JPH08117330A - Device for separating blood components and method for separating and transporting blood components - Google Patents

Abstract

PURPOSE: To improve the yield of desired blood component or the removal rate of other blood components in the blood component in a condition where a blood depot space is substantially filled with separated blood component by starting a pump under rotation of a rotor to supply the blood plasm to the blood depot space from below and floating blood platelet to recover the same. CONSTITUTION: Blood and blood plasm are introduced from a line 2 into a centrifugal bowl 4 driven by a rotation drive unit 5 through a pump 9, then and introduced to a blood depot 106 through a line 3 and a line 10 after the position of interface of centrifuged blood component is detected by an optical sensor 62. At this time, the blood transported from the blood depot 106 is centrifuged by the centrifugal bowl 4, and the blood plasm thus obtained is deposited in a blood plasm bag 21. Thereafter the blood plasm is supplied from below a rotor 42 through the line 2 to float blood platelet and recover the blood platelet in a blood platelet bag 17 through the line 3. In the operation to recover the blood platelet, the blood plasm is supplied to the rotor 42 at the set rate of 10 to 90ml/min.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component separating apparatus and a blood component separating and transferring method for separating a predetermined blood component from blood.

[0002]

2. Description of the Related Art When collecting blood, at present, for the purpose of effective use of blood and reduction of burden on the donor, the collected blood is separated into blood components by centrifugation etc. Blood is collected from other components that are collected and returned to the donor.

In the case of obtaining a platelet preparation in such component blood collection, blood collected from a blood donor is introduced into a blood component separation circuit, and plasma is collected by a centrifuge called a centrifugal bowl installed in the blood component separation circuit. , White blood cells, platelets and red blood cells are separated, and the platelets therein are collected in a container to obtain a platelet preparation, and the remaining plasma, white blood cells and red blood cells are returned to the donor.

However, in this method, since the specific gravity between leukocytes and platelets is a slight difference, the interface between them is not clear, and thus the removal rate of leukocytes (particularly lymphocytes) in the collected platelets is high. And as a result, hepatitis, AIDS, GVH when using the platelet product
There is a problem that the probability of infection of D etc. increases.

Therefore, there has been proposed a method (surge method) of supplying plasma obtained before the bottom of the centrifuge bowl to float the platelets and recovering the platelets. Since it is as fast as 200 ml / min or more, the leukocyte removal rate in platelets is still low, and the above problems have not been solved.

[0006]

DISCLOSURE OF THE INVENTION An object of the present invention is to provide a blood component separating device and a blood component having a high yield of a desired blood component obtained by centrifugation or a high removal rate of other blood components in the blood component. It is to provide a separation transfer method.

[0007]

These objects are achieved by the present invention described in (1) to (8) below.

(1) A blood component separating device for separating blood into a plurality of blood components and transferring the separated blood components, which is in communication with a rotatable rotor having a blood storing space therein and the blood storing space. A centrifuge having an inflow port and an outflow port, for centrifuging the blood introduced from the inflow port into a plurality of blood components in the blood storage space by rotation of the rotor, and a centrifuge connected to the inflow port. 1 line, a second line connected to the outlet, and a pump installed in the middle of the first line, and the blood storage space is substantially filled with the separated blood components. so,
By operating the pump under the rotation of the rotor, plasma is supplied from below to the blood storage space via the first line.
A blood component separation device, characterized in that the platelets are floated by supplying at ~ 90 ml / min, and the platelets are collected through the second line.

(2) The blood component separation device according to (1) above, which has at least control means for controlling the operation of the pump.

(3) A flow path opening / closing means for opening / closing a flow path is installed in the first line and / or the second line, and the control means operates the flow path opening / closing means together with the operation of the pump. The blood component separation device according to (2) above, which controls the operation.

(4) The blood component according to any one of (1) to (3) above, wherein at least a part of the first line is used both for introducing blood into the blood storing space and for introducing plasma. Separation device.

(5) The blood component separation device according to any one of (1) to (4), wherein the second line has a plurality of branch lines for collecting different blood components.

