JP4516043B2 - Blood component collection device - Google Patents

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 are returned (returned) to the blood donor (returning process).

  In this blood component collection device, in the blood return step, a part of the plasma in the plasma collection bag and the white blood cells and red blood cells in the centrifuge are mixed in the middle of the flow path to return blood. (For example, refer to Patent Document 1).

  In such a device, the blood cell component in the circuit is not sufficiently returned to the blood donor, and the plasma component is returned more than necessary, so that the platelet collection efficiency is lowered.

  By the way, citric acid is contained in the anticoagulant, and when the anticoagulant-added blood is separated by the centrifuge, most of the citric acid is contained in the plasma due to its specific gravity.

  However, in the conventional blood component collection device, a part of the plasma in the plasma collection bag is returned to the donor, and if the plasma flow rate (flow rate) at the time of the return is large, the donor In the body, citric acid contained in plasma reduces calcium ions (calcium functions worse) and may cause side effects such as numbness, discomfort, and uncomfortable feeling.

Japanese Patent No. 2575769

  An object of the present invention is to provide a blood component collection device capable of improving the collection efficiency of a target blood component and reducing side effects caused by citric acid contained in the blood component to be returned (mainly plasma). There is to do.

Such an object is achieved by the present inventions (1) to (14) below.
(1) A blood component collecting step for collecting blood from a blood donor, separating blood to which an anticoagulant has been added, collecting a predetermined blood component, and a blood returning step for returning the remaining blood component to the blood donor. A blood component collection device for performing component blood collection by executing,
A blood collection means comprising a hollow needle for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
At least one blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood treatment line connecting the hollow needle and the inlet of the blood separator;
A blood component collection circuit having an anticoagulant injection line for adding an anticoagulant to blood in the blood treatment line;
Flow rate adjusting means for adjusting the flow rate of blood components returned to the donor,
A detection means for detecting the proportion of plasma in the blood component returned to the donor,
In the blood return step, the flow rate adjusting means includes blood containing an anticoagulant returned to the blood donor so that the anticoagulant is not injected into the blood donor at an excessive flow rate based on the detection result of the detection means. A blood component collection device characterized by adjusting the flow rate of components.

(2) The blood component collection bag is a plasma collection bag for collecting plasma separated by the blood separator,
The blood component collection device separates blood to which an anticoagulant has been collected from a blood donor, collects plasma in the plasma bag, and returns the remaining blood components to the blood donor. The blood component collection device according to (1), wherein the blood component collection operation including a blood step is performed at least for one cycle.

(3) The blood component collection bag is a plasma collection bag for collecting plasma separated by the blood separator, and a blood cell component collection bag for collecting predetermined blood cell components separated by the blood separator,
The blood component collection device collects a blood sample collected from a blood donor, separates blood to which an anticoagulant has been added, and collects plasma in the plasma bag, and collects a predetermined blood cell component in the blood cell component collection bag A blood component collecting operation including a blood cell component collecting step, and a blood returning step of returning the remaining blood component and a predetermined amount of plasma in the plasma collection bag to the donor. The blood component collection apparatus according to 1).

(4) Furthermore, a blood supply line branched from a branch provided in the blood processing line and connected to the plasma collection bag, and installed in the blood processing line, the liquid in the blood processing line is supplied A first liquid feeding means, and a second liquid feeding means installed in the plasma liquid feeding line and for feeding the plasma collected in the plasma collection bag,
In the blood return step, the flow rate adjusting means controls the operation of the first liquid feeding means and the second liquid feeding means, so that the blood components in the blood separator and the plasma collection bag Is configured to adjust the flow rate of blood components including anticoagulant returned to the donor so that the anticoagulant is not injected into the donor at an excessive flow rate The blood component collection device according to (3) above.

  (5) The flow rate adjusting means is configured to adjust, in the blood return step, such that the proportion of plasma containing the anticoagulant in the blood components returned to the blood donor is less than or equal to the upper limit value bvol%. The blood component collection device according to (4) above.

  (6) The blood component collection device according to (5), wherein the upper limit b is 50 to 90 vol%.

  (7) The flow rate adjusting means is configured to adjust the flow rate of the plasma component including the anticoagulant returned to the blood donor in the blood return step so as to be not more than the upper limit value amL / min. The blood component collection device according to any one of (1) to (6) above.

  (8) The blood component collection device according to (7), wherein the upper limit value a is 15 to 50 mL / min.

  (9) The determinants of the upper limit value a include at least one of the type of anticoagulant, the composition of the anticoagulant, the mixing ratio of the anticoagulant to the blood, the body weight of the donor, and the circulating blood volume. The blood component collection device according to (7) or (8) above.

  (10) The flow rate adjusting means is configured to terminate the blood return process in the blood return process based on a detection result of the detection means. The blood component collection device described.

  (11) The flow rate adjusting means returns a predetermined amount of blood components to the donor after the ratio of the plasma detected by the detecting means exceeds a threshold value, and ends the blood return process. (10) The blood component collection apparatus according to (10).

  (12) The predetermined amount is an amount corresponding to a volume in a flow path of the blood processing line from a position where a ratio of plasma is detected by the detection means to the hollow needle. Blood component collection device.

  (13) The blood component collection device according to (11) or (12), wherein the threshold value is 60 to 99 vol%.

  (14) The determinants of the threshold include at least one of the type of anticoagulant, the composition of the anticoagulant, the mixing ratio of the anticoagulant to the blood, the donor's weight and the circulating blood volume. The blood component collection device according to any one of (11) to (13).

  According to the present invention, the side effect due to citric acid contained in the blood component to be returned (mainly plasma) can be reduced during the blood return process of component blood collection, thereby reducing the burden on the donor. can do.

  In the case of collecting plasma, in the blood return step, if the ratio of the plasma detected by the detection means exceeds the threshold value is set as the end condition of the blood return step, Side effects caused by citrate can be more reliably reduced, and excessive return of plasma can be prevented, thereby increasing the amount of plasma collected.

  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 a first embodiment of a blood component collection device of the present invention. FIG. 2 is a diagram showing a centrifugal separator mounted on the centrifuge drive device provided in the blood component collection device shown in FIG. It is a partially broken sectional view of a state.

