JP2558509B2 - Plasma collection device - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a plasma collection device that separates only plasma using a plasma separator and returns blood cell components to a donor when collecting blood by donating blood from a donor. .

<Prior Art> As a conventional plasma collection apparatus, there is one shown in FIGS. 3 and 4, for example.

The conventional device shown in FIG. 3 is a plasma separator from the donor side.
A blood delivery line 2 ₀ leading to the inlet of the 1 _0, the anticoagulant line 3 ₀ supplies anticoagulant to the blood delivery line 2 _0, a thick blood vessel 4 ₀ from the outlet of the plasma separator 1 ₀ a blood return line 5 ₀ back to the donor side via, and a plasma line 7 ₀ extending from the secondary outlet of the plasma separator 1 ₀ plasma container 6 _0, blood delivering pump 8 ₀ the blood delivery line 2 _0, the anticoagulant line 3 ₀ anticoagulant pump 9 _0, blood return pump 10 ₀ the blood return line 5 _0, more plasma line 7 ₀ plasma pump 11 ₀ are respectively provided.

Further, the blood delivery line 2 _0, chambers 13 ₀ with the pressure sensor 12 ₀ in front of the plasma separator 1 ₀ is interposed, blood return line 5 ₀
Also, the chamber 15 ₀ of the pressure sensor 14 with ₀ is interposed downstream of the returning blood pump 10 _0.

 This device typically uses two indwelling needles.

Apparatus shown in Fig. 4, summarized in common to one of the blood lines 16 ₀ parts of the donor side of the blood delivery line 2 ₀ and blood return line 5 _0, the forward and reverse operation on the blood line 16 ₀ the blood pump 17 ₀ can be provided, furthermore, is provided with a circulation pump 18 ₀ on blood delivery line 2 _0. Saline line 19 ₀ on the upstream side of the circulation pump 18 ₀ is connected. In the figure, parts corresponding to the respective parts of the apparatus in FIG. 2 are designated by the same reference numerals.

The device is a single needle device that uses a single indwelling needle.

Shown in <invention will to problems Solved> Figure 3 apparatus, blood delivering pump 8 _0, anticoagulant pump 9 _0, a total of four pumps blood return pump 10 ₀ and plasma pumps 11 ₀ Because it is equipped, the whole size increases,
The weight also increased, which made it inconvenient to load and move the blood donation vehicle, and the burden on the donor was large because two indwelling needles were used.

Since the device shown in FIG. 4 is a single needle type, the burden on the donor is reduced, but since it is equipped with four pumps, there is a problem that the entire device becomes large and the weight also increases. It was

On the other hand, it is conceivable to omit one of the four pumps or share it with other pumps. However, if the number of pumps is reduced by omitting or sharing it, plasma collection Since there are various inconveniences such as a decrease in efficiency, it is not easy to reduce the number of pumps.

For example, since the plasma pump 11 _0, If omitted, at the beginning blood collection, although the plasma separator 1 ₀ large amount of plasma is collected, the large amount of plasma is filtered at a time,
Clogging occurs at an early stage, the amount of plasma collected is significantly reduced in the latter half of the blood collection cycle, and the total amount collected during the entire collection cycle is reduced.

Further, a single-needle type of device as shown in Fig. 4, after repeating several times the blood collection and blood return, moves to the blood collection mode, supplying physiological saline to a thick blood vessel 4 _0, saline although return to the donor a mixed solution of a thick blood, wherein, when omitting the circulation pump 18 _0, the supply of saline is difficult and time consuming to blood collection, problems such results.

Further, in the apparatus shown in Fig. 4, respectively pressure sensors 12 ₀ to line the blood flows, 14 ₀ with the chamber 13 _0, 15 ₀
There is interposed, the chambers 13 _0, 15 ₀ large and relatively, since it requires a wide space, This point has been a factor in increasing the size of the entire apparatus. However,
These chambers 13 _0, 15 _0, in addition it is required to detect the pressure of each line of the blood, removal of the air bubbles trapped in the blood, ie, serves as a air vent, it is difficult to omit.

In addition to this, in the above conventional apparatus, the blood line 16 _0,
Plasma unseparated blood even if plasma that moves from flowing also separated erythrocytes concentrated blood, again bled thick blood vessel 4 ₀ from concentrated blood after returning blood to the donor, the blood line 16
₀ has residual thick blood, this residual blood from will be fed into the plasma separator 1 _0, and clogging in the plasma separator 1 _0, which may cause hemolysis, was also a problem that .

