Collection kit and collection method

Abstract

To provide a collection kit and a collection method for efficient culture testing of a blood product.SOLUTION: A collection kit 10 comprises: an inflow tube 12 to which a medical bag containing an object to be collected is connected; a storage section 14 having a first storage chamber 31 and a second storage chamber 32; an air vent 16 for discharging air from the storage section 14; a first adapter 21 connectable to a first culture bottle B1; and a second adapter 22 connectable to a second culture bottle B2. The inflow tube 12 is connected to the second storage chamber 32. A communication path 33 that communicates the first storage chamber 31 and the second storage chamber 32 is formed in the upper part of the storage section 14, and a hydrophilic filter 24 is arranged in the communication path 33. A collection method comprises collecting the object to be collected into the first culture bottle B1 and the second culture bottle B2 using the collection kit 10.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a collection kit and a collection method for transferring a collection target to a culture bottle.

Background Art

[0002] Blood products include red blood cell products, plasma products, platelet products, and whole blood products. Blood products are preparations containing components required by patients and are used for transfusion. Blood products are stored and transported in a state of being contained in a medical bag. In order to ensure safety, a small amount of sample may be collected for a culture test. The culture test is to collect the sample in a culture bottle and place the culture bottle in an environment suitable for the growth of bacteria to detect the presence or absence of pathogens.

[0003] For example, the test of platelet products is performed according to the following procedure. A small-volume collection bag is connected to a medical bag (hereinafter referred to as a platelet bag) containing platelet products. Then, a part of the platelet products in the platelet bag is transferred to the collection bag. Next, the collection bag is detached from the platelet bag.

[0004] Next, the collection bag is carried to a clean bench. In the clean bench, the platelet products are injected from the collection bag into a blood culture bottle. Prior to the injection, the tube of the collection bag is connected to the tube extending from the sample collection tube. Based on the scale of the sample collection tube as a reference, a specified amount of platelet products is transferred from the collection bag to the sample collection tube.

[0005] Thereafter, while visually observing the scale of the sample collection tube, the operator operates the valve of the sample collection tube to transfer a specified amount of platelet products from the sample collection tube to the blood culture bottle. In the culture test, anaerobic culture and aerobic culture are performed. Therefore, the platelet products are dispensed into a culture bottle used for anaerobic culture and a culture bottle used for aerobic culture. Thereafter, each culture bottle is set in a culture device and subjected to a culture test for a predetermined period.

[0006] For example, Patent Document 1 discloses a sample collection kit for collecting samples from a medical bag. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] U.S. Patent No. 8777921 [Overview of the project] [Problems that the invention aims to solve]

[0008] When performing large-scale culture tests on blood products, improving the efficiency of the culture testing process is essential. The conventional testing procedure, as described above, involves the cumbersome process of dispensing blood products from the blood product bag into culture bottles, requiring the attachment and detachment of collection bags and sample collection tubes. Furthermore, with conventional collection kits, if the operator is unfamiliar with handling the kit, a large amount of air may enter the anaerobic culture bottle through the air vent. Conventional collection kits also cannot simultaneously collect blood products into two culture bottles.

[0009] The present invention aims to solve the problems described above. [Means for solving the problem]

[0010] (1) A first aspect of the present invention is a sampling kit comprising: an inlet tube to which a medical bag containing a sample to be collected is connected; a storage section connected downstream of the inlet tube and having a first storage chamber and a second storage chamber capable of containing the sample to be collected; an air vent connected to the upper part of the first storage chamber and for discharging air from the storage section; a first adapter communicating with the first storage chamber and connectable to a first culture bottle; and a second adapter communicating with the second storage chamber and connectable to a second culture bottle, wherein the inlet tube is connected to the second storage chamber, a communication passage is formed at the upper part of the storage section that connects the first storage chamber and the second storage chamber, and a hydrophilic filter is arranged in the communication passage.

