Blood preparation inspection device and blood preparation inspection method

Abstract

To shorten the inspection time of blood preparations and improve accuracy.SOLUTION: An inspection device 1 comprises: a housing 2 having an opening / closing door 2a with an opening on its upper surface, a handle 2b provided on the opening / closing door 2a, and an illumination box 2c extending upward from the opening and having an internal space; a transparent placement section 4 provided inside the housing 2 for placing a transfusion bag 3; a drive section 7 having a pressing plate 5 capable of pressing the transfusion bag 3 and an electromagnetic actuator 6 that reciprocates the pressing plate 5 in a specific direction X of the housing 2; and a two-dimensional colorimeter 9 that images the transfusion bag 3 from below under illumination from an illumination section 8 provided inside the illumination box 2c, and generates an image.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention relates to a blood product inspection apparatus and method for inspecting swirling of blood products.

Background Art

[0002] In the invention of Patent Document 1, the blood product imaging unit 11 includes a pressurizing device 12 that generates swirling by tilting an infusion bag 30 at a predetermined angle obliquely, placing it, and pressurizing and releasing it, a CCD color camera 18 that images the infusion bag 30 placed on the pressurizing device 12 from the front side thereof, and an illumination unit 15 that irradiates light onto the infusion bag 30 for imaging.

[0003] The swirling generation unit 3 of the invention of Patent Document 2 has a space for accommodating the bag B, and includes a slider 32 provided with a glass plate 31 forming an imaging surface on the bottom surface so as to be imaged by a two-dimensional colorimeter 9 from below, and a support portion 34 having a slide mechanism 33 including a spring for sliding the slider 32. The bag B is slid while being accommodated in the slider 32, and swirling is generated in the bag B by oscillation due to the impact of the slider 32 colliding with the wall of the support portion 34.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, the inventions of Patent Documents 1 and 2 have the following problems and are not yet sufficient.

[0006] The invention of Patent Document 1 requires a great deal of time to complete the inspection for at least one blood product bag, from imaging, grayscale inspection, dimming control, driving of the pressurizing mechanism, imaging by a CCD camera, binarization processing of the image, area ratio calculation, correlation comparison, to result display. The pressurizing mechanism also has a complex structure. Therefore, there is a problem that a large amount of blood products cannot be efficiently inspected in a short time.

[0007] Also, as described above, various processes and comparisons are performed to obtain the final result of the inspection of blood products. Since multiple images are captured, there are variations due to the repetition accuracy of image capture. The binarization of the captured image performs image processing based on a threshold value, so the result varies greatly depending on the setting of the threshold value. Since the result is displayed by looking at the correlation with a known evaluation method, it is also affected by the reliability of the known evaluation method. The more procedures are involved in such processing, the more the cumulative errors generated in each of the above processes are superimposed on the raw information, resulting in low inspection accuracy.

[0008] In the case of Patent Document 2, when the slider is slid, the spring extends and is held in the slid state. It is a method of generating swirling by the impact force of the slider colliding with the wall due to the return force of the spring caused by operating the return switch to release the slider. Hard operations such as manually sliding the lid to a predetermined position and operating the return switch for applying an impact are troublesome. Since the blood product in the bag swings greatly, it takes time until the movement of the blood product subsides. Therefore, there is a problem that the imaging time by the two-dimensional colorimeter is delayed.

[0009] Also, since the swirling is caused by the force of the spring, it is considered that the occurrence condition of swirling varies each time the inspection is performed due to two factors: the variation of the impact generated when the spring contracts and the variation of the content volume of the infusion bag. Ideally, an apparatus that can obtain the same result regardless of how many times a sample is measured is ideal. However, since the measured value may vary each time the sample changes or each time the same sample is measured, the accuracy is not yet sufficient.

[0010] In view of the above problems, the present invention aims to shorten the inspection time of blood products and improve the accuracy.

Means for Solving the Problems

[0011] In view of the above problems, the present invention includes a drive unit having a transparent placement portion provided in a housing for placing a blood product bag, a pressing portion capable of pressing the blood product bag, and an electromagnetic actuator that reciprocates the pressing portion in a specific direction of the housing; and a two-dimensional colorimeter that captures an image of the blood product bag from below under the illumination of an illumination unit provided in the housing and generates an image. When the pressing portion descends as the electromagnetic actuator is driven, a part of the blood product bag is pushed down. When the pressing portion ascends as the electromagnetic actuator is driven, it disengages from the blood product bag, generating swirling in the blood product in the blood product bag, capturing an image of the lower surface of the blood product bag, and generating a swirling image showing the swirling. And analyzing the color distribution of the swirling image to inspect the swirling. It is a blood product inspection device characterized by the above.

[0012] According to the principle of the swirling generation mechanism of the present invention, when the pressing portion is lowered to push down a part of the blood product bag to a specific thickness, the non-pressed part bulges. When the pressing portion is raised, swirling occurs due to the movement of the bulging part trying to return to its original position under gravity. The strength of the swirling phenomenon of the blood product can be seen depending on the quality of the blood product. The pressing portion presses a part of the blood product bag, returns upward, and disengages from the blood product bag, causing the blood product to move, and it is possible to capture an image of the blood product bag by a two-dimensional colorimeter for the generated swirling.

