JPH02274261A - Single drive type blood plasma-collecting system - Google Patents

Abstract

PURPOSE:To reduce weight and size and improve separating efficiency of blood plasma by providing an anticoagulant mechanically interlocked with a blood- collecting/blood-returning switching pump to inject an anti-coagulant to an external circulating system only at the time of bleeding. CONSTITUTION:A blood-collecting/blood-returning switching pump 11 for switching collecting/returning of blood by changing the rotating direction of a driving source 18, and an anticoagulant pump 12 are driven by the same driving source 18. Only at the time of bleeding, the anticoagulant pump 12 is interlocked by a mechanical connecting part 9 such as gear and belt. An anticoagulant is supplied into a blood circuit by a one-directional operating part 20 only at the time of bleeding, and an anticoagulant circuit 6 is closed at the time of blood-returning to prevent the back flow of the blood in the anticoagulant circuit at that time. Hence, a reduction in weight and size of the system and an improvement in separating efficiency of blood plasma can be achieved simultaneously.

Description

Detailed Description of the Invention (Field of Industrial Application) The present invention separates blood collected from a blood donor or patient into plasma and blood cell components, collects only the plasma, and transfers the blood cell components to the donor or patient. Light, small and highly portable for return shipping.
This invention relates to a plasma collection device that can be easily mounted on a vehicle.

(Prior art) In recent years, when collecting plasma from blood donors in Japan, etc., it has become common to set up the blood collection site in a place where donors can easily gather, and it is necessary to move the equipment or use a dedicated blood collection vehicle. The importance of installing it on the aircraft is becoming extremely high.

In order to collect blood at such locations, it is desired to realize a lighter and more compact device.

In addition, from a similar perspective, it is also desired to shorten the plasma collection time to reduce donor detention time as much as possible, and it is necessary to increase the separation efficiency of plasma from whole blood as much as possible. .

When blood plasma is continuously collected from a blood donor or patient, a single blood collection needle is used, and a measuring means and a control means are used to collect and return blood in order to minimize the burden on the donor or patient. There is a system in which these steps are carried out alternately, which is a common method in the field of blood donation (Japanese Patent Laid-Open No. 61-859).
No. 50, etc.).

However, in conventional systems, in the case of membrane-based plasma separation, there are two systems: one for blood collection (if a circulation pump is used, this may also serve as blood return), and one for blood return or circulation. Bombs are prepared independently and each is controlled in relation to each other. Furthermore, in addition to this,
Pumps for anticoagulant and plasma collection can also be used independently.
It was operated and controlled in conjunction with the blood collection pump.

On the other hand, in the case of blood plasma collection using a continuous centrifugation method, there is a method in which a single pump serves both blood collection and blood return, but in this case, separate power for centrifugation is required. Furthermore, a pump for anticoagulant is provided separately.
It is electrically controlled, and no matter what type of system it is, three to four or more mechanical drive sources are required to drive the device, and the shape and weight of the device are considerably large and heavy. Moreover, the control system was also complicated.

Recently, a system using a small and lightweight device has been developed, in which a blood storage bag is inserted into a vacuum/pressurization box instead of the usual one-roller pump, and blood is collected from the donor by reducing the pressure. A method (Japanese Patent Application Laid-Open No. 63-235866) has also appeared in which a certain amount of blood is stored in a blood storage bag and then returned under pressure (the plasma is collected at this time). If an anticoagulant pump is required, or if no anticoagulant pump is provided, reduce the diameter of the tube on the blood circuit side so that a large amount of anticoagulant is not aspirated due to negative pressure during blood aspiration. , the anticoagulant flow path can be easily controlled by providing resistance to the anticoagulant flow path. However, in the latter case,
Although this method is quite effective in reducing the size and weight of the device, control of the amount of anticoagulant flowing in requires sacrificing accuracy to some extent, and improvements in this aspect are desired.

In terms of plasma separation efficiency, it is known that increasing the shear rate of blood passing through the H1 membrane improves the separation efficiency, but there is a limit to the amount of blood collected from blood donors or patients (Japanese 40 to 120 mJ2/min), and there are limits to the structure of the separator, so the simplest and most effective method is to increase the blood flow rate per unit time passing through the plasma separator. For this purpose, systems have been devised in which the collected blood is first stored in a blood storage tank such as a blood bag, and then passed through a plasma separator while being circulated by a circulation pump. Kaisho 64-22259, etc.).

Regardless, blood circuits and devices themselves have become more complex in order to efficiently collect plasma.

(Problems to be Solved by the Invention) The present invention has been made in view of the drawbacks of the conventional example, and its purpose is to improve the conventional device in consideration of the case where plasma collection is carried out by moving the vehicle-mounted device. The object of the present invention is to provide an apparatus that can simultaneously reduce the size of the system and improve plasma separation efficiency while maintaining ease of use and accuracy.

