WO2023134330A1 - 一种样本采集装置及样本采集方法 - Google Patents

一种样本采集装置及样本采集方法 Download PDF

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Publication number
WO2023134330A1
WO2023134330A1 PCT/CN2022/136774 CN2022136774W WO2023134330A1 WO 2023134330 A1 WO2023134330 A1 WO 2023134330A1 CN 2022136774 W CN2022136774 W CN 2022136774W WO 2023134330 A1 WO2023134330 A1 WO 2023134330A1
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WO
WIPO (PCT)
Prior art keywords
detection
sample
sample collection
collection device
core
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
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PCT/CN2022/136774
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English (en)
French (fr)
Inventor
姚磊
凌世生
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ASSURE Tech (HANGZHOU) CO Ltd
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ASSURE Tech (HANGZHOU) CO Ltd
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Application filed by ASSURE Tech (HANGZHOU) CO Ltd filed Critical ASSURE Tech (HANGZHOU) CO Ltd
Priority to AU2022433254A priority Critical patent/AU2022433254B2/en
Priority to EP22919963.3A priority patent/EP4446721A4/en
Priority to CA3248372A priority patent/CA3248372A1/en
Publication of WO2023134330A1 publication Critical patent/WO2023134330A1/zh
Priority to ZA2024/05162A priority patent/ZA202405162B/en
Priority to US18/769,694 priority patent/US20240361302A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/14—Suction devices, e.g. pumps; Ejector devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150946—Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5029—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures using swabs
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0627—Sensor or part of a sensor is integrated
    • B01L2300/0663—Whole sensors
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0861—Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0864—Configuration of multiple channels and/or chambers in a single devices comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G01N1/14—Suction devices, e.g. pumps; Ejector devices
    • G01N2001/1472—Devices not actuated by pressure difference

Definitions

  • the present application relates to the field of medical devices, in particular to a sample collection device and a sample collection method.
  • sample collection devices In the field of sample collection and detection, for liquid samples such as blood and saliva, conventional sample collection devices mainly use the siphon effect to draw biological samples into the interior, and the collection volume of this sample collection device is relatively large. Small, limited acquisition angle, resulting in low detection accuracy, inconvenient operation, etc. Therefore, it is necessary to propose a sample collection device with large collection volume and unlimited collection angle.
  • the sample collection device includes: a collection part, a detection part, and a connection part connecting the collection part and the detection part; the collection part includes a core body, and the connection part It includes a hollow structure, at least part of the core body is arranged in the hollow structure; the core body has hydrophilicity.
  • the core includes a hydrophilic fiber bundle structure, and the fiber bundle structure has voids for the sample to pass through.
  • the fiber bundle structure is adsorbable to red blood cells in the sample.
  • connection part includes a collection end, the collection end is far away from the detection part; the collection end has a gap, and part of the surface of the core body is exposed from the gap.
  • the hollow structure is provided with a first channel and a second channel, and the first channel and the second channel communicate with each other and pass through the connecting portion; the inner diameter of the first channel is larger than that of the The inner diameter of the second channel.
  • the core is disposed in the first channel, and the outer diameter of the core is larger than the inner diameter of the second channel.
  • At least one support structure is provided on the inner wall of the first channel, and the support structure protrudes from the inner wall of the first channel; the plurality of support structures are connected to the peripheral side of the core Abut.
  • the detection part includes a detection cavity, and the void of the core communicates with the detection cavity through the hollow structure.
  • the detection part includes a detection element disposed in the detection cavity.
  • the detection element includes an adsorption section and a detection section arranged in sequence; the adsorption section is used to absorb red blood cells in the sample; and the detection section is used to detect the sample.
  • the detection element includes a plurality of detection elements distributed along the radial direction of the detection cavity, and each detection content of the plurality of detection elements is different.
  • an operation port is provided at the end of the detection chamber away from the connection part, and the detection element is put into and/or taken out of the detection chamber through the operation port; the operation port is provided with a cover , the cover is detachably connected to the operation port.
  • the detection part includes a bracket for supporting the detection element; the bracket is connected to the inner wall of the detection cavity.
  • the detection part includes a buffer unit disposed between the connection part and the detection chamber, and the buffer unit is used to reduce the flow velocity of the sample flowing to the detection chamber.
  • the detection part includes a connecting end connected to the connecting part, and the connecting end is provided with a limiting structure; the connecting part includes a locking structure, and the locking structure is connected to the limiting structure.
