WO2023176707A1 - Inspection device for blood product, inspection method, and program - Google Patents

Inspection device for blood product, inspection method, and program Download PDF

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Publication number
WO2023176707A1
WO2023176707A1 PCT/JP2023/009199 JP2023009199W WO2023176707A1 WO 2023176707 A1 WO2023176707 A1 WO 2023176707A1 JP 2023009199 W JP2023009199 W JP 2023009199W WO 2023176707 A1 WO2023176707 A1 WO 2023176707A1
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WIPO (PCT)
Prior art keywords
blood
bag
blood bag
data
color
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PCT/JP2023/009199
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French (fr)
Japanese (ja)
Inventor
岡部博
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テルモ株式会社
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Publication of WO2023176707A1 publication Critical patent/WO2023176707A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/88—Investigating the presence of flaws or contamination
    • G01N21/90—Investigating the presence of flaws or contamination in a container or its contents

Definitions

  • the present invention relates to a testing device that tests blood products, a computer-executable blood product testing method, and a program that causes a computer to execute the testing method.
  • JP 2016-106012A discloses a blood bag system.
  • the blood bag system has multiple blood bags.
  • Each of the plurality of blood bags stores blood components (blood products).
  • Visual inspection is one of the tests to ensure the quality of blood products.
  • the inspector visually checks the blood products in the blood bag.
  • the problem with visual inspection is that it places a heavy burden on the inspector.
  • the present invention aims to solve the above-mentioned problems.
  • a first aspect of the present invention includes a color tone acquisition unit that acquires color tone data of the blood bag containing the blood product based on imaging data of a blood bag containing the blood product; a color determination unit that determines whether the color of the blood product is within an acceptable range based on a comparison between the data and reference color data of the blood bag containing no blood product;
  • the blood product testing device includes a standard determination unit that determines that the blood product in the blood bag does not conform to the standard when the color is outside the allowable range.
  • the color tone acquisition unit acquires the color tone data from the imaged data based on shape information of the imaged blood bag.
  • the acquisition range may be recognized.
  • the blood product testing device including a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags;
  • the standard data determination unit determines the bag standard data corresponding to the imaged blood bag based on the manufacturer of the blood bag, and the color tone acquisition unit is configured to perform color tone acquisition based on the bag standard data determined by the standard data determination unit.
  • the acquisition range may be recognized based on the shape information of the bag reference data.
  • the foreign object may further include a foreign object determining section that determines whether or not a foreign object exists based on the imaging data.
  • the foreign object determining section determines whether the foreign object is present in the blood bag based on binary image data obtained by binarizing the imaging data. It may be determined whether or not it is mixed.
  • the method further includes a shaking determination unit that determines whether or not the determined blood bag has already been subjected to a shaking process for a predetermined time or longer based on the execution history of the shaking process, and the standard determining unit includes: The blood product in the blood bag that is determined to be contaminated with the foreign matter and that has been shaken for longer than the predetermined time may be determined to be non-compliant.
  • the specification determination section determines that the foreign substance is mixed in, and the blood product has not been shaken for more than the predetermined time.
  • the blood bag may be determined to be subject to the shaking process.
  • a second aspect of the present invention is an inspection method in which a computer inspects blood products contained in a blood bag, the test method including the blood products containing the blood products based on imaging data obtained by imaging the blood bag.
  • a color tone acquisition step of acquiring color tone data of the blood bag, and determining a color tone of the blood product within an acceptable range based on a comparison between the color tone data and reference color tone data of the blood bag without the blood product contained therein; a color determination step of determining whether the color is within the acceptable range; and a standard determination step of determining that the blood product in the blood bag does not conform to the standard if the color is outside the tolerance range.
  • This is an inspection method including:
  • the computer acquires the color tone data from the imaged data based on shape information of the imaged blood bag.
  • the acquisition range may be recognized.
  • the computer includes a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags;
  • the inspection method further includes a reference data determining step of determining the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag, and in the color tone acquisition step, the reference data is determined based on the manufacturer of the imaged blood bag.
  • the acquisition range may be recognized based on the shape information of the bag reference data determined in the determination step.
  • the method may further include a foreign object determining step of determining whether or not the object is a foreign object based on the imaging data.
  • the foreign object is determined to be mixed in the blood bag based on binary image data obtained by binarizing the imaging data. It may also be determined whether or not there is one.
  • the blood bag further includes a shaking determination step of determining whether or not the blood bag has already been subjected to a shaking process for a predetermined time or longer based on the execution history of the shaking process, and in the standard determining step, the foreign matter is detected.
  • the blood product in the blood bag that has been determined to be contaminated and has been shaken for more than the predetermined time may be determined to be non-compliant.
  • a third aspect of the present invention is a program that causes the computer to execute the inspection method according to any one of items (8) to (14) above.
  • the burden on inspectors is reduced.
  • FIG. 1 is a configuration diagram of an inspection system according to an embodiment.
  • FIG. 2 is a configuration diagram of the inspection device.
  • FIG. 3 is a flowchart illustrating the flow of the blood product testing method according to the embodiment.
  • FIG. 4 is a configuration diagram of an inspection system according to Modification 1.
  • FIG. 1 is a configuration diagram of an inspection system 10 according to an embodiment.
  • the inspection system 10 is a system that inspects the appearance of a blood product P made based on blood collected from a donor.
  • the testing system 10 is installed at a blood center, for example.
  • the blood product P is contained in a plurality of blood bags BG.
  • the appearance inspection of the blood product P is performed for each blood bag BG containing the blood product P.
  • the testing system 10 includes an imaging device 12, a testing device (testing device for blood product P) 14, and a display device 16.
  • the imaging device 12 is, for example, a camera.
  • the imaging device 12 images the blood bag BG containing the blood product P.
  • the inspector sets the blood bag BG at a predetermined setting position in advance.
  • the imaging device 12 images the blood bag BG set at a predetermined setting position according to instructions from the examiner.
  • the predetermined set position is, for example, the suspension table 18 on which the blood bag BG can be suspended. Note that a plurality of blood bags BG may be suspended from one suspension stand 18.
  • the imaging device 12 outputs the captured imaging data 20 of the blood bag BG to the inspection device 14 (see also FIG. 2).
  • the display device 16 is a display device controlled by the inspection device 14.
  • the display device 16 has a display screen 161.
  • the display screen 161 is, for example, a liquid crystal screen.
  • FIG. 2 is a configuration diagram of the inspection device 14.
  • the inspection device 14 is a computer that performs an external appearance inspection of the blood bag BG (blood product P in the blood bag BG) based on the input imaging data 20.
  • the testing device 14 may be included in a server device that manages a blood center.
  • the inspection device 14 includes a storage section 22 and a calculation section 24.
  • the storage unit 22 includes a storage circuit.
  • This storage circuit includes one or more memories such as RAM (Random Access Memory) and ROM (Read Only Memory).
  • the storage unit 22 stores an appearance inspection program 26 and bag standard data 48.
  • the appearance inspection program 26 is a program for causing the inspection apparatus 14 to execute the inspection method for the blood product P according to the present embodiment.
  • the bag reference data 48 is data (data group) regarding the corresponding blood bag BG.
  • the bag reference data 48 includes a manufacturer 481, shape information 482, and reference color tone data 483.
  • the manufacturer 481 indicates the manufacturer that manufactured the blood bag BG.
  • Shape information 482 indicates the shape, size, etc. of blood bag BG without blood product P contained therein.
  • the reference color tone data 483 indicates a reference color tone that is the color tone of the blood bag BG in a state in which no blood product P is contained.
  • the storage unit 22 may store a plurality of bag reference data 48 having different combinations of manufacturer 481, shape information 482, reference color tone data 483, and the like.
  • the data stored in the storage unit 22 is not limited to the visual inspection program 26.
  • the storage unit 22 may store various data as necessary.
  • the calculation unit 24 includes a processing circuit.
  • This processing circuit includes, for example, one or more processors.
  • the processing circuit of the calculation unit 24 may include an integrated circuit such as an ASIC (Application Specific Integrated Circuit) or an FPGA (Field-Programmable Gate Array).
  • the processing circuit of the calculation unit 24 may include a discrete device.
  • the calculation unit 24 includes an imaging data acquisition unit 28, a reference data determination unit 29, a tone acquisition unit 30, a tint determination unit 32, a binarization processing unit 34, a foreign object determination unit 36, and a shaking determination unit. 38, a standard determination section 40, and a display control section 42.
  • the unit 40 and the display control unit 42 are realized by the processor of the calculation unit 24 executing the visual inspection program 26.
  • the above-mentioned integrated circuit, discrete device, etc. are the imaging data acquisition section 28, the reference data determination section 29, the tone acquisition section 30, the tint determination section 32, the binarization processing section 34, and the foreign matter determination section. 36, the shaking determination section 38, the standard determination section 40, and the display control section 42 may be implemented.
  • the imaging data acquisition unit 28 causes the storage unit 22 to store the imaging data 20 input from the imaging device 12. Note that a plurality of imaging data 20 corresponding to each of the plurality of blood bags BG is input to the inspection device 14. Therefore, the imaging data acquisition unit 28 causes the storage unit 22 to store the plurality of imaging data 20. However, the imaging data acquisition unit 28 stores each of the plurality of imaging data 20 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
  • the identification information 44 includes, for example, an identification number given in advance to each of the plurality of blood bags BG, and information for specifying the bag reference data 48 corresponding to each blood bag BG.
  • the information for specifying the bag standard data 48 includes, for example, the manufacturer of the blood bag BG.
  • the identification information 44 is shown, for example, in a barcode attached to each blood bag BG in advance. In that case, the identification information 44 of each blood bag BG carried into the blood center is read by a barcode reading device (barcode reader) and stored in the storage unit 22.
  • a barcode reading device barcode reader
  • an electronic tag that stores identification information 44 using RFID may be attached to each blood bag BG in advance.
  • the identification information 44 of each blood bag BG carried into the blood center is read by an electronic tag reading device (RFID reader) and stored in the storage unit 22.
  • RFID reader electronic tag reading device
  • the reference data determining unit 29 determines bag reference data 48 corresponding to the blood bag BG.
  • the identification information 44 includes the manufacturer of the blood bag BG.
  • the reference data determination unit 29 checks the manufacturer indicated by the identification information 44 and the manufacturer 481 of each of the plurality of bag reference data 48 .
  • the reference data determination unit 29 determines the bag reference data 48 including the same manufacturer 481 as the manufacturer indicated by the identification information 44 as the bag reference data 48 corresponding to the blood bag BG.
  • the color tone acquisition unit 30 acquires color tone data 46 of the blood bag BG shown in the image data 20 based on the image data 20.
  • the acquired color tone data 46 indicates the color tone of the blood bag BG including the blood product P in the blood bag BG.
  • the color tone acquisition unit 30 may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. Thereby, the color tone acquisition unit 30 can acquire the shape, size, etc. of the blood bag BG.
  • the color tone acquisition unit 30 may recognize the acquisition range for acquiring the color tone data 46 of the blood bag BG out of the imaging data 20 based on the shape, size, etc. of the blood bag BG. Thereby, the color tone acquisition unit 30 can more accurately acquire the color tone data 46 of the blood bag BG based on the acquisition range.
