Sample measurement system
Patent Information
- Application Number
- CN202610210532.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2025-02-17
- Filing Date
- 2026-02-13
- Publication Date
- 2026-08-18
AI Technical Summary
[0012] According to the present invention, functional extensions can be easily made to display statistical information based on metadata including information representing blood cell images of a sample for each cell type, and to display anomaly markers about the sample based on multiple metadata as the basis of the statistical information.
Smart Images

Figure CN122598162A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to a sample measurement system. Background Technology
[0002] Patent document 1 discloses providing abnormal result information corresponding to the detected abnormalities in the smear based on the smear analysis results of the sample.
[0003] [Preliminary Technology Documents]
[0004] [Patent Literature]
[0005] Patent Document 1: Chinese Patent Application Publication No. 114424065 Summary of the Invention
[0006] [The problem the invention aims to solve]
[0007] The sample measurement system described in Patent Document 1 has the function of comparing the analysis results of smears with anomaly rules and generating and displaying anomaly result information. When adding such new functions to expand functionality, it is sometimes necessary to rewrite the software. However, if the software has already been certified by a certification body as a component of a medical device, recertification may be required along with the software rewriting. Due to these circumstances, functional expansion is sometimes difficult to implement easily in conventional sample measurement systems.
[0008] The purpose of this invention is to provide a system that can be easily extended to display the function of anomaly markers on a sample.
[0009] [Methods used to solve problems]
[0010] A sample measurement system capable of optically measuring a sample, the sample measurement system comprising: a sample measuring device configured to optically measure the sample, the sample measuring device comprising: (i) a sample suction unit configured to attract the sample, the sample suction unit including a nozzle for attracting the sample from a sample container, a moving mechanism configured to move the nozzle into the sample container, and a pump configured to apply negative pressure to cause the nozzle to attract the sample; (ii) a sample preparation unit configured to prepare a measurement sample by mixing the attracted sample and a reagent in a container; (iii) an optical detection unit configured to detect light from the prepared measurement sample; and (iv) a controller configured to control the sample suction unit, the sample preparation unit, and the optical detection unit according to control software, such that the sample measuring device optically measures the sample, wherein the sample measuring device analyzes optical information derived from the detected light to obtain measurement results and manages data about the sample measuring device according to management software, wherein the data includes the measurement results; An imaging device configured to capture images of blood cells in a smear of the sample; and a computer capable of running an interface to interact with application software programmed to utilize the data and the images, wherein the application software is independent of the sample measuring device; wherein the interface performs operations including: (a) receiving a request from the application software; (b) retrieving an image corresponding to the request according to preset rules, wherein the retrieved image is associated with metadata including morphological features of blood cells; and (c) providing the retrieved image to the application software so that the application software displays: (1) a summary of the morphological features in numerical and / or linguistic terms, wherein the summary is derived from metadata associated with the retrieved image that visually displays the morphological features of blood cells; and (2) a notification based on the metadata indicating the possibility of the presence of specific blood cells in the retrieved image.
[0011] [Invention Effects]
[0012] According to the present invention, functional extensions can be easily made to display statistical information based on metadata including information representing blood cell images of a sample for each cell type, and to display anomaly markers about the sample based on multiple metadata as the basis of the statistical information. Attached Figure Description
[0013] Figure 1 This is a diagram showing the constituent elements of the sample measurement system according to this embodiment.
[0014] Figure 2 This is a diagram illustrating an example of computer configuration.
[0015] Figure 3 This is a diagram illustrating Example 1 of the configuration of the sample measurement system according to this embodiment.
[0016] Figure 4 This is a diagram illustrating Example 1 of the configuration of the sample measurement system according to this embodiment.
[0017] Figure 5 This is a diagram illustrating Example 2 of the configuration of the sample measurement system according to this embodiment.
[0018] Figure 6 This is a diagram illustrating Example 3 of the configuration of the sample measurement system according to this embodiment.
[0019] Figure 7 This is a diagram illustrating Example 4 of the configuration of the sample measurement system according to this embodiment.
[0020] Figure 8 This is a diagram illustrating Example 4 of the configuration of the sample measurement system according to this embodiment.
[0021] Figure 9 This is a diagram illustrating Example 5 of the configuration of the sample measurement system according to this embodiment.
[0022] Figure 10 This is a diagram illustrating Example 5 of the configuration of the sample measurement system according to this embodiment.
[0023] Figure 11 This is a diagram illustrating Example 6 of the configuration of the sample measurement system according to this embodiment.
[0024] Figure 12 This is a diagram illustrating Example 7 of the configuration of the sample measurement system according to this embodiment.
[0025] Figure 13 This is a diagram illustrating an example of the configuration of a sample measuring device and an imaging device.
[0026] Figure 14 This is a diagram illustrating an example of the hardware configuration of a control unit.
[0027] Figure 15 This is a diagram illustrating an example of the structure of control software and data management software.
[0028] Figure 16 This is a diagram illustrating a modified example of a control unit configuration.
[0029] Figure 17 This is a diagram showing an example of the configuration of a measurement unit.
[0030] Figure 18 This is a diagram illustrating an example configuration when the measuring unit is a blood cell analyzer.
[0031] Figure 19 This is a schematic diagram illustrating the sample suction section and sample preparation section when supplying a measurement sample to the FCM detection section.
[0032] Figure 20 This is a schematic diagram illustrating the sample suction section and sample preparation section when supplying a measurement sample to the RBC / PLT detection unit.
[0033] Figure 21 This is a schematic diagram illustrating the sample suction section and sample preparation section when supplying a measurement sample to the HGB detection section.
[0034] Figure 22 This is a diagram showing an example of the configuration of an imaging unit.
[0035] Figure 23 This is a diagram illustrating an example of interface construction.
[0036] Figure 24 This is a flowchart illustrating an example of a processing flow (collaborative method) based on an interface of a sample measurement device.
[0037] Figure 25 This is a diagram illustrating an example of the interface structure of a data management system.
[0038] Figure 26 This is a diagram representing an example data structure of the HTTP request body when updating batch information for quality control.
[0039] Figure 27 This is a diagram illustrating an example of a request for information about a sample measuring device and a response to that request.
[0040] Figure 28 This is a diagram illustrating an example of a request for information about sample measurements and a response to that request.
[0041] Figure 29 This is a diagram illustrating an example of a request for / response to information regarding the maintenance of a sample measuring device.
[0042] Figure 30 This is a diagram illustrating an example of a request for the operation of a sample measuring device.
[0043] Figure 31 This is a diagram illustrating an example of a request for information about an imaging device and a response to that request.
[0044] Figure 32 This is a diagram representing an example of a request for information about imaging / a response to a request.
[0045] Figure 33 This is a diagram illustrating an example of a request for information regarding the maintenance of an imaging device and a response to that request.
[0046] Figure 34 This is a diagram illustrating an example of a request for the operation of an imaging device.
[0047] Figure 35 This diagram illustrates a configuration example of a push notification from a sample measuring device to a data management system.
[0048] Figure 36 This is a diagram representing an example of an event and an example of the information corresponding to the event (information that is the object of the PUSH notification).
[0049] Figure 37 This is a diagram illustrating an example of the structure of application software.
[0050] Figure 38 This diagram illustrates an example of how application software functionality is provided as a Web service.
[0051] Figure 39 This diagram illustrates another example of providing application software functionality as a Web service.
[0052] Figure 40 This diagram represents another further example of providing application software functionality as a Web service.
[0053] Figure 41 This is a diagram illustrating an example of the structure of an application software provider server.
[0054] Figure 42 This is a diagram illustrating an example of how application software can be provided in a secure communication environment.
[0055] Figure 43 This is a diagram illustrating an example of how application software can be provided using an MDM or MAM.
[0056] Figure 44 This is a diagram illustrating an example data structure when the database of an MDM / MAM system is a relational database.
[0057] Figure 45 This is a diagram illustrating Example 1, which shows the provision of blood cell imaging results and abnormal markers via a GUI.
[0058] Figure 46 This is a diagram illustrating Example 2, which shows the provision of blood cell imaging results and abnormal markers via a GUI.
[0059] Figure 47 This is a diagram illustrating an example data structure within the data storage device involved in this embodiment.
[0060] Figure 48 This is a flowchart illustrating the software-based processing flow involved in this embodiment.
[0061] Figure 49 This is a flowchart illustrating the details of the software-based processing flow involved in this embodiment.
[0062] Figure 50 This is a diagram illustrating example 1 of GUI-based rule settings for exception flags.
[0063] Figure 51 This is a diagram illustrating Example 2 of GUI-based rule settings for exception flags.
[0064] Figure 52 This is a diagram of example 3, which shows the provision of blood cell imaging results and abnormal markers via a GUI.
[0065] Figure 53 This is a flowchart illustrating a variation of the software-based processing flow involved in this embodiment.
[0066] Figure 54 This is a diagram of example 4, which shows how blood cell imaging results and abnormal markers are provided via a GUI.
[0067] Figure 55 This is a diagram of example 4, which shows how blood cell imaging results and abnormal markers are provided via a GUI.
[0068] Figure 56 This is a diagram of example 5, which shows the provision of blood cell imaging results and abnormal markers via a GUI.
[0069] Figure 57 This is a diagram of example 5, which shows the provision of blood cell imaging results and abnormal markers via a GUI.
[0070] Figure 58 This is a diagram of example 6, which shows how blood cell imaging results and abnormal markers are provided via a GUI.
[0071] Figure 59 This is a diagram of example 7, which shows how blood cell imaging results and abnormal markers are provided via a GUI.
[0072] Explanation of icon numbers
[0073] 1: Sample Measurement System
[0074] 2: Measurement Unit
[0075] 3: Control software
[0076] 4. 4A: Data Management Software
[0077] 5. 5A: Interface
[0078] 6: Application Software
[0079] 11: Sample measuring device
[0080] 12: Imaging device
[0081] 21: Sample Processing Department
[0082] 22: Testing Department
[0083] 61: Functional Provision Department
[0084] 62: Request Department
[0085] 63: Response Receiving Unit
[0086] 2000: Imaging Unit
[0087] C: Command
[0088] R: Rules Detailed Implementation
[0089] [Components of a Sample Measurement System]
[0090] like Figure 1 As shown, the sample measurement system 1 according to this embodiment, as an example, includes a measurement unit 2, control software 3, data management software 4, and an interface 5 as its constituent elements. The measurement unit 2, for example, measures a sample and acquires measurement data. Furthermore, the control software 3 and data management software 4 can be integrated. The sample measurement system 1 is, for example, a sample measurement device including the measurement unit 2, control software 3, data management software 4, and interface 5. The sample measurement system 1 may include, for example, a sample measurement device, and other components such as... Figure 4 As shown, it may also include an imaging device 12 comprising an imaging unit 2000, control software 3, data management software 4, and an interface 5. The imaging unit 2000, for example, images a smear formed by applying a sample to a glass slide. The sample measurement system 1 is, for example, a system comprising a sample measurement device including a measurement unit 2, control software 3, data management software 4, and an interface 5, as well as other devices or software. The sample measurement device is, for example, a blood cell analysis device that acquires hematological test results by classifying and counting the blood cell components contained in a blood sample. The imaging device 12 is, for example, a blood cell image imaging device that acquires the results of imaging a smear formed by applying a blood sample to a glass slide.
[0091] Measurement unit 2 measures the sample inserted into it and acquires data corresponding to the measurement results. An example of measurement unit 2 is a unit that performs measurements for blood cell analysis. Measurement unit 2 operates under the control of control software 3. Measurement unit 2 provides the acquired data to data management software 4 via control software 3. Imaging unit 2000 images a smear inserted into it and acquires data corresponding to the imaging results. An example of imaging unit 2000 is a unit that performs imaging for blood cell analysis. Imaging unit 2000 operates under the control of control software 3. Imaging unit 2000 provides the acquired data to data management software 4 via control software 3.
[0092] Control software 3 and data management software 4 collaborate to control the operation of measurement unit 2. Control software 3 issues instructions to measurement unit 2 to execute measurement actions corresponding to the measurement order for the sample inserted into measurement unit 2. Control software 3 analyzes the data acquired by measurement unit 2 and obtains measurement data as the measurement result. Furthermore, control software 3 and data management software 4 collaborate to control the operation of imaging unit 2000. Control software 3 issues instructions to imaging unit 2000 to execute imaging actions corresponding to the imaging order for the smear inserted into imaging unit 2000. Control software 3 analyzes the data acquired by imaging unit 2000 and obtains imaging data as the imaging result.
[0093] Data management software 4 manages data related to measurement unit 2. Data management software 4 has the function of providing the operator with measurement results acquired by control software 3 (e.g., UI: User interface). Data management software 4 has functions related to device operation such as registration and acquisition of measurement orders, and provides information about measurement orders to control software 3. Data management software 4 can manage the data based on classification corresponding to the type of data related to measurement unit 2. For example, data management software 4 can classify and manage the data according to the type of the cooperating measurement unit 2. The type of measurement unit 2 is, for example, a unit that performs measurements for blood cell analysis. Control software 3 and data management software 4 can be independent software. Software with the same functions as control software 3 and data management software 4 can perform control of measurement unit 2 and management of data related to measurement unit 2. Furthermore, data management software 4 manages data related to imaging unit 2000. Data management software 4 has the function of providing the operator with imaging results acquired by control software 3 (e.g., UI: User interface). Data management software 4 has functions related to device operation such as registration and acquisition of imaging orders, and provides information about imaging orders to control software 3. Data management software 4 can manage the data based on classifications corresponding to the types of data related to imaging unit 2000. For example, data management software 4 can classify and manage the data according to the type of the cooperating imaging unit 2000. The type of imaging unit 2000 is, for example, a unit that performs imaging for blood cell analysis. Control software 3 and data management software 4 can be independent software. Software with the same functions as control software 3 and data management software 4 can perform control of imaging unit 2000 and management of data related to imaging unit 2000.
[0094] The measurement unit 2 or imaging unit 2000, control software 3, and data management software 4 described above, when used as medical devices, sometimes require certification from a certification body. Medical devices requiring certification are, for example, in vitro diagnostic medical devices. In this case, the measurement unit 2, control software 3, and data management software 4 provide functions corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, measuring samples and providing measurement results. In the case of a blood cell analysis device, for example, it measures blood samples and provides blood cell-related measurement results (e.g., red blood cell count, white blood cell count, white blood cell differential, etc.).
[0095] Application software (hereinafter simply referred to as "application") 6 is software independent of control software 3 and data management software 4. Application 6, for example, has functions built into prior art software related to sample measurement devices. Application 6, for example, has functions built into prior art software related to imaging smear devices. That is, application 6 has functions separated from prior art software related to devices for measuring samples or smear imaging devices. Application 6 may also have new functions not built into prior art software related to devices for measuring samples. Application 6 may also have new functions not built into prior art software related to imaging smear devices. The sample measurement system 1 according to this embodiment, for example, displays statistical information (i.e., the summary in the claims) related to blood cell images based on metadata including information representing cell types in sample blood cell images. The sample measurement system 1, for example, obtains the cell type classification category of the blood cell images from the metadata and displays the number and proportion of blood cell images belonging to each classification category as statistical information for each classification category. The display of statistical information is performed by application software 6, which can be added to the sample measurement system 1. The sample measurement system 1, for example, displays anomaly markers (i.e., notifications in the claims) about the sample based on the aforementioned metadata. The display of these anomaly markers is performed, for example, by application software 6, which can be added to the sample measurement system 1. As described above, the sample measurement system 1 can display the overall picture of the smear analysis results as statistical information and display anomaly markers corresponding to anomalies detected from the smear analysis results. By displaying not only statistical information as the overall picture of the analysis results but also anomaly markers corresponding to anomalies detected from the analysis results, the sample measurement system 1 can provide a function that allows for multi-faceted evaluation of the smear analysis results. In the sample measurement system 1 according to this embodiment, for example, application software with the function of providing hematological test results of the sample and blood cell imaging results in the sample (results of imaging sample smears) can be added to the system. For example, since the sample measurement system 1 can display the hematological test results of the sample acquired by the sample measurement device 11 and the blood cell imaging results of the sample acquired by the imaging device 12 (results of imaging sample smears), the user can simultaneously verify the results by comparing the hematological test results and the blood cell imaging results (results of imaging smears). By comparing and confirming hematological test results and blood cell imaging results (image smear results), users can, for example, assess the appropriateness of blood cell imaging results (image smear results) while referring to hematological test results, or vice versa. Application 6 provides functions that differ from, for example, those corresponding to the "Intended Use" of medical devices.Examples of Application 6 include software used for healthcare purposes other than medical care (hereinafter referred to as "non-medical device software") and software not used for healthcare purposes (hereinafter referred to as "non-health software"). Non-medical device software and non-health software are software that does not require certification as a medical device or only requires partial certification. Alternatively, Application 6 can also include applications that require certification as medical devices.
