A biological sample collection device

Abstract

A biological sample collection device comprises: a tube body, the tube body comprising a accommodating space and an isolating member arranged in the accommodating space, the isolating member dividing the accommodating space into a first compartment and a second compartment, the isolating member having a hole, the first compartment and the second compartment being connected to each other through the hole of the isolating member, the first compartment having a first opening, and the second compartment having a second opening; a cover body, the cover body being detachably connected to the first opening; a sampling portion, the sampling portion being connected to the cover body; and a piston, the piston being arranged in the second opening of the second compartment. The sampling device of the present application integrates the functions of collecting and pre-processing biological samples, which can not only avoid the biological risks brought by biological samples faced by doctors, but also avoid the external contamination faced by biological samples during the collection and pre-processing process, thereby ensuring the accuracy of the test results.

Description

Technical Field

[0001] The present application relates to the field of biomedical detection technology, and in particular to a biological sample collection device. Background Art

[0002] In clinical testing, biological samples, such as human or animal feces and secretions, are often tested to form the basis for doctors' preliminary diagnosis of a condition. From collecting the original sample to obtaining the test result, four steps are typically required: 1. Collecting the original sample; 2. Pre-processing the original sample; 3. Extracting the final test sample; and 4. Testing the final test sample.

[0003] In the first stage, for some biological samples that need to be collected manually, because the biological sample to be collected is exposed to the collector, there is a risk of mutual biological contamination between the collector and the biological sample. For example, in existing clinical testing, when collecting feces, the collector generally collects it manually using a collection stick. The collection stick with the biological sample is then placed in a container with an opening, and then the testing doctor performs the test. Because the biological sample is directly exposed to the outside world, there is not only the risk of external contamination of the biological sample, but also the risk of biological contamination of the biological sample to the testing doctor.

[0004] As for stool testing, although stool collection tubes are already in use on the market, they only have the function of collecting stool. However, the collected stool (original sample) cannot be used directly for testing, and it needs to go through a pretreatment step (i.e., the second step mentioned above) before the biological sample that is ultimately used for testing can be extracted. In the prior art, the pretreatment process of the original stool sample requires manual operation, that is, the appropriate amount of original biological sample that has been collected in the container is transferred to another container, and then certain reagents are added for pretreatment (for example, diluted in proportion). The process of pretreating the original sample not only consumes manpower costs and is cumbersome to operate, but also the testing doctor directly contacts the sample during the pretreatment process, and may face the risk of biological contamination.

[0005] Therefore, in the process of collecting and preprocessing raw biological samples in the existing technology, the operation is cumbersome and labor-intensive, the biological samples may be subject to the hidden danger of external contamination, and the testing doctors may also face the risk of biological contamination from the biological samples. Summary of the Invention

[0006] To address the problems in the prior art of collecting and pre-processing biological samples, such as cumbersome operations, labor-intensive processes, the potential for external contamination of biological samples, and the risk of biological contamination faced by doctors, the present application provides a biological sample collection device, comprising:

[0007] a tube body, the tube body comprising a receiving space and a separator disposed in the receiving space, the separator dividing the receiving space into a first compartment and a second compartment, the separator having a hole, the first compartment and the second compartment being connected to each other through the hole of the separator, the first compartment having a first opening, and the second compartment having a second opening;

[0008] a cover body, the cover body being detachably connected to the first opening;

[0009] a sampling portion connected to the cover; and

[0010] A piston is disposed in the second opening of the second compartment.

[0011] Furthermore, the sampling portion is a sampling rod.

[0012] Furthermore, a sampling port is provided on the cover body, and the sampling port is covered with a sealing film.

[0013] Furthermore, the sealing film is an adhesive film or an aluminum foil film.

[0014] Furthermore, the biological sample collection device further includes a reagent, which is disposed in the second compartment. The piston moves toward the second compartment under the action of an external force, and the reagent enters the first compartment through the hole.

[0015] Furthermore, the reagent is a buffer solution.

[0016] Furthermore, the tube body further includes a plurality of positioning members, and the positioning members are arranged on the outer surface of the tube body.

[0017] Furthermore, the tube body and the cover body are connected by screw connection, snap connection or press connection.

[0018] Furthermore, the end of the sampling portion away from the cover body is spoon-shaped or wing-shaped, or the end of the sampling portion away from the cover body has a thread or fiber structure.

[0019] Furthermore, the isolating member is funnel-shaped and protrudes from the second compartment toward the first compartment.

[0020] Compared with the prior art, the advantages of the present invention are:

[0021] 1. The sampling device of the present application integrates the functions of collecting and pre-processing biological samples. The collection and pre-processing process is simple to operate and eliminates the labor cost of the biological sample pre-processing process in the prior art.