  • the clamping connection restricts the separation of the collection part and the detection part from each other.
  • the connecting portion includes a stop structure, the stop structure is arranged around the peripheral side of the connecting portion and extends along the radial direction of the connecting portion, the diameter of the stop structure is larger than the The inner diameter of the connecting end.
  • the sample collection device further includes a buffer pre-storage part, and the buffer pre-storage part includes a buffer, a pre-storage cavity, and a sealing sheet; the buffer is stored in the pre-storage cavity, and the sealing sheet Seal the pre-cavity.
  • the buffer pre-storage part further includes a guide cavity connected to the pre-storage cavity, and the sealing sheet is disposed between the pre-storage cavity and the guide cavity.
  • the collection part is set separately from the buffer pre-storage part, and the collection part enters the buffer pre-storage part through the guide cavity.
  • One of the embodiments of this specification provides a sample collection method, the method includes: contacting the sample through the collection end of the connection part of the sample collection device, so that the core body absorbs and stores the sample; wherein, the core body is arranged on the Inside the connection part, the core has hydrophilicity; insert the connection part into the buffer pre-storage part of the sample collection device, and insert the core body into the buffer in the buffer pre-storage part; through the The buffer agent flushes the sample from the core into the detection part of the sample collection device to obtain a detection result.
  • the method further includes: connecting the connection part and the detection part.
  • the method further includes: placing a detection element into a detection cavity of the detection part; and closing the detection cavity with a cover.
  • Figure 1A is a front view of a sample collection device according to some embodiments of the present application.
  • Figure 1B is a side view of a sample collection device according to some embodiments of the present application.
  • Figure 2 is a cross-sectional view of a core according to some embodiments of the present application.
  • Fig. 3 is a schematic structural diagram of an acquisition unit and a connection unit according to some embodiments of the present application;
  • Fig. 4 is a cross-sectional view of a connecting part according to some embodiments of the present application.
  • Fig. 5A is a schematic structural diagram of a sample collection device according to some embodiments of the present application.
  • Fig. 5B is a structural schematic diagram of another viewing angle of the sample collection device according to some embodiments of the present application.
  • Fig. 6 is a schematic structural view of a buffer pre-storage part according to some embodiments of the present application.
  • Fig. 7 is a schematic flowchart of a sample collection method according to some embodiments of the present application.
  • the sample collection device of one or more embodiments of the present application can be used to collect various biological samples or chemical samples, including but not limited to liquid samples such as blood, saliva, urine, chemical solutions, enzyme solutions, and drug solutions.
  • the sample collection device can also detect the collected samples, so as to provide references for disease diagnosis, immune detection, drug inspection and the like.
  • an exemplary application scenario of the sample collection device may be collecting and testing blood, which may come from the blood stored in a blood collection tube or blood bag, or from human blood directly obtained by a blood collection needle , such as fingertip blood.
  • the sample collection device may be a collection device provided with a siphon tube, which absorbs the sample by using the siphon effect of the siphon tube, and transfers the sample to the detection chamber for detection.
  • a siphon tube which absorbs the sample by using the siphon effect of the siphon tube, and transfers the sample to the detection chamber for detection.
  • a core with strong hydrophilicity is provided in the collection part, and the core absorbs the sample, which can increase the sample volume and efficiency of collection, and the core has a maintenance effect on the sample, so that
  • the acquisition angle is also not limited.
  • Fig. 1A is a front view of a sample collection device 1 according to some embodiments of the present application.
  • Fig. 1B is a side view of a sample collection device 1 according to some embodiments of the present application.
  • the embodiment of this specification provides a sample collection device 1 , which includes a collection part 10 , a detection part 20 and a connection part 30 connecting the collection part 10 and the detection part 20 .
  • the collection unit 10 can be used to collect samples, which can be collection objects such as blood, saliva, urine, chemical solutions, enzyme solutions, and the like.
  • the detection unit 20 can be used to detect various indicators of the sample.
  • the indicators may include but not limited to medical indicators, biological indicators or chemical indicators and so on.
  • the sample may be blood, and the detection unit 20 may detect indicators such as serum lipids, trace elements, antibiotics, virus antibodies, and pH in the blood sample.
  • the sample may be saliva, and the detection unit 20 may detect indicators such as enzymes, polysaccharides, alcohol, and virus antibodies in the saliva sample.
