Sample collection kit and sample collection method

Abstract

To provide an improved sample collection kit and a sample collection method.SOLUTION: A sample collection kit 10 comprises: a tube member 180 to which a medical bag 20 can be connected, and in which a channel of a liquid sample is formed; a storage part 42 which has a decompression container 112 for guiding thereinto, a prescribed amount of the liquid sample by a negative pressure for temporarily storing the same; and an adapter 50 to which a culture bottle 30 is connected, the culture bottle collecting the liquid sample from the decompression container 112. The storage part 42 further has: a holder 122 for allowing communication between the inside of the tube member 180 and the inside of the decompression container 112; and a block member 132 for blocking entry of ambient air to a space between the decompression container 112 and the holder 122.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a sample collection kit and a sample collection method.

Background Art

[0002] Patent Document 1 discloses a sampling method and a sampling device for aseptically sampling a blood preparation in a bag (pouch) into a vacuum bottle. The blood preparation in the bag is, for example, platelets. The sampling device includes a tube connected to the bag, a chamber for storing a liquid sample via the tube, and a sample port connected to the chamber.

[0003] In using the sampling device, while visually confirming the scale of the chamber and the liquid level of the liquid sample, after measuring a desired amount of the liquid sample into the chamber, a vacuum bottle is connected to the sample port. When the vacuum bottle is connected to the sample port, the liquid sample migrates from the chamber into the vacuum bottle due to the negative pressure in the vacuum bottle.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] According to the invention disclosed in Patent Document 1, it is difficult to measure a desired amount of the liquid sample into the chamber. Therefore, the liquid sample collected in the vacuum bottle may exceed the desired amount or be less than the desired amount.

[0006] An object of the present invention is to solve the above-described problems.

Means for Solving the Problems

[0007] A first aspect of the present invention is a sample collection kit comprising: a tubular member to which a medical bag can be connected and which forms a flow path for a liquid sample inside; a storage section connected to the tubular member and having a vacuum container for temporarily storing a predetermined amount of the liquid sample by guiding it into the interior by negative pressure; and an adapter connected to the tubular member and to which a culture bottle for collecting the liquid sample from the vacuum container can be connected, wherein the storage section further comprises a holder for holding the vacuum container and being connectable to the vacuum container, and which enables communication between the inside of the tubular member and the inside of the vacuum container when connected to the vacuum container; and a blocking member for blocking the inflow of outside air between the vacuum container and the holder.

[0008] A second aspect of the present invention is a sample collection method using a sample collection kit according to the first aspect, comprising: a joining step of joining the medical bag and the tube member; a storage step of connecting the vacuum container to the holder while blocking the inflow of outside air with the blocking member, and causing the liquid sample to be contained in the vacuum container from the medical bag via the tube member by the negative pressure of the vacuum container; and a collection step of connecting the culture bottle to the adapter, transferring the liquid sample from the vacuum container to the culture bottle by the negative pressure of the culture bottle, and detaching the culture bottle from the adapter. [Effects of the Invention]

[0009] According to the present invention, a predetermined amount of liquid sample can be accurately collected into a culture bottle. [Brief explanation of the drawing]

[0010] [Figure 1] Figure 1 shows a sample collection kit, a medical bag, and a culture bottle according to one embodiment. [Figure 2] Figure 2A is a cross-sectional view of the storage compartment in its initial state. Figure 2B is a cross-sectional view of the storage compartment in use. [Figure 3] Figure 3 illustrates the joining process for connecting the tube of the medical bag with the sample collection tube of the sample collection kit. [Figure 4] Figure 4 illustrates the first containment step, in which a liquid sample is transferred from a medical bag to a first vacuum container. [Figure 5] Figure 5 illustrates the second containment step, in which the liquid sample is transferred from the medical bag to the second vacuum container. [Figure 6] Figure 6 illustrates the sealing process, which involves sealing the sample collection tube of the sample collection kit and separating the medical bag from the sample collection kit. [Figure 7] Figure 7 shows the state after the liquid sample in the first vacuum container has been transferred to the first culture bottle during the first liquid sample collection step. [Figure 8] Figure 8 shows the state after the first culture bottle has been detached from the adapter during the first liquid sample collection step. [Figure 9] Figure 9 shows the state after the liquid sample in the second vacuum container has been transferred to the second culture bottle during the second liquid sample collection step. [Figure 10] Figure 10A is a cross-sectional view of the housing in its initial state in Modification Example 1. Figure 10B is a cross-sectional view of the housing in use. [Figure 11] Figure 11 is a cross-sectional view of the housing in its initial state in the modified example 2. [Figure 12] Figure 12 is a cross-sectional view of the housing in its initial state in the modified example 3. [Figure 13] Figure 13 shows Modification 4, in which a cross stopcock is used as a switching mechanism for the liquid sample flow path. [Figure 14] Figure 14 shows Modification 5, in which the adapter includes a first adapter and a second adapter. [Modes for carrying out the invention]

[0011] FIG. 1 is a diagram showing a sample collection kit 10, a medical bag 20, and a culture bottle 30 according to an embodiment. The sample collection kit 10 according to the present embodiment is used to collect a liquid sample from a blood product in the medical bag 20 into the culture bottle 30. The medical bag 20 contains a blood product (for example, a platelet product).

[0012] The sample collection kit 10 has a tube member 180, two storage portions 42, 44, an adapter 50, an air recovery member 60, and a switching mechanism 90. Hereinafter, one storage portion 42 will be referred to as the "first storage portion 42", and the other storage portion 44 will be referred to as the "second storage portion 44". The first storage portion 42, the second storage portion 44, the adapter 50, and the air recovery member 60 are connected to the tube member 180. The tube member 180 forms a flow path for the liquid sample inside. The tube member 180 has a sampling tube 70, a first tube 72, a second tube 74, and a transfer tube 76.

