WO2023048137A1

WO2023048137A1 - Collection kit

Info

Publication number: WO2023048137A1
Application number: PCT/JP2022/034972
Authority: WO
Inventors: 佐々木道弘
Original assignee: テルモ株式会社
Priority date: 2021-09-27
Filing date: 2022-09-20
Publication date: 2023-03-30

Abstract

A collection kit (10) comprises a first tube line (22) that can be connected to a platelet bag (90), a second tube line (24) that is connected to a reservoir vessel (12), a third tube line (28) that is connected to a holder (14), and a second branching joint (32) connecting the first through third tube lines (22, 24, 28). At least a part of the reservoir vessel (12) elastically deforms between a contracted state and an original state, thereby causing the reservoir vessel (12) to draw in a platelet preparation through the first tube line (22) and second tube line (24).

Description

collection kit

The present invention relates to a collection kit for collecting blood products for testing.

Blood products include red blood cell products, plasma products, platelet products, and whole blood products. Blood products containing components required by patients are used for blood transfusion. Blood products are stored and transported in medical bags. Culture tests may be performed to ensure the safety of blood products. A culture test detects the presence or absence of pathogens by collecting a small amount of sample in a culture bottle and placing the culture bottle in an environment suitable for the growth of bacteria.

Among the blood products, platelet products are tested according to the following procedure. A small-capacity collection bag is connected to a medical bag containing a platelet preparation (hereinafter referred to as a platelet bag). A portion of the platelet product in the platelet bag is then transferred to the collection bag. The collection bag is then separated from the platelet bag.

Next, the collection bag is carried to the clean bench. At the clean bench, the platelet product from the collection bag is injected into the blood culture bottle. Prior to injection, the tubing of the collection bag is connected to tubing extending from the sample collection tube. Using the scale of the sample collection tube as a guide, a specified amount of platelet product is transferred from the collection bag to the sample collection tube.

After that, using the scale of the sample collection tube as a guide, the platelet product is transferred from the sample collection tube to the blood culture bottle in a specified amount. For the culture test, anaerobic culture and aerobic culture are performed. Therefore, platelet preparations are dispensed into culture bottles used for anaerobic culture and culture bottles used for aerobic culture. After that, the blood culture bottle is set in a culture apparatus and subjected to a culture test for a predetermined period.

For example, US Pat. No. 8,777,921 discloses a collection device for collecting samples from medical bags.

From the perspective of further improving the safety of platelet products, culture tests are being considered for the total number of platelet products. Therefore, it is required to improve the working efficiency of culture test of platelet preparations.

However, the conventional testing procedure requires detachment of the collection bag and sample collection tube in the process of dispensing platelet products from the platelet bag to the culture bottle as described above. An aseptic connecting device for aseptically welding or cutting the tubes is used for the detachment work. Multiple attachment/detachment operations using an aseptic joining apparatus require much labor and waiting time. Also, conventional testing procedures leave platelet products inside the tube when the tube is welded or cut. Therefore, the conventional examination procedure has the problem that valuable platelet preparations are wasted.

An object of the present invention is to solve the above problems.

(1) A first aspect of the disclosure below includes a storage container for storing a predetermined amount of platelet preparation, a holder connected to a culture bottle, and a tube line connecting the storage container and the holder, The tubing lines include a first tubing line connectable to a platelet bag containing the platelet product, a second tubing line connected to the storage container, a third tubing line connected to the holder, and the a branch joint connecting one tube line, the second tube line, and the third tube line; and the platelet product is aspirated through the first tube line and the second tube line by changing from the second state to the first state.

The collection kit of item (1) above can reduce the number of times of joining or cutting using an aseptic joining device. Also, the collection kit can reduce the amount of platelet product remaining in the disconnected tube.

(2) In the collection kit described in item (1) above, the storage container may spontaneously change from the second state to the first state by elastic deformation.

The collection kit of item (2) above simplifies the user's operation because the storage container spontaneously aspirates the platelet products.

(3) In the collection kit according to item (1) or (2) above, the storage container may have a dropper structure.

In the collection kit of item (3) above, the storage container can be constructed from inexpensive materials. Therefore, the collection kit can significantly reduce the cost of performing a 100% inspection of the platelet bags.

