JPH0534341A - Separating and preserving apparatus of blood constituent - Google Patents

Abstract

PURPOSE:To improve yields of a hemocyte and a serum. CONSTITUTION:An apparatus is constructed of a blood constituent separating means 3 and of a blood collecting means 2, a hemocyte preserving liquid supply means 4, a hemocyte preserving means 5 and a serum preserving means 6 connected together through liquid delivering means. It is so designed that, after separation of constituents of blood collected by the blood collecting means 2, a hemocyte preserving liquid is sent into the hemocyte preserving means 5 via the blood constituent separating means 3 and that hemocytes remaining in the blood constituent separating means 3 can be collected by the hemocyte preserving liquid.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component separating and storing device using a membrane type blood component separator.

[0002]

2. Description of the Related Art Conventionally, as a method of collecting blood from a healthy person and separating and collecting blood into blood cell components and plasma components, a blood bag containing the collected whole blood is placed in a centrifuge,
A centrifugal method for separating concentrated blood cell fluid and plasma and a membrane method for separating concentrated blood cell fluid and plasma by contacting blood with a membrane are known.

In the above-mentioned centrifugation method, a blood collection bag is connected to a bag containing a blood cell preservation solution, and a blood bag that allows long-term preservation of blood cells by adding the blood cell preservation solution to the separated concentrated blood cell solution. The system is being developed.

The membrane method is a method of separating blood cells and plasma using a membrane-type plasma separator. There are a method of using a device and a method of using a head. Usually, a concentrated blood cell fluid is supplied to a donor. In many cases, blood is returned, but for example, JP-A-63-2263.
As disclosed in Japanese Patent Laid-Open No. 64, a system has been proposed in which each of concentrated blood cell fluid and plasma is collected in a bag.

However, in the case of the above-mentioned centrifugal method, a separate device for centrifugal separation is required,
The whole equipment required for the separation work becomes large. In particular, since the blood components are separated by the difference in specific gravity, clear and reliable separation cannot be performed. Further, since the work of collecting the separated components is a manual work, there is a possibility that platelets, white blood cells and the like may be mixed in the collected plasma, which is inferior in workability and strictness.

When the blood cell preservation solution is not used,
When separating blood cells and plasma, the blood cell concentration in the blood cell concentrate must be maintained at about 60%, and therefore a portion of the plasma must remain on the blood cell side, which is inefficient in terms of plasma collection. .

On the other hand, when using a membrane type plasma separator,
There is a drawback that the obtained blood cells cannot be stored for a long period of time because a blood cell storage solution is not used. In addition, since the blood cells remain in the separator even at the end of the separation operation, the yield of concentrated blood cell liquid deteriorates.

Further, when the membrane type plasma separator is autoclave sterilized, the liquid is filled in the separator by the time of use, and it is necessary to dispose of this liquid when using it. However, there was a drawback that the preparation work took time.

[0009]

SUMMARY OF THE INVENTION An object of the present invention is to solve the above problems and to provide a blood component separation / preservation apparatus capable of easily and reliably separating blood components and having a high yield of concentrated blood cells and plasma. To provide.

[0010]

Such an object is achieved by the present invention described below. That is,

(1) Blood collecting means for collecting blood, and blood component separating means connected to the blood collecting means for separating the blood collected by the blood collecting means into plasma and concentrated blood cell fluid
Plasma storage means and blood cell storage means connected to the blood component separation means and respectively storing plasma and concentrated blood cell fluid separated by the blood component separation means, and a blood cell storage means via the blood component separation means An apparatus for separating and storing blood components, comprising: a blood cell storage solution supply means for supplying a blood cell storage solution; and a liquid sending means for connecting the respective means.

(2) The blood component separating and storing apparatus according to the above (1), wherein a leukocyte removal filter is arranged on the liquid feeding means for connecting the blood component separating means and the blood cell fluid storing means.

(3) A detachable connecting portion is provided between the blood component separating means and the blood collecting means, blood cell preserving means, plasma preserving means, and blood cell preserving solution supplying means, and the connecting portion is used. The blood component separation storage device according to (1) or (2) above, which is to be sent blood.