[0096] Application 6 can be added to sample measurement system 1. In other words, application software 6 can be added to sample measurement system 1. Application 6, added to sample measurement system 1, becomes a component of sample measurement system 1. Application 6, added to sample measurement system 1, provides, for example, the functionality to utilize information managed by data management software 4 (e.g., data related to measurement unit 2, data related to imaging unit 2000), and the functionality to utilize data management software 4. The functionality provided by application 6 may be, for example, functionality not possessed by data management software 4, or functionality that extends the functionality possessed by data management software 4. The functionality provided by application 6 may be, for example, new functionality different from the functionality corresponding to the intended use as a medical device. In this way, application 6 added to sample measurement system 1 provides functionality for expanding sample measurement system 1. In other words, application 6 added to sample measurement system 1 can also be said to supplement the functionality of data management software 4.
[0097] Because Application 6 is separate from Data Management Software 4 and Control Software 3, Application 6 can be easily added to Sample Measurement System 1 without rewriting Data Management Software 4 and Control Software 3. Furthermore, if Application 6 is non-medical device software or non-health software that does not require medical device certification, no certification from a certification body is required when adding Application 6. Similarly, removing Application 6 from Sample Measurement System 1 does not require rewriting Data Management Software 4 and Control Software 3.
[0098] Application 6, separate from data management software 4, can collaborate with data management software 4 via interface 5. Interface 5 is, for example, a software interface or an API (Application Programming Interface). Interface 5 enables application 6 to utilize information managed by data management software 4 (e.g., measurement data, imaging data, and related data of measurement unit 2 and imaging unit 2000) and the functions of data management software 4. Specifically, interface 5 receives requests from application 6 and, by responding to those requests, enables application 6 to utilize, for example, the data or functions corresponding to the request. Requests from application 6 may be, for example, requests to utilize data managed by data management software 4 or requests to utilize the functions of data management software 4. Responses to application 6 may be, for example, providing the data or functions corresponding to the request.
[0099] Application 6 collaborates with Interface 5 according to pre-agreed rules (hereinafter referred to as "Rule R"). Interface 5, based on Rule R, enables Application 6 to utilize information and functions related to Data Management Software 4. In the case where Interface 5 is configured as a Web API, Rule R is defined as: a combination of a URI (Uniform Resource Identifier) specifying the processing object in a defined syntax and a defined HTTP (Hypertext Transfer Protocol) method representing an operation on the processing object. Application 6, based on Rule R, creates a request to Interface 5 that specifically defines the processing object and the operation on the processing object, using the URI and HTTP method combination. This request is also referred to as "Command C". Application 6 sends Command C, created based on Rule R, to Interface 5. Interface 5 provides Application 6 with a response based on Command C sent from Application 6. For example, based on Command C sent from Application 6, Interface 5 enables Application 6 to utilize at least one of the following: data related to Measurement Unit 2, measurement action data related to Measurement Unit 2, maintenance data related to Measurement Unit 2, and operation data related to Measurement Unit 2. For example, interface 5, based on command C sent from application 6, causes application 6 to utilize data related to imaging unit 2000, operational data related to imaging unit 2000, etc. Furthermore, for example, interface 5, based on command C sent from application 6, causes application 6 to perform at least one of the following: acquiring data related to measurement unit 2, registering the data, updating the data, or deleting the data. For example, depending on the type of sample measuring device 11, there may be multiple rules R. For example, depending on the type of sample measuring device 11, the information management style of data management software 4 or data management system 15 may sometimes be different. In this case, for example, by collaborating with application 6 through interface 5 / 5A based on multiple rules R corresponding to the information management style, application 6 can utilize multiple types of information, each with its own distinct information management style. Interface 5, based on command C sent from application 6, causes application 6 to perform at least one of the following: acquiring data related to imaging unit 2000, registering the data, updating the data, or deleting the data.
[0100] Interface 5 can enable multiple applications 6 to utilize data related to measurement unit 2 based on a common set of rules R applicable to multiple applications 6 that provide different functions. Interface 5 can also enable applications 6 to utilize data related to measurement unit 2 based on a common set of rules R applicable to multiple applications 6 created for different operating systems.
[0101] Interface 5 can be built into data management software 4, or it can be built into other software programs independent of data management software 4. Interface 5 can also be software independent of data management software 4, control software 3, and other software programs. Furthermore, data management software 4 can consist of a single software program (e.g., an executable file) or multiple software programs (e.g., multiple executable files). For example, the software implementing interface 5 and the software implementing data management software 4 can consist of multiple different executable files.
[0102] [Example of software operating environment]
[0103] Control software 3, data management software 4, interface 5, and application 6 may run on one or more computers 900. Computer 900 may be, for example, a smartphone (iPhone, Android device), a tablet computer (iPad, Android tablet, Windows tablet), a Windows PC running Windows OS, or a Mac running Mac OS (iPhone, iPad, Android, Windows, and Mac OS are registered trademarks). Furthermore, application 6 may be created separately for various operating systems. For example, for a given application 6, separate applications may be created for Windows OS and iOS.
[0104] Figure 2 This illustrates an example of the configuration of a computer 900. The computer 900, as an example, includes a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, and a communication unit 78. The terminal device 101 and control unit 7, described later, have... Figure 2 The computer 900 shown has the same configuration.
[0105] Storage unit 74 is, for example, a non-volatile memory such as SSD (Solid State Drive), flash memory, HDD (Hard Disk Drive), or a combination thereof. Storage unit 74 stores various programs, including, for example, control software 3, data management software 4, interface 5, and application 6, as well as various data.
[0106] The processor 71 is, for example, an IPU (Infrastructure Processing Unit), a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), a DSP (Digital Signal Processor), an MPU (Micro Processing Unit), or a combination thereof. The processor 71 can be implemented, for example, through logic circuitry. The processor 71 reads various programs from the storage unit 74 and expands them into the memory 72 for execution. The memory 72 is, for example, a volatile memory such as RAM (Random Access Memory) or DRAM (Dynamic Random Access Memory).
[0107] Interface 751 connects bus 73 to display unit 75 such as a monitor. Interface 761 connects bus 73 to operation unit 76 such as a keyboard and mouse. Communication unit 78 is responsible for communication with external devices.
[0108] In the following description, in order to simplify the operation of the control software 3, data management software 4, interface 5 or application 6, the description of the corresponding components in the processor 71, storage unit 74 and memory 72 used to execute these programs will sometimes be omitted.
[0109] Furthermore, the computer 900 may be further equipped with a communication interface for communicating with other devices. Additionally, the computer 900 may be further equipped with an input / output interface for connecting input / output devices such as a keyboard, mouse, monitor, and printer.
[0110] [Example of sample measurement system configuration]
[0111] [Example 1]
[0112] Figure 3 This figure illustrates an example configuration of a sample measurement system 1. In this example, the sample measurement system 1 is configured as a sample measurement device 11 comprising a measurement unit 2, execution control software 3, data management software 4, an interface 5, and an application 6. In this example, the application 6 is executed within the sample measurement device 11, and utilizes information managed by the data management software 4 and the functions of the data management software 4 via the interface 5. The sample measurement system 1 may, for example, include, in addition to the sample measurement device 11, other components... Figure 4 The imaging device 12 shown. The imaging device 12 includes, for example, an imaging unit 2000, and a control unit 7 consisting of operation control software 3, data management software 4, interface 5, and application 6.
[0113] [Example 2]
[0114] Application 6 can be mounted in a device different from the sample measuring device 11 and the imaging device 12. Figure 5 In the illustrated configuration example, the sample measurement system 1 includes a sample measuring device 11 installed in an inspection chamber, an imaging device 12 installed in the inspection chamber, and a terminal device 101 connected to the sample measuring device 11 and the imaging device 12 via a communication network 201. The terminal device 101 is used, for example, in the inspection chamber. The communication network 201 is, for example, an internal network.
[0115] The sample measuring device 11 includes a measuring unit 2, execution control software 3, data management software 4, and a control unit 7 with an interface 5. The imaging device 12 includes an imaging unit 2000, execution control software 3, data management software 4, and a control unit 7 with an interface 5. The terminal device 101 is a computer used by the user of the sample measuring system 1, such as a PC, smartphone, or tablet. The terminal device 101 carries and executes application 6.
[0116] In this configuration example, application 6, running in terminal device 101, accesses interface 5 of sample measuring device 11 and imaging device 12 via communication network 201. Interface 5, via communication network 201, enables application 6 of terminal device 101 to utilize information managed by data management software 4 and the functions of data management software 4.
[0117] [Example 3]
[0118] The terminal device 101 equipped with application 6 can be used in a different location than the facility where the sample measuring device 11 and imaging device 12 are located (e.g., outside the inspection room, or in another room within the same facility as the inspection room). Figure 6 In the illustrated configuration example, the sample measurement system 1 includes a sample measuring device 11 and an imaging device 12 installed in an inspection room, and a terminal device 101 used in a different facility from the inspection room and connected to the sample measuring device 11 and the imaging device 12 via a communication network 202. The communication network 202 is, for example, the Internet or an intranet. The sample measuring device 11 includes a measuring unit 2 and a control unit 7 that executes control software 3, data management software 4, and an interface 5. The imaging device 12 includes an imaging unit 2000 and a control unit 7 that executes control software 3, data management software 4, and an interface 5. The terminal device 101 carries and executes an application 6.
[0119] In this configuration example, application 6 running in terminal device 101 accesses interface 5 of sample measuring device 11 via communication network 202. Interface 5, via communication network 202, enables application software 6 of terminal device 101 to utilize information managed by data management software 4 and the functions of data management software 4. Furthermore, application 6 running in terminal device 101 accesses interface 5 of imaging device 12 via communication network 202. Interface 5, via communication network 202, enables application 6 of terminal device 101 to utilize information managed by data management software 4 and the functions of data management software 4.
[0120] [Example 4]
[0121] When the sample measuring device 11 is equipped with application 6, application 6 itself can also access other sample measuring devices 11 and utilize the information managed by the data management software 4 of those other sample measuring devices 11, as well as the functions of that data management software 4. Figure 7 In the illustrated configuration, the sample measurement system 1 is composed of sample measurement devices 11 equipped with a measurement unit 2, execution control software 3, data management software 4, interface 5, and application 6, which are communicatively connected to each other via a communication network 203. The communication network 203 is, for example, an internal network or the Internet. Figure 8 In the illustrated configuration example, the sample measurement system 1 is composed of the following devices communicatively connected via a communication network 203: a sample measurement device 11 equipped with a measurement unit 2, control software 3, data management software 4, interface 5, and a control unit 7 executing an application 6; and an imaging device 12 equipped with an imaging unit 2000, control software 3, data management software 4, interface 5, and a control unit 7 executing an application 6. The communication network 203 is, for example, an intranet or the Internet.
[0122] exist Figure 7 In the illustrated configuration example, application 6 running in a sample measuring device 11 can access the information managed by the data management software 4 of that sample measuring device 11 via its interface 5, and can also access the interfaces 5 of other sample measuring devices 11 connected via the communication network 203, and access the information managed by the data management software 4 of those same devices, as well as the functions of that software. Furthermore, in Figure 8 In the case of this configuration example, for example, the application 6 executed in the imaging device 12 can access the information managed by the data management software 4 of the imaging device 12 and the functions of the data management software 4 via the interface 5 of the imaging device 12, and can access the interface 5 of the sample measuring device 11 connected via the communication network 203, and access the information managed by the data management software 4 of the sample measuring device 11 and the functions of the data management software 4.
[0123] [Example 5]
[0124] Information managed by the data management software 4 (such as measurement data) can also be managed by a device different from the sample measurement device 11. Figure 9 In the illustrated configuration example, the sample measurement system 1 includes a sample measurement device 11 and a data management system 15 connected to the sample measurement device 11 via a communication network 204. The communication network 204 is, for example, an intranet or the Internet. Information managed by the data management software 4 (e.g., measurement data) can also be managed by both the sample measurement device 11 and the data management system 15. For example, all or part of the information managed by the data management software 4 of the sample measurement device 11 can be managed by the data management system 15. Figure 10 In the illustrated configuration example, the sample measurement system 1 includes an imaging device 12 and a data management system 15 connected to the imaging device 12 via a communication network 204. The communication network 204 is, for example, an intranet or the Internet. Information managed by the data management software 4 (e.g., imaging data) can also be managed by both the imaging device 12 and the data management system 15. For example, all or part of the information managed by the data management software 4 of the imaging device 12 can be managed by the data management system 15.
[0125] like Figure 9 As shown, the sample measuring device 11 includes a measuring unit 2 and a control unit 7 comprising execution control software 3, data management software 4, an interface 5, and an application 6. The sample measuring device 11 has the function of providing information managed by the data management software 4 to the data management system 15. Details will be described later. As an example of this function, the interface 5 can provide information (measurement data, etc.) corresponding to a predetermined event to the data management system 15 via a PUSH notification through the communication network 204. The PUSH notification can also be executed by something other than the interface 5 (e.g., the data management software 4, or other software mounted on the control unit 7). The sample measuring device 11 can also, instead of the PUSH notification, provide information managed by the data management software 4 to the data management system 15 in response to a query from the data management system 15. Providing information to the data management system 15 is also the same in configuration examples 6 and 7 described later. Furthermore, as... Figure 10As shown, the imaging device 12 includes an imaging unit 2000 and a control unit 7 that executes control software 3, data management software 4, an interface 5, and applications 6. The imaging device 12 has the function of providing information managed by the data management software 4 to the data management system 15. Details will be described later. As an example of this function, the interface 5 can provide information (measurement data, etc.) corresponding to a predetermined event to the data management system 15 via a push notification through the communication network 204. The push notification can also be executed by something other than the interface 5 (e.g., the data management software 4, or other software mounted on the control unit 7). Similar to the sample measurement device 11, the imaging device 12 can also, in response to a query from the data management system 15, provide information managed by the data management software 4 to the data management system 15, instead of a push notification.
[0126] like Figure 9 As shown, the data management system 15 includes, for example, a control unit 17 that executes data management software 4A, an interface 5A, and a communication control unit 16. The control unit 17 and... Figure 2 The processor 902 shown is equivalent. The data management system 15 includes a data memory 18 as a storage device. The data management software 4A accumulates and manages information from the sample measuring device 11 via PUSH notifications into the data memory 18. The communication control unit 16 has the function of controlling communication regarding PUSH notifications from the sample measuring device 11. Furthermore, as... Figure 10 As shown, the data management software 4A can also accumulate and manage the information from the imaging device 12 via PUSH notifications into the data storage 18. The communication control unit 16 has the function of controlling communication regarding PUSH notifications from the imaging device 12.
[0127] like Figure 9 As shown, application 6 can collaborate with data management software 4A via interface 5A. Data management software 4A retrieves data from data storage 18 corresponding to the request received from application 6 via interface 5A and provides it to application 6, which is the request source. Interface 5A has the function of enabling application 6, which executes in sample measuring device 11, to utilize information managed by data storage 18 via data management software 4A. Interface 5A is equivalent to interface 5, for example, a software interface, typically an API. Interface 5A enables application 6 to utilize information managed by data management software 4A. Application 6 collaborates with interface 5A based on rule R, and interface 5A, based on rule R, enables application 6 to utilize relevant information and functions of data management software 4A. Furthermore, as... Figure 10As shown, interface 5A enables application 6, which runs in imaging device 12, to utilize information managed by data memory 18 via data management software 4A. Interface 5A is equivalent to interface 5, for example, a software interface, typically an API. Interface 5A enables application 6 to utilize information managed by data management software 4A. Application 6 collaborates with interface 5A based on rule R, and interface 5A, based on rule R, enables application 6 to utilize information and functions related to data management software 4A.
[0128] In the case of this configuration example, such as Figure 9 As shown, application 6, executed in sample measuring device 11, accesses interface 5A of data management system 15 via communication network 204 and requests access to information accumulated in data storage 18 of data management system 15. Data management system 15 may be located in an examination room or medical facility, in which case application 6 of sample measuring device 11 accesses interface 5A, for example, via communication network 204, which serves as an internal network. Furthermore, as... Figure 10 As shown, application 6, executed in imaging device 12, accesses interface 5A of data management system 15 via communication network 204 and requests access to information accumulated in data storage 18 of data management system 15. Data management system 15 may be located in an examination room or medical facility, in which case application 6 of imaging device 12 accesses interface 5A, for example, via communication network 204, which serves as an internal network.
[0129] [Example 6]
[0130] Information accumulated in the data storage 18 of the data management system 15 can also be utilized by the application 6 running in the terminal device 101. Figure 11 In the example configuration shown, the sample measurement system 1 is composed of a sample measurement device 11, an imaging device 12, a data management system 15, and a terminal device 101 connected via a communication network 204.