(6) Using a centrifuge having a rotor having a blood storage space formed therein, blood is introduced into the blood storage space, the blood is centrifuged to separate into a plurality of blood components, and the blood components are separated. A method of separating and transferring a predetermined blood component from the upper side of the rotor and transferring the blood component, wherein plasma is supplied to the blood storage space from below under the rotation of the rotor to float and collect platelets. And a plasma supply rate of 10 to 90 ml /
A method for separating and transferring blood components, which is characterized by setting min.

(7) The ratio of the volume of the red blood cell layer existing in the blood storage space to the volume of the blood storage space is 86-9.
The method for separating and transferring blood components according to (6) above, wherein the supply of the plasma is started in a state of reaching 6%.

(8) The method for separating and transferring blood components according to the above (6) or (7), wherein the interface position of the blood components separated by the sensor is detected, and the supply of the plasma is started based on this detection.

[0016]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The blood component separating apparatus and blood component separating and transferring method of the present invention will be described below in detail with reference to the preferred embodiments shown in the accompanying drawings.

FIG. 1 is a plan view showing a constitutional example of a blood component separating apparatus of the present invention, and FIG. 2 is a block diagram showing a control system of the blood component separating apparatus shown in FIG. As shown in these drawings, the blood component separation device 1 includes a centrifuge bowl (centrifugal separator) 4, a rotation drive device 5 thereof, and a first line 2 for selectively introducing blood and plasma into the centrifuge bowl 4. (Blood or plasma introduction line), second line 3 (blood component collection line) for collecting blood components separated in centrifuge bowl 4, optical sensors 61, 62, control means 7, and blood reservoir It has a third line 10 (a blood removal / returning line assuming a donor) 10 and a pump 9 installed in the first line 2.

As shown in FIG. 1, the third line 10 is
Mainly, a tube 101 and a tube 1 which is connected to the tube 101 via a branch-shaped branch connector 102 in the middle of the tube 101.
03 and blood bags 104 and 105 connected to the tips of the tubes 101 and 103, respectively.
The blood reservoir 106 is formed by the blood bags 104 and 105.
Is configured.

The base end of the tube 101 is connected to one ends of the tubes 13 and 20 via a T-shaped branch connector 12. In the middle of the tube 101, the tube 1
A valve 83, which is a flow path opening / closing means capable of blocking and opening the internal flow path 01, is installed.

The first line 2 comprises a tube 13 and a branch connector 12 connected to one end thereof. The other end of the tube 13 is connected to the inflow port 4 of the centrifuge bowl 4.
3, a pump 9 for liquid delivery, which is a roller pump, is installed in the middle of the tube 13.

As shown in FIG. 3, the centrifuge bowl 4 has a vertically extending tubular body 41 having an inflow port 43 formed at its upper end.
And a rotor 42 that rotates around the tubular body 41 and is liquid-tightly sealed to the upper portion 45. An annular blood storage space 46 is formed inside the rotor 42 along the inner surface of the rotor peripheral wall. The blood storage space 46 has a shape (taper shape) such that the inner and outer diameters thereof gradually decrease from the lower part to the upper part in FIG. The lower portion of the blood storage space 46 communicates with the lower end opening of the tubular body 41 via a substantially disc-shaped flow passage 47 formed along the bottom of the rotor 42, and the upper portion of the blood storage space 46 passes through a flow passage 48. It communicates with the outlet 44. Further, in the rotor 42, the volume of the blood storage space 46 is, for example, about 100 to 350 ml.

The rotor 42 is rotated by the rotary drive device 5 under predetermined centrifugal conditions (rotation speed and rotation time) set in advance. By this centrifugation condition, the separation pattern of blood in the rotor 42 (for example, the number of blood components to be separated) can be set. In the present embodiment, as shown in FIG. 3, the centrifugation conditions are set so that blood is separated from the inner layer into the plasma layer 31, the buffy coat layer 32, and the red blood cell layer 33 in the flow path of the rotor 42.

As shown in FIG. 3, the rotary drive device 5 includes a housing 51 for accommodating the centrifugal bowl 4, a leg portion 52,
It is composed of a motor 53 which is a drive source and a disk-shaped fixed base 55 which holds the centrifugal bowl 4.