The present invention has been made in view of the above-mentioned problems, and reduces the number of pumps, enables the omission of chambers, and achieves downsizing and weight reduction of the apparatus, and also reduces the number of pumps. It is an object of the present invention to prevent the occurrence of inconvenience due to the omission of the chamber and chamber, and enable efficient plasma collection.

<Means for Solving Problems> In order to achieve the above-mentioned object, the plasma collection device of the present invention has an indwelling needle indwelling in a blood vessel of a donor and an outer blood supply line connected to the indwelling needle. And an anticoagulant line that guides the anticoagulant to the inlet of this outer blood supply line, an anticoagulant pump provided on this anticoagulant line, and a continuous line to the outer blood supply line. A blood line that also serves as a blood return line, a blood pump that is provided on the blood line and that can perform forward and reverse operations, a plasma separator, and an inner blood supply line that extends from the blood line to the lower end inlet of the plasma separator. And a concentrated blood container connected to the outlet at a position higher than the upper end outlet of the plasma separator, an inner blood return line from the outlet of the concentrated blood container to the inner end of the blood line, and an outer end of the blood line Blood return line from the outside to the indwelling needle A physiological saline line that guides physiological saline to the outlet side of the concentrated blood container from a liquid level higher than the concentrated blood container; a plasma line that guides plasma from the plasma separator to the plasma container; and a plasma line provided on this plasma line. With the automatic flow rate control means provided, at least both of the internal and external blood supply lines, both internal and external blood return lines and physiological saline line are respectively provided with clamps, and the blood line outside the blood pump is provided. Has a bubble sensor.

In addition, the plasma collection apparatus of the present invention further supplies the anticoagulant to the outer blood supply line by driving the anticoagulant pump, and the outer blood supply line, the blood line, and the inner blood supply line. To the inlet of the plasma separator to drive the blood pump in the blood feeding direction, while in the plasma line, the blood collection mode control means for operating the automatic flow rate control means so that the plasma flow rate is almost averaged, and the concentrated blood container. Respond to the detection of air bubbles when the air pump detects the air bubbles by connecting the inner blood return line and the blood line to the outer blood return line at the outlet of the blood pump to drive the blood pump in the blood return direction. Then, the blood line is connected to the outlet of the concentrated blood container via the inner blood return line, and the blood return mode control means for driving the blood pump in the blood feeding direction so that the blood in the blood line returns to the concentrated blood container. When, The liquid line is connected to the outlet of the concentrated blood container through the inner blood return line, the blood pump is driven in the blood feeding direction to clear the blood in the blood line, and then the operation in the blood collection mode described above is performed. Mode control means,
After supplying physiological saline to the concentrated blood container through the physiological saline line, connect the inner blood supply line, the blood line and the outer blood returning line to the inlet of the plasma separator to make the physiological saline in the concentrated blood container The blood recovery mode control means for driving the blood pump in the blood return direction is provided so that the concentrated blood containing the blood flows through the plasma separator from top to bottom.

<Operation> According to the plasma collection device of the present invention, the blood collected from the donor is mixed with the anticoagulant during blood collection, and the blood thus anticoagulated is sent to the plasma separator.
In the plasma separator, plasma is separated from the collected blood and sent to the plasma container, and the red blood cell rich blood after the plasma is separated is stored in the concentrated blood container. In this case, in the plasma line, the flow rate of plasma is almost averaged by the automatic flow rate control means, and a large amount of plasma is not filtered at one time, so clogging does not occur in the plasma separator.

At the time of returning blood, the concentrated blood stored in the concentrated blood container is returned to the donor through the inner blood returning line, the blood line, the outer blood returning line and the indwelling needle. In this case, if the blood to be returned contains air bubbles, the air bubbles are detected by the air bubble sensor, the blood pump feed direction is reversed in response to this detection, and the blood containing air bubbles is returned to the inner blood return line. Is reversely circulated and returned to the concentrated blood container, does not flow into the plasma separator, and the plasma separator does not cause an obstacle such as an air block due to air bubbles. Further, the blood returned to the concentrated blood container is deflated inside the container. Therefore,
It is possible to omit the chamber for bleeding air.

At the time of re-collection after returning blood, concentrated blood remains in the blood line which is part of the distribution route of the collected blood.The residual blood in this blood line is directly concentrated at the beginning of the blood collection cycle. When the blood is returned to the container and there is no concentrated blood in the blood line, the distribution route is switched to the plasma separator side. Therefore, the remaining concentrated blood does not flow into the plasma separator, and only new blood collected flows into the plasma separator.