[0013] One end of the sampling tube 70 is closed in the initial state. One end of the sampling tube 70 can be joined to the tube 20a of the medical bag 20 by, for example, a sterile joining device. The tube 20a of the medical bag 20 communicates with the inside of the medical bag 20 through the output port 20b of the medical bag 20. The first tube 72, the second tube 74, and the transfer tube 76 branch from the sampling tube 70.

[0014] The first tube 72 is connected to the first storage portion 42. The second tube 74 is connected to the second storage portion 44. The transfer tube 76 is connected to the adapter 50.

[0015] FIG. 2A is a cross-sectional view of the first storage portion 42 in the initial state. As shown in FIG. 2A, the first storage portion 42 has a first decompression container 112, a first holder 122, and a blocking member 132.

[0016] The first vacuum container 112 is capable of holding a predetermined amount (e.g., 8 mL to 10 mL) of liquid sample. The inside of the first vacuum container 112 is set to negative pressure. The first vacuum container 112 guides a predetermined amount of liquid sample from the medical bag 20 (see Figure 1) into the first vacuum container 112 via the sampling tube 70 and the first holder 122, using the negative pressure of the first vacuum container 112 to temporarily contain it.

[0017] The first vacuum container 112 has a bottomed cylindrical container body 112a and a sealing part 112b attached to the container body 112a. The container body 112a is preferably transparent so that the inside can be seen. The sealing part 112b is located at the opening provided at the top 112p of the container body 112a. The sealing part 112b is, for example, a rubber stopper.

[0018] The first holder 122 holds the first vacuum container 112 and is connectable to the first vacuum container 112. The first holder 122 is also able to communicate with the sampling tube 70 via the first tube 72. When the first holder 122 is connected to the first vacuum container 112, it enables communication between the inside of the first tube 72 and the inside of the first vacuum container 112. The material used for the first holder 122 and the first vacuum container 112 is, for example, a resin material such as PET.

[0019] The first holder 122 has a holder body 122a, a needle portion 122b, and a connecting cylinder 122c. The holder body 122a is formed in a cylindrical shape. The holder body 122a holds the first vacuum container 112 so that it can move relative to the first holder 122 in the axial direction AX. The holder body 122a has a first end portion 122p connected to the first tube 72 via the connecting cylinder 122c, and a second end portion 122q which is the end opposite to the first end portion 122p. An opening 122e is provided in the second end portion 122q. The first vacuum container 112 is inserted into the opening 122e of the holder body 122a.

[0020] The needle portion 122b and the connecting tube 122c are attached to the first end 122p of the holder body 122a. The needle portion 122b is located inside the holder body 122a and is capable of puncturing the sealing portion 112b of the first vacuum container 112. The needle portion 122b extends inward from the first end 122p of the holder body 122a toward the opening 122e. The connecting tube 122c extends outward from the holder body 122a toward the first end 122p. The first tube 72 communicates with the needle portion 122b via the connecting tube 122c.

[0021] The sealing member 132 blocks the inflow of outside air between the first vacuum container 112 and the first holder 122. In this embodiment, the sealing member 132 includes a holder-side packing 132h and a container-side packing 132c. The materials used for the holder-side packing 132h and the container-side packing 132c are, for example, rubber or resin. Both the holder-side packing 132h and the container-side packing 132c are annular sealing members positioned between the outer circumferential surface 112s of the first vacuum container 112 and the inner circumferential surface 122s of the holder body 122a of the first holder 122.

[0022] Both the holder-side packing 132h and the container-side packing 132c prevent outside air from entering the space S between the first vacuum container 112 and the first holder 122. Therefore, the sterile state of the space S is maintained. Note that the first housing section 42 may be provided with only one of the holder-side packing 132h or the container-side packing 132c as the blocking member 132.

[0023] The container-side packing 132c is provided on the outer circumferential surface 112s of the first vacuum container 112. The container-side packing 132c is positioned in the annular groove 112g formed on the outer circumferential surface 112s of the first vacuum container 112. The inner circumference of the container-side packing 132c is in airtight contact with the outer circumferential surface 112s (annular groove 112g) of the first vacuum container 112 over its entire circumference. The outer circumference of the container-side packing 132c is in airtight contact with the inner circumferential surface 122s of the holder body 122a over its entire circumference.

[0024] In the initial state, the container-side packing 132c is located between the first end 122p and the second end 122q of the holder body 122a. The region formed between the outer circumferential surface 112s of the first vacuum container 112 and the inner circumferential surface 122s of the holder body 122a is called the annular region 200. The container-side packing 132c blocks the inflow of outside air into the inside (space S) of the holder body 122a at the location of the annular region 200.

[0025] The holder-side packing 132h is positioned at the second end 122q of the holder body 122a. The holder-side packing 132h is located inside the holder body 122a. The holder-side packing 132h is positioned in the annular groove 122g formed on the inner circumferential surface 122s of the holder body 122a. The inner circumferential portion of the holder-side packing 132h shown in Figure 2A is in airtight contact with the inner circumferential surface 122s (annular groove 122g) of the holder body 122a over its entire circumference. The outer circumferential portion of the holder-side packing 132h is in airtight contact with the outer circumferential surface 112s of the first vacuum container 112 over its entire circumference.

[0026] As shown in Figure 2A, in the initial state before the first vacuum container 112 is pushed inward into the holder body 122a, the sealing portion 112b of the first vacuum container 112 is separated from the needle portion 122b of the first holder 122. Also in the initial state, the top portion 112p of the first vacuum container 112, the container-side packing 132c, and the holder-side packing 132h are located inside the holder body 122a.

