JP2000051347A - Filter unit and usage therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a filter unit for transfusion which is capable of efficiently recovering blood or infusion remaining in the unit by using air outside the unit at the end of filtering, and excellent in operability. SOLUTION: This filter unit includes a piercing needle 1 which has a first passage and a second passage independent of each other in the interior thereof and has a gas-liquid separating filter installed in the second passage to intercept the second passage, a first conduit 11, a filter device 2 formed by at least an upstream space, a filter material and a downstream space, a second conduit 12, and a by-pass pipe 13. After the end of transfusion(infusion), the air outside the unit is passed through the gas-liquid separating filter 3, the second passage of the piercing needle 1, a blood (transfusion) container, the first passage and the first conduit, or further through the by-pass pipe 13 to be introduced into the filter device, thereby discharging the blood (transfusion) from the second conduit.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a filter unit used for treating blood or infusion and a method for using the same.

[0002]

2. Description of the Related Art In recent years, due to advances in medicine, especially in immunology,
Infusing blood or infusions suitable for therapeutic purposes into patients has provided tremendous healing effects. The blood or infusion to be infused is generally processed using a filter unit having a filter device such as a leukocyte removal filter, a micro-agglutination removal filter, and a particle removal filter in order to prevent side effects on the patient. I have.

Hereinafter, a blood filter unit conventionally used for blood transfusion will be described as an example. The blood filter unit is used by connecting blood circuits above and below the blood filter, and is mainly a bedside type that directly transfuses blood into patients,
There are laboratory types prepared at blood centers. In the bedside type, a puncture needle for connecting to a container (formulation bag) containing blood is connected by a blood circuit on the upstream side of the blood filter, and a drip chamber (drip tube) and A connection adapter for connecting a blood transfusion needle is connected by a blood circuit. In the laboratory type, a puncture needle for connecting to a container (formulation bag) containing blood is connected by a blood circuit upstream of the blood filter, and a container for storing processed blood downstream of the blood filter. (Formulation bag) and the like are connected by a blood circuit.

[0004] However, since the blood filter is a filter using a non-woven fabric made of very fine fibers or a porous material having a small pore size, it becomes very difficult for gas to pass through once the filter material is wetted with blood or an infusion solution. Has properties.

[0005] For this reason, blood effective for patient treatment remains in the blood filter unit at the end of the filtration process unless a collection operation is performed, and thus requires a medical worker to perform a complicated collection operation. There were drawbacks. There is a need for an improvement that simplifies the operation of processing blood using a blood filter unit.

As a method of recovering blood remaining in the blood filter unit, there is a method in which a physiological solution such as a physiological saline solution is flown from the upstream side of the blood filter to replace the blood, and the blood is recovered. The risk of bacterial contamination when connecting the puncture needle to the container containing the blood to be used may be increased once more when the puncture needle is connected to the saline solution bottle, and complicated collection operations may be required. You will have to ask your healthcare professional.

Further, there is a method in which a sterilizing filter capable of entering and exiting a gas is installed in a blood filter or a blood circuit, and air in the atmosphere is introduced into the blood filter unit and collected. Although it is possible to collect blood downstream from the place where the filter is installed, it is possible to collect blood remaining upstream in the place where the disinfecting filter is installed and in the container containing blood in advance. This may be impossible or require a complicated recovery operation from the medical staff.

[0008]

SUMMARY OF THE INVENTION An object of the present invention is to overcome the above-mentioned drawbacks of the prior art, and to provide a filter unit for treating blood or infusion, which processes blood or infusion and retains blood remaining in the filter unit. Another object of the present invention is to provide a filter unit that can easily perform operations of discharging and collecting an infusion solution and has excellent operability.

[0009]

Means for Solving the Problems The present inventor has conducted intensive studies to solve the above-mentioned problems. As a result, as shown in the schematic diagram of FIG. 1, in place of the conventional puncture needle, there are two mutually independent first and second flow paths inside, and the second flow path Gas-liquid separation filter that allows gas to pass through but not liquid (hereinafter referred to as gas-liquid separation filter) (3)
Puncture needle (1) installed in such a way as to block the second flow passage,
A first conduit (11) connected to the downstream end of the first flow passage of the puncture needle, connected to the downstream end of the first conduit, at least from the upstream space, the filter material, and the downstream space. Filter device (2), one end of the first conduit (1
By using a bypass pipe (13) connected to 1) and the other end connected to the downstream space of the filter device (2),
The present inventors have found that blood or infusion solution remaining in the filter unit can be efficiently discharged out of the unit and recovered by a simple operation at the end of the filtration process, and have completed the present invention.

