JPH0696042B2 - Single needle plasma separator and plasma extractor - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial field of application] The present invention uses a plasma separator used for collecting plasma from blood, particularly a single-needle plasma separator and a single-needle plasma separator circuit. The present invention relates to a plasma collection device.

[Prior Art] As a conventional plasma separation apparatus, for example, as shown in FIG. 14, two blood collection containers are alternately moved up and down, and gravity is used to continuously separate plasma. A needle-type plasma separator (Japanese Patent Laid-Open No. 59-209347) has been proposed.

Further, for example, as shown in FIG. 15, a single-needle plasma separation device (see Japanese Patent Laid-Open No. 60-7852) in which one blood collection container is moved up and down and plasma is intermittently separated by utilizing gravity. Is also proposed.

[Problems to be Solved by the Invention] Two-needle plasma separation in which two blood collection containers 66, 65 as shown in FIG. 14 are alternately moved up and down, and the plasma is continuously separated using gravity. In the device, the donor must be punctured with two needles, a blood collection needle 61 and a blood return needle 68. Further, in this device, blood collected from the donor's vein is supplied to the donor and the plasma separator 63. Therefore, the blood must be perfused due to the difference between the blood plasma and the plasma separator 63, and the plasma collection container 60 and the concentrated red blood cell storage containers 66 and 65 must be located below to collect the plasma. The position to perform is considerably low, making it difficult to perform plasma collection operation, and it is difficult to secure the head between the blood donor and the plasma separator 63, and it is particularly difficult to secure the necessary head in a narrow blood donation vehicle. Have a point.
Further, since the respective constituent elements of the plasma separation device are located apart from each other, the operation parts are dispersed, which makes the operation difficult.

Further, even in a single-needle plasma separation apparatus in which one blood collection container 75 as shown in FIG. 15 is moved up and down and the plasma is separated intermittently by utilizing gravity, blood collected from a donor's vein is Perfusion must be performed due to the drop between the blood donor and the plasma separator 73, and plasma is collected with the plasma collection container 79 and the concentrated red blood cell storage container 75 positioned below the plasma separator 73. This means that the position where the operation is performed becomes considerably low, making it difficult to perform the plasma collection operation, and it is also difficult to secure the head between the blood donor and the plasma separator 73, especially in a narrow blood donation vehicle. Has a problem that it is difficult. Moreover, since the respective constituent elements of the plasma separation device are separated, the operation parts are dispersed,
It was difficult to operate.

Therefore, an object of the present invention is a simple circuit configuration, the entire device can be miniaturized, it can be used even in a narrow blood donation car, it is not necessary to secure a head for perfusing blood to the plasma separator, and the operation can be performed. A single-needle plasma separation device capable of concentrating sites and easily collecting plasma, and a plasma collection device for collecting plasma using a single-needle plasma separation circuit.

What achieves the above-mentioned object is to collect a blood collecting needle, a blood collecting container, a first blood vessel for connecting the blood collecting needle and the blood collecting container, a plasma separator, the blood collecting container and the plasma separator. Second blood vessel communicating with the blood inlet of the blood vessel, a third blood vessel communicating with the blood outlet of the plasma separator and the first blood vessel, a plasma collection container, and plasma of the plasma separator. Single-needle plasma separation consisting of a plasma transport tube that communicates an outlet with the plasma collection container, a storage part for the blood collection container, and a blood collection container storage device having a depressurizing and pressurizing function inside the storage part It is a device.

Further, it is preferable that the first blood supply vessel has a blood chamber in the middle thereof, and the plasma chamber has a communication tube having an air filter and an atmosphere opening means.
Further, it is preferable that the blood container container has a function of stirring the blood collected in the blood container. Further, it is preferable to have a storage part for the plasma collection container and a plasma collection container storage part having a decompression function inside the storage part. Furthermore, it is preferable that an anticoagulant solution is stored inside the blood collection container.

Further, what achieves the above-mentioned object is to collect a blood collecting needle, a blood collecting container, a first blood vessel for communicating the blood collecting needle and the blood collecting container, a plasma separator, the blood collecting container and the plasma separation. Second blood vessel communicating with the blood inlet of the blood vessel, third blood vessel communicating with the blood outlet of the plasma separator and the first blood vessel, a plasma collection container, and the plasma separator What is claimed is: 1. A plasma collection device having a single-needle plasma separation circuit, the plasma collection device having a plasma outlet connected to the plasma collection container, the plasma collection device comprising a blood collection container housing part, and a blood collection container. Depressurizing / pressurizing means for pressurizing and depressurizing the inside of the blood vessel container, a plasma separator attaching portion for detachably attaching the plasma separator, and opening and closing the first blood supply vessel of the single-needle plasma separating circuit A first circuit opening / closing means for opening and closing the second blood supply vessel A second circuit closing means, a third plasma collection device having a circuit switch means for opening and closing the plasma transportation tube.

Further, it is preferable that the plasma collection apparatus has a pressure detection unit that detects a pressure inside the blood collection container storage unit. Further, it is preferable that the plasma collection apparatus has a weight detection unit for detecting the weight of the blood collection container stored in the blood collection container storage unit. At the same time, the plasma collection apparatus controls the depressurizing / pressurizing means, the second circuit opening / closing means, the second circuit opening / closing means, and the second circuit opening / closing means by the output of the weight detection unit. It is preferable to have a control unit. Further, it is preferable that the plasma collection apparatus uses a swinging unit that is housed inside the blood collection container storage unit and that shakes the blood collection container. The single-needle plasma separation circuit has, for example, an anticoagulant storage container, and an anticoagulant transport pipe that communicates the anticoagulant storage container with the blood collection container, and the plasma collection device is And a fourth circuit opening / closing means for opening / closing the anticoagulant transport pipe. Further, it is preferable that the control section has a control function of the fourth circuit opening / closing means. Further, it is preferable that the plasma collection apparatus has a cuff pressurizing means that is attached to the blood donor.

