JPH0470910B2 - - Google Patents

Description

[Detailed Description of the Invention] (Industrial Application Field) The present invention relates to a selectively permeable membrane (hereinafter simply referred to as a membrane).
The present invention relates to a blood processing device that uses blood for extracorporeal circulation processing.

(Prior Art) Conventionally, in blood processing apparatuses using membranes such as plasma exchange, hemodialysis, and heart-lung machines, physiological saline has been used to clean membrane modules.

For example, when separating plasma using a model plasma separator, physiological saline is used to wash the membrane module, but this remains in the blood circuit including the blood processing device at the beginning of blood collection, and this residual saline is used to clean the membrane module. Replace with blood (hereinafter referred to as blood priming)
In this case, the first part of the blood will naturally be diluted. Such dilution of blood with physiological saline results in a decrease in the protein concentration of the collected plasma, leading to a decrease in the quality of the plasma preparation. Therefore, the blood introduced during blood priming has been discarded together with physiological saline (priming solution).

(Problems to be Solved by the Invention) As described above, discarding blood during blood priming results in loss of blood cell components that have a slow regeneration rate, which also affects the safety of blood collectors.

Therefore, the present invention provides a membrane-type blood processing device that can improve the recovery rate of blood cell components in extracorporeally circulating blood and ensure the safety of blood donors. The purpose is to

(Means for Solving the Problems) As a means for solving the above problems, the present invention introduces blood from a donor into a blood circuit including a blood processing device, performs blood priming, and then performs blood priming.
In the blood processing device for processing blood by flowing blood through the blood circuit, a blood collection pump is disposed in the circuit upstream of the blood processing device, and a storage container is connected to the circuit upstream of the blood collection pump via a clamp. The priming liquid discharged from the blood processing device is temporarily stored in the storage container, and the priming liquid discharged from the blood processing device is temporarily stored in the storage container. The present invention provides a blood processing device characterized in that the blood processing device is refilled with a priming liquid from the storage container after blood processing.

(Function) In the blood processing device of the present invention, priming with physiological saline is first performed to clean the membrane module, and then blood is introduced from the blood donor's vein into the blood circuit including the blood processing device, and blood priming is performed. It is carried out. The blood introduced during this blood priming is diluted with physiological saline. It is therefore temporarily introduced into the reservoir. After blood priming is completed, a blood collection operation is started, a predetermined blood processing operation is performed, and after the blood processing operation is completed, a cleaning operation is started. In the cleaning operation, a blood priming solution, i.e., physiological saline containing blood, is introduced into the blood processing device through the cleaning line to clean the inside of the device, and blood priming is performed by switching the open/closed state of each clamp in the blood processing circuit. The fluid is transported to each line and any remaining blood is washed away. The priming liquid containing blood collected by this washing operation is returned into the blood donor's vein.

Therefore, according to the blood processing device of the present invention which is equipped with a storage container, the blood temporarily discharged outside the system is collected and returned to the blood donor at the same time as the blood processing device is cleaned. It is possible to reduce the loss of components, perform efficient blood processing, and ensure the safety of blood collectors.

(Example) FIG. 1 shows an example in which the blood processing apparatus according to the present invention is applied to a single-puncture membrane type plasma separation apparatus, which is constructed as follows.

An indwelling needle 4 is connected to one end of a blood collection line 2 equipped with a blood collection pump 1 via a clamp 3, and a plasma separation device 5 is connected to the other end. One end of a first washing line 7 equipped with a clamp 6 is connected between the clamp 3 and the blood collection pump 1, and the other end is connected to a washing container/storage container 8.
Furthermore, one end of a second blood return line 10 equipped with a clamp 9 is connected between the blood collection pump 1 and the plasma separation device 5 of this blood collection line 2, and the other end is connected to a blood storage container 11. . This blood storage container 1
1 is connected to a plasma separation device 5 via a first blood return line 13 equipped with a clamp 12 . A second washing line 14 led out from the washing container/storage container 8 is connected between the plasma separator 5 and the clamp 12. Note that this second cleaning line 14 is also provided with a clamp 15. The plasma separation device 5 includes a plasma collection container 16 for storing plasma separated by the plasma separation device 5, and a plasma collection pump 17.
It is connected via a serum sampling line 18 equipped with a.