[0011] The sampling kit minimizes the number of times tubes need to be joined and separated during the process of collecting samples into culture bottles, resulting in superior work efficiency. Furthermore, a hydrophilic filter is placed in the connecting passage between the first and second containment chambers, preventing air from flowing from the first to the second. Therefore, if the second culture bottle is for anaerobic bacteria, the risk of a large amount of air entering the anaerobic culture bottle is reduced. By connecting the first adapter to the first culture bottle and the second adapter to the second culture bottle simultaneously, samples can be collected into both culture bottles at the same time.

[0012] (2) In the sampling kit described in item (1) above, the containment section may have a partition wall separating the first containment chamber and the second containment chamber, and the hydrophilic filter may be fixed to the upper end of the partition wall.

[0013] This makes it possible to construct a housing unit with a simple configuration in which the first housing chamber and the second housing chamber are connected via a hydrophilic filter.

[0014] (3) In the sampling kit described in item (1) or (2) above, the inflow tube may be connected to the second containment chamber at a location horizontally away from the hydrophilic filter.

[0015] This ensures that air is reliably discharged from the second containment chamber to the first containment chamber as the sample flows in from the inflow tube into the second containment chamber.

[0016] (4) In the sampling kit described in item (1) or (2) above, the first containment chamber and the second containment chamber may be integrated to form the containment section.

[0017] (5) A second aspect of the present invention is a collection method for collecting a sample into two culture bottles using a collection kit, the collection kit comprising: an inlet tube to which a medical bag containing the sample is connected; a storage section connected downstream of the inlet tube and having a first storage chamber and a second storage chamber capable of containing the sample; an air vent connected to the upper part of the first storage chamber and for discharging air from the storage section; a first adapter communicating with the first storage chamber and connectable to a first culture bottle; a second adapter communicating with the second storage chamber and connectable to a second culture bottle, wherein the inlet tube is connected to the second storage chamber and the storage section A connecting passage is formed at the top of the device, connecting the first containment chamber and the second containment chamber, and a hydrophilic filter is placed in the connecting passage. The sampling method comprises a joining step of joining the medical bag to the inflow tube, an introduction step of introducing the sample to be collected into the first containment chamber and the second containment chamber via the inflow tube, a first transfer step of connecting the first culture bottle to the first adapter and transferring the sample to be collected from the first containment chamber to the first culture bottle, and a second transfer step of connecting the second culture bottle to the second adapter and transferring the sample to be collected from the second containment chamber to the second culture bottle.

[0018] (6) In the sampling method described in item (5) above, the first transfer step may be performed before the second transfer step.

[0019] (7) In the sampling method described in item (5) above, the first transfer step and the second transfer step may be performed simultaneously. [Effects of the Invention]

[0020] According to the present invention, in the operation of collecting a target object into a culture bottle using a collection kit, the number of connections and separations between tubes can be minimized, so the working efficiency is excellent. Further, since a hydrophilic filter is disposed in the communication path that connects the first storage chamber and the second storage chamber, air is prevented from flowing from the first storage chamber into the second storage chamber. Therefore, when the second culture bottle is a culture bottle for anaerobic bacteria, the risk of a large amount of air being mixed into the culture bottle for anaerobic bacteria can be reduced. If the connection of the first adapter to the first culture bottle and the connection of the second adapter to the second culture bottle are performed simultaneously, the target object can be collected into the two culture bottles at the same time.

Brief Description of the Drawings

[0021] [Figure 1] FIG. 1 is an overall schematic view of a collection kit according to an embodiment of the present invention. [Figure 2] FIG. 2 is a first diagram for explaining the usage method of the collection kit. [Figure 3] FIG. 3 is a second diagram for explaining the usage method of the collection kit. [Figure 4] FIG. 4 is a third diagram for explaining the usage method of the collection kit. [Figure 5] FIG. 5 is a fourth diagram for explaining the usage method of the collection kit. [Figure 6] FIG. 6 is a fifth diagram for explaining the usage method of the collection kit. [Figure 7] FIG. 7 is a diagram for explaining another usage method of the collection kit.

