Sample collection device and sample collection kit

Abstract

[Problem] To provide a specimen collection device and a specimen collection kit that are capable of restricting a specimen from flowing out into a collection container. [Solution] A specimen collection device according to an embodiment of the present invention comprises: a tube path configured to cause a specimen flowing into a first end portion from the outside of a container that is depressurized for collection of the specimen, to flow out into the container through a second end portion disposed opposite to the first end portion; a holding member configured to hold the container and the tube path; and a restriction member configured to cause the specimen to flow out into the container when opened, and to restrict the specimen from flowing out into the container when closed.

Description

Technical Field

[0001] The present disclosure relates to a sample collection device and a sample collection kit for collecting samples from animals including humans for sample testing. relates to.

Background Art

[0002] For clinical examinations in medical care targeting humans and other animals, sample testing for examining liquid samples such as blood and urine may be performed. For example, when the sample is blood, a method may be adopted in which blood is collected from a subject using a syringe, and then the injection needle of the syringe is pierced through the lid of a collection container such as a decompressed test tube to allow blood to flow into the collection container. For example, Patent Documents 1 and 2 disclose sample collection devices that collect blood as a sample.

[0003] However, when using the sample collection devices as disclosed in these documents, operations for regulating the start and stop of the outflow of the sample into the collection container are not easy.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

Summary of Invention

Problems to be Solved by the Invention

[0005] Accordingly, in view of the above technologies, the present disclosure provides, in various embodiments, a sample collection device and a sample collection kit that can regulate the outflow of a sample into a collection container.

Means for Solving the Problems

[0006] To solve the above problem, one aspect of the present disclosure is: (1) A conduit configured to allow the sample, which is flowed into a first end from outside a container whose interior has been depressurized for sample collection, to flow into the interior of the container from a second end positioned opposite the first end; a holding member configured to hold the container and the conduit; and a restricting member configured to allow the sample to flow into the container when open and to restrict the flow of the sample into the container when closed. The restricting member comprises a lever member rotatably attached to the holding member via an axis, and a biasing member that biases one end of the lever member away from the conduit. By biasing the one end with the biasing member, the other end of the lever member moves towards the conduit around the axis, thereby closing the conduit. By moving the one end against the biasing force of the biasing member, the other end moves away from the conduit around the axis, thereby opening the conduit. This is a specimen collection device.

[0007] Preferred embodiments of this disclosure are It is as follows: (2) The shaft is located between the one end and the other end of the lever member, and the one end and the other end move in opposite directions with the shaft as the center of rotation. (1) above This is the specimen collection device described in [reference]. (3) The conduit is connected to the holding member via an elastic membrane member. (1) above This is the specimen collection device described in [reference]. ( 4 The aforementioned sample is, Biological origin The specimen collection device described in (1) above is a bodily fluid. (5) The tubing is the specimen collection device described in (1) above, comprising a hollow pipe and a hollow needle tube configured to be inserted into the inside of the container from the lid of the container. (6) The restricting member is the sample collection device described in (5) above, which restricts the flow of the sample into the container by blocking the pipe. (7) The sample collection device according to (5) above, wherein the pipe is configured to be crushed by pressurization in at least the short direction of the cross-section of the pipe, the restricting member restricts the flow of the sample into the container by pressurizing the pipe in the short direction, and the restricting member is positioned on the holding member. (8) A conduit configured to allow the sample, which is flowed into a first end from outside a container whose interior has been depressurized for sample collection, to flow into the interior of the container from a second end positioned opposite to the first end; a holding member configured to hold the container and the conduit; and a restricting member configured to allow the sample to flow into the container when open and to restrict the flow of the sample into the container when closed, wherein the first end is connected to a tube whose tip is drawn into another container different from the container, and the restricting member is connected to the tube The sample collection device comprises a lever member that is rotatably mounted to the other container via an axis and restricts the outflow of the sample into the container, and a biasing member that biases one end of the lever member away from the tube, wherein the biasing member biases the one end, causing the other end of the lever member to move towards the tube around the axis to close the tube, and the one end moves against the biasing force of the biasing member, causing the other end to move away from the tube around the axis to open the tube. (9) The restricting member is the sample collection device described in (8) above, which is arranged at a distance from the holding member. (10) A sample collection kit comprising a collection container configured to be depressurized inside and sealed with a lid for the purpose of collecting a sample, and the sample collection device described in (1) above. [Effects of the Invention]

[0016] According to various embodiments of this disclosure, it is possible to provide a sample collection device and a sample collection kit that can restrict the leakage of the sample into the collection container.

[0017] The effects described above are merely illustrative for the sake of explanation and are not limiting. In addition to, or in lieu of, any other effects described herein or that would be obvious to those skilled in the art may be achieved. [Brief explanation of the drawing]

[0018] [Figure 1]Figure 1 is a diagram illustrating the configurations of a specimen collection device 12 according to the first embodiment and a specimen collection kit 1 including the specimen collection device 12. [Figure 2A] This is the first diagram illustrating the configurations of the specimen collection device 12 according to the first embodiment and the specimen collection kit 1 including the specimen collection device 12. [Figure 2B] This is the second diagram illustrating the configurations of the specimen collection device 12 according to the first embodiment and the specimen collection kit 1 including the specimen collection device 12. [Figure 3A] This is the first diagram illustrating the configurations of the specimen collection device 12 according to the first embodiment and the specimen collection kit 1 including the specimen collection device 12. [Figure 3B] This is the second diagram illustrating the configurations of the specimen collection device 12 according to the first embodiment and the specimen collection kit 1 including the specimen collection device 12. [Figure 3C] This is the third diagram illustrating the configurations of the specimen collection device 12 according to the first embodiment and the specimen collection kit 1 including the specimen collection device 12. [Figure 4] Figure 4 is a diagram illustrating the method of using the specimen collection kit 1 shown in Figures 3A and 3B. [Figure 5A] Figure 5A is a diagram showing the configuration of a specimen collection device 13 that can replace the specimen collection device 12 in the specimen collection kit 1 according to the first embodiment. [Figure 5B] Figure 5B is a diagram showing the configuration of a specimen collection device 13 that can replace the specimen collection device 12 in the specimen collection kit 1 according to the first embodiment. [Figure 5C] Figure 5C is a diagram showing examples of usable abutting members in the specimen collection kit 1 according to the first embodiment. [Figure 6A] Figure 6A is the first diagram showing the configuration of a specimen collection device 14 that can replace the specimen collection device 12 in the specimen collection kit 1 according to the first embodiment. [Figure 6B] Figure 6B is the second diagram showing the configuration of a specimen collection device 14 that can replace the specimen collection device 12 in the specimen collection kit 1 according to the first embodiment. [Figure 7A]Figure 7A is a first diagram showing the configuration of a sample collection device 15 that can replace the sample collection device 12 in the sample collection kit 1 according to the first embodiment. [Figure 7B] Figure 7B is a second diagram showing the configuration of a sample collection device 15 that can replace the sample collection device 12 in the sample collection kit 1 according to the first embodiment. [Figure 8] Figure 8 is a diagram illustrating the configuration of a sample collection device 22 and a sample collection kit 20 including the sample collection device 22 according to the second embodiment. [Figure 9] Figure 9 is a diagram illustrating the configuration of a sample collection kit 26 including a sample collection device 22 as a modified example of the second embodiment. [Figure 10A] Figure 10A is a first diagram illustrating the configuration of a sample cylinder 3 according to a third embodiment, which can be used for sample collection by the sample collection devices 12, 14, 15, and 22 shown in the first and second embodiments. [Figure 10B] Figure 10B is a second diagram illustrating the configuration of a sample cylinder 3 according to a third embodiment, which can be used for sample collection by the sample collection devices 12, 14, 15, and 22 shown in the first and second embodiments. [Figure 11A] Figure 11A is a first diagram illustrating the configuration of a sample cylinder 3 according to a third embodiment used for sample collection using the sample collection kit 1. [Figure 11B] Figure 11B is a second diagram illustrating the configuration of a sample cylinder 3 according to a third embodiment used for sample collection using the sample collection kit 1. [Figure 12] Figure 12 shows the method of collecting a sample placed in the sample cylinder 3 shown in Figures 11A and 11B using the sample collection kit 1. [Figure 13A] Figure 13A is the first diagram illustrating an enlarged cross-section of a sample collection device 40 and a sample collection kit 4 including the sample collection device 40 according to the fourth embodiment. [Figure 13B] Figure 13B is a second diagram illustrating an enlarged cross-section of a sample collection device 40 and a sample collection kit 4 including the sample collection device 40 according to the fourth embodiment. [Figure 13C] Figure 13C is a third diagram illustrating an enlarged cross-section of a sample collection device 40 and a sample collection kit 4 including the sample collection device 40 according to the fourth embodiment. [Figure 14] Figure 14 is a diagram illustrating a cross-section of a sample cup 8 in which the sample collection kit 1 according to the fifth embodiment is used. [Figure 15] Figure 15 shows a modified example of the fifth embodiment. [Modes for carrying out the invention]