Therefore, the single needle plasma separator of the present invention will be described with reference to the embodiments shown in the drawings.

The single-needle plasma separation apparatus 1 of the present invention comprises a blood collection needle 21, a blood collection container 5, a first blood supply tube 2 that connects the blood collection needle 21 and the blood collection container 5, a plasma separator 7, and a blood collection container. 5 and plasma separator 7
Second blood vessel 6 communicating with the blood inlet 7a of the blood vessel, a third blood vessel 8 communicating with the blood outlet 7b of the plasma separator 7 and the first blood vessel 2, a plasma collection container 10, and plasma. Plasma transport pipe 9 that connects the plasma outlet 7c of the separator 7 and the plasma collection container 10
And a blood-collecting-container container 18 and a blood-collecting-container container 18 having a depressurizing and pressurizing function inside the container.

In the single-needle plasma separation device of the present invention, by having a blood collection container housing portion and a blood collection container housing having a depressurizing and pressurizing function inside the housing portion, it is possible to collect blood in the blood collecting container and collect the collected blood. Since blood can be sent to the plasma separator and the concentrated red blood cells flowing out from the plasma separator can be returned, the entire device can be downsized with a simple circuit configuration, and it can be used even in a narrow blood donation car. It is not necessary to secure a head for perfusing blood into the vessel, the operation site can be concentrated, and plasma can be easily collected.

Therefore, the plasma separation apparatus of the present invention will be described with reference to the embodiment shown in FIG.

As the blood collection needle 21 used in the plasma separation device 1 of the present invention, a known metal blood collection needle or a resin blood collection needle is used.

The blood collection needle 21 is attached to the tip of the first blood supply tube 2,
The other end communicates with the blood collection container 5. Further, two or more blood collection containers may be attached to the other end of the first blood supply vessel 2. Then, as shown in FIG. 1, it is preferable to provide a blood chamber 3 in the middle of the first blood supply tube 2. That is, the first blood supply vessel 2 is divided into the first blood supply vessels 2a and 2b, and the blood chamber 3 is provided in the middle thereof. The blood chamber 3 is preferably provided with a communication pipe 15 for communicating the inside of the blood chamber 3 with the outside air, an air filter 16 and an atmosphere opening means 17. By providing these, the blood remaining in the first blood supply tube 2b can be sent to the blood collection container 5, and the blood can be effectively used. As the blood chamber 3, a soft or hard one having a small amount of blood storage space is used. The air filter 16 is provided with a filter having a bacterium impermeable property and a gas permeable property inside, and more safely, it has a blood impermeable property. Atmosphere opening means 17
As such, a two-way stopcock or a valve such as a solenoid valve, forceps, or the like can be used.

The second blood supply vessel 6 has one end communicating with the blood collection container 5 and the other end communicating with the blood inlet 7 a of the plasma separator 7. One end of the third blood supply vessel 8 communicates with the blood outlet 7b of the plasma separator 7,
The other end communicates with the first blood supply vessel 2. When the first blood vessel 2 has the blood chamber 3 as described above, the third blood vessel 8 is preferably in communication with the blood chamber 3.

The plasma transport tube 9 has one end communicating with the plasma outlet 7c of the plasma separator 7 and the other end communicating with the plasma collection container 10.

Then, in the first blood supply vessel 2, the position between the blood collection needle 21 and the blood chamber 3 and the position between the blood chamber 3 and the blood storage container 5, that is, the first blood supply vessel 2a, 2b, respectively. Circuit opening / closing means 11 and 12 are provided. Furthermore, the second
The blood vessel 6 is provided with a circuit opening / closing means 13. A circuit opening / closing means 20 is provided in the third blood supply vessel 8. The circuit opening / closing means 13 and 20 need only be provided with one of them, and need not be provided with both. When only one is provided, it is preferable that the circuit opening / closing means 13 is provided. More preferably, both are provided. Further, the plasma transport tube 9 is provided with a circuit opening / closing means 14.

Then, the first blood vessel 2, the second blood vessel 6, the third blood vessel 8,
As the plasma transportation tube 9, for example, a transparent flexible synthetic resin tube such as vinyl chloride resin or silicone rubber can be preferably used. Furthermore, the first blood vessel 2 and the second blood vessel 6
The third blood supply vessel 8 does not need to have a length that allows a certain height to be formed between the plasma separator 4 and the blood collection container 5 that are in communication with each other, and thus the third blood vessel 8 and the third blood vessel 8 communicate with each other. It suffices to have the minimum length that can be achieved, the length of the entire circuit can be shortened, and the entire device can be downsized and further simplified.

The blood collection container 5 and the plasma collection container 10 are made of a soft synthetic resin (for example, vinyl chloride resin),
Hermetically-sealed blood storage container or open-type blood storage container, for example, a hard synthetic resin having a bacteria-impermeable hydrophobic filter (eg, polycarbonate, hard vinyl chloride resin)
A container or the like can be preferably used. Furthermore, the blood collection container 5
An anticoagulant solution such as an ACD solution, a CPD solution, sodium citrate, or heparin is stored in the inside of the, and preferably, the anticoagulant solution is a physiological isotonic solution. This is because the concentrated red blood cells that have been collected in the blood collection container 5 and the plasma has been separated by the plasma separator 7 are directly returned to the blood donor. Therefore, by storing the anticoagulant solution, which is a physiologically isotonic solution, inside the blood collection container 5 in advance, the anticoagulant injection line can be omitted, and the plasma separation apparatus can be made smaller. Can be converted. Further, in the plasma separation device 1 of the present invention, the blood collection container 5
Since the second blood supply vessel 6 that communicates with the blood plasma separation device 7 is not in communication with the first blood supply vessel 2, the second blood supply vessel 6 is used during blood collection.
The blood does not flow into the inside of the second blood vessel, therefore, it is not necessary to remove the blood and the blood does not coagulate inside the second blood supply vessel 6.

