JP4558401B2 - Blood component collection device - Google Patents

Description

  The present invention relates to a blood component collection device.

  At the time of blood collection, for the purpose of effective use of blood and reduction of burden on donors, blood samples are separated into blood components by centrifugation, etc., and only necessary components are collected from donors. However, other components are collected to return to the blood donor.

  In such component blood collection, for example, when obtaining a plasma preparation, blood collected from a blood donor is introduced into a blood component collection circuit, and plasma and a plasma are collected by a centrifuge called a centrifuge bowl installed in the blood component collection circuit. It is separated into blood cells, and the plasma therein is collected in a blood component collection bag to obtain a plasma preparation, and the blood cells are returned (returned) to the blood donor together with the remaining plasma.

  By the way, in a blood component collection apparatus that collects such component blood, for example, when collecting plasma, a blood component collection step for collecting plasma, and a blood component return for returning the remaining blood components (mainly blood cells) to the donor The process is performed alternately (see, for example, Patent Document 1).

  In this blood component collection step and blood component return step, red blood cells are damaged by a pump (peristaltic pump) by passing through a line (inlet line) connecting the phlebotomy needle to the inlet of the centrifuge. receive.

  Moreover, in this blood component collection device, the blood component return step is completed in a state where the blood to be returned remains in the line in order to avoid injecting air into the blood donor. For this reason, damaged red blood cells remain, and the remaining red blood cells are further damaged because they pass through the pump again in the blood component collection step of the next cycle. Since the damaged red blood cells are reintroduced into the centrifuge, the quality of the collected blood product is reduced.

  In addition, in a blood component blood collection device that performs such component blood collection, the amount of blood that can be processed in one cycle depends on the amount of red blood cells introduced into the centrifuge, so that concentrated red blood cells remain in the inlet line. There is a problem that the amount of blood collected from a blood donor introduced into the centrifuge decreases, and the amount of other blood components recovered decreases.

JP 2001-17540 A

  An object of the present invention is to provide a blood component collection device that can efficiently collect a desired blood component of high quality.

Such an object is achieved by the present inventions (1) to ( 5 ) below.
(1) Blood collection means for collecting blood from a donor,
A centrifuge having an inlet and an outlet, and centrifuges blood collected by the blood collection means and introduced from the inlet;
A first line connecting the inlet and the blood collection means;
A second line connected to the outlet;
A plasma collection bag connected to the second line for collecting plasma separated by the centrifuge ;
A blood component collection circuit comprising a third line branched from the middle of the first line and connected to the plasma collection bag ;
Blood that is subjected to a plurality of cycles of blood component collection, which includes centrifugation of blood collected from the blood donor and collecting at least blood plasma, and blood component collection operation including a blood component return step of returning the remaining blood components to the blood donor A component collecting device,
In the blood component collection operation of at least one cycle excluding the final cycle of the plurality of cycles, the plasma collected in the plasma collection bag during the blood component return step is passed through the third line. A blood component configured to perform a red blood cell return step of supplying red blood cells supplied to the first line and returning red blood cells remaining in the first line to the blood donor via the blood collecting means Collection device.

( 2 ) The blood component collection circuit further includes a platelet collection bag for collecting platelets branched from the middle of the second line and separated by the centrifuge,
The blood component collection device according to (1 ) , wherein the blood component collection device is configured to collect plasma and platelets in the blood component collection step.

( 3 ) The plasma supplied to the first line via the third line during the red blood cell return step is configured to be supplied by a drop, as described in (1) or (2) above Blood component collection device.

( 4 ) Furthermore, it has a detection means which detects the gas in the said 1st line,
When returning the remaining blood components to the blood donor, if the air in the first line is detected by the detection means, any of the above (1) to ( 3 ) is started to start the red blood cell return process A blood component collecting device according to claim 1.

( 5 ) When using the blood component collection device, the plasma collection bag is provided so that the outlet side of the plasma in the plasma collection bag is vertically downward when the red blood cell return step is executed. The blood component collection device according to any one of 1) to ( 4 ).

