JP5782340B2 - Plasma product testing device and blood component separation device - Google Patents

Description

  The present invention relates to a blood component preparation testing apparatus for testing a blood component preparation such as a plasma preparation and a blood component separation apparatus for separating blood into components.

  Conventionally, a color sensor having a light emitting unit that projects light toward a plasma product (including a pre-formation plasma bag) and a light receiving unit that receives light that is transmitted or reflected through the plasma product as an inspection device for plasma product, There is known a plasma preparation testing device including a control unit having storage means for storing color information and a changeover switch for switching color information to be compared (for example, see Patent Document 1).

  According to the conventional testing apparatus for plasma preparation, since the color sensor and the control unit described above are provided, the color of transmitted light or reflected light received by the light receiving unit and the color information stored in the storage unit are compared. Thus, it is possible to determine whether the plasma preparation is a good product or a defective product.

  In addition, since the thickness of the bag differs depending on the bag volume, and the material used for the bag also differs depending on the bag manufacturer, even if the same plasma is injected into such different types (volumes and manufacturers) of the plasma preparation, The color tone of the plasma preparation may be slightly different, which may affect the test results.

  On the other hand, according to the conventional testing device for plasma preparation, since the above-described changeover switch is provided, the user can change the type of bag by operating the changeover switch according to the type of bag to be placed. The quality of the plasma preparation can be determined with suitable color information. As a result, it is possible to suppress the influence on the inspection result due to the different types of bags.

JP 2009-85824 A

  By the way, in the field where a test of a plasma product is actually performed, since a large number of plasma products must be handled, there is a demand for more easily discriminating the quality of the plasma product.

  However, in the conventional testing apparatus for plasma preparations, the changeover switch must be manually operated according to the type of bag to be placed, and the changeover operation is troublesome.

  Note that the above-mentioned demands are not limited to plasma product testing devices for testing plasma products, but also exist for testing devices for testing blood component products composed of other blood components such as platelet products. To do. Further, the above-described demand is not limited to an inspection apparatus for inspecting a blood component preparation, but also exists for a blood component separation apparatus for separating blood into components.

  Therefore, the present invention has been made in view of the above-described demand, and it is possible to determine the quality of a blood component preparation relatively easily regardless of the type of bag, and a blood component preparation inspection apparatus and blood component separation apparatus The purpose is to provide.

  As a result of intensive studies to achieve the above-described object, the inventors of the present invention have obtained a second-order differentiation of the spectrum obtained when the blood component preparation is irradiated with visible light. Hereinafter, it was found that the peak is sharpened in a predetermined wavelength region of abbreviated as a secondary differential spectrum. Further, it was also found that the peak appearing in the second derivative spectrum always appears in a predetermined wavelength region even if the type (capacity or manufacturer) of the bag is changed.

  Therefore, based on the above knowledge, the present inventors secondarily differentiated the spectrum obtained by irradiating the blood component preparation with visible light, and the absolute value of the peak intensity at the peak appearing in the second derivative spectrum. It is conceived that it is possible to determine the quality of a blood component preparation relatively easily regardless of the type of bag by determining whether or not the value or the converted value exceeds a predetermined reference value. It came to complete.

  That is, the blood component preparation test apparatus (1) of the present invention includes a light emitting unit (26) that irradiates visible light toward a blood component preparation to be tested, and the blood component irradiated from the light emitting unit (26). A light-receiving unit (28) that receives light transmitted through the preparation or light reflected by the blood component preparation, and an arithmetic process that measures the spectrum of the light received by the light-receiving unit (28) and performs mathematical processing on the spectrum Unit (30) and a determination unit (36) for determining the quality of the blood component preparation based on the calculation result by the calculation processing unit (30), wherein the calculation processing unit (30) includes the light receiving unit. (28) has a spectrum measuring unit (32) for measuring the spectrum of the received light, and a peak intensity calculating unit (34) for secondarily differentiating the spectrum to calculate a peak intensity in a predetermined visible light wavelength region. And said The separate unit (36) determines whether the calculated absolute value or converted value of the peak intensity exceeds a predetermined reference value, and determines the quality of the blood component preparation based on the determination result It has the function to perform.

  For this reason, according to the test apparatus for blood component preparation of the present invention, since it includes the arithmetic processing section and the determination section having the spectrum measuring section and the peak intensity calculating section, visible light is irradiated toward the blood component preparation. Thus, it is possible to secondarily differentiate the spectrum obtained and determine whether the absolute value or converted value of the peak intensity at the peak appearing in the second derivative spectrum exceeds a predetermined reference value. As a result, it is possible to determine the quality of the blood component preparation relatively easily regardless of the type of bag. Further, with regard to the “manual operation by a changeover switch” required in the case of a conventional blood component preparation testing apparatus, such a troublesome operation is not required in the blood component preparation inspection apparatus of the present invention.

  The blood component preparation testing apparatus (1) of the present invention further includes a storage unit (42) for storing reference value information related to the predetermined reference value, and the determination unit (36) performs the determination. It is preferable to have a function of referring to the reference value information stored in the storage unit (42).

  With this configuration, the reference value information can be stored in the storage unit in advance, so that the quality of the blood component preparation can be more easily determined.

  In the blood component preparation testing apparatus (1) of the present invention, the predetermined visible light wavelength region to be calculated by the peak intensity calculation unit (34) is preferably in the range of 400 nm to 600 nm.

  According to the experiments by the present inventors, a clear peak appeared in the range of 400 nm to 600 nm in the second derivative spectrum when a plasma preparation was used as a test object. For this reason, the test apparatus for blood component preparation of the present invention is a particularly suitable test apparatus when the test object is a plasma preparation.

  In the blood component preparation testing apparatus (1) of the present invention, the predetermined visible light wavelength region to be calculated by the peak intensity calculation unit (34) is preferably in the range of 500 nm to 600 nm.

  According to the experiments of the present inventors, when a plasma preparation in which hemoglobin is mixed by hemolysis or a plasma preparation in which red blood cells are mixed as it is without being hemolyzed is clearly examined in the range of 500 nm to 600 nm in the second derivative spectrum. Peak appeared. From this, it can be said that the test apparatus for blood component preparation of the present invention is a test apparatus suitable for discriminating hemoglobin contamination or erythrocyte contamination in a plasma preparation.

  In the blood component preparation testing apparatus (1) of the present invention, the light emitting section (26) is preferably composed of LEDs.

  According to the experiments by the present inventors, when a plasma preparation in which hemoglobin is mixed by hemolysis or a plasma preparation in which red blood cells are mixed as it is is a subject to be examined, when the light-emitting part is a halogen lamp, hemoglobin is mixed into the plasma preparation. However, it was found that it was not easy to determine the contamination of erythrocytes in the plasma preparation. On the other hand, when the light-emitting part is changed from a halogen lamp to the above-described LED, it has been found that both hemoglobin contamination and red blood cell contamination in the plasma preparation can be well distinguished. From this, it can be said that the test apparatus for blood component preparation of the present invention is a more suitable test apparatus for discriminating hemoglobin contamination or erythrocyte contamination in a plasma preparation.

  In the blood component preparation testing apparatus (1) of the present invention, an optical path length adjusting unit (for adjusting the optical path length until the visible light irradiated from the light emitting unit (26) is received by the light receiving unit (28) ( 38).