The apparatus of FIG. 1 is operated as follows. First, for cleaning and priming the circuit and plasma separator, the clamp 3 of the blood collection line 2, the second blood return line, the clamp 9 of 10, and the second cleaning line 14
The blood collection pump 1 is rotated counterclockwise with the clamp 15 of the first washing line 7 closed and the clamp 12 of the first blood return line 13 opened. As a result, the physiological saline solution used for washing is stored in the blood storage container 11. Next, the clamp 6 of the first washing line 7, the clamp 12 of the first blood return line 13, and the second
By closing the clamp 15 of the cleaning line 14, opening the clamp 3 of the blood collection line 2 and the clamp 9 of the second blood return line 10, and rotating the blood collection pump 1 clockwise, the blood is stored in the blood storage part 11 used for cleaning. Drain the saline solution out of the circuit to complete cleaning and priming.

Next, the clamp 6 of the first washing line 7, the clamp 12 of the first blood return line 13, and the clamp 9 of the second blood return line 10 are closed, and the clamp 3 of the blood collection line 2 and the clamp of the second washing line 14 are closed. 1
Insert the indwelling needle 4 into the donor's vein with the needle 5 open.
is punctured, and by rotating the blood collection pump counterclockwise, blood is introduced into the plasma separation device to perform blood priming. At this time, the physiological saline that has been filled in the blood collection line 2, plasma separator 5, and part of the first blood return line 13 passes through the second washing line 14 and is stored in the storage container 8. Further, in the circuit, the physiological saline and blood are partially mixed by diffusion and agitation, and the blood is diluted, so that some of the blood at the initial stage of blood introduction continues to be stored in the storage container 8. When a predetermined amount of blood has been introduced, the clamp 15 of the second washing line 14 is closed, the clamp 12 of the first blood return line 13 is opened, and the blood is stored in the blood storage portion 11. At the same time, the plasma collection pump 17 is rotated clockwise to collect the plasma separated by the plasma separator 5 into the plasma collection section 16. After collecting a predetermined amount of blood, the first blood return line 13
By closing the clamp 12 of the second blood return line 10, opening the clamp 9 of the second blood return line 10, and simultaneously rotating the blood collection pump 1 clockwise, blood with a high hematocrit from which plasma has been separated is returned to the donor. At this time, the serum sampling pump 17 stops.

Thereafter, the above blood collection and blood return are repeated until a predetermined amount of plasma is collected. Finally, return blood and wash. Washing is performed after all the blood stored in the blood storage portion 11 is removed by the blood return operation. First, the clamp 3 of the blood collection line 2, the clamp 9 of the second blood return line 10, and the clamp 1 of the second washing line 14.
5, open the clamp 6 of the first washing line 7 and the clamp 12 of the first blood return line 13, and rotate the blood collection pump 1 counterclockwise to open the storage container 8.
A small amount of physiological saline mixed with blood is introduced into the plasma separator to clean the circuit and plasma separator. Next, the clamp 6 of the first washing line 7, the clamp 15 of the second washing line 14, and the clamp 12 of the first blood return line 13 are closed, and the second blood return line 1 is closed.
0 clamp 9 and the blood collection line 2 clamp 3, and rotate the blood collection pump 1 clockwise to remove the blood storage part 11.
Return all cleaning fluid inside to the blood donor. The indwelling needle 4 is removed to complete the plasma separation operation.

FIG. 2 shows an example in which the blood processing apparatus according to the present invention is applied to a membrane-type plasma separation apparatus using two punctures, and is constructed as follows.

A first indwelling needle 24 is connected to one end of a blood collection line 22 equipped with a blood collection pump 21 via a clamp 23, and a plasma separation device 25 is connected to the other end. One end of a first cleaning line 27 equipped with a clamp 26 is connected between the clamp 23 and the blood collection pump 21, and the other end is connected to a cleaning container/storage container 28. Furthermore, a blood return line 29 is led out from the plasma separation device 25, and its tip is connected to the second indwelling needle 30 via a clamp 31. In addition to the first cleaning line 27, one end of a second cleaning line 33 equipped with a clamp 32 is connected to the cleaning container/storage container 28,
The other end is a cleaning container/storage container 28 and a clamp 3
1 and is connected to a blood return line 29. Further, a plasma collection container 34 for storing plasma separated by the plasma separation device 25 is connected to the plasma separation device 25 via a plasma collection line 36 equipped with a plasma collection pump 35 .