The plasma separator 7 has a blood inlet 7a, a blood outlet 7b which is concentrated red blood cells, a blood separating function for separating blood into a plasma component and a blood cell component, and an outlet 7c for the separated plasma component. There is. As the structure of the plasma separator, a hollow fiber membrane type, a flat membrane type or the like is used.

The blood collection container container 18 has a container for housing the blood collection container 5 and a function of decompressing and pressurizing the inside of the container. When the blood collection container 5 is a flexible container, the storage portion has a capacity that can be stored when the blood collection container stores the maximum amount of blood. The depressurizing function of the storage unit is for depressurizing the inside of the stored blood storage container and sending blood to the blood storage container via the first blood supply tube 2. The pressurizing function of the storage unit pressurizes the blood stored in the blood storage container, sends the blood to the plasma separator 7, and supplies the concentrated red blood cells flowing out of the plasma separator 7 to the third blood supply tube 8. This is for returning blood via the first blood supply tube 2 and the blood collecting needle 21.

Specifically, as the blood vessel container container 18, for example, as shown in JP-B-51-3153 and JP-A-63-23644, it is possible to seal in a state in which a blood storage container is housed. What has a storage part and a pump connected to this storage part for performing intake and air supply is preferably used. More preferably, the blood collection container container 18 has a function of stirring the blood contained in the blood collection container 5 (such as the devices disclosed in JP-B-51-3153 and JP-A-63-23644). It has a shaking function). The stirring function is to stir the anticoagulant solution stored in the blood collecting container 5 and the inflowing blood. As the stirring function, for example, a function of repeatedly moving up and down the front and rear ends of the blood collection container storage unit such as the device of Japanese Patent Publication No. 51-3153, or a function of giving vibration to the entire storage unit, etc. Conceivable.

The embodiment shown in FIG. 1 has a container 19 for collecting blood plasma. The container 19 for collecting blood plasma has a storage part for the container 10 for collecting plasma and a decompression function inside the storage part. As the container container 19 for collecting blood plasma, the container part is
When the plasma-collecting container 10 is a flexible container, the plasma-collecting container has a capacity that can be stored when the plasma-collecting container stores the maximum amount of plasma. The decompression function of the storage unit is for depressurizing the inside of the stored blood storage container and sending plasma from the plasma separator 7 to the plasma collection container. As the blood plasma collection container storage unit 19, the blood collection container storage unit 18 described above can be preferably used. The TMP of the plasma separator at the time of plasma separation can be changed by selecting the depressurization rate of the plasma collection container storage section 19. It should be noted that it is not necessary to have the pressurizing function and the agitating function that the blood vessel container 18 has.

Further, the container 19 for collecting plasma is not necessarily used. For example, as in the embodiment shown in FIG. 2, the plasma transport pipe 9 is provided so that the height of the container 10 for collecting plasma is higher than that of the plasma separator 7. It may have a sufficient length and flexibility so that it can be changed, and the inflow of plasma into the plasma collection container 10 may be performed by a drop. By doing so, by changing the position of the plasma collection container during plasma separation, it is possible to omit the liquid feeding means for transporting the plasma to the plasma collection container, and further to select the position of the plasma collection container. This makes it possible to change the TMP of the plasma separator during plasma separation.

Further, the plasma transportation tube 9 may be provided with a liquid feeding means (not shown). In this case, the plasma transport tube 9 may not be provided with circuit opening / closing means. When the plasma transport pipe 9 is provided with a liquid feeding means, it is not necessary to use the plasma collection container housing 19, and the plasma transport pipe 9 and the plasma collection container 10 are further used.
The position of does not need to be changed with respect to the plasma separator 7,
It is used by being fixed with a fixed liquid feeding means. A pump such as a roller pump or a peristaltic pump is preferably used as the liquid feeding means.

Then, as the circuit opening / closing means 11, 12, 13, 14, 20, you may use forceps or the like. Alternatively, a clamp that opens and closes by electromagnetic action may be used.

Further, as shown in FIG. 3, circuit opening / closing means 11, 12, 13, 14
(When circuit opening / closing means 20 is not provided)
A switching means 32 for outputting an opening / closing signal is provided for the switch 17, and the four circuit opening / closing means and the atmosphere opening means 17 are electrically connected to the switching means 32, and the mode (the blood sampling Mode, blood delivery mode in the second blood supply vessel 2b, blood return and plasma separation mode) selection switch to switch the four circuit opening / closing means and the atmosphere opening means 17 to open / closed states that match the intended mode. It may be one.

In the blood sampling mode, the circuit opening / closing means 11 and 12 are in the open state and the circuit opening / closing means 13 and 14 and the atmosphere are output signals when the changeover switch of the above-mentioned three modes included in the switching means 32 is selected. The opening means 17 is closed (14 is also preferably closed, but may be open). As the blood supply mode in the second blood supply vessel 2b, the circuit opening / closing means 11 is closed,
The circuit opening / closing means 12 and the atmosphere opening means 17 are opened. In the blood return and plasma separation modes, the circuit opening / closing means 12 and the atmosphere opening means 17 are closed, and the circuit opening / closing means 11, 13, 14 are opened.

Further, an anticoagulant transport pipe and an anticoagulant storage container communicating with this transport pipe may be provided in the first blood supply vessel. By doing so, blood collection and plasma separation can be performed multiple times in one blood collection container.

Next, an example of the plasma collection apparatus of the present invention will be described.

The schematic diagram of the basic configuration of the plasma collection device 40 of this embodiment is shown in FIG.
Shown in the figure. It should be noted that FIG. 4 shows the plasma collection device 40 with the single-needle plasma separation circuit attached.