By the way, for example, in some plasma preparations, plasma is clouded by chyle (a fat component contained in blood), and in the case of determining hemoglobin contamination or erythrocyte contamination in a plasma preparation with strong chyle, It cannot be considered that the inspection cannot be performed due to the magnitude of the degree, or even if the inspection can be performed, the inspection result may be adversely affected.
In contrast, according to the blood component preparation testing apparatus of the present invention, since the optical path length can be adjusted by providing the optical path length adjustment unit, the optical path length is shortened according to the turbidity of the plasma preparation. It becomes possible. Here, based on Lambert's law and Beer's law, the effect of the concentration of the solution on the absorbance can be reduced by shortening the optical path length. Even when a blood component preparation having a relatively large turbidity, such as a plasma preparation having a high turbidity, is inspected, the inspection apparatus can perform a good inspection.

  In the blood component preparation testing apparatus (1) of the present invention, the spectrum measuring unit (32) preferably has a function of adjusting the measurement time of the spectrum.

  By configuring in this way, in the case of inspecting a blood component preparation with a relatively large turbidity, such as a plasma preparation with strong chyle, for example, by increasing the measurement time of the spectrum, The influence can be reduced.

  The blood component separation device (100) of the present invention includes a liquid feeding mechanism (150) for separating blood containing a plurality of blood components into blood bags and feeding the blood components to the bag, and the bag ( 191) a light emitting unit (126) that emits visible light, and a light receiving unit that receives the light emitted from the light emitting unit (126) and transmitted through the bag (191) or reflected by the bag (191). (128), based on the calculation result by the arithmetic processing unit (130) that measures the spectrum of the light received by the light receiving unit (128) and performs mathematical processing on the spectrum, and the arithmetic processing unit (130) A determination unit (136) for determining the quality of the bag (191), and a control unit (140) for controlling at least the liquid feeding mechanism (150), the light emitting unit (126), and the arithmetic processing unit (130). The The arithmetic processing unit (130) includes a spectrum measuring unit (132) that measures a spectrum of light received by the light receiving unit (128), and a second derivative of the spectrum to obtain a peak in a predetermined visible light wavelength region. A peak intensity calculation unit (134) for calculating intensity, and the determination unit (136) determines whether the calculated absolute value or converted value of the peak intensity exceeds a predetermined reference value. And it has the function to discriminate | determine the quality of the said bag (191) based on the said determination result, It is characterized by the above-mentioned.

  For this reason, according to the blood component separation device of the present invention, since the arithmetic processing unit and the discrimination unit having the spectrum measurement unit and the peak intensity calculation unit described above are provided, the blood component separation device is obtained by irradiating visible light toward the bag. The obtained spectrum is second-order differentiated, and it can be determined whether or not the absolute value or converted value of the peak intensity at the peak appearing in the second-order derivative spectrum exceeds a predetermined reference value. As a result, regardless of the type of bag, it is possible to determine the quality of blood components sent to the bag relatively easily.

  The blood component separation device (100) of the present invention further includes a sealing mechanism (160) for sealing a tube communicating with the bag, and the control unit (140) is configured to display the determination result of the determination unit (136). Based on this, it is preferable to further have a function of controlling the sealing operation of the sealing mechanism (160).

  With this configuration, it is possible to determine whether or not the seal is possible based on the result of the quality determination by the determination unit.

  The blood component separation device (100) of the present invention further includes a storage unit (142) that stores reference value information relating to the predetermined reference value, and the determination unit (136) performs the determination when performing the determination. It is preferable to have a function of referring to the reference value information stored in the unit (142).

  With this configuration, the reference value information can be stored in the storage unit in advance, so that the quality of the blood component sent to the bag can be more easily determined.

  In the blood component separation device (100) of the present invention, the predetermined visible light wavelength region to be calculated by the peak intensity calculation unit (134) is preferably in the range of 400 nm to 600 nm, preferably 500 nm to 600 nm. A range is more preferable.

  By comprising in this way, it becomes possible to discriminate | determine favorably the hemoglobin mixing or red blood cell contamination to the said bag about the bag which sent the plasma component.

  In the blood component separation device (100) of the present invention, the light emitting section (126) is preferably composed of LEDs.

  By configuring in this way, it is possible to better determine whether hemoglobin or red blood cells are mixed into the bag with respect to the bag to which the plasma component has been sent.

  In the blood component separation device (100) of the present invention, the optical path length adjustment unit (138) that adjusts the optical path length until the visible light irradiated from the light emitting unit (126) is received by the light receiving unit (128). It is preferable to further comprise.

  By configuring in this way, even when blood components with relatively high turbidity, such as plasma components with strong chyle, are sent to the bag, a good inspection can be performed by shortening the optical path length. Is possible.

  In the blood component separation device (100) of the present invention, the spectrum measurement unit (132) preferably has a function of adjusting the measurement time of the spectrum.

  By configuring in this way, even when blood components with relatively large turbidity, such as plasma components with strong chyle, are sent to the bag, it is possible to check well by extending the spectrum measurement time. It becomes possible to do.

  In addition, the reference numerals added in parentheses below the wording of each member, etc. described in the claims and in this column (column of means for solving the problems) are the contents described in the claims and this column. It is used for facilitating understanding of the present invention, and does not limit the contents described in the claims and in this section.

The block diagram which shows the electrical constitution of the test | inspection apparatus 1 for blood component preparations which concern on 1st Embodiment. 1 is an external perspective view of a blood component preparation testing apparatus 1 according to a first embodiment. The block diagram which shows the electrical constitution of the blood component separation apparatus 100 which concerns on 2nd Embodiment. The external appearance perspective view of the blood component separation apparatus 100 which concerns on 2nd Embodiment. The figure which looked at blood component separation device 100 concerning a 2nd embodiment from the front upper part. The figure shown in order to demonstrate the blood component separation apparatus 100 which concerns on 2nd Embodiment. The figure which shows the light-absorption spectrum of sample A-1 and A-2. The figure which shows the secondary differential spectrum of sample A-1 and A-2. The figure which shows the relationship between the hemoglobin density | concentration in Test Example 1, and a light absorbency. The figure which shows the relationship between the hemoglobin density | concentration in Test Example 1, and an absorbance secondary differential value. The figure which shows the light-absorption spectrum of sample B-1 and B-2. The figure which shows the secondary differential spectrum of sample B-1 and B-2. The figure which shows the relationship between the hemoglobin density | concentration in Test Example 2, and a light absorbency. The figure which shows the relationship between the hemoglobin density | concentration in Test Example 2, and an absorbance secondary differential value. The figure which shows the absorbance spectrum of sample C-1 and C-2. The figure which shows the secondary differential spectrum of sample C-1 and C-2. The figure which shows the light-absorption spectrum of sample D-1 and D-2. The figure which shows the secondary differential spectrum of sample D-1 and D-2. The figure which shows the relationship between the hemoglobin density | concentration in Test Example 4, and an absorbance secondary differential value.

  Hereinafter, a blood component preparation testing apparatus and a blood component separation apparatus of the present invention will be described based on the embodiments shown in the drawings.

[First Embodiment]
1st Embodiment is embodiment for demonstrating the test | inspection apparatus for blood component preparations of this invention.

First, the configuration of the blood component preparation testing apparatus 1 according to the first embodiment will be described with reference to FIGS. 1 and 2.
FIG. 1 is a block diagram showing an electrical configuration of a blood component preparation testing apparatus 1 according to the first embodiment. FIG. 2 is an external perspective view of the blood component preparation testing apparatus 1 according to the first embodiment.

