JP2005066018A - Blood separator and blood separation method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood separator and a blood separation method capable of withstanding refrigeration preservation by preventing air bubbles from being mixed at the time of forcibly feeding a plasma layer forcibly fed from a first container which is a master bag to a separate container. <P>SOLUTION: In a blood separator 1, a multiple type container in which a plurality of flexible containers are connected through tubes 11, 14, 15a and 15b to a flexible first container 2a is used, raw blood stored in the first container 2a is centrifuged to separate a plasma layer and a red blood cell layer, the first container 2a is set to a first housing part 3 provided with a first force feed means, the middle parts of the tubes are clamped by the respective clamp parts 36, 37, 38 and 39 of the tubes, and the plasma layer is forcibly fed to the separator container 2b, which is detached and used. The blood separator 1 is provided with a level detector 35 for detecting the level of the boundary layer of the plasma layer and the red blood cell layer, and an air bubble sensor 13 for clamping the middle part of the tube and detecting the presence/absence of the air bubbles. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a blood separation apparatus and method thereof, in which plasma, red blood cells, etc. are preliminarily separated and stored in a flexible container such as a blood bag, and are taken out after being pumped to individual containers. The present invention relates to a blood separation technique.

A first container, which is a parent bag in which raw blood is centrifuged into a plasma layer and a red blood cell layer, is set in a blood separation device, and the plasma layer pumped from the first container is tubed into a second container, which is a small bag. There is known a blood separation apparatus configured to measure the weight of a second container that is gradually increased through pressure, display a weight measurement result, and automatically stop the pressure-feeding when a set weight is reached. (Patent Document 1)
On the other hand, when the raw blood is sucked and stored in the first container, bubbles may be mixed into the first container. For example, when using a leukocyte removal set that can be stored while removing leukocytes from the raw blood, bubbles are mixed in the first container. By removing the leukocytes, the leukocyte layer in the boundary layer between the plasma layer and the erythrocyte layer after centrifugation is reduced, so that there is an advantage that the leukocyte layer separation step is unnecessary.
Japanese Patent Publication No. 6-22603.

  However, when the leukocyte removal set is used to remove leukocytes as described above, bubbles corresponding to the volume of leukocytes are mixed into the first container. The air bubbles mixed in this way are located above the plasma layer due to the specific gravity. For this reason, when the plasma layer pumped from the first container is pumped through the tube toward the second container, which is a small bag, for example, bubbles are pumped into the second container.

  When a predetermined weight of the plasma layer is stored, the second container is taken out after the tube has been welded and sealed, and then stored in a refrigerator-freezer or freezer in a horizontal state and stored frozen, and thawed when used. To be used.

  However, if air bubbles are mixed, a space part corresponding to the volume of the air bubbles is formed between the plasma layer and the inner surface of the container bag forming the second container. Because it is made of a material such as vinyl chloride that has a solidifying property, the frozen and solidified vinyl chloride is extremely vulnerable to external forces, so it will break when external forces act on the space. There is a fear.

  Therefore, the present invention has been made in view of the above-mentioned problems, and when mixing the plasma layer pumped from the first container that is the parent bag into another container, by preventing the mixing of bubbles, An object of the present invention is to provide a blood separation apparatus and a blood separation method that can withstand cryopreservation.

  In order to solve the above-described problems and achieve the object, according to the present invention, a multiple container in which a plurality of flexible containers are connected to a flexible first container via a tube is used. The raw blood stored in the first container is centrifuged into at least a plasma layer and an erythrocyte layer, the first container is set in a first housing part having a first pumping means, and an intermediate part of the tube is a tube. A blood separation device that is used to clamp with a clamping means, to pump a plasma layer into one of the other containers by the first pressure feeding means, store it in one of the other containers, and to remove the multiple container In order to detect the level of the boundary layer between the plasma layer and the red blood cell layer, the presence or absence of bubbles is detected by sandwiching the level detection means disposed in the first housing part and the middle part of the tube. Bubble detection means and connected to the level detection means Together it is, is characterized by and a control means for controlling said first pumping means in response to the presence detection by the bubble detection means.

  In addition, a multiple-type container in which a plurality of flexible other containers are connected to the flexible first container via a tube is used, and at least a plasma layer and a red blood cell layer are used as raw material blood stored in the first container. And the first container is set in a first accommodating portion having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and the plasma layer is separated by the first pressure feeding means. A blood separation device used for pressure-feeding to one of the separate containers and storing it in one of the separate containers, followed by welding and sealing with a tube welding means, and removing the multiple container, comprising a plasma layer and In order to detect the level of the boundary layer of the erythrocyte layer, level detection means disposed in the first accommodating portion, bubble detection means for detecting the presence or absence of bubbles by sandwiching a middle portion of the tube, and the level When connected to the detection means To, is characterized by and a control means for controlling said first pumping means in response to the presence detection by the bubble detection means.

  In addition, a multiple-type container in which a plurality of flexible other containers are connected to the flexible first container via a tube is used, and the raw blood stored in the first container is divided into at least a plasma layer and a red blood cell layer. Centrifugation, the first container is set in a first accommodating part having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and the plasma layer is separated by the first pressure feeding means into the separate container. A blood separation method for removing the multiple-type container by pumping to one of the containers and removing the multiple-type container, wherein the plasma layer and the red blood cell layer are detected by the level detection means disposed in the first storage unit. Detecting the level of the boundary layer, detecting the presence / absence of bubbles by sandwiching the middle part of the tube by the bubble detection means, and detecting the bubbles by the control means connected to the level detection means The presence detection by It is characterized by and a step of performing control of the first pumping means in response.

  And the multiple container which connected the several flexible another container via the tube with respect to the flexible 1st container is used, The raw material blood stored in the said 1st container at least a plasma layer and a red blood cell layer And the first container is set in a first accommodating portion having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and the plasma layer is separated by the first pressure feeding means. A blood separation method used for pressure-feeding to one of the separate containers and storing it in one of the separate containers, followed by welding and sealing with a tube welding means, and removing the multiple-type container. A step of detecting a level of a boundary layer between a plasma layer and a red blood cell layer by a level detection unit disposed in the storage unit, a step of detecting presence / absence of bubbles by sandwiching a middle portion of the tube by a bubble detection unit, For level detection means The control means being continued, it is characterized by comprising a step for performing control of the first pumping means in response to the presence detection by the bubble detection means.

  According to the present invention, when the plasma layer pumped from the first container which is the parent bag is pumped to another container, the blood separation device capable of withstanding the cryopreservation of the container by preventing the mixing of bubbles, and A blood separation method can be provided.

  Hereinafter, an example of a so-called quadruple blood bag, which is a preferred embodiment of the present invention, will be described with reference to the accompanying drawings. However, the present invention can also be applied to a triple blood bag (not shown).

  First, FIG. 1 (a) shows each container through tubes 11, 14, 15a, and 15b so that the baffle coat layer is removed and the first container 2a, which is a parent bag, is injected for blood preservation solution injection. It is the top view of the multiple container 2 which connected the 2nd thru | or 4th container which is a child bag, and was extended flatly. FIG. 1B is a cross-sectional view of the plug body 18.

  In FIG. 1 (a), the multi-container container 2, which is a quadruple blood bag, forms a volume portion from a translucent resin that previously contains raw blood separated into a plasma layer, a buffy coat layer, and a red blood cell layer. As described above, the first container 2a of the flexible parent bag such as vinyl chloride, the second container 2c which is the child bag having flexibility in the empty state, and the first container of the child bag having flexibility in the empty state. 3 container 2b and flexible 4th container 2d, which is a child bag pre-stored with a necessary amount of blood preservation solution, are made flexible by branching from branch pipes 82 and 82 in the middle as shown in the figure. The tubes 11, 14, 15 a and 15 b are connected and prepared. Each container is formed by forming a volume portion indicated by a broken line in a joint along the outer peripheral surface.

  To the first container 2a, a tube 79 for introduction, in which a puncture needle 81 is connected to the end for introducing the raw blood from a blood donor, is further connected as shown in the figure, and the inside of the first container 2a For example, 400 ml of raw material blood is introduced into the tube 79, and thereafter, the middle portion of the tube 79 is clamped with a welding seal or a clamp member to store the blood in the first container 2a.

  In the first container 2a, a pair of left and right holes 7a and 7a set in a suspended state with respect to a hook provided in a first accommodating portion of a blood separation device (hereinafter also referred to as device 1) form a volume portion. It is formed in the joint part to be. Further, a plug body 18 called “click chip (registered trademark of Terumo Corporation)” is connected to the inside of the tube 11 connected to the first container 2a on the first container 2a side. As shown in FIG. 1 (b), the plug 18 is grasped with both fingertips from the outside of the bag, and the distal end portion is bent to the left and right so that the thin plug 18a provided therein is It is injection-molded from a predetermined resin material so that the volume portion and the tube 11 communicate with each other by being broken.