[0022] 2. The collected biological samples are sealed in the tube, which not only avoids the biological risks brought by the biological samples to the testing doctors, but also avoids the external contamination faced by the biological samples during the collection and pretreatment process, thereby ensuring the accuracy of the test results. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a front view of a sampling device according to an embodiment of the present application;

[0024] Figure 2 This is a cross-sectional view of a sampling device at AA according to an embodiment of the present application.

[0025] Reference numerals:

[0026] 10-tube body, 111-first compartment, 112-second compartment, 1111-first opening, 1121-second opening, 12-isolator, 121-hole, 20-cover, 21-sampling port, 22-sealing membrane, 30-sampling part, 40-piston, 50-reagent, 60-positioning part. DETAILED DESCRIPTION

[0027] The advantages of the present invention are described in detail below with reference to the accompanying drawings and specific embodiments. The terms "first" and "second" in this application do not limit the order of priority, but are only used to distinguish different structures.

[0028] According to one embodiment of the present application, Figure 1-2As shown, the present application provides a biological sample collection device comprising: a tube body 10, the tube body 10 comprising a receiving space and an isolating member 12 disposed in the receiving space, the isolating member 12 dividing the receiving space into a first compartment 111 and a second compartment 112, the isolating member 12 having a hole 121, the first compartment 111 and the second compartment 112 being connected to each other through the hole 121, the first compartment 111 having a first opening 1111, and the second compartment 112 having a second opening 1121; a cover body 20, The cover 20 is detachably connected to the first opening 1111; the sampling portion 30 is connected to the cover 20; the piston 40 is disposed in the second opening 1121 of the second compartment 112; the reagent 50 is disposed in the second compartment 112, and the piston 40 is moved into the second compartment 112 by an external force, and the reagent 50 enters the first compartment 111 through the hole 121; and a plurality of positioning members 60 are disposed on the outer surface of the tube 10. In other embodiments, the second compartment 112 of the biological sample collection device may not include the reagent 50. In other words, the reagent 50 is not pre-installed in the second compartment 112 of the biological sample collection device, and the reagent 50 is added to the second compartment 112 when the collected biological sample needs to be pre-processed. In other embodiments, the biological sample collection device may not include the plurality of positioning members 60.

[0029] Preferably, the biological sample is a body fluid, excrement or secretion of a human or animal. Preferably, the biological sample is feces. The specific composition of the reagent 50 depends on different biological samples and different test items. Preferably, the reagent 50 is a buffer solution. Preferably, the buffer solution is physiological saline or water for diluting the biological sample. When the collection device in this embodiment leaves the factory, the reagent 50 is preset in the second compartment 112, and the piston 40 moves from the second compartment 112 to the first compartment 111 relative to the inner wall of the tube body 10, so that the reagent 50 enters the first compartment 111, thereby mixing the reagent 50 with the biological sample, that is, the pretreatment process of the biological sample.

