JP2022120286A - medical evaluation device - Google Patents

Abstract

To provide a novel technique for evaluating a medical scanning device which scans a living body and collects data.SOLUTION: A medical evaluation device (an ophthalmologic device) according to an exemplary mode is used to acquire evaluation information of a medical scanning device (an ophthalmologic device) which scans a living body and collects data. The medical evaluation device (an ophthalmologic device) includes a reference device (600) and an evaluation unit. In the reference device (600), patterns (601, 602) designed based on at least one scanning condition of the medical scanning device (the ophthalmologic device) are formed. The evaluation unit generates position evaluation information on a position of scanning applied to the reference device, based on the data collected by scanning the reference device (600).SELECTED DRAWING: Figure 6A

Description

The present invention relates to medical evaluation equipment.

In the medical field, various devices such as inspection devices, measurement devices, and imaging devices are used. A medical device is a precision instrument, and in order to fully demonstrate its performance, adjustment and calibration (calibration) based on rigorous evaluation are required. Although there are various methods for evaluating medical devices, a method using a standard is widely used. The reference device is also called standard or etalon.

Standards used for evaluation of medical equipment are typically models (simulators) of tissues and organs of the living body, and are used as phantoms for evaluation of radiological diagnostic equipment and model eyes for evaluation of ophthalmic equipment. It is The standard is designed according to the type, standard, specification, performance, evaluation items, etc. of the medical device to be evaluated.

Japanese Patent Application Laid-Open No. 2004-357868 JP 2013-188314 A JP 2011-053462 A

SUMMARY OF THE INVENTION An object of the present invention is to provide a new technique for evaluating a medical scanning device that scans a living body and collects data.

A medical evaluation device according to an exemplary embodiment is used to obtain evaluation information for a medical scanning device that scans a living body and collects data. A medical evaluation device includes a reference instrument and an evaluation unit. The datum is formed with a pattern designed based on at least one scan condition of the medical scanning device. The estimator generates position estimation information regarding the position of the scan applied to the datum based on the data collected by scanning the datum.

According to some exemplary aspects, it is possible to facilitate evaluation work of an ophthalmologic apparatus using a model eye.

1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of an eye model for evaluating an ophthalmic apparatus according to an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of a datum for evaluating an ophthalmic device in accordance with an exemplary aspect of an embodiment; FIG. 1 is a schematic diagram representing an example configuration of a datum for evaluating an ophthalmic device in accordance with an exemplary aspect of an embodiment; FIG. 1 is a schematic representation of an example scan of a datum for evaluating an ophthalmic device in accordance with an exemplary aspect of an embodiment; FIG. 1 is a schematic representation of an example scan of a datum for evaluating an ophthalmic device in accordance with an exemplary aspect of an embodiment; FIG. FIG. 4A is a schematic diagram representing an example of a luminance profile obtained in a scan of a fiducial for evaluating an ophthalmic device in accordance with an exemplary aspect of the embodiments; 4 is a flowchart representing an example of operations that may be performed by an ophthalmic device in accordance with an exemplary aspect of an embodiment; 4 is a flowchart representing an example of operations that may be performed by an ophthalmic device in accordance with an exemplary aspect of an embodiment; 4 illustrates several examples of data generated by an ophthalmic device in accordance with exemplary aspects of an embodiment; 1 illustrates an example of visualization information generated by an ophthalmic device in accordance with an exemplary aspect of an embodiment; 1 illustrates an example of visualization information generated by an ophthalmic device in accordance with an exemplary aspect of an embodiment; 4 is a flowchart representing an example of operations that may be performed by an ophthalmic device in accordance with an exemplary aspect of an embodiment; FIG. 4 is a diagram for explaining an example of an operation that can be performed by an ophthalmic device according to an exemplary aspect of an embodiment; 1 illustrates an example of visualization information generated by an ophthalmic device in accordance with an exemplary aspect of an embodiment;

Several exemplary aspects of embodiments are described. While the exemplary aspects detailed below deal with the evaluation of an ophthalmic device that combines an optical coherence tomography (OCT) device and a retinal camera, the device (or system) to which the evaluation according to embodiments can be applied is not limited to this.

Some embodiments may evaluate an ophthalmic scanning device that scans a living eye and collects data. Ophthalmic scanning devices include OCT devices as well as ophthalmic examination devices (ophthalmic imaging devices, ophthalmic measuring devices, etc.) such as scanning laser ophthalmoscopes (SLO). Also, some embodiments can evaluate devices for biometric authentication (such as retinal scanners).

Additionally, some embodiments can evaluate devices in clinics other than ophthalmology. For example, some embodiments can evaluate devices used in radiology, dermatology, or dentistry. Specific device types include X-ray computed tomography (CT) scanners, ultrasound scanners, OCT scanners, and laser scanners.

Thus, the subject to which the evaluation according to embodiments is applied may be any medical scanning device. In general, a medical scanning device is an inspection device (imager, measuring device, etc.) that sequentially acquires data (information) from multiple positions on a living body. configured to scan and collect data.

The scanning conditions may be arbitrary conditions (parameters, options, etc.) related to scanning, examples of which include scan patterns (scan locus shape), scan area shapes, scan dimensions , perimeter), scan space interval (scan space density), scan time interval, scan pattern repetition time interval, and so on. Note that the scanning conditions are not limited to these.

An evaluation parameter according to the embodiment may be an evaluation parameter corresponding to any scan condition, or may be any evaluation parameter related to any scan condition. A parameter related to a scan condition can be, for example, any evaluation parameter that affects the scan condition.

At least some of the functionality of the elements disclosed herein are implemented using circuitry or processing circuitry. Circuitry or processing circuitry may be a general purpose processor, special purpose processor, integrated circuit, CPU (Central Processing Unit), GPU (Graphics Processing Unit) configured and/or programmed to perform at least a portion of the disclosed functions. ), ASIC (Application Specific Integrated Circuit), programmable logic device (for example, SPLD (Simple Programmable Logic Device), CPLD (Complex Programmable Logic Device), FPGA (Field Programmable Gate Array), conventional circuit configuration, and any of them A processor may be considered processing circuitry or circuitry, including transistors and/or other circuitry, including any combination thereof.In this disclosure, circuitry, units, means, or like terms may be used to refer to hardware that performs at least some of the functions described herein, or hardware that is programmed to perform at least some of the functions disclosed herein. processor, or known hardware programmed and/or configured to perform at least some of the functions described. , a circuit arrangement, unit, means or like terminology is a combination of hardware and software, the software being used to configure the hardware and/or the processor.

An exemplary embodiment of an ophthalmic device is shown in FIG. The ophthalmologic apparatus 1 of this example is a multi-function machine of an OCT apparatus and a fundus camera. The method of this OCT apparatus is spectral domain OCT, but it may be swept source OCT. Spectral domain OCT divides light from a low coherence light source into measurement light and reference light, generates interference light by superimposing the return light of the measurement light from the object on the reference light, and generates the interference light spectrum In this method, the distribution is detected by a spectrometer, and the detected spectral distribution is subjected to Fourier transform or the like to form an image. On the other hand, the swept source OCT splits the light from the wavelength tunable light source into measurement light and reference light, generates interference light by superimposing the return light of the measurement light from the object on the reference light, and generates the interference light. is detected by a photodetector such as a balanced photodiode, and Fourier transform or the like is performed on the detection data collected in response to wavelength sweeping and measurement light scanning to form an image. As described above, spectral domain OCT is an OCT technique for obtaining spectral distribution by spatial division, and swept source OCT is an OCT technique for obtaining spectral distribution by time division.

In this aspect, unless otherwise specified, "image data" is not distinguished from "image" which is visualization information generated based thereon. In addition, unless otherwise specified, the part of the eye to be examined (organ, tissue, etc.) is not distinguished from the corresponding part of the phantom (reference device, eye model, etc.). Furthermore, unless otherwise specified, the part of the eye to be examined and the data corresponding to it (images, etc.) are not distinguished. do not distinguish between The same may be true when scanning parts (organs, tissues, etc.) other than the eye.

The ophthalmologic apparatus 1 includes a fundus camera unit 2 , an OCT unit 100 and an arithmetic control unit 200 . The fundus camera unit 2 is provided with an optical system and a mechanism for acquiring a front image of the eye E to be examined, and an optical system and a mechanism for applying an OCT scan to the eye E to be examined. The OCT unit 100 is provided with an optical system and a mechanism for executing OCT scanning. The arithmetic control unit 200 includes one or more processors configured to perform various types of processing (calculation, control, etc.).

The ophthalmologic apparatus 1 includes a lens unit 400 for switching the site to which OCT scanning is applied. The lens unit 400 can be arranged between the objective lens 22 and the eye E to be examined. By inserting the lens unit 400 into the optical path, the application site for OCT scanning is switched from the fundus oculi Ef to the anterior segment of the eye.

The fundus camera unit 2 is provided with an optical system for photographing the subject's eye E (fundus Ef and anterior segment). The acquired digital image is a front image such as an observed image or a photographed image. Typically, an observation image is obtained by moving image photography using continuous light in the near-infrared region, and a photographed image is obtained as a still image using flash light in the near-infrared region or visible region.

The fundus camera unit 2 includes an illumination optical system 10 and an imaging optical system 30 . The illumination optical system 10 projects illumination light onto the eye E to be examined. The imaging optical system 30 detects return light of the illumination light projected onto the eye E to be inspected. Measurement light from the OCT unit 100 is guided to the subject's eye E through an optical path in the fundus camera unit 2 . Return light of the measurement light projected onto the subject's eye E is guided to the OCT unit 100 through the same optical path in the fundus camera unit 2 .

Light (observation illumination light) output from the observation light source 11 of the illumination optical system 10 is reflected by the concave mirror 12, passes through the condenser lens 13, passes through the visible cut filter 14, and becomes near-infrared light. Further, the observation illumination light is once converged in the vicinity of the photographing light source 15, reflected by the mirror 16, passed through the relay lens system 17, the relay lens 18, the diaphragm 19, and the relay lens system 20, to the perforated mirror 21. be guided. The observation illumination light is reflected by the periphery of the perforated mirror 21 (area around the perforation), passes through the dichroic mirror 46, is refracted by the objective lens 22, and illuminates the eye E to be examined. The return light of the observation illumination light from the subject's eye E is refracted by the objective lens 22, passes through the dichroic mirror 46, passes through the hole formed in the central region of the apertured mirror 21, and passes through the dichroic mirror 55. , through a focusing lens 31 and reflected by a mirror 32 . Further, this return light passes through the half mirror 33A, is reflected by the dichroic mirror 33, and is imaged on the light receiving surface of the image sensor 35 by the imaging lens . The image sensor 35 detects returned light at a predetermined frame rate. The focus of the imaging optical system 30 can be adjusted to match the fundus oculi Ef or its vicinity, and can also be adjusted to match the anterior segment of the eye or its vicinity.

The light (imaging illumination light) output from the imaging light source 15 is projected onto the fundus oculi Ef through the same path as the observation illumination light. The return light of the imaging illumination light from the subject's eye E is guided to the dichroic mirror 33 through the same path as the return light of the observation illumination light, passes through the dichroic mirror 33 , is reflected by the mirror 36 , is reflected by the imaging lens 37 . An image is formed on the light receiving surface of the image sensor 38 .

A liquid crystal display (LCD) 39 displays a fixation target (fixation target image). A part of the visible light flux output from the LCD 39 is reflected by the half mirror 33A, reflected by the mirror 32, passes through the photographing focusing lens 31 and the dichroic mirror 55, and passes through the aperture of the perforated mirror 21, It passes through the dichroic mirror 46, is refracted by the objective lens 22, and is projected onto the fundus oculi Ef. A fixation target is typically used for eye guidance and fixation. The direction in which the line of sight of the subject's eye E is guided (and fixed), that is, the direction in which fixation of the subject's eye E is encouraged is called a fixation position. By changing the display position of the fixation target image on the screen of the LCD 39, the fixation position can be changed. The ophthalmologic apparatus 1 may be capable of providing a graphical user interface (GUI) for changing the fixation position.

The alignment optical system 50 generates an alignment index used for alignment of the optical system with respect to the eye E to be examined. Alignment light output from a light-emitting diode (LED) 51 passes through a diaphragm 52, a diaphragm 53, and a relay lens 54, is reflected by a dichroic mirror 55, passes through the hole of the perforated mirror 21, and passes through the dichroic mirror 46. It is transmitted and projected onto the subject's eye E via the objective lens 22 . The return light of the alignment light from the eye to be examined E is guided to the image sensor 35 through the same path as the return light of the observation illumination light. Manual alignment or automatic alignment can be performed based on the received light image (alignment index image).