  • the collecting part 10 includes a core body 110
  • the connecting part 30 includes a hollow structure
  • at least part of the core body 110 is disposed in the hollow structure of the connecting part 30, that is, the hollow structure of the connecting part 30 can accommodate and fix the core body 110, wherein at least part of the core 110 may refer to the whole of the core 110 or a part of the core 110.
  • all of the core 110 is disposed in the hollow structure of the connection part 30 .
  • a part of the core 110 is disposed in the hollow structure of the connection part 30 , and another part of the core 110 is exposed outside the hollow structure of the connection part 30 .
  • core 110 may be used to draw a sample.
  • core 110 may also be used to store samples.
  • the core 110 has hydrophilicity, and hydrophilicity may refer to a property capable of attracting water molecules.
  • the hydrophilic core 110 has a great liquid surface tension for water molecules, so that water molecules can be absorbed and kept on the core 110. Generally speaking, it is the property that the core 110 is easily wetted by the moisture in the sample .
  • the hydrophilicity of the core 110 may include that the outer surface of the core 110 is hydrophilic, and may also include that the interior of the core 110 is hydrophilic.
  • the hydrophilicity of the core 110 can be obtained through special processing.
  • the hydrophilicity of the core 110 can also be obtained by the properties of the material itself.
  • the hydrophilicity of the core 110 can also be obtained by designing the internal structure of the core 110 . Utilizing the hydrophilicity of the core 110, the attraction of the core 110 to water molecules can be enhanced, and the water molecules will quickly diffuse from the wet area of the core 110 to the dry area under the action of this attraction, which is manifested by the gradual immersion of the sample. wet core 110 process.
  • the hydrophilicity of the core body 110 can increase the amount of sample absorbed to meet the detection requirements of the detection part 20, and the attraction force of the core body 110 to water molecules can increase the speed of absorbing water molecules and improve the sample collection speed; not only In this way, by utilizing the hydrophilicity of the core 110, after the core 110 absorbs the sample, the sample stored on the core 110 has strong stability and is less affected by gravity. Aspirate the sample, making the sample collection operation easier and more casual.
  • FIG. 2 and related descriptions please refer to FIG. 2 and related descriptions.
  • the detection unit 20 is connected to the collection unit 10 through the connection unit 30 .
  • the connection part 30 can be detachably connected to the detection part 20, and the connection methods include but not limited to clamping, threaded connection, interference fit and the like.
  • the connection part 30 may be non-detachably connected to the detection part 20, and the connection methods include but are not limited to integral molding, adhesive connection and the like.
  • the detection part 20 may include a detection cavity 210 for accommodating a sample when detecting a sample. For more details about the detection part 20 and the detection cavity 210, please refer to FIG. 5A and FIG. 5B and their related descriptions.
  • FIG. 2 is a cross-sectional view of core 110 according to some embodiments of the present application.
  • the arrangement of the fiber bundle structure and the arrangement of the voids 111 in FIG. 2 are only for reference, and FIG. 2 does not limit the fiber bundle arrangement and density of the fiber bundle structure.
  • the core 110 includes a hydrophilic fiber bundle structure
  • the fiber bundle structure may be a structure in which a large number of single fibers 112 are bonded to each other and consolidated into a bundle.
  • the material of the fiber bundle structure can be selected from materials that have good biocompatibility and are not easy to damage the tissue cells in the sample, such as polyester fiber, polyester, medical cotton, etc. This material can reduce the damage of the core 110 material to the sample and improve the quality of the sample.
  • the stability of the aspirated sample due to the good biocompatibility of the material, can avoid the rupture of the cell membrane of the tissue cells and the substances in the tissue cells to affect the test results.
  • the fiber bundle structure can be treated by chemical or physical methods to enhance its biocompatibility and other properties.
  • almost all the fibers 112 in the treated fiber bundle structure can be Extending in the axial direction, for another example, the treated fiber bundle structure may have a cross-section of equal density, and so on.
  • the core body 110 can be modified to obtain hydrophilicity.
  • the modification treatment refers to endowing the core 110 with new properties, such as hydrophilicity, on the premise of maintaining the original properties of the core 110 or the material of the core 110 .
  • the single fiber 112 of the core 110 can be subjected to surface treatment or cross-section treatment to obtain hydrophilicity, such as processing micro-concaves and convexes on the surface of the single fiber 112, and then for example, treating the cross-section of the single fiber 112 L-shape or C-shape, these treatment methods can increase the surface area of a single fiber 112, thereby improving hydrophilicity.