(4) Each of the means is provided with a thermoplastic tube having a sealed connection end as a liquid feeding means, and the thermoplastic tube can feed blood during use in a sterile state by the connecting means. (1) to be welded to the state
Alternatively, the blood component separation storage device according to (2).

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An apparatus according to a preferred embodiment of the present invention will be described below with reference to the drawings.

In the illustrated example, the blood component separating and storing apparatus 1 is composed of a blood collecting means 2, a blood component separating means 3, a blood cell preservation solution supplying means 4, a blood cell fluid preservation means, and a plasma preservation means. The blood component separating means 3 is connected to the other means described above through the liquid feeding means 7.

The blood collecting means 2 is for collecting blood from a blood donor, and has a blood collecting needle 21, a blood storage container 22, and a blood supply vessel 2 for connecting the blood storage container 22 and the blood collecting needle 21.
3 and 3. As the blood collection needle 21, a known metal blood collection needle having a puncture needle capable of puncturing a vein of a blood donor at its tip, or a resin blood collection needle is preferably used. Further, as the blood storage container 22, a blood bag formed of a soft synthetic resin (for example, soft vinyl chloride resin) is preferably used.

Inside the blood storage container 22, the ACD
Solution, CPD solution, sodium citrate, anticoagulant solution such as heparin may be contained. Such an anticoagulant solution is preferably a physiological isotonic solution.

As the blood supply vessel 23, a transparent flexible synthetic resin such as soft vinyl chloride resin or silicone rubber is preferably used.

The blood storage container 22 is further provided with a first connecting portion 221. The connecting portion 221 is constituted by, for example, a bottle needle, a hollow needle or the like that can be punctured, or a connector.

The blood component separating means 3 is a membrane type plasma separator 3
It is composed of 1. The plasma separator 31 is for separating the blood collected in the blood storage container 22 into a plasma component and a blood cell component. The plasma separator 31 is
Blood inflow port 32 and blood outflow port 33 through which concentrated blood cell fluid flows out
And a blood separating function for separating blood into a plasma component and a blood cell component, and a plasma outlet 34 through which the separated plasma component flows out.

As the structure of the plasma separator 31, a hollow fiber membrane type, a flat membrane type or the like is used. Then, the inflowing blood is separated into a plasma component and a blood cell component by contacting the hollow fiber membrane or the flat membrane.

The blood inflow port 32, the blood outflow port 33, and the plasma outflow port 34 are respectively provided with a liquid delivery pipe 7 as a liquid delivery means.
1, 72, 73 are connected. Each of the liquid supply pipes is made of a thermoplastic resin, and examples thereof include soft polyvinyl chloride, silicone rubber, and polyolefin. The liquid delivery pipe 71 has a bifurcated end portion, and a second connection portion 711 and a third connection portion 712 are provided at the respective tip ends.

The second connecting portion 711 is the first connecting portion 22.
1, which can be connected to the device 1, and is composed of, for example, a bottle needle, a hollow needle or a connector. The third connecting portion 712 is
It can be connected to a blood cell preservation solution supply means 4 described later, and is constituted by, for example, a bottle needle, a hollow needle, a connector, or the like.

Further, the fourth connecting portion 721 and the fifth connecting portion 731 are similarly provided at the tips of the liquid supply pipes 72 and 73. The configurations of these connecting portions 721 and 731 may be the same as those of the second and third connecting portions.

As the blood cell preservation solution supply means 4, a bag 41 made of a soft synthetic resin (eg, soft vinyl chloride resin) is preferably used. The bag 41 is provided with a sixth connecting portion 411, and the sixth connecting portion 411 is composed of, for example, a bottle needle, a hollow needle or the like that can be punctured, or a connector. Then, the aforementioned third connecting portion 712 is connected to the sixth connecting portion 411.

Examples of the blood cell preservation solution contained in the bag include MAP solution, SAGM solution, OPTISOL solution and the like.