  The blood component preparation inspection apparatus 1 according to the first embodiment is an inspection apparatus for inspecting, for example, hemoglobin contamination or red blood cell contamination in a plasma preparation, and as shown in FIG. 1 and FIG. A light emitting unit 26 that emits visible light toward the plasma preparation placed on the placement unit 12, a light receiving unit 28 that receives light emitted from the light emitting unit 26 and reflected by the plasma preparation, and the light receiving unit 28 receives the light. An arithmetic processing unit 30 that measures the spectrum of light and performs mathematical processing on the spectrum, a determination unit 36 that determines the quality of the plasma product based on a calculation result by the calculation processing unit 30, and a quality determination by the determination unit 36 An informing unit 24 for informing the operator of the result, a storage unit 42, a rewriting unit 44, a power supply unit 46 for supplying power to each unit in the blood component preparation testing apparatus 1, and an upper surface of the apparatus main body 10. Power supply provided It comprises a pitch 22, the optical path length adjuster 38, and a control unit 40 that collectively controls each unit of the blood components inspection apparatus 1. Among these units, those other than the notification unit 24 and the power switch 22 are provided inside the apparatus main body 10.

  On the upper surface of the apparatus main body 10, a placement unit 12 is provided on which a bag to be inspected is placed. The mounting portion 12 is composed of an inclined surface that is inclined so as to become higher from the front of the apparatus main body 10 toward the back. When the plasma preparation is placed on the inclined placement part 12, the air in the plasma preparation moves upwards of the bag, so that the spectrum can be accurately measured.

  A light emitting part hole 16 for allowing light from the light emitting part 26 to pass therethrough, and a light receiving part hole 18 for allowing the light irradiated from the light emitting part 26 and reflected by the plasma preparation to pass therethrough are substantially at the center of the mounting part 12. Is formed. Although explanation by illustration is omitted, a light emitting unit 26 and a light receiving unit 28 are installed below the mounting unit 12, and light from the light emitting unit 26 is favorably irradiated to the plasma preparation through the light emitting unit hole 16. And the installation angle of the light emission part 26 and the light-receiving part 28 is adjusted so that the light reflected by the plasma preparation may inject into the light-receiving part 28 favorably through the hole 18 for light-receiving parts.

  As shown in FIG. 2, a slot portion 14 into which an external memory as an external recording medium (for example, an SD card or a compact flash (registered trademark)) can be inserted is provided on the front surface of the apparatus main body 10.

  The light emitting unit 26 is composed of, for example, a white LED that combines a blue light emitting element and a yellow phosphor.

  The light receiving unit 28 is composed of, for example, a spectroscopic sensor.

  As shown in FIG. 1, the arithmetic processing unit 30 secondarily differentiates the spectrum measured by the spectrum measuring unit 32 that measures the spectrum of the light received by the light receiving unit 28 and the spectrum measured by the spectrum measuring unit 32, and the second derivative spectrum. And a peak intensity calculator 34 for calculating a peak intensity in the range of 500 nm to 600 nm.

  The spectrum measurement unit 32 further has a function of adjusting the measurement time when measuring a spectrum.

  The peak intensity calculation unit 34 converts the calculated peak intensity into a hemoglobin amount, and outputs the converted value to the determination unit 36.

  The determination unit 36 determines whether or not the calculated peak intensity conversion value exceeds a predetermined reference value, and determines whether or not the plasma product is good or bad based on the determination result. In performing, it has the reference value information reference function which refers the reference value information memorize | stored in the memory | storage part 42. FIG.

  The storage unit 42 stores, as reference value information, the amount of hemoglobin that serves as a boundary between a plasma product as a non-defective product and a plasma product as a defective product. When the determination unit 36 performs the above-described reference value information reference function, the reference value information is output to the determination unit 36.

  The rewriting unit 44 has a function of receiving data related to the reference value information from the outside of the apparatus and rewriting the reference value information stored in the storage unit 42 based on the data. Specifically, when an external memory is inserted into the slot section 14 of the apparatus main body 10, the rewrite section 44 reads data related to the reference value information stored in the external memory, and stores it in the storage section 42 based on the read data. The stored reference value information (old reference value information) is rewritten with new reference value information. The means for the rewriting unit 44 to read data from the external memory may be electrical, magnetic or optical.

  The power supply unit 46 guides AC power from an external commercial power supply or the like via a power cable (not shown), and performs processing such as transformation, rectification, and smoothing by a built-in AC / DC conversion unit (not shown). And has a function of supplying electric power to each part of the blood component preparation testing apparatus 1.

  By switching the power switch 22 to the ON / OFF side, the power supply of the blood component preparation testing apparatus 1 can be switched ON / OFF.

  The optical path length adjustment unit 38 has a function of adjusting the optical path length until visible light emitted from the light emitting unit 26 is received by the light receiving unit 28 according to an instruction from the control unit 40. Specifically, the optical path length is adjusted by adjusting the position of the light receiving unit 28 according to an instruction from the control unit 40.

  The control unit 40 is composed of, for example, a microcomputer.

  The alerting | reporting part 24 is a liquid crystal monitor, for example, and is installed in the back surface side of the upper cover 20, as shown in FIG. The notification unit 24 is configured to be able to notify the operator of the quality determination result by the determination unit 36 using character information and image information. The apparatus main body 10 and the upper lid 20 are connected by a hinge (not shown), and the space on the placement portion 12 (that is, the periphery of the plasma preparation) is brought into a dark room state by tilting the upper lid 20. it can.

  The blood component preparation testing apparatus 1 according to the first embodiment configured as described above includes the arithmetic processing unit 30 and the determination unit 36 having the spectrum measuring unit 32 and the peak intensity calculating unit 34 described above. Therefore, the spectrum obtained by irradiating the plasma preparation with visible light is second-order differentiated, and whether or not the converted value of the peak intensity at the peak appearing in the second-order derivative spectrum exceeds a predetermined reference value. Can be determined. As a result, it is possible to determine the quality of the plasma preparation relatively easily regardless of the type of bag.

  In the blood component preparation testing apparatus 1 according to the first embodiment, since the determination unit 36 has the above-described reference value information reference function, the reference value information can be stored in the storage unit 42 in advance. . As a result, it is possible to more easily determine the quality of the plasma preparation.

  In the blood component preparation testing apparatus 1 according to the first embodiment, the visible light wavelength region to be calculated by the peak intensity calculation unit 34 is in the range of 500 nm to 600 nm. Although it demonstrates in detail in an Example, in the range of 500 nm-600 nm in a second derivative spectrum, when the plasma preparation which hemoglobin mixed by hemolysis or the plasma preparation mixed as it is in the state which erythrocytes are not hemolyzed is examined. Since a clear peak appears, the blood component preparation inspection apparatus 1 is a suitable inspection apparatus for determining hemoglobin contamination or erythrocyte contamination in a plasma preparation.

  In the blood component preparation testing apparatus 1 according to the first embodiment, the light emitting unit 26 is formed of an LED (a white LED in which a blue light emitting element and a yellow phosphor are combined), so that it is determined whether hemoglobin or red blood cells are mixed into the plasma preparation. Therefore, the inspection apparatus is more suitable for this. Note that the emission spectrum of a white LED combining a blue light emitting element and a yellow phosphor has peaks in the vicinity of about 450 nm and in the range of 500 nm to 650 nm, and the visible light wavelength to be calculated by the peak intensity calculation unit 34. Since a part of the peak overlaps in the region (range of 500 nm to 600 nm), the light emitting unit 26 composed of a white LED combining a blue light emitting element and a yellow phosphor is a light source suitable for the peak intensity calculating unit 34. .

  In the blood component preparation testing apparatus 1 according to the first embodiment, the optical path length until the visible light irradiated from the light emitting unit 26 is received by the light receiving unit 28 is adjusted by including the optical path length adjusting unit 38. Therefore, the optical path length can be shortened according to the turbidity of the plasma preparation. As a result, the blood component preparation testing apparatus 1 according to the first embodiment can perform a good test even when testing a blood component preparation having a relatively high turbidity, such as a plasma preparation with strong chyle. It becomes a possible inspection device.