(Means for Solving the Problems) The present invention is a membrane-type plasma collection system that involves extracorporeal circulation of blood, and is a blood collection/removal system that performs blood collection outside the body and return of the blood collected outside the body. A single-drive device characterized by comprising a separation switching pump 11 and an anticoagulant pump 12 that is mechanically interlocked with the blood collection/blood return switching pump 11 and injects an anticoagulant into the extracorporeal circulation system only when blood is collected. This is a plasma collection system.

1 and 2 are schematic explanatory diagrams showing an embodiment of the system of the present invention, FIG. 5 is a perspective view showing an example of the system of the present invention, and FIG. 6 is a diagram showing the same drive source. An example of the structure of a blood collection/return switching pump and an anticoagulant pump is shown below.

As shown in FIG. 6, the system of the present invention includes a blood collection/return switching pump (11) that switches blood collection/return by changing the rotational direction of a drive source (18), and an anticoagulant. The same drive source (18) as the pump (12) (
For example, it is driven by an electric drive source such as a DC motor, induction motor, pulse motor, or ultrasonic motor, or a drive source that uses compressed gas such as a pneumatic motor, and is further driven by a mechanical connection part such as a gear or belt (19 ), the anticoagulant pump (12) is operated only during blood collection.

The directional actuator (20) (for example, one-way clutch, etc.) supplies anticoagulant into the blood circuit only when blood is collected, closes the anticoagulant circuit (6) when blood is returned, and closes the anticoagulant circuit (6) when blood is returned. (6) It is a mechanism that does not cause backflow of blood.

In this case, control of the inflow of anticoagulant is controlled by K! IJl source (
18) at the catastrophic connection (19) directly connected to the 5 drive side and driven side gear ratio, or by appropriately selecting the reduction ratio such as the gear ratio of the 5 drive side and the driven side, or the anticoagulant pump tube section (7) of the blood circuit section.
By appropriately selecting the inner diameter of the tube, it is possible to easily and accurately control the inflow rate of the anticoagulant at different ratios to the blood flow rate.

As a result, it is possible to combine three or four drive sources into one, which conventionally required three or four, and it has become possible to simplify and reduce the weight of the device. Furthermore, since there are fewer driving sources, less power is used, and a portable auxiliary power source (17) such as a storage battery can be used for sufficient operation. In addition, the blood circuit part includes a connection part to the blood donor (1) (for example, an indwelling needle, etc.), a common blood collection/return line (2), a plasma separator (3), a pump tube part (4), and a blood storage bag. The parts constituting the blood flow path of the blood storage part (5), etc., the anticoagulant line (6), the anticoagulant pump tube part (7), and the anticoagulant feeding path of the anticoagulant bag (8). , as well as the plasma collection line (9
), the minimum blood circuit can be configured by the part that constitutes the plasma flow path of the plasma storage part (10) such as a plasma collection bag that stores plasma, and it is possible to significantly simplify the blood circuit compared to conventional products. Cost reduction is also possible.

In implementing the present invention, blood collection/return switching pump (1
1) and membrane type plasma 1! In terms of positional relationship with II (3), depending on which side is placed on the side that connects to the blood donor,
As shown in Figure 1, the plasma separator is placed on the blood discharge side of the blood collection/blood return pump when blood is returned, and as shown in Figure 2, the plasma separator is placed on the blood collection/blood return switching pump (11) when blood is collected. Two mechanical arrangements are possible: one is placed on the blood discharge side of It is controlled by opening the valve (Step 3) at each time of plasma collection.

Flow diagrams of blood and plasma are shown in FIGS. 3 and 4.

The blood is connected to the donor (1) (e.g. indwelling needle, etc.)
The plasma flows into the blood circuit used in the invention and is mixed with the anticoagulant sent by the anticoagulant pump (12) mechanically linked to the blood collection/return switching pump (11). Separation′? : Enter i(3), pass through the pump tube part (4), and enter the blood storage part such as a blood storage bag (
It accumulates in 5). In addition, in FIG. 2, on the contrary, after passing through the pump tube section (4), the plasma enters the plasma separator (3) and is collected in a blood storage section (5) such as a blood storage bag. In Fig. 2, the plasma collection valve (13) opens at this time.
Collect plasma. The first blood collected in the blood storage bag part (5)
The blood in the figure or the 115J red blood cells in Figure 2 is detected by detecting a certain amount by appropriate means (for example, a weight sensor (15) or a level sensor), and then reversing the blood collection/blood return switching pump (11). to return blood. At this time, in the embodiment shown in FIG. 1, the plasma collection valve (
13) is opened and plasma is collected.

The collected plasma passes through the plasma channel (9) and is collected in a plasma storage unit (1O) such as a plasma bag, and the amount of collected plasma is monitored by a plasma collection amount monitor (14) such as a weight sensor. When a predetermined collection amount is reached, a notification will be given.

In the system of the present invention, the plasma separator (3) is connected to the blood discharge side of the blood collection/return switching pump (11) when blood is returned. This is preferable because the blood flow rate per unit time passing through the plasma separator increases and the efficiency of plasma collection improves.

