JPH0736838B2 - Plasma collection device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial application] The present invention separates blood collected from a blood donor into plasma and blood cell components, collects only plasma, and returns a red blood cell concentrate to the blood donor. The present invention relates to an efficient plasma collection 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 separator is the simplest and most effective method.

However, there is naturally an upper limit to the amount of blood collected from a blood donor, so it is difficult to only increase the blood flow rate.

Therefore, recently proposed as an efficient plasma collection system uses blood flow from a blood donor to a blood plasma separator and blood return from the blood plasma separator to a blood donor using a measuring means and a control means. Therefore, there is a plasma collection system that is performed alternately. This system temporarily stores the blood separated into plasma and blood cell components by the plasma separator in the blood reservoir on the return side of the plasma separator to the donor when the blood is delivered to the plasma separator. At the same time, stop returning the blood to the blood donor, and when returning to the blood donor, stop the blood supply to the plasma separator and return the blood in the blood reservoir to the measuring means. And the control means. (JP Sho
(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. 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 this blood is to be collected at the same time as blood is returned to the donor, blood with a high Ht value enters the plasma separator, and the pressure at the inlet and outlet of the plasma separator rises sharply. 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.

It should be noted that suppressing the occurrence of this unfavorable situation makes it possible to slow down the rate of returning blood to the blood donor, but on the other hand, it has the drawback of increasing the time of returning blood.

[Means for Solving the Problems] Therefore, as a result of intensive studies to solve the above-mentioned problems in the prior art, the present inventors have determined that the blood reservoir has a specific configuration, and thus a plasma separator. Of the concentrated blood with high Ht blood that has passed through the plasma and has been separated, only the blood with a low Ht value is recirculated with fresh blood, resulting in efficient plasma collection and rapid increase in pressure in the plasma separator. The present invention is capable of preventing the above.

That is, according to the present invention, there is provided a plasma collection device comprising at least a needle, a blood sampling / returning blood pump, a blood reservoir, and a plasma separator, wherein the blood sampling / returning blood pump is a plasma collected from a donor. The blood is sent to the separator, and the blood is returned from the plasma separator to the donor.
The blood line from the blood outlet of the plasma separator is connected to the blood line that is connected to the blood-return dual-use pump, and the blood line is connected to the blood reservoir, and the blood reservoir is fresh blood from the donor. Is divided into a second chamber in which is stored and a first chamber in which concentrated blood after plasma separation from the plasma separator is stored,
When the concentrated blood sent to the first chamber exceeds the capacity of the first chamber, the blood having a low hematocrit value preferentially overflows from the first chamber and flows into the second chamber. A plasma collection device is provided.

[Operation] The blood collected from the puncture part is once stored in the second chamber of the blood storing part, and then sent to the plasma separator by the circulation pump provided on the downstream side of the blood storing part to perform plasma collection. It

The concentrated blood having a high Ht value after the plasma collection is sent to and stored in the first chamber of the blood storage unit. Concentrated blood causes a difference in Ht value due to the difference in position between the upper and lower layers during storage, and when the stored blood exceeds the capacity of the first chamber, only blood with a low Ht value overflows, that is, Ht value. Low blood preferentially flows into the second chamber.

Next, when a certain amount of blood is collected, the dual blood collection / return blood pump reverses to return the blood stored in the first chamber of the blood storage unit to the donor. At this time, the stored blood in the second chamber also passes through the plasma separator, is plasma-collected, and is then returned.

[Examples] Hereinafter, the present invention will be described in detail based on examples, but it will be apparent that the present invention is not limited to the examples.

FIG. 1 schematically shows a blood flow chart of the plasma collection apparatus according to the present invention.

In the embodiment shown in FIG. 1, the blood reservoir (blood reservoir) 20
The partition 21 that divides the upper chamber 22 into the upper chamber 22 and the lower chamber 23 has an obtuse-angled cross section as illustrated.