  In the blood component preparation testing apparatus 1 according to the first embodiment, the spectrum measuring unit 32 has a function of adjusting the spectrum measurement time. As a result, for example, in the case of inspecting a plasma preparation with strong chyle, it is possible to reduce the influence of the turbidity on the test result by lengthening the measurement time of the spectrum.

[Second Embodiment]
The second embodiment is an embodiment for explaining the blood component separation device of the present invention.

First, the configuration of the blood component separation device 100 according to the second embodiment will be described with reference to FIGS.
FIG. 3 is a block diagram showing an electrical configuration of the blood component separation device 100 according to the second embodiment. FIG. 4 is an external perspective view of the blood component separation device 100 according to the second embodiment. FIG. 5 is a view of the blood component separation device 100 according to the second embodiment as viewed from the front upper side.

  A blood component separation device 100 according to the second embodiment is a separation device for separating blood into, for example, a red blood cell component and a plasma component, and as shown in FIGS. A light emitting unit 126 that emits visible light toward the placed bag 191, a light receiving unit 128 that receives light emitted from the light emitting unit 126 and reflected by the bag 191, and a spectrum of light received by the light receiving unit 128 are measured. An arithmetic processing unit 130 that performs mathematical processing on the spectrum, a determination unit 136 that determines the quality of the bag 191 based on a calculation result by the arithmetic processing unit 130, and a notification unit that notifies the operator of various types of information. First notification unit 124 and second notification unit 125, storage unit 142, rewrite unit 144, power supply unit 146 for supplying power to each unit in blood component separation device 100, and device body 11. A power switch 122 provided at the lower front of the battery, an operation panel 123 provided above the power switch 122, an optical path length adjusting unit 138, and blood containing red blood cell components and plasma components are separated into blood bags. A liquid feeding mechanism 150 for feeding the liquid to the bag, a seal mechanism 160 for sealing the tube communicating with the bag, and a control unit 140 for performing overall control of each part in the blood component separation device 100. Among these parts, the liquid supply mechanism 150, the seal mechanism 160, the first notification unit 124 and the second notification unit 125, the power switch 122, and the operation panel 123 are provided inside the apparatus main body 110.

  A bag mounting portion 111 on which the bag 190 is mounted is provided on the front surface of the apparatus main body 110. A first placement portion 112 on which the bag 191 is placed is provided on the upper left side of the upper surface of the apparatus body 110, and a second placement on which the bag 192 is placed on the upper right side of the upper surface of the apparatus body 110. A portion 113 is provided.

  Here, the bags 190 to 192 attached to the blood component separation device 100 will be described. The bag 190 shown in FIG. 5 is a blood bag containing blood containing red blood cell components and plasma components, and is stored in a state where the red blood cell components and the plasma components are separated vertically by using another centrifuge or the like. ing. When the bag 190 is mounted on the bag mounting portion 111, the red blood cell component is the lower layer and the plasma component is the upper layer. The bag 191 is a bag for containing only the plasma component in the bag 190, and is empty before the plasma component in the bag 190 is moved. The bag 192 is a bag for storing an erythrocyte storage additive solution such as a MAP solution (mannitol-adenine-phosphate). These bags 190 to 192 are connected by tubes 193 to 195 and a Y-shaped tube 196.

  As shown in FIG. 4, a light passage hole 116 is formed in the substantially central portion of the first mounting portion 112 to allow the light from the light emitting portion 126 and the light irradiated from the light emitting portion 126 and reflected by the bag 191 to pass therethrough. Has been. Although a description by illustration is omitted, a light emitting unit 126 and a light receiving unit 128 are installed below the first placement unit 112, and light from the light emitting unit 126 is favorably applied to the bag 191 through the light passing hole 116. The installation angles of the light emitting unit 126 and the light receiving unit 128 are adjusted so that the light that is irradiated and reflected by the bag 191 enters the light receiving unit 128 through the light passage hole 116 satisfactorily.

  Although not shown, on the back surface of the apparatus main body 110, for example, a slot portion 114 into which an external memory as an external recording medium (for example, an SD card or a compact flash (registered trademark)) can be inserted is provided.

  The light emitting unit 126 is composed of, for example, a white LED that combines a blue light emitting element and a yellow phosphor.

  The light receiving unit 128 is composed of, for example, a spectroscopic sensor.

  As shown in FIG. 3, the arithmetic processing unit 130 secondarily differentiates the spectrum measured by the spectrum measuring unit 132 that measures the spectrum of the light received by the light receiving unit 128 and the spectrum measured by the spectrum measuring unit 132, and the second derivative spectrum. And a peak intensity calculator 134 for calculating a peak intensity in the range of 500 nm to 600 nm.

  The spectrum measurement unit 132 further has a function of adjusting the measurement time when measuring a spectrum.

  The peak intensity calculation unit 134 converts the calculated peak intensity into a hemoglobin amount, and outputs the converted value to the determination unit 136.

  The determination unit 136 determines whether or not the calculated peak intensity conversion value exceeds a predetermined reference value, and determines whether or not the bag 191 is good based on the determination result, In performing, it has the reference value information reference function which refers the reference value information memorize | stored in the memory | storage part 142. FIG.

  The storage unit 142 stores, as reference value information, the amount of hemoglobin that serves as a boundary between the non-defective bag 191 and the defective bag 191. When the determination unit 136 performs the above-described reference value information reference function, the reference value information is output to the determination unit 136.

  The rewriting unit 144 has a function of receiving data related to the reference value information from the outside of the apparatus and rewriting the reference value information stored in the storage unit 142 based on the data. Since the specific function and configuration of the rewrite unit 144 are the same as those of the rewrite unit 44 described in the first embodiment, detailed description thereof is omitted.

  The power supply unit 146 guides AC power from an external commercial power supply or the like via a power cable (not shown), and performs processing such as transformation, rectification, and smoothing by a built-in AC / DC conversion unit (not shown). And has a function of supplying power to each part of the blood component separation device 100.

  By pressing the power switch 122, the power supply of the blood component separation device 100 can be switched ON / OFF.

  The optical path length adjustment unit 138 has a function of adjusting the optical path length until visible light emitted from the light emitting unit 126 is received by the light receiving unit 128 according to an instruction from the control unit 140. Specifically, the optical path length is adjusted by adjusting the position of the light receiving unit 128 according to an instruction from the control unit 140.

  As shown in FIG. 3, the liquid feeding mechanism 150 pressurizes the bag 190 attached to the bag attaching portion 111 from the outer surface of the bag to send a part of blood components in the bag 190 to another bag. The first liquid feeding part 151 and the bag 191 placed on the first placing part 112 are pressurized from the outer surface of the bag, thereby feeding a part of blood components in the bag 191 to another bag. The second liquid feeding part 152 and the third liquid feeding part for feeding the liquid in the bag 192 to another bag by pressurizing the bag 192 placed on the second placing part 113 from the bag outer surface. 153.

  The first liquid delivery unit 151 includes a first pressure plate 154 shown in FIGS. 4 and 5, a motor (not shown) for rotating the first pressure plate 154, red blood cell components and plasma in the bag 190. A boundary detection sensor (not shown) for detecting a boundary surface with the component. The first pressure plate 154 is installed on the front surface of the apparatus main body 110 so as to cover the bag mounting portion 111 shown in FIG. 4, and the front / rear direction of the apparatus main body 110 is centered on the lower portion of the first pressure plate 154. It is provided so that rotation is possible.

  The second liquid feeding unit 152 has a second pressure plate 155 shown in FIGS. 4 and 5 and a motor (not shown) for rotating the second pressure plate 155. The second pressure plate 155 is installed above the first mounting portion 112 and is provided to be rotatable in the vertical direction of the apparatus main body 110 with the back side portion of the second pressure plate 155 as a rotation center. .

