JP7808980B2 - Collection kit - Google Patents

Description

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

To ensure the safety of blood products, a small amount of liquid sample is collected and cultured before the product is shipped. For culture testing, a specified amount of liquid sample (blood product) is collected in a culture bottle, which is then stored for a specified period in a temperature environment of 30-40°C, which is favorable for bacterial growth. The growth of bacteria in the culture bottle is then confirmed.

A dedicated collection kit is used to collect liquid samples into a culture bottle. For example, Patent Document 1 discloses a collection kit for collecting liquid samples from blood bags. This collection kit collects a predetermined amount of liquid sample into a sample collection tube in advance. Next, the liquid sample is transferred to the culture bottle while checking the amount of liquid sample transferred using the markings on the sample collection tube.

U.S. Patent No. 8,777,921

With conventional collection kits, the liquid level in the collection bottle changes quickly due to suction caused by the negative pressure in the culture bottle. This makes it difficult for inexperienced workers to measure out a consistent amount of liquid sample and place it in the culture bottle, which can result in either too much or too little liquid sample being placed in the culture bottle. Furthermore, with conventional collection kits, there is a risk that the user may accidentally mix in air when transferring the liquid sample to the anaerobic culture bottle.

The present invention aims to solve the above-mentioned problems.

One aspect of the following disclosure is a collection kit comprising: a connection tube to which a medical bag containing a liquid sample can be connected; a syringe that communicates with the connection tube and contains a predetermined amount of the liquid sample; and a sampling holder that communicates with the syringe and to which a culture bottle can be connected, wherein the syringe has a barrel body, a gasket that slides inside the barrel body, and a plunger attached to the gasket, the barrel body has a capacity sufficient to contain the amount of liquid sample to be collected in two culture bottles, and the syringe has a stopper structure that abuts against the plunger and prevents the plunger from moving axially against the negative pressure of the culture bottle.

The collection kit described above allows the transfer of liquid sample to the culture bottle to be controlled by operating the syringe. Therefore, the collection kit allows even inexperienced operators to collect an accurate amount of liquid sample into the culture bottle. Furthermore, a gasket separates the liquid sample from the air inside the barrel body, preventing air from entering the culture bottle used for anaerobic culture.

FIG. 1 is a plan view of a collection kit according to a first embodiment. FIG. 2 is a cross-sectional view of the collection kit of FIG. 3A is a perspective view of a plunger assembly of the syringe of FIG. 1, and FIG. 3B is a perspective cross-sectional view of a barrel body of the syringe of FIG. 4A is a plan view showing a step of connecting a platelet bag to the collection kit of FIG. 1, and FIG. 4B is a cross-sectional view showing a step of collecting a liquid sample (platelet preparation) into the syringe of FIG. 4A. Figure 5A is an explanatory diagram showing the process of connecting the first culture bottle to the collection kit of Figure 4B, and Figure 5B is a cross-sectional view showing the operation of the syringe when transferring a liquid sample to the first culture bottle. Figure 6A is an explanatory diagram showing the process of removing the first culture bottle from the collection kit of Figure 5A and connecting the second culture bottle, and Figure 6B is a cross-sectional view showing the operation of the syringe when transferring a liquid sample to the second culture bottle. FIG. 7A is a plan view of a syringe according to a modified example of the first embodiment, and FIG. 7B is a perspective cross-sectional view of a barrel body of the syringe of FIG. 7A. FIG. 8A is a perspective view of a gasket and a plunger of a syringe according to a second embodiment, and FIG. 8B is a perspective cross-sectional view of a barrel body of the syringe according to the second embodiment. FIG. 9A is a cross-sectional view of a syringe according to a third embodiment, and FIG. 9B is a diagram illustrating the operation of the syringe of FIG. 9A. FIG. 10 is an explanatory diagram showing a modified example of the syringe of FIG.