The housing 51 is placed and fixed on the upper portion of the leg portion 52. Further, the motor 5 is attached to the lower surface of the housing 51 by a bolt 56 via a spacer 57.
3 is fixed. A fixed base 55 is fitted on the tip of the rotary shaft 54 of the motor 53 so as to rotate coaxially with the rotary shaft 54 and integrally with the rotary shaft 54.
A recess 551 to which the bottom of the rotor 42 is fitted is formed. The upper portion 45 of the centrifuge bowl 4 is fixed to the housing 51 by a fixing member (not shown).

In such a rotary drive device 5, the motor 5
3 is driven, the fixed base 55 and the rotor 42 fixed to the fixed base 55 are rotated at, for example, 3000 to 6000 rpm.
To rotate.

On the inner wall of the housing 51, the rotor 42
An optical sensor 61 that optically detects the position of the interface of the separated blood components in the inside, that is, the position of the interface B between the buffy coat layer 32 and the red blood cell (thickened red blood cell) layer 33 is installed and fixed by the mounting member 58. There is. This optical sensor 6
A line sensor that can scan in the up-down direction along the outer peripheral surface of the rotor 42 is used as 1. That is, L
A light-emitting element such as an ED and a light-receiving element such as a photodiode are arranged in a row, and the reflected light of the blood component of the light emitted from the light-emitting element is received by the light-receiving element, and the received light amount is photoelectrically converted. Is configured to. Since the buffy coat layer 32 and the red blood cell layer 33 that have been separated have different reflected light intensities, the position corresponding to the light receiving element in which the amount of received light, that is, the output voltage has changed is detected as the position of the interface B.

As shown in FIG. 1, one end of the tube 14 is connected to the outlet 44 of the centrifuge bowl 4, and the tube 1
The other end of 4 is connected to one ends of tubes 16 and 18 via a T-shaped branch connector 15.

The other end of the tube 16 is connected to the platelet bag 17
A valve 85 that opens and closes the flow path in the tube 16 is installed in the middle of the tube 16. Also,
The other end of the tube 18 is connected to a bubble removing chamber 19, and a valve 86 for opening and closing a flow path in the tube 18 is installed in the middle of the tube 18.

The other end of the tube 20, one end of which is connected to the branch connector 12, is connected to the bubble removing chamber 19, and a valve 84 for opening and closing the flow path inside the tube 20 is installed in the middle of the tube 20. Has been done.

The air storage bag 22 is a bag for discharging air from the inside of the plasma bag 21 after a series of treatments and storing the air. Therefore, the plasma bag 21 and the air storage bag 22 are connected by the tube 23. The insides of the two communicate with each other. Further, one end of the tube 24 is connected to the plasma bag 21, and the other end of the tube 24 is connected to the bubble removal chamber 19.

In such a structure, the tubes 14,
The second line 3 is constituted by 16, 18, 20, 23, 24, the branch connector 15, the chamber 19 and the bags 17, 21, 22. Of these, tube 1
8, the chamber 19, the tubes 23 and 24, and the bags 21 and 22 constitute a plasma recovery branch line for collecting plasma, and the tubes 14 and 16 and the platelet bag 17 are for collecting platelets for collecting platelets. Configure a branch line.

Although not shown, the plasma bag 2
1 may be set in a device capable of selectively orienting the connecting end of the tube 24 upward or downward.

An optical sensor 62 capable of detecting the concentration of platelets in the blood component flowing in the tube 14 is installed in the middle of the tube 14. This optical sensor 62
Is composed of a light projecting portion (light source) 63 and a light receiving portion (photodiode) 64 which are arranged opposite to each other via the tube 14. The light (for example, laser light) emitted from the light projecting unit 63 passes through the tube 14 and is received by the light receiving unit 64, and is converted into an electric signal corresponding to the received light amount.
Since the transmittance changes according to the platelet concentration in the blood component flowing in the tube 14 and the amount of light received by the light receiving unit 64 changes, this change can be detected as a change in the output voltage from the light receiving unit 64. .

Each of the valves 83 to 86 is operated by a drive source such as a solenoid, an electric motor, a cylinder (hydraulic pressure or pneumatic pressure), and the drive source is operated based on a signal from the control means 7 described later. To do. In the present invention, the flow path opening / closing means is not limited to the valve (cock), but may be, for example, a clamp that holds a flexible tube and can close the lumen thereof.

Each of the bags 17, 21, 22, 104,
Reference numeral 105 denotes a bag-like member formed by stacking flexible sheet materials made of resin, and fusing the peripheral portions thereof (heat fusion, high frequency fusion, etc.) or adhering.

