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WO2012131892A1 - Dispositif pour l'inspection de qualité d'une préparation sanguine et procédé associé - Google Patents

Dispositif pour l'inspection de qualité d'une préparation sanguine et procédé associé Download PDF

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Publication number
WO2012131892A1
WO2012131892A1 PCT/JP2011/057771 JP2011057771W WO2012131892A1 WO 2012131892 A1 WO2012131892 A1 WO 2012131892A1 JP 2011057771 W JP2011057771 W JP 2011057771W WO 2012131892 A1 WO2012131892 A1 WO 2012131892A1
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WO
WIPO (PCT)
Prior art keywords
blood product
swirling
image
quality inspection
quality
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2011/057771
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English (en)
Japanese (ja)
Inventor
泰史 水田
晋吾 山本
一成 下垣
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japanese Red Cross Society
Inaba Denki Sangyo Co Ltd
Original Assignee
Japanese Red Cross Society
Inaba Denki Sangyo Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japanese Red Cross Society, Inaba Denki Sangyo Co Ltd filed Critical Japanese Red Cross Society
Priority to JP2011533441A priority Critical patent/JP4929422B1/ja
Priority to PCT/JP2011/057771 priority patent/WO2012131892A1/fr
Publication of WO2012131892A1 publication Critical patent/WO2012131892A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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