(4) In the collection kit described in item (3) above, the storage container may have an extendable bellows structure.

In the collection kit of (4) above, since the volume of the storage container changes greatly, the storage container can be made smaller and stored.

(5) The collection kit according to any one of items (1) to (4) above, wherein at least one of the first tube line, the second tube line, and the third tube line has a clamp. may be attached.

The collection kit of item (5) above is excellent in operability because the tube line can be easily occluded.

(6) The collection kit according to any one of items (1) to (5) above, which is connected to the tube line and has an air vent that allows gas to be discharged and prevents passage of liquid. You may

The collection kit in item (6) above makes it easy to remove air from the dropper.

(7) The collection kit according to any one of items (1) to (6) above, which includes a collection bag connected to the first tube line and containing the platelet product in the platelet bag. may

With the collection kit of item (7) above, a specified amount of platelet products can be dispensed into multiple culture bottles by containing platelet products larger than the capacity of the storage container in the collection bag.

(8) In the collection kit according to any one of items (1) to (6) above, a plurality of the storage containers may be connected to the tube line.

With the collection kit in item (8) above, the process is simplified because the platelet product in the platelet bag is collected directly into the dropper. In addition, the collection kit can further reduce the loss of valuable platelet preparations.

(9) In the collection kit described in item (8) above, the plurality of storage containers may be connected from the holder with the same channel length.

With the collection kit of item (9) above, since there is no difference between the upstream and downstream of multiple droppers, there is no need to consider the order of operations according to the position of the dropper, improving operability. In addition, the collection kit can reduce errors in the amount injected into the culture bottle due to the difference between the upstream and downstream sides of the dropper.

As described above, the collection kit from the above viewpoint reduces the labor required for the culture test. In addition, the collection kit of the above aspect suppresses wastage of valuable platelet preparations.

FIG. 1 is a plan view of the collection kit according to the first embodiment. FIG. FIG. 2 is an explanatory view showing a method of collecting a sample from a collection bag using the collection kit of FIG. 1. FIG. FIG. 3 is an explanatory diagram showing a method of transferring a sample to a culture bottle using the collection kit of FIG. 2. FIG. FIG. 4 is a plan view of the collection kit according to the second embodiment. FIG. 5 is a plan view of the collection kit of the third embodiment. FIG. 6 is a plan view of the collection kit according to the fourth embodiment. FIG. 7 is a plan view of the collection kit according to the fifth embodiment.

(First embodiment)
A collection kit 10 according to this embodiment includes a storage container 12, a holder 14, a tube line 16, and a collection bag 18, as shown in FIG.

The collection bag 18 is a medical bag. The collection bag 18 has a structure in which two resin sheets are overlapped and the peripheral edge portion 181 is welded. As the resin constituting the collection bag 18, a flexible material such as vinyl chloride resin can be used. The collection bag 18 has a storage space 182 for storing the collected sample (liquid). Since the collection bag 18 is sufficient if it can contain a small amount of platelet preparation, a small-capacity bag may be used. The capacity of the accommodation space 182 is smaller than that of the platelet bag 90 shown in FIG. A marking line 183 is attached to the outer surface of the collection bag 18 to indicate the amount of liquid collected. The collecting bag 18 can collect a predetermined amount of platelet products when the platelet products are collected up to the marked line 183 with the lower end 184 facing down. Marked line 183 on collection bag 18 indicates a volume of, for example, 20 ml. Collection bag 18 has a port 186 at top end 185 for connecting medical tubing. A collection tube 187 is connected to the port 186 . Collection tube 187 is a tube that fluidly connects tubing line 16 and collection bag 18 .

The storage container 12 is a container that temporarily stores a small amount of platelet products. The storage container 12 of this embodiment is a dropper 20 (pipette). The dropper 20 is an elongated cylindrical member. The dropper 20 has a housing space 203 with a first end 201 and a second end 202 in the longitudinal direction closed. Dropper 20 has a second port 204 for connecting medical tubing to first end 201 . The accommodation space 203 is fluidly connected to the tubing line 16 via the second port 204 . The dropper 20 is made of a soft, transparent or translucent resin material such as low-density polyethylene resin, for example. When the side of the syringe 20 is pressed, the syringe 20 is easily crushed and deformed into the second state. When the pressure is released, the dropper 20 spontaneously changes to the first state having the original cylindrical shape by elastic deformation. The dropper 20 changes its internal volume when changing from the second state to the first state. At that time, the dropper 20 can generate negative pressure and suck the liquid into the housing space 203 .