  The stopper 18 is also provided in the fourth container 2d in the same manner as shown in order to prevent the stored blood preservation solution from flowing out, and after setting each container in the apparatus 1, Each plug body 18 is bent to the left and right to be brought into a communication state via the tubes 11, 15 a, and 15 b, whereby preparation for separation is performed. Further, the third container 2b connected from the branch pipe 82 via the tube 14 in order to store the white blood cells of the buffy coat layer is discarded.

In addition, a label sheet 1000 provided with a double-sided adhesive layer that is bonded in a subsequent process of the manufacturing process is attached to the first container 2a as illustrated. The label sheet 1000 is printed with a description of predetermined items relating to the raw blood and a barcode obtained by encrypting the predetermined items, and automatically reads the contents of the barcode using a handy barcode reader described later, It can be displayed.
Next, in the second container 2c, a horizontally long hole 7b suspended from a hook, which will be described later, is formed at the joint of the volume portion so that it can sufficiently withstand the load during suspension. . The third container 2b is placed on a tray 12 provided with a weight measuring unit 101 as third weight measuring means. Since the fourth container 2d is suspended by a pair of left and right hooks provided in an airtight case, which will be described later, which is the second storage means, the horizontally long hole 7b similar to the second container 2c has a joint of the volume part. Is formed.

  As described above, the holes 7a and 7b of the respective containers are formed in different shapes or positions so as to eliminate setting errors of the respective containers. Further, the intermediate portions of the tubes 11, 11a, 11b, and 14 are set as described later in the clamp portions of the tube clamper means described later in a state of being moderately elastically deformed and are welded and sealed by high frequency. It is prepared from a flexible resin material such as vinyl chloride.

  Next, FIG. 2A is a left side view with a part broken away to show the schematic configuration of the apparatus 1, and FIG. 2B is a rear view of the apparatus 1. First, FIG. 2A shows a state before the multiple container 2 described in FIG. 1 is set. Further, the device 1 is designed on the assumption that even a nurse having a relatively short height as shown in the figure is used in a standing state. For this reason, the height dimension of the apparatus 1 is set to about 780 mm, the width dimension is set to 350 mm, and the depth dimension is set to 600 mm. In addition, since the weight is as heavy as about 40 kilograms, the apparatus 1 can be easily mounted by mounting or fixing the apparatus 1 on a moving table 500 provided with casters having rotating rollers and stoppers on the bottom surfaces of the leg portions at the four corners. And can be used fixedly in a predetermined place. Or when installing in fixed positions, such as a predetermined shelf, since the right-and-left wall surface of the apparatus 1 is only a cover, it can be used also in the state which installed another apparatus without the clearance gap.

  In this device 1, a base portion 27, which is partially broken in FIG. 2A, is used as an attachment portion having a configuration described below. An upper surface of the base 27 is provided with a substantially horizontal operation surface 27a and an operation surface 27b inclined at a predetermined angle of about 15 degrees so as to rise toward the back side. A portion 27c is provided. In order to make it possible to confirm the operation status of the apparatus 1 from a distance, the operation indicator 20 has a built-in light-emitting LED, and notifies the nurse by blinking or lighting in different colors. Is provided.

  On the front side of the apparatus 1, a first housing 3 is provided in which the first lid member 4 is open. The first lid member 4 is openable and closable in the direction of the arrow. The first lid member 4 hangs on a hook, which will be described later, inside the first accommodating portion 3 and on a first pressing member 10 that is rotatably provided. After the 1 container 2a is set, the first lid member 4 is automatically closed. An end of a rod 57 reciprocated by a reciprocating mechanism driven by a motor M1 is fixed to the first pressing member 10 at a substantially central position as shown in the figure. In addition, an air compressor 55 for generating positive and negative air pressure is disposed on the back side of the reciprocating mechanism.

  On the operation surfaces 27a and 27b, the first clamp part 36, the second clamp part 38, the third clamp part 39, the first clamp part 36 of the tube clamper means for clamping the intermediate part of the tubes 11, 11a, 11b and 14 described in FIG. A four clamp portion 37 is arranged. Among these clamp parts, the second clamp part 38 and the third clamp part 39 are located on the inclined operation surface 27b because they are far from the front surface because they are on the back side as shown in the figure and are difficult to operate. , Making it easy to set the tube.

  A hook 107 for suspending the second container 2c is provided on the front upper side of the upright portion 27c, and the hook 107 is provided with a second weight measuring means. A space K is provided below the hook 107.

  Moreover, the 2nd accommodating part 70 shown with the broken line is comprised from the airtight case which the front surface opened. In addition, a second lid member 104 is provided that is openable and closable in the direction of the arrow and is airtight with respect to the opening, and that is maintained in a locked state with respect to the second housing portion 70. Since the second lid member 104 is greatly opened upward as shown in the figure, it cannot be opened and closed by the nurse's hand, and is therefore opened and closed by a motor. And this 2nd cover member is automatically hold | maintained in the latching state with respect to the 2nd accommodating part 70, and the lid switch for detecting the latching state is provided.

  Next, in FIG. 2B, a power connector 140 and an extended communication board 141 for enabling remote operation via the Internet or a communication line are provided on the back surface of the apparatus 1 so as to be mounted later. ing. This extended communication board 141 is prepared as a so-called option together with the above-mentioned handy barcode reader, and can be added as required by the user.

  Next, FIG. 3 is an external perspective view of the device 1 as viewed from the front from the viewpoint of the nurse. In this figure, components already described with reference to FIG. 2 are denoted by the same reference numerals and description thereof is omitted. Below the front surface of the apparatus 1, a seesaw type power source operated to start the entire apparatus is shown. A switch 41 is provided. Next to this, a cord connection connector 401 extending from the handy bar code reader 400 is provided. The handy barcode reader 400 can be hung from a hook (not shown).

  Below the handy bar code reader 400 is provided an initial setting unit 300 in which a plurality of switch keys operated for initial setting are arranged. On the left side of the handy barcode reader 400, there is provided a first accommodating portion 3 in which the first lid member 4 is closed. This first lid member 4 is made of a thick acrylic resin, and the inside can be confirmed from the front side, and one of level (interface) detecting means 25 for detecting the level of the boundary layer between the plasma layer and the red blood cell layer. For example, a light receiving element 35 made of, for example, a photodiode is provided at the center of the back surface, and is covered from the outside with a stainless plate.

  The hooks 7 and 7 are fixed on a scale member, which will be described later, so that the first container 2a is suspended and the weight is measured by the first weight measuring unit 102b which is the first weight measuring means shown by the broken line. It is configured. A tube hook 78 having a groove portion shown in the figure is fixed to the rear of the hooks 7 and 7 in order to maintain the tube 11 in a clamped state on the operation surface 27a. A first clamp portion 36 is fixed on the operation surface 27 a behind the tube hook 78. Behind the first clamp part 36, a bubble sensor 13 as a bubble detection means is arranged.

  Further, a branch pipe holder 21 for holding the branch pipe 82 described in FIG. 1 is provided so as to be in a straight line further behind the bubble sensor 13. And the 2nd clamp part 38 is provided in the slightly slanted state like illustration at the left side of this branch pipe holder 12. As shown in FIG. Further, a third clamp part 39 is provided on the right side of the branch pipe holder 12 so as to be in the front-rear direction as shown in the figure. A fourth clamp portion 37 is provided in front of the third clamp portion 39. A third weight measuring unit 101 (shown by a broken line), which is a third weight measuring unit, is provided on the bottom surface of the third clamp unit 39 on the right side, and a resin tray 12 having a large opening upward is provided. . On the front side of the tray 12 are switches for performing welding and sealing with tube welding means described later, a display unit for displaying a weight for displaying the weight of each container that has been weighed, a start switch 42, and a stop switch 44. Is provided.

  A hook 107 is provided above the opening K in the substantially left half of the standing portion 27c. The hook 107 is provided with a second weight measuring unit 102a (shown by a broken line) as second weight measuring means. ) Is provided.

  Further, a second accommodating portion 70 shown in a state where the second lid member 104 is closed is provided in a substantially right half portion of the standing portion 27c.

  Next, FIG. 4 is an external perspective view of the device 1 as viewed from the front of the nurse after the multiple container 2 described in FIG. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted, and the first container 2a is disposed in the first container 3 after the first lid member 4 is automatically opened. Set to. For this purpose, the holes 7 a and 7 a are hooked on the hooks 7 and 7. Thereafter, the tube 11 is inserted into the tube holder 78 and set, and the plug 18 is folded.

  Subsequently, the tube 11 is set so as to be sandwiched between the first clamp part 36 and the bubble sensor 13, and the branch pipe 82 is set in the branch pipe holder 21 as illustrated. Then, the tube 15 a is set on the second clamp part 38, and the hole 7 b of the second container 2 c is hooked on the hook 107.

  The third container 2 b is placed in the tray 12 after setting the tube 14 to the fourth clamp portion 37.

  In addition, the fourth container 2d that pre-stores a blood preservation solution (also referred to as MAP) has holes 7a and 7a for setting the second storage member 70 after the second lid member 104 is automatically opened. The tube 15b is hooked on the hooks 7 and 7 before and after this, and the tube 15b is inserted and set in the third clamp part 39, and the plug body 18 is folded to bring it into a communicating state.

