JPH0793945B2 - Donorpheresis device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial field of application] The present invention separates blood collected from a blood donor into plasma and blood cell components, collects only plasma, and returns the blood cell components to the blood donor. Good donor pheresis device.

[Prior Art] In order to efficiently collect plasma from a blood donor, increasing the blood flow rate per unit time passing through a plasma exchanger is the simplest and most effective method.

However, it is difficult to increase only the blood flow rate because the blood cell collection amount from the blood donor naturally has an upper limit.

Therefore, recently proposed as an efficient plasma collection system uses blood flow from a blood donor to a plasma separator and blood return from the blood plasma exchanger to a blood donor using a measuring means and a control means. Thus, there is a plasma collection system (so-called donor pheresis system) that is alternately performed. In this donor pheresis system, when blood is sent to a plasma exchanger, the blood separated into plasma and blood cell components by the plasma exchanger is temporarily stored in a blood reservoir on the return side of the plasma exchanger to the donor. Storage to the blood donor at the same time is stopped, and when blood is returned to the blood donor, the blood supply to the plasma exchanger is stopped and the blood in the blood reservoir is returned. The measurement means and the control means are used. (Japanese Patent Laid-Open No. 61-85950) [Problems to be Solved by the Invention] However, in the conventional system, the blood stored in the blood reservoir is obtained by separating and collecting a part of plasma. Therefore, the volume ratio of red blood cells in blood (hematocrit value, hereinafter referred to as Ht value) is high, and the red blood cell concentrate has high viscosity. Therefore, if blood is to be collected and blood is collected at the same time as blood is returned to the donor, the blood with a high Ht value enters the plasma exchanger, so that the inlet pressure and the outlet pressure of the plasma exchanger rise rapidly. In the vicinity of increased pressure, undesired situations such as breakage of tubes forming blood lines and hemolysis due to destruction of blood cell components are likely to occur.

Further, the occurrence of this unfavorable situation can be achieved by slowing the blood returning rate to the blood donor, but on the other hand, there is a drawback that the blood returning time becomes long.

[Means for Solving Problems] Therefore, as a result of earnest research to solve the problems in the above-mentioned conventional techniques, the present inventors have found that a plasma exchanger module, a blood reservoir, a plurality of blood collecting / returning blood pumps, The present inventors have found that it is possible to perform small-sized, efficient, and safe plasma collection by functionally arranging a serum collection bag and the like and connecting them by a blood line, and arrived at the present invention.

That is, according to the present invention, a puncture portion for collecting blood from the living body and returning blood to the living body, a blood reservoir connected to the blood line from the puncture portion via the first forward / reverse dual-purpose pump, A plasma exchange module connected from the blood reservoir via a second forward / reverse dual-purpose pump, a blood collection bag for storing plasma collected by the blood plasma exchange module, and a blood line from the puncture part. An anticoagulant bottle for supplying a coagulant and a physiological saline solution bottle for storing a physiological saline solution for preliminarily washing the inside of the plasma exchange module are functionally arranged, and the blood reservoir is collected from a living body. It is divided by a partition plate into two chambers, a first chamber for storing blood and a second chamber for storing concentrated blood from which plasma has been collected by the plasma exchange module, and the second chamber when the set amount is exceeded. Stored blood overflows into the first chamber It is formed so as to donor pheresis apparatus according to claim, it is provided.

[Examples] Hereinafter, the present invention will be described in more detail with reference to Examples.
It will be clear that the invention is not limited to these examples.

FIG. 1 is an explanatory view showing a panel portion of a donor pheresis device which is an embodiment of the present invention.

In the figure, 10 is a plasma exchange module, 11 is a blood reservoir, and 12
Is a sampling bag, 13 is a drainage bag, 14 is a saline bottle, and 15 is an ACD bottle. Further, 16, 17, 18 are roller pumps, 19 is an ACD pump, 20 is a puncture portion, and 21, 22, 23 and 24 are clamps.

Also, in order to make the liquid flow smoothly due to the difference in position,
The physiological saline bottle 14 and the ACD bottle 15 are arranged above the plasma exchange module 10 and the blood reservoir 11, while the blood collection bag 12 and the drainage bag 13 are placed in the plasma exchange module 10 and the blood reservoir.
It is placed below 11.

ACD is an anticoagulant that prevents blood from coagulating in the blood circuit, and physiological saline is a liquid having an osmotic pressure equal to that of blood, and both are colorless and transparent. The blood reservoir 11 temporarily stores the blood after separating the blood and plasma derived from the living body, and has a capacity of 200 to 400 ml.

The size of the device was such that the front surface of the panel section was about 400 × 500 mm, the lower side of the panel section was about the bed height, and the weight was 60 to 70 kg.

The operation of this device consists of four steps: a priming step, a conditioning step, a blood sampling step and a blood returning step.

Therefore, first, the priming operation in this device will be described.

Initially, the plasma exchange module is pre-filled with distilled water, which is sterile water.

First, the blood circuit is set in the donor pheresis device, and then the plasma exchange module 10 is connected to the blood circuit.

At this point, make sure the circuit connections are complete.

Next, the distilled water that is the sterile water prefilled in the plasma exchange module 10 is discarded.

Then, the plasma exchange module 10 from the saline bottle 14
A physiological saline solution is introduced into the inside. This naturally flows in due to gravity.

After completely replacing the inside of the plasma exchange module 10 with the physiological saline solution, the blood circuit is filled with the physiological saline solution.

The priming operation is completed as described above, and then the conditioning operation is performed. Conditioning is performed for the purpose of starting blood collection, determining the optimal blood collection volume, and preparing for plasma collection.