(First embodiment)
The collection kit 10 according to this embodiment shown in FIG. 1 is used, for example, in a culture test to confirm the safety of blood products at a facility such as a blood center that produces blood products. The culture test involves culturing anaerobic bacteria and aerobic bacteria. Therefore, two culture bottles 90 (see FIG. 6A ), one for aerobic culture and one for anaerobic culture, are used in the culture test. The collection kit 10 is used to collect a liquid sample, such as a platelet product, and to collect predetermined amounts (e.g., 8 ml or 10 ml) of the liquid sample into an aerobic culture bottle 92 and an anaerobic culture bottle 94, respectively.

As shown in FIG. 1, the collection kit 10 comprises a connecting tube 12, a syringe 14, a sampling holder 16, a three-way stopcock 18, and a second tube 20. The connecting tube 12 and the second tube 20 are translucent medical tubes made of thermoplastic resin such as polyvinyl chloride resin. By using a sterile joining device, the connecting tube 12 can be connected to other medical tubes without exposing the interior to the outside air. Furthermore, by using a tube sealer, the connecting tube 12 can be separated from other medical tubes and the ends sealed without exposing the interior to the outside air.

The connecting tube 12 has a first end 12a on the upstream side and a second end 12b on the downstream side. The first end 12a is welded and sealed in the initial state (when the product is first provided). The second end 12b is connected to the first port 18a of the three-way stopcock 18.

The three-way stopcock 18 connects the connection tube 12, syringe 14, and sampling holder 16. The three-way stopcock 18 has a first port 18a, a second port 18b, a third port 18c, and a flow path switching cock 18d. The connection tube 12 is connected to the first port 18a. The sampling holder 16 is connected to the second port 18b. The syringe 14 is connected to the third port 18c via the second tube 20.

The flow path switching cock 18d has a T-shaped flow path 18e as shown in Figure 2. In its initial first position, the flow path switching cock 18d fluidly connects the connecting tube 12 and the second tube 20 (and the syringe 14) as shown. In the first position, the flow path switching cock 18d blocks fluid communication between the sampling holder 16 and the connecting tube 12 and syringe 14.

When in a second position rotated 180° from the first position, the flow path switching cock 18d fluidly connects the sampling holder 16, the connecting tube 12, and the syringe 14.

The second tube 20 connects the three-way stopcock 18 and the syringe 14. One end of the second tube 20 is connected to the third port 18c of the three-way stopcock 18, and the other end is connected to the nozzle 34 of the syringe 14. The second tube 20 is a medical tube with the same flexibility as the connecting tube 12. The second tube 20 serves both as a path for introducing the liquid sample from the platelet bag 100 into the syringe 14 and as a path for transferring the liquid sample from the syringe 14 to the culture bottle 90.

The syringe 14 includes a barrel body 22, a gasket 24, and a plunger 26. The barrel body 22 has a cylindrical main body portion 30, and the gasket 24 and plunger 26 are housed in the housing space 36 of the main body portion 30.

As shown in FIG. 3A, the gasket 24 and plunger 26 are assembled together to form a plunger assembly 27. As shown in FIG. 2, the base end of the plunger 26 protrudes toward the base end of the barrel body 22. The plunger 26 displaces integrally with the gasket 24. The plunger 26 transmits the operating force of the user to the gasket 24.

The plunger 26 has a first uneven structure 25, a flange 26b, and a gasket mounting portion 26c. The first uneven structure 25 is, for example, a pair of protrusions 26a. The protrusions 26a are rod-shaped members that protrude radially outward from the central axis of the plunger 26. The pair of protrusions 26a are located approximately midway between the flange 26b located at the base end and the gasket mounting portion 26c located at the tip end. The pair of protrusions 26a are arranged 180° apart in the circumferential direction. The number of protrusions 26a is not limited to two, and may be one or three or more.

The protrusion 26a is formed integrally with the plunger 26. The distance from the central axis of the plunger 26 to the tip (radially outer end) of the protrusion 26a is set to a value slightly smaller than half the inner diameter of the barrel body 22. Therefore, within the barrel body 22, the protrusion 26a is located near the inner circumferential surface 40 of the barrel body 22.

