JPH0788179A - Blood plasma exchange device - Google Patents

Abstract

PURPOSE:To constitute the device so that a blood corpuscle component which remains in a blood plasma exchanging circuit can also be returned effectively, and also, without using a physiological saline solution. CONSTITUTION:This blood plasma exchange device is a device for controlling a blood plasma exchanging circuit in which a blood extracting needle, a blood storage vessel 12, a blood plasma separator 15, a blood plasma extraction vessel 20, and a purification blood plasma containing vessel 26 are connected as desired by a tube, and is provided with circuit opening/closing means 33, 34, 35, 36 and 37 and a liquid feeding means 63. After the extraction of blood plasma is finished, the opening/closing means 33, 35, 36 and 37, and 34 are set to a closed state and an open state, respectively, purification blood plasma in the vessel 26 is guide into the vessel 12 by the liquid feeding means 63, and thereafter, the opening/closing means 33, 35 and 36, and 34 and 37 are set to an open state and a closed state, respectively, the vessel 26 is pressurized and the purification blood plasma is fed through the blood plasma separator 15, and a blood corpuscle component which remains in the circuit is returned to a patient together with the purification blood plasma.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to plasma purification in which plasma containing a harmful substance is collected from a patient whose component is in the blood of his own, and the harmful substance is removed and returned to the patient again. The present invention relates to a plasmapheresis device used for therapy and the like.

[0002]

2. Description of the Related Art Albumin, immunoglobulins (IgG, IgA, IgM), proteins such as fibrinogen, and other nucleic acids, lipids, etc. are contained in human plasma. These components maintain their systematic balance by various mechanisms in the body, but may lose their balance due to some extrinsic or intrinsic factors. It is known that this causes abnormal generation or increase of a specific component in plasma, resulting in various diseases.

Examples of these diseases include renal diseases involving immune (acute rejection at the time of renal transplantation, GOODPASTURE syndrome, etc.), collagen diseases (rheumatoid arthritis, systemic lupus erythematosus, myasthenia gravis, Graves' disease, self Immune hemolytic anemia, etc., Plasma protein abnormalities (multiple myeloma, primary macroglobulinemia, etc.), Cholesterol (low density lipoprotein) metabolism disorders (familial hypercholesterolemia), liver disease (Bilirubinemia, etc.), drug poisoning, etc. are known. As these treatment methods, so-called plasma exchange therapy is performed, in which plasma containing harmful substances is separated and removed, and fresh frozen plasma, albumin preparation and the like are supplemented as replacement fluid, and its clinical effect has been confirmed. However, this plasma exchange therapy has a problem that a large amount of the replacement liquid is required because the plasma of the patient is replaced with the replacement liquid. Also, when an albumin preparation is used as a replacement solution, it does not supplement all the necessary plasma components, while when fresh frozen plasma is used as a replacement solution, it is used as a plasma source for another person, so hepatitis and acquired immunity There are also problems of infection with insufficiency syndrome (AIDS) and development of allergies.

Therefore, a plasma purification method has been proposed in which plasma containing a pathogenic substance is separated from a patient, the pathogenic substance is removed, and the plasma is returned to the patient again. In this plasma purification therapy, blood is taken out of the body from a patient by a pump or the like at a flow rate of about 100 ml / min, and this blood is separated into blood cell components and plasma by a centrifugal separation method or a membrane separation method. Is removed, the purified plasma is mixed with blood cell components and returned to the patient again.

The inventor of the present invention has investigated plasma purification therapy using the plasma of the patient himself, which does not have the problems of the above-described plasma purification therapy by the extracorporeal blood circulation system, and has been investigated as such plasma purification therapy. After considering the plasma exchange device to be used, it has a blood collection circuit, a plasma separation means, a plasma adding circuit for purification, a blood return circuit, etc., and after separating and collecting the plasma containing the pathogenic substance from the patient, A plasma exchange device was invented, which was purified by salting-out treatment, and when the next plasma was collected, the purified plasma was added to the blood cell components separated by the plasma separation means and the blood was infused to the patient. March 3, 1993 Filed a patent on the date.

[0006]

However, in such a device, blood cell components remain between the blood collection circuit and the purification plasma addition circuit, particularly between the plasma separation means and the purification plasma addition circuit. And after a series of operations,
Blood cell components useful for the living body are wastefully discarded together with the circuit. Especially in cases where plasma purification therapy is applied,
Since it is often accompanied by anemia such as rheumatoid arthritis, it is desirable to return more blood cell components to the patient, and discarding the blood cell components as they are can be said to be a considerably serious loss.

As a means for solving such a problem, as in the case of the conventional plasma separation device, the circuit is washed with physiological saline after the end of plasma collection to return the remaining blood cell components to the patient. Can be considered. However, in order to wash the circuit with physiological saline, attach a container containing physiological saline to the circuit in advance, or remove the bottle needle connected to the container containing anticoagulant after removing plasma, for example Since it has to be connected to a container, the manufacturing cost is high in the former case and the latter case is not hygienic. Further, in order to sufficiently clean the inside of the circuit, a certain amount of physiological saline is required, but infusion of a large amount of physiological saline causes discomfort to the patient.

[0008]

Therefore, an object of the present invention is to solve the above-mentioned problems and to effectively return blood cell components remaining in the plasma exchange circuit, and also to return plasma exchange without using physiological saline. A device is provided.