On the other hand, a bag 51 formed of a soft synthetic resin (for example, soft vinyl chloride resin) is preferably used as the blood cell storage means 5 for storing the concentrated blood cell fluid. A seventh connecting portion 511 to which the fourth connecting portion 721 of the liquid feeding pipe 72 is connected is provided. The seventh connecting portion 511 is, for example, one capable of being pierced with a bottle needle, a hollow needle, or the like,
Alternatively, it is composed of a connector and the like. The blood cell fluid from which blood plasma has been removed by the blood component separation means 3 is fed into the blood cell storage means 5 through the liquid feed pipe 72.

Further, as the plasma storage means 6 for storing plasma, a bag 61 formed of a soft synthetic resin (for example, soft vinyl chloride resin) is preferably used.
An eighth connecting portion 611 to which the fifth connecting portion 731 of the liquid feeding pipe 73 is connected is provided. This 8th connection part 6
Reference numeral 11 is composed of, for example, a bottle needle, a hollow needle or the like that can be punctured, or a connector or the like. The plasma liquid from which blood cells have been removed by the blood component separating unit 3 is sent into the plasma storing unit 6 through the liquid supply pipe 73. Further, a leukocyte removal filter may be arranged on the liquid supply pipe 72. In this case, there is an effect that after the blood transfusion, a concentrated blood cell fluid with less side effects due to white blood cells can be obtained.

Each of these means is sterilized before use. As a sterilization method, radiation sterilization treatment, EOG sterilization treatment, or the like is performed in advance. Such a sterilization treatment has an advantage that there is no water in the plasma separator 31 and the work of discarding the filled liquid at the time of use becomes unnecessary and the plasma separator 31 can be used immediately. Further, when a hydrophilic membrane is used for the membrane that constitutes the plasma separator 31, wet heat sterilization can be performed without allowing water to exist in the plasma separator 31.

In particular, in the case of the above-mentioned configuration example, since each means is individually configured, there is an advantage that the above sterilization processing can be performed for each means and the processing is easy. Furthermore, when collecting blood, only the blood collecting means 2 can be used alone, and since it is not necessary to return the blood cell fluid to the blood donor, it is sufficient to restrain the blood donor only at the time of blood collection, which imposes a burden on the blood donor. There is an advantage that it decreases. Further, the blood cell preservative supply means 4 and the blood cell preserving means 5 are used according to the amount of collected blood.
Further, the bag of the plasma storage means 6 can be replaced with a bag having a volume suitable for the amount of collected blood.

The operation of such a blood component separating and storing device will be described below. First, the blood collecting needle 21 of the blood collecting means 2 is punctured into a vein of a blood donor, and blood is collected in the blood storage container 12. After the blood collection is completed, the first connecting portion 22 of the blood storage container 22
The second connecting portion 711 is connected to 1. On the other hand, the fourth connecting portion 721 and the fifth connecting portion 731 communicating with the blood outlet 33 and the blood plasma outlet 34 of the blood component separating means 3 are connected to the seventh connecting portion 511 of the blood cell storing means 5 and the blood plasma storing means 6. The 8th
The connection parts 611 are connected to connect the blood component separation means 3, the blood cell storage means 5, and the plasma storage means 6 to each other. Since such a connection does not require preparatory work because each means is sterilized in advance, it can be completed quickly and easily.

From the blood storage container 12 in which the collected blood is stored, the blood is sent to the plasma separator 31 constituting the blood component separating means 3 by a drop through the liquid supply pipe 71. In the plasma separator 31, the blood in contact with the membrane is separated into plasma that has permeated the membrane and concentrated blood cell components that do not permeate the membrane other than plasma, and flow out from the blood outlet 33 and the plasma outlet 34, respectively. The concentrated blood cell component flows into the bag 51 of the blood cell storage means 5 through the liquid supply pipe 72, and the plasma flows into the bag 61 of the plasma storage means 6 through the liquid supply pipe 73.