The volume of the blood storage tank 20 is usually about 100 to 500 ml, and the volume of the upper chamber 22 is about 20 to 200 ml, although it depends on the amount of collected blood.

The blood collected by the piercing part 11 is mixed with the anticoagulant carried by the anticoagulant pump 13 from the anticoagulant tank 13 by the blood collecting / returning blood pump 12 and then passed through the line 31. From the first blood port (blood sampling port) 24, the blood is temporarily stored in the lower chamber 23 of the blood storage tank 20.

The stored blood is sent from the second blood port (blood sending port) 25 by the circulation pump 15 to the plasma separator 16 via the line 32, and a part of the plasma is collected.

The collected plasma is stored in the plasma bag 18 via the line 33 by the plasma collection pump 17.

On the other hand, the blood obtained by collecting a part of the plasma is stored in the upper chamber 22 of the blood reservoir 20 through the third blood inlet (return tank inlet) 26, and the upper layer portion is temporally changed due to the difference in specific gravity between the blood cell component and the plasma component. Has a low Ht value, the lower layer has a high Ht value, and the upper chamber has a certain volume.
When the volume exceeds 22, the blood with a low specific gravity, that is, a low Ht value, preferentially overflows into the lower chamber 23.

The blood overflowing from the upper chamber 22 and flowing into the lower chamber 23 is sent from the blood donor 25 to the plasma separator 16 together with the blood newly collected from the donor and stored in the lower chamber 23, and the blood is collected. Done.

When a certain amount of blood has been collected, blood collection from the blood donor is completed,
The blood collection and blood return pump 12 is reversed. Then, the blood stored in the upper chamber 22 is returned from the fourth blood port (blood supply port) 27 to the puncture section 11 by the dual blood collection / return pump 12 and returned to the blood donor. At this time, the blood stored in the lower chamber 23 is sent to the upper chamber 22 after passing through the plasma separator 16 and returned to the blood donor as described above.

Not limited to this embodiment, the third blood port (return tank port) 26 is
It is desirable to install it at the lowermost end of the upper chamber 22 and near the inner wall of the blood storage tank 20.

FIG. 2 is a perspective view showing another embodiment of the blood storage tank 20 used in the present invention.

In this embodiment, the blood reservoir 20 is composed of a main body 40 and a lid 41, and the partition 21 that divides the blood reservoir 20 into two chambers is a vertical plate.

A room divided into two by a partition 21 (that is, a small room 42 into which concentrated blood after plasma separation is sent and a large room 4 into which fresh blood flows in)
On the side of 3), there are provided about three level sensors (not shown) for detecting the blood surface, respectively, for accurate and precise blood inflow / outflow control, and the plasma separator 16 or the needle 11
It is designed to prevent the inflow of air.

In the case of this embodiment, it is preferable that both the main body 40 and the lid 41 are made of a rigid material and are partitioned by the partition 21 because the small chamber 42 and the large chamber 43 can have a constant blood storage amount.

Further, 44 is an open end leading to the air outlet, 45 is an open end for inserting a line to the third blood port (return tank port) 26,
Reference numeral 46 indicates a fourth blood opening (return opening), 47 indicates a first blood opening (collecting opening), and 48 indicates a blood supply opening.

In carrying out the plasma collection of the present invention, an appropriate amount of blood anticoagulant is used. When a blood circuit of anticoagulant and a plasma separator are developed, they are required only for collected plasma. Any anticoagulant may be used as long as it can be used for external blood perfusion, and for example, citric acid (ACD, CPD, etc.), heparin, prostaglandin, FOY, MD-805, etc. are used. These can be administered by injecting to a blood donor due to their characteristics, and as shown in one example in this Example, a branch is provided in the puncture part or the blood line downstream thereof, and It is also possible to administer by continuous administration or infusion.

Further, the plasma separator 16 has a high plasma separation rate,
Any membrane-type plasma separator having a good plasma protein permeability can be used, and it is preferable to use a hollow fiber membrane-type separation membrane module.