The dropper 20 has a marked line 205 on the side so that a specified amount of platelet preparation can be measured. Marked line 205 indicates a volume of, for example, 8 ml. When liquid is stored in the storage space 203 with the second end 202 of the dropper 20 facing downward, by aligning the liquid surface with the marked line 205, a volume of 8 ml of liquid can be measured. The dropper 20 is formed in an appropriate size according to the amount of sample required for inspection. Also, the position of the marked line 205 can be appropriately set according to the specified amount.

The holder 14 can be connected to the mouth portion 82 of the culture bottle 80 shown in FIG. Holder 14 has the same structure as a so-called blood collection holder. The holder 14 has a cylindrical body portion 141 . The body portion 141 has a lid body 143 provided near the opening portion 144 . The lid body 143 is rotatably attached to the body portion 141 via the hinge portion 142 . The lid 143 keeps the inside of the main body 141 clean by covering the opening 144 of the main body 141 until just before use. The holder 14 has a port 146 to which the tube line 16 is connected at one end of the body portion 141 . The holder 14 has a needle tube 147 protruding toward the opening 144 along the center of the main body 141 inside the main body 141 . The lumen of needle tube 147 fluidly communicates with port 146 . The holder 14 is not limited to the configuration described above, and may be a blood collection needle with a cap.

The tube line 16 constitutes a flow path that connects the storage container 12 and the holder 14 . The tube line 16 has multiple medical tubes and multiple joints. The medical tubing used for the tubing line 16 is a flexible tubing such as vinyl chloride resin or silicone resin. Specifically, the tubeline 16 has a first tubeline 22 , a second tubeline 24 , a third tubeline 28 , a first branch joint 30 and a second branch joint 32 .

The first tube line 22 has a tube 220 and a tube 221 to which the platelet bag 90 is connected. A tube 221 connects the first branch joint 30 and the second branch joint 32 . A first end 122 of the first tubing line 22 is connected to the second branch joint 32 . A second end 124 of the first tubing line 22 is connected to the air vent 33 . The air vent 33 is a valve that allows air to be discharged. The air vent 33 blocks the inflow of air into the first tube line 22 and the flow of liquid. Air vent 33 allows air to escape from collection kit 10 . A first branch joint 30 is mounted between the first end 122 and the second end 124 of the first tubeline 22 .

The first branch joint 30 is a joint that branches in three directions and has three

connection ports

301, 302, and 303. The first branch joint 30 fluidly connects the first end 122 and the second end 124 of the first tubing line 22 through two connection ports 302,303. A collection tube 187 extending from the collection bag 18 is connected to the connection port 301 of the first branch joint 30 . First tubing line 22 is fluidly connected to collection bag 18 via first branch joint 30 .

A first clamp 34 is attached to the tube 221 between the first branch joint 30 and the second branch joint 32 in the first tube line 22 . The first clamp 34 blocks the flow of fluid through the first tube line 22 by compressing the first tube line 22 in the closed state.

The second branch joint 32 is a three-branched joint and has three

connection ports

321 , 322 and 323 . The first tube line 22 is connected to the connection port 321 of the second branch joint 32 . The second tube line 24 is connected to the connection port 322 of the second branch joint 32 . A connection port 323 of the second branch joint 32 is connected to the third tube line 28 .

The second tube line 24 is connected to the dropper 20 that is the storage container 12 . Dropper 20 is fluidly connected to second branch joint 32 via second tubing line 24 .

One end of the third tube line 28 is connected to the connection port 323 of the second branch joint 32 . The other end of third tube line 28 is connected to port 146 of holder 14 . A third tube line 28 fluidly connects the holder 14 and the second branch joint 32 . A second clamp 36 is attached to the third tube line 28 . In the closed state, the second clamp 36 presses against the third tube line 28 to block the flow of fluid through the third tube line 28 .