The plasma collection device 40 includes a blood collection needle 21, a blood collection container 5,
A first blood supply vessel 47 that connects the blood collection needle 21 and the blood collection container 5;
The plasma separator 7, the second blood supply vessel 6 that connects the blood collection container 5 and the blood inlet of the plasma separator 7 with each other, and the third blood vessel that connects the blood outlet of the plasma separator 7 with the first blood supply 47 A plasma collection device equipped with a single-needle plasma separation circuit having a blood supply vessel 8, a plasma collection container 10, and a plasma transport pipe 9 that communicates the plasma outlet of the plasma separator 7 and the plasma collection container 10. In this plasma collection device 40, a blood collection container storage portion 41, a decompression / pressurizing means 58 for pressurizing and depressurizing the inside of the blood collection container storage portion 41, and a plasma separator 7 are directly and detachably attached. The plasma separator mounting portion, the first circuit opening / closing means 12 for opening / closing the first blood supply vessel 47 of the single-needle plasma separation circuit, and the second circuit opening / closing means 13 for opening / closing the second blood supply vessel 6. And plasma transport tube 9
And a third circuit opening / closing means 14 for opening / closing. Further, this plasma collection device 40 is provided with a blood container container storage section.
Swinging means 42 for shaking the blood collection container stored inside 41, a pressure detection unit 55 for detecting the pressure inside the blood collection container storage unit 41, and blood collection stored in the blood collection container storage unit A weight detection unit 57 for detecting the weight of the container and a pressurizing unit 44 for pressurizing the cuff 49 attached to the arm of the blood collector.
And a pressure detector 56 for detecting the pressure of the cuff 49. Further, the plasma separation circuit shown here has an anticoagulant storage container 45 and an anticoagulant transport pipe 48 that connects the anticoagulant storage container 45 and the blood collection container 5 to each other. The plasma collection device 40 has a fourth circuit opening / closing means 46 for opening / closing the anticoagulant transport tube 48.

More specifically, the pressure reducing / pressurizing means 58 is an air supply / exhaust circuit.
53, pressurization / decompression switching valves 51, 52, and vacuum pump 43
And a leak valve 50. The rocking means 42 is composed of a rocking crank and a rocking motor for rocking the blood collection container storage base 98 provided in the blood collection container storage portion 41. Also, decompression / pressurization means 5
8, rocking means 42, pressure detection unit 55, weight detection unit 57, cuff 49
Pressurizing means 44, cuff 49 pressure detector 56, leak valve 5
4. The circuit opening / closing means 12, 13, 14, 46 are all electrically connected to the controller 59. This control unit 59 is shown in FIG.
Each component is controlled as shown in the flowcharts of FIGS. 8b, 9 and 10.

An embodiment in which a plasma collection device having such a structure is specifically prepared is shown in FIGS. 5 to 7. FIG. 5 is a perspective view of an embodiment of the plasma collection apparatus of the present invention with a single-needle plasma separation circuit attached, and FIG. 6 is a plasma collection of the present invention with only a plasma separator attached. FIG. 7 is a front view of an embodiment of the device, and FIG. 7 is a central cross-sectional schematic view of FIG.

Therefore, the plasma collection device 40 of the present invention is shown in FIGS.
A more specific description will be given with reference to the drawings.

This plasma collection device 40 has a lid 83 that is obliquely provided on the upper surface.
Further, the lid 83 is provided with a lid opening / closing detection unit. As shown in FIG. 7, this lid open / closed detection unit includes, for example, a magnet 86 and a Hall IC 87 installed on a lid 83,
It is configured to open and close using both. And
As shown in FIG. 7, inside the lid 83, there is formed a blood collection container storage section 41 which becomes a closed space when the lid 83 is closed. Inside the blood collection container storage section 41, A blood collection container storage base 98 is provided obliquely. The blood collection container is installed in the storage base 98 so that the tube side is lower (front side). Also, a container storage stand for blood collection
As shown in FIG. 7, 98 is a rocking means pivotally supported on the tube side, and is composed of a rocking crank 90 and a rocking motor 91 for vertically driving the rocking crank 90. Is provided. The blood collection container storage base 98 is set in the initial state and the stop position at an inclination angle of + 20 °, and the swinging means moves the storage base 98 relative to the above horizontal state ±.
It is configured to oscillate with an amplitude of 20 °. Also,
A depressurizing / pressurizing means is connected to the blood collection container storage section 41, and the inside of the storage section 41 can be pressurized and depressurized. This pressure reducing / pressurizing means is, as shown in FIG. 4, an air supply / exhaust circuit 53, a vacuum pump 43, and two 3-port valves 51, 5
It is composed of two. The depressurizing / pressurizing means 58 can set -100 to -200 mmHg for every 10 mmHg as a depressurized state, and +50 to +200 mmHg for 10 mmHg as a pressurized state.
It is configured so that it can be set for each. This set pressure can be input from the front panel 80 shown in FIGS. 5 and 6. In the depressurized and pressurized states, as shown in FIG. 11, a substantially constant pressure is maintained by turning on / off the vacuum pump 43, and the depressurized / pressurized state is switched by switching the 3-port valves 51 and 52. Is configured. Therefore, the operation of the pressure reducing / pressurizing means will be described with reference to FIG. 13 including the operating states of the three-port valves 51 and 52. The three-port valves 51, 52 are in a ventilation state as shown in FIG. 13a in the ON state, and are in an atmosphere open state as shown in FIG. 13b in the OFF state. Therefore, as shown in FIG. 13c, if only the 3 port valve 51 is turned on (the 3 port valve 52 is turned off), the operation of the vacuum pump 43 causes
Evacuation is performed, and the inside of the blood collection container storage portion 41 shown in FIG. 4 is depressurized. On the contrary, as shown in FIG. 13d, if only the 3 port valve 52 is turned on (the 3 port valve 51 is turned off), the vacuum pump 43 operates to supply air, and the inside of the blood collection container storage portion 41 Is in a pressurized state. Further, a pressure sensor 55 for detecting the internal pressure is attached to the blood collection container storage portion 41. As the pressure sensor 55,
A diffusion type semiconductor pressure sensor is preferably used. further,
A weight sensor 57 is provided in the blood collection container storage portion 41. Specifically, the weight sensor 57 includes a blood collection container storage base 98.
Is attached to. The weight sensor detects the weight of blood in the blood collection container, and a load cell is preferably used as the weight sensor. Further, a blood leak sensor (not shown) is attached to the blood collection container storage portion 41. This blood leakage sensor is also attached to the storage base 98 so that the sensor section is exposed on the upper surface of the blood collection container storage base 98. 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.

