JP2006034468A - Filter monitoring system and platelet sampling device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a filter monitoring system and a platelet sampling device capable of detecting the occurrence of the clogging of a cell separation filter in an early stage. <P>SOLUTION: The platelet sampling device 1 is provided with a platelet sampling circuit 2. The platelet sampling circuit 2 is provided with a centrifuge 20, a first line 21 with a blood sampling needle 29, a second line 22, a third line 23, a plasma sampling bag 25, an air bag 27b, an intermediate bag 27a, a platelet sampling bag 26, a leukocyte removal filter 261 and a bag 28. Also, the platelet sampling device 1 is provided with a flow speed detection means for transferring thick platelets by the difference in elevation in a filtering operation and detecting the flow speed of the thick platelets supplied from the intermediate bag 27a to the leukocyte removal filter 261, and a clogging detection means for performing a clogging detection processing for discriminating the occurrence of the clogging of the leukocyte removal filter 261 on the basis of the detected results in the flow speed detection means. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a filter monitoring system and a platelet collecting apparatus.

  When collecting blood, the collected blood is separated into each blood component by centrifugation, etc. for reasons such as effective use of the blood and reduction of the burden on the donor, and only the components necessary for the transfuser are collected. Blood is collected to return to the person.

  In such component blood collection, a blood component collection device is known in which a collected blood component is supplied to a leukocyte removal filter, and a filtration operation for separating and removing leukocytes can be performed by the leukocyte removal filter (for example, Patent Documents). 1).

  By the way, platelets taken out of the body tend to be activated rather than in the body. In particular, the tendency of platelets obtained by centrifugation is remarkable. Moreover, the state of the platelets stabilizes with time.

In the current blood component collection apparatus, in order to satisfy the number of contaminating leukocytes of 1.0 × 10 ⁶ or less (statistically 95% confidence interval), leukocytes are collected from the collected platelets by filtration using a leukocyte removal filter. Is separated and removed.

  This filtration operation is performed immediately after collection. For this reason, unlike the case of filtering stabilized platelets (platelet preparation), platelets that tend to be more activated are filtered, and the frequency of platelet aggregation caused by a predetermined stimulus is increased. .

  If platelets aggregate during filtration, the number of platelets finally collected decreases, and if platelet aggregation is significant, the leukocyte removal filter becomes clogged, making it impossible to perform filtration operations. The loss is even greater. Thereby, even when a target amount of platelets is collected at the time of blood collection, the target amount of platelets may not be ensured at the end of the filtration operation.

  The blood component collection device described in Patent Document 1 can detect the pressure in the leukocyte removal filter and determine whether or not the leukocyte removal filter is clogged based on the pressure. .

  However, in the blood component collection device described in Patent Document 1, since the occurrence of clogging of the leukocyte removal filter is determined based on the pressure in the leukocyte removal filter, when it is determined that clogging has occurred. The leukocyte removal filter is almost completely clogged, and it is difficult to recover the clogging.

  Further, in the blood component collecting device described in Patent Document 1, when the blood component is transferred by operating the pump in the filtration operation, clogging of the leukocyte removal filter can be detected. When transferring blood components by a drop, even if clogging occurs, the pressure in the leukocyte removal filter hardly changes, and therefore there is a drawback that clogging of the leukocyte removal filter cannot be detected.

JP 10-212237 A

  An object of the present invention is to provide a filter monitoring system and a platelet collection device that can detect clogging of a cell separation filter at an early stage.

Such an object is achieved by the present inventions (1) to (30) below.
(1) A supply unit for supplying blood or blood components, a cell separation filter for separating and removing predetermined cells from the liquid supplied from the supply unit, and a filtrate for collecting the filtrate after passing through the cell separation filter A blood processing circuit comprising a recovery unit;
Flow rate detection means for detecting the flow rate of the liquid supplied from the supply unit to the cell separation filter;
Clogging detection means for performing clogging detection processing for determining occurrence of clogging of the cell separation filter based on the detection result of the flow velocity detection means,
The blood or blood component supplied from the supply unit is transferred by a head, supplied to the cell separation filter, and the cell separation filter separates and removes predetermined cells from the liquid supplied from the supply unit. A filter monitoring system configured to perform the clogging detection process by the clogging detection means while performing an operation.

(2) The supply unit is a storage unit that stores blood or blood components,
The flow rate detection means includes weight detection means for detecting the weight of blood or blood components in the reservoir, and time measurement means for measuring time, and the detection result of the weight detection means and the time measurement means The filter monitoring system according to (1), which is configured to obtain a flow rate of the liquid based on a measurement result.

  (3) The clogging detection unit is configured to perform the clogging detection process based on a difference between a set flow rate of the liquid in the filtration operation and a flow rate of the liquid detected by the flow rate detection unit. The filter monitoring system according to (1) or (2) above.

  (4) The clogging detection means starts the filtration operation when it is determined that the clogging of the cell separation filter has not occurred until a predetermined time has elapsed since the filtration operation was started. After the predetermined time has passed, based on the difference between the flow velocity of the liquid detected by the flow velocity detection means and the flow velocity of the liquid detected by the flow velocity detection means until the predetermined time elapses. The filter monitoring system according to any one of (1) to (3), wherein the clogging detection process is performed.

  (5) In the clogging detection process, the clogging detection means sets a value corresponding to an initial stage of occurrence of clogging of the cell separation filter as a threshold value of the divergence, The filter monitoring system according to (3) or (4), wherein when the threshold value is reached, the cell separation filter is determined to be clogged.

  (6) The filter according to any one of (1) to (5), further including a notification unit that issues a warning when the clogging detection unit determines that the cell separation filter is clogged. Monitoring system.

  (7) The above-described (1) to (6) configured to stop or interrupt the filtration operation when the clogging detection means determines that the cell separation filter is clogged. The filter monitoring system according to any one of the above.

  (8) When the clogging detection unit determines that the cell separation filter is clogged, the filtration operation is interrupted and a recovery operation is performed to recover the clogging. The filter monitoring system according to any one of (1) to (6) above.

(9) having a recovery state determination means for determining a recovery state of clogging of the cell separation filter;
The filter monitoring system according to (8), wherein the filtering operation is resumed when the recovery state determination unit determines that the clogging of the cell separation filter has been recovered.

(10) having pressure detection means for detecting the pressure in the cell separation filter;
The filter monitoring system according to (9), wherein the recovery state determination unit is configured to determine a recovery state of clogging of the cell separation filter based on a detection result of the pressure detection unit.

  (11) The above recovery operation includes a step of supplying a liquid having a lower pH than the liquid supplied from the supply unit to the cell separation filter, and lowering the pH of the liquid in the cell separation filter. (10) The filter monitoring system according to any one of (10).

  (12) The flow rate of the liquid when the liquid having a lower pH than the liquid supplied from the supply unit is supplied to the cell separation filter is that the cell separation filter is clogged by the clogging detection means. The filter monitoring system according to the above (11), which is lower than the flow velocity detected by the flow velocity detection means when it is determined.

  (13) The filter monitoring system according to (11) or (12), wherein the liquid having a lower pH than the liquid supplied from the supply unit is a liquid containing an anticoagulant.

  (14) The filter monitoring system according to any one of (1) to (13), wherein the liquid supplied from the supply unit is plasma containing platelets.

  (15) The filter monitoring system according to any one of (1) to (14), wherein the cell separation filter is a leukocyte removal filter.

(16) Blood collection means for collecting blood from a blood donor, a centrifuge for centrifuging blood collected by the blood collection means, and a temporary storage for temporarily containing plasma containing platelets separated by the centrifuge A platelet collection circuit comprising: a storage bag; a cell separation filter that separates and removes predetermined cells from the plasma containing platelets; and a platelet collection bag that stores the plasma containing platelets after passing through the cell separation filter; ,
A flow rate detecting means for detecting a flow rate of plasma containing platelets supplied from the temporary storage bag to the cell separation filter;
Clogging detection means for performing clogging detection processing for determining occurrence of clogging of the cell separation filter based on the detection result of the flow velocity detection means,
The collected blood is centrifuged, the plasma containing the platelets is collected, the remaining blood components are returned, and the platelet-containing plasma temporarily stored in the temporary storage bag is transferred by a drop. And supplying the cell separation filter, and performing the clogging detection process by the clogging detection means while performing a filtration operation for separating and removing predetermined cells from the plasma containing the platelets by the cell separation filter. It is comprised in the platelet collection apparatus characterized by the above-mentioned.

  (17) The flow velocity detection means includes a weight detection means for detecting the weight of the temporary storage bag and a time measurement means for measuring time, and the detection result of the weight detection means and the measurement of the time measurement means. The platelet collection device according to (16), which is configured to obtain a flow rate of plasma containing the platelets based on the result.

  (18) The clogging detection means detects the clogging based on a difference between a set flow rate of the plasma containing platelets in the filtration operation and a flow rate of the plasma containing platelets detected by the flow rate detection means. The platelet collection device according to (16) or (17), which is configured to perform processing.

  (19) The clogging detection unit starts the filtration operation when it is determined that the clogging of the cell separation filter has not occurred until a predetermined time has elapsed since the filtration operation was started. After the elapse of the predetermined time, the flow rate of the plasma containing the platelets detected by the flow rate detection means until the elapse of the predetermined time, and the plasma containing the platelets detected by the flow rate detection means The platelet collection device according to any one of (16) to (18), wherein the clogging detection process is performed based on a deviation from a flow rate.

  (20) In the clogging detection process, the clogging detection unit sets a value corresponding to an initial stage of occurrence of clogging of the cell separation filter as a threshold value of the divergence, The platelet collection device according to (18) or (19), wherein when the threshold value is reached, the cell separation filter is determined to be clogged.

  (21) The platelet according to any one of the above (16) to (20), which has a notification means for giving a warning when it is determined by the clogging detection means that the cell separation filter is clogged. Collection device.

  (22) The above (16) to (21) configured to stop or interrupt the filtration operation when the clogging detection means determines that the cell separation filter is clogged. ). The platelet collecting device according to any one of

  (23) When the clogging detection means determines that the cell separation filter is clogged, the filtration operation is interrupted, and a recovery operation for recovering the clogging is performed. The platelet collection device according to any one of (16) to (21).

(24) having recovery state determination means for determining a recovery state of clogging of the cell separation filter;
The platelet collection device according to (23), wherein when the recovery state determination unit determines that the clogging of the cell separation filter is recovered, the filtration operation is resumed.

(25) having pressure detection means for detecting the pressure in the cell separation filter;
The platelet collection device according to (24), wherein the recovery state determination unit is configured to determine a recovery state of clogging of the cell separation filter based on a detection result of the pressure detection unit.

  (26) The recovery operation includes a step of supplying a liquid having a lower pH than the plasma containing platelets supplied from the temporary storage bag to the cell separation filter, and lowering the pH of the plasma containing platelets in the cell separation filter. The platelet collecting device according to any one of (23) to (25), comprising:

  (27) The flow rate of the liquid when the liquid having a lower pH than the plasma containing platelets supplied from the temporary storage bag is supplied to the cell separation filter is determined so that the clogging of the cell separation filter is caused by the clogging detection means. The filter monitoring system according to (26), wherein the flow rate is lower than the flow rate detected by the flow rate detection means when it is determined that the flow has occurred.

  (28) The platelet collection device according to (26) or (27), wherein the liquid having a lower pH than the plasma containing platelets supplied from the temporary storage bag is a liquid containing an anticoagulant.

  (29) The platelet collection device according to any one of (16) to (28), wherein the cell separation filter is a leukocyte removal filter.