What achieves the above object is the plasma exchange device described in (1) below. Further, the following (2) to (5) are preferable.

(1) A blood collection circuit for collecting whole blood from a patient, a plasma separation means for separating whole blood into a plasma component containing a pathogenic substance and a blood cell component, and a plasma component separated by the plasma separation means A plasma collection container for collecting, and a purification plasma addition circuit for adding purification plasma that does not substantially contain a pathogenic substance to the blood cell components separated by the plasma separation means,
A plasma exchange device for controlling a plasma exchange circuit having at least a blood return circuit for returning blood cell components and purified plasma to a patient, wherein the plasma exchange device opens and closes a predetermined portion of the plasma exchange circuit. Circuit opening / closing means and at least a control part having a function of controlling opening / closing of the circuit by the circuit opening / closing means, and by the control part, after the plasma collection is completed, the purified plasma is added to the purified plasma adding circuit and A plasma exchange apparatus, wherein the circuit opening / closing means is controlled so as to be delivered to the blood collecting circuit via the plasma separating means.

(2) The plasma exchange apparatus has a weight detection unit for detecting the weight of the plasma collection container, and the weight detected by the weight detection unit has reached a preset target plasma collection amount. At this time, after the plasma collection is completed by the control means,
The plasma exchange device according to (1), wherein the circuit opening / closing means is controlled so as to send the purified plasma to the blood collecting circuit via the purified plasma adding circuit and the plasma separating means.

(3) The plasma exchange apparatus has a purification plasma delivery amount detecting means for detecting the amount of purification plasma delivered to the purification plasma adding circuit, and the delivery amount detecting means The detected amount of purified plasma delivery is compared with a preset target infusion purification plasma amount, and the difference between the target infusion purification plasma amount and the delivery amount is equal to or less than a preset purification plasma residual amount value. When it becomes, the circuit opening / closing means is controlled by the control unit so as to deliver the purifying plasma to the blood collecting circuit via the purifying plasma adding circuit and the plasma separating means. The plasmapheresis device according to 1) or 2).

(4) The amount of residual blood plasma for purification is 30 to 2
The plasmapheresis apparatus according to (3) above, which is 00 ml.

(5) The plasma exchange apparatus according to any one of the above (1) to (4), which has a liquid feeding means for feeding the purification plasma to the purification plasma addition circuit.

The plasmapheresis apparatus of the present invention will be described with reference to the embodiments shown in the drawings. A schematic diagram of the basic configuration of the plasmapheresis apparatus 1 of this embodiment is shown in FIG. It should be noted that FIG. 1 shows the plasma exchange apparatus 1 with the plasma exchange circuit attached.

The plasma exchange apparatus 1 is a plasma exchange apparatus for controlling a plasma exchange circuit. This plasma exchange device 1
The blood sampling circuit attached to the blood sampling circuit is a blood sampling circuit for collecting whole blood from a patient, an anticoagulant addition circuit for adding a blood anticoagulant to the collected whole blood, and an anticoagulant is added. A plasma separation means for separating whole blood into plasma components containing pathogenic substances (hereinafter simply referred to as “plasma components”) and blood cell components; and a plasma collection container for collecting the plasma components separated by the plasma separation means, A purifying plasma adding circuit for adding purifying plasma to the blood cell components separated by the plasma separating means,
At least a blood return circuit for returning the blood cell component and the plasma for purification to the patient.

In the plasma exchange circuit shown in FIG. 1, the blood collecting circuit includes a blood collecting needle 11, a blood collecting container 12, and a blood collecting needle 11.
And a first blood supply tube 13 that communicates with the blood collection container 12. As the plasma separation means, a plasma separator 15
Is used. The second blood supply vessel 16 is connected to the first blood supply vessel 13 in the vicinity of the blood collection container 12, and introduces blood from the blood collection container 12 into the blood inlet of the plasma separator 15. Further, the purification plasma storage container 26 is in communication with the first blood supply vessel 13 by the purification plasma transportation pipe 27, and constitutes a purification plasma addition circuit. The blood cell component outlet of the plasma separator 15 and the first blood supply vessel 13 communicate with each other by the third blood supply vessel 17, and form a blood return circuit. The plasma outlet of the plasma separator 15 and the plasma collection container 20 communicate with each other via a plasma transportation pipe 21. Further, the anticoagulant storage container 23 communicates with the blood collection container 12 through the anticoagulant transport pipe 24, and constitutes an anticoagulant addition circuit. In addition,
The plasma collection circuit is not limited to that shown in FIG.
For example, the first blood vessel, the second blood vessel, the anticoagulant transport tube,
It may be directly connected to a blood collection container, and instead of providing an anticoagulant addition circuit, for example, heparin, prostaglandins, urokinase, streptokinase, sulfated polysaccharide may be added to a tube or a container forming a plasma exchange circuit. , Anti-thrombogenic substances such as albumin, polyhydroxyethyl methacrylate-polystyrene block copolymer (HEMA-St), etc. may be bound directly or through an appropriate coupling agent, and tubes may be block copolymer of polypropylene oxide and nylon 610. The plasma exchange circuit itself may be anticoagulated by being made of an antithrombotic material such as a polymer.