  When the setting of the multiple container 2 to the apparatus 1 is completed as described above, the first lid member 4 and the second lid member 104 are automatically closed, and the standby state shown in FIG. 4 is established. The second lid member 104 is also made of a thick transparent or light-transmitting acrylic resin like the first lid member 4 so that the inside can be confirmed from the front side. Hereinafter, each component will be described with reference to individual drawings.

  FIG. 5 is an external perspective view showing a state after the first container 2 a is suspended inside the first housing 3. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted, and the first accommodating portion 3 is prepared as a box body having a predetermined strength with an open front surface and is fixed to the base portion 27. The The first lid member 4 is made of an acrylic plate that is a transparent resin member having a thickness of about 10 mm or more so that the inside of the first housing portion 3 can be seen when the first housing portion 3 is closed. A shaft support portion 4a is provided on both side surfaces of the lower side of the first lid member 4, and the shaft support portions 4a and 4a are supported by the base portion 27 to be in an opened state and a closed state which will be described later. Lets you do it automatically. For this purpose, it is driven by a motor M4. Further, locking portions 4 b and 4 b are further formed on the upper portion of the first lid member 4, and these locking portions 4 b and 4 b are held against the locking claws 5 and 5 held rotatably at the base portion 27. And is configured to be locked.

  Since these locking claws 5 and 5 are fixed to the shaft body 5a, and the shaft body 5a is further pivotally supported at the base portion 27, the rotation state of the shaft body 5a is changed by the lid switch 6. By detecting, the open / closed state of the first lid member 4 can be detected.

  Next, the first pressing member 10 is a plate member as shown in the figure, and pivot shaft support portions 10a at both ends (only the front side is shown in the figure) are provided above. One end of a rod 57 is pivotally connected to the approximate center of the back surface side of the first pressing member 10, and with respect to the reciprocating mechanism or the pneumatic cylinder for moving the first pressing member 10. By connecting the other end of the rod 57, the first pressing member 10 is configured to be pushed forward.

  FIG. 6 is a cross-sectional view taken along the line X-X in FIG. 5, and shows a state after the first container 2 a is set in the first housing 3. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted. In the first container 2a after being centrifuged, a plasma layer C, a buffy coat layer D, an erythrocyte layer E, and Are separated and incorporated as shown in the figure, so that the pressure control described later is performed by detecting the interface or interface level between these layers.

  For this purpose, a photo sensor, that is, a light emitting / receiving element is generally used as a pair, depending on the difference in light absorption rate of each layer (light receiving rate of light from the light emitting element 25a at the light receiving element 35). The boundary surface is detected by the level (interface) boundary surface detection means 25. The mounting position of the detection means 25 can be slightly corrected in the vertical direction. The boundary surface detection means 25 is electrically connected to the arithmetic control unit via an input / output port described later. For this purpose, the boundary surface detection means 25 is fixed to the base 27 at a position inside the first housing 3 and sandwiched between the hooks 7 and 7.

  The light emitting element constituting the boundary surface detecting means 25 is composed of 15 infrared light emitting diodes, and the light receiving elements are arranged in parallel with two light emitting diodes arranged opposite to each other in a longitudinal direction (vertical direction) in a row. It is formed from connected plate-like light emitting diodes. With the above configuration, the boundary surface setting position (the position of the boundary surface that should be at the end of separation) with respect to the first container 2a set as shown in FIG. The detection result of the boundary surface is sent to the boundary surface setting unit for setting (according to the capacity of the first container 2a used or the centrifugal separation condition of the previous process).

  As shown in the figure, the first container 2a is suspended from the hooks 7 and 7 so that the weight of only the first container 2a of the first accommodating portion 3 is measured. Therefore, the hooks 7 and 7 are fixed to the scale member 47. ing. As will be described later, the scale member 47 is provided on the base 27 so as to be movable in the vertical direction. On the other hand, the first weight measuring unit 102b is configured so as to improve the resolution of measurement accuracy, and only the first container 2a is provided. The weight measurement of can be performed with high accuracy.

  The capacity of the first container 2a is 200 ml (cc) or 400 ml, and in addition to the set for removing the buffy coat layer containing leukocytes, the flexible first container of the set after removing leukocytes described in FIG. 2a is set as shown. The first container 2a held in the first container 3 is pressurized by the first pressing member 10 and the blood component in the upper plasma layer in the first container 2a is pumped upward. From the tube 11 of the first container 2a, it is accommodated in the second container 2c that is in an empty state via the tube 15a. In addition, the liquid is sent between the fourth container 2d that preliminarily stores the blood preservation solution, the empty third container 2b that contains the white blood cell component of the buffy coat layer, and the fourth container 2d that preliminarily contains the blood preservation solution. Is configured to do.

  FIGS. 7A to 7C are cross-sectional views for explaining the operation showing a state in which the first container 2a set in the first housing part 3 is pressed. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted. First, in FIG. 7A, the first lid member 4 is driven by a biasing member (spring) or a motor M4. As a result, the first container 2 a is suspended from the hook 7. Thereafter, the first lid member 4 is closed in the direction of the arrow manually or driven by the motor M4. At this time, the first pressing member 10 hangs downward.

  Next, in FIG. 7 (b), when the first lid member 4 is closed, the lid switch (see FIG. 5) is turned on and the completion of the loading is sent to the arithmetic control unit described later as an electrical signal via the lid switch circuit 43. send. Thus, the first container 2a is pressed and the plasma is ready to be pumped first.

  Therefore, in FIG. 7C, the first pressing member 10 is moved in the direction of the arrow by sending air pressure to the motor M1 of the reciprocating mechanism described in FIG. 1 The cover member 4 is turned and moved. As a result, the first container 2a is compressed as shown, and the plasma in the plasma layer is pumped in the direction of the arrow through the tube 11.

  As will be described later, when the blood preservation solution is introduced into the first container 2a, the first container 2a is first accommodated by moving the rod 57 in the direction opposite to the arrow direction in FIG. Enable to expand in part 3. After the blood preservation solution is pumped, a part of the tube 11 is welded and sealed from the clamped state by a high-frequency sealing device which is a welding means described later.

  Then, the first lid member 4 is automatically opened as shown in FIG. 7A, so that the first container 2a can be taken out. Thus, by performing the pressing by the flat flat surface portion 10f of the first pressing member 10 using the vicinity of the hook 7 as a rotation fulcrum, the first container 2a is connected to the flat surface portion 10f of the first pressing member 10 and the first flat surface portion 10f. Since the liquid level is gradually increased with the flat surface portion 4f of the lid member 4, the first container 2a is pushed uniformly. If the first pressing member 10 driven in this way is not pressed, the first container 2a is compressed in a non-uniform state, and there is a disadvantage that detection of the buffy coat layer cannot be performed correctly.

  Next, the structure of the 2nd accommodating part 70 is demonstrated based on sectional drawing of the 2nd accommodating part 70 of Fig.8 (a), and principal part sectional drawing of FIG.8 (b). The configuration for feeding the second container 70 is partially similar to the first container 3 described above, but the red blood cell layer may be fed into the fourth container 2d containing the blood storage solution. From the following points.

  First, the container of the second housing portion 70 is prepared as a sealed aluminum case or a stainless steel case having a predetermined strength with an open front, for example, a sealed aluminum case or a stainless steel case, and a flange along the edge of the opening portion of the second housing portion 70. The part 70f is formed over the entire circumference. Further, an elastomer rubber type or silicon rubber seal member 9 is embedded in the flange portion 70f over the entire circumference at a half depth. With the above configuration, when the second lid member 104 is driven and closed by the motor M2, the inside of the second housing portion 70 is completely shut off from the outside air, so that the second housing portion The inside of 70 can be maintained in a reduced pressure state.

  Further, a second pressing member 110 having a pivot shaft support portion 110a (shown only on the front side in the drawing) at the upper end is built in, and hooks 7 and 7 fixed above the second pressing member 110 are incorporated. On the other hand, the hole 7b (see FIG. 1) of the fourth container 2d is set as shown. An air bag 156 for rotationally driving the second pressing member 110 is arranged on the back surface side as shown in the drawing, and further, a pipe 72 for bringing the inside of the second accommodating portion 70 into a pressurized and exhausted state, 73 are connected as shown. These pipes 72 and 73 are connected to the compressor 55 so as to be connected to the pressurized tank storing the pressurized air and the decompressing tank storing the decompressed air through an open / close valve. Pressurized air and reduced pressure air are introduced into the second storage part 70 through these pipes. It should be noted that only the reduced pressure air may be introduced and only the suction operation function may be provided without introducing the pressurized air.