[0131] In this configuration example, application 6, running in terminal device 101, accesses interface 5A of data management system 15 via communication network 204 and requests access to information accumulated in data storage 18 of data management system 15. Application 6, running in terminal device 101, collaborates with interface 5A based on rule R.
[0132] [Example 7]
[0133] As a variation of Example 6, the sample measuring device 11 and the imaging device 12 may not be equipped with data management software 4 and interface 5. Figure 12 The configuration shown is the same as configuration 6, except that the sample measuring device 11 and the imaging device 12 are not equipped with data management software 4 and interface 5.
[0134] In this configuration example, the measurement data and other information acquired by the control software 3 through controlling the measurement unit 2 are sent to the data management system 15 via the communication network 204, and accumulated in the data memory 18 by the data management software 4A of the data management system 15. Similarly, the imaging data and other information acquired by the control software 3 through controlling the imaging unit 2000 are sent to the data management system 15 via the communication network 204, and accumulated in the data memory 18 by the data management software 4A of the data management system 15. The application 6 running in the terminal device 101, similar to configuration example 6, accesses the interface 5A of the data management system 15 via the communication network 204 and requests access to the information accumulated in the data memory 18 of the data management system 15.
[0135] [Example of the configuration of a sample measuring device / imaging device]
[0136] As described above, for example, the sample measuring device 11 is as follows: Figure 13 The device shown includes a control unit 7 and a measurement unit 2. Furthermore, as an example, the imaging device 12... Figure 13 The device shown is equipped with a control unit 7 and an imaging unit 2000.
[0137] [Control Unit]
[0138] The control unit 7 of the sample measuring device 11 and the imaging device 12 is, for example, a computer. Figure 14 This section illustrates an example of the hardware configuration of the control unit 7. As an example, the control unit 7 includes a processor 71, a memory 72, a bus 73, a storage unit 74, a display unit 75, an interface 751, an operation unit 76, an interface 761, an interface 77, and a communication unit 78. Figure 14 An example of connecting the measurement unit 2 and the control unit 7 via interface 77 is shown, but the imaging unit 2000 and the control unit 7 can also be connected via interface 77.
[0139] Processor 71 is the control unit that unifies the functions of control unit 7. Processor 71 and... Figure 2 The processor 71 shown is equivalent. For example, the processor 71 reads control software 3 and data management software 4 from storage unit 74 and expands them into memory 72 for execution. Storage unit 74 and... Figure 2 The storage unit 74 shown is equivalent. The memory 72 is the same as... Figure 2 The memory 72 shown is equivalent.
[0140] Interface 751 connects bus 73 to display unit 75 such as a monitor. Interface 761 connects bus 73 to operation unit 76 such as a keyboard and mouse. Interface 77 connects bus 73 to measurement unit 2. Communication unit 78 is responsible for communication with external devices.
[0141] [Example of the composition of control software and data management software]
[0142] Figure 15 This describes an example of the configuration of control software 3 and data management software 4 executed in control unit 7. Control software 3 includes, for example, a unit control unit 31 and a parsing unit 32. Unit control unit 31, connected to measurement unit 2, issues instructions to measurement unit 2 to execute actions corresponding to the measurement order of the sample being measured. Unit control unit 31, connected to imaging unit 2000, issues instructions to imaging unit 2000 to execute actions corresponding to the imaging order of the sample being imaged. Parsing unit 32, connected to measurement unit 2, parses the data acquired by measurement unit 2 acting according to the instructions of unit control unit 31, generates measurement data as a measurement result, and stores the generated measurement data in storage unit 74. Parsing unit 32, connected to imaging unit 2000, parses the imaging data imaged by imaging unit 2000, generates a classification result of cells contained in the imaging data, and stores the classification result and imaging data in storage unit 74. Alternatively, control software 3 of control unit 7 connected to imaging unit 2000 may not include a parsing unit 32. In this case, the control software 3 acquires the imaging data captured by the imaging unit 2000 from the imaging unit 2000 and stores the acquired imaging data in the storage unit 74.
[0143] The data management software 4 includes, for example, a result provision unit 41 and an operation unit 42. The result provision unit 41 has the function of acquiring measurement data generated by the parsing unit 32 from the storage unit 74 and providing the acquired measurement data to the operator (e.g., a GUI: Graphical User Interface). The operation unit 42 has: a function for registering measurement orders / sample information by the operator (UI); a function for acquiring measurement orders and sample information from a Laboratory Information System (LIS) and / or a Hospital Information System (HIS); a function for registering measurement instructions based on measurement orders; various settings for the device and system; and operation functions such as registering reagent information and consumable information. The information set and registered by the operation unit 42 is stored in the storage unit 74. The operation functions of the data management software 4 are, for example, those required for the intended use of the sample measurement device 11 approved as a medical device (e.g., the minimum functions required to measure samples and provide measurement results specified in the intended use). The data management software 4 possesses operational functions such as those required for its intended use as a medical device-approved sample measuring device 11, as well as additional functions to improve user convenience. The operational functions of the data management software 4 can be expanded, for example, by adding an application 6. Furthermore, the operational functions of the data management software 4 can also be those required for its intended use as a medical device-approved imaging device 12 (e.g., the minimum functions required to image smears and provide the imaging results specified in the intended use), as well as additional functions to improve user convenience. The operational functions of the data management software 4 can be expanded, for example, by adding an application 6.
[0144] As a variation, such as Figure 16 As shown, the control unit 7 of the sample measuring device 11 may not be equipped with data management software 4. Figure 16 The control unit 7 in the example is used, for example, for... Figure 12In the example system, the unit control unit 31, for example, issues an instruction to the measurement unit 2 to perform an action corresponding to a measurement order obtained from the LIS / HIS. The parsing unit 32 parses the data acquired by the measurement unit 2, which operates according to the instruction of the unit control unit 31, generates measurement data as a measurement result, and sends the generated measurement data to the data management system 15, for example, via the communication unit 78. The control unit 7 of the imaging device 12 may not be equipped with data management software 4. In this case, the unit control unit 31, for example, issues an instruction to the imaging unit 2000 to perform an action corresponding to an imaging order obtained from the LIS / HIS. The parsing unit 32 may also parse the data acquired by the imaging unit 2000, which operates according to the instruction of the unit control unit 31, generate imaging data as an imaging result, and send the generated imaging data to the data management system 15.
[0145] The sample measuring device 11 of this embodiment measures the inserted sample and acquires data corresponding to the measurement results. The sample measuring device 11 is, for example, a device that performs measurements for blood cell analysis (e.g., complete blood count (CBC)). The sample measuring device 11 can be integrated from multiple devices; for example, it can be an automated analysis device that integrates a device for blood cell analysis measurements with a device for C-reactive protein (CRP) analysis measurements.
[0146] The imaging apparatus 12 of this embodiment images a smear of an inserted sample and acquires data corresponding to the imaging results. The imaging apparatus 12 is, for example, a device for photographing blood cells on a smear. The imaging apparatus 12 can be integrated from multiple devices; for example, it can be an integrated device combining a smear-making apparatus for smearing blood samples onto a glass slide and an imaging apparatus.
[0147] The sample measuring device 11 and imaging device 12 described above, each being a medical device, sometimes require certification from a certification body. Medical devices requiring certification are, for example, in vitro diagnostic medical devices. The sample measuring device 11, for example, provides functions corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, measuring a sample and providing measurement results. In the case of a hematology analyzer, it measures a sample from a subject and provides measurement data on blood cells (e.g., red blood cell count, white blood cell count, white blood cell differential, etc.). The imaging device 12, for example, provides functions corresponding to the intended use of the certified medical device. The intended use of the medical device is, for example, taking a smear and providing imaging results. In the case of a hematology imaging device, it takes a smear and provides morphological data on blood cells (e.g., classification of band neutrophils, segmented neutrophils, eosinophils, basophils, etc.).
[0148] As a system for displaying hematological test results and imaging results of blood cells in a sample (sample smear imaging results), each of the hematological test results and blood cell imaging results can be associated with identification information about the sample (e.g., a sample identifier (ID)). In this case, hematological test results and blood cell imaging results associated with the same sample identification information can be displayed.
[0149] Blood tests measure red blood cell count, white blood cell count, platelet count, hemoglobin concentration, and hematocrit. These tests, known as hematological tests (blood cell count tests), are used for diagnosing health conditions and for screening disease progression. Furthermore, hematological tests often utilize automated blood cell analyzers, which employ flow cytometry (described later) to acquire information optically, classifying and counting the various cellular components in a blood sample.
[0150] When a blood disorder is suspected based on hematological test results, in addition to hematological examination, it is necessary to prepare a smear from the blood sample collected from the subject and observe the morphology of the blood cells to check for any morphological abnormalities. For the smear, a blood cell imaging device such as imaging device 12 can be used to capture images of the blood sample, and each of the multiple images captured can be classified according to the attributes of the blood cells (e.g., cell type) to identify abnormal cells.
[0151] In addition, the system involved in this embodiment includes various sample measuring devices 11 and imaging devices 12, but as long as the result of the imaging device 12 taking pictures of the smear is obtained, the sample measuring device 11 may not be included in the system.
[0152] [Example of GUI construction]
[0153] exist Figure 11 In the configuration shown, the application software of the terminal device 101 displays data collected by the data management software of the data management system 15 on the display unit provided on the terminal device 101. Figure 45 An example of a GUI (Graphical User Interface) is shown, displaying data associated with each of the following: blood cell image A1, blood cell image classification results (hereinafter referred to as statistics) A2, and anomaly markers B3, and the identification information (sample ID) A4 regarding the sample. Figure 45 The system categorizes multiple blood cell images by cell type, with display areas for statistical information A2 and anomaly markers B3. Anomaly markers B3, for example, display on the GUI anomalies related to the content of statistical information A2 (e.g., "Breast cells detected," "Platelet aggregation detected," "Anisocytosis detected," etc.). Figure 45 As shown, by explicitly displaying anomalies related to the statistical information as anomaly markers while displaying the statistical information, omissions can be prevented compared to simply displaying the statistical information. This GUI can display multiple anomaly markers B3. Users can enter any comments in the display area of anomaly marker B3. Anomaly marker B3 can be omitted from the display area of statistical information A2. For example, anomaly marker B3 can be displayed independently above the display area of blood cell image A1. Figure 45 In the image, blood cell images A1 are categorized and displayed according to attributes (e.g., BL (blast cells), MY (myeloblasts), MMY (metapyeloblasts)). The number of blood cell images displayed can range from several to hundreds. The displayed blood cell images can be, for example, single images of blood cells taken from a photograph, or images generated by stitching together multiple blood cell images.
[0154] [Measurement Unit]
[0155] The structure of measurement unit 2 is as follows: Figure 17As shown, the measurement unit 2, as an example, includes a sample processing unit 21 and a detection unit 22. The sample processing unit 21 prepares a measurement sample based on a sample and a reagent. The detection unit 22 measures the measurement sample prepared by the sample processing unit 21. The unit control unit 31 of the control software 3 cooperates with the operation unit 42 of the data management software 4 (according to instructions from the operation unit 42) to control the operation of the sample processing unit 21 and the detection unit 22. The unit control unit 31, for example, controls the operation of the mechanisms and fluid circuits constituting the sample processing unit 21 and the detection unit 22. This operation control may include, for example, at least one of the following controls: control of the suction action of a liquid including at least one of the sample and a reagent; control of mixing the sample and the reagent to prepare the measurement sample; control of causing the detection unit 22 to detect the measurement sample; and control of detecting at least one of optical information and electrical signals about the measurement sample by the detection unit 22 and analyzing the measurement result based on the detected detection result.
[0156] [Blood cell analysis device]
[0157] Figure 18 Here is an example configuration when the measurement unit 2 is a blood cell analysis device. In this case, the sample processing unit 21 includes, for example, a sample aspiration unit 211 and a sample preparation unit 212, and the detection unit 22 includes, for example, an FCM detection unit 221, an RBC / PLT detection unit 222, and an HGB detection unit 223.
[0158] Figure 19 This is a schematic diagram illustrating the sample suction unit 211 and the sample preparation unit 212 when supplying a measurement sample to the FCM detection unit 221. The sample suction unit 211 is equipped with a suction nozzle 2111 for aspirating blood samples (whole blood) from the blood collection tube T, and a pump 2112 for applying negative / positive pressure to the suction nozzle. The suction nozzle 2111 is inserted into the blood collection tube T by moving it up and down via a device mechanism (not shown). With the suction nozzle 2111 inserted into the blood collection tube T, when negative pressure is applied by the pump 2112, the blood sample is aspirated through the suction nozzle 2111. Furthermore, the device mechanism may include a hand component for inverting and mixing the blood collection tube T before aspirating blood from it.
[0159] The sample preparation unit 212 is equipped with five reaction chambers 212a to 212e. Reaction chambers 212a to 212e are used for the measurement channels (also called measurement systems) of DIFF, RET, WPC, PLT-F, and WNR, respectively. Each reaction chamber is connected via a flow channel to a hemolysin container containing a hemolysin that serves as the reagent corresponding to that measurement channel, and a staining solution container containing a staining solution. A measurement channel is constituted by one reaction chamber and the reagents (hemolysin and staining solution) connected to it. For example, the DIFF measurement channel corresponds to the measurement item of classifying white blood cells into multiple subgroups (five-part differential white blood cell classification), and consists of a DIFF hemolysin, a DIFF staining solution, and a DIFF reaction chamber, which are reagents for DIFF measurement. The RET measurement channel corresponds to the measurement item of reticulocytes, the WPC measurement channel corresponds to the measurement item of abnormal white blood cells, the PLT-F measurement channel corresponds to the measurement item of platelet optical measurement, and the WNR measurement channel corresponds to the measurement item of white blood cells and nucleated red blood cells. These measurement channels are configured in the same way as the DIFF measurement channels.
[0160] The suction nozzle 2111, which has attracted the blood sample, moves horizontally / vertically via the device mechanism to access the reaction cell corresponding to the measurement channel in reaction cells 212a-212e from above, and then ejects the attracted blood sample. The sample preparation unit 212 supplies the corresponding hemolysin and staining solution to the reaction cell from which the blood sample has been ejected, and prepares a measurement sample by mixing the blood sample with the hemolysin and staining solution in the reaction cell. The prepared measurement sample is then supplied from the reaction cell to the FCM detection unit 221 via a flow channel for flow cytometry-based cell measurement.
[0161] Figure 20 This is a schematic diagram illustrating the sample suction section 211 and the sample preparation section 212 when supplying a measurement sample to the RBC / PLT detection unit 222. The sample suction section 211 and... Figure 17 The sample aspiration section 211 shown is similar. The sample preparation section 212 is equipped with a reaction cell 212f. The reaction cell 212f is connected via a flow channel to a diluent container that holds a diluent corresponding to RBC / PLT. The measurement sample is prepared by mixing the blood sample and the diluent in the reaction cell 212f. The prepared measurement sample is supplied from the reaction cell to the RBC / PLT detection section 222 via the flow channel.
[0162] Figure 21 This is a schematic diagram illustrating the sample suction section 211 and the sample preparation section 212 when supplying a measurement sample to the HGB detection unit 223. The sample suction section 211 and... Figure 17The sample aspiration section 211 shown is similar. The sample preparation section 212 is equipped with a reaction cell 212g. The reaction cell 212g is connected via a flow channel to a hemolysin container containing a hemolysin that is a reagent corresponding to HGB. The measurement sample is prepared by mixing the blood sample and the hemolysin in the reaction cell 212g. The prepared measurement sample is supplied from the reaction cell to the HGB detection section 223 via the flow channel.
[0163] [Imaging device]
[0164] Figure 22 express Figure 13 An example of the configuration of the imaging unit 2000 of the imaging device 12 shown. Figure 22 As shown, the imaging unit 2000 includes, for example, an imaging section 121, a delivery section 122, a transport section 123, and an oiling section 124. The imaging unit 2000 supplies impregnation oil to the smear surface of the smear 120 transported from the transport section 123, and images the smear 120 using an objective lens provided in the imaging section 121. The imaging unit 2000, for example, detects the position of each of multiple cells in the smear 120, adds impregnation oil to the smear 120, and acquires a blood cell image in the smear 120 by magnifying and photographing each of the multiple cells contained in the smear. Furthermore, the imaging unit 2000 can capture images of a predetermined area to acquire a wide-area image of the smear. The imaging unit 2000 can, for example, acquire metadata from the blood cell image and classify the cells contained in the blood cell image based on the metadata. The metadata includes, for example, marker information indicating that the cells contained in the blood cell image are abnormal cells, and information representing the attributes of the cells contained in the blood cell image (e.g., cell classification category). The classification of the blood cell image can be performed by... Figure 13 The imaging device 12 shown can operate automatically, or it can be operated automatically or manually by application software. The imaging device 12 is equipped with a control unit 7, which can, for example, acquire data and communicate with a data management system. Furthermore, the imaging device 12 can also be connected to a smear preparation device, automating the process from smear preparation to the classification of multiple blood cell images.