  The third liquid feeding unit 153 includes a third pressure plate 156 shown in FIGS. 4 and 5 and a motor (not shown) for rotating the third pressure plate 156. The third pressure plate 156 is installed above the second mounting portion 113 and is provided so as to be rotatable in the vertical direction of the apparatus main body 110 with the back side portion of the third pressure plate 156 as a rotation center. .

  As shown in FIGS. 3 to 5, the seal mechanism 160 includes a first seal portion 161 for sealing the tube 193 that connects the bag 190 to the Y-shaped tube 196, and a tube that connects the Y-shaped tube 196 to the bag 191. The second seal portion 162 for sealing 194 and the third seal portion 163 for sealing the tube 195 connecting the Y-shaped tube 196 to the bag 192 are provided. The portions of the first to third seal portions 161 to 163 that are in contact with the tubes are composed of electrodes, and the tubes can be sealed (sealed) by applying a current while the tubes are sandwiched between the electrodes. It is configured. In addition, these 1st-3rd seal | stickers 161-163 can also interrupt | block the communication state in a tube temporarily by clamping a tube, without applying an electric current to each electrode.

  The control unit 140 is composed of, for example, a microcomputer.

  The first notification unit 124 is a liquid crystal monitor, for example, and is installed at a position on the front right side of the apparatus main body 110 as shown in FIGS. 4 and 5. The 1st alerting | reporting part 124 is comprised so that an operator can alert | report the quality determination result by the discrimination | determination part 136 by character information and image information.

  The 2nd alerting | reporting part 125 is a warning indicator lamp, for example, and is installed in the upper surface back (near the 1st mounting part 112) of the apparatus main body 110, as shown in FIG. The 2nd alerting | reporting part 125 is comprised, for example so that the light of three colors, green, yellow, and red, can be lighted or blinked. The 2nd alerting | reporting part 125 is comprised so that an operator can be alert | reported by the lighting or blinking of the light by the discrimination | determination part 136.

  The operation panel 123 is installed on the front surface of the apparatus main body 110 and below the first notification unit 124. A plurality of buttons are provided on the operation panel 123, and by pressing each button, it is possible to operate various numerical value setting changes, execution or stop of an operation when separating blood components, and the like.

Next, the flow in which the blood component in the bag 190 is separated into the red blood cell component and the plasma component by the blood component separation device 100 will be described with reference to FIG.
FIG. 6 is a diagram for explaining a blood component separation device 100 according to the second embodiment. 6A to 6F schematically show a flow in which blood components in the bag 190 are separated and accommodated in the bags 190 and 191. FIG. In addition, in the bags 190 to 192 shown in FIGS. 6 (a) to 6 (f), the slanting lines that rise to the right and narrow intervals indicate red blood cell components, and the slanting lines that rise to the right and wide intervals indicate plasma components. The slanting line to the right indicates the red blood cell storage additive, and the crossed diagonal line shown in FIG. 6 (f) indicates the red blood cell component after the addition of the red blood cell storage additive. Bags shown in white are empty bags.

  In separating blood components using the blood component separation device 100, first, a bag 190 containing blood containing red blood cell components and plasma components is attached to the bag attachment portion 111, and a bag 191 made of an empty bag is first mounted. The bag 192 placed on the placement unit 112 and containing the erythrocyte storage additive solution is placed on the second placement unit 113. The tubes 193 to 195 and the Y-shaped tube 196 are arranged and fixed at predetermined positions (see FIGS. 5 and 6A).

  When the operator operates the operation panel 123 to perform the separation operation, the control unit 140 controls the drive of the seal mechanism 160, opens the first and second seal units 161 and 162, and communicates the tubes 193 and 194. And the third seal portion 163 is closed to temporarily block the communication state of the tube 195. In this state, the control unit 140 further drives and controls the motor of the first liquid feeding unit 151, and rotates the first pressure plate 154 to pressurize the bag 190 (see FIG. 6B).

  Then, the plasma component in the upper layer among the blood components housed in the bag 190 moves to the bag 191 through the tubes 193 and 194. When most of the plasma component in the upper layer moves and the boundary surface between the red blood cell component and the plasma component is detected by a boundary detection sensor (not shown), the detection signal is sent to the control unit 140. Upon receiving the detection signal, the control unit 140 stops driving the motor of the first liquid feeding unit 151, stops the pressurization of the bag 190 by the first pressure plate 154, and closes the second seal unit 162. The communication state of the tube 194 is temporarily blocked. As a result, only the red blood cell component remains in the bag 190, and the plasma component moves in the bag 191 (see FIG. 6C).

  Next, the control unit 140 controls the light emitting unit 126, the arithmetic processing unit 130, and the like to inspect for hemoglobin contamination or red blood cell contamination in the bag 191 (see FIG. 6D). The quality determination result by the determination unit 136 is sent to the first notification unit 124 and the second notification unit 125 through the control unit 140 and notified to the worker.

  After confirming that the bag 191 is a non-defective product by inspection, the control unit 140 controls the drive of the seal mechanism 160 and opens the third seal unit 163 to ensure the communication state of the tubes 193 and 195. In this state, the control unit 140 further drives and controls the motor of the third liquid feeding unit 153 to rotate the third pressure plate 156 to pressurize the bag 192 (see FIG. 6E).

  Then, the red blood cell storage additive contained in the bag 192 moves to the bag 190 through the tubes 193 and 195. When the movement of the erythrocyte storage additive solution is completed, the control unit 140 stops driving the motor of the third liquid feeding unit 153, stops the pressurization of the bag 192 by the third pressure plate 156, and the first seal unit. 161 is closed to temporarily block the communication state of the tube 193. As a result, a red blood cell preparation in which the red blood cell additive is added to the red blood cell component is produced in the bag 190 (see FIG. 6F).

  Finally, the controller 140 applies current to the electrodes of the first seal portion 161 and the second seal portion 162 to seal and disconnect the tubes 193 and 194. Thereby, the erythrocyte preparation (bag 190) in which the erythrocyte storage additive solution is added to the erythrocyte component and the plasma preparation (bag 191) composed of the plasma component can be obtained.

  In the inspection process shown in FIG. 6D, if it is determined that the bag 191 is defective, the control unit 140 controls the liquid feeding mechanism 150 described in FIGS. 6E and 6F. The drive control of the seal mechanism 160 is not performed, and a transition is made to a standby state waiting for an instruction from the operator.

  The blood component separation device 100 according to the second embodiment configured as described above includes the arithmetic processing unit 130 and the determination unit 136 having the spectrum measurement unit 132 and the peak intensity calculation unit 134 described above. A spectrum obtained by irradiating visible light toward the bag 191 is second-order differentiated, and it is determined whether or not a converted value of peak intensity at a peak appearing in the second-order derivative spectrum exceeds a predetermined reference value. be able to. As a result, regardless of the type of bag, the quality of the plasma component fed to the bag 191 can be determined relatively easily.

  In the blood component separation device 100 according to the second embodiment, the control unit 140 has a function of controlling the seal operation of the seal mechanism 160 (seal operation control function) based on the determination result of the determination unit 136. It is possible to determine whether or not the seal is possible based on the result of the quality determination by the unit 136. That is, for example, if the control unit 140 is programmed to “do not seal the tube when it is determined to be defective by the determination unit 136”, the tube is not sealed when the determination unit 136 determines that it is defective. It will be over. If the bag determined to be defective is due to red blood cell contamination, the bag is temporarily removed from the apparatus and again applied to the centrifuge, and then set again in the blood component separation apparatus 100 to separate the red blood cell components. Is possible. That is, since the control unit 140 has the above-described sealing operation control function, it is possible to effectively use the bag determined to be defective.