The double-puncture membrane plasma separation device shown in FIG. 2 is operated as follows.

First, priming with physiological saline is performed in the same manner as the apparatus shown in FIG. 1, and then blood priming is started. The blood passes through the blood collection line 22 by the drive of the blood collection pump 21 and is transferred to the plasma separator 2.
However, since the initial blood for blood priming is diluted with physiological saline, the clamp 26 of the first washing line 27 and the clamp 31 of the blood return line 29 are closed, and the blood sampling line 22
The clamp 23 of the second cleaning line 33 and the clamp 32 of the second cleaning line 33 are opened, and the liquid is temporarily stored in the storage container 28. After blood priming is completed, the actual blood collection operation begins. The plasma separated by the plasma separator 25 is transferred to the plasma collection line 36 by driving the plasma collection pump 35.
The blood passes through the membrane and is collected into the serum collection portion 34. In addition, the high hematocrit blood separated by the plasma separator 25 is
The blood is returned to the vein via a second indwelling needle 30 that is secured separately from blood collection. The blood collection operation is performed until a predetermined amount of plasma is collected, and then the washing operation is started, and the physiological saline solution containing the blood in the storage container 28 is returned to the vein.

FIG. 3 shows an example in which the blood processing apparatus of the present invention is applied to a single needle membrane type plasma separation system, which is constructed as follows.

The indwelling needle 40 is connected to one end of the first waste liquid line 41 and is detachable from the connection port 43 of the waste liquid bag 42 . At the other end of the first waste liquid line 41
Each end of an ACD line 45 with an ACD pump 44 and an intravenous line 46 are connected. this
The other end of the ACD line 45 is connected to an ACD bag 47, and the other end of the venous line 46 is connected to one end of a blood collection line 50 with a clamp 50a and a blood collection pump 49, and one end of a blood return line 52 with a clamp 52a and an air trap 51. Each end is connected to the other end. The other end of the blood collection line 50 is connected to a blood storage container 57, and the other end of the blood return line 52 is connected to the junction between the recirculation line 53 and the outlet line 54. The recirculation line 53 includes a clamp 53a, the tip of which is connected to a portion of the blood collection line 50 downstream of the blood collection pump 49. The outlet line 54 is connected to a blood outlet 56 of a plasma separator 55 and is used to discharge blood after plasma separation.

One end of the first cleaning line 58, which includes a clamp 58a between the clamp 50a of the blood collection line 50 and the blood collection pump 49, is connected to the clamp 5 of the blood return line 52.
There is also a clamp 6 between 2a and the air trap 51.
One end of the second cleaning line 60 provided with Oa is connected to each other, and the other ends of the first and second cleaning lines 58 and 60 are connected to the storage container 61. A blood supply line 62 for sending blood from the blood storage container 53 to the plasma separator 55 is provided between the plasma separator 55 and the blood container 57. This blood feeding line 62 is provided with a blood feeding pump 63 and an air trap 64 downstream thereof. A plasma collection pump 66 and a plasma collection line 68 equipped with a clamp 68a downstream thereof are connected to the plasma separator 55 liquid outlets, for example 65a and 65b, and the plasma separated by the plasma separator 55 is transferred to a plasma collection container. 69 can be accommodated. One end of a second waste liquid line 71 equipped with a clamp 71a is connected between the serum sampling pump 66 and the clamp 68a of the serum sampling line 68, and the other end is connected to the waste liquid bag 42 to carry out priming liquid, etc. It is adapted to be housed in a waste liquid bag 42.

Note that the first washing line 58 includes a venous pressure gauge 72,
A blood outlet pressure gauge 7 is attached to the outlet side air trap 51.
3. A plasma pressure gauge 74 is provided upstream of the plasma sampling pump 66 in the plasma sampling line 68, and a blood inlet pressure gauge 75 is provided in the air trap 64 of the blood feeding line 62, so that the respective pressures can be monitored. ing.

The membrane type plasma separator shown in FIG. 3 is operated as follows.