[0019] Various embodiments for implementing the specimen collection device and specimen collection kit of this disclosure are described in detail below. However, the embodiments described below are examples for illustrating this disclosure, and this disclosure is not limited to these embodiments.

[0020] [First Embodiment] First, a first embodiment will be described. Figure 1 is a diagram illustrating the configuration of a sample collection device 12 and a sample collection kit 1 including the sample collection device 12 according to the first embodiment. Specifically, Figure 1 is a perspective view showing the components of the sample collection kit 1. According to Figure 1, the sample collection kit 1 includes a sample collection device 12 and a collection container 18.

[0021] Sample collection kit 1 is used to collect a sample into a predetermined container. Herein, in this disclosure, the sample includes bodily fluids such as blood, urine, tears, sweat, nasal mucus, sputum, saliva, bile, digestive fluid, lymph, or cerebrospinal fluid collected from a living body, samples containing organs, tissues, cells (including cultured cells), nucleic acids, proteins, viruses, samples collected from outside the living body such as groundwater, rivers, oceans, rainwater, beverages, food, pharmaceuticals, or combinations thereof, preferably including bodily fluids such as blood, urine, tears, sweat, nasal mucus, sputum, saliva, bile, digestive fluid, lymph, or cerebrospinal fluid collected from a living body, samples containing organs, tissues, cells (including cultured cells), nucleic acids, proteins, viruses, or combinations thereof, and more preferably including bodily fluids such as blood, urine, tears, sweat, nasal mucus, sputum, saliva, bile, digestive fluid, lymph, or cerebrospinal fluid collected from a living body. Note that the sample is typically a liquid of biological origin, but it may also be a gas such as air. Living organisms include not only vertebrates such as mammals (including humans), birds, reptiles, and amphibians, but also invertebrates, plants, bacteria, and viruses.

[0022] Such a sample collection kit 1 can be used in a variety of locations, including medical facilities, laboratories, testing facilities, environmental survey sites, farms, livestock farms, or fieldwork sites, preferably medical facilities, laboratories, or testing facilities, more preferably medical facilities. Typically, the sample collection kit 1 is used in a medical setting to collect blood from a living organism using a syringe, and then introduce the blood into a container included in the sample collection kit 1 via a sample collection device 12. This is just one example of use, and the method of use may be modified as appropriate depending on the type of sample and the site in which it is used.

[0023] The sample collection device 12 includes a conduit 128, a holding member 120, and a regulating member 16. The holding member 120 includes a main body 121 and a pipe holding member 122. The conduit 128 includes a first end 130 into which the sample flows, and a second end 131 positioned opposite the first end 130. The second end 131 is positioned inside the collection container 18, and is configured so that the sample that has flowed through the conduit 128 flows out into the collection container 18 from the second end 131. Therefore, the conduit 128 is hollow so that the sample can flow through it. The conduit 128 is formed from, for example, metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy; polyolefins such as polyethylene (PE), polypropylene (PP), polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, or mixtures thereof; synthetic resin materials such as acrylonitrile-styrene resin (AS), acrylonitrile-butadiene-styrene resin (ABS), polyvinyl chloride (PVC), methacrylic resin (PMMA), polyethylene terephthalate (PET), polyamide (PA), polyamide elastomer, polyester, polyester elastomer, polyurethane (PU), fluororesin, or other thermoplastic resins; silicone rubber, latex rubber, plant-based plastic, waterproof paper, or combinations thereof.

[0024] Furthermore, in order to more effectively implement the regulation by the regulating member 16, it is desirable that the conduit 128 includes a flexible region formed of a synthetic resin material such as polyethylene (PE), polypropylene (PP), polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer or mixtures thereof, synthetic resin material such as polyethylene (PE), polyvinyl chloride (PVC), polyamide (PA), polyamide elastomer, polyester, polyester elastomer, polyurethane (PU), thermoplastic resin such as fluororesin, silicone rubber, latex rubber, etc., in at least a portion thereof.

[0025] The conduit 128 may be composed of a single material as listed above, but it can also be composed of a combination of multiple materials as shown in Figure 1. According to Figure 1, the conduit 128 includes a needle tube 124 and a pipe 126. The needle tube 124 is made of synthetic resin materials such as thermoplastic resins such as polyethylene (PE), polypropylene (PP), polystyrene (PS), acrylonitrile-styrene resin (AS), acrylonitrile-butadiene-styrene resin (ABS), polyvinyl chloride (PVC), methacrylic resin (PMMA), polyethylene terephthalate (PET), etc., metallic materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy, waterproof paper, plant-based plastic, or a combination thereof. The needle tube 124 is formed in a hollow cylindrical shape so that a sample can pass through it. It is made of a thickness suitable for sample collection. The needle tube 124 is arranged so that one end 132 is housed inside the main body 121. The other end 133 of the needle tube 124, which is located opposite one end 132, is formed in a needle shape oblique to the longitudinal direction shown by the dotted line in Figure 1, so that it can be easily inserted into the collection container 18. That is, the other end 133 of the needle tube 124 is inserted into the collection container 18, and the sample flows out from that other end 133 into the collection container 18. In this embodiment, the case in which the needle tube 124 is used to insert the conduit 128 into the inside of the collection container 18 has been described, but of course, it may also be inserted using a cylindrical object other than the needle tube 124.

[0026] The pipe 126 is formed from, for example, polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, or mixtures thereof, synthetic resin materials such as polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, thermoplastic resins such as fluororesin, flexible materials such as silicone rubber and latex rubber. The pipe 126 is hollow so that a sample can flow through it, and is formed to a diameter and length suitable for sample collection. The length of the pipe 126 can be cut at the medical site by the user who intends to collect a sample to a length suitable for sample collection. Preferably, the pipe 126 has enough flexibility and pliability in the short direction to deform and collapse and close the hollow portion when pressed in the short direction of its cross-section by the restricting member 16. Furthermore, the pipe 126 has enough resilience to return to its original shape and open the hollow portion when the pressure is released after being pressed in the short direction by the restricting member 16 and collapsing to close the hollow portion.