  In the blood component separation device 100 according to the second embodiment, since the determination unit 136 has the above-described reference value information reference function, the reference value information can be stored in the storage unit 142 in advance. As a result, the quality of the plasma component fed to the bag 191 can be more easily determined.

  In the blood component separation device 100 according to the second embodiment, the visible light wavelength region to be calculated by the peak intensity calculation unit 134 is in the range of 500 nm to 600 nm. As a result, it is possible to satisfactorily determine whether hemoglobin or red blood cells are mixed into the bag 191 to which the plasma component has been fed.

  In the blood component separation device 100 according to the second embodiment, since the light emitting unit 126 is composed of LEDs, it is possible to better determine whether hemoglobin or red blood cells are mixed into the bag 191 to which the plasma component has been sent. . Further, since the light emitting unit 126 is composed of a white LED that combines a blue light emitting element and a yellow phosphor, the light emitting unit 126 is a suitable light source for the peak intensity calculating unit 134 whose calculation target wavelength region is 500 nm to 600 nm.

  Since the blood component separation device 100 according to the second embodiment further includes the optical path length adjustment unit 138, a plasma component having a relatively large turbidity, such as a plasma component having strong chyle, is sent to the bag 191. Even in such a case, it is possible to perform a good inspection by shortening the optical path length.

  In the blood component separation device 100 according to the second embodiment, the spectrum measurement unit 132 has a function of adjusting the spectrum measurement time. As a result, even when a plasma component having a relatively high turbidity, such as a plasma component with strong chyle, is sent to the bag 191, it can be satisfactorily inspected by extending the spectrum measurement time. It becomes.

  As mentioned above, although the test | inspection apparatus for blood component preparations and the blood component separation apparatus of this invention were demonstrated based on said each embodiment, this invention is not limited to said each embodiment, and does not deviate from the summary. The present invention can be implemented in various modes within the scope, and for example, the following modifications are possible.

(1) In each of the embodiments described above, the case where the light receiving unit receives light irradiated from the light emitting unit and reflected by the plasma preparation (bag 191) has been described, but the present invention is limited to this. is not. For example, the light emitting unit and the light receiving unit may be arranged to face each other so that the light receiving unit receives light irradiated from the light emitting unit and transmitted through the plasma preparation (bag 191).

(2) In each of the above embodiments, the peak intensity calculation unit converts the peak intensity calculated from the second derivative spectrum into the amount of hemoglobin, and determines whether or not the converted value exceeds a predetermined reference value. However, the present invention is not limited to this. For example, the peak intensity calculation unit may be configured to calculate an absolute value of the peak intensity from the secondary differential spectrum, and to determine whether or not the absolute value exceeds a predetermined reference value. That is, the pass / fail judgment may be made based on the converted value obtained by converting the peak intensity calculated from the second derivative spectrum into the hemoglobin amount, or the peak intensity calculated from the second derivative spectrum without converting into the hemoglobin amount. The pass / fail determination may be performed based on the absolute value of.

(3) In each of the above embodiments, the case where the light emitting unit is configured by a white LED in which a blue light emitting element and a yellow phosphor are combined has been described as an example, but the present invention is not limited thereto. Absent. For example, a substantially yellow-green LED having relatively high luminance in the wavelength band of 500 nm to 600 nm may be used. The substantially yellow-green LED may be a single LED that emits substantially yellow-green, or an LED aggregate that exhibits a substantially yellow-green color by combining a plurality of LEDs that emit light of a color other than substantially yellow-green. May be.

(4) In each of the above embodiments, the case where the light receiving unit is formed of a spectroscopic sensor has been described as an example. However, the present invention is not limited to this. For example, three sensors that directly read stimulation values are used. May be.

(5) In each of the above embodiments, the case where the rewriting unit is configured to read data from the external memory inserted in the slot unit has been described as an example, but the present invention is limited to this. is not. For example, it may be configured to receive data information transmitted from an external information terminal such as a personal computer and rewrite the reference value information stored in the storage unit based on the data information.

(6) In each of the above embodiments, the case where the optical path length adjustment unit adjusts the optical path length by adjusting the position of the light receiving unit has been described as an example, but the present invention is not limited to this. . For example, the optical path length may be adjusted by adjusting the position of the light emitting unit, or the optical path length may be adjusted by adjusting the positions of both the light emitting unit and the light receiving unit. Further, the present invention is not limited to the case where the optical path length is adjusted by an instruction from the control unit. For example, the operator can adjust the optical path length by actively adjusting the positions of the light receiving unit and the light emitting unit. May be.

(7) In the first embodiment, the case where the light emitting portion hole 16 and the light receiving portion hole 18 are separated has been described as an example. However, the present invention is not limited to this, and the second embodiment. It may be integrated like the light passage hole 116 described in the embodiment. Conversely, the light passage hole 116 described in the second embodiment may be separated like the light emitting portion hole 16 and the light receiving portion hole 18 described in the first embodiment.

(8) In the first embodiment, the case where the notification unit having the function of notifying the operator of the quality determination result by the determination unit is described as an example, but the present invention is not limited to this. It may be an image display means composed of a display element other than liquid crystal (for example, an organic EL element), or an illumination means configured to be able to notify an operator by lighting or blinking light. Alternatively, sound generation means configured to be able to notify the worker by sound may be used. Similarly, in the second embodiment, the case where the notification unit includes the first notification unit 124 including a liquid crystal monitor and the second notification unit 125 including a warning indicator lamp that emits light of three colors has been described as an example. However, the present invention is not limited to this, the type of the image display means may be changed, an illumination means having another configuration may be used, and the sound generation means is used as the third notification unit. May be added.

(9) In the first embodiment described above, the inspection apparatus for inspecting the plasma preparation for hemoglobin contamination or erythrocyte contamination has been described as an example, but the present invention is not limited to this, for example, a platelet preparation Needless to say, it can also be used as an inspection apparatus for inspecting blood component preparations comprising other blood components, such as an inspection apparatus for inspecting hemoglobin contamination or red blood cell contamination.

(10) In the first embodiment, as shown in FIG. 2, the case where the inspection apparatus is a stationary inspection apparatus that becomes a box shape when the upper lid 20 is closed has been described. However, the present invention is not limited thereto. For example, it may be a portable inspection device having a shape like a barcode reader.

(11) In the second embodiment, as shown in FIG. 6D and FIG. 6E, after confirming that the bag 191 is a non-defective product by inspection, the bag 192 is pressurized. The case of transferring the red blood cell storage additive solution has been described as an example, but the present invention is not limited to this. For example, the erythrocyte storage additive solution may be moved by pressurizing the bag 192 while determining whether the bag 191 is good or bad. After the movement, the bag 191 may be determined to be good or bad.

  In configuring the blood component preparation test apparatus 1 according to the first embodiment and the blood component separation apparatus 100 according to the second embodiment, the results of the following test examples were referred to.

[Test Example 1]
Test Example 1 is a test example for confirming the influence due to the difference in bags. In the test, two types of bags from different manufacturers were used, each bag was filled with a predetermined amount of a hemoglobin solution made of bovine blood adjusted to a hemoglobin concentration of 20 mg / dL, and two types of samples (samples A-1 and A-2) were filled. ) Was produced. Then, while measuring the absorbance spectrum of each sample, the spectrum was second-order differentiated to obtain the second-order derivative spectrum of each sample.

  FIG. 7 is a diagram showing the absorbance spectra of Samples A-1 and A-2. FIG. 8 is a diagram showing the second derivative spectra of Samples A-1 and A-2.

