • Another object of the present invention is to provide an intelligent fundus laser surgery imaging diagnostic device and method, which can support real-time acquisition of fundus images in a multi-mode manner, and assist clinicians to perform various operations, including pre-surgery diagnosis plan formulation and surgery The determination of the target, the postoperative effect judgment, and the archive of treatment and diagnosis records.
  • An intelligent fundus laser surgery treatment device including an imaging diagnosis module and a laser treatment module; wherein:
  • the imaging diagnosis module is used to obtain the reflection signal returned from any angle of the fundus or/and obtain the image data of the fundus through the first imaging module (11) and the coupling module (14) in real time;
  • the laser treatment module is used to track and lock the fundus target in real time through the second imaging module (12), and adjust the laser output through the laser output adjustment module (13).
  • the laser treatment module can share hardware with the second imaging module (12).
  • the first imaging module (11) is one or more of confocal laser scanning imaging SLO, line scan fundus camera LSO, fundus camera, or adaptive fundus imager AOSLO.
  • the second imaging module (12) is an optical coherence tomography scanner OCT or a confocal laser scanning imaging SLO.
  • the first imaging module (11) and the second imaging module (12) support a combination of multiple imaging forms, including one or more of SLO+OCT, fundus camera+OCT, fundus camera+SLO or AOSLO+SLO.
  • the laser output adjustment module (13) adjusts the output of the laser, including adjusting the laser output dose and controlling the size of the laser spot on the fundus.
  • the first imaging module (11) receives a control signal through a scanning mirror to realize scanning in any direction in a two-dimensional space.
  • the second imaging module (12) controls the aiming light and the treatment laser by changing the position of the movable mirror to realize the switching between the image stabilization function and the laser treatment function.
  • a smart fundus laser surgery treatment system includes the smart fundus laser surgery treatment device, and also includes a data control device (2), which further includes a laser control module (21) for controlling or/and modulating laser signals, An imaging control module (22) for real-time control of fundus imaging and real-time fundus target tracking and locking for the first imaging module (11) and the second imaging module (12), and an imaging control module (22) for controlling the fundus imaging from the first imaging module ( 11) and a second imaging module (12) to obtain an image data acquisition module (23) of fundus imaging and laser treatment target image data.
  • a data control device (2) which further includes a laser control module (21) for controlling or/and modulating laser signals, An imaging control module (22) for real-time control of fundus imaging and real-time fundus target tracking and locking for the first imaging module (11) and the second imaging module (12), and an imaging control module (22) for controlling the fundus imaging from the first imaging module ( 11) and a second imaging module (12) to obtain an image data acquisition module (23) of fundus imaging and laser treatment target image data.
  • It also includes a data processing device (4) connected to the data control device (2) for data receiving and storing the fundus image data in a patient database file.
  • An implementation method of an intelligent fundus laser surgery treatment system includes the following steps:
  • the imaging diagnosis module of the laser image stabilization and treatment device is used to obtain the reflection signal returned from any angle of the fundus or/and the image data of the fundus through the first imaging module (11) and the coupling module (14) built in it. ; And using the laser treatment module, through its built-in second imaging module (12) real-time tracking and locking of fundus targets, using the laser output adjustment module (13) to adjust the output of the laser;
  • step B it also includes: C. Through the image display device (3) connected with the image data acquisition module (23), real-time display and observation of the image of the fundus treatment site.
  • step C it also includes: D. Using the data processing device (4) connected with the data control device (2) to receive the fundus image data and save it in the patient database file.
  • the intelligent fundus laser surgery treatment device, system and implementation method of the present invention have the following beneficial effects:
  • the fundus laser surgery treatment device and system of the present invention provide a visualized intelligent solution for ophthalmic fundus laser surgery, by providing real-time human fundus image acquisition, real-time disease analysis, planning treatment reference area, and adaptive adjustment of laser dose , Can perform laser treatment under the intervention of the operator.
  • the present invention integrates a variety of ophthalmological fundus imaging technologies and laser treatment technologies, which can realize one-stop diagnosis + treatment services, and at the same time, it can also realize intelligent, automated, and high-precision treatment, and simplify the operation To improve the patient’s experience.
  • the fundus laser surgery treatment device of the present invention can integrate the treatment laser function through a mechanical device and share hardware with the imaging device, which has the characteristics of cost saving.
  • the fundus laser surgery treatment device of the present invention also provides a variety of imaging diagnostic functions, including: confocal laser (SLO) or line scan imaging (LSO), cross-sectional tomography (OCT), fundus camera (fundus camera) ), even ultra-high-definition adaptive fundus imager (AOSLO); at the same time, it also provides a variety of imaging module combinations, such as SLO+OCT, fundus camera+OCT, fundus camera+SLO, or AOSLO+SLO. Therefore, it can adapt to different and complex application scenarios, and provide real-time fundus imaging and real-time image stabilization.
  • SLO confocal laser
  • LSO line scan imaging
  • OCT cross-sectional tomography
  • fundus camera fundus camera
  • AOSLO ultra-high-definition adaptive fundus imager
  • the present invention is based on the fundus retinal surface imaging function, such as SLO or fundus camera's high-precision fundus navigation and target tracking system, which can ensure that clinicians can easily select pathological areas; at the same time, it also provides intelligent disease diagnosis functions (using artificial intelligence technology), Help doctors plan before surgery, provide reference areas for surgery, and simplify operations.
  • the fundus retinal surface imaging function such as SLO or fundus camera's high-precision fundus navigation and target tracking system
  • the present invention adopts a data control and data processing system, which can analyze preoperative imaging, diagnose the condition and record the image data into the database; it can combine real-time imaging to facilitate the doctor to confirm the accuracy of the treatment area during treatment; and analyze after the operation Imaging is convenient for clinicians to evaluate surgery, and at the same time, post-operative imaging data is entered into the database for easy indexing and further application.
  • the laser output adjustment module and laser control module of the present invention can combine fundus image data feedback to perform intelligent laser strikes, can achieve precise strikes, use low-power, same-color light for target recognition, and achieve precise laser treatment after locking the treatment area. Help clinicians to operate.
  • the laser treatment device can also automatically adjust the size of the spot. The operator can choose the spot size according to the needs; traditional CW laser can be used as the laser source, or picosecond or femtosecond laser can be used as the light source; when using femtosecond laser for fundus In laser surgery, photomechanical effects can be used to achieve the purpose of precise treatment.
  • Figure 1 is a schematic diagram of a smart fundus laser surgery treatment system according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of a hardware implementation of the laser image stabilization and treatment device 1 shown in FIG. 1 of the present invention
  • Figure 3 is a schematic diagram of a typical SLO fast scan and slow scan mechanism
  • FIG. 4 is a schematic diagram of an implementation manner of the spectroscopic device S1 shown in FIG. 2;
  • Figure 5 is a schematic diagram of fundus tracking in the sawtooth wave scanning direction realized by the sawtooth wave superimposed offset
  • FIG. 6 is a schematic diagram of a mechanical device for controlling the mirror M3 according to an embodiment of the present invention.
  • FIG. 7 is a schematic diagram of a two-dimensional scanning method for controlling the position of OCT in the scanning space of the fundus according to an embodiment of the present invention
  • FIG. 8 is a schematic diagram of a design method of a spectroscopic device S3 corresponding to the auxiliary module light source according to an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of a mechanical and electronic combined device for notifying the user and the host control system of whether the current auxiliary module is imaging mode 2 or laser treatment according to an embodiment of the present invention.
  • Fig. 1 is a schematic diagram of a smart fundus laser surgery treatment system according to an embodiment of the present invention.
  • the intelligent fundus laser surgery treatment system is also an ophthalmology diagnosis and treatment platform. It mainly includes laser image stabilization and treatment device 1, data control device 2, image display device 3. Preferably, a data processing device 4 may also be included. among them:
  • the laser image stabilization and treatment device 1 further includes an imaging diagnosis module 1A and a laser treatment module 1B.
  • the laser treatment module 1B can be combined with one of the imaging modules (ie, the second imaging module 12); preferably, it can also share hardware with the second imaging module 12 to achieve savings The purpose of cost and convenience control.
  • the laser treatment module 1B includes a laser output adjustment module 13 and a second imaging module 12;
  • the imaging diagnosis module 1A includes a first imaging module 11 and a coupling module 14.
  • the first imaging module 11 is set as a master module, and correspondingly, the internal scanning mirrors are master scanners.
  • the second imaging module 12 and the laser output adjustment module 13 (used for laser treatment) are configured as slave modules, and the corresponding internal scanning mirrors are slave scanners.
  • the first imaging module 11 may be a confocal laser scanning imaging (SLO) or a line scan fundus camera (LSO), or a fundus camera (fundus camera), or an ultra-high definition adaptive fundus imager (AOSLO).
  • the second imaging module 12 may be an optical coherence tomography (OCT) or SLO.
  • the first imaging module 11 and the second imaging module 12 support multiple imaging module combinations, such as SLO+OCT, fundus camera+OCT, fundus camera+SLO, or AOSLO+SLO.
  • the laser output adjustment module 13 has a built-in zoom lens for adjusting the laser output dose, and can also control the size of the fundus laser spot by changing the position of the zoom lens, which is convenient for clinical operation.
  • the data control device 2 further includes a laser control module 21, an imaging control module 22 and an image data acquisition module 23. among them:
  • the first imaging module 11 and the second imaging module 12 are controlled in real time. Further, the first imaging module 11, such as SLO, LSO, or/and the second imaging module 12, such as OCT, are used for scanning and imaging through a galvanometer.
  • the data control module 2 realizes real-time scanning of the fundus by adjusting the clock signal, amplitude, frequency and other parameters of the system.
  • the data control module 2 can also control the vibrating optics in the first imaging module 11 and the second imaging module 12 at the same time, and change the scanning parameters arbitrarily (angle), such as the size of the image, the frame rate of the image, and the image brightness.
  • image acquisition can be performed through the data acquisition port of the image data acquisition module 23, and the fundus images of the first imaging module 11 and the second imaging module 12 can be displayed on the image display device 3 in real time to facilitate clinicians Perform real-time observation and diagnosis.
  • the clinician can use the data processing device 4 to analyze the obtained images in real time, and provide relevant reference treatment plans. For example: mark the reference treatment area, give the reference laser dose standard corresponding to each area, give the laser spot size corresponding to each area, etc.
  • the laser image stabilization and treatment device 1 of the embodiment of the present invention can realize fundus target tracking and locking functions.
  • the specific process is: using the fundus image information acquired by the first imaging module 11 to calculate real-time human eye movement signals (including motion signal x and y) are sent to the data control device 2.
  • the data control device 2 outputs real-time control signals through the imaging control module 22 to change the position of the galvanometer in the second imaging module 12 and lock it with the target in real time , To achieve the purpose of real-time target tracking and locking.
  • the real-time control signal will be calibrated in advance to ensure that the change of the galvanometer position is consistent with the actual eye offset.
  • the laser output adjustment module 13 and the second imaging module 12 of the laser treatment device support sharing a hardware system.
  • the function of fundus imaging and laser treatment can also be realized through the cooperation of the coupler.
  • the data control device 2 can control the fundus target to perform imaging and adjust the laser output in the laser output adjustment module 13 in real time through the imaging control module 22 and the laser control module 21, respectively, including adjusting output power, output switches, and output signals. Modulation and so on.
  • the laser control module 21 can use two lasers with similar wavelengths, or the same laser can be used as both the treatment laser and the reference light.
  • the laser light source can be a 532nm CW or a femtosecond laser system.
  • the clinician can also observe the image of the fundus of the patient after treatment in real time through the display screen of the image display device 3, evaluate the results of the operation in real time, and support the upload of the fundus image to the patient database file in the data processing device 4 , In order to facilitate later follow-up observation.
  • the human eye fundus is taken as an example.
  • the laser image stabilization and treatment device 1 composed of the first imaging module 11, the second imaging module 12, and the coupling module 14 can also be used for other different biological tissues, such as stomach, skin and other parts. The following description is still applied to human fundus as an example.
  • FIG. 2 is a schematic diagram of a hardware implementation of the laser image stabilization and treatment device 1 shown in FIG. 1 of the present invention.
  • the laser image stabilization and treatment device can be used as an independent laser fundus navigation and treatment equipment, or it can be combined with other data control devices as a complete laser surgery treatment system for clinical application .
  • the light sources L11, L12,..., L1n are multiple imaging light sources that are controlled (or modulated) by the control (signal) 11, 12,..., 1n, respectively, for the first imaging module 11 to perform imaging.
  • the control (signal) 11, 12,..., 1n, respectively, for the first imaging module 11 to perform imaging For example, infrared light with a wavelength of 780 nm is used for fundus reflection imaging, and light with a wavelength of 532 nm is used for fundus autofluorescence imaging, or light sources of other wavelength bands are used for other forms of fundus imaging.
  • the multiple imaging light sources can enter the optical system through the fiber coupling device FC2, and any one of the light sources L11...L1n is controllable (or modulated), as shown in the control signal of the main module in Figure 2 , Namely control (signal) 11,..., control (signal) 1n.
  • the control (or modulation) parameters including output power, switch state, etc., can also be selectively synchronized with the scanning mirror or asynchronously. Among them, the related technology synchronized with the scanning mirror has been described in detail in the previously filed patent application, and will not be repeated here.
  • the imaging light sources L11...L1n pass through the beam splitting device S1, pass through the scanning mirror M11 and the scanning mirror M12, and then pass through the beam splitting device S2, and enter the bottom of the eye.
  • the signal returned from the fundus such as the reflected signal of the photoreceptor cells, or the fluorescent signal excited by the fundus protein, or other signals returned from the fundus, will be reflected along the same optical path to reach the spectroscopic device S1, and then pass through another optical path.
  • the moving spectroscopic device S3 arrives at a photodetector, such as an avalanche photodiode (APD).
  • APD avalanche photodiode
  • the APD is used as a photodetector as an example for description.
  • the photodetector can also be a photomultiplier tube (PMT), CMOS, CCD, or other photodetector devices.