[0027] Figure 2B is a cross-sectional view of the first housing 42 in use. As shown in Figure 2B, when the first vacuum container 112 is pushed inward into the holder body 122a, the needle portion 122b of the holder body 122a of the first holder 122 punctures the sealing portion 112b of the first vacuum container 112. The puncture of the first vacuum container 112 by the needle portion 122b connects the first holder 122 to the first vacuum container 112. While the top portion 112p of the first vacuum container 112 is pushed inward into the holder body 122a of the first holder 122, the holder-side packing 132h slides along the outer circumferential surface 112s of the first vacuum container 112. At the same time, the container-side packing 132c slides along the inner circumferential surface 122s of the holder body 122a.

[0028] In Figure 1, the second holder 164 holds the second vacuum container 154 and is connectable to the second vacuum container 154. The second holder 164 is also able to communicate with the sampling tube 70 via the second tube 74. When the second holder 164 is connected to the second vacuum container 154, it enables communication between the inside of the second tube 74 and the inside of the second vacuum container 154.

[0029] The second housing section 44 includes a second pressure reducing container 154, a second holder 164, and a blocking member 174. The configuration of the second housing section 44 is the same as that of the first housing section 42 described above. Therefore, a description of the configuration of the second housing section 44 will be omitted.

[0030] The adapter 50 is connected to the first tube 72 and the second tube 74 via the transfer tube 76. The culture bottle 30 can be connected to the adapter 50 by inserting it into the opening of the adapter 50. The inside of the culture bottle 30 is under negative pressure.

[0031] Inside the adapter 50, a needle 50a capable of puncturing the rubber stopper of the culture bottle 30 is positioned. The needle 50a is covered by a rubber cover 50b. When the needle 50a pierces the rubber stopper of the culture bottle 30, the needle 50a penetrates the rubber cover 50b. When the culture bottle 30 is detached from the adapter 50, the rubber cover 50b again covers and seals the needle 50a. The adapter 50 may also have a film (not shown) that covers the opening of the adapter 50 in its initial state. From the initial state until the film is peeled off and the opening is exposed, a sterile state is maintained inside the adapter 50.

[0032] The air recovery member 60 is connected to the collection tube 70 via a tube 60a. A clamp 60b that can be opened and closed is attached to the tube 60a of the air recovery member 60. The material used for the air recovery member 60 is, for example, polyvinyl chloride, polyolefin, or polyurethane.

[0033] The switching mechanism 90 is attached to the tube member 180. In this embodiment, the switching mechanism 90 includes a first clamp 90A, a second clamp 90B, and a third clamp 90C. The switching mechanism 90 switches the communication state between the first holder 122, the second holder 164, and the adapter 50.

[0034] The first clamp 90A is attached to the first tube 72. When the first clamp 90A is open, the liquid sample can flow through the first tube 72. When the first clamp 90A is closed, the flow of the liquid sample through the first tube 72 is blocked.

[0035] The second clamp 90B is attached to the second tube 74. When the second clamp 90B is open, the liquid sample can flow through the second tube 74. When the second clamp 90B is closed, the flow of the liquid sample through the second tube 74 is blocked.

[0036] The third clamp 90C is attached to the transfer tube 76. When the third clamp 90C is open, the liquid sample can flow through the transfer tube 76. When the third clamp 90C is closed, the flow of the liquid sample through the transfer tube 76 is blocked.

[0037] The sample collection kit 10, configured as described above, is used as follows.

[0038] Figure 3 is a diagram illustrating the joining process for joining the tube 20a of the medical bag 20 to the collection tube 70 of the sample collection kit 10. In this joining process, the user joins one end of the tube 20a of the medical bag 20 to one end of the collection tube 70 using a sterile joining device. The first to third clamps 90A to 90C are closed before the joining process. The lumen of the tube 20a of the medical bag 20 and the lumen of the collection tube 70 are in communication with each other through the joint 220 thus formed.

[0039] The user opens the clamp 60b attached to the tube 60a of the air recovery member 60. The air recovery member 60 recovers the air discharged from the sampling tube 70 as the liquid sample moves from the medical bag 20 into the sampling tube 70 (air recovery process). The air recovered by the air recovery member 60 also includes the air that has moved from the medical bag 20 into the sampling tube 70. The user can also recover the air inside the medical bag 20 by pressing the medical bag 20 with their hand.

[0040] Figure 4 illustrates the first containment step of transferring a liquid sample from the medical bag 20 to the first vacuum container 112. In this first containment step, the user closes the clamp 60b and opens the first clamp 90A. The user pushes the first vacuum container 112 into the holder body 122a of the first holder 122 so that the top 112p of the first vacuum container 112 approaches the first end 122p of the first holder 122.

[0041] The user can connect the first holder 122 to the first vacuum container 112 while blocking the inflow of outside air with the holder-side packing 132h and the container-side packing 132c. Due to the negative pressure inside the first vacuum container 112, a predetermined amount of liquid sample is collected from the medical bag 20 into the first vacuum container 112 via the sampling tube 70 and the first tube 72.

[0042] Figure 5 illustrates the second containment step, in which the liquid sample is transferred from the medical bag 20 to the second vacuum container 154. In this second containment step, the user closes the first clamp 90A and opens the second clamp 90B. The user pushes the second vacuum container 154 into the second holder 164.