  (30) The platelet collecting apparatus performs a blood component collecting operation including a blood component collecting step of centrifuging collected blood and collecting plasma containing the platelets, and a blood component returning step of returning the remaining blood components. The platelet collecting apparatus according to any one of (16) to (29), wherein the platelet collecting apparatus is performed at least for one cycle.

  According to the filter monitoring system of the present invention, the occurrence of clogging of the cell separation filter based on the detection result of the flow rate detection means for detecting the flow rate of the liquid (blood or blood component) supplied from the supply unit to the cell separation filter. Determine.

  As a result, when the liquid is transferred by a drop and a filtration operation is performed, clogging of the cell separation filter can be detected at an early stage. For this reason, the clogging can be easily recovered by performing a recovery operation for recovering the clogging of the cell separation filter, and thereby the filtration operation for separating and removing predetermined cells from the blood or blood components can be performed. This can be performed reliably, and a reduction in the amount of blood or blood components (filtrate) collected in the filtrate collection unit can be prevented (or suppressed).

  In addition, according to the platelet collection device of the present invention, the occurrence of clogging of the cell separation filter based on the detection result of the flow rate detection means for detecting the flow rate of plasma containing platelets supplied from the temporary storage bag to the cell separation filter. Determine.

  As a result, when the plasma containing platelets is transferred by a drop and a filtration operation is performed, clogging of the cell separation filter can be detected at an early stage. For this reason, the clogging can be easily recovered by performing a recovery operation for recovering the clogging of the cell separation filter, thereby performing a filtration operation for separating and removing predetermined cells from the plasma containing platelets. This can be performed reliably, and a reduction in the amount of platelets (platelet preparation) collected in the platelet collection bag can be prevented (or suppressed).

  Hereinafter, a filter monitoring system and a platelet collection device (blood component collection device) of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  FIG. 1 is a plan view showing an embodiment of the platelet collecting apparatus of the present invention, and FIG. 2 is a partially broken view showing a state in which a centrifuge is mounted on a centrifuge driving device included in the platelet collecting apparatus shown in FIG. FIG. 3 to FIG. 5 are flow charts for explaining the operation of the platelet collecting apparatus shown in FIG.

  A platelet collection device (blood component collection device) 1 shown in FIG. 1 is a device for separating blood into a plurality of blood components and collecting plasma containing separated platelets (blood component containing platelets), and a filter. Has a monitoring system. This platelet collecting apparatus 1 has a rotor 142 having a blood storage space 146 therein, an inlet 143 communicating with the blood storage space 146, and an outlet (outlet) 144, and is introduced from the inlet 143 by the rotation of the rotor 142. A centrifuge 20 that centrifuges the collected blood in the blood storage space 146, a first line 21 that connects the blood collection needle (blood collection means) 29 and the inlet 143 of the centrifuge 20, and the centrifuge 20 The second line 22 connected to the outlet 144, the third line 23 connected to the first line 21, the first line 21 via the tubes 49 and 50, and the tube 43 and A plasma collection bag (collection bag) 25 connected to the second line 22 via 44, and an air bag 27 b connected to the second line 22 via the tube 42; An intermediate bag (temporary storage bag) (supply unit) 27a connected to the second line 22 through the tubes 43 and 45, and a platelet collection bag (connected to the intermediate bag 27a through the tubes 46, 47 and 48) A platelet collection circuit (blood component collection circuit) (blood processing apparatus) 2 having a collection bag) (filtrate collection unit) 26 and a bag 28 connected to the platelet collection bag 26 via a tube 51 is provided.

  Further, the platelet collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20, a first liquid feeding pump 11 for the first line 21, and a third line 23. A plurality of (first to ninth nine in this embodiment) channel opening / closing means 81, 82 that can open and close the middle of the channel of the platelet collecting circuit 2; 83, 84, 85, 86, 87, 88, 89, the centrifuge drive device 10, the first liquid feed pump 11, the second liquid feed pump 12, and the plurality of flow path opening / closing means 81 to 89 are controlled. Control unit (control means) 13, a plurality (in this embodiment, one) turbidity sensor (platelet concentration sensor) 14, an optical sensor 15, and a plurality (in this embodiment, two). Weight sensors (weight detection means) 16, 18 and pressure sensors (pressure detection) And means) 19, a plurality (in this embodiment, and a bubble sensor 31,32,33,34,35,36 of six).

First, the platelet collection circuit 2 will be described.
The platelet collection circuit 2 connects a blood collection needle (blood collection means) 29 for collecting blood from a donor (blood donor) and an inlet 143 of the centrifuge 20 and has a first line including a first pump tube 21g. (Blood collection and return line) 21, one end side is connected to the second line 22 connected to the discharge port (outlet) 144 of the centrifuge 20, and the blood collection needle 29 of the first line 21 is connected to the vicinity. A third line (anticoagulant injection line) 23 provided with a second pump tube 23a, a tube 50 connected to the blood collection needle 29 side from the pump tube 21g of the first line 21, and a tube 50 A tube 49, a tube 43 connected to the second line 22, a tube 44 connected to the tube 43, a plasma collection bag 25 connected to the tubes 44 and 49, and a second A tube 42 connected to the line 22, an air bag 27b connected to the tube 42, a tube 45 connected to the tube 43, an intermediate bag 27a connected to the tube 45, and a tube connected to the intermediate bag 27a 46, tubes 47 and 52 connected to tube 46, tube 48, platelet collection bag 26 connected to tube 48, tube 51 connected to platelet collection bag 26, and bag connected to tube 51 28, and a tube 53 that connects the tube 47 and the third line 23. The air bag 27b and the intermediate bag 27a are integrally formed (integrated).

  The first line 21 is connected to the blood collection needle side first line 21a to which the blood collection needle 29 is connected, one end side is connected to the blood collection needle side first line 21a, and the other end side is connected to the inlet 143 of the centrifuge 20. Centrifuge side first line 21b. As the blood collection needle 29, for example, a known metal needle is used.

  The blood collection needle side first line 21a, the centrifuge side first line 21b, the second line 22 and the third line 23 described later are each connected by a soft resin tube or a plurality of soft resin tubes. Has been formed.

  The blood collection needle side first line 21a is connected to the third line 23 from the blood collection needle 29 side, the chamber 21d for removing bubbles and microaggregates, and the branch connector for connection to the tube 50. 21f.

  Air bubble sensors 35, 36 and 32 are installed along the blood collection needle side first line 21a from the blood collection needle 29 side. In this case, the bubble sensors 35 and 36 are disposed between the branch connector 21c and the chamber 21d, and the bubble sensor 32 is disposed between the chamber 21d and the branch connector 21f.

  The bubble sensors 35, 36, and 32 transmit and receive ultrasonic waves from the outside of the tube, and make use of the fact that the transmittance of ultrasonic waves differs between the liquid and the bubble, so that the gas and liquid in the tube (separate gas / liquid) It is a detection means which can detect. The bubble sensors 31, 33 and 34 are also detection means having the same function as described above. The bubble sensor (gas and liquid detection means) is not limited to the ultrasonic sensor, and an optical sensor, an infrared sensor, or the like may be used.

  The chamber 21d is connected with a gas-permeable and bacteria-impermeable filter 21i through a tube 21h. This line can be used for detecting the internal pressure of the blood collection needle side first line 21a, for example.

  On the other hand, the centrifuge-side first line 21b is connected to a branch connector 21f for connection with the tube 50, and has a first pump tube 21g formed in the middle thereof.

One end of the second line 22 is connected to the outlet 144 of the centrifuge 20.
The second line 22 includes a branch connector 22b for connection to the tubes 42 and 43.

  A turbidity sensor 14 and a bubble sensor 34 are installed along the second line 22 from the centrifuge 20 side. In this case, the turbidity sensor 14 and the bubble sensor 34 are disposed between the centrifuge 20 and the branch connector 22b.

  The branch connector 22b is connected with a filter 22f that is air-permeable and bacteria-impermeable through a tube 41. This line can be used for detecting the internal pressure of the second line 22, for example.

  One end of the third line 23 is connected to a connecting branch connector 21 c provided on the first line 21. That is, the third line (flow path) 23 branches from the first line (flow path) 21 via the branch connector (branch portion) 21c. The branch connector 21c is located (provided) in the vicinity of the blood collection needle 29.

  The third line 23 includes, from the branch connector 21c side, a connecting branch connector 23e, a second pump tube 23a, a sterilizing filter (foreign matter removing filter) 23b, a bubble removing chamber 23c, and an anticoagulant. And a drug container connecting needle 23d.

  A bubble sensor 31 is installed along the third line 23. The bubble sensor 31 is disposed between the branch connector 21c and the branch connector 23e.

  The anticoagulant container connecting needle 23d of the third line 23 is connected to a container (not shown) in which an anticoagulant (anticoagulant liquid) is housed (contained), whereby the anticoagulant in the container is As will be described later, the anticoagulant container connecting needle 23d flows through the third line 23 toward the branch connector 21c and is supplied (injected) to the blood collection needle side first line 21a. Thereby, for example, the anticoagulant can be added (mixed) to the blood collected by the blood collection needle 29 via the third line 23.

  In addition, although it does not specifically limit as an anticoagulant, For example, ACD-A liquid etc. can be used.

  A plasma collection bag (third container) 25, which is a blood component collection bag, is a container for collecting (storing) plasma (second blood component). One end of the tube 49 is connected to the plasma collection bag 25, and a connecting branch connector 22d is provided in the middle thereof. One end of the tube 50 is connected to the branch connector 22d, and the other end is connected to the branch connector 21f.

  One end of the tube 43 is connected to the branch connector 22b, and the other end is provided with a connection branch connector 22c. One end of the tube 44 is connected to the branch connector 22c, and the other end is connected to the plasma collection bag 25.

  A bubble sensor 33 is installed along the tube 46 in the middle of the tube 46.

  The plasma collection bag 25 and tubes 43 and 44 constitute a plasma collection branch line for collecting plasma.

  A platelet (platelet preparation) collection bag (second container) 26, which is a blood component collection bag, collects (stores) plasma containing platelets (first blood component) after passing through a leukocyte removal filter 261 described later. It is a container for. That is, the platelet collection bag 26 constitutes a filtrate collection unit that collects the filtrate after passing through the leukocyte removal filter 261. In the following description, plasma containing platelets (first blood component) is referred to as “concentrated platelets”, and concentrated platelets collected (stored) in the platelet collection bag 26 are referred to as “platelet preparations”.

  One end of the tube 51 is connected to the platelet collection bag 26, and the bag 28 is connected to the other end.

  The air bag 27b is a container for temporarily storing (reserving) air.

  At the time of blood collection to be described later, air (sterilized air) in the platelet collection circuit 2 such as the blood storage space 146 of the centrifuge 20 is transferred and stored in the airbag 27b. In the blood return process (blood component return process), the air stored in the air bag 27b is transferred into the blood storage space 146 of the centrifuge 20 and returned. Thereby, a predetermined blood component is returned to the donor.

  One end of the tube 42 is connected to the branch connector 22b, and the other end is connected to the airbag 27b.

  The intermediate bag (temporary storage bag) (first container) 27a is a container (storage part) for temporarily storing concentrated platelets (first blood component). The intermediate bag 27a constitutes a supply unit that supplies blood or blood components (in the present embodiment, concentrated platelets). One end of the tube 45 is connected to the branch connector 22c, and the other end is connected to the intermediate bag 27a.

  One end of the tube 46 is connected to the intermediate bag 27a, and a connecting branch connector 22e is provided at the other end. The other end of the tube 49 is connected to the branch connector 22e.