  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 (collection bag) 25 connected to the second line 22 via the tubes 43 and 44, and an air connected to the second line 22 via the tube 42. A bag (storage bag) 27b, an intermediate bag (temporary storage bag) (collection bag) 27a connected to the second line 22 via tubes 43 and 45, and an intermediate bag 27a via tubes 46, 47 and 48 A blood component collection circuit (collection circuit) 2 having a platelet collection bag (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 collecting device 1 includes a centrifuge driving device 10 for rotating the rotor 142 of the centrifuge 20, and a first liquid feeding pump (first liquid feeding means) for the first line 21. ) 11, a second liquid feed pump (second liquid feed means) 12, a third liquid feed pump (third liquid feed means) 13 for the third line 23, and a blood component collection circuit A plurality of (sixth, first to sixth in this embodiment) channel opening / closing means 81, 82, 83, 84, 85, 86 that can open and close the middle of the two channels, and the centrifuge drive device 10. A control unit (control means) 3 for controlling the first liquid delivery pump 11, the second liquid delivery pump 12, the third liquid delivery pump 13, and the plurality of flow path opening / closing means 81 to 86, and turbidity Sensor (platelet concentration sensor) 14, optical sensor 15, weight sensor 16, and blood return (return to donor) ) The turbidity sensor 19 which is a detection means for detecting the ratio (plasma concentration) of the plasma in the blood component to be detected, and a plurality (six in this embodiment) of bubble sensors 31, 32, 33, 34, 35, 36.

  The detection means is not limited to the turbidity sensor, but may also be, for example, a red blood cell concentration sensor that detects a red blood cell closing ratio or a red blood cell concentration.

First, the blood component collection circuit 2 will be described.
This blood component collection circuit 2 connects a blood collection needle (hollow needle) (blood collection means) 29 for collecting blood from a donor (blood donor) and an inlet 143 of the centrifuge 20 and connects the first pump tube 21g. A first line 21 (blood collection and blood return line) (blood treatment line) 21 that is also used as both a blood collection line and a blood return line, and one end side is connected to an outlet (outlet) 144 of the centrifuge 20 The second line 22 formed, the third line (anticoagulant injection line) 23 connected to the blood collection needle 29 of the first line 21 and including the third pump tube 23a, and the first line 21 is connected to the centrifuge 20 side from the first pump tube 21g, a tube 49 connected to the tube 50, a part of which constitutes the second pump tube 22a, and a second line. 22, a tube 44 connected to the tube 43, a plasma collection bag 25 connected to the tubes 44 and 49, a tube 42 connected to the second line 22, and a connection to the tube 42 Air bag 27b, tube 45 connected to tube 43, intermediate bag 27a connected to tube 45, tube 46 connected to intermediate bag 27a, tube 47 connected to tube 46, tube 48, a platelet collection bag 26 connected to the tube 48, a tube 51 connected to the platelet collection bag 26, and a bag 28 connected to the tube 51. 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. And a first pump tube 21g formed between the chamber 21d and the branch connector 21f.

  Further, the turbidity sensor 19 and the 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 turbidity sensor 19 and 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 first pump tube 21g. .

  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 21 b is connected to a branch connector 21 f for connection with the tube 50.

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 third 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 third 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 containing citric acid (anticoagulant liquid) is housed (contained). As will be described later, the anticoagulant flows through the third line 23 from the anticoagulant container connection needle 23d 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 containing the citric acid to be used, For example, ACD-A liquid etc. can be used.
Moreover, the density | concentration of the citric acid in such an anticoagulant is about 20-35 mg / mL.

  The plasma collection bag 25 that is a blood component collection bag is a container for collecting (storing) plasma (second blood component). One end of the tube 49 is connected to the plasma collection bag 25, and a connecting branch connector 22d is provided in the middle thereof. One end of the tube 50 is connected to the branch connector 22d, and the other end is connected to the branch connector 21f. The second pump tube 22a is located between the plasma collection bag 25 and the branch connector 22d. The tubes 49 and 50 and the branch connector 22d constitute the main part of the plasma circulation line (plasma feeding line) 24.

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

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

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

  A platelet (platelet preparation) collection bag 26 which is a blood component collection bag (blood cell component collection bag) collects platelets (blood cell component) (first blood component) containing plasma after passing through a leukocyte removal filter 261 described later. It is a container for (storage). 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 (storage bag) 27b is a container for temporarily storing (storing) air (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.

  An intermediate bag (temporary storage bag) 27a, which is a blood component collection bag (blood cell component collection bag), is used for temporarily storing concentrated platelets, that is, platelets containing blood (blood cell components) (first blood component). It is a container (storage part). 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 and the pump tubes 21g, 22a and 23a, and the other tubes 41 to 51 and 21h, respectively, Vinyl chloride 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, 22a, 23a, what has the intensity | strength of the grade which is not damaged even if it presses by each liquid feeding pump (for example, roller pump etc.) 11, 12, 13 mentioned later, respectively is used. Has been.

  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.

  In the cassette housing, both ends of the first pump tube 21g, both ends of the second pump tube 22a, and both ends of the third pump tube 23a are fixed. These pump tubes 21g, 22a, and 23a are respectively connected to the cassette housing. From the housing, it protrudes in the shape of a loop corresponding to the shape of each liquid feed pump (for example, roller pump etc.) Therefore, the first, second, and third pump tubes 21g, 22a, and 23a can be easily attached to the liquid feeding pumps 11, 12, and 13, respectively. The cassette housing is provided with respective flow path opening / closing means 81 to 86 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 driving 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 tube 49. The second liquid delivery pump 12 installed in the middle, the third liquid delivery pump 13 installed in the middle of the third line 23, and the blood component collection circuit 2 (first line 21, tube 42, tube 44, tube 45, tube 47, tube 49), a plurality of flow path opening / closing means 81, 82, 83, 84, 85, 86 that can open and close the flow path, and display means for displaying (notifying) various information. (Notification means) and a display / operation section 17 which is an operation means for performing each operation, a storage section (storage means) 18, a centrifuge drive device 10, a first liquid feed pump 11, a second liquid feed pump 12. Third liquid pump 3, and a control section (control means) 3 for controlling the plurality of flow path shutter means 81 to 86, units such as the display and operation unit 17 and the storage unit 18.

  Furthermore, the blood component collection device 1 includes a turbidity sensor 19 attached (installed) to the blood collection needle side first line 21 a of the first line 21 and a turbidity sensor attached (installed) to the second line 22. 14, an optical sensor 15 installed in the vicinity of the centrifuge 20, a plurality of bubble sensors 31 to 36, and a weight sensor 16 for measuring the weight of plasma together with the plasma collection bag 25. .