[0043] The user can connect the second holder 164 to the second vacuum container 154 while blocking the inflow of outside air with the blocking member 174. Due to the negative pressure inside the second vacuum container 154, a predetermined amount of liquid sample is collected from the medical bag 20 into the second vacuum container 154 via the sampling tube 70 and the second tube 74.

[0044] Figure 6 illustrates the sealing process for sealing the collection tube 70 of the sample collection kit 10 and separating the medical bag 20 from the sample collection kit 10. In this sealing process, the user closes the second clamp 90B, seals the collection tube 70 using a tube sealer, and cuts it. The sample collection kit 10 is separated from the medical bag 20. The user prepares a first culture bottle 30A to be used as a culture bottle 30 for collecting a predetermined amount of liquid sample contained in the first vacuum container 112.

[0045] Figure 7 shows the state after the liquid sample in the first vacuum container 112 has been transferred to the first culture bottle 30A in the first liquid sample collection step. After the sealing step described above, the user opens the first clamp 90A and the third clamp 90C. The absolute value of the negative pressure in the first culture bottle 30A is greater than the absolute value of the negative pressure in the first vacuum container 112. Therefore, when the user connects the prepared first culture bottle 30A to the adapter 50, the liquid sample is transferred from the first vacuum container 112 to the first culture bottle 30A due to the negative pressure in the first culture bottle 30A.

[0046] Figure 8 shows the state after the first culture bottle 30A has been detached from the adapter 50 in the first liquid sample collection step. After the liquid sample is transferred from the first vacuum container 112 to the first culture bottle 30A in the first collection step described above, the user closes the first clamp 90A and the third clamp 90C to detach the first culture bottle 30A from the adapter 50.

[0047] Figure 9 shows the state after the liquid sample in the second vacuum container 154 has been transferred to the second culture bottle 30B during the second liquid sample collection step. After the first culture bottle 30A is detached from the adapter 50, the user opens the second clamp 90B and the third clamp 90C to prepare the second culture bottle 30B. The absolute value of the negative pressure in the second culture bottle 30B is greater than the absolute value of the negative pressure in the second vacuum container 154. Therefore, when the user connects the prepared second culture bottle 30B to the adapter 50, the liquid sample is transferred from the second vacuum container 154 to the second culture bottle 30B due to the negative pressure in the second culture bottle 30B.

[0048] After the liquid sample is transferred from the second vacuum container 154 to the second culture bottle 30B in the second sampling step described above, the user closes the second clamp 90B and the third clamp 90C to detach the second culture bottle 30B from the adapter 50.

[0049] Furthermore, the liquid samples collected in the first culture bottle 30A and the second culture bottle 30B described above may be used for culturing aerobic bacteria and anaerobic bacteria, respectively. That is, the first culture bottle 30A may be an aerobic bacteria culture bottle, and the second culture bottle 30B may be an anaerobic bacteria culture bottle. Through the joining process, containment process, sealing process and collection process shown in Figures 3 to 7, the air in the collection tube 70, the first tube 72, and the transfer tube 76 is removed when the liquid sample is collected in the first culture bottle 30A.

[0050] As shown in Figure 3, the air in the collection tube 70 and the tube 60a is removed during the air recovery process, and as shown in Figure 4, the remaining air in the collection tube 70 is removed during the first containment process. Therefore, when the second containment process shown in Figure 5 is carried out, the only air that flows into the second depressurization container 154 is the air that was present in the second tube 74 and the needle portion 122b of the second holder 164.

[0051] Furthermore, the air inside the transfer tube 76 and the needle 50a is removed during the first sampling process shown in Figure 7. Therefore, the amount of air flowing into the second culture bottle 30B shown in Figure 9 is significantly less than the amount of air flowing into the first culture bottle 30A shown in Figure 7. By setting the length of the second tube 74 as short as possible without interfering with use, the amount of air flowing into the second culture bottle 30B can be minimized, and the second culture bottle 30B can be used for culturing anaerobic bacteria.

[0052] [Differentiation] The above-described embodiment may be modified as follows.

[0053] (Variation 1) Figure 10A is a cross-sectional view of the first housing section 42A in its initial state in modified example 1. The first holder 122A of the first housing section 42A shown in Figure 10A differs from the first holder 122 of the first housing section 42 shown in Figure 2A in that it has an annular projection 230. The projection 230 is provided on the inner circumferential surface 122s of the holder body 122a of the first holder 122A between the first end 122p and the second end 122q of the holder body 122a.

[0054] As shown in Figure 10A, in the initial state before the first vacuum container 112 is connected to the first holder 122A, the container-side packing 132c is located between the projection 230 and the second end portion 122q. Although a holder-side packing 132h is shown in Figure 10A, the holder-side packing 132h is not essential.

[0055] Figure 10B is a cross-sectional view of the first housing section 42A in use. While the top 112p of the first vacuum container 112 is pushed into the inside of the holder body 122a to connect the first vacuum container 112 to the first holder 122A, the container-side packing 132c slides along the inner circumferential surface 122s of the holder body 122a. When the first vacuum container 112 is connected to the first holder 122A, the container-side packing 132c moves over the projection 230.

[0056] This prevents the first vacuum container 112 from detaching from the first holder 122A. Figure 10B shows how the projection 230 supports the container-side packing 132c, preventing the first vacuum container 112 from detaching from the first holder 122A. Although not shown, the second holder 164 of the second housing section 44 in Modification 1 also has an annular projection similar to the first holder 122A of the first housing section 42A, but its explanation is omitted.

[0057] (Modification 2) In the above-described embodiment, the holder-side packing 132h and the container-side packing 132c, both of which are annular sealing members, are used as the blocking member 132. However, instead of these sealing members, a covering member that covers the annular region 200 between the outer circumferential surface 112s of the first vacuum container 112 and the inner circumferential surface 122s of the holder body 122a may be used as the blocking member 132.