  In addition, one end of a tube 47 is connected to the branch connector 22e for connection, and a leukocyte removal filter (cell separation filter) (filtering) that separates and removes leukocytes (predetermined cells) from the concentrated platelets is provided in the middle of the tube 47. 261) is installed.

  The other end of the tube 47 is provided with a connecting branch connector 22g, and the other end of the tube 48, one end of which is connected to the platelet collection bag 26, is connected to the branch connector 22g.

  Further, a filter main body provided with a vent filter and a filter 22h provided with a cap are installed at the port of the branch connector 22g.

  A branch connector 22 i is provided in the middle of the tube 46, and a breathable and bacteria-impermeable filter 22 k is connected to the branch connector 22 i through a tube 52. A pressure sensor 19 is connected to the filter 22k. This line can be used, for example, for detecting the pressure (internal pressure) in the leukocyte removal filter 261.

  A branch connector 22j is provided in the middle of the tube 47. One end of the tube 53 is connected to the branch connector 22j, and the other end of the tube 53 is connected to the branch connector 23e.

  Here, in a filtration operation for separating and removing leukocytes in the concentrated platelets described later, the tubes 46 and 47 constitute a supply tube for supplying the concentrated platelets from the intermediate bag 27a to the leukocyte removal filter 261. Constitutes a discharge tube for discharging the concentrated platelets after the white blood cells have been separated and removed from the white blood cell removal filter 261 (supplied to the platelet collection bag 26).

  That is, the tubes 46, 47, 48, the intermediate bag 27a, the leukocyte removal filter 261 and the platelet collection bag 26 constitute a filtration line for separating and removing leukocytes from the concentrated platelets.

  Further, in a recovery operation for recovering clogging of the leukocyte removal filter 261 described later, the third line 23 and the tube 53 are provided with an anticoagulant (having a pH lower than that of concentrated platelets) upstream of the leukocyte removal filter 261 in the filtration line. An anticoagulant supply line for supplying liquid) is configured. That is, the third line 23 and the tubes 47 and 53 constitute an anticoagulant supply line for supplying an anticoagulant (liquid having a pH lower than that of concentrated platelets) to the leukocyte removal filter 261.

  With the platelet collection device 1 assembled (when using the platelet collection device 1), the intermediate bag 27a, the leukocyte removal filter 261, the platelet collection bag 26, and the plasma collection bag 25 are each collected by the intermediate bag 27a. The leukocyte removal filter 261 is set at a position lower than the bag 25 (downward in the vertical direction) at a position lower than the intermediate bag 27a, and the platelet collection bag 26 is set at a position lower than the leukocyte removal filter 261 (located). The intermediate bag 27a and the plasma collection bag 25 are respectively positioned higher (vertically upward) than the blood storage space 146 of the rotor 142 of the centrifuge 20.

  In this case, the platelet collection device 1 is provided with hangers (hooks) (not shown), which are support portions that detachably support the plasma collection bag 25, the intermediate bag 27a, and the air bag 27b. The plasma collection bag 25 and the intermediate bag 27a are respectively hooked and hung (suspended) on the corresponding hangers so that the outlet side (inlet side) is vertically downward.

  Further, as the leukocyte removal filter 261, for example, in a casing having an inlet and an outlet at both ends, for example, a woven fabric, a nonwoven fabric, a mesh, a foam or the like made of a synthetic resin such as polypropylene, polyester, polyurethane, polyamide, etc. The thing constituted by inserting the filtration member which laminated one layer or two layers or more of a porous body can be used.

  As the constituent materials of the tubes used for forming the first to third lines 21 to 23, the pump tubes 21g and 23a, and the other tubes 41 to 53 and 21h, polyvinyl chloride is used. Is preferred.

  If these tubes are made of polyvinyl chloride, sufficient flexibility and softness can be obtained, so that they are easy to handle and are suitable for clogging with a clamp or the like.

  Further, as the constituent materials of each of the branch connectors 21c, 21f, 22b, 22c, 22d, 22e, 22g, 22i, 22j, and 23e described above, the same constituent materials as those mentioned for the tube can be used. .

  In addition, as each pump tube 21g and 23a, what has the intensity | strength of the grade which is not damaged even if it presses with each liquid feeding pump (for example, roller pump etc.) 11 and 12 mentioned later, respectively is used.

  Each of the plasma collection bag 25, the platelet collection bag 26, the intermediate bag 27a, the air bag 27b, and the bag 28 is laminated with a resin-made flexible sheet material, and the peripheral portions thereof are fused (thermal fusion, high frequency fusion). Or a bag formed by bonding with an adhesive or the like. As described above, the air bag 27b and the intermediate bag 27a are integrally formed (integrated).

  As a material used for each bag 25, 26, 27a, 27b, 28, for example, soft polyvinyl chloride is preferably used.

  In addition, as a sheet material used for the platelet collection bag 26, it is more preferable to use a material excellent in gas permeability in order to improve platelet storage stability.

  As such a sheet material, for example, polyolefin, DnDP plasticized polyvinyl chloride, or the like is used, and a sheet material of the above-described material is used without using such a material. What was thin (for example, about 0.1-0.5 mm, especially about 0.1-0.3 mm) is suitable.

  Although the main part of such a platelet collection circuit 2 is not shown, it is of a cassette type, for example. That is, the platelet collection circuit 2 partially stores each line (the first line 21, the second line 22, the third line 23) and each predetermined tube, and partially holds them, In other words, a cassette housing in which they are partially fixed is provided.

  The centrifuge 20 provided in the platelet collecting circuit 2 is generally called a centrifuge bowl, and separates blood into a plurality of blood components by centrifugal force.

  As shown in FIG. 2, the centrifuge 20 has a vertically extending tube 141 with an inlet 143 formed at the upper end, and rotates around the tube 141 and is liquid-tightly sealed with respect to the upper portion 145. And a hollow rotor 142.

  An annular blood storage space 146 is formed in the rotor 142 along the inner surface of the peripheral wall. The blood storage space 146 has a shape (tapered shape) in which the inner and outer diameters gradually decrease from the lower part toward the upper part in FIG. The upper end of the tubular body 141 communicates with the discharge port (outlet) 144. Further, in the rotor 142, the volume of the blood storage space 146 is, for example, about 100 to 350 mL, and the maximum inner diameter (maximum radius) from the rotating shaft of the rotor 142 is, for example, about 55 to 65 mm.

  Such a rotor 142 rotates under predetermined centrifugal conditions (rotation speed and rotation time) set in advance by the centrifuge drive device 10 included in the platelet collection device 1. Under this centrifugal condition, a blood separation pattern (for example, the number of blood components to be separated) in the rotor 142 can be set.

  In the present embodiment, as shown in FIG. 2, the centrifugal conditions are set so that the blood is separated from the inner layer into the plasma layer 131, the buffy coat layer 132, and the red blood cell layer 133 in the blood storage space 146 of the rotor 142.

Next, the overall configuration of the platelet collecting apparatus 1 shown in FIG. 1 will be described.
The platelet collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20, a first liquid feed pump 11 installed in the middle of the first line 21, and a third line. 23 and the platelet collecting circuit 2 (first line 21, third line 23, tube 42, tube 44, tube 45, tube 46, tube 49, tube 50). , A plurality of flow path opening / closing means 81, 82, 83, 84, 85, 86, 87, 88, 89 that can open and close the flow path of the tube 53) and display means for displaying (notifying) various information. Notification means) and a display / operation unit 17 which is an operation means for performing each operation, a centrifuge drive device 10, a first liquid feed pump 11, a second liquid feed pump 12, and a plurality of flow path opening / closing means 81-. 89 and table Controller for controlling the part 17 and a (control means) 13.

  Furthermore, the platelet collection device 1 includes a turbidity sensor 14 mounted (installed) on the second line 22, an optical sensor 15 installed near the centrifuge 20, and a plurality of bubble sensors 31 to 36. A weight sensor 16 for measuring the weight of plasma together with the plasma collection bag 25, a weight sensor 18 for measuring the weight of concentrated platelets together with the intermediate bag 27a, and a pressure for detecting the pressure in the leukocyte removal filter 261. And a sensor (pressure detecting means) 19.

  The control unit 13 includes two pump controllers (not shown) for the first liquid feeding pump 11 and the second liquid feeding pump 12, and the control unit 13, the first liquid feeding pump 11, and the second liquid feeding pump 12. The liquid feed pump 12 is electrically connected via a pump controller.

  A drive controller (not shown) included in the centrifuge drive device 10 is electrically connected to the control unit 13.

Each of the channel opening / closing means 81 to 89 is electrically connected to the control unit 13.
Further, the turbidity sensor 14, the optical sensor 15, the weight sensors 16 and 18, the pressure sensor 19, the bubble sensors 31 to 36, and the display unit 17 are each electrically connected to the control unit 13.

  The control unit 13 is configured by a microcomputer, for example, and the control unit 13 includes detection from the turbidity sensor 14, the optical sensor 15, the weight sensors 16 and 18, the pressure sensor 19, and the bubble sensors 31 to 36 described above. Each signal is input as needed. A signal (input) from the display / operation unit 17 is also input to the control unit 13.

  The control unit 13 is set in advance based on the detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensors 16 and 18, the pressure sensor 19, the bubble sensors 31 to 36 and the signal from the display / operation unit 17. According to the program, the operation of each part of the platelet collection device 1, that is, the rotation, stop, and rotation direction (forward / reverse rotation) of each liquid feeding pump 11, 12 is controlled, and each flow channel opening / closing means 81- The opening / closing operation 89, the operation of the centrifuge drive device 10 and the drive of the display / operation unit 17 are controlled.

  The first flow path opening / closing means 81 is provided to open and close the first line 21 from the first pump tube 21g to the blood collection needle 29 side, that is, between the branch connector 21f and the chamber 21d. The ninth flow path opening / closing means 89 is provided to open and close the third line 23 between the branch connector 21c and the branch connector 23e.

  The second flow path opening / closing means 82 is provided to open / close the tube 50. The third flow path opening / closing means 83 is provided for opening and closing the tube 44. The fourth flow path opening / closing means 84 is provided to open and close the tube 45. The fifth flow path opening / closing means 85 is provided for opening and closing the tube 42. The sixth flow path opening / closing means 86 is provided to open and close the tube 49. The seventh flow path opening / closing means 87 is provided to open and close the tube 46 between the intermediate bag 27a and the branch connector 22i. The eighth channel opening / closing means 88 is provided to open and close the tube 53.

  Each of the channel opening / closing means 81 to 89 includes an insertion part into which the first line 21, the tubes 50, 44, 45, 42, 49, 47, 53, and the first line 23 can be inserted. Includes a clamp that operates with a drive source such as a solenoid, an electric motor, or a cylinder (hydraulic pressure or pneumatic pressure). Specifically, an electromagnetic clamp that operates with a solenoid is suitable.

  Each of these flow path opening / closing means (clamps) 81 to 89 operates based on a signal from the control unit 13.

  The display / operation unit 17 includes, for example, a touch panel including a liquid crystal display panel, an EL display panel, and the like.

  In addition, a display unit (for example, a liquid crystal display panel, an EL display panel, etc.) that is a display unit (notification unit) for displaying (notifying) various information, and an operation unit (for example, an operation button) that is an operation unit for performing each operation. , An operation switch, an operation dial, etc.) may be provided separately.

  As shown in FIG. 2, the centrifuge drive device 10 includes a housing 201 that houses the centrifuge 20, a leg portion 202, a motor 203 that is a drive source, and a disk-shaped fixing that holds the centrifuge 20. And a table 205.