[0165] A smear is a specimen that has been stained with bright-field staining, such as May-Giemsa staining. There are no restrictions on the specimen as long as the morphology of multiple blood cells can be observed, such as a smear made from peripheral blood.
[0166] [Example of interface construction]
[0167] Interface 5 receives a request from application 6, collaborates with data management software 4 (results providing unit 41 and operation unit 42), and responds to application 6 in response to the request. Figure 23This section describes an example of the configuration of interface 5. Interface 5, as an example, includes a request receiving unit 51, a collaboration unit 52, and a response unit 53. The request receiving unit 51 receives a request from application 6. The request receiving unit 51 parses the content of the request based on rule R, and based on the parsed request, issues an instruction to the collaboration unit 52 to collaborate with the data management software 4 to obtain a response to the request. The collaboration unit 52 collaborates with the data management software 4 according to the instruction and obtains a response corresponding to the request. The response unit 53 provides the response obtained by the collaboration unit 52 to application 6.
[0168] Figure 24 This is a flowchart illustrating an example of the processing flow (collaboration method) of interface 5 based on sample measuring device 11. First, interface 5 waits for a request from application 6 (S1). In response to receiving a request from application 6 (Yes in S1), interface 5 parses the content of the request based on rule R (S2). Interface 5 issues an instruction to data management software 4 to perform processing corresponding to the parsed request (S3). Data management software 4 performs processing according to this instruction. For example, if application 6 requests information about measurement results (e.g., measurement data measured by measurement unit 2 of a specific sample measuring device 11, and measurement results of quality control samples within a period specified in the request (e.g., a period in days, weeks, or months), the result providing unit 41 of data management software 4 determines the data corresponding to the request and provides this information to application 6 via interface 5. For example, in response to a measurement command registration request from application 6, the operation unit 42 of data management software 4 registers a measurement command and provides a response indicating registration completion to application 6 via interface 5. In response to data management software 4 performing processing, interface 5 returns a response to application 6 (S4). Therefore, interface 5 enables application 6 to utilize the data and functions corresponding to the request.
[0169] Figure 25 This section illustrates an example of the configuration of interface 5A in the data management system 15. Interface 5A, as an example, includes a request receiving unit 51A, a collaboration unit 52A, and a response unit 53A. The request receiving unit 51A receives a request from application 6 via communication network 204. The request receiving unit 51A parses the content of the request and, based on the parsed request, instructs the collaboration unit 52A to collaborate with the data management software 4A to obtain a response to the request. The collaboration unit 52A collaborates with the data management software 4A according to the instruction and obtains a response corresponding to the request. The response unit 53A provides the response obtained by the collaboration unit 52A to application 6 via communication network 204.
[0170] When interfaces 5 and 5A are configured as Web APIs, application 6 accesses interfaces 5 and 5A using the URIs determined by rule R. The structure of the URIs determined by rule R is shown in Equation 1.
[0171] http: / / [server address] / [interface ID] / [device ID]{ / [resource] / [query parameters]}… (Equation 1)
[0172] In Equation 1, the "server address" is the communication address corresponding to interfaces 5 and 5A. The server address is specified, for example, by an IP address and a port number.
[0173] Interfaces 5 and 5A can be configured, for example, according to the categories of sample measuring device 11 and imaging device 12. In this case, the "interface ID" in Equation 1 is specified to identify interfaces 5 and 5A. The interface ID is, for example, an ID corresponding to the categories of sample measuring device 11 and imaging device 12. Specifying the "interface ID" in Equation 1 is not mandatory; if this ID is not specified, wildcards (space, double, double, double, double) can be used. (etc.). The interface ID, for example, corresponds to the type of rule R. For example, depending on the type of sample measuring device 11 and imaging device, there are multiple rules R. In other words, the interface ID, for example, corresponds to the type of sample measuring device 11 and the type of imaging device, respectively. For example, depending on the type of sample measuring device 11, the information management style of data management software 4 or data management system 15 may sometimes be different. In this case, for example, by collaborating with application 6 through interface 5 / 5A based on multiple rules R corresponding to the information management style, application 6 can utilize multiple types of information, each with its own distinct information management style.
[0174] In Equation 1, "Device ID" refers to the ID of the sample measuring device 11 and the imaging device 12, which are the objects of information and function utilization. The Device ID is, for example, the serial number of the sample measuring device 11. Specifying the "Device ID" in Equation 1 is not mandatory; if this ID is not specified, wildcards (spaces, double spaces ... wait).
[0175] In Equation 1, "resource" refers to the resource of the API endpoint. This resource could be, for example, a directory on a database corresponding to information about the object being utilized.
[0176] In Equation 1, the "query parameter" is used to uniquely identify multiple data points and control objects on a resource. For example, it's used to determine measurement data from multiple measurement data points based on conditions specified by the query parameter (a specific period, a specific sample, or measurement data where a measurement anomaly occurred). Specifying the "resource" in Equation 1 is not mandatory; if the resource is not specified, wildcards (spaces, spaces, etc.) can be used. (etc.). The specified styles of "resources" and "query parameters" can vary, for example, depending on the type of sample measurement device 11. For instance, in the acquisition of "measurement data," the specified styles of "resources" and / or "query parameters" for acquiring "measurement data" from a hematology analyzer may differ from those for acquiring "measurement data" from an immunoassay analyzer. Even for the same type of information, i.e., "measurement data," depending on the type of sample measurement device 11, for example, sometimes the resources used as API endpoints differ, or sometimes specific query parameters are required for each type of sample measurement device 11. In this case, the specified styles of "resources" and "query parameters" can, for example, differ depending on the type of sample measurement device 11 and the type of imaging device 12, respectively. Since the specified styles of "resources" and "query parameters" are part of rule R, in other words, "resources" and / or "query parameters" can be set based on multiple rules R depending on the type of sample measurement device 11.
[0177] Operations on the resource specified by the URI are determined, for example, via HTTP methods. Examples of HTTP methods include "GET", "PUT", "DELETE", and "POST". Using "GET", information specified by the "resource" and "query parameters" of the URI is retrieved.
[0178] By using "PUT", you can update or edit the information specified by the "resource" and "query parameters" of the URI. In this case, the new data (the content of the resource that should be updated or edited) is included in the HTTP request body. Figure 26This example shows a sample data structure for the HTTP request body when updating batch information for quality control. The example is described in JSON (JavaScript Object Notation) format (JavaScript is a registered trademark). For example, the "Server Address" of Control Unit 7, specified as the object of "PUT" processing (update), is "127.0.0.1", with URI = "http: / / 127.0.0.1:8080 / qcdata / qcLotsInfo?lotNumber=QC22421101". The QC (Quality Control) data held by Control Unit 7, specified by "Resource" = "qcdata" and "Server Address" = "127.0.0.1", is specified. The "PUT" processing (update) is specified for the QC batch information with "Query Parameter" = "QC22421101" (QC batch number) in the QC data held by Control Unit 7, with "Server Address" = "127.0.0.1". The HTTP request body = "{"Limits":[{"parameter":"WBC","lowerLimit":10.0,"upperLimit":100.0},{"parameter":"RBC","lowerLimit":20.0,"upperLimit":200.0},{"parameter":"HGB","lowerLimit":30.0,"upperLimit":300.0},]}" specifies the object and content to be "PUT" processed (updated) for the specified QC batch information. Through this combination of URI and HTTP request body, the lower limit of WBC (white blood cell count) is updated to 10.0 / the upper limit to 100.0, the lower limit of RBC (red blood cell count) is updated to 20.0 / the upper limit to 200.0, and the lower limit of HGB (hemoglobin concentration) is updated to 30.0 / the upper limit to 300.0 in the specified QC batch information. Here, by updating the lower and upper limits of WBC (white blood cell count), RBC (red blood cell count), and HGB (hemoglobin concentration), QC can be implemented using these updated lower and upper limits. These lower and upper limits, also known as management values, are set to ensure the accuracy of measurement results and to demonstrate the appropriateness of the measurement and management methods through the recording of measurement results. Furthermore, management values are also used as indicators of abnormal or incorrect measurement results when measurement results deviate from the lower or upper limits.
[0179] By using "DELETE", the information specified by the "resource" and "query parameters" of the URI is deleted.
[0180] When registering or creating new information, use "POST" without specifying the "resource" and "query parameters". In this case, include the new data (the content of the resource to be registered or created) in the HTTP request body.
[0181] The request receiving unit 51 of interface 5 receives, for example, the URI and HTTP method received from application 6. The cooperation unit 52 of interface 5 cooperates with the data management software 4 based on the URI and HTTP method received by the request receiving unit 51. For example, in response to a request (HTTP method "GET") to obtain the measurement result at the sample measuring device 11 specified by the "device ID" of the URI, the cooperation unit 52 cooperates with the result providing unit 41 and obtains the corresponding measurement result. The response unit 53 of interface 5 sends a response based on the received URI and HTTP method to application 6.
[0182] Similarly, the request receiving unit 51A of interface 5A receives, for example, the URI and HTTP method received from application 6. The cooperation unit 52A of interface 5A, for example, cooperates with the data management software 4A based on the URI and HTTP method received by the request receiving unit 51A. For example, in response to a request (HTTP method "GET") to obtain the measurement result at the sample measuring device 11 specified by the "device ID" of the URI, the cooperation unit 52A cooperates with the data management software 4A and obtains the corresponding measurement result. The response unit 53A of interface 5A sends a response based on the received URI and HTTP method to application 6.
[0183] Figures 27-30 Examples of requests and responses to interfaces 5 and 5A of the sample measuring device 11 are shown. Figure 27 An example of a request for information about the sample measuring device 11 and a response to that request is shown. Figure 27 Examples shown include: (1) requests and responses to information inherent in the sample measuring device 11 or a system including the sample measuring device 11; (2) requests and responses to information related to the state of the sample measuring device 11; and (3) requests and responses to information related to the operation of the sample measuring device 11. Figure 27 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, can summarize and provide information about multiple sample measuring devices 11 (e.g., serial numbers of multiple sample measuring devices 11 set in the inspection chamber, error conditions of multiple sample measuring devices 11 set in the inspection chamber, etc.) to application 6. Figure 28 An example of a request for / response to information related to sample measurement is shown. Figure 28The following examples are shown: (1) requests and responses to information related to measurement results; (2) requests and responses to quality control measurements; and (3) requests and responses to information related to measurement commands. Figure 28 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, can summarize and provide information about multiple sample measuring devices 11 (e.g., the results of multiple sample measuring devices 11 in the inspection room measuring samples within a specified period, the results of multiple sample measuring devices 11 in the inspection room measuring quality control samples within a specified period, etc.) to application 6. Figure 29 An example of a request for / response to a request for maintenance-related information regarding the sample measuring device 11 is shown. Figure 29 Examples are shown below: (1) requests and responses to reagent-related information; (2) requests and responses to maintenance / care-related information. Figure 29 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Figure 29 The “consumables” described herein include, for example, reaction cups (cuvettes) used for measurement, cleaning solutions for cleaning the flow channels inside the device, and pipette tips. Interface 5, for example, can summarize and provide information about multiple sample measuring devices 11 (e.g., reagent balance information of multiple sample measuring devices 11 installed in the inspection chamber, maintenance schedule information of multiple sample measuring devices 11 installed in the inspection chamber, etc.) to application 6. Figure 30 An example of a request for operation of the sample measuring device 11 is shown. Figure 30 Examples shown include: (1) requests and responses to operations related to sample measurement; (2) requests and responses to operations related to maintenance / care; and (3) requests and responses to operations related to the sample measuring device 11. Figure 30 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, enables application 6 to aggregate operations performed on multiple sample measuring devices 11 (e.g., registration of Rerun / Reflex rules for multiple sample measuring devices 11 set up in the inspection chamber, start / stop requests for multiple sample measuring devices 11 set up in the inspection chamber, etc.). Figure 30 In the example, as a response to an operation request, information is shown, for example, indicating whether the operation has been completed (e.g., ACK corresponding to a completed operation, and NACK corresponding to an incomplete operation (e.g., an error)).
[0184] Figures 31-34Examples of requests and responses to interfaces 5 and 5A of the imaging device 12 are shown. Figure 31 An example of a request for / response to an information related to the imaging device 12 is shown. Figure 31 Examples shown include: (1) requests and responses to information inherent to the imaging device 12 or a system including the imaging device 12; (2) requests and responses to state-related information of the imaging device 12; and (3) requests and responses to operation-related information of the imaging device 12. Figure 31 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, can summarize and provide information about multiple imaging devices 12 (e.g., serial numbers of multiple imaging devices 12 installed in the examination room, error conditions of multiple imaging devices 12 installed in the examination room, etc.) to application 6. Figure 32 An example of a request for information about imaging and a response to that request is shown. Figure 32 Examples of the following are shown: (1) requests and responses to information related to imaging results; (2) requests and responses related to quality control; and (3) requests and responses to information related to imaging commands. Figure 32The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5 can, for example, provide application 6 with information about imaging results (e.g., blood cell images, metadata associated with blood cell images, etc.). Information about imaging results is associated, for example, with identification information about the sample (e.g., sample ID). For example, it is possible to request information about imaging results from interface 5 based on the identification information about the sample, and provide application 6 with information about imaging results including blood cell images and metadata. In addition, the metadata includes, for example, marker information that suggests that the cells contained in the blood cell image are abnormal cells, and information indicating the attributes of the cells contained in the blood cell image (e.g., cell classification category). For example, application 6 can generate classification results (statistical information) for each sample by classifying multiple blood cell images by cell attributes based on the metadata. Interface 5 can, for example, provide application 6 with information about imaging commands (e.g., a list of imaging commands, whether there is an imaging command, a list of sample IDs associated with the imaging command, etc.). For example, interface 5 can extract identification information about the sample based on information about the imaging command, and summarize and provide information about the imaging data associated with the extracted identification information about the sample to application 6. Interface 5 can, for example, summarize and provide information about multiple imaging devices 12 (e.g., the results of multiple imaging devices 12 in the examination room capturing samples within a specified period, the results of multiple imaging devices 12 in the examination room performing quality control within a specified period, etc.) to application 6. Here, quality control in the imaging device 12 is performed to confirm whether the imaging device 12 can correctly detect cells in the smear. For example, a specified number of images can be captured by the imaging device 12 of a smear made by smearing blood samples onto a glass slide, and whether cells in the smear are correctly detected can be used as an indicator of quality control. Figure 33 An example of a request for / response to a request for maintenance-related information regarding the imaging device 12 is shown. Figure 33 Examples of the following are shown: (1) requests and responses regarding oil information; (2) requests and responses regarding maintenance / care information. Figure 33 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, can summarize information about multiple imaging devices 12 (e.g., oil level information of multiple imaging devices 12 installed in the inspection chamber, maintenance schedule information of multiple imaging devices 12 installed in the inspection chamber, etc.) and provide it to application 6. Figure 34 An example of a request for information regarding the operation of imaging device 12 is shown. Figure 34Examples shown include: (1) requests and responses to imaging operations; (2) requests and responses to maintenance / care-related operations; and (3) requests and responses to operations related to the imaging device 12. Figure 34 The table shows examples of various information corresponding to requests and responses, but the various information corresponding to requests and responses is not limited to the examples shown in the table. Interface 5, for example, enables application 6 to aggregate operations for multiple imaging devices 12 (e.g., start / stop requests for multiple imaging devices 12 located in the examination room, etc.). Figure 34 In the example, as a response to an operation request, information is shown, for example, indicating whether the operation has been completed (e.g., ACK corresponding to a completed operation, and NACK corresponding to an incomplete operation (e.g., an error)).
[0185] [PUSH Notification]
[0186] Figure 35 An example configuration is shown in which the data management software 4 of the sample measuring device 11 and the imaging device 12 sends a PUSH notification to the data management system 15. The interface 5 may be equipped with a notification unit 54 that has the function of sending PUSH notifications. For example, when a specified event occurs, the notification unit 54 provides information corresponding to the event to the data management system 15 via the communication network 204 through a PUSH notification. Figure 36 An example of an event and an example of the corresponding information (information as the object of a PUSH notification) are shown. For example, in response to the sample measuring device 11 acquiring a measurement result of a sample, the notification unit 54 provides the measurement result to the data management system 15. For example, in response to performing a prescribed operation on the sample measuring device 11 (e.g., reagent replacement, maintenance, information setting, etc.), the notification unit 54 provides operation-related information to the data management system 15. For example, based on changes in the state of the sample measuring device 11 (error occurrence, error resolution, etc.), the notification unit 54 provides information related to the state change (e.g., error information, error operation history, etc.). Furthermore, as another example, in response to the imaging device 12 acquiring a result of imaging blood cells in a sample, the notification unit 54 provides the imaging result to the data management system 15. For example, in response to performing a prescribed operation on the imaging device 12 (e.g., oil replacement, maintenance, information setting, etc.), the notification unit 54 provides operation-related information to the data management system 15. For example, the notification unit 54 provides information related to the state change (such as error information, operation history about the error, etc.) to the data management system 15 based on the change in the state of the imaging device 12 (error occurrence, error resolution, etc.).