[0027] The collection container 18 includes a container body 180, such as a test tube, and its lid 182. The container body 180 is formed from, for example, thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polymethyl methacrylate, and polyacrylonitrile; thermosetting resins such as unsaturated polyester resins, epoxy resins, and epoxy-acrylate resins; modified natural resins such as cellulose acetate, cellulose propionate, ethylcellulose, and ethyl chitin; silicate glass such as soda-lime glass, phosphate silicate glass, and borosilicate glass; glass materials such as quartz glass; or a combination thereof. The container body 180 has a capacity suitable for the amount of sample to be collected, and it is desirable that the inside is depressurized relative to the outside air for sample collection. The internal pressure of the container body 180 may be appropriately determined according to the type and amount of sample to be collected.

[0028] The lid 182 is formed from synthetic resin, elastomer, rubber, metal foil, etc. Examples of such rubber include butyl rubber and halogenated butyl rubber. Examples of such metal foil include aluminum foil. From the viewpoint of ensuring the airtightness of the container body 180, the lid 182 is preferably made of butyl rubber. The lid 182 seals the opening of the container body 180 and maintains the reduced pressure of the container body 180. The other end 133 of the needle tube 124 is inserted into the lid 182 by the user using the sample collection kit 1, and its tip is positioned inside the container body 180, causing the sample that has flowed from the pipe 126 into the needle tube 124 to flow into the inside of the container body 180.

[0029] The retaining member 120 includes a main body 121 and a pipe retaining member 122. The retaining member 120 is formed from, for example, thermoplastic resins such as polyethylene, polypropylene, polystyrene, polyethylene terephthalate, polymethyl methacrylate, and polyacrylonitrile; thermosetting resins such as unsaturated polyester resins, epoxy resins, and epoxy-acrylate resins; modified natural resins such as cellulose acetate, cellulose propionate, ethylcellulose, and ethyl chitin; silicate glasses such as soda-lime glass, phosphate silicate glass, and borosilicate glass; glass materials such as quartz glass; or a combination thereof. The main body 121 and the pipe retaining member 122 may be integrally formed from the materials exemplified above, or multiple materials may be combined and joined after molding.

[0030] The main body 121 has an opening at one end in its longitudinal direction, through which at least a portion of the collection container 18 is inserted, and is configured to accommodate the collection container 18 inside. Furthermore, the outer circumference of the main body 121 in the longitudinal direction is formed to follow the outer circumference of the collection container 18 in the longitudinal direction. That is, the main body 121 typically has a substantially cylindrical shape that extends in the direction into which the collection container 18 is inserted. Its interior is formed to have a predetermined depth along the longitudinal direction of the collection container 18.

[0031] The main body 121 has a connection hole with a diameter slightly larger than the diameter of the conduit 128, located approximately in the center of the other end opposite to the end having an opening. The main body 121 is connected to one end of the pipe holding member 122 at this connection hole.

[0032] The pipe holding member 122 is formed in a hollow, approximately cylindrical shape with a diameter slightly larger than the diameter of the conduit 128. One end of the pipe holding member 122 is connected to the connection hole of the main body 121. The other end of the pipe holding member 122, located in a direction opposite to the one end, is open, allowing the conduit 128 to be inserted through this opening. That is, the conduit 128 is inserted into the opening formed at the other end of the pipe holding member 122, passes through the hollow interior of the pipe holding member 122, and is then inserted out through the connection hole. As a result, as shown in Figure 1, the pipe 126 of the conduit 128 is held by the pipe holding member 122, while the needle tube 124 is exposed inside the main body 121.

[0033] In this embodiment, the restricting member 16 is formed on at least a part of the pipe holding member 122 and restricts the passage of the sample through the inside of the pipe 126 by applying pressure to the pipe 126 passing through its interior. The detailed configuration will be described later, but restriction by pressure is just one example, and of course, restriction may be performed by other methods.

[0034] Figures 2A and 2B illustrate the configuration of a sample collection device 12 and a sample collection kit 1 including the sample collection device 12 according to the first embodiment. Specifically, Figure 2A shows the side structure of the sample collection kit 1 including the regulating member 16, and Figure 2B shows a longitudinal cross-section of the sample collection kit 1 including the regulating member 16. In Figures 2A and 2B, Φ1 indicates the inner diameter of the main body 121 shown in Figure 1, and L1 indicates the longitudinal length of the main body 121, i.e., the depth of the main body 121. Also, L2 indicates the longitudinal length of the needle tube 124. Since one end 132 of the needle tube 124 is housed inside the main body 121, L1 and L2 have the relationship L1 > L2. As shown in Figures 2A and 2B, the regulating member 16 is positioned in an opening 160 formed in the pipe holding member 122 and, for example, includes a lever member 162, an elastic member 164, a projection member 166, and a support member 168. The support member 168 is formed, for example, from the same material as the pipe holding member 122 and two are attached to the edge of the opening 160, facing each other in the short direction of the pipe holding member 122. The support members 168 rotatably support each of the short sides (long sides) of the lever member 162 with respect to the support member 168 as an axis.

[0035] The elastic member 164 is, for example, a member that has been given elasticity by bending a stainless steel plate or rod. An example of such an elastic member 164 is a leaf spring. The elastic member 164 is disposed between the pipe holding member 122 and one end of the lever member 162, and biases that end of the lever member 162 upward relative to the pipe holding member 122. As a result, the lever member 162 rotates around the support member 168 as an axis, and the other end of the lever member 162, which is located in the direction opposite to that end, is biased downward relative to the pipe holding member 122. In addition, the other end of the lever member 162 is biased downward relative to the pipe holding member 122 by the elastic member 164 and comes into contact with the projection member 166 located inside the pipe holding member 122 (when the conduit 128 is not inserted inside the pipe holding member 122). In other words, if the user does not apply a sufficient force F to one end of the lever member 162 to separate the other end of the lever member 162 from the projection member 166, the elastic member 164 applies a force in a direction that causes the other end of the lever member 162 to rotate toward the projection member 166. As a result, when the pipe 126 is not inserted between the lever member 162 and the projection member 166, at least a portion of the other end of the lever member 162 that is inside the pipe holding member 122 comes into contact with the projection member 166. Furthermore, when the pipe 126 of the conduit 128 is inserted inside the pipe holding member 122, the elastic member 164 biases the other end of the lever member 162 toward the projection member 166, causing the other end and the projection member 166 to deform the pipe 126 by crushing it in the shorter direction.

[0036] On the other hand, in this state, if the user applies the force F, the other end of the lever member 162 is rotated away from the projection member 166 by the force F, against the elastic force of the elastic member 164, and the other end of the lever member 162 and the projection member 166 are separated from each other. As a result, the pipe 126, which was deformed by being compressed in the short direction by the other end of the lever member 162 and the projection member 166 due to the biasing by the elastic member 164, is released from the pressure and returns to the original shape of the pipe 126 before deformation. Note that the elastic member 164 does not have to be made of stainless steel; it is also possible to use a material selected from the group including alloys containing iron other than stainless steel, alloys containing copper, titanium, or Inconel (registered trademark). Although a leaf spring was used as an example in the explanation, the elastic member 164 only needs to be able to bias the lever member 162 in the desired direction, and may be a coil spring, spiral spring, rubber, etc. Furthermore, it is sufficient that the pipe 126 can be deformed, and the protruding member 166 does not necessarily need to be placed.

