JP2007054297A - Blood component collecting apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood component collecting apparatus capable of reducing the burden on a donor and surely obtaining blood preparation (for example, platelet preparation) in conformity to preparation specifications. <P>SOLUTION: This blood component sampling device 1 has two or more platelet collecting operation cycles, predicts the total volume amount of the plasma to be collected and the plasma contained in platelet concentrate to be collected when performing a full cycle, calculates a difference value between the predicted value and a required volume amount, or the total of the plasma and the plasma contained in the platelet concentrate, and when the predicted value is larger than the required volume amount, performs a surplus plasma return process returning the plasma in a plasma sampling bag 25 to the donor by setting the upper limit to the difference value in a first cycle of the platelet collecting operation. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a blood component collection device.

  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, blood collected from a blood donor is introduced into a blood component collection circuit using a blood component collection device, and plasma is collected by a centrifuge called a centrifuge bowl installed in the blood component collection circuit. The buffy coat and red blood cells are separated, the platelets (platelet containing plasma) are separated from the buffy coat, the platelets containing plasma are collected in a platelet collection bag to obtain a platelet preparation, and the plasma is also collected in the plasma collection bag. The remaining plasma, white blood cells, and red blood cells are used as raw materials for the plasma preparation or plasma fraction preparation, and returned to the donor (see, for example, Patent Document 1).

  In addition, the number of cycles of blood component collection operation in such a blood component collection device is set with priority on the number of platelets so that the number of platelets (unit number) collected in the platelet collection bag conforms to the formulation standard. . If the volume of platelets including the collected plasma (hereinafter also simply referred to as “amount”) is expected to be below the product specification, the plasma is adjusted so that the amount of platelets including plasma conforms to the product specification. An operation (amount adjustment operation) of adding plasma in the collection bag and adjusting the amount of platelets containing the plasma is performed.

  By the way, in the blood component collection device described in Patent Document 1, in the blood return step of each cycle prior to the final cycle, a predetermined amount is secured among the plasma collected in the plasma collection bag, and the remaining plasma is collected. By returning the blood to the blood donor, the extracorporeal blood volume (blood removal amount) is suppressed, and the burden on the blood donor, particularly the blood donor with a small physique, is reduced.

  However, in the blood component collection device described in Patent Document 1, only the amount of plasma collected in the plasma collection bag is considered in the step of returning the plasma in the plasma collection bag to the donor, and the platelet collection bag The amount of platelets, including plasma collected, is not considered. Further, only the amount of plasma actually collected is considered, and the amount of plasma scheduled to be collected in a later cycle is not considered. For this reason, the amount of collected plasma is reduced, and even if the amount adjustment operation is performed, the amount of plasma is insufficient, and the amount of platelets including plasma in the platelet collection bag corresponds to the number of platelets. May fall below the standard. In this case, platelets containing plasma collected in the platelet collection bag cannot be made into a platelet product in a unit suitable for the number even though the platelet count sufficiently satisfies the formulation standard, and discarded. This is uneconomical because it is used as a raw material for a plasma fractionated preparation or a low unit preparation.

JP 2000-325467 A

  An object of the present invention is to provide a blood component collection device that can reduce the burden on blood donors and can reliably obtain a blood product (for example, a platelet product) that complies with the product specification.

Such an object is achieved by the present inventions (1) to (20) below.
(1) Blood collection means for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
A plasma collection bag for collecting plasma separated by the blood separator;
A blood component collection circuit comprising a blood component collection bag for collecting a predetermined blood cell component separated by the blood separator;
The collected blood is separated, the plasma collection step for collecting plasma in the plasma collection bag, the blood component collection step for collecting predetermined blood cell components in the blood component collection bag, and the remaining blood components are returned to the donor A blood component collection device for performing at least one cycle of a blood component collection operation including a blood return step,
When the number of cycles of the blood component collection operation is 2 cycles or more and the whole number of cycles is performed, the collection amount for predicting the total volume of the collected plasma and the plasma contained in the predetermined blood cell component to be collected Prediction means;
A difference value calculating means for calculating a difference value between a predicted value of the volume amount predicted by the collection amount predicting means and a required volume amount of plasma and plasma contained in a predetermined blood cell component;
And determining means for determining whether or not the predicted value of the volume amount predicted by the collection amount predicting means is larger than the required volume amount of plasma and plasma included in a predetermined blood cell component. And
If the determination means determines that the predicted value is greater than the required volume, the plasma in the plasma collection bag is set with the difference value as the upper limit in the blood component collection operation of the first cycle. A blood component collection device, which is configured to perform a surplus plasma return step of returning the blood to a blood donor.

  (2) The blood component collection device according to (1), wherein the excess plasma return step is configured to leave a predetermined volume of plasma in the plasma collection bag.

  (3) The surplus plasma return step is configured to return the plasma in the plasma collection bag to the donor as much as possible with the difference value as an upper limit, as described in (1) or (2) above Blood component collection device.

  (4) The collection amount prediction means is configured to obtain the predicted value after the plasma collection step and the blood component collection step of the blood component collection operation in the first cycle are completed. The blood component collection device according to any one of (3) to (3).

  (5) The collection amount prediction means performs the blood component collection operation from the second cycle to the final cycle after the plasma collection step and the blood component collection step of the blood component collection operation in the first cycle are completed. Predicting the total volume of plasma collected in the plasma collection bag and plasma contained in a predetermined blood cell component collected in the blood component collection bag, and collecting in the plasma collection bag in the first cycle To obtain an actual measurement value of the total volume of the plasma and the plasma contained in the predetermined blood cell component collected in the blood component collection bag, the total volume amount from the predicted second cycle to the final cycle, The blood component according to any one of (1) to (3), which is configured to obtain the predicted value by adding the actual measurement values in the first cycle. Winding device.

  (6) When the surplus plasma return step of the blood component collection operation in the n-th cycle (where n is an integer from 1 to 1 less than the total number of cycles) is completed, the first cycle to the n-th cycle If the total volume of plasma returned to the donor in the blood plasma collection step of the blood component collection operation up to the cycle does not reach the difference value, the blood component collection operation in the (n + 1) cycle In the first cycle to the nth cycle, with the upper limit being a subtracted value obtained by subtracting the total value of the volume of plasma returned to the blood donor in the surplus plasma return step of the blood component collection operation from the difference value, the plasma The blood component collection device according to any one of the above (1) to (5), which is configured to perform a surplus plasma return step of returning the plasma in the collection bag to a blood donor.

  (7) When the surplus plasma return step of the blood component collection operation in the n-th cycle (where n is an integer from 1 to 1 less than the total number of cycles) is completed, the first cycle to the n-th cycle If the total volume of plasma returned to the donor in the blood plasma collection step of the blood component collection operation up to the cycle does not reach the difference value, the blood component collection operation in the (n + 1) cycle In the above, the collection amount prediction means obtains and updates the prediction value, and the surplus plasma of the blood component collection operation from the first cycle to the n-th cycle from the difference value calculated from the updated prediction value The surplus plasma return step of returning the plasma in the plasma collection bag to the donor is performed with the subtracted value obtained by subtracting the total value of the volume of plasma returned to the donor in the return step as an upper limit. That the (1) to the blood component collection apparatus according to any one of (5).

