Automatic dyeing device and automatic dyeing substance estimation system

The automatic staining device and system automate the smear microscopy process, addressing the time and skill requirements of traditional smear microscopy, enabling rapid and accurate estimation of staining substances.

JP2025169266APending Publication Date: 2025-11-12GRAMEYE CO LTD
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Patent Information

Application Number
JP2025124323
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-11-12
Filing Date
2025-07-24
Publication Date
2025-11-12

AI Technical Summary

Technical Problem

Smear microscopy tests for detecting staining substances like pathogens and cells require skilled technicians and are time-consuming, leading to delayed communication of results to doctors and inadequate reflection in antibiotic prescriptions.

Method used

An automatic staining device and system that includes a holding unit, moving unit, staining reagent supply unit, and control unit to automate the staining process, enabling rapid estimation of staining substances.

Benefits of technology

Facilitates quicker examination results for smear microscopy, reducing the need for skilled technicians and improving the timeliness of test results in clinical settings.

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Abstract

To provide an automatic dyeing device capable of estimating dyeing substances.SOLUTION: A device includes a holder 201, a moving unit 202, a dyeing reagent supply unit 203, and a control unit 204. The holder 201 is capable of holding a glass slide 10, and the glass slide 10 is smeared with a sample collected from a living organism to be tested. The moving unit 202 is connected to the holder 201 and is capable of moving the holder 201. The dyeing reagent supply unit 203 includes multiple reagent dropping units 2031, and the multiple reagent dropping units 2031 are arranged side by side according to a dyeing process. Each of the multiple reagent dropping units 2031 is capable of dropping one type of reagent according to the dyeing process. The holder 201 is arranged below the reagent dropping units 2031. The control unit 204 controls the moving unit 202 to move the holder 201 to a position below the reagent dropping units 2031 that can drop the reagent required to be supplied to the glass slide 10 according to the dyeing process.SELECTED DRAWING: Figure 6
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Description

[Technical Field]

[0001] The present invention relates to an automatic staining device and an automatic staining substance estimation system. [Background technology]

[0002] Smear microscopy is considered useful for determining the antibiotics to be used in the treatment of infectious diseases. For example, Patent Document 1 discloses a technology for classifying smear microscopy images and displaying similar images. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Publication No. 2018-54472 Summary of the Invention [Problem to be solved by the invention]

[0004] However, tests such as smear microscopy, which detect staining substances (e.g., pathogens and cells), involve multiple steps, require the skills of clinical laboratory technicians, and take time to obtain results. As a result, in actual clinical settings, there is also the problem that test results are rarely communicated to doctors before prescribing antibiotics and are rarely reflected in prescriptions.

[0005] Therefore, an object of the present invention is to provide an automatic staining device and an automatic staining substance estimation system that can estimate a staining substance. [Means for solving the problem]

[0006] The automatic staining apparatus of the present invention includes a holding unit, a moving unit, a staining reagent supply unit, and a control unit, wherein the holding unit is capable of holding a glass slide, on which a sample collected from a living organism to be tested is smeared, the moving unit is connected to the holding unit and is capable of moving the holding unit, the staining reagent supply unit includes a plurality of reagent dropping units, which are arranged in a row according to the staining process, and each of the plurality of reagent dropping units is capable of dropping one type of reagent according to the staining process, the holding unit is arranged below the reagent dropping units, and the control unit controls the moving unit to move the holding unit to a position below the reagent dropping unit that can drop the reagent that needs to be supplied to the glass slide according to the staining process. [Effects of the Invention]

[0007] According to the present invention, it is possible to estimate the staining substance, which can support examinations such as smear microscopy (also called smear microscopy), and enable the examination results to be obtained more quickly. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a block diagram showing an example of the configuration of a microscopy support device according to the first embodiment. [Figure 2] FIG. 2 is a block diagram showing an example of the hardware configuration of the microscopy support device of the first embodiment. [Figure 3] FIG. 3 is a flowchart showing an example of processing in the microscopy examination assistance method of the first embodiment. [Figure 4] FIG. 4 is a schematic diagram showing an example of control by the microscope control unit. [Figure 5] FIG. 5 is a schematic diagram showing another example of control by the microscope control unit. [Figure 6] FIG. 6 is a block diagram showing an example of the configuration of the automatic staining apparatus of the second embodiment. [Figure 7] FIG. 7 is a schematic diagram showing an example of processing by the control unit during the staining process. [Figure 8] FIG. 8 is a block diagram showing an example of the configuration of an automatic staining substance estimation system according to the third embodiment. [Figure 9] FIG. 9 is a schematic diagram showing an example of a slide glass moving from below the reagent dropping section of an automatic staining device to below the objective lens of a microscope device. [Figure 10] FIG. 10 is a schematic diagram showing an example in which a slide glass moves from a specimen fixing device, passes below a reagent dropping section of an automatic staining device, and moves to below an objective lens of a microscope device. [Figure 11] FIG. 11 is a block diagram showing an example of the configuration of a microscopy support device including a related information acquisition unit according to the first embodiment. [Figure 12] FIG. 12 is a schematic diagram showing an example of information displayed on the display. [Figure 13] FIG. 13 is a block diagram showing an example of the configuration of an automatic staining substance estimation system including a shade recognition device in the third embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0009] In the microscopy support device of the present invention, for example, the image acquisition unit may acquire multiple microscopic images of the stained specimen, and the recognition and estimation unit may recognize the stained substance image in the multiple microscopic images and estimate the type of stained substance from the stained substance image to generate estimated stained substance type information.

[0010] In the microscopy support device of the present invention, for example, the image acquisition unit may acquire microscopic images of the stained specimen taken at multiple magnifications, and the recognition and estimation unit may recognize the stained substance image in each of the microscopic images at multiple magnifications, and estimate the type of stained substance from the stained substance image to generate estimated stained substance type information.

[0011] In the microscopy support device of the present invention, for example, the recognition and estimation unit may calculate the probability of the type of estimated staining substance to generate estimated type probability information, and the information output unit may output the estimated type probability information in association with the estimated staining substance type information.

[0012] In the microscopy support device of the present invention, for example, the recognition and estimation unit may generate staining substance list information that lists a plurality of estimated staining substances according to the magnitude of the probability, and the information output unit may output the staining substance list information.

[0013] In the microscopy support device of the present invention, for example, the staining substance may be at least one of a pathogen, a non-pathogen, and a cell derived from the organism to be examined.

[0014] In the microscopy support device of the present invention, for example, when the staining substance includes cells derived from the organism to be examined, the recognition and estimation unit may generate Geckler classification information based on the estimated staining substance type information and the estimated staining substance number information, and the information output unit may output the Geckler classification information.

[0015] The microscopy support device of the present invention may further include, for example, a related information acquisition unit, which acquires related information regarding the stained specimen, and the recognition and estimation unit generates the estimated staining substance type information by referring to the related information.

[0016] In the microscopy support device of the present invention, for example, the related information may be at least one of information on the specimen target organism, information on the specimen, and information on the environment.

[0017] The microscopy support device of the present invention may, for example, further include a recommended information generation unit, which generates recommended information based on the estimated staining substance type information, and the information output unit outputs the recommended information.

[0018] In the microscopy support device of the present invention, for example, the recommendation information may be at least one of recommended examination information and recommended treatment information.

[0019] The microscopy examination support device of the present invention may, for example, further include a medical record information acquisition unit that acquires medical record information of the organism to be examined, and the recommended information generation unit that generates the recommended treatment information based on the medical record information.

[0020] The microscopy support device of the present invention may, for example, include a medical record information acquisition unit that acquires medical record information of the organism being examined, the recognition and estimation unit uses the medical record information to calculate the probability of developing a disease and generate estimated onset probability information, and the information output unit outputs the estimated onset probability information in association with the estimated type information of the staining substance.

[0021] The microscopy examination support device of the present invention may further include, for example, an infected organ estimation unit, which uses the stained substance image recognized by the recognition and estimation unit to estimate the organ from which the specimen was collected as an infected organ and generate estimated infected organ information, and the information output unit outputs the estimated infected organ information.

[0022] The microscopy support device of the present invention may further include, for example, an image switching judgment unit that judges, in the image acquisition unit, when the microscopic image is being acquired and when the microscopic image is not being acquired, and the recognition and estimation unit and the counting unit, after switching from when the microscopic image is being acquired to when the microscopic image is not being acquired, respectively, generate the estimated staining substance type information and the estimated staining substance number information.