Regarding the absorbance spectrum of each sample, as shown in FIG. 7, in both samples A-1 and A-2, a conspicuous peak does not appear in the range of 500 nm to 600 nm, and a very slight fluctuation is observed in the vicinity of 568 nm. On the other hand, while a gentle decrease in absorbance was observed, as shown in FIG. 8, the samples A-1 and A-2 showed multiple large fluctuations in the range of 500 nm to 600 nm. It was.
In other words, it was confirmed that when the spectrum obtained when the visible light was irradiated toward the bag was second-order differentiated, the peak was sharpened in the range of, for example, 500 nm to 600 nm of the second-order derivative spectrum.

Further, when comparing the data of Sample A-1 and Sample A-2, the absorbance spectrum shown in FIG. 7 shows a difference in absorbance value in the range of about 500 nm to 700 nm, while the second derivative shown in FIG. Regarding the spectrum, the wavelength at which the peak appears in the range of at least 500 nm to 600 nm and the height of the peak are substantially the same, and extremely high coincidence was observed between the curves drawn by both.
From this, it was confirmed that the peak appearing in the second-order differential spectrum always appears in the predetermined wavelength region (500 nm to 600 nm) even if the bag type is changed.

  Next, the following additional tests were performed in order to confirm the effect of different bags when the hemoglobin concentration of each bag was changed.

  First, the same two types of bags as those used when the hemoglobin concentration was 20 mg / dL were prepared, and after preparing samples with hemoglobin concentrations set in three stages of 10 mg / dL, 25 mg / dL, and 30 mg / dL The absorbance spectrum and second derivative spectrum of each sample were determined. And while calculating | requiring the light absorbency in 568 nm from which the some fluctuation | variation was seen in the case of sample A-1 and A-2 from the light absorbency spectrum of each sample, sample A-1 and A- In the case of 2, the second order differential value of absorbance at 582 nm that appeared as one of the peaks was obtained, and after adding the values in the case of samples A-1 and A-2 as data to these values, the relationship with the hemoglobin concentration Is shown in a graph.

  FIG. 9 is a diagram showing the relationship between hemoglobin concentration and absorbance in Test Example 1. FIG. 10 is a diagram showing the relationship between the hemoglobin concentration and the absorbance second derivative value in Test Example 1. In the figure, the points indicated by white diamonds are “data obtained from the bag made by company A”, and the straight line consisting of the bold line is the regression line. A point indicated by a black triangle is “data obtained from a bag manufactured by B company”, and a straight line formed by a thin line is a regression line.

  According to the result of this additional test, as can be seen from FIG. 9 and FIG. 10, a positive correlation is observed between the hemoglobin concentration and the absorbance, and a negative correlation is observed between the hemoglobin concentration and the absorbance second derivative value. It was observed. When the strength of the correlation between the two was compared with the square value of the correlation coefficient R, the correlation between the hemoglobin concentration and the absorbance was 0.845 for the A company bag and 0.516 for the B company bag. . On the other hand, regarding the correlation between the hemoglobin concentration and the second-order differential value of absorbance, the bag manufactured by Company A was 0.997 and the bag manufactured by Company B was 0.986. From this, it was confirmed that the relationship between the hemoglobin concentration and the second-order absorbance value was stronger in both the A company bag and the B company bag.

[Test Example 2]
Test Example 2 is a test example for clarifying that the quality of a blood component preparation can be discriminated whether it is mixed with red blood cells or hemoglobin due to hemolysis. In the test, a hemoglobin solution having a predetermined concentration was prepared based on human blood, and the solution was diluted until the hemoglobin concentration became 20 mg / dL and filled in a predetermined amount in a bag. At this time, the sample using physiological saline as dilution water is a sample (sample B-1) for confirming the mixing of red blood cells, and the sample using pure water as the dilution water confirms hemoglobin contamination due to hemolysis. Sample (sample B-2). Then, while measuring the absorbance spectrum of each sample, the spectrum was second-order differentiated to obtain the second-order derivative spectrum of each sample. All the bags used are of the same type.

  FIG. 11 is a diagram showing the absorbance spectra of Samples B-1 and B-2. FIG. 12 is a diagram showing second-order differential spectra of Samples B-1 and B-2.

Regarding the absorbance spectrum of each sample, as shown in FIG. 11, both the samples B-1 and B-2 show a slight variation in the range of 500 nm to 600 nm, while the second derivative spectrum of each sample. As shown in FIG. 12, both the samples B-1 and B-2 showed a plurality of large fluctuations in the range of 500 nm to 600 nm.
That is, even when red blood cells are mixed as they are or when hemoglobin is mixed due to hemolysis, the absolute value or converted value of the peak intensity at the peak appearing in the second derivative spectrum is a predetermined reference value. It was confirmed that the quality of the blood component preparation can be determined relatively easily if it is determined whether or not it exceeds the above.

  Next, in order to confirm whether or not the above could be said even if the hemoglobin concentration in the bag was other than 20 mg / dL, the following additional test was performed.

  First, in each of samples using physiological saline as dilution water (erythrocyte contamination model) and using pure water (hemolysis model), samples having hemoglobin concentrations set in two stages of 10 mg / dL and 25 mg / dL are prepared. After preparation, the absorbance spectrum and second derivative spectrum of each sample were determined. And while calculating | requiring the light absorbency in 570 nm from which the fluctuation | variation was seen in the case of sample B-1 and B-2 from the absorbance spectrum of each sample, from the secondary differential spectrum of each sample, the sample B-1 and B-2 In this case, the second derivative of absorbance at 580 nm, which appeared as one of the peaks, was obtained, and the numerical values for samples B-1 and B-2 were added to these numerical values as data, and the relationship with the hemoglobin concentration was graphed. It showed in.

  FIG. 13 is a diagram showing the relationship between hemoglobin concentration and absorbance in Test Example 2. FIG. 14 is a diagram showing the relationship between the hemoglobin concentration and the absorbance second derivative value in Test Example 2. In the figure, the points indicated by white diamonds are data of the erythrocyte contamination model, and the straight line consisting of the bold line is the regression line. The points indicated by black triangles are the data of the hemolysis model, and the straight line consisting of thin lines is the regression line.

  According to the results of this additional test, as can be seen from FIGS. 13 and 14, a positive correlation is observed between the hemoglobin concentration and the absorbance, and a negative correlation is observed between the hemoglobin concentration and the second-order absorbance value. It was observed. When the strength of the correlation between the two was compared by the square value of the correlation coefficient R, the correlation between the hemoglobin concentration and the absorbance was 0.996 for the erythrocyte contamination model and 0.781 for the hemolysis model. On the other hand, regarding the correlation between the hemoglobin concentration and the second-order absorbance differential value, the erythrocyte contamination model was 0.999 and the hemolysis model was 0.989. From this, it was confirmed that the relationship between the hemoglobin concentration and the second-order absorbance differential value was stronger in both the erythrocyte contamination model and the hemolysis model.

[Test Example 3]
Test Example 3 is a test example for confirming the influence due to the difference in blood donors. In the test, two types of hemoglobin solutions having a predetermined concentration were prepared based on two different human bloods, and the solutions were diluted to a hemoglobin concentration of 20 mg / dL and filled in a predetermined amount in a bag. At this time, those using physiological saline as dilution water are erythrocyte contamination models (samples C-1, C-2), and those using pure water as dilution water are hemolysis models (samples D-1, D-). 2). Samples C-1 and D-1 are samples prepared based on blood from donor A, and samples C-2 and D-2 are samples prepared based on blood from donor B. Then, while measuring the absorbance spectrum of each sample, the spectrum was second-order differentiated to obtain the second-order derivative spectrum of each sample. All the bags used are of the same type.

  FIG. 15 is a diagram showing absorbance spectra of samples C-1 and C-2. FIG. 16 is a diagram showing second-order differential spectra of samples C-1 and C-2. FIG. 17 is a diagram showing absorbance spectra of samples D-1 and D-2. FIG. 18 is a diagram showing second-order differential spectra of samples D-1 and D-2.