As the circuit opening / closing means 12, 13, 14, 46, a solenoid pinch valve which is closed in a normal state is preferably used.

Further, as shown in FIGS. 5 and 6, an ACD bag hanger 85 is provided on the left side surface of the plasma collection device 40. Further, a plasma separator holder 84 forming a plasma separator attachment portion is provided on the front surface of the plasma collection device 40. The plasma separator holder 84 can be mounted with the plasma separator tilted about 20 mm from the center to the front by about 20 ° as a fulcrum, and the mounted state can be held and released by a latch-type magnetic catch. Is configured. Further, a cuff pressurizing port 93 is provided on the front surface of the plasma collection apparatus 40, and as shown in FIG. 4, a tube connected to the cuff can be attached. The cuff pressurizing port 93 is connected to a pump provided in the plasma collection device 41, and further, the port
93 A pressure sensor for detecting the internal pressure and a leak valve are installed. A small blood pressure monitor pump can be preferably used as the pump, and a diffusion type semiconductor pressure sensor can be preferably used as the pressure sensor. The pressure applied to the cuff from the cuff pressurizing port 93 is +10 to +10.
It is configured so that 0 mmHg can be set for each 10 mmHg. This set pressure can be input from the front panel 80 shown in FIGS. 5 and 6.

[Operation] The operation of the single-needle plasma separator of the present invention will be described with reference to FIG.

First, the circuit opening / closing means 11 and 12 are opened / closed, the circuit opening / closing means 13 and 14 and the atmosphere opening means 17 are closed, and the blood collecting needle 21 is punctured into the vein of the blood donor. Then, by operating the decompression function of the blood container container 18 to decompress the interior of the container to a constant pressure, blood is drawn from the blood collecting needle 21 punctured into the vein,
The blood is stored in the blood collection container 5 through the first blood supply 2a, the blood chamber 3, and the second blood supply line 2b. Then, while maintaining the above depressurized state (blood collecting state), by operating the stirring function (shaking function) of the blood collecting container container 18,
The blood is mixed with the anticoagulant inside the blood collection container. The operation of the stirring function (shaking function) of the blood collection container container 18 may be performed after a certain amount of blood flows into the blood collection container 5 and the depressurization function is stopped. After the completion of a certain amount of blood collection, the circuit opening / closing means 11 is closed and the atmosphere opening means 17 is opened so that the blood in the second blood supply tube 2b flows into the blood collection container 5.

Subsequently, the procedure returns to blood return / plasma separation.

At this time, the circuit opening / closing means 12 is closed, the circuit opening / closing means 11, 13, 14 are opened, and the atmosphere opening means 17 is closed. Then, while the inside of the blood collection container storage 18 is pressurized to a constant pressure and the inside of the storage of the plasma collection container storage 19 is depressurized to a constant pressure, the blood inside the blood collection container 5 is supplied to the third blood supply vessel. Blood is sent to the plasma separator 7 via 6 and the separated plasma is sent to the plasma collection container 10 via the plasma transport tube 9. In addition, the high Ht value blood (thickened red blood cells) flowing out from the blood outlet 7b of the plasma separator 7 is
Blood is returned to the vein through the fourth blood supply vessel 8, the blood chamber 3, the first blood supply vessel 2a, and the blood collecting needle 21.

Next, the operation of the plasma collection device 40 of the present invention will be described with reference to FIGS.
This will be described with reference to FIGS. 8b, 9 and 10.
In particular, here, a case of performing plasma collection five times using a 200 ml blood collecting container will be described as an example.

First, the power switch of the plasma collection device 40 is turned on.
In this state, the circuit opening / closing means 12, 13, 14, 46 is in a closed state, and any one of the vacuum pump 43, the swinging means 42, and the cuff pressurizing pump 44 of the depressurizing / pressurizing means 58 of the blood sampling container storage portion 41. Is not working. Further, the leak valve 50 of the pressure reducing / pressurizing means 58 is open, and both the pressure reducing / pressurizing switching valves 51, 52 of the pressure reducing / pressurizing means 58 are open to the atmosphere.
Further, the electrical abnormality of each part is automatically checked, the blood sampling weight of 200 ml and the blood sampling frequency (N _S ) = 5 are input, and the weight of the blood sampling container 5 is set to zero. Then, the plasma collection device 40
Attach a single-needle plasma separation circuit to the cuff pressurization port 93
The tube connected to the cuff 49 is attached to the blood vessel, and the blood vessel is covered with the cuff 49. After the above set is completed,
Turn on the start switch on the front panel.

