JPH0788180A - Blood plasma exchange device - Google Patents

Abstract

PURPOSE:To constitute the device so that it is effective as a blood plasma exchange device, and it can used separately as a blood plasma extracting device and a fluid therapy device, respectively. CONSTITUTION:This device is a blood plasma exchange device for controlling a blood plasma exchanging circuit having a blood extracting circuit for extracting blood from a patient, a blood plasma separating means for separating the extracted blood into a blood plasma component and a blood corpuscle component, a blood plasma extracting vessel for extracting the blood plasma component, a blood corpuscle component returning circuit for returning the blood corpuscle component to the patient, and a purified blood plasma therapeutically injecting circuit for injecting therapeutically the purified blood plasma to the patient. This blood plasma exchange device 1 is provided with a blood plasma extracting device part 2 for controlling the blood extracting circuit, and antiwagulant adding circuit, a blood separating operation by the blood plasma separating means and a blood corpuscle component returning circuit, and a blood plasma therapeutically injecting device part 3 for controlling the purified blood plasma theraoeutically injecting circuit. The blood plasma extracting device part 2 and the blood plasma therapeutically injecting device part 3 are connected so as to be detachable by a communication cable 4.

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. As a method for removing harmful substances from plasma, for example, a method of applying a solubility fractionation method in which a salting-out agent or the like is added to plasma, and a causative substance is separated and separated and removed from the difference in solubility (USP4321192), etiologic A method of adsorbing a substance with an adsorbent having a specific adsorption performance (USP4814077), a method of cooling plasma and precipitating and removing harmful substances (USP43501).
56), a method of removing the harmful substance to be removed by filtration with a filter having a pore size that does not pass a molecular weight or more of the harmful substance (Japanese Patent Publication 4-70027).

In these methods, blood is extracorporeally circulated at a constant flow rate as described above, and each process is performed in fluid communication with each other.
The so-called on-line method is used. But,
These plasma purification methods have various problems. Specifically, it requires a large amount of extracorporeal blood circulation, which may cause hypotension, bradycardia, imbalance syndrome, etc. in patients, blood separation, and purification of separated plasma. Since it is performed at the same time, an abnormality at the time of enforcement may occur in both the plasma separation means and the plasma purification means in the state where the extracorporeal blood circulation circuit is connected to the patient. You will have to wait, 100 ml
20 ml / m by circulating blood at a blood flow rate of about / min
Even if purification is performed with in plasma flow rate, it takes about 2 hours to purify about 100% of the total plasma volume of the patient, and it takes a long time to restrain the patient for treatment. It has problems such as that.

[0006] Therefore, the inventor of the present invention examined a plasma purification therapy using the plasma of the patient himself, which does not have the problems of the plasma purification therapy by the extracorporeal blood circulation system, and the plasma purification therapy is The plasma exchange device used was examined.

[0007]

The plasma exchange device needs to have both a plasma collection function and a purified plasma infusion function that was collected and purified from a patient last time, which makes the device large and expensive. Becomes Further, since it is a dedicated device, its use is limited to blood plasma exchange, and there is a problem that it cannot be effectively used.

Therefore, an object of the present invention is to solve the above problems and to provide a plasma exchange device which is effective as a plasma exchange device and which can be used individually as a plasma collection device and an infusion device and has high use efficiency. It is provided.

[Means for Solving the Problems]

What achieves the above object is to collect a blood from a patient, a blood collecting circuit, a plasma separating means for separating the collected blood into a plasma component and a blood cell component, and a plasma component separated by the plasma separating means. A plasma collection container for collecting
A plasma exchange device for controlling a plasma exchange circuit having at least a blood cell component return circuit for returning the blood cell components separated by the plasma separation means to a patient and a purified plasma infusion circuit for infusing purified plasma to the patient. The plasma exchange apparatus includes a blood collection circuit for controlling the blood collection circuit, the anticoagulant addition circuit, a blood separation operation by the plasma separation means and a blood cell component return circuit, and a purified plasma infusion circuit. It has a plasma infusion device section for controlling,
A plasma exchange apparatus in which the plasma collection apparatus section and the plasma infusion apparatus section are detachably electrically connected.