The collection kit 10 of this embodiment is configured as described above, and its operation will be described below.

The first step includes removing air from the collection kit 10 shown in FIG. This step expels the air inside the dropper 20 and collection bag 18 . At that time, the first clamp 34 is maintained in an open state. The user expels the air by squeezing the dropper 20 and collection bag 18 . The dropper 20 changes from the first state to the second state. Air in the collection kit 10 is discharged through the air vent 33 . After the air is exhausted, the user closes the first clamp 34 and the second clamp 36 .

Next, the process proceeds to the operations shown in FIG. This step includes the operation of connecting the platelet bag 90 to the collection kit 10 . Platelet bag 90 has a connecting tube 92 . The connecting tube 92 is connected to the first tubing line 22 by a sterile joining device. As shown, the connecting tube 92 and the first tube line 22 are connected via a weld 94 . A portion of the first tube line 22 near the second end 124 and the air vent 33 shown in FIG. 1 are separated from the collection kit 10 .

Next, the process proceeds to the operation of transferring the platelet product in the platelet bag 90 to the collection bag 18, as shown in FIG. The user places the platelet bag 90 above and the collection bag 18 below. As a result, the platelet product flows through the first tube line 22 toward the collection bag 18 due to its own weight. When the platelet product is transferred to the marked line 183 of the collection bag 18, the user stops transfer of the platelet product.

After that, as shown in FIG. 3, the user aseptically cuts the tube 220 of the first tube line 22 . The cut portion of the first tube line 22 is sealed with a weld 96 (see FIG. 3). Platelet bag 90 and connecting tube 92 are separated from collection kit 10 . Platelet bag 90 is provided for storage and use. At this point, collection bag 18 contains a small amount of platelet product, on the order of 20 ml.

Next, the collection kit 10 is transported to the clean bench. The next step includes a weighing step of transferring the platelet product in the collection bag 18 to the dropper 20 and a dispensing step of transferring the platelet product in the dropper 20 to the culture bottle 80 . First, in this process, a weighing process is performed first. The user opens the first clamp 34 and closes the second clamp 36 . Opening the first clamp 34 fluidly connects the dropper 20 to the collection bag 18 . As the syringe 20 elastically restores, the syringe 20 changes from the second state to the first state. At that time, the dropper 20 aspirates the platelet product in the collection bag 18 . The user continues to aspirate the platelet product with the dropper 20 until the liquid surface of the platelet product matches the marked line 205 of the dropper 20 .

When the dropper 20 aspirates the platelet product up to the marked line 205, the user closes the first clamp 34. Thereby, a prescribed amount (eg, 8 ml) of platelet preparation is accommodated in the dropper 20 .

Next, the process proceeds to the dispensing process. The mouth portion 82 of the culture bottle 80 is attached to the holder 14 . When the culture bottle 80 is attached to the holder 14 , the needle tube 147 penetrates the stopper 84 of the mouth portion 82 of the culture bottle 80 . Thereby, the needle tube 147 fluidly connects the culture bottle 80 and the tube line 16 . After that, the user opens the second clamp 36 . The first clamp 34 remains closed. The culture bottle 80 is in a negative pressure state. Therefore, when the second clamp 36 is opened, substantially all of the platelet product in the dropper 20 is sucked into the culture bottle 80 . After that, the user closes the second clamp 36 and removes the culture bottle 80 from the holder 14 . The above operation completes the dispensing process.

After that, in order to introduce the platelet preparation into another culture bottle 80, the process includes repeating the above weighing process and dispensing process. Through the above steps, collection of platelet preparations into a plurality of culture bottles 80 is completed. In the above description, the sample is a platelet product, but the present embodiment is not limited to this example. The collection kit 10 can also be used to collect liquid samples other than platelet preparations.

(Second embodiment)
A collection kit 101 of this embodiment shown in FIG. 4 has a bellows-shaped dropper 40 . Collection kit 101 differs from collection kit 10 shown in FIG. Dropper 40 has a bellows portion 42 . The bellows portion 42 can extend and contract in the longitudinal direction of the dropper 40 . The pipette 40 can be changed between the first state and the second state by expanding and contracting the bellows portion 42 . The dropper 40 aspirates the platelet product when changing from the second state to the first state. Other configurations of the collection kit 101 of the present embodiment are the same as those of the collection kit 10 of FIG. The collection kit 101 has the same effects as the collection kit 10 of FIG.

