JP3487609B2 - Blood processing equipment - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION The present invention relates to a blood processing apparatus, and more particularly to
The present invention relates to a device for separating blood components from collected blood and returning the blood.

[0002]

2. Description of the Related Art Conventionally, as a method of collecting blood from a donor (blood donor, patient) and separating and collecting the blood into a blood cell component and a plasma component, a blood bag containing the collected blood is subjected to centrifugation, A centrifugation method for separating concentrated blood cell fluid and plasma and a membrane method for separating concentrated blood cell fluid and plasma by contacting blood with the membrane are known.

Of these, the membrane method is a method of separating plasma that passes through the membrane and blood cells that do not pass through the membrane by using a membrane-type plasma separator, and each separated blood component is put in a separate bag. Recovery system (JP-A-63-22636)
4) and a system for returning separated concentrated red blood cells to a blood donor (JP-A-59-209374, JP-A-60-7852, JP-A-2-98365).
There is.

By the way, in the blood processing circuit having the plasma separator as described above, air bubbles may be generated in the circuit for some reason. Especially, in the case of a circuit having a blood returning line to the donor, When air bubbles are mixed in the blood component to be blood and injected into the blood donor, there is a possibility that harmful effects such as air embolism may occur.

Therefore, conventionally, a chamber is provided in the blood return line so that bubbles can be removed from the blood components to be returned. However, the chamber has a limited amount of bubbles to be removed, When a large amount is generated, it is not possible to completely remove the air bubbles and the presence of the chamber
There are drawbacks such as an increase in the amount of priming.

There is also a method of visually confirming the generation of air bubbles in a circuit and, if air bubbles are found, stopping blood processing and manually removing the air bubbles. There is a risk of overlooking the occurrence, it takes time and time to remove the bubbles, and during the bubble removal operation,
There is a drawback that an accident may occur in which bubbles are accidentally injected into the blood donor due to an operation error.

[0007]

SUMMARY OF THE INVENTION An object of the present invention is to provide a blood processing apparatus which can prevent harmful effects caused by the inclusion of air bubbles and which is highly safe.

[0008]

These objects are achieved by the present invention described in (1) to (7) below.

(1) A puncture needle, a blood storage container, a plasma separator, a plasma storage container, a first flow path connecting the puncture needle and the blood storage container, the blood storage container or the first flow path And a blood flow inlet of the plasma separator, a second flow passage, a third flow passage connecting the red blood cell outlet of the plasma separator and the first flow passage, and a plasma flow of the plasma separator. A fourth flow path connecting the outlet and the plasma storage container, a fifth flow path whose one end is connected to the first flow path, and a connection portion of the third flow path of the first flow path, Flow path opening / closing means for opening / closing the puncture needle side and the blood storage container side, the middle of the second flow path, the middle of the third flow path and the middle of the fifth flow path, and the first flow path. Bubbles in the flow path are installed on the blood storage container side and in the middle of the third flow path with respect to the connection portion with the third flow path. Two bubble detection means may issue,
Liquid sending means for obtaining liquid flow in each of the flow paths, and gas-liquid separating means provided in the middle or the other end of the fifth flow path,
At least the control means having a function of controlling the opening and closing of the flow path by the flow path opening and closing means and the operation of the liquid feeding means is provided, and the control means is provided by one of the two bubble detection means. The flow channel opening / closing means and the liquid feeding means are configured to change the open / closed state of each flow channel as desired in accordance with the detection of bubbles, and to discharge the bubbles to the gas / liquid separating means via the fifth flow channel. A blood processing apparatus characterized by controlling the.

(2) The blood processing apparatus according to (1), wherein the fifth flow path also serves as a flow path for introducing an anticoagulant into the blood storage container.

(3) The blood processing apparatus according to (1) or (2), wherein the liquid feeding means has a function of pressurizing and depressurizing the blood storage container.

(4) The blood processing apparatus according to any one of (1) to (3), wherein the puncture needle is used for blood collection and blood return.

(5) The blood processing apparatus according to any one of (1) to (4) above, which has a purified plasma adding means for adding purified plasma to the blood components to be returned.

(6) The blood according to (5), wherein the control means controls the purified plasma adding means so as to add purified plasma in an amount according to the amount of plasma separated in the plasma separator. Processing equipment.

(7) The blood processing apparatus according to any one of (1) to (6) above, including means for determining whether or not the plasma separator is operating normally.

[0016]

[0017]

[0018]

[0019]

[0020]

[0021]

[0022]

[0023]

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

FIG. 1 is a plan view showing a structural example of the main part of the blood processing apparatus of the present invention. Blood processing apparatus 1 shown in FIG.
A is used, for example, for component blood donation, and includes a puncture needle 2, a blood bag 3 as a blood storage container, and a plasma separator 4.
And a plasma bag 5 which is a plasma collection means (plasma storage container)
And have.

The puncture needle 2 is used to puncture a blood vessel or the like of a blood donor, and one end of a tube 6 is connected to its rear end. The other end of the tube 6 is connected to one end of the tube 7 via a branch connector 14 that branches in three directions, and a dogleg-shaped branch connector 15 is installed at the other end of the tube 7. . The branch end 151 of the branch connector 15 and the blood bag 3 are attached to the tube 8
Connected by. As a result, the puncture needle 2 and the blood bag 3 communicate with each other via the first flow path formed by the lumens of the tubes 6, 7, 8 and the branch connectors 14, 15.

The puncture needle 2 and the lumen of the tube 6 are not only a blood sampling line from the blood donor but also a blood returning line of the concentrated red blood cells separated by the plasma separator 4 to the blood donor to the blood donor. With such a configuration, since the blood donor is punctured with only one puncture needle 2, the burden on the blood donor is reduced as compared with the conventional two-needle type in which blood collection and blood return are performed by different puncture needles.