What achieves the above-mentioned object is to collect a blood from a patient, a blood collecting circuit, a plasma separating means for separating the collected blood into a plasma component and a blood cell component, and a plasma component separated by the plasma separating means. A plasma collection container for collecting
A plasma exchange device for controlling a plasma exchange circuit having at least a blood cell component return circuit for returning the blood cell components separated by the plasma separation means to a patient and a purified plasma infusion circuit for infusing purified plasma to the patient. The plasma exchange apparatus includes a blood collection circuit for controlling the blood collection circuit, the anticoagulant addition circuit, a blood separation operation by the plasma separation means and a blood cell component return circuit, and a purified plasma infusion circuit. It has a plasma infusion device section for controlling,
The plasma collection device unit and the plasma infusion device unit each have a communication function, and are plasma exchange devices electrically connected by the communication function.

The communication function is preferably a wired communication function or a wireless communication function. Further, the plasma collection device unit has a weight detection unit of the plasma collection container mounting unit provided in the plasma collection container mounting unit, and further, a measured value based on a detection signal detected by the weight detection unit. It is preferable to have a transmission function for transmitting the information to the plasma infusion device section. Further, the plasma collection device unit calculates a target infusion purified plasma volume based on the infusion purified plasma container weight detected by the weight detection unit of the plasma collection container placement unit,
Transmitting the target infusion purified plasma volume to the plasma infusion device section,
It is preferable that the plasma infusion device section controls the infusion of purified plasma based on the target infusion purified plasma volume.

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
A plasma collection circuit attached to the blood collection circuit for collecting blood from a patient, a plasma separation means for separating the collected blood into a plasma component and a blood cell component, and a plasma component separated by the plasma separation means It has at least a plasma collection container, a blood cell component returning circuit for returning the blood cell components separated by the plasma separating means to the patient, and a purified plasma transfusion circuit for injecting the purified plasma into the patient. Then, it is preferable to have an anticoagulant addition circuit for adding a blood anticoagulant to the collected blood.

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. The blood cell component outlet of the plasma separator 15 and the first blood supply tube 13 are
The third blood vessel 17 communicates with each other and constitutes a blood cell component 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. Furthermore, the purified plasma storage container 2
Reference numeral 6 communicates with the first blood supply vessel 13 through the purified plasma transport tube 27, and constitutes a purified plasma infusion circuit. Also,
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 the blood collection container. Instead of providing an anticoagulant addition circuit, it is assumed that the blood contact part of the plasma exchange circuit, specifically, the blood contact part such as a tube, a blood collection container, a plasma separator, etc., has been subjected to antithrombotic treatment. Good. There are various antithrombotic treatments, and for example, it is considered to fix an antithrombotic material such as heparin, HEMA-St copolymer, and urokinase.

The plasma exchange apparatus 1 is divided into a plasma collection apparatus section 2 and a plasma infusion apparatus section 3, both of which are
It is detachably electrically connected. Particularly, in the plasma exchange device of the embodiment shown in FIG. 1, the plasma collection device part 2 and the plasma infusion device part 3 are electrically connected by a wired communication circuit, and the communication cable 4 connecting them is removed. Thus, the plasma collection device unit 2 can be used as a plasma collection device, and the purified plasma infusion device unit 3 can be used as an infusion device.

The plasma collection device section 2 includes a blood collection container storage section 30.
A depressurizing / pressurizing means 32 for pressurizing and depressurizing the inside of the blood collection container storage section 30, a plasma separator attaching section to which the plasma separator 15 is detachably attached, and a first plasma collecting circuit.
In order to open / close the blood supply vessel 13, the first circuit opening / closing means 33 for opening / closing the circuit at the position of the blood collecting needle side of the connection portion of the purified plasma transportation tube 27 with the first blood vessel 13 and the purified plasma transportation tube 27.
Second circuit opening / closing means 34 for opening / closing the circuit at a position closer to the blood collection container 12 than the connection portion with the first blood sending vessel 13, and third circuit opening / closing means 35 for opening / closing the second blood sending vessel 16. ,
Fourth circuit opening / closing means 3 for opening / closing the third blood supply vessel 17
6, a fifth circuit opening / closing means 37 for opening / closing the anticoagulant transport tube 24, a first weight detection unit 40 for detecting the weight of the plasma collection container 12 in the blood collection container storage unit 30, and plasma collection In the vicinity of the container placement part 41, the second weight detection part 42 for detecting the weight of the object placed on the plasma collection container placement part 41, the second circuit opening / closing means 34 and the fourth circuit opening / closing means 36. At, a bubble detection unit 43 for detecting bubbles in the first blood supply vessel 13 and the third blood supply vessel 17, a pressure detection unit 44 for detecting the pressure in the blood collection container storage unit 30, and a control unit 45. And switch panel 46 and interface 4
7 and 7. Further, the depressurizing / pressurizing means 32 is connected to the air supply / exhaust circuit 50 communicating with the collection container storage section 30,
The pressure reducing switching valves 51 and 52, a vacuum pump 53, and a leak valve 54 are included. Pressure reducing / pressurizing means 3
2, pressure detector 44, first weight detector 40, second weight detector 42, circuit opening / closing means 33, 34, 35, 36,
37, interface 47, switch panel 46,
All are electrically connected to the control unit 45.