  • the above-mentioned photodetectors (such as APD, PMT, CMOS, CCD) are equipped with a controllable or programmable gain adjustment mechanism, which can be dynamically adjusted by receiving the program control signal of the system host, so as to Adapt to different imaging modes, for example, through the control signal 4 shown in Figure 2 for dynamic adjustment.
  • a controllable or programmable gain adjustment mechanism which can be dynamically adjusted by receiving the program control signal of the system host, so as to Adapt to different imaging modes, for example, through the control signal 4 shown in Figure 2 for dynamic adjustment.
  • the set of scanning mirrors M11 and M12 shown in FIG. 2 are mainly used for orthogonal scanning of the fundus imaging position.
  • the scanning axes of the scanning mirrors M11 and M12 are usually 90 degrees.
  • the scanning mirror M11 can be a resonant scanner.
  • a typical practical application scenario is: setting the scanning mirror M11 to scan in the horizontal direction and setting M12 to scan in the vertical direction , M12 is a slow linear scanning mirror.
  • the orthogonal scanning direction of the scanning mirrors M11 and M12 supports scanning in any direction of 360 degrees in a two-dimensional space.
  • the scanning mirror M11 adopts the CRS8k fast resonant mirror of Cambridge Technology. In other application systems, the CRS12k or other fast resonant mirrors can also be used.
  • the scanning mirror M12 in the embodiment of the present invention may be implemented by one two-dimensional steering mirror or two one-dimensional tilting scanning mirrors.
  • the scanning mirror M12 adopts a set of two-dimensional scanning mirrors 6220H (or 6210H) of Cambridge Technology.
  • the first axis of the 6220H-the slow scan axis is orthogonal to the scan direction of the M11 fast scan axis; the second axis of the 6220H, does not participate in scanning but is only used for target tracking, and is parallel to the scan axis of M11.
  • the scanning field of the scanning mirror M11 as a fast resonant mirror is controlled by the system host or manually.
  • the scanning motion track of M12 orthogonal to M11 is a triangular wave.
  • the sweep parameters such as the amplitude and frequency of the triangle wave, the climb period and the return period of the triangle wave, and so on are controlled by the system host.
  • the amplitude of the triangle wave determines the size of the field of view in the slow scan direction, and the frequency of the triangle wave determines the frame rate of the image system (refer to Figure 3).
  • Figure 3 is a schematic diagram of a typical SLO fast scan and slow scan mechanism.
  • the fast resonant mirror scans one cycle, the slow mirror linearly increases by one step.
  • the fast (resonant) scan of the SLO completes a sine (or cosine) period 11
  • the slow (linear) scan moves one step 12 in the orthogonal direction.
  • the image frame rate (fps), the resonance frequency (f) of the fast scanning mirror, and the number of lines (N) contained in each frame of the image meet the following requirements relationship:
  • N includes all the scan lines 121 and 122 in the part of FIG. 3. Among them, 121 is the rising creeping period of the sawtooth wave, and 122 is the returning period.
  • the SLO image generally does not include the 122 part of FIG. 3, because the image during the 122 period and the image during the 121 period have different pixel compression ratios. SLO images are generally only obtained from part 121 of Figure 3.
  • the function of the spectroscopic device S1 shown in Figure 2 is to transmit all the incident light from the coupling device FC2, but reflect all the signals from the fundus to the APD.
  • One implementation mode is to dig out a hollow cylinder at the axis of S1 to allow the incident focused light from FC2 to pass through, but reflect all the expanded light from the fundus to the photodetector APD, as shown in Figure 4 and Figure 2
  • a schematic diagram of an implementation of the spectroscopic device S1 is shown.
  • the scanning mirror M12 of FIG. 2 has two independent motion axes.
  • the first movement axis is orthogonal to the movement (scanning) axis of M11, and the second movement axis is parallel to the movement (scanning) axis of M11.
  • the movement (scanning) axis of the scanning mirrors M12 and M11 are orthogonal to the movement axis, which can receive two signals from the system host: one is the sawtooth wave shown in Figure 3 (such as 121 and 122), and the other is superimposed on the sawtooth The translation signal above the wave.
  • the sawtooth wave is used to scan the fundus to obtain a fundus image
  • the translation signal is used to optically track the eyeball movement of the fundus in the scanning direction of the sawtooth wave. As shown in Figure 5.
  • Fig. 5 is a schematic diagram of fundus tracking mode of sawtooth wave superimposed offset in the sawtooth wave scanning direction.
  • the control host adjusts the offset of the sawtooth wave in real time to track the position of the fundus relative to this reference surface.
  • the system control host mentioned above can be a PC equipped with a corresponding control program module, or a device containing a field programmable logic array (Field Programming Gate Array, FPGA), or a digital signal processor ( Digital Signal Processor (DSP) devices may also be devices that use other types of electronic signal processors, or they may be combined devices that include these hardware.
  • FPGA Field Programming Gate Array
  • DSP Digital Signal Processor
  • the control device uses an Intel PC (Intel i7) machine equipped with nVidia graphics processing unit (GPU), such as GTX1050, for calculating eye movement signals (x, y , ⁇ ), and then through Xilinx FPGA (considering cost factors, the embodiment of the present invention uses Virtex-5 device ML507 or Spartan 6 SP605; more powerful but also more expensive Virtex-6, Virtex-7 , Kintex-7, Artix-7 and other latest series of FPGA devices, or other manufacturers such as Altera FPGA devices), by digitally synthesizing the y part of (x, y, ⁇ ) into the signal form of Figure 5, and then send it Go to a Digital-to-Analog Converter (DAC), such as Texas Instruments' DAC5672, to control the first movement axis of the scanning mirror M12.
  • DAC Digital-to-Analog Converter
  • the signal in Figure 5 can also be realized by analog synthesis.
  • the sawtooth wave in Figure 5 is generated by the first DAC to generate the first analog signal.
  • the offset in Figure 5 is also the y component of (x, y, ⁇ ), and the second analog signal is generated by the second DAC.
  • the two analog signals are synthesized by the analog signal mixer, and finally sent to the first movement axis of the scanning reflector M12.
  • the x of the signal (x, y, ⁇ ) is an analog signal generated by another separate DAC and sent to the second movement axis of M12 to track the movement of the eyeball on the second movement axis.
  • the second movement axis of the scanning mirror M12 is parallel to the scanning axis of M11.
  • the translational part (x, y) of the above-mentioned eye movement signal (x, y, ⁇ ) has two orthogonal movement axes of M12 to realize closed-loop optical tracking.
  • the rotating part ( ⁇ ) of the first imaging module 11 is implemented by digital tracking in the embodiment of the invention, but it can also be implemented by optical or/and mechanical closed-loop tracking in the future.
  • the optical or/and mechanical tracking related technology of the rotating part ( ⁇ ) has been described in detail in US Patent No. 9775515.
  • fundus tracking and eye tracking are a concept. In clinical application, most of the physical movement comes from the eyeball, and the movement of the eyeball causes the fundus image obtained by the imaging system to change randomly in space with time. The equivalent consequence is that at any time of the imaging system, different images are obtained from different fundus positions, and the observed result is that the images jitter randomly over time.
  • the tracking technology in the embodiment of the present invention is to capture eye movement signals (x, y, ⁇ ) in real time through fundus images in the imaging system, and then feed back (x, y) to M12 in FIG.
  • the scanning space of two scanning mirrors (M11 and M12 are orthogonal to the direction of M11) is locked in a pre-defined fundus physical space, so as to realize accurate fundus tracking and stabilize the random changes of fundus images in space over time.
  • the imaging mode in Figure 2 (corresponding to the main module) constitutes a complete closed-loop control system for high-speed real-time tracking of fundus position. This part of the technology has been described in detail in two US patents US9406133 and US9226656.
  • the imaging mode 2 in FIG. 2 that is "slave L2-M3-M2-S2- fundus" on the left corresponds to the imaging mode 1 (main module) shown in FIG.
  • a typical application is the application of optical coherence tomography (Optical Coherence Tomography, OCT) imaging technology.
  • OCT optical Coherence Tomography
  • L31/L32-M2-S2-Fundus corresponds to the fundus laser treatment device described in Figure 1.
  • the functional realization of OCT and fundus laser treatment is described in detail below.
  • the M3 is a movable mirror.
  • the movement method can be mechanical, electronic, or a combination of the two.
  • the movable part of the mirror M3 can also be replaced by a beam splitting device.
  • the state of the mirror M3 is controlled mechanically.
  • the state of the M3 entry/exit optical system is determined by the state of the coupling device FC1 in Figure 2.
  • FC1 the coupling device
  • Fig. 6 is a schematic diagram of a mechanical device for controlling the mirror M3 according to an embodiment of the present invention.
  • the M3 is pushed out or put into the optical system according to the FC1's insertion and withdrawal mechanism.
  • the switch is connected to the foldable frame through a connecting rod.
  • the frame is opened and the FC1 interface is also opened, allowing access to the treatment laser.
  • Figure 6A When the switch is closed, as shown in Figure 6B, when it is at 0 degrees, the FC1 interface is closed. At this time, the treatment laser cannot be connected.
  • the foldable frame returns to the original position (refer to Figure 2), and the imaging laser L2 can be reflected. enter the system.
  • the function of the mirror M3 is to allow the user to select one of the functions of imaging mode 2 or fundus laser treatment in the slave module.
  • M3 When realizing OCT imaging, that is, imaging mode 2 shown above, M3 is placed in the optical path of "L2-M3-M2-S2-fundus" shown in Figure 2, so that the light source of L2 reaches the fundus.
  • M2 is a two-dimensional scanning mirror.
  • a fast tilt mirror with two independent orthogonal control axes and a single reflective surface can also be controlled by two one-dimensional tilt mirrors for orthogonal scanning.
  • the latter case is used in the present invention, and the 6210H dual-mirror combination of Cambridge Technology of the United States is used.
  • M2 in FIG. 2 has multiple functions.
  • the system host In the case of imaging mode 2 shown in Figure 2, the system host generates an OCT scan signal to control the scanning mode of M2, thereby controlling the two-dimensional imaging space of L2 in the fundus.
  • the system generates a set of orthogonal host program scan control group as shown in FIG. 7 S x S y and the control FPGA.
  • S x and Sy are vectors with directions.
  • FIG. 7 is a schematic diagram of a two-dimensional scanning method for controlling the position of OCT in the scanning space of the fundus according to an embodiment of the present invention.
  • the system host program controls the two scanning bases of the FPGA (as shown in Figure 7) to multiply their respective amplitudes (Ax and Ay) and positive and negative signs to realize OCT in any direction of the fundus 360 degrees, and specify the two-dimensional field of view size Scanning can be expressed by the following relation:
  • OCT scan S x A x +S y A y ;
  • the parameters A x and A y are also vectors with signed (or) directions; S x A x +S y A y can realize OCT in any direction in the 360-degree two-dimensional fundus space, as any field size allowed by the optical system scanning.
  • L2 is an imaging light source with a wavelength of 880 nm
  • light source L31 has a wavelength of 561 nm
  • light source L32 has a wavelength of 532 nm.
  • the design of the light splitting device S3 needs to be changed differently for different auxiliary module light sources. One way is to customize a different light splitting device S3 for different slave module light sources and place it at the S3 position in FIG. 2, as shown in FIG. 8.
  • FIG. 8 is a schematic diagram of a design method of a light splitting device S3 corresponding to the auxiliary module light source according to an embodiment of the present invention.
  • the spectroscopic device S3 transmits 90%-95% and reflects 5%-10% of light at 532nm and above 830nm, and transmits 5%-10% and reflects 90%-95% of light in other wavelength bands.
  • the light source L31 in the auxiliary module is the aiming light for laser treatment.
  • the aiming light reaches the fundus, and the light spot reflected from the fundus is received by the APD of the first imaging module 11, and a light spot generated by L31 is superimposed on the SLO image.
  • This spot position indicates that the treatment light L32 will have a nearly uniform spatial position on the fundus.
  • the degree of overlap of the light sources L31 and L32 on the fundus depends on the transverse chromatic aberration (TCA) produced by the two wavelengths of 532nm and 561nm on the fundus.
  • TCA transverse chromatic aberration
  • the light with wavelengths of 532nm and 561nm, the TCA generated on the fundus will not exceed 10 microns.
  • the wrong position of the 532nm treatment light of L32 will not exceed 10 microns.
  • the power of the aiming light of L31 to reach the fundus is generally below 100 microwatts, and the power of the treatment light of L32 to reach the fundus can be several hundred milliwatts or higher.
  • the amplitude of the signal reflected by L31 from the fundus to the APD is close to the amplitude of the image signal of the SLO, but the 532nm high-power therapeutic light still has a considerable signal reflected to the SLO through the spectroscopic device S3.
  • the 532nm signal returned from the fundus reaches the SLO and impacts the APD and causes the APD to be overexposed.
  • a spectroscopic device S3 is placed in front of the APD. S3 reflects all light below 550nm and transmits all light above 550nm to protect the APD.
  • the beam splitter S3 in Fig. 3 is movable, and its moving state is just the opposite of that of M3.
  • S3 is also connected to the optical system; when FC1 is not connected to the system, S3 is pushed out of the optical system.
  • the S3 access and push-out optical system can be mechanical, electronic, or a combination of the two. In the embodiment of the present invention, a mechanical method is adopted, as shown in FIG. 6.
  • the auxiliary module integrates two functions, namely, laser imaging, image stabilization, and the use of the second imaging module 12 and the laser output adjustment module 13 to achieve laser treatment.
  • the switching between the above two functions is achieved by changing the position of M3.
  • M3 When M3 is placed in the optical system, the second imaging module 12 is activated and the laser treatment device does not work.
  • the laser treatment function When the M3 is pushed out of the optical system, the laser treatment function is activated, and the second imaging module 12 does not work at this time.
  • the position of the M3 and S3 in the optical system is controlled by the position of the knob installed on the coupling device FC1 to realize the function of dynamically switching imaging mode 2 and laser clinical treatment.
  • Another function of the FC1 knob is to connect and disconnect one or more electronic devices to remind the user and the system host control program which of the two functions should be run.
  • FIG. 9 is a schematic diagram of a mechanical and electronic combined device for notifying the user and the host control system of whether the current auxiliary module is imaging mode 2 or laser treatment according to an embodiment of the present invention.