  The control unit 3 includes three pump controllers (not shown) for the first liquid feeding pump 11, the second liquid feeding pump 12, and the third liquid feeding pump 13, and includes the control unit 3 and the first liquid feeding pump 13. The liquid feed pump 11, the second liquid feed pump 12, and the third liquid feed pump 13 are 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 3.
Each of the channel opening / closing means 81 to 86 is electrically connected to the control unit 3.

  Further, the turbidity sensors 14 and 19, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36, the display / operation unit 17, and the storage unit 18 are each electrically connected to the control unit 3.

  The control unit 3 is composed of, for example, a microcomputer (including a calculation unit and a memory). The control unit 3 includes the turbidity sensors 14 and 19, the optical sensor 15, the weight sensor 16, and the bubble sensor 31 described above. The detection signals from .about.36 are input as needed. A signal (input) from the display / operation unit 17 is also input to the control unit 3.

  Based on the detection signals from the turbidity sensors 14 and 19, the optical sensor 15, the weight sensor 16, the bubble sensors 31 to 36 and the signal from the display / operation unit 17, the control unit 3 The operation of each part of the component collection device 1, that is, the rotation, stop, and rotation direction (forward / reverse rotation) of each liquid feed pump 11, 12, 13 is controlled, and each flow path opening / closing means 81-86 as necessary. Control of opening / closing, operation of the centrifuge drive device 10 and driving of the display / operation unit 17 are controlled.

  The control unit 3 achieves the main function of the flow rate adjusting means that adjusts the flow rate of plasma (plasma containing an anticoagulant) to be returned (returned) to the donor.

  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 first pump tube 21g and the chamber 21d. Yes.

  The second flow path opening / closing means 82 is provided for opening and closing the tube 47. 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 between the branch connector 22d and the branch connector 22e.

  Each flow path opening / closing means 81-86 includes an insertion part into which the first line 21 and tubes 47, 44, 45, 42, 49 can be inserted. The insertion part includes, for example, a solenoid, an electric motor, It has a clamp that operates with a drive source such as a cylinder (hydraulic or pneumatic). Specifically, an electromagnetic clamp that operates with a solenoid is suitable.

  These flow path opening / closing means (clamps) 81 to 86 are operated based on signals from the control unit 3.

  The display / operation unit 17 includes, for example, a touch panel including a liquid crystal display panel, an EL display panel, and the like. The display / operation unit 17 constitutes input means for inputting predetermined information and data (for example, an initial value of the target number of platelets (blood cell components) to be collected, a blood count of a donor (donor), etc.).

  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.

  The storage unit 18 includes a storage medium (also referred to as a recording medium) in which various information, data, tables, arithmetic expressions, programs, and the like are stored (also referred to as a recording medium). It is composed of various semiconductor memories, IC memories, and the like, such as volatile memories such as RAM, nonvolatile memories such as ROM, rewritable (erasable and rewritable) nonvolatile memories such as EPROM, EEPROM, and flash memory. Control such as writing (storage), rewriting, erasing, and reading in the storage unit 18 is performed by the control unit 3.

  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.

  The turbidity sensor 19 is for detecting the turbidity of the fluid flowing in the first line 21 (blood collection needle side first line 21a) on the blood collection needle 29 side from the branch connector 21f, in particular, the blood return process. , The blood flow in the blood collection needle side first line 21a and for detecting the proportion of plasma in the blood component returned (returned) to the donor, and outputs a voltage value corresponding to the turbidity. Specifically, the turbidity sensor 19 has a low voltage value when the turbidity is high (when the ratio of plasma in the blood component returned to the donor is low), and when the turbidity is low (returned to the donor). A high voltage value is output when the proportion of plasma in the blood component to be blood is high).

  The turbidity sensor 19 flows through the blood collection needle side first line 21a and, in addition to the ratio of the plasma in the blood component returned to the donor, for example, the plasma in the blood component returned to the donor It is possible to detect a change in the occupying ratio.

  As the turbidity sensors 14 and 19 and the bubble sensors 31 to 36, for example, an ultrasonic sensor, an optical sensor, an infrared sensor, or the like can be used.

  The first liquid feed pump 11 to which the first pump tube 21g is attached, the second liquid feed pump 12 to which the second pump tube 22a is attached, and the third pump to which the third pump tube 23a is attached. As the liquid feeding pump 13, for example, a non-blood contact type pump such as a roller 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.

  By the operation of the first liquid feeding pump 11, for example, liquid (fluid) such as blood and blood components in the first line 21 can be fed. Further, by the operation of the second liquid feeding pump 12, for example, plasma collected in the plasma collection bag 25 can be fed. Further, by the operation of the third liquid feed pump 13, for example, a liquid (fluid) such as an anticoagulant (anticoagulant liquid) in the third line 23 can be fed.

  Next, the action (operation) of the blood component collection device 1, that is, the platelet collection operation (blood component collection operation) using the blood component collection device 1 will be described.

  The blood component collection device 1 is controlled by the control unit 3 so that a first plasma collection step (blood component collection step) for collecting plasma in the plasma collection bag 25 and the plasma collected in the plasma collection bag 25 are centrifuged. A constant-velocity plasma circulation step (plasma circulation step) that circulates in the 20 blood storage spaces 146 at a constant speed; a second plasma collection step (blood component collection step) that collects plasma in the plasma collection bag 25; and a plasma collection bag The plasma collected in 25 is accelerated and circulated in the blood storage space 146 of the centrifugal separator 20 while being circulated (plasma circulation step), and the third plasma collection step (blood) for collecting plasma in the plasma collection bag 25 A component collecting step), a platelet collecting step (blood cell component collecting step) (blood component collecting step) for collecting concentrated platelets (platelets) in the intermediate bag 27a, and a blood return step (blood component returning step) described later. Platelet collection operation to be operated to perform apheresis running (blood component collection operation). One or both of the two plasma circulation steps may be omitted.

  When collecting this component, the first liquid pump 11 is operated (forward rotation), blood is collected from the donor via the first line 21, and the third liquid pump 13 is operated, For example, an anticoagulant containing citric acid such as ACD-A solution is supplied through the line 23, and this anticoagulant is mixed (injected) into the blood sample. As a result, blood (anticoagulant-added blood) is transferred through the first line 21 and introduced into the blood storage space 146 of the rotor 142 via the tube 141 from the inlet 143 of the centrifuge 20. At this time, the air (sterilized air) in the centrifuge 20 is sent into the air bag 27b through the second line 22 and the tube 42. The mixing ratio (volume ratio) of the anticoagulant to blood (blood collected: blood before addition of the anticoagulant) is preferably about 1/20 to 1/6 (for example, 1/9). .