Definitions

  • the present invention relates to a blood product quality inspection apparatus and method, and more particularly to a blood product quality inspection apparatus and method for inspecting the quality of a blood product using a swirling phenomenon.
  • swirling inspections are performed at the time of preparation of preparations, delivery to medical institutions, and at each hospital where stored platelet preparations are stored.
  • Swirling is a spiral pattern seen when a platelet preparation is slowly stirred over light and reflects the morphology of the platelets. This is based on the fact that high-quality platelets have many swirling phenomena and are seen for a relatively long time, and on the contrary, low-quality platelets are based on the fact that almost no swirling phenomenon is seen.
  • this inspection is a visual appearance inspection, there is a problem that the subjectivity of the observer enters and lacks objectivity.
  • the content is a measurement based on platelet morphology, which can be roughly classified into a closed type and an open type, and a destructive type and a non-destructive type.
  • the closed type is a method of measuring through a blood bag
  • the open type is a method of extracting platelets from a preparation bag and measuring the platelet morphology of the extracted platelets.
  • the destructive type uses a visible light laser irradiation, a fluorescent substance, a sheath liquid, and the like, so that the function as platelets is destroyed after measurement, and it cannot be reused. Therefore, the open type and the destructive type are not practical for the preparation process, the inspection at the time of shipment, and the inspection at each hospital.
  • Patent Document 1 A conventional method for measuring platelet activity is disclosed, for example, in JP-A-60-113153 (Patent Document 1).
  • Patent Document 1 the blood product in the blood bag is flowed and the platelet activity is measured based on the fluctuation range of scattered light from the flowed platelets, and compared with numerical values measured under the same conditions for fresh platelets. .
  • This is a closed, non-destructive measurement method based on platelet morphology.
  • Patent Document 2 Another example of a conventional platelet freshness measuring apparatus is disclosed in, for example, Japanese Patent Laid-Open No. 10-197523 (Patent Document 2).
  • Patent Document 2 the quality is determined by a correlation index between a fluctuation range of numerical values obtained by receiving scattered light from platelets with a light receiving element and converting the amount of received light into digital data and an elapsed time after blood collection. This is also a closed and non-destructive measurement method based on platelet morphology.
  • Patent Document 3 Still another apparatus for measuring conventional platelet activity is disclosed in, for example, Japanese Patent Application Laid-Open No. 9-318624 (Patent Document 3).
  • a blood product is irradiated with illumination light, and its transmittance is obtained as a transmission amount in a stationary state to obtain static transmission strength, and dynamic transmission strength is obtained under lateral vibration.
  • Calculate the rate of change of the light transmission intensity which is the ratio of the difference between the dynamic and static transmission intensity and the static transmission intensity, and calculate the platelet ratio from the correlation between this and the normal platelet ratio. Yes.
  • the conventional methods for measuring the quality of blood products are all measurement methods based on platelet morphology as described above.
  • the fluctuation range of the amount of received light of scattered light or transmitted light is measured, so it is influenced by the material and density of the blood product bag, and is not compared with actual high quality platelet data. For this reason, there was a problem that it was limited to judgment as an index.
  • these conventional measurement methods have a problem that they are not put into practical use because they have no objective, effective, and practical aspects.
  • the present invention has been made in view of the above problems, and a blood product quality inspection apparatus capable of objectively, quantitatively and practically measuring the quality of platelets contained in a blood product, and The purpose is to provide an inspection method.
  • the blood product quality inspection apparatus includes a swirling generator that generates swirling in a blood product, an image detector that detects a swirling image generated by the swirler generator, and an image detector. Calculation means for calculating a parameter having a correlation with the quality of the blood product based on the detected swirling image.
  • an evaluation means for evaluating the quality of the blood product based on the parameter calculated by the calculation means is included.
  • the image detection means detects the color of the blood product.
  • the evaluation unit may evaluate the blood product by comparing the color of the blood product detected by the detection unit with the color obtained by inspecting a sample of a blood product that is registered in advance as a reference.
  • the swirl generating means includes a holding means for holding the blood product at an angle and a pressure releasing means for pressurizing and releasing the blood product held by the holding means.
  • the image detecting means may include a swirling image extracting means for extracting only the image of the swirling phenomenon from the captured image, and a calculating means for calculating the swirling image extracted by the swirling image extracting means as an area.
  • the parameters correlated with blood product quality may include% Discs or Stop & Flow method.
  • the image detection means may be a color camera.
  • the illumination device includes LED white parallel light transmission illumination.
  • the blood product may have data defining the blood product, and the evaluation means may evaluate the blood product in consideration of the data defining the blood product.
  • a blood product quality inspection method includes the steps of generating swirling in a blood product, detecting a test image including an image of the generated swirling, and detected swirling Calculating a parameter having a correlation with the quality of the blood product based on the image.
  • the quality of the blood product in order to generate a swirling in the blood product, to detect the generated swirling image, and to calculate a parameter having a correlation with the quality of the blood product based on the detected swirling image,
  • the quality of the blood product can be known from the detected swirling image.
  • FIG. 1 is a block diagram showing an overall configuration of a blood product quality inspection apparatus according to an embodiment of the present invention.
  • blood product quality inspection apparatus 10 includes blood product imaging unit 11 and control unit 20.