Alignment methods that can be applied to the embodiments are not limited to those using such alignment indices. For example, methods using stereo cameras, methods using Purkinje images, methods using optical levers, and any of these may be a combination of

The focus optical system 60 generates a split index used for focus adjustment of the eye E to be examined. The focus optical system 60 is moved along the optical path of the illumination optical system 10 (illumination optical path) in conjunction with the movement of the imaging focusing lens 31 along the optical path of the imaging optical system 30 (imaging optical path). The reflecting bar 67 is inserted into and removed from the illumination optical path. When performing focus adjustment, the reflecting surface of the reflecting bar 67 is arranged at an angle in the illumination optical path. Focus light output from the LED 61 passes through a relay lens 62, is split into two light beams by a split index plate 63, passes through a two-hole diaphragm 64, is reflected by a mirror 65, and is reflected by a condenser lens 66 onto a reflecting rod 67. is once imaged on the reflective surface of , and then reflected. Further, the focused light passes through the relay lens 20 , is reflected by the perforated mirror 21 , passes through the dichroic mirror 46 , and is projected onto the subject's eye E via the objective lens 22 . The return light of the focus light from the eye to be examined E is guided to the image sensor 35 through the same path as the return light of the alignment light. Manual focusing and autofocusing can be performed based on the received light image (split index image).

Diopter correction lenses 70 and 71 can be selectively inserted in the imaging optical path between the apertured mirror 21 and the dichroic mirror 55 . The dioptric correction lens 70 is a plus lens (convex lens) for correcting high hyperopia. The dioptric correction lens 71 is a minus lens (concave lens) for correcting strong myopia.

The dichroic mirror 46 synthesizes the fundus camera optical path and the OCT scanning optical path (measurement arm). The dichroic mirror 46 reflects light in the wavelength band used for OCT scanning and transmits light in the wavelength band used for the fundus camera. The measurement arm is provided with a collimator lens unit 40, a retroreflector 41, a dispersion compensation member 42, an OCT focusing lens 43, an optical scanner 44, and a relay lens 45 in order from the OCT unit 100 side.

The retroreflector 41 is movable along the path of the measuring light LS incident on it, thereby changing the length of the measuring arm. The change in measurement arm length is used, for example, for optical path length correction according to the axial length of the eye, adjustment of the interference state, and the like.

The dispersion compensating member 42 works together with a dispersion compensating member 113 (described later) arranged on the reference arm to match the dispersion characteristics of the measurement light LS and the reference light LR.

An OCT focusing lens 43 is moved along the measuring arm to focus the measuring arm. In addition, the movement of the imaging focusing lens 31, the movement of the focusing optical system 60, and the movement of the OCT focusing lens 43 can be controlled in a coordinated manner.

The optical scanner 44 is substantially arranged at a position optically conjugate with the pupil of the eye E to be examined. A light scanner 44 deflects the measuring light LS guided by the measuring arm. The optical scanner 44 is, for example, a galvanometer scanner capable of two-dimensional scanning. Typically, the optical scanner 44 includes a one-dimensional scanner (x-scanner) for deflecting the measurement light in ±x directions and a one-dimensional scanner (y-scanner) for deflecting the measurement light in ±y directions. including. In this case, one one-dimensional scanner is placed at a position optically conjugated with the pupil, or a position optically conjugated with the pupil is placed between two one-dimensional scanners.

The exemplary OCT unit 100 shown in FIG. 2 is provided with optics for spectral domain OCT. This optical system includes interference optics. This interference optical system divides light from a low coherence light source (broadband light source) into measurement light and reference light, and superimposes the return light of the measurement light projected on the subject's eye E onto the reference light that has passed through the reference arm. to generate interference light. A spectral distribution of interference light generated by the interference optical system is detected by a spectroscope. An output (detection signal) from the spectroscope is sent to the arithmetic control unit 200 .

The light source unit 101 outputs broadband low-coherence light L0. The low-coherence light L0 includes, for example, a near-infrared wavelength band (about 800 nm to 900 nm) and has a temporal coherence length of about several tens of micrometers. The low-coherence light L0 may be near-infrared light having a wavelength band invisible to the human eye, for example, a center wavelength of about 1040 to 1060 nm. The light source unit 101 includes light output devices such as superluminescent diodes (SLDs), LEDs, semiconductor optical amplifiers (SOAs), and the like.

In embodiments employing swept-source OCT, the light source unit includes, for example, a near-infrared tunable laser that rapidly changes the wavelength of emitted light.

The low-coherence light L0 output from the light source unit 101 is guided to the polarization controller 103 by the optical fiber 102, and its polarization state is adjusted. The light L0 whose polarization state has been adjusted is guided by the optical fiber 104 to the fiber coupler 105 and split into the measurement light LS and the reference light LR.

The reference light LR generated by the fiber coupler 105 is guided by the optical fiber 110 to the collimator 111 , converted into a parallel beam, and guided to the retroreflector 114 via the optical path length correction member 112 and the dispersion compensation member 113 . The optical path length correction member 112 acts to match the optical path length of the reference light LR and the optical path length of the measurement light LS. The dispersion compensation member 113 works together with the dispersion compensation member 42 arranged on the measurement arm to match the dispersion characteristics between the reference light LR and the measurement light LS. The retroreflector 114 is movable along the optical path of the reference beam LR incident on it, thereby changing the length of the reference arm. A change in the reference arm length is used, for example, for optical path length correction according to the axial length of the eye, adjustment of the interference state, and the like.

The reference light LR that has passed through the retroreflector 114 passes through the dispersion compensating member 113 and the optical path length correcting member 112 , is converted by the collimator 116 from a parallel beam into a focused beam, and enters the optical fiber 117 . The reference light LR incident on the optical fiber 117 is guided to the polarization controller 118 to have its polarization state adjusted, guided to the attenuator 120 through the optical fiber 119 to have its light amount adjusted, and passed through the optical fiber 121 to the fiber coupler 122. be guided.

On the other hand, the measurement light LS generated by the fiber coupler 105 is guided to the collimator lens unit 40 through the optical fiber 127 and converted into a parallel light beam, which is then converted into a parallel light beam by a retroreflector 41, a dispersion compensation member 42, an OCT focusing lens 43, and an optical scanner 44. , and a relay lens 45, reflected by a dichroic mirror 46, refracted by an objective lens 22, and projected onto an eye E to be examined. The measurement light LS is scattered and reflected at various depth positions of the eye E to be examined. The return light of the measurement light LS from the subject's eye E travels in the opposite direction through the measurement arm, is guided to the fiber coupler 105 , and reaches the fiber coupler 122 via the optical fiber 128 .

The fiber coupler 122 superimposes the measurement light LS input via the optical fiber 128 and the reference light LR input via the optical fiber 121 to generate interference light LC.

Interference light LC generated by fiber coupler 122 is guided to spectroscope 130 through optical fiber 123 . The spectroscope 130 includes, for example, a collimator lens that converts the incident interference light LC into a parallel light flux, a diffraction grating that resolves the interference light LC that has been converted into the parallel light flux into spectral components, and detects the resolved spectral components. including an image sensor. This image sensor is, for example, a line sensor, and detects a plurality of spectral components of the interference light LC to generate electrical signals (detection signals). The generated detection signal is sent to the arithmetic control unit 200 .

In a mode employing swept-source OCT, interference light generated by superimposing measurement light and reference light is split at a predetermined splitting ratio (for example, 1:1) to generate a pair of interference lights. A pair of interfering light beams are directed to a photodetector. The photodetector includes, for example, a balanced photodiode. A balanced photodiode includes a pair of photodetectors that respectively detect a pair of interference lights, and outputs a difference between a pair of detection signals obtained by these. The photodetector sends this output (a detected signal such as a differential signal) to a data acquisition system (DAQ). The data acquisition system is clocked from the light source unit. A clock is generated in the light source unit in synchronization with the output timing of each wavelength swept within a predetermined wavelength range by the wavelength tunable light source. The light source unit, for example, splits light of each output wavelength to generate two split lights, optically delays one of these split lights, combines these split lights, and detects the resulting combined light. , generates a clock based on the detected signal. The data collection system samples the detection signal (difference signal) input from the photodetector based on the clock. The data obtained by this sampling is used for processing such as image construction.

The ophthalmologic apparatus 1 shown in FIGS. 1 and 2 includes an element for changing the measurement arm length (for example, the retroreflector 41) and an element for changing the reference arm length (for example, the retroreflector 114 or the reference mirror). ) are provided, although in some exemplary embodiments only one of these elements is provided. By changing the relative lengths of the measurement arm and the reference arm (ie, by changing the optical path length difference between the measurement arm and the reference arm), the coherence gate position is changed. Elements for changing the optical path length difference are not limited to the elements disclosed in this embodiment, and may be arbitrary elements (optical members, mechanisms, etc.).

The arithmetic control unit 200 controls each part of the ophthalmologic apparatus 1 . Also, the arithmetic control unit 200 executes various kinds of arithmetic operations. For example, the arithmetic control unit 200 forms a reflection intensity profile for each A line by performing signal processing such as Fourier transform on the spectral distribution obtained by the spectroscope 130 . Furthermore, the arithmetic and control unit 200 forms image data by imaging the reflection intensity profile of each A-line. Arithmetic processing therefor is the same as in conventional spectral domain OCT.

The arithmetic control unit 200 includes, for example, a processor, RAM (Random Access Memory), ROM (Read Only Memory), hard disk drive, communication interface, and the like. Various computer programs are stored in a storage device such as a hard disk drive. The arithmetic and control unit 200 may include an operation device, an input device, a display device, and the like.

An example of the configuration of the processing system of the ophthalmologic apparatus 1 is shown in FIGS. 3A to 4E. FIG. 3A shows a configuration example of the entire processing system. The ophthalmologic apparatus 1 of FIG. 3A includes a control section 210, an image forming section 220, and a data processing section 230. As shown in FIG. The control section 210, the image forming section 220, and the data processing section 230 are provided in the arithmetic control unit 200, for example. FIG. 3B shows a configuration example of the data processing unit 230. As shown in FIG. The data processing unit 230A of FIG. 3B includes an evaluation unit 250 and a visualization information generation unit 270. FIG. 4A to 4E show some configuration examples of the evaluation unit 250. FIG.

In this aspect, the evaluation unit 250 and the visualization information generation unit 270 are provided in the ophthalmologic apparatus 1 to be evaluated. On the other hand, in some aspects, an element corresponding to at least part of the evaluation unit 250 and/or an element corresponding to at least part of the visualization information generation unit 270 is a device to be evaluated (medical scanning device, ophthalmic scanning device) may be provided outside the For example, an element corresponding to at least part of the evaluation unit 250 and/or an element corresponding to at least part of the visualization information generation unit 270 is connected to an information processing device (computer) wired or wirelessly connected to the device to be evaluated. may be provided. In addition, an element corresponding to at least a part of the evaluation unit 250 is provided in the first information processing device connected by wire or wirelessly to the device to be evaluated, and an element corresponding to at least a part of the evaluation unit 250 is provided, An element corresponding to at least part of the visualization information generation unit 270 may be provided in the second information processing device. Here, each of the information processing device, the first information processing device, and the second information processing device may be a single computer, or may be two or more computers.

At least two of the example configurations of FIGS. 3A-4E can be combined. Also, any one or a combination of two or more of these configuration examples can be combined with any known technique and/or an equivalent technique. In addition, any one or a combination of two or more of these configuration examples can be combined with techniques equivalent to any of the configuration examples. This "combination" may be any modification such as addition, substitution, or omission. The same applies to constituent elements (arbitrary items in the present disclosure) other than the processing system.

The control unit 210 includes a processor and controls each unit of the ophthalmologic apparatus 1 . Control unit 210 includes main control unit 211 and storage unit 212 .

The main controller 211 includes a processor and controls each element of the ophthalmologic apparatus 1 (including the elements shown in FIGS. 1 to 4E). The main control unit 211 is realized, for example, by cooperation of hardware including a circuit and control software.