[0037] Figures 3A to 3C illustrate the configuration of a sample collection device 12 and a sample collection kit 1 including the sample collection device 12 according to the first embodiment. Specifically, Figure 3A shows the side view of the collection container 18 and the conduit 128 connected and held together by the holding member 120. Figures 3B and 3C show the cross-sectional view of the collection container 18 and the conduit 128 connected and held together by the holding member 120.

[0038] Here, as shown in Figures 3A and 3B, the main body 121 of the holding member 120 has an opening in the direction into which the sampling container 18 is inserted, a bottom surface located in the opposite direction, and a cup-shaped structure with walls extending from the bottom surface toward the opening. The conduit 128 is inserted through the opening formed at the other end of the pipe holding member 122 until at least the tip of the needle tube 124, which is positioned at one end (the second end) of the conduit 128, is exposed to the inside from the bottom surface of the cup-shaped main body 121. At this time, the lever member 162 is biased toward the projection member 166 by the elastic member 164 and is in contact with the projection member 166, so the user needs to apply a force F in the opposite direction to release the contact with the projection member 166. In this way, the conduit 128 is held by the holding member 120.

[0039] Furthermore, as described above, the main body 121 of the holding member 120 has an opening in the direction into which the collection container 18 is inserted. The collection container 18 is then inserted into the holding member 120 through this opening until the lid 182 of the collection container 18 is in contact with or close to the bottom surface of the main body 121, which is located in the direction opposite to the opening. As the collection container 18 is inserted into the main body 121, the lid 182 of the collection container 18 comes into contact with the tip of the needle tube 124 of the conduit 128 that is exposed inside the main body 121, and by further insertion (applying force), the tip of the needle tube 124 penetrates and passes through the lid 182. When the collection container 18 is inserted until the lid 182 of the collection container 18 is in contact with or close to the bottom surface of the main body 121, the second end 131 of the conduit 128 is located inside the container body 180 of the collection container 18. As a result, the conduit 128 and the collection container 18 are connected to each other while maintaining the reduced pressure state of the collection container 18, and the conduit 128 and the collection container 18 are held by the holding member 120. It should be noted that although it is stated that the holding member 120 holds the conduit 128 and the collection container 18, this does not only mean that the holding member 120 holds the conduit 128 and the collection container 18 in a fixed position, but also includes cases where the conduit 128 is simply inserted inside the pipe holding member 122, or the collection container 18 is simply housed inside the main body 121, or where each component is positioned within any space of the pipe holding member 122. Furthermore, the conduit 128 only needs to be structured in such a way that a sample can be inserted from the first end, pass through its interior, and discharged to the outside from the second end. In other words, the needle tube 124 may be fixed to the main body 121 of the holding member 120 in advance, and the pipe 126 may be connected later to the end of the needle tube 124 opposite to the end that is inserted into the collection container 18, thereby forming the conduit 128.

[0040] Here, Figures 3A and 3B show the state in which the conduit 128 and the collection container 18 are connected to each other as described above and held by the holding member 120, respectively. In this state, the other end of the lever member 162 of the regulating member 16 is biased by the elastic member 164 in a direction toward contact with the projection member 166. As a result, at least a flexible part of the conduit 128 (specifically the pipe 126) is deformed in a way that it is crushed in its cross-section in the short direction. Consequently, in this state, the conduit 128 restricts the sample inserted from one end (the first end) from passing through its interior and flowing out from the other end (the second end).

[0041] Next, Figure 3C shows the case where the restriction by the restricting member is released when a force F is applied to one end of the lever member 162, while the conduit 128 and the collection container 18 are connected to each other as described above and held by the holding member 120. Specifically, when the user applies force F to one end of the lever member 162, the lever member 162 rotates around the support member 168 as an axis, and the other end of the lever member 162 moves in the opposite direction to the projection member 166. As a result, the cross-section of the pipe 126, which had been deformed as if being crushed by the other end and the projection member 166, is released from that pressure and returns to its normal cross-sectional shape. Therefore, in this state, the restriction on the passage of the sample by the restricting member 16 is released from the conduit 128, and the sample inserted from one end (the first end) passes through its interior and flows out from the other end (the second end 131).

[0042] Figure 4 illustrates the method of using the sample collection kit 1 shown in Figures 3A and 3B. According to Figure 4, a sample 135, such as human blood or urine, is already placed in the test tube 134. Then, in the state shown in Figures 3A and 3B, the first end of the conduit 128 of the sample collection device 12 (i.e., the tip of the pipe 126) is inserted into the sample 135 through the opening of the test tube 134.

[0043] Next, when the user applies an appropriate force F to one end of the lever member 162, the other end of the lever member 162 rotates on the support member 168 in the opposite direction to the projection member 166, releasing the blockage of the pipe 126 and opening the hollow portion of the conduit 128. Then, as shown by the dotted arrow in Figure 3C, the sample 135 can flow through the conduit 128, that is, through the needle tube 124 and the pipe 126. Here, the inside of the container body 180 of the collection container 18 is held in a state of reduced pressure relative to the outside air. Therefore, when the restriction by the restricting member 16 is released, the sample 135 can flow from the first end of the conduit 128 into the pipe 126 until the air pressure inside the container body 180 becomes the same as the outside air pressure. Furthermore, the sample 135 flows into the needle tube 124 connected to the pipe 126. Furthermore, the sample 135 flows through the inside of the needle tube 124 and flows out into the container body 180 from the tip (second end) located inside the container body 180. When the required amount of sample 135 has been collected inside the container body 180, the user stops applying force F to the lever member 162, the pipe 126 closes, and the collection of sample 135 is completed.

[0044] Here, Figure 5A shows the configuration of a sample collection device 13 that can replace the sample collection device 12 in the sample collection kit 1. As shown in Figure 5A, the sample collection device 13 omits the pipe holding member 122 from the sample collection device 12, and has a configuration in which the second end of the pipe 126 is directly connected to the first end of the needle tube 124 via the main body 121, so as to prevent leakage of liquid and air. Such connection of the pipe 126 to the main body 121 and the needle tube 124 can be achieved, for example, by bonding the needle tube 124 and the pipe 126 to the main body 121 and the second end of the needle tube 124 with adhesive. Since the sample collection device 13 has a simpler structure than the sample collection device 12, it can be manufactured at a lower cost than the sample collection device 12.

[0045] Figure 5B shows the configuration of a sample collection device 13 that can replace the sample collection device 12 in the sample collection kit 1. As shown in Figure 5B, the main body 121 of the collection container 18 of the sample collection device 13 includes a contact member 148 near its opening. The contact member 148 is formed in a shape that follows the outer circumference of the main body 121 and is installed inside the main body 121. Here, Figure 6C shows a contact member 148 that can be additionally installed for each sample collection device. As shown in Figure 6C, the contact member 148 is formed from an elastic material and has a shape with multiple cuts made from the periphery toward the center and multiple elastic pieces. Therefore, when the collection container 18 is inserted through the opening of the main body 121 and comes into contact with the contact member 148, each elastic piece of the contact member 148 is bent toward the bottom surface of the main body 121 due to its elasticity. Then, when the collection container 18 is further inserted, the collection container 18 passes through the opening formed by the bent elastic pieces. Then, the tip of the needle tube 124 is inserted into the lid 182 of the collection container 18. By using the contact member 148 in this way, it is possible to prevent the needle tube 124 from being directly exposed to the outside before insertion into the collection container 18, thereby increasing safety.