[0023] The microscopy support device of the present invention may further include, for example, at least one of a staining device control unit, a microscope control unit, and a specimen fixing device control unit, wherein the staining device control unit controls a staining device that automatically stains the specimen to prepare a stained specimen, the microscope control unit controls a microscope that captures a microscopic image of the stained specimen, and the specimen fixing device control unit controls a specimen fixing device that performs a fixation process on a specimen smeared on a slide glass.

[0024] In the microscopy examination support device of the present invention, for example, the microscope control unit may determine whether each microscopic image is appropriate or not, and if it determines that the image is not appropriate, control the movement of the holding unit so that the holding unit moves in the longitudinal direction of the slide glass, and if it determines that the image is appropriate, control the movement of the holding unit so that the holding unit moves in the short direction of the slide glass.

[0025] In the microscopy examination support device of the present invention, for example, the microscope control unit may acquire shading data for the entire slide glass, analyze the shading data to identify a position having a shading within a predetermined range, and control the microscope to start field search from that position.

[0026] In the microscopy support device of the present invention, for example, the staining device control unit may be capable of specifying the bleaching time in the bleaching process, which is one step in the staining process, for each specimen, and may control the staining device so that the bleaching process is carried out for the specified bleaching time.

[0027] The microscopy support device of the present invention may further include, for example, a priority setting unit, which is capable of setting an arbitrary priority for each specimen, and at least one of the staining device control unit, the microscope control unit, and the specimen fixing device control unit controls the staining device, the microscope, and the specimen fixing device so that processing is performed in order of highest priority.

[0028] In the microscopy examination support method of the present invention, for example, the image acquisition process may acquire multiple microscopic images of the stained specimen, and the recognition and estimation process may recognize the stained substance image in the multiple microscopic images and estimate the type of stained substance from the stained substance image to generate estimated stained substance type information.

[0029] In the microscopy examination support method of the present invention, for example, the image acquisition process may acquire microscopic images of the stained specimen taken at multiple magnifications, and the recognition and estimation process may recognize the stained substance image in each of the microscopic images at multiple magnifications, and estimate the type of stained substance from the stained substance image to generate estimated stained substance type information.

[0030] In the microscopy examination support method of the present invention, for example, the recognition and estimation process may calculate the probability of the type of estimated staining substance to generate estimated type probability information, and the information output process may output the estimated type probability information in association with the estimated staining substance type information.

[0031] In the microscopy examination support method of the present invention, for example, the recognition estimation step may generate staining substance list information that lists the estimated staining substances according to the magnitude of the probability, and the information output step may output the staining substance list information.

[0032] In the microscopy examination support method of the present invention, for example, the staining substance may be at least one of a pathogen, a non-pathogen, and a cell derived from the organism to be examined.

[0033] In the microscopy examination support method of the present invention, for example, when the staining substance includes cells derived from the organism to be examined, the recognition and estimation step may generate Geckler classification information based on the estimated staining substance type information and the estimated staining substance number information, and the information output step may output the Geckler classification information.

[0034] The microscopy examination support method of the present invention may further include, for example, a related information acquisition step, in which the related information acquisition step acquires related information regarding the stained specimen, and the recognition and estimation step generates the estimated type information of the staining substance by referring to the related information.

[0035] In the microscopy examination support method of the present invention, for example, the related information may be at least one of information on the specimen target organism, information on the specimen, and information on the environment.

[0036] The microscopy examination support method of the present invention may, for example, further include a recommended information generation step, in which the recommended information generation step generates recommended information based on the estimated type information of the staining substance, and the information output step outputs the recommended information.

[0037] In the microscopy examination support method of the present invention, for example, the recommended information may be at least one of recommended examination information and recommended treatment information.

[0038] The microscopy examination support method of the present invention may further include, for example, a medical record information acquisition step, in which the medical record information of the organism to be examined is acquired, and the medical record information includes the estimated cell type information and the estimated cell number information, and the recommended information generation step generates the recommended information based on the medical record information.

[0039] The microscopy examination support method of the present invention may further include, for example, a medical record information acquisition step, in which the medical record information of the organism to be examined is acquired, and the medical record information includes the estimated cell type information and the estimated cell number information, the recognition and estimation step uses the medical record information to calculate the probability of developing a disease and generate estimated onset probability information, and the information output step outputs the estimated onset probability information in association with the estimated staining substance type information.

[0040] The microscopy examination support method of the present invention may further include, for example, an infected organ estimation step, in which the infected organ estimation step uses the stained substance image recognized by the recognition estimation step to estimate the organ from which the specimen was collected as the infected organ, thereby generating estimated infected organ information, and the information output step outputs the estimated infected organ information.

[0041] The microscopy examination support method of the present invention may further include, for example, an image switching determination step, which determines, in the image acquisition step, whether the microscopic image is being acquired or not, and the recognition estimation step and the counting step generate the estimated staining substance type information and the estimated staining substance number information, respectively, after switching from the time when the microscopic image is being acquired to the time when the microscopic image is not being acquired.

[0042] The microscopy examination support method of the present invention may further include, for example, at least one of a staining device control step, a microscope control step, and a specimen fixing device control step, wherein the staining device control step controls a staining device that automatically stains the specimen to prepare a stained specimen, the microscope control step controls a microscope that captures a microscopic image of the stained specimen, and the specimen fixing device control step controls a specimen fixing device that performs a fixation process on a specimen smeared on a slide glass.

[0043] In the microscopy examination support method of the present invention, for example, the microscope control process may determine whether each microscopic image is an appropriate image, and if it is determined that the image is not appropriate, control the movement of the holding unit so that the holding unit is moved in the longitudinal direction of the slide glass, and if it is determined that the image is appropriate, control the movement of the holding unit so that the holding unit is moved in the lateral direction of the slide glass.

[0044] In the microscopy examination support method of the present invention, for example, the microscope control process may be configured to acquire shading data for the entire slide glass, analyze the shading data to identify a position having a shading within a predetermined range, and control the microscope to start field search from that position.

[0045] In the microscopy examination support method of the present invention, for example, the staining device control process may be configured such that the bleaching time in the bleaching process, which is one of the staining processes, can be specified for each specimen, and the staining device is controlled so that the bleaching process is carried out for the specified bleaching time.

[0046] The microscopy examination support method of the present invention may further include, for example, a priority setting process, in which an arbitrary priority can be set for each specimen, and at least one of the staining device control process, the microscope control process, and the specimen fixing device control process controls the staining device, the microscope, and the specimen fixing device so that processing is performed in order of highest priority.

[0047] The program of the present invention is a program for causing a computer to execute the steps of the method of the present invention as a procedure.

[0048] The recording medium of the present invention is a computer-readable recording medium on which the program of the present invention is recorded.

[0049] In the automatic staining apparatus of the present invention, for example, the control unit may be configured to control the moving unit after the destaining solution has been dripped onto the slide glass by the reagent dripping unit, thereby driving the holding unit so as to tilt the slide glass around an axis that is at least one of the longitudinal and lateral directions of the slide glass.

[0050] In the automatic staining apparatus of the present invention, for example, the control unit may be configured to drive the holding unit in at least one of a clockwise and a counterclockwise direction, with at least one of the longitudinal and lateral directions of the slide glass as an axis, when the holding state of the slide glass before the dripping of the destaining solution is used as a reference, so that the inclination of each end of the slide glass in the lateral and longitudinal directions, which are not the axis, is a predetermined degree from the reference.

[0051] The automatic staining substance estimation system of the present invention includes an automatic staining device, a microscope device, and a microscopy support device, and the microscopy support device is the microscopy support device of the present invention.

[0052] In the automatic staining substance estimation system of the present invention, for example, the automatic staining device may be the automatic staining device of the present invention.

[0053] In the automatic staining substance estimation system of the present invention, for example, the microscopy support device may include a display unit, and the display unit may be capable of displaying the information output by the information output unit.

[0054] In the automatic staining substance estimation system of the present invention, for example, the display unit may be capable of displaying microscopic images captured at different focal points for the same field of view.

[0055] The automatic staining substance estimation system of the present invention may further include, for example, a user terminal, which is capable of displaying information output by the information output unit and is capable of adding arbitrary information to the information output by the information output unit in a situation where it can be shared with other user terminals.

[0056] The automatic staining substance estimation system of the present invention may be configured, for example, to further include a specimen fixing device.

[0057] The automatic staining substance estimation system of the present invention may be configured such that, for example, in the microscopy support device, the information output unit also outputs notification information in accordance with the information to be output.