  • hydrophilicity can include attractiveness to water molecules.
  • hydrophilic groups can be added in the core 110 to enhance the attraction to water molecules, thereby obtaining hydrophilicity, for example, adding amino groups, amino groups, Hydrophilic group components such as hydroxyl, carboxyl, and amide groups, thereby increasing its hydrophilicity.
  • hydrophilicity may also include the ability to maintain water molecules, also known as water-holding ability.
  • hydrophilic groups and hydrophobic groups can be added to the material of the core 110 to form a cross-linked network polymer structure.
  • the attraction of the core 110 to water molecules can be improved, while the hydrophobic groups can make the water molecules entering the interior of the grid lose their mobility due to polarity, thereby The water molecules are maintained inside the material of the core body 110 to improve the water-locking ability of the core body 110 .
  • the water absorption capacity of the core 110 can reach more than 100 times its own weight, greatly improving the water attraction and water retention capacity of the core 110 .
  • the fiber bundle structure has a void 111 inside for the sample to pass through.
  • the void 111 may be composed of the fiber 112 and the gap between the fibers 112, and the sample moves through the void 111.
  • the voids 111 inside the fiber bundle structure can increase the hydrophilic area of the core 110 , making it easier for the sample to be sucked onto the core 110 .
  • the core 110 since the core 110 has strong attraction and water-holding capacity for water molecules, the core 110 can absorb samples and store the samples in the voids 111 of the core 110. Under the effect of hydrophilicity, it can overcome the gravity and remain in the core 110 .
  • the core 110 can aspirate and store a sample volume as high as 60 microliters to 70 microliters.
  • the volume ratio of the void 111 to the fiber bundle structure can be set in different ranges according to requirements, so as to obtain different effects.
  • the volume ratio of the void 111 to the fiber bundle structure may be in the range of 1%-10%, for example, the volume ratio of the void 111 to the fiber bundle structure may be 3%, 6%, 7%, 8% or 9%.
  • the volume ratio of the voids 111 to the fiber bundle structure is relatively low, for example, the volume ratio of the voids 111 to the fiber bundle structure is in the range of 1%-5%, indicating that the fiber bundle structure in the core 110 is relatively dense (That is, the gap between the fibers 112 is small), which will generate appropriate resistance to the sample flowing on the core 110 , slow down the flow velocity of the sample through the gap 111 , and thus play a buffering role for the sample.
  • the core 110 whose volume ratio of the void 111 to the fiber bundle structure is lower than that of the core 110 its ability to maintain the sample inside is relatively strong, which can avoid sample backflow.
  • the volume ratio of the voids 111 to the fiber bundle structure is relatively high, for example, the volume ratio of the voids 111 to the fiber bundle structure is in the range of 5%-10%, indicating that the fiber bundle structure in the core 110 is relatively sparse (That is, the gap between the fibers 112 and the fibers 112 is large), the resistance of the sample to flow on the core 110 is small, the speed at which the core 110 absorbs the sample can be increased, so that the sample can reach the detection chamber 210 quickly, and the detection efficiency is improved.
  • the volume ratio of the void 111 to the fiber bundle structure should not be too high or too low. If the volume ratio of the gap 111 to the fiber bundle structure is too low, the flow resistance to the sample will be too large, which may reduce the collection efficiency, and hinder or even destroy the detection components in the sample (such as plasma in the blood sample). Tissue cells in the sample. If the volume ratio of the voids 111 to the fiber bundle structure is too high, the total hydrophilic surface area of the core 110 will decrease too much, thereby reducing the amount of sample absorbed by the core 110 . Preferably, the volume ratio of the void 111 to the fiber bundle structure is in the range of 5%-6%.
  • the volume ratio of the void 111 to the fiber bundle structure may also be in other ranges or set arbitrarily, which is not limited in this specification.
  • the colored components in some samples may interfere with the detection results, therefore, the fiber bundle structure can be processed to have the ability to adsorb the colored components or non-detected components in the sample.
  • blood samples are taken as an example.
  • the red blood cells in the blood sample may affect the test results. Therefore, the fiber bundle structure has adsorption properties for the red blood cells in the sample.
  • the red blood cells remain in the fiber bundle structure, and the serum continues to flow to the test. Detection is performed in chamber 210.