First, priming with physiological saline is performed to clean the membrane module. The physiological saline introduced at this time is drained into a waste liquid bag where the indwelling needle 40 and the connection port 43 of the waste liquid bag 42 are connected. After priming with physiological saline is completed, the indwelling needle 40 connected to the waste fluid bag 42 is removed, the indwelling needle 40 is connected to the blood donor's vein, and blood priming is started. In the blood priming operation, blood flowing out from the donor's veins is sent to the blood storage container 57 via the venous line 46 and the blood collection line 50. At this time, by driving the ACD pump (pump for adding anticoagulant) 44 at a constant rate with respect to the flow rate of the blood collection pump 49, the anticoagulant in the ACD bag 47 is pumped through the ACD line 45. It is added at a fixed rate to the blood flowing out from the veins.

The plasma separator described above includes clamping means 50a, 52a, 53a,
58a, 68a, and 71a are provided. 1st
Clamp 58a of cleaning line 58 and blood return line 5
With the second clamp 52a closed, the clamp 50a of the blood collection line 50 is opened, and the blood collection pump 49 starts collecting blood. Blood collection is started and the blood stored in the blood storage container 57 is transferred to the blood pump 63.
After the blood is temporarily stored in the inlet side air trap 64 equipped with the blood inlet pressure gauge 75, the blood is stored in the inlet side air trap 64.
The plasma is introduced into the plasma separator 55. Plasma separator 5
Recirculation line 5 through which the blood separated by 5 flows
The clamp 53a of No. 3 and the clamp 68a of the blood sampling line 68 are in a closed state, and the blood flowing out from the blood outlet 56 is temporarily stored in the outlet side air trap 64 equipped with the blood outlet pressure gauge 73. Further, the clamp 52a of the blood return line 52 is closed, and the clamp 60a of the second washing line 60 is opened, so that blood diluted with physiological saline is temporarily stored in the storage container 61 during blood priming. On the other hand, during blood priming, the plasma separated by the plasma separator 55 and diluted with physiological saline is transferred to the plasma collection line 68.
clamp 68a is closed, and the second waste liquid line 7
1 clamp 71a is opened, and the waste liquid bag 42
will be discarded. After blood priming is completed, the actual blood collection operation is started by driving the blood collection pump 49. At this time, the venous pressure gauge 72 connected to the first washing line 58 monitors the state of blood collection at the time of blood collection. Blood is sent to the plasma separator 55 using the same procedure as blood priming. At this time, a blood inlet pressure gauge 75 is connected to the blood supply line 62, and a blood outlet pressure gauge 73 is connected to the blood return line 52.
measures the inlet pressure and outlet pressure of each plasma separator 55, and thereby monitors the state of blood feeding to the plasma separator 55. The plasma separated here is collected into a plasma sampling container 69 through a plasma sampling line 68 from liquid outlets 65a and 65b by driving a plasma sampling pump 66. At this time, the plasma pressure blood 74 connected to the plasma collection line 68 measures plasma pressure and monitors the plasma collection state.

The plasma separator 55 continues until a certain amount of blood is collected.
Blood with a high hematocrit value flowing out from the outlet side 56 is driven by the blood pump 63, passes through the outlet line 54, joins the blood in the blood collection line 50, and is sent to the blood storage container 57. The combined blood is mixed in the blood storage container 57, and then mixed in the blood pump 6.
3, blood is sequentially fed to the plasma separator 55 via the blood feeding line 62. Next, begin the blood return operation. When returning blood, ACD pump 44 and blood collection pump 4
9 and also clamp 5 of the recirculation line 53.
3a and the clamp 60a of the second wash line 60, while closing the clamp 5 downstream of the outlet line 54.
2a is opened. The blood stored in the blood storage container 57 is sent to the plasma separator 55 by driving the blood pump 63, and after undergoing a plasma separation operation, is passed through the outlet line 54, the blood return line 52, and the venous line 46. Blood is returned into the donor's vein. The blood return operation ends when the blood stored in the blood storage container 57 is exhausted. The blood collection and blood return operation constitutes one cycle. When the blood return operation is completed, each clamp means is returned to the same state as in the previous blood collection, and the next blood collection operation is started. The above cycle is repeated until a predetermined amount of plasma is stored in the plasma sampling container 69, and the plasma separation operation is completed, and the next washing operation is started.