  • the device controls an LED indicator light and provides a high/low level signal to the electronic hardware through a conductive metal sheet mounted on the FC1 knob to notify the user and the host control system of the current Does the slave module work in imaging, image stabilization mode or laser treatment mode.
  • point C In the default setting, A and B are disconnected, the LED is off, and point C outputs a 0V voltage or low level.
  • point C is connected to the FPGA to detect whether the input terminal is low level (0V) or high level (3.3V or 2.5V), so as to control the software to automatically switch to imaging, image stabilization or laser therapy mode.
  • the entire system can also be used as imaging mode 1 only, for example, only SLO/SLO imaging is performed without OCT. This way of working can be achieved through the system host control program.
  • control M2 in Figure 2 combines a variety of laser strike modes, including: 1) single-point strike mode; 2) regular space area array strike mode; 3) custom none Multi-point strike mode in regular space area.
  • the user uses the real-time image of imaging mode 1 to determine the laser strike position in the pathological area, and after aiming at the target with the aiming light, the therapeutic light is activated to preset the laser dose, exposure time, etc. Parameters for target strike.
  • the regular space area array strike mode is a combination of the single-point strike mode and the scanning mode of imaging mode 2, allowing the user to define the laser dose and other parameters for each position, then start the treatment light, and wait for time Hit predetermined targets one by one at intervals.
  • the customized multi-point strike mode in an irregular space area is a completely free strike mode.
  • the user customizes the laser dose, exposure time and other parameters of any strike position in the pathological zone, and then strikes the predetermined targets one by one.
  • a beam splitting device is used to send a part of the light obtained from the treatment light L32 to a power meter.
  • the value of the power detector is read in real time through the control program, and the laser dose of the L32 power reaching the strike target is dynamically adjusted to a preset value.
  • an FPGA hardware clock is used to control the on and off states of the L32.
  • a control method can be implemented through a real-time operating system, such as Linux.
  • Another control method can be implemented by installing real-time control software (Wind River) on a non-real-time operating system such as Microsoft Windows; another control method can be controlled by a timer on a completely non-real-time operating system such as Microsoft Windows.
  • Wind River real-time control software
  • the host control software displays the stable SLO/LSO image in real time.
  • the spatial resolution of the image stabilization technology is approximately 1/2 of the lateral optical resolution of the imaging module 1.
  • the stabilized real-time SLO/LSO image allows the user to conveniently locate the fundus space position to be processed by the auxiliary module.
  • the fundus tracking of the main module is a closed-loop control system. After the fundus tracking function is activated, the command of the master module (master module) to control the tracking mirror M12 is sent to M2 of the slave module (slave module) according to the pre-calibrated mapping relationship. Therefore, the light coming from L2 or L31/L32 can be locked to the predetermined fundus position with considerable accuracy after reaching the fundus through M2.
  • a core technology here is to use the closed-loop control command of the main module to drive the open-loop tracking of the auxiliary module.
  • the spatial mapping relationship between M12 and M2, that is, how to convert the control commands (x, y, ⁇ ) of M12 into the control commands (x', y', ⁇ ') of M2 depends on the design of the optical system.
  • (x', y', ⁇ '; x, y, ⁇ ) can be realized by calibration of the optical system.
  • the core technology that is, the closed-loop control command of the master module is used to drive the open-loop tracking of the slave module, which is an M12 closed-loop and M2 open-loop optical tracking.
  • the scanning mirror M2 of the auxiliary module can perform optical scanning in any direction of 360° in the two-dimensional space. Therefore, the auxiliary module M2 is the open-loop optical tracking of the three variables (x', y', ⁇ ') in the above formula, although the main module only has the closed-loop optical tracking of translation (x, y) and digital tracking of rotation ⁇ .
  • the closed-loop tracking accuracy of the main module and the calibration accuracy of the above formula determine the open-loop tracking accuracy of the light from the auxiliary module to the fundus, or the accuracy of target locking.
  • the closed-loop optical tracking accuracy of the main module is equivalent to the optical resolution of the imaging system of the main module, about 15 microns, and the open-loop optical tracking accuracy of the auxiliary module can reach 2/3 of the closed-loop optical tracking accuracy of the main module. -1/2, or 20-30 microns. What needs to be emphasized is that in different system devices, these accuracy will have different changes.
  • the invention is mainly applied to ophthalmology, and the targeted cases are diabetic retinal degeneration, age-related macular degeneration and the like.
  • the fundus laser treatment technology provided by the present invention supports intelligent automatic fundus diagnosis and treatment solutions, and also provides a material basis for future one-stop diagnosis and treatment services.

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Abstract

An intelligent fundus laser surgery treatment apparatus and system, and a system implementation method. The apparatus comprises an imaging diagnosis module and a laser treatment module; the imaging diagnosis module is configured to obtain, in real time, a reflected signal returned at any angle from the fundus or/and image data of the fundus by means of a first imaging module (11) and a coupling module (14); the laser treatment module is configured to perform real-time tracking and locking of a fundus target by means of a second imaging module (12) and adjust laser output by means of a laser output adjustment module (13). The system comprises the intelligent fundus laser surgery treatment apparatus, and further comprises a data control apparatus (2) for controlling laser output, imaging, and image data collection.

Description

一种智能眼底激光手术治疗装置、***及其实现方法Intelligent fundus laser surgery treatment device, system and realization method thereof 技术领域Technical field
本发明涉及眼底激光治疗技术，尤其涉及一种智能眼底激光手术治疗装置、***及其实现方法。The invention relates to fundus laser treatment technology, in particular to an intelligent fundus laser surgery treatment device, system and implementation method thereof.
背景技术Background technique
糖尿病视网膜病变(DR)是工作年龄人群排在第一位的致盲性疾病。DR患者视力损害和失明的主要原因是增生性糖尿病视网膜病变(PDR)和糖尿病黄斑水肿(DME)，而激光光凝法是糖尿病视网膜病变(DR)患者最主要的治疗方法。Diabetic retinopathy (DR) is the first blinding disease among working-age people. The main causes of visual impairment and blindness in patients with DR are proliferative diabetic retinopathy (PDR) and diabetic macular edema (DME), and laser photocoagulation is the main treatment method for patients with diabetic retinopathy (DR).
当前用于糖尿病视网膜病变(DR)患者、黄斑变性等眼科疾病患者的眼底激光治疗技术，主要依赖医生通过手动操作激光进行定点打击，或者采用二维振镜进行阵列形状的激光进行打击的方式来治疗。但是这些技术往往打击精度不够，而且治疗措施是基于机械接触式的，普遍存在手术时间较长，临床医生和患者的体验差(如加重DME造成永久中心视力受损、激光癜痕扩大等副作用，引起患者周边视觉下降、视野缩小、暗视力下降)的不足。另外，现有采用手动眼底激光手术，或者用扫描振镜进行点阵激光打击进行治疗的方法，均不能实现自动化、智能化实施激光眼底手术。而且无法做到实时查看和检查治疗效果，因此效率不高。The current fundus laser treatment technology for patients with diabetic retinopathy (DR), macular degeneration and other ophthalmic diseases mainly relies on doctors to manually operate lasers for fixed-point strikes, or use two-dimensional galvanometers for array-shaped laser strikes. treatment. However, these technologies are often not precise enough, and the treatment measures are based on mechanical contact. It is common that the operation time is longer and the experience of clinicians and patients is poor (such as aggravating DME, causing permanent central vision damage, laser scars and other side effects. Cause the patient's peripheral vision decline, visual field reduction, and scotopic vision deficiency). In addition, the existing methods of manual fundus laser surgery or fractional laser strike with scanning galvanometer cannot realize automatic and intelligent laser fundus surgery. Moreover, it is impossible to view and check the treatment effect in real time, so the efficiency is not high.
目前最新先进的眼底激光治疗手术，如Navilas***导航激光眼底治疗仪所采用的技术，能够使活体眼底成像、荧光素眼底血管造影和视网膜激光光凝结合在一起，通过临床医生在计算机屏幕上获得视网膜图像，然后使用计算机执行预先设计好的视网膜激光范围和模式进行治疗。该眼底激光治疗技术，通过计算机图像和目标辅助***提供视网膜激光导航，具体是利用一 部眼底相机进行导航，外接治疗用的激光源以此实现激光手术治疗，其具有比较高的精度和理论上小于60～100μm的视网膜再现性。但是，该眼底治疗仪的成像方式单一，即只有眼底相机，并不能提供高精度的人眼跟踪和实现高精度的激光治疗措施，因此具有明显的局限性。At present, the latest advanced laser fundus surgery, such as the technology used in the Navilas system navigation laser fundus therapy instrument, can combine in vivo fundus imaging, fluorescein fundus angiography and retinal laser photocoagulation, which can be obtained by clinicians on a computer screen Retina image, and then use the computer to execute the pre-designed laser range and pattern of the retina for treatment. This fundus laser treatment technology provides retinal laser navigation through computer images and target assistance systems. Specifically, it uses a fundus camera for navigation and an external laser source for treatment to achieve laser surgery. It has relatively high accuracy and theoretically Reproducibility of retina less than 60-100μm. However, the imaging method of the fundus treatment instrument is single, that is, only a fundus camera, which cannot provide high-precision human eye tracking and high-precision laser treatment measures, and therefore has obvious limitations.
发明内容Summary of the invention
有鉴于此，本发明的主要目的在于提供一种智能眼底激光手术治疗装置、***及其实现方法，旨在解决现有激光手术治疗的痛点，简化临床医生操作，改善患者体验，优化治疗效果，提高治疗精度和效率，同时降低手术治疗风险。In view of this, the main purpose of the present invention is to provide an intelligent fundus laser surgery treatment device, system and implementation method thereof, aiming to solve the pain points of existing laser surgery treatment, simplify the operation of clinicians, improve patient experience, and optimize the treatment effect. Improve the accuracy and efficiency of treatment, while reducing the risk of surgical treatment.
本发明的另一目的在于提供一种智能眼底激光手术成像诊断装置及其方法，能够以多模式方式支持实时采集眼底图像，以及辅助临床医生进行多种操作，包括手术前的诊断方案制定、术中靶标的确定和术后的效果判断以及治疗诊断记录存档等。Another object of the present invention is to provide an intelligent fundus laser surgery imaging diagnostic device and method, which can support real-time acquisition of fundus images in a multi-mode manner, and assist clinicians to perform various operations, including pre-surgery diagnosis plan formulation and surgery The determination of the target, the postoperative effect judgment, and the archive of treatment and diagnosis records.
为达到上述目的，本发明的技术方案是这样实现的：In order to achieve the above objective, the technical solution of the present invention is achieved as follows:
一种智能眼底激光手术治疗装置，包括成像诊断模块和激光治疗模块；其中：An intelligent fundus laser surgery treatment device, including an imaging diagnosis module and a laser treatment module; wherein:
所述成像诊断模块，用于通过第一成像模块(11)和耦合模块(14)实时获取从眼底任意角度返回的反射信号或/和获取眼底的影像数据；The imaging diagnosis module is used to obtain the reflection signal returned from any angle of the fundus or/and obtain the image data of the fundus through the first imaging module (11) and the coupling module (14) in real time;
所述激光治疗模块，用于通过第二成像模块(12)实时进行眼底目标的跟踪与锁定，并通过激光输出调节模块(13)调节激光的输出。The laser treatment module is used to track and lock the fundus target in real time through the second imaging module (12), and adjust the laser output through the laser output adjustment module (13).
其中：所述激光治疗模块能够与所述第二成像模块(12)共享硬件。Wherein: the laser treatment module can share hardware with the second imaging module (12).
所述第一成像模块(11)为共聚焦激光扫描成像SLO、线扫描眼底相机LSO、眼底相机，或自适应眼底成像仪AOSLO中的一种或多种。The first imaging module (11) is one or more of confocal laser scanning imaging SLO, line scan fundus camera LSO, fundus camera, or adaptive fundus imager AOSLO.
所述第二成像模块(12)为光相干断层扫描仪OCT或共聚焦激光扫描成像SLO。The second imaging module (12) is an optical coherence tomography scanner OCT or a confocal laser scanning imaging SLO.
第一成像模块(11)和第二成像模块(12)，支持多种成像形式的组合，包括SLO+OCT、眼底相机+OCT、眼底相机+SLO或AOSLO+SLO中的一种或多种。The first imaging module (11) and the second imaging module (12) support a combination of multiple imaging forms, including one or more of SLO+OCT, fundus camera+OCT, fundus camera+SLO or AOSLO+SLO.
所述激光输出调节模块(13)调节激光的输出，包括调节激光输出剂量大小、控制眼底的激光光斑的大小。The laser output adjustment module (13) adjusts the output of the laser, including adjusting the laser output dose and controlling the size of the laser spot on the fundus.
所述第一成像模块(11)通过扫描反射镜接收控制信号实现二维空间任意方向的扫描。The first imaging module (11) receives a control signal through a scanning mirror to realize scanning in any direction in a two-dimensional space.
所述第二成像模块(12)通过改变可移动的反射镜的位置控制瞄准光和治疗激光实现稳像功能和激光治疗功能的切换。The second imaging module (12) controls the aiming light and the treatment laser by changing the position of the movable mirror to realize the switching between the image stabilization function and the laser treatment function.
一种智能眼底激光手术治疗***，包括所述智能眼底激光手术治疗装置，还包括数据控制装置(2)，其进一步包括用于控制或/和调制激光信号的激光控制模块(21)、用于对第一成像模块(11)和第二成像模块(12)进行实时的控制眼底成像和实时的眼底目标跟踪与锁定的成像控制模块(22)、以及用于分别从所述第一成像模块(11)和第二成像模块(12)获取眼底成像和激光治疗目标的影像数据的图像数据采集模块(23)。A smart fundus laser surgery treatment system includes the smart fundus laser surgery treatment device, and also includes a data control device (2), which further includes a laser control module (21) for controlling or/and modulating laser signals, An imaging control module (22) for real-time control of fundus imaging and real-time fundus target tracking and locking for the first imaging module (11) and the second imaging module (12), and an imaging control module (22) for controlling the fundus imaging from the first imaging module ( 11) and a second imaging module (12) to obtain an image data acquisition module (23) of fundus imaging and laser treatment target image data.