According to the present invention, by performing the red blood cell return step, the plasma collected in the plasma collection bag is supplied to the first line, and the red blood cells (concentrated red blood cells) remaining in the blood component collection circuit are supplied to the donor (donor) Therefore, in the blood component collection step of the next cycle, introduction of red blood cells into a centrifuge other than whole blood collected from the donor in this blood component collection step can be suppressed. Thereby, a desired blood component with high quality can be collected in each cycle.
In addition, by performing the red blood cell return process, the plasma collected in the plasma collection bag is supplied to the first line, and the red blood cells (concentrated red blood cells) remaining in the blood component collection circuit are returned to the donor (donor). Therefore, in the blood component collection step of the next cycle, the amount of blood (particularly, the amount of plasma and platelets) introduced into the centrifuge can be increased. Therefore, more blood components can be collected in one cycle, and blood components can be collected efficiently.

  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. FIG. 3 to FIG. 4 are flow charts for explaining the operation of the blood component collection device shown in FIG.

  A blood component collection device 1 shown in FIG. 1 is a device for separating blood into a plurality of blood components and collecting a blood component containing platelets (particularly, plasma containing platelets). 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. The centrifuge 20 that centrifuges the introduced blood in the blood storage space 146, the first line 21 that connects the blood collection needle (blood collection means) 29 and the inlet 143 of the centrifuge 20, and the centrifuge 20 A second line 22 connected to the discharge port 144, a third line 37 connecting the branch connector (branch part) 21f and the plasma collection bag 25, and a fourth line connected to the first line 21. A plasma collection bag (collection) connected to the first line 21 via lines 23 and tubes 49 and 50 and to the second line 22 via tubes 43 and 44. 25), an air bag 27b connected to the second line 22 via the tube 42, and an intermediate bag (temporary storage bag) 27a connected to the second line 22 via the tubes 43 and 45 A blood component collection circuit (collection bag) 26 connected to the intermediate bag 27a via the tubes 46, 47 and 48 and a bag 28 connected to the platelet collection bag 26 via the tube 51 ( A platelet collection circuit 2.

  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 feed pump (liquid feed pump) 11 for the first line 21, and A plurality of (seventh in the present embodiment, first to seventh) flows that can open and close the flow path of the second liquid delivery pump 12 for the fourth line 23 and the blood component collection circuit 2. The path opening / closing means 81, 82, 83, 84, 85, 86, 87, the centrifuge drive device 10, the first liquid feeding pump 11, the second liquid feeding pump 12, and the plurality of flow path opening / closing means 81-87. , A turbidity sensor (platelet concentration sensor) 14, an optical sensor 15, a weight sensor 16, and a plurality (six in this embodiment) of bubble sensors 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 return line) 21, a second line 22 having one end connected to the outlet (outlet) 144 of the centrifuge 20, a branch connector 21 f, and a plasma collection bag 25 are connected to each other. 3, a line 37 connected to the blood collection needle 29 of the first line 21, a fourth line (anticoagulant injection line) 23 having a second pump tube 23 a, and a second line 22. The tube 43 connected to the tube 43, the plasma collection bag 25 connected to the tubes 44 and 49, the tube 42 connected to the second line 22, and the tube. 42, an air bag 27 b connected to 42, a tube 45 connected to the tube 43, an intermediate bag 27 a connected to the tube 45, a tube 46 connected to the intermediate bag 27 a, and a tube 47 connected to the tube 46. A 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, the third line 37, and the fourth line 23, which will be described later, are respectively a soft resin tube or its soft A plurality of resin tubes are connected.

  The blood collection needle side first line 21a is connected from the blood collection needle 29 side to a branch connector 21c for connection to the fourth line 23, a chamber 21d for removing bubbles and microaggregates, and a 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 (near the branch connector 21f).

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

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

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

One end of the second line 22 is connected to the outlet 144 of the centrifuge 20.
The second line 22 includes a branch connector 22 b for connecting the tubes 41, 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.

  The third line 37 has one end connected to the branch connector 21 f and the other end connected to the plasma collection bag 25. The third line 37 includes tubes 49 and 50 and a connecting branch connector 22d.

  The tube 50 is connected to the blood collection needle 29 side from the pump tube 21 g of the first line 21, and the tube 49 is connected to the tube 50.

  The tube 49, the tube 50, and the connecting branch connector 22d constitute the main part of the third line 37.

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

  The fourth 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 fourth 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 fourth 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 fourth 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 fourth 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 (storing) plasma. 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 is connected to the second line via the tubes 43 and 44. The plasma collection bag 25 and the 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, is a container for collecting (storing) plasma (first blood component) containing platelets after passing through a leukocyte removal filter 261 described later. In the following description, plasma containing platelets (first blood component) is referred to as “concentrated platelets”, and concentrated platelets collected (stored) in the platelet collection bag 26 are referred to as “platelet preparations”.