[0058] In the present invention, a "stained substance" refers to a substance stained by a staining process. Specific examples include pathogens, non-pathogens (e.g., resident bacteria, etc.), cells derived from the organism to be tested, and substances derived from the organism to be tested (e.g., fibrin, crystals, etc.), but the present invention is not limited thereto. Pathogens are substances that exhibit pathogenicity, such as protozoa, bacteria, viruses, and fungi. Non-pathogens are substances that do not exhibit pathogenicity, and the examples of pathogens mentioned above can be used. The staining process is not particularly limited. Examples of the staining process include known staining processes such as Gram staining, Ziehl-Nielsen staining, India ink staining, Giemsa staining, and Grocott staining. A stained specimen, as described below, is prepared by the staining process.

[0059] Next, embodiments of the present invention will be described with reference to the drawings. The present invention is not limited to the following embodiments. In the following drawings, the same parts are denoted by the same reference numerals. Furthermore, the descriptions of the embodiments can be mutually incorporated unless otherwise specified, and the configurations of the embodiments can be combined unless otherwise specified.

[0060] [Embodiment 1] FIG. 1 is a block diagram showing an example of the configuration of a microscopy support device 100 according to this embodiment. As shown in FIG. 1, the device 100 includes an image information acquisition unit 101, a recognition / estimation unit 102, a counting unit 103, and an information output unit 104. The device 100 may further include, as optional components, a related information acquisition unit 105, a recommended information generation unit 106, a medical record information acquisition unit 107, an infected organ estimation unit 108, an image switching determination unit 109, a staining device control unit 110, a microscope control unit 111, a priority setting unit 112, a specimen fixing device control unit 113, a display unit 114, and the like. The image information acquisition unit 101, the recognition / estimation unit 102, the counting unit 103, the information output unit 104, the related information acquisition unit 105, the recommended information generation unit 106, the medical record information acquisition unit 107, the infected organ estimation unit 108, and the image switching determination unit 109 may also be referred to as, for example, an examination support processing unit 100A. The above-mentioned units are connected to each other by, for example, an internal bus.

[0061] The device 100 may be, for example, a single device including the above-described units, or a device in which the units can be connected via a communication network. The device 100 can also be connected to an external device (described later) via the communication network. The communication network is not particularly limited and any known network can be used, for example, a wired or wireless network. Examples of the communication network include the Internet, the World Wide Web (WWW), a telephone line, a Local Area Network (LAN), a Storage Area Network (SAN), a Delay Tolerant Networking (DTN), a Low Power Wide Area Network (LPWA), and a Local 5G (L5G). Examples of wireless communication include Wi-Fi (registered trademark), Bluetooth (registered trademark), Local 5G, and LPWA. Examples of the wireless communication include direct communication between devices (Ad Hoc communication), infrastructure communication, and indirect communication via an access point. The device 100 may be incorporated into a server as a system. Furthermore, the present device 100 may be, for example, a personal computer (PC, for example, a desktop or notebook type) on which the program of the present invention is installed, a smartphone, a tablet terminal, a wearable terminal, or the like. Furthermore, all or part of the components of the present device 100 may be realized on the cloud. Specifically, the present device 100 may be in the form of cloud computing or edge computing, for example, in which at least one of the components is on a server (cloud) and the other components are on a terminal.

[0062] FIG. 2 shows an example block diagram of the hardware configuration of the device 100. The device 100 may include, for example, a central processing unit (CPU, GPU, etc.) 1, a memory 2, a bus 3, a storage device 4, an input device 5, an output device 6, and a communication device 7. Note that these are merely examples, and the hardware configuration of the device 100 is not limited to these as long as it is capable of executing the processing of each of the above-mentioned units. Furthermore, the number of central processing units 1, etc. included in the device 100 is not limited to the example shown in FIG. 2; for example, the device 100 may include multiple central processing units 1. The units in the hardware configuration of the device 100 are connected to each other via their respective interfaces (I / F) and a bus 3.

[0063] The central processing unit 1 is responsible for overall control of the device 100. In the device 100, the central processing unit 1 executes, for example, the program of the present invention and other programs, and also reads and writes various types of information. The central processing unit 1 can then execute the processing of each part of the device 100.

[0064] The bus 3 can also be connected to, for example, external devices. Examples of the external devices include an external storage device (such as an external database), an external input device, and an external output device. The device 100 can be connected to an external network (the communication line network) by, for example, a communication device 7 connected to the bus 3, and can also be connected to other devices via the external network.

[0065] An example of the memory 2 is a main memory (primary storage device). When the central processing unit 1 performs processing, the memory 2 reads various operating programs, such as the program of the present invention, stored in a storage device 4 (described later), and the central processing unit 1 receives data from the memory 2 and executes the programs. The main memory is, for example, a RAM (random access memory). Alternatively, the memory 2 may be, for example, a ROM (read only memory).

[0066] The storage device 4 is also referred to as an auxiliary storage device, for example, in contrast to the main memory (primary storage device). As described above, the storage device 4 stores an operating program including the program of the present invention. The storage device 4 may be, for example, a combination of a recording medium and a drive for reading and writing data from and to the recording medium. The recording medium is not particularly limited and may be, for example, an internal or external type, such as a hard disk (HD), CD-ROM, CD-R, CD-RW, MO, DVD, flash memory, or memory card. The storage device 104 may be, for example, a hard disk drive (HDD) or a solid state drive (SSD) in which the recording medium and drive are integrated.

[0067] In the present device 100, the memory 2 and storage device 4 can also store various information such as log information, information acquired from an external database (not shown) or an external device, information generated by each process of the present device 100, and information used when the present device 100 executes each process. Note that at least a portion of the information may be stored, for example, in an external server other than the memory 2 and storage device 4, or may be stored in a distributed manner across multiple terminals using blockchain technology or the like.

[0068] The device 100 may further include, for example, an input device 5 and an output device 6. The input device 5 is a device for inputting, for example, letters, numbers, the position of an object displayed on the screen, an image, sound, etc., and specific examples thereof include a digitizer (touch panel, etc.), a keyboard, a mouse, a scanner, an imaging device, a microphone, a sensor, etc. The output device 6 may be, for example, a display device (LED display, LCD display), a printer, a speaker, etc. The display unit 114 may display various information using, for example, the display device of the output device 6.

[0069] The device 100 can be applied to, for example, an examination using a microscopic image captured by a microscope. The examination is not particularly limited, and examples thereof include smear microscopy (examinations involving staining such as Gram staining, Ziehl-Nielsen staining, fungal staining, and Giemsa staining), examination of a pathological specimen, and the like.

[0070] Next, an example of the microscopy support method of this embodiment will be described with reference to the flowchart of Fig. 3. The microscopy support method of this embodiment is implemented as follows, for example, using the microscopy support device 100 of Fig. 1. Note that the microscopy support method of this embodiment is not limited to use with the microscopy support device 100 of Fig. 1.

[0071] In the following, the image information acquisition step can be performed by, for example, an image information acquisition unit 101, the recognition estimation step can be performed by, for example, a recognition estimation unit 102, the counting step can be performed by, for example, a counting unit 103, the information output step can be performed by, for example, an information output unit 104, the related information acquisition step can be performed by, for example, a related information acquisition unit 105, the recommended information generation step can be performed by, for example, a recommended information generation unit 106, and the medical record information acquisition step can be performed by, for example, a medical record information acquisition unit 107. The infected organ estimation step can be executed by, for example, an infected organ estimation unit 108, the image switching determination step can be executed by, for example, an image switching determination unit 109, the staining device control step can be executed by, for example, a staining device control unit 110, the microscope control step can be executed by, for example, a microscope control unit 111, the priority setting step can be executed by, for example, a priority setting unit 112, and the specimen fixing device control step can be executed by, for example, a specimen fixing device control unit 113.

[0072] First, the image information acquisition unit 101 acquires a microscopic image of a stained specimen of a specimen collected from a living organism to be examined (S101). The living organism to be examined is not particularly limited and may be, for example, a human or a non-human organism. The microscopic image refers to an image captured by a microscope.

[0073] Next, the recognition and estimation unit 102 recognizes a stained substance image in the microscope image and estimates the type of stained substance from the stained substance image to generate estimated stained substance type information (S102A). The stained substance image refers to an image in which a stained substance is captured. In other words, it can be said that the recognition and estimation unit 102 recognizes the stained substance in the microscope image. The recognition and estimation unit 102 may be capable of estimating, for example, a plurality of types of the stained substance. In this case, the estimated stained substance type information may indicate, for example, a plurality of types of the stained substance.