If the blood leaks or the lid is open, the alarm activates, and if the weight is 5g or less, it is detected that the blood sampling container is not stored in the blood sampling container storage part, and the alarm is activated. If the above alarm is not activated, the blood collection amount will be 20
Judge whether it is 0 ml or 400 ml. Here, 200 ml
Is provided on the front panel
The ACD lamp lights up, then the start lamp lights up, and the anticoagulant injection mode is entered. And P = 0, weight W =
0, the number of blood sampling N = 5 is automatically input, and the blood sampling amount is 400 m
In the case of 1, since the anticoagulant is stored in the blood collection container 5 in advance, this anticoagulant injection mode is omitted, and here, P = 0 and weight W = W ₀ , The blood collection number N = 1 is automatically input. By the above input, the leak valve 50 is closed and the pressure reducing / pressurizing switching valve 51
Becomes the ventilation state, the circuit opening / closing means 46 becomes the open state,
Further, the vacuum pump 43 is operated, and the inside of the blood collection container storage portion 41 is depressurized, and the anticoagulant (for example, ACD solution) is injected from the anticoagulant storage container 45 into the blood collection container 5. The injection of this anticoagulant is performed by the weight detection unit 57 by the blood collection container 5
The weight (W) of the anticoagulant is greater than or equal to the set weight (W ₀ ) of the anticoagulant (W ≧
W ₀₎ to reach is performed until the detected, reaches the set weight of the, ACD light turns off, with operation of the vacuum pump 43 is stopped, the circuit opening and closing means 46 becomes the closed state, the leak valve 50 Is opened. Then, the blood sampling lamp blinks and then the start lamp blinks. Then, the first circuit opening / closing means 12 is opened, the cuff pressurizing pump 44 is operated, preparation for puncturing the blood donor is completed, and the blood collecting mode is entered. After confirming the melody alarm indicating that the cuff pressure has reached the set value, the puncture needle 21 was punctured into the vein of the blood donor, and it was confirmed that blood had flowed into the blood vessel from the puncture needle due to the venous pressure of the blood donor. After that, the start switch provided on the front panel 80 is turned on. As a result, the blood sampling lamp lights up, and then the start lamp lights up. Then, the leak valve 50 is closed, the vacuum pump 43 and the swing motor 42 operate, and
The cuff pressurizing pump 44 maintains the operating state, and the pressure is maintained within a predetermined pressure range by turning the pump ON / OFF as in the vacuum pump described later. Blood flows into the blood collection container 5 by the operation of the pump. The weight of the blood sampling container 5 is sequentially detected by the weight detection unit 57, and the weight (W) of the blood sampling container 5 is equal to the set weight [the set blood sampling weight (W ₁ ) + the anticoagulant weight (W ₀ )] or more (W ≧ W ₀ + W ₁ )
When the temperature reaches, the blood collection lamp is turned off, the leak valve 50 is opened, the vacuum pump 43, the swing motor 42, and the cuff pressurizing pump 44 are stopped, and the valve 51 is also opened to the atmosphere. Then, the separation / return blood lamp is turned on, and the mode returns to the small blood return mode. This small blood return mode is
The blood in the first blood supply vessel 47 remains in a state in which the anticoagulant is not added. Therefore, if left as it is, the blood in the first blood supply vessel 47 is coagulated. Therefore, a small amount of blood is returned to replace the blood in the first blood supply vessel 47 with the blood in the blood collection container 5 to which the anticoagulant has been added, thereby preventing blood coagulation in the blood supply vessel 47. To do so.

In this small blood return mode, the circuit opening / closing means 12 is in an open state,
Leak valve 50 is closed, valve 51 is open to the atmosphere,
The valve 52 is ventilated, the vacuum pump 43 is operated, and the inside of the blood collection container storage portion 41 is pressurized. In this small amount blood return, the weight (W) of the blood collection container 5 is the set weight [the set blood collection weight (W ₁ ) + anticoagulant weight (W ₀ ) −anticoagulant added blood return weight (W ₂ )] or less (W ≦ W ₀ + W ₁ −W ₂ ), and when the set weight is reached, the remaining number of blood sampling times is determined and the first time, that is, the remaining number of blood sampling times is the blood sampling frequency set value. If it is equal to, the process returns to the blood return mode, and if it is the second time, the process directly shifts to the separation / return mode. In the blood return mode, the opening timing of the circuit opening / closing means 14 is delayed by 10 to 20 seconds in order to prevent the plasma from being diluted by the priming liquid (physiological saline) filled in the plasma separator 7 (the priming liquid ( After flowing out only (physiological saline), the circuit opening / closing means 13, 14 are opened, the blood in the blood collection container 5 flows into the plasma separator 7, and the plasma component separated by the plasma separator 7 is It flows through the plasma transport tube 9 and flows into the plasma collection container 10. The blood cell component flowing out from the plasma separator 7 is returned to the donor through the third blood supply vessel 8 and the first blood supply vessel 47. Then, this blood return is performed by the blood collection container 5
Is performed until the weight (W) becomes less than the set weight (Wth) (W <Wth), and when the set weight is reached, the separation / return lamp turns off and the remaining number of blood collection is less than 1 time. If there is more than once, move to the flowchart,
Again, the ACD lamp is turned on again, the anticoagulant (for example, ACD solution) is put into the blood collecting container from the anticoagulant container 45, the weight (W) of the blood collecting container 5 is the set weight of the anticoagulant (W ₀ ) Above (W
When the weight is set to ≧ W ₀ ) and reaches the set weight, the operation of the vacuum lamp 43 is stopped, the circuit opening / closing means 46 is closed, and the leak valve 50 is opened. Then, the ACD lamp is turned off, the circuit opening / closing means 12 is opened, the blood collecting lamp is lit, the start lamp is lit, and the blood collecting mode is entered.

When it is judged whether the remaining number of blood samplings is less than or equal to 1,
If it is less than once, the melody alarm sounds, the start lamp goes off, and then the end lamp lights up, and the plasma collection work ends. After the end, the puncture needle 21 is removed from the blood donor. Then, by shifting to the flow chart and opening the lid of the plasma collection device 40, the circuit opening / closing means 12, 13, 14, 4 is opened.
All of 6 are opened, the end lamp goes off, 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, and the plasma blood collection work is completed.

Next, the warning flow of the plasma collection device 40 of the present invention will be described with reference to FIGS. 9 and 10.