In the cleaning operation, first, the clamp 5 of the blood collection line 50 is
0a, clamp 53a of recirculation line 53, second
The clamp 60a of the cleaning line 60 is closed, and the first
The clamp 58a of the cleaning line 58 and the clamp 52a of the blood return line 52 are opened, and the blood collection pump 49 and the blood feeding pump 63 transfer the physiological saline containing the blood stored in the storage container 61 to the first cleaning line 5.
8. The blood is introduced into the plasma separator 55 via the blood storage container 57 and the blood supply line 62, and then returned to the vein via the outlet line 54, the blood return line 52, and the venous line 46.

(Effects of the Invention) According to the blood processing apparatus of the present invention, a storage container is connected to the discharge port, the storage container is connected to a washing line, and after blood processing is completed, a physiological saline solution containing blood in the storage container ( The priming solution) is introduced into the cleaning line to clean the blood circuit including the blood processing device, and at the same time, the blood temporarily discharged outside the system is collected and returned to the donor, thereby removing blood cell components that have a slow regeneration rate. The loss of blood components is reduced and blood components are efficiently recovered. If the storage container at this time is a sealed bag of physiological saline used for priming made of soft synthetic resin, there is no need to provide a separate storage container and the complexity of the circuit can be avoided.

As described above, according to the blood processing apparatus according to the present invention, the loss of blood cell components of the blood donor is reduced, and the safety of the blood donor is improved due to the recovery of blood components.

[Brief explanation of the drawing]

Figures 1 to 3 show circuit diagrams of membrane-type plasma separators according to embodiments of the present invention, in which Figure 1 shows one using a single puncture, and Figure 2 shows one using two punctures. , FIG. 3 shows a single needle type. In the figure, 1...Blood collection pump, 2...Blood collection line,
3... Clamp, 4... Indwelling needle, 5... Plasma separator, 6... Clamp, 7... First washing line,
8...Cleaning container/storage container, 9...Clamp, 1
0...Second blood return line, 11...Blood storage container, 12
...Clamp, 13...First blood return line, 14...
...Second cleaning line, 15...Clamp, 16...
Plasma collection container, 17... Plasma collection pump, 18... Plasma collection line, 21... Blood collection pump, 22... Blood collection line, 23... Clamp, 24... First indwelling needle, 2
5...Plasma separator, 26...Clamp, 27...
...First cleaning line, 28...Cleaning container/storage container, 29...Blood return line, 30...Second indwelling needle,
31... Clamp, 32... Clamp, 33...
Second washing line, 34... Serum collection line, 35...
Serum collection pump, 36... Serum collection line, 40... Indwelling needle, 41... First waste liquid line, 42... Waste liquid bag, 43... Connection port, 44... ACD pump, 4
5...ACD line, 46...Intravenous line, 47
...ACD bug, 49...Blood collection pump, 50...
...Blood collection line, 51...Air trap, 52...
...Blood return line, 52a...Clamp, 53...Recirculation line, 53a...Clamp, 54...Outlet line, 55...Plasma separator, 56...Blood outflow port, 57...Blood storage container, 58... ...First cleaning line, 58a... Clamp, 60... Second washing line, 60a... Clamp, 61... Storage container, 6
2...Blood supply line, 63...Blood supply pump, 64...
...air trap, 65a, 65b...liquid outlet, 66...serum sampling pump, 68...serum sampling line,
68a... Clamp, 69... Serum collection container, 71...
...Waste liquid line, 71a... Clamp, 72... Venous pressure gauge, 73... Blood outlet pressure gauge, 74... Plasma pressure gauge, 75... Blood inlet pressure gauge.

Claims (1)

[Scope of Claims] 1. A blood processing device for introducing blood from a donor into a blood circuit including a blood processing device to perform blood priming, and then flowing the blood into the blood circuit for blood processing. A blood collection pump is disposed in a circuit upstream of the blood processing device, and a storage container is communicated with the circuit upstream of the blood collection pump via a clamp, and also connected to a circuit downstream of the blood processing device via a clamp. to temporarily store the priming liquid discharged from the blood processing device in the storage container, and to refill the blood processing device from the storage container with the stored priming liquid after blood processing. A blood processing device characterized by: 2. The blood processing device according to claim 1, wherein the storage container also serves as a priming liquid filling container. 3. The blood processing device according to claim 1 or 2, wherein the blood circuit is for a membrane-type plasma separation device using a single puncture. 4. The blood processing device according to claim 1 or 2, wherein the blood circuit is for a double-puncture membrane-type plasma separation device.