[0074] For example, in the above estimation, the recognition estimation unit 102 may estimate morphological characteristics such as gram-positive streptococcus, gram-negative short bacillus, yeast-like fungus, etc., or may estimate using family names and genus names in biological classification such as Enterobacteriaceae, Pseudomonas, Streptococcus, etc., or may estimate using species names in biological classification such as Streptococcus agalactiae, Escherichia coli, Pseudomonas aeruginosa, etc.

[0075] Next, the counting unit 103 counts the stained substance image to generate estimated stained substance number information (S103). More specifically, the number of stained substances recognized by the recognition and estimation unit 102 in the stained substance image is counted. The estimated stained substance number information is information indicating the number of stained substances. The counting may be performed for each type of stained substance estimated by the recognition and estimation unit 102.

[0076] Then, the information output unit 104 outputs the estimated staining substance type information and the estimated staining substance number information (S104), and the process ends (END). The method of output by the information output unit 104 is not particularly limited, and may be output using the output device 6, or may be output to an external device using the communication device 7, for example.

[0077] According to this embodiment, the type of staining substance can be automatically estimated, and the counting can also be automated. Therefore, according to this embodiment, it is possible to support examinations such as smear microscopy. Specifically, the automation can reduce the time and labor costs required for the examination. It can also reduce the burden on laboratory technicians. Furthermore, according to this embodiment, by outputting the information on the estimated type of staining substance and the information on the estimated number of staining substances, it is possible to present this information to medical professionals.

[0078] The image information acquisition unit 101 may acquire multiple microscopic images of the stained specimen in step S101, for example. In this case, the recognition and estimation unit 102 may recognize the stained substance images in the multiple microscopic images in step S102A, for example, and estimate the type of stain from the stained substance images to generate estimated stained substance type information. The recognition and estimation unit 102 may generate the estimated stained substance type information for each microscopic image, or may generate one piece of estimated stained substance type information for one stained specimen (estimated stained substance type information that summarizes the estimation results for multiple microscopic images). The multiple microscopic images may be images captured in different fields of view, or may be images captured at different focal points for one field of view. In this way, acquiring multiple microscopic images can improve the processing by the recognition and estimation unit 102 and, ultimately, the accuracy of the inspection.

[0079] For example, in step S101, the image information acquisition unit 101 may acquire the microscopic images of the stained specimen captured at multiple magnifications. In this case, for example, in step S102A, the recognition and estimation unit 102 may recognize the stained substance image in each of the microscopic images at multiple magnifications and estimate the type of stained substance from the stained substance image to generate estimated stained substance type information. For example, the recognition and estimation unit 102 may generate the estimated stained substance type information for each of the microscopic images at each magnification, or may generate one piece of estimated stained substance type information for one of the stained specimens (estimated stained substance type information that summarizes the estimation results for the microscopic images at each magnification). In this way, acquiring the microscopic images captured at multiple magnifications can improve the processing by the recognition and estimation unit 102 and, ultimately, the accuracy of the inspection.

[0080] The recognition and estimation unit 102 may, for example, calculate the probability of the type of the estimated staining substance in step S102A to generate estimated type probability information. The probability of the type of the staining substance means "the likelihood that the staining substance is of that type." The method for calculating the probability may be, for example, a known method or a method described below. The recognition and estimation unit 102 may, for example, calculate the probability of the type of the estimated staining substance by machine learning. The estimated type probability information may be linked to the type of the staining substance and express the probability as a numerical value (e.g., a percentage), such as "Pseudomonas 90%," or may express the probability in a way other than numbers, such as letters (e.g., "high probability," "low probability," etc.) or symbols. When the estimated type probability information is generated, the information output unit 104 may, for example, output the estimated type probability information in step S104, linked to the estimated staining substance type information. Specifically, an example of the estimated type probability information linked to the estimated staining substance type information is a format that combines a staining substance name and a probability, such as "Streptococcus pneumoniae 95%," "Mycoplasma 80%," etc., but this is merely an example and is not limited to this. By generating the estimated type probability information in this way, it is possible to further support testing, and a person who obtains the estimated type probability information (e.g., a medical professional) can easily understand the type of the staining substance and its probability.

[0081] An example of a method for calculating the probability of an estimated type of staining substance will be described. Note that the following description is merely an example, and the method is not limited to the following description. The probability is calculated using, for example, quantified test information and text information recorded in a medical record. The test information includes, for example, information on various tests such as CRP (C-reactive protein), which indicates the degree of inflammation, white blood cell count, body temperature, respiratory function, urine volume, and β-D glucan. The text information includes, for example, information on the presence or absence of cough, dyspnea, lower back pain, X-ray findings, severity, infected organs, and drug treatment function. The test information and the text information may be acquired by, for example, the medical record information acquisition unit 107 described below. The recognition estimation unit 102, for example, uses each piece of information included in the test information and the text information as a parameter, calculates weights of the parameters for each type of staining substance, and calculates the probability using a specific calculation formula using the weights of the parameters. The specific calculation formula is not particularly limited and can be set arbitrarily. The recognition estimation unit 102 may calculate the probability using, for example, in addition to the test information and the text information, various pieces of information generated by the device 100, such as the estimated type information of the staining substance and the estimated number information of the staining substance.

[0082] The recognition and estimation unit 102 may generate, for example, staining substance list information in step S102A, which lists a plurality of estimated staining substances according to the magnitude of the probability of the estimated staining substance type. The staining substance list information may also serve as the estimated type probability information linked to the estimated staining substance type information. The staining substance list information may be a list of staining substance types arranged in descending order of the probability, or may be a list of staining substance types arranged in descending order of the probability. The information output unit 104 may output the staining substance list information in step S104, for example. Generating the staining substance list information in this way can further support the examination, and a person (e.g., a medical professional) who has obtained the staining substance list information can easily understand the type of staining substance and its probability.

[0083] The staining substance is, for example, at least one of a pathogen, a non-pathogen, and a cell derived from the test organism. When the test organism is a human, the cell derived from the test organism is, for example, an epithelial cell, a white blood cell, or a phagocytosed white blood cell in a sputum sample.

[0084] When the staining substance includes cells derived from the test subject organism, the recognition / estimation unit 102 may generate Geckler classification information based on the estimated staining substance type information and the estimated staining substance number information, for example, after step S103. The generation of the Geckler classification information may be performed, for example, before step S104 or after step S104. The information output unit 104 may output the Geckler classification information. Here, the Geckler classification information is information indicating to which group of the Geckler classification the test subject organism specimen belongs. In other words, in this embodiment, the recognition / estimation unit 102 estimates at least white blood cells and squamous epithelial cells from the staining substance image, and the counting unit 13 counts at least the number of the white blood cells and the squamous epithelial cells. Generating the Geckler classification information in this manner enables evaluation of the specimen.

[0085] As described above, the present apparatus 100 may further include, for example, a related information acquisition unit 105. An example of the configuration of the present apparatus 100 including the related information acquisition unit 105 is shown in FIG. 11. The related information acquisition unit 105 acquires related information about the stained specimen (S105), for example, before step S102A. Step S105 is an optional step and may not be executed. The related information is, for example, at least one of information about the specimen target organism, information about the specimen, and information about the environment. More specifically, it may include, for example, the age of the specimen target organism (e.g., human), the name of a disease, the biological condition of the specimen target organism, medication history, the location of a medical institution, an antibiogram within the medical institution, etc. In this embodiment, the recognition / estimation unit 102 may generate the estimated staining substance type information by referring to the related information, for example, in step S102A. Generally, substances (pathogens, etc.) that may cause a disease (e.g., pneumonia, etc.) vary depending on the age, underlying disease, etc. of the specimen target organism. For example, pneumonia in elderly people is often caused by bacteria in the oral cavity. In this way, by taking into account the related information, it is possible to improve the accuracy of estimation by the recognition estimation unit 102.

[0086] In the medical field, it is necessary to narrow down the types of pathogens and other diseases that cause them based on test results. Therefore, as in Patent Document 1, efforts have been made to use specific devices to more accurately narrow down the types of pathogens. However, because previous attempts have been made to classify pathogens based solely on morphological characteristics, it has not been possible to narrow down the types to the point where decisive information can be obtained for selecting therapeutic drugs, etc. In contrast, the present invention makes it possible to estimate staining substances more precisely and accurately by acquiring the related information. Therefore, medical professionals can effectively use the results of the estimation (information on the estimated type of staining substance) for selecting therapeutic drugs, etc.