The depressurizing / pressurizing means 32 is in a depressurized state.
-100 to -200 mmHg can be set for every 10 mmHg, and as a pressurized state, +50 to +200 mmHg
It is configured so that g can be set for each 10 mmHg. This set pressure can be input from the switch panel 46. And the depressurized and pressurized states are
The vacuum pump 53 is configured to be turned on / off to maintain a substantially constant pressure, and the 3-port valves 51 and 52 are switched to switch between a depressurized state and a pressurized state. 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. As a pressure sensor,
A diffusion type semiconductor pressure detecting means is preferably used.

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. Further, a blood leak sensor (not shown) is attached to the blood collection container storage portion 41. 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. Further, as shown in FIG. 2, a hanger for an ACD bag is preferably provided on the right side surface of the plasma collection device unit 2. Further, a plasma collection container mounting portion 41 is fixed to the left side surface of the plasma collection device portion 2, and the plasma collection container and the purified plasma mounted on the mounting portion 41 are fixed to the mounting portion 41. A second weight detection unit 42 for detecting the weight of the container is provided. In other words, in the plasma collection device section 2, the weight of the purified plasma container to be infused can be measured using the second weight detection section 42, and the measured weight detection signal is the control section 45.
Is input to the control unit 60 of the purified plasma infusion device unit 3 described later via the interface and the communication cable 4 automatically or by pressing the switch of the switch panel 46. As the weight detection unit 42, the same one as the first weight detection unit 40 can be preferably used. In this way, the second weight detection unit is used to measure the weight of both the purified plasma container for infusion and the plasma collection container for collection. In this way, since the same weight detection unit is used for measurement, there is substantially no measurement error and accurate measurement can be performed, and plasma collection and purified plasma infusion can be performed accurately.

The plasma collection device interface 47 and the infusion device interface 61, which will be described later, may be of any type as long as they can perform data communication between them. For example, a RS232C compliant modem interface can be preferably used. Also, the communication method is
The communication is not limited to serial communication using RS232C described above, and parallel communication may be used. Furthermore, the communication method is
Not only wired communication but also wireless communication method may be used. In this case, plasma collection device unit 2 and purified plasma infusion device unit 3
Are each equipped with a transmission / reception circuit. As a wireless communication system, a digital communication system is preferable in order to prevent malfunction more reliably. And the plasma collection device section 2
The plasma transfusion device unit 3 and the plasma transfusion device unit 3 need only be capable of unidirectional transmission from the plasma collection device unit 2 to the plasma transfusion device unit 3, but preferably bidirectional communication is preferable. If two-way communication is possible, it is possible to perform transmission from the plasma transfusion device unit 3 to the plasma collection device unit 2 and to confirm whether the control has been correctly executed.

The plasma infusion device unit 3 is electrically connected to the plasma collection device unit 2 by the communication cable 4 as described above. The plasma infusion device unit 3 includes an infusion device unit interface 61 corresponding to the plasma collection device unit interface 47.
A liquid delivery pump 63 for delivering purified plasma from the purified plasma container 26 to the first blood vessel via the purified plasma transport pipe 27, a display unit 64, a switch panel 65, and a control unit 60, It has a bubble detection unit 66. The control unit 60 of the plasma infusion device unit 3 has a function of calculating the total amount of liquid delivery based on the drive amount of the liquid delivery pump. As the liquid feed pump 63, a rotary pump, a peristaltic pump, or the like can be preferably used. The control unit 60 stores, for example, the liquid transfer amount per one rotation of the rotor of the rotary pump in consideration of the inner cross-sectional area of the liquid transfer pipe, and determines the total amount of the infused purified plasma from the liquid transfer amount and the rotation speed of the rotor. Calculate Further, a flowmeter may be attached to the purified plasma transportation pipe 27, and the control unit 60 may calculate the infused purified plasma total amount based on the flowmeter detected by the flowmeter. Further, a third weight detection unit for detecting the weight of the purified plasma container may be provided, and the total infusion purified plasma volume may be calculated based on the weight detection signal from the weight detection unit.