It is well known that when blood is collected, a larger amount of blood can be collected when returning blood than when collecting blood, and there is some literature that states that the flow rate is approximately 1.5 times the amount of blood collected. According to their experience, when returning blood at a rate of approximately 100 to 120 mff1/min, care should be taken to avoid an abnormal increase in the internal pressure of the blood vessels:
If everything is fine, the blood flow rate at the time of blood collection is 20-30ml.
It seems to be possible even for people who only take one minute.

Compared to collecting plasma by flowing blood through a plasma separator, which has an unstable flow rate during blood collection, which largely depends on individual differences in blood vessels and puncture conditions, plasma collection during blood return allows for a stable and large flow rate. It has been found that efficiency can be improved by doing so. Furthermore, this eliminates the need for a circulation pump to increase the separation efficiency of the plasma separator, greatly contributing to the simplification of the system including the device and blood circuit.

In the actual implementation of the present invention, the connection part with a blood donor such as an indwelling needle, the blood circuit part, the blood storage part such as a blood storage bag, the anticoagulant bag part, etc. are currently generally approved for use in medical devices. Any material (such as vinyl chloride) can be used.

Regarding the plasma separator, in the reference data for this example (Tables 1 and 2), an example of a deformed plasma separator using a hollow fiber microporous membrane made of polyethylene was given, but the material is a material that is currently generally approved for use in medical equipment.
Membranes made of materials that can easily create micropores large enough to separate components that need to be separated from components that do not need to be separated in blood (e.g., using a stretching method or neutron beam method) (e.g., olefin-based materials such as polysulfone) membranes, synthetic membranes such as polyvinyl alcohol ethylene copolymer, polymethyl methacrylate, and polyacrylonitrile, cellulose membranes such as cuprophane and diacetyl cellulose, and inorganic ceramic membranes). .

Furthermore, in terms of shape, any separator suitable for separating blood components using a microporous membrane can be used, such as not only the hollow fiber type but also the plain clothes type and the coil type.

Although not shown in the specific example of this embodiment, when blood is collected from a donor, a system or system is used that sufficiently monitors the donor's intravascular pressure and takes sufficient care not to take an unreasonable amount of blood to be collected. It is extremely effective in carrying out the present invention to have a control mechanism designed to keep the ultrafiltration pressure within the plasma separator within a range that does not cause hemolysis.

Compared to the system of the present invention, the devices currently used as plasma collection systems for boat fishing are summarized in Table 1, focusing on drive sources such as pumps. It can be seen that there are 3 to 4 items, which increases the overall weight, making it difficult to transport.

Regarding the present invention, the same <as shown in Table 1, weight,
Both dimensions are lighter and smaller than the other products listed in the table, and the significance of the invention is obvious.

Table 2 shows the time required to collect plasma using a conventional plasma separation system with separate pumps for blood collection and return or circulation, and the time required to collect plasma using the system of the present invention. I gave a comparison. The time required to complete blood collection of 450 mff1 was 40 to 50 minutes in the conventional method, but in the present invention, it was shortened to 15 to 20 minutes, which clearly demonstrates the effectiveness of the present invention.

(Effects of the Invention) By using the membrane-type plasma collection system of the present invention, it is possible to simultaneously reduce the size of the device and improve the plasma separation efficiency.

[Brief explanation of drawings]

Figures 1 and 2 are schematic explanatory diagrams showing embodiments of the system of the present invention. Figure 1 shows an example of a system for collecting plasma when blood is returned, and Figure 2 shows an example of a system for collecting plasma when blood is collected. An example of a system for collecting plasma is shown. Figures 3 and 4 show an example of a flowchart of the operation of the blood collection/return switching pump of the present invention, the resulting collected plasma, and the actual return blood flow. ,
This corresponds to the embodiment shown in FIG. FIG. 5 is a perspective view showing an example of the system of the present invention, and FIG. 6 shows an example of the structure of a blood collection/blood return switching pump and an anticoagulant pump in which the same driving source is used. 1. Connection part to blood donor 2. Common line for blood collection and blood return 3. Plasma separator 4, pump tube section 5, blood storage section 6. Anticoagulant line 7, pump tube section 8. Anticoagulant bag 9, blood sampling line, io, plasma storage section 11, blood sampling/blood return switching pump 12, anticoagulant pump 13. Blood collection method valve 14, plasma collection amount monitor 151 weight sensor 16, display section
17. Portable auxiliary g source 18, drive unit
19° Mechanical connection part 20, one-way operating part

Claims (1)

[Claims] A membrane-type plasma collection system that involves extracorporeal circulation of blood,
A blood collection/blood return switching pump 11 that collects blood outside the body and returns the blood collected outside the body, and a blood collection/blood return switching pump 11 that mechanically interlocks with the blood collection/blood return switching pump 11 to apply an anticoagulant to the outside of the body only when blood is collected. 1. A single-drive plasma collection system characterized by having an anticoagulant pump 12 for injecting into the circulatory system.