In this warning flow, as shown by the route on the left side in FIG. 9, the lid is opened while the plasma collection device 40 is in operation, whether the stop switch is pressed, whether the blood flow is reduced, or not. It is configured to sequentially determine whether or not there is blood leakage, and to shift to a warning flow when each is determined to be YES. First, if a decrease in blood collection is detected, it is determined whether it is time to collect blood, and if so, A = 1
(If A = 1, it means a decrease in blood collection again), and if A = 1, the process moves to the subroutine A shown in FIG. In this plasma collection device 40,
As shown in FIG. 11, the pressure inside the blood collection container storage section 41 has the set pressure as the upper limit, and by repeating ON / OFF of the vacuum pump so that the lower limit is 0.8 to 0.9 of the set pressure, within the above range. The pressure is controlled to be maintained. In addition, as shown in FIG. 12, the weight detection unit provided in the blood collection container storage unit 41 detects the weight as shown in FIG. 12 in which the swinging means 42 of the blood collection container storage unit 41 swings (3 to 4 seconds). ), And by comparing the weight with the weight detected four times before, it is configured to detect a decrease in the blood collection volume.
Then, when this decrease in blood collection amount is detected, the process shifts to the subroutine A shown in FIG. 10 as described above. And
As shown in FIGS. 10 and 12, the vacuum pump 43 and the swinging means 42 are stopped, the leak valve 50 is opened, and this state is maintained for 1 second (T ₄ ). Then, half of the set blood collection pressure pressure (P _1), i.e. automatically set to P _1/2, by operating the vacuum pump 43 and the swinging pump 42, a leak valve 50 and closed, the A = 1 Automatically input and start blood collection again. Then, when the blood collection amount decreases again,
As shown in the flowchart of FIG. 9, it is determined whether A = 1, and whether the weight (W) of the blood collection container 5 is greater than the set weight (Wth) (W> Wth), and YES is determined. If so (in the case of NO, since it corresponds to the termination condition of FIG. 8b, there is no transition to the NO branch in FIG. 9 showing the warning flow), the alarm lamp (2) blinks and A = 0 is automatically input, an alarm 82 is activated, and as shown in FIGS. 9 and 12, the vacuum pump 43 and the swinging means 42 are stopped,
Open the leak valve 50 and the leak valve 54,
Then, all the circuit opening / closing means are closed, the start switch blinks, and the interruption switch blinks.

Then, start switch ON / OFF, interrupt switch ON / OFF
The warning lamp, the start switch, and the interruption switch are turned off by checking that the interruption switch is ON, and the 8a
The flow shifts to the flow chart shown in the figure, and the plasma collection operation is stopped. [Examples] Examples of the present invention will be described below.

(Example 1) In a blood collection container, 446 ml of ACD-added bovine blood adjusted to Ht 40% was stored. The container containing the above-described blood was set in the blood collection container storage portion of the blood collection container storage device. Then, the pressure inside the storage part of the blood vessel container was set to 60 mmHg. Further, the plasma blood collection container was set inside the plasma collection container housing, and the internal pressure was set to -30 mmHg. As a container container for plasma collection,
Hemoquick (registered trademark) manufactured by Terumo Corporation was used. At this time, the circuit configuration as shown in FIG. 1 was used, and among the circuit opening / closing means 11, 11, 14 were opened, and the circuit opening / closing means 12 and the atmosphere opening means 17 were closed.
The processing time of 446 ml of blood contained in the blood collection container was 16 minutes and 35 seconds, and 196 ml of plasma could be collected.

(Example 2) Instead of using a container for collecting plasma, a container for collecting plasma from the plasma outlet of the plasma separator as shown in FIG.
An experiment similar to that of Example 1 was carried out except that the height h up to 10 was 47 cm, and substantially the same results as in Example 1 were obtained.

(Example 3) A blood plasma collecting apparatus having the above-described structure shown in Figs. 4 to 9 was prepared. The single-needle plasma separation circuit had a circuit configuration as shown in FIG. 4, 16 G was used as a puncture needle, and a flat membrane laminated type was used as the plasma separator. Then, a container containing ACD-added bovine blood 4 adjusted to Ht 40% was used in the container, and the puncture needle of the plasma separation circuit was put in this container to perform a plasma collection experiment. The blood pressure in the blood collection container storage part of the plasma collection device is -180 mmHg, the pressurization during blood return is +155 mmHg, and the blood collection container storage table swings for 3 seconds. The number of blood collections was 5 times. Further, during the plasma blood collection operation, the container containing the bovine blood was stirred using a rotor. The blood sampling results were as shown in Table 1.

[Effects of the Invention] A single-needle plasma separation device of the present invention is a blood collection needle, a blood collection container, a first blood supply line communicating the blood collection needle and the blood collection container, a plasma separator, and the blood collection. A second blood vessel for communicating the blood vessel with the blood inlet of the plasma separator, a third blood vessel for communicating the blood outlet of the plasma separator with the first blood vessel, and a plasma collection container A plasma transport pipe that communicates the plasma outlet of the plasma separator with the plasma collection container; a storage part for the blood collection container and a blood collection container storage device having a depressurizing and pressurizing function inside the storage part. Consisting of, in particular,
By having a blood sampling container housing portion and a blood sampling container housing having a depressurizing and pressurizing function inside the housing portion, blood is collected in a blood collecting container, and the collected blood is sent to a plasma separator and a plasma separator. Since the concentrated erythrocytes that flow out more can be returned, the entire device can be downsized with a simple circuit configuration, and there is no need to secure a head for perfusing the blood to the plasma separator, so a narrow blood donation vehicle In addition, it can be used also in, and the operation site can be concentrated, the operability is improved, and plasma can be easily collected. In addition, the length of the blood supply vessel that communicates each component is also shortened, the priming volume in the plasma separation device can be reduced, and automation can be supported.

Further, in the device of the present invention, since the second blood sending vessel is configured not to communicate with the first blood sending vessel, blood does not flow into the second blood sending vessel at the time of blood collection, and thus the removal thereof. No work required.

Further, the first blood supply vessel has a blood chamber in the middle thereof, and if the blood chamber has a communication tube having an air filter and an atmosphere opening means, the blood remaining in the first blood supply vessel is used as a blood collection container. It becomes possible to send blood to, and the blood can be effectively used.