  • the color tone acquisition unit 30 acquires color tone data 46 of each of the plurality of blood bags BG.
  • the tone acquisition section 30 causes the storage section 22 to store the plurality of acquired tone data 46.
  • the color tone acquisition unit 30 stores each of the plurality of color tone data 46 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
  • the color determination unit 32 determines that the color of the blood product P in the blood bag BG is within the allowable range based on the comparison between the color data 46 and the reference color data 483 of the blood bag BG corresponding to the color data 46. Determine whether or not.
  • the allowable range indicates the range of color that meets the standards for the blood product P.
  • the permissible range is stored in the storage unit 22 in advance. Note that there are multiple types of blood products P, such as red blood cell products, plasma products, and platelet products. Therefore, the storage unit 22 may store a plurality of allowable ranges depending on the type of blood product P.
  • the storage unit 22 may store in advance the correspondence between the identification information 44 of the blood bag BG and the type of blood product P in the blood bag BG. Thereby, the color determination unit 32 can automatically use different allowable ranges corresponding to the blood products P in each blood bag BG based on the corresponding relationship.
  • the reference color tone may vary depending on the blood bag BG, for example, depending on the manufacturer of the blood bag BG.
  • the binarization processing unit 34 binarizes the imaging data 20 to create binary image data 50 corresponding to the imaging data 20.
  • the binarization processing unit 34 stores the created binary image data 50 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
  • the threshold value necessary for the binarization process is stored in advance in the storage unit 22. Similar to the above-mentioned allowable range, the storage unit 22 may store a plurality of threshold values depending on the type of blood product P. This threshold value is determined so that the color shown in the binary image data 50 differs between the blood product P (blood bag BG containing the blood product P) and other parts of the imaging data 20.
  • the blood product P (blood bag BG containing the blood product P) is represented, for example, in white.
  • foreign objects are represented, for example, in black.
  • the foreign object determining unit 36 determines whether or not a foreign object is mixed in the blood bag BG based on the imaging data 20 corresponding to the blood bag BG.
  • the foreign object determination unit 36 refers to the binary image data 50 created based on the imaging data 20.
  • the portion of the binary image data 50 that contains foreign matter is represented in a color different from that of the blood product P.
  • the foreign object determination unit 36 can accurately determine whether or not a foreign object is mixed in the blood bag BG.
  • the foreign object determination unit 36 may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. Thereby, the foreign object determination unit 36 can acquire the shape, size, etc. of the blood bag BG.
  • the foreign object determination unit 36 may recognize a determination range for determining the presence or absence of a foreign object in the binary image data 50 based on the shape, size, etc. of the blood bag BG. Thereby, the foreign object determination unit 36 can more accurately determine the presence or absence of a foreign object based on the determination range.
  • the foreign matter determining section 36 may recognize the determination range based on the acquisition range recognized by the tone acquiring section 30.
  • the blood bags BG to be determined whether foreign matter is mixed are limited to blood bags BG containing blood products P whose color is determined to be within an acceptable range. This improves the time efficiency of the visual inspection performed by the inspection device 14.
  • the foreign matter determination unit 36 it is determined whether or not a foreign matter is mixed in the blood bag BG.
  • the foreign matter in the blood bag BG may be removed from the blood bag BG by subjecting the blood bag BG to a shaking process.
  • the platelets may aggregate within the blood bag BG.
  • the aggregated platelet mass (agglomerate) is represented as a foreign object in the binary image data 50 described above.
  • this aggregate is diffused within the blood bag BG by subjecting the blood bag BG to a shaking process for a predetermined period of time or more. That is, if the aggregated platelet mass is shaken for a predetermined period of time or longer, it will disappear from the blood bag BG.
  • the predetermined time is, for example, 24 hours.
  • the shaking determination unit 38 determines whether or not the blood bag BG has already been subjected to a shaking process for a predetermined period of time or longer. The determination is made based on the execution history 52 of the shaking process. Note that the storage unit 22 stores the execution history 52 of the shaking process.
  • the standard determination section 40 determines whether or not the blood product P in the blood bag BG does not conform to the standards, based on the determination results of the color determination section 32, the foreign object determination section 36, and the shaking determination section 38. judge.
  • the standard determining unit 40 determines whether the blood product P does not conform to the standard based on the following determination criteria (1) to (3).
  • a blood product P whose color is outside the permissible range does not meet the specifications.
  • the blood product P contained in the blood bag BG which is contaminated with foreign matter and has not been shaken for a predetermined period of time, is subject to a shaking process for a predetermined period of time.
  • the blood product P contained in the blood bag BG which is contaminated with foreign matter and which has not been shaken for a predetermined period of time can be made to meet the standards by subjecting the blood bag BG to shaking treatment for at least the predetermined period of time. there's a possibility that.
  • the standard determination unit 40 may store the determination result of the blood product P in the storage unit 22 in association with the corresponding blood bag BG (identification information 44).
  • the display control unit 42 causes the display screen 161 of the display device 16 to display that the blood product P does not conform to the specifications. This notifies the inspector of the inspection results. Note that if the standard determination unit 40 determines that the above (3) applies, the display control unit 42 controls the display device 16 to instruct the examiner to subject the blood bag BG to a shaking process for a predetermined period of time. A prompt may be displayed on the display screen 161.
  • the display control unit 42 displays the possibility that the blood product P complies with the standard by subjecting the blood bag BG to a shaking process for at least a predetermined period of time. A message is displayed on the display screen 161 to the effect that there is. Thereby, it is possible to reduce the possibility that the blood product P will be discarded.
  • the inspector can remove the foreign matter from the blood bag BG using a syringe, etc. to ensure that it meets the standards. there's a possibility that.
  • the display control unit 42 displays a message that if the reason why the blood product P does not conform to the standards is the above (2), there is a possibility that it will conform to the standards by removing foreign substances from the blood bag BG. It is more preferable to display it on the screen 161.
  • the inspector can notice the blood product P that has been determined to be non-compliant due to the foreign matter mixed in the blood bag BG, even though the color is within the allowable range. In other words, it is possible to further reduce the possibility that the blood product P will be discarded.
  • FIG. 3 is a flowchart illustrating the flow of the blood product P testing method according to the embodiment.
  • the inspection device 14 can execute the inspection method illustrated in FIG. 3.
  • This inspection method includes an imaging data acquisition step S1, a reference data determination step S2, a color tone acquisition step S3, a color determination step S4, a binarization processing step S5, a foreign object determination step S6, and a shaking determination step. S7 and a standard determination step S8.
  • the standard determination step S8 includes a first conclusion step (standard conformity) S81, a second conclusion step (shaking treatment proposal) S82, and a third conclusion step (standard nonconformity) S83.
  • the imaging data acquisition unit 28 acquires the imaging data 20.
  • the reference data determination unit 29 determines bag reference data 48 corresponding to the imaging data 20. That is, in the reference data determining step S2, the reference data determining unit 29 determines the bag reference data 48 corresponding to the imaged blood bag BG.
  • the tone acquisition section 30 acquires tone data 46 based on the imaged data 20.
  • the color tone data 46 indicates the color tone of the blood bag BG including the blood products P in the blood bag BG.
  • the color determination unit 32 determines whether the color of the blood product P in the blood bag BG is within an acceptable range. The color determination unit 32 determines whether the color of the blood product P is within the allowable range by comparing the color tone data 46 acquired in the color tone acquisition step S3 and the reference color tone data 483 stored in the storage unit 22. Accurate judgments can be made based on comparisons.
  • the binarization processing step S5 and the foreign matter determination step S6 are performed in order. If the color of the blood product P in the blood bag BG is outside the allowable range, a third conclusion step S83 is performed in the standard determination step S8.
  • the binarization processing unit 34 creates binary image data 50 based on the imaging data 20.
  • the binary image data 50 the blood product P and the foreign matter are represented by different colors.
  • the foreign object determination section 36 determines whether or not a foreign object is mixed in the blood bag BG based on the binary image data 50 created based on the imaging data 20.
  • a shaking determination step S7 is performed. If it is determined that no foreign matter is mixed in the blood bag BG, a first conclusion step S81 is performed in the standard determination step S8.
  • the shaking determining unit 38 refers to the execution history 52 of the shaking process stored in the storage unit 22 to determine whether the blood bag BG has already been subjected to the shaking process for a predetermined time or longer. Determine whether or not there is.
  • the third conclusion step S83 of the standard determination step S8 is performed. If the blood bag BG has not been subjected to the shaking process for a predetermined period of time or longer, the second conclusion step S82 of the standard determination step S8 is performed.
  • the standard determination unit 40 determines that the blood product P in the blood bag BG conforms to the standard. This determination result is displayed on the display screen 161 by the display control unit 42.
  • the standard determination unit 40 determines that there is a possibility that foreign substances may be removed from the blood bag BG by subjecting the blood bag BG to a shaking process for at least a predetermined period of time. Furthermore, based on this determination result, the display control unit 42 causes the display screen 161 to display a message suggesting that the blood bag BG be shaken, for example.
  • the standard determination unit 40 determines that the blood product P in the blood bag BG does not comply with the standard. This determination result is displayed on the display screen 161 by the display control unit 42 similarly to the determination result of the standard determination step S8.
  • the display control unit 42 it is preferable for the display control unit 42 to further display on the display screen 161 a message proposing that foreign matter be removed with respect to the blood bag BG that falls under (2) above. Thereby, it is possible to reduce the possibility that the blood product P will be discarded.
  • the result of the color determination step S4 is YES (the color is within the allowable range), and the result of the shaking determination step S7 is YES (the result has been shaken for a predetermined time or longer). ) is the blood bag BG.
  • the inspection device 14 By completing the standard determination step S8, the visual inspection of one blood bag BG is completed. According to this embodiment, the inspection device 14 accurately performs an appearance inspection of the blood product P contained in the blood bag BG at a certain level. This reduces the amount of work for the inspector.
  • FIG. 4 is a configuration diagram of an inspection system 101 (10) according to Modification 1.
  • the number of imaging devices 12 and display devices 16 is not limited to one.
  • the inspection system 101 includes a single inspection device 14, a plurality of imaging devices 12, and a plurality of display devices 16. Imaging data 20 is input to the inspection device 14 from each of the plurality of imaging devices 12 .
  • the inspection device 14 performs a visual inspection of the plurality of blood bags BG based on each image data 20.
  • the inspection results of the visual inspection performed by the inspection device 14 based on each image data 20 are displayed on the display screens 161 of the plurality of display devices 16 as necessary.
  • the testing system 10 may further include a working device that sets the blood bag BG at a predetermined setting position. In this case, there is no need for the inspector to set the blood bag BG in a predetermined setting position.
  • the working device is, for example, a robot equipped with an arm that grips the blood bag BG.
  • the imaging device 12 may automatically image the set blood bag BG in conjunction with the above-mentioned work device setting the blood bag BG at a predetermined set position. In this case, there is no need for the inspector to instruct the imaging device 12 to take an image.
  • At least a portion of the storage unit 22 may be realized by an external storage device installed at a location different from the inspection device 14.
  • the inspection device 14 and the external storage device are communicably connected via the network.
  • the testing system 10 may further include a transport robot that transports the plurality of blood bags BG.