  • the blood product imaging unit 11 generates swirling by placing a bag (hereinafter referred to as “blood product”) 30 containing the blood product obliquely by a predetermined angle, pressurizing and releasing it.
  • the pressurizing device 12, the CCD color camera 18 that images the blood product 30 placed on the pressurizing device 12 from the front side, and an illumination unit (illuminating means) 15 that irradiates the blood product 30 with light for imaging.
  • the pressurizing device 12 operates as a swirling generator and a holding unit.
  • the CCD color camera 18 operates as an image detection means.
  • the illumination unit 15 includes an LED white diffuse reflection illumination 15a that irradiates the blood product 30 from the front right side, an LED white diffuse reflection illumination 15b that irradiates the blood product 30 from the front left side, and the blood product 30 from the back pressure plate side.
  • LED white parallel light transmitting illumination 15c to be irradiated Further, it includes first and second light control sections (light control means) 19a and 19b that control the light applied to each of the above-described lights 15a to 15c. Each of the lights 15a to 15c and the dimming units 19a and 19b are controlled by a control controller 21.
  • a barcode reader 31 for reading a barcode attached to the blood product 30 is provided.
  • the control unit 20 includes a control controller 21 for controlling the whole blood product quality inspection apparatus 10, a start button 21 a for starting the operation of the control controller 21, and a display for displaying a calculation result in the control controller 21. It includes a dual operation touch monitor 22 and an image processing system 23.
  • the image processing system 23 controls the CCD color camera 18 and inputs an image captured by the CCD color camera 18, an image processing unit 26 that performs image processing on an image captured by the image capture control unit 25, and a predetermined
  • the calculation unit 27, the determination result calculation result display unit 28, and the data storage unit 29 for storing imaging data and calculation results are included.
  • FIG. 2 is a diagram showing a specific configuration of the pressurizing device 12.
  • the pressurizing device 12 has a tiltable back pressure plate 12a and an insertion portion for inserting the blood product 30 therebetween, and a holding plate 12b for holding the inserted blood product from above.
  • a holding portion 12c that holds the back pressure plate 12a and the holding plate 12b, and a pressure mechanism (not shown) that pressurizes the blood product 30 by changing the position of the back pressure plate 12a relative to the holding plate 12b.
  • the central part of the back pressure plate 12a and the holding plate 12b is transparent, and the blood product 30 can be seen from the outside through the holding plate 12b.
  • the CCD color camera 18 images the blood product 30 at a substantially central portion (indicated by A in the figure) where the blood in front of it is located.
  • FIG. 3 is a graph when the blood product 30 is pressurized and released by a pressure mechanism (not shown).
  • the horizontal axis is time, and the vertical axis is the swirling area in the inspection region.
  • the blood product 30 is pressurized and released to generate swirling in the blood product. This pressurization time can be adjusted, and is preset in the inspection.
  • the blood product 30 is pressurized to a thickness of 1 mm as a pressurizing amount and held for 0.1 seconds in that state.
  • FIG. 4 is a flowchart showing the operation of the blood product quality inspection apparatus. Basically, it is the operation of the control unit 20.
  • the operator inserts the blood product 30 into a predetermined position of the pressurizing device 12 (FIG. 1, S11).
  • the blood product is set so that the back pressure plate 12a is inclined in order to move bubbles when swirling occurs to the upper part which is a non-measurement region.
  • the pressurizing device 12 moves the back pressure plate 12a until the distance between the back pressure plate 12a and the holding plate 12b becomes 7 mm in order to fix the blood product 30 (S12, S13).
  • LED white diffuse reflection lights 15a and 15b installed on the left and right of the blood product 30 are irradiated (S14), and the blood product 30 is imaged with the CCD color camera 18 installed on the front of the blood product 30 (S15).
  • the image processing system 23 measures the intensity of the captured image (S16).
  • the second light control unit 19b is operated to adjust the illuminance of the LED white diffuse reflection illumination 15a (S17). This is to eliminate the influence of the blood product material and the concentration of the blood product. Thereafter, a light-adjusted image is picked up by the CCD color camera 18, and the values for each of R, G, and B are inspected by the image processing unit 26 of the image processing system 23 (S18, S19).
  • test result is compared with the master data of the actual blood product registered in the data storage unit 29 in advance by the calculation unit 27 to determine whether the color is appropriate or inappropriate, and the display unit 28 displays the determination result as test data (S20). , S21).
  • LED white parallel light transmission illumination 15c is irradiated from the back of the blood product (S22), and an image is taken by the CCD color camera 18 installed in front of the blood product (S23).
  • the image processing system 23 checks the intensity of the captured image (S24), and adjusts the illuminance of the LED white parallel light transmitting illumination 15c by the first dimming unit 19a according to the intensity (S25).
  • driving with a DC power source enables stable and uniform illumination, and by using the LED white parallel light transmissive illumination 15c, the swirling phenomenon can be clearly projected.
  • a swirling phenomenon is generated by pressurizing the blood product 30 to a thickness of 1 mm and releasing it at once by driving a pressurizing mechanism (not shown) (S26). These series of operations are preferably time-controlled with the amount of pressurization.
  • the pressure device 12 is preferably a mechanical type. This is because the repeatability and position accuracy are high. In addition, swirling does not occur in low-quality products.
  • the inspection area including the swirling phenomenon part generated by the release is imaged by the CCD color camera 18 (S27).
  • the image captured by the CCD color camera 18 is inspected by the image processing unit 26 using the swirling phenomenon portion as a swirling area value (S28).
  • the calculation unit 27 uses the determination data based on the correlation between the swirling area value in the actual preparation registered in advance in the data storage unit and the% Discs of the platelet morphology evaluation method or the measurement result obtained by the Stop & Flow method.
  • step S29 whether the quality is appropriate or inappropriate is determined (S29), and the determination result and the inspection data are displayed on the display unit 28 (S30).