The photographing focusing lens 31 arranged in the photographing optical path and the focusing optical system 60 arranged in the illumination optical path are integrally or cooperatively operated by a photographing focusing driving unit (not shown) under the control of the main control unit 211. is moved to A retroreflector 41 provided on the measurement arm is moved by a retroreflector (RR) driving section 41A under the control of the main control section 211 . The OCT focus lens 43 placed on the measurement arm is moved by the OCT focus driver 43A under control of the main controller 211 . Note that the movement of the OCT focusing lens 43 can be coordinated with the movement of the imaging focusing lens 31 and the focusing optical system 60 . A retroreflector 114 located on the reference arm is moved by a retroreflector (RR) driver 114A under the control of the main controller 211 . Each of the mechanisms illustrated here typically includes an actuator such as a pulse motor that operates under the control of main control section 211 . The optical scanner 44 provided on the measurement arm operates under the control of the main controller 211 . Furthermore, the main controller 211 can control arbitrary elements included in the ophthalmologic apparatus 1, such as the polarization controller 103, the polarization controller 118, the attenuator 120, various light sources, various optical elements, various devices, and various mechanisms. . In addition, the main control unit 211 controls arbitrary peripheral equipment (apparatuses, equipment, devices, etc.) connected to the ophthalmologic apparatus 1, and controls arbitrary equipment, equipment, devices, etc. accessible by the ophthalmologic apparatus 1. It may be possible.

The moving mechanism 150 moves, for example, at least the retinal camera unit 2 three-dimensionally. In a typical example, the moving mechanism 150 includes an x-stage movable in ±x directions (horizontal direction), an x-moving mechanism for moving the x-stage, and a movable mechanism in ±y directions (vertical direction). It includes a y-stage, a y-moving mechanism for moving the y-stage, a z-stage movable in the ±z direction (depth direction), and a z-moving mechanism for moving the z-stage. Each of these moving mechanisms includes an actuator such as a pulse motor that operates under control of the main control section 211 .

The storage unit 212 stores various data. The data stored in the storage unit 212 includes, for example, image data of an OCT image, image data of a fundus image, information on an eye to be examined, and the like. The eye information to be examined includes subject information such as a patient ID and name, left/right eye identification information, electronic medical record information, and the like.

Furthermore, the storage unit 212 can store data generated by the data processing unit 230 . For example, evaluation information described later and/or visualization information described later is stored in the storage unit 212 . In addition, the storage unit 212 can store information on a reference device (eye model), which will be described later. For example, standard information, which will be described later, is stored in the storage unit 212 .

User interface 240 includes display unit 241 and operation unit 242 . The display unit 241 displays information under the operation of the main control unit 211 and includes the display device 3, for example. The operation unit 242 includes various operation devices and input devices, generates signals corresponding to operations and inputs, and sends the signals to the main control unit 211 . The user interface 240 may include a device, such as a touch panel, that combines a display function and an operation function. An ophthalmic device according to some example aspects may not include at least a portion of the user interface. For example, the display device and/or the operating device may be peripherals of the ophthalmic equipment.

The image forming section 220 forms OCT image data based on the data acquired by the spectroscope 130 . Image forming unit 220 includes a processor. The image forming unit 220 is realized by, for example, cooperation of hardware including a circuit and image forming software.

The image forming unit 220 forms cross-sectional image data based on the data acquired by the spectroscope 130 . This image formation processing includes signal processing such as sampling (A/D conversion), noise removal (noise reduction), filtering, and fast Fourier transform (FFT), similar to conventional spectral domain OCT.

The image data formed by the image forming unit 220 is a group of images formed by imaging reflection intensity profiles in a plurality of A-lines (scan lines along the z-direction) arranged in the area to which the OCT scan is applied. 1 is a data set containing image data (a group of A-scan image data);

The image data formed by the image forming unit 220 is, for example, one or more B-scan image data or stack data formed by embedding a plurality of B-scan image data in a single three-dimensional coordinate system. The image forming unit 220 can also construct volume data (voxel data) by voxelizing the stack data. Stack data and volume data are typical examples of three-dimensional image data represented by a three-dimensional coordinate system.

The data processing unit 230 executes various data processing. For example, the data processing unit 230 can apply image processing or analysis processing to OCT image data, or apply image processing or analysis processing to observed image data or photographed image data. Data processing unit 230 includes a processor. The data processing unit 230 is realized, for example, by cooperation of hardware including a circuit and data processing software.

The data processing section 230 can process the three-dimensional image data constructed by the image forming section 220 . For example, the data processing unit 230 can apply rendering to the 3D image data to construct new image data. Rendering techniques include volume rendering, maximum intensity projection (MIP), minimum intensity projection (MinIP), surface rendering, and multiplanar reconstruction (MPR). Further, the data processing unit 230 can construct projection data by projecting the three-dimensional image data in the z direction (A-line direction, depth direction). Similarly, the data processing unit 230 can construct a shadowgram by projecting a part of the three-dimensional image data (three-dimensional partial image data) in the z-direction. Here, the 3D partial image data is set, for example, by applying segmentation to the 3D image data. This segmentation may include, for example, image analysis (image processing) such as threshold processing and edge detection, or may include semantic segmentation using machine learning.

A data processing unit 230A shown in FIG. 3B is an example of the data processing unit 230. As shown in FIG. The data processing unit 230A includes an evaluation unit 250 and a visualization information generation unit 270. FIG. It should be noted that the data processing unit 230 of some aspects may include only the evaluation unit 250 .

The evaluation unit 250 is configured to generate evaluation information for the ophthalmologic apparatus 1 . The evaluation unit 250 generates evaluation information based on data collected by scanning a reference device (eye model), which will be described later. More generally, the evaluation unit 250 of some aspects uses a device (medical scanning device, ophthalmic scanning device) that scans a living body and collects data based on preset scanning conditions to obtain evaluation information from the device. based on the data collected by scanning the The evaluation information is information representing a predetermined quality of the target device, such as quality of operation, quality of function, quality of control, quality of obtained data, quality of data processing, and the like.

Some examples of evaluator 250 are shown in FIGS. 4A-4E. As noted above, evaluator 250 may be a combination of any two or more of exemplary evaluators 250A-250E. An outline of the evaluation units 250A to 250E, which are several examples of the evaluation unit 250, will be described first, and then specific aspects of the evaluation of the ophthalmologic apparatus 1 that can be performed using the evaluation unit 250 will be described.

The evaluation unit 250A in FIG. 4A is configured to generate evaluation information based on the projection data of the three-dimensional image data constructed by the image forming unit 220. FIG. The evaluation section 250A includes a projection processing section 251 and an evaluation information generation section 252 .

The projection processing unit 251 is configured to construct projection data (two-dimensional image data) from three-dimensional image data collected by scanning the three-dimensional area of the reference device with the ophthalmologic apparatus 1 . The process (projection) of constructing projection data from three-dimensional image data includes, for example, an operation of adding the values of a plurality of pixels included in each A-scan image data constituting the three-dimensional image data in the z direction. Projection data of three-dimensional image data expressed in the xyz coordinate system is two-dimensional image data expressed in the xy coordinate system.

The evaluation information generator 252 is configured to generate evaluation information based on the projection data constructed by the projection processor 251 .

The evaluation unit 250 (e.g., the evaluation unit 250A) may be configured to generate evaluation information based on the data collected by scanning the standard device with the ophthalmologic apparatus 1 and the standard information of the pattern.

A predetermined pattern is formed on the standard. The pattern standard information referred to by the evaluation unit 250 represents the mode of the pattern formed on the standard. The aspect of the pattern represented by this standard information may be arbitrary parameters relating to the pattern, such as shape, size, distribution, number, spacing, and the like. The shape of the pattern may be a three-dimensional shape, a two-dimensional shape, a cross-sectional shape, or the like. When a pattern consists of a plurality of sub-patterns (basic patterns or combinations thereof), the shape of the pattern represented by the standard information may be the shape of the sub-patterns or the shape of the entire pattern. Pattern dimensions may be length, width, depth, diameter, area, volume, and the like. When a pattern consists of a plurality of sub-patterns, the dimensions of the pattern represented by the standard information may be the dimensions of the sub-patterns or the dimensions of the entire pattern. The pattern distribution may be the distribution of a plurality of sub-patterns forming the pattern. The distribution may be, for example, the density, the ratio between the dimension of the pattern portion and the dimension of the non-pattern portion, or the ratio between the dimension of the fiducial and the pattern portion. The number of patterns may be the number of sub-patterns forming the pattern. The pattern interval may be the distance between two adjacent sub-patterns among the plurality of sub-patterns forming the pattern. When a pattern consists of multiple sub-patterns, the standard information of the pattern may include statistics calculated based on at least part of the multiple sub-patterns, or values for individual sub-patterns. good too.

The pattern standard information is created in advance, for example, based on the design information of the reference device and/or the measurement data of the reference device. The design information of the reference device is information referred to for forming a pattern on the reference device. The design information is created based on at least one scan condition for OCT scans that can be performed by the ophthalmologic apparatus 1 . In other words, the evaluation of this aspect uses a reference device on which a pattern designed based on at least one scanning condition is formed. On the other hand, the measurement data of the reference device is data obtained by actually measuring the reference device, and includes information about the pattern formed on the reference device. The standard information created in this manner is stored, for example, in the storage unit 212 and/or stored in a storage device or recording medium accessible by the ophthalmologic apparatus 1 .

In evaluating the ophthalmic device 1, the ophthalmic device 1 can apply a predetermined pattern of scans to the fiducial. This scanning pattern includes a line scan, for example a raster scan. A raster scan consists of multiple line scans that are parallel to each other.

Furthermore, the evaluation unit 250 may be configured to obtain the straightness (linearity, degree of linearity) of the line scan as evaluation information based on the data collected in the scan applied to the fiducial. Although the trajectory of the line scan is ideally a straight line, there is a possibility that the trajectory of the line scan deviates from the straight line due to errors in the configuration and control of the ophthalmologic apparatus 1 . The evaluation unit 250 of this example can evaluate whether or not the line scan trajectory of the ophthalmologic apparatus 1 can be regarded as a straight line, and can evaluate the degree of deviation from the straight line.

A linear pattern is formed on the standard used for evaluating the straightness of the line scan. This linear pattern may be, for example, recesses (grooves, valleys) and/or protrusions formed in a straight line. The dimensions of the groove may be designed based on the scanning conditions of line scanning. For example, the groove length may be designed based on the length of the line scan, or the like. Also, the depth of the groove may be designed based on the length of the A-scan (imaging range in the depth direction, imaging range in the axial direction) and the like. Also, the width of the groove may be designed based on the beam diameter of the measurement light, the line scan interval in raster scan, and the like. The convex portion can also be designed in the same way.

The ophthalmologic apparatus 1 scans the reference device on which such a linear pattern is formed. This scan may be at least one line scan set parallel to the linear pattern, typically a raster scan. For example, the application positions of the scans are set such that at least a portion of one or more line scans coincides with at least a portion of the linear pattern. The evaluation unit 250 can obtain the straightness of the line scan of the ophthalmologic apparatus 1 based on the data collected by this scan and the standard information of the linear pattern. Here, the standard information of the linear pattern is included in the standard information of the pattern described above.

FIG. 4B shows a configuration example of the evaluation unit 250 for evaluating straightness of line scan. The evaluation unit 250</b>B of this example includes a projection processing unit 253 , a position data generation unit 254 and a straightness calculation unit 255 . In this example, the ophthalmologic apparatus 1 applies a scan to a three-dimensional area (including at least part of the linear pattern) of the fiducial on which the linear pattern is formed. This scanning is, for example, raster scanning.

The projection processing unit 253 is configured to construct projection data from data (three-dimensional data) acquired by scanning the three-dimensional area of the reference device. The projection processing unit 253 constructs projection data from the three-dimensional image data acquired by scanning the three-dimensional area of the reference device by executing the same processing as the projection processing unit 251 described above. This projection data is, for example, two-dimensional image data expressed in an xy coordinate system.

The position data generator 254 is configured to obtain the position data of the linear pattern based on the projection data constructed by the projection processor 253 . This position data includes position information of the linear pattern image rendered in the projection data (two-dimensional image data). The position data generator 254 analyzes the projection data and detects the image of the linear pattern. This image detection may include segmentation. This segmentation may include, for example, image analysis (image processing) such as threshold processing and edge detection, or may include semantic segmentation using machine learning.

The straightness calculator 255 is configured to calculate the straightness of the line scan of the ophthalmologic apparatus 1 based on the position data generated by the position data generator 254 and the standard information of the linear pattern. This straightness describes the error of the line scan (its trajectory) relative to a straight geometric line.