In the plasma exchange apparatus 1, the blood collection container storage section 30, the decompression / pressurization means 32 for pressurizing and depressurizing the inside of the blood collection container storage section 30, and the plasma separator 15 are detachably attached. In order to open and close the plasma separator attachment part and the first blood supply tube 13 of the plasma collection circuit, the circuit is opened and closed at a position closer to the blood collection needle than the connection part of the purification plasma transport tube 27 with the first blood supply tube 13. The blood collection container 1 is connected to the first circuit opening / closing means 33 and the connection portion of the purification plasma transport tube 27 with the first blood supply tube 13.
Second circuit opening / closing means 34 for opening / closing the circuit at the position on the second side
A third circuit opening / closing means 35 for opening / closing the second blood supply vessel 16, a fourth circuit opening / closing means 36 for opening / closing the third blood supply vessel 17, and an open / close state of the anticoagulant transport tube 24. A fifth circuit opening / closing means 37, a first weight detection unit 40 for detecting the weight of the blood collection container 12 in the blood collection container storage unit 30,
Plasma collection container placement part 41 and second weight detection part 42 for detecting the weight of the object placed on the plasma collection container placement part 41.
In the vicinity of the second circuit opening / closing means 34 and the fourth circuit opening / closing means 36, the first blood vessel 13 and the third blood vessel 17
A bubble detection unit 43 for detecting bubbles inside and a pressure detection unit 44 for detecting the pressure inside the blood collection container storage unit 30.
A controller 45, a switch panel 46, a liquid delivery pump 63 for delivering the purification plasma to the first blood vessel from the purification plasma container 26 via the purification plasma transport pipe 27, and bubble detection. And a portion 66. Further, the depressurizing / pressurizing means 32 is connected to the sampling container housing portion 30 and is connected to the air supply / exhaust circuit 50.
And pressurization / decompression switching valves 51 and 52, and vacuum pump 5
3 and a leak valve 54. Decompression
Pressurizing means 32, pressure detector 44, first weight detector 4
0, second weight detector 42, circuit opening / closing means 33, 34,
35, 36, 37 and the switch panel 46 are all electrically connected to the control unit 45.

The purified plasma used in the present invention is, for example, purified plasma obtained by subjecting plasma collected from a patient to salting out, filtration, adsorption treatment, etc. to remove pathogenic substances and purification, or commercially available plasma. Examples include plasma substitutes using formulations, hydroxystarch, dextran, and the like. The depressurizing / pressurizing means 32 has a depressurized state of -100 to -200 mm.
Hg can be set for every 10 mmHg, and as a pressurization state, +50 to +200 mmHg can be set for every 10 mmHg. This set pressure can be input from the switch panel 46. The depressurized and pressurized states are ON / OFF of the vacuum pump 53.
Maintains a nearly constant pressure by turning off the 3 port valve 5
It is configured such that the pressure reduction / pressurization state is switched by switching between 1, 52. The pressure detection unit 44 is for detecting the pressure inside the blood collection container storage unit 30, and a pressure sensor is used. Specifically, the pressure detection unit 44 is attached so as to communicate with the blood collection container storage unit 41 via a tube. A diffusion type semiconductor pressure detecting means is preferably used as the pressure sensor.

The illustrated plasma separator 15 is a flat-membrane type plasma separator and separates plasma components containing pathogenic substances (for example, high molecular weight proteins) from whole blood. As such a plasma separator, any separator capable of separating the above-mentioned pathogenic substance together with plasma may be used, and for example, one having a membrane pore size of 0.1 to 0.8 μm is preferable. The plasma separating means that can be used in the present invention is not limited to the flat membrane type plasma separator, and may be, for example, a hollow fiber membrane type or a centrifugal type plasma separator. .

A weight sensor is used as the weight detection unit 40 of the blood collection container in the blood collection container storage unit 12. Specifically, the first weight detection unit 40 is attached to the mounting table that constitutes the bottom surface of the blood collection container storage unit. Weight detector 57
For this, a load cell is preferably used. A blood leak sensor (not shown) is attached to the blood collection container storage unit 30. This blood leak sensor is also attached to the upper surface of the mounting table so that the sensor section is exposed. The blood leak sensor is configured, for example, by fixing a spacer on a load cell that constitutes a weight sensor and then fixing a printed circuit board that constitutes the blood leak sensor thereon.

Circuit opening / closing means 33, 34, 35, 36, 3
For 7, a solenoid pinch valve that is closed in a normal state is preferably used. Furthermore, as shown in FIG. 2, it is preferable to provide a hanger for an ACD bag on the front surface or the side surface of the plasma exchange apparatus 1. A plasma collection container mounting portion 41 is fixed to the left side surface of the plasma exchange apparatus 1, and the weight of the plasma collection container mounted on the mounting portion 41 is detected on the mounting portion 41. A second weight detection unit 42 for doing so is provided. As the weight detection unit 42,
The same thing as the 1st weight detection part 40 can be used conveniently.

Then, the control unit 45 collects whole blood by the blood collection circuit, separates the collected whole blood into a plasma component and a blood cell component, collects the plasma component in a plasma collection container, and returns the blood cell component to the patient. Plasma collection work (separation / return step)
Is continued until the total plasma collection amount reaches the target set plasma collection amount, and when the total plasma collection amount reaches the target set plasma collection amount, the plasma collection work is controlled to be terminated. Specifically, the control unit 45 compares the plasma collection amount measured based on the weight detection signal of the second weight detection unit 42 with the target set plasma collection amount input from the switch panel 46 in advance, and sets the target setting. When the plasma collection amount is reached, the pressurizing / depressurizing means 32 and the circuit opening / closing means are controlled so as to end the plasma collecting operation. It should be noted that whether or not the total amount of collected plasma has reached the target set amount of collected plasma may be detected by, for example, providing a flow meter in the plasma transport pipe 21 and controlling the control unit 45 based on the flow rate value detected by the flow meter. .