The gasket 24 has an outer diameter that allows it to be inserted into the storage space 36 of the barrel body 22. The outer peripheral surface 24a of the gasket 24 is a smooth cylindrical surface, and it can slide axially while making liquid-tight contact with the inner peripheral surface 40 of the barrel body 22. The gasket 24 is attached to the plunger 26 by the gasket attachment portion 26c. The gasket 24 moves integrally with the plunger 26.

The barrel body 22 has a cylindrical body portion 30, a neck portion 32 formed at the tip of the body portion 30, and a nozzle 34 protruding from the tip of the neck portion 32 toward the tip. As shown in FIG. 2 , the body portion 30 has a cylindrical storage space 36 inside. The storage space 36 opens at the base end. A gasket 24 is stored in the storage space 36. The gasket 24 is inserted through the opening at the base end of the storage space 36. The tip side of the storage space 36 is covered by the neck portion 32. The storage space 36 between the gasket 24 and the neck portion 32 forms a storage section 38 that is liquid-tightly sealed by the gasket 24. The storage section 38 stores a liquid sample. Note that in the initial state, the gasket 24 abuts the neck portion 32, and the volume of the storage section 38 is zero.

The inner circumferential surface 40 of the main body 30 surrounds the storage space 36. The inner circumferential surface 40 has a smooth cylindrical surface. The inner circumferential surface 40 allows the gasket 24 to slide smoothly while maintaining liquid-tight and airtight properties. The barrel body 22 has a second uneven structure 23. The second uneven structure 23 is, for example, a guide rail 42 protruding from the inner circumferential surface 40. The guide rail 42 has a pair of linear protrusions 44 and a guide groove 46. The pair of linear protrusions 44 have a crank shape and are spaced a certain distance apart. The guide groove 46 is formed between the pair of linear protrusions 44. The guide groove 46 has a width sufficient to accommodate the protrusion 26a of the plunger 26. The guide groove 46 slidably accommodates the protrusion 26a, thereby restricting the direction in which the plunger 26 can move.

The guide groove 46 has a crank shape and includes a first axial groove 46a and a second axial groove 46b that extend axially, and a circumferential groove 46c that extends circumferentially perpendicular to the axial direction. The first axial groove 46a and the second axial groove 46b are connected via the circumferential groove 46c. The first axial groove 46a and the second axial groove 46b are offset at different angles circumferentially. Therefore, when the plunger 26 moves significantly in the axial direction, the protrusion 26a of the plunger 26 enters the circumferential groove 46c. The protrusion 26a of the plunger 26 abuts against the linear protrusion 44 adjacent to the circumferential groove 46c, thereby restricting the axial movement of the plunger 26. The guide rail 42 and the protrusion 26a form a stopper structure 28 that restricts the axial movement of the plunger 26.

When the plunger 26 is rotated circumferentially, the protrusion 26a of the plunger 26 moves along the circumferential groove 46c. When the protrusion 26a moves from the first axial groove 46a to the second axial groove 46b (or vice versa), the restriction on axial movement of the plunger 26 by the stopper structure 28 is released.

The circumferential groove 46c stops the plunger 26 at an intermediate axial position. The intermediate position is a stop position of the plunger 26 corresponding to the position where the amount of liquid sample contained in the syringe 14 is the amount for one culture bottle 90. When the plunger 26 stops at the intermediate position, the volume of the storage section 38 is, for example, 8 ml or 10 ml, which is equal to the amount of liquid sample to be collected in one culture bottle 90.

The barrel body 22 is provided with the above-mentioned guide rails 42, the number of which corresponds to the number of protrusions 26a on the plunger 26. In the illustrated example, two guide rails 42 are arranged circumferentially, spaced 180° apart.

The barrel body 22 is made of a transparent resin material, allowing the liquid sample and air bubbles contained therein to be visually observed. Marked lines 35 are placed on the outer periphery of the barrel body 22 at locations corresponding to the first and second stop positions (see Figure 1).