When the inside of the blood storage container 12 is emptied, the bag 61 of the plasma storage means 6 is removed to close the liquid supply pipe 73, and further the second connecting portion 711 of the liquid supply pipe 71 is closed. Then, the third connection portion 712 of the liquid supply pipe 71 is connected to the sixth connection portion 411 of the bag 41 of the blood cell storage solution supply means 4, and the blood cell storage solution is sent to the plasma separator 31. The blood cell preservation solution sent to the plasma separator 31 is washed with the blood cell fluid remaining in the plasma separator 31 to obtain the bag 5 of the blood cell preservation means 5.
1 mixed in the blood cell fluid together with the washed blood cells. In this way, by allowing the blood cell preservative solution to flow in through the plasma separator 31, the blood cells remaining in the plasma separator 31 can also be stored in the bag 51 together with the blood cell preservative solution, and the blood cell yield can be improved. improves. Further, as a result of mixing the blood cell preservation solution into blood cells, it is not necessary to leave a part of the plasma on the blood cell side, so that the whole amount of the separated and collected plasma can be recovered, and the plasma yield is also improved.

As described above, the blood cell component and the plasma component are separated and stored by each storage means. It should be noted that the liquid supply pipe 71 is not branched and only the second connecting portion 711 is connected to the second connecting portion 71 when the blood storage container 12 becomes empty.
The same effect can be obtained by removing 1 from the first connecting portion 221 of the blood storage container 22 and connecting it to the sixth connecting portion 411 of the blood cell preservation solution supply means 4.

The blood component separation / preservation apparatus constituted by the above-mentioned constitution means has a structure in which each means separately provided is joined and integrated at the time of use through each connecting portion, and also in FIG. As shown, each means may be integrally configured in advance. In the embodiment shown in FIG. 2, the blood component separating means 3, the blood collecting means 2, the blood cell preserving solution supply means 4, the blood cell preserving means 5, and the plasma preserving means 6 are the liquid delivery pipes 7.
They are connected at 1, 72 and 73. Further, the bifurcated liquid supply pipe 71 is provided with a sealing means 8 which is brought into a communication state by refraction breakage, and breaks when necessary to establish a communication state.

The sealing means 8 will be described below with reference to FIG. The sealing means 8 is composed of a tubular body 81 made of a flexible material similar to that of the liquid feed pipe 71, and a sealing member 82 tightly fixed in the tubular body 81. The sealing member 82 is a cylinder whose one end is closed, and a small-diameter broken portion 83 is formed on the outer periphery, and the closed end (solid columnar portion) 84 is bent and broken at the broken portion 83 to enable communication. Is configured to be. As the material of the sealing member 82,
For example, polyvinyl chloride, polycarbonate, or thermoplastic polyester elastomer may be used.

If necessary, the end face of the solid columnar portion 84 has a flat plate-like protruding portion 85 (in FIG. 3, the long side having a long side corresponding to the outer diameter length of the solid columnar portion 84). It is preferable that the short side when viewed from the direction perpendicular to the side is formed) so that the solid columnar portion 84 piece does not block the liquid supply pipe 71 after the solid columnar portion 84 is cut. .

When the sealing means 8 as described above is used, for example, after blood collection, the sealing member 8a is broken to allow the blood storage container 22 and the plasma separator 31 to communicate with each other, and when the blood storage container 22 becomes empty, blood is stored. The liquid supply pipe on the container 22 side is sealed, and then the sealing member 8
By breaking b, the blood cell preservation solution supply means 4 and the plasma separator 31
To communicate.

As described above, by using the sealing member 8, the device of the present invention can be maintained in a completely sterile condition.

Furthermore, in order to facilitate handling during blood collection,
As shown in FIG. 4, only the blood collecting means 2 is connected to the connecting portion 2.
21 and 711 may be used for connection, and the blood cell preservation solution supply means 4 and the plasma separator 31 may be connected by the sealing means 8. With such a structure, the blood collecting means 2 can be used independently, the blood collecting operation can be facilitated, and the sterile state of the device can be reliably maintained.

The sealing means 8 described above may be provided between the plasma separator 31 and the blood cell storage means 5 or the plasma storage means 6.