[0046] Figures 6A and 6B show the configuration of a sample collection device 14 that can replace the sample collection device 12 in the sample collection kit 1. As shown in Figure 6A, the sample collection device 14 includes a conduit 128, a holding member 120, and a regulating member 16, similar to the sample collection device 12. An elastic member 142 is positioned at the bottom of the main body 121 of the holding member 120, which biases the collection container 18 in the direction opposite to the insertion direction along its longitudinal direction when the collection container 18 is inserted into the main body 121 through the opening. The elastic member 142 can be any of the following: a leaf spring, a coil spring, a spiral spring, or rubber, as long as it can bias the collection container 18 in that direction via the elastic member 142. Figure 6A illustrates the case where the elastic member 142 is a coil spring.

[0047] A contact member 144 is positioned on the opening side of the elastic member 142 so as to be connected to the elastic member 142. When the collection container 18 is inserted into the main body 121, the contact member 144 comes into contact with the lid 182 of the collection container 18. The contact member 144 is formed in a substantially circular shape to match the substantially cylindrical cross-sectional shape of the main body 121, and an opening 146 is provided in the contact member 144 at a position opposite the needle tube 124 so as to allow the needle tube 124 to pass through. When the collection container 18 is not inserted into the main body 121, the contact member 144 is supported by the elastic member 142 so as to be located further from the bottom of the main body 121 than the other end 133 of the needle tube 124. For example, the contact member 144 is formed from the same material as the retaining member 120 and the lid 182.

[0048] In the state shown in Figure 6A, when the collection container 18 is inserted toward the opening of the main body 121, the collection container 18 first comes into contact with the contact member 144. Then, as shown in Figure 6B, a force is applied to the collection container 18 along its longitudinal direction toward the bottom of the main body 121, and it is inserted into the main body 121 through the opening. As a result, the longitudinal length of the elastic member 142 shortens, and the contact member 144 moves toward the bottom of the main body 121. This causes the opening 146 of the contact member 144 to allow the needle tube 124 to pass toward the lid 182 of the collection container 18. As a result, the needle tube 124 is inserted into the lid 182, and the sample 135 that has flowed through the conduit 128 can flow into the inside of the container body 180. In this way, by arranging the elastic member 142 and the contact member 144 inside the main body 121, the needle tube 124 can be made to protrude from the opening 146 into the opening inside the main body 121 only when collecting a sample 135. In other words, when not collecting a sample 135, the contact member 144 covers the other end 133 of the needle tube 124, thus preventing needle stick injuries caused by the needle tube 124.

[0049] Furthermore, Figures 7A and 7B show the configuration of a sample collection device 15 that can replace the sample collection device 12 in the sample collection kit 1 according to the first embodiment. As shown in Figure 7A, the sample collection device 15 includes a holding member 150 and further includes a conduit 128 and a regulating member 16, similar to the sample collection devices 12 and 14. The holding member 150 includes a main body 151, a flexible, elongated needle cover 153 that covers the other end 133 of the needle tube 124 at one end 154 when a sample 135 is not collected, and a pipe holding member 122. The main body 151 is made of the same material as the main body 121 and its shape is substantially the same as that of the main body 121. However, at the bottom of the main body 151, near the part where the needle cover 153 and the pipe holding member 122 are connected, an opening 152 is provided to allow the other end 155 of the needle cover 153 to be pulled out of the main body 151.

[0050] The needle cover 153 is made of a flexible material with a certain degree of rigidity, such as butyl rubber, thermoplastic elastomer, polypropylene, polyethylene, polydimethylsiloxane (PDMS), or a combination thereof. The needle cover 153 is also formed to cover the entire needle tube 124, and in particular to cover the other end 133 of the needle tube 124 with a material thickness of 1 to 5 mm. Furthermore, by making the material covering the other end 133 of the needle tube 124 longer, the possibility of needle stick injuries is reduced, making the specimen collection kit 1 using the needle cover 153 even safer.

[0051] As shown in Figure 7B, before the collection of the sample 135, a force is applied to the other end 155 of the needle cover 153, which has been pulled out of the main body 151 through the opening 152, in the direction of pulling the needle cover 153 out of the main body 151. In this case, one end 154 of the needle cover 153 separates from the other end 133 of the needle tube 124, and the entire needle cover 153 is pulled out of the main body 151 through the opening 152. Once the needle cover 153 is pulled out and the collection container 18 is inserted into the main body 151, the other end 133 of the needle tube 124 is inserted into the lid 182 of the collection container 18. Once the other end 133 is inserted into the lid 182, the sample 135 that has flowed through the conduit 128 can flow into the container body 180. Similar to the sample collection device 14, if the sample 135 is not collected by the sample collection device 15, the needle cover 153 covers the other end 133 of the needle tube 124, thereby preventing needle stick injuries caused by the needle tube 124.

[0052] In this embodiment, it is possible to provide a sample collection device and a sample collection kit that can restrict the outflow of the sample into the sample collection container. In particular, by effectively restricting the passage of the sample through the conduit 128 using the restricting member 16, it is possible to easily adjust the amount of sample collected into the collection container 18. Furthermore, safety can be further enhanced by using a needle cover 153, contact members, etc.

[0053] [Second Embodiment] Next, a second embodiment will be described. Except for the points that will be specifically described below, the second embodiment has the same configuration as the first embodiment, so a detailed explanation will be omitted. Figure 8 is a diagram illustrating the configuration of a sample collection device 22 and a sample collection kit 20 including the sample collection device 22 according to the second embodiment. The sample collection kit 20 includes the sample collection device 22 and the collection container 24. The sample collection device 22 includes a conduit 128, a holding member 220, and a regulating member 16. The holding member 220 includes a main body 222 and a pipe holding member 122. The collection container 24 includes a container body 180 and a sealing member 240. Figure 8 shows a cross-section of the sample collection kit 20 with the collection container 24 inserted into the sample collection device 22.

[0054] The main body 222 has a cylindrical shape similar to the main body 121, but is formed to be longer and narrower than the main body 121. That is, the main body 222 is formed to be roughly cylindrical, similar to the main body 121, but the longitudinal length L3 of its cup-shaped portion is longer than the longitudinal length L1 (Figure 2A) of the cup-shaped portion of the main body 121. Therefore, lengths L1 and L3 are in the relationship L3 > L1. Also, the inner diameter Φ2 of the opening of the main body 222 is narrower than the inner diameter Φ1 of the opening of the main body 121. Therefore, inner diameters Φ1 and Φ2 are in the relationship Φ1 > Φ2. On the other hand, in the main body 222, the length L3 from the bottom to the other end 133 of the needle tube 124 is the same as in the main body 121. Therefore, the distance from the opening to the bottom of the main body 222 is longer than the distance from the opening to the other end 133 of the needle tube 124 in the main body 121. Furthermore, the inner diameter Φ2 of the opening of the main body 222 is shorter than the inner diameter Φ1 of the main body 121. Therefore, even when the sample collection kit 20 is used by a medical professional with slender fingers, the likelihood of their fingers touching the other end 133 of the needle tube 124 is lower than when using the sample collection kit 1. Consequently, using the holding member 220 of the sample collection kit 20 reduces the likelihood of needle-stick injuries.