[0187] The notification unit 54 can be installed in the data management software 4 instead of the interface 5. Alternatively, the notification unit 54 can be installed in the control unit 7 as software independent of the interface 5 and the data management software 4.
[0188] [Application Software]
[0189] Figure 37 This illustrates an example of the configuration of application 6. Application 6 includes, for example, a function providing unit 61, a request unit 62, and a response receiving unit 63.
[0190] The function providing unit 61 provides functions for expanding the sample measurement system 1. The function providing unit 61 provides functions according to the type of application 6. For example, depending on the type of application 6, the function providing unit 61 provides functions such as providing QC results (QC charts, etc.), managing reagents mounted on the sample measurement device 11, managing errors occurring in the sample measurement device 11, maintaining the sample measurement device 11, and managing the operation of the sample measurement device 11. For example, depending on the type of application 6, the function providing unit 61 provides functions such as displaying blood cell images, displaying statistical information based on meta-information of blood cell images, displaying anomaly markers based on meta-information of blood cell images, and displaying measurement results obtained from the sample measurement device 11.
[0191] The function providing unit 61 may have the function of allowing users to log in using the service provider's account of the services provided by application 6. In this case, application 6 provides the services implemented by the function providing unit 61 only if the user logs in using the service provider's account.
[0192] For example, when information about the sample measuring device 11 and the imaging device 12 is needed, the function providing unit 61 requests the information from the requesting unit 62. In response to the request from the function providing unit 61, the requesting unit 62 requests the information from interfaces 5 and 5A. The requesting unit 62 requests the information using command C, defined by a combination of URI and HTTP method, as described above. Furthermore, depending on the action of the function providing unit 61, for example, when control of the sample measuring device 11 is needed (e.g., registration and modification of setting information of the sample measuring device 11), the function providing unit 61 requests the requesting unit 62 regarding such control (e.g., requests for registration and modification of setting information). Similarly, depending on the action of the function providing unit 61, for example, when control of the imaging device 12 is needed (e.g., registration and modification of setting information of the imaging device 12), the function providing unit 61 requests the requesting unit 62 regarding such control (e.g., requests for registration and modification of setting information). The requesting unit 62 sends the request regarding such control to interfaces 5 and 5A. The request unit 62, for example, as described above, sends a request for control via a command C defined by a combination of a URI and an HTTP method. The request unit 62, for example, generates a command C including a URI based on information provided by the function providing unit 61 and sends the request to interface 5 / 5A. For example, in the case of a request for information about the sample measuring device 11, the function providing unit 61 notifies the request unit 62 of an instruction regarding the requested information (e.g., the measurement results of the sample measuring device 11 with a specific ID within a specified period). For example, in the case of a request for information about the imaging device 12, the function providing unit 61 notifies the request unit 62 of an instruction regarding the requested information (e.g., the image captured by the imaging device 12 with a specific ID within a specified period). The request unit 62 generates the command C based on the notified instruction. The instruction sent from the function providing unit 61 to the request unit 62 is, for example, notified based on an operation performed by the user of application 6. For example, if the user requests measurement results obtained by the sample measuring device 11 with a specific ID on a specific date, the function providing unit 61 notifies the request unit 62 of an instruction corresponding to that request. For example, when a user requests imaging results acquired by imaging device 12 with a specific ID on a specific date, function provision unit 61 notifies request unit 62 of an instruction corresponding to the request. Request unit 62 generates command C by referring, for example, to setting information regarding URI creation (e.g., the IP address of the server being requested). The setting information can be the IP address of the server being requested itself, or it can be the server's URL (Uniform Resource Locator). The address of the server being requested could be, for example, the IP address of the sample measuring device 11 and the control unit 7 of the imaging device 12 located in the inspection room, or the IP address of the data management system 15.When the address of the server to which the request is made is set by the URL, the request unit 62 queries the DNS (Domain Name System) for the IP address, for example, based on the domain name contained in the URL. The request unit 62 generates a URI based on the IP address notified by the DNS. The IP address or URL can be entered by the user via the GUI of application 6. The generation of the URI implemented by the request unit 62 and command C are also the same in the application software examples described later.
[0193] The response receiving unit 63 receives the response corresponding to the request issued by the requesting unit 62 from the interfaces 5 and 5A, and hands over the response content to the function providing unit 61.
[0194] [Example of an error flag displayed in application software]
[0195] An explanation will be given of the anomaly labeling application software used in application 6 to display statistical information and anomaly labels. The anomaly labeling application software provides functions such as: collecting metadata from the imaging device 12, including information on cell types representing blood cell images of the sample, and displaying statistical information and anomaly labels based on the metadata. The anomaly labeling application software provides, for example,... Figure 45 The function shown is to display statistical information A2 and anomaly markers B3.
[0196] Refer again Figure 37 The various parts of the anomaly marker display application software are described below. The function providing unit 61 requests the request unit 62 to obtain information about the imaging device 12. This information is a management object for data used to display statistical information and anomaly markers. For example, the function providing unit 61 requests the request unit 62 to obtain metadata including cell type information from a blood cell image of a sample acquired by the imaging device 12, the blood cell image of the sample, and attribute information about the subject. In the case of multiple imaging devices 12, for example, the request unit 62 can be requested to obtain the device IDs and names of multiple imaging devices 12.
[0197] The request unit 62 generates a URI based on the request content from the function providing unit 61, and requests information from interfaces 5 and 5A by generating a command C by combining the generated URI with the HTTP method "GET". The URI generated by the request unit 62, when retrieving information about the imaging device 12, is, for example, "http: / / 128.0.0.1:8080 / DI / / YYYY". In this example URI, the "server address" is specified as "128.0.0.1:8080", the "interface ID" is specified as "DI", the "device ID" is not specified, the "resource" is specified as "YYYY", and the "query parameters" are not specified. "YYYY" is an API endpoint corresponding to information about the imaging device 12 (e.g., information about the type of imaging device 12, imaging data of the patient acquired by the imaging device 12, etc.). The "server address" "128.0.0.1:8080" is, for example, an address corresponding to an interface of a data management system that manages information about the imaging device 12. In the presence of multiple "server addresses," multiple URIs can be generated (each URI corresponding to multiple addresses). The "DI," serving as the "interface ID," is set, for example, according to the type of imaging device 12 to which information is being obtained. Multiple URIs can be generated based on the type of requested information. The response receiving unit 63 receives the response corresponding to the request from the requesting unit 62 and sends the received information to the function providing unit 61. For example, the requesting unit 62 generates a URI based on the request and requests information from the data management software that manages information about interfaces 5, 5A, and the imaging device 12 by generating a command C by combining the generated URI with the HTTP method "GET." Furthermore, if the imaging device 12 does not have an interface, data can be sent from the imaging device 12 (which lacks an interface) to the data storage 18 of the data management system 15 via interface 5. For example, data can be sent from the imaging device 12 to the data storage 18 of the data management system 15 via interface 5. In this scenario, an application for data transmission is added to the imaging device 12. This application generates a URI, and a command C, generated by combining the generated URI with the HTTP methods "POST" and "PUT," is used to send data to the interface 5 of the data management system 15. The data sent to the data management system 15 can be obtained by the exception flag display application. Therefore, the request unit 62 generates a URI based on the request content from the function providing unit 61, and requests data transmission from the interface 5 of the data management system 15 by generating a command C, which combines the generated URI with the HTTP method "GET."
[0198] The function providing unit 61 determines, for example, whether to generate an anomaly marker by comparing rules regarding anomaly markers with metadata. The function providing unit 61 generates an anomaly marker if, for example, it determines that the metadata satisfies the rules regarding anomaly markers. The metadata includes information indicating the cell type of the blood cell image of the sample. The function providing unit 61 determines, for example, that the rules regarding anomaly markers are satisfied if, for example, there exists a predetermined number (e.g., "1") of metadata containing information indicating that the cell type of the blood cell image of the sample is a blast cell. The function providing unit 61 displays statistical information and the anomaly marker based on the determination result.
[0199] Application 6 expands the functionality of displaying statistical information and anomaly markers. In Application 6, to differentiate data for each sample, metadata can be associated with identification information about the sample (e.g., sample ID).
[0200] Figure 45 Example 1 illustrates a GUI provided by a function providing unit 61 that displays statistical information and anomaly markers. Function providing unit 61, for example, acquires multiple blood cell images associated with sample identification information A4. Function providing unit 61, for example, displays a list A1 of blood cell images associated with sample identification information A4. Function providing unit 61, for example, groups and displays blood cell images according to the cell classification categories (BL (brood cells), MY (myeloblasts), MMY (metapyeloblasts)) in the blood cell images. Function providing unit 61, for example, identifies the classification category based on the metadata of each blood cell image and groups the blood cell images. Function providing unit 61, for example, displays statistical information A2 based on the metadata corresponding to the multiple blood cell images associated with sample identification information A4. Function providing unit 61, for example, displays the number and proportion of blood cell images classified into multiple classification categories as statistical information A2 based on the classification categories contained in the metadata. In addition to statistical information A2, the function providing unit 61 also displays abnormal markers based on the metadata of each blood cell image, which forms the basis of statistical information A2. Figure 45 In the statistics section A2, an example is shown marked as "Mother cell detected".
[0201] [Examples of application software variations displayed by anomaly markers]
[0202] The following variation is shown: Application 6 is an abnormality marker display application software that further displays hematological test results. The abnormality marker display application software of this variation provides, for example, Figure 46 The diagram shows the display of statistical information A2 and abnormal markers B3, and further displays the function of the hematological test results A3 of the sample measuring device 11.
[0203] Refer again Figure 37 The following describes the various parts of the application software that further displays abnormal markers for hematological test results. The function providing unit 61 requests the request unit 62 to obtain information about the sample measuring device 11 and the imaging device 12, which are managed objects of the integrated display data. For example, the function providing unit 61 requests the request unit 62 to obtain hematological test results obtained by the sample measuring device 11, results of blood cell imaging obtained by the imaging device 12 (e.g., multiple blood cell images, metadata as additional information associated with each of the multiple blood cell images), and attribute information about the examinee. In the case of multiple sample measuring devices 11 and imaging devices 12, for example, the request unit 62 can request the device ID and the name of each of the multiple sample measuring devices 11 and multiple imaging devices 12.
[0204] The request unit 62 generates a URI based on the request content from the function providing unit 61, and requests information from interfaces 5 and 5A by generating a command C by combining the generated URI with the HTTP method "GET". The URI generated by the request unit 62, when retrieving information about the sample measuring device 11, is, for example, "http: / / 127.0.0.1:8080 / XR / / XXXX". In this example URI, the "server address" is specified as "127.0.0.1:8080", the "interface ID" is specified as "XR", the "device ID" is not specified, the "resource" is specified as "XXXX", and the "query parameters" are not specified. "XXXX" is the API endpoint corresponding to information about the sample measuring device 11 (e.g., information about the type of sample measuring device 11, patient measurement data obtained by the sample measuring device 11, etc.). The "server address" "127.0.0.1:8080" is, for example, the address corresponding to interface 5A of the data management system 15 that manages information about the sample measuring device 11. In the presence of multiple "server addresses," multiple URIs can also be generated (each URI corresponding to multiple addresses). The "XR" as the "interface ID" is set, for example, according to the type of sample measuring device 11 to which information is obtained. Multiple URIs can be generated based on the type of information requested. Similarly, the URI generated by the request unit 62, when obtaining information about the imaging device 12, is, for example, "http: / / 128.0.0.1:8080 / DI / / YYYY". In this example URI, the "server address" is specified as "128.0.0.1:8080", the "interface ID" is specified as "DI", the "device ID" is not specified, the "resource" is specified as "YYYY", and the "query parameters" are not specified. "YYYY" is the API endpoint corresponding to information about the imaging device 12 (e.g., information about the type of imaging device 12, imaging data of the patient obtained by the imaging device 12, etc.). The "server address" "128.0.0.1:8080" is, for example, the address corresponding to the interface of a data management system that manages information about the imaging device 12. In the presence of multiple "server addresses," multiple URIs can be generated (each URI corresponding to multiple addresses). The "DI," serving as the "interface ID," is set, for example, according to the type of imaging device 12 to which information is being acquired. Multiple URIs can be generated depending on the type of information requested. The response receiving unit 63 receives the response corresponding to the request from the requesting unit 62 and delivers the received information to the function providing unit 61. For example, the requesting unit 62 generates a URI based on the request and requests information from interface 5 and / or 5A by combining the generated URI with the HTTP method "GET" to generate command C.
[0205] The function providing unit 61 provides the following functions: displaying statistical information and abnormal markers, and further displaying the obtained hematological test results.
[0206] Figure 46 Example 2 illustrates the provision of a GUI implemented by the function providing unit 61. Example 2 is an example of comprehensively displaying statistical information, abnormality markers, and hematological examination results. For example, the function providing unit 61 acquires multiple blood cell images associated with sample identification information A4. For example, the function providing unit 61 displays a list A1 of blood cell images associated with sample identification information A4. For example, the function providing unit 61 groups and displays blood cell images according to the cell classification categories (BL (blastocysts), MY (myeloblasts), MMY (metapyeloblasts)) in the blood cell images. For example, the function providing unit 61 identifies the classification category based on the metadata of each blood cell image and groups the blood cell images. For example, the function providing unit 61 displays statistical information A2 based on the metadata corresponding to the multiple blood cell images associated with sample identification information A4. For example, the function providing unit 61 displays the number and proportion of blood cell images classified into multiple classification categories as statistical information A2 based on the classification categories contained in the metadata. In addition to statistical information A2, the function providing unit 61 also displays anomaly markers B3. For example, the function providing unit 61 acquires hematological test results A3 associated with sample identification information A4, and displays the hematological test results A3, a list of blood cell images A1, statistical information A2, and anomaly markers B3 together. The hematological test results A3, for example, include CBC (Complete Blood Count) results and results regarding white blood cell differential count.
[0207] By adding application 6 to the system, the display can be expanded. Figure 46 The example GUI demonstrates functionality. To utilize data within this system, it's necessary to differentiate the data used for each sample. For instance, metadata from blood cell images and hematological examination results can each be associated with identification information about the sample (e.g., sample ID). In this case, it's possible to display statistical information, anomaly markers, and hematological examination results associated with the identification information of the same sample.
[0208] [Example of data structure in data storage]
[0209] Figure 47This is a diagram illustrating an example data structure when the database storage 18 or storage unit 74 is a relational database. As shown in the diagram, the information managed by the data storage 18 or storage unit 74 includes data associated with "sample identification information," such as "hematological test results" and "blood cell images," where the "hematological test results" are acquired by the sample measuring device 11 and the "blood cell images" are acquired by the imaging device 12. The "blood cell image" is associated, for example, with an "image ID" and "meta-information" used to identify the "blood cell image." The "meta-information" includes, for example, the classification category of the cells contained in the blood cell image; a label about the cell (e.g., a label indicating that the cell is an abnormal cell); annotations from the laboratory technician who classified the cell; the date the blood cell image was captured; and information about the scale / size of the cells contained in the blood cell image (e.g., a scale / size preset according to the classification category). Interfaces 5 and 5A, for example, specify the blood cell image and meta-information of the object to be used based on the sample identification information and / or image ID. Application 6 generates statistical information, for example, based on the meta-information associated with the sample. The statistical information can be as follows: Figure 47 The example shown is stored in data memory 18 or storage unit 74. For example, the data management software 4 of imaging device 12 can generate statistical information based on blood cell images captured for the sample and metadata, and store it in data memory 18 or storage unit 74. In this case, application 6 can obtain the statistical information stored in data memory 18 or storage unit 74 and display the obtained statistical information. Application 6 can provide functions for correcting the metadata of the blood cell images. For example, application 6 can... Figure 46The GUI shown in the example provides functionality for changing the cell classification category contained in a blood cell image. In response to changing the cell classification category via the GUI, application 6 updates the metadata of data storage 18 and / or storage unit 74, for example, via interface 5 or 5A. Application 6 can, for example, provide the following functionality: displaying blood cell images acquired via interface 5 or 5A together with reference images. Application 6, for example, refers to metadata corresponding to multiple acquired blood cell images and groups and displays the blood cell images according to the cell classification category. Application 6, for example, displays reference images corresponding to the classification category of the group in the grouped display area. Application 6, for example, provides reference images based on the classification category. The reference image is, for example, an image serving as a reference for cells corresponding to the classification category (e.g., in the case of "neutrophils: Neutrophil"), the reference image is a blood cell image of neutrophils as a typical example. Application 6 can, for example, display a scale as an indicator of the size of the cells contained in the blood cell image. Application 6, for example, displays the scale with reference to metadata. Meta-information may include, for example, information representing pre-set scales / sizes based on the cell classification categories in a blood cell image. Application 6, for example, displays a ruler based on the scale / size information contained in the meta-information. Application 6, for example, in... Figure 46 The example GUI may provide functionality for operators to register information indicating that the displayed hematological test results and / or blood cell images have been verified. Hematological test results may include, for example, the number / proportion of blood cells (e.g., the number / proportion of white blood cells), blood cell classification and the number / proportion of each classification, histograms, and scatter plots.