[0087] As described above, the apparatus 100 may further include, for example, a recommendation information generating unit 106. For example, after step S102A, the recommendation information generating unit 106 may generate recommendation information based on the estimated staining substance type information (S106). Step S106 is an optional step and may not be executed. The recommendation information may be, for example, at least one of recommended test information and recommended treatment information. The recommended test information may be, for example, information regarding additional tests, such as culture, to identify bacterial species. More specifically, for example, when a fungus-like substance is confirmed in a Gram stain of sputum, recommended test information is generated recommending culturing the substance in a selective medium that selectively grows fungi. The recommended treatment information may be, for example, information regarding the type of antibiotic to be prescribed, a treatment plan, etc. The recommendation information generating unit 106 may generate the recommendation information by referring to the related information. Then, the information output unit 104 may output the recommendation information (S104). For example, when the recommended test information is generated, the information output unit 104 may notify a medical professional, such as a laboratory technician, that the recommended test information has been generated. In this way, generating the recommended information can support medical professionals, such as laboratory technicians. In particular, as described above, according to the present invention, since staining substances can be estimated more precisely and accurately, the recommended treatment information also becomes more detailed and accurate, thereby better supporting medical professionals in selecting therapeutic drugs and determining treatment plans.

[0088] As described above, the apparatus 100 may further include, for example, a medical record information acquisition unit 107. The medical record information acquisition unit 107 acquires medical record information of the test subject organism (S107), for example, before step S102B or step S106 described below. Step S107 is an optional step and may not be executed. The medical record information may include, for example, the test information and text information described above. More specifically, the medical record information may include information about the living body of the test subject organism, such as test results, body temperature, white blood cell count, C-reactive protein value, X-ray findings, severity, infected organs, and drug treatment function. The test results may include, for example, the estimated stain type information and the estimated stain number information. The medical record information acquisition unit 107 may acquire the medical record information from an external device via the communication network, or may acquire the medical record information input via the input device 5. When the medical record information is acquired, the recommendation information generation unit 106 may generate the recommended treatment information based on the medical record information in step S106, for example. In clinical settings, it is necessary to comprehensively assess various factors and select an antibiotic that can suppress infection and has as narrow a spectrum as possible. Sometimes, it is necessary to make a decision without some information. Selecting a narrow-spectrum antibiotic can reduce the occurrence of drug-resistant bacteria and drug costs. By generating the recommended treatment information using the medical record information, the present invention can support the selection of a narrow-spectrum antibiotic, enabling more appropriate and effective treatment.

[0089] When the medical record information is acquired, the recognition and estimation unit 102 may, for example, calculate the probability of developing a disease using at least the medical record information to generate estimated development probability information (S102B). The recognition and estimation unit 102 may, for example, calculate the probability using information generated by the device 100, such as the estimated stain type information and the estimated stain number information, in addition to the medical record information. The method for calculating the probability may be, for example, a known method or a method described below. The recognition and estimation unit 102 may, for example, calculate the probability of developing a disease by machine learning. The estimated development probability information may, for example, be linked to the type of the disease and expressed as a numerical value (e.g., a percentage), or may be expressed in a way other than numbers, such as characters (e.g., "high probability," "low probability," etc.) or symbols. When the estimated development probability information is generated, the information output unit 104 may, for example, output the estimated development probability information linked to the estimated stain type information in step S104. Specifically, an example of the estimated type probability information linked to the estimated staining substance type information is a format combining a staining substance name and a probability, such as "bacterial pneumonia 95%" or "atypical pneumonia 80%." However, this is merely an example and is not limiting. Generally, it is difficult to determine whether or not something is an infectious disease, and even experienced physicians often have difficulty distinguishing between an infectious disease and another type of inflammation. In response to this, according to the present invention, the estimated onset probability information is linked to the estimated onset probability information and output, which can assist, for example, medical professionals.

[0090] An example of a method for calculating the probability of developing a disease will be described. Note that the following description is merely an example, and the method is not limited to the following description. The probability is calculated using, for example, quantified test information and text information recorded in a medical record. The test information and the text information are the same as those described above. For example, the recognition estimation unit 102 uses each piece of information included in the test information and the text information as a parameter, calculates weights for the parameters for each type of disease, and calculates the probability using a specific calculation formula using the parameter weights. The specific calculation formula is not particularly limited and can be set arbitrarily.

[0091] As described above, the apparatus 100 may further include, for example, an infected organ estimation unit 108. For example, after step S102A, the infected organ estimation unit 108 may estimate the organ from which the specimen was collected as the infected organ by analyzing the stained substance image recognized by the recognition / estimation unit 102, thereby generating estimated infected organ information (S108). The infected organ estimation unit 108 may also estimate the organ from which the specimen was collected, for example, by analyzing the stained substance image. Here, the infected organ refers to an organ infected with the stained substance (particularly, at least one of a pathogen and a non-pathogen). The information output unit 104 then outputs the estimated infected organ information, for example, in step S104. In this way, according to this aspect, it is possible to estimate the infected organ based on the stained substance, thereby assisting in identifying the cause of a disease.

[0092] The infected organ estimation unit 108 may estimate that the organ from which the specimen was collected is an infected organ, for example, when the recognition and estimation unit 102 recognizes (observes) at least one of the following (1) and (2) from the stained substance image: (1) At least one of the pathogen and the non-pathogen, and both the pathogen and the non-pathogen, and the leukocyte. (2) The pathogen

[0093] That is, in the case of (1) above, if both the non-pathogen and white blood cells are recognized, it is estimated that the non-pathogen is likely to be the cause of the disease, and therefore the organ from which the specimen was collected is estimated to be the infected organ. In the case of (2) above, if the pathogen is recognized, it is estimated that the pathogen is likely to be the cause of the disease, and therefore the organ from which the specimen was collected is estimated to be the infected organ. Generally, the cause of disease is not limited to the pathogen, and for example, resident bacteria can also be the cause of disease. In contrast, according to this aspect, even if resident bacteria (the non-pathogen) are the cause of the disease, it is possible to estimate the infected organ, and the accuracy of estimation by the infected organ estimation unit 108 is further improved.

[0094] As described above, the present device 100 may further include, for example, an image switching determination unit 109. For example, in step S101 by the image acquisition unit 101, the image switching determination unit 109 determines whether the microscope image is being acquired or not (S109). Then, after switching from the time when the microscope image is being acquired to the time when the microscope image is not being acquired, the recognition and estimation unit 102 and the counting unit 103 may generate the estimated staining substance type information and the estimated staining substance number information, respectively.

[0095] As described above, the apparatus 100 may further include at least one of a staining apparatus control unit 110, a microscope control unit 111, and a specimen fixation apparatus control unit 113. The staining apparatus control unit 110 controls a staining apparatus that automatically stains the specimen to prepare the stained specimen. The timing of control by the staining apparatus control unit 110 is not particularly limited, but may be performed, for example, before step S101. The staining apparatus may be, for example, the automatic staining apparatus of the present invention. The microscope control unit 111 controls a microscope that captures a microscopic image of the stained specimen. The timing of control by the microscope control unit 111 is not particularly limited, but may be performed, for example, before step S101. The image acquisition unit 101, for example, acquires the microscopic image captured by the microscope. The microscope control unit 111 may control the microscope to capture, for example, a part or the entire stained specimen smeared on a slide glass at high magnification. Here, high magnification refers to an objective lens of 40x or 100x, etc. The microscope control unit 111 may control the microscope so that an image is captured using multiple magnifications for one slide glass. The specimen fixing device control unit 113 controls a specimen fixing device that fixes the specimen smeared on the slide glass. The specimen fixing device will be described later.

[0096] Here, the "slide glass" in the present invention may be laminated with a cover glass, if necessary. That is, the "slide glass" in the present invention can be read as a "preparate" if necessary. For example, if the staining method for the specimen is Gram staining, imaging with the microscope may be performed without a cover glass.