As shown in FIG. 10 , the syringe 14 may further include a sealing member 49 connecting the base end of the barrel body 22 and the plunger 26. The sealing member 49 is a tubular member formed from a flexible resin sheet or the like. One end of the sealing member 49 is connected to the base end of the barrel body 22, and the other end is connected to the base end of the plunger 26. The sealing member 49 is bellows-shaped. The sealing member 49 deforms from a folded bellows-like shape to an extended tubular shape depending on the position of the plunger 26. That is, the sealing member 49 follows the displacement of the plunger 26 as the bellows expand. The sealing member 49 seals the gap between the plunger 26 and the barrel body 22 from the outside air, maintaining the sterility of the storage space 36. By preventing bacterial adhesion to the inner wall of the barrel body 22, the sealing member 49 prevents false positives in tests in which a formulation is deemed contaminated despite being sterile.

As shown in FIG. 2, the sampling holder 16 has a needle tube 50, a needle hub 52, and a cap 54. The needle tube 50 is inserted into and penetrates the stopper 96 of the culture bottle 90 (described below). The needle tube 50 has an internal lumen 50a. When the needle tube 50 penetrates the stopper 96, the lumen 50a communicates with the internal space of the culture bottle 90. The needle hub 52 supports the base of the needle tube 50. The needle hub 52 has a flow path 52a that communicates with the lumen 50a. The needle hub 52 also has a cylindrical portion 52b that holds the inlet of the culture bottle 90.

The sampling holder 16 has a cap 54 to prevent bacterial adhesion to the needle 50. In the initial state, the cap 54 covers and closes the cylindrical portion 52b. The needle 50 is sealed between the cylindrical portion 52b of the needle hub 52 and the cap 54. The cap 54 is releasably connected to the needle hub 52 by a hinge portion 56. When the cap 54 is opened, the needle 50 is exposed. The needle hub 52 has an internal flow path 52a that communicates with the second port 18b of the three-way stopcock 18.

The collection kit 10 of this embodiment is configured as described above. This collection kit 10 is used as follows.

As shown in Figure 4A, first, a platelet bag 100 (medical bag) containing a platelet preparation is connected to the connecting tube 12 of the collection kit 10. This process is performed by joining the tube 102 extending from the platelet bag 100 to the connecting tube 12 using a sterile joining device.

Next, as shown in Figure 4B, a step is performed in which a liquid sample (a part of the platelet preparation) is placed in the syringe 14. Prior to this step, a step is performed in which the air inside the connecting tube 12 and the second tube 20 is replaced with the liquid sample. This step is performed by, for example, compressing the connecting tube 12 and the second tube 20 with the platelet bag 100 positioned above.

The plunger 26 of the syringe 14 is then retracted toward the base end, thereby storing the liquid sample in the storage section 38 of the syringe 14. During this operation, the plunger 26 may be moved back and forth in small increments in the axial direction to remove air bubbles from inside the syringe 14. When the plunger 26 reaches the second stop position, the axial movement of the plunger 26 is prevented by the stopper structure 28. By rotating the plunger 26 circumferentially by a predetermined angle, the prevention of axial movement of the plunger 26 by the stopper structure 28 is released.

Furthermore, as the plunger 26 is retracted, the amount of liquid sample contained in the storage section 38 increases. The retraction of the plunger 26 is stopped when the tip of the gasket 24 coincides with the marked line 35 on the base end side (first stop position). Through these operations, the syringe 14 contains the amount of liquid sample necessary to collect in two culture bottles 90.

Then, the platelet bag 100 is separated from the collection kit 10. This step is performed by cutting and separating the tubing 102 of the platelet bag 100 and the connecting tubing 12 while welding the cut portions using a tube sealer.

Next, as shown in Figure 5A, a process is performed in which a liquid sample is placed in the first culture bottle 90. In this process, the first culture bottle 90 is connected to the sampling holder 16 of the collection kit 10. The first culture bottle 90 is an aerobic culture bottle 92. The flow path switching cock 18d is then rotated to the second position. With the flow path switching cock 18d in the second position, communication is established between the sampling holder 16, the second tube 20, and the connection tube 12.