Another example of evaluation according to this aspect will be described. The evaluation unit 250 may be configured to generate position evaluation information regarding the position of the scan applied to the fiducial as evaluation information. The position of the scan evaluated in this example may be the application position of that scan relative to the fiducial. If the scan to be position-evaluated consists of multiple sub-scans, i.e. if the scan pattern consists of multiple sub-patterns, the position of the scan to be evaluated in this example is determined by two or more sub-patterns applied to the datum. , or the sub-scan application position with respect to the reference device.

The pattern formed on the reference device of this example may include a group of linear patterns. A linear pattern group includes two or more linear patterns. The ophthalmologic apparatus 1 applies a plurality of line scans to this standard and collects data. The multiple line scans may be raster scans, for example. The evaluation unit 250 generates evaluation information regarding the positional relationship of the plurality of line scans as position evaluation information based on the data collected by the plurality of line scans and the standard information of the linear pattern group created in advance. can be done. The position evaluation information generated here is called positional relationship evaluation information. The evaluation unit 250 performs, for example, a process of constructing projection data from data (three-dimensional image data) collected from a reference device by raster scanning, and a process of analyzing the projection data to detect images of respective linear patterns. and generating positional relationship evaluation information based on the detected image of the linear pattern group and the standard information of the linear pattern group. Here, the process of detecting the image of the linear pattern group may include arbitrary segmentation.

The linear pattern group formed on the reference device may include two (or more) linear patterns parallel to each other. In this case, the ophthalmic device 1 can evaluate the scan interval. Thus, an estimate can be made of the distance between these two line scans.

A configuration example of the evaluation unit 250 for evaluating the scan interval is shown in FIG. 4C. The evaluation unit 250</b>C of this example includes an interval data generation unit 256 and an interval evaluation information generation unit 257 . The ophthalmologic apparatus 1 collects data by applying a plurality of line scans to a reference device on which two (or more) parallel linear patterns are formed. The multiple line scans may be raster scans, for example.

The interval data generator 256 generates data indicating the interval between the two linear patterns (that is, the distance between the two linear patterns) based on the data collected by the multiple line scans. is configured to The data generated by the interval data generator 256 is called interval data. For example, the interval data generation unit 256 performs, for example, a process of constructing projection data from data (three-dimensional image data) collected from a reference device by raster scanning, and an image of each linear pattern by analyzing this projection data. It may be configured to execute a process of detecting and a process of calculating the distance (interval data) between the images of the two detected linear pattern groups. Here, the process of detecting the image of the linear pattern group may include arbitrary segmentation.

The interval evaluation information generation unit 257 calculates two lines corresponding to the two linear patterns based on the interval data generated by the interval data generation unit 256 and the pre-created standard information of the two linear patterns. It is configured to generate interval rating information about intervals between scans. The generated interval evaluation information is an example of positional relationship evaluation information.

The linear pattern group formed on the reference device may include a plurality of parallel linear patterns. In this case, the ophthalmologic apparatus 1 can evaluate overscan. Overscan is a technique that constructs an image by removing data in the periphery of the area to which the scan was applied. When scanning is performed using the optical scanner 44 that reciprocates like a galvanometer scanner, the motion of the scanner becomes unstable in the interval before and after switching the direction of motion. For example, a sudden change in the motion speed of the scanner (sudden deceleration and sudden acceleration) occurs in the section. As a result, artifacts such as image distortion occur. Overscan is a technique for constructing an image that eliminates areas where such artifacts occur. In this aspect, for example, the standard information can be created by obtaining the artifact generation area from the performance and specifications of the optical scanner 44 . Evaluation of overscan in this example can provide a way of providing information about, for example, whether the artifact generation area is properly set. Also, the overscan assessment in this example may be able to provide the presence, extent, amount, acceptability, etc. of overscan artifacts.

A configuration example of the evaluation unit 250 for evaluating overscan is shown in FIG. 4D. The evaluation unit 250</b>D of this example includes an interval data generation unit 258 , an interval evaluation information generation unit 259 , a distribution generation unit 260 and an overscan evaluation information generation unit 261 . The ophthalmologic apparatus 1 collects data by applying a plurality of line scans to a reference device on which a plurality of mutually parallel linear patterns are formed. The multiple line scans may be raster scans, for example.

The interval data generation unit 258 and the interval evaluation information generation unit 259 have the same configuration as the interval data generation unit 256 and the interval evaluation information generation unit 257 in FIG. 4C, respectively, and perform the same processing. A plurality of linear patterns parallel to each other are called first to N-th linear patterns (N is an integer equal to or greater than 2) in order of arrangement.

The interval data generator 258 obtains interval data between the n-th linear pattern and the (n+1)-th linear pattern (n=1, 2, . . . , N−1). That is, the interval data generator 258 calculates the distance between any two linear patterns adjacent to each other.

Furthermore, the interval evaluation information generation unit 259 generates interval data obtained for the n-th linear pattern and the n+1-th linear pattern, and standard values created in advance for the n-th linear pattern and the n+1-th linear pattern. Based on the information, interval evaluation information is generated for the n-th linear pattern and the n+1-th linear pattern. As a result, N−1 pieces of space evaluation information corresponding to N−1 pairs obtained from N linear patterns are obtained.

The distribution generator 260 is configured to generate information representing the distribution of the N−1 pieces of interval evaluation information thus acquired. The generated information is called interval evaluation information distribution. For example, the distribution generator 260 may determine the spacing by determining the position of each of the N-1 spacing evaluation information according to the placement of the N linear patterns (eg, relative placement or placement in a reference device). A rating information distribution can be generated.

The overscan evaluation information generation unit 261 generates evaluation information on overscan (overscan evaluation information) based on the interval evaluation information distribution generated by the distribution generation unit 260 and overscan standard information created in advance. is configured to The generated overscan evaluation information is an example of positional relationship evaluation information.

Still another example of evaluation according to this aspect will be described. This example can be used to evaluate a measurement method in which multiple scans are applied to the same part of an object (that is, evaluation of reproducibility of scans). Examples of such measurement methods in the field of ophthalmology include OCT angiography (OCT angiography), which emphasizes the blood vessel portion from the difference between multiple images of the eye to be inspected, and random noise by averaging multiple images of the eye to be inspected. There are image averaging for removing , and techniques for generating time-series data from a plurality of images of the subject's eye (for example, OCT blood flow measurement, motion measurement, etc.). In these measurement methods, it is necessary to repeatedly scan the same area of the object (eye to be inspected) with high accuracy. This example evaluates whether the position reproducibility of such repetitive scanning is sufficient.

In this example, the ophthalmic device 1 applies repetitive scans to the fiducial. In other words, the ophthalmologic apparatus 1 scans the same pattern a plurality of times, targeting the same area of the reference device. This provides multiple data collected from the fiducial in the same pattern of scans.

It should be noted that although the plurality of data are collected by a plurality of scans targeting the same area, they are not necessarily collected from the same area. If the position repeatability of the scans is low, the multiple data will be collected from substantially different regions. Here, the reference (threshold value) for determining whether or not the position reproducibility is sufficient may be set according to the type of measurement method.

FIG. 4E shows a configuration example of the evaluation unit 250 for evaluating the position reproducibility of repetitive scanning. The evaluation unit 250</b>E of this example includes a reproducibility evaluation information generation unit 262 . The reproducibility evaluation information generation unit 262 generates position reproducibility evaluation information (reproducibility evaluation information) of repetitive scanning based on a plurality of data collected by repetitive scanning. The generated reproducibility evaluation information is an example of position evaluation information.

Next, the visualization information generator 270 will be described. The visualization information generation unit 270 generates visualization information from the evaluation information generated by the evaluation unit 250 . The visualization information is information that visually represents at least part of the evaluation information or information obtained therefrom.

The assessment information input to visualization information generator 270 may be any type of assessment information collected by scanning the fiducials, such as any of the following exemplary assessment information: Evaluation information based on projection data; Evaluation information based on standard information of patterns formed on a reference device; Evaluation information on linearity (straightness) of line scans; Evaluation information on scan positions (position evaluation information); positional relationship evaluation information (positional relationship evaluation information); line scan interval evaluation information (interval evaluation information); overscan evaluation information (overscan evaluation information); evaluation information that is a combination of any two or more of the above examples; evaluation information similar to any of the above examples; evaluation information based on any of the above examples. A specific example of the visualization information will be described later.

The overview of the evaluation units 250A to 250E, which are several examples of the evaluation unit 250, has been described above. Some specific aspects of the evaluation of the ophthalmologic apparatus 1 that can be performed using such an evaluation unit 250 will be described below.

In some embodiments, for example, an eye model is used to evaluate the ophthalmic device 1 . The model eye is provided with a reference device. As described above, the reference device is formed with a pattern designed based on one or more scanning conditions of the ophthalmologic apparatus 1 . The standard is used, for example, as a part of the eye model corresponding to the fundus (simulated fundus). The reference device is not limited to the simulated fundus, and may be a part of the model eye corresponding to any part of the eye. The reference device does not need to be a part of the model eye, and may be, for example, a single reference device, or may be provided as a part of the simulated fundus.

An example of a model eye is shown in FIG. The model eye 500 of this example is placed in front of the objective lens 22 for performance evaluation of the ophthalmologic apparatus 1 . For example, the model eye 500 is attached to a face holding portion (a chin rest, a forehead rest, etc.) via a dedicated attachment. As a result, the eye model 500 is arranged at the same position as the eye E to be examined. The alignment function of the ophthalmologic apparatus 1 can be used to align the ophthalmologic apparatus 1 with respect to the model eye 500 . This makes it possible to facilitate the work of evaluating the ophthalmologic apparatus 1, and to evaluate the ophthalmologic apparatus 1 while considering the alignment quality evaluation.

The model eye 500 includes a cornea portion 510 (cornea equivalent lens) corresponding to the cornea, an iris portion 520 corresponding to the iris, a lens portion 550 (lens equivalent to the lens) corresponding to the crystalline lens, and a vitreous portion corresponding to the vitreous body. 560 and a fundus portion 570 corresponding to the fundus. The number of elements (for example, the number of lenses) included in the eye model 500 is arbitrary.

The iris portion 520 forms an aperture 540 corresponding to the pupil. Also, the iris portion 520 may be provided with a variable portion 530 for changing the size (aperture diameter) of the opening 540 . The variable part 530 is, for example, detachable from the iris part 520, and a plurality of members corresponding to different aperture diameters are selectively applied. Alternatively, variable portion 530 is configured to be movable with respect to iris portion 520 . Note that the size of the opening 540 may be fixed. The vitreous part 560 is filled with liquid such as oil, for example. In addition, the substance with which the vitreous part 560 is filled is arbitrary, and may be, for example, any one of arbitrary gas, arbitrary liquid, and arbitrary solid. Gas (air) typically exists in the space between the corneal portion 510 and the lens portion 550 . Any substance may be provided in the space between the corneal portion 510 and the lens portion 550, and may be, for example, any gas, any liquid, or any solid.

The fundus 570 is a pseudo-fundus and includes a fiducial. Details and specific examples of the reference device will be described later.

The fundus part 570 may have a layered structure corresponding to the fundus of the human eye. For example, fundus 570 may comprise one or more layers that correspond to any tissue of the fundus of the human eye. The tissues of the ocular fundus include the inner limiting membrane, nerve fiber layer, ganglion cell layer, inner reticular layer, inner nuclear layer, outer reticular layer, outer nuclear layer, outer limiting membrane, photoreceptor layer, retinal pigment epithelium layer, and Bruch's membrane. , choroid, and sclera. The thickness and refractive index of each layer formed in the fundus 570 may be equivalent to the thickness and refractive index of one or more corresponding tissues.

The shape of the fundus 570 is not limited to a flat plate shape as shown in FIG. 5, and may be a curved shape. For example, the shape of the fundus 570 may be a partial spherical shape or a partial ellipsoidal shape that mimics the shape of the fundus of the human eye.

The fundus 570 may have a structure corresponding to any part or tissue of the human eye. For example, the fundus 570 may include structures corresponding to the macula, structures corresponding to the optic disc, structures corresponding to blood vessels, and the like. In addition, the fundus 570 may have a structure corresponding to any disease, any pathological condition, or any lesion. For example, it may include structures corresponding to age-related macular degeneration (AMD) (such as drusen), structures corresponding to retinal detachment, structures corresponding to hemorrhages, structures corresponding to tumors, structures corresponding to atrophy, and the like.