That is, the present invention is a filter unit comprising at least the following A) to E) as shown in FIG. A) Two independent passages, a first passage and a second passage, are provided inside, and a gas-liquid separation filter is provided in the second passage.
(3) is a puncture needle installed so as to block the second flow passage
(1) (see FIG. 3); B) a first conduit (11) connected to the downstream end of the first flow passage of the puncture needle; C) connected to the downstream end of the first conduit; A filter device (2) comprising at least an upstream space, a filter material and a downstream space, D) a second conduit connected to the downstream end of the filter device
(12), E) A bypass pipe (13) having one end connected to the first conduit (11) and the other end connected to a space downstream of the filter device (2).

In the present invention, the gas-liquid separation filter (3) may be a filter unit having a disinfecting action.

Further, according to the present invention, as shown in FIG. 6, a drip chamber (14) is connected in the middle of the second conduit (12),
The downstream end of the upstream second conduit penetrates into the upper space of the drip chamber and has an open nozzle (21) (FIG. 7).
The downstream outlet of the drip chamber and the upstream end of the second downstream conduit are connected, and one end is open to the outside of the drip chamber, and the other end is inside the drip chamber space. A filter unit having a flow passage (22) opened downstream of the nozzle (21), and a gas-liquid separation filter (23) installed so as to block the flow passage.

Further, the present invention provides at least the following A) to D)
A) communicating the puncture needle (1) in a liquid-tight manner with the container containing blood or infusion, and B) passing the blood or infusion in the container through the first flow passage of the puncture needle (1). C) The air outside the filter unit is passed through the gas-liquid separation filter (3) and the second needle (1) of the puncture needle (1). Through the flow path, the communicating container, the first flow path of the puncture needle (1), and the first conduit (11), the liquid is introduced into the space on the upstream side of the filter device (2). Allowing the remaining blood or infusion to flow down in the direction of the second conduit (12), D) or / and air outside the filter unit,
Gas-liquid separation filter (3), second flow path for puncture needle (1),
The above-mentioned communicating container, the first flow passage of the puncture needle (1), the first conduit (11), the bypass pipe (13), the filter device (2)
Blood or infusion remaining on the downstream side of the filter device by being introduced into the downstream space of the filter device is discharged from the second conduit (12). Is the way.

The puncture needle used in the present invention has at least two mutually independent first flow passages and second flow passages therein, and allows gas to pass through but liquid to pass through the second flow passage. A container for blood or infusion (formulation bag), with no gas-liquid separation filter installed blocking the second flow path
Is a double-structured puncture needle for fluid-tight communication with the puncture needle. With this puncture needle, blood or infusion in the container is introduced into the filter unit, and air for collecting blood or infusion remaining in the container and the filter unit is introduced from the gas-liquid separation filter at the end of the filtration process. Is what makes it possible. For example, a plastic double needle, a metal double needle, or the like can be used.

[0015] In the two independent first and second flow paths of the double puncture needle, a puncture portion in the container for efficiently collecting the remaining blood or infusion solution at the end of the filtration process. It is preferable to devise the size, position, shape, etc. of the opening.

For example, when a puncture needle is connected in a liquid-tight manner to a container containing blood to be transfused, an opening suitable for collecting blood from the blood container is provided below the puncture portion in the blood container. A second flow passage with a large first flow passage and a small opening above the puncture portion in the blood container, suitable for introducing air into the container without entraining the air in the first flow passage It is preferable to arrange a road.

FIG. 3 is a longitudinal sectional view showing an example of a preferred embodiment of the puncture needle. The puncture needle of FIG. 3 has a first flow path (31) and a second flow path (32) that are independent of each other, and allows the puncture needle to communicate in a liquid-tight manner with a container containing blood or infusion to be transfused. When the puncture part (33) of the puncture needle punctured in the container, the position of the opening (31a) of the first flow passage is lower than the position of the opening (32a) of the second flow passage. By setting the cross-sectional area of the opening (31a) of the first flow passage to be larger than the cross-sectional area of the opening (32a) of the second flow passage, during the collection operation at the end of the filtration process, The air introduced in the direction of the container can be discharged in the direction of the first conduit so as not to be caught in the collected blood or infusion, and the remaining blood or infusion can be efficiently collected. it can.