[0013] With this configuration, the present invention generates swirling by a simple mechanism in which the pressing portion deforms when pressing the blood product bag downward and the blood product moves when the blood product bag returns to its original shape when the pressing portion ascends. By capturing an image of this swirling from below, it is possible to shorten the inspection time of blood products and improve the accuracy.

[0014] It is preferable that the surface area of the lower surface of the pressing portion is set smaller than the area of the upper surface of the blood preparation bag.

[0015] With this configuration, the pressing plate 5 can be downsized, the area where the pressing portion presses the blood preparation bag can be reduced, and the momentum of the blood preparation bag can be reduced. Therefore, it is possible to further shorten and accurately measure the inspection time.

[0016] The specific direction is the drive axis of the electromagnetic actuator. When inspecting the blood preparation bag, it is preferable that the drive axis and the imaging axis of the two-dimensional colorimeter are arranged at a specific distance and offset.

[0017] With this configuration, in the present invention, the setting of the angle of view of the two-dimensional colorimeter becomes appropriate, and the inspection area can be set in an area where the pressing portion does not hold the blood preparation. Therefore, it can be set small, and it is possible to further shorten and accurately measure the inspection time.

[0018] It is preferable that the inspection area of the blood preparation bag is set to an area smaller than the surface area of the blood preparation bag. For example, it is exemplified that an area with a surface area of one-fifth to one-half of the surface area of the blood preparation is set as the inspection area.

[0019] With this configuration, in the present invention, the image processing time can be shortened, and it is possible to further shorten and accurately measure the inspection time.

[0020] It is preferable to provide an opening / closing portion in the housing, provide the driving portion in the opening / closing portion, make the placement portion visible when the opening / closing portion is in an open state, and make the inside of the front housing in a dark room state when the opening / closing portion is in a closed state.

[0021] With this configuration, in the present invention, the driving portion does not interfere with the placement of the blood preparation bag, and the housing can be made compact.

[0022] It is preferable that the lighting unit is a surface-emitting lighting unit that illuminates the blood product bag from above, and the two-dimensional colorimeter images the blood product bag from the lower surface of the placement unit.

[0023] With this configuration, the present invention can improve the lighting efficiency and make the housing more compact.

[0024] The present invention includes a monitor and a computer. The computer has a storage unit, an arithmetic unit, a determination unit, and a command unit. The computer images the blood product bag before swirling caused by the pressing unit with the two-dimensional colorimeter, generates a first color distribution of the acquired first image, images the blood product bag in a state where swirling is caused by the pressing unit again with the two-dimensional colorimeter, generates a second color distribution of the acquired second image, compares the first color distribution and the second color distribution, detects the degree of coincidence of the color distributions of the first color distribution and the second color distribution, and evaluates the strength of swirling based on the degree of coincidence. It is preferable to execute an evaluation display process for displaying the evaluation of the swirling on the monitor.

[0025] With this configuration, the present invention only needs to image before and after the occurrence of swirling, so the inspection time can be further shortened.

[0026] The blood product inspection method of the present invention includes a placement step of placing a blood product bag on a transparent placement unit provided in a housing, a first imaging step of acquiring a reference image by imaging a inspection region, which is the front part or a part of the blood product bag, from below with a two-dimensional colorimeter under illumination while the blood product bag is stopped on the placement unit, a generation step of generating swirling by pressing the blood product bag with a pressing unit that descends and then raising the pressing unit to separate it from the blood product bag, a second imaging step of acquiring a swirling image by imaging the inspection region of the blood product bag from below with a two-dimensional colorimeter after the pressing unit has risen under illumination, and a comparison step of comparing the color distribution of the reference image and the color distribution of the swirling image.

[0027] With this configuration, the present invention generates swirling by a simple mechanism in which when the pressing part presses the blood product bag downward, it deforms, and when it rises, the blood product moves when the blood product bag returns to its original shape. By imaging this swirling from below, it is possible to shorten the inspection time of the blood product and improve the accuracy.

Effects of the Invention

[0028] According to the present invention, accurate quantification as a swirling measurement device can be established, and shortening of the swirling inspection time can be realized.

Brief Description of the Drawings

[0029]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Modes for Carrying Out the Invention

[0030] Hereinafter, a blood product inspection apparatus 1 (hereinafter referred to as the inspection apparatus 1), which is an embodiment of the present invention, will be described with reference to the drawings.

[0031] This inspection apparatus 1 includes a housing 2 having an opening / closing door 2a with an opening on the upper surface, a handle 2b provided on the opening / closing door 2a, and a lighting box 2c having an internal space and extending upward from the opening; a transparent placement portion 4 provided in the housing 2 for placing a blood product bag 3 (hereinafter referred to as the infusion bag 3) in which a blood product is enclosed; a pressing plate 5 capable of pressing the infusion bag 3; and a drive unit 7 having an electromagnetic actuator 6 that reciprocates the pressing plate 5 in a specific direction X of the housing 2. The inspection apparatus 1 also includes a two-dimensional colorimeter 9 that captures an image of the infusion bag 3 from below and generates an image under the illumination of a surface-emitting illumination unit 8 provided in the lighting box 2c.