  • the core body 110 can be modified to obtain the property of absorbing red blood cells.
  • groups such as hemagglutinin capable of adsorbing red blood cells can be added to the cellulose 112 structure of the core 110 , so that the red blood cells can be combined with the groups such as hemagglutinin and remain in the core 110 .
  • the volume ratio of the voids 111 to the fiber bundles may be in the range of 5%-10%, so that the core 110 has a better property of absorbing red blood cells.
  • the volume ratio of the void 111 to the fiber bundle should neither be too high nor too low. If the volume ratio of the voids 111 to the fiber bundles is too high, it means that the amount of fibers 112 in the core 110 is small, and the voids 111 are large, and the amount of groups such as hemagglutinin is correspondingly small, which will reduce the amount of red blood cell adsorption .
  • the gap 111 between the fibers 112 is relatively large, which easily causes red blood cells to be washed to the detection part 20 before they are fully combined with groups such as hemagglutinin, reducing the filtering effect of the core body 110 on red blood cells. If the volume ratio of the gap 111 to the fiber bundle is too low, it means that the fiber 112 in the core 110 is relatively large, and the gap 111 is small, and red blood cells are easy to block the gap 111 and affect the speed at which the core 110 absorbs samples, and the red blood cells enter the core 110. The gap is easily crushed and damaged, causing the substances in the red blood cells to be washed to the detection part 20, affecting the detection result.
  • Fig. 3 is a schematic structural diagram of the collection part 10 and the connection part 30 according to some embodiments of the present application;
  • Fig. 4 is a cross-sectional view of the connection part 30 according to some embodiments of the present application.
  • connection part 30 can be configured as a hollow columnar structure, that is, the connection part 30 can include a hollow structure, and the hollow structure can include but not limited to cylindrical, prism and other shapes.
  • the connection part 30 includes a collection end 310 and an assembly end 320 , the collection end 310 is away from the detection part 20 , and may be an end connected to the collection part 10 ; the assembly end 320 may be an end connected to the detection part 20 .
  • the collecting end 310 has a notch 311 , and part of the surface of the core 110 is exposed from the notch 311 , thereby increasing the area of the core 110 exposed outside the collecting end 310 .
  • this configuration can increase the contact area between the core body 110 and the sample, and improve the sample collection efficiency.
  • the part of the collection end 310 except the notch 311 can provide support for the core 110 to prevent the deformation of the core 110 from affecting the collection effect.
  • the orthographic projection refers to the projection along the direction perpendicular to the notch
  • the number of notches 311 may be N, where N is a natural number.
  • the hollow structure of the connection part 30 may include a first channel 330 and a second channel 340 , the first channel 330 and the second channel 340 communicate with each other and pass through the connection part 30 , so that An inlet 312 allowing the sample to flow in and an outlet 321 allowing the sample to flow out are formed.
  • the inlet 312 of the connection part 30 is located at the collection end 310
  • the outlet 321 of the connection part 30 is located at the assembly end 320 .
  • the first channel 330 can be close to the collection end 310, one end of the first channel 330 forms the inlet 312 of the connection part 30, and the other end communicates with the second channel 340; the second channel 340 can be close to the assembly end 320, and the second One end of the channel 340 forms the outlet 321 of the connecting portion 30 , and the other end communicates with the first channel 330 .
  • the first channel 330 can be used to install the core 110
  • the second channel 340 can be used as a hollow channel for guiding water.
  • the axes of the first channel 330 and the second channel 340 may be straight, curved, or the like.
  • the inner diameter of the first channel 330 is greater than the inner diameter of the second channel 340 .
  • the inner diameter of the first channel 330 is larger and can accommodate a core body 110 with a larger cross-section, which helps to increase the rate of sample collection.
  • the inner diameter of the second channel 340 is smaller, and capillary phenomenon is more likely to occur, so that the sample flows from the core 110 toward the outlet 321 under capillary action.
  • the core 110 is disposed in the first channel 330 , and the outer diameter of the core 110 is larger than the inner diameter of the second channel 340 .
  • the inner diameter of the first channel 330 is greater than the inner diameter of the second channel 340, a step 350 is formed at the junction of the first channel 330 and the second channel 340, and the end of the core 110 can abut on the step 350, so as to Displacement of the core 110 toward the second channel 340 is restricted.