FIG. 3 shows an example of a preferred embodiment of the internal structure of the puncture needle used in the present invention. However, the present invention is not limited to this example. It is preferable to devise the size, position, shape, and the like of the opening of the punctured portion so that air is not involved in blood or infusion discharged from the flow passage.

A gas-liquid separation filter installed in such a manner as to block the second flow passage of the puncture needle enables a selective flow of gas, such as a hydrophobic filter, and does not allow blood or infusion to pass therethrough. This makes it possible to introduce air outside the filter unit into the filter unit. The material of the filter exhibiting hydrophobicity is not particularly limited, but polytetrafluoroethylene (PTFE), polyvinylidene difluoride (PVDF) and the like are preferably used. Further, it is preferable that this filter has a sterilization function. In general, a filter having a nominal pore size of 0.45 μm or less, preferably a nominal pore size of 0.22 μm or less is said to have a disinfecting effect.
A commercially available filter having a size of 0.22 μm or less can be suitably used as the filter of the present invention.

The first conduit, the second conduit, and the bypass pipe of the present invention are hollow pipes for connecting parts in a liquid-tight manner and for flowing gas and / or liquid, and are flexible tubes. Is preferred. In addition, a flow path closing device such as a clamp, a roller clamp with a flow regulator, forceps, a communication piece, etc., and a safety valve such as a check valve (check valve) or a hydrophobic filter should be installed in this part according to the purpose of use. Can be.

The filter device of the present invention includes a leukocyte removal filter, a microaggregate removal filter, a particulate removal filter, and the like, and includes at least an upstream space, a filter material, and a downstream space. The leukocyte removal filter is a filter device that selectively captures only white blood cells or white blood cells and platelets in blood, but hardly captures other blood components. The micro-aggregate removal filter is a filter device for removing micro-aggregates present in blood. The fine particle removal filter is a filter device for removing fine particles present in an infusion.

As the main filter material of the filter device, a well-known filter material made of a fibrous substance, a porous substance, a particulate substance, a microporous membrane, or the like can be used. In addition, any of a hydrophilic material and a hydrophobic material can be used.

As the leukocyte removal filter, a filter made of a fibrous substance or a porous substance is preferable because of its high efficiency of capturing leukocytes. As the form of the fibrous substance, any of a woven form, a nonwoven form, and a cotton form can be used, but a nonwoven form is particularly preferable from the viewpoint of blood permeability and leukocyte removal efficiency.

A preferred example of the above leukocyte removal filter device is one in which a nonwoven fabric is filled in a container as a main material of the filter. Fiber diameter is 0.3 μm
~ 20μm is used.
Synthetic fibers, semi-synthetic fibers such as regenerated cellulose, natural fibers such as cotton, and inorganic fibers are used. Among them, synthetic fibers such as polyester, nylon, polypropylene,
Fibers such as polyacrylonitrile are preferred.

Further, the surface of the nonwoven fabric can be coated with a low platelet-capturing polymer so as to suppress the capture of platelets and to selectively capture only white blood cells. Examples of such a coating material include a polymer material having a basic nitrogen-containing functional group, such as a copolymer of diethylaminoethyl (meth) acrylate and hydroxyethyl (meth) acrylate.

A preferred example of the filter device for removing micro-agglomerates is a device in which woven fabric or mesh is filled in a container as a main material of the filter. Fibers having a diameter of about 1 μm to 100 μm are used, and synthetic fibers, semi-synthetic fibers such as regenerated cellulose, natural fibers such as cotton, and inorganic fibers are used as fiber materials.
Among them, synthetic fibers such as fibers of polyester, nylon, polypropylene, polyacrylonitrile and the like are preferably used.

A preferred example of the filter device for removing fine particles is a filter in which a hydrophilic microporous membrane of about 0.22 μm to 0.45 μm is filled in a container as a main material of the filter.