  • the inspection device 14 may instruct the transport robot to transport the blood bag BG corresponding to (3) above to a shaking device that shakes and stores the blood bag BG, for example. This further reduces the work burden on the inspector.
  • the display control unit 42 may display not only the determination result of the standard determination unit 40 but also various data on the display screen 161 as appropriate.
  • the display control unit 42 may display the imaging data 20, color tone data 46, binary image data 50, etc. acquired by the inspection device 14 on the display screen 161.

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Abstract

This inspection device (14) for a blood product (P) comprises: a colour tone acquisition unit (30) which acquires colour tone data (46) on the basis of captured image data (20) captured of a blood bag (BG) containing the blood product (P); a colour determination unit (32) which, on the basis of the colour tone data (46) and reference colour tone data (483) for a blood bag (BG) not containing a blood product (P), determines whether or not the colour of the blood product (P) is within a permissible range; and a standard assessment unit (40) which, when the colour is not within the permissible range, determines that the blood product (P) in the blood bag (B) does not conform to a standard.

Description

血液製剤の検査装置、検査方法、およびプログラムBlood product testing equipment, testing methods, and programs
　本発明は、血液製剤を検査する検査装置と、コンピュータが実行可能な血液製剤の検査方法と、その検査方法をコンピュータに実行させるプログラムとに関する。 The present invention relates to a testing device that tests blood products, a computer-executable blood product testing method, and a program that causes a computer to execute the testing method.
　特開２０１６－１０６０１２号公報には、血液バッグシステムが開示される。血液バッグシステムは、複数の血液バッグを有する。複数の血液バッグの各々は、血液成分（血液製剤）を保存する。 JP 2016-106012A discloses a blood bag system. The blood bag system has multiple blood bags. Each of the plurality of blood bags stores blood components (blood products).
　血液製剤の品質を担保するための検査の一つに、外観検査がある。外観検査では、検査員が、血液バッグ内の血液製剤を目視確認する。しかしながら、外観検査には、検査員の負担が大きいという問題がある。 Visual inspection is one of the tests to ensure the quality of blood products. In the visual inspection, the inspector visually checks the blood products in the blood bag. However, the problem with visual inspection is that it places a heavy burden on the inspector.
　本発明は、上述した課題を解決することを目的とする。 The present invention aims to solve the above-mentioned problems.
　（１）本発明の第１の態様は、血液製剤が入った血液バッグを撮像した撮像データに基づいて、前記血液製剤を含めた前記血液バッグの色調データを取得する色調取得部と、前記色調データと、前記血液製剤が入っていない状態の前記血液バッグの基準色調データとの比較に基づいて、前記血液製剤の色味が許容範囲内であるか否かを判定する色味判定部と、前記色味が前記許容範囲外である場合に、前記血液バッグ内の前記血液製剤は規格不適合であると判定する規格判定部と、を備える、血液製剤の検査装置である。 (1) A first aspect of the present invention includes a color tone acquisition unit that acquires color tone data of the blood bag containing the blood product based on imaging data of a blood bag containing the blood product; a color determination unit that determines whether the color of the blood product is within an acceptable range based on a comparison between the data and reference color data of the blood bag containing no blood product; The blood product testing device includes a standard determination unit that determines that the blood product in the blood bag does not conform to the standard when the color is outside the allowable range.
　これにより、検査員の負担が低減する。 This reduces the burden on inspectors.
　（２）上記項目（１）に記載の血液製剤の検査装置であって、前記色調取得部は、撮像された前記血液バッグの形状情報に基づいて、前記撮像データのうち前記色調データを取得する取得範囲を認識してもよい。 (2) The blood product testing device according to item (1) above, wherein the color tone acquisition unit acquires the color tone data from the imaged data based on shape information of the imaged blood bag. The acquisition range may be recognized.
　これにより、色調データがより正確に取得される。 This allows more accurate acquisition of color tone data.
　（３）上記項目（２）に記載の血液製剤の検査装置であって、前記形状情報と製造メーカとを含むバッグ基準データを、複数の前記血液バッグごとに記憶する記憶部と、撮像された前記血液バッグの製造メーカに基づいて、撮像された前記血液バッグに対応する前記バッグ基準データを決定する基準データ決定部と、をさらに備え、前記色調取得部は、前記基準データ決定部が決定した前記バッグ基準データの前記形状情報に基づいて、前記取得範囲を認識してもよい。 (3) The blood product testing device according to item (2) above, including a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags; The standard data determination unit determines the bag standard data corresponding to the imaged blood bag based on the manufacturer of the blood bag, and the color tone acquisition unit is configured to perform color tone acquisition based on the bag standard data determined by the standard data determination unit. The acquisition range may be recognized based on the shape information of the bag reference data.
　これにより、色調データがより正確に取得される。 This allows more accurate acquisition of color tone data.
　（４）上記項目（１）～（３）のいずれか１項に記載の血液製剤の検査装置であって、前記色味が前記許容範囲内である場合に、前記血液バッグに異物が混入しているか否かを前記撮像データに基づいて判定する異物判定部をさらに備えてもよい。 (4) In the blood product testing device according to any one of items (1) to (3) above, when the color is within the allowable range, there is no possibility that foreign matter has entered the blood bag. The foreign object may further include a foreign object determining section that determines whether or not a foreign object exists based on the imaging data.
　これにより、外観検査の時間効率が向上する。 This improves the time efficiency of visual inspection.
　（５）上記項目（４）に記載の血液製剤の検査装置であって、前記異物判定部は、前記撮像データを二値化処理した二値画像データに基づいて、前記血液バッグに前記異物が混入しているか否かを判定してもよい。 (5) In the blood product testing device according to item (4) above, the foreign object determining section determines whether the foreign object is present in the blood bag based on binary image data obtained by binarizing the imaging data. It may be determined whether or not it is mixed.
　これにより、血液バッグに異物が混入しているか否かを正確に判定することができる。 With this, it is possible to accurately determine whether foreign matter is mixed in the blood bag.
　（６）上記項目（４）または（５）に記載の血液製剤の検査装置であって、前記血液バッグに前記異物が混入していると判定された場合に、前記異物が混入していると判定された前記血液バッグに所定時間以上の振とう処理が既に施されているか否かを、前記振とう処理の実行履歴に基づいて判定する振とう判定部をさらに備え、前記規格判定部は、前記異物が混入していると判定され、且つ、前記所定時間以上振とうされた前記血液バッグ内の前記血液製剤を規格不適合であると判定してもよい。 (6) In the blood product testing device according to item (4) or (5) above, when it is determined that the blood bag is contaminated with the foreign substance, it is determined that the blood bag is contaminated with the foreign substance. The method further includes a shaking determination unit that determines whether or not the determined blood bag has already been subjected to a shaking process for a predetermined time or longer based on the execution history of the shaking process, and the standard determining unit includes: The blood product in the blood bag that is determined to be contaminated with the foreign matter and that has been shaken for longer than the predetermined time may be determined to be non-compliant.
　これにより、異物の混入が原因で規格不適合と判定される血液製剤を減らすことができる。 This makes it possible to reduce the number of blood products that are determined to be non-compliant due to contamination with foreign substances.
　（７）上記項目（６）に記載の血液製剤の検査装置であって、前記規格判定部は、前記異物が混入していると判定され、且つ、前記所定時間以上振とう処理がされていない前記血液バッグを、前記振とう処理の対象であると判定してもよい。 (7) In the blood product testing device according to item (6) above, the specification determination section determines that the foreign substance is mixed in, and the blood product has not been shaken for more than the predetermined time. The blood bag may be determined to be subject to the shaking process.
　これにより、異物の混入が原因で規格不適合と判定される血液製剤をさらに減らすことができる。 This makes it possible to further reduce the number of blood products that are determined to be non-compliant due to contamination with foreign substances.
　（８）本発明の第２の態様は、血液バッグに入っている血液製剤をコンピュータが検査する検査方法であって、前記血液バッグを撮像した撮像データに基づいて、前記血液製剤を含めた前記血液バッグの色調データを取得する色調取得ステップと、前記色調データと、前記血液製剤が入っていない状態の前記血液バッグの基準色調データとの比較に基づいて、前記血液製剤の色味が許容範囲内であるか否かを判定する色味判定ステップと、前記色味が前記許容範囲外である場合に、前記血液バッグ内の前記血液製剤は規格不適合であると判定する規格判定ステップと、を含む、検査方法である。 (8) A second aspect of the present invention is an inspection method in which a computer inspects blood products contained in a blood bag, the test method including the blood products containing the blood products based on imaging data obtained by imaging the blood bag. a color tone acquisition step of acquiring color tone data of the blood bag, and determining a color tone of the blood product within an acceptable range based on a comparison between the color tone data and reference color tone data of the blood bag without the blood product contained therein; a color determination step of determining whether the color is within the acceptable range; and a standard determination step of determining that the blood product in the blood bag does not conform to the standard if the color is outside the tolerance range. This is an inspection method, including:
　これにより、検査員の負担が低減する。 This reduces the burden on inspectors.
　（９）上記項目（８）に記載の検査方法であって、前記色調取得ステップでは、前記コンピュータが、撮像された前記血液バッグの形状情報に基づいて、前記撮像データのうち前記色調データを取得する取得範囲を認識してもよい。 (9) In the testing method according to item (8) above, in the color tone acquisition step, the computer acquires the color tone data from the imaged data based on shape information of the imaged blood bag. The acquisition range may be recognized.
　これにより、色調データがより正確に取得される。 This allows more accurate acquisition of color tone data.
　（１０）上記項目（９）に記載の検査方法であって、前記コンピュータは、前記形状情報と製造メーカとを含むバッグ基準データを、複数の前記血液バッグごとに記憶する記憶部を備え、前記検査方法は、撮像された前記血液バッグの製造メーカに基づいて、撮像された前記血液バッグに対応する前記バッグ基準データを決定する基準データ決定ステップをさらに含み、前記色調取得ステップでは、前記基準データ決定ステップで決定した前記バッグ基準データの前記形状情報に基づいて、前記取得範囲を認識してもよい。 (10) The testing method according to item (9) above, wherein the computer includes a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags; The inspection method further includes a reference data determining step of determining the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag, and in the color tone acquisition step, the reference data is determined based on the manufacturer of the imaged blood bag. The acquisition range may be recognized based on the shape information of the bag reference data determined in the determination step.
　これにより、色調データがより正確に取得される。 This allows more accurate acquisition of color tone data.
　（１１）上記項目（８）～（１０）のいずれか１項に記載の検査方法であって、前記色味が前記許容範囲内である場合に、前記血液バッグに異物が混入しているか否かを前記撮像データに基づいて判定する異物判定ステップをさらに含んでもよい。 (11) In the testing method according to any one of items (8) to (10) above, if the color is within the acceptable range, it is determined whether foreign matter is mixed in the blood bag. The method may further include a foreign object determining step of determining whether or not the object is a foreign object based on the imaging data.
　これにより、外観検査の時間効率が向上する。 This improves the time efficiency of visual inspection.
　（１２）上記項目（１１）に記載の検査方法であって、前記異物判定ステップでは、前記撮像データを二値化処理した二値画像データに基づいて、前記血液バッグに前記異物が混入しているか否かを判定してもよい。 (12) In the inspection method according to item (11) above, in the foreign object determination step, the foreign object is determined to be mixed in the blood bag based on binary image data obtained by binarizing the imaging data. It may also be determined whether or not there is one.