The blood bag 3 is formed by stacking resin sheet materials.
The edge portion is sealed by fusion (for example, heat fusion or high frequency fusion) or adhesive to be formed into a bag shape, and one end of the tube 8 is sandwiched between both sheet materials in the seal portion 35. It is fixed by fusion or adhesion.

As the sheet material constituting the blood bag 3, for example, soft polyvinyl chloride, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer (EVA), polyamide, polyurethane series, polyester series, polyamide series, olefin Examples thereof include those made of a flexible resin such as various elastomers such as styrene and styrene, or a mixture thereof.

The illustrated plasma separator 4 is a flat membrane type plasma separator, and includes a casing 40, a stack of disc-shaped membranes (filtration membranes) housed in the casing 40, and a blood inlet 4.
1 and a red blood cell outlet 4 through which the separated concentrated red blood cells flow out
2 and a plasma outlet 43 through which the separated plasma flows out. The blood inlet 41 and the red blood cell outlet 42 communicate with the space formed between each membrane and the casing 40, and the plasma outlet 43 communicates with the space formed inside each membrane.

The plasma separator that can be used in the present invention is not limited to the flat membrane type shown in the drawing, but may be a hollow fiber membrane type.

A blood inlet 41 of such a plasma separator 4
And the branch connector 15 are connected by a tube 9. As a result, the first flow path and the blood inlet 41 communicate with each other via the second flow path formed in the tube 9.

The red blood cell outlet 42 of the plasma separator 4
And a branch end 141 on the left side of FIG. 1 of the branch connector 14.
Are connected by a tube 10. As a result, the red blood cell outlet 42 and the first flow path communicate with each other via the third flow path formed in the tube 10.

In addition, the plasma outlet 43 of the plasma separator 4,
The plasma bag 5 is connected by a tube 11. As a result, the fourth portion formed in the lumen of the tube 11
The plasma outlet 43 and the plasma bag 5 communicate with each other via the flow path.

The plasma bag 5 is the blood bag 5 described above.
In the same manner as above, resin sheet materials are stacked, and the edges are sealed by fusion (for example, heat fusion or high frequency fusion) or adhesion to form a bag, and one end of the tube 11 is
At the seal portion 55, it is sandwiched between the two sheet materials and is fixed by fusion or adhesion. Also, this plasma bag 5
An outlet 51 for taking out the collected plasma is formed in the peel tab while being encapsulated in the peel tab.

The branch end 1 on the right side of FIG. 1 of the branch connector 14
One end of the tube 12 is connected to 42, and the tube 1
At the other end of 2, a resin needle tube (bottle needle) 13 having a side hole 131 at the tip is attached, for example. The tube 12 and the needle tube 13 are, for example, ACD in the blood bag 3.
Solution, CPD solution, anticoagulant solution such as sodium citrate, heparin. FIG. 2 described later
The needle tube 13 is attached to the drain port of the container 23 containing the anticoagulant solution shown in FIG.
When the liquid feeding means described later is operated, the anticoagulant liquid in the container passes through the fifth flow path formed in the tube 12 and the needle tube 13 and the first flow path communicating with this, It is introduced into the blood bag 3.

Further, the tube 12 and the needle tube 13 are not only a passage for introducing the anticoagulant liquid but also a passage for discharging bubbles described later.

The tubes 6, 7, 8, 9, 10, 11 and 12 are preferably flexible, and the constituent materials thereof are, for example, polyvinyl chloride, polyethylene, polypropylene. Polyolefins such as EVA, PET, polyesters such as PET and PBT,
Examples thereof include polyurethane, polyamide, silicone, polyester elastomer, polyamide elastomer, thermoplastic elastomer such as styrene-butadiene-styrene copolymer, or a combination thereof. Each of the tubes 6 to 12 is preferably transparent or translucent in order to ensure the internal visibility.

Flow passage opening / closing means 16, 17, 18, 19 and 20 for opening / closing the flow passages in the tubes are provided in the middle of the tubes 6, 7, 9, 10 and 12, respectively. That is, the flow path opening / closing means 16 opens / closes the puncture needle 2 side of the branch connector 14 of the first flow path, and the flow path opening / closing means 17 opens / closes the first flow path between the branch connectors 14 and 15. The middle of the second flow path is opened and closed by 18, the middle of the third flow path is opened and closed by the flow path opening and closing means 19, and the middle of the fifth flow path is opened and closed by the flow path opening and closing means 20.

The flow path opening / closing means 16 to 20 are, for example, electromagnetic valves, valves and cocks that are opened and closed manually,
In the normal state, there is a solenoid pinch valve that closes the tube by pressure, and in the normal state, a clamp that closes the tube by pressure and manually releases it.

The opening / closing of the flow paths by the flow path opening / closing means 16 to 20 is controlled by the control means 33 described later.

In the middle of the tubes 10 and 7,
Bubble detecting means (bubble sensors) 21 and 22 for detecting the presence of bubbles in the liquid flowing in the tube are provided respectively. Examples of the bubble detection means 21 and 22 include those that detect bubbles optically, electrically, and magnetically.
It may have any configuration.

Each of the bubble detecting means 21 and 22 as described above is always activated, but is activated only when necessary (for example, when returning blood to a donor or preparing for it), as described later. You can do it.

The bubble detecting means 2 of the tubes 10 and 7
In order to easily detect air bubbles, the place where 1 and 22 are installed,
For example, it may be formed in any shape such as a flat shape or a tapered shape, and a member having such a shape may be installed.