  • At least one support structure 360 is disposed on the inner wall of the first channel 330 , the support structure 360 protrudes from the inner wall of the first channel 330 , and the support structure 360 is used to support and limit the core 110 .
  • the height of the support structure 360 protruding from the inner wall of the first channel 330 is smaller than the height of the step 350 protruding from the inner wall of the first channel 330 , so as to accommodate the core 110 having a larger inner diameter than the second channel 340 .
  • the support structure 360 can be configured as a long protrusion, for example, the long protrusion can extend along the axial direction of the first channel 330 , or the long protrusion can extend obliquely relative to the side wall of the first channel 330 .
  • the supporting structure 360 may be configured as a plurality of bumps arranged at intervals.
  • the support structure 360 can be configured as an annular protrusion, for example, the annular protrusion can be a closed ring extending along the circumferential direction, or the annular protrusion can be helically extended along the inner wall of the first channel 330 spiral ring.
  • the embodiment of the present disclosure does not limit the configuration of the support structure 360 to the embodiment of this specification, and its configuration may be a strip protrusion, a protrusion, a ring protrusion or any other protrusion shape. one or a combination of several.
  • the supporting structure 360 is arranged in such a way that the peripheral side of the core 110 can form a gap with the inner wall of the first channel 330 , for example, four elongated protrusions are arranged at equal intervals along the circumferential direction.
  • the core body 110 forms a gap with the inner wall of the first channel 330, which can reduce the contact area between the core body 110 and the inner wall, thereby reducing the frictional resistance of the core body 110 in the process of being assembled into the first channel 330, and making the core body 110 more compact. Easy insertion into first channel 330 .
  • a gap is formed between the core body 110 and the inner wall of the first channel 330 , which can avoid adhesion and blockage after the sample enters. Moreover, the core body 110 will slightly expand and deform after absorbing the sample, and the gap between the core body 110 and the inner wall of the first channel 330 provides a deformation space for the expansion of the core body 110 .
  • the connecting part 30 can be made of a transparent material, such as transparent plastic, glass, etc., so as to observe the condition of the core 110 in the first channel 330, such as observing the degree of the sample infiltrating the core 110, the core 110 expansion deformation and so on.
  • the connecting part 30 can be made of non-transparent materials, such as non-transparent plastics, metal materials and the like.
  • Fig. 5A is a schematic structural diagram of a sample collection device 1 according to some embodiments of the present application
  • Fig. 5B is a schematic structural diagram of another viewing angle of the sample collection device 1 according to some embodiments of the present application.
  • the detection part 20 includes a detection cavity 210 , and the gap 111 of the core 110 communicates with the detection cavity 210 through the hollow structure of the connection part 30 . In this way, after the sample is sucked into the hollow structure of the connection part 30 by the core body 110 , it can enter the detection cavity 210 from the hollow structure.
  • the detection part 20 further includes a detection element 220 disposed in the detection cavity 210 .
  • the detection cavity 210 may be a hollow cavity capable of accommodating the detection element 220 .
  • the detection chamber 210 can provide a sealed environment for the detection element 220 to prevent substances in the external environment from contaminating the sample and the detection element 220 and affecting the detection results, for example, preventing the entry of substances such as external humidity, bacteria, and dirt.
  • the detection chamber 210 ensures detection accuracy.
  • the detection part 20 may include a casing 230 , and the casing 230 defines a detection cavity 210 of the detection part 20 .
  • the shape of the casing 230 may include, but not limited to, a cylindrical shape, a prismatic shape, or an irregular shape.
  • the casing 230 can be made of transparent material, so as to facilitate observation of the detection result of the detection element 220 .
  • the detection cavity 210 can communicate with the hollow structure of the connection part 30 (for example, the outlet 321 of the connection part 30), so that the gap 111 of the core body 110 communicates with the detection cavity 210 through the hollow structure of the connection part 30, realizing The sample is transported from the collection unit 10 to the detection unit 20 .
  • an operation port is provided at the end of the detection cavity 210 away from the connection part 30 , and the detection element 220 is put into and/or taken out of the detection cavity 210 through the operation port.
  • the operation port is provided with a cover 240, and the cover 240 is detachably connected to the operation port. .
  • the surface of the cover 240 inside the detection chamber 210 may be provided with slots for fixing and installing the detection element 220 .
  • the detection element 220 may be an element for detecting a sample and displaying the detection result.