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

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

  At the time of blood collection to be described later, air (sterilized air) in the 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) (first container) 27a is a container (storage part) for temporarily storing concentrated platelets (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.

  Further, the other end of the tube 47 is provided with a connecting branch connector 22g, and the other end of the tube 48 having one end 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.

  The platelet collection bag 26 is connected to the second line via a tube 48, a leukocyte removal filter 261, tubes 47 and 46, an intermediate bag 27a, and tubes 45 and 43.

  Here, the tubes 46 and 47 constitute a supply tube for supplying concentrated platelets from the intermediate bag 27a to the leukocyte removal filter 261, and the tube 48 is concentrated platelets after separating and removing leukocytes from the leukocyte removal filter 261. Is discharged (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, 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).

  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 etc. can be used.

  As the constituent materials of the tubes used for forming the first to fourth lines 21, 22, 37, and 23, the pump tubes 21g and 23a, and the other tubes 41 to 51 and 21h, respectively. Polyvinyl 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 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 its peripheral portion is 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, the third line 37, the fourth line 23) and each predetermined tube. The cassette housing which holds them in part, in other words, in which they are partially fixed.

  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 fourth 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 that can be opened and closed, a display unit (notification means) 17 for displaying (notifying) various information, and a centrifuge drive device 10, a first liquid feeding pump 11, a second liquid feeding pump 12, a plurality of flow path opening / closing means 81 to 87, and a control unit (control means) 13 for controlling the display unit 17.

  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 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.

  Based on the detection signals from the turbidity sensor 14, the optical sensor 15, the weight sensor 16, and the bubble sensors 31 to 36, the control unit 13 operates each part of the blood component collection device 1 according to a preset program, that is, While controlling the rotation, stop, and rotation direction (forward / reverse rotation) of each liquid feed pump 11, 12, opening / closing of each flow path opening / closing means 81-87, operation and display of the centrifuge drive device 10 as necessary The driving of the unit 17 is controlled.

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

  The 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 unit 17 includes, for example, a liquid crystal display panel, an EL display panel, or the like. The display unit 17 may be a display / operation unit that performs display and operation. In this case, the display unit 17 includes, for example, a touch panel provided with a liquid crystal display panel, an EL display panel, and the like.

  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.

  This blood component collection device 1 is configured to return plasma collected in the plasma collection bag 25 when returning each blood component (remaining blood component) including red blood cells (concentrated red blood cells) in the blood storage space 146 of the rotor 142 to the donor. Is supplied to the first line 21, and a red blood cell return step is performed in which substantially all of the red blood cells remaining in the blood component collection circuit 2 are returned to the donor via the blood collection needle 29.

  This red blood cell return process is performed when blood is not substantially present in the blood storage space 146 in the blood return process of the platelet collection operation (blood component collection operation) described later (during the blood return process) or in the blood storage space 146. This is started when the amount of blood reaches a predetermined amount.

  In addition, it is preferable to perform this red blood cell return process in all cycles except the last cycle.

  By performing this red blood cell return step, a predetermined amount of plasma in the plasma collection bag 25 is supplied to the first line 21 and substantially all of the plasma (concentrated red blood cells) mainly containing red blood cells remaining in the first line 21 is obtained. Can be returned to the donor. Therefore, in the blood component collection step (described later) in the next cycle, the concentrated red blood cells remaining in the blood component collection step pass through the first liquid feeding pump 11 and the remaining concentrated red blood cells are centrifuged. Introduction to the separator 20 can be prevented. Thereby, a desired blood component with high quality can be collected in each cycle.

  In addition, by performing the red blood cell return step, the plasma collected in the plasma collection bag 25 can be supplied to the first line 21, and the red blood cells remaining in the first line 21 can be returned to the donor. The amount of blood (particularly, the amount of plasma and platelets) introduced into the centrifuge 20 in the blood component collection step of the next cycle can be increased. For this reason, it becomes possible to collect more blood components in one cycle, and blood components can be collected efficiently.

  Moreover, it is preferable that the amount of plasma supplied from the plasma collection bag 25 to the first line 21 during the red blood cell return step is about 10 to 50 mL.

  Thereby, the remaining red blood cells in the first line 21 can be reliably returned to the donor without wasting the plasma collected in the plasma collection bag 25.