FIG. 2 is a circuit diagram schematically showing a configuration example of the blood processing apparatus of the present invention. As shown in the figure, in addition to the circuit shown in FIG. 1 described above, the blood processing apparatus 1A detects decompression / pressurization means 24 for decompressing or pressurizing the blood bag 3 and the weight of the plasma bag 5. Weight detection means 3
2 and control means 33.

The pressure-reducing / pressurizing means 24 corresponds to a liquid-supplying means for obtaining a liquid flow in each flow path of the circuit shown in FIG. 1 by putting the blood bag 3 into a pressure-reduced or pressurized state. Storage part 25 for hermetically storing blood bag 3, weight detection means 26 for detecting the weight of blood bag 3 in storage part 25, air supply / exhaust circuit 27, and pressure detection means for detecting the internal pressure of storage part 25. 31 and 31.

A weight sensor such as a load cell is preferably used as the weight detecting means 26. The weight of the blood bag 3 may be measured by the weight detection means 26 continuously (real time) or intermittently, that is, at a constant cycle.

The air supply / exhaust circuit 27 includes a vacuum pump 28 and a vacuum pump 28.
Three 3-port valves 29a, 29b and leak valve 3
It has 0 and. The 3 port valves 29a and 29b are
When it is on, it is ventilated, and when it is off, it is open to the atmosphere.
Therefore, if the 3 port valve 29a is turned on and the 3 port valve 29b is turned off and the vacuum pump 28 is operated,
Exhaust is performed and the inside of the storage unit 25 is depressurized. Conversely, if the 3 port valve 29a is turned off and the 3 port valve 29b is turned on to operate the vacuum pump 28, air is supplied and the storage unit is stored. The inside of 25 is pressurized.

When the inside of the storage portion 25 is brought into a depressurized state or a pressurized state, the leak valve 30 is closed,
When returning from the depressurized state or the pressurized state to the atmospheric pressure, the leak valve 30 is opened.

As the pressure detecting means 31, a pressure sensor, especially a diffusion type semiconductor pressure sensor is preferably used. The information obtained by the pressure detection means 31 is mainly used for controlling the air supply / exhaust in the air supply / exhaust circuit 27. For example, when the inside of the storage unit 25 is in a depressurized state or a pressurized state, the storage unit 2 is based on the information obtained by the pressure detection unit 31.
The pressure of 5 is controlled to be kept constant.

As the weight detecting means 32, the same means as the weight detecting means 26 can be used. The weight of the plasma bag 5 may be measured by the weight detection means 32 continuously (real time) or intermittently, that is, in a fixed cycle.

The control means 33 is composed of, for example, a microcomputer, and the flow path opening / closing means 16, 17, 1 is used.
8, 19, 20, bubble detecting means 21, 22, weight detecting means 26, 32, vacuum pump 28, 3 port valve 29
a, 29b, leak valve 30, and pressure detection means 31
And are electrically connected to each other.

The control means 33 includes a weight detecting means 26,
32, the pressure detecting means 31, the bubble detecting means 21, 22, and the like, the operation (switching operation) of each of the flow path opening / closing means 16 to 20, the vacuum pump 28 of the pressure reducing / pressurizing means 24, and 3 ports. The operations of the valves 29a and 29b and the leak valve 30 are respectively controlled to set the liquid flow state in each flow path of the circuit as desired.

Hereinafter, an example of control by the control means 33 will be described.
A description will be given based on the flowcharts shown in FIGS.
The blood processing apparatus 1A of the present invention can select the following four modes, and the control means 33 performs control according to each mode.

[1] Anticoagulant Injection Mode FIG. 3 is a flowchart of control in the anticoagulant injection mode.

For example, the anticoagulant injection mode is set by an input from an input means (not shown) such as a keyboard or a mode setting switch (step 100).

Each of the flow path opening / closing means 16 to 20 has a flow path opening / closing pattern 0 (basic pattern) shown in Table 1 below, which is set to the flow path opening / closing pattern 1 shown in Table 1 (step 101).

[0057]

[Table 1]

Next, in the pressure reducing / pressurizing means 24, the leak valve 30 is closed, and the three-port valves 29a and 2 are used.
9b is turned on and off, respectively, and the vacuum pump 28 is operated to depressurize the inside of the storage portion 25 in which the blood bag 3 is stored (step 10).
2). As a result, the pressure in the blood bag 3 is reduced, and the anticoagulant solution in the container 23 is sequentially introduced into the blood bag 3 through the needle tube 13, the tube 12, the branch connector 14, the tube 7, the branch connector 15 and the tube 8. be introduced.

Next, the total weight of the blood bag 3 is measured by the weight detecting means 26, and the weight when the preset injection amount of the anticoagulant liquid (target anticoagulant injection amount) is introduced (setting) (Weight) is determined (step 1
03). Since the target anticoagulant injection amount is proportional to the target blood collection amount described later, it may be calculated from the target blood collection amount.

If the set weight is not reached as a result of step 103, the process returns to step 102.

When the set weight is reached as a result of step 103, the flow path opening / closing means 16 to 20 are set again to the flow path opening / closing pattern 0 shown in Table 1 (step 104), and the vacuum pump 28 is stopped. (Step 105), the leak valve 30 is opened (step 106).

With the above, the program in the anticoagulant injection mode is completed.

[2] Blood collection mode FIG. 4 is a flowchart of control in the blood collection mode.

For example, the blood collection mode is set by the input from the same input means as described above (step 110).

The flow passage opening / closing patterns 16 to 20 having the flow passage opening / closing pattern 0 shown in Table 1 are set in advance to the flow passage opening / closing pattern 2 shown in Table 1 (step 111).