[0030] Preferably, the tube body 10 is a hollow cylindrical shape, for example, a cylindrical shape, a square prism shape, a triangular prism shape, etc. Preferably, the tube body 10 is a transparent structure so that the tester can observe the interior of the tube body 10. The outer surface of the tube body 10 is provided with the plurality of positioning members 60. During clinical testing, it is often necessary to test multiple biological samples at the same time. In order to improve work efficiency, it is necessary to place multiple collection devices containing biological samples on the test stand at the same time to perform batch sampling and testing. In order to ensure the accuracy of the sampling needle insertion position, it is necessary to unify the position of each collection device on the test stand. In particular, when the central axis of the sampling port 21 is not coaxial with the central axis of the tube body 10, in order to ensure the accuracy of the sampling needle insertion position, it is necessary to accurately control the orientation of each tube body 10 when it is inserted into the test stand by the positioning member 60, so that the positions of the sampling ports 21 of multiple sampling devices remain consistent, for example, all sampling ports 21 are on the same straight line and the intervals between the sampling ports 21 are the same. Preferably, the sampling device of the present application includes two positioning members 60 arranged relatively on the side surface of the tube body 10. Preferably, the positioning member 60 is a columnar structure protruding from the outer surface of the tube body 10. Preferably, the two positioning members 60 are provided on the outer surface of the end of the tube body 10 away from the cover body 20. Preferably, the central axis of the sampling port 21 and the two positioning members 60 are on the same plane. Preferably, the positioning member 60 is provided on the outside of the first compartment 111 or the second compartment 112. Preferably, the positioning member 60 is provided on the outer surface of the tube body 10 outside the piston 40. Figure 2As shown, the interior of the tube body 10 is provided with the isolating member 12. The isolating member 12 divides the accommodating space of the tube body 10 into a first compartment 111 and a second compartment 112. The first format is used to accommodate a collection rod and a biological sample, and is used to accommodate a mixture of a biological sample and a reagent 50, that is, as a place for pretreatment. The second compartment 112 is used to accommodate the reagent 50 before pretreatment, so that the reagent 50 and the biological sample do not contact each other before pretreatment, in preparation for the subsequent pretreatment process. The reagent 50 in this embodiment is arranged in the second compartment 112, and the piston 40 moves into the second compartment 112 under the action of an external force, and the reagent 50 enters the first compartment 111 through the hole 121. The isolating member 12 is in the shape of an inverted funnel, and the isolating member 12 protrudes from the second compartment 112 to the first compartment 111. Preferably, the central axis of the hole 121 is coaxial with the central axis of the sampling rod, and a certain distance exists between the end of the sampling rod away from the cover 20 and the hole 121 of the isolation member 12, so that the sampling rod does not block the reagent 50 from entering the first compartment 111. The reagent 50 exiting the hole 121 is precisely sprayed onto the end of the sampling rod away from the body, so that the biological sample is separated and dispersed from the end of the sampling rod. The isolation member 12 is configured in an inverted funnel shape (i.e., the isolation member 12 protrudes from the second compartment 112 toward the first compartment 111) to prevent the reagent 50 from accidentally entering the first compartment 111 before pretreatment. In other embodiments, the hole 121 may also be covered with a protective film to prevent the reagent 50 in the second compartment 112 from accidentally entering the first compartment 111. When the piston 40 squeezes the reagent 50, the pressure in the second compartment 112 is greater than the pressure in the first compartment 111, thereby breaking through the protective film and allowing the reagent 50 to smoothly enter the first compartment 111.When the piston 40 moves toward the isolation member 12 under the action of an external force, for example, by using a tool (such as a pusher of a detector) or by hand, the piston 40 is pushed toward the first compartment 111 until an appropriate amount of the reagent 50 in the second compartment 112 enters the first compartment 111. At this time, the isolation member 12 is configured to protrude from the second compartment 112 toward the first compartment 111 and the hole 121 is configured to be smaller in diameter. The purpose is: 1. When the reagent 50 in the first compartment 111 When the amount is small, the hole 121 of the isolation member 12 is higher than or equal to the horizontal plane of the reagent 50, so that the reagent 50 entering the first compartment 111 cannot flow back to the second compartment 112; 2. When the amount of the reagent 50 in the first compartment 111 is large, the hole 121 of the isolation member 12 is lower than the horizontal plane of the reagent 50, so that the reagent 50 entering the first compartment 111 cannot quickly flow back to the second compartment 112, thereby reserving sufficient extraction time for extracting the final test biological sample.

[0031] The cover body 20 is detachably connected to the first opening 1111 of the tube body 10. Preferably, the tube body 10 and the cover body 20 are spirally connected, snap-connected or press-connected. Preferably, the connection between the cover body 20 and the tube body 10 is a spiral connection with a 0-180° tightening method. A sampling port 21 is provided on the cover body 20, and the sampling port 21 is covered with a sealing film 22. The central axis of the sampling port 21 is coaxial or non-coaxial with the central axis of the tube body 10. The sampling needle extracts the pretreated biological sample from the tube body 10 through the sampling port 21 for subsequent testing. Preferably, the sealing film 22 is a rubber film or an aluminum foil film, or other structure that can be pierced by a sampling needle. The sealing film 22 is covered on the sampling port 21 by gluing or other means.

[0032] Preferably, the sampling portion 30 is a sampling rod. One end of the sampling rod is connected to the inner surface of the cover body 20. The end of the sampling rod away from the main body (i.e., the tip) extends into the first compartment 111. Preferably, one end of the sampling rod is vertically connected to the inner surface of the main body, and the end of the sampling portion 30 away from the cover body 20 is spoon-shaped or wing-shaped, or the end of the sampling portion 30 away from the cover body 20 has a threaded or fiber structure, so as to facilitate the collection of a sufficient amount of biological samples. In this embodiment, the sampling rod is fixedly connected to the cover body 20. In other embodiments, the sampling portion 30 can also be detachably connected to the cover body 20, and the cover body 20 and the sampling portion 30 are connected by a spiral connection or a connector. In other embodiments, the sampling portion 30 may also be a rubber-tipped pipette, comprising a rubber cap and a pipette, one end of the pipette passing through the cover 20 and connected to the rubber cap, the rubber cap being exposed outside the cover 20, and the other end of the pipette extending into the first compartment 111. In other embodiments, the sampling portion 30 may also be rotatably connected to the cover 20, and the sampling portion 30 may rotate relative to the cover 20 around the central axis of the sampling portion 30, thereby quickly separating the biological sample at the end of the sampling portion 30 and simultaneously stirring the sample to achieve a more uniform mixing between the biological sample and the reagent 50. For example, a drive unit is provided between the sampling rod and the cover 20 to drive the rotation of the sampling rod. Alternatively, the end of the sampling rod connected to the cover 20 is further connected to a rotating member, which is exposed outside the cover 20. The sampling rod and the rotating member are coaxial, and the user rotates the rotating member with their fingers to drive the rotation of the sampling rod. For example, the rotating member is a handle.