Next, the filter unit of the present invention and a method for treating blood using the same will be described in more detail with reference to the drawings. FIG. 2 is a schematic diagram showing an example of the embodiment of the present invention. In the example of FIG. 2, the first conduit (11), the second conduit (12), and the bypass pipe (13) are respectively provided with flow path closing devices.
(5), (6) and (7) are provided so that they can be opened and closed as required. Further, a safety valve (9) is provided in the bypass pipe (13) to prevent blood not yet treated with the blood filter from entering the downstream side.

The flow path closing device (6) is preferably a roller clamp with a flow path adjuster for adjusting the infusion rate to the patient. Any clamps can be used for the channel closing devices (5) and (7). The safety valve (9) is desirably a hydrophobic filter that does not allow blood to pass through and allows the selective flow of gas in order to prevent unfiltered blood from entering the patient.

First, the flow of the gas-liquid separation filter (3) installed so as to block the second flow passage of the puncture needle is closed,
The clamps (5), (6) and (7) are closed, and the puncture needle (1) is pierced into the container containing the blood to be treated to establish a fluid-tight communication.

Next, a clamp (5) and a roller clamp
(6) is opened, and a small amount of blood is introduced into the first conduit (11) through the first flow passage of the puncture needle (1), thereby causing a gravitational drop of blood in the filter unit. Due to this head, blood flows downstream in the order of the first conduit (11) and the filter device (2). Blood is processed by passing through the filter device (2).

Further, the blood flows down to the second conduit (12) and is introduced into a drip chamber (drip tube) (4) connected in the middle of the second conduit (12). 4) upside down, 1/1 of the drip chamber
After filling the blood to 3 to 1/2, drip chamber (4)
To its original state.

A drip chamber is a container having a space in which gas and liquid can be stored, and is usually cylindrical, and after storing 1/3 to 1/2 amount of blood or infusion in this container. , Refers to a structure in which blood or infusion drops in a drip form from a drip nozzle provided on the upper surface when blood or infusion flows, and adjusts the infusion rate (processing speed) by the amount of blood or infusion dropped. It is used as a guide and is intended to prevent air from entering the veins of the patient, and is preferably connected in a liquid-tight manner in the middle of the second conduit (12). The drip nozzle is located at the upper part of the drip chamber and is for dropping blood or infusion from the nozzle.

The drip chamber used in the present invention includes the following. A flow passage different from the second conduit is connected to the drip chamber in a liquid-tight manner, and one end of the flow passage is located downstream of the chamber from the drip nozzle, and passes blood or infusion into the drip chamber cylinder. It is opened at a position where it can be stored in 1/3 to 1/2 volume, the other end is opened outside the drip chamber, and has a gas-liquid separation filter installed so as to block the flow passage. is there. By using this drip chamber, blood or infusion is stored in a 1/3 to 1/2 volume in the drip chamber cylinder without turning the drip chamber upside down as has been done in the past, and Until it flows into the flow passage and reaches the gas-liquid separation filter provided in the middle of the flow passage and stops,
It enables the air inside the filter unit to be discharged out of the drip chamber.

FIGS. 7 and 8 are longitudinal sectional views showing a preferred embodiment of the drip chamber. FIG. 7 shows the nozzle (21).
8 and the flow passage (22) have a shape that penetrates and opens from the upper part of the drip chamber into the chamber space.
Has a shape in which the flow passage (22) is open to the side surface of the chamber space. 7 and 8, the open end of the flow passage (22) in the drip chamber cylinder is located downstream of the open end of the drip nozzle (21), and 1 / It is in a position to store blood or infusion in 3 to 1/2 volume. Not limited to FIGS. 7 and 8,
Blood or infusion liquid dripping from the drip nozzle (21) in a drop-like manner touches the flow passage (22) in the drip chamber and the amount of dripping cannot be determined, and as a result, the blood transfusion rate cannot be adjusted. In order to prevent the generation of the water, it is preferable to devise the size, relative position, shape, etc. of the nozzle (21) and the flow passage (22) in the drip chamber.

A gas-liquid separation filter installed so as to block the flow passage of the drip chamber enables a gas to selectively flow, for example, a hydrophobic filter, and does not allow blood or infusion to pass through the filter unit. This allows the air in the container and the filter unit to be exhausted. The material of the filter exhibiting hydrophobicity is not particularly limited, but polytetrafluoroethylene (PTFE), polyvinylidene difluoride (PVDF) and the like are preferably used. Further, it is preferable that the filter has a filter sterilization function. Generally, the nominal pore size is 0.45μm or less,
Preferably, a filter having a nominal pore size of 0.22 μm or less is said to have a disinfecting effect. Therefore, a commercially available filter having a hydrophobic pore size of 0.22 μm or less can be suitably used as the filter of the present invention.