  In addition, the centrifuge drive device 10 is operated to rotate the rotor 142 of the centrifuge 20, and blood introduced into the blood storage space 146 is separated from the plasma layer (PPP layer) 131, the buffy coat layer (BC layer) from the inside. ) 132 and the red blood cell layer (CRC layer) 133 is separated into three layers. In this case, most of the citric acid contained in the anticoagulant is contained in the plasma layer 131 (plasma) due to its specific gravity.

  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 are performed in this order. Thus, a predetermined amount of plasma is collected in the plasma collection bag 25, and a predetermined amount and a predetermined number (predetermined number of units) of concentrated platelets are collected (temporarily stored) in the intermediate bag 27a. In addition, blood components remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 (mainly red blood cells) (mainly red blood cells and white blood cells) are returned to the inlet of the centrifuge 20 by performing the blood return process. The blood is discharged from 143 and returned (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), and usually a plurality of times (multiple cycles).

  The platelet collection operation can be performed using a method described in, for example, Japanese Patent Application Laid-Open No. 2005-152362, although the circuit configuration is slightly different. In this case, as a main difference, in this embodiment, in the constant-speed plasma circulation process and the accelerated plasma circulation process, a plasma circulation line (plasma) in which main parts are constituted by the tube 49, the branch connector 22d, and the tube 50, respectively. 24), branch connector 21f, centrifuge-side first line 21b, blood storage space 146 of the centrifuge 20, second line 22, branch connector 22b, tube 43, and branch connector 22c, the tube 44, and the plasma collection bag 25 form (configure) a circulation circuit, and the operation of the second liquid feeding pump 12 causes the circulation circuit (to pass through the blood storage space 146) to collect plasma. That is, the plasma in the bag 25 is circulated.

  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 3, 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 second flow path opening / closing means 82 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.

By the way, the number of “one unit” of platelets is 0.2 × 10 ¹¹ , and the following four types (1) to (4) are used as platelet preparations (those defined in the preparation standard). There is.

(1) 5-unit preparation The volume (volume) is 100 mL ± 20%, and the number is 1.0 × 10 ^{11 to} 1.9 × 10 ¹¹

(2) 10-unit preparation The volume (volume) is 200 mL ± 20%, and the number is 2.0 × 10 ^{11 to} 2.9 × 10 ¹¹

(3) 15-unit preparation The volume (volume) is 250 mL ± 20%, and the number is 3.0 × 10 ^{11 to} 3.9 × 10 ¹¹

(4) 20 unit preparation The volume (volume) is 250 mL ± 20%, and the number is 4.0 × 10 ¹¹ or more.

  Now, the blood component collection device 1 operates (reverses) the first liquid feeding pump 11 and the second liquid feeding pump 12 in the blood return process, and stores blood in the rotor 142 of the centrifuge 20. Returning blood to the donor (returning) while mixing a blood component remaining in the space 146 and a predetermined amount of plasma in the plasma collection bag 25, that is, a part of surplus plasma (surplus plasma). (Hereinafter, also simply referred to as “mixed blood return”).

  That is, the blood component remaining in the blood storage space 146 is discharged from the inlet 143 of the centrifuge 20 by the operation of the first liquid feeding pump 11, flows in the centrifuge-side first line 21b, and collects plasma. The plasma in the bag 25 flows through the plasma circulation line (plasma feeding line) 24 by the operation of the second feeding pump 12, and the blood components in the blood storage space 146 and the plasma in the plasma collection bag 25 are Are joined and mixed by the branch connector 21f, flow through the blood collection needle side first line 21a, and are returned to the donor through the blood collection needle 29.

  It should be noted that the total flow rate (flow velocity) of blood components returned to the donor, that is, the blood components in the blood storage space 146 returned to the donor, depending on the rotational speed (number of rotations) of the first liquid delivery pump 11. The total flow rate of the plasma in the plasma collection bag 25 is regulated, and the overall flow rate of the blood components returned to the donor can be adjusted by adjusting the rotation speed of the first liquid feeding pump 11. In addition, the flow rate of plasma in the plasma collection bag 25 returned to the donor is regulated by the rotational speed of the second liquid pump 12, and the rotational speed of the second liquid pump 12 is adjusted to adjust the rotational speed of the second liquid pump 12. The flow rate of plasma in the plasma collection bag 25 to be returned to can be adjusted.

  In the blood returning process, the blood component collecting device 1 flows in the first line 21 (the blood collecting needle side first line 21a) from the branch connector 21f to the blood collecting needle 29 side by the turbidity sensor 19 and returns blood to the donor. The ratio (plasma concentration) of plasma (plasma containing an anticoagulant) in the blood component (returned) is detected. Then, based on the detection result (detection value) of the turbidity sensor 19, plasma (including anticoagulant) is returned to the donor so that the anticoagulant (citric acid) is not injected into the donor at an excessive flow rate. It is characterized by adjusting the flow rate of plasma) (blood component). Hereinafter, the adjustment of the flow rate of plasma returned to the donor in the blood return step is also simply referred to as “plasma flow rate adjustment”.

  As a result, the flow rate of citrate contained in the plasma can be adjusted so that the flow rate does not become excessive during the blood return process, and as a result, it is included in the blood components to be returned (mainly plasma). Side effects caused by citric acid can be reduced. Thereby, the burden on the donor can be reduced.

  In the storage unit 18, based on the detection result (detection value) of the turbidity sensor (detection means) 19, that is, the output voltage (output value) from the turbidity sensor 19, the blood collection needle side first line 21 a is displayed. For example, a calibration curve such as an arithmetic expression or a table for storing the flow rate of plasma that flows and returns to the donor is stored, and the flow rate of plasma that is returned to the donor is calculated using this calibration curve. It can be determined (based on a calibration curve). When adjusting the flow rate of the plasma, the flow rate of the plasma flowing through the blood collection needle side first line 21a and returning to the donor is obtained using the calibration curve, and the flow rate of the plasma is adjusted. The main function of the means (flow rate calculation means) for obtaining the flow rate of plasma returned to the donor based on the detection result of the turbidity sensor 19 is achieved by the control unit 3.