Then, the control unit 60 stores the purified plasma amount measured by the plasma collection device unit 2 and transmitted to the plasma infusion device unit 3 as the target infusion plasma amount, and the value is displayed on the display unit 64.
To display. Further, the control unit 60 sequentially compares the stored set purified plasma residual amount value with the calculated purified plasma residual amount, and performs a predetermined control when the purified plasma residual amount reaches the set purified plasma residual amount value. I do. The display unit 64 has a function of displaying the amount of purified plasma delivered by the delivery pump and further displaying the remaining amount. Further, it may have a function of displaying the total amount of purified plasma for liquid delivery. Further, the control unit 60 controls the O of the liquid delivery pump based on the signal transmitted from the plasma collection device unit 2.
Perform N / OFF. Further, when the purified plasma residual amount calculated by the control unit 60 reaches the set purified plasma residual amount value, a signal notifying it is transmitted to the plasma collection device unit 2, and the control unit 45 of the plasma collection device unit 2 Predetermined control is performed based on the signal. An ultrasonic bubble sensor can be preferably used as the bubble detecting means 43, 66.

On the front surface of the plasma exchange device section 2, there is provided a plasma separator holder which forms a plasma separator mounting portion. This plasma separator holder is about 30
The plasma separator can be attached by inclining about 20 ° to the front with the lower part of mm as the fulcrum, and the attached state can be held and released by the latch type magnetic catch. Then, in the plasma exchange device unit 2, 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 weight detection of the plasma collection container 20 is performed by the second weight detection unit 42 at appropriate time intervals, and the detected weight detection signal is input to the control unit 45.

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 time and is collected, and the plasma collection amount increasing plasma exchange for converting the purified plasma collected previously and purified 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.) , Continuously collect the target plasma purification replacement amount of plasma,
Plasma purification therapy is performed to return purified plasma obtained by removing pathogenic substances from previously collected plasma 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.

Further, the plasma collection rate and the purified plasma infusion rate are preferably controlled to be substantially equal.
As the method, for example, the control unit 45 of the plasma collection device unit 2 calculates the plasma collection speed during the plasma collection from the plasma collection amount sequentially detected by the weight detection unit 42, and the plasma collection speed is calculated as the plasma transfusion device. It is transmitted to the control unit 60 of the unit 3. The control unit 60 can perform this by controlling the liquid sending speed of the liquid sending pump 63 based on the sent plasma collection speed. Further, the plasma collection device unit 2 and the plasma infusion device unit 3 are not limited to be connected by communication means and may be directly connected by an electric cord.

Next, the operation of the plasmapheresis device 1 of the present invention will be described.
Description will be made with reference to FIGS. 1 to 11. Particularly, as the plasma exchange apparatus 1, the decompression / pressurization means 3 of the plasma collection apparatus section 2 is used.
2 is operated to reduce the pressure inside the blood collection container storage portion 30, and a predetermined amount of the anticoagulant is injected into the blood collection container 12 from the anticoagulant storage container 23; After the step is completed, the depressurizing / pressurizing means 32 is operated to bring the inside of the blood collection container storage unit 30 into a decompressed state, and a predetermined amount of blood is drawn from the patient into the blood collection container 12, and a blood collection step. After completion of the operation, the depressurizing / pressurizing means 32 is operated to operate the blood collection container storage section 1
The inside of the blood vessel 2 is pressurized to return the blood in the first blood supply vessel 13 to the patient, and the blood collection container 1
2) A small amount blood returning step in which blood is collected inside the blood containing the anticoagulant added thereto, and after the small amount blood returning step is completed, the depressurizing / pressurizing means 32 is operated to operate the inside of the blood collecting container storage portion 30. Is brought to a pressurized state, the blood collected in the blood collecting container 12 is caused to flow into the plasma separator 15, and the plasma separator 1
The blood plasma component flowing out from the blood plasma outlet of 5 is collected in the blood plasma collecting container 20, the blood cell component flowing out of the blood cell outlet of the plasma separator 15 is returned to the patient, and the liquid transfer of the plasma infusion device unit 3 is performed. The pump 63 is driven to perform the separation, blood return, and infusion steps of delivering the purified plasma inside the purified plasma container 26 to the patient, and the steps are repeated a set number of times to determine the amount of the purified plasma remaining in the purified plasma container 26. When the quantitation is reached,
The liquid supply pump 63 is stopped, and if necessary, the separation / return operation in the plasma collection device unit 2 is maintained, and after the separation / return operation is completed, the purified plasma in the purified plasma container 26 flows into the blood collection container 12. It is preferable to perform a circuit cleaning / residual purification plasma conversion step in which the plasma is separated and passed through the plasma separator 15 to be converted into a patient.