还包括与所述图像数据采集模块(23)数据相连的图像显示装置(3)，用于实时显示和观察眼底治疗部位的影像。It also includes an image display device (3) connected with the image data acquisition module (23), which is used for real-time display and observation of images of the fundus treatment site.
还包括与所述数据控制装置(2)数据相连的数据处理装置(4)，用于接收眼底影像数据并保存在患者数据库文档中。It also includes a data processing device (4) connected to the data control device (2) for data receiving and storing the fundus image data in a patient database file.
一种智能眼底激光手术治疗***的实现方法，包括如下步骤：An implementation method of an intelligent fundus laser surgery treatment system includes the following steps:
A、利用激光稳像及治疗装置的成像诊断模块，通过其内设的第一成像模块(11)和耦合模块(14)实时获取从眼底任意角度返回的反射信号或/和获取眼底的影像数据；并利用激光治疗模块，通过其内设的第二成像模块(12)实时进行眼底目标的跟踪与锁定，利用激光输出调节模块(13)调节激光的输出；A. The imaging diagnosis module of the laser image stabilization and treatment device is used to obtain the reflection signal returned from any angle of the fundus or/and the image data of the fundus through the first imaging module (11) and the coupling module (14) built in it. ; And using the laser treatment module, through its built-in second imaging module (12) real-time tracking and locking of fundus targets, using the laser output adjustment module (13) to adjust the output of the laser;
B、设定数据控制装置，利用成像控制模块(22)对第一成像模块(11) 和第二成像模块(12)进行实时的控制眼底成像和实时的眼底目标跟踪与锁定；利用激光控制模块(21)控制或/和调制激光信号，并通过激光输出调节模块(13)调节激光的输出；以及利用图像数据采集模块(23)分别从所述第一成像模块(11)和第二成像模块(12)获取眼底成像和激光治疗目标的影像数据。B. Set the data control device, use the imaging control module (22) to control the fundus imaging and real-time fundus target tracking and locking on the first imaging module (11) and the second imaging module (12); use the laser control module (21) Control or/and modulate the laser signal, and adjust the output of the laser through the laser output adjustment module (13); and use the image data acquisition module (23) to separately obtain data from the first imaging module (11) and the second imaging module (12) Obtain image data of fundus imaging and laser treatment targets.
步骤B之后还包括：C、通过与所述图像数据采集模块(23)数据相连的图像显示装置(3)，实时显示和观察眼底治疗部位的影像。After step B, it also includes: C. Through the image display device (3) connected with the image data acquisition module (23), real-time display and observation of the image of the fundus treatment site.
步骤C之后还包括：D、利用与所述数据控制装置(2)数据相连的数据处理装置(4)，接收眼底影像数据并保存在患者数据库文档中。After step C, it also includes: D. Using the data processing device (4) connected with the data control device (2) to receive the fundus image data and save it in the patient database file.
本发明的智能眼底激光手术治疗装置、***及其实现方法，具有如下有益效果：The intelligent fundus laser surgery treatment device, system and implementation method of the present invention have the following beneficial effects:
1)本发明的眼底激光手术治疗装置和***，为眼科眼底激光手术提供了可视化的智能解决方案，通过提供实时的人眼眼底图像采集、实时疾病分析和规划治疗参考区域以及自适应调整激光剂量，能够在操作员的干预下，进行激光治疗。1) The fundus laser surgery treatment device and system of the present invention provide a visualized intelligent solution for ophthalmic fundus laser surgery, by providing real-time human fundus image acquisition, real-time disease analysis, planning treatment reference area, and adaptive adjustment of laser dose , Can perform laser treatment under the intervention of the operator.
2)本发明将多种眼科眼底成像技术与激光治疗技术融为一体，可实现一站式的诊断+治疗的服务，同时，还可实现智能化、自动化、高精度的治疗，并简化了操作，提高患者的体验。2) The present invention integrates a variety of ophthalmological fundus imaging technologies and laser treatment technologies, which can realize one-stop diagnosis + treatment services, and at the same time, it can also realize intelligent, automated, and high-precision treatment, and simplify the operation To improve the patient’s experience.
3)本发明的眼底激光手术治疗装置，能够通过机械装置，集成治疗激光功能，并与成像装置共享硬件，具有节约成本的特点。3) The fundus laser surgery treatment device of the present invention can integrate the treatment laser function through a mechanical device and share hardware with the imaging device, which has the characteristics of cost saving.
4)本发明的眼底激光手术治疗装置，还提供了多种成像诊断功能，包括：共聚焦激光(SLO)或者线扫描成像(LSO)，横截面断层扫描成像(OCT)，眼底相机(fundus camera)，甚至超高清的自适应眼底成像仪(AOSLO)；同时，还提供多种成像模块组合，比如SLO+OCT，fundus camera+OCT，fundus camera+SLO，或者AOSLO+SLO等。因此，能够适应不同的、复杂的应用场景，提供实时的眼底成像和实时的稳像。4) The fundus laser surgery treatment device of the present invention also provides a variety of imaging diagnostic functions, including: confocal laser (SLO) or line scan imaging (LSO), cross-sectional tomography (OCT), fundus camera (fundus camera) ), even ultra-high-definition adaptive fundus imager (AOSLO); at the same time, it also provides a variety of imaging module combinations, such as SLO+OCT, fundus camera+OCT, fundus camera+SLO, or AOSLO+SLO. Therefore, it can adapt to different and complex application scenarios, and provide real-time fundus imaging and real-time image stabilization.
5)本发明基于眼底视网膜面成像功能，比如SLO或fundus camera的高精度眼底导航与目标跟踪***，能够保证临床医生方便选择病理区；同时，还提供智能疾病诊断功能(采用人工智能技术)，帮助医生进行术前的规划，提供手术参考区域，简化操作。5) The present invention is based on the fundus retinal surface imaging function, such as SLO or fundus camera's high-precision fundus navigation and target tracking system, which can ensure that clinicians can easily select pathological areas; at the same time, it also provides intelligent disease diagnosis functions (using artificial intelligence technology), Help doctors plan before surgery, provide reference areas for surgery, and simplify operations.
6)本发明采用了数据控制和数据处理***，能够分析术前成像，对病情进行诊断和影像资料进数据库备案；能够结合实时成像，方便医生在治疗时确认治疗区域准确无误；以及分析术后成像，方便临床医生进行手术评价，同时将术后影像数据录入数据库，方便索引和进一步应用。6) The present invention adopts a data control and data processing system, which can analyze preoperative imaging, diagnose the condition and record the image data into the database; it can combine real-time imaging to facilitate the doctor to confirm the accuracy of the treatment area during treatment; and analyze after the operation Imaging is convenient for clinicians to evaluate surgery, and at the same time, post-operative imaging data is entered into the database for easy indexing and further application.
7)本发明的激光输出调节模块和激光控制模块，能够结合眼底影像数据反馈进行智能激光打击，可以实现精准打击，利用低功率同色光进行目标识别，在锁定治疗区域后，实现精确激光治疗，帮助临床工作者进行操作。激光治疗装置，还可以自动调节光斑大小，操作人员可以根据需要自行选择光斑尺寸；可以用传统的CW激光做激光源，也可用皮秒或者飞秒激光做为光源；在采用飞秒激光进行眼底激光手术时，可利用photomechanical光机械效应，达到精准治疗的目的。7) The laser output adjustment module and laser control module of the present invention can combine fundus image data feedback to perform intelligent laser strikes, can achieve precise strikes, use low-power, same-color light for target recognition, and achieve precise laser treatment after locking the treatment area. Help clinicians to operate. The laser treatment device can also automatically adjust the size of the spot. The operator can choose the spot size according to the needs; traditional CW laser can be used as the laser source, or picosecond or femtosecond laser can be used as the light source; when using femtosecond laser for fundus In laser surgery, photomechanical effects can be used to achieve the purpose of precise treatment.
附图说明Description of the drawings
图1为本发明实施例智能眼底激光手术治疗***示意图；Figure 1 is a schematic diagram of a smart fundus laser surgery treatment system according to an embodiment of the present invention;
图2为本发明图1所示激光稳像及治疗装置1的一种硬件实现方式原理示意图；FIG. 2 is a schematic diagram of a hardware implementation of the laser image stabilization and treatment device 1 shown in FIG. 1 of the present invention;
图3为一个典型的SLO快扫描和慢扫描的机制示意图；Figure 3 is a schematic diagram of a typical SLO fast scan and slow scan mechanism;
图4为图2所示的分光装置S1的一种实现方式示意图；4 is a schematic diagram of an implementation manner of the spectroscopic device S1 shown in FIG. 2;
图5为锯齿波叠加偏移量实现在锯齿波扫描方向的眼底跟踪方式示意图；Figure 5 is a schematic diagram of fundus tracking in the sawtooth wave scanning direction realized by the sawtooth wave superimposed offset;
图6为本发明实施例控制反射镜M3的一种机械装置原理示意图；6 is a schematic diagram of a mechanical device for controlling the mirror M3 according to an embodiment of the present invention;
图7为本发明实施例用于控制OCT在眼底的扫描空间位置的一种二维扫描方式示意图；FIG. 7 is a schematic diagram of a two-dimensional scanning method for controlling the position of OCT in the scanning space of the fundus according to an embodiment of the present invention;
图8为本发明实施例与所述辅模块光源对应的一种分光装置S3的设计方式示意图；FIG. 8 is a schematic diagram of a design method of a spectroscopic device S3 corresponding to the auxiliary module light source according to an embodiment of the present invention;
图9为本发明实施例用于通知用户以及主机控制***当前辅模块是成像模式2还是激光治疗的一种机械结合电子相结合的装置原理示意图。FIG. 9 is a schematic diagram of a mechanical and electronic combined device for notifying the user and the host control system of whether the current auxiliary module is imaging mode 2 or laser treatment according to an embodiment of the present invention.
具体实施方式Detailed ways
下面结合附图及本发明的实施例对本发明作进一步详细的说明。The present invention will be further described in detail below in conjunction with the drawings and embodiments of the present invention.
图1为本发明实施例智能眼底激光手术治疗***示意图。Fig. 1 is a schematic diagram of a smart fundus laser surgery treatment system according to an embodiment of the present invention.
如图1所示，该智能眼底激光手术治疗***，也是一个眼科诊疗平台。主要包括激光稳像及治疗装置1、数据控制装置2、图像显示装置3。较佳地，还可以包括数据处理装置4。其中：As shown in Figure 1, the intelligent fundus laser surgery treatment system is also an ophthalmology diagnosis and treatment platform. It mainly includes laser image stabilization and treatment device 1, data control device 2, image display device 3. Preferably, a data processing device 4 may also be included. among them:
所述的激光稳像及治疗装置1，进一步包括成像诊断模块1A和激光治疗模块1B。作为另一个实施例，所述激光治疗模块1B，可以与其中一个成像模块(即第二成像模块12)组合构成；较佳地，还可以与所述第二成像模块12共享硬件，以达到节约成本和方便控制的目的。The laser image stabilization and treatment device 1 further includes an imaging diagnosis module 1A and a laser treatment module 1B. As another embodiment, the laser treatment module 1B can be combined with one of the imaging modules (ie, the second imaging module 12); preferably, it can also share hardware with the second imaging module 12 to achieve savings The purpose of cost and convenience control.
其中，所述激光治疗模块1B，包括激光输出调节模块13和第二成像模块12；所述成像诊断模块1A，包括第一成像模块11和耦合模块14。Wherein, the laser treatment module 1B includes a laser output adjustment module 13 and a second imaging module 12; the imaging diagnosis module 1A includes a first imaging module 11 and a coupling module 14.
具体的，在本实施例中，将第一成像模块11设置为主模块(master module)，相应的其内部的扫描镜为主扫描镜(master scanners)。将第二成像模块12和激光输出调节模块13(用于激光治疗)设置为辅模块(slave module)，相应的其内部的扫描镜即为辅扫描镜(slave scanners)。所述第一成像模块11，可以为共聚焦激光扫描成像(SLO)或者线扫描眼底相机(LSO)、或者眼底相机(fundus camera)，或超高清的自适应眼底成像仪(AOSLO)。所述第二成像模块12，可以是光相干断层扫描仪(OCT)或SLO。相应的，所述的第一成像模块11和第二成像模块12，支持多种成像模块组合，例如SLO+OCT、fundus camera+OCT、fundus camera+SLO、或 者AOSLO+SLO等形式。Specifically, in this embodiment, the first imaging module 11 is set as a master module, and correspondingly, the internal scanning mirrors are master scanners. The second imaging module 12 and the laser output adjustment module 13 (used for laser treatment) are configured as slave modules, and the corresponding internal scanning mirrors are slave scanners. The first imaging module 11 may be a confocal laser scanning imaging (SLO) or a line scan fundus camera (LSO), or a fundus camera (fundus camera), or an ultra-high definition adaptive fundus imager (AOSLO). The second imaging module 12 may be an optical coherence tomography (OCT) or SLO. Correspondingly, the first imaging module 11 and the second imaging module 12 support multiple imaging module combinations, such as SLO+OCT, fundus camera+OCT, fundus camera+SLO, or AOSLO+SLO.
所述激光输出调节模块13内置变焦镜头，用于调节激光输出剂量大小，还可通过改变变焦透镜(zoom lens)的位置，控制眼底激光光斑的大小，方便临床操作。The laser output adjustment module 13 has a built-in zoom lens for adjusting the laser output dose, and can also control the size of the fundus laser spot by changing the position of the zoom lens, which is convenient for clinical operation.
所述的数据控制装置2，进一步包括激光控制模块21、成像控制模块22和图像数据采集模块23。其中：The data control device 2 further includes a laser control module 21, an imaging control module 22 and an image data acquisition module 23. among them:
通过所述数据控制装置2，通过成像控制模块22，实时的控制第一成像模块11和第二成像模块12。进一步的，利用第一成像模块11，如SLO、LSO或/和第二成像模块12，如OCT，通过振镜进行扫描成像。Through the data control device 2 and the imaging control module 22, the first imaging module 11 and the second imaging module 12 are controlled in real time. Further, the first imaging module 11, such as SLO, LSO, or/and the second imaging module 12, such as OCT, are used for scanning and imaging through a galvanometer.