　これにより、血液バッグに異物が混入しているか否かを正確に判定することができる。 With this, it is possible to accurately determine whether foreign matter is mixed in the blood bag.
　（１３）上記項目（１１）または（１２）に記載の検査方法であって、前記血液バッグに前記異物が混入していると判定された場合に、前記異物が混入していると判定された前記血液バッグに所定時間以上の振とう処理が既に施されているか否かを、前記振とう処理の実行履歴に基づいて判定する振とう判定ステップをさらに含み、前記規格判定ステップでは、前記異物が混入していると判定され、且つ、前記所定時間以上振とうされた前記血液バッグ内の前記血液製剤を規格不適合であると判定してもよい。 (13) In the test method described in item (11) or (12) above, when it is determined that the foreign substance is mixed in the blood bag, it is determined that the foreign substance is mixed in the blood bag. The blood bag further includes a shaking determination step of determining whether or not the blood bag has already been subjected to a shaking process for a predetermined time or longer based on the execution history of the shaking process, and in the standard determining step, the foreign matter is detected. The blood product in the blood bag that has been determined to be contaminated and has been shaken for more than the predetermined time may be determined to be non-compliant.
　これにより、異物の混入が原因で規格不適合と判定される血液製剤を減らすことができる。 This makes it possible to reduce the number of blood products that are determined to be non-compliant due to contamination with foreign substances.
　（１４）上記項目（１３）に記載の検査方法であって、前記規格判定ステップでは、前記異物が混入していると判定され、且つ、前記所定時間以上振とう処理がされていない前記血液バッグを、前記振とう処理の対象であると判定してもよい。 (14) The testing method according to item (13) above, wherein in the standard determination step, the blood bag is determined to be contaminated with the foreign matter and has not been shaken for the predetermined period of time or more. may be determined to be a target of the shaking process.
　これにより、異物の混入が原因で規格不適合と判定される血液製剤をさらに減らすことができる。 This makes it possible to further reduce the number of blood products that are determined to be non-compliant due to contamination with foreign substances.
　（１５）本発明の第３の態様は、上記項目（８）～（１４）のいずれか１項に記載の検査方法を前記コンピュータに実行させる、プログラムである。 (15) A third aspect of the present invention is a program that causes the computer to execute the inspection method according to any one of items (8) to (14) above.
　これにより、検査員の負担が低減する。 This reduces the burden on inspectors.
　本発明によれば、検査員の負担が低減する。 According to the present invention, the burden on inspectors is reduced.
図１は、実施形態に係る検査システムの構成図である。FIG. 1 is a configuration diagram of an inspection system according to an embodiment. 図２は、検査装置の構成図である。FIG. 2 is a configuration diagram of the inspection device. 図３は、実施形態に係る血液製剤の検査方法の流れを例示するフローチャートである。FIG. 3 is a flowchart illustrating the flow of the blood product testing method according to the embodiment. 図４は、変形例１に係る検査システムの構成図である。FIG. 4 is a configuration diagram of an inspection system according to Modification 1.
　［実施形態］
　図１は、実施形態に係る検査システム１０の構成図である。 [Embodiment]
FIG. 1 is a configuration diagram of an inspection system 10 according to an embodiment.
　検査システム１０は、ドナーから採取した血液を基に作られた血液製剤Ｐの外観を検査するシステムである。検査システム１０は、例えば血液センタに備えられる。なお、血液製剤Ｐは、複数の血液バッグＢＧに入っている。血液製剤Ｐの外観検査は、血液製剤Ｐが入った血液バッグＢＧごとに行われる。 The inspection system 10 is a system that inspects the appearance of a blood product P made based on blood collected from a donor. The testing system 10 is installed at a blood center, for example. Note that the blood product P is contained in a plurality of blood bags BG. The appearance inspection of the blood product P is performed for each blood bag BG containing the blood product P.
　検査システム１０は、撮像装置１２と、検査装置（血液製剤Ｐの検査装置）１４と、表示装置１６とを備える。 The testing system 10 includes an imaging device 12, a testing device (testing device for blood product P) 14, and a display device 16.
　撮像装置１２は、例えばカメラである。撮像装置１２は、血液製剤Ｐが入った血液バッグＢＧを撮像する。 The imaging device 12 is, for example, a camera. The imaging device 12 images the blood bag BG containing the blood product P.
　撮像装置１２が血液バッグＢＧを撮像するために、検査員（作業者）は、所定のセット位置に、血液バッグＢＧを予めセットする。撮像装置１２は、検査員の指示に従って、所定のセット位置にセットされた血液バッグＢＧを撮像する。所定のセット位置は、例えば、血液バッグＢＧを吊り下げることができる懸架台１８である。なお、１つの懸架台１８に複数の血液バッグＢＧが吊り下げられてもよい。 In order for the imaging device 12 to image the blood bag BG, the inspector (operator) sets the blood bag BG at a predetermined setting position in advance. The imaging device 12 images the blood bag BG set at a predetermined setting position according to instructions from the examiner. The predetermined set position is, for example, the suspension table 18 on which the blood bag BG can be suspended. Note that a plurality of blood bags BG may be suspended from one suspension stand 18.
　撮像装置１２は、撮像した血液バッグＢＧの撮像データ２０を、検査装置１４に出力する（図２も参照）。 The imaging device 12 outputs the captured imaging data 20 of the blood bag BG to the inspection device 14 (see also FIG. 2).
　表示装置１６は、検査装置１４に制御される表示器である。表示装置１６は、表示画面１６１を有する。表示画面１６１は、例えば液晶画面である。 The display device 16 is a display device controlled by the inspection device 14. The display device 16 has a display screen 161. The display screen 161 is, for example, a liquid crystal screen.
　図２は、検査装置１４の構成図である。 FIG. 2 is a configuration diagram of the inspection device 14.
　検査装置１４は、入力された撮像データ２０に基づいて、血液バッグＢＧ（血液バッグＢＧ内の血液製剤Ｐ）の外観検査を行うコンピュータである。検査装置１４は、血液センタを管理するサーバ装置に含まれてもよい。検査装置１４は、記憶部２２と、演算部２４とを備える。 The inspection device 14 is a computer that performs an external appearance inspection of the blood bag BG (blood product P in the blood bag BG) based on the input imaging data 20. The testing device 14 may be included in a server device that manages a blood center. The inspection device 14 includes a storage section 22 and a calculation section 24.
　記憶部２２は、記憶回路を備える。この記憶回路は、例えば、ＲＡＭ（Random Access Memory）、ＲＯＭ（Read Only Memory）等のメモリを１以上含む。 The storage unit 22 includes a storage circuit. This storage circuit includes one or more memories such as RAM (Random Access Memory) and ROM (Read Only Memory).
　記憶部２２は、外観検査プログラム２６と、バッグ基準データ４８とを記憶する。外観検査プログラム２６は、本実施形態に係る血液製剤Ｐの検査方法を検査装置１４に実行させるためのプログラムである。バッグ基準データ４８は、対応する血液バッグＢＧに関するデータ（データ群）である。例えば、バッグ基準データ４８は、製造メーカ４８１と、形状情報４８２と、基準色調データ４８３とを含む。製造メーカ４８１は、血液バッグＢＧを製造したメーカを示す。形状情報４８２は、血液製剤Ｐが入っていない状態の血液バッグＢＧの形状、大きさ等を示す。基準色調データ４８３は、血液製剤Ｐが入っていない状態の血液バッグＢＧの色調である基準色調を示す。記憶部２２は、製造メーカ４８１、形状情報４８２、基準色調データ４８３等の組み合わせが異なる複数のバッグ基準データ４８を記憶してもよい。 The storage unit 22 stores an appearance inspection program 26 and bag standard data 48. The appearance inspection program 26 is a program for causing the inspection apparatus 14 to execute the inspection method for the blood product P according to the present embodiment. The bag reference data 48 is data (data group) regarding the corresponding blood bag BG. For example, the bag reference data 48 includes a manufacturer 481, shape information 482, and reference color tone data 483. The manufacturer 481 indicates the manufacturer that manufactured the blood bag BG. Shape information 482 indicates the shape, size, etc. of blood bag BG without blood product P contained therein. The reference color tone data 483 indicates a reference color tone that is the color tone of the blood bag BG in a state in which no blood product P is contained. The storage unit 22 may store a plurality of bag reference data 48 having different combinations of manufacturer 481, shape information 482, reference color tone data 483, and the like.
　なお、記憶部２２が記憶するデータは、外観検査プログラム２６に限定されない。記憶部２２は、必要に応じて各種データを記憶してもよい。 Note that the data stored in the storage unit 22 is not limited to the visual inspection program 26. The storage unit 22 may store various data as necessary.
　演算部２４は、処理回路を備える。この処理回路は、例えば、１以上のプロセッサを含む。ただし、演算部２４の処理回路は、ＡＳＩＣ（Application Specific Integrated Circuit）、ＦＰＧＡ（Field－Programmable Gate Array）等の集積回路を含んでもよい。また、演算部２４の処理回路は、ディスクリートデバイスを含んでもよい。 The calculation unit 24 includes a processing circuit. This processing circuit includes, for example, one or more processors. However, the processing circuit of the calculation unit 24 may include an integrated circuit such as an ASIC (Application Specific Integrated Circuit) or an FPGA (Field-Programmable Gate Array). Furthermore, the processing circuit of the calculation unit 24 may include a discrete device.
　演算部２４は、撮像データ取得部２８と、基準データ決定部２９と、色調取得部３０と、色味判定部３２と、二値化処理部３４と、異物判定部３６と、振とう判定部３８と、規格判定部４０と、表示制御部４２とを備える。 The calculation unit 24 includes an imaging data acquisition unit 28, a reference data determination unit 29, a tone acquisition unit 30, a tint determination unit 32, a binarization processing unit 34, a foreign object determination unit 36, and a shaking determination unit. 38, a standard determination section 40, and a display control section 42.
　撮像データ取得部２８と、基準データ決定部２９と、色調取得部３０と、色味判定部３２と、二値化処理部３４と、異物判定部３６と、振とう判定部３８と、規格判定部４０と、表示制御部４２とは、演算部２４のプロセッサが外観検査プログラム２６を実行することで、実現される。ただし、前述の集積回路、ディスクリートデバイス等が、撮像データ取得部２８と、基準データ決定部２９と、色調取得部３０と、色味判定部３２と、二値化処理部３４と、異物判定部３６と、振とう判定部３８と、規格判定部４０と、表示制御部４２との少なくとも一部を実現してもよい。 Imaging data acquisition section 28, reference data determination section 29, color tone acquisition section 30, tint determination section 32, binarization processing section 34, foreign object determination section 36, shaking determination section 38, standard determination section The unit 40 and the display control unit 42 are realized by the processor of the calculation unit 24 executing the visual inspection program 26. However, the above-mentioned integrated circuit, discrete device, etc. are the imaging data acquisition section 28, the reference data determination section 29, the tone acquisition section 30, the tint determination section 32, the binarization processing section 34, and the foreign matter determination section. 36, the shaking determination section 38, the standard determination section 40, and the display control section 42 may be implemented.