[0097] An example of control by the microscope control unit 111 will be described with reference to FIG. 4. As shown on the left side of FIG. 4, the specimen is often spread on the glass slide 10 from A in the direction of the arrow. Therefore, when the glass slide 10 is observed with a microscope in the longitudinal direction, thick smears of the specimen appear at regular intervals, as shown on the right side of FIG. 4. The right side of FIG. 4 is a partially enlarged view of the glass slide 10. In this partially enlarged view, the shading indicates the thickness of the specimen smear, and the darker the shading in the view, the darker the specimen smear. In addition, in the partially enlarged view on the right side of FIG. 4, the area surrounded by a bold frame indicates the field of view of the microscope (i.e., the microscope image), and the arrow indicates the movement of the field of view (i.e., the movement of the holder holding the glass slide 10). First, the microscope control unit 111 determines whether the microscope image of the field of view (1) is an appropriate image. Here, an appropriate image is, for example, an image in which a stained substance is well stained or an image in which the stained substance is clearly visible. In the viewing area (1), the specimen smear is too thin, making the stained substance unclear and determining that the image is not appropriate. Next, the microscope control unit 111 moves the holder in the longitudinal direction of the glass slide 10 and determines whether the microscope image in the viewing area (2) is appropriate. In the viewing area (2), the specimen smear is neither thick nor thin, making the stained substance clearly visible, and therefore the image is determined to be appropriate. After determining that the image is appropriate, the microscope control unit 111 controls the microscope to switch from longitudinal movement, such as movement from viewing area (1) to (2), to lateral movement, such as movement from viewing area (2) to (4). In this way, the microscope control unit 111 determines whether each microscope image is appropriate, and controls the movement of the holder to move in the longitudinal direction of the glass slide 10 if it is determined that the image is not appropriate, or to move in the lateral direction of the glass slide 10 if it is determined that the image is appropriate. As mentioned above, the sample is often spread out on the slide glass 10 as shown on the left side of Figure 4. Therefore, when the slide glass 10 is observed under a microscope in the longitudinal direction, thickly smeared areas of the sample appear at regular intervals, as shown on the right side of Figure 4.Therefore, when an image with the appropriate density that is useful for clinical judgment is found, there is a high possibility that an equally appropriate image will be found on the short side of it. Thus, according to this aspect, more efficient visual field search is possible.

[0098] Another example of control by the microscope control unit 111 will be described with reference to FIG. 5 . First, the microscope control unit 111 acquires shading data for the entire glass slide 10. The shading data is information indicating the shading of the sample smear, generated by scanning the entire glass slide 10 with a shading recognition device 20, as shown on the left side of FIG. 5 . The shading recognition device 20 can be, for example, a camera, a sensor, or other known device. The shading recognition device 20 may be, for example, the input device 5 or an external device. Next, the microscope control unit 111 analyzes the shading data to identify a position having a shading within a predetermined range. The shading can be set arbitrarily. The microscope control unit 111 then controls the movement of the holder to start visual field search from the identified position. The sample is smeared on the glass slide by a laboratory technician, but because shading variations occur within the glass slide, it takes a long time to search for the appropriate visual field and identify pathogens, etc. For example, when a specimen with a low density of pathogens, cells, etc. is smeared onto a glass slide, even if the thinly smeared portion of the specimen is observed under a microscope, the pathogens, cells, etc. are often not visible. In contrast, according to this embodiment, it is possible to grasp the density of the smear, thereby enabling more efficient visual field search.

[0099] The staining apparatus control unit 110 may be capable of, for example, specifying a destaining time for a destaining step, which is one of the staining steps, for each specimen. Specifically, the destaining time can be specified by a user (e.g., a medical professional) inputting the destaining time. The staining step is not particularly limited and may be a conventionally known staining method. Specific staining methods include Gram staining, which primarily examines the presence and characteristics of bacteria, and Ziehl-Nielsen staining, which primarily examines the presence and characteristics of acid-fast bacteria. The staining apparatus control unit 110, for example, controls the staining apparatus to perform the destaining step for the specified destaining time. The staining apparatus control unit 110 may also be capable of, for example, specifying the time required for a step other than the destaining step for each specimen. The staining apparatus control unit 110 may then control the staining apparatus to perform the step for the specified time. This can improve the accuracy of staining.

[0100] In particular, during the destaining process, excessive destaining can cause pathogens that should stain Gram-positive (purple) to stain Gram-negative (red), or pathogens that should stain Gram-negative (red) to stain Gram-positive (purple). This problem is not limited to Gram staining. This can lead to erroneous test results. Factors that determine the degree of destaining generally include the destaining time and the method of contacting the sample with the destaining solution. The destaining time is approximately 5 to 7 seconds for watery samples that produce thin smears (e.g., blood culture samples and urine), but may take 10 seconds or longer for samples with high viscosity, such as sputum. Thus, the appropriate destaining time varies depending on the type of sample, which can lead to excessive destaining, as described above. To address this issue, the staining device control unit 110 allows the user to specify the destaining time for each sample, enabling appropriate destaining for any sample.

[0101] As described above, the device 100 may further include, for example, a priority setting unit 112. The priority setting unit 112 can set an arbitrary priority for each sample. Specifically, the device 10 sets the priority for each sample input by a medical professional via, for example, the input device 5. The priority is expressed, for example, by numbers, letters, symbols, etc. At least one of the staining device control unit 110, the microscope control unit 111, and the specimen fixation device control unit 113 controls the staining device, the microscope, and the specimen fixation device to process in descending order of priority. This allows samples to be processed in order of priority rather than in the order in which they were loaded into the various devices, which can lead to a so-called interruption, where one sample is processed before another sample that was loaded earlier. Generally, the time priority for returning test results varies depending on the type of sample and the department. For example, if a blood culture sample turns out positive, sepsis is suspected. However, sepsis is a highly urgent disease, requiring immediate identification of the bacterial species (staining substance) and administration of antibiotics. It is also desirable to return test results quickly for specimens submitted by emergency departments. In response to this, the priority setting unit 112 can set priorities, so specimens with higher priorities can be given priority for processing by the device 100, etc.

[0102] [Embodiment 2] FIG. 6 is a schematic diagram showing an example of the configuration of an automatic staining apparatus 200 of this embodiment. As shown in FIG. 6, this apparatus 200 includes a holding unit 201, a moving unit 202, a staining reagent supply unit 203, and a control unit 204. Furthermore, this apparatus 200 may further include, as optional components, a waste liquid tank 205, a staining reagent bottle 206, or other conventionally known components. The control unit 204 is executed, for example, by a central processing unit 1, which is one piece of hardware included in the automatic staining apparatus 200. The configuration of the other hardware of the automatic staining apparatus 200 is not particularly limited, and for example, the hardware configuration described in the first embodiment can be used.

[0103] The holder 201 can hold the glass slide 10. As described above, in this embodiment, too, the term "glass slide" can be replaced with "preparation" as needed. For example, after the staining process is completed, a cover glass is placed on the glass slide 10 to form a preparation. The shape of the holder 201 is not particularly limited as long as it can hold the glass slide 10. For example, as shown in FIG. 6, the holder 201 may be a stage-like holder 201 capable of placing and holding the glass slide 10, or a clip-like holder 201 capable of clamping and holding the glass slide 10, as described below. It is assumed that the glass slide 10 is smeared with a sample collected from a living organism to be tested. As shown in FIG. 6, the holder 201 is disposed below the reagent dropping portion 2031 and holds the surface of the glass slide 10 on which the sample is smeared, facing the reagent dropping portion 2031.

[0104] The moving unit 202 is connected to the holding unit 201 and is capable of moving the holding unit 201. The form of the moving unit 202 is not particularly limited as long as it is capable of moving the holding unit 201. The movement may be horizontal movement, vertical movement, or rotational movement.

[0105] The staining reagent supply unit 203 includes a plurality of reagent dropping units 2031. The plurality of reagent dropping units 2031 are arranged in a row according to the staining process, as shown in FIG. 6 . The staining process is not particularly limited and may be, for example, the same as described above. Each of the plurality of reagent dropping units 2031 can drop one type of reagent according to the staining process. The reagent is contained, for example, in a staining reagent bottle 206. The staining reagent supply unit 203 supplies the reagent from the staining reagent bottle 206 to the reagent dropping unit 2031. The reagent dropping unit 2031 may, for example, drop the reagent only onto the specimen or its periphery, or may drop the reagent so as to fill the stage-shaped holder 201 with the reagent.

[0106] The control unit 204 controls the moving unit 202 to move the holder 201 to a position below a reagent dropping unit 2031 that can drop a reagent that needs to be supplied to the slide glass 10 depending on the staining process. The control unit 204 controls each unit, such as the movement, in accordance with control from the staining apparatus control unit 110 described in the first embodiment. The control unit 204 may be controlled, for example, in accordance with control from the staining apparatus control unit 110 described in the first embodiment. The control unit 204 may control the timing of dropping a reagent from the reagent dropping unit 2031, for example, by controlling the staining reagent supply unit 203. Specifically, the control unit 204 may control each unit so that the reagent is dropped after a time instructed by the staining apparatus control unit 110 has elapsed. The control unit 204 may also control, for example, the time from dropping the reagent to discharging the reagent into the waste liquid tank 205, by controlling the staining reagent supply unit 203. Specifically, the control unit 204 may, for example, move each of the above-mentioned parts so that the reagent dropped onto the surface of the slide glass 10 on which the sample has been smeared is discharged into the waste liquid tank 205 after the time instructed by the staining device control unit 110 has elapsed.