Further, at the time of blood collection, physiological saline is directly supplied to the concentrated blood container by utilizing the difference in liquid level. In this case, since the air in the concentrated blood container is discharged from the air line, it takes no time to introduce the physiological saline solution. In addition, the concentrated blood mixed with physiological saline will pass through the plasma separator from the top to the bottom, and the suction force of the blood pump and the pressure due to the difference in the liquid level act on this liquid, so Circulate. Therefore, blood collection can be completed in a short time.

<Examples> Hereinafter, the present invention will be described in detail based on Examples shown in the drawings.

FIG. 1 is a block diagram of a plasma collection device according to the present invention.
As shown in the figure, the plasma collection apparatus of this embodiment includes a single indwelling needle 1 placed in the blood vessel of the donor D and a plasma separator 2.
With. The plasma separator 2 is, for example, a membrane-type plasma separator composed of a hollow fiber, and is supported in the device in an up-down direction, and its upper end outlet stores red blood cell-rich blood after plasma separation. A rich blood container 3 is provided. The rich blood container 3 is made of a hard material and shaped like a case. The concentrated blood container 3 is provided with level sensors 4 capable of detecting at least upper and lower two liquid levels.

In addition, this plasma collection device includes an outer blood supply line 5 located on the donor D side, an anticoagulant line 6, a blood line 7 also used for returning blood, and an inner blood supply line located on the plasma separator 2 side. A blood line 8, an inner blood returning line 9, an outer blood returning line 10, a physiological saline solution line 11, and a plasma line 12 are provided.

The outer blood supply line 5 is connected to the indwelling needle 1 and is connected to the outer end of the blood line 7, and an outer blood supply clamp 13 is provided on this. The anticoagulant agent line 6 is an anticoagulant agent container 14 and an anticoagulant agent is supplied from the anticoagulant agent container 14.
Which is provided with an anticoagulant pump 15.

The blood line 7 is provided between the outer blood supply line 5 and the blood return line 10 and the inner blood supply line 8 and the blood return line 9 and connects them to each other. An operable blood pump 16 is provided, and a bubble sensor 17 is attached to a position outside the blood pump 16. The inner blood supply line 8 extends from the inner end of the blood line 7 to the lower end inlet of the plasma separator 2, and an inner blood supply clamp 18 and a pressure sensor 19 are provided in the middle thereof. In this embodiment, the pressure sensor 19 is composed of an expandable / contractible cylindrical body that is a part of the line and a portion that outputs a detection signal according to the expansion / contraction of the cylindrical body.

The inner blood return line 9 extends from the outlet of the concentrated blood container 3 to the inner end of the blood line 7 and is provided with an inner blood return clamp 20.

The outer blood return line 10 extends from the outer end of the blood line 7 to the indwelling needle 1, and is provided with a pressure sensor 21 and an outer blood return clamp 22. This pressure sensor 22
The same pressure sensor 19 on the inner blood supply line 8 as described above is used.

The physiological saline line 11 guides the physiological saline from the physiological saline container 23 to the outlet of the concentrated blood container 3 by utilizing the level difference, and is provided with the physiological saline clamp 24.

The plasma line 12 guides plasma from the lower secondary outlet of the plasma separator 2 to the plasma container 25, and includes a plasma clamp.
26 and automatic flow control means 27 are provided. As the automatic flow rate control means 27, for example, a so-called “auto clamp” that changes the opening of the plasma passage steplessly by driving a motor is used.

Further, air lines 29 and 30 are connected to the upper part of the concentrated blood container 3 and the upper secondary outlet of the plasma separator 2 via an air filter 28, and both air lines 29 and 30 are provided with a single air pump 31. It is connected to the. 32, 33 are each airline 2
Air clamps provided on 9,30 and 34 are intake and exhaust clamps.

Then, the bubble sensor 17 and the pressure sensor 1 which are the detection means.
Detection signals from the 9,21 and the level sensor 4 are input to a control unit (not shown), and the anticoagulant pump 15 and blood pump are supplied.
16, the air pump 31, the clamp on each line, and the automatic flow rate control means 27 are controlled by a command signal from the control section.