In addition to the embodiment described above, as shown in FIG. 5, as a liquid feeding pipe 71, a thermoplastic material is connected to each connecting portion of the blood collecting means 2, the blood component separating means 3, and the blood cell preservation liquid supplying means 4. Resin tubes 71a, 71b, 71c, 71
It is also possible to have a structure in which d is connected and the closed end side of the tube is connected by a heating connection means 9 as described below while maintaining the sterile condition.

Examples of the thermoplastic resin forming the tube include soft polyvinyl chloride and polyolefin.

As an example of the means for connecting the tube 71 as described above, there is a structure as described below. As shown in FIGS. 6 to 10, a wafer 93 is arranged between a pair of holders 91 and 92, the tube 8 is installed between the holders 91 and 92, and the wafer 93 is heated. After cutting and melting, one holder 91 is moved, and the wafer 93 is removed and welding is performed.

More specifically, the holders 91 and 92
Are holder pieces 911 and 91 which are respectively divided into upper and lower parts.
2 and 921 and 922. And
Two grooves 941 and 942 each having a semicircular cross section are formed on the facing surfaces of the holder pieces 911, 912 and 921, 922, respectively.
The tube holding portions 951 and 952 having a circular cross section are formed when 21 and 922 are overlapped. The wafer 93 is made of, for example, a material such as copper, aluminum, silver, gold, or an alloy of these metals, and has a sharp edge 93 at the end that first contacts the tube 8.
1 is formed.

As shown in FIG. 7, the tube 8 is installed between the two holders 91 and 92 so that the sealed ends of the tube 8 are directed in mutually opposite directions. Then, the tube 8 held in parallel by the blade 931 of the heated wafer 93 is cut (FIG. 8), the cut portion of the tube 8 is melted by the heat of the wafer 93, and sterilized by the heat. One holder 91 is moved in parallel and fixed at a position where cut ends of the cut tube 8 face each other (FIG. 9). Next, the wafer 93 is pulled out in a direction perpendicular to the tube 8, and one holder 91 is attached to the other holder 92.
By pressing in the direction of, the cut end of the melted tube 8 is bonded (FIG. 10). In this way, the tube 8 is sterilized at the time of connection, so that each means is connected while surely maintaining a sterile condition.

The operation of the apparatus of this embodiment using the connecting means 9 described above will be explained. As shown in FIG. 5, the liquid feeding of the blood collecting means 2 in which the blood collected in the blood storage container 2 is contained. The tube 71b and the liquid delivery tube 71a connected to the blood inlet 32 of the plasma separator 31 are connected to the grooves 94 of the holders 91 and 92 of the connecting means 9 so that their sealing ends face in mutually opposite directions.
It is installed between 1 and 942 respectively. Then, according to the procedure described above, the liquid feeding pipe 71a and the liquid feeding pipe 71b are welded while ensuring a sterile state, and the collected blood is made ready to be fed to the plasma separator 31, as shown in FIG. . In this state,
Blood cells and plasma are separated, and each is stored in a blood cell storage means and a plasma storage means. When the blood storage container 22 is emptied and the separation work is completed, the blood supply vessels 71a and 71b are
Then, the blood collecting means 2 is cut off. Also, the liquid supply pipe 7
Similarly, 3 is sealed and the plasma storage means 6 is released. Then, as shown in FIG. 12, the liquid supply pipe 71c and the liquid supply pipe 71d are welded by the connecting means 9 to connect the blood cell preservation liquid supply means 4 and the plasma separator 31 to each other. And
The blood cell preservation solution is sent to the blood cell preservation means 5 via the plasma separator 31.

With such a structure, the liquid supply pipe 7 can be connected while the aseptic condition is secured, and the blood cell solution and the like can be stored for a long period of time.

[0050]

As described above, according to the blood component separation / preservation apparatus of the present invention, it can be used in the vehicle or outdoors without using another independent separation apparatus, and the blood can be easily stored at any place. The components can be separated.

Further, there is an advantage that mixing of other components into the obtained component is small and blood cells can be stored for a long period of time. In particular, the blood cells remaining in the blood component separating means are also collected in the blood cell preserving means together with the blood cell preserving solution, so that the yield of blood cells is improved.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing the structure of a first embodiment of a blood component separation / preservation apparatus of the present invention.