The parameter values of the model eye 500 may be designed to be equivalent or similar to those of the human eye. Values for the parameters of the eye model 500 are obtained, for example, from standard eye models or clinical data. Standard eye models include Gullstrand eye models, Navarro eye models, Liou-Brennan eye models, Badal eye models, Arizona eye models, Indiana eye models, any standardized eye models, and models equivalent to any of these. There are eyes. The eye model 500 may also be designed based on an eye with a disease such as high myopia. For example, the curvature of the fundus (reference device) of the model eye corresponding to high myopia is designed to be larger than the curvature of the fundus (reference device) of other model eyes (for example, model eyes corresponding to normal eyes). Also, the model eye 500 may have a structure corresponding to any disease, any pathological condition, or any lesion. For example, the model eye 500 may have a structure corresponding to any corneal disease, any lens disease, or the like. Moreover, the eye model 500 may have a structure corresponding to an artificial object. For example, eye model 500 may comprise an intraocular lens (IOL) or equivalent structure.

The distance between the center position of the front surface of the corneal portion 510 (the position corresponding to the apex of the cornea) and the front surface of the fundus portion 570 may be designed based on the axial length of the human eye. In addition, the focal length of the cornea portion 510, the lens portion 550, and the vitreous portion 560 as a whole may be designed to have a value equivalent to the focal length of the human eye. For example, it may have means (eg, spacers) for changing the optical distance between the lens portion 550 and the fundus portion 570 . This makes it possible to change the refractive power of the eye model 500 and, for example, to evaluate the imaging and measurement of an eye with a long axial length.

The reflectance of the front surface of the iris portion 520 (variable portion 530) (the surface on the cornea portion 510 side) may be designed to have the same reflectance as that of the human eye. This reflectance may be, for example, the reflectance of infrared wavelengths. Similarly, the front surface of the corneal portion 510 can be designed to have a reflectance equivalent to that of the human eye. Further, the model eye 500 may be designed such that the entrance pupil of the iris portion 520 (variable portion 530, aperture 540) is located at the same position as the entrance pupil of the iris of the human eye.

Light used for scanning the model eye 500 (measurement light LS in this aspect) and light used for alignment (alignment light output from the LED 51 in this aspect) are prevented from being multiple-reflected inside the model eye 500. For this purpose, it is possible to provide an antireflection film on the lens or the like, or to apply an antireflection paint to the internal member.

When performing alignment with the pupil as a reference, such as alignment using a stereo camera, for example, the following parameter values can be set. First, the entrance pupil of aperture 540 may be positioned approximately 3.06 millimeters away from corneal portion 510 . Further, the diameter of opening 540 may be set to a value within the range of 2 to 10 millimeters. In addition, the infrared reflectance of iris portion 520 (variable portion 530) may be set to a value within the range of 2.0 to 2.5 percent. Such a design makes it possible to perform alignment with respect to the model eye 500 with the opening 540 as a reference, similar to the case of performing alignment with the pupil of the human eye as a reference.

Even when another alignment method is used, the parameter values of the eye model 500 are set according to that method. For example, when performing alignment using a corneal reflection image (Purkinje image), the radius of curvature of the corneal portion 510 (the radius of curvature of the front surface of the cornea-equivalent lens) may be set to approximately 7.7 millimeters. Similarly, when alignment is performed using an optical lever, the radius of curvature of the cornea portion 510 (the radius of curvature of the front surface of the cornea-equivalent lens) can be set to approximately 7.7 millimeters.

Next, the reference device will be explained. In this aspect, the reference device is part of the eye model 500 (the eye fundus 570), but the embodiment is not limited to this, and for example, some aspects of the reference device may be used alone for evaluation. However, it may be built in the ophthalmic device.

Examples of datums of this aspect are shown in FIGS. 6A and 6B. FIG. 6A is a front view (top view) of the reference device 600 of this example, and FIG. 6B is a sectional view showing the AA section (xy section) of FIG. 6A.

The reference device 600 has a plurality of linear patterns formed vertically and horizontally. In other words, the reference device 600 is formed with a checkerboard (lattice, grid) pattern.

As shown in FIG. 6B, the pattern in this example is formed by concave portions (grooves), but some patterns may be formed by convex portions. Also, the patterns of some aspects may be formed of two or more materials with different optical characteristics. For example, a base (substrate, substrate, etc.) is made of a first material having a first scattering property, and a pattern portion is made of a second material having a second scattering property different from the first scattering property. can do. Alternatively, the grooved datum can be made of a first material and a second material can be placed in the groove (eg, the second material can be filled into the groove). Optical properties are not limited to scattering properties, and may be arbitrary optical properties such as absorption properties, reflection properties, transmission properties, and polarization properties.

As described above, the reference device 600 is formed with a grid pattern. This grid pattern includes a plurality of linear patterns 601 along a first direction and a plurality of linear patterns 602 along a second direction different from the first direction. In this example, the first direction and the second direction are orthogonal to each other, but embodiments are not limited to this, for example, in some aspects the first direction and the second direction are They may be oblique to each other.

When using the ophthalmologic apparatus 1, the reference device 600 (eye model 500) is attached to the ophthalmologic apparatus 1 so that the first direction substantially coincides with the y direction and the second direction substantially coincides with the x direction. placed. Such configurations and arrangements correspond to, for example, x-direction line scan, y-direction line scan, cross-scan, multi-cross-scan, and raster scan.

A plurality of linear patterns 601 along the first direction are arranged substantially parallel to each other at substantially equal intervals I. As shown in FIG. In other words, the plurality of linear patterns 601 along the first direction are periodically formed in the arrangement direction (second direction). Also, the dimensions of the plurality of linear patterns 601 are substantially equal. As shown in FIG. 6B, the linear patterns 601 have substantially equal widths W and substantially equal depths D. As shown in FIG.

Similarly, the plurality of linear patterns 602 along the second direction are arranged substantially parallel to each other at substantially equal intervals. That is, the plurality of linear patterns 602 along the second direction are periodically formed in the arrangement direction (first direction). Here, the interval between the plurality of linear patterns 602 may be equal to or different from the interval I between the plurality of linear patterns 601 . Also, the dimensions of the plurality of linear patterns 602 are substantially equal. Here, the dimensions (width, depth, etc.) of the linear pattern 602 may be equal to or different from the dimensions (width W, depth D, etc.) of the linear pattern 601 .

The relationship between the parameters (dimensions, intervals, etc.) of the plurality of linear patterns 601 and the parameters of the plurality of linear patterns 602 may be designed based on the scanning conditions used in evaluating the ophthalmologic apparatus 1 . For example, when the spacing in the x direction and the spacing in the y direction between multiple scanning points (plural grid points) in raster scanning used for evaluation are equal, the spacing I between the multiple linear patterns 601 and the multiple linear patterns 602 can be equal to each other. Further, when the spacing in the x direction and the spacing in the y direction of the plurality of scanning points (plural grid points) in the raster scan used in the evaluation are different, the spacing I between the plurality of linear patterns 601 and the spacing I between the plurality of linear patterns 601 602 can be different from each other.

Although the datum 600 shown in FIGS. 6A and 6B has a pattern formed on its surface, embodiments are not so limited, for example, in some aspects the datum has a pattern formed therein. can be prepared.

Although the reference device 600 of this example is a flat member, the embodiment is not limited to this. For example, it may be a member having a curved surface or a curved plate member. . Such a curved shape imitates the shape of the fundus of the human eye.

The material (material) of the reference device 600 may be arbitrary, and may be, for example, porous glass. More generally, the material of the reference device 600 may be any material having scattering properties in the wavelength band (near-infrared light) of the measurement light LS, such as porous quartz glass.

Reference numeral 601a in FIG. 6B indicates the central axis (central position) of the linear pattern 601. FIG. In this embodiment, for example, the shape (width W) has been created.

Examples of scans applied to the fiducial 600 for evaluation of the ophthalmic device 1 are shown in FIGS. 7A and 7B. Reference numeral 700 in FIG. 7A indicates the application area (outer edge, contour) of the scan of this example with respect to the fiducial 600 . The scan of this example is a three-dimensional scan applied to a three-dimensional region of the reference device 600 defined by the scan area 700 in the xy direction. An example of this three-dimensional scan is shown in FIG. 7B. The three-dimensional scan in this example is a raster scan consisting of a plurality of line scans 700-k (k=1, 2, . . . , K: K is a positive integer) along the x direction. The K line scans 700-1 through 700-K are parallel to each other. In some aspects, a raster scan consisting of multiple line scans along the y-direction can be applied to datum 600 . Note that the scanning mode (raster scanning mode, three-dimensional scanning mode, etc.) is not limited to these.

An example of a luminance profile obtained using such a scan is shown in FIG. The brightness profile of this example constructs three-dimensional image data from data collected from the three-dimensional area of the reference device 600 by raster scanning, projects this three-dimensional image data in the z-direction to construct projection data, and constructs projection data. It is generated by finding the luminance distribution on a line along the x-direction of the projection data.

The horizontal and vertical axes of the luminance profile in FIG. 8 indicate the x-coordinate (position in the x-direction) and the luminance value, respectively. Each plotted point indicates the luminance value at the corresponding x-coordinate. The graph is obtained by interpolating the plotted points with a spline curve. Each dashed line parallel to the vertical axis indicates the estimated position of the center of gravity (groove center of gravity) of the groove (recess, linear pattern 601) of the reference device 600. FIG. The distance between two adjacent groove centroids is an estimate of the spacing of the corresponding two linear patterns 601 .

Several specific examples of evaluation of the ophthalmologic apparatus 1 using the reference device 600 and the raster scans 700-1 to 700-K will be described below.

A first specific example of evaluation will be described with reference to FIG. In this example, the straightness of the line scan of the ophthalmologic apparatus 1 is evaluated. First, the eye model 500 (reference device 600) is installed (S1). For example, the eye model 500 is attached to the chin rest via a dedicated attachment. The manner in which the eye model 500 is worn is not limited to this.

After the eye model 500 is attached, the ophthalmologic apparatus 1 starts alignment with the eye model 500 (S2). Alignment may be performed by any of the exemplary schemes described above.

After completing the alignment, the ophthalmologic apparatus 1 applies an OCT scan to the reference device 600 of the eye model 500 (S3). The OCT scan in this example is the raster scan shown in FIGS. 7A and 7B.

Next, the ophthalmologic apparatus 1 constructs three-dimensional image data from the data collected by the raster scanning in step S3 (S4), and constructs projection data from this three-dimensional image data (S5).

Furthermore, the ophthalmologic apparatus 1 creates a luminance profile similar to that shown in FIG. 8 from this projection data (S6). A luminance profile is created for at least one line. The at least one line for which an intensity profile is created may include at least one of lines along the x-direction, lines along the y-direction, and lines along other directions. Typically, an intensity profile can be created for lines parallel to the line scan 700-k shown in FIG. 7B (lines along the x-direction in this example). This allows the straightness of line scan 700-k to be evaluated. The alignment of two or more line scans 700-k (such as their alignment in the y-direction) can be evaluated if straightness is to be determined for lines along directions different from the x-direction.

Subsequently, the ophthalmologic apparatus 1 detects the center of gravity of the groove from the luminance profile created in step S6 (S7). Any method may be used to detect (estimate) the center of gravity of the groove. For example, by analyzing the luminance profile in FIG. An estimated location of the groove centroid can be determined.

Next, the ophthalmologic apparatus 1 identifies the coordinates of the center of gravity of each groove identified in step S7 (S8). Here, at least the x-coordinate of the groove centroid is specified. This gives the coordinates (at least the x-coordinate) of each linear pattern 601 intersecting the line for which the intensity profile was created. In other words, the distribution of the centroid positions of the plurality of linear patterns 601 on the line is obtained.

Next, the ophthalmologic apparatus 1 calculates the interval between the groove centroids from the coordinates of the plurality of groove centroids specified in step S8 (S9). The calculation of the groove center-of-gravity interval may be performed for each pair of adjacent groove center-of-gravity points, or may be performed for a pair selected from these pairs. In addition, when the groove center-of-gravity intervals are calculated for two or more pairs, the statistics of the obtained two or more groove center-of-gravity intervals (for example, average, mode, median, variance, standard deviation, etc.) are calculated. You may Alternatively, by calculating the distance between two non-adjacent groove gravity centers and dividing the calculated distance by a value obtained by adding 1 to the number of other groove gravity centers existing between the two groove gravity centers, the groove gravity center Intervals may be estimated.

Subsequently, the ophthalmologic apparatus 1 generates evaluation information based on at least one of the groove center-of-gravity coordinates specified in step S8, the groove center-of-gravity interval calculated in step S9, and information obtained from at least one of these. (S10).