Next, in the pressure reducing / pressurizing means 24, the leak valve 30 is closed and the three-port valves 29a and 29a are closed.
9b is turned on and off, respectively, and the vacuum pump 28 is operated to depressurize the inside of the storage portion 25 in which the blood bag 3 is stored (step 11).
2). As a result, the pressure in the blood bag 3 is reduced, and the blood is sequentially passed through the tube 6, the branch connector 14, the tube 7, the branch connector 15 and the tube 8 from the puncture needle 2 punctured in the blood vessel of the blood donor. It is introduced into the bag 3.

Next, the weight detection means 26 measures the total weight of the blood bag 3 to determine whether or not the preset target blood collection amount has reached the weight at the time of introduction (set weight) ( Step 113).

If the result of step 113 is that the set weight has not been reached, the process returns to step 112.

When the set weight is reached as a result of step 113, the flow passage opening / closing means 16 to 20 are set again to the flow passage opening / closing pattern 0 shown in Table 1 (step 114), and the vacuum pump 28 is stopped. (Step 115), the leak valve 30 is opened (step 116).

With the above, the program in the blood sampling mode ends.

[3] Plasma Separator Priming Mode FIG. 5 is a flowchart of control in the plasma separator priming mode (plasma separator preparation mode).

For example, the plasma separator priming mode is set by the input from the input means similar to the above (step 120).

The flow path opening / closing patterns 16 to 20 having the flow path opening / closing pattern 0 shown in Table 1 are set in the flow path opening / closing pattern 3 shown in Table 1 (step 121), and the control means 3 is set.
Start the operation of the timer built into 3 (Step 1
22).

Next, in the pressure reducing / pressurizing means 24, the leak valve 30 is in the closed state, and the three-port valves 29a and 29a.
9b is turned off and on, respectively, and the vacuum pump 28 is operated to bring the inside of the storage portion 25 in which the blood bag 3 is stored into a pressurized state (step 12).
3). As a result, the pressure inside the blood bag 3 rises, and the blood inside the blood bag 3 is transferred to the tube 8 and the branch connector 1.
5, the tube 7, the branch connector 14, the tube 10, and the red blood cell outlet 42 in order, and the blood inlet 41 and the red blood cell outlet 42 formed between the respective membranes in the plasma separator 4 and the casing 40 are communicated with each other. The space is filled (liquid level is formed).

By the formation of the liquid surface, the plasma separator 4
The air existing in the space communicating between the blood inlet 41 and the red blood cell outlet 42 formed between each membrane inside and the casing 40 permeates each membrane, and is discharged from the plasma outlet 43 to form a tube. It is introduced into the plasma bag 5 via 11.

Next, it is determined whether or not the timer in step 122 has expired (step 124). If the timer has not expired, the process returns to step 123. In addition,
The set time of this timer is sufficient for filling the space communicating with the blood inlet 41 and the red blood cell outlet 42 formed between each membrane in the plasma separator 4 and the casing 40 with blood. The time is sufficient to fill the pores (gaps) of each film described below with blood.

If the result of step 124 is that the timer has expired, it is judged whether or not the current flow path opening / closing means 16 to 20 are the flow path opening / closing pattern 4 shown in Table 1 (step 125). If it is not the passage opening / closing pattern 4, each passage opening / closing means 16 to 20 is set to the passage opening / closing pattern 4 shown in Table 1 (step 126), and then step 12
2 to 124 are executed.

At this time, since the flow path opening / closing pattern 4 is formed, when the inside of the storage portion 25 is pressurized in step 123, the blood in the blood bag 3 is collected in the tube 8, the branch connector 15, and the tube. 9 and the blood inlet 41 are sequentially filled in the holes (gaps) of the respective membranes contained in the plasma separator 4 (blood filling).

By the filling of blood, the air existing in the pores (gap) of each membrane is discharged from the plasma outlet 43 and introduced into the plasma bag 5 through the tube 11.

If the result of step 125 is the flow path opening / closing pattern 4, the flow path opening / closing patterns 16 to 20 are set again to the flow path opening / closing pattern 0 shown in Table 1 (step 12
7) Then, the vacuum pump 28 is stopped (step 128) and the leak valve 30 is opened (step 129).

As described above, the program in the plasma separator priming mode is completed.

[4] Blood Return Mode FIG. 6 is a flowchart of control in the blood return mode.

For example, the blood return mode is set by the input from the same input means as described above (step 130).

The flow passage opening / closing patterns 16 to 20 having the flow passage opening / closing pattern 0 shown in Table 1 in advance are set to the flow passage opening / closing pattern 5 shown in Table 1 (step 131).

Next, in the pressure reducing / pressurizing means 24, the leak valve 30 is closed, and the three-port valves 29a and 2 are used.
9b is turned off and on, respectively, and the vacuum pump 28 is operated to bring the inside of the storage portion 25 in which the blood bag 3 is stored into a pressurized state (step 13).
2).

As a result, the pressure in the blood bag 3 rises, and the blood in the blood bag 3 sequentially passes through the tube 8, the branch connector 15, the tube 9 and the blood inlet 41,
It is introduced into the plasma separator 4 and comes into contact with the respective membranes contained in the casing 40 of the plasma separator 4 to be separated into plasma and concentrated red blood cells. The separated plasma is discharged from the plasma outlet port 43 and collected in the plasma bag 5 via the tube 11. In addition, the separated concentrated red blood cells pass through the red blood cell outlet 42.
The blood is discharged from the blood vessel, is passed through the tube 10, the branch connector 14, the tube 6, and the puncture needle 2, and is returned to the blood vessel of the donor.

During the separation of blood components as described above, the bubble detection means 21 preferably detects the bubbles continuously (real time) to judge whether or not the bubbles are detected in the tube 10. Yes (Step 13
3).