  The housing 201 is placed and fixed on the upper portion of the leg portion 202. In addition, a motor 203 is fixed to the lower surface of the housing 201 via a spacer 207 with bolts 206.

  A fixed base 205 is fitted on the tip of the rotating shaft 204 of the motor 203 so as to rotate coaxially and integrally with the rotating shaft 204, and the bottom of the rotor 142 is fitted on the upper portion of the fixed base 205. A concave portion is formed.

  The upper portion 145 of the centrifuge 20 is fixed to the housing 201 by a fixing member (not shown).

  In such a centrifuge drive device 10, when the motor 203 is driven, the fixed base 205 and the rotor 142 fixed thereto rotate at, for example, about 3000 to 6000 rpm.

  The optical sensor 15 is installed on the side of the housing 201 (left side in FIG. 2).

  The optical sensor 15 is configured to project light toward the blood storage space 146 and to receive the reflected light.

  The optical sensor 15 irradiates (projects) light (for example, laser light) from the light projecting unit 151, and the reflected light reflected by the reflecting surface 147 of the rotor 142 is received by the light receiving unit 152. The light receiving unit 152 converts the received light quantity into an electrical signal.

  Here, the optical sensor 15 has a reflecting surface on one side and a reflecting plate 153 that changes the optical path, and the light irradiated from the light projecting unit 151 passes through the reflecting plate 153 and is reflected on the reflecting surface 147. The light that is irradiated to the light and reflected by the reflecting surface 147 is received by the light receiving unit 152 via the reflecting plate 153.

  At this time, the projection light and the reflected light are transmitted through the blood component in the blood storage space 146, but the position of the blood component interface (the interface B between the plasma layer 131 and the buffy coat layer 132 in this embodiment). Accordingly, since the abundance ratio of each blood component at a position where the light projection light and the reflected light are transmitted is different, the transmittance thereof is changed. As a result, the amount of light received by the light receiving unit 152 varies (changes), and this variation can be detected as a change in the output voltage from the light receiving unit 152.

  That is, the optical sensor 15 can detect the position of the blood component interface based on the change in the amount of light received by the light receiving unit 152.

  The interface of the blood component detected by the optical sensor 15 is not limited to the interface B, and may be the interface between the buffy coat layer 132 and the red blood cell layer 133, for example.

  Here, each of the layers 131 to 133 in the blood storage space 146 has a different color depending on the blood component, and in particular, the red blood cell layer 133 is red with the color of the red blood cells. For this reason, from the viewpoint of improving the accuracy of the optical sensor 15, there is a range suitable for the wavelength of the projection light, and the wavelength range is not particularly limited, but is preferably about 600 to 900 nm, for example. 750 to 800 nm is more preferable.

  The turbidity sensor 14 is for detecting the turbidity (platelet concentration) of the fluid (liquid) flowing through the second line 22 and outputs a voltage value corresponding to the turbidity. Specifically, the turbidity sensor 14 outputs a low voltage value when the turbidity is high and a high voltage value when the turbidity is low.

  The turbidity sensor 14 can detect, for example, the concentration of platelets in plasma flowing through the second line 22, the change in platelet concentration in plasma, and the mixing of red blood cells into the plasma.

  Further, the bubble sensor 34 can detect, for example, the replacement of the fluid flowing in the second line 22 from air to plasma.

  As the turbidity sensor 14 and the bubble sensors 31 to 36, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.

  As the first liquid delivery pump 11 to which the first pump tube 21g is attached and the second liquid delivery pump 12 to which the second pump tube 23a is attached, for example, non-blood such as a roller pump, respectively. A contact type pump is preferably used.

  Further, as the first liquid feeding pump (blood pump) 11, a pump capable of feeding blood in any direction is used. Specifically, a roller pump capable of forward rotation and reverse rotation is used.

  This platelet collecting apparatus 1 has a filter monitoring system provided with a flow rate detecting means and a clogging detecting means, and concentrates platelets (plasma containing platelets) temporarily stored in the intermediate bag 27a by a drop. The clogged portion is transported and supplied to a leukocyte removal filter (cell separation filter) 261, and the clogging is performed while performing filtration operation (filtration process) for separating and removing concentrated platelets, that is, separating and removing leukocytes in the concentrated platelets. The detection means is configured to perform clogging detection processing for determining occurrence of clogging of the leukocyte removal filter 261 based on the detection result of the flow velocity detection means. The main part of the flow velocity detection means is constituted by the weight sensor 18 and the control unit 13, and the main part of the clogging detection means is constituted by the control unit 13.

  Here, clogging of the leukocyte removal filter (cell separation filter) does not mean a state in which the liquid is completely blocked, and is not suitable as a leukocyte removal filter in the filtration operation, that is, filtration of the leukocyte removal filter. Deterioration of performance (state in which filtration performance is reduced).

Hereinafter, the filter monitoring system of the platelet collecting apparatus 1 will be described.
The filter monitoring system uses the flow rate detection means to remove the leukocytes from the intermediate bag 27a, ie, the flow rate (flow rate per unit time) of the concentrated platelets (liquid) flowing through the filtration line (upstream and downstream of the leukocyte removal filter 261, etc.). The flow rate of the concentrated platelets supplied to the filter 261 is detected.

  In this case, the flow velocity detection means has a weight sensor 18 and a time measurement means for measuring time (elapsed time), and the weight sensor 18 detects (measures) the weight of the concentrated platelet (liquid) together with the intermediate bag 27a. The elapsed time is measured by the time measuring means, and the flow rate of the concentrated platelets is obtained based on the detection result of the weight sensor 18 and the measurement result of the time measuring means. The main part of the time measuring means is configured by the control unit 13.

  The clogging detection means then detects a difference (for example, a difference) between the set flow rate of concentrated platelets (liquid) in the filtration operation (hereinafter also simply referred to as “set flow rate”) and the flow rate of the concentrated platelets detected by the flow rate detection means. Clogging detection processing for determining occurrence of clogging of the leukocyte removal filter 261 based on the ratio and the like.

  When the flow rate of the concentrated platelets detected by the flow rate detection means is lower than the set flow rate, it can be estimated that platelet aggregation has occurred in the leukocyte removal filter 261.

  Therefore, the clogging detection means uses the occurrence of clogging of the leukocyte removal filter 261 as a threshold value of the degree of deviation between the set flow rate and the flow rate of the concentrated platelets detected by the flow rate detection means in the clogging detection process. A value corresponding to the initial stage (initial stage) is set, and when the deviation reaches the threshold value, it is determined that clogging of the leukocyte removal filter 261 has occurred.

  For example, when the set flow rate is set to 1 in the clogging detection process, the clogging detection means is less than 1 as the threshold value of the flow rate of the concentrated platelets detected by the flow rate detection means used in the clogging detection process. When the value (threshold value) α corresponding to the initial stage of occurrence of clogging of the removal filter 261 is set, and the flow rate of the concentrated platelets detected by the flow rate detection means reaches (decreases) the threshold value α, white blood cells It is configured to determine that the removal filter 261 is clogged. This threshold value α is preferably about 0.5 to 0.8, and more preferably about 0.6 to 0.7.

  Moreover, although the said setting flow rate is suitably set according to various conditions, it is preferable to set it as about 15-50 mL / min, and it is more preferable to set it as about 25-35 mL / min.

  The threshold value α may be set in plural (α1 to αn (n is an integer of 2 or more)).

  In the present embodiment, when the clogging detection means determines that clogging of the leukocyte removal filter 261 has occurred before the predetermined time t has elapsed since the start of the filtration operation, the threshold value α Is set (changed) to a smaller value. The threshold value α is preferably about 0.3 to 0.7, and more preferably about 0.5 to 0.6. The predetermined time t is preferably about 0.5 to 3 minutes, and more preferably about 1.5 to 2.5 minutes.

  On the other hand, when it is determined that the clogging of the leukocyte removal filter 261 has not occurred until the predetermined time t has elapsed since the start of the filtration operation, the clogging detection means starts the filtration operation and then After the predetermined time t elapses, the flow rate of the concentrated platelets detected by the flow rate detecting means until the predetermined time t elapses (hereinafter also simply referred to as “initial stage flow rate when no clogging occurs”). ) And the flow rate of concentrated platelets detected by the flow rate detection means (for example, a difference, a ratio, etc.), a clogging detection process for determining occurrence of clogging of the leukocyte removal filter 261 is performed.

  As the initial stage flow velocity when this clogging does not occur, for example, the average value between the start of the filtration operation and the predetermined time t, the intermediate value between the maximum value and the minimum value, the filtration operation is started. For example, a value when a predetermined time t elapses can be used.

  If the flow rate of the concentrated platelets detected by the flow rate detection means is lower than the initial flow rate when no clogging has occurred, it can be estimated that platelet aggregation has occurred in the leukocyte removal filter 261. .

  Therefore, the clogging detection means, in the clogging detection process, as a threshold value of the degree of deviation between the initial stage flow rate when the clogging has not occurred and the flow rate of the concentrated platelets detected by the flow rate detection unit, A value corresponding to the initial stage (initial stage) of occurrence of clogging of the leukocyte removal filter 261 is set, and when the deviation reaches the threshold value, it is determined that clogging of the leukocyte removal filter 261 has occurred. Configured as follows.

  For example, the clogging detection means has a flow rate of concentrated platelets detected by the flow rate detection means used in the clogging detection process when the initial stage flow rate when clogging does not occur is 1 in the clogging detection process. As a threshold value, a value (threshold value) β smaller than 1 and corresponding to the initial stage of occurrence of clogging of the leukocyte removal filter 261 is set, and the flow rate of concentrated platelets detected by the flow rate detecting means is the threshold value. When β is reached (decreased), it is determined that clogging of the leukocyte removal filter 261 has occurred. The threshold value β is preferably about 0.3 to 0.7, and more preferably about 0.4 to 0.6.

  If it is determined by the clogging detection means that clogging of the leukocyte removal filter 261 has occurred, the filtering operation is stopped or interrupted. Then, a warning is given by the notification means. In the present embodiment, a warning display indicating that, for example, clogging of the leukocyte removal filter 261 has occurred is displayed on the display / operation unit 17. Note that the notification means is not limited to this, and examples thereof include lighting and blinking of a light emitting unit, sound of a buzzer, an announcement, and the like.

  If the clogging detection means determines that clogging of the leukocyte removal filter 261 has occurred, a recovery operation for recovering the clogging of the leukocyte removal filter 261 is performed. The recovery operation includes a step of supplying a liquid having a pH lower than that of the concentrated platelet (liquid) supplied from the intermediate bag 27a to the leukocyte removal filter 261 to lower the pH of the concentrated platelets in the leukocyte removal filter 261. This recovery operation is preferably performed while the filtration operation is interrupted. The pH of the concentrated platelets supplied from the intermediate bag 27a is about 6.9-7.

  The pH of the liquid that is lower than that of the concentrated platelets and is supplied to the leukocyte removal filter 261 is preferably about 4 to 6.5, and more preferably about 5 to 6.

  Examples of the liquid supplied to the leukocyte removal filter 261 include a liquid containing an anticoagulant. Examples of the liquid containing the anticoagulant include an anticoagulant (anticoagulant liquid), a mixed liquid of an anticoagulant and plasma, a mixed liquid of an anticoagulant and physiological saline, an anticoagulant and plasma and physiological saline. Examples thereof include a mixed solution of water.