Next, the operation of the apparatus having the above configuration will be described. The apparatus is provided with a control unit for controlling the operation shown in the flowcharts of FIGS. 2 (a), (b), and (c), and the control unit is the blood collection mode control means and the blood return mode control of the present invention. And means for recollection mode control means and blood collection mode control means. For one donor, normally, blood collection and blood return are repeated several times, and when the plasma collection amount reaches a certain amount, the blood collection mode is entered, and physiological saline is added to the remaining concentrated blood. It is designed to be returned to the donor.

Blood collection mode As shown in FIG. 2 (a), it is judged in step S1 whether or not the blood is collected after the blood is returned.
At S2, the outer blood supply clamp 13 and the inner blood supply clamp 18 are opened, and the blood pump 16 is driven in the blood supply direction (step S5).
At the same time, drive the anticoagulant pump 15 (step S
6). In this case, the outer blood return clamp 22, the inner blood return clamp 20, and the saline solution clamp 24 are closed. In the plasma line 12, the plasma clamp 26 is opened (step S3), and the automatic flow rate control means 27 is put into operation (step S4).

Thereby, the blood collected from the donor is mixed with the anticoagulant, and the blood thus anticoagulated is separated into plasma through the outer blood supply line 5, the blood line 7 and the inner blood supply line 8. It is sent to the bottom entrance of the vessel 2. The plasma separated by the plasma separator 2 is the plasma line 12
Is sent to the blood plasma container 25 through which the blood plasma is separated, and the red blood cell-rich blood is stored in the blood rich container 3.

In the plasma line 12, the flow rate of plasma is adjusted by the automatic flow rate control means 27 to prevent the flow rate of plasma from becoming excessive at the beginning of the blood collection cycle. This prevents clogging of the plasma separator 2.

Further, when the blood flow volume collected by the donor is small and the plasma flow volume is accordingly low, or when the plasma flow volume is decreased in the latter half of the blood collection cycle, the step of determining the plasma volume (step S7) proceeds to step S8, and the air pump is used. The pressure from 31 is applied to the upper portion of the concentrated blood container 3 through the airline 29. This increases the internal pressure on the primary side of the plasma separator 2, increasing the plasma flow rate and ensuring the required plasma flow rate.

If you want to collect blood again after returning blood,
Moving from S1 to step S9, the inner blood supply clamp 18 is closed and the inner blood return clamp 20 is opened, whereby the blood line 7 is communicated with the outlet of the concentrated blood container 3, and in this state, the blood pump 16 is in the blood supply direction. Drive (step S10). Thus, the concentrated blood remaining in the blood line 7 is returned to the concentrated blood container 3. Then, at the time when there is no concentrated blood in the blood line 7 (step S11), the above step S2 is performed.
The following normal blood collection mode is entered, and the distribution route from the blood line 7 is switched to the plasma separator 2 side.

Therefore, the concentrated blood does not flow into the plasma separator 2, and only new blood collected flows into the plasma separator 2.

Blood Return Mode As shown in FIG. 2 (b), in step T1, the outer blood return clamp 22 and the inner blood return clamp 20 are opened, and the inner blood return line 9 and blood line 7 are opened at the outlet of the concentrated blood container 3. And the outside blood return line 10 are connected, and in this state, the blood pump
Drive 16 in the blood return direction (step T2). In this case, both the internal and external blood supply clamps 13 and 18 and the physiological saline clamp 24 are closed, and the drive of the anticoagulant pump 15 is stopped.

Thus, the concentrated blood stored in the concentrated blood container 3 is returned to the donor through the inner blood returning line 9, the blood line 7, the outer blood returning line 10 and the indwelling needle 1.

When air bubbles are detected by the air bubble sensor 17 at the time of returning blood, the process moves from step T3 to step T4, and in response to the detection signal, the blood line 7 is sent through the inner blood returning line 9 to the outlet of the concentrated blood container 3. The blood pump 16 is driven in the blood feeding direction by switching the driving direction.

Thus, the blood containing bubbles that had been returning blood is returned to the concentrated blood container 3 by communicating the inside blood return line 9 in reverse, and does not flow into the plasma separator 2. The blood returned to the concentrated blood container 3 is deaerated inside the container 3.

Blood collection mode As shown in FIG. 2 (c), first, in step U1, the inner blood return clamp 20 is closed, and then the saline solution clamp 24 and the intake / exhaust clamp 34 are opened (step U1). The physiological saline is supplied to the concentrated blood container 3 through the physiological saline line 11 by utilizing the difference in the liquid level between the physiological saline 3 and the physiological saline container 23.