[0058] Figure 11 is a cross-sectional view of the first housing section 42B in its initial state in the modified example 2. In this modified example, a bag member 132b is provided in the first housing section 42B as a covering member, covering the opening 122e at the second end 122q of the holder body 122a of the first holder 122B. The bag member 132b is transparent and flexible. The bag member 132b is attached annularly to the second end 122q of the holder body 122a and accommodates the bottom 112q of the first vacuum container 112. The material used for the bag member 132b is, for example, PET.

[0059] In the initial state of the first housing section 42B, the bag member 132b blocks the inflow of outside air into the holder body 122a. When the user operates the first housing section 42B to connect the first vacuum container 112 to the first holder 122B, the first vacuum container 112 can be pushed into the holder body 122a via the bag member 132b. The blockage of outside air is maintained even while the top 112p of the first vacuum container 112 is pushed into the holder body 122a. The blockage of outside air is also maintained when the first vacuum container 112 is connected to the first holder 122B.

[0060] (Variation 3) The covering member in Modification 2 is not limited to the bag member 132b. Figure 12 is a cross-sectional view of the first housing section 42C in its initial state in Modification 3. In this modification, a bellows-shaped membrane member 132f that covers the annular region 200 is provided in the first housing section 42C as a covering member. The membrane member 132f is attached annularly to the second end 122q of the holder body 122a and is also attached to the first vacuum container 112 so as to surround the first vacuum container 112 annularly.

[0061] In the initial state of the first housing section 42C, the membrane member 132f blocks the inflow of outside air into the holder body 122a. When the user operates the first housing section 42C to connect the first vacuum container 112 to the first holder 122C, the first vacuum container 112 can be pushed into the holder body 122a. As the first vacuum container 112 is pushed into the holder body 122a, the membrane member 132f contracts. The blockage of outside air is maintained even while the top 112p of the first vacuum container 112 is pushed into the holder body 122a. The blockage of outside air is also maintained when the first vacuum container 112 is connected to the first holder 122C.

[0062] (Modification 4) Figure 13 shows a modified example 4 in which a cross stopcock 92 is used as a switching mechanism 90 for the flow path of a liquid sample. The sampling tube 70, the first tube 72, the second tube 74, and the transfer tube 76 are connected to the cross stopcock 92. The cross stopcock 92 has a housing 92a, a flow path member 92b, and a lever 92d. Along the outer circumference of the housing 92a, four ports 93a to 93d are provided at 90° angular intervals, to which the sampling tube 70, the first tube 72, the transfer tube 76, and the second tube 74 are respectively connected.

[0063] The flow channel member 92b has an L-shaped flow channel 92c. By operating the lever 92d, the flow channel member 92b rotates relative to the housing 92a. Any two of the four ports 93a to 93d are connected by the flow channel member 92b. In this way, the flow path of the liquid sample is switched.

[0064] The cross stopcock 92 can be selectively switched between a first switching state, a second switching state, a third switching state, and a fourth switching state. The first switching state is a state in which the lumen of the sampling tube 70 and the lumen of the first tube 72 are connected. In the first switching state, port 93a and port 93b are connected via the flow path 92c. In the first containment step of containing a liquid sample from the medical bag 20 into the first vacuum container 112, the user sets the cross stopcock 92 to the first switching state.

[0065] The second switching state is a state in which the lumen of the sampling tube 70 and the lumen of the second tube 74 are connected. In the second switching state, port 93a and port 93d are connected via the flow path 92c. In the second storage step, in which the liquid sample is placed from the medical bag 20 into the second vacuum container 154, the user sets the cross stopcock 92 to the second switching state.

[0066] The third switching state is a state in which the lumen of the first tube 72 and the lumen of the transfer tube 76 are connected. In the third switching state, port 93b and port 93c are connected via the flow path 92c. In the first sampling step, in which the liquid sample in the first vacuum container 112 is transferred to the first culture bottle 30A, the user sets the cross stopcock 92 to the third switching state.

[0067] The fourth switching state is a state in which the lumen of the second tube 74 and the lumen of the transfer tube 76 are connected. In the fourth switching state, port 93d and port 93c are connected via the flow path 92c. In the second sampling step, in which the liquid sample in the second vacuum container 154 is transferred to the second culture bottle 30B, the user sets the cross stopcock 92 to the fourth switching state.

[0068] (Variation 5) Figure 14 shows a modified example 5 in which the adapter 50 includes a first adapter 50X and a second adapter 50Y. The first adapter 50X is connected to the first tube 72 via a transfer tube 76A. The first culture bottle 30A can be connected to the first adapter 50X by inserting it into the opening of the first adapter 50X. The second adapter 50Y is connected to the second tube 74 via a transfer tube 76B. The second culture bottle 30B can be connected to the second adapter 50Y by inserting it into the opening of the second adapter 50Y.

[0069] In this modified example, the switching mechanism 90 uses the same first clamp 90A and second clamp 90B as in the embodiment described above, but the third clamp 90C is not used. In the first liquid sample containment step, the user closes clamp 60b and opens the first clamp 90A (the second clamp 90B is closed). The user connects the first holder 122 to the first vacuum container 112. A predetermined amount of liquid sample is contained in the first vacuum container 112 from the medical bag 20.

[0070] In the second containment step, the user closes the first clamp 90A and opens the second clamp 90B. The user connects the second holder 164 to the second vacuum container 154. A predetermined amount of liquid sample is contained in the second vacuum container 154 from the medical bag 20. Once the liquid sample has been contained in the second vacuum container 154, the user closes the second clamp 90B to seal the collection tube 70. At this point, both the first clamp 90A and the second clamp 90B are closed.