[0210] "Subject attribute information" can be associated with identification information about the sample. "Subject attribute information" may include, for example, the subject's gender, age, medical department, medical record information about diagnosis and medical history, etc.
[0211] The data storage unit 18 or storage unit 74 can store the "meta-information ID" inherent to the meta-information in association with the meta-information. In the case of acquiring, for example, meta-information of a blood cell image, application 6 can request the required meta-information from interface 5 and / or 5A based on the meta-information ID. By making a request based on the meta-information ID, application 6 can, for example, specify any meta-information from multiple meta-information related to sample identification information and make a request.
[0212] Hematological test results may include, for example, values relating to the number of each cell type selected from at least one of the following: red blood cells, nucleated red blood cells, microcytes, platelets, hemoglobin, reticulocytes, promyelocytes, neutrophils, eosinophils, basophils, lymphocytes, and monocytes; values relating to the ratio of each cell type selected from at least one of the following: red blood cells, nucleated red blood cells, microcytes, platelets, hemoglobin, reticulocytes, promyelocytes, neutrophils, eosinophils, basophils, lymphocytes, and monocytes; and values relating to at least one of the following: hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and mean platelet volume (MPV). Hematological test results may include scatter plots and histograms (e.g., frequency distribution plots for red blood cells, frequency distribution plots for white blood cells, etc.).
[0213] The results of blood cell imaging include the following markers, which indicate that the cells contained in each blood cell image may contain abnormal cells. Markers for abnormal cells may include, for example, values associated with at least one selected from abnormal nuclear morphology, granular abnormalities, abnormal cell size, cell malformation, cell destruction, vacuolation, immature myelocytes, presence of inclusion bodies, Dohlebodies, satellite phenomena, abnormal nuclear network, petal-like nuclei, high N / C ratio, bubble-like appearance, smudge cells, and hairy cell-like morphology. Abnormal nuclear morphology may include at least one selected from over-lobulation, under-lobulation, pseudo-Pelig-Huet nuclear abnormalities, ringed nuclei, spherical nuclei, elliptical nuclei, apoptosis, multinucleation, nuclear collapse, enucleation, naked nuclei, irregular nuclear margins, nuclear fracture, internuclear bridges, multiple nuclei, notched nuclei, mitotic figures, and nucleosome abnormalities. Particle abnormalities can include at least one selected from degranulation, abnormal particle distribution, toxic particles, Auer bodies, Faggot cells, and pseudo-Chediak-Higashi granular particles. Furthermore, markers indicating that cells in the blood cell images contained in the blood cell imaging results are abnormal cells can be added as additional metadata related to the blood cell images.
[0214] The classification results of multiple blood cell images included in the blood cell imaging results, categorized according to each cell attribute, can be classification results based on cell type or morphological classification results. Morphological classification of cells can include: values related to the quantity of each type of cell selected from at least one cell type among neutrophils, eosinophils, platelets, lymphocytes, monocytes, basophils, metamyelocytes, myeloblasts, promyelocytes, blast cells, plasma cells, atypical lymphocytes, juvenile eosinophils, juvenile basophils, nucleated erythrocytes, and megakaryocytes; and values related to at least one of the following ratios: the ratio of each type of cell selected from at least one cell type among neutrophils, eosinophils, platelets, lymphocytes, monocytes, basophils, metamyelocytes, myeloblasts, promyelocytes, blast cells, plasma cells, atypical lymphocytes, juvenile eosinophils, juvenile basophils, nucleated erythrocytes, and megakaryocytes. The classification of multiple blood cell images can be performed by the operator on the application software, or automatically using mechanical classification and artificial intelligence algorithms. Furthermore, the operator can reclassify the results of the initial classification in the imaging device 12 using the application software.
[0215] The classification results (statistical information) can be corrected, for example, based on manual or automatic correction of the metadata.
[0216] [Application software processing flow]
[0217] To construct Example 1 (refer to) Figure 4 Taking the following example, the data management software of the data management system 15 collects data including the imaging results obtained by the imaging device 12. For example, the data management software of the data management system 15 collects data from the imaging device 12 that correlates the results of blood cell imaging with identification information about the sample. Furthermore, it can collect statistical information and data related to abnormal markers and identification information about the sample. Further, the data management software of the data management system 15 can collect data including the hematological examination results obtained by the sample measuring device 11. For example, the data management software of the data management system 15 can collect data from the sample measuring device 11 that correlates the hematological examination results with identification information about the sample.
[0218] Next, application 6 of terminal device 101 displays the data collected by the data management software of data management system 15 on the display unit of terminal device 101. The data displayed on the display unit of terminal device 101 is, for example, data related to imaging results and identification information about the sample. Figure 45This example shows a GUI (Graphical User Interface) that displays data associated with each of the blood cell images, statistics, and anomaly markers, along with identification information about the sample (sample ID). Figure 45 In this system, blood cell images are grouped and displayed according to each taxonomic category (e.g., BL (blast cells), MY (myeloblasts), MMY (metapyeloblasts), VLY (atypical lymphocytes)). The display can show several to hundreds of images, ranging from single images to a single image stitched together from multiple images. Users can enter arbitrary annotations in the display area for anomaly markers.
[0219] Figure 48 A flowchart illustrating an example of the processing flow of application software 6 on terminal device 101. Figure 48 In this process, the application software 6 of the terminal device 101 collects data including the results of imaging the smear obtained by the imaging device 12 (S11). The collected data may include hematological test results. The application software 6 collects data, for example, from the data management system 15. The application software 6 generates statistical information based on the collected data (S222). The application software 6 may, for example, collect statistical information generated by the data management system 15. The application software 6 of the terminal device 101 displays statistical information and anomaly markers for each sample ID (S333). The application software 6 can display statistical information, anomaly markers, and hematological test results. In addition, the application software 6 can, as Figure 45 As in the example, it displays imaging results, statistical information, and anomaly markers. Furthermore, application software 6 can, as... Figure 46 As shown in the example, it displays imaging results, statistics, abnormal markers, and hematological test results.
[0220] Figure 49 It means Figure 48 A flowchart detailing the processing flow. Application software 6 of terminal device 101 collects data including imaging results of smears (S11). The collected data may include hematological examination results. Application software 6 collects data, for example, from data management system 15. Application software 6 generates statistical information based on the collected data (S222). Application software 6 may, for example, collect statistical information generated by data management system 15. Application software 6 compares metadata contained in the collected data with rules regarding anomaly marking (S1001). Rules regarding anomaly marking are, for example, pre-set in application software 6. Rules regarding anomaly marking can be set by the user of application software 6. For example, through... Figure 50 The example GUI allows users to set rules. For example, the content displayed in exception marker B3 is set to... Figure 50 The "standard document". Rules for anomaly marker detection, for example, are provided by... Figure 50 The settings are configured using combinations of "Item," "Symbol," and "Value." For example, each of the "Item," "Symbol," and "Value" settings is based on the options displayed in the dropdown menu. Figure 50 In the example, "item" is the object to be judged for anomaly labeling, "symbol" is the comparison operator used for judgment, and "value" is the threshold used for judgment. These combinations are used to set rules regarding anomaly labeling. Users... Figure 50 Press the "OK" button in the settings screen, and the rule will be set in the application software 6 of the terminal device 101. Figure 50 In the example, the phrase displayed as an anomaly marker is "Mother cells detected," and the rule for the anomaly marker is "Mother cell percentage exceeds 0%." Figure 50 In the example rule shown, if the image of blood cells containing cells classified as blast cells accounts for 0.1% of the total image based on the metadata, the application software 6 of the terminal device 101 determines that the rule meets the requirement. Figure 50 The example rule is "the proportion of mother cells exceeds 0%". Based on the rule-based determination, the application software 6 of the terminal device 101 generates anomaly markers (S2001) and displays statistical information and anomaly markers for each sample ID (S333). The statistical information and anomaly markers are, for example, as shown in... Figure 45 That's how it's displayed. Furthermore, in S1001, the rules regarding anomaly markers are compared with the metadata. If it's determined that the rules regarding anomaly markers are not met, no anomaly marker is generated; for example, only statistical information is displayed in the GUI.
[0221] The application software 6 of the terminal device 101 can be as follows: Figure 51 As in the example, anomaly markers are generated by utilizing rules corresponding to the "level" of the judgment objects that are anomaly markers. The "level" is, for example, an indicator corresponding to the number of judgment objects with anomaly markers detected in a blood cell image, the proportion of blood cell images containing judgment objects with anomaly markers, etc. For example, the "level" is determined by multiple indicators based on the amount of cells containing judgment objects with anomaly markers. The "level" is, for example, represented as "0", "1+", "2+", "3+". For example, the amount of judgment objects with anomaly markers increases in the order of "0", "1+", "2+", "3+". The correspondence between the amount of judgment objects with anomaly markers and the "level" is, for example, pre-set in application software 6. The correspondence between the amount of judgment objects with anomaly markers and the "level" can, for example, be set by the user. Application software 6 can, for example, set rules based on a combination of "level" and "item" / "symbol". Figure 51 The example shows an instance of the following rule setting: setting the anomaly marker to anisocytosis (unequal red blood cell sizes). Figure 51The following example is shown: When the "Level" is "1+" or higher, anomaly markers are generated regarding unequal red blood cell sizes. For example, a user in... Figure 51 Press the "OK" button in the settings screen, and the rule will be set in the application software 6 of the terminal device 101. Figure 52 This shows an example of the imaging results using "level". In Figure 52 In the example, the level of unequal red blood cell sizes is "1+", which is... Figure 51 The example rule generates anomaly markers for unequal red blood cell sizes. Figure 52 In the image obtained by imaging a smear, the blood cell image A1 containing red blood cells is displayed at a magnification that makes it easy to grasp the morphological characteristics of the red blood cells, such as size, color, and shape, as well as an overview of the field of view.
[0222] Figure 53 It means Figure 48 The flowchart of a variant example. In Figure 49 In the example, application software 6 is able to change the displayed content in response to GUI operations. Figure 53 In step S4444, following step S4444, application software 6 displays an additional screen related to attribute selection (S5555). The attribute of the blood cell image is, for example, the cell classification category. Application software 6 can, for example, display the relevant hematological test results as an additional screen based on the selected classification category. Figure 54 as well as Figure 55 Is with Figure 53 Example 4 provides a GUI corresponding to the flowchart. It displays statistical information A2, abnormality markers B3, and hematological test results A3. Figure 54 In the image shown, as Figure 55 As shown, when the selection of an attribute (categorization type represented by a thick box: BL (mother cell)) contained in statistical information A2 is received (S4444), the blood cell image A1 related to the selection of the attribute (BL (mother cell)) is displayed as an additional screen (S5555). The application software 6 can, for example, emphasize the display of the selected attribute (e.g., cell classification type) compared to the display of unselected attributes. As an example of emphasis, the selected classification type can be displayed in a square frame or in a color that distinguishes it from the display of unselected classification types. The operation of selecting an attribute includes at least one of mouse operation, touch panel operation, and sound operation. Figure 56 as well as Figure 57 Example 5 shows the provision of a GUI. Figure 56 as well as Figure 57As shown, a first region B1 displays statistics by each attribute (e.g., each classification category) and displays anomaly marker B3, and a second region B2 displays multiple blood cell images. In response to the selection of an attribute (the part indicated in bold), hematological test results A3 related to the selection of the attribute can be displayed as an additional screen. Figure 58 Example 6 illustrates the provision of a GUI. Figure 58 As shown, for example, it can display a first region B1 that displays statistical information A2 and abnormal markers B3 and a second region B2 that displays blood cell images A1, and in response to the selection of attributes (e.g., the classification category indicated by a thick box: BL (breast cells)), it can display a scatter plot contained in the hematological test results A3 related to the selection of the attribute (e.g., a scatter plot of cell populations representing Blasts (breast cells) appears). Figure 59 Example 7 provides a GUI. In the GUI of Example 7, an image A1 of blood cells showing confirmed platelet aggregation, an abnormality marker B3 (e.g., "Platelet aggregation detected"), and statistical information A2 are displayed. In the GUI of Example 7, for example... Figure 59 As shown, the number of non-leukocytes can be displayed as statistical information A2, categorized by cell type. Figure 59 In the image, non-leukocyte cell types are displayed, such as nucleated red blood cells, giant platelets, large platelets, platelet aggregates, smear cells, artifacts, and megakaryocytes. The number of platelet aggregates included in the statistical information A2 can, for example, represent an aggregate of five or more platelets as a single platelet aggregate. In the GUI provided in Example 7, a digital slide can be displayed alongside the blood cell images, which simulates the locations where the blood cell images were captured on the smear 120 by the imaging device 12. Figure 59 The digital slides shown use white dots to represent platelet aggregations (e.g., aggregates of five or more platelets) in a blood cell image detected by imaging device 12. By reviewing the digital slides, the operator can determine, for example, whether the platelet aggregations in the blood cell image are located on the top / bottom or left / right side of the smear 120.
[0223] In the past, in the imaging device 12, the operator verified whether the obtained results could be output for diagnostic purposes. A marker indicating whether the operator has verified the results of the captured blood cells can also be displayed as reference information when confirming the results on the application software.
[0224] [Example of providing application software functionality as a Web service]
[0225] Application 6 is not limited to being provided as standalone software running on terminal device 101 and sample measuring device 11, but can also be provided as a web service.
[0226] Figure 38 This diagram illustrates a configuration example where the functionality of application 6 is provided as a Web service. In this configuration example, the sample measurement system 1 includes a sample measurement device 11 equipped with a web browser 8, and a Web service system 301 connected to the sample measurement device 11 via a communication network 205. The communication network 205 is, for example, the Internet. The sample measurement device 11 includes a measurement unit 2 and a control unit 7 having execution control software 3, data management software 4, an interface 5, and a processor 71 with a web browser 8.
[0227] Web service system 301 includes a control unit 302 equipped with a processor for executing a service function providing unit 6A that functions as a Web service. The service function providing unit 6A has the same functions as application 6. The service function providing unit 6A includes, for example, a function providing unit 61A, a request unit 62A, and a response receiving unit 63A. The function providing unit 61A, request unit 62A, and response receiving unit 63A each have the same functions as the function providing unit 61, request unit 62, and response receiving unit 63, respectively.
[0228] In this configuration example, by accessing the service function provision unit 6A, which functions as a Web service, via the web browser 8 of the sample measuring device 11, information and functions can be utilized through the interface 5 of the sample measuring device 11.
[0229] Figure 39 This illustrates another configuration example where the functionality of application 6 is provided as a Web service. In the configuration example shown in this figure, the sample measurement system 1 is configured to consist of a sample measurement device 11, a Web service system 301, a data management system 15, and a terminal device 101 equipped with a web browser 8 connected via a communication network 205.
[0230] In this configuration example, by accessing the service function provision unit 6A, which functions as a Web service, via the web browser 8 of the terminal device 101, information managed by the data storage 18 can be utilized through the interface 5A of the data management system 15.
[0231] Figure 40 This illustrates another further example of providing the functionality of application 6 as a Web service. In the example shown in the figure, the sample measurement system 1 is configured to consist of a sample measurement device 11, a Web service system 301, and a terminal device 101 equipped with a web browser 8 connected via a communication network 205.
[0232] In this configuration example, by accessing the service function provisioning unit 6A, which functions as a Web service, via the web browser 8 of the terminal device 101, information and functions can be utilized through the interface 5 of the sample measuring device 11.
[0233] [Application software delivery methods]
[0234] The provision format of application 6 is explained. Figure 41 This describes an example of the configuration of an application providing server 401 that provides application 6. The application providing server 401 is configured in the cloud, for example, and communicatively connected to the terminal device 101 and the control unit 7 via a communication network. The terminal device 101 and the control unit 7 are, for example, smartphones (iPhones, Android terminals), tablet computers (iPads, Android tablets, Windows tablets), Windows PCs running Windows OS, and Macs running Mac OS. The application providing server 401 includes: a control unit 402 equipped with a processor that executes a download request receiving unit 403 and an application providing unit 404; and an application memory 405 storing application 6.