　撮像データ取得部２８は、撮像装置１２から入力された撮像データ２０を、記憶部２２に記憶させる。なお、検査装置１４には、複数の血液バッグＢＧの各々に対応する複数の撮像データ２０が入力される。したがって、撮像データ取得部２８は、複数の撮像データ２０を記憶部２２に記憶させる。ただし、撮像データ取得部２８は、複数の撮像データ２０の各々を、対応する血液バッグＢＧの識別情報４４と関連付けて、記憶部２２に記憶させる。 The imaging data acquisition unit 28 causes the storage unit 22 to store the imaging data 20 input from the imaging device 12. Note that a plurality of imaging data 20 corresponding to each of the plurality of blood bags BG is input to the inspection device 14. Therefore, the imaging data acquisition unit 28 causes the storage unit 22 to store the plurality of imaging data 20. However, the imaging data acquisition unit 28 stores each of the plurality of imaging data 20 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
　識別情報４４は、例えば複数の血液バッグＢＧの各々に予め付与された識別番号と、各血液バッグＢＧに対応するバッグ基準データ４８を特定するための情報とを含む。バッグ基準データ４８を特定するための情報は、例えば血液バッグＢＧの製造メーカを含む。 The identification information 44 includes, for example, an identification number given in advance to each of the plurality of blood bags BG, and information for specifying the bag reference data 48 corresponding to each blood bag BG. The information for specifying the bag standard data 48 includes, for example, the manufacturer of the blood bag BG.
　識別情報４４は、例えば、各血液バッグＢＧに予め付されるバーコードに示される。その場合、血液センタに搬入された各血液バッグＢＧの識別情報４４は、バーコード用の読み取り装置（バーコードリーダ）によって読み取られて、記憶部２２に記憶される。 The identification information 44 is shown, for example, in a barcode attached to each blood bag BG in advance. In that case, the identification information 44 of each blood bag BG carried into the blood center is read by a barcode reading device (barcode reader) and stored in the storage unit 22.
　なお、識別情報４４をＲＦＩＤ（Radio Frequency Identifier）によって記憶する電子タグが、各血液バッグＢＧに予め付されてもよい。その場合、血液センタに搬入された各血液バッグＢＧの識別情報４４は、電子タグ用の読み取り装置（ＲＦＩＤリーダ）によって読み取られて、記憶部２２に記憶される。 Note that an electronic tag that stores identification information 44 using RFID (Radio Frequency Identifier) may be attached to each blood bag BG in advance. In that case, the identification information 44 of each blood bag BG carried into the blood center is read by an electronic tag reading device (RFID reader) and stored in the storage unit 22.
　基準データ決定部２９は、血液バッグＢＧの識別情報４４に基づいて、その血液バッグＢＧに対応するバッグ基準データ４８を決定する。例えば、前述の通り、識別情報４４が、血液バッグＢＧの製造メーカを含む。基準データ決定部２９は、識別情報４４が示す製造メーカと、複数のバッグ基準データ４８の各々の製造メーカ４８１とを照合する。基準データ決定部２９は、識別情報４４が示す製造メーカと同じ製造メーカ４８１を含むバッグ基準データ４８を、血液バッグＢＧに対応するバッグ基準データ４８として決定する。 Based on the identification information 44 of the blood bag BG, the reference data determining unit 29 determines bag reference data 48 corresponding to the blood bag BG. For example, as described above, the identification information 44 includes the manufacturer of the blood bag BG. The reference data determination unit 29 checks the manufacturer indicated by the identification information 44 and the manufacturer 481 of each of the plurality of bag reference data 48 . The reference data determination unit 29 determines the bag reference data 48 including the same manufacturer 481 as the manufacturer indicated by the identification information 44 as the bag reference data 48 corresponding to the blood bag BG.
　色調取得部３０は、撮像データ２０に基づいて、撮像データ２０に示される血液バッグＢＧの色調データ４６を取得する。取得される色調データ４６は、血液バッグＢＧ内の血液製剤Ｐを含めた血液バッグＢＧの色調を示す。 The color tone acquisition unit 30 acquires color tone data 46 of the blood bag BG shown in the image data 20 based on the image data 20. The acquired color tone data 46 indicates the color tone of the blood bag BG including the blood product P in the blood bag BG.
　ここで、色調取得部３０は、血液バッグＢＧに対応するバッグ基準データ４８の形状情報４８２を参照してもよい。これにより、色調取得部３０は、血液バッグＢＧの形状、大きさ等を取得することができる。色調取得部３０は、血液バッグＢＧの形状、大きさ等に基づいて、撮像データ２０のうち、血液バッグＢＧの色調データ４６を取得する取得範囲を認識してもよい。これにより、色調取得部３０は、取得範囲に基づいて、血液バッグＢＧの色調データ４６をより正確に取得することができる。 Here, the color tone acquisition unit 30 may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. Thereby, the color tone acquisition unit 30 can acquire the shape, size, etc. of the blood bag BG. The color tone acquisition unit 30 may recognize the acquisition range for acquiring the color tone data 46 of the blood bag BG out of the imaging data 20 based on the shape, size, etc. of the blood bag BG. Thereby, the color tone acquisition unit 30 can more accurately acquire the color tone data 46 of the blood bag BG based on the acquisition range.
　色調取得部３０は、複数の血液バッグＢＧの各々の色調データ４６を取得する。色調取得部３０は、取得した複数の色調データ４６を記憶部２２に記憶させる。ただし、色調取得部３０は、複数の色調データ４６の各々を、対応する血液バッグＢＧの識別情報４４と関連付けて、記憶部２２に記憶させる。 The color tone acquisition unit 30 acquires color tone data 46 of each of the plurality of blood bags BG. The tone acquisition section 30 causes the storage section 22 to store the plurality of acquired tone data 46. However, the color tone acquisition unit 30 stores each of the plurality of color tone data 46 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
　色味判定部３２は、色調データ４６と、色調データ４６に対応する血液バッグＢＧの基準色調データ４８３との比較に基づいて、血液バッグＢＧ内の血液製剤Ｐの色味が許容範囲内であるか否かを判定する。 The color determination unit 32 determines that the color of the blood product P in the blood bag BG is within the allowable range based on the comparison between the color data 46 and the reference color data 483 of the blood bag BG corresponding to the color data 46. Determine whether or not.
　許容範囲は、血液製剤Ｐとしての規格に適合する色味の範囲を示す。許容範囲は、記憶部２２に予め記憶される。なお、血液製剤Ｐには、赤血球製剤、血漿製剤、血小板製剤等の複数の種類がある。したがって、記憶部２２は、血液製剤Ｐの種類に応じて複数の許容範囲を記憶してもよい。 The allowable range indicates the range of color that meets the standards for the blood product P. The permissible range is stored in the storage unit 22 in advance. Note that there are multiple types of blood products P, such as red blood cell products, plasma products, and platelet products. Therefore, the storage unit 22 may store a plurality of allowable ranges depending on the type of blood product P.
　また、記憶部２２は、血液バッグＢＧの識別情報４４と、血液バッグＢＧ内の血液製剤Ｐの種類との対応関係を予め記憶してもよい。これにより、色味判定部３２は、当該対応関係に基づいて、各血液バッグＢＧ内の血液製剤Ｐに対応する許容範囲を自動で使い分けることができる。 Furthermore, the storage unit 22 may store in advance the correspondence between the identification information 44 of the blood bag BG and the type of blood product P in the blood bag BG. Thereby, the color determination unit 32 can automatically use different allowable ranges corresponding to the blood products P in each blood bag BG based on the corresponding relationship.
　基準色調は、例えば血液バッグＢＧの製造メーカの違いに応じて、血液バッグＢＧごとに異なる可能性がある。各バッグの色調データ４６と基準色調データ４８３とを比較することで、色調データ４６と基準色調データ４８３との差分に基づいて、血液バッグＢＧ内の血液製剤Ｐの色調を正確に抽出することができる。これにより、色味判定部３２は、各血液バッグＢＧの基準色調の相違に拘わらず、各血液バッグＢＧ内の血液製剤Ｐの色味を一定の水準で正確に検査することができる。 The reference color tone may vary depending on the blood bag BG, for example, depending on the manufacturer of the blood bag BG. By comparing the color tone data 46 of each bag with the reference color tone data 483, it is possible to accurately extract the color tone of the blood product P in the blood bag BG based on the difference between the color tone data 46 and the reference color tone data 483. can. Thereby, the color determination section 32 can accurately test the color of the blood product P in each blood bag BG at a constant level, regardless of the difference in the reference color tone of each blood bag BG.
　二値化処理部３４は、撮像データ２０を二値化処理して、撮像データ２０に対応する二値画像データ５０を作成する。二値化処理部３４は、作成した二値画像データ５０を、対応する血液バッグＢＧの識別情報４４に関連付けて、記憶部２２に記憶させる。 The binarization processing unit 34 binarizes the imaging data 20 to create binary image data 50 corresponding to the imaging data 20. The binarization processing unit 34 stores the created binary image data 50 in the storage unit 22 in association with the identification information 44 of the corresponding blood bag BG.
　なお、二値化処理に必要な閾値は、記憶部２２に予め記憶される。前述の許容範囲と同様に、記憶部２２は、血液製剤Ｐの種類に応じて複数の閾値を記憶してもよい。この閾値は、撮像データ２０のうち、血液製剤Ｐ（血液製剤Ｐを含む血液バッグＢＧ）と、その他の部分とで、二値画像データ５０に示される色が異なるように、決められる。 Note that the threshold value necessary for the binarization process is stored in advance in the storage unit 22. Similar to the above-mentioned allowable range, the storage unit 22 may store a plurality of threshold values depending on the type of blood product P. This threshold value is determined so that the color shown in the binary image data 50 differs between the blood product P (blood bag BG containing the blood product P) and other parts of the imaging data 20.
　これにより、二値画像データ５０において、血液製剤Ｐ（血液製剤Ｐを含む血液バッグＢＧ）は、例えば白色で表される。これに対し、二値画像データ５０において、異物は、例えば黒色で表される。 Thereby, in the binary image data 50, the blood product P (blood bag BG containing the blood product P) is represented, for example, in white. On the other hand, in the binary image data 50, foreign objects are represented, for example, in black.
　異物判定部３６は、血液バッグＢＧに異物が混入しているか否かを、血液バッグＢＧに対応する撮像データ２０に基づいて判定する。ここで、異物判定部３６は、撮像データ２０に基づいて作成された二値画像データ５０を参照する。 The foreign object determining unit 36 determines whether or not a foreign object is mixed in the blood bag BG based on the imaging data 20 corresponding to the blood bag BG. Here, the foreign object determination unit 36 refers to the binary image data 50 created based on the imaging data 20.
　前述の通り、二値画像データ５０のうち異物が含まれる部分は、血液製剤Ｐとは異なる色で表される。異物判定部３６は、二値画像データ５０に基づくことで、血液バッグＢＧに異物が混入しているか否かを正確に判定することができる。 As mentioned above, the portion of the binary image data 50 that contains foreign matter is represented in a color different from that of the blood product P. Based on the binary image data 50, the foreign object determination unit 36 can accurately determine whether or not a foreign object is mixed in the blood bag BG.