The control unit 45 has a function of calculating the total amount of liquid supply based on the drive amount of the liquid supply pump 63. Liquid delivery pump 6
As 3, a rotary pump, a peristaltic pump or the like can be preferably used. The control unit 45 is, for example, one of
The liquid supply amount per rotation is stored, and the total volume of plasma for infusion purification is calculated from the liquid supply amount and the rotation speed of the rotor. Also,
A flowmeter is attached to the plasma transport pipe 27 for purification, and the control unit 45
Thus, the total blood volume for infusion purification may be calculated based on the flow rate value detected by the flow meter. Further, a third weight detection unit for detecting the weight of the purification plasma container may be provided, and the total infusion purification plasma amount may be calculated based on the weight detection signal from the weight detection unit.

Then, when the amount of the purifying plasma in the purifying plasma container 26 is input from the switch panel 46, the control unit 45 stores this amount as the target infused plasma amount, and displays the value on the display unit 64. To do. Further, the control unit 45 subtracts the total infusion purification plasma volume from the target infusion plasma volume to calculate the purification plasma remaining amount, and sequentially stores the stored set purification plasma remaining amount value and the purification plasma remaining amount. In comparison, when the purification plasma remaining amount reaches the set purification plasma remaining amount value, predetermined control is performed. The display unit 64 has a function of displaying the amount of purification plasma delivered by the delivery pump and further displaying the remaining amount. Further, it may have a function of displaying the total amount of plasma for liquid purification. Further, the control unit 45 turns on / off the liquid delivery pump 63 based on the amount of plasma collected that is measured based on the weight detection signal of the second weight detection unit 42. When the purification plasma remaining amount calculated by the control unit 45 becomes equal to or less than the set purification plasma remaining amount value, the control unit 45
Performs predetermined control. An ultrasonic bubble sensor can be preferably used as the bubble detecting means 43, 66.

The target infused plasma volume is set by inputting the weight of the purification plasma storage container 26 from the switch panel 46 and calculating it by excluding the tare weight of the purification plasma storage container 26 in the control unit 45. You can go. Also, the set plasma residual amount for purification varies depending on the circuit configuration, but is 3
It is preferably 0 to 200 ml, and particularly preferably 60 to 100 ml. If it is less than 30 ml, there is a possibility that the blood cell components remaining in the circuit may not be sufficiently returned to the patient in the circuit cleaning / residual plasma conversion step described below. Further, in plasma exchange therapy, usually, plasma is collected and purified plasma is infused so that the amount of purified plasma infused into the patient and the amount of collected plasma from the patient are approximately equal, so the above value is 200
If it exceeds the ml, the plasma purification residual amount will reach the set purification plasma residual amount value before the plasma collection amount reaches the target set plasma collection amount. The plasma collection rate will be significantly increased relative to the plasma infusion rate, and the burden on the patient will increase in both cases.

On the front surface of the plasma exchange apparatus 1, there is provided a plasma separator holder which forms a plasma separator mounting portion. This plasma separator holder is about 30m from the center
The plasma separator can be attached by inclining about 20 ° to the front with the lower part as a fulcrum, and the attached state can be held and released by a latch type magnetic catch. And in this plasmapheresis device 1,
The first weight detection unit 40 detects the weight of the blood collection container 12 at appropriate time intervals, and the detected weight detection signal is input to the control unit 45. Similarly, the second weight detection unit 42 detects the weight of the plasma collection container 20 at appropriate time intervals, and the detected weight detection signal is detected by the control unit 4.
Input to 5.

Further, the control unit 45 collects whole blood by a blood collection circuit, separates the collected whole blood into a plasma component and a blood cell component, collects the plasma component in a plasma collection container, and returns the blood cell component to the patient. Plasma collection work (separation and blood return step)
It is preferable to control so as to be repeatedly performed until the total plasma collection amount reaches the target set plasma collection amount. In particular, the control unit 45 calculates the plasma collection amount measured based on the weight detection signal of the second weight detection unit 42 based on the following formulas (1) to (5): Plasma collection efficiency (η) = previous plasma collection amount / One set blood collection amount or the previous blood collection amount measured based on the weight detection signal of the second weight detection unit ... (1) Plasma remaining amount (A ₁ ) = target Set plasma collection amount-total plasma collection amount (2) Next expected plasma collection amount (A ₂ ) = η × 1 set blood collection amount or the weight detection signal of the second weight detection unit (3) If A ₁ + β ≧ A ₂ , the amount of blood collected last time based on the following: If the amount of blood collected next time is the set amount of blood collected once or the weight of the second weight detector. It metered previous blood volume ....... based on a detection signal (4) a ₁ + β <for a _2, next blood collection amount = a ₁ / η + α ··· (5) (where, alpha, beta is a correction value that is set in anticipation of lowering plasma collection efficiency degradation increase and plasma separating means hematocrit of the patient, alpha is 10 to 30
It is preferable that g and β have a blood collection volume control mechanism that calculates an appropriate blood collection volume in the next plasma collection work according to 5 to 21 g) and controls collection of whole blood based on the calculated value.