[0032] The pressing plate 5 extends horizontally from the lower end of the cylinder portion of the electromagnetic actuator 6. As the pressing plate 5 descends with the drive of the electromagnetic actuator 6, a part of the infusion bag 3 is pushed down. Also, as the pressing plate 5 ascends with the drive of the electromagnetic actuator 6, the pushed-down part tries to return to its original position, thereby generating swirling in the blood product inside the infusion bag 3. At this time, a part of the lower surface of the infusion bag 3 is imaged to generate a swirling image indicating the swirling, and a swirling inspection is performed by analyzing the color distribution of the swirling image.

[0033] The housing 2 is a horizontally long box (its shape can be set as appropriate), has an opening / closing door 2a on the upper surface, and the upper surface is openable. One side of the opening / closing door 2a is hinge-connected to the upper part of the main body of the housing 2 and is rotatable about a rotation axis. When imaging the infusion bag 3, it is desirable that the inside of the housing 2 is in a darkroom environment as much as possible, so the entire back surface of the opening / closing door 2a and the lighting box 2c is painted black.

[0034] The lighting box 2c is provided because it is necessary to increase the distance between the surface-emitting illumination unit 8, which is a light source, and the two-dimensional colorimeter 9. If this distance can be ensured, the lighting box 2c is not necessary, and its structure can be other appropriate configurations.

[0035] When the opening / closing door 2a is closed and the surface light-emitting illumination unit 8 is OFF, the interior of the main body 2 is in a darkroom environment. This is because when the surface light-emitting illumination unit 8 emits light, an image is generated by the light entering the two-dimensional colorimeter 9, and it is desirable that the measurement environment does not change during the swirling measurement. If it is not a darkroom environment, the external disturbance light (such as sunlight) entering from the outside is irregular in terms of the position and time of entry, which will cause variations in the measurement environment. If the measurement environment is not stable, accurate measurement cannot be performed. Even if there are fluctuations in the measurement values, it is impossible to distinguish whether they are [differences caused by the measurement object] or [differences caused by the environment]. Therefore, ideally, no external disturbance light should enter. Thus, the purpose of the darkroom environment is to unify the measurement environment.

[0036] The inspection area of the infusion bag 3 is set to an area smaller than the surface area of the infusion bag 3.

[0037] The placement part 4 is located below the opening / closing door 2a at the upper part inside the housing 2 and is placed at a specific angle obliquely toward the open end of the opening / closing door 2a. The placement part 4 has a surface area larger than the surface area of the infusion bag 3, and its area is set so that the infusion bag 3 can be stably placed.

[0038] When placing the bag on the placement part 4, the liquid will shake slightly. However, since the process is to place the infusion bag 3 on the placement part 4, close the opening / closing door 2a, perform software operations, and start the inspection, the shaking of the liquid has subsided sufficiently by the time the inspection starts.

[0039] Since air bubbles are visible in the infusion bag 3 and the measurement values will be affected if the air bubbles enter the viewing angle of the two-dimensional colorimeter 9, the placement part 4 is provided with an inclination for the purpose of moving the air bubbles outside the viewing angle.

[0040] The pressing plate 5 extends horizontally from the main body of the electromagnetic actuator 6. The pressing plate 5 is preferably a plate with a specific shape, for example, a square plate, and has an area of not more than half of the upper surface area of the infusion bag 3 and not less than one-fifth of the lower surface area. However, the area can be set to an appropriate value. In the figure, the driving shaft of the cylinder of the electromagnetic actuator 6 is orthogonal to the plate direction of the pressing plate 5, but an appropriate angle is acceptable.

[0041] When imaging the infusion bag 3, in the embodiment, the pressing plate 5 is not transparent and will interfere with imaging. Therefore, for the purpose of avoiding this, as shown in FIG. 6, the imaging angle is set. At this imaging angle, an imaging image corresponding to the imaging range is captured, and further, an inspection range (a partial range on the imaging image arbitrarily set by the user as the inspection location) is set. Note that even if the material of the pressing plate 5 is made transparent, there is a possibility of interfering with imaging regardless of the color. Therefore, it is preferable to set the imaging angle as shown in FIG. 6.

[0042] To image the swirling, it is necessary to ensure that the pressing plate 5 and the electromagnetic actuator 6 do not fall within the imaging angle of the two-dimensional colorimeter 9, or, when they fall within the imaging angle of the two-dimensional colorimeter 9, perform image analysis with the pressing plate 5 and the electromagnetic actuator 6 excluded from the inspection range.

[0043] The electromagnetic actuator 6 is exemplified by an electromagnetic cylinder composed of a solenoid, a motor, a piston, a cylinder, a controller, etc. The main body of the electromagnetic actuator 6 is fixed to the opening / closing door 2a, and the driving shaft is movable in the vertical direction with respect to the through hole of the opening / closing door 2a. In FIGS. 5, 6, etc., the electromagnetic actuator 6 appears to be in contact with the surface-emitting illumination unit 8, but it is not necessary for the two to be in contact. The specific direction X is the driving axis of the electromagnetic actuator 6, and this driving axis and the imaging axis Y (optical axis) of the two-dimensional colorimeter 9 are arranged with a specific distance and offset (a specific distance and deviation). This is to prevent the electromagnetic actuator from entering the imaging angle of the two-dimensional colorimeter 9 or to reduce the part that enters the imaging angle.