FIG. 2 is a schematic diagram showing the structure of a second embodiment of the blood component separating and storing apparatus of the present invention.

FIG. 3 is a cross-sectional side view showing the structure of sealing means.

FIG. 4 is a schematic diagram showing the structure of a third embodiment of the blood component separating and storing apparatus of the present invention.

FIG. 5 is a schematic view showing the structure of the fourth embodiment of the blood component separating and storing apparatus of the present invention, showing the state before welding the liquid feeding pipe.

FIG. 6 is an overall perspective view showing a structure of connecting means.

FIG. 7 is a perspective view showing a connection procedure of the liquid feed pipes by the connecting means, showing a state in which two liquid feed pipes are set.

FIG. 8 is a perspective view showing a connection procedure of the liquid feed pipe by the connecting means, showing a state in which the liquid feed pipe is cut.

FIG. 9 is a perspective view showing a connection procedure of the liquid supply pipe by the connecting means, showing a state in which the liquid supply pipe to be connected is moved to a connection position.

FIG. 10 is a perspective view showing a connection procedure of the liquid feed pipe by the connecting means, showing a state in which the liquid feed pipe is connected.

FIG. 11 is a schematic view showing the structure of the fourth embodiment of the blood component separating and storing apparatus of the present invention, showing a state in which the liquid supply pipe of the blood collecting means is welded.

FIG. 12 is a schematic view showing the structure of the fourth embodiment of the blood component separating and storing apparatus of the present invention, showing a state in which the blood collecting means and the plasma storing means are cut off and the liquid feeding pipe of the blood cell preservation solution supplying means is welded. It is shown.

[Explanation of symbols]

1 Blood component separation storage device 2 Blood sampling means 21 Blood collection needle 22 Blood storage container 221 First connection part 23 blood vessels 3 Blood component separation means 31 Plasma Separator 32 Blood inlet 33 Blood outlet 34 Plasma outlet 4 Blood cell preservation solution supply means 41 bags 411 sixth connection 5 Blood cell preservation means 51 bags 511 7th connection part 6 Plasma storage means 61 plasma bag 611 Eighth connection part 71 Liquid transfer pipe 71a-d Liquid transfer pipe 711 Second connection part 712 Third connection part 72 Liquid transfer pipe 721 Fourth connection part 73 Liquid transfer pipe 731 Fifth connection part 8 sealing means 81 cylinder 82 sealing member 83 fracture 84 Closed end (solid column) 85 Flat protrusion 9 Connection means 91 holder 911 holder piece 912 Holder piece 92 wafers 921 Holder piece 922 Holder piece 93 wafer 931 blade 941 groove 942 groove 951 tube holder 952 tube holder

Claims (4)

[Claims] 1. A blood collecting means for collecting blood, a blood component separating means connected to the blood collecting means for separating the blood collected by the blood collecting means into plasma and concentrated blood cell fluid, and the blood component separating means. Plasma storage means and blood cell storage means connected to each other for storing plasma and concentrated blood cell fluid separated by the blood component separation means; and a blood cell storage solution is supplied to the blood cell storage means via the blood component separation means. An apparatus for separating and storing blood components, comprising a blood cell preservation solution supply means and a solution delivery means connecting the respective means. 2. The blood component separation / preservation apparatus according to claim 1, wherein a leukocyte removal filter is arranged on the liquid feeding means that connects the blood component separation means and the blood cell storage means. 3. A detachable connecting portion is provided between the blood component separating means and the blood collecting means, blood cell storing means, plasma storing means and blood cell storing solution supplying means, and the connecting portion is connected via the connecting portion. The blood component separating and storing apparatus according to claim 1 or 2, which is blood. 4. A thermoplastic tube having a sealed connection end is provided as a liquid feeding means in each of the means, and the thermoplastic tube is in a state capable of feeding blood during use in a sterile state by the connecting means. The blood component separation storage device according to claim 1 or 2, which is welded to.