  • the pressurizer 12 returns to the original position (15 mm thickness) (S31), and the operator takes out the blood product.
  • the swirling area value becomes a parameter having a correlation with the quality of the blood product
  • the image processing unit 26 operates as the calculation unit
  • the calculation unit 27 operates as the evaluation unit.
  • the swirling image inspection is performed using the swirling area value obtained by the image processing unit 26.
  • the method for obtaining the swirling area is as follows. Note that the image processing unit 26 operates as a swirling image extraction unit.
  • the inspection area is set from the captured image captured by the CCD color camera 18. This inspection area is determined in advance. It should be noted that it is preferable that a predetermined region is set in advance at the time of inspection.
  • the method for obtaining the swirling area value is as follows. First, using the CCD color camera 18 and installing the LED white parallel light transmitting illumination 15c on the back of the blood product 30 to generate the swirling phenomenon, Take still images continuously. Here, the imaging time is 5 seconds. By installing the LED white parallel light transmitting illumination 15c, the imaged image can be clearly black in the spiral pattern. A peak value of a swirling area obtained from an image captured by continuous imaging is determined by an area ratio (% display) in the inspection region.
  • FIG. 5A to FIG. 5C and FIG. 6A to FIG. 6C are diagrams for explaining the contents of the inspection.
  • FIG. 5A is a schematic diagram illustrating a captured image 41 captured by the CCD color camera 18
  • FIG. 5B is a diagram illustrating an inspection image 42 created based on the captured image 41 when swirling is large, and FIG. It is a figure which shows the test
  • the captured image 41 includes a portion 41a that has become white due to the transmission of light from the back surface at the center by irradiation with the LED white parallel light transmission illumination 15c, and a black spiral pattern 41b therein.
  • image processing of this image as shown in FIGS. 5B and 5C, only the swirling phenomenon portions (portions surrounded by solid lines in the drawing) 42a and 43a are whitened and the other portions are binarized black.
  • FIGS. 5A to 5C are diagrams for explaining a method of detecting only the swirling phenomenon portion.
  • 6A is a view similar to FIG. 5A
  • FIG. 6B is a view showing an enlarged image 45 in which a part of the inspection region 44 in FIG. 6A (portion surrounded by a dotted line in the drawing) is enlarged.
  • an element 46 for binarization detection is shown.
  • An element is a collection of pixels that can be arbitrarily set within the inspection region 44. Here, the number of pixels is 7 in the vertical and horizontal directions. In all the areas in the inspection area 44 in FIG.
  • the amount of color change (color difference) between adjacent elements in the vertical and horizontal directions is obtained.
  • This comparison interval can be set in advance.
  • Four elements surrounded by squares on the top, bottom, left and right around the element 46 are elements to be compared.
  • the elements to be compared are determined at intervals of 10 pixels from the center position of the element 46.
  • elements exceeding the preset change amount are whitened, and elements below the same are blackened. It is preferable that the change amount set in advance is determined appropriately by visually confirming the swirling phenomenon.
  • FIG. 6C shows an enlarged inspection image 47 binarized by performing the above-described image processing on the enlarged image 45 shown in FIG. 6B.
  • the hatched part is the part binarized black.
  • the inspection image 42 shows a predetermined inspection area.
  • the inspection area is, for example, vertical 330 pixels and horizontal 385 pixels, and a total of 1,207,050 pixels.
  • the area ratio in the inspection area is calculated in order to judge whether the quality is appropriate or not. This is based on the determination that it is easier to understand than the area determination based on the number of pixels because of the request from the inspector.
  • the element size has been described for the case where each of the vertical and horizontal dimensions is 7 pixels, but according to the experiments by the inventors, the most suitable pixel that can clarify the swirling area according to the size of this pixel. It was a number.
  • the method for obtaining color data is as follows. An inspection area is set from the captured image captured by the CCD color camera 18. This inspection area can be arbitrarily set in the captured image. In this inspection area, R, G, and B values are represented by 256 gradations for each pixel. Then, all the pixel data (R, G, B values) in the inspection area are averaged. As a result, even subtle color differences can be inspected.
  • the quality of the blood product 30 is evaluated by comparing this with reference data stored in advance in the data storage unit 29.
  • the determination result (the ratio of the swirling area) by the apparatus according to this embodiment reflects the morphology of the platelets.
  • Table 1 shows the results of evaluating the simultaneous reproducibility of swirling analysis.
  • the test blood number in which swirling was observed had a coefficient of variation (CV) of less than 10% and high co-reproducibility in any blood.
  • the determination result (the ratio of swirling area) by the apparatus according to this embodiment was highly correlated with the evaluation result of platelet morphology, so the analysis result is an objective value of swirling It was thought that it could be used.
  • the determination result (swirling area ratio) of the apparatus according to this embodiment has high simultaneous reproducibility, it can be sufficiently used as a quality inspection apparatus in the manufacturing department and the sales department.
  • the ratio data of the swirling area indicates an average value ⁇ standard deviation when measured six times continuously.
  • the barcode having data defining the collection time of the blood product attached to the blood product is read with a barcode reader, and the degree of deterioration of the blood product is determined from the read barcode. It is also possible to judge.
  • the blood product quality inspection apparatus according to the present invention can be used advantageously as a blood product quality inspection apparatus because the quality of the blood product can be known from the swirling image.
  • 10 blood product quality inspection device 11 blood product imaging unit, 12 pressurization device, 15 illumination unit, 18 CCD color camera, 19a, 19b dimming unit, 20 control unit, 21 control controller, 21a start button, 22 display Combined operation touch monitor, 23 image processing system, 25 imaging control unit, 26 image processing unit, 27 calculation unit, 28 determination result calculation result display unit, 29 data storage unit, 30 blood product, 31 barcode reader.