[0044] The cylinder lifting speed of the electromagnetic cylinder 6 is related to the liquid sloshing of the blood preparation. The cylinder lifting speed operates, for example, at about 30 [mm / s] (about 1 second for a stroke of 30 mm), but is not limited to this meaning. If the cylinder lifting speed is too slow, swirling may not occur. If it is too fast, the sloshing may increase. Therefore, appropriate upper and lower limit values are determined for the cylinder lifting speed with respect to the swirling occurrence phenomenon.

[0045] The drive unit 7 is composed of a pressure plate 5 and an electromagnetic actuator 6. The drive shaft of the electromagnetic actuator 6 is in a specific direction X. The pressure plate 5 is fixed orthogonally to this drive shaft. The electromagnetic actuator 6 is provided on the opening / closing door 2a of the housing 2, and the pressure plate 5 is provided so as to be located below the electromagnetic actuator 6.

[0046] The surface-emitting illumination unit 8 is fixed to the opening / closing door 2a. When the opening / closing door 2a is closed, the light emitted from the surface-emitting illumination unit 8 irradiates the upper surface of the infusion bag 3.

[0047] The two-dimensional colorimeter 9 images a part of the infusion bag 3 from below. The two-dimensional colorimeter 9 may image the entire infusion bag 3. The specific direction X, which is the drive axis of the electromagnetic actuator 6, and the imaging axis Y of the two-dimensional colorimeter 9 are arranged offset. This is to avoid the reflection entering the inspection range of the images of the pressure plate 5 and the electromagnetic actuator 6 as much as possible.

[0048] Regarding the reflection entering this inspection range, those outside the measurement target reflected in the background of the swirling image are excluded from the inspection range. The swirling image on the lower side of the pressure plate 5 is not used because light cannot reach it. Ideally, the imaging range for swirling judgment is desirably as wide as possible. However, if a range where the swirling phenomenon can be sufficiently observed is ensured, the judgment can be made even from the imaging images of a partial range.

[0049] The two-dimensional colorimeter 9 is exemplified by the two-dimensional colorimeters described in the applicant's Japanese Patent Application Laid-Open Nos. 2018-141687, 2016-194456, 2016-164559, Patent No. 5895094, 2015-155892, Re-Publication No. 2015 / 107889, 2014-187558, etc., and the two-dimensional colorimeters of the applicant's products RC-300, RC-500, RC-4000, etc.

[0050] The two-dimensional colorimeter 9 has three spectral sensitivities (S1(λ), S2(λ), S3(λ)) that are linearly transformed equivalently to the CIE XYZ color-matching functions and generates 3-band visual sensitivity images S1i, S2i, S3i.

[0051] The spectral sensitivity of the two-dimensional colorimeter 9 satisfies the router condition, and its spectral sensitivities (S1(λ), S2(λ), S3(λ)) are equivalent transformations from the XYZ color-matching functions under the conditions of having no negative values, being mountain-shaped with single peaks, having equal peak values for each spectral sensitivity curve, and minimizing the overlap of the spectral sensitivity curves as much as possible. Specifically, the spectral sensitivities (S1(λ), S2(λ), S3(λ)) have the following characteristics. Record Peak wavelength Half-value width 1 / 10 width S1 582nm 523~629nm 491~663nm S2 543nm 506~589nm 464~632nm S3 446nm 423~478nm 409~508nm

[0052] The spectral sensitivities (S1(λ), S2(λ), S3(λ)) of the two-dimensional colorimeter 9 are mountain-shaped with a single peak and no negative values from the CIE XYZ spectral characteristics. They are equivalently converted under the conditions that the peak values of each spectral sensitivity curve are equal and overlap of the spectral sensitivity curves is minimized. The curve of the spectral characteristics S1 has a peak wavelength of 582 nm, a half-width of 523 to 629 nm, and a 1 / 10 width of 491 to 663 nm. The curve of the spectral characteristics S2 has a peak wavelength of 543 nm, a half-width of 506 to 589 nm, and a 1 / 10 width of 464 to 632 nm. The curve of the spectral characteristics S3 has a peak wavelength of 446 nm, a half-width of 423 to 478 nm, and a 1 / 10 width of 409 to 508 nm.

[0053] The peak wavelength of the above-mentioned spectral characteristic S1 can be treated as 580±4 nm, the peak wavelength of the spectral characteristic S2 as 543±3 nm, and the peak wavelength of the spectral characteristic S3 as 446±7 nm.

[0054] The relationship between the three spectral sensitivities (S1(λ), S2(λ), S3(λ)) and normalized x, y, and z is defined by the following equation 1. For details about the spectral characteristics themselves, see JP-A-2005-257827, etc.

[0055]

number

[0056] The specifications of the 2D Colorimeter 9 are, for example, an effective frequency value of approximately 2 to 3 million pixels, an effective area of 5.12 mm x 3.84 mm, an image size of 2.5 μm x 2.45 μm, a 10-bit video output, a camera interface called Camera Link, a shutter speed of 1 / 10,000 sec to 1 / 15 sec, an accumulation time of 30 frames, an S / N ratio of 56 dB or higher, and a C-mount lens mount.