所述数据控制模块2通过调节***的时钟信号、振幅、频率等参数，实现对眼底的实时扫描。同时，所述数据控制模块2，还能够同时控制第一成像模块11、第二成像模块12里的振动光学器件，任意(角度)改变扫描参数，如成像的大小、图像的帧频、图像亮度和灰度控制以及图像像素分辨率、图像的动态范围等。并且，还能够通过所述图像数据采集模块23的数据采集端口进行图像采集，并实时将第一成像模块11、第二成像模块12的眼底影像通过图像显示装置3上显示出来，以方便临床医生进行实时观察和诊断。The data control module 2 realizes real-time scanning of the fundus by adjusting the clock signal, amplitude, frequency and other parameters of the system. At the same time, the data control module 2 can also control the vibrating optics in the first imaging module 11 and the second imaging module 12 at the same time, and change the scanning parameters arbitrarily (angle), such as the size of the image, the frame rate of the image, and the image brightness. And gray scale control, image pixel resolution, image dynamic range, etc. In addition, image acquisition can be performed through the data acquisition port of the image data acquisition module 23, and the fundus images of the first imaging module 11 and the second imaging module 12 can be displayed on the image display device 3 in real time to facilitate clinicians Perform real-time observation and diagnosis.
较佳地，临床医生可以通过数据处理装置4，对获得的影像进行实时分析，并给出相关的参考治疗方案。例如：标出参考治疗区域，给出每个区域对应的参考激光剂量标准，给出每个区域对应的激光光斑大小等。Preferably, the clinician can use the data processing device 4 to analyze the obtained images in real time, and provide relevant reference treatment plans. For example: mark the reference treatment area, give the reference laser dose standard corresponding to each area, give the laser spot size corresponding to each area, etc.
此外，本发明实施例的激光稳像及治疗装置1，能够实现眼底目标跟踪和锁定功能，具体过程是：通过第一成像模块11获取的眼底图像信息，计算出实时的人眼运动信号(包括motion signal x和y)，被发送到数据控制装置2中，所述数据控制装置2通过成像控制模块22输出实时的控制信号，改变第二成像模块12中振镜的位置，并与目标实时锁定，达到实时的目标跟踪与锁定的目的。其中，实时控制信号会经过事先的标定，以保证振镜位置的改变与实际人眼偏移的大小一致。In addition, the laser image stabilization and treatment device 1 of the embodiment of the present invention can realize fundus target tracking and locking functions. The specific process is: using the fundus image information acquired by the first imaging module 11 to calculate real-time human eye movement signals (including motion signal x and y) are sent to the data control device 2. The data control device 2 outputs real-time control signals through the imaging control module 22 to change the position of the galvanometer in the second imaging module 12 and lock it with the target in real time , To achieve the purpose of real-time target tracking and locking. Among them, the real-time control signal will be calibrated in advance to ensure that the change of the galvanometer position is consistent with the actual eye offset.
在本发明实施例中，激光治疗装置的激光输出调节模块13和第二成像模块12支持共用一个硬件***。也可以通过耦合器配合来实现眼底成像与激光治疗一体工作的功能。In the embodiment of the present invention, the laser output adjustment module 13 and the second imaging module 12 of the laser treatment device support sharing a hardware system. The function of fundus imaging and laser treatment can also be realized through the cooperation of the coupler.
所述数据控制装置2，能够分别通过成像控制模块22和激光控制模块21，分别实时的控制眼底目标进行成像和调节激光输出调节模块13中激光的输出，包括调节输出功率、输出开关、输出信号的调制等。The data control device 2 can control the fundus target to perform imaging and adjust the laser output in the laser output adjustment module 13 in real time through the imaging control module 22 and the laser control module 21, respectively, including adjusting output power, output switches, and output signals. Modulation and so on.
所述激光控制模块21，可以用两个波长接近的激光，也可以用同一个激光既作治疗激光，也做参考光。在本实施例中，激光光源可以选择532nm的CW，或者飞秒激光***。The laser control module 21 can use two lasers with similar wavelengths, or the same laser can be used as both the treatment laser and the reference light. In this embodiment, the laser light source can be a 532nm CW or a femtosecond laser system.
在激光治疗结束后，临床医生还可以通过图像显示装置3的显示屏幕实时观察治疗后患者眼底的影像，实时评判手术结果，并支持将眼底的影像上传至数据处理装置4中的患者数据库文档中，以方便后期随访观察。After the laser treatment is over, the clinician can also observe the image of the fundus of the patient after treatment in real time through the display screen of the image display device 3, evaluate the results of the operation in real time, and support the upload of the fundus image to the patient database file in the data processing device 4 , In order to facilitate later follow-up observation.
本发明实施例中是以人眼眼底为例。由所述第一成像模块11、第二成像模块12以及耦合模块14等构成的激光稳像及治疗装置1，还可以用于其他不同的生物组织,比如肠胃、皮肤等部位。以下描述内容仍然以应用于人的眼底为例进行说明。In the embodiment of the present invention, the human eye fundus is taken as an example. The laser image stabilization and treatment device 1 composed of the first imaging module 11, the second imaging module 12, and the coupling module 14 can also be used for other different biological tissues, such as stomach, skin and other parts. The following description is still applied to human fundus as an example.
图2为本发明图1所示激光稳像及治疗装置1的一种硬件实现方式原理示意图。FIG. 2 is a schematic diagram of a hardware implementation of the laser image stabilization and treatment device 1 shown in FIG. 1 of the present invention.
如图2所示，该激光稳像及治疗装置，可以作为一种独立的激光眼底导航和治疗设备使用，也可以与其他的数据控制装置相结合作为一套完整的激光手术治疗***进行临床应用。As shown in Figure 2, the laser image stabilization and treatment device can be used as an independent laser fundus navigation and treatment equipment, or it can be combined with other data control devices as a complete laser surgery treatment system for clinical application .
图2中，光源L11、L12、…、L1n，为分别通过控制(信号)11、12、…、1n控制(或调制)，用于第一成像模块11进行成像的多个成像光源。例如，将波长为780nm的红外光用于眼底反射成像，将波长为532nm的光用于眼底自发荧光成像,或者采用其他波段的光源用于其他形式的眼底成像。所述多个成像光源，可以通过光纤耦合器件FC2进入光学***，所述的光源 L11…L1n的任何一个光源，都是可控制(或者调制)的，如图2中主模块所示的控制信号，即控制(信号)11，…，控制(信号)1n。所述的控制(或调制)参数，包括输出功率、开关状态等，还可以选择性地和扫描镜同步或者非同步进行。其中，与扫描镜同步进行的相关技术已在之前提交的专利申请中有详细说明，这里不再赘述。In FIG. 2, the light sources L11, L12,..., L1n are multiple imaging light sources that are controlled (or modulated) by the control (signal) 11, 12,..., 1n, respectively, for the first imaging module 11 to perform imaging. For example, infrared light with a wavelength of 780 nm is used for fundus reflection imaging, and light with a wavelength of 532 nm is used for fundus autofluorescence imaging, or light sources of other wavelength bands are used for other forms of fundus imaging. The multiple imaging light sources can enter the optical system through the fiber coupling device FC2, and any one of the light sources L11...L1n is controllable (or modulated), as shown in the control signal of the main module in Figure 2 , Namely control (signal) 11,..., control (signal) 1n. The control (or modulation) parameters, including output power, switch state, etc., can also be selectively synchronized with the scanning mirror or asynchronously. Among them, the related technology synchronized with the scanning mirror has been described in detail in the previously filed patent application, and will not be repeated here.
所述成像光源L11…L1n，透射过分光装置S1,经过扫描反射镜M11和扫描反射镜M12后，再经过分光装置S2后，进入眼(eye)底。The imaging light sources L11...L1n pass through the beam splitting device S1, pass through the scanning mirror M11 and the scanning mirror M12, and then pass through the beam splitting device S2, and enter the bottom of the eye.
从眼底返回的信号，如感光细胞的反射信号，或者眼底蛋白质被激发出来的荧光信号，或者其他从眼底返回的信号，会沿着同样的光学路径，反射到达分光装置S1，然后经过另一个可移动的分光装置S3到达光电探测器，如雪崩光电二极管(Avalanche Photo Diode，APD)。本发明实施例中，以APD作为一个光电探测器为例进行说明。所述的光电探测器，还也可以是光电倍增管(Photo Multiplier，PMT)、CMOS、CCD,或者其他光电探测器件。The signal returned from the fundus, such as the reflected signal of the photoreceptor cells, or the fluorescent signal excited by the fundus protein, or other signals returned from the fundus, will be reflected along the same optical path to reach the spectroscopic device S1, and then pass through another optical path. The moving spectroscopic device S3 arrives at a photodetector, such as an avalanche photodiode (APD). In the embodiment of the present invention, the APD is used as a photodetector as an example for description. The photodetector can also be a photomultiplier tube (PMT), CMOS, CCD, or other photodetector devices.
本发明实施例中，以上所述的光电探测器(如APD、PMT,CMOS,CCD)均设置有可控或者可编程的增益调节机制,能够通过接收***主机的程序控制信号进行动态调整,以便适应不同的成像模式，例如，通过图2所示的控制信号4进行动态调整。In the embodiment of the present invention, the above-mentioned photodetectors (such as APD, PMT, CMOS, CCD) are equipped with a controllable or programmable gain adjustment mechanism, which can be dynamically adjusted by receiving the program control signal of the system host, so as to Adapt to different imaging modes, for example, through the control signal 4 shown in Figure 2 for dynamic adjustment.
图2所示的一组扫描反射镜M11和M12，主要用于正交扫描眼底成像位置，扫描反射镜M11和M12的扫描轴通常是90度。The set of scanning mirrors M11 and M12 shown in FIG. 2 are mainly used for orthogonal scanning of the fundus imaging position. The scanning axes of the scanning mirrors M11 and M12 are usually 90 degrees.
第一成像模块11在对应SLO的情况下，扫描反射镜M11可以是快速共振镜(resonant scanner)，一个典型的实际应用场景是：设置扫描反射镜M11在水平方向扫描，设置M12在垂直方向扫描，M12为一个慢速线性扫描镜。在通用的情况下，扫描反射镜M11和M12的正交扫描方向，支持在二维空间的360度任意方向扫描。在本发明实施例中，扫描反射镜M11采用Cambridge Technology的CRS8k快速共振镜，在其他应用***中，还可以采 用CRS12k或者其他型号的快速共振镜。In the case of the first imaging module 11 corresponding to SLO, the scanning mirror M11 can be a resonant scanner. A typical practical application scenario is: setting the scanning mirror M11 to scan in the horizontal direction and setting M12 to scan in the vertical direction , M12 is a slow linear scanning mirror. In general, the orthogonal scanning direction of the scanning mirrors M11 and M12 supports scanning in any direction of 360 degrees in a two-dimensional space. In the embodiment of the present invention, the scanning mirror M11 adopts the CRS8k fast resonant mirror of Cambridge Technology. In other application systems, the CRS12k or other fast resonant mirrors can also be used.
第一成像模块11在对应SLO的情况下，本发明实施例的扫描反射镜M12，可以由一个二维倾斜扫描镜(steering mirror)或者两个一维倾斜扫描镜来实现。在本发明的实际光机***中，扫描反射镜M12采用Cambridge Technology的一组2维扫描镜6220H(或者6210H)。6220H的第一个轴-慢速扫描轴,与M11快速扫描轴的扫描方向正交；6220H的第二个轴，不参与扫描而是仅用于目标跟踪，与M11的扫描轴平行。When the first imaging module 11 corresponds to the SLO, the scanning mirror M12 in the embodiment of the present invention may be implemented by one two-dimensional steering mirror or two one-dimensional tilting scanning mirrors. In the actual opto-mechanical system of the present invention, the scanning mirror M12 adopts a set of two-dimensional scanning mirrors 6220H (or 6210H) of Cambridge Technology. The first axis of the 6220H-the slow scan axis, is orthogonal to the scan direction of the M11 fast scan axis; the second axis of the 6220H, does not participate in scanning but is only used for target tracking, and is parallel to the scan axis of M11.
在上述对应SLO的情况下，扫描反射镜M11作为快速共振镜的扫描视场(scanning field)由***主机控制,或者手动控制。In the case of the above corresponding SLO, the scanning field of the scanning mirror M11 as a fast resonant mirror is controlled by the system host or manually.
在上述实施例中，所述M12正交于M11的扫描运动轨迹是一个三角波。三角波的振幅、频率、三角波的爬升期和回程期，等扫描参数由***主机控制。三角波的振幅决定了慢扫描方向的视场大小，三角波的频率决定了图像***的帧频(参考图3)。In the above embodiment, the scanning motion track of M12 orthogonal to M11 is a triangular wave. The sweep parameters such as the amplitude and frequency of the triangle wave, the climb period and the return period of the triangle wave, and so on are controlled by the system host. The amplitude of the triangle wave determines the size of the field of view in the slow scan direction, and the frequency of the triangle wave determines the frame rate of the image system (refer to Figure 3).
图3为一个典型的SLO快扫描和慢扫描的机制示意图。快速共振镜每扫描一个周期，慢速镜线性增加一步。Figure 3 is a schematic diagram of a typical SLO fast scan and slow scan mechanism. The fast resonant mirror scans one cycle, the slow mirror linearly increases by one step.
如图3所示，通常情况下，所述SLO的快(共振)扫描每完成一个正弦(或者余弦)周期11，慢(线性)扫描在正交方向移动一步12。这样，图像帧频(fps)，快速扫描镜的共振频率(f)，以及每帧图像包含的线的数量(N)(通常代表最大图像高度，特殊情况下也可以作为图像宽度)，满足如下关系：As shown in Fig. 3, under normal circumstances, each time the fast (resonant) scan of the SLO completes a sine (or cosine) period 11, the slow (linear) scan moves one step 12 in the orthogonal direction. In this way, the image frame rate (fps), the resonance frequency (f) of the fast scanning mirror, and the number of lines (N) contained in each frame of the image (usually representing the maximum image height, in special cases can also be used as the image width), meet the following requirements relationship:
f＝fps·Nf=fps·N
上式中，N包含了图3部分的所有扫描线121和122。其中，121是锯齿波的上升爬行期，122是回程期。In the above formula, N includes all the scan lines 121 and 122 in the part of FIG. 3. Among them, 121 is the rising creeping period of the sawtooth wave, and 122 is the returning period.