Each bag 17, 21, 22, 104, 10
As a constituent material of the sheet material that constitutes No. 5, for example, soft polyvinyl chloride is preferably used. As the plasticizer in this soft polyvinyl chloride, for example, di (ethylhexyl) phthalate (DEHP), di- (n-decyl) phthalate (DnDP), etc. are used. The content of such a plasticizer is preferably about 30 to 70 parts by weight with respect to 100 parts by weight of polyvinyl chloride.

The bags 17, 21, 22, 10 are also provided.
As another constituent material of the sheet material of Nos. 4 and 105, a polyolefin, that is, a polymer obtained by polymerizing or copolymerizing olefins or diolefins such as ethylene, propylene, butadiene, and isoprene can be used. For example, polyethylene, polypropylene, Examples thereof include an ethylene-vinyl acetate copolymer (EVA), a polymer blend of EVA and various thermoplastic elastomers, and any combination thereof. Further, polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), poly-1,4-cyclohexanedimethyl terephthalate (PCHT), and polyvinylidene chloride can also be used.

The sheet material constituting the platelet bag 17 is preferably excellent in gas permeability in order to improve the shelf life of the platelets. Therefore, for example, as the sheet material, the polyolefin or DnDP plasticized polychlorinated material is used. Vinyl or the like is used, and the thickness of the sheet material is relatively thin (for example, about 0.1 to 0.5 mm, particularly 0.1 to 0.
3 mm) is preferable.

Blood is stored in advance in at least one of the blood bags 104 and 105. In this blood, for example, ACD-A solution, CPD solution, CPD1 solution,
An anticoagulant such as sodium heparin solution is preferably added. The number of blood bags installed in the blood storage unit 106 may be one or three or more, and the connection method and connection pattern thereof may be arbitrary. For example, one or two or more blood bags can be used aseptically connected and exchanged by the tube connecting device described in Japanese Utility Model Laid-Open No. 6-26877.

The platelet bag 17 may be in an empty state, for example, physiological saline, GAC, PAS, PSM.
A platelet preservative such as -1 may be added in advance.

Tubes 101, 103, 13, 14, 1
As the constituent materials of 6, 18, 20, 23 and 24,
For example, polyvinyl chloride, polyethylene, polypropylene, polyesters such as PET and PBT, ethylene-
Examples thereof include thermoplastic elastomers such as vinyl acetate copolymer, polyurethane, polyester elastomer, and styrene-butadiene-styrene copolymer. Among them, polyvinyl chloride is particularly preferable. This is because if each tube is made of polyvinyl chloride, sufficient flexibility and flexibility can be obtained, so that it is easy to handle, and it is also suitable for clogging due to a clamp or the like.

Further, as the constituent material of the branch connectors 102, 12, and 15, the same constituent material as that of the tube can be used.

As shown in FIG. 2, the blood component separation device 1
Has a control means 7 composed of, for example, a microcomputer, and the control means 7 includes the pump 9 and the valve 8
3 to 86, the optical sensors 61 and 62, and the rotation driving device 5 are electrically connected to each other.

The detection signal from the optical sensor 61 (interface position detection information) and the detection signal from the optical sensor 62 (platelet concentration information) are input to the control means 7 as needed. The control means 7 controls the rotation / stop, the rotation direction (forward / reverse rotation) and the rotation speed of the pump 9 based on the detection signals from the optical sensors 61 and 62, and if necessary, the valves 83 to 86. And the operation of the rotary drive unit 5 are controlled.

Next, a preferred embodiment of the blood component separating and transferring method of the present invention using the blood component separating device 1 shown in FIG. 1 will be described.

[1] Each of the blood bags 104 and 105 is filled with, for example, 400 ml of collected blood, and the tube 103 is closed with a clamp so that the valve 8
The pump 9 is operated (normal rotation) with the valves 3 and 85 open and the other valves closed. As a result, the blood bag 10
The blood in 4 is transferred via the tubes 101 and 13 and is introduced into the rotor 42 from the inflow port 43 of the centrifuge bowl 4 via the tube 41. The rotation speed of the pump 9 is such that the blood discharge amount (blood supply speed) is, for example, 30 to 80 ml.
It is set to be about / min.