  About the absorbance spectrum of each sample, as shown in FIG.15 and FIG.17, the sample C-1 and C-2 and D-1 and D-2 have some fluctuations in the range of 500 nm to 600 nm. On the other hand, as shown in FIGS. 16 and 18, the second-order differential spectrum of each sample has a large variation in the range of 500 nm to 600 nm in both samples C-1 and C-2 and D-1 and D-2. Several were seen.

  Further, when comparing the data of Sample C-1 and Sample C-2, the absorbance spectrum shown in FIG. 15 shows a difference in absorbance value in the range of about 460 nm to 700 nm, while the second derivative shown in FIG. Regarding the spectrum, the wavelengths at which peaks appear in the range of at least 500 nm to 600 nm are almost the same, and extremely high coincidence was observed between the curves drawn by both. This is also true when the data of the sample D-1 and the sample D-2 shown in FIGS. 17 and 18 are compared.

  That is, even when red blood cells are mixed as they are or when hemoglobin is mixed due to hemolysis, a predetermined wavelength region (500 nm to 600 nm) in the secondary differential spectrum regardless of the blood donor. It was confirmed that the quality of the blood component preparation can be determined relatively easily by determining whether the absolute value or the converted value of the peak intensity at the peak appearing in FIG.

[Test Example 4]
Test Example 4 is a test example for confirming the relationship between the hemoglobin concentration and the absorbance second derivative value based on human blood. In the test, based on a plurality of human specimen blood, each of them was centrifuged under a predetermined condition to collect supernatant plasma, and the hemoglobin concentration in the plasma was measured by the leuco crystal violet method (LCV method). . Moreover, the absorbance spectrum of each plasma was measured, and the absorbance second derivative value obtained by second derivative of the spectrum was calculated.

  FIG. 19 is a diagram showing the relationship between the hemoglobin concentration and the absorbance second derivative value in Test Example 4. The straight line shown in the figure is a regression line obtained from each data.

  According to the test results, as can be seen from FIG. 19, a negative correlation was found between the hemoglobin concentration and the second-order absorbance differential value. Since the square value of the correlation coefficient R was 0.95, it was confirmed that there was a relatively strong correlation between the hemoglobin concentration and the absorbance second derivative value.

  As shown in the regression line shown in FIG. 19, if a relational expression between the hemoglobin concentration and the absorbance second derivative value is obtained in advance based on a plurality of data, the absorbance obtained by measuring the absorbance of the test object. A peak intensity converted value can be obtained by calculating the absorbance second derivative value of the peak intensity from the spectrum and its second derivative spectrum and further substituting it into the relational expression.

  The blood component preparation testing apparatus and blood component separation apparatus of the present invention can determine the quality of blood component preparations (including bags before preparation) such as plasma preparations relatively easily regardless of the type of bag. It can be used as a possible inspection device or separation device.

DESCRIPTION OF SYMBOLS 1 Blood component product test | inspection apparatus 10 and 110 Apparatus main body 12 Mounting part 14 Slot part 16 Light emission part hole 18 Light reception part hole 20 Upper cover 22,122 Power switch 24 Notification part 26,126 Light emission part 28,128 Light reception part 30 , 130 Arithmetic processing unit 32, 132 Spectrum measurement unit 34, 134 Peak intensity calculation unit 36, 136 Discrimination unit 38, 138 Optical path length adjustment unit 40, 140 Control unit 42, 142 Storage unit 44, 144 Rewrite unit 46, 146 Power supply unit 100 Blood component separation device 111 Bag mounting part 112 First mounting part 113 Second mounting part 116 Light passage hole 123 Operation panel 124 First notification part 125 Second notification part 150 Liquid feeding mechanisms 151, 152, 153 First -3rd liquid feeding part 154,155,156 1st-3rd pressurizing plate 160 Seal mechanism 161,162,163 1st-3rd sea Parts 190, 191, 192 bag 193,194,195 tube 196 Y-shaped tube

Claims (6)

A testing device for testing hemoglobin contamination or red blood cell contamination in a plasma product,
A light emitting unit (26) that emits visible light toward a plasma preparation to be examined;
Light receiving portion for receiving the light reflected by the light or the plasma product is irradiated passed through the plasma products from the light emitting portion (26) and (28),
An arithmetic processing unit (30) for measuring a spectrum of light received by the light receiving unit (28) and performing mathematical processing on the spectrum;
A discriminating unit (36) for discriminating the quality of the plasma preparation based on the calculation result by the arithmetic processing unit (30) ;
A storage unit (42) for storing, as reference value information, the amount of hemoglobin that serves as a boundary between a plasma product as a non-defective product and a plasma product as a defective product ;
The arithmetic processing unit (30)
A spectrum measuring unit (32) for measuring a spectrum of light received by the light receiving unit (28);
A peak intensity calculator (34) that secondarily differentiates the spectrum and calculates a peak intensity in a visible light wavelength region of 500 nm to 600 nm,
The determination unit (36) determines whether the calculated absolute value or converted value of the peak intensity exceeds a predetermined reference value, and determines the quality of the plasma preparation based on the determination result A plasma product testing device (1) , comprising: a quality determination function for performing the determination, and a reference value information reference function for referring to the reference value information stored in the storage unit (42) in performing the determination. . The test apparatus for plasma preparation according to claim 1,
The plasma product testing device further comprising an optical path length adjusting unit (38) for adjusting an optical path length until the visible light irradiated from the light emitting unit (26) is received by the light receiving unit (28). (1). In the plasma product testing device (1) according to claim 1 or 2,
The spectrum measuring unit (32)
A plasma preparation test apparatus (1) having a function of adjusting a measurement time of the spectrum . A separation device for separating blood into a red blood cell component and a plasma component,
A liquid feeding mechanism (150) for separating blood containing red blood cell components and plasma components into blood bags after separating the blood components;
A light emitting unit (126) for irradiating visible light toward the bag (191) to which a plasma component has been fed;
A light receiving unit (128) that receives light emitted from the light emitting unit (126) and transmitted through the bag (191) or reflected by the bag (191);
An arithmetic processing unit (130) for measuring a spectrum of light received by the light receiving unit (128) and applying a mathematical process to the spectrum;
A determination unit (136) for determining the quality of the bag (191) based on a calculation result by the calculation processing unit (130);
A storage unit (142) for storing, as reference value information, the amount of hemoglobin that serves as a boundary between the bag (191) as a non-defective product and the bag (191) as a defective product;
A control unit (140) for controlling at least the liquid feeding mechanism (150), the light emitting unit (126), and the arithmetic processing unit (130);
The arithmetic processing unit (130)
A spectrum measuring unit (132) for measuring a spectrum of light received by the light receiving unit (128);
A peak intensity calculator (134) that secondarily differentiates the spectrum to calculate a peak intensity in a visible light wavelength region of 500 nm to 600 nm,
The determination unit (136) determines whether the calculated absolute value or converted value of the peak intensity exceeds a predetermined reference value, and the quality of the bag (191) is determined based on the determination result. A blood component separation device (100), comprising: a pass / fail discrimination function for discriminating; and a reference value information reference function for referring to the reference value information stored in the storage unit (142) in performing the determination. ). The blood component separation device according to claim 4 ,
Blood components, characterized in that it further comprises an optical path length adjusting unit (1 38) for adjusting an optical path length to the visible light emitted is received by the light receiving portion (1 28) from said light emitting portion (1 26) Separation device (100) . The blood component separation device according to claim 4 or 5 ,
The spectrum measurement unit ( 1 32)
A blood component separation device (100) having a function of adjusting the measurement time of the spectrum.