[0071] In the first sampling step, the user connects the first culture bottle 30A to the first adapter 50X. The liquid sample is transferred from the first vacuum container 112 into the first culture bottle 30A. In the second sampling step, the user connects the second culture bottle 30B to the second adapter 50Y. The liquid sample is transferred from the second vacuum container 154 into the second culture bottle 30B. The first and second sampling steps may be performed sequentially with a time difference, or they may be performed simultaneously. The second sampling step may also be performed before the first sampling step.

[0072] [Invention obtained from the embodiment] The inventions that can be understood from the above embodiments are described below.

[0073] (1) The sample collection kit (10) includes a tubular member (180) to which a medical bag (20) can be connected, which forms a channel for a liquid sample inside, a storage section (42, 42A, 42B, 42C, 44) connected to the tubular member and having a vacuum container (112, 154) that guides a predetermined amount of the liquid sample into the interior by negative pressure and temporarily stores it, and a culture bottle (30, 30A, 30B) connected to the tubular member for collecting the liquid sample from the vacuum container. The device comprises an adapter (50, 50X, 50Y) to which a vacuum container can be connected, and the housing part further comprises a holder (122, 122A, 122B, 122C, 164) that holds the vacuum container and is connectable to the vacuum container, and which enables communication between the inside of the tube member and the inside of the vacuum container when connected to the vacuum container, and a blocking member (132, 132c, 132h, 132b, 132f) that blocks the inflow of outside air between the vacuum container and the holder. This allows a predetermined amount of liquid sample to be easily and accurately collected in a sterile state.

[0074] (2) The holder is formed in a cylindrical shape and has a holder body (122a) that holds the vacuum container so that it can move relative to the holder in the axial direction (AX) of the holder, and a needle portion (122b) that is disposed inside the holder body and can puncture the sealing portion (112b) of the vacuum container, and the needle portion may puncture the sealing portion as the vacuum container is pushed inside the holder body in order to connect the holder to the vacuum container. This allows the holder to be reliably connected to the vacuum container with a simple operation.

[0075] (3) The blocking member may be an annular sealing member positioned between the outer circumferential surface (112s) of the vacuum container and the inner circumferential surface (122s) of the holder body. This effectively blocks the inflow of outside air into the holder body.

[0076] (4) The sealing member includes a holder-side packing (132h) provided on the inner circumferential surface of the holder body, and the holder-side packing may slide along the outer circumferential surface of the vacuum container while the top portion (112p) of the vacuum container is pushed into the inside of the holder body in order to connect the vacuum container to the holder. This maintains the sterile state inside the holder body.

[0077] (5) The sealing member includes a container-side packing (132c) provided on the outer circumferential surface of the vacuum container, and the container-side packing may slide along the inner circumferential surface of the holder while the top of the vacuum container is pushed into the inside of the holder body in order to connect the vacuum container to the holder. This more effectively maintains the sterile state inside the holder body.

[0078] (6) The holder body has a first end (122p) connected to the tube member and a second end (122q) having an opening (122e) into which the vacuum container is inserted, and the sealing member includes a container-side packing (132c) provided on the outer circumferential surface of the vacuum container, and a projection (230) is provided on the inner circumferential surface of the holder body between the first end and the second end, and before the vacuum container is connected to the holder, the container-side packing is located between the projection and the second end, and when the vacuum container is connected to the holder, the container-side packing may overcome the projection, thereby preventing the vacuum container from detaching from the holder. This allows for stable collection of liquid samples.

[0079] (7) The blocking member may be a covering member that covers the annular region (200) formed between the outer circumferential surface (112s) of the vacuum container and the inner circumferential surface (122s) of the holder body. This makes it possible to easily realize a structure that blocks the inflow of outside air into the inside of the holder body.

[0080] (8) The holder body has an opening (122e) into which the vacuum container is inserted, and the covering member is attached annularly to the holder body so as to cover the opening and may also include a bag member (132b) that accommodates the bottom (112q) of the vacuum container. This maintains the sterile condition inside the holder body.

[0081] (9) The holder body has an opening into which the vacuum container is inserted, and the covering member may include a bellows-shaped membrane member (132f) that is attached annularly to the holder body so as to cover the annular region and is attached to the vacuum container so as to surround the vacuum container annularly. This maintains the sterile state inside the holder body. Furthermore, a covering member with good operability can be realized with less material.

[0082] (10) The vacuum container includes a first vacuum container (112) and a second vacuum container (154), and the holder includes a first holder (122, 122A, 122B, 122C) to which the first vacuum container is connected and a second holder (164) to which the second vacuum container is connected, and the sample collection kit may further include a switching mechanism (90, 90A, 90B, 90C, 92) for switching the communication state between the adapter and the first and second holders. This allows liquid samples to be collected into two culture bottles.

[0083] (11) The tubing member has a collection tube (70) that can be connected to the medical bag, a first tube (72) connected to the first holder, and a second tube (74) connected to the second holder, wherein the first holder can communicate with the collection tube via the first tube, and the second holder can communicate with the collection tube via the second tube, and the switching mechanism may have a first clamp (90A) attached to the first tube and a second clamp (90B) attached to the second tube. This allows liquid samples to be collected into two culture bottles with a simple structure.

[0084] (12) The tubing member has a sampling tube (70) that can be connected to the medical bag, and the switching mechanism has a cross stopcock (92) connected to the sampling tube, and the cross stopcock may be selectively switchable to a first switching state in which the sampling tube and the first holder are connected, a second switching state in which the sampling tube and the second holder are connected, a third switching state in which the first holder and the adapter are connected, and a fourth switching state in which the second holder and the adapter are connected. This makes it easy to switch the flow path of the liquid sample.