SLO的图像一般不包括图3的122部分，因为122期间的图像和121期间的有不同的像素压缩比例。SLO的图像一般仅仅从图3的121部分获取。The SLO image generally does not include the 122 part of FIG. 3, because the image during the 122 period and the image during the 121 period have different pixel compression ratios. SLO images are generally only obtained from part 121 of Figure 3.
图2中所示的分光装置S1作用是透过所有从耦合器件FC2过来的入射 光，但是反射所有从眼底过来的信号到APD。一种实现模式是在S1的轴心挖出一个空心圆柱让从FC2过来的入射聚焦光透过，但是反射所有从眼底过来的扩展光到光电探测器APD，如图4所示，为图2所示的分光装置S1的一种实现方式示意图。The function of the spectroscopic device S1 shown in Figure 2 is to transmit all the incident light from the coupling device FC2, but reflect all the signals from the fundus to the APD. One implementation mode is to dig out a hollow cylinder at the axis of S1 to allow the incident focused light from FC2 to pass through, but reflect all the expanded light from the fundus to the photodetector APD, as shown in Figure 4 and Figure 2 A schematic diagram of an implementation of the spectroscopic device S1 is shown.
如上所述，图2的扫描反射镜M12有两个独立的运动轴。第一个运动轴和M11的运动(扫描)轴正交，第二个运动轴和M11的运动(扫描)轴平行。As mentioned above, the scanning mirror M12 of FIG. 2 has two independent motion axes. The first movement axis is orthogonal to the movement (scanning) axis of M11, and the second movement axis is parallel to the movement (scanning) axis of M11.
扫描反射镜M12和M11的运动(扫描)轴正交的运动轴，可接收***主机的两种信号：一种是图3显示的锯齿波(如121和122)，另一种是叠加在锯齿波之上的平移信号。其中，锯齿波用来扫描眼底得到眼底图像，平移信号用于光学跟踪眼底在锯齿波扫描方向的眼球运动。如图5所示。The movement (scanning) axis of the scanning mirrors M12 and M11 are orthogonal to the movement axis, which can receive two signals from the system host: one is the sawtooth wave shown in Figure 3 (such as 121 and 122), and the other is superimposed on the sawtooth The translation signal above the wave. Among them, the sawtooth wave is used to scan the fundus to obtain a fundus image, and the translation signal is used to optically track the eyeball movement of the fundus in the scanning direction of the sawtooth wave. As shown in Figure 5.
图5为锯齿波叠加偏移量实现在锯齿波扫描方向的眼底跟踪方式示意图。Fig. 5 is a schematic diagram of fundus tracking mode of sawtooth wave superimposed offset in the sawtooth wave scanning direction.
如图5所示，当目标(如眼球)在某一个参考时刻的时候，也就是跟踪算法的参考面，锯齿波的扫描中心在一个相对的零位置。当眼球相对于这个参考面开始运动时，控制主机实时调整锯齿波的偏移量来跟踪眼底相对于这个参考面的位置。As shown in Figure 5, when the target (such as the eyeball) is at a certain reference moment, that is, the reference plane of the tracking algorithm, the scan center of the sawtooth wave is at a relative zero position. When the eyeball starts to move relative to this reference surface, the control host adjusts the offset of the sawtooth wave in real time to track the position of the fundus relative to this reference surface.
以上所述的***控制主机，可以是一个设置有相应控制程序模块的PC机，也可以是包含场可编程逻辑阵列(Field Programming Gate Array，FPGA)的装置，也可以是包含数字信号处理器(Digital Signal Processor，DSP)的装置，也可以是采用其他类型电子信号处理器的装置，还也可以是包含这些硬件的组合装置。The system control host mentioned above can be a PC equipped with a corresponding control program module, or a device containing a field programmable logic array (Field Programming Gate Array, FPGA), or a digital signal processor ( Digital Signal Processor (DSP) devices may also be devices that use other types of electronic signal processors, or they may be combined devices that include these hardware.
例如：本发明的实施例中，该控制装置中，采用了一个Intel PC(Intel i7)机搭载nVidia图像处理器(Graphic Processing Unit，GPU)，如GTX1050，用于计算眼球运动信号(x,y,θ)，然后通过Xilinx FPGA(考虑到成本因素，本发明实施例采用Virtex-5的器件ML507或者Spartan 6的SP605；将来也可以用功能更强大但也更昂贵的Virtex-6，Virtex-7，Kintex-7，Artix-7 等最新系列的FPGA器件，也可以用其他厂家比如Altera的FPGA器件)，通过将(x,y,θ)的y部分数字合成为图5的信号形式，之后送到一个数模转换芯片(Digital-to-Analog Converter，DAC)，如Texas Instruments的DAC5672，去控制扫描反射镜M12的第一个运动轴。For example, in the embodiment of the present invention, the control device uses an Intel PC (Intel i7) machine equipped with nVidia graphics processing unit (GPU), such as GTX1050, for calculating eye movement signals (x, y ,θ), and then through Xilinx FPGA (considering cost factors, the embodiment of the present invention uses Virtex-5 device ML507 or Spartan 6 SP605; more powerful but also more expensive Virtex-6, Virtex-7 , Kintex-7, Artix-7 and other latest series of FPGA devices, or other manufacturers such as Altera FPGA devices), by digitally synthesizing the y part of (x, y, θ) into the signal form of Figure 5, and then send it Go to a Digital-to-Analog Converter (DAC), such as Texas Instruments' DAC5672, to control the first movement axis of the scanning mirror M12.
图5中的信号也可以通过模拟合成来实现。这种情况下，图5的锯齿波由第一个DAC产生第一个模拟信号。图5的偏移量，也是(x,y,θ)的y分量，由第二个DAC产生第二个模拟信号。通过模拟信号混合器把这两个模拟信号合成，最后送到扫描反射器M12的第一个运动轴。The signal in Figure 5 can also be realized by analog synthesis. In this case, the sawtooth wave in Figure 5 is generated by the first DAC to generate the first analog signal. The offset in Figure 5 is also the y component of (x, y, θ), and the second analog signal is generated by the second DAC. The two analog signals are synthesized by the analog signal mixer, and finally sent to the first movement axis of the scanning reflector M12.
所述信号(x,y,θ)的x由另外一个单独的DAC产生模拟信号，输送到M12的第二个运动轴，用来跟踪眼球在第二个运动轴的运动。本发明实施例里，扫描反射镜M12的第二个运动轴和M11的扫描轴平行。The x of the signal (x, y, θ) is an analog signal generated by another separate DAC and sent to the second movement axis of M12 to track the movement of the eyeball on the second movement axis. In the embodiment of the present invention, the second movement axis of the scanning mirror M12 is parallel to the scanning axis of M11.
上述眼球运动信号(x,y,θ)的平移部分(x,y)有M12的两个正交运动轴来实现闭环光学跟踪。第一成像模块11的旋转部分(θ)在发明实施例中，采用数字跟踪来实现，但是将来也可以用光学或/和机械的闭环跟踪方式来实现。旋转部分(θ)的光学或/和机械跟踪相关技术，已经在美国专利US9775515中有详细的描述。The translational part (x, y) of the above-mentioned eye movement signal (x, y, θ) has two orthogonal movement axes of M12 to realize closed-loop optical tracking. The rotating part (θ) of the first imaging module 11 is implemented by digital tracking in the embodiment of the invention, but it can also be implemented by optical or/and mechanical closed-loop tracking in the future. The optical or/and mechanical tracking related technology of the rotating part (θ) has been described in detail in US Patent No. 9775515.
本发明实施例中提到的经常切换的两个关键术语：眼底跟踪和眼球跟踪。在本发明相关的技术里，眼底跟踪和眼球跟踪是一个概念。临床应用时，物理上的绝大部分运动来自眼球，眼球的运动导致成像***得到的眼底图像在空间上伴随时间的随机变化。等效的后果是成像***的任意一个时刻，从不同的眼底位置得到了不同的图像，观察到的结果是图像随时间在随机抖动。本发明实施例中的跟踪技术是在成像***里，通过眼底图像实时捕捉眼球运动信号(x,y,θ)，然后把(x,y)反馈到图2的M12里，实现任意时刻把两个扫描镜(M11和M12正交于M11的方向)的扫描空间锁定在一个预先定义好的眼底物理空间，从而实现精确的眼底跟踪，稳定了眼底图像在空间上随时间的随机变化。Two key terms that are frequently switched mentioned in the embodiment of the present invention: fundus tracking and eye tracking. In the technology related to the present invention, fundus tracking and eye tracking are a concept. In clinical application, most of the physical movement comes from the eyeball, and the movement of the eyeball causes the fundus image obtained by the imaging system to change randomly in space with time. The equivalent consequence is that at any time of the imaging system, different images are obtained from different fundus positions, and the observed result is that the images jitter randomly over time. The tracking technology in the embodiment of the present invention is to capture eye movement signals (x, y, θ) in real time through fundus images in the imaging system, and then feed back (x, y) to M12 in FIG. The scanning space of two scanning mirrors (M11 and M12 are orthogonal to the direction of M11) is locked in a pre-defined fundus physical space, so as to realize accurate fundus tracking and stabilize the random changes of fundus images in space over time.
图2中的成像模式(对应主模块)构成一个完整的闭环控制***，用于高速实时跟踪眼底位置。该部分的技术已经在两个美国专利US9406133和US9226656中有详细的描述。The imaging mode in Figure 2 (corresponding to the main module) constitutes a complete closed-loop control system for high-speed real-time tracking of fundus position. This part of the technology has been described in detail in two US patents US9406133 and US9226656.
图2的成像模式2即左侧“从L2-M3-M2-S2-眼底”和图1中所示的成像模式1(主模块)相对应。一个典型的应用是应用光学相干断层扫描(Optical Coherence Tomography,OCT)成像技术。The imaging mode 2 in FIG. 2 that is "slave L2-M3-M2-S2- fundus" on the left corresponds to the imaging mode 1 (main module) shown in FIG. A typical application is the application of optical coherence tomography (Optical Coherence Tomography, OCT) imaging technology.
图2中，“L31/L32-M2-S2-眼底”和图1描述的眼底激光治疗装置相对应。OCT和眼底激光治疗的功能实现，在下文有详细说明。In Figure 2, "L31/L32-M2-S2-Fundus" corresponds to the fundus laser treatment device described in Figure 1. The functional realization of OCT and fundus laser treatment is described in detail below.
M3为一个可移动的反射镜。移动方式可以是机械方式，也可以是电子方式，也可以是两者的结合。所述反射镜M3的可移动的部件也可以由一个分光装置来取代。M3 is a movable mirror. The movement method can be mechanical, electronic, or a combination of the two. The movable part of the mirror M3 can also be replaced by a beam splitting device.
本发明实施例中，使用机械的方式控制反射镜M3的状态。M3进/出光学***的状态由图2的耦合器件FC1状态决定。当光源L31/L32通过FC1接入光学***时，M3被推出光学***，L31/L32的光直接到达反射镜M2。当FC1没有接入光学***时，M3放置在图2所示的位置，用来反射L2过来的光到达反射镜M2。可移动的反射镜M3受FC1机械控制的原理如图6所示。In the embodiment of the present invention, the state of the mirror M3 is controlled mechanically. The state of the M3 entry/exit optical system is determined by the state of the coupling device FC1 in Figure 2. When the light source L31/L32 is connected to the optical system through FC1, M3 is pushed out of the optical system, and the light of L31/L32 directly reaches the mirror M2. When FC1 is not connected to the optical system, M3 is placed in the position shown in Figure 2 to reflect the light from L2 to the mirror M2. The principle that the movable mirror M3 is mechanically controlled by FC1 is shown in Figure 6.
图6为本发明实施例控制反射镜M3的一种机械装置原理示意图。Fig. 6 is a schematic diagram of a mechanical device for controlling the mirror M3 according to an embodiment of the present invention.
如图6所示，在该机械装置中，根据FC1的***和拔出机制来将M3推出或者放入光学***。开关通过一个连杆连接可以折叠的镜架，当开关位于图示90度时，镜架打开，同时FC1的接口也打开，可以接入治疗激光。如图6A所示。当开关合上，如图6B所示，位于0度时，FC1接口关闭，此时不能接入治疗激光，同时，可折叠镜架也回到原位(参考图2)，可以反射成像激光L2进入***。As shown in Figure 6, in this mechanical device, the M3 is pushed out or put into the optical system according to the FC1's insertion and withdrawal mechanism. The switch is connected to the foldable frame through a connecting rod. When the switch is at 90 degrees as shown in the figure, the frame is opened and the FC1 interface is also opened, allowing access to the treatment laser. As shown in Figure 6A. When the switch is closed, as shown in Figure 6B, when it is at 0 degrees, the FC1 interface is closed. At this time, the treatment laser cannot be connected. At the same time, the foldable frame returns to the original position (refer to Figure 2), and the imaging laser L2 can be reflected. enter the system.
反射镜M3的作用是，允许用户选择辅模块(slave module)里成像模式2或者眼底激光治疗的功能之一。The function of the mirror M3 is to allow the user to select one of the functions of imaging mode 2 or fundus laser treatment in the slave module.
在实现OCT成像时，也就是以上所示的成像模式2，M3放置在图2所示“L2-M3-M2-S2-眼底”的光学路径里，让L2的光源到达眼底。When realizing OCT imaging, that is, imaging mode 2 shown above, M3 is placed in the optical path of "L2-M3-M2-S2-fundus" shown in Figure 2, so that the light source of L2 reaches the fundus.