  The amount of liquid supplied to the leukocyte removal filter 261 is appropriately set according to the capacity of the leukocyte removal filter 261 and the like. For example, when the capacity of the leukocyte removal filter 261 is 15 mL, the amount of liquid supplied to the leukocyte removal filter 261 is preferably about 15 to 30 mL, and more preferably about 15 to 20 mL.

  Further, the flow rate of the liquid supplied to the leukocyte removal filter 261 is lower than the flow rate detected by the flow rate detection means when the clogging detection means determines that the leukocyte removal filter 261 is clogged. Is set. Thus, white blood can be prevented (or suppressed) from passing through the leukocyte removal filter 261 during the recovery operation.

  Further, during the recovery operation, that is, when the liquid is supplied to the leukocyte removal filter 261, the pressure sensor 19 detects the pressure in the leukocyte removal filter 261, and based on this detection result, the leukocyte removal filter Control is performed so that the pressure in 261 becomes a predetermined value (for example, 200 mmHg) or less (for example, the operation of the second liquid feeding pump 11 is controlled). Thus, white blood can be prevented (or suppressed) from passing through the leukocyte removal filter 261 during the recovery operation.

  In this recovery operation, for example, when an anticoagulant is used, the anticoagulant is removed from the leukocyte removal filter 261 of the filtration line via the third line 23 and the tube 53 by the operation of the second liquid feeding pump 11. Supplied upstream and transferred to the leukocyte removal filter 261 via the tube 47. This anticoagulant lowers the pH of the concentrated platelets in the leukocyte removal filter 261, loosens the aggregated platelets, and restores clogging of the leukocyte removal filter 261. The anticoagulant and the concentrated platelets pass through the leukocyte removal filter 261 and are transferred into the platelet collection bag 26 through the tube 48.

  By this recovery operation, the pH of the concentrated platelets in the leukocyte removal filter 261 is preferably lowered to about 5 to 6.5, more preferably about 5.5 to 6. As a result, the aggregated platelets are more reliably loosened, and the clogging of the leukocyte removal filter 261 is more reliably recovered.

  When the recovery operation is completed, the recovery state determination unit determines the recovery state of clogging of the leukocyte removal filter 261. The main part of the recovery state determination means is configured by the control unit 13.

  In this case, first, the pressure in the leukocyte removal filter 261 is detected by the pressure sensor 19. The recovery state determination means determines the recovery state of clogging of the leukocyte removal filter 261 based on the detection result of the pressure sensor 19.

  When clogging of the leukocyte removal filter 261 is recovered by the recovery operation, the pressure in the leukocyte removal filter 261 becomes approximately 0 mmHg.

  Therefore, the recovery state determination means is configured to determine that the clogging of the leukocyte removal filter 261 has been recovered, for example, when the pressure in the leukocyte removal filter 261 detected by the pressure sensor 19 reaches (reduces) 0 mmHg. Is done.

  When the recovery state determination means determines that the clogging of the leukocyte removal filter 261 has been recovered, the filtration operation is resumed.

Thereby, clogging of the leukocyte removal filter 261 can be prevented, and the filtration operation can be performed reliably.
Needless to say, the recovery operation is not limited to the above-described method.

  Next, a platelet collection operation (blood component collection operation) and a filtration operation (filtration process) using the platelet collection apparatus 1 will be described with reference to the flowcharts shown in FIGS. 1 and 3 to 5.

  The platelet collection device 1 is controlled by the control unit 13 so that the first plasma collection step, the constant-speed plasma circulation step, the second plasma collection step, the accelerated plasma circulation step, the third plasma collection step, It operates to perform a platelet collection operation (blood component collection operation) having a platelet collection step and a blood return step (blood component return step). This platelet collection operation is performed at least once. The blood component collection step includes the first plasma collection step, the constant-speed plasma circulation step, the second plasma collection step, the accelerated plasma circulation step, the third plasma collection step, and the platelet collection step. Composed.

  In the present embodiment, the platelet collection operation is repeated a plurality of times (1st cycle to nth cycle, n is an integer of 2 or more).

  In parallel with the final-cycle platelet collection operation or after completion of the final-cycle platelet collection operation, the platelet collection device 1 is temporarily collected in the intermediate bag 27a under the control of the control unit 13 ( The concentrated platelets stored) are supplied to the leukocyte removal filter 261 to perform a filtration operation (filtration step) for separating and removing leukocytes in the concentrated platelets.

  The timing for starting this filtration operation is not particularly limited, but from the viewpoint of shortening the donor's restraint time, this filtration operation is performed simultaneously with the platelet collection operation of the final cycle (particularly in the early stages of the platelet collection operation). It is preferable to start. In the blood component collection device 1 of this embodiment, the filtration operation is started almost simultaneously with the start of the second plasma collection step in the platelet collection operation in the final cycle (for example, before step S105 in FIG. 3). Although configured, in the flowcharts shown in FIGS. 3 and 4, the description of the step of the filtration operation start (filtration process start) is omitted.

[0] First, under the control of the control unit 13, the third line 23 and the first line 21 in a state where the ninth flow path opening / closing means 89 is opened and the other flow path opening / closing means are closed. The blood collection needle 29 to the chamber 21d are primed with an anticoagulant, and then the blood collection needle 29 is punctured into a donor (blood donor) blood vessel.

[1] Platelet collection operation in the first cycle (see FIGS. 3 and 4)
[11] First, the platelet collection device 1 performs a first plasma collection step. In the first plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142 and plasma (PPP) separated by centrifuging the blood is collected in the plasma collection bag 25.

  In the first plasma collection step, first, the control unit 13 collects plasma (second blood component) (step S101 in FIG. 3).

  Specifically, under the control of the control unit 13, the first liquid supply / closing means 81 and the fifth flow path opening / closing means 85 are opened, and the other liquid flow opening / closing means are closed, and the first liquid supply The pump 11 is operated (forward rotation) at a predetermined rotational speed (preferably about 250 mL / min or less, more preferably about 40 to 150 mL / min, for example, 60 mL / min), and blood collection from the donor is started.

  Simultaneously with this blood collection, the second liquid pump 12 is operated under the control of the control unit 13 to supply an anticoagulant such as an ACD-A solution via the third line 23, This anticoagulant is mixed into the collected blood.

  At this time, the rotation speed of the second liquid feeding pump 12 is adjusted by the control unit 13 so that the anticoagulant is mixed with the collected blood at a predetermined ratio (preferably about 1/20 to 1/6, for example 1/10) To be controlled.

  As a result, blood (anticoagulant-added blood) is transferred through the first line 21 and introduced into the blood storage space 146 of the rotor 142 through the tube 141 from the inlet 143 of the centrifuge 20.

  At this time, air (sterilized air) in the centrifuge 20 is sent into the air bag 27b through the second line 22 and the tube 42.

  Simultaneously with or before or after the blood collection, the control unit 13 operates the centrifuge drive device 10 to control the rotor 142 to rotate at a predetermined rotation speed.

  By the rotation of the rotor 142, the blood introduced into the blood storage space 146 is separated from the inside into three layers: a plasma layer (PPP layer) 131, a buffy coat layer (BC layer) 132, and a red blood cell layer (CRC layer) 133. The

  The rotational speed of the rotor 142 is preferably about 3000 to 6000 rpm, more preferably about 4200 to 5800 rpm. In the following steps, the control unit 13 does not change the rotational speed of the rotor 142 unless otherwise specified.

  Further, when the blood collection and the supply of the anticoagulant are continued and blood (about 270 mL) exceeding the capacity of the blood storage space 146 is introduced into the blood storage space 146, the blood storage space 146 is filled with blood and centrifuged. Plasma (PPP) flows out from the outlet 144 of the vessel 20.

  At this time, the bubble sensor 34 installed in the second line 22 detects that the fluid flowing in the second line 22 has changed from air to plasma, and the control unit 13 detects the bubble sensor 34. Based on the signal, control is performed so that the fifth flow path opening / closing means 85 is closed and the third flow path opening / closing means 83 is opened.

  As a result, plasma is introduced into and collected in the plasma collection bag (third container) 25 through the second line 22 and the tubes 43 and 44.

  The weight of the plasma collection bag 25 is measured by the weight sensor 16, and the measured weight signal is input to the control unit 13.

  Next, the control unit 13 determines whether or not a predetermined amount of plasma has been collected in the plasma collection bag 25 based on information (weight signal) from the weight sensor 16 (step S102 in FIG. 3).

  The amount of plasma collected (predetermined amount) is preferably about 10 to 150 g, more preferably about 20 to 40 g.

  In step S102, when a predetermined amount of plasma is not collected in the plasma collection bag 25, the control unit 13 returns to step S101 and repeats step S101 and subsequent steps again.

  In step S102, when a predetermined amount of plasma is collected in the plasma collection bag 25, the control unit 13 ends this step [11] (first plasma collection step) and performs constant-speed plasma. Move to circulation process.

[12] Next, the platelet collecting apparatus 1 performs a constant-speed plasma circulation step. In the constant-speed plasma circulation step, the plasma in the plasma collection bag 25 is circulated at a constant speed through the blood storage space 146.

  In the constant-speed plasma circulation step, first, the control unit 13 circulates plasma (step S103 in FIG. 3).

  Specifically, under the control of the control unit 13, the first flow path opening / closing means 81 is closed, the second flow path opening / closing means 82 is opened, the second liquid feed pump 12 is stopped, and the first flow path opening / closing means 82 is stopped. The liquid feed pump 11 is operated (normally rotated) at a predetermined rotation speed (preferably about 60 to 250 mL / min, for example, 200 mL / min).

  As a result, the blood collection is temporarily interrupted, and the plasma in the plasma collection bag 25 is introduced into the blood storage space 146 through the tubes 49 and 50 and the first line 21 at a constant speed, and the outlet 144 of the centrifuge 20 is introduced. The plasma flowing out of the plasma is collected in the plasma collection bag 25 through the second line 22 and the tubes 43 and 44. That is, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 at a constant speed.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 10 to 90 seconds, for example, 30 seconds) has elapsed since the start of constant-speed plasma circulation (step S104 in FIG. 3).

  In step S104, when the predetermined time has not elapsed since the start of constant-speed plasma circulation, the control unit 13 returns to step S103, and repeats step S103 and subsequent steps again.

  In step S104, when a predetermined time has elapsed since the start of constant-speed plasma circulation, the control unit 13 ends this step [12] (constant-speed plasma circulation step), and the second plasma Move to the collection process.

[13] Next, the platelet collection device 1 performs a second plasma collection step. In the second plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142, and the plasma separated by centrifuging the blood is collected in the plasma collection bag 25.

  In the second plasma collecting step, the step [11] except that the position of the interface B between the plasma layer 131 and the buffy coat layer 132 is detected instead of measuring the amount of collected plasma by the weight sensor 16. A step similar to the (first plasma collection step) is performed.

  In the second plasma collection step, first, the control unit 13 collects plasma (step S105 in FIG. 3).

  At this time, the control unit 13 controls the second flow path opening / closing means 82 to be closed and the first flow path opening / closing means 81 to be opened.

  Thereby, as the amount of red blood cells in the blood storage space 146 increases, that is, as the layer thickness of the red blood cell layer 133 increases, the interface B gradually moves in the direction of the rotation axis of the rotor 142.

  Next, the control unit 13 determines whether or not the interface B has reached a predetermined level (first position) based on the detection signal (interface position detection information) from the optical sensor 15 (step S106 in FIG. 3). ).

  The first position of the interface B is preferably the position at which the detection signal from the first optical sensor 15 (output voltage from the light receiving unit 152) is about 1 to 2V. .