In this example, standard information of the reference device 600 is stored in the storage unit 212 . The standard information in this example includes standard information on the groove center-of-gravity position (groove center-of-gravity coordinates), standard information on the groove center-of-gravity interval, and standard information on parameters obtained from the groove center-of-gravity position and/or the groove center-of-gravity interval. The ophthalmologic apparatus 1 compares the groove center-of-gravity coordinates identified in step S8, the groove-center-of-gravity interval calculated in step S9, information obtained from at least one of these, and the like with such standard information, thereby determining the linearity of the scan. Evaluation information regarding sex can be generated. For example, the ophthalmologic apparatus 1 calculates the difference between the groove center-of-gravity coordinates specified in step S8 and the groove center-of-gravity position (coordinates) included in the standard information, and calculates the calculated difference (that is, the standard groove center-of-gravity position The linearity evaluation information (straightness) of the line scan 700-k can be obtained based on the actually measured displacement of the groove center-of-gravity coordinates. Further, the ophthalmologic apparatus 1 calculates the difference between the groove center-of-gravity interval calculated in step S9 and the groove center-of-gravity interval included in the standard information, Linearity evaluation information (straightness) of the line scan 700-k can be obtained based on the calculated groove center-of-gravity interval error).

Subsequently, the ophthalmologic apparatus 1 generates visualization information from the evaluation information generated in step S10 (S11). The ophthalmologic apparatus 1 can display the generated visualization information on the display unit 241 . The visualization information may be, for example, a map (heat map, etc.) showing the distribution of the evaluation information, a luminance profile (graph, plot, etc.), or the like. A specific example of the visualization information will be described later.

The ophthalmologic apparatus 1 can transmit evaluation information and visualization information to an external apparatus, and can record them on a recording medium. This concludes the explanation of the first specific example of evaluation (end).

A second specific example of evaluation will be described with reference to FIG. In this example, the straightness of the line scan of the ophthalmologic apparatus 1 is evaluated. Steps S21 to S25 may be performed in the same manner as steps S1 to S5 of the first specific example, respectively.

Furthermore, the ophthalmologic apparatus 1 creates a luminance profile similar to that shown in FIG. 8 from the projection data constructed in step S25. In this example, the ophthalmologic apparatus 1 creates at least one brightness profile along the x direction and at least one brightness profile along the y direction (S26).

Subsequently, the ophthalmologic apparatus 1 detects the center of gravity of the groove from each luminance profile created in step S26 (S27). This process may be performed in the same manner as step S7 in the first specific example. Furthermore, the ophthalmologic apparatus 1 identifies the coordinates of the center of gravity of each groove identified in step S27 (S28). Here, the x- and y-coordinates (that is, the coordinates in the xy coordinate system) of the groove center of gravity are specified.

Next, the ophthalmologic apparatus 1 creates a scatter diagram by plotting the position of each groove centroid on a predetermined two-dimensional coordinate system based on the xy coordinates of the plurality of groove centroids specified in step S28 (S29). . For example, the horizontal and vertical axes of this two-dimensional coordinate system are the distance in the x-direction and the distance in the y-direction, respectively. The unit of distance is, for example, micrometers.

Some examples of data generated in step S29 are shown in FIG. Reference numeral 800 indicates the portion of the standard (scan application area) corresponding to the scan area 700 in FIG. 7A. Reference numeral 801 indicates one line along the x-direction in the scan coverage area 800, and reference numerals 802 and 803 indicate two lines along the y-direction. Reference numeral 811 denotes a scatterplot created by plotting the positions of multiple groove centroids on line 801 . Similarly, reference numeral 812 indicates a scatter plot created by plotting the locations of multiple groove centroids on line 802, and reference numeral 813 indicates a scatter plot created by plotting the locations of multiple groove centroids on line 803. A scatter plot is shown.

Next, the ophthalmologic apparatus 1 applies polynomial fitting to each scatter diagram created in step S29 (S30). The polynomial used for this polynomial fitting may be, for example, at least one of a second order polynomial, a third order polynomial, and a fourth order polynomial. It should be noted that arbitrary curve fitting may be performed instead of or in addition to polynomial fitting.

Subsequently, the ophthalmologic apparatus 1 generates linearity evaluation information (straightness) based on the polynomial coefficients obtained by the polynomial fitting performed in step S30 (S31). More specifically, the ophthalmologic apparatus 1 can generate linearity evaluation information based on the magnitude of the polynomial coefficients. For example, if the deviation of the center of gravity of the groove is small and the groove is close to a straight line, the coefficient value can be converted into a straightness value according to a conversion formula generated in advance using the property that the coefficient becomes zero. Alternatively, it is possible to determine whether the linearity is good or bad from the value of the coefficient based on a threshold value generated in advance using the property.

Furthermore, the ophthalmologic apparatus 1 can generate visualization information from the evaluation information generated in step S31. In addition, the ophthalmologic apparatus 1 can display the generated visualization information on the display unit 241 . In addition, the ophthalmologic apparatus 1 can transmit evaluation information and visualization information to an external apparatus and record them on a recording medium. This completes the explanation of the second specific example of evaluation (end).

A third specific example of evaluation will be described with reference to FIG. This example provides an example of visualization information that visually expresses the evaluation information. The visualization information of this example expresses the distribution of the groove center-of-gravity intervals in the scan applicable area 800 similar to that in FIG.

Reference numeral 821 denotes a groove interval map obtained by two-dimensionally mapping groove intervals in the x direction at a plurality of positions in the scan applicable area 800 . For example, the x-direction groove spacing 805 at a certain position is represented at the corresponding position (the position indicated by the arrow) in the groove spacing map 821 .

Similarly, reference numeral 822 denotes a groove interval map that two-dimensionally maps groove intervals in the y direction at a plurality of positions in the scan applicable area 800 . For example, the y-direction groove spacing 804 at a location is represented by its corresponding location (indicated by the arrow) in the groove spacing map 822 .

The groove-gap maps 821 and 822 may be color maps that express the magnitude of the value of the groove-gap using different colors. On the right side of the groove interval map 821 as a color map, a color code indicating the correspondence between the value of the groove interval and the color is arranged. Similarly, on the right side of the groove interval map 822 as a color map, a color code indicating the correspondence relationship between the value of the groove interval and the color is arranged. The ophthalmic device 1 assigns the groove spacing value at each position a corresponding color in the color code.

In some embodiments, the color code is set such that the higher the groove spacing value, the closer the color is to yellow, and the lower the groove spacing value, the closer to blue the color is.

At least one of the groove interval maps 821 and 822 may be visualization information in a form different from the color map. For example, it is possible to use a map that expresses the value of the groove interval by means of contrast or pattern. Also, the groove interval may be expressed numerically.

In this example, groove spacing is defined as the distance between two adjacent groove centroids, but embodiments are not so limited. For example, in some embodiments, the groove spacing is defined as the deviation amount (distance value, variance value, standard deviation value, etc.) of each groove spacing from the representative value (average value, mode value, median value, etc.) of a plurality of groove spacings. may be defined.

Further, by presetting a threshold for the groove spacing and comparing the value of the groove spacing at each position with the threshold, the quality of the groove spacing at each position can be determined. Furthermore, it is possible to provide visualization information indicating the result of this pass/fail judgment. For example, it is possible to provide a map showing the distribution of pass/fail judgment results.

A fourth specific example of evaluation will be described with reference to FIG. This example provides an example of visualization information that visually expresses the evaluation information. The visualization information of this example visually expresses the overscan evaluation information of the scan applicable area 800 similar to that in FIG.

As described above, the overscan evaluation can provide, for example, whether or not the artifact generation area is appropriately set, the presence/absence/degree/quantity of overscan artifacts, whether or not they are acceptable, and the like. good.

In this example, the ophthalmologic apparatus 1 can evaluate the state of the image in the x-direction end region of the scan applicable area (800) in the manner described above. Here, the x-direction is the direction along each line scan 700-k.

The ophthalmologic apparatus 1 can determine the relative position of two images corresponding to a pair of adjacent line scans 700-k and 700-(k+1) in the x-direction edge region of the scan coverage area (800). For example, the ophthalmologic apparatus 1 can obtain at least one of the distance (interval) in the y direction and the displacement in the x direction between these two images. In addition, the ophthalmologic apparatus 1 can obtain the degree of uniformity (uniformity) of the intervals in the x direction of a plurality of A-scan image data included in the image (B-scan image data) corresponding to the line scan 700-k.

The ophthalmologic apparatus 1 can generate visualization information that visually expresses the overscan evaluation information based on the information of such overscan evaluation parameters. Visualization information (overscan evaluation map) 823 on overscan shown in FIG. It is a representation of the distribution.

The overscan evaluation map 823 may be a color map that expresses the values of the overscan evaluation parameters with different colors. On the right side of the overscan evaluation map 823 as a color map, color codes indicating the correspondence between overscan evaluation parameter values and colors are arranged. The ophthalmologic apparatus 1 assigns a corresponding color in the color code to the value of the overscan evaluation parameter at each position. As in the third specific example, the overscan evaluation map 823 may be visualization information in a form different from the color map.

In addition, by presetting a threshold for the overscan evaluation parameter and comparing the value of the overscan evaluation parameter at each position with the threshold, it is possible to determine whether the overscan evaluation parameter is good or bad at each position. Furthermore, it is possible to provide visualization information indicating the result of this pass/fail judgment. For example, it is possible to provide a map showing the distribution of pass/fail judgment results.

A fifth specific example of evaluation will be described. This example provides evaluation and visualization information regarding the position repeatability of repetitive scans performed in OCT angiography, image averaging, OCT blood flow measurement, motion measurement, and the like. FIG. 14 shows an example of processing for generating reproducibility evaluation information and its visualization information. Steps S41 and S42 may be performed in the same manner as steps S1 and S2 of the first example, respectively.

After completing the alignment in step S42, the ophthalmologic apparatus 1 applies iterative scanning to the eye model 500 (S43). In other words, the ophthalmologic apparatus 1 performs multiple scans targeting the same portion of the reference device 600 . The repetitive scans in this example are multiple raster scans.

The number of scan repetitions in the iterative scan may be any number of times greater than or equal to two. The number of iterations may be determined, for example, according to the type of measurement method to be evaluated. In some aspects, the number of repetitions of repetitive scanning when the measurement method to be evaluated is OCT angiography may be 4 times, which is the same as the number of scanning performed targeting the same location in OCT angiography. . The number of iterations for other measurement methods to be evaluated may also be determined in the same manner. In this example, raster scanning is performed four times for the same location (scan application area 800) of the reference device 600. FIG.

The ophthalmologic apparatus 1 constructs three-dimensional image data from each of the four acquired data sets obtained by the repetitive scanning in step S43. As a result, four pieces of three-dimensional image data corresponding to the four raster scans are obtained (S44). Further, the ophthalmologic apparatus 1 constructs projection data from each three-dimensional image data constructed in step S44. As a result, four projection data corresponding to four raster scans are obtained (S45).

Next, the ophthalmologic apparatus 1 creates a luminance profile similar to that shown in FIG. 8 from each projection data obtained in step S45 (S46). In this example, the ophthalmologic apparatus 1 creates, for example, one or both of a plurality of brightness profiles along the x direction and a plurality of brightness profiles along the y direction. As a result, four luminance profile groups corresponding to four raster scans are obtained.

Next, the ophthalmologic apparatus 1 detects the center of gravity of the groove from each luminance profile created in step S46 (S47). This process may be executed in the same manner as step S7 in the first specific example. As a result, four groups of groove centroids corresponding to four raster scans are obtained.

Next, the ophthalmologic apparatus 1 identifies the coordinates of the center of gravity of each groove identified in step S47 (S48). In this example, the x- and y-coordinates (ie, the coordinates in the xy coordinate system) of the groove center of gravity are specified. As a result, four groove center-of-gravity coordinate groups corresponding to four raster scans are obtained.

Next, the ophthalmologic apparatus 1 selects 1 from the group of four groove barycentric coordinates identified in step S48 for each point of the reference device 600 (each point within the range to which the repetitive scanning is applied; the same applies hereinafter in this example). Select the groove barycentric coordinates corresponding to each point. This assigns four groove centroid coordinates to each point on the datum 600 . That is, four groove centroids are associated with each point on the datum 600 . Furthermore, the ophthalmologic apparatus 1 calculates, for each point of the reference device 600, the positional error between the four groove centroids associated with that point (S49).