As the hollow fiber membrane used in the plasma separation membrane module,
Those having hydrophilicity are preferably used. On the other hand, those which are originally hydrophobic but have been hydrophilically treated with a surfactant or a coating agent can also be preferably used. Furthermore, the hydrophobic hollow fiber membrane is washed with a substance that has good compatibility with water and low surface tension, such as alcohol,
It can be used as the hollow fiber membrane of the present invention by filling it with sterile water such as physiological saline or dust-free water and replacing it with blood before use.

The material of the hollow fiber is not particularly limited. Examples of materials made of polymer materials include polyolefins (high-density polyethylene, polypropylene, poly (4-methyl-pentene-1), etc.), fluorine-containing polymer compounds, polysulfones, polycarbonates, polyvinyl chloride, cellulose acetate, Examples thereof include porous hollow fibers such as polyacrylonitrile, polyvinyl alcohol, polymethylmethacrylate, and polyamide. Moreover, examples of the inorganic material include porous hollow fibers such as glass, ceramics and carbon. Among the above, a membrane made of polyolefin is preferable from the viewpoint of high hemolysis resistance. Outer diameter of porous hollow fiber,
The thickness of the peripheral wall and the hole diameter are not particularly limited, but generally the outer diameter is about 10 to 1000 μm, and the thickness of the peripheral wall is about 10 to about 50.
It is preferably 0 μm and the pore size is about 0.01 to about 7 μm.

Next, a concrete implementation result will be described using the present invention.

(Examples and Comparative Examples) Using the plasma collection device shown in FIG. 1, a blood collection rate of 100 ml / mi
n, serum collection rate 30 ml / min, blood chamber upper chamber volume 150 ml, blood collection volume 500 ml per time, 400 ml of bovine blood (hematocrit blood 40%) was sampled and the number of blood collection and The separation time was measured.

For comparison, the same procedure was performed for a case where a conventional plasma collection device having a one-unit type blood reservoir (blood storage volume: 500 ml) was used.

The results are shown in the table below.

As a separation membrane in the plasma separator 16, a polypropylene hollow fiber membrane (Ube Industries, Ltd., average pore diameter 0.37μ)
m, outer diameter 400 μm, inner diameter 300 μm, porosity 74%).

[Effects of the Invention] As described above, according to the plasma collection device of the present invention,
The blood storage part is divided into a second chamber where fresh blood is stored and a first chamber where concentrated blood after plasma separation is stored, and when the concentrated blood exceeds the capacity of the first chamber, blood with a low Ht value Since it preferentially overflows from the first chamber and flows into the second chamber, there is an advantage that efficient and safe plasma collection can be performed.

[Brief description of drawings]

FIG. 1 is a schematic explanatory view of a plasma collection apparatus showing an embodiment of the present invention, and FIG. 2 is a perspective view showing another embodiment of a blood reservoir used in the present invention. 11 ... Needle part, 12 ... Blood collection / return blood pump, 15 ... Circulation pump, 16 ... Plasma separator, 20 ... Blood reservoir, 21 ... Partition, 22 ... Upper chamber, 23 ... Lower chamber, 42 ... Small chamber, 43 … Omuro.

Claims (1)

[Claims] 1. A plasma collection device comprising at least a puncture part, a blood sampling / returning blood pump, a blood reservoir, and a plasma separator, wherein the blood sampling / returning blood pump is from a donor to a plasma separator. And the blood is returned from the plasma separator to the blood donor, and the blood reservoir is provided between the blood line connecting the plasma separator and the blood collecting / returning blood pump. The blood line from the blood outlet of the separator is connected to the blood reservoir, and the blood reservoir is a second chamber where fresh blood from the donor is stored and the plasma after separation from the plasma separator. If the concentrated blood sent to the first chamber exceeds the capacity of the first chamber, the blood is divided into the first chamber where the concentrated blood is stored, and blood with a low hematocrit value preferentially overflows from the first chamber. Flow into the second chamber.