The aerobic culture bottle 92 has a negative pressure inside, which causes it to suck in the liquid sample from the syringe 14. The negative pressure causes the plunger assembly 27 to displace axially toward the tip. The protrusion 26a of the plunger 26 moves along the first axial groove 46a of the guide rail 42. As shown in Figure 5B, when the plunger 26 reaches the intermediate stop position, the protrusion 26a enters the circumferential groove 46c and abuts against the linear protrusion 44. As a result, the stopper structure 28 restricts the axial movement of the plunger 26. The transfer of the liquid sample to the aerobic culture bottle 92 is stopped.

At this point, a predetermined amount (e.g., 8 ml or 10 ml) of liquid sample is collected in the aerobic culture bottle 92. In this embodiment, the collection kit 10 reliably stops the plunger 26 at the intermediate stop position, allowing even inexperienced operators to collect an accurate amount of liquid sample in the aerobic culture bottle 92.

As the liquid sample is transferred to the aerobic culture bottle 92, air within the lumen 50a of the needle tube 50 and the flow path 52a of the needle hub 52 is expelled into the aerobic culture bottle 92. In other words, the transfer of the liquid sample to the aerobic culture bottle 92 also serves as a priming process, replacing the lumen 50a and flow path 52a with the liquid sample. This process prevents air from being mixed into the anaerobic culture bottle 94 later.

Then, as shown in FIG. 6A, the aerobic culture bottle 92 is removed from the collection kit 10. Next, a liquid sample is collected in the second culture bottle 90. The second culture bottle 90 is the anaerobic culture bottle 94. The plunger 26 is then rotated circumferentially by a predetermined angle. This operation causes the protrusion 26a (see FIG. 3A) of the plunger 26 to move circumferentially along the circumferential groove 46c (see FIG. 3B) and into the second axial groove 46b. This operation releases the stopper structure 28 from preventing the plunger 26 from moving axially. Note that the operation of rotating the plunger 26 may be performed after the aerobic culture bottle 92 is removed from the collection kit 10 and before the anaerobic culture bottle 94 is connected.

The negative pressure inside the anaerobic culture bottle 94 causes the liquid sample in the storage portion 38 of the syringe 14 to be drawn into the anaerobic culture bottle 94. The plunger 26 of the syringe 14 is displaced axially toward the tip. The transfer of the liquid sample to the anaerobic culture bottle 94 continues until the gasket 24 abuts against the neck 32, as shown in Figure 6B. When the gasket 24 abuts against the neck 32, the transfer of the liquid sample is complete.

This process completes the collection of a predetermined amount (e.g., 8 ml or 10 ml) of liquid sample into the anaerobic culture bottle 94. In the collection kit 10 of this embodiment, the liquid sample is isolated from air by the gasket 24. Therefore, even when the anaerobic culture bottle 94 is under negative pressure, the syringe 14 can prevent air from entering the anaerobic culture bottle 94.

Then, the anaerobic culture bottle 94 is removed from the collection kit 10. This completes the collection of liquid samples into the aerobic culture bottle 92 and the anaerobic culture bottle 94.

(Modification of the first embodiment)
The collection kit 10 of the first embodiment is not limited to the above example. As shown in FIG. 7A , the collection kit 10 of this modified example includes a connecting tube 12, a syringe 14, a sampling holder 16, a three-way stopcock 18, and an air vent 19. The air vent 19 is attached to the end of the connecting tube 12. The air vent 19 includes a filter that allows air to pass through but prevents liquid from passing through. The air vent 19 allows air to be discharged from within the flow path of the collection kit 10.

Furthermore, in this modification, the syringe 14 has a guide groove 46A as the second uneven structure 23A. The guide groove 46A is formed by penetrating the outer peripheral wall of the barrel body 22. As shown in FIG. 7B , the guide groove 46A has a first axial groove 46a and a second axial groove 46b extending in the axial direction, and a circumferential groove 46c extending in the circumferential direction. The first axial groove 46a is located on the base end side, and the second axial groove 46b is located on the tip end side. The first axial groove 46a and the second axial groove 46b are located at different circumferential positions. The circumferential groove 46c connects the first axial groove 46a and the second axial groove 46b. The circumferential groove 46c constitutes a stopper structure 28 that restricts axial movement of the plunger 26.