[2] Simultaneously with the blood transfer in the step [1], the rotary drive device 5 is operated to rotate the rotor 42 preferably at 3000 to 6000 rpm (for example, 4800 rpm).
rpm). The blood flowing out from the lower end opening of the tubular body 41 is subjected to the centrifugal force generated by the rotation of the rotor 42, so
7 flow radially toward the outer circumference and are collected in the blood storage space 46. In the blood storage space 46, the plasma layer 31 from the inner layer,
The buffy coat layer 32 and the red blood cell layer 33 are separated.

[3] When the plasma layer 31 reaches the upper part of the blood storage space 46 while continuing the steps [1] and [2],
The valve 85 is closed and the valve 86 is opened. As a result, the plasma in the rotor 42 overflows from the outlet 44, and the tubes 14, 18, the chamber 19, and the tube 2
4 is collected in the plasma bag 21.

[4] As the plasma is discharged from the rotor 42, the interface B between the buffy coat layer 32 and the red blood cell layer 33 also gradually rises. This interface B is an optical sensor 61
When it is detected that the interface B has reached a predetermined level (surge start level), the control means 7 determines, based on the detection signal (interface position detection information),
The valve 83 is controlled to be closed and the valve 84 is controlled to be opened. As a result, the transfer of blood and the collection of plasma are completed.

The surge initiation level is preferably when the ratio of the volume of the red blood cell layer 33 existing in the blood storage space 46 to the volume of the blood storage space 46 reaches 86 to 96%, more preferably 92 to 94%. Level. This ratio is a larger value than in the past. That is,
As will be described later, in the next surge step [5], platelets are floated against the centrifugal force due to the supply of plasma, but since the plasma supply rate is low, the platelets are floated out of the buffy coat layer 32. In order to do so, it is necessary to reduce the centrifugal force acting on the platelets. Therefore, the ratio is made larger than in the conventional case and the distance of the buffy coat layer 32 from the center of rotation of the rotor 42 is reduced. Therefore, the ratio is 8
If it is less than 6%, the recovery rate of platelets in the surge process becomes low. Further, when the ratio exceeds 96%, the centrifugal force acting is too small, so that the platelets float up with leukocytes depending on the conditions such as the plasma supply rate in the surge step, and the leukocytes in the collected platelets are The removal rate decreases.

[5] Subsequently, the valves 84 and 85 are opened and the other valves are closed under the control of the control means 7.
While operating (normally rotating) the pump 9, the connection side end of the tube 24 of the plasma bag 21 is directed downward to transfer the plasma in the plasma bag 21 to the tube 24, the chamber 19 and the tube 2.
It is supplied into the rotor 42 through 0, 13 and the tube 41. The plasma flowing out from the lower end opening of the tubular body 41 radially flows in the flow passage 47 toward the outer peripheral direction by the centrifugal force generated by the rotation of the rotor 42, and rises in the blood storage space 46 via the lower portion of the blood storage space 46. As a result, the platelets in the buffy coat layer 32 float (float) against the centrifugal force, flow out from the outlet 44 via the flow path 48, and are collected in the platelet bag 17 via the tubes 14 and 16. (Surge process).

In this surge process, the control means 7
By controlling the rotation speed of the pump 9 (the amount of discharged plasma), the supply speed of the plasma into the rotor 42 is 10 to 90 ml.
/ Min, preferably 10-70 ml / min. If the plasma supply rate is less than 10 ml / min, it will take a long time to collect platelets, and if it exceeds 90 ml / min, the leukocyte floatation amount will increase together with the platelets, and the removal rate of leukocytes in the collected platelets will decrease. Is.

During the collection of platelets, the plasma supply rate may be appropriately changed within the range of 10 to 90 ml / min. In this case, the maximum supply rate of plasma is 25 to 90
It is preferably set to ml / min, particularly 30 to 70 ml / min. Such a change in the plasma supply rate can be performed based on, for example, a timer built in the control means 7 or according to platelet concentration information detected by the optical sensor 62.

In this surge process, the rotation speed of the rotor 42 may be the same as or different from that in the process [1].