Embodiments for Carrying Out the Invention

[0022] The sample collection kit 10 according to this embodiment, shown in Figure 1, is used to transfer the blood product, which is the sample to be collected, to culture bottles B1 and B2. The sample collection kit 10 is used, for example, in a blood center or other facility that manufactures blood products, for culture tests to confirm the safety of the product. In the culture test, tests are performed for the culture of anaerobic bacteria and aerobic bacteria. Therefore, two culture bottles are used in the culture test: culture bottle B1 for aerobic culture (hereinafter also referred to as "first culture bottle B1") and culture bottle B2 for anaerobic culture (hereinafter also referred to as "second culture bottle B2"). The sample collection kit 10 is used to collect a liquid sample (platelet preparation) and dispense predetermined amounts into the two culture bottles B1 and B2.

[0023] In this embodiment, an example in which a platelet preparation is used as the blood product will be described below, but the blood product collected by the collection kit 10 may also be a red blood cell preparation, a plasma preparation, or a whole blood preparation.

[0024] The sampling kit 10 comprises an inlet tube 12, a housing section 14, an air vent 16, a first adapter 21, and a second adapter 22. In the sampling kit 10, based on the arrangement during use, the direction in which the inlet tube 12 and air vent 16 are located is referred to as the upper side or upward, and the direction in which the first adapter 21 and second adapter 22 are located is referred to as the lower side or downward.

[0025] The inlet tube 12 is a translucent medical tube made of a thermoplastic resin such as polyvinyl chloride resin. The inlet tube 12 can be connected to or separated from other medical tubes without exposing its interior to the outside air, for example, by an aseptic bonding device or a tube sealer. The inlet tube 12 has an upstream first end 121 and a downstream second end 122. The first end 121 is initially welded and sealed. The second end 122 is connected to the upper end of the housing section 14.

[0026] The containment section 14 is connected to the downstream end (second end 122) of the inflow tube 12. The containment section 14 is made of a rigid material. Examples of materials used to make up the containment section 14 include rigid resin materials such as polypropylene, polyethylene, cyclic polyolefin, and polyacetal resin. The containment section 14 has a first containment chamber 31 and a second containment chamber 32 capable of containing the sample to be collected. The first containment chamber 31 and the second containment chamber 32 together form the containment section 14. The containment section 14 has a capacity of, for example, about 20 mL. The first containment chamber 31 has a volume that can contain a predetermined amount (for example, about 10 mL) of platelet preparation. The second containment chamber 32 has a volume that can contain a predetermined amount (for example, about 10 mL) of platelet preparation. The capacities of the first containment chamber 31 and the second containment chamber 32 are the same. The inflow tube 12 is connected to the second containment chamber 32.

[0027] A connecting passage 33 is formed at the top of the housing section 14, connecting the first housing chamber 31 and the second housing chamber 32. A hydrophilic filter 24 is positioned in the connecting passage 33. The housing section 14 has a partition wall 26 that separates the first housing chamber 31 and the second housing chamber 32. The partition wall 26 extends upward from the lower part (bottom) of the housing section 14. The hydrophilic filter 24 is fixed to the upper end of the partition wall 26. The hydrophilic filter 24 has the property of making it difficult for gas to pass through when wet.

[0028] The inflow tube 12 is connected to the second containment chamber 32 at a location horizontally away from the hydrophilic filter 24. It is preferable that the inflow tube 12 is separated from the hydrophilic filter 24 so that the platelet preparation does not come into direct contact with the hydrophilic filter 24 when it flows into the second containment chamber 32 via the inflow tube 12. In this embodiment, the inflow tube 12 is connected to the upper corner 14c of the containment section 14 (the corner opposite to the first containment chamber 31).

[0029] The air vent 16 is connected to the top of the first containment chamber 31 and discharges air from the containment section 14. The air vent 16 has a vent pipe 161 that constitutes the vent body and a lid 162 that can open and close the opening of the vent pipe 161. A sterile filter 163 is placed inside the vent pipe 161. The lid 162 can airtightly close the opening of the vent pipe 161. When the lid 162 is opened, the first containment chamber 31 is opened to the atmosphere. When the lid 162 is closed, the inflow of air from outside the containment section 14 into the first containment chamber 31 is prevented.