When the required amount of physiological saline is supplied to the concentrated blood container 3 (Yes at step U2), the intake / exhaust clamp 34 is closed (step U3), and the inner blood supply clamp 18 and the outer blood return clamp 22 are closed. Open (Step U4) to connect the inner blood supply line 8, the blood line 7 and the outer blood return line 10 to the inlet of the plasma separator 2, and drive the blood pump 16 in the blood returning direction in this state. Yes (step U5).

Now, the concentrated blood containing the physiological saline in the concentrated blood container 3 flows through the plasma separator 2 from top to bottom and is returned to the donor through the inner blood supply line 8.

<Effects of the Invention> As described above, according to the present invention, the required pumps can be reduced to two, and the system can be made compact and lightweight.

Further, in the present invention, when the blood return contains air bubbles,
Since the air is bleeded in the concentrated blood container by switching the blood path, a relatively large chamber as in the past can be omitted, and from this point also, the system can be made smaller and lighter. Can be planned.

In addition, inconveniences due to the reduction of the number of pumps, such as insufficient plasma collection volume, clogging and hemolysis in the plasma separator, and increase in the time required for blood collection, are prevented in advance, and efficient plasma collection is possible. Can be performed without any trouble.

[Brief description of drawings]

FIG. 1 is a block diagram of an embodiment of the present invention, and FIG. 2 (a).
(B) and (c) are flowcharts for explaining the control operation in each mode of blood collection, blood return, and blood collection, FIGS. 3 and 4.
Each of the figures is a configuration diagram of a conventional example. 1 ... Indwelling needle, 2 ... Plasma separator, 3 ... Concentrated blood container, 5 ... Outer blood supply line, 6 ... Anticoagulant line,
7 ... Blood line, 8 ... Inner blood sending line, 9 ... Inner blood returning line, 10 ... Outer blood returning line, 11 ... Saline line, 12 ... Plasma line, 15 ... Anticoagulant pump, 16 ... Blood pump, 17 ... Bubble sensor, 27 ... Automatic flow control means.

Claims (2)

(57) [Claims] 1. An indwelling needle to be placed in a blood vessel of a donor, an outer blood supply line connected to the indwelling needle, and an anticoagulant line for guiding an anticoagulant to the entrance of the outer blood supply line. And an anticoagulant pump provided on this anticoagulant line, a blood line for both returning and returning blood continuous to the outer blood supply line, and forward and reverse operations provided on this blood line. Possible blood pump, plasma separator, blood delivery line from the blood line to the lower end inlet of the plasma separator, and a concentrated blood container connected to the outlet at a position higher than the upper end outlet of the plasma separator An inner blood return line from the outlet of the concentrated blood container to the inner end of the blood line, an outer blood return line from the outer end of the blood line to the indwelling needle, and a liquid level position higher than the concentrated blood container. Saline solution from the A physiological saline line leading to the side, a plasma line guiding plasma from the plasma separator to a plasma container, and an automatic flow rate control means provided on the plasma line, and at least both the internal and external blood supply lines of the respective lines. A plasma collection device, wherein clamps are provided on both the internal and external blood return lines and the physiological saline line, and a bubble sensor is provided on the blood line outside the blood pump. 2. An anticoagulant is supplied to an outer blood supply line by driving an anticoagulant pump, and an outer blood supply line, a blood line and an inner blood supply line are provided to an inlet of a plasma separator. Drive the blood pump in the blood supply direction by communicating
On the other hand, in the plasma line, the blood collection mode control means that operates the automatic flow rate control means so that the plasma flow rate is almost averaged, and the inner blood return line and the blood line and the outer blood return line communicate with the outlet of the concentrated blood container. Drive the blood pump in the blood return direction, and when air bubbles are detected by the air bubble sensor, in response to the air bubble detection, the blood line is routed to the outlet of the concentrated blood container via the inner blood return line. The blood return mode control means that drives the blood pump in the blood feeding direction so that the blood in the blood line returns to the concentrated blood container, and the blood line communicates with the outlet of the concentrated blood container through the inner blood return line. After that, the blood pump is driven in the blood supply direction to clean the blood in the blood line, and then the re-collection mode control means for shifting to the operation of the blood collection mode described above and the physiological blood line to the concentrated blood container through the physiological saline line. After supplying saline, connect the inner blood supply line, the blood line and the outer blood return line to the inlet of the plasma separator, and the concentrated blood containing physiological saline in the concentrated blood container from the top of the plasma separator. The plasma collection apparatus according to claim 1, further comprising: a blood collection mode control unit that drives the blood pump in a blood returning direction so as to flow downward.