  (8) In the blood component collection operation in the (n + 1) th cycle (where n is an integer from 1 to 1 less than the total number of cycles), the collection amount prediction means obtains and updates the prediction value Then, the difference value calculated from the updated predicted value is obtained from the total value of the volume of plasma returned to the blood donor in the surplus plasma return step of the blood component collection operation from the first cycle to the nth cycle. If larger, the upper limit is a subtraction value obtained by subtracting the total value of the volume of plasma returned to the blood donor in the surplus plasma return step of the blood component collection operation from the first cycle to the nth cycle from the difference value, The blood component collection device according to any one of the above (1) to (5), which is configured to perform a surplus plasma return step of returning the plasma in the plasma collection bag to a donor.

  (9) In the update of the predicted value in the blood component collection operation in the (n + 1) th cycle, the collection amount prediction means obtains the predicted value after the plasma collection step and the blood component collection step are completed. The blood component collection device according to (7) or (8), which is configured as described above.

  (10) In the update of the predicted value in the blood component collection operation of the (n + 1) th cycle, excluding the final cycle when the set number of cycles of the blood component collection operation is 3 cycles or more, the collection amount When the blood component collection operation is performed from the (n + 2) cycle to the final cycle after the plasma collection step and the blood component collection step are completed, the predicting means collects the plasma and the blood collected in the plasma collection bag Predicting the total volume of plasma and plasma contained in a predetermined blood cell component collected in the component collection bag, and the plasma and blood component collected in the plasma collection bag from the first cycle to the (n + 1) th cycle An actual measurement value of the total volume with plasma contained in a predetermined blood cell component collected in the collection bag is obtained, and the predicted (n + 2) cycle is obtained. (7) or (7), wherein the total volume amount from the first cycle to the final cycle and the total measured value from the first cycle to the (n + 1) th cycle are summed to obtain the predicted value. The blood component collection device according to 8).

  (11) In the update of the predicted value in the blood component collection operation in the final cycle, the collection amount prediction means may perform the first cycle to the final cycle after the plasma collection step and the blood component collection step are completed. An actual measurement value of the total volume of plasma collected in the plasma collection bag and plasma contained in a predetermined blood cell component collected in the blood component collection bag is obtained, and the actual measurement value is updated as the predicted value. The blood component collection device according to any one of (7) to (10), which is configured as described above.

  (12) In the surplus plasma return step of the blood component collection operation in the (n + 1) -th cycle, the above-described (6) to (11) configured to leave a predetermined volume of plasma in the plasma collection bag. The blood component collection device according to any one of the above.

  (13) In the surplus plasma return step of the blood component collection operation in the (n + 1) th cycle, the plasma returned to the blood donor in the surplus plasma return step of the blood component collection operation from the first cycle to the nth cycle The above-mentioned (6) to (12) are configured to return the plasma in the plasma collection bag to the donor as much as possible with the subtraction value obtained by subtracting the total value of the volume of the blood from the difference value as an upper limit. The blood component collection device according to any one of the above.

  (14) The required volume is the target value of the volume of plasma collected in the plasma collection bag and the target value of the volume of plasma contained in a predetermined blood cell component collected in the blood component collection bag The blood component collection device according to any one of the above (1) to (13), which is set to be equal to or greater than a total target value obtained by summing.

  (15) The required volume is set to a value equal to or greater than the total target value plus a minimum value of the volume of plasma that must be stored in the plasma collection bag. The blood component collection device described.

  (16) The blood component collection apparatus according to (14), wherein the required volume is set to be equal to or greater than a value obtained by adding a reserve amount to the total target value.

  (17) The required volume is set to a value equal to or greater than the total target value plus the minimum value of the volume of plasma that must be stored in the plasma collection bag and the reserve volume. The blood component collection device according to (14) above.

(18) In the blood return step, the blood return washing step is performed to supply plasma from the plasma collection bag to the blood separator and wash the outlet of the blood separator,
The required volume amount includes the total target value, the preliminary amount, the minimum value of the volume of plasma that must be stored in the plasma collection bag, and the blood component collection operation in one cycle. The blood component collection device according to (14), wherein the blood component collection device is set to a value obtained by adding a volume of plasma required in the blood return washing step.

  (19) The blood component collection apparatus according to any one of (1) to (18), wherein the excess plasma return step is configured to be performed in the blood return step.

  (20) The blood component collection device according to any one of (1) to (19), wherein the predetermined blood cell component is platelets.

  According to the present invention, in the component blood collection, excess plasma (surplus plasma) out of the plasma collected in the plasma collection bag is returned (returned blood) to the blood donor, so that the extracorporeal blood volume (blood removal amount) is increased. It can be suppressed and the burden on blood donors (particularly those with a small physique) can be reduced. In particular, in the blood component collection operation in the first cycle, excess plasma is returned to the donor, so the amount of extracorporeal blood can be reduced from the initial stage of component blood collection, which greatly reduces the burden on the donor. Can be reduced.

  In addition, when the blood component collection operation is performed for the entire cycle, the total volume of the plasma collected in the plasma collection bag and the plasma contained in a predetermined blood cell component (for example, platelets) collected in the blood component collection bag In the surplus plasma return step, the amount of plasma in the plasma collection bag is limited to the upper limit of the difference between the predicted value and the required volume amount of plasma and the plasma contained in the predetermined blood cell component. Is returned to the blood donor, so that it is possible to prevent the volume of plasma from being insufficient, and thus a blood product (for example, a platelet product) that conforms to the product specification can be obtained with certainty.

  Hereinafter, the 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 a blood component collection device of the present invention, and FIG. 2 is a state in which a centrifuge is attached to a centrifuge drive device provided in the blood component collection device shown in FIG. It is a fragmentary sectional view.

  A blood component collection apparatus 1 shown in FIG. 1 separates blood into a plurality of blood components, and separates blood platelets (platelets including plasma) (blood components), which are predetermined blood cell components, and plasma (blood components). It is a device for collecting. The blood component collection device 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. The rotor 142 rotates to rotate the inlet 142 from the inlet 143. A centrifuge (blood separator) 20 that centrifuges the introduced blood in the blood storage space 146, a first line 21 that connects a blood collection needle (blood collection means) 29 and the inlet 143 of the centrifuge 20; The second line 22 connected to the outlet 144 of the centrifuge 20, the third line 23 connected to the first line 21, and the first line 21 via the tubes 49 and 50. And a plasma collection bag (blood component collection bag) 25 connected to the second line 22 via the tubes 43 and 44, and connected to the second line 22 via the tube 42. Air bag 27b, intermediate bag (temporary storage bag) (blood component collection bag) 27a connected to second line 22 via tubes 43 and 45, and intermediate bag 27a via tubes 46, 47 and 48. A blood component collection circuit (blood processing circuit) 2 having a platelet collection bag (blood component collection bag) 26 connected to the blood vessel and a bag 28 connected to the platelet collection bag 26 via a tube 51 is provided.