When air bubbles are detected as a result of step 133, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 6 shown in Table 1 (step 134) and are incorporated in the control means 33. The operation of the timer is started (step 135). At this time, since the concentrated red blood cells are continuously discharged from the red blood cell outlet 42, the air bubbles in the tube 10 ride on the flow of the concentrated red blood cells to cause the tube 10,
There is no chance that the blood will be discharged from the circuit through the branch connector 14, the tube 12 and the needle tube 13 in order, and will not be accidentally injected into the blood vessel of the blood donor.

Next, it is determined whether or not the timer in step 135 has expired (step 136). If the timer has not expired, the process returns to step 135, and if the timer has expired, the process returns to step 133. In addition,
The set time of this timer is set to a time sufficient to discharge the bubbles in the tube 10.

As a result of step 133, when no bubbles are detected, it is determined whether or not the plasma separator 4 is operating normally, that is, the membrane is clogged, etc. It is determined whether or not the speed has decreased (step 137). In addition, this judgment is
For example, the weight reduction rate detected by the weight detection means 26 or the weight increase rate detected by the weight detection means 32 (these are calculated by the control means 33), or the tubes 6, 8, 9, 10. Alternatively, when a flow rate sensor (not shown) is provided in 11, it can be performed based on the fluctuation of the flow rate in the tube detected by the flow rate sensor.

When the plasma separator 4 is operating normally as a result of step 137, it is determined whether or not the remaining amount of blood in the blood bag 3 is 0 (step 138). This determination is made based on the weight of the blood bag 3 detected by the weight detecting means 26.

As a result of step 138, when the remaining amount of blood in the blood bag 3 is not 0, the process returns to step 133.

As a result of step 138, when the remaining amount of blood in the blood bag 3 is 0, the flow path opening / closing means 16 to
20 is again set to the flow path opening / closing pattern 0 shown in Table 1 (step 139), and the vacuum pump 28 is stopped (step 1
40), the leak valve 30 is opened (step 1)
41). This ends the program in the blood return mode.

As a result of step 137, when the plasma separator 4 is abnormal, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 2 shown in Table 1 (step 14).
2). As a result, the blood in the blood bag 3 bypasses the plasma separator 4, passes through the tube 8, the branch connector 15, the tube 7, the branch connector 14, the tube 6 and the puncture needle 2 in order and returns to the blood vessel of the donor. To be done.

During the blood return, the bubble detection means 22 preferably detects the bubbles continuously (real time) to judge whether or not the bubbles are detected in the tube 7 ( Step 143).

When bubbles are detected as a result of step 143, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 1 shown in Table 1 (step 144), and are incorporated in the control means 33. The operation of the timer is started (step 145). At this time, since the blood is continuously discharged from the blood bag 3, the air bubbles in the tube 7 ride on the flow of the blood and sequentially pass through the tube 7, the branch connector 14, the tube 12 and the needle tube 13 outside the circuit. It will not be accidentally injected into the blood vessel of the donor.

Next, it is determined whether or not the timer of step 145 has expired (step 146). If the timer has not expired, the process returns to step 145, and if the timer has expired, the process returns to step 143. In addition,
The set time of this timer is set to a time sufficient to discharge the air bubbles in the tube 7.

As a result of the step 143, when no air bubble is detected, the process returns to the step 138, and thereafter, the steps 133 and 1 are repeated until the remaining amount of blood in the blood bag 3 becomes zero.
Repeat steps 37, 142 and 143. When the remaining amount of blood in the blood bag 3 becomes 0, steps 139, 140 and 141 are executed as described above, and the program in the blood return mode ends.

When the required amount of plasma (target amount of collected blood) cannot be obtained in one blood collection, the anticoagulant injection mode, blood collection mode and blood return are performed until the target amount of collected blood is reached. This is repeatedly executed by setting the mode as one cycle. The control means 33 determines whether or not the plasma in the plasma bag 5 has reached the target amount of plasma to be collected by the weight detection means 32.
Is performed based on the weight detected by.

Further, in the case of collecting blood a plurality of times as described above, in order to avoid adverse effects such as citric acid poisoning, the blood collection amount should be kept to a necessary minimum, that is, excess blood collection exceeding the target blood collection amount should not be performed. Therefore, it is preferable to estimate the blood collection amount to be collected next time (scheduled blood collection amount) from the previous plasma collection efficiency (sampling amount / blood collection amount), and it is preferable to collect blood in an amount equal to the planned blood collection amount. . In this case, the plasma collection efficiency can be calculated based on the weights detected by the weight detection means 26 and 32, respectively.

As another method of using the blood processing apparatus 1A, for example, in the blood sampling mode, each channel opening / closing means 1 is used.
6 to 20 are set to the flow path opening / closing pattern 5 shown in Table 1,
The storage unit 25 is decompressed, and blood from the donor is punctured by the puncture needle 2, the tube 6, the branch connector 14, and the tube 10.
And the erythrocyte outflow port 42 are sequentially introduced into the plasma separator 4, and the plasma separated therefrom is recovered in the plasma bag 5 via the plasma outflow port 43 and the tube 11.
The separated concentrated red blood cells may be collected in the blood bag 3 through the blood inlet 41, the tube 9, the branch connector 15 and the tube 8 sequentially. In this case, the injection of anticoagulant in the anticoagulant injection mode is
The flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 6 shown in Table 1, and the storage section 25 is depressurized.

In the blood return mode in this method, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 2 shown in Table 1, the storage portion 25 is set to the pressurized state, and the inside of the blood bag 3 is closed. Concentrated red blood cells from tube 8, branch connector 1
5, the tube 7, the branch connector 14, the tube 6 and the puncture needle 2 are sequentially passed so that blood is returned to the blood vessel of the donor. At this time, the bubble detecting means 22 always detects the bubbles, and when the bubbles are detected, the steps similar to the steps 144 to 146 are executed to discharge the bubbles, and the blood is detected in the state where the bubbles are not detected. Blood is returned until the remaining amount of concentrated red blood cells in the bag 3 becomes zero.