[0057] The inspection device 1 has a computer section 10 (hereinafter referred to as PC section 10) and a monitor 11, and the screen of the monitor 11 is used to operate the main body and display results, etc.

[0058] The input means of the PC unit 10 is a keyboard, a mouse, a touch panel provided on the monitor 11, etc.

[0059] With reference to FIG. 3, the PC unit 10 responsible for the control related to the swirling inspection will be described. This PC unit 10 is formed by mutually connecting a CPU 101, a RAM 102, a ROM 103, a counter 104, a timer 105, an audio control unit 106, a storage unit 107, and an input / output interface 108 via a bus line 109. Connected to the input / output interface 108 are a monitor 11, a two-dimensional colorimeter 9, a surface-emitting illumination unit 8, an electromagnetic actuator 6, an input unit 117 for starting imaging, etc. The CPU 101 performs predetermined operations such as initial settings or upon receiving an input signal, and control signals are transmitted thereto.

[0060] There are two control methods for the PC unit 10. For example, (1) performing a manual operation on software (pressing an imaging button / stop button, etc. on the screen), (2) when the measurement start button is pressed on software, a series of operations including imaging, cylinder operation, waiting for a certain delay time, and imaging are automatically performed.

[0061] The CPU 101 generates control signals to be output to each part, and by outputting the control signals under program control, it executes swirling detection, etc. The RAM 102 temporarily reads and writes data such as swirling detection. Programs such as swirling detection are stored in the ROM 103 in a read-only manner. The CPU 101 generates control signals to be output to each part, and by outputting the control signals, it executes swirling detection. Instead of program control, it can also be implemented by hardware control such as LSI logic.

[0062] The counter 104 functions as a counting unit indicating a count value N1 of pixels, etc., a cumulative value N2 of pixels, the number of imaging times, etc. After power-on, the initial values of the count value N1, cumulative value N2, etc. of the counter 104 are set to "0", etc., and it counts and increments with reference to various input signals.

[0063] The timer 105 performs time arithmetic processing and the like related to swirling inspection and the like.

[0064] The voice control unit 106 is composed of a sound source IC, an amplifier, etc., and is in charge of driving control of a speaker or the like.

[0065] The storage unit 107 stores data imaged by the two-dimensional colorimeter 9, arithmetic data such as swirling inspection and color distribution, etc. The storage unit 107 is a hard disk, a flash memory, etc.

[0066] The PC unit 10 has a storage unit (RAM 102, ROM 103, storage unit 107), an arithmetic unit (CPU 101), a determination unit (CPU 101), and a command unit (CPU 101). It images the infusion bag 3 with the two-dimensional colorimeter 9, generates the first color distribution of the acquired first image, images the infusion bag 3 in a state where swirling is caused by the pressing plate 5 again with the two-dimensional colorimeter 9, generates the second color distribution of the acquired second image, a color distribution generation process, compares the first color distribution and the second color distribution, detects and displays the degree of coincidence of the color distributions of the first color distribution and the second color distribution, and further, if necessary, a swirling evaluation process for detecting the strength of swirling based on the degree of coincidence, and an evaluation display process for causing the monitor 11 to display the evaluation of swirling. For details regarding the calculation of the degree of coincidence and the like, refer to Patent Document 2.

[0067] As a modified example of the pressing plate 5, the pressing plate 5 may be fixed in an inverted T shape with respect to the shaft of the electromagnetic actuator 6.

[0068] As shown in FIGS. 7(a) to 7(d), in addition to being plate-shaped, the pressing plate 5 can take various forms such as a curved longitudinal section, a cylindrical shape, a columnar shape, a hemispherical shape, a cross-sectioned oval shape, a circular longitudinal section, a U-shaped longitudinal section, a hollow body, a solid body, etc. Also, the inclination of the pressing plate 5 during imaging of the infusion bag 3 is not limited to horizontal, and it may be in an inclined state. For example, it may be adjusted according to the inclination of the placement portion 4. The materials include steel, aluminum, stainless steel, resin, ceramic, etc. The hardness of the pressing portion is preferably hard, but a composite of hard and soft may also be used.

[0069] With reference to the drawings, the blood product inspection method of the present invention (hereinafter, this inspection method) by the inspection device 1 will be described.

[0070] On the screen of the monitor 11, there are provided various display parts such as a reference image display part, an inspection image display part, a measurement result display part such as a degree of coincidence, an imaging button, a start button, a stop button, a cylinder setting, an imaging start delay (cylinder operation delay), a save button, etc. By the cylinder setting, arbitrary numerical values are input into the number of up and down movements (the number of times the cylinder moves up and down. For example, if set to 1 time, it makes one reciprocating movement up and down) and the imaging start delay (the number of standby seconds from the end of the cylinder operation to the start of imaging). When imaging with the specified ID is performed for the first time, a pattern of a specific color is displayed in the reference image display column. When imaging with the specified ID is performed for the second time or later, the image captured for the first time is displayed in the reference image display column. When the start button is pressed, the operation and imaging are automatically performed under the conditions input by the cylinder setting. Then, a real-time captured image is displayed in the inspection image column. If there is no problem with the captured image, when the save button is pressed, the captured image and the measurement result are saved in a specific folder.