  In step S106, when the interface B has not reached the first position, the control unit 13 returns to step S105 and repeats step S105 and subsequent steps again.

  In Step S106, when interface B reaches the 1st position, control part 13 ends this process [13] (2nd plasma collection process), and shifts to an acceleration plasma circulation process. .

[14] Next, the platelet collecting apparatus 1 performs an accelerated plasma circulation step. In the accelerated plasma circulation step, the plasma in the plasma collection bag 25 is circulated while being accelerated into the blood storage space 146.

  In the accelerated plasma circulation process, first, the control unit 13 circulates plasma (step S107 in FIG. 3).

  Specifically, under the control of the control unit 13, the first flow path opening / closing means 81 is closed, the second flow path opening / closing means 82 is opened, the second liquid feed pump 12 is stopped, and It operates (forward rotation) so that the rotational speed of the first liquid feeding pump 11 increases (increases) at a constant acceleration.

  As a result, the blood collection is temporarily interrupted, and the plasma in the plasma collection bag 25 is introduced into the blood storage space 146 through the tubes 49 and 50 and the first line 21 while being accelerated, and the outlet 144 of the centrifuge 20 is introduced. The plasma flowing out of the plasma is collected in the plasma collection bag 25 through the second line 22 and the tubes 43 and 44. That is, the plasma in the plasma collection bag 25 is circulated while being accelerated into the blood storage space 146.

  At this time, the control unit 13 increases (increases) the rotation speed of the first liquid feeding pump 11 at a constant acceleration from a speed (initial speed: for example, 60 mL / min) slower than the constant-speed plasma circulation. To control.

  The acceleration condition (acceleration) is preferably about 1 to 10 mL / min / sec, more preferably about 3 to 6 mL / min / sec. Further, the acceleration may not be constant, and may change stepwise or continuously within the above range, for example.

  Next, the control unit 13 determines whether or not the circulating speed of plasma into the blood storage space 146 has reached a predetermined speed, that is, the rotational speed of the first liquid feeding pump 11 is a predetermined speed (preferably 130 to 250 mL / min). It is determined whether or not a certain level (eg, 155 mL / min) has been reached (step S108 in FIG. 3).

  This step S108 is continued until the circulating speed of plasma into the blood storage space 146 reaches a predetermined speed.

  In step S108, when the circulation speed of plasma into the blood storage space 146 reaches a predetermined speed, the control unit 13 ends this process [14] (accelerated plasma circulation process), and collects the third plasma. Move to the process.

[15] Next, the platelet collection device 1 performs a third plasma collection step. In the third plasma collection step, blood is introduced into the blood storage space 146 of the rotor 142, and the plasma separated by centrifuging the blood is collected in the plasma collection bag 25.

  In the third plasma collection step, first, the control unit 13 collects plasma (step S109 in FIG. 3).

  At this time, the control unit 13 controls the second flow path opening / closing means 82 to be closed and the first flow path opening / closing means 81 to be opened.

  Next, the control unit 13 determines whether or not a predetermined amount of plasma has been collected in the plasma collection bag 25 based on the amount and the number of rotations of the first liquid pump 11 per rotation (FIG. 3). Step S110).

  The amount of plasma collected (predetermined amount) is preferably about 2 to 30 g, more preferably about 5 to 15 g.

  In step S110, when a predetermined amount of plasma is collected in the plasma collection bag 25, the control unit 13 ends this step [15] (third plasma collection step), and the platelet collection step. (Transition to 1 in FIG. 4).

[16] Next, the platelet collecting apparatus 1 performs a platelet collecting step. In the platelet collection step, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration, and then changed to a second acceleration larger than the first acceleration. The blood is circulated while being accelerated at an acceleration of 2, the platelets are discharged from the blood storage space 146, and the concentrated platelets are collected (stored) in the intermediate bag 27a.

  In the platelet collection step, first, the control unit 13 performs plasma circulation with the first acceleration (step S111 in FIG. 4).

  Specifically, under the control of the control unit 13, the first flow path opening / closing means 81 is closed, the second flow path opening / closing means 82 is opened, the second liquid feed pump 12 is stopped, and It operates (forward rotation) so as to increase (increase) the rotation speed of the first liquid feeding pump 11 at the first acceleration.

  Thereby, the blood collection is interrupted, and the plasma in the plasma collection bag 25 is introduced into the blood storage space 146 through the tubes 49 and 50 and the first line 21 while being accelerated at the first acceleration, and the centrifuge The plasma flowing out from the 20 outlets 144 is collected in the plasma collection bag 25 via the second line 22 and the tubes 43 and 44. That is, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated at the first acceleration.

  At this time, if plasma is circulated in the blood storage space 146 while accelerating at the first acceleration, the red blood cell layer 133 is diffused (increase in layer thickness), and the interface B gradually moves in the direction of the rotation axis of the rotor 142. To do.

  The first acceleration is preferably about 0.5 to 10 mL / min / sec, more preferably about 1.5 to 2.5 mL / min / sec. The first acceleration may not be constant, and may change stepwise or continuously within the above range, for example.

  The initial speed of the first liquid delivery pump 11 in the plasma circulation by the first acceleration is preferably about 40 to 150 mL / min, more preferably about 50 to 80 mL / min.

  Next, the control unit 13 continues Step S111 until the circulating speed of plasma into the blood storage space 146 reaches a predetermined speed (Step S112 in FIG. 4).

  The predetermined speed, that is, the rotational speed of the first liquid delivery pump 11 when the plasma circulation by the first acceleration is completed is preferably about 100 to 180 mL / min, more preferably 140 to 160 mL / min. About min.

  In step S112, when the circulation speed of the plasma into the blood storage space 146 reaches a predetermined speed, the control unit 13 performs plasma circulation by the second acceleration (step S113 in FIG. 4).

  Specifically, under the control of the control unit 13, the acceleration of the first liquid feed pump 11 is changed from the first acceleration to the second acceleration, and the rotation speed of the first liquid feed pump 11 is changed to the second speed. It operates (forward rotation) to increase (increase) at an acceleration of. Thereby, the plasma in the plasma collection bag 25 is circulated in the blood storage space 146 while being accelerated by the second acceleration.

  At this time, if plasma is circulated in the blood storage space 146 while accelerating at the second acceleration, the red blood cell layer 133 is diffused (increase in layer thickness), and the interface B gradually moves in the direction of the rotation axis of the rotor 142. At the same time, the platelet (PC) in the buffy coat layer 132 rises (swells) against the centrifugal force and moves toward the discharge port 144 of the rotor 142.

  The second acceleration is set to be greater than the first acceleration, and is preferably about 3 to 20 mL / min / sec, more preferably about 5 to 10 mL / min / sec. Note that the second acceleration may not be constant, and may change stepwise or continuously within the above range, for example.

  Next, the control unit 13 determines whether or not the circulating speed of plasma into the blood storage space 146 has reached a predetermined speed, that is, the rotational speed of the first liquid feeding pump 11 is a predetermined speed (preferably 120 to 300 mL / min). It is determined whether or not a certain level (for example, 200 mL / min) has been reached (step S114 in FIG. 4).

  In step S114, when the circulation speed of plasma into the blood storage space 146 has not reached the predetermined speed, the control unit 13 returns to step S113 and repeats step S113 and subsequent steps again.

  In step S114, when the circulation speed of plasma into the blood storage space 146 reaches a predetermined speed, the control unit 13 continues the plasma circulation (step S115 in FIG. 4).

  Specifically, the control unit 13 controls (maintains) the rotational speed of the first liquid feed pump 11 at the predetermined speed in step S114. Thereby, the circulation rate of plasma into the blood storage space 146 is preferably about 120 to 300 mL / min, for example, 200 mL / min.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 5 to 15 seconds, for example, 10 seconds) has elapsed since the start of Step S115 (Step S116 in FIG. 4).

  In step S116, when the predetermined time has not elapsed since the start of step S115, the control unit 13 then determines that the output voltage (PC concentration voltage) from the turbidity sensor 14 is a predetermined value (preferably 2. It is determined whether or not the voltage has decreased to about 5 to 3.5 V, for example, 3.0 V (step S117 in FIG. 4).

  In step S117, if the output voltage from the turbidity sensor 14 has not decreased below the predetermined value, the control unit 13 returns to step S115 and repeats step S115 and subsequent steps again.

  While repeating steps S115 to S117, in step S116, when a predetermined time has elapsed since the start of step S115, the control unit 13 ends this step [16] (platelet collection step). Then, the process proceeds to step S122 described later.

  In step S117, when the output voltage from the turbidity sensor 14 decreases to a predetermined value or less, that is, as platelets flow out from the discharge port 144 of the rotor 142, the second line 22 flows. When the platelet concentration in plasma reaches a predetermined value or more, the control unit 13 collects platelets (PC) (step S118 in FIG. 4).

  Specifically, the control unit 13 controls the third flow path opening / closing means 83 to be closed and the fourth flow path opening / closing means 84 to be opened based on the detection signal of the turbidity sensor 14.

  Thereby, concentrated platelets are introduced into the intermediate bag 27a via the second line 22 and the tubes 43 and 45, and collected (stored). At this time, since the seventh flow path opening / closing means 87 is closed, the concentrated platelets do not flow out from the intermediate bag 27a.

  Further, the control unit 13 calculates the platelet concentration (cumulative PC concentration) in the intermediate bag 27a based on the output voltage (detection signal) from the turbidity sensor 14. The platelet concentration continues to rise after the start of PC collection, and once it reaches the maximum concentration, it begins to fall.

  Next, the control unit 13 determines whether or not a predetermined time (preferably about 10 to 25 seconds, for example, 15 seconds) has elapsed since the start of PC collection (step S119 in FIG. 4).

  If the predetermined time has not elapsed since the start of the PC sampling in step S119, the control unit 13 then determines whether the output voltage (PC concentration voltage) of the turbidity sensor 14 has reached a predetermined value or less. Is determined (step S120 in FIG. 4).

  The predetermined value of the output voltage of the turbidity sensor 14 is a value near the time when red blood cells are mixed in the plasma flowing in the second line 22, and is preferably about 0.5 V or less.

  In step S120, when the output voltage of the turbidity sensor 14 has not reached the predetermined value or less, the control unit 13 then determines whether or not the concentrated platelets in the intermediate bag 27a have reached a predetermined amount. (Step S121 in FIG. 4).

  The collection amount (predetermined amount) of the concentrated platelets is preferably about 20 to 100 mL, more preferably about 40 to 80 mL.

  In step S121, when the concentrated platelets in the intermediate bag 27a do not reach the predetermined amount, the control unit 13 returns to step S118 and repeats step S118 and subsequent steps again.

  While repeating steps S118 to S121, when a predetermined time has elapsed since the start of PC sampling in step S119, or when the output voltage of the turbidity sensor 14 has reached a predetermined value or less in step S120 The control unit 13 ends this step [16] (platelet collection step), and proceeds to step S122 described later.

  In step S121, when the concentrated platelets in the intermediate bag 27a reach a predetermined amount, the control unit 13 opens the fifth channel opening / closing means 85 and all the other channel opening / closing means 81. ˜84, 86, 87 are closed, the first liquid pump 11 is stopped, and this step [16] (platelet collecting step) is completed.

[17] Next, the platelet collecting apparatus 1 performs a step of stopping the centrifuge 20.
In this step, first, the control unit 13 decelerates the centrifuge 20 (step S122 in FIG. 4).

  Specifically, under the control of the control unit 13, the rotational speed of the centrifuge drive device 10 is decreased and the rotor 142 is decelerated.