  Further, the blood component 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. A plurality of (first to seventh seven in this embodiment) channel opening / closing means 81 that can open and close the middle of the channel of the second liquid-feeding pump 12 and the blood component collection circuit 2; 82, 83, 84, 85, 86, 87 for controlling 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 87. A weight sensor (detection means) which is a weight detection means for detecting the weight of plasma collected in the plasma collection bag 25, a control unit (control means) 13, a turbidity sensor (platelet concentration sensor) 14, an optical sensor 15, and a plasma collection bag 25. ) 16 and multiple (in this embodiment, 6) And a bubble sensor 31,32,33,34,35,36.

First, the blood component collection circuit 2 will be described.
This blood component 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 includes a first pump tube 21g. A line (blood collection and blood return line) 21, one end side of the second line 22 connected to the outlet (outlet) 144 of the centrifuge 20, and a blood collection needle 29 of the first line 21 are connected. A third line (anticoagulant injection line) 23 having a second pump tube 23 a, a tube 50 connected to the blood collection needle 29 side from the pump tube 21 g of the first line 21, and a tube 50. 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; The tube 42 connected to the line 22, the air bag 27b connected to the tube 42, the tube 45 connected to the tube 43, the intermediate bag 27a connected to the tube 45, and the intermediate bag 27a Tube 46, Tube 47 connected to tube 46, Tube 48, Platelet collection bag 26 connected to tube 48, Tube 51 connected to platelet collection bag 26, Bag 28 connected to tube 51 And. 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 ultrasonic conductivity differs between the liquid and the bubbles (gas), so that the gas and liquid (gas / liquid) in the tube are used. Or a gas / liquid level). The bubble sensors 31, 33 and 34 are also detection means having the same function as described above. Further, the bubble sensor (gas and liquid detection means) is not limited to the ultrasonic sensor, and for example, 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 second pump tube 23a, a sterilizing filter (foreign matter removing filter) 23b, a bubble removing chamber 23c, and an anticoagulant container connecting needle 23d. It has.

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

  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.

  The plasma collection bag 25 is a container for collecting (storage) 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.

  The platelet (platelet preparation) collection bag 26 is a container for collecting (reserving) platelets (blood cell component) (first blood component) containing plasma after passing through a leukocyte removal filter 261 described later. In the following description, platelets including plasma (first blood component) are 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 blood component collection circuit 2 such as in the blood storage space 146 of the centrifuge 20 is transferred and stored in the air bag 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) 27a, which is a blood component collection bag, is a container (storage unit) for temporarily storing concentrated platelets, that is, platelets including plasma (first blood component). 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.

  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.

  With the blood component collection device 1 assembled (when the blood component collection device 1 is used), the intermediate bag 27a, the leukocyte removal filter 261, the platelet collection bag 26, and the plasma collection bag 25 are respectively the intermediate bag 27a. The leukocyte removal filter 261 is set at a position lower than the plasma collection 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 (positioned). 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 blood component 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 51 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 the branch connectors 21c, 21f, 22b, 22c, 22d, 22e, and 22g described above, the same materials as those described 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 blood component collection circuit 2 is not shown, it is of a cassette type, for example. That is, the blood component collection circuit 2 partially stores each line (the first line 21, the second line 22, and the third line 23) and each predetermined tube, and partially holds them. In other words, it comprises a cassette housing in which they are partially fixed.

  Both ends of the first pump tube 21g and the both ends of the second pump tube 23a are fixed to the cassette housing. The pump tubes 21g and 23a are respectively connected to the liquid feeding pumps (for example, roller rollers) from the cassette housing. The pump protrudes in a loop shape corresponding to the shape of 11 and 12. For this reason, the 1st and 2nd pump tubes 21g and 23a are easy to mount on the liquid feeding pumps 11 and 12, respectively. The cassette housing is provided with respective flow path opening / closing means 81 to 87 described later.

  The centrifuge 20 provided in the blood component collection 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. 2, and the lower part is formed in a substantially disc shape formed along the bottom part of the rotor 142. 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 blood component 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 blood component collection device 1 shown in FIG. 1 will be described.
The blood component collection device 1 includes a centrifuge drive device 10 for rotating the rotor 142 of the centrifuge 20, a first liquid feeding pump 11 installed in the middle of the first line 21, and a third The flow path of the second liquid feeding pump 12 installed in the middle of the line 23 and the blood component collection circuit 2 (first line 21, tube 42, tube 44, tube 45, tube 47, tube 49, tube 50). A plurality of flow path opening / closing means 81, 82, 83, 84, 85, 86, 87, a display means (notification means) for displaying (notifying) various information, and an operation means for performing each operation. In order to control a certain display / operation unit 17, the centrifuge drive device 10, the first liquid feeding pump 11, the second liquid feeding pump 12, the plurality of channel opening / closing means 81 to 87, and the display / operation unit 17. Control part (control And it means) 13.

  Furthermore, the blood component 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. And a weight sensor 16 for measuring the weight of the plasma together with the plasma collection bag 25.

  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 87 is electrically connected to the control unit 13.

  Further, the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36, and the display / operation unit 17 are each electrically connected to the control unit 13.

  The control unit 13 is composed of, for example, a microcomputer. The control unit 13 receives detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, and the bubble sensors 31 to 36, as needed. Entered. A signal (input) from the display / operation unit 17 is also input to the control unit 13.

  The control unit 13 collects blood components according to a preset program based on the detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36 and the signal from the display / operation unit 17. The operation of each part of the apparatus 1, that is, the rotation, stop, and rotation direction (forward / reverse rotation) of each of the liquid feed pumps 11 and 12 is controlled. The operation of the separator driving device 10 and the driving of the display / operation unit 17 are controlled. In addition, the control part 13 grasps | ascertains the rotational speed (rotation number), the rotation frequency, etc. of each liquid feeding pump 11 and 12, for example.

  A platelet collection operation (blood component collection), which will be described later, is set by the control unit 13 so that the number (unit number) of platelets of concentrated platelets collected in the intermediate bag 27a reaches the target value (first target value). The number of cycles of operation) is 2 cycles or more, and when the whole cycle is performed, the plasma collected in the plasma collection bag 25 and the plasma contained in the concentrated platelets (platelets containing plasma) collected in the intermediate bag 27a A volume amount required for the sum of the predicted amount of the volume amount predicted by the collection amount prediction means and the plasma contained in the plasma and the concentrated platelets. The difference value calculation means for calculating the difference value between the volume value and the predicted value of the volume amount predicted by the collection amount prediction means is more than the required volume amount of plasma and plasma contained in the concentrated platelets. The main function is achieved (configuration) of the discriminating means for discriminating whether heard or not.

  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 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 / close the tube 47.

  Each of the flow path opening / closing means 81 to 87 includes an insertion portion into which the first line 21 and the tubes 50, 44, 45, 42, 49, and 47 can be inserted. It has a clamp that operates with a drive source such as a motor or cylinder (hydraulic or pneumatic). Specifically, an electromagnetic clamp that operates with a solenoid is suitable.