As shown in Figure 7A, a protrusion 26a protruding radially outward from the side of the plunger 26 is inserted into the guide groove 46A. The tip of the protrusion 26a protrudes outward from the barrel body 22. The protrusion 26a slides within the guide groove 46A. The movement direction of the plunger 26 is restricted by the protrusion 26a and the guide groove 46A. The collection kit 10 in Figure 7A functions in the same way as the collection kit 10 in Figure 1, and the stopper structure 28 of the guide groove 46A allows a predetermined amount of liquid sample to be collected into two culture bottles 90.

Second Embodiment
A syringe 14A of this embodiment shown in Figures 8A and 8B can be used in place of the syringe 14 of Figure 1. In the description of this embodiment, only the main parts of the syringe 14A will be described, and detailed description of other components will be omitted. In the configuration of the syringe 14A, components similar to those of the syringe 14 of Figure 1 will be assigned the same reference numerals, and detailed description thereof will be omitted.

As shown in FIG. 8A, the syringe 14A has a plunger 26A. The plunger 26A has a stopper plate 58 at a predetermined position near the center in the axial direction. The stopper plate 58 has a circular plate shape that extends in a direction perpendicular to the axial direction. The diameter of the stopper plate 58 is smaller than the inner diameter of the barrel body 22A. Therefore, the stopper plate 58 is housed inside the barrel body 22A and is movable in the axial direction.

The stopper plate 58 has a notch 58a in part of its circumferential direction. The notch 58a extends at a constant width in the radial direction of the stopper plate 58. The width of the notch 58a is greater than the width of the restricting protrusion 60, which will be described later. Therefore, the notch 58a serves as a passage through which the restricting protrusion 60 passes in the axial direction.

As shown in FIG. 8B , the barrel body 22A has a restricting protrusion 60 at a predetermined position on the main body portion 30. The restricting protrusion 60 is a short protrusion that protrudes inward from the inner circumferential surface 30a of the main body portion 30. The protrusion height of the restricting protrusion 60 on the inner circumferential surface 30a is set to a height that allows it to abut against the stopper plate 58. By abutting against the stopper plate 58, the restricting protrusion 60 restricts the axial movement of the plunger 26A. That is, in the syringe 14A of this embodiment, the stopper plate 58 and the restricting protrusion 60 form the stopper structure 28A.

When the plunger assembly 27 is rotated to align the circumferential position of the notch 58a with the position of the restricting protrusion 60, the stopper plate 58 can pass through the restricting protrusion 60, and the restriction on axial movement of the plunger assembly 27 is released. The restricting protrusion 60 prevents the plunger assembly 27 from moving toward the tip at a position where the volume of the storage compartment 38 (see Figure 5B, etc.), which is liquid-tightly sealed by the gasket 24, reaches a predetermined volume (e.g., 8 ml or 10 ml), making it easier to collect a predetermined volume of liquid sample.

The syringe 14A of this embodiment has the same effects as the syringe 14 in Figure 1.

(Third embodiment)
The syringe 14B of this embodiment shown in Figure 9A can be used in place of the syringe 14 of Figure 1. In the description of this embodiment, only the main parts of the syringe 14B will be described, and detailed description of other components will be omitted. In the configuration of the syringe 14B, components similar to those of the syringe 14 of Figure 1 will be assigned the same reference numerals, and detailed description thereof will be omitted.

The syringe 14B has a plunger assembly 27 with a plunger 26B and a barrel body 22B. The plunger 26B has a pair of arms 62 that protrude radially outward at predetermined axial positions. The pair of arms 62 are spaced 180° apart circumferentially. The arms 62 are long enough that their tips are positioned slightly outside the inner diameter of the main body 30 of the barrel body 22B. As a result, the arms 62 are slightly curved inside the barrel body 22B. Due to their elastic restoring force, the arms 62 slide while constantly biased against the inner circumferential surface 30a of the main body 30.