  The second lid member 104 that allows the inside of the second housing portion 70 to be seen when the second housing portion 70 is closed is formed of an acrylic plate that is a transparent resin member having a thickness of about 10 mm or more. A pair of shaft support portions 104a are provided on both side surfaces above the second lid member 4, and the shaft support portions 104a are supported by the base portion 27 to be opened halfway in the figure and closed as will be described later. The motor M2 is connected so that the state can be automatically set. In addition, a pair of locking portions 104b are further formed in the lower portion of the second lid member 104, and these locking portions 104b are locked to the locking claws 5 that are rotatably held by the base portion 27. It is configured as follows.

  Since these locking claws 5 are fixed to the shaft body 5a, and the shaft body 5a is further pivotally supported at the base 27, the rotation state of the shaft body 5a is detected by a lid switch. Thus, the open / close state of the second lid member 4 can be detected.

  FIG. 8B is a cross-sectional view showing how the tube 15b is held between the seal member 9 and the second lid member 104 to maintain an airtight state. In this figure, a concave portion 9a slightly smaller than the semicircle of the tube 15b is formed in a part of the seal member 9 provided so that half of the flange portion 70f of the second housing portion 70 is embedded over the entire circumference. Has been. On the other hand, the second lid member 104 is also formed with a recess 104k that is slightly smaller than the semicircle of the tube 15b. With the above configuration, the tube 15b can also be maintained in an airtight state between the seal member 9 and the second lid member 104.

  FIG. 9 is a cross-sectional view of the seal member 9 and shows a state after being set by being press-fitted into the flange portion 70f. The lip portion having a sufficiently long dimension (mm) is shown on trial and error. It has been finally confirmed that a good airtight state can be maintained by molding 9a at an inclination angle of approximately 45 degrees.

  Next, FIGS. 10A to 10C are operation explanatory views of the second accommodating portion 70 shown in FIG. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted, and piping 72 is provided to the airbag 156 below the second pressing member 110 provided in the second housing portion 70. When air is supplied through a pipe (not shown) branched from the bottom, the space between the bottom surface of the second housing part 70 and the second pressing member 110 swells, and the state shown in FIG. It becomes.

  As a result, the fourth container 2d is compressed between the second lid member 104 and the blood preservation solution can be pumped toward the first container 2a via the tube 15b. At this time, the entire outer peripheral surface of the fourth container 2d may be pressed evenly by sending air into the case to be in a pressurized state, and may be more actively pumped.

  Thereafter, the air is exhausted through a pipe (not shown) branched from the pipe 73 so that the air is extracted, so that the airbag 156 is formed in the space between the bottom surface of the second housing portion 70 and the second pressing member 110. Since it contracts, it returns to the state shown in FIG. In addition, after the locking portion 4b is locked by the locking claws 5 to make the inside airtight, the reduced pressure air is introduced into the inside of the fourth container 2d through the pipe 73, so that the plasma is introduced into the fourth container 2d. Can be pumped. After the tube 15b is sealed with high frequency and welded, the tube 15b is cut, and then the second lid member 104 is automatically opened as shown in FIG. It is configured so that it can be removed and taken out.

  In the above-described configuration, the clamper portions 36, 37, 38, 39 of the tube clamper are sequentially opened and closed, and the first container 2a is pressed to press the plasma layer to the second container 2c, and the first container The state where the buffy coat layer containing leukocytes is pumped from 2a to the third container 2b, the state where the blood preservation solution is pumped from the fourth container 2d to the first container 2a, and the plasma from the second container 2c to the fourth container 2d. By appropriately switching to the sucking state to be sent, it is possible to execute a separation mode in which the blood preservation solution and the red blood cell layer are accommodated in the first container 2a and the plasma is accommodated in the second container 2c and the fourth container 2d. Thereafter, each tube is welded and sealed to prevent leakage, and each container can be taken out after being cut with a pinch or the like.

  FIG. 11A is a front view of the second weight measuring unit 102a that measures the weight of the second container 2c through the scale member 47a to which the hook 107 is fixed. FIG. 11B is an external perspective view of the first weight measuring unit 102b that measures the weight of the first container 2a via the scale member 47b to which the hooks 7 and 7 are fixed, as viewed obliquely from the lower right.

  Each of the weight measuring units 101, 102a, and 102b detects the weight of each container by a weighing mechanism including a strain gauge that forms a Wheatstone bridge circuit capable of performing accurate and stable weight measurement. However, as described above, since the operation of making the communication state by bending each plug 18 after hooking each container on the hook 7, 107, 207 is added, an extra load unrelated to weight measurement is applied. . Since this load may cause damage to the strain gauge and the like, the load is not directly applied.

  Specifically, in FIG. 11A, the scale member 47a to which the hook 107 is fixed fixes the linear bush 49a to the back surface. The linear bush 49a is guided in the vertical direction with no load by a linear guide 50a fixed to the base 27. A hemispherical action member 48a is fixed to the bottom surface of the scale member 47a.

  On the other hand, while the Whitstone bushing circuit 53a is fixed to the upper surface and the strain gauge 54a is fixed to the lower surface, the strain member 51a having the "8" -shaped hole as shown in the figure is supported as shown in FIG. It is being fixed to the rotation member 66 so that it may be in a state. The rotating member 66 is rotatably provided around the pin 68a of the base 27, and is configured to move upward in response to the compression force of the compression coil spring 67a. A member 52a having a contact surface with which the action member 48a contacts is fixed to the left end of the strain member 51a. The member 52a contacts the lower pin 64 and moves downward excessively. That has been prevented.

  In the above configuration, the scale member 47a moves downward when the container is hung on the hook 107, and the action member 48a moves while pressing the member 52a downward, so that the strain member 51a is deformed downward. Thus, an electrical output signal corresponding to the amount of deformation is obtained. As described above, after the second container 2c is hooked on the hook 107, the extra load generated when the plug body 18 is bent is in the left-right direction, and is not transmitted to the strain member 51a.

  The scale member 47b to which the hooks 7 and 7 shown in FIG. 11B are fixed is configured in substantially the same manner, and a linear bush 49b guided by a linear guide 50b fixed to the base portion 27b with no load in the vertical direction. It is fixed on the back side. A hemispherical action member 48b (shown by a broken line) is fixed to the back surface of the scale member 47b. The action member 48b is prepared as a right-angled member as shown in the figure so as to abut against the action surface 52b1 of the member 52b, and is fixed to the lower side of the strain member 51b.

  In the above configuration, the scale member 47b moves downward by hanging the holes 7a, 7a (see FIG. 1) of the first container 2a on the hooks 7, 7, and the action member 48b moves the action surface 52b1 of the member 52b. By pressing and moving downward, the strain member 51b is deformed downward, and an electrical output signal corresponding to the amount of deformation is obtained. By configuring as described above, an excessive load generated when the plug body 18 is bent after the first container 2a is hooked on the hooks 7 and 7 is in the left-right direction, and is not transmitted to the strain member 51b. The accuracy can be guaranteed over a long period of time.

  Next, FIG. 12A is a plan view showing the configuration of the first clamp part 36 and the bubble sensor 13 of the tube clamping means, and FIG. 12B is a sectional view thereof. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted, and the tube is temporarily attached to the first clamp portion 36, the second clamp portion 38, and the third clamp portion 39 of the tube. In addition to the tube closing function for stopping the pumping by closing (clamping), a welding seal function for closing the tube by melting and welding at a high frequency is incorporated.

  The configuration of each of these clamp parts will be described as a representative of the first clamp part 36 in FIG. A first air cylinder 36a is fixed to the base plate 201 fixed to the base 27 in a single-supported state as shown. The first air cylinder 36a is provided with an actuator 205 that reciprocates when supplied with air. The actuator 205 is driven between an open position shown in the drawing and a closed position that will be described later. The illustrated metal member 204 is fixed to the upright member 202. The high frequency generator 205a is fixed so that the actuator 205 is sandwiched from the side surface side.

  A groove 203 is formed in the upright member 202 between the metal member 204 and the actuator 205, and the tube is elastically deformed and held in the groove 203. A resin cover 208 is detachably provided using two screws 210. The cover 208 is provided with a groove 208b at a position corresponding to the groove 203 described above. A shutter portion 208a extends downward from the cover 208, and the state where the cover 208 is fixed can be detected by blocking the sensor 211 fixed on the base 201 with the shutter portion 208a. The light emitting LED element 212 is provided so as to be exposed from the opening 208c of the cover 208, and is lit in green when the tube is loaded normally by a sensor (not shown). Further, when the cover 208 is removed, it is lit in orange to call attention. Here, the tube may be closed by an actuator driven by an electromagnetic solenoid, but as is well known, an air cylinder driven by air pressure does not press the tube excessively and can cope with tube clamping failure. desirable.

  On the other hand, the bubble sensor 13 incorporates the ultrasonic oscillator 222 and the receiver 233 in the cover 223, and holds the tube between them to detect the bubble. On the other hand, a sensor (not shown) detects the tube 11 and the cover. The loading state is detected, and the setting state of the tube is notified by the light emitting LED 212.

  Next, FIG. 13 is a view schematically showing a state after the multiple container 2 described above is set in the apparatus 1. FIG. 14 is a block diagram of the device 1.