  Each of these channel opening / closing means (clamps) 81 to 87 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 flowing in 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, changes in the platelet concentration in plasma, and contamination 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.

Next, the operation (operation) of the blood component collection device 1 will be described.
First, a platelet collection operation (blood component collection operation) using the blood component collection apparatus 1 will be described.

  The blood component collection device 1 is controlled by the control unit 13 so that the first plasma collection step of collecting plasma in the plasma collection bag 25, the constant-speed plasma circulation step, and the second of collecting plasma in the plasma collection bag 25 A plasma collection step, an accelerated plasma circulation step, a third plasma collection step for collecting plasma in the plasma collection bag 25, a platelet collection step (blood component collection step) for collecting concentrated platelets in the intermediate bag 27a, and blood return It operates to perform a platelet collection operation (blood component collection operation) having a process (blood component return process).

  A plasma collection bag is obtained by performing 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. A predetermined amount of plasma is collected at 25, and concentrated platelets are collected (temporarily stored) in the intermediate bag 27a. In addition, blood components (remaining blood components) remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 (mainly red blood cells, white blood cells, and remaining plasma) are removed from the centrifuge by performing the blood return process. The blood is discharged from the 20 inlets 143 and returned to the donor via the first line 21 (blood collection needle 29). In component blood collection, this platelet collection operation (blood component collection operation) is performed at least once (one cycle). The platelet collection operation is usually performed a plurality of times (a plurality of cycles).

  In addition, the said platelet collection operation can be performed using the method described in Unexamined-Japanese-Patent No. 2005-152362 etc., for example.

  In addition, the blood component collection device 1 supplies the concentrated platelets temporarily collected (stored) in the intermediate bag 27a to the leukocyte removal filter 261 under the control of the control unit 13, and filters the concentrated platelets, that is, the concentrated platelets. A filtration operation (filtration process) for separating and removing white blood cells in platelets is performed.

  In this filtering operation, 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.

  This filtration operation is performed in parallel with the final-cycle platelet collection operation or after the completion of the final-cycle platelet collection operation.

  The transfer of the concentrated platelets from the intermediate bag 27a to the platelet collection bag 26 may be performed using a pump.

  Moreover, the blood component collection device 1 supplies the plasma in the plasma collection bag 25 to the intermediate bag 27a as required by the control of the control unit 13, whereby the amount of concentrated platelets collected in the intermediate bag 27a ( The volume adjustment operation is performed to adjust the volume). Thus, the amount (volume) of the platelet preparation collected in the platelet collection bag 26 is adjusted.

  Now, the blood component collection device 1 is configured so that the number (unit number) of concentrated platelets collected in the intermediate bag 27a reaches the target value (first target value) by the control or calculation of the control unit 13. When the set number of cycles of the platelet collection operation (blood component collection operation) is 2 cycles or more and all cycles are performed, the plasma collected in the plasma collection bag 25 and the concentrated sample collected in the intermediate bag 27a Predicts the total volume of plasma (hereinafter also referred to simply as “amount”) contained in platelets (including platelets including plasma), and the predicted value (hereinafter referred to as “total volume amount predicted value”) and plasma The total volume is calculated by calculating the difference value (hereinafter referred to as the “total required volume”) of the total volume of blood and plasma contained in the concentrated platelets (hereinafter referred to as the “total required volume”). The amount predicted value is If the total volume predicted value is determined to be larger than the total required volume amount, the total surplus amount (difference value) is calculated in the platelet collection operation of the first cycle. As an upper limit, it is configured to perform a surplus plasma return step of returning (returning) the plasma in the plasma collection bag 25 to the donor. In the following description, the volume of plasma contained in concentrated platelets is also simply referred to as the volume of concentrated platelets.

  In this surplus plasma return step, a predetermined volume of plasma remains in the plasma collection bag 25, and the plasma in the plasma collection bag 25 is returned to the donor as much as possible up to the total surplus.

  Thus, by returning blood plasma to the donor as much as possible, the extracorporeal blood volume (blood removal amount) can be suppressed, and the burden on the donor (particularly, a small physique donor) can be reduced. In the first cycle of platelet collection, plasma is returned to the donor as much as possible, so that extracorporeal blood volume can be reduced from the initial stage of component blood collection, thereby greatly reducing the burden on the donor. Can be made.

  In addition, by setting the total surplus as the upper limit, it is possible to prevent the plasma volume from becoming insufficient, and thereby to reliably obtain a platelet preparation that conforms to the specification (preparation standard) of the platelet preparation. Can do. In this case, for example, even when the volume of concentrated platelets collected in the intermediate bag 27a is lower than the formulation standard, a sufficient volume of plasma is collected in the plasma collection bag 25. By performing the operation, the concentrated platelets in the intermediate bag 27a can be adapted to the formulation standard, and thereby, a platelet formulation that conforms to the formulation standard and is stored (collected) in the platelet collection bag 26 can be obtained. .

  Here, in the surplus plasma return step, the predetermined volume of plasma is left in the plasma collection bag 25 because, for example, the plasma in the plasma collection bag 25 is used in various situations such as the blood return step. This is to secure the minute plasma.

  The volume of plasma (predetermined volume) left in the plasma collection bag 25 is the minimum value of the volume of plasma that must be stored in the plasma collection bag 25 (hereinafter referred to as “the minimum amount of plasma collection bag”). ) Although it is set as described above, it is particularly preferable to set the minimum amount of the plasma collection bag.

  The minimum amount of the plasma collection bag is appropriately set according to various conditions, but is preferably about 8 to 20 mL, and more preferably about 10 to 15 mL.

Further, in the blood return process, plasma is supplied from the plasma collection bag 25 to the centrifuge 20 to wash the discharge port 144 of the centrifuge 20.
The surplus plasma return step is performed in the blood return step.

  The volume of plasma used in the blood return washing step (supplied to the centrifuge 20) is appropriately set according to various conditions, but is preferably about 1 to 20 mL, and about 3 to 7 mL. Is more preferable.

  The total volume predicted value is obtained after the first plasma collection step, the second plasma collection step, the third plasma collection step, and the platelet collection step of the platelet collection operation in the first cycle (immediately after ), That is, obtained before (immediately before) the blood return process. In this case, when the platelet collection operation is performed from the second cycle to the final cycle, the total volume amount of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a is predicted, and the first To obtain an actual measurement of the total volume of plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a in the cycle, and the predicted total volume from the second cycle to the final cycle; The total measured value in the first cycle is summed to obtain the total volume amount predicted value.

  The method for obtaining the actual measurement value is not particularly limited, but in the present embodiment, the method is obtained as follows.

  In order to obtain an actual measurement value of the volume of plasma collected in the plasma collection bag 25 in the first cycle, first, the weight of the plasma collected in the plasma collection bag 25 in the first cycle is calculated by the weight sensor 16 in the plasma collection bag. Measure (detect) every 25. Then, the weight of the plasma collection bag 25 is subtracted from the measured value (detected value) to obtain the weight of the plasma, and the obtained weight of plasma is multiplied by the specific gravity of the plasma.