The error calculated in step S49 represents the amount of deviation (displacement, variation) of the scanning position (scanning range) between the four raster scans sequentially executed with the same area of the reference device 600 as the target. . As a result, the distribution of the scan position deviation amount in the reference device 600 (the range to which the repetitive scan is applied) is obtained. The value calculated in step S49 may be, for example, any amount calculated from four groove center-of-gravity positions (coordinates), such as standard deviation, maximum error, or average error.

Subsequently, the ophthalmologic apparatus 1 generates reproducibility evaluation information based on the error distribution of the position of the center of gravity of the groove obtained in step S49 (S50). This process may include, for example, a process (threshold process) of comparing at least some of the multiple errors obtained in step S49 or a value obtained based thereon with a predetermined threshold.

Furthermore, the ophthalmologic apparatus 1 generates visualization information (reproducibility visualization information) from the reproducibility evaluation information generated in step S50 (S51). Examples of aspects of the reproducibility visualization information will be described later. In addition, the ophthalmologic apparatus 1 can display the generated reproducible visualization information on the display unit 241 . In addition, the ophthalmologic apparatus 1 can transmit the reproducibility evaluation information and the reproducibility visualization information to an external device and record them on a recording medium. This completes the description of the series of processes shown in FIG. 14 (end).

A specific example of the series of processes shown in FIG. 14 will be described with further reference to FIGS. 15 and 16. FIG. In this example, as shown in FIG. 15, four pieces of projection data 831 to 834 corresponding to four raster scans are obtained.

First, the ophthalmologic apparatus 1 calculates a position (second position) 832a of the second projection data 832 corresponding to the arbitrary position (first position) 831a of the first projection data 831. to decide.

For example, the ophthalmologic apparatus 1 specifies the xy coordinates (first xy coordinates) of the first position in the xy coordinate system (first xy coordinate system) in which the first projection data 831 is defined, Identifying a position having the same x and y coordinates as the first xy coordinates in the xy coordinate system (second xy coordinate system) in which the projection data 832 is defined, and setting this specific position as the second position 832a can be done. Determining a position (third position) 833a of third projection data 833 corresponding to first position 831a and a position (fourth position) of fourth projection data 834 corresponding to first position 831a The determination of 834a can be performed in the same manner. Note that the method of determining the four mutually corresponding positions in the four projection data 831 to 834 is not limited to this.

Next, as shown in FIG. 16, the ophthalmologic apparatus 1 generates data P(1) of the first projection data 831 at the first position 831a (and its vicinity) and data P(1) of the first projection data 831a (and its vicinity) at the second position 832a (and its vicinity). data P(2) of the second projection data 833 at, data P(3) of the third projection data 833 at the third position 833a (and its vicinity), and fourth position 834a (and its vicinity) Information at positions (defined positions) defined from these positions 831a to 834a is generated based on the data P(4) of the fourth projection data 834 at .

For example, the data P(1) to P(4) may be pixel information at the corresponding first to fourth positions 831a to 834a, or may be data generated from pixel information. In addition, the data P(1) to P(4) may include pixel information at positions near the corresponding first to fourth positions 831a to 834a, or may be generated from pixel information at positions near the corresponding first to fourth positions 831a to 834a. may contain data. Further, the defined position may be any one of the first to fourth positions 831a to 834a (for example, the first position 831a), or may be from at least two of the first to fourth positions 831a to 834a. It may be a determined position (eg, an average position).

By assigning the information obtained in this way to the defined positions, reproducibility visualization information 841 in FIG. 16 is obtained. The reproducibility visualization information 841 is a color map representing the distribution of the amount of deviation of the center of gravity of the groove in the x direction. Information (values) generated from four data P(1) to P(4) corresponding to the first to fourth positions 831a to 834a, respectively, at the position of the reproducibility visualization information 841 (position defined above) is assigned a corresponding color. By executing such processing for each point of the first projection data 831, reproducibility visualization information 841, which is a map representing the distribution as reproducibility evaluation information, is generated. The reproducibility visualization information 843, which is a color map indicating the amount of deviation of the center of gravity of the groove in the y direction, is also generated in the same manner.

Another example for generating reproducibility evaluation information will be described. This example utilizes registration of projection data (or 3D image data). The ophthalmologic apparatus 1 provides registration for the first to fourth projection data 831-834. This registration may be a global registration or a local registration.

Global registration is image processing aimed at aligning the entirety of each of the first to fourth projection data 831-834. For example, the ophthalmologic apparatus 1 uses the first projection data as reference data, and registers the second to fourth projection data 832 to 834 with this reference data. Any registration method may be used, but for example, a process of detecting feature points in each of the projection data 831 to 834, and a second registration process for the first projection data 831 based on errors in the positions of the detected feature points. . . determining the displacement of each of the fourth projection data 832-834. This deviation is employed as the amount of positional deviation between projection data.

Local registration is image processing aimed at aligning partial regions (local regions) of the projection data 831-834. For example, the ophthalmologic apparatus 1 first sets the first projection data as reference data and sets one local area (reference local area) of the first projection data 831 . The size and shape of the reference local region may be arbitrary. For example, an arbitrary point of the first projection data 831 can be specified, and the vicinity area of this specified point can be set as the reference local area. Next, the ophthalmologic apparatus 1 identifies partial regions corresponding to the reference local regions by analyzing the second to fourth projection data 832 to 834, respectively. As a result, the local positional deviation amount between the first projection data 831 and each of the second to fourth projection data 832 to 834 can be obtained. For example, the amount of positional deviation between an arbitrary point (specified point above) of the first projection data 831 and corresponding points of the second to fourth projection data 832 to 834 can be obtained. By executing such processing for a plurality of points of the projection data 831, it is possible to acquire the distribution of positional deviation amounts among the first to fourth projection data 831-834.

Some features, some actions, and some effects of this aspect will be described. A plurality of features described below can be features of this aspect individually, and can be features of this aspect as a combination of any two or more. It should be noted that the features provided by the present disclosure are not limited to those described above.

This aspect provides a reference device for evaluating a scan-type medical device, in which a pattern corresponding to the scanning conditions of the medical device is formed. More specifically, the reference device 600 of this embodiment is a reference device for acquiring evaluation information of a medical scanning device (ophthalmic device 1) that scans a living body and collects data based on preset scanning conditions. A pattern designed based on at least one scanning condition of the ophthalmologic apparatus 1 is formed. The reference device in which the pattern corresponding to the scanning conditions of the medical scanning device is formed in this way is novel. It enables new evaluation techniques for medical scanning devices, such as evaluations for (such as OCT angiography).

The pattern formed on the reference device 600 is designed, for example, based on arbitrary scan conditions in the OCT scan executed by the ophthalmologic apparatus 1 . The scanning conditions referred to in pattern design may include, for example, at least one of scan pattern, scan dimensions (length, area, volume, diameter, etc.), scan interval, scan density, and scan repetition number, Also, at least one of the other scan conditions exemplified in this aspect may be included.

The pattern formed on the datum 600 of this aspect may include a first periodic pattern along at least a first direction. Each of the plurality of linear patterns 601 and the plurality of linear patterns 602 in this aspect provide examples of such first periodic patterns. According to such aspects, for example, one or more scans along the first direction may be evaluated.

The pattern formed on the datum 600 of this aspect may further include a second periodic pattern along a second direction different from the first direction. In this aspect, both the plurality of linear patterns 601 and the plurality of linear patterns 602 are formed on the reference device 600, and the combination of the plurality of linear patterns 601 and the plurality of linear patterns 602 is the first An example of a combination of a periodic pattern and a second periodic pattern is provided. That is, one of the plurality of linear patterns 601 and the plurality of linear patterns 602 provides an example of a first periodic pattern, and the other provides an example of a second periodic pattern. Also, the combination of linear patterns 601 and linear patterns 602 provides an example of a grid pattern. According to such aspects, for example, one or more scans along the first direction can be evaluated, and one or more scans along the second direction can also be evaluated. . In this embodiment, evaluation of raster scan, evaluation of one line scan that constitutes raster scan, evaluation of two or more line scans that constitute raster scan, evaluation of multiple raster scans, and the like are performed. . Conventionally, a reference device with a cross pattern formed thereon was used to evaluate the length of a scan, but since evaluation could only be performed on the cross pattern, it was not possible to evaluate oblique scans, for example. It was not possible to assess scan distortion. Such inconvenience is eliminated by this aspect.

At least part of the pattern formed on the reference device 600 of this aspect may be recesses (grooves, valleys) and/or protrusions (mountains) formed on the surface or inside. In the example shown in FIG. 6B, recesses formed on the surface of the reference device 600 constitute the pattern. Although illustration is omitted, the pattern may be configured by forming a convex portion on the surface of the reference device, or the pattern may be configured by forming a concave portion and/or a convex portion inside the reference device. . According to such an aspect, a specific configuration is provided for including pattern information in the data collected by scanning.

At least part of the pattern formed on the reference device 600 of this aspect may be formed of two or more materials having different optical properties. For example, although illustration is omitted, for a specific optical property, a base (substrate, substrate, etc.) is made of a first material having a first property quantity, and a second property different from the first property quantity is created. A pattern portion can be formed by a second material having an amount. According to such aspects, specific arrangements are provided for including pattern information in data collected by optical scanning.

At least part of the pattern formed on the reference device 600 of this aspect may be formed of two or more materials with different light scattering properties. According to this aspect, a specific configuration is provided for including pattern information in data collected by optical scanning of a measurement method that utilizes differences in light scattering properties between tissues, such as OCT.

The present aspect provides a periodically patterned datum for evaluating a scan-type ophthalmic device. More specifically, the reference device 600 of this embodiment has patterns such as a plurality of linear patterns 601 and a plurality of linear patterns 602 that are spatially and periodically arranged. A periodic pattern may include a pattern that is periodically arranged in one direction, or may include a pattern that is periodically arranged in two or more directions. The reference device for evaluation of an ophthalmic device in which a periodic pattern is formed in this way is novel, and by using this reference device, it is possible to evaluate the linearity of the scan of the ophthalmic device and the position reproducibility of the scan of the ophthalmic device. , it becomes possible to perform new evaluation methods for ophthalmic devices, such as evaluations related to motion contrast imaging (OCT angiography, etc.) of ophthalmic devices.

This aspect provides an eye model in which a reference device having at least one of the plurality of features described above is used as a simulated fundus. More generally, the eye model provided by this aspect provides an eye model in which a reference device having at least one configuration among various configurations described in the present disclosure is used as a pseudo-fundus. Note that the eye model provided by the present embodiment is not limited to the above, and for example, the tissue simulated by the standard may be any eye tissue such as the cornea, lens, iris, and vitreous body.

In the eye model provided by this aspect, at least part of the surface of the reference device may be formed as a curved surface. Further, a pattern may be formed on or within the curved surface. According to this aspect, it is possible to evaluate an ophthalmologic apparatus using an eye model including a reference device having a curved surface that imitates the shape of the fundus of the eye. As a result, it is possible to more accurately reproduce the state of the scan that is actually applied to the living eye and perform the evaluation, so it is possible to improve the quality of the evaluation.

This aspect provides a novel medical evaluation device for acquiring evaluation information of a medical scanning device that scans a living body and collects data. The medical scanning device includes a reference device and an evaluation unit. The datum is formed with a pattern designed based on at least one scan condition of the medical scanning device. In addition, the evaluation unit generates evaluation information based on data collected by scanning the standard. For example, the ophthalmologic apparatus 1 described above collects data by applying an OCT scan to the eye E to be examined. and an evaluator 250 (eg, at least one of evaluators 250A-250E).

Some aspects of the medical evaluation device may be integral with the medical scanning device. For example, some aspects of the medical evaluation device are incorporated into a medical scanning device, in other words, the medical scanning device has configuration and functionality to evaluate itself. In contrast, some aspects of the medical evaluation device may be separate from the medical scanning device. For example, some aspects of the medical evaluation device may be a combination of an information processing device (computer) including an evaluation unit and a reference device. Thus, the implementation of the medical evaluation device may be arbitrary.

In some aspects, the pattern formed on the datum of the medical evaluation device may include a first periodic pattern along at least a first direction and a second direction different from the first direction. may further include a second periodic pattern along . For example, the pattern formed on the datum of the medical evaluation device may be a grid pattern.