　なお、異物判定部３６は、血液バッグＢＧに対応するバッグ基準データ４８の形状情報４８２を参照してもよい。これにより、異物判定部３６は、血液バッグＢＧの形状、大きさ等を取得することができる。異物判定部３６は、血液バッグＢＧの形状、大きさ等に基づいて、二値画像データ５０のうち、異物の有無を判定する判定範囲を認識してもよい。これにより、異物判定部３６は、判定範囲に基づいて、異物の有無をより正確に取得することができる。ただし、異物判定部３６は、色調取得部３０が認識した取得範囲に基づいて、判定範囲を認識してもよい。 Note that the foreign object determination unit 36 may refer to the shape information 482 of the bag reference data 48 corresponding to the blood bag BG. Thereby, the foreign object determination unit 36 can acquire the shape, size, etc. of the blood bag BG. The foreign object determination unit 36 may recognize a determination range for determining the presence or absence of a foreign object in the binary image data 50 based on the shape, size, etc. of the blood bag BG. Thereby, the foreign object determination unit 36 can more accurately determine the presence or absence of a foreign object based on the determination range. However, the foreign matter determining section 36 may recognize the determination range based on the acquisition range recognized by the tone acquiring section 30.
　仮に、血液製剤Ｐの色味が許容範囲外である場合、その血液製剤Ｐは、異物の混入の有無に拘わらず、規格不適合である。したがって、異物が混入しているか否かの判定対象となる血液バッグＢＧは、色味が許容範囲内であると判定された血液製剤Ｐが入った血液バッグＢＧに限定されると、好ましい。これにより、検査装置１４が行う外観検査の時間効率が向上する。 If the color of the blood product P is outside the allowable range, the blood product P does not conform to the specifications, regardless of the presence or absence of foreign matter. Therefore, it is preferable that the blood bags BG to be determined whether foreign matter is mixed are limited to blood bags BG containing blood products P whose color is determined to be within an acceptable range. This improves the time efficiency of the visual inspection performed by the inspection device 14.
　異物判定部３６によれば、血液バッグＢＧに異物が混入しているか否かが判定される。ただし、血液バッグＢＧ内の異物は、血液バッグＢＧに振とう処理を施すことで、血液バッグＢＧ内から除去される可能性がある。 According to the foreign matter determination unit 36, it is determined whether or not a foreign matter is mixed in the blood bag BG. However, the foreign matter in the blood bag BG may be removed from the blood bag BG by subjecting the blood bag BG to a shaking process.
　例えば、血液製剤Ｐが血小板製剤である場合、血液バッグＢＧ内で血小板が凝集する場合がある。凝集した血小板の塊（凝集塊）は、前述の二値画像データ５０において、異物として表される。しかし、この凝集塊は、所定時間以上の振とう処理を血液バッグＢＧに施すことで、血液バッグＢＧ内で拡散する。つまり、凝集した血小板の塊は、所定時間以上振とうすれば、血液バッグＢＧ内から消失する。所定時間は、例えば２４時間である。 For example, if the blood product P is a platelet product, the platelets may aggregate within the blood bag BG. The aggregated platelet mass (agglomerate) is represented as a foreign object in the binary image data 50 described above. However, this aggregate is diffused within the blood bag BG by subjecting the blood bag BG to a shaking process for a predetermined period of time or more. That is, if the aggregated platelet mass is shaken for a predetermined period of time or longer, it will disappear from the blood bag BG. The predetermined time is, for example, 24 hours.
　以上を踏まえ、振とう判定部３８は、血液バッグＢＧに異物が混入していると判定された場合に、その血液バッグＢＧに所定時間以上の振とう処理が既に施されているか否かを、振とう処理の実行履歴５２に基づいて判定する。なお、振とう処理の実行履歴５２は、記憶部２２が記憶している。 Based on the above, when it is determined that a foreign substance is mixed in the blood bag BG, the shaking determination unit 38 determines whether or not the blood bag BG has already been subjected to a shaking process for a predetermined period of time or longer. The determination is made based on the execution history 52 of the shaking process. Note that the storage unit 22 stores the execution history 52 of the shaking process.
　規格判定部４０は、色味判定部３２と、異物判定部３６と、振とう判定部３８との各々の判定結果を踏まえ、血液バッグＢＧ内の血液製剤Ｐが規格不適合であるか否かを判定する。規格判定部４０は、次の判定基準（１）～（３）に基づいて、血液製剤Ｐが規格不適合であるか否かを判定する。 The standard determination section 40 determines whether or not the blood product P in the blood bag BG does not conform to the standards, based on the determination results of the color determination section 32, the foreign object determination section 36, and the shaking determination section 38. judge. The standard determining unit 40 determines whether the blood product P does not conform to the standard based on the following determination criteria (1) to (3).
　（１）色味が許容範囲外である血液製剤Ｐは、規格不適合である。 (1) A blood product P whose color is outside the permissible range does not meet the specifications.
　（２）異物が混入しており、且つ所定時間以上振とうされた後の血液バッグＢＧに入っている血液製剤Ｐは、色味が許容範囲内であっても、規格不適合である。 (2) The blood product P contained in the blood bag BG that has been contaminated with foreign matter and has been shaken for a predetermined period of time or longer does not meet the specifications even if the color is within the allowable range.
　（３）異物が混入しており、且つ所定時間以上振とうされる前の血液バッグＢＧに入っている血液製剤Ｐは、所定時間の振とう処理の対象である。すなわち、異物が混入しており、且つ所定時間以上振とうされる前の血液バッグＢＧに入っている血液製剤Ｐは、血液バッグＢＧに少なくとも所定時間の振とう処理を施すことで、規格に適合する可能性がある。 (3) The blood product P contained in the blood bag BG, which is contaminated with foreign matter and has not been shaken for a predetermined period of time, is subject to a shaking process for a predetermined period of time. In other words, the blood product P contained in the blood bag BG which is contaminated with foreign matter and which has not been shaken for a predetermined period of time can be made to meet the standards by subjecting the blood bag BG to shaking treatment for at least the predetermined period of time. there's a possibility that.
　なお、規格判定部４０は、血液製剤Ｐの判定結果を、対応する血液バッグＢＧ（識別情報４４）と関連付けて、記憶部２２に記憶させてもよい。 Note that the standard determination unit 40 may store the determination result of the blood product P in the storage unit 22 in association with the corresponding blood bag BG (identification information 44).
　表示制御部４２は、血液バッグＢＧ内の血液製剤Ｐが上記（１）または（２）に該当する場合、血液製剤Ｐが規格不適合である旨を、表示装置１６の表示画面１６１に表示させる。これにより、検査員に検査結果が知らされる。なお、規格判定部４０によって上記（３）に該当すると判定された場合、表示制御部４２は、表示装置１６を制御して、所定時間の振とう処理を血液バッグＢＧに施すことを検査員に促す旨を表示画面１６１に表示させてもよい。 If the blood product P in the blood bag BG falls under (1) or (2) above, the display control unit 42 causes the display screen 161 of the display device 16 to display that the blood product P does not conform to the specifications. This notifies the inspector of the inspection results. Note that if the standard determination unit 40 determines that the above (3) applies, the display control unit 42 controls the display device 16 to instruct the examiner to subject the blood bag BG to a shaking process for a predetermined period of time. A prompt may be displayed on the display screen 161.
　表示制御部４２は、血液バッグＢＧ内の血液製剤Ｐが上記（３）に該当する場合、血液バッグＢＧに少なくとも所定時間の振とう処理を施すことで、血液製剤Ｐが規格に適合する可能性がある旨を、表示画面１６１に表示させる。これにより、血液製剤Ｐが廃棄されるおそれを低減することができる。 When the blood product P in the blood bag BG falls under (3) above, the display control unit 42 displays the possibility that the blood product P complies with the standard by subjecting the blood bag BG to a shaking process for at least a predetermined period of time. A message is displayed on the display screen 161 to the effect that there is. Thereby, it is possible to reduce the possibility that the blood product P will be discarded.
　なお、上記（２）に該当する血液バッグＢＧの血液製剤Ｐは、色味が許容範囲内であれば、検査員がシリンジ等を用いて血液バッグＢＧから異物を除去することで、規格に適合する可能性がある。 If the color of the blood product P in the blood bag BG that falls under (2) above is within the allowable range, the inspector can remove the foreign matter from the blood bag BG using a syringe, etc. to ensure that it meets the standards. there's a possibility that.
　これを踏まえ、表示制御部４２は、血液製剤Ｐが規格不適合である理由が上記（２）である場合、血液バッグＢＧから異物を除去することで、規格に適合する可能性がある旨を表示画面１６１に表示させると、より好ましい。 Based on this, the display control unit 42 displays a message that if the reason why the blood product P does not conform to the standards is the above (2), there is a possibility that it will conform to the standards by removing foreign substances from the blood bag BG. It is more preferable to display it on the screen 161.
　これにより、検査員は、色味が許容範囲であるにも拘わらず、血液バッグＢＧに異物が混入しているために規格不適合と判定された血液製剤Ｐに気付くことができる。つまり、血液製剤Ｐが廃棄されるおそれをさらに低減することができる。 Thereby, the inspector can notice the blood product P that has been determined to be non-compliant due to the foreign matter mixed in the blood bag BG, even though the color is within the allowable range. In other words, it is possible to further reduce the possibility that the blood product P will be discarded.
　図３は、実施形態に係る血液製剤Ｐの検査方法の流れを例示するフローチャートである。 FIG. 3 is a flowchart illustrating the flow of the blood product P testing method according to the embodiment.
　検査装置１４は、図３に例示される検査方法を実行することができる。この検査方法は、撮像データ取得ステップＳ１と、基準データ決定ステップＳ２と、色調取得ステップＳ３と、色味判定ステップＳ４と、二値化処理ステップＳ５と、異物判定ステップＳ６と、振とう判定ステップＳ７と、規格判定ステップＳ８とを含む。規格判定ステップＳ８は、第１結論ステップ（規格適合）Ｓ８１と、第２結論ステップ（振とう処理の提案）Ｓ８２と、第３結論ステップ（規格不適合）Ｓ８３と、を含む。 The inspection device 14 can execute the inspection method illustrated in FIG. 3. This inspection method includes an imaging data acquisition step S1, a reference data determination step S2, a color tone acquisition step S3, a color determination step S4, a binarization processing step S5, a foreign object determination step S6, and a shaking determination step. S7 and a standard determination step S8. The standard determination step S8 includes a first conclusion step (standard conformity) S81, a second conclusion step (shaking treatment proposal) S82, and a third conclusion step (standard nonconformity) S83.
　撮像データ取得ステップＳ１では、撮像データ取得部２８が、撮像データ２０を取得する。 In the imaging data acquisition step S1, the imaging data acquisition unit 28 acquires the imaging data 20.
　基準データ決定ステップＳ２では、基準データ決定部２９が、撮像データ２０に対応するバッグ基準データ４８を決定する。すなわち、基準データ決定ステップＳ２では、基準データ決定部２９が、撮像された血液バッグＢＧに対応するバッグ基準データ４８を決定する。 In the reference data determination step S2, the reference data determination unit 29 determines bag reference data 48 corresponding to the imaging data 20. That is, in the reference data determining step S2, the reference data determining unit 29 determines the bag reference data 48 corresponding to the imaged blood bag BG.