[0235] The operator of the terminal device 101 and the control unit 7 may log in to the designated download application software (such as the App Store, Google Play Store, Windows Store) using an account ID (such as Apple ID, Google account, Microsoft account, etc.) managed by the application software provider, and request the application 6 to be downloaded from the application provider server 401 through the download application software.
[0236] The download request receiving unit 403, for example, notifies the application providing unit 404 of information about the requested application 6. The application providing unit 404 searches for and retrieves the notified application 6 from the application memory 405 and sends it to the requesting source (terminal device 101 or control unit 7). The application providing unit 404 may, for example, send the installation program of application 6 to the requesting source (terminal device 101 or control unit 7). The terminal device 101 or control unit 7, upon receiving the installation program, installs application 6 based on the installation program.
[0237] The application provider server 401 can support multiple platforms (e.g., Windows, macOS, iOS, Android). Furthermore, multiple application provider servers 401 can exist depending on the platform. For example, there could be an application provider server 401 providing application 6 for iOS (e.g., the App Store), an application provider server 401 providing application 6 for Android (e.g., Google Play), and an application provider server 401 providing application 6 for Windows (e.g., the Microsoft Store). In this case, the terminal device 101 and the control unit 7 request the provision of application 6 according to a platform-specific method.
[0238] A terminal device 101 running iOS and a control unit 7, for example, request an application server 401 providing iOS application 6 to download the desired application 6 found by a specified download application software (such as the App Store). Similarly, a terminal device 101 running Android OS and a control unit 7, for example, request an application server 401 providing Android application 6 to download the desired application 6 found by a specified download application software (such as the Google Play Store). Furthermore, a terminal device 101 running Windows OS and a control unit 7, for example, request an application server 401 providing Windows application 6 to download the desired application 6 found by a specified download application software (such as the Microsoft Store).
[0239] Depending on the medical facility, examination room, etc., it is also possible to assume that the terminal device 101 and control unit 7 are not connected to the Internet. In this case, for example, maintenance personnel can copy the installation program (e.g., CD / DVD / USB memory / external HDD / SSD) containing the installation program of application 6 to the terminal device 101 and control unit 7, and install application 6 on the terminal device 101 and control unit 7.
[0240] Depending on the medical facility and examination room, terminal device 101 and control unit 7 may only be allowed to communicate with the outside world within a secure communication network (e.g., VPN: Virtual Private Network). In this case, for example, application 6 may be published from a server capable of setting up a secure communication network with terminal device 101 and control unit 7. Figure 42 This illustrates a configuration example of providing application 6 within a secure communication environment. Furthermore, the secure communication environment includes an environment where the file distribution server 501 is located within the facility's internal network and can be accessed from the terminal device 101 and the control unit 7 via the internal network.
[0241] The file distribution server 501 includes a processor that executes the communication unit 502 and the information providing unit 503, and a memory 504 that stores data required for the installation of application 6 (e.g., the installer or the configuration file of application 6). The communication unit 502 may have, for example, VPN server functionality. The information providing unit 503 may have, for example, web server functionality.
[0242] The terminal device 101 and the control unit 7 have processors that execute the communication client unit 91 and the information acquisition unit 92. The communication client unit 91 has, for example, a VPN client function and establishes a secure communication network 206 between itself and the communication unit 502. The information acquisition unit 92 is, for example, a web browser.
[0243] The information acquisition unit 92 of the terminal device 101 and the control unit 7 accesses the information provision unit 503 of the file publishing server 501 via the secure communication network 206. The information provision unit 503 provides, for example, data that the terminal device 101 and the control unit 7 can download to the information acquisition unit 92. The information acquisition unit 92 displays this data via a web page. The operator of the terminal device 101 and the control unit 7 selects the data they wish to download on this web page, and the information provision unit 503 retrieves the corresponding data from the memory 504 and sends it to the information acquisition unit 92. The information acquisition unit 92 installs application 6 based on the acquired data.
[0244] Terminal device 101 and control unit 7 can download the installation program of application 6 via the Internet and use the installation program to install application 6.
[0245] [Web Editing]
[0246] Application 6 can provide the functionality of a web clip (a shortcut to a website) to terminal device 101 and control unit 7. The service provider, for example, notifies terminal device 101 and control unit 7 of the URL (Uniform Resource Locator) to be accessed as the web clip. The operator of terminal device 101 and control unit 7, for example, bookmarks the notified URL as a web clip on the main screen or desktop of terminal device 101 and control unit 7. The operator of terminal device 101 and control unit 7, for example, can access the service provider's website using a web browser installed on terminal device 101 and control unit 7, and access a menu from that website that provides the required services, bookmarking the website in that menu as a web clip.
[0247] System configuration examples for using Web clipping to leverage the functionality of application 6 and Figures 38-40 Similarly. Figure 38 In the illustrated configuration example, the service function provision unit 6A, which operates by accessing a web service via a URL specified by a web clip through the web browser 8 of the control unit 7, can utilize information and functions via the interface 5 of the sample measuring device 11. Similarly, in Figure 39 In the illustrated configuration example, the service function provisioning unit 6A, which operates by accessing a web service via a URL specified by a web clip through a web browser 8 of the terminal device 101, can utilize information managed by the data storage 18 via the interface 5A of the data management system 15. Similarly, in Figure 40In the configuration example shown, the service function providing unit 6A, which operates by accessing a web service as a URL specified by a web clip via the web browser 8 of the terminal device 101, can utilize information and functions through the interface 5 of the sample measuring device 11.
[0248] [Using MDM / MAM to provide application software]
[0249] Application 6 can also be provided without going through a designated application software provider (such as the Apple Store, Google Play Store, or Microsoft Store). For example, application 6 can be provided to terminal device 101 and control unit 7 without going through a designated application software provider by using MDM (Mobile Device Management) or MAM (Mobile Application Management) mechanisms.
[0250] Figure 43 This illustrates a configuration example of application 6 provided using an MDM or MAM. Terminal device 101 and control unit 7 are communicatively connected to the MDM / MAM system 601 via communication network 207. Terminal device 101 and control unit 7 are registered in the MDM / MAM system 601 and managed by the MDM / MAM system 601 according to a management policy. For the MDM / MAM system 601 to manage terminal device 101 and control unit 7, a management profile is installed in terminal device 101 and control unit 7, for example. For example, terminal device 101 and control unit 7 are notified (e.g., via email) of information for installing the management profile (e.g., a URL for downloading the installation program).
[0251] When the management description file is installed in the terminal device 101 and the control unit 7, the terminal device 101 and the control unit 7 are registered in the MDM / MAM system 601, and information about the terminal device 101 and the control unit 7 is registered in the database 604 of the MDM / MAM system 601.
[0252] The MDM / MAM execution unit 603 obtains information about the application 6 installed on the terminal device 101 and the control unit 7, and registers it in the application list of the database 604. The MDM / MAM execution unit 603 can distribute the application 6 to the terminal device 101 and the control unit 7. The terminal device 101 and the control unit 7 install the distributed application 6. Thus, the application 6 can be provided without going through a designated application software provider (such as the App Store).
[0253] The management function providing unit 602 provides management functions for the terminal device 101 and control unit 7 for the MDM / MAM management terminal 701. For example, the management function providing unit 602 provides a website for managing the terminal device 101 and control unit 7 for the MDM / MAM management terminal 701. Through this website, the operator of the MDM / MAM management terminal 701 can, for example, register and change management policies for the terminal device 101 and control unit 7, publish application 6 to the terminal device 101 and control unit 7, and manage the application 6 installed on the terminal device 101 and control unit 7.
[0254] Figure 44 This is a diagram illustrating an example data structure of Database 604 when it is a relational database. As shown in the diagram, the information managed by Database 604 includes, for example, user identification information, organization affiliation, device type, device identification information, policies, and an application list.
[0255] User identification information is information used to identify the user of the terminal device 101 and the control unit 7. Examples include the user's ID assigned by the MDM / MAM system 601, the user's name, and combinations thereof.
[0256] The organization to which the terminal device 101 and control unit 7 belong is the organization's identification information. For example, it may be the organization's ID, organization name, or a combination thereof assigned to the organization by the MDM / MAM system 601.
[0257] Device type is information used to identify the device platform. For example, it could be iOS, Android, Windows, or Mac.
[0258] Device identification information is the inherent identification information of the terminal device 101 and control unit 7, which are managed objects in the MDM / MAM system 601. For example, it is IMEI (International Mobile Equipment Identifier), serial number, SIM (Subscriber Identity Module) card number, telephone number, MAC (Media Access Control) address, and combinations thereof.
[0259] The policy is a management policy implemented by the MDM / MAM system 601. For example, it includes the configuration information for the management policy.
[0260] The application list contains information about application 6 installed on the terminal device 101 and control unit 7 corresponding to the user identification information. For example, it may be a list describing the identification information (application software name, application software ID) and version of application 6.
[0261] This invention is not limited to the embodiments described above. Various modifications can be made within the scope of the claims. Embodiments that appropriately combine the technical means disclosed in different embodiments are also included within the technical scope of this invention.
[0262] (Postscript)
[0263] From the above embodiments, the inventions involved in the following technical solutions can be extracted.
[0264] (Technical Solution 1)
[0265] A system includes a measurement unit for measuring a sample and an imaging unit for imaging blood cells in the sample.
[0266] The system includes:
[0267] First control software that controls the measurement unit;
[0268] First data management software for managing first data about the measurement unit;
[0269] Second control software for controlling the imaging unit;
[0270] Second data management software for managing second data, the second data including blood cell images obtained by the imaging unit capturing blood cells from a sample, and metadata of the blood cell images; and
[0271] An interface is provided to enable application software that can be added to the system to utilize the first data and the second data.
[0272] The interface enables the application software to utilize the second data, which includes the metadata regarding the classification of the blood cells.
[0273] By adding the application software to the system, the functionality of the system is expanded, which displays statistical information based on multiple metadata for each classification category, and displays anomaly markers for the samples based on the multiple metadata.
[0274] (Technical Solution 2)
[0275] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and identification information about the sample.
[0276] (Technical Solution 3)
[0277] According to the system of technical solution 1, wherein the interface enables the application software to use the second data associated with the plurality of blood cell images and the plurality of metadata with identification information about the sample.
[0278] (Technical Solution 4)
[0279] According to the system of technical solution 1, wherein the interface enables the application software to associate the plurality of metadata, the plurality of blood cell images, and the plurality of image IDs that distinguish each of the plurality of blood cell images with the second data associated with identification information about the sample.
[0280] (Technical Solution 5)
[0281] According to the system of technical solution 1, wherein the interface enables the application software to utilize the hematological test results of the sample, a plurality of blood cell images, the first data and the second data, each of the plurality of metadata being associated with identification information about the sample.
[0282] (Technical Solution 6)
[0283] According to the system of technical solution 1, wherein the interface enables the application software to use the first data and the second data associated with the identification information of the sample, respectively, the plurality of blood cell images, the plurality of metadata, the hematological test results of the sample, and information about the subject's attributes.
[0284] (Technical Solution 7)
[0285] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the identification information about the sample, each of the plurality of blood cell images, the plurality of metadata, and platelet information based on the metadata.
[0286] (Technical Solution 8)
[0287] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0288] The application software extends the functionality of the system to display the anomaly marker based on the result of comparing pre-set rules with the results of the multiple metadata.
[0289] (Technical Solution 9)
[0290] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0291] The application software extends the functionality of the system to display the anomaly marker based on the results of comparing multiple pre-set rules with multiple metadata.
[0292] (Technical Solution 10)
[0293] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0294] The application software extends the functionality of the system to display the anomaly marker based on the result of comparing the statistical information with a rule based on a threshold used for comparing the statistical information.
[0295] (Technical Solution 11)
[0296] According to the system described in technical solution 1, wherein the interface enables the application software to associate the multiple metadata, the multiple blood cell images, and the multiple image IDs that distinguish each of the multiple blood cell images with the second data associated with the identification information about the sample.
[0297] The application software extends the functionality of the system, which, in response to the selection of a classification category for the statistical information, displays a blood cell image related to the selection of the classification category.
[0298] (Technical Solution 12)
[0299] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data associated with the plurality of blood cell images and the plurality of metadata with identification information about the sample.
[0300] The application software expands the functionality of the system to display the blood cell image associated with the abnormal marker.
[0301] (Technical Solution 13)
[0302] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data associated with the plurality of blood cell images and the plurality of metadata with identification information about the sample.
[0303] The application software expands the functionality of the system to display blood cell images associated with the abnormal markers indicating the presence of blast cells.
[0304] (Technical Solution 14)
[0305] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data associated with the plurality of blood cell images and the plurality of metadata with identification information about the sample.
[0306] The application software expands the functionality of the system to display blood cell images associated with the abnormal markers indicating the presence of platelet aggregation.
[0307] (Technical Solution 15)
[0308] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data, which associates the plurality of metadata and the plurality of blood cell images with identification information about the sample.
[0309] The application software expands the functionality of the system, highlighting information related to the anomaly markers in the statistical information.
[0310] (Technical Solution 16)
[0311] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0312] The application software is used to extend the function of receiving settings for rules regarding the anomaly markers, thus serving as a function of the system.
[0313] (Technical Solution 17)
[0314] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data, which associates the plurality of metadata and the plurality of blood cell images with identification information about the sample.
[0315] The application software extends the functionality of modifying statistical information based on the correction of the metadata, thus serving as functional metadata for the system.
[0316] (Technical Solution 18)
[0317] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data, which associates the plurality of metadata and the plurality of blood cell images with identification information about the sample.
[0318] The system's function is to extend the display of reference images as comparison objects for cells contained in the blood cell image through the application software.
[0319] (Technical Solution 19)
[0320] According to the system of technical solution 1, wherein the interface enables the application software to utilize the second data, which associates the plurality of metadata and the plurality of blood cell images with identification information about the sample.
[0321] The application software is used to extend the function of displaying a scale representing the size index of the cells contained in the blood cell image, which is a function of the system.
[0322] (Technical Solution 20)
[0323] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0324] The application software expands the functionality of the system to display indicators for each level corresponding to the quantity or proportion of each category, as well as the anomaly markers.
[0325] (Technical Solution 21)
[0326] According to the system of technical solution 1, wherein the interface enables the application software to associate the second data with the plurality of metadata and the identification information about the sample.
[0327] The application software is extended to include the following functionality as part of the system: receiving the setting of rules that use the indicators of each level corresponding to the quantity or proportion of each of the classification categories as thresholds.
[0328] (Technical Solution 22)
[0329] According to the system described in technical solution 1, the interface is based on prescribed rules, enabling the application software to utilize the data.
[0330] (Technical Solution 23)
[0331] According to the system described in technical solution 1, the interface is based on the following rules, enabling the various application software to utilize the data: the data is universal for the various application software that provide different functions.
[0332] (Technical Solution 24)
[0333] According to the system of technical solution 1, the interface responds to a request from the application software and provides a response to the request to the application software.
[0334] (Technical Solution 25)
[0335] According to the system of technical solution 1, the interface is based on commands created by the application software according to prescribed rules, enabling the application software to utilize the data.
[0336] (Technical Solution 26)
[0337] According to the system of technical solution 1, wherein the interface is based on commands created by the application software according to prescribed rules, enabling the application software to utilize at least one of the data related to the measurement unit, the data about the measurement actions performed by the measurement unit, the data about the maintenance of the measurement unit, and the data about the operation of the measurement unit.
[0338] (Technical Solution 27)
[0339] According to the system of technical solution 1, the interface is based on commands created by the application software according to prescribed rules, causing the application software to perform at least one of the following: data acquisition, data registration, data update, and data deletion.
[0340] (Technical Solution 28)
[0341] According to the system described in technical solution 1, the interface is based on the following rules to enable the various application software to utilize the data: it is universal for the various application software that operate on various operating systems.
[0342] (Technical Solution 29)
[0343] According to the system described in technical solution 1, the data management software manages the data based on a classification according to the data type.
[0344] (Technical Solution 30)
[0345] According to the system described in technical solution 1, the interface is based on prescribed rules, enabling the application software to utilize the data.
[0346] The data management software manages the data based on classifications corresponding to the defined rules.
[0347] (Technical Solution 31)
[0348] According to the system described in technical solution 1, the system includes a sample measurement device comprising the measurement unit, the control software, and the data management software.
[0349] The interface is based on multiple defined rules corresponding to the types of sample measuring devices, enabling the application software to utilize the data.
[0350] (Technical Solution 32)
[0351] According to the system described in technical solution 1, the system includes a sample measurement device comprising the measurement unit, the control software, and the data management software.
[0352] The sample measuring device is certified as a medical device.
[0353] (Technical Solution 33)
[0354] According to the system of technical solution 1, the interface enables the application software, which is a non-medical device, to utilize the data.
[0355] (Technical Solution 34)
[0356] According to the system described in technical solution 1, the control software and the data management software are software independent of the application software.