By performing such control, an appropriate blood collection amount in the next plasma collection work is calculated, and whole blood is collected based on the calculated value, so that an accurate amount of plasma can be collected, The target amount of plasma can be efficiently collected without performing unnecessary blood collection. In particular, in plasma purification therapy in which plasma is collected from a patient containing a pathogenic substance in his own plasma, the etiological substance in the plasma is removed, and the treated plasma is returned to the patient, the total circulating blood volume of the patient is A volume of plasma equivalent to within 12% was collected at the first time and 2
From the second time onward, the plasma collection amount is increased stepwise from the previous collection, and the plasma collection increase plasma exchange for converting the purification plasma collected and purified previously is repeated. After reaching the target amount of plasma purification replacement (set by considering the patient's weight, age, disease state, type of etiological agent to be removed, and the targeted amount of etiological agent to be removed, etc.) ,
A plasma purification therapy is performed in which a target plasma purification replacement amount of plasma is continuously collected, and purification plasma in which a pathogenic substance is removed from previously collected plasma is returned to the patient. In the case of this therapy, a large amount and accurate amount of plasma collection are required as compared with the case of normal plasma blood donation, so this plasma exchange device is effective.

Furthermore, it is preferable that the plasma collection rate and the purification plasma infusion rate are controlled to be substantially equal. As the method, for example, the control unit 45 of the plasma exchange apparatus 1 calculates a plasma collection rate during plasma collection from the amount of plasma collection sequentially detected by the weight detection unit 42, and sends the plasma collection rate based on this plasma collection rate. This can be performed by controlling the liquid feeding speed of the liquid pump 63.

Next, the operation of the plasmapheresis device 1 of the present invention will be described.
This will be described with reference to FIGS. 1 to 10. Particularly, as the plasma exchange apparatus 1, the depressurizing / pressurizing means 32 is operated to depressurize the inside of the blood collection container storage unit 30, and a predetermined amount of the anticoagulant is stored in the blood collection container 12 from the anticoagulant storage container 23. After the anticoagulant injecting step for injecting blood and the anticoagulant injecting step are completed, the depressurizing / pressurizing means 32 is activated to depressurize the inside of the blood sampling container storage section 30, and the patient is placed inside the blood sampling container 12. A blood collecting step of collecting a predetermined amount of blood and, after the blood collecting step is completed, the depressurizing / pressurizing means 32 is operated to bring the inside of the blood collecting container storage section 12 into a pressurized state, thereby removing the blood in the first blood supply tube 13. Return blood to the patient and first
A small amount blood returning step of allowing blood to be drawn into the blood collecting container 12 into the blood supply vessel 13 and having the anticoagulant added therein, and a pressure reducing / pressurizing means 3 after the small amount blood returning step is completed.
2 is activated to bring the inside of the blood collection container storage portion 30 into a pressurized state, the blood collected inside the blood collection container 12 is caused to flow into the plasma separator 15, and the plasma component is discharged from the plasma outlet of the plasma separator 15. Blood is collected in the blood plasma collection container 20, the blood cell components flowing out from the blood cell outlet of the plasma separator 15 are returned to the patient, and the liquid feeding pump 63 is driven to clean the inside of the blood plasma container 26 for purification. The separation, blood return, and infusion steps of sending the blood plasma to the patient are repeated a set number of times, and when the amount of the remaining plasma for purification in the blood plasma container for purification 26 reaches a predetermined amount, the liquid delivery pump 63 is operated. After stopping and maintaining the separation / return operation as necessary, after the separation / return operation is completed, the purification plasma in the purification plasma container 26 is collected.
It is preferable to perform a plasma conversion step for circuit cleaning / residual purification, in which the plasma is converted into a patient by flowing it into the blood vessel 2 and passing it through the plasma separator 15.

As described above, by performing the circuit cleaning using the purifying plasma, especially the purifying plasma of the patient, the blood cell components remaining in the circuit after the plasma separation / collection can be returned to the patient without waste. Further, it is possible to eliminate the use of physiological saline for washing, and to prevent the physiological saline from being uncomfortable due to infusion. Then, in the plasmapheresis apparatus of this embodiment, these steps and the progress of the steps are substantially automated.

A plasma exchange operation using the plasma exchange apparatus of this embodiment will be described with reference to FIGS. 2 to 10.
In FIG. 5 to FIG. 10, when divided roughly, [A
1] to [A2] are anticoagulant injection steps, [B1] to [B2] are blood collection steps, [C1] to [C2] are small blood return steps, and [D1 ] To [D2] are the steps of separation, blood return, and infusion, and [E1] to [E2] are the circuit cleaning steps.
It is a plasma conversion step for residual purification. First, as shown in the flowchart of FIG. 5, the power switch of the switch panel 46 of the plasmapheresis apparatus 1 is turned on. As initialization, the CPU of the plasma exchange apparatus 1 is initialized and the electrical abnormality of the apparatus is automatically checked. Then, the weight of the purification plasma container 26 is first measured, and the tare weight of the purification plasma container 26 is subtracted from this weight value,
The amount of purification plasma in the container is calculated, and this value is input to the control unit 45 by the target infusion purification plasma weight input switch (not shown) of the switch panel 46. Then, this input value is stored in the control unit 45 as the target infusion purification plasma weight and displayed on the display unit 64 as shown in FIG.