[0071] Hereinafter, taking the case where a series of operations are automatically performed under the control of the PC unit 10 as an example, with reference to FIG. 8, the inspection method of the present invention will be described.

[0072] First, in the placement step, under the illumination of the surface light-emitting illumination unit 8, the opening / closing door 2a is opened, and the infusion bag 3 is placed on the transparent placement portion 4 provided in the housing 2. When the opening / closing door 2a is closed with the infusion bag 3 stopped on the placement portion 4, the inside of the housing 2 is illuminated in a darkroom state.

[0073] Next, as shown in FIG. 8, when the start button is pressed, the first imaging step is performed. In the first imaging step, under the illumination of the surface-emitting illumination unit 8, the inspection area, which is a part of the infusion bag 3, is imaged by the two-dimensional colorimeter 9 to obtain a reference image of the infusion bag 3 before swirling occurs.

[0074] Imaging of the infusion bag 3 before swirling occurs is essential. Therefore, imaging once before swirling occurs and once after swirling occurs is required for the same infusion bag 3. The reference image for the inspection is the image of the infusion bag 3 before swirling occurs. Basically, there is no such thing as a reference infusion bag common to all infusion bags 3 to be inspected.

[0075] Next, after a specific delay time, in the generation step, automatically, by turning on / off the cylinder power supply and the cylinder polarity switching, the infusion bag 3 is pressed by the pressing portion 5 that descends, the pressing portion 5 is raised and separated from the infusion bag 3, and this is repeated twice to generate swirling. For the convenience of explaining the delay time of the cylinder polarity switching, the number of operations is set to 2 times, but basically, it is the number of operations of 1 time.

[0076] Next, after the pressing plate 5 is raised, after a specific delay time (delay after cylinder operation) has elapsed, in the second imaging step, under the illumination of the surface-emitting illumination unit 8, the inspection area, which is a part of the infusion bag 3, is imaged by the two-dimensional colorimeter 9 to obtain a swirling image.

[0077] In FIG. 8, the cylinder energization time (ON / OFF) can be set respectively in the initial file. The cylinder energization must be set to 1 second or more. In response to the touch of the start button, the cylinder polarity switching (port2) of the electromagnetic actuator 6 is turned on and off, and in response to this, the cylinder power supply (port1) is turned on and off. When the cylinder is energized with port2 OFF, the cylinder extends, and the pressing plate 5 descends to crush the infusion bag 3. When the cylinder is energized with port2 ON, the cylinder contracts, and the pressing plate 5 rises to release the infusion bag 3. The delay times between each operation can be set from the following four in the initial file. Delay time 1 (D1) is from the OFF of the polarity switching to the ON of the cylinder energization, delay time 2 (D2) is from the OFF of the cylinder energization to the ON of the polarity switching, delay time 3 (D3) is from after the ON of the polarity switching to the ON of the cylinder energization, and delay time 4 (D4) is the time from the OFF of the cylinder energization to the OFF of the polarity switching.

[0078] As shown in FIG. 8, in the second imaging step, after the ON period of the cylinder power supply (port1) ends, since time is required until the infusion stops, after the delay time (delay after cylinder operation) elapses, imaging of the swirling generated image is performed. The delay times 1 (D1) to 4 (D4) are exemplified to be less than 1 second, but depending on the setting conditions of the swirling inspection, the time width may be changed. The delay times 1 (D1) to 4 (D4) can be changed on the screen of the monitor 11. Note that in a series of operations of two ON / OFFs of port1 and one ON / OFF of port2, the number of times the cylinder moves up and down is counted as one time.

[0079] The reason for the cylinder moving up and down multiple times is that usually, swirling occurs with one press on the infusion bag 3, but various inspection conditions are assumed, and it is possible that swirling may not occur sufficiently with one press on the infusion bag 3. Therefore, a function of controlling multiple times is provided so that the infusion bag 3 can be continuously pressed.

[0080] Furthermore, this inspection method includes a comparison step of calculating and displaying the degree of match of the color distribution by comparing the color distribution of the reference image and the color distribution of the swirling image. Furthermore, it may have an evaluation step of determining the suitability of the infusion bag 3 from the degree of match of the color distribution and evaluating the swirling. It may also have an evaluation display step of displaying the evaluation result obtained in the evaluation step on the monitor 11.

[0081] In this comparison step, since the infusion bag 3 varies greatly in color and content volume depending on the item, it is a test object for which it is difficult to define the color standard in absolute values. Therefore, one image of each sample before and after the occurrence of swirling is captured, and the inspection standard is defined for the difference (numerical value of the degree of match) between the images before and after the occurrence. For example, when it is defined that a degree of match index of 80% or more indicates no swirling, if the comparison result of the images of sample A before and after the occurrence of swirling is a degree of match of 75%, it is determined that there is swirling. When the comparison result of the images of sample B before and after the occurrence of swirling is a degree of match of 81%, it is determined that there is no swirling. That is, the higher the degree of match, the less the occurrence of swirling, so it can be determined that the blood product is inappropriate. An appropriate degree of match may be set as the determination criterion (inspection threshold).