(Third embodiment)
The collection kit 102 of this embodiment shown in FIG. 5 differs from the collection kit 10 shown in FIG. 1 in the dropper 46 . The dropper 46 has a measuring portion 48 and a suction portion 50 . The weighing portion 48 is formed in a tubular shape. The weighing portion 48 is made of a transparent or translucent material that allows the inside to be visually recognized. The weighing portion 48 has a marking line group 481 on its outer side to indicate the amount of platelet product contained in the weighing portion 48 . The suction portion 50 is connected to one end of the weighing portion 48 . The suction unit 50 is made of, for example, a bellows-shaped resin member. The suction unit 50 is easily changed from the first state to the second state by being pressed. The suction part 50 can also be made of rubber or the like. The suction unit 50 generates negative pressure for sucking the platelet product into the weighing unit 48 when changing from the second state to the first state.

The configuration of the collection kit 102 other than the dropper 46 is the same as that of the collection kit 10 of FIG. 1, so description thereof will be omitted. The collection kit 102 of this embodiment has the same effects as the collection kit 10 of FIG.

Note that the storage container 12 of this embodiment is not limited to the

droppers

20, 40, and 46. The reservoir 12 may be, for example, a syringe. The syringe can change the internal volume of the storage container 12 from the second state to the first state by a user-operated plunger.

(Fourth embodiment)
The collection kit 103 of this embodiment includes a storage container 52, a holder 14, and a tube line 56, as shown in FIG. In the collection kit 103, the same components as in the collection kit 10 of FIG.

The collection kit 103 of this embodiment has a storage container 52 . The storage container 52 has two syringes 20 . The two syringes 20 and the holder 14 are connected to each other via a tube line 56 . The tubeline 56 has a first tubeline 58 , a first branch joint 60 , a second tubeline 62 , a second branch joint 64 and a third tubeline 66 .

The first tube line 58 has a first end 581 sealed by welding. The first tubing line 58 has a length that allows the platelet bag 90 to be connected. The first tubing line 58 is connected at a second end 582 to the second branch joint 64 . A first branch joint 60 is connected in the middle of the first tube line 58 .

The first branch joint 60 is a three-branched Y-shaped joint. An air vent 33 is attached to one connection port 601 of the first branch joint 60 . Air vent 33 is connected to first tube line 58 via first branch joint 60 . The first tubing line 58 between the first branch joint 60 and the first end 581 is used for connection with the platelet bag 90 . A first clamp 68 is attached to the first tubing line 58 between the first branch joint 60 and the second end 582 . In the closed state, the first clamp 68 compresses the first tube line 58 to block the flow of fluid therein.

The second branch joint 64 is a π-shaped joint with four branches. The second branch joint 64 connects the first tube line 58 , the first tube 621 , the second tube 622 and the third tube line 66 . The second tube line 62 of this embodiment includes two first tubes 621 and a second tube 622 . The first tube 621 connects the upstream dropper 20 and the connection port 641 of the second branch joint 64 . The second tube 622 connects the dropper 20 on the downstream side and the connection port 642 of the second branch joint 64 . Here, the upstream side refers to the side relatively close to the first tube line 58 . Moreover, the downstream side refers to the side relatively close to the third tube line 66 .

A second clamp 70 is attached to the first tube 621 . In the closed state, the second clamp 70 compresses the first tube 621 to block the flow of fluid inside. A third clamp 72 is attached to the second tube 622 . In the closed state, the third clamp 72 compresses the second tube 622 to block the flow of fluid inside.

The third tube line 66 fluidly connects the second branch joint 64 and the holder 14 . A fourth clamp 74 is attached to the third tube line 66 . In the closed state, the fourth clamp 74 presses the third tube line 66 to block the flow of fluid therein.

The collection kit 103 of this embodiment is configured as described above. In the following description, the action and method of use of collection kit 103 will be described.

The first step is to exhaust the air inside the collection kit 103 . The first clamp 68, the second clamp 70 and the third clamp 72 are kept open. The user squeezes the two droppers 20 to exhaust the air in the droppers 20 . After that, the user closes the second clamp 70 and the third clamp 72 .