[0107] An example of the processing performed by the control unit 204 during the staining step will be described. The upper diagram of FIG. 7 shows an example of a glass slide 10 held by a clip-shaped holder 201. As shown in the figure, a sample collected from a test organism is smeared on the surface of the glass slide 10 facing the reagent dropping unit 2031. As shown in the lower diagram of FIG. 7, after the decolorizing solution is dropped onto the glass slide 10 by the reagent dropping unit 2031, the control unit 204 controls the moving unit 202 to drive the holder 201 so that the glass slide 10 tilts in the short direction around the longitudinal direction of the glass slide 10 as an axis. The example shown in FIG. 7 is not limiting, and the control unit 204 may also drive the holder 201 so that the glass slide 10 tilts in the long direction around the short direction of the glass slide 10 as an axis, for example. Furthermore, the control unit 204 may drive the holding unit 201 so that the slide glass 10 is tilted alternately in the longitudinal direction and the lateral direction, for example, with the longitudinal direction and the lateral direction of the slide glass 10 as axes alternately.

[0108] Specifically, the control unit 204 may drive the holding unit 201 clockwise or counterclockwise around at least one of the longitudinal and lateral directions of the slide glass 10 as an axis, so that, when the holding state of the slide glass 10 before the destaining solution is taken as a reference, the inclination of each end of the slide glass 10 in at least one of the lateral and longitudinal directions other than the axis is a predetermined degree from the reference state. The degree is not particularly limited and can be set arbitrarily. Specifically, the degree is, for example, a value within a range of −10 degrees to +10 degrees, −5 degrees to +5 degrees, or −3 degrees to +3 degrees, when the inclination of one end in the reference state is 0 degrees. The control unit 204 controls the moving unit 202 to drive the holding unit 201. The control unit 204 may repeat driving the holding unit 201 in this manner for a specific number of seconds (e.g., 1 to 5 seconds, 1 to 3 seconds, 1 second, etc.) or at specific time intervals (e.g., 1 to 5 seconds, 1 to 3 seconds, 1 second, etc.) By performing such control, each reagent can be evenly supplied to the specimen, thereby improving the accuracy of staining.

[0109] In particular, as mentioned above, the destaining step is a step in which it is difficult to achieve proper destaining. As mentioned above, factors that determine the degree of destaining include the destaining time and the method of contacting the specimen with the destaining solution. The control unit 204 can efficiently bring these into contact through the above control, thereby improving the accuracy of the destaining.

[0110] According to this embodiment, the sample staining process can be performed automatically, making it possible to support examinations such as smear microscopy.

[0111] [Embodiment 3] FIG. 8 is a schematic diagram showing an example of the configuration of an automatic staining substance estimation system 1000 of this embodiment. As shown in FIG. 8, the automatic staining substance estimation system 1000 includes an automatic staining apparatus 200, a microscope apparatus 300, and a microscopy support apparatus 100. The microscopy support apparatus 100 is the microscopy support apparatus 100 described in the first embodiment. The automatic staining substance estimation system 1000 may further include, for example, a user terminal 400 and a specimen fixation apparatus 500 as an optional configuration. The microscopy support apparatus 100 is capable of communicating with the automatic staining apparatus 200, the microscope apparatus 300, the user terminal 400, and the specimen fixation apparatus 500 via the communication network. The automatic staining substance estimation system 1000 can also be referred to as an automatic staining substance estimation system apparatus 1000. Note that the number of each apparatus and terminal in FIG. 8 is merely an example, and there may be more than one.

[0112] The specimen fixing device 500 is not particularly limited as long as it is a device that performs a fixation process on a specimen smeared on a slide glass. The fixation process is not particularly limited, and any conventionally known fixation process can be applied. Examples of the fixation process include a process using heat and a process using alcohol. The specimen that has undergone the fixation process is stained by the automatic staining device 200.

[0113] Generally, when performing staining such as Gram staining, a specimen in a tube or the like is smeared onto a glass slide, bacteria and viruses are killed, and a fixation process is performed. The subsequent processes of staining, drying, microscopic observation, and recording in a medical record are performed in succession. The process using alcohol (also called alcohol fixation) requires the specimen to be immersed in alcohol for approximately 3 to 5 minutes. Thus, the fixation process is labor-intensive. By using the specimen fixation device 500, the fixation process can be automated, further reducing the burden on the site. Furthermore, by using the specimen fixation device 500, the fixation method can be standardized, thereby improving the accuracy of the test.

[0114] The automatic staining apparatus 200 is not particularly limited as long as it is an apparatus that automatically stains the specimen and prepares a stained specimen, and is, for example, the automatic staining apparatus 200 described in the second embodiment. The stained specimen prepared by the automatic staining apparatus 200 is set in a microscope apparatus 300, and a microscopic image is captured. The setting may be performed manually, for example.

[0115] The slide glass 10 may be moved from below the reagent dropping unit 2031 of the automatic staining apparatus 200 to below the objective lens 301 of the microscope apparatus 300 manually or by moving the moving unit 202 as shown in FIG. 9 . Before moving the slide glass 10 below the objective lens 301 of the microscope apparatus 300, a cover glass may or may not be placed on the slide glass 10 as necessary. The placement may be performed manually, for example. FIG. 9 is a schematic diagram illustrating an example of moving the slide glass 10 from below the reagent dropping unit 2031 of the automatic staining apparatus 200 to below the objective lens 301 of the microscope apparatus 300. As shown in FIG. 9 , the slide glass 10 held by the holder 201 is moved from below the reagent dropping unit 2031 of the automatic staining apparatus 200 to below the objective lens 301 of the microscope apparatus 300 by the moving unit 202. The moving unit 202 may move in this manner under the control of, for example, the control unit 204. That is, in the automatic staining substance estimation system 1000, the moving unit 202 may be movable not only below the automatic staining device 200 but also below the objective lens 301 of the microscope device 300. The microscope device 300 captures a microscopic image of the glass slide 10 that has moved below the objective lens 301 and outputs the image to the microscopy support device 100. With the moving unit 202 that enables such movement, a laboratory technician can smear a sample on the glass slide 10 and set the glass slide 10 in the holder 201, allowing the staining process, microscopic imaging, and estimation of the staining substance to be performed fully automatically. This significantly reduces the effort required for Gram staining, Ziehl-Neelsen staining, and the like.

[0116] The slide glass 10 may be moved from the specimen fixing device 500 to below the reagent dropping unit 2031 of the automatic staining device 200 manually, or may be moved by moving a moving unit 202 as shown in FIG. 10 . FIG. 10 is a schematic diagram showing an example in which the slide glass 10 moves from the specimen fixing device 500, passing below the reagent dropping unit 2031 of the automatic staining device 200, to below the objective lens 301 of the microscope device 300. As shown in FIG. 10 , the moving unit 202 may be movable to, for example, below the specimen fixing device 500. The moving unit 202 may move in this manner under the control of, for example, the control unit 204. In this way, the moving unit 202 may be movable, for example, from the specimen fixing device 500, passing below the reagent dropping unit 2031 of the automatic staining device 200, to below the objective lens 301 of the microscope device 300. This allows the entire process, from fixation, staining, microscopic imaging, and estimation of the staining substance, to be carried out fully automatically, further reducing the amount of work required.

[0117] The microscope device 300 (also simply referred to as the microscope 300) is not particularly limited as long as it is a device that can capture a microscopic image of the stained specimen, and may be, for example, a known device. The microscopic image captured by the microscope device 300 is acquired by the microscopy support device 100.

[0118] The microscopy support device 100 may include, for example, a display unit 114 that displays information output by the information output unit 104. The display unit 114 may be capable of displaying microscopic images captured at different focal points for the same field of view, for example, by a user operation. The microscopic images captured at different focal points are included in the estimated staining substance type information, for example. The user operation is not particularly limited and may be, for example, an operation such as moving the mouse wheel. This enables three-dimensional observation. This aspect is particularly useful, for example, when confirming an image of capsule formation of pneumococcus. An image of capsule formation of pneumococcus is difficult to confirm in a two-dimensional view, but can be confirmed by deliberately shifting the focus. The various processes performed by the display unit 114 may also be referred to as, for example, a display process.