  Further, in order to obtain an actual measurement value of the volume of concentrated platelets collected in the intermediate bag 27a in the first cycle, first, the first liquid feeding pump when the concentrated platelets are collected (period) in the intermediate bag 27a. The number of rotations of 11 is counted (detected). Then, the count value (detected value), that is, the number of rotations of the liquid feeding pump 11 is multiplied by the liquid feeding amount per one rotation of the first liquid feeding pump 11.

  Then, the obtained actual measurement value of the volume of plasma and the actual measurement value of the volume of thick platelets are summed.

  The control unit 13 achieves (configures) the main function of a rotation number detection means (detection means) that detects the number of rotations of the first liquid delivery pump 11. Further, the control unit 13 and the weight sensor 16 achieve the main function of the plasma collection bag side measurement means that measures the volume of plasma collected in the plasma collection bag 25 in the first cycle (determines the measured value of volume). Further, the control unit 13 measures the volume of the concentrated platelets collected in the intermediate bag 27a in the first cycle (determines the measured value of the volume) intermediate bag side measurement means (blood component collection bag) The main function of the side measurement means) is achieved (configured). That is, the control unit 13 and the weight sensor 16 measure the total volume of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a in the first cycle (actual measurement of the total volume). The main function of the actual measurement means (for obtaining the value) is achieved (configured).

  A method for predicting (determining) the total volume of plasma collected in the plasma collection bag 25 and concentrated platelets collected in the intermediate bag 27a when the platelet collection operation is performed from the second cycle to the final cycle. Is not particularly limited, but in the present embodiment, it is predicted (obtained) as follows.

  In other words, the predicted value of the total volume of plasma and concentrated platelets collected from the second cycle to the final cycle is calculated based on the plasma collected in the plasma collection bag 25 when the platelet collection operation is performed for one cycle. Then, the total volume amount (collected amount per cycle) with the concentrated platelets collected in the intermediate bag 27a is obtained from the following formula (1), and the value (collected amount per cycle) is calculated from the second cycle. Obtained by multiplying the number of cycles up to the final cycle.

Collected volume per volume (volume) = volume of processed blood x a-volume of blood storage space of the centrifuge at the time of rotation (1)
However, in the above formula (1), processed blood volume × a: processed blood volume including anticoagulant (blood processed volume including anticoagulant)
a: Ratio of the total volume of the collected blood and the anticoagulant added (mixed) to the collected blood to the volume of the collected blood (collected blood and anticoagulant Total volume / volume of blood collected)
Further, the amount of blood to be processed (blood processing amount) in the above equation (1) is obtained from the following equation (2).

Processed blood volume = K x B / Hct (2)
However, in the above formula (2), K: volume occupied by the red blood cell layer in the blood storage space of the centrifuge at the end of blood collection (just before the start of the platelet collection process) B: centrifugation at the end of blood collection (just before the start of the platelet collection process) Hematocrit value of the red blood cell layer in the blood reservoir space of the vessel Hct: Hematocrit value of the donor's blood The value of K is experimentally determined and set in advance. The value of Hct is obtained by preliminary blood collection and is set in advance.

Further, the value of B in the above equation (2) is obtained as follows.
First, an actual measurement value of the processed blood volume in the first cycle is obtained. In order to obtain the measured value of the processed blood volume, first, the number of rotations of the first liquid delivery pump 11 when blood is collected (collected) from a donor (period) is counted (detected). Then, the count value (detected value), that is, the number of rotations of the liquid feeding pump 11 is multiplied by the liquid feeding amount per one rotation of the first liquid feeding pump 11.

  Next, the actually measured value of the processed blood volume in the first cycle is substituted into the following formula (3).

B = Treatment blood volume × Hct / K Formula (3)
K and Hct in the above formula (3) are the same as those in the above formula (2), respectively.

  The total volume predicted value may be obtained without using an actual measurement value. When the actual measurement value is not used, the total volume amount prediction value is obtained, for example, by obtaining the sampling amount per cycle from the above formula (1) and multiplying the value by the number of cycles from the first cycle to the final cycle. be able to. In this case, the value of B is experimentally obtained and set in advance.

  Moreover, the said total volume amount prediction value may be calculated | required at any timing as long as it is not after the said platelet collection process is complete | finished but before the surplus plasma return process. Other timings for obtaining the predicted total volume amount include, for example, before starting blood collection, after starting blood collection, and before the completion of the platelet collection process.

Further, the number of cycles for platelet collection operation is set as follows.
That is, based on the donor's hematocrit value, platelet count blood count, etc., the number of platelets (unit number) of the concentrated platelets collected in the intermediate bag 27a is a target value that conforms to the platelet product standard (target standard) The minimum number of cycles of the platelet collection operation required to reach the value is obtained, and the obtained number of cycles is set as the number of cycles of the platelet collection operation.

As platelet preparations, there are the following four types (1) to (4).
(1) 5 unit preparation Volume (amount) is 100 mL ± 20%, number is 1.0 × 10 ^{11 to} 1.9 × 10 ¹¹ (2) 10 unit preparation Volume (amount) is 200 mL ± 20% The number is 2.0 × 10 ^{11 to} 2.9 × 10 ¹¹ (3) 15 unit preparation The volume (amount) is 250 mL ± 20%, the number is 3.0 × 10 ^{11 to} 3.9 × 10 ^Eleven (4) 20 unit preparations Volume (amount) is 250 mL ± 20%, number is 4.0 × 10 ¹¹ or more, and “1 unit” of platelets is 0.2 × 10 ¹¹ .

  Note that the number of cycles for the platelet collection operation may not be automatically obtained in the blood component collection device 1. For example, the operator obtains the number of cycles for the platelet collection operation and determines the number of cycles. It may be configured to input to the device.

  In addition, the total required volume amount includes a target value (third target value) of the volume of plasma collected in the plasma collection bag 25 and a target value (second value) of the volume of concentrated platelets collected in the intermediate bag 27a. The total target value is preferably set to be equal to or higher than the total target value, more preferably set to be equal to or higher than the sum of the total target value and the minimum plasma collection bag or reserve amount. More preferably, the value is set to be equal to or greater than the value obtained by adding the minimum plasma collection bag amount and the reserve amount.

  In the present embodiment, the total required volume is obtained by adding, to the total target value, a preliminary amount, a minimum amount of plasma collection bag, and a volume of plasma required in the blood return washing step of the platelet collection operation in one cycle. Set to the added value.

  The target value of the volume of concentrated platelets collected in the intermediate bag 27a is appropriately set according to various conditions, but the volume of the concentrated platelets (platelet preparation) collected in the platelet collection bag 26 is determined as follows. It is preferable to set the volume so as to be in a range that conforms to the formulation standard (target formulation standard).

  That is, the target value of the volume of concentrated platelets collected in the intermediate bag 27a is taken into account (added) the volume lost by performing a filtration operation to separate and remove white blood cells in the concentrated platelets. It is preferable to set according to the formulation standard of the volume amount.