The next step is to transfer a specified amount of platelet preparation to each of the two droppers 20 of the collection kit 103 . The user connects the platelet bag 90 (see FIG. 2) to the first tubing line 58 using a sterile connector. Next, the user opens the second clamp 70 and measures a specified amount of platelet product into the dropper 20 on the upstream side. After that, the user closes the second clamp 70 . Next, the user opens the third clamp 72 and measures a specified amount of platelet preparation into the dropper 20 on the downstream side. After that, the user closes the third clamp 72 . The user then disconnects the platelet bag 90 from the collection kit 103 using a sterile connector.

The next step is to inject the platelet preparations contained in the two droppers 20 of the collection kit 103 into the two culture bottles 80 (see FIG. 3). Injection from the collection kit 103 to the culture bottle 80 is performed on a clean bench. The user closes the first clamp 68 , the second clamp 70 , the third clamp 72 and the fourth clamp 74 . Next, the user attaches the culture bottle 80 to the holder 14 . After that, the user opens the fourth clamp 74 and the third clamp 72 . Due to the negative pressure of the culture bottle 80 , the platelet product in the dropper 20 on the downstream side is sucked into the culture bottle 80 .

Next, the user closes the third clamp 72 and the fourth clamp 74 and attaches another culture bottle 80 to the holder 14 . After that, the user releases the second clamp 70 and the fourth clamp 74 . As a result, the platelet preparation is sucked into the culture bottle 80 from the dropper 20 on the upstream side. By the above operation, injection of the specified amount of platelet preparation into each of the two culture bottles 80 is completed.

As described above, the collection kit 103 of the present embodiment directly measures the platelet product from the platelet bag 90 into the dropper 20. As a result, the collection kit 103 enables further simplification of the process of weighing the platelet product into the culture bottle 80 . Moreover, since the collection kit 103 does not use the collection bag 18 (see FIG. 1), it is possible to further reduce the loss of platelet products.

(Fifth embodiment)
As shown in FIG. 7 , the collection kit 104 of this embodiment differs from the collection kit 103 of FIG. 6 in the second branch joint 76 . The second branch joint 76 is dendritic and branches into four. The first tube 621 and the second tube 622 are connected at the same position when viewed from the upstream/downstream direction of the flow path from the first tube line 58 to the holder 14 . That is, the two syringes 20 are connected from the holder 14 with the same channel length. Therefore, there is no upstream and downstream relationship between the two syringes 20 .

According to the collection kit 104 of the present embodiment, it is possible to reduce measurement errors caused by the positions of the two droppers 20. In addition, since there is no upstream/downstream relationship between the two syringes 20, the two syringes 20 can be used in any order.

The present invention is not limited to the above-described embodiments, and can take various configurations without departing from the gist of the present invention.

Claims

a storage container for storing a predetermined amount of platelet preparation;
a holder to which the culture bottle is connected;
a tube line connecting the storage container and the holder,
The tube line is
a first tube line connectable to a platelet bag containing the platelet product;
a second tube line connected to the storage container;
a third tube line connected to the holder;
a branch joint connecting the first tube line, the second tube line, and the third tube line to each other;
The storage container is configured to be changeable between a first state and a second state having an internal volume smaller than that of the first state. A collection kit for aspirating the platelet product through the first tube line and the second tube line.
The collection kit according to claim 1, wherein the storage container spontaneously changes from the second state to the first state by elastic deformation.
The collection kit according to claim 1, wherein the storage container has a dropper structure.
The collection kit according to claim 3, wherein the storage container has a stretchable bellows structure.
The collection kit according to claim 1, wherein a clamp is attached to at least one of the first tube line, the second tube line and the third tube line.
The collection kit according to claim 1, comprising an air vent connected to the tubing line to allow gas to escape and block passage of liquid.
The collection kit according to any one of claims 1 to 6, comprising a collection bag connected to the first tube line and containing the platelet product of the platelet bag.
The collection kit according to any one of claims 1 to 6, wherein a plurality of said storage containers are connected to said tube line.
The collection kit according to claim 8, wherein the plurality of storage containers are connected from the holder with the same channel length.