A connection adapter (8) is attached to the downstream (patient side) end of the second conduit (12), and blood is connected to the connection adapter.
When you reach (8), close the roller clamp (6), attach the transfusion needle to the connection adapter, and complete the preparation for transfusion.

The connection adapter is an adapter for connecting a blood transfusion injection needle used at the time of blood transfusion, and it is preferable to use a commonly used one such as a luer lock type connector or an octopus tube. Further, a blood transfusion needle can be connected to the connection adapter (8).

Open the roller clamp (6), fill the blood to the tip of the transfusion injection needle with blood, close the roller clamp (6), puncture the transfusion needle into the patient's vein, and open the roller clamp (6) little by little. Adjust the transfusion rate while counting the drops from the drip nozzle in the drip chamber. The blood thus processed in the blood filter unit is transfused into the patient.

After the blood to be transfused in the container flows down into the blood filter unit and the blood in the container almost disappears, the gas-liquid installed in the form of blocking the second flow passage of the puncture needle (1) The circulation of the separation filter (3) is released, and the air outside the filter unit is released by the filter (3), the puncture needle.
By introducing the second flow path of (1), the container, the first flow path of the puncture needle (1), the first conduit (11), and the upstream space of the blood filter device (2) in this order, the container The blood remaining inside the filter unit and in the filter unit on the upstream side of the filter device (2) can flow down in the direction of the second conduit on the downstream side.

Further, by opening the clamp (7) and introducing air into the space downstream of the filter device (2) through the bypass pipe (13), the blood remaining on the downstream side of the filter device (2) is reduced. (Patient side) Blood can flow down in the direction of the terminal, and blood can be transfused without wastefully remaining in the blood filter unit.

Further, as a filter unit which does not directly administer blood to the patient, a storage device (10) can be attached to the downstream end of the second conduit (12) as shown in FIG. The storage device is, for example, a blood container, a flexible container having a space capable of storing gas and liquid, and stores the blood processed by the filter device (2). It is preferable to connect to the downstream end of (12) in a liquid-tight manner.

[0043]

Next, the present invention will be described in more detail and concretely with reference to examples.

[0044]

Example 1 The components of the filter unit shown in FIG. 2 were prepared in the following sizes. The puncture needle (1)
Needle outer diameter 5.6 mm, cross-sectional area of opening (31a) of first flow passage (31) 3.5 mm ² , cross-sectional area of opening (32a) of second flow passage (32) 1.
0 mm ² , gas-liquid separation filter (3) is a commercially available hydrophobic filter, the first conduit (11) is a polyvinyl chloride tube with an inner diameter of 2.9 mm, length 300 mm, and the filter device (2) is a commercially available filter Sepacell RZ20 (made by Asahi Medical Co., Ltd.) with a new circulation port in the upper part of the downstream space, the drip chamber (4) is a polyvinyl chloride cylinder with an inner diameter of φ18 mm,
Length (inside dimension) 60mm, second conduit (12) is 2.9mm id polyvinyl chloride tube, 1200mm long, bypass pipe
(13) is a 2.9 mm ID polyvinyl chloride tube, 150 mm long, safety valve (9) is a commercially available hydrophobic filter, closing devices (5) and (7) are commercially available clamps and closing devices
(6) is a commercially available roller clamp with a flow controller, and the connection adapter (8) was assembled using a commercially available luer-lock type connector according to FIG. 2, inserted into a sterilization bag, and sterilized with ethylene oxide gas. .

The gas-liquid separation filter (3) installed in the second flow passage of the puncture needle (1) of the sterilized filter unit shown in FIG. 2 is closed, and clamps (5), (6) , And (7) were closed, and the puncture needle (1) was punctured into a container containing 300 ml of blood to communicate in a liquid-tight manner. Hang the blood container and the filter unit on the Irrigator table, open the clamp (5) and the roller clamp (6), and transfer a small amount of blood to the first conduit (1) through the first flow passage of the puncture needle (1). The introduction caused a gravity drop of blood in the filter unit. Due to this head, the blood flows down in the order of the first conduit (11), the blood filter device (2), and the blood flows in the filter device (2).
And filtered.