[0082] As described above, the case of automatic control has been explained. In the case of manual operation, in the first imaging step, after pressing the imaging button on the display screen of the monitor 11 and the real-time captured image is displayed in the inspection image display column, the stop button is pressed, and after adjusting the sample position, the reference image can also be captured.

[0083] By the way, in the embodiment of the present invention, the degree of match is determined from the color distribution mapped in the color space. In the present invention, since the swirling color distribution (three-dimensional distribution) is measured, even if the swirling pattern of the real image changes, it becomes almost the same swirling color distribution, so stable evaluation (numerical conversion, graphing, etc.) can be performed.

[0084] Color distribution refers to the distribution of independent amounts of color in color space. "Color space" is a space in which color can be specified by three independent amounts, and if the magnitude of each amount is represented by the distance from the origin in the three axial directions, the color can be specified as the coordinates of a point in space.

[0085] For the colorimetric system of color distribution, an appropriate colorimetric system can be adopted. For example, the "XYZ colorimetric system" was defined by the CIE in 1931 simultaneously with the RGB colorimetric system so that no negative values would appear in the simple linear transformation of the RGB colorimetric system. The "XYZ colorimetric system" includes, for example, CIE colorimetric systems such as xyY, Yxy, XYZ, Lab, Luv, etc., and is a concept including two-dimensional color distribution or three-dimensional color space. In the XYZ colorimetric system, it is generally used that x = X / (X + Y + Z) and y = Y / (X + Y + Z) are normalized and defined as Yxy.

[0086] The XYZ colorimetric system includes color spaces defined by two-dimensional coordinates and three-dimensional coordinates. Representative examples of color spaces include the XYZ color space and compositional examples such as the Lab color space. In the case of a two-dimensional color space, for example, in the case of the Yxy color space and the Luv color space, there are the xy chromaticity diagram (xy chromaticity values (plane) normalized in the Yxy color space), uv chromaticity diagram, and u'v' chromaticity diagram, which are two-dimensional planes. Corresponding to these are xy chromaticity histogram distributions or Luv chromaticity histogram distributions expressed as the density of pixel count values in the two-dimensional chromaticity diagram on the plane. The XYZ colorimetric system having three spectral sensitivities (S1(λ), S2(λ), S3(λ)) linearly transformed equivalently to color functions such as CIEXYZ is also included. In the case of a three-dimensional color space, for example, the XYZ color space and the Lab color space can be mentioned. By performing mapping processing of pixel color information on the three-dimensional color space, color distribution can be obtained.

[0087] The L*a*b* colorimetric system is CIEL*a*b*, which is derived for measuring color differences due to differences in perception and devices from the XYZ colorimetric system and is specified in JIS Z8729 in Japan. This colorimetric system was established to correct the fact that the previous XYZ colorimetric system has uneven color discrimination sensitivity of the human eye on the color space, and the color differences measured in this space are widely used. Generally, Lab values are referred to as L*a*b* values.

[0088] The L*u*v* color space system is one of the uniform color spaces defined by the CIE in 1976. CIEL*u*v* is based on the wavelength of light and improves the uniformity of the wavelength intervals in the xy chromaticity diagram of the XYZ color space system. It is specified in JIS Z8518 in Japan.

[0089] The two-dimensional colorimeter 9 is a measuring instrument that measures the light from the object to be measured and outputs it as coordinates in the color space.

[0090] The color distribution is based on the L*a*b* color space system or the L*u*v* color space system. This can improve the accuracy of the swirling inspection.

[0091] As described above, when the pressing plate 5 is lowered by the inspection device 1 to push down a part of the infusion bag 3 to a specific thickness, the non-pressed part bulges. When the pressing plate 5 is raised and the pressing plate 5 separates from the infusion bag 3, the pressed part and the bulging part return to their original positions due to gravity, and the blood preparation in the infusion bag 3 is stirred, generating swirling. It is possible to image the strength of the swirling phenomenon of the blood preparation seen at that time with the two-dimensional colorimeter 9.

[0092] When the pressing plate 5 of the inspection device 1 presses the infusion bag 3 downward, it deforms, and when it rises, the infusion bag 3 returns to its original shape. Due to the simple mechanism that the blood preparation moves, swirling is generated. By imaging this swirling from below, the inspection device 1 can shorten the inspection time of the blood preparation and improve the accuracy. For one infusion bag, the total number of seconds required for all processes is, for example, about 4.3 [seconds], so the inspection time can be significantly shortened.

[0093] Since the surface area of the lower surface of the pressing plate 5 is set smaller than the area of the upper surface of the infusion bag 3, the pressing plate 5 can be miniaturized, the area for pressing the infusion bag 3 can be reduced, and the momentum of the infusion bag 3 can be reduced. Therefore, the inspection device 1 can further shorten and correct the inspection time.

[0094] The specific direction X is the drive axis of the electromagnetic actuator 6, and since the drive axis and the imaging axis Y of the two-dimensional colorimeter 9 are arranged with a specific distance and offset, the setting of the viewing angle of the two-dimensional colorimeter becomes appropriate, the inspection area can be reduced, and the inspection apparatus 1 can further shorten and accurately measure the inspection time.