  In this plasma flow rate adjustment, for example, the type of anticoagulant, the composition of the anticoagulant (eg, the concentration of citric acid in the anticoagulant, etc.), the mixing ratio of the anticoagulant to the blood, the donor (donor) The control pattern (for example, the upper limit value a, the upper limit value b, the threshold value, etc.) can be changed according to the body weight, the circulating blood volume, and the like.

  For example, when an anticoagulant that does not contain citric acid is used, the plasma flow rate is adjusted with a control pattern corresponding to the anticoagulant (for example, the upper limit value a is set relatively high), or the plasma flow rate The blood component collection device 1 has a plurality of modes, such as no adjustment.

  In addition, the flow rate adjustment of the plasma may be performed in the whole (total) of the blood return process, or may be performed in a part of the blood return process or in a part of the time period. This is preferably performed during the mixed blood return.

  The flow rate of plasma during mixed blood return is controlled by controlling the operation of the second liquid feeding pump 12 and adjusting the rotation speed thereof. In this mixed blood return, only the flow rate of plasma returned to the donor can be changed (adjusted) without changing (maintaining constant) the overall flow rate of blood components returned to the donor. .

  In addition, in the flow rate adjustment of the plasma at the time of the mixed blood return, the rotation speed of the first liquid feeding pump 11 may or may not be adjusted. That is, the operation of the first liquid delivery pump 11 may be controlled, the rotation speed thereof may be adjusted, and the overall flow rate of blood components returned to the donor may be adjusted, or blood may be returned to the donor. The entire flow rate of the blood component may be fixed to a predetermined value (a constant value) set in advance.

  Here, in the plasma flow rate adjustment, the plasma flow rate returned to the donor is not more than the upper limit value a [mL / min], for example, a- (a × 0.1) to a [mL / min]. Make adjustments.

  Determinants of the upper limit value a include, for example, the type of anticoagulant, the composition of the anticoagulant (eg, the concentration of citric acid in the anticoagulant, etc.), the mixing ratio of anticoagulant to blood, and the weight of the donor The upper limit value a is determined based on at least one of them so that citric acid is not injected into the donor at an excessive flow rate.

  Examples of the composition of the anticoagulant include the concentration of citric acid in the anticoagulant.

  The upper limit value a is appropriately set according to the determining factor, but is preferably about 15 to 50 mL / min, more preferably about 24 to 36 mL / min.

  Thereby, it can prevent more reliably that the flow volume of the citric acid contained in plasma becomes excessive, and the side effect by a citric acid can be reduced.

  In the plasma flow rate adjustment, the proportion of plasma in the blood components returned to the donor is less than or equal to the upper limit b [vol%], for example, b- (b × 0.1) to b [vol%. It is preferable to make adjustments so that

  Determinants of this upper limit value b include, for example, blood return speed, type of anticoagulant, composition of anticoagulant (for example, concentration of citric acid in the anticoagulant, etc.), mixing ratio of anticoagulant to blood The upper limit value b is determined based on at least one of them so that the citric acid is not injected into the donor at an excessive flow rate.

  Examples of the composition of the anticoagulant include the concentration of citric acid in the anticoagulant.

The upper limit b is appropriately set according to the determinant, but is preferably about 50 to 90 vol%, and more preferably about 60 to 80 vol%.
Thereby, the side effect by a citric acid can be reduced more reliably.

  Further, in the blood component collecting apparatus 1, in the blood return process, the ratio of the plasma ratio detected by the turbidity sensor 19 exceeds the threshold value is set as the end condition of the blood return process ( Based on the detection result of the turbidity sensor 19, the blood return process is completed).

  Determinants of this threshold include, for example, the type of anticoagulant, the composition of the anticoagulant (eg, the concentration of citrate in the anticoagulant, etc.), the mixing ratio of anticoagulant to blood, and the donor's weight And circulating blood volume, and the threshold value is determined based on at least one of them.

  Examples of the composition of the anticoagulant include the concentration of citric acid in the anticoagulant.

  The threshold value is appropriately set according to the determining factor, but is preferably about 60 to 99 vol%, more preferably about 80 to 90 vol%.

  As a result, the amount of citric acid that is injected into the donor's body during the blood return step can be reduced, thereby reducing the side effects caused by citric acid.

  When the ratio of plasma detected by the turbidity sensor 19 exceeds the threshold value and the blood return process is terminated, the ratio of plasma detected by the turbidity sensor 19 is the threshold value. When the blood pressure exceeds the predetermined value, a predetermined amount of blood components are returned to the donor, and the blood return process is completed. The predetermined amount of the first line 21 from the location (position) where the turbidity sensor 19 is installed, that is, the location (position) where the proportion of plasma is detected by the turbidity sensor 19 to the blood collection needle 29 is determined. This is an amount (volume) corresponding to the volume (volume) in the flow path.

  As a result, blood components whose proportion of plasma exceeds the threshold value are not returned to the donor, but in the flow path of the first line 21 from the position where the turbidity sensor 19 is installed to the blood collection needle 29. Only the blood component of which the proportion of plasma is less than or equal to the threshold is returned to the donor. As a result, more blood components such as red blood cells and white blood cells can be returned to the donor while reducing side effects due to citric acid.

Next, operation | movement of the blood component collection device 1 in the case of a blood return process is demonstrated.
3 and 4 are flowcharts for explaining the operation of the blood component collection device shown in FIG. 1, and FIG. 3 and FIG. 4 show the control operation of the control unit 13 in the blood return process. .

  After the platelet collection process is completed and the centrifuge drive device 10 (centrifuge 20) is stopped, the process returns to the blood return process.

  As shown in FIG. 3, in the blood return step, first, the first channel opening / closing means 81 and the fifth channel opening / closing means 85 are opened, and the first liquid feeding pump 11 is operated at a predetermined rotational speed. In addition, the second liquid feeding pump 12 is operated at a predetermined rotational speed to perform mixed blood return (step S101).

In this step S101, the blood component remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 and the surplus plasma in the plasma collection bag 25 are returned, but the surplus plasma in the plasma collection bag 25 is returned. Then, the amount of surplus plasma excluding the amount used in step S103 and later described below is returned, and when the amount of surplus plasma has been returned, the second liquid feeding pump 12 is stopped.
However, when there is no surplus plasma, mixed blood return can be stopped or omitted.

  In step S101, the plasma flow rate adjustment described above is performed, and the plasma flow rate adjustment is also performed in step S103 and later.