[0030] The first adapter 21 communicates with the first containment chamber 31 and is connectable to the first culture bottle B1. The first adapter 21 comprises a containment cylinder 34 capable of accommodating the top of the first culture bottle B1, a transfer tube 38 having a tubular needle portion 36 positioned inside the containment cylinder 34, and a rubber cover 40 covering the needle portion 36. The containment cylinder 34 has an openable and closable lid 341. However, the lid 341 is not required. If the lid 341 is not provided, the opening of the containment cylinder 34 may be sealed with a sealant such as a thin film. The containment cylinder 34 can be opened by peeling off the sealant when in use. The needle portion 36 can puncture the rubber stopper attached to the top of the first culture bottle B1. When the needle portion 36 of the first adapter 21 penetrates the rubber stopper of the first culture bottle B1, the first culture bottle B1 and the first containment chamber 31 are connected. When the needle portion 36 punctures the rubber stopper of the first culture bottle B1, the rubber cover 40 is pushed inward towards the proximal end, causing the needle portion 36 to penetrate the rubber cover 40. When the needle portion 36 is withdrawn from the rubber stopper of the first culture bottle B1, the rubber cover 40 stretches due to its elastic restorative force and covers the needle portion 36 again.

[0031] The second adapter 22 communicates with the second containment chamber 32 and can be connected to the second culture bottle B2. The second adapter 22 has the same configuration as the first adapter 21. When the needle portion 36 of the second adapter 22 penetrates the rubber stopper of the second culture bottle B2, the second culture bottle B2 and the second containment chamber 32 are connected.

[0032] The collection kit 10 configured as described above is used as follows. In this embodiment, a collection method is described in which platelet preparations are dispensed into two culture bottles B1 and B2 using the collection kit 10.

[0033] As shown in Figure 2, the platelet bag 50 is attached to the collection kit 10 (attachment process). The platelet bag 50 is a medical bag containing a platelet preparation. The platelet bag 50 has a connecting tube 52. The tube 52 is attached to the inflow tube 12. The tube 52 is attached to the inflow tube 12 using a sterile joining device without coming into contact with the outside air.

[0034] Next, the platelet preparation is introduced into the containment section 14 (introduction process). In this process, the platelet bag 50 is positioned above the containment section 14, and the lid 162 of the air vent 16 is opened. The platelet preparation flows out of the platelet bag 50 by gravity and is stored in the containment section 14 via the tube 52 and the inflow tube 12.

[0035] As shown in Figure 3, the platelet preparation is first stored in the second storage chamber 32 of the two storage chambers 31 and 32 (first introduction step). In this case, the platelet preparation is stored from the bottom of the second storage chamber 32, and the liquid level of the platelet preparation rises within the second storage chamber 32. As the liquid level of the platelet preparation rises within the second storage chamber 32, the air inside the second storage chamber 32 is pushed out by the platelet preparation and discharged into the first storage chamber 31 via the hydrophilic filter 24 located in the communication passage 33, and further discharged to the outside of the storage section 14 via the air vent 16.

[0036] Once the second containment chamber 32 is filled with the platelet preparation, the platelet preparation then flows into the first containment chamber 31 via the hydrophilic filter 24, as shown in Figure 4, and is stored in the first containment chamber 31 (second introduction step). In this case, as the flow of the platelet preparation into the first containment chamber 31 progresses, the liquid level of the platelet preparation inside the first containment chamber 31 rises. As the liquid level of the platelet preparation inside the first containment chamber 31 rises, the air in the first containment chamber 31 is discharged from the air vent 16. Eventually, the first containment chamber 31 is filled with the platelet preparation. This completes the introduction of the platelet preparation into the containment section 14. The first containment chamber 31 and the second containment chamber 32 each contain a predetermined amount (for example, about 10 mL) of the platelet preparation. After the introduction step, the lid 162 of the air vent 16 is closed.

[0037] Subsequently, the platelet bag 50 is separated from the inflow tube 12 using a tube sealer (high-frequency sealer or ultrasonic sealer). The tube sealer separates the inflow tube 12 from the tube 52 of the platelet bag 50 and simultaneously seals the first end 121 of the inflow tube 12 by welding. The separation of the inflow tube 12 and tube 52 is performed without exposing the internal flow path to the outside air.