  Note that the weight of the plasma collection bag 25 is measured by the weight sensor 16, and the measured weight signal is input to the control unit 13, and the control unit 13 generates an appropriate amount of plasma based on this signal. Supply to line 21.

  Next, a platelet collection operation (blood component collection operation) using the blood component collection apparatus 1 will be described with reference to the flowcharts shown in FIGS. 1 and 3 to 4.

  Under the control of the control unit 13, the blood component collection device 1 includes a first plasma collection process, a constant-speed plasma circulation process, a second plasma collection process, an accelerated plasma circulation process, and a third plasma collection process. The platelet collection operation (blood component collection operation) having a platelet collection step and a blood return step is operated. This platelet collection operation is performed at least once.

  The blood component collection according to this embodiment includes the first plasma collection step, the constant-speed plasma circulation step, the second plasma collection step, the accelerated plasma circulation step, the third plasma collection step, and the platelet collection step. The main process steps are configured.

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

  In parallel with the final-cycle platelet collection operation, the blood component collection device 1 controls the control unit 13 to control the platelets temporarily collected (stored) in the intermediate bag 27a, and the leukocyte removal filter. It supplies to H.261, and it is comprised so that the filtration operation (filtration process) which isolate | separates and removes the white blood cell in thick platelets may be performed.

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

  [0] First, the blood collection needle 29 on the fourth line 23 and the first line 21 to the chamber 21d is primed with an anticoagulant, and then the blood collection needle 29 is placed in the blood vessel of the donor (blood donor). Puncture.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  [18] Next, the blood component collection device 1 performs a blood return process. In the blood return process, blood components (remaining blood components) including red blood cells (concentrated red blood cells) in the blood storage space 146 of the rotor 142 are returned.

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

  As a result, the concentrated red blood cells remaining in the blood storage space 146 of the rotor 142 are discharged from the inlet 143 of the centrifuge 20 and returned (returned) to the donor via the first line 21 (blood collection needle 29). The

  Next, the control unit 13 determines whether or not the remaining amount of red blood cells (residual blood amount) in the blood storage space 146 of the centrifuge 20 has reached a set amount (predetermined amount).

  Whether or not the remaining amount (remaining blood amount) of each blood component including red blood cells in the blood storage space 146 has reached a set amount is determined by counting the number of rotations of the first liquid feeding pump 11. . That is, the control unit 13 determines whether or not the remaining amount of blood components in the blood storage space 146 has reached a set amount based on the number of rotations of the first liquid delivery pump 11 since the start of the blood return process. .

  The set amount is not particularly limited, but is preferably smaller. Specifically, the air in the centrifuge 20 is not discharged, and is preferably about 30 to 100 mL, for example, about 65 mL.

  Thereby, the plasma in the plasma collection bag 25 can be supplied to the blood storage space 146 immediately before the blood component in the blood storage space 146 substantially disappears, and in the red blood cell return step, the blood component and the plasma The red blood cells in the blood storage space 146 and the first line 21 can be returned to the donor safely and reliably without air mixing therebetween.

  When the remaining amount of blood components in the blood storage space 146 reaches a set amount, the blood component collection device 1 performs a red blood cell return process.

  Specifically, under the control of the control unit 13, the third flow path opening / closing means 83 is opened, the fifth flow path opening / closing means 85 is closed, and the first liquid feed pump 11 is rotated at a predetermined rotational speed ( Preferably, it operates (reverses) at about 30 to 150 mL / min (for example, 90 mL / min).

  Thereby, the plasma collected in the plasma collection bag 25 is supplied to the first line (the blood collection needle side first line 21a) via the tube 44, the tube 43, the second line 22 and the centrifuge 20; At that time, substantially all of the red blood cells (concentrated red blood cells) remaining in the centrifuge 20 and in the first line 21 are swept away by the plasma and returned to the donor.

  Note that the amount of plasma supplied from the plasma collection bag 25 to the first line 21 during the red blood cell return process is preferably about 10 to 50 mL as described above.

After the plasma is supplied, the third flow path opening / closing means 83 is closed and the fifth flow path opening / closing means 85 is opened. Thereafter, the air discharged from the centrifugal separator 20 is detected by the bubble sensor 32 and the first liquid feed pump 11 is rotated a predetermined number of times, and then the first flow path opening / closing means 81 and the fifth flow path. The opening / closing means 85 is closed, the first liquid pump 11 is stopped, the red blood cell return step is ended, and this step [18] (blood return step) is ended.
Thereby, the platelet collection operation in the first cycle is completed.