Further, the control unit 13 stops the centrifuge 20 (step S123 in FIG. 4).
Specifically, under the control of the control unit 13, the rotation of the centrifuge drive device 10 is stopped and the rotor 142 is stopped.

[18] Next, the platelet collecting apparatus 1 performs a blood return process. In the blood return process, blood components (remaining blood components) in the blood storage space 146 of the rotor 142 are returned.

In the blood return process, the control unit 13 returns blood (step S124 in FIG. 4).
Specifically, under the control of the control unit 13, the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85 are opened, and the first liquid feed pump 11 is rotated at a predetermined rotational speed (preferably 20). Operates (reverses) at about 120 mL / min, for example, 90 mL / min.

  As a result, blood components (mainly red blood cells and white blood cells) remaining in the blood storage space 146 of the rotor 142 are discharged from the inlet 143 of the centrifuge 20 and are passed through the first line 21 (blood collection needle 29). Blood is returned (returned) to the donor.

Then, after the air discharged from the centrifugal separator 20 is detected by the bubble sensor 32 and the first liquid feeding pump 11 is rotated a predetermined number of times, the first flow path opening / closing means 81 and the fifth flow path are While closing the opening / closing means 85, the first liquid pump 11 is stopped, and this step [18] (blood returning step) is completed.
Thereby, the platelet collection operation in the first cycle is completed.

[2] Platelet collection operation in the second cycle that is not the final cycle (see FIGS. 3 and 4)
Subsequently, the platelet collection operation of the second cycle is performed.

  In the platelet collecting operation in the second cycle, the same steps as the platelet collecting operation in the first cycle are performed as follows.

[21] to [28] Steps similar to the steps [11] to [18] are performed, respectively.
Thereby, the platelet collection operation in the second cycle is completed.
The same applies to the platelet collection operation after the third cycle which is not the final cycle.

[3] Platelet collection operation in the final cycle (see FIGS. 3 and 4)
Subsequently, the platelet collection operation for the final cycle is performed.

  In the platelet collection operation in the final cycle, the same process as the platelet collection operation in the first cycle is performed except that a filtration operation (filtration step) for separating and removing white blood cells from concentrated platelets is performed.

[31] to [37] Steps similar to the steps [11] to [17] are performed except that the filtration operation is performed. The filtration operation will be described in detail later.

[38] The air discharged from the centrifugal separator 20 is detected by the bubble sensor 35 or 36 to close the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85, and the first liquid feed Except for stopping the pump 11 and ending this step [38] (blood return step), the same step as the step [18] is performed.
Thereby, the platelet collection operation in the final cycle is completed.

  Next, filtration operation (filtration process) will be described based on the flowchart shown in FIG.

Under the control of the control unit 13, a filtration operation (filtration process) is started (step S201).
In step S201, the seventh flow path opening / closing means 87 is opened. Thereby, the concentrated platelets in the intermediate bag 27a are transferred into the platelet collection bag 26 through the tubes 46 and 47, the leukocyte removal filter 261 and the tube 48 due to a drop (self-weight). At this time, most of the concentrated platelets pass through the filtration member of the leukocyte removal filter 261, but the leukocytes are captured by the filtration member. For this reason, the removal rate of leukocytes in the platelet preparation can be made extremely high.

  Next, measurement of the elapsed time since the start of the filtration operation is started, and continuous platelet flow velocity measurement (flow velocity continuous detection) is started (step S202).

  In this flow velocity continuous measurement, the weight sensor 18 continuously detects (measures) the weight of the concentrated platelets in the intermediate bag 27a (the weight including the intermediate bag 27a). And the process which calculates | requires the flow rate of a thick platelet based on the amount of decrease of the thick platelet in the intermediate | middle bag 27a, and the elapsed time in the meantime is performed.

  Next, a clogging detection process is performed using the result of the continuous flow velocity measurement (step S203).

  In step S203, the flow rate of the detected concentrated platelets is determined when the set flow rate is 1, and it is determined whether or not the obtained value is equal to or less than the threshold value α1 (has reached the threshold value α1). .

  The threshold value α1 is a threshold value of the flow rate of the thick platelets to be detected used in the clogging detection process when the set flow rate is 1. It is set to a value corresponding to the initial value. As described above, the threshold value α1 is preferably about 0.5 to 0.8, more preferably about 0.6 to 0.7, for example, 0.65. The

  In step S203, when the detected flow rate of the concentrated platelets is larger than the threshold value α1 (when the threshold value α1 is not reached), the filtering operation is continued (step S204), and the filtering operation is started for a predetermined time. It is determined whether or not elapses (step S205). The predetermined time is preferably about 0.5 to 3 minutes, more preferably about 1.5 to 2.5 minutes, for example, 2 minutes.

  In step S205, when the predetermined time has not elapsed since the start of the filtration operation, the process returns to step S203, and step S203 and subsequent steps are executed again.

  On the other hand, when a predetermined time has elapsed since the start of the filtration operation in step S205, a clogging detection process is performed using the result of the flow velocity continuous measurement (step S206).

  In step S206, the flow rate of the concentrated platelets detected when the initial stage flow rate when no clogging has occurred (the flow rate (for example, average flow rate) of filtration (1) in FIG. 5) is set to 1. Then, it is determined whether or not the obtained value is equal to or less than the threshold value β (has reached the threshold value β).

  The threshold value β is a threshold value of the flow rate of the concentrated platelets to be detected used in the clogging detection process when the initial stage flow rate when clogging does not occur is 1, and is smaller than 1. A value corresponding to the initial stage of occurrence of clogging of the leukocyte removal filter 261 is set. As described above, this threshold value β is preferably about 0.3 to 0.7, more preferably about 0.4 to 0.6, for example, 0.5. The

  In step S206, if the flow rate of the concentrated platelets detected is greater than the threshold value β (if the threshold value β is not reached), the filtering operation is continued (step S207), and air is detected by the bubble sensor 33. It is determined whether or not (step S208).

  If air is not detected in step S208, the process returns to step S206, and step S206 and subsequent steps are executed again. Thus, the filtration operation is continued until the air is detected in step S208, and the clogging detection process is continuously performed.

  On the other hand, in step S206, when the detected flow rate of the concentrated platelets is equal to or less than the threshold value β (when the threshold value β is reached), it is determined that clogging of the leukocyte removal filter 261 has occurred, The seventh flow path opening / closing means 87 is closed and the filtration operation is interrupted (step S209).

  Next, as a recovery operation, a predetermined amount of anticoagulant is supplied to the leukocyte removal filter 261 (step S210).

  In step S210, the eighth channel opening / closing means 88 is opened, and the second liquid feeding pump 12 is operated (forward rotation) at a predetermined rotational speed. Thereby, the anticoagulant is supplied (transferred) to the leukocyte removal filter 261 via the third line 23 and the tubes 53 and 47. This anticoagulant lowers the pH of the concentrated platelets in the leukocyte removal filter 261 and loosens the aggregated platelets. The anticoagulant and the concentrated platelets pass through the leukocyte removal filter 261 and are transferred into the platelet collection bag 26 through the tube 48.

  In this recovery operation, when a predetermined amount of the anticoagulant is supplied to the leukocyte removal filter 261, the second liquid feeding pump 12 is stopped and the eighth flow path opening / closing means 88 is closed. The supply amount of the anticoagulant in the recovery operation is, for example, about 15 mL.

  Next, the recovery state of clogging of the leukocyte removal filter 261 is determined (step S211).

  In step S211, the pressure sensor 19 detects the pressure in the leukocyte removal filter 261, and determines whether or not the detected pressure in the leukocyte removal filter 261 is 0 mmHg.

  In step S211, when the detected pressure in the leukocyte removal filter 261 is not 0 mmHg (when greater than 0 mmHg), it is determined whether or not a predetermined time has elapsed since the recovery operation was completed (step S212). The predetermined time is preferably about 5 to 20 minutes, more preferably about 5 to 10 minutes, for example, 5 minutes.

  In step S212, when a predetermined time has elapsed since the recovery operation was completed, the process returns to step S210, and step S210 and subsequent steps are executed again.

  On the other hand, if the detected pressure in the leukocyte removal filter 261 is 0 mmHg in step S211, it is determined that the clogging of the leukocyte removal filter 261 has been recovered, and the seventh flow path opening / closing means 87 is opened and filtered. The operation is resumed (step S210), and the process proceeds to step S207.

  In step S203, if the detected flow rate of the concentrated platelets is equal to or less than the threshold value α1 (when the threshold value α1 is reached), it is determined that the leukocyte removal filter 261 is clogged, 7 is closed to interrupt the filtering operation (step S214).

  Next, as a recovery operation, a predetermined amount of anticoagulant is supplied to the leukocyte removal filter 261 (step S215).

  In step S215, the eighth flow path opening / closing means 88 is opened, and the second liquid feeding pump 12 is operated (forward rotation) at a predetermined rotational speed. Accordingly, the anticoagulant is supplied (transferred) to the leukocyte removal filter 261 via the third line 23 and the tubes 53 and 47. This anticoagulant lowers the pH of the concentrated platelets in the leukocyte removal filter 261 and loosens the aggregated platelets. The anticoagulant and the concentrated platelets pass through the leukocyte removal filter 261 and are transferred into the platelet collection bag 26 through the tube 48.

  In this recovery operation, when a predetermined amount of the anticoagulant is supplied to the leukocyte removal filter 261, the second liquid feeding pump 12 is stopped and the eighth flow path opening / closing means 88 is closed. The supply amount of the anticoagulant in the recovery operation is, for example, about 15 mL.

  Next, the recovery state of clogging of the leukocyte removal filter 261 is determined (step S216).

  In step S216, the pressure sensor 19 detects the pressure in the leukocyte removal filter 261, and determines whether or not the detected pressure in the leukocyte removal filter 261 is 0 mmHg.

  In step S216, if the detected pressure in the leukocyte removal filter 261 is not 0 mmHg (greater than 0 mmHg), it is determined whether or not a predetermined time has passed since the recovery operation was completed (step S217). The predetermined time is preferably about 5 to 20 minutes, more preferably about 5 to 10 minutes, for example, 5 minutes.

  In step S217, when a predetermined time has elapsed after the recovery operation is completed, the process returns to step S215, and step S215 and subsequent steps are executed again.

  On the other hand, if the detected pressure in the leukocyte removal filter 261 is 0 mmHg in step S216, it is determined that the clogging of the leukocyte removal filter 261 has been recovered, and the seventh flow path opening / closing means 87 is opened to perform filtration. The operation is resumed (step S218).

  Next, clogging detection processing is performed using the result of the continuous flow velocity measurement (step S219).

  In step S219, the flow rate of the detected concentrated platelets is determined when the set flow rate is 1, and it is determined whether or not the obtained value is equal to or less than the threshold value α2 (has reached the threshold value α2). .

  The threshold value α2 is a threshold value of the flow rate of the concentrated platelets to be detected used in the clogging detection process when the set flow rate is 1, and is smaller than 1, and the occurrence of clogging of the leukocyte removal filter 261 is less than 1. It is set to a value corresponding to the initial value. As described above, this threshold value α2 is preferably about 0.3 to 0.7, more preferably about 0.4 to 0.6, for example, 0.5. The

  In step S219, if the detected flow rate of the concentrated platelets is larger than the threshold value α2 (when the threshold value α2 is not reached), the filtration operation is continued (step S220), and air is detected by the bubble sensor 33. It is determined whether or not (step S221).

  If air is not detected in step S221, the process returns to step S219, and step S219 and subsequent steps are executed again. Thus, the filtration operation is continued until air is detected in step S221, and the clogging detection process is continuously performed.