  Next, it is determined whether or not the amount of blood components remaining in the blood storage space 146 of the rotor 142 of the centrifuge 20 has reached a predetermined amount (step S102).

  The predetermined amount is preferably about 25 to 100 mL, and more preferably about 40 to 80 mL.

  In step S102, when the amount of the blood component remaining in the blood storage space 146 is not a predetermined amount, the process returns to step S101, and step S101 and subsequent steps are executed again.

  In step S102, when the amount of blood component remaining in the blood storage space 146 reaches a predetermined amount, the operation of the first liquid feed pump 11 is continued (at this stage, the second liquid feed is performed). The pump 12 is stopped), the fifth flow path opening / closing means 85 is closed, the third flow path opening / closing means 83 is opened, and the excess plasma in the plasma collection bag 25 is discharged from the centrifuge 20. The blood is introduced into the blood storage space 146 from the outlet 144, and the blood is returned through the centrifuge 20 (step S103).

  Next, it is determined whether or not the amount of plasma introduced into the blood storage space 146 has reached a predetermined amount (step S104).

  The predetermined amount is preferably about 10 to 60 mL, and more preferably about 30 to 45 mL.

  In step S104, when the amount of plasma introduced into the blood storage space 146 is not a predetermined amount, the process returns to step S103, and step S103 and subsequent steps are executed again.

  In step S104, when the amount of plasma introduced into the blood storage space 146 reaches a predetermined amount, the third flow path opening / closing means 83 is opened while continuing the operation of the first liquid feeding pump 11. Then, the fifth channel opening / closing means 85 is opened and the blood component remaining in the blood storage space 146 is returned (step S105).

  Subsequently, the turbidity sensor 19 detects the proportion of plasma in the blood components returned to the donor, and determines whether the proportion exceeds the threshold (step S106).

  In step S106, when the ratio of the plasma in the blood component returned to the donor does not exceed the threshold value, the process proceeds to the next step (step S107) to return the blood component returned to the donor. If the proportion of plasma in the sample exceeds the threshold value, the process proceeds to step S116.

  Next, it is determined whether or not the bubble sensor 32 has detected air that has come out with the blood component in the blood storage space 146 almost empty (step S107).

  In step S107, when air is not detected, it returns to step S105 and performs step S105 and subsequent steps again.

  If air is detected in step S107, the first liquid pump 11 is stopped, the second liquid pump 12 is operated at a predetermined rotational speed, and surplus in the plasma collection bag 25 is detected. Plasma is introduced into the blood storage space 146 from the inlet 143 of the centrifuge 20 (step S108).

  Next, it is determined whether or not the amount of plasma introduced into the blood storage space 146 has reached a predetermined amount (step S109).

  The predetermined amount is preferably about 2 to 30 mL, and more preferably about 5 to 15 mL.

  If the amount of plasma introduced into the blood storage space 146 is not a predetermined amount in step S109, the process returns to step S108, and step S108 and subsequent steps are executed again.

  In step S109, when the amount of plasma introduced into the blood storage space 146 reaches a predetermined amount, the second liquid feeding pump 12 is stopped and the centrifuge is driven as shown in FIG. The apparatus 10 is operated, the rotor 142 of the centrifuge 20 is rotated for a predetermined time (for example, about 1 second), and the blood components in the blood storage space 146 are agitated (step S110).

  Next, the first liquid feeding pump 11 is operated at a predetermined rotation speed, and the blood component remaining in the blood storage space 146 is returned (step S111).

  Subsequently, the turbidity sensor 19 detects the proportion of plasma in the blood components returned to the donor, and determines whether the proportion exceeds a threshold value (step S112).

  In step S112, when the ratio of the plasma in the blood component returned to the donor does not exceed the threshold value, the process proceeds to the next step (step S113), and the blood component returned to the donor If the proportion of plasma in the sample exceeds the threshold value, the process proceeds to step S116.

  Next, it is determined whether or not the bubble sensor 32 has detected air that has come out with almost empty blood components in the blood storage space 146 (step S113).

  In step S113, when air is not detected, it returns to step S111 and performs step S111 and subsequent steps again.

If air is detected in step S113, the fifth flow path opening / closing means 85 is closed, and the operation of the first liquid feed pump 11 is continued while the second liquid feed pump 12 is turned on. The surplus plasma in the plasma collection bag 25 is returned without going through the centrifuge 20 by operating at the same rotational speed as that of the first liquid feeding pump 11 (step S114).
Note that steps S108 to S113 can be omitted.

  Subsequently, the turbidity sensor 19 detects the proportion of plasma in the blood components returned to the donor, and determines whether the proportion exceeds a threshold value (step S115).

  In step S115, when the ratio of the plasma in the blood component returned to the donor does not exceed the threshold value, the process returns to step S114, and step S114 and subsequent steps are executed again.

  In step S115, when the ratio of the plasma in the blood component returned to the donor exceeds the threshold value, the fifth flow path opening / closing means 85 is closed and the first liquid feeding is performed. The operation of the pump 11 and the second liquid feeding pump 12 at the same rotational speed is continued, and the excess plasma in the plasma collection bag 25 is returned without going through the centrifuge 20 (step S116).

  Next, it is determined whether or not the blood return amount (the amount of plasma discharged from the plasma collection bag 25) has reached a predetermined amount (step S117).

  This predetermined amount is set to an amount corresponding to the volume in the flow path of the first line 21 from the place where the turbidity sensor 19 is installed to the blood collection needle 29. That is, the amount of blood components returned in steps S116 to S117 is an amount corresponding to the volume in the flow path of the first line 21 from the place where the turbidity sensor 19 is installed to the blood collection needle 29. It is like that.

In this case, the volume in the flow path of the first line 21 from the place where the turbidity sensor 19 is installed to the blood collection needle 29 is preferably about 5 to ³⁰ cm ³ , more preferably 10 to 20 cm. Since it is set to about ³ , the predetermined amount is preferably about 5 to 30 mL, and more preferably about 10 to 20 mL.

  In step S117, when the blood return amount is not the predetermined amount, the process returns to step S116, and step S116 and subsequent steps are executed again.

  In step S117, when the blood return amount reaches a predetermined amount, it is determined whether or not the current cycle is the final cycle (step S118).

  In step S118, when the current cycle is a cycle other than the final cycle, the first liquid feed pump 11 and the second liquid feed pump 12 are stopped. Thus, the blood return process in the cycle other than the final cycle is completed, and the process proceeds to the next cycle.