Furthermore, if necessary, parameters such as the blood return pressure are changed using the parameter setting switch provided on the switch panel 46 of the plasma exchange apparatus 1. Then, as shown in FIG. 2, the plasma exchange circuit is attached to the plasma exchange apparatus. In addition, a cuff (not shown) is applied to the patient. After the above setting is completed, the start switch (not shown) of the switch panel is turned on. As a result, the process proceeds to the anticoagulant injection step.

When the start switch is pressed, the anticoagulant lamp (ACD lamp) provided on the switch panel is turned on, the pressurizing / depressurizing means 32 is operated, and the blood collection container storage section 30 is activated.
The inside is in a decompressed state, only the fifth circuit opening / closing means 37 is opened, and the blood collection container 1
An anticoagulant (for example, ACD solution) is injected into 2. The injection of this anticoagulant is performed by the weight detection unit 40.
2 weight (NWn) before weight of anticoagulant (NW
This is performed until it is detected that the weight obtained by subtracting o) reaches or exceeds the anticoagulant set weight (Wo) (NWn-NWo ≧ Wo). When the above state is reached, the flow chart [1] in FIG. 6 is displayed. Then, the pressurizing / depressurizing means 32 is stopped, the injection work of the anticoagulant is completed, and the first circuit opening / closing means 33 and the second circuit opening / closing means 34 are opened for the puncture standby.

Further, within a predetermined time, NWn-NWo ≧ W
Before reaching o, it is always judged whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. And
After puncturing the vein of the patient with the puncture needle 11 and confirming that blood has flowed into the blood vessel from the puncture needle by the venous pressure of the patient, the start switch provided on the switch panel 46 is turned on. As a result, the blood collection step is started, the start lamp is turned on, the pressurizing / depressurizing means 32 is activated, the inside of the blood collecting container storage section 30 is depressurized, and the first circuit opening / closing means 33 and the second circuit opening / closing means 33 and the second circuit opening / closing means 33 are operated. The circuit opening / closing means 34 maintains the open state, and blood flows into the blood collection container 12. The weight of the blood collection container 12 is sequentially detected by the weight detection unit 40, and the weight of the blood collection container 12 (NWn)
However, set weight [W1 = planned blood collection + anticoagulant weight (W
o)] or more (NWn ≧ W1) is reached, the depressurizing operation is stopped by the pressurizing / depressurizing means 32, the circuit opening / closing means 33 and 34 are closed, and the blood collecting operation is completed. Then, the process returns to the small blood return step.

Further, before NWn ≧ W1 is reached, it is always judged whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed. Then, the process proceeds to the flowchart [2] of FIG. 7, and the small blood return step is performed. In this small amount blood return step, the blood in the first blood supply tube 13 is in a state in which no anticoagulant is added after the blood collection is completed,
If left as it is, the blood inside the first blood supply tube 13 will coagulate. Therefore, by returning a small amount of blood, the blood inside the first blood supply tube 13 will be returned to the patient, and blood will be collected in the first blood supply tube 2. This is performed in order to prevent blood from coagulating in the blood supply vessel 2 by allowing the blood containing the anticoagulant added thereto to flow into the container 5. In this small blood volume returning step, the pressurizing / depressurizing means 32 is activated to bring the inside of the blood collection container storage section 30 into a pressurized state. The weight of the blood collection container 12 at this time is stored as TW3, and the circuit opening / closing means 33 is stored.
And 34 are opened. In this small amount blood return step, the weight obtained by subtracting the weight (NWn) of the blood collection container from the weight of the blood collection container (TW3) before the blood return is equal to or greater than [the set blood return weight of anticoagulant-added blood (W2)] -NWn ≧ W2) is reached, and when the set weight is reached, the small amount blood returning operation is completed. Further, before TW3-NWn ≧ W2 is reached, it is always determined whether or not an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed.

Then, the procedure goes to the separating / returning blood / infusion step. In this separating / returning / infusion step, the operation of the pressurizing / depressurizing means 32 causes the inside of the blood collecting container storage section 30 to be in a pressurized state, and the circuit opening / closing means 33, 35, 36 to be in an open state, so that the blood collecting container 12 Blood inside is plasma separator 15
The plasma component that has flowed into the plasma separator 15 and has been separated by the plasma separator 15 flows into the plasma collection container 20 through the plasma transport tube 21. The blood cell component flowing out from the plasma separator 15 is returned to the patient through the third blood supply vessel 17 and the first blood supply vessel 13. Further, the control unit 45 drives the liquid feed pump 63. As a result, the purifying plasma in the purifying plasma container is
It passes through the liquid supply pipe 27 and the first blood supply vessel 13 and is converted into a patient.

During this work, the weight of the blood sampling container 5 is also measured by the second weight detection unit 42 at a constant cycle, and the weight of the blood sampling container (TW
Until the value obtained by subtracting the weight (NWn) of the blood collection container from 5) becomes less than or equal to the predetermined value (Wt), the separation / blood return operation in this separation / blood return / transfusion step is continuously performed. Further, the purification plasma infusion remaining amount is also calculated, and it is determined whether or not the purification plasma remaining amount (PW1) ≦ setting purification plasma remaining amount value (PW2), and the purification plasma remaining amount (PW1) ≦ setting. When it is determined that the amount is the plasma residual amount for purification (PW2), the liquid feed pump 63 is stopped and only the infusion work is stopped. And T
If it is determined that W5-NWn≤Wt, the process proceeds to the flowchart [3] of FIG. 8 and the separating / returning blood / infusion step is ended. Then, it is determined whether or not the amount of collected plasma measured by the weight detection unit 42 is equal to or larger than the set amount of collected plasma (target amount of collected plasma). If not, the control unit 45 determines the next blood collection amount.
And the next blood collection is performed based on the blood collection amount. The content of the next blood collection amount is calculated based on the above-described formula, the appropriate blood collection amount in the next plasma collection work is calculated, and the process proceeds to the flowchart [4] of FIG. 10.