Further, the blood flowed down to the second conduit (12). At this time, only the drip chamber (drip tube) (4) connected in the middle of the second conduit (12) was inverted, and the drip was performed. After storing the blood to 1/2 (6 ml) in the chamber (4), the direction of the drip chamber (4) is returned to the original state, and the subsequent second conduit (12) is filled with blood, and the roller clamp ( 6) was closed.

A commercially available injection needle for blood transfusion was connected to the connection adapter (8), and the roller clamp (6) was adjusted to send blood out of the filter unit at 5 ml / min (ie, the state of transfusion to the patient). After all the blood in the container has flowed into the filter unit, the gas-liquid separation filter (3) installed in the second flow passage of the puncture needle (1) is opened, and the air outside the filter unit is punctured with the puncture needle (1). 1) through the second flow path, the container, the first flow path of the puncture needle (1), the first conduit (1)
1), the blood remaining on the upstream side of the blood filter device (2) flows down from the inside of the container toward the second conduit (12) on the downstream side by being introduced in the order of the upstream space of the filter device (2). I let it.

After the blood remaining on the upstream side of the blood filter device (2) flows down, the clamp (7) is opened,
The air outside the filter unit introduced from the gas-liquid separation filter (3) installed in the second flow path of the puncture needle (1) is used for the second flow path, container, and puncture needle (1) of the puncture needle (1). Through a first flow passage, a first conduit (11), a bypass pipe (13), a space downstream of the filter device (2), and a second conduit (12) in this order, whereby the filter device ( The blood remaining downstream of 2) was drained down the downstream end of the second conduit (12). Perform the above steps in this order, 300ml
As a result of processing the blood, the residual blood was 198 ml.

[0049]

Embodiment 2 The components of the filter unit shown in FIG. 6 were prepared in the following sizes. The puncture needle (1)
Needle outer diameter 5.6 mm, cross-sectional area of opening (31a) of first flow passage (31) 3.5 mm2, cross-sectional area of opening (32a) of second flow passage (32)
1.0 mm ² , the gas-liquid separation filter (3) is a commercially available hydrophobic filter, the first conduit (11) is a polyvinyl chloride tube with an inner diameter of 2.9 mm, a length of 300 mm, and the filter device (2) is
A new circulation port is provided above the downstream space of the commercially available Sepacell RZ200 (manufactured by Asahi Medical Co., Ltd.). Nozzle (21) in the drip chamber space is a small tube of 3.0mm in outer diameter, 1.8mm in inner diameter, 12mm in length (from the upper part of the drip chamber space), and the flow passage (22) in the drip chamber space is outside. Diameter 3.0mm, inside diameter 1.8mm,
The length (from the upper part of the space of the drip chamber) 30 mm polyvinyl chloride tube, the gas-liquid separation filter (23) provided in the middle of the flow passage is a commercially available hydrophobic filter, the second conduit (12) is 2.9 mm id polyvinyl chloride tube, 1200 mm long, bypass pipe (13) is a 2.9 mm id polyvinyl chloride tube, 150 mm length, safety valve (9)
Commercially available hydrophobic filters, closing devices (5), (7) and (16)
Is a commercially available clamp, a closing device (6) is a commercially available roller clamp with a flow regulator, and a connection adapter (8) is assembled using a commercially available luer lock connector according to FIG. 6 and inserted into a sterilization bag. , And ethylene oxide gas sterilization.

The gas-liquid separation filter (3) installed in the second passage of the puncture needle (1) of the filter unit shown in FIG. 6 which has been sterilized is closed, and the clamps (5) and (6) are closed. ,
(7) and (16) were closed, and the puncture needle (1) was punctured into a container containing 300 ml of blood to communicate in a liquid-tight manner, and the container with blood and the filter unit were hung on an illrigger table.

The clamps (5) and (16) are opened, and the puncture needle (1)
A small amount of blood was introduced into the first conduit (11) through the first flow passage of, causing a gravitational drop of blood in the blood filter unit. This head causes blood to flow into the first conduit
(11), the filter device (2), the second conduit (12), and the drip chamber (14). At the same time, the air sealed in the filter unit is pushed by the movement of the blood, and the first conduit (11), the filter device (2), the second conduit (12), the drip chamber (14), the flow passage It moved to (22) and the filter (23) in order, and was discharged out of the filter unit. The blood was filtered by passing through the filter device (2).