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

  In the platelet collection operation of the second cycle, the same steps as the platelet collection operation of the first cycle are performed as follows.

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

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

In the platelet collection operation of the final cycle, the same process as the platelet collection operation of the first cycle is performed except that a filtration step of separating and removing white blood cells from the concentrated platelets is performed. The filtration process will be described in detail later.
[31] to [37] Steps similar to the steps [11] to [17] are performed, respectively.

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

In the final cycle, the red blood cell return step does not have to be performed.
Next, the filtration process will be described.

  In the present embodiment, almost simultaneously with the second plasma collection step, the control unit 13 supplies the concentrated platelets temporarily collected (stored) in the intermediate bag 27a to the leukocyte removal filter 261 to concentrate the platelets. Filtration of platelets, that is, separation and removal of white blood cells in concentrated platelets.

  Specifically, before the step S104, the seventh flow path opening / closing means 87 is opened under the control of the control unit 13 to start the filtration process (not shown). Needless to say, the timing of starting the filtration step is not limited to this.

  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 by 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.

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

  Further, the seventh flow path opening / closing means 87 may be a clamp or the like that can manually open and close the middle of the flow path of the tube 47 instead of the one operated by the control of the control unit 13.

  Moreover, the platelet remaining in the tube 48 can be more reliably collected in the platelet collection bag 26 by opening the cap of the filter 22h after the filtration step.

  The number of platelet collection operations can be set to any number of one or more.

The configuration of the platelet collection circuit 2 can be set as appropriate, and is not limited to the configuration shown in the figure.
In addition, when the number of cycles is a plurality of times, the red blood cell return step is not limited to being performed every time, and may be performed at least once in any one of the first cycle to the final cycle, for example. Further, when not performed every time, it is preferably performed at least once in any cycle of the cycle before the first cycle to the last cycle, and more preferably performed in the initial cycle.

  As described above, according to this blood component collection device 1, when the blood components (remaining blood components) in the blood storage space 146 of the rotor 142 are returned to the donor, plasma collection is performed by performing the red blood cell return step. Since a predetermined amount of plasma in the bag 25 can be supplied to the first line 21 and almost all of the red blood cells (concentrated red blood cells) remaining in the first line 21 can be returned to the donor, blood in the next cycle In the component collection step, it is possible to prevent the concentrated red blood cells remaining in the blood component collection step from passing through the first liquid feeding pump 11 and the introduction of the remaining concentrated red blood cells into the centrifuge 20. Thereby, a desired blood component with high quality can be collected in each cycle.

  In addition, by performing the red blood cell return step, the plasma collected in the plasma collection bag 25 can be supplied to the first line, and the red blood cells remaining in the first line 21 can be returned to the donor. In the blood component collecting step of the cycle, the amount of blood (particularly, the amount of plasma and platelets) introduced into the centrifuge 20 can be increased. For this reason, since more blood components can be collected in one cycle, blood components can be collected efficiently.

  In the present embodiment, the red blood cell return process is started when the amount of blood in the blood storage space 146 reaches a predetermined amount in the blood return process, but the blood is not substantially present in the blood storage space 146. You may start.

  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.

Next, a second embodiment of the blood component collection device of the present invention will be described.
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.

  The blood component collection device 1 of the second embodiment supplies the plasma collected in the plasma collection bag 25 to the first line 21 via the third line 37 in the red blood cell return process in the first embodiment. Is different.

  In the present embodiment, when used, the plasma collection bag 25 is set so as to be higher than the first line 21 (upward in the vertical direction) and so that the plasma outlet side of the plasma collection bag 25 is in the lower vertical direction. The As a result, the plasma in the plasma collection bag 25 can be easily and reliably supplied to the first line 21 via the third line 37 and the branch connector 21f due to a drop (self-weight).

  In the red blood cell return process of the present embodiment, during the blood return process, the fluid flowing through the part where the bubble sensor 32 of the blood collection needle side first line 21a is provided by the bubble sensor (detection means) 32 is gas from blood This is started when it is detected that the air has changed, that is, when air (gas) flowing through the part of the blood collection needle side first line 21a where the bubble sensor 32 is provided is detected.

  When it is detected that the fluid flowing through the site where the bubble sensor 32 of the blood collection needle side first line 21 a is provided has changed from blood to gas, the control unit 13 moves into the blood storage space 146 of the centrifuge 20. It is determined that the blood component stored in is not substantially present.