  On the other hand, in step S219, when the detected flow rate of the concentrated platelets is equal to or less than the threshold value α2 (when the threshold value α2 is reached), it is determined that the clogging of the leukocyte removal filter 261 has occurred, The seventh flow path opening / closing means 87 is closed to interrupt the filtering operation (step S222).

  Next, as a recovery operation, a predetermined amount of anticoagulant is supplied to the leukocyte removal filter 261 (step S223).

  In step S223, the eighth flow path opening / closing means 88 is opened, and the second liquid feeding pump 12 is operated (forward rotation) at a predetermined rotational speed. Accordingly, the anticoagulant is supplied (transferred) to the leukocyte removal filter 261 via the third line 23 and the tubes 53 and 47. This anticoagulant lowers the pH of the concentrated platelets in the leukocyte removal filter 261 and loosens the aggregated platelets. The anticoagulant and the concentrated platelets pass through the leukocyte removal filter 261 and are transferred into the platelet collection bag 26 through the tube 48.

  In this recovery operation, when a predetermined amount of the anticoagulant is supplied to the leukocyte removal filter 261, the second liquid feeding pump 12 is stopped and the eighth flow path opening / closing means 88 is closed. The supply amount of the anticoagulant in the recovery operation is, for example, about 15 mL.

  Next, the clogged recovery state of the leukocyte removal filter 261 is determined (step S224).

  In step S224, the pressure sensor 19 detects the pressure in the leukocyte removal filter 261, and determines whether the detected pressure in the leukocyte removal filter 261 is 0 mmHg.

  If the detected pressure in the leukocyte removal filter 261 is not 0 mmHg (greater than 0 mmHg) in step S224, it is determined whether or not a predetermined time has elapsed since the recovery operation was completed (step S225). The predetermined time is preferably about 5 to 20 minutes, more preferably about 5 to 10 minutes, for example, 5 minutes.

  In step S225, when a predetermined time has elapsed after the recovery operation is completed, the process returns to step S223, and step S223 and subsequent steps are executed again.

  On the other hand, if the detected pressure in the leukocyte removal filter 261 is 0 mmHg in step S224, it is determined that the clogging of the leukocyte removal filter 261 has been recovered, and the seventh flow path opening / closing means 87 is opened to perform filtration. The operation is resumed (step S226), and the process proceeds to step S220.

  When air is detected in the step S208 or when air is detected in the step S221, predetermined processes are performed and the filtering operation is terminated.

The platelet collection operation is not limited to being performed a plurality of times, and may be performed only once, for example.
The configuration of the platelet collection circuit 2 can also be set as appropriate, and is not limited to the illustrated configuration.

  As described above, according to the platelet collecting apparatus 1, when the concentrated platelets are transferred by the drop and the filtration operation is performed, occurrence of clogging of the leukocyte removal filter 261 can be detected at an early stage.

  Further, by performing a recovery operation for recovering clogging of the leukocyte removal filter 261, the clogging can be easily recovered, whereby the filtering operation can be performed reliably and collected in the platelet collection bag 26. Reduction (or suppression) of the amount of platelet product produced.

  In this platelet collecting apparatus 1, since the leukocytes are separated and removed from the concentrated platelets separated and collected from the blood by the leukocyte removal filter 261, a platelet preparation with extremely low leukocyte contamination can be obtained.

  As described above, the filter monitoring system and the platelet collection device of the present invention have been described based on the illustrated embodiment, but the present invention is not limited to this, and the configuration of each unit is an arbitrary configuration having the same function Can be substituted. Moreover, other arbitrary structures and processes may be added to the present invention.

  Moreover, the platelet collection device of the present invention is not limited to a device that can obtain a platelet preparation and a plasma preparation, and can be applied to, for example, a device that obtains only a platelet preparation.

  In the present invention, the cells separated and removed by the cell separation filter (filter) are not limited to leukocytes.

  In the present invention, the optical sensor is not limited to the illustrated one, and may be a line sensor, for example.

  Further, in the present invention, in the recovery operation, a liquid having a lower pH than the liquid supplied from the supply part (plasma containing platelets supplied from the temporary storage bag) is transferred by a drop (self-weight) to the cell separation filter. You may supply.

  Moreover, the system of the platelet collection device of the present invention is not limited to the intermittent type, and may be, for example, a continuous type.

  The filter monitoring system of the present invention is not limited to a platelet collection device, and can be used for, for example, a device for obtaining a white blood cell preparation, a red blood cell preparation, etc. from blood, a device for collecting blood (whole blood), and the like. .

  In the filter monitoring system of the present invention, the liquid supplied from the supply unit is not limited to concentrated platelets, that is, plasma containing platelets, and may be other blood components or blood (whole blood), for example.

It is a top view which shows embodiment of the platelet collection apparatus of this invention. It is a fragmentary sectional view in the state where the centrifuge was equipped with the centrifuge drive device with which the platelet collection device shown in Drawing 1 is provided. 2 is a flowchart for explaining the operation of the platelet collecting apparatus shown in FIG. 2 is a flowchart for explaining the operation of the platelet collecting apparatus shown in FIG. 2 is a flowchart for explaining the operation of the platelet collecting apparatus shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Platelet collection apparatus 2 Platelet collection circuit 10 Centrifuge drive device 11 1st liquid feeding pump 12 2nd liquid feeding pump 13 Control part 14 Turbidity sensor 15 Optical sensor 151 Light projection part 152 Light receiving part 153 Reflector 16 , 18 Weight sensor 17 Display / operation unit 19 Pressure sensor 20 Centrifuge 21 First line 21a Blood collection needle side first line 21b Centrifuge side first line 21c Branch connector 21d Chamber 21f Branch connector 21g Pump connector 21h Tube 21i Filter 22 Second line 22b Branch connector 22c Branch connector 22d Branch connector 22e Branch connector 22f Filter 22g Branch connector 22h Filter 22i Branch connector 22j Branch connector 22k Filter 23 First Line 23a Pump tube 23b Bacteria removal filter 23c Bubble removal chamber 23d Anticoagulant container connection needle 23e Branch connector 25 Plasma collection bag 26 Platelet collection bag 261 Leukocyte removal filter 27a Intermediate bag 27b Air bag 28 Bag 29 Blood collection needle 31- 36 Bubble sensor 41 to 53 Tube 81 to 89 First to ninth flow path opening / closing means 131 Plasma layer 132 Buffy coat layer 133 Red blood cell layer 141 Tubular body 142 Rotor 143 Inlet port 144 Outlet port 145 Upper portion 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg 203 Motor 204 Rotating shaft 205 Fixing stand 206 Bolt 207 Spacer S101-S124 Step S201-S227 Step

Claims (13)

A supply unit that supplies blood or blood components; a cell separation filter that separates and removes predetermined cells from the liquid supplied from the supply unit; and a filtrate collection unit that collects the filtrate after passing through the cell separation filter; A blood processing circuit comprising:
Flow rate detection means for detecting the flow rate of the liquid supplied from the supply unit to the cell separation filter;
Clogging detection means for performing clogging detection processing for determining occurrence of clogging of the cell separation filter based on the detection result of the flow velocity detection means,
The blood or blood component supplied from the supply unit is transferred by a head, supplied to the cell separation filter, and the cell separation filter separates and removes predetermined cells from the liquid supplied from the supply unit. A filter monitoring system configured to perform the clogging detection process by the clogging detection means while performing an operation. The supply unit is a storage unit that stores blood or blood components,
The flow rate detection means includes weight detection means for detecting the weight of blood or blood components in the reservoir, and time measurement means for measuring time, and the detection result of the weight detection means and the time measurement means The filter monitoring system according to claim 1, wherein the filter monitoring system is configured to obtain a flow rate of the liquid based on a measurement result.   The clogging detection unit is configured to perform the clogging detection process based on a difference between a set flow rate of the liquid in the filtration operation and a flow rate of the liquid detected by the flow rate detection unit. The filter monitoring system according to claim 1 or 2.   When the clogging detection means determines that clogging of the cell separation filter has not occurred until a predetermined time has elapsed since the start of the filtration operation, the clogging detection means After the predetermined time has elapsed, based on the difference between the flow rate of the liquid detected by the flow rate detection unit and the flow rate of the liquid detected by the flow rate detection unit until the predetermined time elapses, 4. The filter monitoring system according to claim 1, wherein the filter monitoring system is configured to perform clogging detection processing.   In the clogging detection process, the clogging detection means sets a value corresponding to an initial stage of occurrence of clogging of the cell separation filter as a threshold value of the deviation, and the deviation is the threshold value. The filter monitoring system according to claim 3 or 4, wherein the filter monitoring system is configured to determine that clogging of the cell separation filter has occurred when the value of the cell separation filter is reached.   The filtration operation is stopped or interrupted when the clogging detection means determines that the cell separation filter is clogged. 6. Filter monitoring system.   When the clogging detection means determines that the cell separation filter is clogged, the filtration operation is interrupted and a recovery operation is performed to recover the clogging. Item 6. The filter monitoring system according to any one of Items 1 to 5. A recovery state determination means for determining a recovery state of clogging of the cell separation filter;
The filter monitoring system according to claim 7, wherein the filtering operation is resumed when the recovery state determination unit determines that the clogging of the cell separation filter has been recovered.   9. The recovery operation according to claim 7, wherein the recovery operation includes a step of supplying a liquid having a lower pH than the liquid supplied from the supply unit to the cell separation filter to lower the pH of the liquid in the cell separation filter. Filter monitoring system. Blood collection means for collecting blood from a donor, a centrifuge for centrifuging blood collected by the blood collection means, and a temporary storage bag for temporarily storing plasma containing platelets separated by the centrifuge A platelet collection circuit comprising: a cell separation filter for separating and removing predetermined cells from the plasma containing platelets; and a platelet collection bag for storing the plasma containing platelets after passing through the cell separation filter;
A flow rate detecting means for detecting a flow rate of plasma containing platelets supplied from the temporary storage bag to the cell separation filter;
Clogging detection means for performing clogging detection processing for determining occurrence of clogging of the cell separation filter based on the detection result of the flow velocity detection means,
The collected blood is centrifuged, the plasma containing the platelets is collected, the remaining blood components are returned, and the platelet-containing plasma temporarily stored in the temporary storage bag is transferred by a drop. And supplying the cell separation filter, and performing the clogging detection process by the clogging detection means while performing a filtration operation for separating and removing predetermined cells from the plasma containing the platelets by the cell separation filter. It is comprised in the platelet collection apparatus characterized by the above-mentioned.   The flow rate detection means includes a weight detection means for detecting the weight of the temporary storage bag and a time measurement means for measuring time, and includes a detection result of the weight detection means and a measurement result of the time measurement means. The platelet collection device according to claim 10, wherein the platelet collection device is configured to obtain a flow rate of plasma containing the platelets based on the blood flow.   The clogging detection means performs the clogging detection process based on a difference between a set flow rate of the plasma containing platelets in the filtration operation and a flow rate of the plasma containing platelets detected by the flow rate detection means. The platelet collecting apparatus according to claim 10 or 11, which is configured as described above.   When the clogging detection means determines that clogging of the cell separation filter has not occurred until a predetermined time has elapsed since the start of the filtration operation, the clogging detection means After the predetermined time elapses, the flow rate of the plasma containing the platelets detected by the flow rate detection unit and the flow rate of the plasma containing the platelets detected by the flow rate detection unit until the predetermined time elapses. The platelet collection device according to any one of claims 10 to 12, configured to perform the clogging detection process based on a deviation.

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