在图2所示的成像模式2情况下，L2的光经过M3到达M2，M2是一个二维扫描镜，可以用一个具备两个独立正交控制轴有单一反射面的快速倾斜镜(如Physik Instrumente的S334.2SL)，也可以用两个一维倾斜镜正交扫描控制。本发明中使用了后者的情况，采用了美国Cambridge Technology的6210H双镜组合。In the case of imaging mode 2 shown in Figure 2, the light of L2 reaches M2 through M3. M2 is a two-dimensional scanning mirror. A fast tilt mirror with two independent orthogonal control axes and a single reflective surface (such as Physik Instrumente's S334.2SL) can also be controlled by two one-dimensional tilt mirrors for orthogonal scanning. The latter case is used in the present invention, and the 6210H dual-mirror combination of Cambridge Technology of the United States is used.
在本发明实施例，图2中的M2有多种功能。在图2所示的成像模式2情况下，***主机产生OCT扫描信号，控制M2的扫描方式，从而控制L2在眼底的二维成像空间。In the embodiment of the present invention, M2 in FIG. 2 has multiple functions. In the case of imaging mode 2 shown in Figure 2, the system host generates an OCT scan signal to control the scanning mode of M2, thereby controlling the two-dimensional imaging space of L2 in the fundus.
本发明实施例中，***主机程序通过控制FPGA产生一组如图7所示的正交扫描控制基S x和S y。这里S x和S y是带方向的矢量。 Embodiments of the present invention, the system generates a set of orthogonal host program scan control group as shown in FIG. 7 S x S y and the control FPGA. Here S x and Sy are vectors with directions.
图7为本发明实施例用于控制OCT在眼底的扫描空间位置的一种二维扫描方式示意图。FIG. 7 is a schematic diagram of a two-dimensional scanning method for controlling the position of OCT in the scanning space of the fundus according to an embodiment of the present invention.
***主机程序通过控制FPGA(如图7所示)的两个扫描基相乘各自的幅度(Ax和Ay)和正负符号，实现OCT在眼底360度任意一个方向，指定视场尺寸的二维扫描，可用以下关系式表示：The system host program controls the two scanning bases of the FPGA (as shown in Figure 7) to multiply their respective amplitudes (Ax and Ay) and positive and negative signs to realize OCT in any direction of the fundus 360 degrees, and specify the two-dimensional field of view size Scanning can be expressed by the following relation:
OCT扫描＝S xA x+S yA y； OCT scan=S x A x +S y A y ;
其中，参数A x和A y也是带符号(或者)方向的矢量；S xA x+S yA y可以实现OCT在360度二维眼底空间的任何方向，作光学***允许的任何视场尺寸扫描。 Among them, the parameters A x and A y are also vectors with signed (or) directions; S x A x +S y A y can realize OCT in any direction in the 360-degree two-dimensional fundus space, as any field size allowed by the optical system scanning.
光源L2的光经过反射镜M3，扫描镜M2，再通过分光装置S3到达眼底。本发明实施例中，L2为波长为880nm的成像光源，光源L31波长为561nm，光源L32波长为532nm。相应的，分光装置S3的设计对应不同的辅模块光源需要做不同的变更。一种方式是，对不同的辅模块(slave module)光源定制一个不同的分光装置S3放置在图2的S3位置，如图8所示。The light from the light source L2 passes through the mirror M3, the scanning mirror M2, and then reaches the fundus through the spectroscopic device S3. In the embodiment of the present invention, L2 is an imaging light source with a wavelength of 880 nm, light source L31 has a wavelength of 561 nm, and light source L32 has a wavelength of 532 nm. Correspondingly, the design of the light splitting device S3 needs to be changed differently for different auxiliary module light sources. One way is to customize a different light splitting device S3 for different slave module light sources and place it at the S3 position in FIG. 2, as shown in FIG. 8.
图8为本发明实施例与所述辅模块光源对应的一种分光装置S3的设计方式示意图。FIG. 8 is a schematic diagram of a design method of a light splitting device S3 corresponding to the auxiliary module light source according to an embodiment of the present invention.
如图8所示，分光装置S3，透射90％-95％、反射5％-10％的532nm以及830nm以上的光，透射5％-10％反射90％-95％的其他波段的光。As shown in Fig. 8, the spectroscopic device S3 transmits 90%-95% and reflects 5%-10% of light at 532nm and above 830nm, and transmits 5%-10% and reflects 90%-95% of light in other wavelength bands.
参考图2，辅模块中光源L31是用于激光治疗的瞄准光。瞄准光到达眼底，从眼底反射回来的光斑被第一成像模块11的APD接收，在SLO图像上叠加一个L31产生的光斑。这个光斑位置预示着治疗光L32在眼底将会有接近一致的空间位置。光源L31和L32在眼底的重叠程度取决于两个波长532nm和561nm在眼底产生的横向色差值(Transverse Chromatic Aberration，TCA)。Referring to Fig. 2, the light source L31 in the auxiliary module is the aiming light for laser treatment. The aiming light reaches the fundus, and the light spot reflected from the fundus is received by the APD of the first imaging module 11, and a light spot generated by L31 is superimposed on the SLO image. This spot position indicates that the treatment light L32 will have a nearly uniform spatial position on the fundus. The degree of overlap of the light sources L31 and L32 on the fundus depends on the transverse chromatic aberration (TCA) produced by the two wavelengths of 532nm and 561nm on the fundus.
本发明实施例中，所述532nm和561nm波长的光，在眼底产生的TCA不会超过10微米。也就是说，在L31的561nm瞄准光对准眼底打击位置之后，L32的532nm治疗光打错位置不会超过10微米。In the embodiment of the present invention, the light with wavelengths of 532nm and 561nm, the TCA generated on the fundus will not exceed 10 microns. In other words, after the 561nm aiming light of L31 is aimed at the striking position of the fundus, the wrong position of the 532nm treatment light of L32 will not exceed 10 microns.
L31的瞄准光到达眼底的功率一般在100微瓦以下，L32的治疗光到达眼底的功率可以是几百毫瓦或者更高功率。L31从眼底反射到APD的信号幅度和SLO的图像信号幅度接近，但是532nm的大功率治疗光仍然有相当大的信号通过分光装置S3反射到SLO。The power of the aiming light of L31 to reach the fundus is generally below 100 microwatts, and the power of the treatment light of L32 to reach the fundus can be several hundred milliwatts or higher. The amplitude of the signal reflected by L31 from the fundus to the APD is close to the amplitude of the image signal of the SLO, but the 532nm high-power therapeutic light still has a considerable signal reflected to the SLO through the spectroscopic device S3.
为了防止治疗光开启眼底激光打击，从眼底返回的532nm信号到达SLO冲击APD并且导致APD过度曝光，本发明实施例的装置里，在APD前面放置一个分光装置S3。S3反射所有550nm以下的光，透射所有550nm以上的光，起到保护APD的作用。In order to prevent the treatment light from turning on the fundus laser strike, the 532nm signal returned from the fundus reaches the SLO and impacts the APD and causes the APD to be overexposed. In the device of the embodiment of the present invention, a spectroscopic device S3 is placed in front of the APD. S3 reflects all light below 550nm and transmits all light above 550nm to protect the APD.
图3的分光镜S3是可移动的，移动状态和M3正好相反。当耦合器FC1接入光学***时，S3也接入光学***；当FC1没有接入***时，S3被推出光学***。S3的接入和推出光学***可以是机械方式、电子方式，也可以是两者方式的结合。本发明实施例中，采用的是机械方式，参考图6所示。The beam splitter S3 in Fig. 3 is movable, and its moving state is just the opposite of that of M3. When the coupler FC1 is connected to the optical system, S3 is also connected to the optical system; when FC1 is not connected to the system, S3 is pushed out of the optical system. The S3 access and push-out optical system can be mechanical, electronic, or a combination of the two. In the embodiment of the present invention, a mechanical method is adopted, as shown in FIG. 6.
如上所述，辅模块集成了两种功能，即激光成像、稳像功能，以及利用 第二成像模块12和激光输出调节模块13实现激光治疗的功能。As described above, the auxiliary module integrates two functions, namely, laser imaging, image stabilization, and the use of the second imaging module 12 and the laser output adjustment module 13 to achieve laser treatment.
上述两种功能之间的切换，是通过改变M3的位置来实现的。当M3被放置在光学***中时，第二成像模块12被激活，激光治疗装置不工作。当M3被推出光学***时，激光治疗的功能被激活，此时第二成像模块12不工作。The switching between the above two functions is achieved by changing the position of M3. When M3 is placed in the optical system, the second imaging module 12 is activated and the laser treatment device does not work. When the M3 is pushed out of the optical system, the laser treatment function is activated, and the second imaging module 12 does not work at this time.
以上是对涉及第二成像模块12的工程实现的说明。下面对本发明实施例涉及的激光治疗功能的工程实现进行描述。The above is the description of the engineering implementation involving the second imaging module 12. The engineering realization of the laser treatment function involved in the embodiment of the present invention will be described below.
参考图6，通过装在耦合器件FC1的旋钮位置来控制M3和S3在光学***的位置，实现动态切换成像模式2和激光临床治疗的功能。FC1的旋钮的另外一个作用是连接和断开一个或者多个电子装置，来提醒用户以及***主机控制程序，应该运行两种功能的哪一个。Referring to Fig. 6, the position of the M3 and S3 in the optical system is controlled by the position of the knob installed on the coupling device FC1 to realize the function of dynamically switching imaging mode 2 and laser clinical treatment. Another function of the FC1 knob is to connect and disconnect one or more electronic devices to remind the user and the system host control program which of the two functions should be run.
图9为本发明实施例用于通知用户以及主机控制***当前辅模块是成像模式2还是激光治疗的一种机械结合电子相结合的装置原理示意图。FIG. 9 is a schematic diagram of a mechanical and electronic combined device for notifying the user and the host control system of whether the current auxiliary module is imaging mode 2 or laser treatment according to an embodiment of the present invention.
如图9所示，该装置通过一个装在FC1旋钮上的一个导电金属片来控制一个LED指示灯以及给电子硬件提供高/低电平信号，以此用来通知用户和主机控制***，当前的辅模块(slave module)是工作在成像、稳像模式下还是激光治疗模式下。As shown in Figure 9, the device controls an LED indicator light and provides a high/low level signal to the electronic hardware through a conductive metal sheet mounted on the FC1 knob to notify the user and the host control system of the current Does the slave module work in imaging, image stabilization mode or laser treatment mode.
默认设置下，A和B断开，LED熄灭，C点输出0V电压或者低电平。本发明实施例中，将C点连接到FPGA用于探测输入端是低电平(0V)还是高电平(3.3V或2.5V)，以便控制软件自动切换到成像、稳像模式还是激光治疗模式。In the default setting, A and B are disconnected, the LED is off, and point C outputs a 0V voltage or low level. In the embodiment of the present invention, point C is connected to the FPGA to detect whether the input terminal is low level (0V) or high level (3.3V or 2.5V), so as to control the software to automatically switch to imaging, image stabilization or laser therapy mode.
当FC1旋钮旋转90度(或者其他角度，但是与图6一致)时，导电金属片接通A和B，使LED发光，同时C点电位上拉至高电平。以此控制程序自动切换激光治疗的功能。When the FC1 knob is rotated 90 degrees (or other angles, but consistent with Figure 6), the conductive metal piece connects A and B to make the LED light, and at the same time the potential of point C is pulled up to a high level. This control program automatically switches the function of laser treatment.
当设置为用于成像、稳像模式时，整个***也可以仅作为成像模式1的成像，比如只进行SLO/SLO成像，没有OCT。这种工作方式可以通过*** 主机控制程序实现。When set to imaging and image stabilization mode, the entire system can also be used as imaging mode 1 only, for example, only SLO/SLO imaging is performed without OCT. This way of working can be achieved through the system host control program.
在成像模式1结合激光治疗的工作模式下，图2的控制M2结合了多种的激光打击模式，包括：1)单点打击模式；2)规则空间区域阵列式打击模式；3)自定义无规则空间区域多点打击模式。In the working mode of imaging mode 1 combined with laser treatment, the control M2 in Figure 2 combines a variety of laser strike modes, including: 1) single-point strike mode; 2) regular space area array strike mode; 3) custom none Multi-point strike mode in regular space area.
所述的单点打击模式，就是用户通过成像模式1的实时图像在病理区确定欲进行激光打击位置，用瞄准光对准目标后，启动治疗光，以预先设置好的激光剂量、曝光时间等参数进行目标打击。In the single-point strike mode, the user uses the real-time image of imaging mode 1 to determine the laser strike position in the pathological area, and after aiming at the target with the aiming light, the therapeutic light is activated to preset the laser dose, exposure time, etc. Parameters for target strike.
所述的的规则空间区域阵列式打击模式，是结合了所述的单点打击模式和成像模式2的扫描方式，让用户定义好每个位置的激光剂量等参数，然后启动治疗光，等时间间隔地逐个打击预定目标。The regular space area array strike mode is a combination of the single-point strike mode and the scanning mode of imaging mode 2, allowing the user to define the laser dose and other parameters for each position, then start the treatment light, and wait for time Hit predetermined targets one by one at intervals.
所述的自定义无规则空间区域多点打击模式，是完全的自由打击模式。用户自定义打击病理区里任何一个打击位置的激光剂量、曝光时间等参数，然后逐个打击预定目标。The customized multi-point strike mode in an irregular space area is a completely free strike mode. The user customizes the laser dose, exposure time and other parameters of any strike position in the pathological zone, and then strikes the predetermined targets one by one.
较佳地，为了精确控制激光到达打击目标的剂量，在本发明实施例中，采用一个分光装置，将从治疗光L32得到的一部分光，送到一个光功率探测器(power meter)。通过控制程序实时读取功率探测器的数值，动态调整L32功率到达打击目标的激光剂量到预先设定的值。Preferably, in order to precisely control the dose of laser light reaching the strike target, in the embodiment of the present invention, a beam splitting device is used to send a part of the light obtained from the treatment light L32 to a power meter. The value of the power detector is read in real time through the control program, and the laser dose of the L32 power reaching the strike target is dynamically adjusted to a preset value.