  13 and 14, the interface setting position set by the interface setting unit 50 is stored in a non-volatile EEPROM 40c of the storage unit 40 described later. The nonvolatile EEPROM 40c can rewrite and recall the above-mentioned stored data, and does not erase the stored data even when the main power is turned off. As a result, the method in which the interface detection unit 25 detects the boundary surface position set by the interface setting unit 50 is as follows.

  The calculation control unit 26 corresponds the detection position of the interface detection means 25 to the boundary surface setting position stored in the nonvolatile EEPROM 40c by the interface setting unit 50 for the first container 2a this time, and is positioned at this detection work position. For example, the eighth light emitting diode and the elements of the sixth light emitting diode and the tenth light emitting diode, for example, located on both upper and lower sides of the detection work position, are made to emit light sequentially. At the same time, the calculation control unit 26 transfers the received light amount of the light receiving diode constituting the light receiving device after A / D conversion, calculates the difference between the received light amounts of the sixth light emitting diode and the tenth light emitting diode, When the amount of light received by the eight light emitting diodes is reached, it is recognized that the boundary surface has reached the boundary surface setting position.

  On the other hand, a first weight measuring unit 102b that measures the weight of the blood component contained in the first container 2a, a second weight measuring unit 102a that measures the weight of the second container 2c, and a third weight of the third container 2b. Based on the detection signal detected by the measurement unit 101 and the boundary surface detection unit 25, the measurement signal measured by each of the weight measurement units 101 and 102, and the program inputted in advance, the motor M1 and the clamp unit of each tube clamper An arithmetic control unit 26 that calculates and outputs a signal for operating opening and closing of the provided air cylinder is connected. The clamper portions 36, 37, 38 and 39 of each tube are opened and closed by air cylinders 36a, 37a, 38a and 39a, respectively, and an electromagnetic valve drive circuit 36b which controls to supply air to each air cylinder. , 37b, 38b, and 39b are electrically connected to the arithmetic control unit 26 via the input / output port 31, respectively.

  In each of the weight measuring units 101, 102 a, and 102 b, the weight measuring circuit 35 including the strain gauge that forms the Wheatstone bridge circuit as described above is electrically connected to the arithmetic control unit 26 via the input / output port 31. Furthermore, the liquid amount setting part 60 for setting the liquid quantity which should be accommodated in each set container 2b-2d according to the capacity | capacitance of the containers 2b-2d used this time is provided. The set liquid amount set by the liquid amount setting unit 60 is stored in the nonvolatile EEPROM 40c. Since the storage unit 40 can rewrite and read the above-mentioned stored data and does not erase the stored data even when the main power is turned off, each of the weight measuring units 101, 102 a, 102 b has the liquid set by the liquid amount setting unit 60. The amount is measured as follows.

  That is, the arithmetic control unit 26 obtains the storage data of the liquid amount setting unit 60 stored in the nonvolatile EEPROM 40c and the measurement results of the respective weight measuring units 101, 102a, 102b, and obtains the respective weight measuring units 101, 102a. , 102b can be recognized as reaching the set liquid amount.

  In addition, the calculation control unit 26 calculates each operation signal based on each signal input from the input / output port 31 and information read from the storage unit 40 (including the ROM 40a, RAM 40b, and EEPROM 40c) as necessary. Output to each component via a circuit. The ROM 40 a of the storage unit 40 is loaded with a program in which an operation method is stored in advance, and is electrically connected to the arithmetic control unit 26.

  This program includes, for example, a 200 mL double (double) bag, a tribble (triple) bag, a quadruple (quadruple) bag, a 400 mL double bag, a tribble bag, a quadruple bag, and their blood preservation solution. It can be used for each case of various operating directions of the blood bag type such as a bag, and the operating method can be changed variously by selecting this program in the mode setting.

  The program mounted on the ROM 40a may be a system in which a program cassette prepared for each operation method is replaced for each operation method. Here, the ROM 40a is a “read only memory”, which contains a program for automatically performing a liquid separation operation, and its contents are not lost even when the power is turned off. Moreover, the contents cannot be rewritten. The RAM 40b is a “random access memory” that stores the number of steps of the current separation operation in the middle of the liquid separation operation, stores the measurement result of the liquid amount, and detects the boundary surface. This is a memory for storing the measurement results of the units and for storing the results of the calculations being performed by the calculation control unit. All the contents are lost when the power is turned off. Furthermore, the EEPROM 40c is an “electrically erasable programmable read only memory”, and even though it is a read only memory, the contents can be rewritten by applying a high voltage for writing. . The stored contents are not lost even if the power is turned off. This EEPROM stores all the boundary surface detection setting values and liquid volume setting values for each of the above-mentioned various blood bag types for each separation mode, and the setting contents are rewritten only when the mode is changed to the setting change mode. To be able to.

  That is, the calculation control unit 26 detects the detection result detected by the interface detection unit 25, the measurement result measured by the weight measurement units 101, 102a, and 102b, and the pressing of the first container 2a by the pneumatic cylinder based on the program, The liquid separation is automatically performed by controlling the decompression and pressurization state and the opening / closing of each tube clamper. At this time, the calculation control unit 26 stores the interface setting position and set liquid amount data stored in the nonvolatile EEPROM 40C, the detection result of the interface detection unit 25, and the measurement results of the weight measurement units 101, 102a, and 102b. Based on the above, it is recognized that the detection boundary surface of the interface detection unit 25 has reached the interface setting position and / or the measurement results of the respective weight measurement units 101, 102a, and 102b have reached a predetermined liquid amount, and the tube clamp is closed. To end the separation operation. In addition, since the weight measurement results of the respective weight measuring units 101, 102a, and 102b are displayed in real time on each individual display unit as will be described later, the nurse can appropriately seal and take out the container.

  The arithmetic control unit 26 includes a power switch 41 connected to the power supply unit via the input / output port 31, a start switch 42, a lid switch circuit 43 connected to the lid switch 6, a stop switch 44, and the like. The switches and the display unit 500 and the initial setting unit 300 are electrically connected.

  These switches and the display unit are collectively arranged at a predetermined position on the right side of the operation surface 27a that is easy to use as described in FIG. The name of the program used may be displayed on the display unit so that it can be confirmed whether or not the program is correct. Also, if there is an error message, for example if there is an abnormality in the boundary surface level, each weighing scale, if the child bag is not set at a predetermined location, or if the lid member is not locked correctly, this will be described later. It is configured to be displayed.

  Further, in FIG. 13, a pressure tank 57 connected to the compressor 55 and a solenoid valve for driving the on-off valves 62 and 63 connected to the pressure reduction tank 58 via piping and for supplying air to the airbag. Driving solenoids 62a, 63a, and 156a are connected, and a compressor driving circuit 69 for performing on / off control of the compressor 55 is connected.

  An example of the operation of the blood separation device 1 described above will be described based on the flowchart of the operation description of the device 1 of FIG. 15 and the operation description schematic diagrams of FIGS. 16 (a) to 16 (d). In both figures, components that have already been described are denoted by the same reference numerals and description thereof is omitted. A flowchart when the “air bleeding” mode is set will be described later.

  First, the first container 2a, which is a quadruple bag 2 and collected 400 mL (cc) of blood from a blood donor, is centrifuged in the blood separation apparatus 1 for 5 minutes at 3000 to 4000 G, for example, as described in FIG. Therefore, the lid member 4 is automatically opened when the electric switch 41 is turned on. Set other containers in the same way.

  After that, when the start switch 42 is turned on, in step S98, the weight of the first container 2a and the second container 2c of each container is measured, and the weight measurement of the blood component excluding the tare is performed by each of the weight measuring units described above. In step S99, the weight measurement result is displayed. Next, in step S101, the detection result of the interface detection unit 25 is obtained, and whether or not the first container 2a is correctly set at the predetermined position by detecting whether the separation boundary surface level of the buffy coat layer is at the predetermined position. Determine whether. At the same time, it is determined that the lid switches of the storage units are turned on and the lid members 4 and 104 of the first storage unit 3 and the second storage unit 70 are closed. At this time, since it is displayed that there is a set abnormal state, it will be determined by looking at this. Then, the start switch 42 is turned on again. In step S102, the weight measuring units 101, 102a, and 102b indicate predetermined weights (weights excluding the tare), and determine whether or not the containers 2c, 2b, and 2d are set at predetermined positions. Since this is displayed, it is judged by looking at this.

  If the answer to step S102 is affirmative, the process proceeds to step 103, and the first to fourth clamp portions 36, 37, 38, and 39 of the tube clamper means are all closed. Therefore, the plug body 18 built in the tube 11 of the first container 2a is folded so that the first container 2a communicates with the tube 11, and at the same time, the plug body 18 built in the tube 15b of the bag 2d is folded. 2d communicates with the tube 15b.