[0085] (13) The tube member has a collection tube (70) that can be connected to the medical bag, a first tube (72) connected to the first holder, and a second tube (74) connected to the second holder, wherein the first holder can communicate with the collection tube via the first tube, and the second holder can communicate with the collection tube via the second tube, and the switching mechanism has a first clamp (90A) attached to the first tube and a second clamp (90B) attached to the second tube, and the adapter may include a first adapter (50X) connected to the first tube and to which a first culture bottle (30A) is connected as the culture bottle, and a second adapter (50Y) connected to the second tube and to which a second culture bottle (30B) different from the first culture bottle is connected as the culture bottle. This makes it possible to efficiently collect liquid samples into two culture bottles.

[0086] (14) The tube member comprises a collection tube (70) connectable to the medical bag, a first tube (72) connected to the first holder, and a second tube (74) connected to the second holder, wherein the first holder can communicate with the collection tube via the first tube, and the second holder can communicate with the collection tube via the second tube, and the sample collection kit further comprises an air recovery member (60) connected to the collection tube, the air recovery member may recover air discharged from the collection tube as the liquid sample moves through the collection tube from the medical bag. If the liquid sample is collected together with air, there is a risk that the amount of liquid sample collected may fall below a predetermined amount, but this prevents such a problem from occurring.

[0087] (15) A method for collecting a sample using the sample collection kit, comprising: a joining step of joining the medical bag and the tube member; a receiving step of connecting the vacuum container to the holder while blocking the inflow of outside air with the blocking member, and using the negative pressure of the vacuum container to collect the liquid sample from the medical bag through the tube member into the vacuum container; and a collection step of connecting the culture bottle to the adapter, transferring the liquid sample from the vacuum container to the culture bottle using the negative pressure of the culture bottle, and detaching the culture bottle from the adapter. This allows a predetermined amount of liquid sample to be easily and accurately collected in a sterile state.

[0088] 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]

[0089] 10…Sample collection kit 20…Medical bag 30...Culture bottles 42, 44...Storage compartments 50...Adapter 60...Air recovery component 70...Collection tube 72...First tube 74...Second tube 76...Transfer tube 90... Switching mechanism 92... Cross stopcock 112...First vacuum chamber 122...First holder 132, 174... Shielding members 154... Second pressure reducing vessel 164...Second holder 180...Tube member 200...Annular region 220...Joint 230...Protrusion

Claims

1. A tubular member to which a medical bag can be connected and which forms a channel for liquid samples inside, A storage section having a vacuum container connected to the tube member, which guides a predetermined amount of the liquid sample into the interior by negative pressure and temporarily stores it, The system includes an adapter connected to the tube member, to which a culture bottle for collecting the liquid sample from the vacuum container can be connected, The aforementioned housing section is A holder that holds the vacuum container, is connectable to the vacuum container, and enables communication between the inside of the tube member and the inside of the vacuum container when connected to the vacuum container, A blocking member that prevents outside air from flowing between the vacuum container and the holder, Furthermore, The holder is formed in a cylindrical shape and has a holder body that holds the vacuum container so that it can move relative to the holder in the axial direction. The blocking member is an annular sealing member disposed between the outer circumferential surface of the vacuum container and the inner circumferential surface of the holder body. The sealing member includes a holder-side packing provided on the inner circumferential surface of the holder body, A sample collection kit in which, while the top of the vacuum container is pushed into the inside of the holder body in order to connect the vacuum container to the holder, the holder-side packing slides along the outer surface of the vacuum container.

2. A sample collection kit according to claim 1, The holder is positioned inside the holder body and further has a needle portion that can puncture the sealing portion of the vacuum container. A sample collection kit in which the needle portion punctures the sealing portion as the vacuum container is pushed inward into the holder body in order to connect the holder to the vacuum container.

3. A sample collection kit according to claim 1, The sealing member includes a container-side packing provided on the outer circumferential surface of the vacuum container, A sample collection kit, wherein the container-side packing slides along the inner circumferential surface of the holder body while the top of the vacuum container is pushed into the inside of the holder body in order to connect the vacuum container to the holder.

4. A tubular member to which a medical bag can be connected and which forms a flow path for a liquid sample inside, A storage section having a vacuum container connected to the tube member, which guides a predetermined amount of the liquid sample into the interior by negative pressure and temporarily stores it, The system includes an adapter connected to the tube member, to which a culture bottle for collecting the liquid sample from the vacuum container can be connected, The aforementioned housing section is A holder that holds the vacuum container, is connectable to the vacuum container, and enables communication between the inside of the tube member and the inside of the vacuum container when connected to the vacuum container, A blocking member that prevents outside air from flowing between the vacuum container and the holder, Furthermore, The aforementioned holder is, A holder body formed in a cylindrical shape, which holds the vacuum container so that it can move relative to the holder in the axial direction, It is positioned inside the holder body and has a needle portion that can puncture the sealing portion of the vacuum container, As the vacuum container is pushed inward into the holder body in order to connect the holder to the vacuum container, the needle portion is punctured into the sealing portion. The blocking member is an annular sealing member disposed between the outer circumferential surface of the vacuum container and the inner circumferential surface of the holder body. The holder body has a first end connected to the tube member and a second end having an opening into which the vacuum container is inserted. The sealing member includes a container-side packing provided on the outer circumferential surface of the vacuum container, A projection is provided on the inner circumferential surface of the holder body between the first end and the second end. Before the vacuum container is connected to the holder, the container-side packing is positioned between the projection and the second end. A sample collection kit in which, when the vacuum container is connected to the holder, the container-side packing overcomes the projection, thereby preventing the vacuum container from detaching from the holder.