[6] If the platelet concentration detected by the optical sensor 62 becomes less than or equal to a preset reference value,
Considering that the collection of platelets into the platelet bag 17 has been completed, the control means 7 controls the pump 9 to stop the supply of plasma into the rotor 42 and further the rotation drive device 5. This completes the collection of platelets in the surge process.

[7] The valves 83 and 85 are opened and the other valves are closed, and the pump 9 is rotated in the reverse direction. This allows
Red blood cells, white blood cells, and a small amount of plasma remaining in the centrifuge bowl 4 are returned to the blood bag 104 via the tube 41, the tubes 13 and 101.

After or during this step, the valves 84 and 86 are opened and the other valves are closed, so that the pump 9
Is operated (normal rotation), the plasma in the plasma bag 21 is put into the rotor 42 through the tube 24, the chamber 19, and the tubes 20 and 13, and subsequently the valves 83 and 85 are opened.
The other valves are closed, the pump 9 is rotated in the reverse direction, and the plasma in the centrifuge bowl 4 transferred from the plasma bag 21 is transferred to the tubular body 4.
1, blood bag 104 through tubes 13 and 101
You may return blood inside.

[8] The middle of the tube 101 between the branch connector 102 and the blood bag 104 is sealed by, for example, fusion bonding, and the sealed portion is cut and separated. As a result, the blood bag 104 containing the platelet poor blood for blood return is obtained. The platelet poor blood in the blood bag 104 is returned to the donor as needed.

[9] The blockage of the tube 103 due to the clamp is released, the pump 9 is operated (normal rotation), the step [1] is performed, and the steps [2] to [7] are performed.
As a result, the blood collected in the blood bag 105 is recovered in the platelet bag 17 and the other blood components are returned to the blood bag 105.

[10] The tube 103 is sealed in the middle by, for example, fusion bonding, and the sealed portion is cut and separated. As a result, the blood bag 105 containing platelet poor blood for blood return is obtained. The platelet poor blood in the blood bag 105 is returned to the donor as needed.

[11] The tube 16 near the platelet bag 17 is sealed by, for example, fusion bonding, and the sealed portion is cut and separated to obtain the platelet bag 17 containing the platelet preparation.

As described above, according to the present invention, the rotor 42
In the step of supplying plasma to the inside to float and recover the platelets, the plasma supply rate is set to 10 to 90 ml / min to optimally adjust the floating of the platelets, and thus the leukocyte removal rate is extremely high. A high quality platelet product is obtained. Moreover, since the optical sensor 61 detects the interface of the separated blood components and controls the timing of the start of plasma supply (the end of blood supply) based on that, it becomes possible to perform more precise control together with the automation. And the removal rate of leukocytes in the collected platelets are further improved. Therefore, when the platelet preparation is used, infection with hepatitis, AIDS, GVHD and the like can be prevented with a higher probability, and the safety is high.

Next, the present invention will be described in more detail based on specific examples. Using the blood component separation device having the configuration shown in FIGS. 1 and 2, a platelet preparation was prepared by the method described above. The conditions of the surge process were as follows.

(Example 1) When the ratio of the volume of the red blood cell layer 33 existing in the blood storage space 46 to the volume of the blood storage space 46 reaches 92%, the transfer of blood to the rotor 42 is stopped and the plasma is supplied. Started. First, plasma supply rate 40
ml / min for 20 seconds, then plasma feeding rate 14 ml / min
Plasma was supplied for 80 seconds.

Optical sensor 62 in this surge process
FIG. 4 shows the time-dependent change in the received light level (output voltage) of. In the graph of the figure, the lower the received light level, the more the centrifugal bowl 4
It shows that the blood component flowing out from the blood has a high platelet concentration, and the received light level is 1.5 V at the maximum platelet concentration.
When red blood cells are mixed, the light receiving level becomes less than 1.5V. As shown in the graph of FIG.
Approximately 15 seconds later, platelet outflow was observed, and the plasma supply rate was 14 seconds after 20 seconds from the start of plasma supply.
It is reduced to ml / min, which gradually retreats the leukocyte layer in the blood storage space, suppresses its outflow, and starts 3 hours from the start of plasma supply.
The platelet concentration reached the maximum concentration at 0 seconds, the platelet concentration gradually decreased from about 50 seconds after the start of plasma supply, and the plasma supply was stopped at 100 seconds after the start of plasma supply.