The barrel body 22B has a first annular groove 64 and a second annular groove 66 at predetermined axial positions of the main body portion 30. The first annular groove 64 and the second annular groove 66 are grooves recessed into the inner circumferential surface 30a of the main body portion 30 and extend in an annular shape over the entire circumferential area. The first annular groove 64 and the second annular groove 66 have a width (axial dimension) large enough to accommodate the tip of the arm portion 62.

As shown in FIG. 9B , the first annular groove 64 and the second annular groove 66 engage with the arm portion 62, thereby restricting axial movement of the plunger assembly 27. When the user presses or pulls the plunger assembly 27, the arm portion 62 disengages from the first annular groove 64 or the second annular groove 66, thereby releasing the restriction on axial movement of the plunger assembly 27. In this way, the stopper structure 28B of this embodiment is composed of the first annular groove 64 and/or the second annular groove 66 and the arm portion 62.

As shown in FIG. 9B, the first annular groove 64 is positioned to engage with the arm portion 62 when the volume of the storage chamber 38 at the tip of the gasket 24 reaches a predetermined amount (e.g., 8 ml or 10 ml). The second annular groove 66 is formed in a position to engage with the arm portion 62 when the volume of the storage chamber at the tip of the gasket 24 reaches twice the predetermined amount (e.g., 16 ml or 20 ml). In this way, the syringe 14A of this embodiment restricts the movement of the plunger assembly 27 at a position corresponding to the collection amount of the culture bottle 90, thereby reducing variation in the collection amount of the liquid sample.

The above-described embodiments of the present invention are summarized below.

A collection kit 10 according to one aspect comprises a connection tube 12 to which a medical bag containing a liquid sample can be connected; a syringe 14 that communicates with the connection tube and contains a predetermined amount of the liquid sample; and a sampling holder 16 that communicates with the syringe and to which a culture bottle 90 can be connected. The syringe has a barrel body 22, a gasket 24 that slides inside the barrel body, and plungers 26, 26A, 26B attached to the gasket. The barrel body has a capacity sufficient to contain the amount of liquid sample to be collected in two culture bottles. The syringe has stopper structures 28, 28A, 28B that abut against the plungers at predetermined positions and prevent axial movement of the plungers against the negative pressure of the culture bottles.

In the collection kit described above, the plunger is stopped by a stopper structure, so even an unskilled operator can easily collect a predetermined amount of liquid sample into the aerobic culture bottle 92 and the anaerobic culture bottle 94. It also eliminates the risk of air getting into the anaerobic culture bottle. Furthermore, because the entire volume of liquid sample in the syringe can be collected into the culture bottle without air getting mixed in, the amount of valuable liquid sample, such as platelet preparations, collected can be reduced.

The stopper structure has a first uneven structure 25 formed on the plunger and a second uneven structure 23 formed on the barrel body that engages with the first uneven structure of the plunger at a predetermined position. The first uneven structure and the second uneven structure may engage at an intermediate stop position where the syringe contains one amount of the liquid sample for one culture bottle, releasably preventing movement of the plunger in the axial direction. This stopper structure stops the plunger when the transfer of one amount of liquid sample for one culture bottle is completed, allowing even an unskilled operator to collect an accurate amount of liquid sample into the culture bottle.

The first uneven structure is a protrusion 26a that protrudes radially outward from the plunger, and the second uneven structure may be a guide rail 42 formed on the inner surface 40 of the barrel body and having a guide groove 46 that receives and slides the protrusion. The stopper structure 28 described above has a simple configuration consisting of the guide groove 46 and the protrusion 26a, and can reliably prevent the plunger 26 from moving in the axial direction.

The first uneven structure is a protrusion that protrudes radially outward from the plunger, and the second uneven structure may be formed by cutting out the barrel body and have a guide groove 46A that receives and allows the protrusion to slide. This collection kit uses a cutout structure that is easier to manufacture and can achieve a stopper structure that releasably blocks mid-axial movement of the plunger.