[0055] Unlike the sampling container 18, the sampling container 24 is sealed with a sealing member 240 instead of a lid 182. The sealing member 240 is made from synthetic resin materials such as polyethylene (PE), polypropylene (PP), polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer or mixtures thereof, polyolefins, polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane (PU), thermoplastic resins such as fluororesin, natural rubber (NR), styrene-butadiene rubber (SBR), chloroprene rubber (CR), acrylonitrile rubber (NBR), butyl rubber (IIR), ethylene propylene rubber (EPDM), urethane rubber (U), silicone rubber (SI), polydimethylsiloxane (PDMS), or combinations thereof. The sealing member 240 is formed in a hollow shape, like a closed outlet of a long, narrow funnel, and the opening of the sealing member 240 is shaped to fit the opening of the container body 180. The opening of the sealing member 240 is fitted into the opening of the container body 180, closing and sealing the opening of the container body 180. As a result, the reduced pressure inside the container body 180 is maintained by the sealing member 240 fitted into its opening. On the other hand, the end of the sealing member 240 located on the opposite side of the opening is the leading portion 242 that first enters the main body 222 when the sampling container 24 is inserted into the main body 222.

[0056] Before the collection of the sample 135, the collection container 24 is provided to the medical personnel separately from the sample collection device 22, without being inserted into the sample collection device 22. When collecting the sample 135, first, the leading end 242 of the sealing member 240 and the other end 133 of the needle tube 124 are aligned. Then, with the sample collection device 22 fixed, force is applied to the collection container 24 along its longitudinal direction toward the bottom of the main body 222, causing the other end 133 of the needle tube 124 to be inserted into the leading end 242 of the sealing member 240. Furthermore, the collection container 24 is inserted into the main body 222 until the leading end 242 of the sealing member 240 approaches the bottom of the holding member 220. As a result, the other end 133 of the needle tube 124 reaches the hollow part inside the container body 180 or the sealing member 240 from the leading end 242. In this state, when a force F is applied to the lever member 162 as shown in Figure 3C, the blockage of the pipe 126 of the conduit 128 is released, and the sample 135 flows through the conduit 128 into the container body 180 of the collection container 24.

[0057] The following describes a modified version of the second embodiment. Figure 9 is a diagram illustrating the configuration of a sample collection kit 26 including a sample collection device 22 as a modified version of the second embodiment. As shown in Figure 9, the sample collection kit 26 includes a sample collection device 22 and a collection container 28. The collection container 28 includes a container body 180 and a sealing member 280. Figure 9 shows a cross-section of the sample collection kit 26 with the sealing member 240 attached to the sample collection device 22.

[0058] The sample collection kit 26 has a configuration in which the collection container 24 of the sample collection kit 20 is replaced with a collection container 28. In the collection container 28, unlike the collection container 24, the container body 180 is sealed by a sealing member 280 made of a similar material to the sealing member 240, instead of the sealing member 240. The sealing member 280 differs from the sealing member 240 in that it has a cap-like shape on the container body 180. That is, the sealing member 280 covers the opening of the container body 180 from the outside and, when inserted into the body 222, has a gently convex shape relative to the bottom of the body 222. A part of the interior of the sealing member 280 forms a hollow portion 282 located closer to the opening of the sealing member 280. The part of the sealing member 280 that has a convex shape relative to the body 222 becomes the leading part 284 of the sealing member 280 that first enters the body 222 when the collection container 28 is inserted into the body 222.

[0059] Before the collection of the sample 135, the collection container 28, like the collection container 24, is provided to the medical personnel separately from the sample collection device 22, without being inserted into the sample collection device 22. When collecting the sample 135, first, the leading portion 284 of the sealing member 280 is aligned with the opening of the main body 222. Then, with the sample collection device 22 fixed, force is applied to the collection container 28 along its longitudinal direction toward the bottom of the main body 222. As a result, the other end 133 of the needle tube 124 is inserted into the leading portion 284 of the sealing member 240. In this state, the collection container 28 is inserted into the main body 222 until the leading portion 284 of the sealing member 280 approaches the bottom of the holding member 220. As a result, the other end 133 of the needle tube 124 reaches the hollow portion or hollow portion 282 inside the container body 180 from the leading portion 284. In this state, when a force F is applied to the lever member 162 as shown in Figure 3C, the blockage of the pipe 126 of the conduit 128 is released, and the sample 135 flows through the conduit 128 into the container body 180 of the collection container 28.

[0060] [Third Embodiment] The third embodiment will be described in detail below. Except for the points specifically described below, the configuration is the same as that of the first and second embodiments, so a detailed explanation of those embodiments will be omitted. Figures 10A and 10B illustrate the configuration of the sample cylinder 3 according to the third embodiment, which can be used for sample collection by the sample collection devices 12, 14, 15, and 22 shown in the first and second embodiments. Specifically, Figure 10A shows a side view of the sample collection tube 30 and sample collection component 32 included in the sample cylinder 3, and Figure 10B shows a cross-sectional view of the sample collection tube 30 and sample collection component 32 included in the sample cylinder 3.

[0061] According to Figures 10A and 10B, the sample cylinder 3 includes a sample collection tube 30 from which the sample is first collected, and a sample collection component 32 connected to the sample collection tube 30 so as to cover the sample collection tube 30. The sample collection tube 30 includes a collection tube body 300, two openings 302 and 304 of different sizes, a screw structure 306, and a lid 308. The collection tube body 300 has a vertically elongated cylindrical shape with an open top, like a test tube. The openings 302 and 304 are provided on the side connecting the bottom and the top opening. Of the openings 302 and 304, the sample is mainly collected from the opening with the larger opening area, and the sample is discarded from the smaller opening. For example, if the sample is urine, urine is urinated towards the larger opening, and the sample flows into the inside of the collection tube body 300 from that opening. The screw structure 306 is formed adjacent to the lid 308 on the side near the opening of the collection tube body 300. The lid 308 covers and closes the opening of the sampling tube body 300.

[0062] The sample collection component 32 has a cylinder body 320 that has an elongated cylindrical shape with an open top, like a test tube, whose inner diameter is larger than the outer diameter of the sample collection tube body 300 of the sample collection tube 30. A screw structure 322 including a groove that fits into the screw structure 306 is formed on the inner wall of the cylinder body 320 near the opening. The sample collection tube body 300 and the cylinder body 320 are formed from, for example, the same material as the container body 180 of the sample collection kit 1, or the same material as the body 121 and pipe holding member 122 of the sample collection device 12.

[0063] Figures 11A and 11B illustrate the configuration of a sample cylinder 3 according to a third embodiment used for sample collection using the sample collection kit 1 shown in Figures 3A to 3C. Specifically, Figure 11A shows a side view of the sample collection tube 30 and sample collection component 32 included in the sample cylinder 3, and Figure 11B shows a cross-sectional view of the sample collection tube 30 and sample collection component 32 included in the sample cylinder 3.

[0064] Here, although not specifically shown in Figures 11A and 11B, a screw structure similar to the screw structure 306 may also be formed on the upper part of the lid 308 (i.e., on the side opposite to the side where the screw structure 306 is formed). By forming such a screw structure, the screw structure 322 of the sample collection component 32 can be fitted into the screw structure formed on the upper part of the lid 308, thereby connecting the sample collection component 32 to the upper part of the sample collection tube 30. This makes it possible to reduce the risk of contaminating the user's hands, etc., with urine, for example, when collecting urine, by having the user hold the sample collection component 32 and urinate towards either the opening 302 or 304 of the sample collection tube 30.