By performing the circuit cleaning with the purified plasma of the patient as described above, it is possible to eliminate the use of physiological saline for cleaning, and prevent the physiological saline from causing discomfort caused by infusion. it can. 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 11.
6 to 11, when roughly divided, [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 residual purified plasma conversion step. First, as shown in the flowchart of FIG. 6, the power switches of the switch panel 46 of the plasma collection device unit 2 of the plasma exchange device 1 and the switch panel 65 of the plasma infusion device unit 3 are turned on. As initialization, the CPU of each device unit is initialized and the electrical abnormality of each unit is automatically checked. Subsequently, as shown in FIGS. 3 and 6, the purified plasma storage container 26 is placed on the plasma collection container placement unit 41 of the plasma collection device unit 2. As a result, the weight of the purified plasma storage container 26 is detected by the second weight detection unit 42, and the control unit 4
5 calculates the purified plasma volume. Then, when the data transmission switch (not shown) of the switch panel 46 is pressed, the calculated value is transmitted to the interface 47 of the plasma collection device unit 2 and converted into a signal conforming to RS232C by this interface, and the plasma infusion device unit is 3 is transmitted to the interface 61, the interface 61 restores the calculated value, and is input to the control unit 60 of the plasma infusion device unit 3. Then, this calculated value is stored in the control unit 60 as the target infusion-purified plasma weight and displayed on the display unit 64 as shown in FIG.

Further, if necessary, parameters such as the blood return pressure are changed using the parameter setting switch provided on the switch panel 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 activated, 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
It is performed until the weight obtained by subtracting o) reaches the anticoagulant set weight (Wo) or more (NWn-NWo ≧ Wo), and when the above state is reached, the flow chart [1] in FIG. 7 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.

While NWn ≧ W1 is not 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. 8 and the small blood volume returning 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 detected blood collection container from the weight of the blood collection container before returning blood (TW3) is [the set blood return weight of anticoagulant-added blood (W2)]. ] Above (TW3-NW
The process is repeated until n ≧ W2), and when the set weight is reached, the small blood return operation is completed. In addition, TW3-NWn ≧
Before W2 is reached, it is always judged whether an abnormality has occurred, and if an abnormality has occurred, abnormality processing is performed.

Then, the process proceeds to the separating / returning blood / infusion step. At the time of shifting to the separating / returning blood / infusion step, the control unit 45 of the plasma collection device unit 2 transmits a signal for transmitting the shift to the plasma infusion device unit 3. 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 The blood inside flows into the plasma separator 15, and the plasma component separated by the plasma separator 15 flows into the plasma collection container 20 through the plasma transport pipe 21. Also, the plasma separator 1
The blood cell component flowing out from the blood vessel 5 is
Blood is returned to the patient through the blood supply tube 13. Further, the control unit 60 of the plasma infusion device unit 3 drives the liquid delivery pump 63 by the signal transmitted from the control unit 45 of the plasma infusion device unit 3. As a result, the purified plasma in the purified plasma container passes through the liquid supply pipe 27 and the first blood supply vessel 13 and is converted into a patient.