[0357] (Technical Solution 35)
[0358] According to the system of technical solution 1, the measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0359] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0360] The data management software manages the data, which includes measurement results obtained through the actions of the sample processing unit and the detection unit.
[0361] (Technical Solution 36)
[0362] According to the system of technical solution 1, the measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0363] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0364] The data management software manages the data, including measurement results obtained through the actions of the sample processing unit and the detection unit.
[0365] The control software and the data management software are software independent of the application software.
[0366] (Technical Solution 37)
[0367] According to the system of technical solution 1, the measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0368] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0369] The data management software manages the data, including measurement results obtained through the actions of the sample processing unit and the detection unit.
[0370] The control software and the data management software are software independent of the application software.
[0371] The data management software can collaborate with the application software via the interface.
[0372] (Technical Solution 38)
[0373] According to the system described in technical solution 1, the system includes a sample measurement device comprising the measurement unit, the control software, and the data management software.
[0374] The measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0375] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0376] The data management software manages the data, including measurement results obtained through the actions of the sample processing unit and the detection unit.
[0377] The data management software can collaborate with the application software via the interface.
[0378] The measurement unit, the control software, and the data management software are components of a certified medical device.
[0379] The control software and the data management software are software independent of the application software.
[0380] (Technical Solution 39)
[0381] According to the system described in technical solution 1, the system includes a sample measurement device comprising the measurement unit, the control software, and the data management software.
[0382] The measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0383] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0384] The data management software manages the data, including measurement results obtained through the actions of the sample processing unit and the detection unit.
[0385] The data management software can collaborate with the application software via the interface.
[0386] At least a portion of the measurement unit, the control software, and the data management software provides functionality corresponding to the intended use of the sample measurement device as a medical device.
[0387] The functionality of the system is extended by the application software, which provides functionality different from that corresponding to the intended use.
[0388] According to the system of technical solution 1, the measuring unit includes a sample processing unit for preparing a measurement sample based on the sample and reagents, and a detection unit for measuring the prepared measurement sample.
[0389] The control software collaborates with the data management software to control the operations of the sample processing unit and the detection unit.
[0390] The data management software manages the data, which includes measurement results obtained through the actions of the sample processing unit and the detection unit.
[0391] (Technical Solution 40)
[0392] According to the system described in any of technical solutions 35 to 39, the motion control of the sample processing unit and the detection unit implemented by the control software includes at least one of the following controls:
[0393] Control of the suction action of a liquid containing at least one of the sample and the reagent;
[0394] Control of mixing the sample with the reagent to prepare the measurement specimen;
[0395] Control of the detection of the measured sample by the detection unit; and
[0396] The detection unit detects at least one of optical information and electrical signals related to the measurement sample, and interprets the measurement results based on the detected results.
[0397] (Technical Solution 41)
[0398] An application software is used in a system comprising: a measurement unit for measuring a sample; first control software for controlling the measurement unit; first data management software for managing data relating to the measurement unit operating under the control of the control software; an imaging unit for imaging blood cells in the sample; second control software for controlling the imaging unit; and second data management software for managing second data relating to the imaging unit operating under the control of the second control software.
[0399] The application software includes:
[0400] The request unit utilizes the first data and the second data containing metadata in response to an interface request, wherein the metadata includes information metadata representing the classification category of the blood cell image of the sample;
[0401] A response receiving unit receives a response to the request; and
[0402] The function providing unit, as a function to extend the system, provides the following functions: based on the utilization of the first data and the second data, displays statistical information based on multiple metadata for each classification category, and displays anomaly markers for the sample based on the multiple metadata that form the basis of the statistical information.
[0403] (Technical Solution 42)
[0404] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in connection with the interface.
[0405] (Technical Solution 43)
[0406] According to the application software of technical solution 41, the requesting unit requests data associated with the multiple blood cell images and the multiple metadata with identification information about the sample via the interface.
[0407] (Technical Solution 44)
[0408] According to the application software of technical solution 41, the requesting unit requests data associated with the sample identification information using the plurality of metadata, the plurality of blood cell images, and the plurality of image IDs that distinguish each of the plurality of blood cell images.
[0409] (Technical Solution 45)
[0410] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the multiple blood cell images, the multiple metadata, and the hematological examination results of the sample.
[0411] (Technical Solution 46)
[0412] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample, including multiple blood cell images, multiple metadata, hematological test results of the sample, and information about the subject's attributes, in connection with the interface.
[0413] (Technical Solution 47)
[0414] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using multiple blood cell images, multiple metadata, and platelet information based on the metadata.
[0415] (Technical Solution 48)
[0416] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0417] The function provider offers the ability to display the anomaly marker based on the results of comparing pre-set rules with the multiple metadata.
[0418] (Technical Solution 49)
[0419] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0420] The function providing unit provides the function of displaying the anomaly marker based on the multiple metadata compared with multiple pre-set rules.
[0421] (Technical Solution 50)
[0422] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0423] The function providing unit provides a function to display the anomaly marker based on the result of comparing the statistical information with a rule based on a threshold used for comparing the statistical information.
[0424] (Technical Solution 51)
[0425] According to the application software of technical solution 41, the requesting unit requests data associated with the sample identification information using the plurality of metadata, the plurality of blood cell images, and the plurality of image IDs that distinguish each of the plurality of blood cell images.
[0426] The function providing unit provides the function of displaying a blood cell image related to the selection of the classification category in response to the selection of the classification category of the statistical information.
[0427] (Technical Solution 52)
[0428] According to the application software of technical solution 41, the requesting unit requests data associated with the multiple blood cell images and the multiple metadata with identification information about the sample via the interface.
[0429] The function providing unit provides the ability to display the blood cell image associated with the abnormal marker.
[0430] (Technical Solution 53)
[0431] According to the application software of technical solution 41, the requesting unit requests data associated with the multiple blood cell images and the multiple metadata with identification information about the sample via the interface.
[0432] The function providing unit provides the function of displaying blood cell images associated with the abnormal markers indicating the presence of blastocysts.
[0433] (Technical Solution 54)
[0434] According to the application software of technical solution 41, the requesting unit requests data associated with the multiple blood cell images and the multiple metadata with identification information about the sample via the interface.
[0435] The function providing unit provides the function of displaying blood cell images associated with the abnormal markers indicating the presence of platelet aggregation.
[0436] (Technical Solution 55)
[0437] According to the application software of technical solution 41, the requesting unit requests data associated with the plurality of metadata and the plurality of blood cell images and identification information about the sample via the interface.
[0438] The function providing unit provides the function of highlighting and displaying information related to the anomaly marker in the statistical information.
[0439] (Technical Solution 56)
[0440] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0441] The function providing unit provides the function of receiving the settings of the rules regarding the anomaly marker.
[0442] (Technical Solution 57)
[0443] According to the application software of technical solution 41, the requesting unit requests data associated with the plurality of metadata and the plurality of blood cell images and identification information about the sample via the interface.
[0444] The function providing unit provides the function of correcting the statistical information based on the correction of the metadata.
[0445] (Technical Solution 58)
[0446] According to the application software of technical solution 41, the requesting unit requests data associated with the plurality of metadata and the plurality of blood cell images and identification information about the sample via the interface.
[0447] The function providing unit provides the function of displaying a reference image as a comparison object of cells included in the blood cell image.
[0448] (Technical Solution 59)
[0449] According to the application software of technical solution 41, the requesting unit requests data associated with the plurality of metadata and the plurality of blood cell images and identification information about the sample via the interface.
[0450] The function providing unit provides a function to display a scale representing the size index of cells contained in the blood cell image.
[0451] (Technical Solution 60)
[0452] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0453] The function providing unit provides the function of displaying the anomaly markers that reflect the indicators of each level corresponding to the quantity or proportion of each of the said classification categories.
[0454] (Technical Solution 61)
[0455] According to the application software of technical solution 41, the requesting unit requests data associated with the identification information of the sample using the plurality of metadata in response to the interface.
[0456] The function providing unit provides the function of receiving the setting of a rule that uses an indicator corresponding to the quantity or proportion of each of the classification categories as a threshold.
[0457] (Technical Solution 62)
[0458] A sample measurement system capable of measuring samples optically, the sample measurement system comprising:
[0459] A sample measuring device, configured to measure the sample optically, the sample measuring device comprising:
[0460] (i) A sample suction unit configured to suction the sample, the sample suction unit including a nozzle for suctioning the sample in a sample container, a moving mechanism configured to move the nozzle into the sample container, and a pump configured to apply negative pressure to cause the nozzle to suction the sample;
[0461] (ii) A sample preparation unit configured to prepare a measurement sample by mixing the attracted sample and reagent in a container;
[0462] (iii) An optical detection unit configured to detect light from the prepared measurement sample; and
[0463] (iv) A controller configured to control the sample aspiration unit, the sample preparation unit, and the optical detection unit according to control software, so that the sample measuring device measures the sample optically, wherein the sample measuring device analyzes optical information from the detected light in order to obtain measurement results, and manages data about the sample measuring device according to management software, wherein the data includes the measurement results;
[0464] An imaging device is configured to capture images of blood cells in a smear of the sample; and
[0465] A computer capable of running an interface with application software programmed to interact with the data and the images, wherein the application software is independent of the sample measuring device;
[0466] The interface performs the following operations:
[0467] (a) Receive a request from the application software;
[0468] (b) Retrieve an image corresponding to the request according to preset rules, wherein the retrieved image is associated with metadata including morphological features of blood cells; and
[0469] (c) Provide the retrieved image to the application software so that the application software displays (1) statistical information representing morphological features in numerical and / or linguistic terms, wherein the statistical information is derived from metadata associated with the retrieved image that can visually display the morphological features of blood cells; and (2) anomaly markers indicating the possibility of the presence of specific blood cells in the retrieved image based on the metadata.
[0470] (Technical Solution 63)
[0471] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample.
[0472] (Technical Solution 64)
[0473] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample.
[0474] (Technical Solution 65)
[0475] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the metadata, the image, and the image ID for distinguishing each of the images, wherein each of the metadata, the image, and the image ID is associated with identification information about the sample.
[0476] (Technical Solution 66)
[0477] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize hematological test results, the image and the metadata contained in the data, wherein each of the hematological test results, the image and the metadata is associated with identification information about the sample.
[0478] (Technical Solution 67)
[0479] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image, the metadata, the hematological test results contained in the data, and the subject's attribute information, wherein each of the image, the metadata, the hematological test results, and the attribute information is associated with identification information about the sample.
[0480] (Technical Solution 68)
[0481] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image, the metadata, and platelet information based on the metadata, wherein each of the image, the metadata, and the platelet information is associated with identification information about the sample.
[0482] (Technical Solution 69)
[0483] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0484] The application software expands the functionality of the sample measurement system to display the anomaly markers based on a comparison of preset rules and the metadata.
[0485] (Technical Solution 70)
[0486] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0487] The application software expands the functionality of the sample measurement system to display the anomaly markers based on comparisons between multiple preset rules and the metadata.
[0488] (Technical Solution 71)
[0489] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0490] The application software extends the functionality of the sample measurement system to display the anomaly markers based on the comparison results between the statistical information and rules defined based on thresholds used for comparison with the statistical information.
[0491] (Technical Solution 72)
[0492] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the metadata, the image, and the image ID for distinguishing each of the images, wherein each of the metadata, the image, and the image ID is associated with identification information about the sample, and
[0493] The application software extends the functionality of the sample measurement system to display an image related to the selection of blood cell type in the statistical information.
[0494] (Technical Solution 73)
[0495] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0496] The application software is used to extend the functionality of the sample measurement system to display images related to the anomaly markers.
[0497] (Technical Solution 74)
[0498] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0499] The application software is used to extend the functionality of the sample measurement system to display images associated with the anomalous markers that suggest the possibility of the presence of a mother cell.
[0500] (Technical Solution 75)
[0501] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0502] The application software expands the functionality of the sample measurement system to display images associated with the abnormal markers that indicate the possibility of platelet aggregation.
[0503] (Technical Solution 76)
[0504] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0505] The application software expands the functionality of the sample measurement system to highlight and display information related to the anomaly markers in the statistical information.
[0506] (Technical Solution 77)
[0507] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0508] The application software is used to extend the functionality of the sample measurement system to receive rule settings regarding the anomaly markers.
[0509] (Technical Solution 78)
[0510] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0511] The application software extends the functionality of the sample measurement system to correct the statistical information in response to modifications to the metadata.
[0512] (Technical Solution 79)
[0513] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0514] The application software expands the functionality of the sample measurement system to display a reference image as a comparison object of blood cells contained in the image.
[0515] (Technical Solution 80)
[0516] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and
[0517] The application software is used to extend the functionality of the sample measurement system to display a scale representing an indicator of blood cell size contained in the image.
[0518] (Technical Solution 81)
[0519] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0520] The application software expands the functionality of the sample measurement system to display the abnormal markers and graded indicators corresponding to the number or proportion of each blood cell type.
[0521] (Technical Solution 82)
[0522] According to the sample measurement system of technical solution 62, the interface interacts with the application software to utilize metadata associated with identification information about the sample, and
[0523] The application software is used to extend the functionality of the sample measurement system to receive rule settings that use graded indicators corresponding to the number or proportion of each blood cell type as thresholds.
Claims
1. A sample measurement system capable of measuring samples optically, characterized in that, The sample measurement system includes: A sample measuring device, configured to measure the sample optically, the sample measuring device comprising: (i) A sample suction unit configured to suction the sample, the sample suction unit including a nozzle for suctioning the sample in a sample container, a moving mechanism configured to move the nozzle into the sample container, and a pump configured to apply negative pressure to cause the nozzle to suction the sample; (ii) A sample preparation unit configured to prepare a measurement sample by mixing the attracted sample and reagent in a container; (iii) An optical detection unit configured to detect light from the prepared measurement sample; and (iv) A controller configured to control the sample aspiration unit, the sample preparation unit, and the optical detection unit according to control software, so that the sample measuring device measures the sample optically, wherein the sample measuring device analyzes optical information from the detected light in order to obtain measurement results, and manages data about the sample measuring device according to management software, wherein the data includes the measurement results; An imaging device is configured to capture images of blood cells in a smear of the sample; and A computer capable of running an interface with application software programmed to interact with the data and the images, wherein the application software is independent of the sample measuring device; The interface performs the following operations: (a) Receive a request from the application software; (b) Retrieve an image corresponding to the request according to preset rules, wherein the retrieved image is associated with metadata including morphological features of blood cells; and (c) Provide the retrieved image to the application software so that the application software displays: (1) a summary of morphological features in numerical and / or linguistic terms, wherein the summary is derived from metadata associated with the retrieved image that visually displays the morphological features of blood cells; and (2) a notification based on the metadata indicating the possibility of the presence of a specific blood cell in the retrieved image.
2. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample.
3. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample.
4. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the metadata, the images, and image IDs used to distinguish each of the images, wherein each of the metadata, the images, and the image IDs is associated with identification information about the sample.
5. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the hematological test results, the image, and the metadata contained in the data, wherein each of the hematological test results, the image, and the metadata is associated with identification information about the sample.
6. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image, the metadata, the hematological test results contained in the data, and the subject's attribute information, wherein each of the image, the metadata, the hematological test results, and the attribute information is associated with identification information about the sample.
7. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image, the metadata, and platelet-related information based on the metadata, wherein each of the image, the metadata, and the platelet-related information is associated with identification information about the sample.
8. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software expands the functionality of the sample measurement system to display the notification based on a comparison of preset rules and the metadata.
9. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software expands the functionality of the sample measurement system to display the notification based on the comparison results between multiple preset rules and the metadata.
10. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software expands the functionality of the sample measurement system to display the notification based on the summary and the comparison results based on rules defined for comparison with the summary.
11. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the metadata, the images, and image IDs used to distinguish each element in the images, wherein each of the metadata, the images, and the image IDs is associated with identification information about the sample. The application software expands the functionality of the sample measurement system to display an image related to the selection of blood cell type in the summary.
12. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to display images related to the notification.
13. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to display images related to the notification indicating the possibility of the presence of a mother cell.
14. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to display images related to the notification indicating the possibility of platelet aggregation.
15. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to highlight information related to the notification in the summary.
16. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to receive rule settings regarding the notification.
17. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to revise the summary in response to modifications to the metadata.
18. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software expands the functionality of the sample measurement system to display a reference image as a comparison object of blood cells contained in the image.
19. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize the image and the metadata, wherein each of the image and the metadata is associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to display a scale representing an indicator of blood cell size contained in the image.
20. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software expands the functionality of the sample measurement system to display the notification and graded indicators corresponding to the number or proportion of each blood cell type.
21. The sample measurement system according to claim 1, characterized in that, The interface interacts with the application software to utilize metadata associated with identification information about the sample, and The application software is used to extend the functionality of the sample measurement system to receive rule settings that use graded indicators corresponding to the number or proportion of each blood cell type as thresholds.