  The target value of the volume of plasma collected in the plasma collection bag 25 differs depending on the target formulation standard (5, 10, 15, or 20 unit formulation), and does not include the anticoagulant. Is preferably a value obtained by subtracting the target value of the volume of the concentrated platelets collected from the platelet collection bag 26 from about 400 mL without including the anticoagulant, and about 450 to 550 mL in the volume including the anticoagulant. It is preferably a value obtained by subtracting the target value of the volume including the anticoagulant of concentrated platelets collected in the platelet collection bag 26 from the above.

  The preliminary amount of plasma is used in the final cycle of platelet collection operation when the plasma is finally insufficient, and the excess plasma or the preliminary amount of plasma when not used is The blood is returned to the donor in the blood return process of the platelet collection operation in the final cycle.

  The reserve amount is appropriately set according to the cycle-to-cycle variation of the total volume amount predicted value and various conditions, but is preferably about 10 to 100 mL, and more preferably about 15 to 40 mL. .

  Further, the volume of plasma required in the blood return washing step of the one-cycle platelet collection operation (hereinafter referred to as “the blood return rinse amount”) is appropriately set according to various conditions. Thus, it is preferable that it is about 1-20 mL, and it is more preferable that it is about 3-7 mL.

  Next, three configuration examples (configuration examples 1 to 3) will be described for the surplus plasma return step and the related steps (operations) in the platelet collection operation after the second cycle. In the following description, differences from the above-described first cycle plasma collection step will be mainly described, and description of similar matters will be omitted.

[Configuration example 1]
In the surplus plasma return process of the platelet collection operation in the first cycle, when the plasma of the total surplus amount (difference value) can be returned to the donor, the surplus plasma return process is performed in the platelet collection operation after the second cycle. If the total surplus amount of plasma could not be returned to the donor without performing the procedure, the surplus plasma return step of the platelet collection operation after the second cycle is performed.

  That is, platelets from the first cycle to the n-th cycle when the excess plasma return process of the platelet collection operation in the n-th cycle (where n is an integer from 1 to a number smaller than the total number of cycles) is completed. If the total volume of plasma returned to the donor in the surplus plasma return step of the collection operation has not reached the total surplus value, the platelet collection operation in the (n + 1) th cycle performs the first to nth cycles in the platelet collection operation. The plasma in the plasma collection bag 25 is returned to the donor up to the subtracted value obtained by subtracting the total volume of the plasma returned to the donor in the excess plasma return step of the platelet collection operation up to the cycle from the total surplus ( A surplus plasma return process is performed.

  In the surplus plasma return step of the (n + 1) -th cycle platelet collection operation, a predetermined volume of plasma remains in the plasma collection bag 25, and the surplus plasma of the platelet collection operation from the first cycle to the n-th cycle The plasma in the plasma collection bag 25 is returned to the donor as much as possible with the subtraction value obtained by subtracting the total volume of plasma returned to the donor in the return step from the total surplus.

  Here, when the set number of cycles of platelet collection operation (total number of cycles) is 2, the n is only “1”, and the “excess of platelet collection operation from the first cycle to the n-th cycle”. The “total value of the volume of plasma returned to the donor in the plasma return step” is “the volume of plasma returned to the donor in the surplus plasma return step of the platelet collection operation in the first cycle”. This is the same in the description to be described later, but the description is omitted hereinafter.

  In this configuration example 1, the value used in the first cycle is used as it is without changing (updating) the total volume predicted value in the surplus plasma return step of the platelet collection operation after the second cycle.

  Next, configuration example 2 will be described. In the following description, differences from the configuration example 1 described above will be mainly described, and description of similar matters will be omitted.

[Configuration example 2]
In the surplus plasma return process of the platelet collection operation in the first cycle, when the plasma of the total surplus amount (difference value) can be returned to the donor, the surplus plasma return process is performed in the platelet collection operation after the second cycle. If the total surplus amount of plasma could not be returned to the donor without performing the procedure, the surplus plasma return step of the platelet collection operation after the second cycle is performed. And in this structural example 2, when performing a surplus plasma return process in platelet collection operation after the 2nd cycle, a total volume amount prediction value is updated.

  That is, platelets from the first cycle to the n-th cycle when the excess plasma return process of the platelet collection operation in the n-th cycle (where n is an integer from 1 to a number smaller than the total number of cycles) is completed. If the total volume of plasma returned to the donor in the surplus plasma return step of the sampling operation has not reached the total surplus value, the total volume predicted value is calculated in the (n + 1) cycle platelet collection operation. Volume volume of plasma returned to the donor in the surplus plasma return process of the platelet collection operation from the 1st cycle to the nth cycle from the total surplus amount calculated and updated from the updated predicted total volume amount The surplus plasma return step of returning the plasma in the plasma collection bag 25 to the donor is performed using the subtracted value obtained by subtracting the total value of the above as an upper limit.

  In updating the total volume amount predicted value in the (n + 1) cycle platelet collection operation, the total volume amount predicted value is obtained by using the first plasma collection step and the second plasma in the (n + 1) cycle platelet collection operation. It is obtained after the collection step, the third plasma collection step, and the platelet collection step are completed (immediately after), that is, before the blood return step (immediately before).

  When the set number of platelet collection operations (total number of cycles) is 3 cycles or more, in the update of the total volume predicted value in the (n + 1) th platelet collection operation excluding the final cycle, When the collection operation is performed from the (n + 2) cycle to the final cycle, the total volume of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a is predicted, and from the first cycle The measured value of the total volume of the plasma collected in the plasma collection bag 25 by the (n + 1) th cycle and the concentrated platelets collected in the intermediate bag 27a is obtained. From the predicted (n + 2) cycle to the final cycle And the total measured value from the first cycle to the (n + 1) th cycle are totaled to obtain a total body Determine the amount predicted value.

  The method for obtaining the actual measurement value is the same as that in the platelet collecting operation in the first cycle described above.

  There is also a method for predicting the total volume of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a when the platelet collection operation is performed from the (n + 2) cycle to the final cycle. Basically, this is the same as in the case of the platelet collection operation in the first cycle described above, but the value of B in the above equation (2) is changed. That is, an actual measurement value of the processed blood volume in the (n + 1) th cycle is obtained, and the obtained actual measurement value is substituted into the above equation (3) to obtain a value of B. Used as the value of.

  Further, in the update of the total volume predicted value in the platelet collection operation in the final cycle, the total of the plasma collected in the plasma collection bag 25 and the concentrated platelets collected in the intermediate bag 27a from the first cycle to the final cycle is calculated. An actual measurement value of the volume is obtained, and the actual measurement value is updated as a total volume prediction value.

  The method for obtaining the actual measurement value is the same as that in the platelet collecting operation in the first cycle described above.

  Next, Configuration Example 3 will be described. In the following description, differences from the configuration example 2 described above will be mainly described, and description of similar matters will be omitted.

[Configuration example 3]
In the excess plasma return step of the platelet collection operation in the first cycle, the excess plasma in the platelet collection operation in the second cycle and thereafter regardless of whether or not the total excess amount (difference value) of plasma has been returned to the donor. It is determined whether or not a return process is performed, and a surplus plasma return process is performed as necessary.