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Abstract

L'invention concerne un dispositif pour l'inspection de qualité d'une préparation sanguine, comprenant : un moyen induisant un tourbillonnement pour induire un tourbillonnement dans la préparation sanguine; un moyen de détection d'images pour la détection d'images d'inspection, lesdites images d'inspection comprenant une image du tourbillonnement induit par le moyen d'induction de tourbillonnement; et un moyen de calcul pour le calcul d'un paramètre, qui présente une corrélation avec la qualité de la préparation sanguine, sur la base de l'image de tourbillonnement détectée par le moyen de détection d'images.
PCT/JP2011/057771 2011-03-29 2011-03-29 Dispositif pour l'inspection de qualité d'une préparation sanguine et procédé associé Ceased WO2012131892A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2011533441A JP4929422B1 (ja) 2011-03-29 2011-03-29 血液製剤品質検査装置およびその方法
PCT/JP2011/057771 WO2012131892A1 (fr) 2011-03-29 2011-03-29 Dispositif pour l'inspection de qualité d'une préparation sanguine et procédé associé

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PCT/JP2011/057771 WO2012131892A1 (fr) 2011-03-29 2011-03-29 Dispositif pour l'inspection de qualité d'une préparation sanguine et procédé associé

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021126041A1 (fr) * 2019-12-18 2021-06-24 Cyteguard Ab Régulation de concentré de plaquettes
JP2022109095A (ja) * 2021-01-14 2022-07-27 株式会社パパラボ 血液製剤検査装置および血液製剤検査方法
WO2023176707A1 (fr) * 2022-03-14 2023-09-21 テルモ株式会社 Dispositif d'inspection pour produit sanguin, procédé d'inspection et programme

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000046723A (ja) * 1998-07-28 2000-02-18 Sysmex Corp 血小板機能検査方法
JP2008214367A (ja) * 2007-02-28 2008-09-18 Sanyo Chem Ind Ltd 酸素含有ポリウレタンフォーム

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000046723A (ja) * 1998-07-28 2000-02-18 Sysmex Corp 血小板機能検査方法
JP2008214367A (ja) * 2007-02-28 2008-09-18 Sanyo Chem Ind Ltd 酸素含有ポリウレタンフォーム

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
OTO ET AL.: "Kesshoban Seizai ni yoru Haiketsusho no Yobo to Taiosaku ni Kansuru Tebiki", JAPANESE JOURNAL OF TRANSFUSION AND CELL THERAPY, vol. 54, no. 3, 2008, pages 419 - 421 *
SHIMIZU ET AL.: "SWIRLING PATTERN TEST FOR THE EVALUATION OF QUALITY OF PLATELET CONCENTRATES -swirling pattern test", JAPANESE JOURNAL OF TRANSFUSION MEDICINE, vol. 41, no. 3, 1995, pages 207 - 212 *
SHIMOGAKI ET AL.: "Shikaku Sensor o Mochiita Noko Kesshoban Seizai no Swirling Hantei", DAI 32 KAI NIPPON KETSUEKI JIGYO GAKKAI SOKAI SHOROKUSHU, 2008, pages 251 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021126041A1 (fr) * 2019-12-18 2021-06-24 Cyteguard Ab Régulation de concentré de plaquettes
CN114829904A (zh) * 2019-12-18 2022-07-29 赛特加德股份有限公司 浓缩血小板控制
JP2022109095A (ja) * 2021-01-14 2022-07-27 株式会社パパラボ 血液製剤検査装置および血液製剤検査方法
JP7515879B2 (ja) 2021-01-14 2024-07-16 株式会社パパラボ 血液製剤検査装置および血液製剤検査方法
WO2023176707A1 (fr) * 2022-03-14 2023-09-21 テルモ株式会社 Dispositif d'inspection pour produit sanguin, procédé d'inspection et programme

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