Next, the operation | movement in the erythrocyte return process of this embodiment is demonstrated.
First, under the control of the control unit 13, the second flow path opening / closing means 82 is opened, the fifth flow path opening / closing means 85 is closed, and the first liquid feed pump 11 is stopped.

  Thereby, the plasma in the plasma collection bag 25 flows toward the blood collection needle 29 through the third line 37 through the third line 37 due to a drop (self-weight). As a result, red blood cells (concentrated red blood cells) remaining in the first line 21 are swept away by the plasma and returned to the donor.

  When the weight sensor 16 detects that the plasma in the plasma collection bag 25 has decreased by a predetermined amount, the control unit 13 closes the first flow path opening / closing means 81 and the second flow path opening / closing means 82. This completes the red blood cell return process.

  According to this blood component collection device 1, the same effect as the blood component collection device 1 of the first embodiment described above can be obtained.

  In the blood component collection device 1, the plasma in the plasma collection bag 25 can be easily supplied to the first line 21 by using the head.

  In the present embodiment, the method for returning the red blood cells by introducing plasma in the red blood cell return step is not limited to the method using the head described in the present embodiment, and for example, in the same manner as in the first embodiment, a liquid feed pump 11 may be activated to supply plasma collected in the plasma collection bag to the first line and return red blood cells to the donor.

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

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

  The blood component collection apparatus 1 of the present embodiment is an apparatus that can obtain a platelet preparation and a plasma preparation. In the present invention, the blood component collection apparatus 1 is applied to an apparatus that can obtain only a platelet preparation or an apparatus that obtains only a plasma preparation. Also good.

  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, for example, a leukocyte preparation, an erythrocyte preparation from blood.

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 of the blood component collection device shown in FIG. It is a flowchart for demonstrating the effect | action of the blood component collection device shown in FIG.

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 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 Second Line 22b Branch connector 22c Branch connector 22d Branch connector 22e Branch connector 22f Filter 22g Branch connector 22h Filter 23 Fourth line 23a Pump tube 23b Disinfection filter 23c Bubble removal chamber 23 d 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 37 Third line 41-51 Tube 81-87 First -Seventh channel opening / closing means 131 Plasma layer 132 Buffy coat layer 133 Red blood cell layer 141 Tubular body 142 Rotor 143 Inlet port 144 Outlet port 145 Upper portion 146 Blood storage space 147 Reflecting surface 201 Housing 202 Leg portion 203 Motor 204 Rotating shaft 205 Fixing base 206 Bolt 207 Spacer S101-S124 Step

Claims (5)

Blood collection means for collecting blood from a donor,
A centrifuge having an inlet and an outlet, and centrifuges blood collected by the blood collection means and introduced from the inlet;
A first line connecting the inlet and the blood collection means;
A second line connected to the outlet;
A plasma collection bag connected to the second line for collecting plasma separated by the centrifuge ;
A blood component collection circuit comprising a third line branched from the middle of the first line and connected to the plasma collection bag ;
Blood that is subjected to a plurality of cycles of blood component collection, which includes centrifugation of blood collected from the blood donor and collecting at least blood plasma, and blood component collection operation including a blood component return step of returning the remaining blood components to the blood donor A component collecting device,
In the blood component collection operation of at least one cycle excluding the final cycle of the plurality of cycles, the plasma collected in the plasma collection bag during the blood component return step is passed through the third line. A blood component configured to perform a red blood cell return step of supplying red blood cells supplied to the first line and returning red blood cells remaining in the first line to the blood donor via the blood collecting means Collection device. The blood component collection circuit further includes a platelet collection bag that branches from the middle of the second line and collects platelets separated by the centrifuge,
The blood component collection device, in the blood component collection process, the blood component collection apparatus according to claim 1 which is configured to collect plasma and platelets. The blood component collection device according to claim 1 or 2 , wherein the plasma supplied to the first line via the third line during the red blood cell return step is supplied by a drop. Furthermore, it has a detection means for detecting the gas in the first line,
When returning the remaining blood components to the donor, the air of the first in the line is detected by the detection unit, according to any one of claims 1 to 3 starts the erythrocyte return step Blood component collection device. When using the blood component collection device, wherein the plasma collection bag, wherein when running the red blood return step, to the outlet side of the plasma in the plasma collection bag claims 1 provided so as to vertically downward 4 The blood component collection device according to any one of the above.

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