  • the detection element 220 is provided with biological enzymes that can carry out biological or chemical reactions with the blood samples. Personnel can judge whether there is a detection substance in the blood sample according to the color signal.
  • the detection element 220 includes an adsorption segment 221 and a detection segment 222 arranged in sequence along the axis of the detection cavity 210 .
  • the adsorption section 221 is located at one end close to the connection part 30. After the core body 110 in the connection part 30 collects the sample, most of the non-detectable components or colored components in the sample stay in the core body 110, but it is still possible When a small amount of non-detection components or colored components arrive at the detection chamber 210, the adsorption section 221 can adsorb the non-detection components or colored components again.
  • the red blood cells in the blood will interfere with the color display of the detection element 220, so the core body 110 is set to absorb and retain a large amount of red blood cells, and the adsorption section 221 can also be used to absorb red blood cells in the sample, so that even A small amount of red blood cells entering the detection chamber 210 can also be retained in the adsorption section 221 .
  • the core body 110 and the adsorption section 221 Through the cooperation of the core body 110 and the adsorption section 221 , non-detection components or colored components in the sample can be largely prevented from entering the detection section 222 , thereby improving the detection accuracy of the detection element 220 .
  • detection section 222 is used to detect a sample.
  • the detection section 222 is provided with substances capable of reacting with the sample, such as chemical reagents, reaction enzymes, etc. These substances may cover the entire area or a local area of the detection section 222 , which is not limited in the present disclosure.
  • the detection elements can be used to detect serum lipids, trace elements, antibiotics, pH, etc., which are not limited in the embodiments of this specification.
  • the detection element may include multiple (two or more) detection elements, which can detect one or more detection contents of the sample and display the detection results.
  • the detection element may be arranged along the axis of the detection chamber 210 .
  • a detection piece may be disposed in the detection cavity 210 .
  • An indicator can be set on the test piece, and the indicator is composed of substances that can react with the sample.
  • the indicator can be formed in the form of lines, two-dimensional graphics, characters, numbers and other symbols, which are not limited in the embodiment of this specification .
  • the indicator of the detection element can be an indicator line, and different indicator lines can display different colors after encountering different components in the sample, so as to obtain the test result.
  • one detection piece when it is necessary to detect multiple (two or more) detection contents of the sample, one detection piece can be set in the detection cavity 210 . Multiple indicators can be set on the test piece, and each indicator can detect different test content, so multiple test results can be obtained by using one sample and one test piece, improving the efficiency of testing.
  • the number of indicating lines of the detection element may be 1 to 3 indicating lines.
  • multiple detection pieces may also be set in the detection cavity 210 .
  • the detection element 220 includes a plurality of detection pieces distributed radially along the detection cavity 210, the detection pieces are radially distributed in the detection cavity 210, and do not overlap and block each other, so as to facilitate observation of detection results on the detection pieces .
  • each of the plurality of detection elements may extend from the peripheral side of the detection cavity 210 to the axial position of the detection cavity 210 .
  • the three detection pieces can be distributed in three equal parts along the radial direction of the detection cavity 210.
  • each detection piece On a section perpendicular to the axis of the detection cavity 210, each detection piece extends The trisection position of the side extends to the axial position of the detection cavity 210 .
  • the detection content of each of the multiple detection pieces is different, for example, an indicator is set on each detection piece, and each detection piece is used to detect a detection content of the sample, and for another example, each A plurality of indicators are set on the detection piece, and each detection piece is used to detect multiple detection contents of the sample, so that limited detection pieces can be used to detect as many detection contents as possible, and the detection efficiency is improved.
  • the detection element 220 further includes a connection section 223 , one end of the connection section 223 is connected to the detection section 222 , and the other end of the connection section 223 extends to an end of the detection cavity 210 away from the connection part 30 .
  • one end of the connection section 223 is connected to the detection section 222 , and the other end can be inserted into the slot of the cover 240 .
  • the detection element 220 may not include the connection section 223 , the adsorption section 221 of the detection element 220 may be fixed by the bracket 250 described below, and the detection section 222 is supported in the detection chamber 210 by the adsorption section 221 .
  • the adsorption section 221 , the detection section 222 and the connection section 223 of the detection element 220 can be integrally formed.
  • the thickness or hardness of the adsorption section 221 and the connection section 223 can be appropriately increased to provide greater supporting force, and facilitate the fixing of the adsorption section 221 and the connection section 223 in the detection cavity 210 .