[0033] The piston 40 is slidably connected to the inner wall of the end of the tube body 10 away from the cover body 20. Specifically, the piston 40 slides relative to the inner wall of the tube body 10 in the second compartment 112. Preferably, the piston 40 is made of an elastic material and has an interference fit with the tube body 10. Therefore, the piston 40 has a sealing effect, thereby preventing the reagent 50 in the second compartment 112 from leaking from the gap between the piston 40 and the inner wall of the tube body 10. Preferably, the piston 40 is made of rubber material. Preferably, the thickness of the piston 40 is less than the height of the second compartment 112.

[0034] The method for using the biological sample collection device with the reagent 50 preset in the second compartment 112 and the positioning member 60 is as follows:

[0035] 1. Collection: Open the cover 20, then use the sampling portion 30 to collect an appropriate amount of raw biological sample, and then replace the cover 20 after collecting the raw biological sample onto the first opening 1111 of the tube 10;

[0036] 3. Positioning: Install the positioning member 60 of the acquisition device at the corresponding position of the test frame;

[0037] 4. Pretreatment: Push the piston 40 toward the isolation member 12 until an appropriate amount of the reagent 50 in the second compartment 112 enters the first compartment 111 , allowing the original biological sample to fully contact the reagent 50 ;

[0038] 5. Extraction and Testing: Use a sampling needle to pierce the sealing membrane 22 and enter the first compartment 111 through the sampling port 21. An appropriate amount of the original biological sample and the reagent 50 mixture is collected as the final test biological sample for subsequent testing. Even when multiple sampling devices are installed on the test rack, simultaneous extraction can be achieved, saving extraction time.

[0039] In summary, the sampling device of the present application integrates the functions of collecting and preprocessing biological samples. The collection and preprocessing processes are simple to operate and eliminate the labor costs of the biological sample preprocessing process in the prior art. The collected biological samples are always sealed in the tube body 10, and the entire process of preprocessing the biological samples is also carried out in the sealed tube body 10. It can not only avoid the biological risks brought by the biological samples faced by the testers, but also avoid the external contamination faced by the biological samples during the collection and preprocessing process, thereby ensuring the accuracy of the test results.

[0040] While the specific embodiments of the present invention have been described in detail above, these are merely exemplary and the present invention is not limited thereto. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, any equivalent changes and modifications made without departing from the spirit and scope of the present invention are intended to be encompassed within the scope of the present invention.

Claims

1. A biological sample collection device, characterized in that: include: A tube body, the tube body including a storage space and a separator arranged in the storage space, the separator dividing the storage space into a first compartment and a second compartment, the separator having a hole, the first compartment and the second compartment being connected to each other through the hole of the separator, the first compartment having a first opening, the second compartment having a second opening, the separator being funnel-shaped, and the separator protruding from the second compartment to the first compartment, a cover body, the cover body being detachably connected to the first opening; the cover body being provided with a sampling port, the sampling port being covered with a sealing film; a sampling portion connected to the cover; a piston disposed in the second opening of the second compartment; The reagent is arranged in the second compartment, the piston moves into the second compartment under the action of external force, and the reagent enters the first compartment through the hole.

2. The biological sample collection device according to claim 1, wherein: The sampling part is a sampling rod.

3. The biological sample collection device according to claim 1, wherein: The sealing film is a rubber film or an aluminum foil film.

4. The biological sample collection device according to claim 1, wherein: The reagent is a buffer solution.

5. The biological sample collection device according to claim 1, wherein: The tube body further includes a plurality of positioning members, and the positioning members are arranged on the outer surface of the tube body.

6. The biological sample collection device according to any one of claims 1 to 5, characterized in that: The tube body and the cover body are connected by screw connection, snap connection or press connection.

7. The biological sample collection device according to any one of claims 1 to 5, characterized in that: The end of the sampling portion away from the cover body is spoon-shaped or wing-shaped, or the end of the sampling portion away from the cover body has a thread or fiber structure.

8. The biological sample collection device according to any one of claims 1 to 5, characterized in that: The partition is funnel-shaped and protrudes from the second compartment toward the first compartment.

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