Hereinafter, description will be made in order.

After the needle is pierced, the clamp 22 opens, the clamp 21 closes, and the pump
Rotate 16 forward and gradually increase the flow rate. At this time, ACD
The pump 19 rotates in conjunction with the pump 16.

At this point, monitor the blood flow and blood pressure of the donor,
Determine the optimal blood draw.

When the blood collection is completed by the roller pump 16 to the blood reservoir 11b, the roller pump 17 rotates and the plasma exchange module
Guide blood to 10.

The physiological saline previously filled in the blood circuit is guided to the drain bag 13 and after the physiological saline is replaced with blood, the clamp 24 is closed and the clamp 23 is opened to store the blood in the blood reservoir 11a. Let

At this time, the physiological saline solution filling the outside of the hollow fiber of the plasma exchange module 10 is discarded in the drain bag 13.

After the entire blood circuit necessary for blood sampling has been filled with blood, the clamp 22 is closed, the clamp 21 is opened, and the blood reservoir 11
The blood stored in a is returned by reversing the pump 16.

Next, a sampling operation is performed.

The plasma collection operation is a step that is performed after the conditioning, and the plasma collection is not performed during the conditioning, but the roller pump 18 rotates during the plasma collection operation to collect the plasma separated by the plasma exchange module 10. Lead to bag 12.

During conditioning, the blood circuit that is required for blood sampling is filled with blood, so the clamp 22 opens and the clamp
When 21 is closed, the pump 16 rotates in the normal direction, and at the same time, the pump 17 also rotates in the normal direction.

The blood introduced from the blood reservoir 11b via the pump 17 is separated into plasma by the plasma exchange module 10.

Then, the pump 18 is rotated and the sampling is started.

Blood with a high Ht value, from which plasma has been separated, is guided to the blood storage tank 11a. Here, due to the difference in specific gravity of blood, blood is stored in the blood reservoir 11a.
There is a gradient of Ht value in the inside, and the supernatant blood has a low Ht value.

Since the blood reservoir 11 has the partition plate 25, when it exceeds the set amount, the blood reservoir 11 overflows from the blood reservoir 11a and flows into the blood reservoir 11b.

When the extracorporeal blood volume reaches the set value, the clamp 22 is closed, the clamp 21 is opened, the pump 16 is reversed, and blood return is started.

At this time, the blood stored in the blood storage tank 11b is guided to the plasma exchange module 10 by the pump 17, separates the plasma, is guided to the blood storage tank 11a, and is returned by the pump 16.

A predetermined amount of plasma is collected by repeating the above-mentioned collection operation.

Finally, blood return operation is performed.

The blood return here is performed after the blood return of the blood collecting operation is completed, and the blood filled in the blood circuit is returned to the donor.

Since the control is performed so that the collection of a predetermined amount of plasma ends at the same time as the end of the blood collection operation, the pump 17 first reverses and the plasma exchange is performed from the blood circuit above the blood reservoir 11. The blood reaching the lower part of the module 10, the roller pump 17, and the blood reservoir 11 is guided to the blood reservoir 11a, the clamps 21 and 22 are opened, the pump 16 is inverted, and the blood in the blood circuit is returned to the donor.

Next, a specific implementation result using the donor pheresis device will be described.

(Example 1) As a plasma exchange module, a polypropylene hollow fiber membrane (manufactured by Ube Industries, Ltd., average pore diameter 0.37 µm, outer diameter 400 µ)
m, inner diameter of 300 μm, porosity of 74%) was used, and plasma collection operation was performed by the pump operation shown in FIG. 2 using bovine blood having Ht value of 35%. (The volume of the blood reservoir is 250 m
l) The results are shown in FIG.

As is clear from FIG. 3, no sudden increase in Ht value at the module inlet was observed, and the sampling time was within 30 minutes. Then, the sampling operation could be performed efficiently and safely.

[Effects of the Invention] As described above, according to the donor pheresis device of the present invention, the plasma exchanger module, the blood reservoir, the plurality of blood-collecting and returning blood-pumps, the serum collection bag, etc. are mechanically arranged. The whole donor pheresis process including the priming process, the conditioning process, the blood collecting process, and the blood returning process can be efficiently and safely performed with a smaller device.

[Brief description of drawings]

FIG. 1 is an explanatory view showing a panel portion of a donor pheresis device which is an embodiment of the present invention, FIG. 2 is a graph showing an example of pump operation of the present invention, and FIG. 3 is a graph showing results of sampling. is there. 10 ... Plasma exchange module, 11 ... Blood reservoir, 12 ... Serum bag, 13 ... Drainage bag, 14 ... Saline bottle,
15 …… ACD bottle, 16,17,18 …… Roller pump, 19…
… ACD pump, 20 …… needle part, 21,22,23,24 …… clamping device, 25 …… partition plate.

Claims (1)

[Claims] 1. A puncture portion for collecting blood from a living body and returning blood to the living body, a blood reservoir connected to the blood line from the puncture portion via a first forward / reverse dual-purpose pump, and from the blood reservoir. A plasma exchange module connected via a second forward / reverse dual-purpose pump, a plasma collection bag for storing plasma collected by the plasma exchange module, and an anticoagulant supplied to the blood line from the puncture part. An anticoagulant bottle, and a physiological saline solution bottle for preserving the inside of the plasma exchange module to store a physiological saline solution, and the blood reservoir is a first chamber for storing blood collected from a living body. And a partition plate for partitioning the concentrated blood collected from the plasma in the plasma exchange module into the second chamber, and when the set amount is exceeded, the stored blood in the second chamber is stored in the first chamber. Formed to overflow into And donor pheresis and wherein the are.