  That is, in the (n + 1) -th cycle (where n is an integer from 1 to 1 less than the total number of cycles), the total volume amount predicted value is obtained and updated, and the updated total volume is updated. If the total surplus calculated from the predicted amount is greater than the total volume of plasma returned to the donor in the surplus plasma return process of the platelet collection operation from the first cycle to the nth cycle, The plasma in the plasma collection bag 25 is returned to the donor up to the subtracted value obtained by subtracting the total volume of plasma returned to the donor in the excess plasma return step of the platelet collection operation up to the nth cycle from the total surplus. A process for returning excess plasma to blood is performed.

Next, a specific example in which the set number of platelet collection operations (total number of cycles) is 3 will be described. Tables 1 to 3 below show the actually measured values and the predicted values at the stage when the platelet collection process of the first cycle to the third cycle is completed, respectively. In addition, it cannot be overemphasized that each numerical value in the following specific example is an example.
<First cycle>

  After the platelet collection process of the platelet collection operation in the first cycle is completed, a predicted total volume value is obtained. As shown in Table 1 above, the total volume amount predicted value is obtained as follows.

Total volume predicted value = (156 + 45) + (134 + 45) + (134 + 45)
= 559 mL
Further, the target value of the volume of plasma collected in the plasma collection bag 25 is 270 mL, the target value of the volume of concentrated platelets collected in the intermediate bag 27 a is 200 mL, the minimum amount of plasma bag is 10 mL, the preliminary amount is 20 mL, the first When the return blood rinse amount of the cycle is 5 mL, the total required volume amount is as follows.

Total required volume = 270 + 200 + 10 + 20 + 5
= 505 mL
Therefore, the total surplus amount is as follows.

Total surplus = 559-505
= 54 mL
In the surplus plasma returning step of the first cycle, 10 mL of plasma is left in the plasma collection bag 25, and the plasma in the plasma collection bag 25 is returned to the donor as much as possible up to the total surplus amount of 54 mL. That is, when the amount of plasma returned to the donor reaches 54 mL, the return of the plasma is terminated, and before the amount of plasma returned to the donor reaches 54 mL, the remaining plasma in the plasma collection bag 25 remains. When the volume reaches 10 mL, the return of plasma is stopped at that stage.

For example, when the amount of plasma returned to the donor is 40 mL and the remaining amount of plasma in the plasma collection bag 25 reaches 10 mL, the remaining 14 mL of plasma is returned to the donor after the next cycle. To do.
<Second cycle>

  After the platelet collection step of the platelet collection operation in the second cycle is completed, a predicted total volume value is obtained. As shown in Table 2 above, the predicted total volume is obtained as follows.

Total volume predicted value = (156 + 45) + (140 + 45) + (140 + 45)
= 571 mL
That is, in the second cycle, the total volume amount prediction value is updated to 571 mL.

  Further, the target value of the volume of plasma collected in the plasma collection bag 25 is 270 mL, the target value of the volume of concentrated platelets collected in the intermediate bag 27 a is 200 mL, the minimum amount of plasma bag is 10 mL, the preliminary amount is 20 mL, the second When the return blood rinse amount of the cycle is 5 mL, the total required volume amount is as follows.

Total required volume = 270 + 200 + 10 + 20 + 5
= 505 mL
Therefore, the total surplus amount is as follows.

Total surplus = 571-505
= 66 mL
The subtraction value obtained by subtracting the volume of plasma returned to the donor in the surplus plasma return step of the first cycle from the total surplus is as follows.

Subtraction value = 66-40
= 26 mL
In the surplus plasma return step of the second cycle, 10 mL of plasma is left in the plasma collection bag 25, and the plasma in the plasma collection bag 25 is returned to the donor as much as possible with the subtraction value of 26 mL as the upper limit. That is, when the amount of plasma returned to the donor reaches 26 mL, the return of the plasma is terminated, and before the amount of plasma returned to the donor reaches 26 mL, the remaining plasma in the plasma collection bag 25 remains. When the volume reaches 10 mL, the return of plasma is stopped at that stage.
For example, when 26 mL of plasma can be returned to the donor, the return of plasma is terminated.
<Third cycle>

  After the platelet collection step of the platelet collection operation in the third cycle is completed, a predicted total volume value is obtained. As shown in Table 3, the total volume amount prediction value is obtained as follows.

Total volume predicted value = (156 + 45) + (140 + 45) + (132 + 45)
= 563 mL
That is, in the third cycle, the total volume amount predicted value is updated to 563 mL.

  Further, the target value of the volume of plasma collected in the plasma collection bag 25 is 270 mL, the target value of the volume of concentrated platelets collected in the intermediate bag 27 a is 200 mL, the minimum amount of plasma bag is 10 mL, the preliminary amount is 20 mL, When the return blood rinse amount of the cycle is 5 mL, the total required volume amount is as follows.

Total required volume = 270 + 200 + 10 + 20 + 5
= 505 mL
Therefore, the total surplus amount is as follows.

Total surplus = 563-505
= 58mL
Moreover, the subtraction value which subtracted the total value (66 mL) of the plasma volume returned to the donor in the surplus plasma return process of the first cycle and the second cycle from the total surplus is as follows.

Subtraction value = 58-66
= -8mL
Thus, the total surplus volume (58 mL) is 8 mL less (smaller) than the total volume volume (66 mL) of the plasma returned to the donor in the surplus plasma return process of the first cycle and the second cycle. Since the plasma has been returned to the excess of 8 mL, the surplus plasma return step is not performed in the third cycle.

  On the other hand, the deficient 8 mL of plasma is replenished (allocated) from the reserve volume (20 mL), and the remaining 12 mL of plasma is returned to the donor.

  Further, as shown in Table 3 above, the volume of concentrated platelets collected in the intermediate bag 27a is 135 mL, which is 65 mL short of the target value (200 mL). For this reason, the volume adjustment operation is performed to transfer (transfer) 65 mL of plasma in the plasma collection bag 25 to the intermediate bag 27a.

  Since this third cycle is the final cycle, the blood is returned to the donor so as to reach the target value of the volume of the plasma collected in the plasma collection bag 25 without leaving the minimum amount of the plasma collection bag. .

  As described above, according to this blood component collection device 1, extra blood (surplus plasma) out of the plasma collected in the plasma collection bag 25 is returned to the donor during component blood collection. The amount (blood removal amount) is suppressed, and the burden on the donor (particularly a donor with a small physique) can be reduced. In particular, since the excess plasma is returned to the donor in the first cycle of platelet collection operation, the amount of extracorporeal blood can be reduced from the initial stage of component blood collection, thereby greatly reducing the burden on the donor. be able to.

  In addition, since the plasma in the plasma collection bag 25 is returned to the donor with the total surplus as an upper limit, it is possible to prevent the volume of plasma from being insufficient, and thereby a platelet preparation that conforms to the formulation standard. Can be definitely obtained. In this case, for example, even when the volume of concentrated platelets collected in the intermediate bag 27a is less than the formulation standard, a sufficient volume of plasma is collected in the plasma collection bag 25. By performing the above, it is possible to make the concentrated platelets in the intermediate bag 27a conform to the formulation standard, and thereby it is possible to obtain a platelet formulation that conforms to the formulation standard and is stored (collected) in the platelet collection bag 26.