  Next, the start switch 42 is turned on and the process proceeds to step S104, the first clamp part 36 and the second clamp part 38 are opened, and the fourth clamp part 37 and the third clamp part 39 are closed. Next, the process proceeds to step S105, and the first container 2a is pressurized with the first lid member 4 by rotating the first pressing member 10 by energizing the motor M1, whereby the first container The plasma layer C of 2a starts to be pumped to the second container 2c, so that it becomes as shown in FIG.

  Next, the process proceeds to step S106, where it is determined whether or not the interface between the plasma layer C and the buffy coat layer D has reached a position set by the interface detection unit 25. If the answer in step S106 is negative, the process returns to step S105, and the pressing of the first pressing member 10 is continued and the plasma layer C is pumped to the second container 2c. At this time, the weight measurement of the second container 2c is continuously measured by the weight measuring unit 102a, and the measurement result is displayed. If the answer in step S106 is affirmative, the process proceeds to step S107, and as shown in FIG. 16B, the first clamp part 36 and the fourth clamp part 37 of the tube clamper means are opened, and the second clamp part 38 is opened. And the 3rd clamp part 39 will be closed and it will be in the state by which a part of plasma layer C, a buffy coat layer D, and a part of erythrocyte layer E are pumped by the 3rd container 2b.

  Next, it progresses to step S108, the measurement result of the 3rd weight measurement part 101 is obtained, and it is determined whether the weight of the blood which entered the 3rd container 2b became predetermined weight. If the answer in step S108 is negative, the process does not proceed to the next step but waits until the weight reaches a predetermined weight. If the answer in step S108 is affirmative, the process proceeds to step S104, the pressurization of the first pressing member 10 is stopped, and the process proceeds to step S105.

  In step S105, as shown in FIG. 16C, the first clamp part 36 and the third clamp part 39 are open, and the fourth clamp part 37 and the second clamp part 38 are closed. Following this, the process proceeds to step S106, where the airbag 156 in the second storage unit 70 is inflated to move the second pressing member 110, and about half of the blood storage solution stored in the fourth container 2d is the first. It is pumped into the container 2a in a short time. In step S107, this state is detected by the first weight measuring unit 102b, the measurement result is obtained, and it is determined that the weight of the blood storage solution contained in the first container 2a is about half. If the answer in step S107 is affirmative, the process returns to step S106. In this way, the weight of the first container 2a measured by the weight measuring unit 102b is always visible. With the above operation, the blood preservation solution is introduced into the first container 2a.

  Next, in step S108, as shown in FIG. 16D, the clamp portions 38 and 39 are opened, and the clamp portions 36 and 37 are closed. Thereafter, in step S109, the inside of the second container 70 is depressurized via the pipe 73 and the airbag 156 is contracted to store the plasma temporarily stored in the second container 2c in the fourth container 2d. Suction to send in a short time. Here, the communication state between the first to fourth containers which are the operation states shown in FIGS. 16A to 16D may be displayed in color on the display unit 500 shown in FIG.

  Thus, the separation of the centrifuged blood components and the introduction of the blood preservation solution are completed. Thereafter, the tube of each bag is welded and sealed by the high frequency sealing function of each clamp part, and then the tubes of the first container 2a and the fourth container 2d are cut with scissors or the like, and the cut first container 2a and the first container 2a A blood product is obtained by storing the four containers 2d in a predetermined storage location such as a refrigerator. When the automatic seal is selected as an initial setting in advance, the high-frequency seal function of each clamp portion is automatically operated, and the tube is automatically welded and sealed.

  In addition, this invention is not limited to the said embodiment, For example, it replaces with the structure which reciprocates the rod 57 in order to rotationally drive the 1st press member 10 with the feed screw mechanism driven by a motor, and uses a pneumatic cylinder. Also good.

  FIG. 17 is a layout diagram of the switches and display units arranged in the display unit 500 and the initial setting unit 300 shown in FIG. In this figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted. In FIG. 17, a first weight indicating the weight of the first container 2a measured by the first weight measuring unit is displayed. Display means, second weight display means for displaying the weight of the second container 2c measured by the second weight measuring section, and a second weight for displaying the weight of the third container 2b measured by the third weight measuring section. In addition to the 3 weight display means and the fourth weight display means for displaying the weight of the fourth container 2d, each of the start switch 42 and the stop switch 44 is disposed in the same frame as shown in the figure. . Each switch and the display unit shown in the figure are mounted on the same mounting circuit board, and are covered with a resin sheet cover that is dimple-processed in a convex shape on the front surface and printed with predetermined items from the back side, and handles liquid. Waterproofing is ensured from the relation.

  When the start switch 42 is pressed once, all the clamps are closed, so that the standby state is changed to the separation ready state. Moreover, when this is pressed twice, the separation operation starts and the separation preparation state is changed to the separation state. In addition, the upper left LED is turned on when the switch is pressed. When the release switch 501 is pressed, the lid members of the first housing part 3 and the second housing part 70 are automatically opened. In addition, the upper left LED is turned on when the switch is pressed.

  When this switch is pressed during separation, the lower left stop switch 44 interrupts the separation operation and shifts to the end of separation. At this time, the upper left LED is lit. Also, if this switch is pressed while the built-in buzzer is sounding, the buzzer will be muted.

  The open / close switch portion 530 of the second lid member 104, which is a blood preservation solution door above the stop switch 44, is automatically closed by being pushed to open and close the second lid member 104. However, even if pressed during separation, it becomes invalid. The upper left LED blinks during the opening / closing operation of the second lid member 104, and lights up in the opened state. When the manual seal switch 502 on the right side is pressed in a state where the separation is completed, the seal seal is performed at the clamp portion of the tube where the seal is not sealed.

  The bag (container) size switch and its display unit 504 are pressed to select 200 ml or 400 ml, which is the size of the first container 2a, and the result is lit and displayed by the upper left LED.

  Next, the uppermost barcode unread display portion 516 surrounded by a smaller frame is in a parcode unread state, and is lit and displayed when an attempt is made to move to the next process. The “formulation number” display section, the “bag” display section, and the “operator” display section are lit at the timing when the handy barcode reader 400 reads the barcode. Then, it is turned on until the barcode reading is completed, and is turned off when the release switch 501 is pressed to shift to the standby state.

  Next, the plasma weight display unit 517, which is the second weight display means, displays the weight of each separation result with a four-digit light emitting LED during standby after plasma separation is completed. In addition, the blood storage liquid weight display unit 513 serving as the fourth weight display means displays the result of weighing the plasma with a 7-segment LED that displays four digits during standby after the end of the separation. This weighing content display unit 515 in the upper left displays a blood storage in which a built-in LED under the print character “MAP” is determined by the blood storage solution volume in order to display the weighing content of the fourth container 2d which is a blood storage solution container. Lights when the liquid weight is displayed. In addition, the built-in LED below the “plasma volume” printed letter is lit when the plasma subdivided weight is displayed.

  From these display units, the tubes are printed and displayed in the same manner as in the multiple container as shown. The seal selection switch in the middle of this tube printing section and its display section 538 are arranged at a position associated with the clamp section 38. When this switch is pressed during preparation for separation, automatic / manual sealing is switched. The upper left light emitting LED is turned on, and the display color of the light emitting LED of the clamp unit 38 is changed. The seal selection switch and display unit 539 corresponds to the second clamp unit 39. When this switch is pressed during preparation for separation, the automatic / manual seal is switched. Then, the upper left indicator light automatically lights up.

  The buffy coat layer weight display unit 510 that displays the weight measurement result by the third weight measurement unit displays the weighing result of the buffy coat layer during standby after the separation is completed. A clamp 37 is printed as shown.

  Also, the seal selection switch and display unit 536 corresponds to the first clamp unit 36, and when this switch is pressed during preparation for separation or during setting, automatic / manual sealing is switched. Then, the upper left indicator light automatically lights up.

  The weighing content display unit 505, which is a first weight display means, is a first container (parent bag) weight display unit, and after the plasma is separated into the second container 2c, or the blood storage solution is transferred from the fourth container 2d to the second container 2c. The weight is measured during introduction into one container 2a, and the result is displayed. The upper left whole blood volume display portion 508 lights up when displaying the weight of the first container 2a before separation. The CRC display unit 509 on the upper right side lights up when displaying the CRC weight of the first container 2a after separation. Next, the display part 512 during separation arranged in the range partitioned by the vertical line displays that the start switch 42 is depressed once and is ready for separation, and is built in when the second time is pressed. The light-emitting LED lights up to indicate that it is being separated. The abnormality display section 511 below the indicator displays a built-in light-emitting LED under each print character when the amount of each of the whole blood, CRC, plasma, and blood preservation solution is insufficient when the weight is insufficient. In addition, when the weight is excessive, it is lit and displayed when the whole blood, CRC, and plasma are excessive. Hereinafter, a light emitting LED is built in below the display characters and lights up.

  The separation type switch below and the display unit 507 display the separation type as “1 to 9” of the light emitting LED each time one of the up and down arrows is pressed once. The separation type can be arbitrarily set by the user while confirming the weighing content display unit 505 as described later, but is set to realize a necessary separation function by default at the time of shipment.

  The scale display switching unit 506 is for switching the weight display unit to the scale display when the switch is pressed.