[0095] Since the inspection area is set as the area of one-fifth to one-half of the surface area of the infusion bag 3, the time for image processing and the like is shortened. Thereby, the inspection time can be further shortened and made more accurate. The inspection area is an example, and an appropriate area can be set.

[0096] The housing 2 is provided with an opening / closing door 2a, the surface-emitting illumination unit 8 provided on the opening / closing door 2a illuminates the infusion bag 3 from above, and the drive unit 7 is provided on the lower surface of the opening / closing door 2a, so that the housing 2 of the inspection apparatus 1 can be made compact.

[0097] Embodiments of the present invention are not limited to the above-described embodiments, and modifications and the like can be added without departing from the technical idea of the present invention. These modifications, equivalents, etc. are also included in the technical scope of the present invention, and it goes without saying that various forms can be adopted as long as they belong to the technical scope. For example, the housing 2, the placement unit 4, the pressing unit 5, and the electromagnetic actuator 6 can take various forms not limited to the embodiments. Further, the method of acquiring image information according to the three spectral sensitivities (S1(λ), S2(λ), S3(λ)) is merely a specific example, and the present invention is not limited thereto, and the present invention can also be implemented by other configurations.

Industrial Applicability

[0098] The blood product inspection apparatus 1 of the present invention mechanizes the swirling inspection of platelets and can shorten the imaging time and the like, so it can be used at blood donation centers, blood product bag centers (manufacturing plants, sales offices), hospital distribution centers, hospitals, etc., and thus the applicability to the medical industry is great.

Explanation of Reference Numerals

[0099] 1 Blood preparation inspection device 2 Housing 2a Opening / closing door 3 Blood preparation bag (infusion bag) 4 Placement part 5 Pressing plate 6 Electromagnetic actuator 7 Driving part 8 Surface-emitting illumination part 9 Two-dimensional colorimeter 10 Computer part (PC part) 11 Monitor

Claims

1. A transparent placement part provided in a housing for placing a blood product bag, a pressing part capable of pressing the blood product bag, and an electromagnetic actuator that reciprocates the pressing part in a specific direction of the housing, and a driving part having the same, a two-dimensional colorimeter that images the blood product bag from below under the illumination of an illumination part provided in the housing and generates an image, When the pressing part descends as the electromagnetic actuator is driven, a part of the blood product bag is pushed down, and when the pressing part ascends as the electromagnetic actuator is driven, it detaches from the blood product bag, generating swirling in the blood product in the blood product bag, imaging the lower surface of the blood product bag, and generating a swirling image showing the swirling, analyzing the color distribution of the swirling image and inspecting the swirling, A blood product inspection device characterized by the above.

2. The blood product inspection device according to Claim 1, wherein the surface area of the lower surface of the pressing part is set to be smaller than the area of the upper surface of the blood product bag.

3. The specific direction is the driving axis of the electromagnetic actuator, and when inspecting the blood product bag, the driving axis and the imaging axis of the two-dimensional colorimeter are arranged at a specific distance and offset. The blood product inspection device according to Claim 1.

4. The blood product inspection device according to Claim 1, wherein the inspection area of the blood product bag is set to an area smaller than the surface area of the blood product bag.

5. An opening / closing part is provided in the housing, the driving part is provided in the opening / closing part, the placement part is visible when the opening / closing part is in an open state, and the inside of the front housing is in a dark room state when the opening / closing part is in a closed state. The blood product inspection device according to Claim 1.

6. The illumination part is a surface-emitting illumination part that illuminates the blood product bag from above, and the two-dimensional colorimeter images the blood product bag from below the placement part. The blood product inspection device according to any one of Claims 1 to 6.

7. Equipped with a monitor and a computer, the computer has a storage part, a calculation part, a judgment part, and a command part, imaging the blood product bag before swirling is caused by the pressing part with the two-dimensional colorimeter, generating a first color distribution of a first image obtained, imaging the blood product bag in a state where swirling is caused by the pressing part again with the two-dimensional colorimeter, and generating a second color distribution of a second image obtained. A color distribution generation process, A swirling evaluation process that compares the first color distribution with the second color distribution, detects the degree of coincidence of the color distributions of the first color distribution and the second color distribution, and evaluates the strength of swirling based on the degree of coincidence; An evaluation display process that causes the monitor to display the evaluation of the swirling; The blood preparation inspection apparatus according to claim 1, characterized by executing the above.

8. A placement step of placing a blood preparation bag on a transparent placement part provided on the housing; A first imaging step of obtaining a reference image by imaging the inspection area of the blood preparation bag from below with a two-dimensional colorimeter under illumination in a state where the blood preparation bag has stopped on the placement part; A generation step of generating swirling by pressing the blood preparation bag with a pressing part that descends and then rising the pressing part to separate it from the blood preparation bag; A second imaging step of obtaining a swirling image by imaging the inspection area of the blood preparation bag from below with a two-dimensional colorimeter under illumination after the pressing part has risen; A comparison step of comparing the color distribution of the reference image and the color distribution of the swirling image; A blood preparation inspection method, characterized by comprising the above.

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