  In this blood component collection device 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 mentioned above, although the blood component collection device of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this, and the configuration of each part is an arbitrary configuration having the same function. Can be replaced. Moreover, other arbitrary structures and processes may be added to the present invention.

  In addition, the blood component collection device of the present invention is not limited to being applied to obtain a platelet preparation or a plasma preparation (or a raw material plasma of a plasma fractionation preparation). For example, an erythrocyte preparation, a leukocyte preparation, etc. You may apply when you get. That is, in the blood component collection device of the present invention, the blood components collected in the blood component collection bag are not limited to platelets (platelets including plasma), but, for example, red blood cells (red blood cells including plasma), white blood cells (white blood cells including plasma) Or the like. In other words, in the blood component collection device of the present invention, the predetermined blood cell component collected is not limited to platelets, but may be, for example, red blood cells or white blood cells.

  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 blood separator is not limited to the centrifugal type, and may be, for example, a membrane type.

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

It is a top view which shows embodiment of the blood component collection device of this invention. It is a partially broken sectional view of the state where the centrifuge was installed in the centrifuge drive device with which the blood component collection device shown in FIG. 1 is provided.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection apparatus 2 Blood component 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 Reflection Plate 16 Weight sensor 17 Display / operation unit 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 tube 21h Tube 21i Filter 22 First Line 2b 22b Branch connector 22c Branch connector 22d Branch connector 22e Branch connector 22f Filter 22g Branch connector 22h Filter 23 Third line 23a Pump tube 23b Bacteria-removing filter 23c Bubble removal chamber 23d Anticoagulant container connection needle 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 Air bubble sensor 41-51 Tube 81-87 First to seventh flow Road opening / closing means 131 Plasma layer 132 Buffy coat layer 133 Red blood cell layer 141 Tubular body 142 Rotor 143 Inlet 144 Outlet 145 Upper part 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg part 203 Motor 204 Rotating shaft 205 Fixing base 206 Bolt 207 Spacer

Claims (10)

Blood collection means for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
A plasma collection bag for collecting plasma separated by the blood separator;
A blood component collection circuit comprising a blood component collection bag for collecting a predetermined blood cell component separated by the blood separator;
The collected blood is separated, the plasma collection step for collecting plasma in the plasma collection bag, the blood component collection step for collecting predetermined blood cell components in the blood component collection bag, and the remaining blood components are returned to the donor A blood component collection device for performing at least one cycle of a blood component collection operation including a blood return step,
When the number of cycles of the blood component collection operation is 2 cycles or more and the whole number of cycles is performed, the collection amount for predicting the total volume of the collected plasma and the plasma contained in the predetermined blood cell component to be collected Prediction means,
A difference value calculating means for calculating a difference value between a predicted value of the volume amount predicted by the collection amount predicting means and a required volume amount of plasma and plasma contained in a predetermined blood cell component;
And determining means for determining whether or not the predicted value of the volume amount predicted by the collection amount predicting means is larger than the required volume amount of plasma and plasma included in a predetermined blood cell component. And
If the determination means determines that the predicted value is greater than the required volume, the plasma in the plasma collection bag is set with the difference value as the upper limit in the blood component collection operation of the first cycle. A blood component collection device, which is configured to perform a surplus plasma return step of returning the blood to a blood donor.   The blood component collection device according to claim 1, wherein the excess plasma return step is configured to leave a predetermined volume of plasma in the plasma collection bag.   The said collection amount prediction means is comprised so that the said estimated value may be calculated | required after the said plasma collection process of the said blood component collection operation of the 1st cycle and the said blood component collection process are complete | finished. Blood component collection device.   When the blood component collection operation is performed from the second cycle to the final cycle after the plasma collection step and the blood component collection step of the blood component collection operation in the first cycle are completed, The total volume of the plasma collected in the plasma collection bag and the plasma contained in the predetermined blood cell component collected in the blood component collection bag is predicted, and the plasma collected in the plasma collection bag in the first cycle And an actual measurement value of the total volume of plasma contained in a predetermined blood cell component collected in the blood component collection bag, the total volume of the predicted second cycle to the final cycle, and the first volume The blood component collection device according to claim 1 or 2, wherein the predicted value is obtained by summing up the measured values in a cycle.   When the surplus plasma return step of the blood component collection operation of the nth cycle (where n is an integer from 1 to a number smaller than the total number of cycles) is completed, the first cycle to the nth cycle In the case where the total value of the volume of plasma returned to the blood donor in the blood plasma collection step of the blood component collection operation has not reached the difference value, in the blood component collection operation of the (n + 1) cycle, In the plasma collection bag, the upper limit is a subtraction value obtained by subtracting the total value of the volume of plasma returned to the blood donor in the surplus plasma return step of the blood component collection operation from cycle 1 to cycle n from the difference value. The blood component collection device according to any one of claims 1 to 4, wherein the blood plasma collecting step is configured to perform a surplus plasma return step of returning the plasma to the donor.   When the surplus plasma return step of the blood component collection operation of the nth cycle (where n is an integer from 1 to a number smaller than the total number of cycles) is completed, the first cycle to the nth cycle When the total volume volume of plasma returned to the blood donor in the blood plasma collection step of the blood component collection operation has not reached the difference value, in the blood component collection operation of the (n + 1) cycle, The collection amount prediction means obtains and updates the prediction value, and in the surplus plasma return step of the blood component collection operation from the first cycle to the n-th cycle from the difference value calculated from the updated prediction value. A surplus plasma return step of returning the plasma in the plasma collection bag to the donor is performed with the subtracted value obtained by subtracting the total value of the volume of plasma returned to the donor as an upper limit. 1 to a blood component collection apparatus according to any one of 4.   In the blood component collection operation in the (n + 1) -th cycle (where n is an integer from 1 to a number smaller than the total number of cycles), the collection amount prediction means obtains and updates the prediction value, When the difference value calculated from the updated predicted value is larger than the total volume volume of plasma returned to the donor in the surplus plasma return process of the blood component collection operation from the first cycle to the nth cycle The plasma collection with the subtracted value obtained by subtracting the total value of the volume of plasma returned to the blood donor in the blood plasma collection step of the blood component collection operation from the first cycle to the nth cycle from the difference value as the upper limit The blood component collection device according to any one of claims 1 to 4, wherein the blood component collection device is configured to perform a surplus plasma return step of returning the plasma in the bag to a blood donor.   The required volume is the sum of the target value of the volume of plasma collected in the plasma collection bag and the target value of the volume of plasma contained in a predetermined blood cell component collected in the blood component collection bag. The blood component collection device according to any one of claims 1 to 7, wherein the blood component collection device is set to be equal to or greater than the total target value.   The blood component collection device according to any one of claims 1 to 8, wherein the excess plasma return step is configured to be performed in the blood return step. The blood component collection device according to any one of claims 1 to 9, wherein the predetermined blood cell component is platelets.

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