  In step S118, when the current cycle is the final cycle, the second liquid pump 12 is stopped while the operation of the first liquid pump 11 is continued, and the fifth flow path opening / closing means 85 is opened. It is opened and the blood component in the flow path of the first line 21 is returned (step S119).

  Next, it is determined whether or not air is detected by the bubble sensor 35 or 36 (step S120).

  If air is not detected in step S120, the process returns to step S119, and step S119 and subsequent steps are executed again.

  If air is detected by the bubble sensor 35 or 36 in step S120, the first flow path opening / closing means 81 and the fifth flow path opening / closing means 85 are closed, and the first liquid feed pump 11 is closed. To stop. This is the end of the blood return process in the final cycle.

  As described above, according to this blood component collecting device, side effects due to citric acid contained in blood components to be returned (mainly plasma) can be reduced during the blood return step, The burden on the donor can be reduced.

  In addition, since almost all blood cell components in the centrifuge 20 (blood storage space 146) and the circuit can be returned to the donor, the amount of processed blood per cycle can be increased and the number of cycles can be reduced. is there.

Next, a second embodiment of the blood component collection device of the present invention will be described.
FIG. 5 is a plan view showing a second embodiment of the blood component collection device of the present invention.

  Hereinafter, the blood component collection device 1 according to the second embodiment will be described with a focus on differences from the first embodiment described above, and descriptions of similar matters will be omitted.

  A blood component collection device 1 according to the second embodiment shown in FIG. 5 is a device for separating blood into a plurality of blood components and collecting separated plasma (blood components).

  The blood component collection device 1 includes a first flow path opening / closing means 61 that opens and closes the tube 42 and a second flow path opening / closing means 62 that opens and closes the tube 43.

  One end of the tube 43 is connected to the branch connector 22b, and the plasma collection bag 25 is connected to the other end.

  Further, one end of the tube 52 is connected to the plasma collection bag 25, and a bag 71 is connected to the other end.

  Next, an operation (operation) of the blood component collection device 1, that is, a plasma collection operation (blood component collection operation) using the blood component collection device 1 will be described.

  The blood component collection device 1 controls a plasma collection operation (blood component collection operation) having a plasma collection step of collecting plasma in the plasma collection bag 25 and a blood return step (blood component return step) described later under the control of the control unit 3. ) To perform component blood collection. This plasma collection operation (blood component collection operation) is performed at least once (one cycle), and usually a plurality of times (multiple cycles).

  In addition, the said plasma collection operation can be performed using the method described in Unexamined-Japanese-Patent No. 2005-52184 etc., for example.

  In this blood component collecting apparatus 1 as well, in the blood return process, the turbidity sensor 19 flows through the first line 21 (the blood collection needle side first line 21a) and returns to the donor in the blood return process, as in the first embodiment described above. The proportion (plasma concentration) of plasma (plasma containing an anticoagulant) in the blood (returned) blood component is detected, and based on the detection result (detected value) of the turbidity sensor 19, it is It is characterized by adjusting the flow rate of plasma (blood containing anticoagulant) (blood component) returned to the donor so that the coagulant (citric acid) is not injected at an excessive flow rate. Hereinafter, the adjustment of the flow rate of plasma returned to the donor in the blood return step is also simply referred to as “plasma flow rate adjustment”.

  However, this plasma flow rate adjustment is performed by controlling the operation of the first liquid delivery pump 11 and adjusting the rotation speed thereof.

  Similarly to the first embodiment described above, in the blood return process, the ratio of the plasma percentage detected by the turbidity sensor 19 exceeds the threshold value is set as an end condition for the blood return process. Yes.

  Hereinafter, the blood component collection device 1 of the present embodiment will be described in comparison with the blood component collection device described in JP-A-2005-52184. Hereinafter, the blood component collection device described in JP-A-2005-52184 and the like is referred to as a “comparison blood component collection device”. Moreover, the term and code | symbol at the time of describing the blood component collection apparatus for a comparison use the thing of the blood component collection apparatus 1 of this embodiment.

  In the blood component collection device 1 and the comparative blood component collection device of the present embodiment, the air in the blood storage space 146 of the centrifuge 20 in the plasma collection operation after the second cycle, which is not the final cycle, respectively. When the storage in the intermediate bag (storage bag) 27b is completed, the plasma flowing out from the discharge port 144 for the first time, that is, a predetermined amount (set amount) of plasma in the blood storage space 146 is supplied to the second line 22 and the fourth line. This is transferred through the line 24 into the intermediate bag 27b and stored. At this time, blood components (blood cells) other than plasma adhering in the flow path between the blood storage space 146 and the intermediate bag 27b (mainly near the discharge port 144 of the blood storage space 146) are caused by the flowing plasma. , Captured and transferred into the intermediate bag 27b. Thereby, in the plasma collection process of this cycle, mixing of blood components (blood cells) other than plasma into the plasma collection bag 25 is prevented. Next, plasma is collected in the plasma collection bag 25.

  In the blood return step in the plasma collection operation after the second cycle which is not the final cycle, the first liquid pump 11 is operated to return blood to the donor, and the plasma in the intermediate bag 27 b is stored in the centrifuge 20. It is introduced into the space 146. As a result, in the blood storage space 146, a lower layer, mainly an erythrocyte layer, and an upper layer, mainly a plasma layer, are formed. At this time, first, red blood cells flow out from the blood storage space 146 and return to blood, and then plasma flows out and returns.

  Here, in the blood component collection device for comparison, when air is detected by the bubble sensor 32, the first liquid feeding pump 11 is rotated a predetermined number of times, and the blood return process is terminated. That is, almost all blood components in the blood storage space 146 are returned, and the blood return process is completed. For this reason, the separated plasma is returned to the donor, and the amount of collected plasma (yield) is reduced.

  In contrast, in the blood component collection device 1 of the present embodiment, as described above, the turbidity sensor 19 detects the proportion of plasma in the blood component returned to the donor, and the proportion is as follows. It is determined whether or not the threshold value has been exceeded, and if the proportion of plasma in the blood component returned to the donor exceeds the threshold value, from the location where the turbidity sensor 19 is installed to the blood collection needle 29 The blood component of the amount corresponding to the volume in the flow path of the first line 21 (blood component in which the proportion of plasma is equal to or less than the threshold value) is returned, and the blood return process is completed.