  When each of the above display units 505, 510, 513, 517 is in an abnormal state such as an operation error or a tube connection failure at the time of separation, the weight display units 505, 510, 513, 517 The state of no tube is displayed as “E-04” to inform the cause of the abnormality. At this time, the occurrence of abnormality may be simultaneously notified to the operation indicator 20 fixed at the most conspicuous position on the upper surface of the standing portion of the apparatus 1 by blinking with a built-in light emitting LED.

  Next, the calibration / setting switch 301 arranged in the same frame in the initial setting unit 300 is switched every time the separation mode is pressed to the calibration, interface confirmation mode, clock confirmation mode, and setting mode. The item switch 302 on the right is pressed to switch the item of each setting mode.

  Further, the value change switch 303 indicated by the up and down arrows is pressed to change the value of each set value. That is, when the value is increased, the upward arrow switch is pressed, and when the value is decreased, the downward arrow switch is pressed. The right decision switch 304 is pressed to store each set value.

  In the lower part of each of the above switches, a calibration display unit 305 that displays lighting of the built-in LED in the calibration mode, an interface confirmation unit 306 that displays lighting of the built-in LED in the interface confirmation mode, and a built-in LED in the clock setting mode. A clock setting unit 307 that performs LED lighting display and a setting unit 308 that performs built-in LED lighting display when the setting mode is displayed are arranged.

  Next, FIG. 18 is a parameter setting item table, which describes each content and setting range. FIG. 19A is a diagram showing the 4-digit display content of the weighing content display unit 505 when the type of separation is set based on the parameter setting item table. FIG. 19B is a flowchart for setting the separation type by pressing a switch provided in the initial setting unit 300. The types of separation are: Plasma withdrawal, 2. 2. plasma splitting; Surplus plasma, 4. In addition to plasma (2 units ÷ 1 unit), there is air bubble removal when using a set with a leukocyte removal filter.

  When changing the separation type, the release switch 501 is pressed in step S20 in the flowchart of FIG. Next, in step S21, the calibration / setting switch 301 is pressed long (for 2 seconds or more). Then, the light emitting LED of the display unit 505 blinks. Therefore, when the item switch 302 is pressed, “1401” is displayed. This means that when the separation type number is 1, 400 ml of the first container is used and the boundary surface sensor position is 1, so if this is acceptable, the decision switch 304 is pressed. Subsequently, when it is desired to change the boundary level, the switch 303 is pressed and set up and down, and finally the decision switch 304 is pressed in step S26 to complete the registration of the separation mode.

  Further, as shown in FIG. 18, in addition to the boundary surface sensor position, the parameters include bubble removal, setting of the bubble container, four settings of plasma subdivision mode, and setting of plasma volume between zero and 250 grams. , Buffy coat layer weight setting, blood preservation solution weight setting, welding seal manual, automatic switching, etc.

  FIG. 20 is a list of separation parameter initial values, corresponding to the parameters of FIG. 18, in which “200” indicates that the mode is set to a 200 ml container, and “400” is a 400 ml container. Indicates that the mode has been set. Although detailed explanation is omitted, for example, in the chart, in the setting item 1, the interface sensor position can be set in the range of 0 to 8, but at this time, when the plasma division mode is set as the type of separation, this mode Because the interface sensor level is automatically set to 8 because only 400 ml containers are used, the surplus plasma mode is set to 8 levels for 400 ml containers and 8 levels for 200 ml containers as well. The

  Further, in the “air venting” for extracting air bubbles in the setting item 2, the air bubbles are detected only in the plasma extraction mode using the multiple container 20 provided with the separation type leukocyte removal filter 80 (see FIG. 23). Yes is automatically set. Hereinafter, it is set for each setting item as shown in the chart.

  In FIG. 23, components already described with reference to FIG. 1 are denoted by the same reference numerals and description thereof is omitted. As a preliminary stage of blood separation, raw blood is anti-antigen from the blood donor via the puncture needle 81 and the tube 79a. The blood coagulation liquid is introduced into a 200 ml or 400 ml blood collection container 2a0 in which the blood coagulation liquid is stored in advance. Thereafter, the plug 18 is brought into a folded communication state, and the raw blood is introduced into the first container 2a through the leukocyte removal filter 80 and the tube 79 by a gravity drop action. Thereafter, the tube 79 is sealed and cut. As a result, since the leukocytes are removed in advance, the step of separating the buffy coat layer of leukocytes becomes unnecessary, but mainly air bubbles contained in the leukocyte removal filter 80 are introduced into the first container 2a as they are. Therefore, it is necessary to prevent air bubbles from being introduced when the plasma is separated into the second container 2c.

  FIG. 21 is a flowchart for explaining the operation when the “air bleeding” mode is set so as to send bubbles to the third container 2b.

  When this mode is set and the start switch 42 is pressed to start, the weights of the first container 2a and the second container 2c are measured in each weight measurement unit in each container in step S98, and step S99 is performed. The weight measurement result is displayed at. Thereafter, in a step S201 from the state in which all the clamps are opened, each air cylinder is driven so as to close the second clamp part 38 and the third clamp part 39 and open the fourth clamp part 37. Now that the preparation for pressure-feeding the bubbles is completed, the motor is activated in step S202 to drive the first pressing plate to press the first container 2a. Following this, in step S203, bubbles are pumped through the tube 11. Next, in step S204, bubble detection is performed by the ultrasonic sensor built in the bubble sensor, and the detection result is sent to the calculation control unit 26 (see FIG. 14). Next, it progresses to step S205, and if it is judged in the calculation control part 26 that there exists a bubble, it will return to step S202 and will continue sending out a bubble with respect to the 3rd container 2b. When no bubble detection is detected in step S202, the process proceeds to step S206 to close the fourth clamp portion 37, whereby the bubbles are sent into the third container 2b and do not contain plasma or a red blood cell layer, Finish removing bubbles or bleeding. In the subsequent processing, except for the buffy coat layer removing step, the steps described above with reference to FIG. 15 are performed in the same manner to perform blood separation. Note that it is possible to detect the end of introduction of the blood preservation solution in the fourth container 2d into the first container 2a using the bubble sensor 13.

  FIG. 22 is a flowchart for explaining the operation of the apparatus 1. Referring to FIG. 17 further with reference to FIG. 17, when the outline until the end of separation is described, in step S1, the power switch 41 of the apparatus 1 is turned on from the power-off state, and each container and tube are set. A self-check operation is started and a self-check program is automatically started to confirm that each component functions normally. If it is normal, the operation check operation in step S3 is started. In order to confirm various setting modes performed when the initial setting switch 300 is pressed, the process proceeds to step S4, and the on / off state of the calibration / setting switch 301 is confirmed. If it is confirmed in step S4 that the switch is turned on, the process proceeds to step S5, and after the calibration, interface confirmation, clock setting, and mode setting, the process enters the standby state in step S7.

  For example, when calibrating the strain gauge scale of the first weight measuring unit in calibration, any switch 303 is kept until “200” is displayed on the display unit 505 by hooking a 200-gram weight onto the hook. When “200” is displayed, the determination switch 304 is pressed to determine and the calibration of the balance is completed.

  If it is confirmed in step S4 that none of the switches are turned on within a predetermined time, the process returns to step S3. After step S3, the process proceeds to step S6, and when the release switch 501 is pressed, the standby state of step S7 is entered, and the process proceeds to step S8 and waits for the start switch 42 to be pressed. When the start switch 42 is pressed, the process proceeds to step S9, where separation preparations are made for tube closure at each clamp portion and activation of each pressing member, and the separation operation at step S10 is performed.

  If automatic sealing has been set after completion of the separation operation in step S10, the tube is welded and sealed in step S11. If manual sealing is set, manual welding sealing is promoted by notifying the end of the separation process. During the execution of step S10, for example, when it is confirmed by looking at the display 505 that the red blood cell layer remaining in the first container 2a has reached a predetermined amount, the user stops the separation by pressing the stop switch 44. Thus, the process proceeds to step S13.

  As described above, for example, in order to switch to the state in which the plasma separated from the second container 2c to the fourth container 2d is pumped, in the conventional apparatus, the suspended second container 2c is removed from the hook, Since it was configured to send by the action of gravity by placing it in the lower position, there was a problem that required a considerable time, but this work becomes unnecessary.

  In particular, when the operation for switching to the state in which plasma is pumped from the second container to the fourth container is forgotten, the first container 2a contains the blood preservation solution and the red blood cell layer, and the fourth container 2d contains the plasma. Although the state could not be eternal, this separation can be performed fully automatically in the above apparatus.

  Furthermore, since the weight measurement result of the first container, which is the parent bag in which the red blood cell layer remains, is displayed in real time or every predetermined time, the tube is arbitrarily attached to the above-mentioned welding seal or when the first container reaches a desired weight. It can be removed at any time in a closed state using a clamp member such as a clamp. For this reason, even when blood transfusion of erythrocytes is urgently required, it can be flexibly dealt with.