[0038] The removed platelet bag 50 is stored until the culture test is complete before being made available for use. Meanwhile, the collection kit 10 filled with platelet preparation is brought into the clean bench. Next, the user performs the operation to transfer the platelet preparation from the collection kit 10 to the first culture bottle B1 and the second culture bottle B2.

[0039] First, as shown in Figure 5, the sample to be collected is transferred from the first containment chamber 31 to the first culture bottle B1 (first transfer step). In the first transfer step, the first culture bottle B1 (culture bottle for aerobic bacteria) is first connected to the first adapter 21. With this connection, the needle portion 36 of the first adapter 21 penetrates the rubber stopper of the first culture bottle B1. The platelet preparation in the first containment chamber 31 is drawn out by the negative pressure of the first culture bottle B1, and a predetermined amount (for example, about 10 mL) of platelet preparation is introduced into the first culture bottle B1. Next, the first adapter 21 is removed from the first culture bottle B1.

[0040] When collecting platelet preparations into the first culture bottle B1, the lid 162 of the air vent 16 may be closed, but it is preferable to leave it open as shown in Figure 5. This allows air to flow into the first containment chamber 31 via the air vent 16, thus facilitating the smooth transfer of platelet preparations from the first containment chamber 31 to the first culture bottle B1. Furthermore, by leaving the lid 162 of the air vent 16 open when collecting platelet preparations into the first culture bottle B1, it is possible to prevent the platelet preparations from being drawn out from the second containment chamber 32 to the first containment chamber 31 via the hydrophilic filter 24.

[0041] Next, as shown in Figure 6, the sample to be collected is transferred from the second containment chamber 32 to the second culture bottle B2 (second transfer step). In the second transfer step, first, the second culture bottle B2 (culture bottle for anaerobic bacteria) is connected to the second adapter 22. With this connection, the needle portion 36 of the second adapter 22 penetrates the rubber stopper of the second culture bottle B2. The platelet preparation in the second containment chamber 32 is drawn out by the negative pressure of the second culture bottle B2, and a predetermined amount (for example, about 10 mL) of the platelet preparation is introduced into the second culture bottle B2. Next, the second adapter 22 is removed from the second culture bottle B2.

[0042] When collecting platelet preparations into the second culture bottle B2, the hydrophilic filter 24 is wet with the platelet preparations. Because the hydrophilic filter 24 has the property of making it difficult for gases to pass through when wet, the inflow of air from the first containment chamber 31 to the second containment chamber 32 is prevented. The only air that flows into the second culture bottle B2 is the air that was present in the flow path within the transfer tube 38 (including the needle portion 36) of the second adapter 22. Therefore, there is little air contamination into the second culture bottle B2.

[0043] The above steps complete the collection of platelet preparations using the collection kit 10.

[0044] As shown in Figure 4, after placing a predetermined amount of platelet preparation in the first and second storage chambers 31 and 32, the connection of the first adapter 21 to the first culture bottle B1 and the connection of the second adapter 22 to the second culture bottle B2 may be performed simultaneously, as shown in Figure 7. This allows platelet preparation to be collected in both culture bottles B1 and B2 at the same time. In this case as well, since the hydrophilic filter 24 is wet, the inflow of air from the first storage chamber 31 to the second storage chamber 32 is prevented, so there is little air contamination in the second culture bottle B2.

[0045] This embodiment provides the following effects.

[0046] In the process of collecting the target material into culture bottles B1 and B2 using the collection kit 10, the number of times tubes are joined and separated is minimized, resulting in superior work efficiency. Furthermore, since a hydrophilic filter 24 is placed in the connecting passage 33 that connects the first containment chamber 31 and the second containment chamber 32, air is prevented from flowing from the first containment chamber 31 into the second containment chamber 32. This reduces the risk of a large amount of air entering the second culture bottle B2, which is a culture bottle for anaerobic bacteria. By connecting the first adapter 21 to the first culture bottle B1 and the second adapter 22 to the second culture bottle B2 simultaneously, the target material can be collected into both culture bottles B1 and B2 at the same time, which is efficient.