  Further, the plasma in the first line 21 can be introduced (returned) into the blood storage space 146 of the centrifuge 20 again in the plasma collection operation of the next cycle. Thus, in the blood component collection device 1 of the present embodiment, it is possible to prevent the separated plasma from returning excessively to the donor, and the amount of plasma collected can be increased with the same number of cycles. .

According to this blood component collection device 1, the same effects as those of the first embodiment described above can be obtained.
And in this blood component collection device 1, it is possible to prevent the blood from returning excessively, thereby increasing the amount of plasma collected.

  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 a case where it is applied to obtain both a platelet product and a plasma product (or a raw material plasma of a plasma fractionation product), or to obtain only a plasma product. It may be applied when only a platelet preparation is obtained from blood.

  Moreover, the blood component collection device of the present invention is not limited to the application to obtain a platelet preparation or a plasma preparation, and may be applied to obtain an erythrocyte preparation, a leukocyte preparation, etc. from blood, for example. That is, in the blood component collection device of the present invention, the blood cell component collected in the blood component collection bag is 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 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 cells separated and removed by the cell separation filter (filter) are not limited to leukocytes.

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

  Moreover, the system of the blood component collection device of the present invention is not limited to the intermittent type (one arm type), and may be, for example, a continuous type (both arm type).

It is a top view which shows 1st Embodiment of the blood component collection apparatus 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. It is a flowchart for demonstrating the effect | action in the blood return process of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action in the blood return process of the blood component collection device shown in FIG. It is a top view which shows 2nd Embodiment of the blood component collection device of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood component collection apparatus 2 Blood component collection circuit 3 Control part 10 Centrifugal drive device 11 1st liquid feed pump 12 2nd liquid feed pump 13 3rd liquid feed pump 14 Turbidity sensor 15 Optical sensor 151 Throw Light unit 152 Light receiving unit 153 Reflector 16 Weight sensor 17 Display / operation unit 18 Storage unit 19 Turbidity sensor 20 Centrifuge 21 First line 21a Blood collection needle side first line 21b Centrifuge side first line 21c Branch connector 21d chamber 21f branch connector 21g first pump tube 21h tube 21i filter 22 second line 22a second pump tube 22b branch connector 22c branch connector 22d branch connector 22e branch connector 22f filter 22g branch connector 22h filter 23 3 line 23a 3rd pump tube 23b sanitization filter 23c bubble removal chamber 23d anticoagulant container connection needle 24 plasma circulation line 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 41-52 Tube 61 First channel opening / closing means 62 Second channel opening / closing means 71 Bag 81-86 First to sixth channel opening / closing means 131 Plasma layer 132 Buffy coat Layer 133 Red blood cell layer 141 Tubing body 142 Rotor 143 Inlet port 144 Outlet port 145 Upper portion 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg 203 Motor 204 Rotating shaft 205 Fixing stand 206 Bolt 207 Spacer S101 to S120 Step The

Claims (10)

Collecting blood components collected from a donor, separating blood to which an anticoagulant has been added, collecting a predetermined blood component, and performing a blood returning step of returning the remaining blood components to the donor A blood component collecting device for collecting blood components,
A blood collection means comprising a hollow needle for collecting blood from a donor,
A blood separator for separating blood collected by the blood collecting means;
At least one blood component collection bag for collecting a predetermined blood component separated by the blood separator;
A blood treatment line connecting the hollow needle and the inlet of the blood separator;
A blood component collection circuit having an anticoagulant injection line for adding an anticoagulant to blood in the blood treatment line;
Flow rate adjusting means for adjusting the flow rate of blood components returned to the donor,
A detection means for detecting the proportion of plasma in the blood component returned to the donor,
In the blood return step, the flow rate adjusting means includes blood containing an anticoagulant returned to the blood donor so that the anticoagulant is not injected into the blood donor at an excessive flow rate based on the detection result of the detection means. A blood component collection device characterized by adjusting the flow rate of components. The blood component collection bag is a plasma collection bag for collecting plasma separated by the blood separator,
The blood component collection device separates blood to which an anticoagulant has been collected from a blood donor, collects plasma in the plasma bag, and returns the remaining blood components to the blood donor. The blood component collection device according to claim 1, wherein the blood component collection operation including a blood step is performed at least for one cycle. The blood component collection bag is a plasma collection bag for collecting plasma separated by the blood separator, and a blood cell component collection bag for collecting predetermined blood cell components separated by the blood separator,
The blood component collection device collects a blood sample collected from a blood donor, separates blood to which an anticoagulant has been added, and collects plasma in the plasma bag, and collects a predetermined blood cell component in the blood cell component collection bag A blood component collecting operation including a blood cell component collecting step and a blood returning step of returning the remaining blood component and a predetermined amount of plasma in the plasma collection bag to the donor. 2. The blood component collection apparatus according to 1. Further, a plasma liquid supply line branched from a branch portion provided in the blood processing line and connected to the plasma collection bag, and a first liquid which is installed in the blood processing line and supplies liquid in the blood processing line. Liquid feeding means, and a second liquid feeding means that is installed in the plasma liquid feeding line and feeds the plasma collected in the plasma collection bag,
In the blood return step, the flow rate adjusting means controls the operation of the first liquid feeding means and the second liquid feeding means, so that the blood components in the blood separator and the plasma collection bag Is configured to adjust the flow rate of blood components including anticoagulant returned to the donor so that the anticoagulant is not injected into the donor at an excessive flow rate The blood component collection device according to claim 3.   2. The flow rate adjusting means is configured to adjust a flow rate of a plasma component including an anticoagulant returned to a blood donor in the blood return step so that the flow rate is not more than an upper limit value amL / min. 5. The blood component collection device according to any one of 4 to 4.   The blood component collection device according to claim 5, wherein the upper limit value a is 15 to 50 mL / min.   The determinant of the upper limit value a includes at least one of the type of anticoagulant, the composition of the anticoagulant, the mixing ratio of the anticoagulant to the blood, the body weight of the donor, and the amount of circulating blood. Or the blood component collecting apparatus according to 6;   The blood component collection device according to any one of claims 1 to 7, wherein the flow rate adjusting unit is configured to end the blood return step in the blood return step based on a detection result of the detection unit. .   9. The flow rate adjusting means returns a predetermined amount of blood components to the blood donor from the time when the ratio of plasma detected by the detecting means exceeds a threshold value, and ends the blood return process. The blood component collection device described.   The blood component collection apparatus according to claim 9, wherein the threshold value is 60 to 99 vol%.

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