During this operation, the weight of the blood collection container 5 is also measured by the second weight detection unit 42 at a constant cycle, and the weight of the blood collection container (TW) at the end of the small blood return step
The value obtained by subtracting the weight (NWn) of only the blood collection container from 5) is
The separation and blood return work in the separation, blood return, and infusion steps is continuously performed until the value becomes equal to or lower than the predetermined value (Wt).
Further, the purified plasma infusion remaining amount is also calculated, and it is determined whether the purified plasma remaining amount (PW1) ≤ the set purified plasma remaining amount value (PW2), and the purified plasma remaining amount (PW1) ≤ the set purified plasma remaining amount value. When it is determined to be (PW2), the liquid feed pump 63 is stopped and only the infusion work is stopped. And TW5-NW
When it is determined that n ≦ Wt, the process proceeds to the flowchart [3] of FIG. 9 to end the separating / returning blood / transfusion step. Then, it is determined whether or not the amount of collected plasma measured by the weight detection unit 42 is equal to or more than the set amount of collected plasma (target amount of collected plasma), and if not, the next blood collection amount is calculated by the control unit 45 and the blood collection is performed. The next blood collection will be performed based on the 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 operation is calculated, and the process proceeds to the flowchart [4] of FIG. 11.

When the process proceeds to the flowchart [4] in FIG. 11, the ACD lamp is turned on again and the process proceeds to the anticoagulant injection step. In the anticoagulant injection step, the above is repeated. Then, after the step of injecting the anticoagulant is finished, the process proceeds to the flowchart [6] of FIG. 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. 9, the pressurizing / depressurizing means 32 is stopped, the circuit opening / closing means is closed, and the circuit is washed / residual purified plasma conversion step.

In the circuit cleaning / residual purification plasma conversion step, first, as shown in FIG.
2 and if necessary, the liquid delivery pump 63 is operated, the inside of the blood collection container storage section 30 is depressurized, only the second circuit opening / closing means 34 is opened, and the purified plasma in the purified plasma container 26 is stored in the blood collection container 12. Inflow. Then, the control unit 60
When the remaining amount of purified plasma is 0, or when the bubble detection unit 66 detects bubbles continuously for a predetermined time,
Furthermore, when the weight of the blood collection container 12 is not changed for a predetermined time, the liquid feeding pump 63 and the pressurizing / depressurizing means 32 are stopped, and the circuit opening / closing means is also closed. Then, as shown in FIG. 5, the pressurizing / depressurizing means 32 operates again,
The inside of the blood collection container storage unit 30 is pressurized, the circuit opening / closing means 33, 36, 35 are opened, the purified plasma inside the blood collection container 12 flows into the plasma separator 15, and the purified plasma has a flow resistance. Most of the blood flows out from the low blood cell component outlet, 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 purified plasma, the plasma separator, the third
The feeding blood vessel 17 and the first feeding blood vessel 13 are cleaned. This operation is performed until the weight (TW5-NWn) in the blood collection container becomes equal to or less than the predetermined value (Wt), as shown in the flowchart [5] and subsequent figures in FIG. And TW5-N
When Wn ≦ Wt is satisfied or when the bubble sensor 43 continuously detects bubbles for a predetermined time, the circuit cleaning / residual purification plasma conversion step ends. Further, in the circuit cleaning / residual purification plasma conversion step, circuit opening / closing means may be provided in the plasma transportation tube to close the circuit opening / closing means so that plasma does not flow into the plasma collection container. In this way, by closing the plasma transport tube, the circuit can be washed with a small amount of purified plasma.

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 purified plasma residual amount reaches the set value but the plasma collection amount does not reach the target value, as shown in the flow chart, If the plasma collection volume does not reach the target value even during the separation / return step at that time, the anticoagulant injection step and the separation / return step described above are performed. (Do not infuse purified plasma). On the contrary, when the plasma collection amount reaches the target value during the separation, blood return, and infusion steps,
If the purified plasma remaining amount has not reached the set value yet, as shown in the flow chart, the circuit cleaning / residual purified plasma conversion step is performed using all the purified plasma remaining amount. Therefore, whichever reaches the target value or the set value first, plasma exchange is performed without any problem.