[0047] Furthermore, since it eliminates the need to measure and collect platelet preparations by eye according to the scale lines, the work becomes easier and measurement errors can be reduced. Therefore, the collection kit 10 can suppress variations in the amount of platelet preparation introduced into the first culture bottle B1 and the second culture bottle B2.

[0048] The storage section 14 has a partition wall 26 that separates the first storage chamber 31 and the second storage chamber 32, and a hydrophilic filter 24 is fixed to the upper end of the partition wall 26. Therefore, a storage section 14 having a structure in which the first storage chamber 31 and the second storage chamber 32 communicate via the hydrophilic filter 24 can be constructed with a simple configuration.

[0049] The inlet tube 12 is connected to the second containment chamber 32 at a point horizontally away from the hydrophilic filter 24. This configuration ensures that the hydrophilic filter 24 does not get wet until the storage of the sample to be collected in the second containment chamber 32 is complete. Therefore, when the sample to be collected flows from the inlet tube 12 into the second containment chamber 32, air can be reliably discharged from the second containment chamber 32 to the first containment chamber 31.

[0050] Furthermore, the present invention is not limited to the disclosure described above, and can take various configurations without departing from the spirit of the invention. [Explanation of symbols]

[0051] 10...Collection kit 12...Inflow tube 14…Containment area 16…Air vent 21...First adapter 22...Second adapter 24...Hydrophilic filter 33...Connecting passage

Claims

1. An inlet tube to which a medical bag containing the sample to be collected is connected, A containment unit connected downstream of the inflow tube, having a first containment chamber and a second containment chamber capable of containing the object to be collected, An air vent connected to the upper part of the first containment chamber, which discharges air from the containment section, A first adapter that communicates with the first containment chamber and can be connected to the first culture bottle, It comprises a second adapter that communicates with the second containment chamber and is connectable to a second culture bottle, The inlet tube is connected to the second containment chamber, A sampling kit comprising a passage formed in the upper part of the storage section, connecting the first storage chamber and the second storage chamber, and a hydrophilic filter arranged in the passage.

2. In the sampling kit according to claim 1, The sampling kit comprises a housing section having a partition wall separating the first housing chamber and the second housing chamber, with the hydrophilic filter fixed to the upper end of the partition wall.

3. In the sampling kit according to claim 1 or 2, The sampling kit, wherein the inflow tube is connected to the second containment chamber at a point horizontally away from the hydrophilic filter.

4. In the sampling kit according to claim 1 or 2, A sampling kit in which the first containment chamber and the second containment chamber together form the containment section.

5. A sampling method in which the sample to be collected is collected into two culture bottles using a sampling kit, The aforementioned collection kit is An inlet tube to which a medical bag containing the sample to be collected is connected, A containment unit connected downstream of the inflow tube, having a first containment chamber and a second containment chamber capable of containing the object to be collected, An air vent connected to the upper part of the first containment chamber, which discharges air from the containment section, A first adapter that communicates with the first containment chamber and can be connected to the first culture bottle, It comprises a second adapter that communicates with the second containment chamber and is connectable to a second culture bottle, The inlet tube is connected to the second containment chamber, A connecting passage is formed in the upper part of the housing section, connecting the first housing chamber and the second housing chamber, and a hydrophilic filter is placed in the connecting passage. The aforementioned sampling method is A joining step of joining the medical bag to the inlet tube, An introduction step of introducing the sample to be collected into the first and second containment chambers via the inflow tube, A first transfer step involves connecting the first culture bottle to the first adapter and transferring the sample to be collected from the first containment chamber to the first culture bottle, A sampling method comprising a second transfer step of connecting the second culture bottle to the second adapter and transferring the sample to be collected from the second containment chamber to the second culture bottle.

6. In the sampling method described in claim 5, A sampling method wherein the first transfer step is performed before the second transfer step.

7. In the sampling method described in claim 5, A sampling method that performs the first transfer step and the second transfer step simultaneously.

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