较佳地，为了精确控制激光在打击目标的曝光时间，本发明实施例中，采用FPGA硬件时钟来控制L32的打开和关闭状态。一种控制方式可以通过实时操作***实现，比如Linux。另一种控制方式可以通过非实时操作***比如Microsoft Windows安装实时控制软件(Wind River)来实现；还有一种控制方式是，可以通过完全非实时操作***比如Microsoft Windows上的定时器来控制。Preferably, in order to precisely control the exposure time of the laser hitting the target, in the embodiment of the present invention, an FPGA hardware clock is used to control the on and off states of the L32. A control method can be implemented through a real-time operating system, such as Linux. Another control method can be implemented by installing real-time control software (Wind River) on a non-real-time operating system such as Microsoft Windows; another control method can be controlled by a timer on a completely non-real-time operating system such as Microsoft Windows.
以上辅模块的所有功能，成像、稳像功能，以及激光治疗功能的，都会得到主模块实时目标(眼底)跟踪以及实时稳像技术的支持。All the functions of the above auxiliary modules, imaging, image stabilization, and laser treatment functions, will be supported by the real-time target (fundus) tracking and real-time image stabilization technology of the main module.
主模块的闭环眼底跟踪功能启动之后，主机控制软件实时显示稳定了的 SLO/LSO图像。本发明实施例中，采用稳像技术的空间分辨率大约是成像模块1横向光学分辨率的1/2。稳定了的实时SLO/LSO图像为用户方便地定位辅模块即将处理的眼底空间位置。After the closed-loop fundus tracking function of the main module is activated, the host control software displays the stable SLO/LSO image in real time. In the embodiment of the present invention, the spatial resolution of the image stabilization technology is approximately 1/2 of the lateral optical resolution of the imaging module 1. The stabilized real-time SLO/LSO image allows the user to conveniently locate the fundus space position to be processed by the auxiliary module.
所述主模块的眼底跟踪是一个闭环的控制***。眼底跟踪功能启动之后，主模块(master module)控制跟踪镜M12的指令按照预先校准好的映射关系被送到辅模块(slave module)的M2。从而L2或者L31/L32过来的光，经过M2到达眼底后，在相当大的精确度上，可以被锁定到预定的眼底位置。这里的一个核心技术是，采用主模块的闭环控制指令带动辅模块的开环进行跟踪。The fundus tracking of the main module is a closed-loop control system. After the fundus tracking function is activated, the command of the master module (master module) to control the tracking mirror M12 is sent to M2 of the slave module (slave module) according to the pre-calibrated mapping relationship. Therefore, the light coming from L2 or L31/L32 can be locked to the predetermined fundus position with considerable accuracy after reaching the fundus through M2. A core technology here is to use the closed-loop control command of the main module to drive the open-loop tracking of the auxiliary module.
所述的M12和M2的空间映射关系，也就是如何把M12的控制指令(x，y，θ)转化成M2的控制指令(x'，y'，θ')，取决于光学***的设计。The spatial mapping relationship between M12 and M2, that is, how to convert the control commands (x, y, θ) of M12 into the control commands (x', y', θ') of M2 depends on the design of the optical system.
这里，所述(x，y，θ)和(x'，y'，θ')，存在如下关系：Here, the (x, y, θ) and (x', y', θ') have the following relationship:
(x'，y'，θ')＝f(x'，y'，θ'；x，y，θ)(x，y，θ)(x',y',θ')=f(x',y',θ';x,y,θ)(x,y,θ)
其中，(x'，y'，θ'；x，y，θ)可以通过光学***的校准(calibration)来实现。Among them, (x', y', θ'; x, y, θ) can be realized by calibration of the optical system.
所述的核心技术，即用主模块(master module)的闭环控制指令带动辅模块(slave module)的开环跟踪，是一个M12闭环，M2开环的光学跟踪。The core technology, that is, the closed-loop control command of the master module is used to drive the open-loop tracking of the slave module, which is an M12 closed-loop and M2 open-loop optical tracking.
参考图7，又如公式“OCT扫描＝S xA x+S yA y”所示，辅模块的扫描镜M2可以在二维空间360°的任意一个方向进行光学扫描。从而辅模块M2是上式中三个变量(x'，y'，θ')的开环光学跟踪，尽管主模块只有平移(x，y)的闭环光学跟踪和旋转θ的数字跟踪。 Referring to FIG. 7, as shown in the formula "OCT scan=S x A x +S y A y ", the scanning mirror M2 of the auxiliary module can perform optical scanning in any direction of 360° in the two-dimensional space. Therefore, the auxiliary module M2 is the open-loop optical tracking of the three variables (x', y', θ') in the above formula, although the main module only has the closed-loop optical tracking of translation (x, y) and digital tracking of rotation θ.
主模块的闭环跟踪精度，以及上式的校准精度，决定了辅模块出来的光到达眼底的开环跟踪精度，或者目标锁定精度。现有最先进的技术中，主模块的闭环光学跟踪精度和主模块成像***的光学分辨率相当，大约15微米，辅模块的开环光学跟踪精度可以达到主模块闭环光学跟踪精度的2/3-1/2，或者20-30微米。需要强调的是，在不同的***装置里，这些精度会有不同的 变化。The closed-loop tracking accuracy of the main module and the calibration accuracy of the above formula determine the open-loop tracking accuracy of the light from the auxiliary module to the fundus, or the accuracy of target locking. Among the most advanced technologies available, the closed-loop optical tracking accuracy of the main module is equivalent to the optical resolution of the imaging system of the main module, about 15 microns, and the open-loop optical tracking accuracy of the auxiliary module can reach 2/3 of the closed-loop optical tracking accuracy of the main module. -1/2, or 20-30 microns. What needs to be emphasized is that in different system devices, these accuracy will have different changes.
本发明主要应用于眼科，针对的病例为糖尿病视网膜变性，老年黄斑变性等。本发明提供的眼底激光治疗技术，支持智能自动眼底诊疗解决方案，也为将来一站式诊疗服务提供了物质基础。The invention is mainly applied to ophthalmology, and the targeted cases are diabetic retinal degeneration, age-related macular degeneration and the like. The fundus laser treatment technology provided by the present invention supports intelligent automatic fundus diagnosis and treatment solutions, and also provides a material basis for future one-stop diagnosis and treatment services.
以上所述，仅为本发明的较佳实施例而已，并非用于限定本发明的保护范围。The above are only the preferred embodiments of the present invention, and are not used to limit the protection scope of the present invention.

Claims (14)

  1. 一种智能眼底激光手术治疗装置，其特征在于，包括成像诊断模块和激光治疗模块；其中：An intelligent fundus laser surgery treatment device, which is characterized by comprising an imaging diagnosis module and a laser treatment module; wherein:
    所述成像诊断模块，用于通过第一成像模块(11)和耦合模块(14)实时获取从眼底任意角度返回的反射信号或/和获取眼底的影像数据；The imaging diagnosis module is used to obtain the reflection signal returned from any angle of the fundus or/and obtain the image data of the fundus through the first imaging module (11) and the coupling module (14) in real time;
    所述激光治疗模块，用于通过第二成像模块(12)实时进行眼底目标的跟踪与锁定，并通过激光输出调节模块(13)调节激光的输出。The laser treatment module is used to track and lock the fundus target in real time through the second imaging module (12), and adjust the laser output through the laser output adjustment module (13).
  2. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述激光治疗模块能够与所述第二成像模块(12)共享硬件。The intelligent fundus laser surgery treatment device according to claim 1, wherein the laser treatment module can share hardware with the second imaging module (12).
  3. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述第一成像模块(11)为共聚焦激光扫描成像SLO、线扫描眼底相机LSO、眼底相机，或自适应眼底成像仪AOSLO中的一种或多种。The intelligent fundus laser surgery treatment device according to claim 1, wherein the first imaging module (11) is a confocal laser scanning imaging SLO, a line scan fundus camera LSO, a fundus camera, or an adaptive fundus imager AOSLO One or more of.
  4. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述第二成像模块(12)为光相干断层扫描仪OCT或共聚焦激光扫描成像SLO。The intelligent fundus laser surgery treatment device according to claim 1, wherein the second imaging module (12) is an optical coherence tomography scanner OCT or a confocal laser scanning imaging SLO.
  5. 根据权利要求3或4所述智能眼底激光手术治疗装置，其特征在于，第一成像模块(11)和第二成像模块(12)，支持多种成像形式的组合，包括SLO+OCT、眼底相机+OCT、眼底相机+SLO或AOSLO+SLO中的一种或多种。The smart fundus laser surgery treatment device according to claim 3 or 4, wherein the first imaging module (11) and the second imaging module (12) support a combination of multiple imaging forms, including SLO+OCT, fundus camera +OCT, fundus camera+SLO or AOSLO+SLO one or more.
  6. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述激光输出调节模块(13)调节激光的输出，包括调节激光输出剂量大小、控制眼底的激光光斑的大小。The smart fundus laser surgery treatment device according to claim 1, wherein the laser output adjustment module (13) adjusts the output of the laser, including adjusting the laser output dose and controlling the size of the laser spot on the fundus.
  7. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述第一成像模块(11)通过扫描反射镜接收控制信号实现二维空间任意方向的扫描。The intelligent fundus laser surgery treatment device according to claim 1, wherein the first imaging module (11) receives a control signal through a scanning mirror to realize scanning in any direction in a two-dimensional space.
  8. 根据权利要求1所述智能眼底激光手术治疗装置，其特征在于，所述第二成像模块(12)通过改变可移动的反射镜的位置控制瞄准光和治疗激光 实现稳像功能和激光治疗功能的切换。The intelligent fundus laser surgery treatment device according to claim 1, wherein the second imaging module (12) controls the aiming light and the treatment laser by changing the position of the movable mirror to realize the image stabilization function and the laser treatment function. Switch.
  9. 一种智能眼底激光手术治疗***，包括权利要求1～8任一所述智能眼底激光手术治疗装置，其特征在于，还包括数据控制装置(2)，其进一步包括用于控制或/和调制激光信号的激光控制模块(21)、用于对第一成像模块(11)和第二成像模块(12)进行实时的控制眼底成像和实时的眼底目标跟踪与锁定的成像控制模块(22)、以及用于分别从所述第一成像模块(11)和第二成像模块(12)获取眼底成像和激光治疗目标的影像数据的图像数据采集模块(23)。A smart fundus laser surgery treatment system, comprising the smart fundus laser surgery treatment device according to any one of claims 1 to 8, characterized in that it also includes a data control device (2), which further includes a laser for controlling or/and modulating Signal laser control module (21), imaging control module (22) for real-time control of fundus imaging and real-time fundus target tracking and locking for the first imaging module (11) and the second imaging module (12), and An image data acquisition module (23) for acquiring image data of fundus imaging and laser treatment targets from the first imaging module (11) and the second imaging module (12) respectively.
  10. 根据权利要求9所述智能眼底激光手术治疗***，其特征在于，还包括与所述图像数据采集模块(23)数据相连的图像显示装置(3)，用于实时显示和观察眼底治疗部位的影像。The intelligent fundus laser surgery treatment system according to claim 9, further comprising an image display device (3) connected to the image data acquisition module (23) for real-time display and observation of images of the fundus treatment site .
  11. 根据权利要求9所述智能眼底激光手术治疗***，其特征在于，还包括与所述数据控制装置(2)数据相连的数据处理装置(4)，用于接收眼底影像数据并保存在患者数据库文档中。The intelligent fundus laser surgery treatment system according to claim 9, further comprising a data processing device (4) connected to the data control device (2) for receiving fundus image data and storing it in the patient database file in.
  12. 一种智能眼底激光手术治疗***的实现方法，其特征在于，包括如下步骤：An implementation method of an intelligent fundus laser surgery treatment system is characterized in that it comprises the following steps:
    A、利用激光稳像及治疗装置的成像诊断模块，通过其内设的第一成像模块(11)和耦合模块(14)实时获取从眼底任意角度返回的反射信号或/和获取眼底的影像数据；并利用激光治疗模块，通过其内设的第二成像模块(12)实时进行眼底目标的跟踪与锁定，利用激光输出调节模块(13)调节激光的输出；A. The imaging diagnosis module of the laser image stabilization and treatment device is used to obtain the reflection signal returned from any angle of the fundus or/and the image data of the fundus through the first imaging module (11) and the coupling module (14) built in it. ; And using the laser treatment module, through its built-in second imaging module (12) real-time tracking and locking of fundus targets, using the laser output adjustment module (13) to adjust the output of the laser;
    B、设定数据控制装置，利用成像控制模块(22)对第一成像模块(11)和第二成像模块(12)进行实时的控制眼底成像和实时的眼底目标跟踪与锁定；利用激光控制模块(21)控制或/和调制激光信号，并通过激光输出调节模块(13)调节激光的输出；以及利用图像数据采集模块(23)分别从所述第一成像模块(11)和第二成像模块(12)获取眼底成像和激光治疗目标的 影像数据。B. Set the data control device, use the imaging control module (22) to control the fundus imaging and real-time fundus target tracking and locking on the first imaging module (11) and the second imaging module (12); using the laser control module (21) Control or/and modulate the laser signal, and adjust the output of the laser through the laser output adjustment module (13); and use the image data acquisition module (23) to separately obtain data from the first imaging module (11) and the second imaging module (12) Obtain image data of fundus imaging and laser treatment targets.
  13. 根据权利要求12所述智能眼底激光手术治疗***的实现方法，其特征在于，步骤B之后还包括：The method for implementing the intelligent fundus laser surgery treatment system according to claim 12, wherein after step B, it further comprises:
    C、通过与所述图像数据采集模块(23)数据相连的图像显示装置(3)，实时显示和观察眼底治疗部位的影像。C. Through the image display device (3) connected with the image data acquisition module (23), real-time display and observation of the image of the fundus treatment site.
  14. 根据权利要求13所述智能眼底激光手术治疗***，其特征在于，步骤C之后还包括：The intelligent fundus laser surgery treatment system according to claim 13, wherein after step C, it further comprises:
    D、利用与所述数据控制装置(2)数据相连的数据处理装置(4)，接收眼底影像数据并保存在患者数据库文档中。D. Using the data processing device (4) connected with the data control device (2) to receive the fundus image data and save it in the patient database file.
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