　色調取得ステップＳ３では、色調取得部３０が、撮像データ２０に基づいて、色調データ４６を取得する。色調データ４６は、血液バッグＢＧ内の血液製剤Ｐを含めた血液バッグＢＧの色調を示す。 In the tone acquisition step S3, the tone acquisition section 30 acquires tone data 46 based on the imaged data 20. The color tone data 46 indicates the color tone of the blood bag BG including the blood products P in the blood bag BG.
　色味判定ステップＳ４では、色味判定部３２が、血液バッグＢＧ内の血液製剤Ｐの色味が許容範囲内であるか否かを判定する。色味判定部３２は、血液製剤Ｐの色味が許容範囲内であるか否かを、色調取得ステップＳ３で取得された色調データ４６と、記憶部２２に記憶された基準色調データ４８３との比較に基づいて正確に判断することができる。 In the color determination step S4, the color determination unit 32 determines whether the color of the blood product P in the blood bag BG is within an acceptable range. The color determination unit 32 determines whether the color of the blood product P is within the allowable range by comparing the color tone data 46 acquired in the color tone acquisition step S3 and the reference color tone data 483 stored in the storage unit 22. Accurate judgments can be made based on comparisons.
　血液バッグＢＧ内の血液製剤Ｐの色味が許容範囲内である場合、二値化処理ステップＳ５と、異物判定ステップＳ６とが、順番に行われる。血液バッグＢＧ内の血液製剤Ｐの色味が許容範囲外である場合、規格判定ステップＳ８のうち、第３結論ステップＳ８３が行われる。 If the color of the blood product P in the blood bag BG is within the allowable range, the binarization processing step S5 and the foreign matter determination step S6 are performed in order. If the color of the blood product P in the blood bag BG is outside the allowable range, a third conclusion step S83 is performed in the standard determination step S8.
　二値化処理ステップＳ５では、二値化処理部３４が、撮像データ２０に基づいて、二値画像データ５０を作成する。二値画像データ５０において、血液製剤Ｐと、異物とは、異なる色で表される。 In the binarization processing step S5, the binarization processing unit 34 creates binary image data 50 based on the imaging data 20. In the binary image data 50, the blood product P and the foreign matter are represented by different colors.
　異物判定ステップＳ６では、異物判定部３６が、撮像データ２０を基に作成された二値画像データ５０に基づいて、血液バッグＢＧに異物が混入しているか否かを判定する。 In the foreign object determination step S6, the foreign object determination section 36 determines whether or not a foreign object is mixed in the blood bag BG based on the binary image data 50 created based on the imaging data 20.
　血液バッグＢＧに異物が混入していると判定された場合、振とう判定ステップＳ７が行われる。血液バッグＢＧに異物が混入していないと判定された場合、規格判定ステップＳ８のうち、第１結論ステップＳ８１が行われる。 If it is determined that foreign matter is mixed in the blood bag BG, a shaking determination step S7 is performed. If it is determined that no foreign matter is mixed in the blood bag BG, a first conclusion step S81 is performed in the standard determination step S8.
　振とう判定ステップＳ７では、振とう判定部３８が、記憶部２２に記憶された振とう処理の実行履歴５２を参照することで、血液バッグＢＧに所定時間以上の振とう処理が既に施されているか否かを判定する。 In the shaking determination step S7, the shaking determining unit 38 refers to the execution history 52 of the shaking process stored in the storage unit 22 to determine whether the blood bag BG has already been subjected to the shaking process for a predetermined time or longer. Determine whether or not there is.
　血液バッグＢＧに所定時間以上の振とう処理が既に施されている場合、規格判定ステップＳ８のうち、第３結論ステップＳ８３が行われる。血液バッグＢＧに所定時間以上の振とう処理が未だ施されていない場合、規格判定ステップＳ８のうち、第２結論ステップＳ８２が行われる。 If the blood bag BG has already been subjected to the shaking process for a predetermined period of time or more, the third conclusion step S83 of the standard determination step S8 is performed. If the blood bag BG has not been subjected to the shaking process for a predetermined period of time or longer, the second conclusion step S82 of the standard determination step S8 is performed.
　規格判定ステップＳ８のうち、第１結論ステップＳ８１では、規格判定部４０が、血液バッグＢＧ内の血液製剤Ｐは規格に適合すると判定する。この判定結果は、表示制御部４２によって、表示画面１６１に表示される。 In the first conclusion step S81 of the standard determination step S8, the standard determination unit 40 determines that the blood product P in the blood bag BG conforms to the standard. This determination result is displayed on the display screen 161 by the display control unit 42.
　第２結論ステップＳ８２では、血液バッグＢＧに少なくとも所定時間の振とう処理を施すことで、血液バッグＢＧ内から異物が除去される可能性があると、規格判定部４０が判定する。また、この判定結果に基づいて、表示制御部４２は、例えば血液バッグＢＧを振とうすることを提案する旨のメッセージを、表示画面１６１に表示させる。 In the second conclusion step S82, the standard determination unit 40 determines that there is a possibility that foreign substances may be removed from the blood bag BG by subjecting the blood bag BG to a shaking process for at least a predetermined period of time. Furthermore, based on this determination result, the display control unit 42 causes the display screen 161 to display a message suggesting that the blood bag BG be shaken, for example.
　規格判定ステップＳ８のうち、第３結論ステップＳ８３では、規格判定部４０が、血液バッグＢＧ内の血液製剤Ｐは規格に適合しないと判定する。この判定結果は、規格判定ステップＳ８の判定結果と同様に、表示制御部４２によって、表示画面１６１に表示される。 In the third conclusion step S83 of the standard determination step S8, the standard determination unit 40 determines that the blood product P in the blood bag BG does not comply with the standard. This determination result is displayed on the display screen 161 by the display control unit 42 similarly to the determination result of the standard determination step S8.
　ここで、表示制御部４２は、前述の（２）に該当する血液バッグＢＧに関して、異物を除去することを提案する旨のメッセージを、表示画面１６１にさらに表示させると、好ましい。これにより、血液製剤Ｐが廃棄されるおそれを低減することができる。 Here, it is preferable for the display control unit 42 to further display on the display screen 161 a message proposing that foreign matter be removed with respect to the blood bag BG that falls under (2) above. Thereby, it is possible to reduce the possibility that the blood product P will be discarded.
　前述の（２）に該当する血液バッグＢＧは、色味判定ステップＳ４の結果がＹＥＳ（色味が許容範囲内）であって、振とう判定ステップＳ７の結果がＹＥＳ（所定時間以上振とう済）である血液バッグＢＧである。 For the blood bag BG that corresponds to (2) above, the result of the color determination step S4 is YES (the color is within the allowable range), and the result of the shaking determination step S7 is YES (the result has been shaken for a predetermined time or longer). ) is the blood bag BG.
　規格判定ステップＳ８が完了することで、１つの血液バッグＢＧの外観検査が終了する。本実施形態によれば、検査装置１４が、血液バッグＢＧに入った血液製剤Ｐの外観検査を、一定の水準で正確に行う。これにより、検査員の作業量が低減する。 By completing the standard determination step S8, the visual inspection of one blood bag BG is completed. According to this embodiment, the inspection device 14 accurately performs an appearance inspection of the blood product P contained in the blood bag BG at a certain level. This reduces the amount of work for the inspector.
　［変形例］
　以下には、上記実施形態に係る変形例が記載される。ただし、上記実施形態と重複する説明は、以下の説明では可能な限り省略される。上記実施形態で説明済みの構成要素には、特に断らない限り、上記実施形態と同一の参照符号が付される。 [Modified example]
Modifications of the above embodiment will be described below. However, descriptions that overlap with the above embodiments will be omitted as much as possible in the following description. Components already described in the above embodiments are given the same reference numerals as in the above embodiments, unless otherwise specified.
　（変形例１）
　図４は、変形例１に係る検査システム１０１（１０）の構成図である。 (Modification 1)
FIG. 4 is a configuration diagram of an inspection system 101 (10) according to Modification 1.
　撮像装置１２と、表示装置１６との各々の数は、単数に限定されない。例えば、検査システム１０１は、単数の検査装置１４と、複数の撮像装置１２と、複数の表示装置１６とを備える。検査装置１４に、複数の撮像装置１２の各々から撮像データ２０が入力される。検査装置１４は、各撮像データ２０に基づいて、複数の血液バッグＢＧの外観検査を行う。 The number of imaging devices 12 and display devices 16 is not limited to one. For example, the inspection system 101 includes a single inspection device 14, a plurality of imaging devices 12, and a plurality of display devices 16. Imaging data 20 is input to the inspection device 14 from each of the plurality of imaging devices 12 . The inspection device 14 performs a visual inspection of the plurality of blood bags BG based on each image data 20.
　検査装置１４が各撮像データ２０に基づいて行った外観検査の検査結果（規格判定部４０の判定結果）は、複数の表示装置１６の表示画面１６１に、必要に応じて表示される。 The inspection results of the visual inspection performed by the inspection device 14 based on each image data 20 (determination results of the standard determination section 40) are displayed on the display screens 161 of the plurality of display devices 16 as necessary.
　（変形例２）
　検査システム１０は、所定のセット位置に血液バッグＢＧをセットする作業装置をさらに備えてもよい。この場合、血液バッグＢＧを所定のセット位置にセットする作業を検査員が行う必要はない。作業装置は、例えば、血液バッグＢＧを把持するアームを備えたロボットである。 (Modification 2)
The testing system 10 may further include a working device that sets the blood bag BG at a predetermined setting position. In this case, there is no need for the inspector to set the blood bag BG in a predetermined setting position. The working device is, for example, a robot equipped with an arm that grips the blood bag BG.
　また、撮像装置１２は、上記の作業装置が血液バッグＢＧを所定のセット位置にセットすることに連動して、セットされた血液バッグＢＧを自動で撮像してもよい。この場合、撮像装置１２への撮像指示を検査員が行う必要はない。 Furthermore, the imaging device 12 may automatically image the set blood bag BG in conjunction with the above-mentioned work device setting the blood bag BG at a predetermined set position. In this case, there is no need for the inspector to instruct the imaging device 12 to take an image.
　（変形例３）
　記憶部２２の少なくとも一部は、検査装置１４とは別の場所に設置された外部記憶装置によって実現されてもよい。この場合、検査装置１４と外部記憶装置とは、ネットワークを介して通信可能に接続される。 (Modification 3)
At least a portion of the storage unit 22 may be realized by an external storage device installed at a location different from the inspection device 14. In this case, the inspection device 14 and the external storage device are communicably connected via the network.
　（変形例４）
　検査システム１０は、複数の血液バッグＢＧを運搬する運搬ロボットをさらに備えてもよい。検査装置１４は、運搬ロボットに指示することで、例えば血液バッグＢＧを振とう保存する振とう装置まで、上記（３）に該当する血液バッグＢＧを運搬ロボットに運搬させてもよい。これにより、検査員の作業負担がさらに低減する。 (Modification 4)
The testing system 10 may further include a transport robot that transports the plurality of blood bags BG. The inspection device 14 may instruct the transport robot to transport the blood bag BG corresponding to (3) above to a shaking device that shakes and stores the blood bag BG, for example. This further reduces the work burden on the inspector.