[0065] As described above, when a sample is collected in the sample collection tube 30, the collection tube body 300 of the sample collection tube 30 is inserted through the opening of the cylinder body 320 of the sample collection component 32, as shown in Figures 11A and 11B. Furthermore, the collection tube body 300 of the sample collection tube 30 and the cylinder body 320 of the sample collection component 32 are fixed together by screws using the screw structure 306 of the sample collection tube 30 and the screw structure 322 of the sample collection component 32. In this way, by covering and fixing the sample collection tube 30 with the sample collection component 32, it is possible to prevent the sample collected in the collection tube body 300 of the sample collection tube 30 from leaking to the outside.

[0066] Figure 12 shows a method for collecting a sample placed in the sample cylinder 3 shown in Figures 11A and 11B using the sample collection kit 1. According to Figure 12, with the sample 135 collected inside the collection tube body 300 of the sample collection tube 30, the sample collection component 32 is fixed to cover the sample collection tube 30 via the lid 308.

[0067] In this state, with the conduit 128 blocked, the first end of the conduit 128 of the sample collection kit 1 is inserted into the sample collection tube 30 via the lid 308. At this time, the first end of the conduit 128 of the sample collection kit 1 is inserted until it reaches the sample 135. This connects the sample collection kit 1 and the sample cylinder 3. With the sample collection kit 1 and the sample cylinder 3 connected, when the user applies an appropriate force F to one end of the lever member 162 of the regulating member 16, the other end of the lever member 162 rotates around the support member 168 in the opposite direction to the projection member 166. This releases the blockage of the conduit 128 by the regulating member 16, and the hollow portion of the conduit 128 is opened. At this point, the inside of the container body 180 of the collection container 18 is held in a state of reduced pressure relative to the outside air. Therefore, when the restriction by the restricting member 16 is released, the sample 135 can flow into the container body 180 from the tip (second end) located inside the container body 180 until the air pressure inside the container body 180 becomes the same as the air pressure outside. Once the required amount of sample 135 has been collected inside the container body 180 and the user stops applying force F to the lever member 162, the conduit 128 is closed again, and the collection of sample 135 into the sample collection kit 1 is completed.

[0068] Similar to the first and second embodiments, this embodiment provides a sample collection device and sample collection kit capable of restricting the outflow of the sample into the sample collection container. In particular, by effectively restricting the passage of the sample through the conduit 128 using the restricting member 16, it is possible to easily adjust the amount of sample collected into the collection container 18. Furthermore, the sample collection kit 1 of this embodiment makes it possible to collect samples from various containers.

[0069] [Fourth Embodiment] Next, a fourth embodiment will be described. Except for the points that will be specifically described below, the fourth embodiment has the same configuration as the first to third embodiments, so a detailed explanation will be omitted. Figures 13A to 13C are enlarged cross-sectional diagrams illustrating a sample collection device 40 and a sample collection kit 4 including the sample collection device 40 according to the fourth embodiment. As shown in Figure 13A, the sample collection kit 4 includes the sample collection device 40 and the collection container 18. The sample collection device 40 includes a conduit 128 and a holding member 400. The holding member 400 includes a main body 402, a pipe holding member 404, a backflow prevention member 406, and a pressing member 408.

[0070] The main body 402 is made of the same material as the main body 121 and is formed in a cylindrical shape, similar to the main body 121 of the sample collection kit 1. The main body 402 is made of the same material as the pipe holding member 122 of the sample collection kit 1. The bottom of the main body 402 is provided with an opening into which the collection container 18 is inserted from the lid 182 side, and the inserted lid 182 abuts against this bottom. The pipe holding member 404 is made of the same material as the pipe holding member 122 and is connected to the opening at the bottom of the main body 402. The pipe holding member 404 is formed in a substantially cylindrical shape, similar to the pipe holding member 122, and its inner diameter is larger than that of the pipe holding member 122. A conduit 128 passes through the pipe holding member 404, and the conduit 128 is connected to the inner wall of the pipe holding member 404 via a backflow prevention member 406 formed in a highly elastic membrane shape.

[0071] The backflow prevention member 406 is formed from synthetic resin materials such as polypropylene (PP), polystyrene (PS), acrylonitrile-styrene resin (AS), acrylonitrile-butadiene-styrene resin (ABS), polyvinyl chloride (PVC), methacrylic resin (PMMA), polyethylene terephthalate (PET), and other thermoplastic resins; natural rubber (NR), styrene-butadiene rubber (SBR), chloroprene rubber (CR), acrylonitrile rubber (NBR), butyl rubber (IIR), ethylene propylene rubber (EPDM), urethane rubber (U), silicone rubber (SI), polydimethylsiloxane (PDMS), waterproof paper, plant-based plastics, or combinations thereof.

[0072] The backflow prevention member 406 completely seals the gap between the conduit 128 and the inner wall of the pipe holding member 404. The backflow prevention member 406 does not need to be formed in a membrane shape; it only needs to be formed in a shape that completely seals the needle tube 124 and the inner wall of the pipe holding member 404. A pressing member 408 is attached around the pipe 126 of the conduit 128, along its longitudinal direction, to apply a force to push the conduit 128 toward the bottom surface of the main body 402. As shown in Figure 13A, the needle tube 124 of the conduit 128 is housed inside the pipe holding member 404 along its entire length due to the elasticity of the backflow prevention member 406, unless a pressing force is applied to the pressing member 408.

[0073] Before the collection of the sample 135, the collection container 18 is provided to the medical personnel separately from the sample collection device 40, in a state where it is not inserted into the sample collection device 40, similar to the collection container 18 of the sample collection kit 1. When collecting the sample 135, first, the central part of the lid 182 of the collection container 18 is aligned with the opening at the bottom of the main body 402 that connects to the hollow part of the pipe holding member 404. Then, while maintaining the position of the collection container 18, a force is applied to the pressing member 408 along the longitudinal direction in the direction of the collection container 18. As a result, as shown in Figure 13B, the conduit 128 moves in the direction of the collection container 18. As the collection container 18 moves, the backflow prevention member 406 extends significantly towards the bottom of the main body 402, while blocking the space between the conduit 128 and the inner wall of the pipe holding member 404, and the other end 133 of the needle tube 124 of the conduit 128 is inserted into the lid 182. As a result, the other end 133 of the needle tube 124 passes through the lid 182 and reaches the hollow part inside the container body 180, causing the sample 135 to flow through the conduit 128 into the container body 180 of the collection container 28.

[0074] When a force is applied to the pressing member 408 along its longitudinal direction, away from the collection container 18, the other end 133 of the needle tube 124 detaches from the lid 182, as shown in Figure 13C. Furthermore, when the collection container 18 is moved away from the bottom surface of the main body 402, the collection container 18 containing the sample 135 is removed from the sample collection device 40.

[0075] [Fifth Embodiment] The fifth embodiment will now be described in detail. Except for the points specifically described below, the configuration is the same as that of the first to fourth embodiments, so a detailed explanation of those embodiments will be omitted. Figure 14 is a diagram illustrating a cross-section of a sample cup 8 in which the sample collection kit 1 according to the fifth embodiment is used. As shown in Figure 14, the sample cup 8 includes a sample cup body 80 and a lid 82. A sample collection kit 9 ​​and a regulating member 90 are attached to a recess formed in the lid 82. The sample collection kit 9 ​​has a configuration in which an elongated tube 84 is connected to the first end of a conduit 128 in a manner that prevents air and sample leakage. Such connection of the tube 84 to the first end of the conduit 128 is performed, for example, by spreading the second end of the tube 84 and covering the outside of the first end 130 of the conduit 128. Alternatively, this connection may be performed by placing a member for attaching the tube 84 at the first end of the conduit 128. The sample cup 8 is suitable, for example, for collecting a relatively large amount of sample.