The conditions relating to the blood used in Example 1 and the collected platelets are shown in Table 1 below.

[0067]

[Table 1]

(Comparative Example 1) When the ratio of the volume of the red blood cell layer 33 existing in the blood storage space 46 to the volume of the blood storage space 46 reaches 78%, the transfer of blood to the rotor 42 is stopped and the plasma is supplied. The procedure was the same as in Example 1 except that the plasma supply was started and the plasma supply rate was 220 ml / min for 40 seconds.

Table 2 below shows the conditions relating to the blood provided in Comparative Example 1 and the collected platelets.

[0070]

[Table 2]

[Discussion] As shown in Table 1 above, Example 1
Then, the plasma supply rate was low, especially because the plasma supply rate was lowered from 40 ml / min to 14 ml / min in the middle,
The amount of leukocytes in the collected platelet-rich plasma was 500.
Very small quantity / μl. Further, as shown in the graph of FIG. 4, since the minimum value of the light receiving level is 1.5V,
It was confirmed that there was no contamination of red blood cells.

On the other hand, as shown in Table 2 above, in Comparative Example 1, since the plasma supply rate was high, the amount of leukocytes mixed in the collected concentrated platelet plasma was 3100 / μl.
And many.

(Embodiment 2) When the ratio of the volume of the red blood cell layer 33 existing in the blood storage space 46 to the volume of the blood storage space 46 reaches 92%, the transfer of blood to the rotor 42 is stopped and the supply of plasma is stopped. Start and supply plasma at a rotor speed of 5083 rpm and a plasma supply rate of 26 ml /
The same procedure as in Example 1 was carried out except that the operation was performed for 140 seconds at min.

The concentrated platelet plasma flowing out from the centrifuge bowl 4 is sampled every 6 ml, and the platelets (PLT), white blood cells (WBC) and red blood cells (RB) in the sampling solution are sampled.
C) is a blood cell counter (SYSMEX K-2 manufactured by Toa Denshi Co., Ltd.
000). The result is shown in the graph of FIG.

Comparative Example 2 When the ratio of the volume of the red blood cell layer 33 existing in the blood storage space 46 to the volume of the blood storage space 46 reaches 80%, the transfer of blood to the rotor 42 is stopped and the plasma is supplied. Start and supply plasma at a rotor speed of 5083 rpm and a plasma supply rate of 100 ml.
The same procedure as in Example 1 was carried out except that the operation was performed at 70 rpm for 70 seconds.

The concentrated platelet plasma flowing out from the centrifuge bowl 4 was sampled every 6 ml, and the platelets (PLT), white blood cells (WBC) and red blood cells (RB) in the sampling solution were sampled.
The number of C) was counted by the same hemocytometer as described above. The result is shown in the graph of FIG.

[Discussion] As shown in the graph of FIG. 5, in Example 2, the concentration of platelets flowing out from the centrifuge bowl 4 reached a peak, and even if the concentration was reduced, leukocytes and red blood cells were observed to flow out. However, it was confirmed that platelet-poor plasma only flows out even if this state is continued, and stable platelet collection with very little white blood cell contamination is possible.

On the other hand, as shown in the graph of FIG.
In Comparative Example 2, since the concentration of white blood cells begins to increase when the concentration of platelets flowing out from the centrifugal bowl 4 reaches a peak, it is not possible to selectively collect only platelets, and High white blood cell concentration. In order to avoid this, the surge must be terminated at a certain point in time, but the timing of this surge termination is different each time due to various conditions, and high precision is required for detection and control of that timing. The white blood cell concentration in the collected platelets tends to vary.

Although the present invention has been described based on the embodiments, the circuit configuration and the like used in the apparatus and method of the present invention are not limited to those shown in the drawings. For example, the third line 10 is With a puncture needle that punctures the blood vessel of a blood donor
It may be a blood return line. Further, the plasma recovery branch line or the platelet recovery branch line may be omitted. Further, a flow path opening / closing means such as a valve may be provided in the middle of the tube 13 or 24. Moreover, a pump may be provided in the second line 3 or the third line 10.

The blood component separating apparatus and the blood component separating and transferring method of the present invention are not limited to the case of being used for the production of the above-mentioned platelet preparation, but are applicable to the production of other blood preparations, the washing of blood components, etc. can do.