The guide groove may have a circumferential groove 46c extending in the circumferential direction, a first axial groove extending from one end of the circumferential groove toward the base end in the axial direction, and a second axial groove extending from the other end of the circumferential groove toward the tip end in the axial direction, and the circumferential groove may restrict axial movement of the plunger. The guide groove can prevent axial movement of the plunger at a predetermined position. Furthermore, the stopper structure having the guide groove can release the prevention of axial movement of the plunger by rotating the plunger.

The collection kit may further include an air vent 19 connected to the connecting tube for discharging air from the internal flow path. The use of an air vent in this collection kit makes it easy to discharge air from the flow path, more effectively preventing air from entering the culture bottle.

The collection kit described above includes a second tube 20 connected to the nozzle of the syringe, and a three-way stopcock 18 connecting the second tube, the connecting tube, the sampling holder, and the syringe, and the second tube may serve as both a path for transferring the liquid sample from the connecting tube to the syringe and a path for transferring the liquid sample from the syringe to the sampling holder. This collection kit can more effectively prevent the risk of air being mixed in when collecting a liquid sample into an anaerobic culture bottle, reducing the risk of false positives in anaerobic culture tests.

The present invention is not limited to the above-described embodiment, and various configurations are possible without departing from the spirit of the present invention.

DESCRIPTION OF SYMBOLS 10... Collection kit 12... Connection tube 14, 14A, 14B... Syringe 16... Sampling holder 18... Three-way stopcock 20... Second tube 22, 22A, 22B... Barrel body 23, 23A... Second uneven structure 24... Gasket 25... First uneven structure 26, 26A, 26B... Plunger 26a... Protrusion 28, 28A, 28B... Stopper structure 42... Guide rail 46... Guide groove 46c... Circumferential groove

Claims (6)

a connecting tube to which a medical bag containing a liquid sample can be connected;
a syringe communicating with the connecting tube and containing a predetermined amount of the liquid sample;
a sampling holder that communicates with the syringe and to which a culture bottle can be connected;
The syringe includes a barrel body, a gasket that slides inside the barrel body, and a plunger attached to the gasket,
the barrel body has a volume capable of accommodating the amount of the liquid sample to be collected in the two culture bottles;
The syringe comprises:
a stopper structure including a first uneven structure formed on the plunger and a second uneven structure provided on the barrel body and engaging with the first uneven structure;
the second uneven structure has a stopper formed of a groove or a protrusion in a part of the circumferential direction of the barrel body at an intermediate stop position where the syringe accommodates one amount of the liquid sample in the culture bottle,
The first uneven structure engages with the stopper, thereby preventing the plunger from moving in the axial direction against the negative pressure of the culture bottle at the intermediate stop position ;
the stopper structure disengages the second concave-convex structure from the first concave-convex structure by rotating the plunger;
Collection kit. 10. The collection kit of claim 1 ,
the first uneven structure is a protrusion protruding radially outward from the plunger,
A collection kit, wherein the second uneven structure is a guide rail formed on the inner surface of the barrel body and having a guide groove that receives and slides the protrusion. 10. The collection kit of claim 1 ,
the first uneven structure is a protrusion protruding radially outward from the plunger,
The second uneven structure is formed by cutting out the barrel body and has a guide groove that receives and slides the protrusion. 4. The collection kit according to claim 2 or 3 , wherein the guide groove is:
a circumferential groove extending in a circumferential direction;
a first axial groove extending from one end of the circumferential groove toward a base end in the axial direction;
a second axial groove extending from the other end of the circumferential groove toward a tip end in the axial direction,
The collection kit, wherein the circumferential groove restricts the axial movement of the plunger. The collection kit according to any one of claims 1 to 4 , further comprising an air vent connected to the connecting tube for discharging air from the internal flow path. The collection kit according to any one of claims 1 to 5 ,
a second tube connected to the nozzle of the syringe;
a three-way stopcock that connects the second tube, the connecting tube, the sampling holder, and the syringe;
The second tube serves as a path for transferring the liquid sample from the connecting tube to the syringe and also as a path for transferring the liquid sample from the syringe to the sampling holder.