When the flow chart [4] in FIG. 10 is entered, the ACD lamp is turned on again, and the step moves to the anticoagulant injection step. In the anticoagulant injection step, the above is repeated. Then, after the step of injecting the anticoagulant, the process proceeds to the flow chart [6] of FIG. 6, the above-mentioned small blood returning step is performed again, and then the separating / returning / infusion step is performed. When it is determined that the plasma collection amount is equal to or more than the set plasma collection amount (target plasma collection amount),
As shown in FIG. 8, the pressurizing / depressurizing means 32 is stopped, the circuit opening / closing means is closed, and the plasma collection operation is completed.
Go to the plasma conversion step for residual purification.

In the plasma conversion step for circuit cleaning / residual purification, first, as shown in FIG. 4 (a), the pressurizing / depressurizing means 32 and, if necessary, the liquid delivery pump 63 are operated to cause the blood collection container storage section 30 to operate. The inside is depressurized, only the second circuit opening / closing means 34 is opened, and the purifying plasma in the purifying plasma container 26 flows into the blood collecting container 12. And
When the remaining amount of the plasma for purification is 0 by the control unit 45, when the bubble detection unit 66 detects the bubbles continuously for a predetermined time, or when the weight of the blood collection container 12 does not change for the predetermined time. , Liquid feed pump 63 and pressurization
The decompression means 32 is stopped and the circuit opening / closing means is also closed. Then, as shown in FIG. 4B, the pressurizing / depressurizing means 3 is again activated.
2, the inside of the blood collection container storage section 30 is pressurized, the circuit opening / closing means 33, 36, 35 are opened, and the purifying plasma inside the blood collection container 12 flows into the plasma separator 15. Most of the blood plasma for purification flows out from the blood cell component outlet having a low flow resistance, passes through the third blood supply vessel 17 and the first blood supply vessel 13, and is converted into a patient. Due to the circulation of the purifying plasma, the plasma separator, the third blood vessel 17 and the first blood vessel 13
Is washed. As shown in the flowchart [5] and subsequent steps in FIG. 9, this work is performed by measuring the weight (TW5-
The process is repeated until NWn) becomes equal to or less than the predetermined value (Wt). Then, when TW5-NWn ≦ Wt is satisfied, or when the bubble detection unit 43 detects bubbles continuously for a predetermined time, the circuit cleaning / residual purification plasma conversion step ends.

Then, the end alarm sounds, the start lamp goes out, and the puncture needle 11 is removed from the patient. Then, by opening the lid of the plasma exchange apparatus 1, all of the circuit opening / closing means are opened, the blood collection container is taken out from the blood collection container storage part, and the plasma separator is removed from the plasma separator attachment part to perform the plasma collection work. Complete.

In the separation, blood return, and infusion steps, when the amount of plasma collected does not reach the target value even if the amount of remaining plasma for purification reaches the set value, as shown in the flowchart, If the plasma collection volume does not reach the target value even after the separation / return step is performed continuously as described above and the separation / return step at that time is continued, the above-mentioned anticoagulant injection step Perform further steps (no infusion of purifying plasma). On the contrary, when the amount of plasma collected reaches the target value during the separation, blood return, and infusion steps, and when the remaining amount of the plasma for purification has not reached the set value, the purification plasma is used as shown in the flow chart. It is assumed that the circuit conversion / residual plasma conversion step described above is performed using all of the plasma remaining amount. Therefore, whichever reaches the target value or the set value first, plasma exchange, circuit cleaning, and blood cell component collection can be performed without problems.

In the above example, in the plasma conversion step for circuit cleaning and residual purification, the purification plasma was introduced into the plasma separator with the plasma transportation tube left open. This step may be performed without the plasma flowing into the plasma collection container. If you do this,
The circuit can be cleaned with a smaller amount of purifying plasma. Further, not limited to this control method, for example, when the plasma collection amount reaches the target value and the purification plasma residual amount does not reach the set value, only the separation / blood return step is completed, and the transfusion step is performed. May be continued until the amount of plasma for purification reaches the set value, and then the step of plasma conversion for circuit cleaning / residual purification may be performed.

Further, the present invention is not limited to the plasma exchange apparatus applied to the above-mentioned single needle type plasma exchange circuit, but a circuit in which a blood collecting needle and a blood returning needle are separate, that is, a two needle type It may be a device applied to the circuit. As such a circuit, for example, the third blood supply vessel 17 of the above-described embodiment is not connected to the first blood supply vessel 13, a blood return needle is attached to the third blood supply vessel 17, and a purification plasma transport tube is further provided. 27 to the third feeding vessel 1
One connected to 7. Then, as the device of the present invention, for example, a circuit opening / closing means is provided on each of the first blood supply vessel and the third blood supply vessel on the needle side of the purifying plasma transport tube 27, thereby controlling the fluid flow in the circuit, After the plasma collection is completed, the purifying plasma may be infused into the patient from the blood collecting needle through the plasma separator.