[0081]

As described above, according to the blood component separating apparatus and the blood component separating / transferring method of the present invention, when performing separation into a plurality of blood components and transferring of blood components, more accurate separation, It becomes possible to transfer, and in particular, when it is applied to blood collection of components, a high-quality blood product having an extremely high leukocyte (particularly lymphocyte) removal rate can be obtained. As a result, hepatitis,
Infections such as AIDS and GVHD can be prevented with a higher probability, and the safety is high.

Particularly, the supply of plasma is started when the volume ratio of the red blood cell layer existing in the blood storage space to the volume of the blood storage space formed in the rotor of the centrifuge reaches 86 to 96%. In this case, the recovery rate of platelets in the obtained blood product is improved and the removal rate of leukocytes is further improved.

Further, when the interface position of the blood components separated by the sensor is detected and the plasma supply is started based on this detection, the proper plasma supply start timing can be automatically detected. The above effect becomes more remarkable.

[Brief description of drawings]

FIG. 1 is a plan view schematically showing a configuration example of a blood component separation device of the present invention.

FIG. 2 is a block diagram showing a control system of the blood component separation device shown in FIG.

FIG. 3 is a partial sectional front view showing a configuration example of a centrifuge bowl and a rotation drive device according to the present invention.

FIG. 4 is a graph showing changes over time in the platelet concentration (light receiving level of the optical sensor) in the outflowing blood component in the surge process (platelet collection process) in the example of the present invention.

FIG. 5 is a graph showing changes over time in the concentration of each blood component that has flowed out in the surge process (platelet collection process) in the example of the present invention.

FIG. 6 is a surge process (platelet recovery process) in a comparative example.
5 is a graph showing the change over time in the concentration of each blood component that has flowed out.

[Explanation of symbols]

 1 Blood Component Separation and Transfer Device 2 First Line 3 Second Line 4 Centrifugal Bowl 41 Tubular Body 42 Rotor 43 Inlet 44 Outlet 45 Upper 46 Blood Storage Space 47, 48 Flow Path 5 Rotation Drive 51 Housing 52 Leg 53 Motor 54 Rotating shaft 55 Fixed base 551 Recessed portion 56 Bolt 57 Spacer 58 Mounting member 61, 62 Optical sensor 63 Light emitting portion 64 Light receiving portion 7 Control means 83 to 86 Valve 9 Pump 10 Third line 101 Tube 102 Branch connector 103 Tube 104 , 105 blood bag 106 blood storage part 12 branch connector 13, 14 tube 15 branch connector 16 tube 17 platelet bag 18 tube 19 chamber 20 tube 21 plasma bag 22 air storage bag 23, 24 tube 31 plasma layer 32 Buffy coat layer 33 Red blood cell layer B interface

Claims (4)

[Claims] 1. A blood component separation device for separating blood into a plurality of blood components and transferring the separated blood components, the rotatable rotor having a blood storage space therein, and a flow communicating with the blood storage space. A centrifuge having an inlet and an outlet for centrifuging the blood introduced from the inlet by the rotation of the rotor into a plurality of blood components in the blood storage space; and a first separator connected to the inlet. Line, a second line connected to the outlet, and a pump installed in the middle of the first line, in a state where the blood component separated in the blood storage space is substantially filled. Operating the pump under rotation of the rotor,
Plasma is supplied from below to the blood storage space through the first line at a rate of 10 to 90 ml / min to float the platelets and collect the platelets through the second line. Blood component separation device. 2. A centrifuge having a rotor having a blood storage space formed therein is used, blood is introduced into the blood storage space, and the blood is centrifuged to separate into a plurality of blood components. A method for separating and transferring a predetermined blood component from the upper side of the rotor, which comprises transferring plasma from below into the blood storage space under the rotation of the rotor to float and collect platelets. And a blood supply rate of 10 to 90 ml / min in the step. 3. The blood component according to claim 2, wherein the supply of the plasma is started when the ratio of the volume of the red blood cell layer existing in the blood storage space to the volume of the blood storage space reaches 86 to 96%. Separation and transfer method. 4. The method for separating and transferring blood components according to claim 2, wherein the interface position of the blood components separated by the sensor is detected, and the supply of the plasma is started based on this detection.