[0076] Tube 84 is typically formed from a flexible material, such as synthetic resin materials like polyethylene (PE), polypropylene (PP), polystyrene (PS), acrylonitrile-styrene resin (AS), acrylonitrile-butadiene-styrene resin (ABS), polyvinyl chloride (PVC), methacrylic resin (PMMA), polyethylene terephthalate (PET), waterproof paper, plant-based plastics, or combinations thereof.

[0077] A recess 900 is formed in the lid 82, large enough to accommodate the restricting member 16 of the sample collection kit 1, and the restricting member 90 is housed in the recess 900. The restricting member 90 includes a lever member 162, an elastic member 164, a projection member 166, and a support member 168, which are arranged in and around the recess 900. A tube 84 is pulled into the recess 900, and the tube 84 passes between the lever member 162 and the projection member 166. Therefore, in the restricting member 90 as in the restricting member 16, the flow of the sample in the conduit 128 and tube 84 can be restricted by the user applying a force F to the lever member 162.

[0078] One end of tube 84 (the end located opposite to the end connected to the first end 130 of conduit 128) is guided into the sample 135 collected in the sample cup body 80. In this state, when a force F is applied to the lever member 162 of the regulating member 90, the sample 135 flows through tube 84 and conduit 128 and flows into the container body 180, where it accumulates. When a sufficient amount of sample 135 has accumulated inside the container body 180 and the user has finished applying force F to the lever member 162, the flow of sample 135 through tube 84 and conduit 128 stops, and the collection of sample 135 is completed.

[0079] Next, a modified version of the fifth embodiment will be described. Figure 15 shows a modified version of the fifth embodiment. As shown in Figure 15, in this modified version, a lid 92 is attached to the recessed opening of the lid 82 of the sample cup 8, where the main body 121 of the sample collection kit 9 ​​is attached. When the collection container 18 is not inserted into the main body 121, the opening is covered by the lid 92. The lid 92 is made of an elastic material, similar to the contact member 148 shown in Figure 6C, and has multiple cuts made from the periphery towards the center. When the collection container 18 is inserted into the main body 121 from the lid 92, the cut portion of the lid 92 flexes, allowing the collection container 18 to pass through. By attaching such a lid 92 to the recessed opening where the main body 121 of the sample collection kit 9 ​​is attached, needle stick injuries caused by the needle tube 124 are prevented.

[0080] [Differentiation] In each of the embodiments described above, the case in which the regulating member 16 has a structure for elastically closing at least a part of the pipeline 128 by a lever member 162 has been described. The elastic member 184 provided on the regulating member 16 is not limited to a leaf spring, but can be any type that can bias the lever member 162 in a desired direction, such as a coil spring, spiral spring, rubber, etc. Furthermore, the regulating member 16 only needs to be able to restrict the flow of the sample, and can be replaced with or in addition to the lever member 162, with various structures such as clamps, closed connectors, clips, stopcocks, valves, etc.

[0081] As described above, similar to the first to fourth embodiments, this embodiment provides a sample collection device and sample collection kit capable of restricting the outflow of the sample into the sample collection container. In particular, by effectively restricting the passage of the sample through the conduit 128 using the restricting member 16, it is possible to easily adjust the amount of sample collected into the collection container 18. Furthermore, the sample collection kit 1 of this embodiment makes it possible to collect samples from various containers.

[0082] Although several embodiments have been described above, these embodiments are presented as examples and are not intended to limit the scope of the invention. These novel embodiments can be carried out in various other forms and may be omitted, replaced, or modified in various ways without departing from the spirit of the invention. These embodiments and their variations are included in the scope and spirit of the embodiments and in the scope of the invention and its equivalents as described in the claims. [Explanation of Symbols]

[0083] 1, 20, 26, 4, 9: Sample collection kit 12,13,14,15,22,28,40: Sample collection device 120, 150, 220: Retaining member 121,151,222,402: Main unit 122,404: Pipe holding member 124: Needle tube 126: Pipe 128: Conduit 130,131: End 133,134 :edge 134: Test tube 135: Specimen 146,160: Opening 142: Elastic member 144,148: Contact members 153: Needle cover 16,90: Regulating member 162: Lever component 164: Elastic member (Biasing member) 166: Protruding member 168: Support member 18,24,28: Collection container 180: Container body 182,82,92: Lid 240,280: Sealing member 3: Sample cylinder 30: Sample collection tube 300: Collection tube body 302,304: Opening 306,322: Screw structure 32: Sample collection container 320: Cylinder body 322: Screw structure 406: Backflow prevention component (Membrane-like member) 408: Pressing member 8: Specimen cup 80: Sample cup body 84: Tube 900: Concave part

Claims

1. A conduit configured to allow the sample, which flows into a first end from outside a container whose interior has been depressurized for sample collection, to flow out into the interior of the container from a second end positioned opposite the first end, A holding member configured to hold the container and the pipeline, A regulating member configured to allow the sample to flow into the container when opened, and to restrict the flow of the sample into the container when closed, The aforementioned restraining member is A lever member is rotatably attached to the holding member via an axis, The lever member has a biasing member that biases one end of the lever member away from the pipeline, By biasing one end with the biasing member, the other end of the lever member is moved in a direction toward the conduit around the axis, thereby closing the conduit. A sample collection device in which one end moves against the biasing force of the biasing member, thereby moving the other end away from the pipeline around the axis and opening the pipeline.

2. The shaft is located between the one end and the other end of the lever member, The specimen collection device according to claim 1, wherein the one end and the other end move in opposite directions about the axis as the center of rotation.

3. The specimen collection device according to claim 1, wherein the conduit is connected to the holding member via an elastic membrane member.

4. The specimen collection device according to claim 1, wherein the specimen is a bodily fluid of biological origin.

5. The specimen collection apparatus according to claim 1, wherein the conduit includes a hollow pipe and a hollow needle tube configured to be inserted into the inside of the container from the lid of the container.

6. The sample collection device according to claim 5, wherein the restricting member restricts the flow of the sample into the container by blocking the pipe.

7. The pipe is configured to be crushed by pressure in at least the shorter direction of its cross-section, The regulating member restricts the flow of the sample into the container by pressurizing the pipe in the shorter direction. The specimen collection device according to claim 5, wherein the regulating member is arranged on the holding member.

8. A conduit configured to allow the sample, which flows into a first end from outside a container whose interior has been depressurized for sample collection, to flow out into the interior of the container from a second end positioned opposite the first end, A holding member configured to hold the container and the pipeline, A regulating member configured to allow the sample to flow into the container when opened, and to restrict the flow of the sample into the container when closed, The first end is connected to a tube whose tip is drawn into another container different from the aforementioned container. The aforementioned restraining member is The tube restricts the flow of the sample into the container. A lever member that is rotatably attached to the other container via an axis, The lever member has a biasing member that biases one end of the lever member away from the tube, By biasing one end with the biasing member, the other end of the lever member is moved toward the tube around the axis, thereby closing the tube. A sample collection device in which one end moves against the biasing force of the biasing member, thereby moving the other end away from the tube around the axis and opening the tube.

9. The specimen collection device according to claim 8, wherein the restricting member is arranged at a distance from the holding member.

10. A collection container configured to have its interior depressurized and sealed with a lid for the purpose of collecting a sample, A sample collection kit comprising the sample collection device described in claim 1.

Images