[0119] For example, when a slide glass 10 is held in the holder 201, the display unit 114 may assign identification information to each slide glass 10 and display the identification information. The identification information is not particularly limited and may be, for example, numbers, letters, symbols, or a combination thereof. FIG. 12 shows an example of identification information displayed on the display by processing by the display unit 114. As shown in FIG. 12, the display unit 114 may display, for example, the identification information of the slide glass 10 (indicated as a unique number for each slide glass 10) and the insertion status of the slide glass 10 (whether or not it is held in the holder 201) in association with each other. If the slide glass 10 is held in the holder 201, for example, the insertion status may be displayed as "inserted," and if the slide glass 10 is removed from the holder 201, for example, the insertion status may be displayed as "removed." Note that the terms "inserted" and "removed" are merely examples, and the present invention is not limited thereto.

[0120] The display unit 114 may also display the time to be spent on each step of the staining process, which is set by the staining apparatus control unit 110 based on a user's input, in association with the identification information, as shown in Fig. 12. Furthermore, the display unit 114 may also display the priority set by the priority setting unit 112 based on a user's input, in association with the identification information, as shown in Fig. 12. In Fig. 12, the priority is displayed as "○", "△", and "×" in descending order of priority.

[0121] The display unit 114 may display each piece of information generated by the microscopy support device 100 in a table format as shown in FIG. 12, but this is merely an example and is not limiting.

[0122] The user terminal 400 is a terminal of a user such as a medical professional. Specific examples include personal computers (PCs, e.g., desktop or laptop), smartphones, tablet devices, and wearable devices. The user terminal 400 is not particularly limited as long as it can display information output by the information output unit 104 and can add arbitrary information to the information output by the information output unit. The information output by the information output unit 104 may be, for example, in a state in which it can be shared by multiple user terminals 400. For example, the state in which it can be shared by multiple user terminals 400 is a state in which it is stored in a server, database, or the like inside or outside the automatic staining substance estimation system 1000. In a microbiology laboratory, the Gram staining site, the medical record input site, and the process called culture determination, which is a post-staining step in a microorganism identification test, are all performed in separate locations. Even if these tasks are performed in separate locations, the information and the content added to the information can be shared among multiple user terminals 400 by adding information to the information in the above-mentioned state.

[0123] In the microscopy support device 100, the information output unit 104 may output notification information linked to the output information, for example. The notification information is information indicating, for example, a suspected infectious disease or the need for specific measures. For example, the notification information is output when the estimated staining substance type information is generated and an infectious disease is suspected, when the recommended examination information is generated and the need for additional examination (examination other than routine examination) is high, or when it is determined that urgent measures are needed based on the contents of the estimated staining substance type information and the estimated staining substance count information. More specifically, for example, when estimated staining substance type information indicating an estimated Gram-positive Staphylococcus is generated, MRSA, a drug-resistant bacterium, is suspected, and administration of a stronger antibiotic than routine is necessary. In addition, when estimated staining substance type information indicating an estimated white blood cell or phagocytic white blood cell is generated, it means that an inflammatory reaction is occurring at the site where the sample was collected, and if a large number of these objects are found, it is an infectious disease and measures are needed. When such a specimen is confirmed, the notification information is output in association with information such as estimated type of staining substance, allowing medical personnel to respond promptly. When the notification information is output, a specific process associated with the notification information is executed in the output destination device or equipment. For example, if the output destination is a speaker, an alarm sounds; if the output destination is a monitor, the notification information is displayed on the monitor; if the output destination is a lamp, the lamp flashes.

[0124] As shown in FIG. 13 , the automatic staining substance estimation system 1000 may further include, for example, a shade recognition device 20. The microscopy support device 100 is capable of communicating with the shade recognition device 20. The shade recognition device 20 is a device capable of recognizing the shade of an object, and the above description can be used. Although not shown, the automatic staining substance estimation system 1000 may use the shade recognition device 20 in combination with a specimen fixation device 500. The stained specimen prepared by the automatic staining device 200 is provided to the shade recognition device 20. The microscope control unit 111 then acquires the shade data generated by the shade recognition device 20, and the stained specimen is then set in the microscope device 300. The moving unit 202 may be capable of moving to, for example, a position where shade recognition is possible by the shade recognition device 20.

[0125] [Embodiment 4] The program of this embodiment is a program for causing a computer to execute each step of the method of the present invention as a procedure. In the present invention, "procedure" may be read as "processing." The program of this embodiment may be recorded on, for example, a computer-readable recording medium. The recording medium is, for example, a non-transitory computer-readable storage medium. The recording medium is not particularly limited, and examples thereof include a read-only memory (ROM), a hard disk (HD), an optical disk, etc.

[0126] Although the present invention has been described above with reference to the embodiments, the present invention is not limited to the above embodiments. Various modifications that can be understood by those skilled in the art can be made to the configuration and details of the present invention within the scope of the present invention.

[0127] This application claims priority based on Japanese Patent Application No. 2020-199893, filed on November 12, 2020, the disclosure of which is incorporated herein in its entirety. [Industrial Applicability]

[0128] According to the present invention, it is possible to support examinations such as smear microscopy, etc. The present invention is particularly useful in estimating staining substances. [Explanation of symbols]

[0129] 1. Central Processing Unit 2. Memory 3. Bus 4 Storage device 5 Input Devices 6 Output Devices 7. Communication Devices 10 glass slides 20 Shade recognition device 100 Microscopy support device 100A Inspection support processing unit 101 Image information acquisition unit 102 Recognition estimation section 103 Counting section 104 Information output section 105 Related Information Acquisition Department 106 Recommendation information generation unit 107 Medical Record Information Acquisition Department 108 Infected Organ Presumption Department 109 Image switching determination unit 110 Dyeing device control unit 111 Microscope control unit 112 Priority setting section 113 Specimen fixing device control section 200 Automatic stainer 201 Holding part 202 Mobile Department 203 Dyeing Reagent Supply Department 2031 Reagent dropping section 204 Control Unit 205 Waste liquid tank 206 Dyeing Reagent Bottle 300 Microscope equipment 301 Objective Lens 400 User Terminals 500 Specimen Fixation Device

Claims

1. a holding unit, a moving unit, a staining reagent supply unit, and a control unit; the holder is capable of holding a slide glass, The slide glass is smeared with a specimen collected from a test organism, the moving unit is connected to the holding unit and is capable of moving the holding unit, the staining reagent supply unit includes a plurality of reagent dropping units, The plurality of reagent dropping portions are arranged in a line according to the staining process, each of the plurality of reagent dropping units is capable of dropping one type of reagent in accordance with the staining process; the holding portion is disposed below the reagent dropping portion, the control unit controls the moving unit to move the holder to a position below the reagent dropping unit that can drop a reagent that needs to be supplied to the slide glass in accordance with the staining process. Automatic staining equipment.

2. 2. The automatic staining apparatus according to claim 1, wherein the control unit controls the moving unit to drive the holding unit so as to tilt the slide glass about an axis that is an axis of at least one of the longitudinal direction and the lateral direction of the slide glass after the destaining solution is dripped onto the slide glass by the reagent dripping unit.

3. 3. The automatic staining apparatus according to claim 1, wherein the control unit drives the holding unit in at least one of a clockwise direction and a counterclockwise direction, with at least one of the longitudinal direction and the lateral direction of the slide glass as an axis, so that, when the holding state of the slide glass before the dripping of the destaining solution is used as a reference, the inclination of each end of the slide glass in at least one of the lateral direction and the longitudinal direction other than the axis becomes a predetermined degree from the reference.

4. When the holding state of the slide glass before the dripping of the destaining solution is used as a reference, the holding unit is driven in at least one of a clockwise direction and a counterclockwise direction around at least one of a longitudinal direction and a lateral direction of the slide glass as an axis so that the inclination of each end of the slide glass in at least one of a lateral direction and a longitudinal direction other than the axis becomes a predetermined degree from the reference.

4. The automatic staining apparatus according to claim 3,

5. The automatic staining device according to any one of claims 1 to 4 and a microscopy support device are included, the microscopy support device includes an image information acquisition unit, a recognition / estimation unit, and an information output unit; the image information acquisition unit acquires a microscope image of a stained specimen of a specimen collected from a living organism to be inspected; the recognition and estimation unit recognizes a stained substance image in the microscope image, and estimates a type of stained substance from the stained substance image to generate estimated stained substance type information; The information output unit is a device that outputs the estimated staining substance type information.

Citation Information

Patent Citations

  • Information processing device and program

    JP2018054472A