In some aspects, at least a portion of the pattern formed on the datum of the medical evaluation device may be recesses and/or protrusions formed on or within the surface. Also, in some aspects, at least a portion of the pattern of the datum of the medical evaluation device may be formed from two or more materials with different optical properties, which optical properties may include scattering properties.

In addition, this aspect provides a novel medical evaluation device for acquiring evaluation information of a medical scanning device that scans a living body and collects data. The medical scanning device includes a reference device and an evaluation unit. A periodic pattern is formed on this standard. The evaluation unit generates evaluation information based on data collected by scanning the standard. For example, the ophthalmologic apparatus 1 described above collects data by applying an OCT scan to the eye E to be examined. 600 and an evaluator 250 (eg, at least one of evaluators 250A-250E). The implementation of the medical evaluation device may be arbitrary.

In some embodiments, the datum of the medical scanning device may be a simulated fundus of the eye model. In the reference device as the pseudo-fundus, at least part of the surface of the reference device may be formed as a curved surface, and the pattern formed on the reference device may be formed on or inside the curved surface. .

In some aspects, a medical scanning device may be configured to make an assessment based on projection data. Such medical scanning devices collect three-dimensional data by applying a scan to a three-dimensional area of a fiducial. The evaluation section includes a projection processing section and an evaluation information generation section. The projection processing unit is configured to construct projection data (two-dimensional data) from the collected three-dimensional data. The evaluation information generator is configured to generate evaluation information based on the constructed projection data. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, evaluation can be performed using two-dimensional information represented by projection data, and there is an advantage that less processing resources and processing time are required than using collected three-dimensional information. . For example, in the various evaluations performed by the ophthalmologic apparatus 1 described above, z-coordinate information is not necessary, and it can be said that there is no particular problem even if the dimension is reduced to projection data defined by the xy coordinate system.

In some aspects, the evaluation unit of the medical scanning device is configured to generate evaluation information based on data collected from scanning the datum and standard information of patterns formed on the datum. you can As described above, the pattern standard information can be created in advance based on, for example, the design information of the reference device and/or the measurement data of the reference device. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to more accurately compare the actual pattern formed on the reference device and the data collected by scanning the reference device, thereby improving the quality of the evaluation information. becomes possible.

In some aspects, the evaluation portion of the medical scanning device may be configured to determine the straightness of the line scan applied to the datum. Straightness (linearity, linearity) is an example of evaluation information. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to evaluate whether or not the trajectory of the line scan executed by the medical scanning device can be regarded as a straight line. can be evaluated.

In some aspects, the datum pattern of the medical scanning device may comprise a linear pattern. Further, the evaluation unit may be configured to determine the straightness of the line scan based on the data collected by scanning the datum and the standard information of the linear pattern. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to such an aspect, a specific configuration for evaluating the straightness of line scanning is provided.

In some aspects, an evaluator of a medical scanning device may include a projection processor, a position data generator, and a straightness calculator. The projection processor is configured to scan the 3D area of the fiducial and construct projection data from the 3D data collected. The position data generator is configured to obtain position data of the linear pattern formed on the reference device based on the generated projection data. The straightness calculator is configured to calculate the straightness of the line scan based on the obtained position data and the standard information of the linear pattern. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, a more specific configuration for evaluating the straightness of line scanning is provided.

In some aspects, the medical scanning device may further include a visualization information generator that generates visualization information from the evaluation information generated by the evaluator. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to provide the user with visualization information that visually expresses the evaluation information of the medical scanning device.

This aspect provides a novel medical evaluation device for obtaining evaluation information regarding the position of a scan of a medical scanning device that scans a living body and collects data. The medical scanning device includes a reference device and an evaluation unit. The datum is formed with a pattern designed based on at least one scan condition of the medical scanning device. The estimator is configured to generate position estimation information regarding the position of the scan applied to the datum based on the data collected by scanning the datum. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. The implementation of the medical evaluation device may be arbitrary.

In some aspects, the pattern formed on the datum of the medical evaluation device for obtaining evaluation information regarding the position of the scan may include a first periodic pattern along at least a first direction. , further comprising a second periodic pattern along a second direction different from the first direction. For example, the pattern formed on the datum of the medical evaluation device may be a grid pattern.

In some aspects, at least part of the pattern formed on the reference device of the medical evaluation device for obtaining evaluation information regarding the scan position is concave and/or convex formed on the surface or inside. you can Also, in some aspects, at least a portion of the pattern of the datum of the medical evaluation device may be formed from two or more materials with different optical properties, which optical properties may include scattering properties.

This aspect provides a novel medical evaluation device for obtaining evaluation information regarding the position of a scan of a medical scanning device that scans a living body and collects data. The medical scanning device includes a reference device and an evaluation unit. A periodic pattern is formed on the standard. The estimator is configured to generate position estimation information regarding the position of the scan applied to the datum based on the data collected by scanning the datum. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. The implementation of the medical evaluation device may be arbitrary.

In some embodiments, the datum of the medical scanning device for obtaining evaluation information regarding the position of the scan may be a simulated fundus of the model eye. In the reference device as the pseudo-fundus, at least part of the surface of the reference device may be formed as a curved surface, and the pattern formed on the reference device may be formed on or inside the curved surface. .

In some aspects, a medical scanning device for obtaining evaluation information regarding the position of the scan may be configured to perform the evaluation based on the projection data. Such medical scanning devices collect three-dimensional data by applying a scan to a three-dimensional area of a fiducial. The evaluation section includes a projection processing section and an evaluation information generation section. The projection processing unit is configured to construct projection data (two-dimensional data) from the collected three-dimensional data. The evaluation information generator is configured to generate evaluation information based on the constructed projection data. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, the two-dimensional information represented by the projection data can be used to evaluate the position of the scan, and processing resources and processing time can be reduced compared to using the collected three-dimensional information. There is an advantage.

In some aspects, the evaluation unit of the medical scanning device for obtaining evaluation information about the position of the scan is based on data collected by scanning the datum and standard information of patterns formed on the datum. to generate the evaluation information. As described above, the pattern standard information can be created in advance based on, for example, the design information of the reference device and/or the measurement data of the reference device. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to more accurately compare the actual pattern formed on the reference device with the data collected by scanning this reference device, and the evaluation information regarding the scanning position can be obtained. It is possible to improve quality.

In some aspects, the pattern formed on the datum of the medical scanning device for obtaining evaluation information regarding the position of the scan may include linear patterns. Furthermore, the evaluation unit evaluates the positional relationship evaluation information regarding the positional relationship of the plurality of line scans based on the data collected by applying the plurality of line scans to the reference device and the standard information of the linear pattern group. It may be configured to be generated as evaluation information. The positional relationship of a plurality of line scans may be, for example, line scan intervals (eg, raster scan intervals, radial scan angular intervals, etc.).

In some aspects, the group of linear patterns formed on the datum of the medical scanning device for obtaining evaluation information regarding the position of the scan may include two linear patterns that are parallel to each other. Further, the evaluator may include an interval data generator and an interval evaluation information generator. The interval data generator is configured to obtain interval data of the two linear patterns based on the data collected from the reference device. The space evaluation information generating unit generates space evaluation information regarding the space between the two line scans corresponding to the two linear patterns based on the obtained space data and the standard information of the two linear patterns. It is configured. The interval evaluation information is an example of positional relationship evaluation information. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to evaluate the interval of line scans performed by the medical scanning device against standard information.

In some aspects, the group of linear patterns formed on the datum of the medical scanning device for obtaining evaluation information regarding the position of the scan may include a plurality of parallel linear patterns. Further, the estimator may include an interval data generator, an interval evaluation information generator, a distribution generator, and an overscan evaluation information generator. The interval data generator is configured to obtain interval data of a plurality of linear patterns based on the data collected from the reference device. The interval evaluation information generating unit is configured to generate interval evaluation information regarding the intervals of the plurality of line scans corresponding to the plurality of linear patterns based on the obtained interval data and the standard information of the plurality of linear patterns. ing. The distribution generation unit generates an interval evaluation information distribution representing the distribution from the generated interval evaluation information. The overscan evaluation information generator is configured to generate overscan evaluation information based on the generated interval evaluation information distribution and overscan standard information. Overscan evaluation information is an example of positional relationship evaluation information. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to evaluate the state of overscan performed by the medical scanning device against standard information.

In some aspects, the evaluation portion of the medical scanning device for obtaining evaluation information regarding the position of the scan is based on a plurality of data collected from applying the repetitive scans to the datum, and the repetitive scans It is configured to generate reproducibility evaluation information relating to position reproducibility. Reproducibility evaluation information is an example of position evaluation information. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. Such an aspect makes it possible to evaluate the position repeatability of repetitive scans performed by a medical scanning device. For example, such aspects allow for quality assessment of modalities in which repetitive scans are used, such as OCT angiography, image averaging, blood flow measurements, motion measurements, and the like.

In some aspects, the medical scanning device for obtaining evaluation information regarding the position of the scan may further include a visualization information generator that generates visualization information from the evaluation information generated by the evaluation unit. It is obvious to those skilled in the art that the ophthalmologic apparatus 1 described above has such a configuration. According to this aspect, it is possible to provide the user with visualization information that visually expresses the evaluation information of the medical scanning device.

The embodiments described above are merely examples of implementations of the invention. A person who intends to implement this invention can make arbitrary modifications (omission, substitution, addition, etc.) within the scope of the gist of this invention.

1 Ophthalmic device 500 Eye model 600 Reference device

Claims (17)

A medical evaluation device for acquiring evaluation information of a medical scanning device that scans a living body and collects data,
a patterned fiducial designed based on at least one scan condition of the medical scanning device;
an evaluator that generates position estimation information regarding the position of the scan applied to the datum based on data collected from scanning the datum;
Medical evaluation equipment. said pattern of said datum comprises a first periodic pattern along at least a first direction;
The medical evaluation device of Claim 1. said pattern of said fiducials further comprising a second periodic pattern along a second direction different from said first direction;
3. The medical evaluation device of claim 2. wherein the pattern of the fiducials is a grid pattern;
4. The medical evaluation device of claim 3. at least part of the pattern of the reference device is a recess and/or protrusion formed on the surface or inside;
The medical evaluation device according to any one of claims 1 to 4. at least part of the pattern of the reference device is formed of two or more materials with different optical characteristics;
The medical evaluation device according to any one of claims 1-5. the optical properties include scattering properties;
7. The medical evaluation device of claim 6. A medical evaluation device for obtaining evaluation information of an ophthalmic scanning device that scans a living eye to collect data, comprising:
a reference device having a periodic pattern formed thereon;
an evaluator that generates position estimation information regarding the position of the scan applied to the datum based on data collected from scanning the datum;
Medical evaluation equipment. The reference instrument is a simulated fundus of a model eye,
The medical evaluation device according to any one of claims 1-8. At least part of the surface of the reference device is formed as a curved surface,
wherein the pattern is formed on or inside the curved surface;
10. The medical evaluation device of claim 9. The evaluation unit
a projection processing unit that constructs projection data from three-dimensional data collected by scanning the three-dimensional area of the reference device;
an evaluation information generator that generates the position evaluation information based on the projection data;
The medical evaluation device according to any one of claims 1-10. The evaluation unit generates the position evaluation information based on the data collected by scanning the reference device and standard information of the pattern.
The medical evaluation device according to any one of claims 1-11. the pattern of the reference device includes a group of linear patterns;
The evaluation unit evaluates the positional relationship evaluation information regarding the positional relationship of the plurality of line scans based on the data collected by applying the plurality of line scans to the reference device and the standard information of the linear pattern group. generated as evaluation information,
The medical evaluation device according to any one of claims 1-12. The linear pattern group includes two linear patterns parallel to each other,
The evaluation unit
Obtaining interval data of the two linear patterns based on the data collected from the reference device;
generating, as the positional relationship evaluation information, space evaluation information regarding a space between two line scans corresponding to the two linear patterns based on the space data and the standard information of the two linear patterns;
14. The medical evaluation device of claim 13. The linear pattern group includes a plurality of linear patterns parallel to each other,
The evaluation unit
generating a distribution of the interval rating information based on the data collected from the datum;
generating overscan evaluation information as the positional relationship evaluation information based on the distribution and overscan standard information;
15. The medical evaluation device of claim 14. The evaluation unit generates reproducibility evaluation information of the repetitive scanning as the position evaluation information based on a plurality of data collected by applying repetitive scanning to the reference device.
The medical evaluation device according to any one of claims 1-15. further comprising a visualization information generation unit that generates visualization information from the evaluation information;
The medical evaluation device of any one of claims 1-16.

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