(a) is a child bag through tubes 11, 14, 15a and 15b so that each container is connected to the first container 2a which is a parent bag for removing the buffy coat layer and injecting the blood preservation solution. FIG. 4 is a plan view of the multiple container 2 in which the second to fourth containers are connected and spread flat, and (b) is a cross-sectional view of the plug body 18. FIG. 2A is a left side view in which a part is broken to show a schematic configuration of the apparatus 1, and FIG. 2B is a rear view of the apparatus 1. It is the external appearance perspective view which looked at the apparatus 1 from the front from the eyes. FIG. 2 is an external perspective view of the device 1 as viewed from the front from the viewpoint of a nurse after the multiple container 2 described in FIG. 1 is loaded into the device 1. 4 is an external perspective view showing a state after the first container 2a is suspended inside the first housing part 3. FIG. FIG. 6 is a cross-sectional view taken along the line X-X in FIG. 5, illustrating a state after the first container 2 a is set in the first storage unit 3. (A)-(c) is sectional drawing for operation | movement explanation which showed a mode that the 1st container 2a set to the 1st accommodating part 3 was pressed. (A) is sectional drawing of the 2nd accommodating part 70, (b) is the principal part sectional drawing. 3 is a cross-sectional view of a seal member 9. FIG. (a)-(c) is operation | movement explanatory drawing of the 2nd accommodating part 70 shown to Fig.8 (a). (A) is a front view of the 2nd weight measurement part 102a which measures the weight of the 2nd container 2c via the scale member 47 to which the hook 107 was fixed, (b) is the scale member 47 to which the hooks 7 and 7 were fixed. It is the external appearance perspective view which looked at the 1st weight measurement part 102b which measures the weight of the 1st container 2a through from diagonally lower right. (A) is the top view which showed the structure of the 1st clamp part 36 and the bubble sensor 13 of a tube clamp means, (b) is the sectional drawing. It is the figure which showed typically about the mode after setting the multiple container 2 to the apparatus 1. FIG. 2 is a block diagram of the device 1. FIG. 4 is a flowchart for explaining the operation of the device 1. (a)-(d) is a schematic diagram explaining operation | movement of the apparatus 1. FIG. FIG. 4 is a layout diagram of switches and display units arranged in the display unit 500 and the initial setting unit 300 shown in FIG. 3. It is a parameter setting item table describing each content and setting range. (a) is a diagram showing the four-digit display content of the weighing content display unit 505 when setting the type of separation based on the parameter setting item table, and (b) is a setting of the type of separation provided in the initial setting unit 300 It is a flowchart which presses and sets a given switch. It is a separation parameter initial value list. It is a flowchart of operation | movement description in case "air bleeding" mode setting is performed so that a bubble may be sent to the 3rd container 2b. 4 is a flowchart for explaining the operation of the device 1. It is a top view which shows the blood bag with a leukocyte removal filter.

Explanation of symbols

1 Blood Separator 2 Multiple container (quadruple blood bag)
2a First container (parent bag)
2c Second container (child bag)
2b 3rd container (child bag)
2d 4th container (child bag)
3 1st accommodating part 4 1st cover member (door)
6 Lid switch 9 Seal member 10 First pressing member 11, 15a, 15b Tube 13 Bubble sensor 27 Base 36 First clamp portion 37 Fourth clamp portion 38 Second clamp portion 39 Third clamp portion 55 Compressor 72, 73 Piping 70 First 2 housing (airtight case)
80 Leukocyte removal filter 101 Third weight measurement unit 102b First weight measurement unit 102a Second weight measurement unit 110 Second pressing member 505 First weight display unit 517 Second weight display unit 510 Third weight display unit 513 Fourth weight display Part C Plasma layer D Buffy coat layer E Red blood cell layer

Claims (8)

Using a multiple-type container in which a plurality of flexible containers are connected to a flexible first container via a tube, the raw blood stored in the first container is centrifuged into at least a plasma layer and a red blood cell layer Then, the first container is set in a first accommodating portion having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and a plasma layer is placed in one of the separate containers by the first pressure feeding means. A blood separation device used to pump and store in one of the separate containers and to remove the multiple container,
In order to detect the level of the boundary layer between the plasma layer and the erythrocyte layer, level detection means disposed in the first storage unit,
Bubble detection means for detecting the presence or absence of bubbles by sandwiching the middle part of the tube,
A control unit connected to the level detection unit and controlling the first pumping unit in response to the presence / absence detection by the bubble detection unit;
A blood separation device comprising: A multiple container in which a plurality of flexible containers are connected to a flexible first container via a tube is used, and the raw blood stored in the first container is at least in a plasma layer and a red blood cell layer Centrifugation, the first container is set in a first accommodating part having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and the plasma layer is separated by the first pressure feeding means into the separate container. A blood separation device used for pressure-sealing and storing in one of the separate containers, then welding and sealing with a tube welding means, and removing the multiple-type container,
In order to detect the level of the boundary layer between the plasma layer and the erythrocyte layer, level detection means disposed in the first storage unit,
Bubble detection means for detecting the presence or absence of bubbles by sandwiching the middle part of the tube,
A control unit connected to the level detection unit and controlling the first pumping unit in response to the presence / absence detection by the bubble detection unit;
A blood separation device comprising: The plurality of separate containers are:
A leukocyte removal filter container that removes leukocytes by being connected to an intermediate portion of a tube connected for introduction of raw material blood into the first container;
A second container for storing the plasma layer pumped from the first container;
A third container for storing a buffy coat layer of the boundary layer of the first container;
A fourth container that stores in advance a blood storage solution that is set in a second container having second pumping means and pumped to the first container by the second pumping means;
The tube clamping means is
A first clamp part that clamps a tube connected between the first container and the second container near the first container; a second clamp part that clamps near the second container;
A third clamp part for clamping the tube connected between the first container and the fourth container;
A fourth clamp part for clamping the tube connected between the first container and the three containers;
The bubble detection means is disposed between the first clamp part and the second clamp part,
3. The blood separation device according to claim 1, wherein the control unit is connected to a mode switching unit and is set to at least a mode in which bubbles mixed in the first container are not mixed into the second container. 4. . 5. The blood according to claim 3, wherein the bubble detection unit is disposed on the seal display unit in a positional relationship with the first to third seal portions together with the tube welding unit. Separation device. Using a multiple-type container in which a plurality of flexible containers are connected to a flexible first container via a tube, the raw blood stored in the first container is centrifuged into at least a plasma layer and a red blood cell layer Then, the first container is set in a first accommodating portion having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and a plasma layer is placed in one of the separate containers by the first pressure feeding means. A blood separation method in which the container is pumped and stored in one of the separate containers, and the multiple container is removed,
A step of detecting the level of the boundary layer between the plasma layer and the red blood cell layer by the level detection means disposed in the first storage unit;
A step of detecting the presence or absence of bubbles by sandwiching the middle portion of the tube by bubble detection means;
A step of controlling the first pumping means according to the presence / absence detection by the bubble detecting means by a control means connected to the level detecting means;
A blood separation device comprising: A multiple container in which a plurality of flexible containers are connected to a flexible first container via a tube is used, and the raw blood stored in the first container is at least in a plasma layer and a red blood cell layer Centrifugation, the first container is set in a first accommodating part having a first pressure feeding means, a middle portion of the tube is clamped by a tube clamping means, and the plasma layer is separated by the first pressure feeding means into the separate container. A blood separation method that is used to remove the multiple-type container after being sealed by tube welding means after being pumped into one of the above and stored in one of the separate containers,
A step of detecting the level of the boundary layer between the plasma layer and the red blood cell layer by the level detection means disposed in the first storage unit;
A step of detecting the presence or absence of bubbles by sandwiching the middle portion of the tube by bubble detection means;
A step of controlling the first pumping means according to the presence / absence detection by the bubble detecting means by a control means connected to the level detecting means;
A blood separation method comprising: The plurality of separate containers are:
A leukocyte removal filter container that removes leukocytes by being connected to an intermediate portion of a tube connected for introduction of raw material blood into the first container;
A second container for storing the plasma layer pumped from the first container;
A third container for storing a buffy coat layer of the boundary layer of the first container;
A fourth container that stores in advance a blood storage solution that is set in a second container having second pumping means and pumped to the first container by the second pumping means;
A first clamp part for clamping a tube connected between the first container and the second container near the first container; a second clamp part for clamping near the second container; and the first container; The tube clamp means comprising: a third clamp part for clamping the tube connected between the fourth containers; and a fourth clamp part for clamping the tube connected between the first container and the three containers. Clamping with
Detecting the presence or absence of bubbles by the bubble detection means disposed between the first seal portion and the second seal portion;
The control means connected to the mode switching means comprises a step of setting at least a mode in which bubbles mixed in the first container are not mixed in the second container. The blood separation method described. A step of detecting the presence or absence of a bubble by the bubble detection unit disposed in a seal display unit in a positional relationship with the first to third seal portions together with the tube welding unit is included. Item 5. The blood separation device according to Item 3 or 4.

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