Further, not limited to this control method, for example, when the amount of purified plasma does not reach the set value when the amount of collected plasma reaches the target value, only the separating / returning blood step is completed. The infusion step may be continued until the purified plasma amount reaches the set value, and then the circuit cleaning / residual purified plasma conversion step may be performed. Further, the present invention is not limited to the plasma exchange device applied to the single-needle plasma exchange circuit described above, and is a two-needle plasma equipped with a blood collection puncture needle and a blood return puncture needle, respectively. It may be a device applied to an exchange circuit. In such a two-needle plasma exchange circuit, for example, the third blood supply vessel 17 of the above embodiment is not connected to the first blood supply vessel 13, and a puncture needle for blood return prediction is attached to the third blood supply vessel 17. In addition, the purified plasma transportation pipe 27 is connected to the third blood supply line 17. In the case of this plasma exchange circuit, the plasma exchange apparatus of the present invention is, for example, a circuit opening / closing means for controlling each circuit at a position closer to the puncture needle than the purified plasma transport tubes of the first and third blood vessels. After the plasma collection is completed, a circuit cleaning / residual purified plasma conversion step of infusing purified plasma through a plasma separator into a patient through a blood sampling puncture needle is performed.

[0041]

The plasma exchange device of the present invention is separated by the blood collecting circuit for collecting blood from the patient, the plasma separating means for separating the collected blood into the plasma component and the blood cell component, and the plasma separating means. A plasma collection container for collecting plasma components,
A plasma exchange device for controlling a plasma exchange circuit having at least a blood cell component return circuit for returning the blood cell components separated by the plasma separation means to a patient and a purified plasma infusion circuit for infusing purified plasma to the patient. The plasma exchange apparatus includes a blood collection circuit for controlling the blood collection circuit, the anticoagulant addition circuit, a blood separation operation by the plasma separation means and a blood cell component return circuit, and a purified plasma infusion circuit. It has a plasma infusion device section for controlling,
Since the plasma collection device part and the plasma infusion device part are detachably electrically connected, it can be effectively used as a plasma exchange device, and the plasma collection device part can be used alone as a plasma collection device. Further, the plasma infusion device section can be used alone as an infusion device.

[Brief description of drawings]

FIG. 1 is a schematic view of an embodiment of the plasmapheresis apparatus 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 an explanatory diagram for explaining the operation of the plasmapheresis 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.

FIG. 11 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]

 DESCRIPTION OF SYMBOLS 1 Plasma exchange device 2 Plasma collection device part 3 Plasma infusion device part 4 Communication cable 11 Blood collection needle 12 Blood collection container 13 First blood supply vessel 15 Plasma separator 16 Second blood supply vessel 17 Third blood supply vessel 20 Plasma collection container 23 Anticoagulation Agent storage container 24 Anticoagulant transport pipe 26 Purified plasma storage container 27 Purified plasma transport pipe 30 Blood collection container storage unit 32 Pressure reducing / pressurizing 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 47 Plasma collection apparatus Interface 60 control unit 61 plasma infusion device interface 63 liquid transfer pump 63 display unit 65 switch panel 66 air bubble detection unit

Claims (2)

[Claims] 1. A blood collection circuit for collecting blood from a patient, a plasma separation means for separating the collected blood into a plasma component and a blood cell component, and a plasma collection container for collecting the plasma component separated by the plasma separation means. And plasma for controlling a plasma exchange circuit having at least a blood cell component return circuit for returning the blood cell components separated by the plasma separation means to the patient and a purified plasma transfusion circuit for transfusing the purified plasma to the patient An exchanging device, wherein the plasma exchanging device comprises a blood collecting circuit, an anticoagulant adding circuit, a plasma collecting device section for controlling a blood separating operation and a blood cell component returning circuit by the plasma separating means, and purified plasma transfusion. A plasma infusion device section for controlling the circuit, wherein the plasma sampling device section and the plasma infusion apparatus section are detachably electrically connected. Serum exchange device. 2. A blood collection circuit for collecting blood from a patient, a plasma separation means for separating the collected blood into a plasma component and a blood cell component, and a plasma collection container for collecting the plasma component separated by the plasma separation means. And plasma for controlling a plasma exchange circuit having at least a blood cell component return circuit for returning the blood cell components separated by the plasma separation means to the patient and a purified plasma transfusion circuit for transfusing the purified plasma to the patient An exchanging device, wherein the plasma exchanging device comprises a blood collecting circuit, an anticoagulant adding circuit, a plasma collecting device section for controlling a blood separating operation and a blood cell component returning circuit by the plasma separating means, and purified plasma transfusion. A plasma infusion device unit for controlling a circuit, and the plasma collection device unit and the plasma infusion device unit each have a communication function, and are electrically connected by the communication function. A plasma exchange device characterized by being connected.