　（変形例５）
　表示制御部４２は、規格判定部４０の判定結果のみならず、各種データを表示画面１６１に適宜表示させてもよい。例えば、表示制御部４２は、検査装置１４が取得した撮像データ２０、色調データ４６、二値画像データ５０等を、表示画面１６１に表示させてもよい。 (Modification 5)
The display control unit 42 may display not only the determination result of the standard determination unit 40 but also various data on the display screen 161 as appropriate. For example, the display control unit 42 may display the imaging data 20, color tone data 46, binary image data 50, etc. acquired by the inspection device 14 on the display screen 161.
　（複数の変形例の組み合わせ）
　前述された複数の変形例は、矛盾しない範囲内において適宜組み合わされてもよい。 (Combination of multiple variations)
The plurality of modifications described above may be combined as appropriate within the scope of consistency.

Claims (15)

  1. 　血液製剤が入った血液バッグを撮像した撮像データに基づいて、前記血液製剤を含めた前記血液バッグの色調データを取得する色調取得部と、
    　前記色調データと、前記血液製剤が入っていない状態の前記血液バッグの基準色調データとの比較に基づいて、前記血液製剤の色味が許容範囲内であるか否かを判定する色味判定部と、
    　前記色味が前記許容範囲外である場合に、前記血液バッグ内の前記血液製剤は規格不適合であると判定する規格判定部と、
    　を備える、血液製剤の検査装置。     a color tone acquisition unit that acquires color tone data of the blood bag containing the blood product based on imaging data of the blood bag containing the blood product;
    a color determination unit that determines whether the color of the blood product is within an acceptable range based on a comparison between the color data and reference color data of the blood bag containing no blood product; and,
    a standards determination unit that determines that the blood product in the blood bag does not conform to the standards when the color is outside the allowable range;
    A blood product testing device comprising:
  2. 　請求項１に記載の血液製剤の検査装置であって、
    　前記色調取得部は、撮像された前記血液バッグの形状情報に基づいて、前記撮像データのうち前記色調データを取得する取得範囲を認識する、血液製剤の検査装置。     The blood product testing device according to claim 1,
    The color tone acquisition unit is a blood product testing device that recognizes an acquisition range from which the color tone data is to be acquired from among the imaged data based on shape information of the imaged blood bag.
  3. 　請求項２に記載の血液製剤の検査装置であって、
    　前記形状情報と製造メーカとを含むバッグ基準データを、複数の前記血液バッグごとに記憶する記憶部と、
    　撮像された前記血液バッグの製造メーカに基づいて、撮像された前記血液バッグに対応する前記バッグ基準データを決定する基準データ決定部と、
    　をさらに備え、
    　前記色調取得部は、前記基準データ決定部が決定した前記バッグ基準データの前記形状情報に基づいて、前記取得範囲を認識する、血液製剤の検査装置。     The blood product testing device according to claim 2,
    a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags;
    a reference data determination unit that determines the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag;
    Furthermore,
    The color tone acquisition unit recognizes the acquisition range based on the shape information of the bag reference data determined by the reference data determination unit.
  4. 　請求項１～３のいずれか１項に記載の血液製剤の検査装置であって、
    　前記色味が前記許容範囲内である場合に、前記血液バッグに異物が混入しているか否かを前記撮像データに基づいて判定する異物判定部をさらに備える、血液製剤の検査装置。     The blood product testing device according to any one of claims 1 to 3,
    A blood product testing device further comprising: a foreign matter determination unit that determines whether or not foreign matter is mixed in the blood bag based on the imaging data when the color is within the allowable range.
  5. 　請求項４に記載の血液製剤の検査装置であって、
    　前記異物判定部は、前記撮像データを二値化処理した二値画像データに基づいて、前記血液バッグに前記異物が混入しているか否かを判定する、血液製剤の検査装置。     The blood product testing device according to claim 4,
    The foreign substance determination unit is a blood product testing device that determines whether or not the foreign substance is mixed in the blood bag based on binary image data obtained by binarizing the imaging data.
  6. 　請求項４または５に記載の血液製剤の検査装置であって、
    　前記血液バッグに前記異物が混入していると判定された場合に、前記異物が混入していると判定された前記血液バッグに所定時間以上の振とう処理が既に施されているか否かを、前記振とう処理の実行履歴に基づいて判定する振とう判定部をさらに備え、
    　前記規格判定部は、前記異物が混入していると判定され、且つ、前記所定時間以上振とうされた前記血液バッグ内の前記血液製剤を規格不適合であると判定する、血液製剤の検査装置。     The blood product testing device according to claim 4 or 5,
    When it is determined that the foreign substance is mixed in the blood bag, it is determined whether the blood bag determined to be contaminated with the foreign substance has already been subjected to a shaking process for a predetermined time or more, further comprising a shaking determination unit that makes a determination based on the execution history of the shaking process,
    The standard determination unit determines that the blood product in the blood bag that has been determined to be contaminated with the foreign substance and that has been shaken for the predetermined time period or more does not conform to the standard.
  7. 　請求項６に記載の血液製剤の検査装置であって、
    　前記規格判定部は、前記異物が混入していると判定され、且つ、前記所定時間以上振とう処理がされていない前記血液バッグを、前記振とう処理の対象であると判定する、血液製剤の検査装置。     The blood product testing device according to claim 6,
    The standard determination unit determines that the blood bag that is determined to be contaminated with the foreign matter and that has not been shaken for more than the predetermined time is to be subjected to the shaking treatment. Inspection equipment.
  8. 　血液バッグに入っている血液製剤をコンピュータが検査する検査方法であって、
    　前記血液バッグを撮像した撮像データに基づいて、前記血液製剤を含めた前記血液バッグの色調データを取得する色調取得ステップと、
    　前記色調データと、前記血液製剤が入っていない状態の前記血液バッグの基準色調データとの比較に基づいて、前記血液製剤の色味が許容範囲内であるか否かを判定する色味判定ステップと、
    　前記色味が前記許容範囲外である場合に、前記血液バッグ内の前記血液製剤は規格不適合であると判定する規格判定ステップと、
    　を含む、検査方法。     A test method in which a computer tests blood products contained in a blood bag,
    a color tone acquisition step of acquiring color tone data of the blood bag including the blood product based on imaging data of the blood bag;
    a color determination step of determining whether the color of the blood product is within an acceptable range based on a comparison of the color data and reference color data of the blood bag containing no blood product; and,
    a standard determination step of determining that the blood product in the blood bag does not conform to the standard if the color is outside the allowable range;
    Inspection methods, including:
  9. 　請求項８に記載の検査方法であって、
    　前記色調取得ステップでは、前記コンピュータが、撮像された前記血液バッグの形状情報に基づいて、前記撮像データのうち前記色調データを取得する取得範囲を認識する、検査方法。     The testing method according to claim 8,
    In the color tone acquisition step, the computer recognizes an acquisition range from which the color tone data is to be acquired from the imaged data based on shape information of the imaged blood bag.
  10. 　請求項９に記載の検査方法であって、
    　前記コンピュータは、前記形状情報と製造メーカとを含むバッグ基準データを、複数の前記血液バッグごとに記憶する記憶部を備え、
    　前記検査方法は、撮像された前記血液バッグの製造メーカに基づいて、撮像された前記血液バッグに対応する前記バッグ基準データを決定する基準データ決定ステップをさらに含み、
    　前記色調取得ステップでは、前記基準データ決定ステップで決定した前記バッグ基準データの前記形状情報に基づいて、前記取得範囲を認識する、検査方法。     The testing method according to claim 9,
    The computer includes a storage unit that stores bag reference data including the shape information and manufacturer for each of the plurality of blood bags,
    The inspection method further includes a reference data determining step of determining the bag reference data corresponding to the imaged blood bag based on the manufacturer of the imaged blood bag,
    In the inspection method, in the color tone acquisition step, the acquisition range is recognized based on the shape information of the bag reference data determined in the reference data determination step.
  11. 　請求項８～１０のいずれか１項に記載の検査方法であって、
    　前記色味が前記許容範囲内である場合に、前記血液バッグに異物が混入しているか否かを前記撮像データに基づいて判定する異物判定ステップをさらに含む、検査方法。     The testing method according to any one of claims 8 to 10,
    The inspection method further includes a foreign matter determining step of determining whether or not a foreign matter is mixed in the blood bag based on the imaging data when the color is within the allowable range.
  12. 　請求項１１に記載の検査方法であって、
    　前記異物判定ステップでは、前記撮像データを二値化処理した二値画像データに基づいて、前記血液バッグに前記異物が混入しているか否かを判定する、検査方法。     The inspection method according to claim 11,
    In the foreign matter determining step, it is determined whether or not the foreign matter is mixed in the blood bag based on binary image data obtained by binarizing the imaging data.
  13. 　請求項１１または１２に記載の検査方法であって、
    　前記血液バッグに前記異物が混入していると判定された場合に、前記異物が混入していると判定された前記血液バッグに所定時間以上の振とう処理が既に施されているか否かを、前記振とう処理の実行履歴に基づいて判定する振とう判定ステップをさらに含み、
    　前記規格判定ステップでは、前記異物が混入していると判定され、且つ、前記所定時間以上振とうされた前記血液バッグ内の前記血液製剤を規格不適合であると判定する、検査方法。     The testing method according to claim 11 or 12,
    When it is determined that the foreign substance is mixed in the blood bag, it is determined whether the blood bag determined to be contaminated with the foreign substance has already been subjected to a shaking process for a predetermined time or more, further comprising a shaking determination step of determining based on the execution history of the shaking process,
    In the standard determination step, the blood product in the blood bag that has been determined to be contaminated with foreign matter and that has been shaken for more than the predetermined time is determined to be non-compliant with the standard.
  14. 　請求項１３に記載の検査方法であって、
    　前記規格判定ステップでは、前記異物が混入していると判定され、且つ、前記所定時間以上振とう処理がされていない前記血液バッグを、前記振とう処理の対象であると判定する、検査方法。     The testing method according to claim 13,
    In the standard determination step, the blood bag that is determined to be contaminated with the foreign matter and that has not been shaken for a predetermined period of time or more is determined to be subject to the shaking treatment.
  15. 　請求項８～１４のいずれか１項に記載の検査方法を前記コンピュータに実行させる、プログラム。 A program that causes the computer to execute the inspection method according to any one of claims 8 to 14.
PCT/JP2023/009199 2022-03-14 2023-03-10 Inspection device for blood product, inspection method, and program WO2023176707A1 (en)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2009085824A (en) * 2007-10-01 2009-04-23 Kawasumi Lab Inc Blood plasma color tone identifying unit and blood component separator
WO2012131892A1 (en) * 2011-03-29 2012-10-04 因幡電機産業株式会社 Device for quality inspection of blood preparation and method therefor
JP2012235984A (en) * 2011-05-13 2012-12-06 Daido Kogyosho:Kk Cooling device for blood

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Publication number Priority date Publication date Assignee Title
JP2009085824A (en) * 2007-10-01 2009-04-23 Kawasumi Lab Inc Blood plasma color tone identifying unit and blood component separator
WO2012131892A1 (en) * 2011-03-29 2012-10-04 因幡電機産業株式会社 Device for quality inspection of blood preparation and method therefor
JP2012235984A (en) * 2011-05-13 2012-12-06 Daido Kogyosho:Kk Cooling device for blood

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