[0046]

The plasma exchange apparatus of the present invention comprises a blood sampling circuit for collecting whole blood from a patient, plasma separating means for separating whole blood into a plasma component containing a pathogenic substance and a blood cell component, and plasma separation. A plasma collection container for collecting the plasma component separated by the means, a purification plasma addition circuit for adding the purification plasma substantially free of a causative substance to the blood cell component separated by the plasma separation means, and the blood cell component and A plasma exchange device for controlling a plasma exchange circuit having at least a blood return circuit for returning purified plasma to a patient, wherein the plasma exchange device is a circuit capable of opening and closing a predetermined portion of the plasma exchange circuit. It has an opening / closing means and at least a control section having a function of controlling opening / closing of the circuit by the circuit opening / closing means, and by the control section, after the plasma collection is completed, the purified plasma is added to the purification plasma addition circuit. Since the circuit opening / closing means is controlled so as to be sent to the blood collecting circuit via the plasma separating means and the blood plasma separating means, the blood cell components remaining in the circuit after the plasma collection is completed can be returned to the patient without waste and for the circuit cleaning. It is possible to eliminate the use of the physiological saline solution and prevent the discomfort caused by the infusion of the physiological saline solution.

Further, a weight detection unit for detecting the weight of the plasma collection container is further provided, and when the weight detected by the weight detection unit reaches a preset target plasma collection amount, the control means After the plasma collection is completed, if the circuit opening / closing means is controlled so as to send the purified plasma to the blood collection circuit via the purified plasma addition circuit and the plasma separation means, the weight of the plasma collection container The circuit can be cleaned by automatically recognizing the end of plasma collection by the detection. Further, the apparatus further comprises a purification plasma delivery amount detecting means for detecting the amount of the purification plasma delivered to the purification plasma adding circuit, and the purification plasma delivery amount detected by the delivery amount detecting means. Compared with the preset target infusion purification plasma volume, when the difference between the target infusion purification plasma volume and the liquid transfer amount is equal to or less than the preset purification plasma remaining amount value, by the control unit, If the circuit opening / closing means is controlled so as to deliver the purifying plasma to the blood collecting circuit via the purifying plasma adding circuit and the plasma separating means, a certain amount of purifying plasma can be reliably used. The circuit is cleaned, so that the circuit can be cleaned, that is, the blood cell component remaining in the circuit can be reliably collected. Furthermore, the purification plasma residual amount value is 30
When it is set to 200 ml, the plasma collection operation, the infusion of the plasma for purification, and the cleaning of the circuit can be smoothly performed.

[Brief description of drawings]

FIG. 1 is a schematic view of an embodiment of the plasmapheresis device of the present invention with a plasma blood collection circuit attached.

FIG. 2 is a schematic external view of an embodiment of the plasma exchange device of the present invention with a plasma blood sampling circuit attached.

FIG. 3 is an explanatory diagram for explaining the operation of the plasmapheresis device according to the embodiment of the present invention.

FIG. 4 is an explanatory diagram for explaining the operation of the plasmapheresis device according to the embodiment of the present invention.

FIG. 5 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

FIG. 6 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

FIG. 7 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

FIG. 8 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

FIG. 9 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

FIG. 10 is a flow chart for explaining the operation of the blood plasma exchange device according to the embodiment of the present invention.

[Explanation of symbols]

 1 Plasma Exchange Device 11 Blood Collection Needle 12 Blood Collection Container 13 First Blood Vessel 15 Plasma Separator 16 Second Blood Vessel 17 Third Blood Vessel 20 Plasma Collection Container 23 Anticoagulant Storage Container 24 Anticoagulant Transport Pipe 26 Purification Plasma Storage container 27 Purification plasma transport tube 30 Blood collection container storage section 32 Decompression / pressurization means 33 First circuit opening / closing means 34 Second circuit opening / closing means 35 Third circuit opening / closing means 36 Fourth circuit opening / closing means 37 Fifth Circuit opening / closing means 40 First weight detection section 41 Plasma collection container mounting section 42 Second weight detection section 43 Bubble detection section 45 Control section 46 Switch panel 63 Liquid feed pump 63 Display section 66 Bubble detection section

Claims (1)

[Claims] 1. A blood sampling circuit for collecting whole blood from a patient, a plasma separation means for separating whole blood into a plasma component containing a pathogenic substance and a blood cell component, and a plasma component separated by the plasma separation means. A plasma collection container for collecting, a purification plasma addition circuit for adding purification plasma that does not substantially contain a pathogenic substance to the blood cell components separated by the plasma separation means, and the blood cell components and purification plasma are returned to the patient. A blood plasma exchange apparatus for controlling a blood plasma exchange circuit having at least a blood return circuit for use in the blood plasma exchange apparatus, wherein the blood plasma exchange apparatus includes circuit opening / closing means capable of opening / closing a predetermined portion of the blood plasma exchange circuit, and at least the circuit opening / closing. A control unit having a function of controlling the opening and closing of the circuit by the means, and the control unit causes the purified plasma to pass through the purified plasma addition circuit and the plasma separation means after completion of the plasma collection. Apheresis apparatus, wherein the controller controls the circuit switching means to deliver into the blood circuit by.