5. A tubular member to which a medical bag can be connected and which forms a flow path for a liquid sample inside, A storage section having a vacuum container connected to the tube member, which guides a predetermined amount of the liquid sample into the interior by negative pressure and temporarily stores it, The system includes an adapter connected to the tube member, to which a culture bottle for collecting the liquid sample from the vacuum container can be connected, The aforementioned housing section is A holder that holds the vacuum container, is connectable to the vacuum container, and enables communication between the inside of the tube member and the inside of the vacuum container when connected to the vacuum container, A blocking member that prevents outside air from flowing between the vacuum container and the holder, Furthermore, The aforementioned holder is, A holder body formed in a cylindrical shape, which holds the vacuum container so that it can move relative to the holder in the axial direction, It is positioned inside the holder body and has a needle portion that can puncture the sealing portion of the vacuum container, As the vacuum container is pushed inward into the holder body in order to connect the holder to the vacuum container, the needle portion is punctured into the sealing portion. The sample collection kit is a sample collection kit in which the blocking member is a covering member that covers an annular region formed between the outer circumferential surface of the vacuum container and the inner circumferential surface of the holder body.

6. A sample collection kit according to claim 5, The holder body has an opening into which the vacuum container is inserted. The sample collection kit includes a covering member which is attached annularly to the holder body so as to cover the opening, and a bag member which accommodates the bottom of the vacuum container.

7. A sample collection kit according to claim 5, The holder body has an opening into which the vacuum container is inserted. The sample collection kit includes a bellows-shaped membrane member that is attached annularly to the holder body so as to cover the annular region and is attached to the vacuum container so as to surround the vacuum container annularly.

8. A sample collection kit according to any one of claims 1 to 7, The vacuum chamber includes a first vacuum chamber and a second vacuum chamber. The holder includes a first holder to which the first vacuum container is connected, and a second holder to which the second vacuum container is connected. The sample collection kit further comprises a switching mechanism for switching the communication state between the adapter, the first holder, and the second holder.

9. A sample collection kit according to claim 8, The aforementioned tube member is A collection tube that can be connected to the aforementioned medical bag, A first tube connected to the first holder, A second tube connected to the second holder, It has, The first holder is capable of communicating with the sampling tube via the first tube, The second holder is capable of communicating with the sampling tube via the second tube, The aforementioned switching mechanism is The first clamp attached to the first tube, The second clamp attached to the second tube, A sample collection kit that includes the following features.

10. A sample collection kit according to claim 8, The tube member has a collection tube that can be connected to the medical bag, The switching mechanism has a cross stopcock connected to the sampling tube, A sample collection kit in which the cross stopcock can be selectively switched between a first switching state in which the sampling tube and the first holder are connected, a second switching state in which the sampling tube and the second holder are connected, a third switching state in which the first holder and the adapter are connected, and a fourth switching state in which the second holder and the adapter are connected.

11. A sample collection kit according to claim 8, The aforementioned tube member is A collection tube that can be connected to the aforementioned medical bag, A first tube connected to the first holder, A second tube connected to the second holder, It has, The first holder is capable of communicating with the sampling tube via the first tube, The second holder is capable of communicating with the sampling tube via the second tube, The aforementioned switching mechanism is The first clamp attached to the first tube, The second clamp attached to the second tube, It has, The aforementioned adapter is A first adapter is connected to the first tube and to which the first culture bottle is connected as the culture bottle, A sample collection kit comprising a second adapter connected to the second tube and to which a second culture bottle, different from the first culture bottle, is connected as the culture bottle.

12. A sample collection kit, A tubular member to which a medical bag can be connected and which forms a channel for liquid samples inside, A storage section having a vacuum container connected to the tube member, which guides a predetermined amount of the liquid sample into the interior by negative pressure and temporarily stores it, The system includes an adapter connected to the tube member, to which a culture bottle for collecting the liquid sample from the vacuum container can be connected, The aforementioned housing section is A holder that holds the vacuum container, is connectable to the vacuum container, and enables communication between the inside of the tube member and the inside of the vacuum container when connected to the vacuum container, A blocking member that prevents outside air from flowing between the vacuum container and the holder, Furthermore, The vacuum chamber includes a first vacuum chamber and a second vacuum chamber. The holder includes a first holder to which the first vacuum container is connected, and a second holder to which the second vacuum container is connected. The sample collection kit further includes a switching mechanism for switching the communication state between the adapter, the first holder, and the second holder. The aforementioned tube member is A collection tube that can be connected to the aforementioned medical bag, A first tube connected to the first holder, A second tube connected to the second holder, It has, The first holder is capable of communicating with the sampling tube via the first tube, The second holder is capable of communicating with the sampling tube via the second tube, The sample collection kit further comprises an air recovery member connected to the sample collection tube, The air recovery member is a sample collection kit that recovers air discharged from the collection tube as the liquid sample moves through the collection tube from the medical bag.

13. A method for collecting samples using the sample collection kit described in claim 1, A joining step of joining the medical bag and the tube member, A storage step involves connecting the vacuum container to the holder while blocking the inflow of outside air with the blocking member, and using the negative pressure of the vacuum container to store the liquid sample from the medical bag into the vacuum container via the tubing member, A sampling step comprising connecting the culture bottle to the adapter, transferring the liquid sample from the vacuum container into the culture bottle using the negative pressure of the culture bottle, and detaching the culture bottle from the adapter, A sample collection method comprising the following features.

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