FIG. 7 is a plan view showing another configuration example of the main part of the blood processing apparatus of the present invention, and FIG. 8 is a circuit configuration diagram schematically showing the overall configuration of the blood processing apparatus. The blood processing apparatus 1B shown in these figures is an apparatus used for plasma exchange therapy, and has a purified plasma adding means for adding purified plasma to blood components to be returned. Hereinafter, only the difference of the blood processing apparatus 1B from the above-described blood processing apparatus 1A will be described.

The blood processing apparatus 1B has a purified plasma bag 60 as a container for storing purified plasma. Similar to the blood bag 3, the purified plasma bag 60 is formed by stacking resin sheet materials and sealing the edges by fusion (for example, heat fusion or high frequency fusion) or adhesion to form a bag. It is a thing.

The purified plasma bag 60 is filled with purified plasma obtained by, for example, salting out. In this case, the filling amount of the purified plasma in the purified plasma bag 60 is
It is preferable that the amount is approximately equal to or more than the total amount of plasma collected in the plasma bag 5.

Further, a T-shaped branch connector 61 is provided on the side of the red blood cell outlet 42 of the bubble detecting means 21 of the tube 10.
Is installed, and its branched end 611 and the purified plasma bag 60 are connected by a tube 62. As a result, the puncture needle 2 and the purified plasma bag 60 communicate with each other via the tube 6, the branch connector 14, the tube 10, the branch connector 61, and the tube 62.

In the middle of the tube 62, a pump 63 is installed as a liquid sending means for sending the purified plasma in the purified plasma bag 60 to the tube 10. This pump 63
For example, a roller pump, a centrifugal pump, a bellows pump, or the like can be used, and among them, the roller pump is preferable because it is suitable for adjusting the discharge amount and can be easily attached and detached.

As shown in FIG. 8, such a pump 63 is electrically connected to the control means 33, and its drive, especially the discharge amount is controlled. When the pump 63 is a roller pump, the control unit 33 controls the rotation speed of the rotor (revolution speed of the roller).

In such a blood processing apparatus 1B, in the anticoagulant injection mode, the blood collecting mode and the plasma separator priming mode, the same control as the blood processing apparatus 1A is performed with the pump 63 stopped.

In the plasma exchange mode corresponding to the blood return mode, the pump 63 is operated to perform the same control as the blood return mode of the blood processing apparatus 1A, and the purified plasma in the purified plasma bag 60 is activated. Are merged into the tube 10 through the tube 62 and the branch connector 61, and the concentrated red blood cells discharged from the red blood cell outlet 42 of the plasma separator 4 are returned to the blood donor (patient) in a state of being mixed with the purified plasma. .

If bubbles are detected by the bubble detection means 21 during this blood return, the steps 134 to 1 are executed.
Similar to 36, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 6 shown in Table 1 to discharge the bubbles. The pump 63 may be operating or stopped when discharging the bubbles, but it is preferable to keep the pump 63 in the operating state because the bubbles can be discharged more quickly.

The amount of purified plasma added in the plasma exchange mode (blood return mode) is preferably controlled as follows.

That is, the control means 33 calculates the plasma collection rate into the plasma bag 32 based on the change in weight detected by the weight detection means 32, and the plasma collection rate and the purified plasma from the purified plasma bag 60. The discharge amount of the pump 63 is controlled so that the plasma collection amount and the purified plasma supply amount are equal to each other so as to be balanced with the supply rate.

The plasma collected in the plasma bag 5 is subjected to salting-out treatment or the like to prepare purified plasma, which is used for the next plasma exchange. The plasma to be exchanged may be not only the plasma obtained by purifying its own plasma but also a commercially available plasma preparation.

The purified plasma adding means is not limited to the one shown in the figure, which is composed of the purified plasma bag and its supply line, and may be, for example, a plasma purification device itself such as a salting-out device.

In such a blood processing apparatus 1B,
In some cases, it may be difficult to estimate the expected blood collection amount. In this case, blood is collected in the blood bag 3 in an amount larger than the required amount (target blood collection amount), and in order to avoid extra plasma collection, whole blood in excess of the target blood collection amount is not plasma-separated and is directly supplied by the donor. Return blood to (patient).

This blood return is performed in the same manner as when the plasma separator 4 is abnormal in the blood return mode of the blood processing apparatus 1A (steps 142 to 146), and the air bubble detection means 22 detects air bubbles. In this case, the flow path opening / closing means 16 to 20 are set to the flow path opening / closing pattern 1 shown in Table 1 to discharge the bubbles. Note that the operation of the pump 63 is stopped when returning excess blood, and the pump 63 may be stopped or operated when discharging bubbles.

FIG. 9 is a plan view showing another structural example of the main part of the blood processing apparatus of the present invention. The blood processing apparatus 1C shown in the figure is an apparatus used for plasmapheresis, and is installed so that the positional relationship between the flow path opening / closing means 17 and the bubble detecting means 22 on the tube 7 is reversed. A T-shaped branch connector 64 is installed between the flow path opening / closing means 17 and the bubble detecting means 22, and the tube 62 is provided at the branch end 641.
The blood processing apparatus 1B has the same configuration as that of the blood processing apparatus 1B except that the ends thereof are connected.

In this blood processing apparatus 1C, the pump 63 is operated and the purified plasma in the purified plasma bag 60 is sent from the tube 10 through the tube 62, the branch connector 64, the tube 7 and the branch connector 14 in this order. It joins and mixes with the concentrated red blood cells that come in, and returns this to the donor (patient).