The blood introduced into the filter unit fills the lower half (6 ml) in the drip chamber cylinder, and then flows into the flow passage (22), where the gas-liquid separation filter (23) in the flow passage. Reached and stopped. After confirming that the blood flow had stopped, the clamp (16) was closed. The roller clamp (6) was then opened, the second conduit (12) was filled with blood, and the roller clamp (6) was closed.

A commercially available injection needle for blood transfusion was connected to the connection adapter (8), and the blood was pumped out of the blood filter unit at 5 ml / min by adjusting the roller clamp (6) (that is, the state of transfusion to the patient). After all the blood in the container has flowed into the filter unit, the gas-liquid separation filter (3) installed in the second flow passage of the puncture needle (1) is opened, and the air outside the filter unit is punctured with the puncture needle (1). The container is introduced through the second flow path of 1), the container, and the first flow path of the puncture needle (1), the first conduit (11), and the upstream space of the filter device (2) in this order. The blood remaining on the upstream side of the filter device (2) from inside was flowed down toward the second conduit (12) on the downstream side.

After the blood remaining on the upstream side of the filter device (2) flows down, the clamp (7) is opened, and the gas-liquid separation filter set in the second passage of the puncture needle (1) is opened.
The air outside the filter unit introduced from (3) is bypassed through the second flow path of the puncture needle (1), the container, the first flow path of the puncture needle (1), and the first conduit (11). By introducing the pipe (13), the space downstream of the filter device (2), and the second conduit (12) including the drip chamber (14) in this order, blood remaining on the downstream side of the filter device (2) is removed. Second conduit (12)
And discharged in the direction of the downstream end. The above steps were performed in this order, and 300 ml of blood was processed. As a result, the residual blood was 20.5 ml.

[0055]

COMPARATIVE EXAMPLE As a comparative example, a leukocyte-removing blood transfusion unit shown in FIG. 5 was prepared as an example of a conventional filter unit using a puncture needle without a bypass tube and a single flow passage as in the present invention. . The puncture needle (1) is a commercially available plastic spike needle, the first conduit (11) is a 2.9 mm inner diameter polyvinyl chloride tube, 300 mm long, and the filter device (2) is a commercially available Sepacell RZ200 ( Asahi Medical Co., Ltd.
The drip chamber (4) is a cylindrical polyvinyl chloride tube with an inner diameter of φ18 mm and a length (inner dimension) of 60 mm, and the second conduit (12) is a polyvinyl chloride tube with an inner diameter of 2.9 mm. The closing device (5) uses a commercially available clamp, the closing device (6) uses a commercially available roller clamp with a flow regulator, and the connection adapter (8) uses a commercially available luer lock type connector. Assembled according to FIG. 5, inserted into a sterilization bag, and sterilized with ethylene oxide gas.

The clamps (5) and (6) of the sterilized filter unit are closed, the puncture needle (1) is punctured into a container containing 300 ml of blood, and the container is irrigated with the blood container and the filter unit. Hanged on a girdle stand. Then clamp
(5) and the roller clamp (6) were opened, and a small amount of blood was introduced into the first conduit (11) through the puncture needle (1), thereby causing a gravitational drop of blood in the filter unit. Due to this head, the blood flows into the first conduit (11), the blood filter device.
(2) The blood flowed down in this order, and the blood was filtered by passing through the filter device (2).

Further, the blood flows down to the second conduit (12). At this time, only the drip chamber (drip tube) (4) connected in the middle of the second conduit (12) is inverted, and the drip is performed. After storing the blood to 1/2 (6 ml) in the chamber (4), the direction of the drip chamber (4) is returned to the original state, and the subsequent second conduit (12) is filled with blood, and the roller clamp ( 6) was closed.

A commercially available injection needle for blood transfusion was connected to the connection adapter (8), and the blood was pumped out of the blood filter unit at 5 ml / min by adjusting the roller clamp (6) (ie, the state of transfusion to the patient). When all the blood in the container flowed down into the filter unit, the blood flow stopped with the blood remaining in the filter unit. These steps were performed in this order, and as a result of processing 300 ml of blood, the residual blood in the filter unit was 58.3 ml.