Further, in the plasma separation apparatus of the present invention, after the blood is first collected in the blood collection container, the plasma is separated when the blood is returned, so that the blood collection container is preliminarily provided with the anticoagulant. By containing the liquid, the anticoagulant injection line can be omitted.

On the contrary, by providing the blood collection container with the anticoagulant transport pipe and the anticoagulant storage container communicating with the transport pipe, blood collection and plasma separation can be performed multiple times with one blood collection container. It can be carried out.

Further, the plasma collection apparatus of the present invention includes a blood collection needle, a blood collection container, a first blood vessel that connects the blood collection needle and the blood collection container, a plasma separator, the blood collection container and the plasma separation. Second blood vessel communicating with the blood inlet of the blood vessel, third blood vessel communicating with the blood outlet of the plasma separator and the first blood vessel, a plasma collection container, and the plasma separator What is claimed is: 1. A plasma collection device having a single-needle plasma separation circuit, the plasma collection device having a plasma outlet connected to the plasma collection container, the plasma collection device comprising a blood collection container housing part, and a blood collection container. Depressurizing / pressurizing means for pressurizing and depressurizing the inside of the blood vessel container, a plasma separator attaching portion for detachably attaching the plasma separator, and opening and closing the first blood supply vessel of the single-needle plasma separating circuit A first circuit opening / closing means for opening and closing, and a first circuit opening / closing means for opening / closing the second blood vessel. And circuit switch means, since those with a third circuit closing means for opening and closing the plasma transportation tube, using a plasma separation circuit of the plasma can be easily taken.

Further, the plasma collection device uses the output of the weight detection unit to perform the decompression / pressurization means, the first circuit opening / closing means,
If the device has a control unit for controlling the second circuit opening / closing means and the third circuit opening / closing means, the blood plasma collection work can be automated, and therefore plasma can be collected very easily.

[Brief description of drawings]

FIG. 1 is a diagram showing an embodiment of a single-needle plasma separation device of the present invention, FIGS. 2 and 3, a diagram showing another embodiment of a single-needle plasma separation device of the present invention, and FIG. FIG. 5 is a schematic view of an embodiment of the plasma collection apparatus of the present invention with a single-needle plasma separation circuit attached, and FIG. 5 shows a plasma collection apparatus of the present invention with a single-needle plasma separation circuit attached. FIG. 6 is a perspective view of the embodiment, FIG. 6 is a front view of the embodiment of the plasma collection apparatus of the present invention in which only a plasma separator is attached, and FIG. 7 is a schematic sectional view in the center of FIG. 6 and FIG. 8a. And FIG. 8b is a flow chart for explaining the operation of the plasma collection apparatus of the embodiment of the present invention, FIG.
FIG. 10 and FIG. 10 are flow charts for explaining the operation of the plasma collection apparatus of the embodiment of the present invention, and FIG. 11 is ON / OFF of the vacuum pump of the pressure reducing / pressurizing means used in the plasma collection apparatus of the present invention. Explanatory diagram for explaining the set pressure maintaining mechanism by OFF, FIG. 12 is an explanatory view for explaining the operation of the plasma collection device when a decrease in blood collection blood flow during blood collection using the plasma collection device of the present invention is detected Figure, Figure 13a, Figure 13b, Figure 13
FIGS. 14c and 14d are explanatory views for explaining an example of depressurizing / pressurizing means used in the plasma collection device of the present invention, and FIG.
FIG. 15 and FIG. 15 are explanatory views of a conventional plasma separation device. 1 ... Single needle type plasma separator, 2a, 2b ... First blood vessel, 3 ... Blood chamber, 5 ... Blood collection container, 6 ... Second blood vessel, 7 ... Plasma separator, 8 ... … Third blood vessel, 9 …… Plasma transport tube, 10 …… Plasma collection container, 11,12,13,14,20,46 …… Circuit opening / closing means 15 …… Communication tube, 16 …… Air filter, 17 ...... Air release means, 18 …… Blood collection container storage, 19 …… Plasma collection container storage, 21 …… Blood collection needle, 40 …… Plasma collection device, 41 …… Blood collection container storage, 42 …… Swinging means, 44 ... Cuff pressurizing means, 45 ... Anticoagulant container, 57 ... Weight detecting section, 58 ... Pressure reducing / pressurizing means, 59 ... Control section, 80 ... Front panel, 98 ... … Vessel for collecting blood

Claims (2)

[Claims] 1. A blood collecting needle, a blood collecting container, a first blood supply line communicating with the blood collecting needle and the blood collecting container, and a plasma separator.
A second blood supply vessel that connects the blood collection container and the blood inlet of the plasma separator, a third blood supply vessel that connects the blood outlet of the plasma separator and the first blood vessel, and plasma collection A container, a plasma transport pipe that communicates the plasma outlet of the plasma separator with the plasma collection container, a container for the blood collection container, and a container for collecting blood having a depressurizing and pressurizing function inside the container. A single-needle plasma separation device comprising: 2. A blood collecting needle, a blood collecting container, a first blood vessel for communicating the blood collecting needle and the blood collecting container, and a plasma separator.
A second blood supply vessel that connects the blood collection container and the blood inlet of the plasma separator, a third blood supply vessel that connects the blood outlet of the plasma separator and the first blood vessel, and plasma collection What is claimed is: 1. A plasma collection device equipped with a single-needle plasma separation circuit, comprising a container, a plasma outlet of the plasma separator, and a plasma transport pipe that communicates with the plasma collection container. Container storage part, decompression / pressurizing means for pressurizing and depressurizing the inside of the blood collection container storage part, a plasma separator attachment part to which the plasma separator is detachably attached, and the single-needle plasma separation First for opening and closing the first blood supply vessel of the circuit
And a third circuit opening / closing means for opening / closing the plasma transport tube and a second circuit opening / closing means for opening / closing the second blood supply vessel. .