During this blood return, both bubble detecting means 2
When the air bubbles are detected by either one of the air bubble detection means 21, 22 by operating the first and the second air flow detection means 22, the flow passage opening / closing means 16 to 20 are set to the flow shown in Table 1 as in steps 134 to 136. The road opening / closing pattern 6 is set, and bubbles are discharged. It is preferable to keep the pump 63 in an operating state when discharging bubbles.

Further, in the blood processing apparatus 1C, at the time of collecting blood, in order to prevent the collected blood from flowing into the purified plasma bag 60, a closing means for closing the tube 62 (for example, similar to the above-mentioned flow path opening / closing means). Stuff) is required. When a roller pump is used as the pump 63,
The closing means may also be used.

Further, as another configuration example of the blood processing apparatus for plasma exchange, it is possible to have a configuration in which the other end of the tube 62 whose one end is connected to the purified plasma bag 60 is connected in the middle of the tube 6. is there. When the other end of the tube 62 is connected to the middle of the tube 6, a bubble detecting means (not shown) similar to the above is provided in the middle of the tube 62 or on the puncture needle 2 side from the connection portion of the tube 6 with the tube 62. It is preferable to monitor air bubbles because it increases safety.

FIG. 10 is a vertical cross-sectional view showing a structural example of the end portion of the bubble discharging tube. In the embodiment shown in the same figure, a gas-liquid separating means is provided at the end of the tube 12 shown in FIG. 1, 7 or 9 which is opposite to the branch connector 14 shown in the blood processing apparatus 1A, 1B or 1C. It has a chamber 70.

The chamber 70 is composed of a preferably transparent cylindrical main body 71, and a lid 73 mounted so as to close the upper opening of the main body 71 in the figure. Body 7
1, a tubular connecting portion 72 is formed in the lower portion of the drawing, and the end portion of the tube 12 opposite to the branch connector 14 is fitted into the connecting portion 72.

The base end portion of the needle tube 13 is integrally formed with the lid body 73 at substantially the center of the lid body 73 so as to penetrate the lid body 73.

With such a configuration, the fifth flow path in the tube 12 and the inner cavity 132 of the needle tube 13 are separated from each other by the chamber 7
They communicate with each other through an internal space 74 of zero.

Although the volume of the chamber 70 is not particularly limited, the bubbles detected in the tube 7 or 10 are blood, concentrated red blood cells or purified plasma (hereinafter referred to as blood).
It is preferable that a sufficient amount of blood or the like can be stored so that air bubbles can be surely discharged at the time of discharging, and the amount is, for example, about 5 to 80 ml.

Next, the operation of the chamber 70 will be described. As described above, when the air bubbles are discharged, the flow path opening / closing means 20 is brought into an open state, whereby blood or the like containing the air bubbles 76 flows in the tube 12 (fifth flow path), and then from the connecting portion 72. It flows into the internal space 74 of the chamber 70 and is stored therein.

The bubbles 76 contained in the blood or the like stored in the internal space 74 are floated on the liquid surface 75 by the buoyancy and broken, and the gas is accumulated above the liquid surface 75 in the internal space 74. When the collection of air bubbles in the chamber 70 progresses and the pressure in the internal space 74 increases, the gas is stored in the lumen 1 of the needle tube 13.
It passes through 32 and is discharged from the side hole 131. In addition, needle tube 1
When 3 is connected to the container 23 of the anticoagulant, the gas discharged from the side hole 131 is stored in the container 23.

The blood and the like remaining in the internal space 74 of the chamber 70 can be returned to the donor.

Further, in the anticoagulant injection mode, the anticoagulant liquid in the container 23 is temporarily stored in the internal space 74 of the chamber 70 via the side hole 131 and the lumen 132 of the needle tube 13 and then from the connecting portion 72. It is supplied into the tube 12.

By using the chamber 70 as described above, air bubbles are separated from blood or the like and only the air bubbles are discharged, so that blood or the like is prevented from flowing into the container 23 to which the needle tube 13 is connected, and By returning the blood and the like remaining in the internal space 74 to the donor, the waste of blood and the like is eliminated.

The installation position of the chamber 70 is not limited to the end of the tube 12 opposite to the branch connector 14, and
It may be installed at an arbitrary position in the middle of the tube 12.

In the present invention, the gas-liquid separating means is
The configuration is not limited to the chamber 70 as shown, but may be of any configuration as long as it can separate air bubbles from blood or the like. The blood processing apparatus of the present invention has been described above based on the configuration examples shown in the drawings, but the present invention is not limited to these.

In the blood processing apparatus of the present invention, the number of flow path opening / closing means, the installation position, etc. are not limited to those shown in the drawings. Further, the number of installed bubble detection means, the installed positions, etc. are not limited to those shown in the drawings.

In the illustrated construction, the bubble discharge line is also used as the anticoagulant liquid introduction line, but the invention is not limited to this, and a dedicated bubble discharge line may be provided. You may separately provide the container etc. which store.

In the present invention, when a bubble is detected, it is optional whether or not the bubble is discharged to the outside, and the flow path opening / closing pattern by each flow path opening / closing means is used to return at least blood to the donor. However, it is also possible to adopt a configuration in which bubbles are not discharged.

The blood storage container, the plasma storage container, and the purified plasma storage container are not limited to those having flexibility such as the bags 3, 5, and 60 described above, and may be, for example, hard ones that do not deform. Good.

Further, the liquid feeding means is not limited to the above-described pressure reducing / pressurizing means, but may be a pump such as a roller pump. Alternatively, the blood bag may be moved to a high place and a low place without such a liquid feeding means, and the liquid may be circulated in the circuit by the drop of the blood bag.