[0059]

By using the filter unit of the present invention, at the end of the filtration process, the blood or infusion remaining in the filter unit is discharged out of the filter unit by a simple operation using the air outside the filter unit, Since the blood or the infusion solution can be collected, wasteful disposal of the treated blood or the infusion solution is significantly reduced, and more valuable blood or the infusion solution can be recovered than before.

[Brief description of the drawings]

FIG. 1 is a schematic diagram showing a basic configuration of a blood filter unit of the present invention.

FIG. 2 is a schematic view showing one example of a blood filter unit of the present invention.

FIG. 3 is a longitudinal sectional view showing an example of a preferred embodiment of the puncture needle of the present invention.

FIG. 4 is a schematic view showing another example of the blood filter unit of the present invention.

FIG. 5 is a schematic view showing an example of a conventional blood filter unit.

FIG. 6 is a schematic view showing another example of the blood filter unit of the present invention.

FIG. 7 is a longitudinal sectional view showing an example of a preferred embodiment of a drip chamber used in the present invention.

FIG. 8 is a longitudinal sectional view showing another example of the drip chamber used in the present invention.

FIG. 9 is a longitudinal sectional view showing an example of a preferred embodiment of the filter device of the present invention.

[Explanation of symbols]

1: puncture needle 2: filter device 3: gas-liquid separation filter 4: drip chamber 5: closing device 6: closing device (roller clamp with flow regulator) 7: closing device 8: connection adapter 9: safety valve 10: storage device 11: first conduit 12: second conduit 13: bypass pipe 14: drip chamber 16: closing device 21: nozzle 22: flow passage 23: gas-liquid separation filter 31: first flow passage 31a: opening 31b: Opening 32: Second flow passage 32a: Opening 32b: Opening 33: Punctured part 41: Upstream space 42: Downstream space 43: Filter material

Claims (4)

[Claims] 1. A filter unit comprising at least the following A) to E); A) a second flow passage having two independent first and second flow passages inside the filter unit A gas-liquid separation filter (3) that allows gas to pass through but does not allow liquid to pass through the puncture needle (1), B) installed in a manner to block the second flow path, downstream of the first flow path of the puncture needle A first conduit (11) connected to the end, C) a filter device (2) connected to the downstream end of the first conduit and comprising at least an upstream space, a filter material, and a downstream space; D) a second conduit connected to the downstream end of the filter device
(12), E) A bypass pipe (13) having one end connected to the first conduit (11) and the other end connected to a space downstream of the filter device (2). 2. The filter unit according to claim 1, wherein the gas-liquid separation filter has a disinfecting action. 3. A drip chamber is connected in the middle of the second conduit (12), and the downstream end of the upstream second conduit penetrates into the upper space of the drip chamber and has an open nozzle ( 21), the downstream outlet of the drip chamber and the upstream end of the downstream second conduit are connected, and one end is open to the outside of the drip chamber, and the other end is inside the drip chamber space. A gas-liquid separation filter (23) that has a flow passage (22) that is open on the downstream side of the nozzle (21), and that allows gas to pass but does not pass liquid in a form that blocks the flow passage is provided. The filter unit according to claim 1. 4. The method for treating blood or infusion using the filter unit according to claim 1, wherein at least the following steps A) to D) are performed in this order: A) Puncture needle (1) B) the blood or the infusion in the container in a liquid-tight manner through a first flow passage of the puncture needle (1), a first conduit (11), a filter device (2). ) And the second conduit (12) in order, C) a gas-liquid separation filter (3) that passes gas but not liquid outside the filter unit, and a second passage for the puncture needle (1). After passing through the communicating container, the first passage of the puncture needle (1), and the first conduit (11), it is introduced into the space on the upstream side of the filter device (2), thereby remaining on the upstream side of the filter device. D) or / and air outside said filter unit, causing blood or infusion to flow down in the direction of the second conduit (12) ,
Gas-liquid separation filter (3) that allows gas to pass but not liquid
Second flow path of puncture needle (1), said communicating container, puncture needle
(1) first flow passage, first conduit (11), bypass pipe (13)
After that, the blood or the infusion remaining on the downstream side of the filter device is discharged from the second conduit (12) by being introduced into the space downstream of the filter device (2).