Further, in the present invention, the switching of the flow path opening / closing means may be performed while operating the liquid feeding means or after the operation is stopped.

The plasma collecting means is not limited to a plasma container such as a plasma bag, but may be a plasma purifying device that collects the plasma separated by the plasma separator and purifies it.

Although the illustrated configuration is a single-needle circuit having one puncture needle 2 for collecting blood and returning blood, the present invention is not limited to this, and is disclosed in, for example, Japanese Patent Laid-Open No. 61-11053. It may be applied to a two-needle circuit having a blood collection needle and a blood return needle as shown in FIG. In this case, when a bubble is detected, the opening / closing of the flow path opening / closing means is switched to stop the liquid flow to at least the blood return needle. Further, in such a two-needle type circuit, a blood storage container such as a blood bag for storing the collected blood is not necessarily essential.

[0143]

As described above, according to the blood processing apparatus of the present invention, it is possible to prevent the harmful effects caused by the inclusion of air bubbles, in particular, the injection of air bubbles into the living body when returning blood. It is possible and extremely safe.

Further, the generated bubbles can be discharged to the outside of the circuit. In this case, the bubbles can be discharged easily and quickly, and no operation error occurs.

Further, the blood processing apparatus of the present invention is suitable for a plasma separation system for component blood donation and component blood transfusion, and a plasma exchange system.

[Brief description of drawings]

FIG. 1 is a plan view showing a configuration example of a main part of a blood processing apparatus of the present invention.

FIG. 2 is a circuit configuration diagram schematically showing a configuration example of the blood processing apparatus of the present invention.

FIG. 3 is a flowchart showing an example of control in the anticoagulant injection mode of the control means.

FIG. 4 is a flowchart showing an example of control in the blood sampling mode of the control means.

FIG. 5 is a flow chart showing an example of control in the plasma separator priming mode of the control means.

FIG. 6 is a flowchart showing an example of control in the blood return mode of the control means.

FIG. 7 is a plan view showing another configuration example of the main part of the blood processing apparatus of the present invention.

FIG. 8 is a circuit configuration diagram schematically showing another configuration example of the blood processing apparatus of the present invention.

FIG. 9 is a circuit configuration diagram schematically showing another configuration example of the blood processing apparatus of the present invention.

FIG. 10 is a vertical cross-sectional view showing a configuration example of a gas-liquid separating means provided at an end of a bubble discharging tube.

[Explanation of symbols]

1A, 1B, 1C Blood processing device 2 puncture needle 3 blood bags 35 Seal part 4 Plasma separator 40 casing 41 Blood inlet 42 Red blood cell outlet 43 Plasma outlet 5 plasma bags 51 outlet 55 Seal part 6-12 tubes 13 needle tubes 131 side hole 132 lumen 14, 15 branch connector 141, 142, 151 Branch ends 16 to 20 flow path opening / closing means 21, 22 Bubble detection means 23 containers 24 Pressure reducing / pressurizing means 25 Storage 26 Weight detection means 27 Air supply / exhaust circuit 28 Vacuum pump 29a, 29b 3 port valve 30 leak valve 31 Pressure detection means 32 Weight detection means 33 Control means 60 Purified plasma bag 61 Branch connector 611 branch end 62 tubes 63 pumps 64 branch connector 641 branch end 70 chamber 71 body 72 Connection 73 Lid 74 Internal space 75 Liquid level 76 bubbles 100-106 steps 110-116 steps 120-146 steps

─────────────────────────────────────────────────── ─── Continuation of front page (58) Fields surveyed (Int.Cl. ⁷ , DB name) A61M 1/02-1/36

Claims (7)

(57) [Claims] 1. A puncture needle, a blood storage container, a plasma separator,
A plasma storage container, a first flow path connecting the puncture needle and the blood storage container, and a second flow path connecting the blood storage container or the first flow path and a blood inlet of the plasma separator. A third channel connecting the red blood cell outlet of the plasma separator and the first channel, a fourth channel connecting the plasma outlet of the plasma separator and the plasma container, and one end of the channel The fifth flow channel connected to the first flow channel, and the puncture needle side and the blood storage container side with respect to the connection portion of the first flow channel with the third flow channel, in the middle of the second flow channel, and the first flow channel. A channel opening / closing means that can open / close the middle of the third channel and the middle of the fifth channel, and the blood storage container side and the third channel from the connection portion of the first channel with the third channel. Two bubble detection means installed in each of the middle of the passage and capable of detecting bubbles in the passage, and liquid circulation in each passage are obtained. For supplying liquid, a gas-liquid separating means provided in the middle or the other end of the fifth flow path, and a function for controlling opening / closing of the flow path by at least the flow path opening / closing means and operation of the liquid transfer means. And a control means having a control means for changing the open / closed state of each of the flow paths to a desired value in accordance with the detection of a bubble by one of the two bubble detection means. A blood processing apparatus, characterized in that the flow path opening / closing means and the liquid feeding means are controlled so that bubbles are discharged to the gas / liquid separating means via five flow paths. 2. The blood processing apparatus according to claim 1, wherein the fifth flow path also serves as a flow path for introducing an anticoagulant into the blood storage container. 3. The liquid sending means has a function of pressurizing and depressurizing the blood storage container.
The blood processing apparatus according to. 4. The blood processing apparatus according to claim 1, wherein the puncture needle is used for collecting blood and returning blood. 5. The blood processing apparatus according to claim 1, further comprising purified plasma adding means for adding purified plasma to the blood components to be returned. 6. The control means adds purified plasma in an amount according to the amount of plasma separated by the plasma separator,
The blood processing apparatus according to claim 5, wherein the purified plasma adding means is controlled. 7. The blood processing apparatus according to claim 1, further comprising means for determining whether or not the plasma separator is operating normally.