  • the detection part 20 includes a bracket 250 for supporting the detection element 220 .
  • a slot may be provided on the bracket 250, and the adsorption section 221 of the detection element 220 may be inserted into the slot.
  • the bracket 250 is connected to the inner wall of the detection cavity 210, so that the stability of the bracket 250 can be maintained. When the sample collection device 1 is placed in different orientations, the bracket 250 remains in the detection cavity 210 without shaking.
  • the bracket 250 may be connected to the inner wall of the detection cavity 210 along the axis direction of the detection cavity 210 .
  • the bracket 250 can be a hollow cylinder. One end of the bracket 250 is provided with a slot, and the other end is provided with an opening. The adsorption section 221 of the detection element 220 is inserted into the inside of the bracket 250 from the slot and extends to the opening. In some embodiments, an observation window 251 can be provided on the bracket 250 , through which the adsorption effect of the sample on the adsorption section 221 can be observed.
  • the detection part 20 includes a buffer unit 260 connected to the detection cavity 210, and the buffer unit 260 is used to reduce the flow speed of the sample.
  • the sample can be washed to the detection cavity 210 by the buffer 410, and the sample flows to the detection cavity 210 at a faster speed under the action of the scouring force, and the buffer unit 260 can slow down the flow of the sample to the buffer cavity. Prevent the sample from splashing into the detection cavity 210 after rushing out of the second channel 340 of the connecting part 30 . More descriptions about the buffer 410 can be found in the description of FIG. 6 .
  • the buffer unit 260 may be configured as a columnar buffer pad, and the buffer unit 260 may be disposed between the connecting portion 30 and the bracket 250 .
  • the cushioning unit 260 may be made of fiber bundles, polyester fibers 112, cotton, and the like.
  • the detection unit 20 may not be provided with the buffer unit 260 , but by setting the volume ratio of the void 111 in the core 110 to the fiber bundle structure, the core 110 itself can achieve the effect of buffering the sample.
  • the specific setting method of the volume ratio of the void 111 to the fiber bundle structure can refer to the description elsewhere in this specification, and will not be repeated here.
  • the bracket 250 may extend along the axis direction of the detection chamber 210 to an end of the buffer unit 260 away from the connection part 30 .
  • the extension length of the bracket 250 in the detection cavity 210 along the axis direction of the detection cavity 210 can also be set arbitrarily, which is not limited in this embodiment of the present specification.
  • the detection part 20 includes a connection end 270 connected to the connection part 30 , the connection end 270 is provided with a limiting structure, and the limit structure is used to limit the displacement of the connection part 30 from the detection cavity 210 .
  • the limiting structure can be provided on the inner wall of the connecting section 223 .
  • the connecting part 30 includes an engaging structure 370, and the engaging structure 370 is engaged with the limiting structure, so as to limit the separation of the collecting part 10 and the detecting part 20 from each other.
  • the limiting structure can be a limiting step (not shown in the figure)
  • the engaging structure 370 can be a barb
  • the barb has a certain elastic deformation capability. The process of inserting the connecting part 30 into the detection cavity 210 , the barb is radially compressed, and when the barb passes through the limiting step, it expands radially under the action of the elastic restoring force and snaps onto the limiting step, thereby restricting the connection part 30 from detaching from the detection cavity 210 .
  • the inner diameter of the connection end 270 of the detection cavity 210 may be smaller than the inner diameter of other parts of the detection cavity 210 to form a limit step for matching the engaging structure 370 and make the connection end 270 fit more closely with the collection part 10 .
  • the inner diameter of other parts of the detection chamber 210 is larger than the inner diameter of the connection end 270 , which can increase the volume of the detection chamber 210 and facilitate the accommodation of the detection element 220 .
  • connection part 30 includes a stopper structure 380 , the diameter of the stopper structure 380 is larger than the inner diameter of the connection end 270 , and when the connection part 30 is plugged into the connection end 270 , the stopper structure 380 abuts against the connection end 270 The outside of the inlet 312 forms a stopper, which prevents the connecting portion 30 from continuing to move into the connecting end 270 .
  • the connecting part 30 includes a stopper structure 380, which is arranged around the peripheral side of the connecting part 30 and extends along the radial direction of the connecting part 30. The stopper structure 380 may protrude from the connecting part 30.
  • the connecting part 30 is clamped on the limiting structure of the connecting end 270 by setting the engaging structure 370 to restrict the connecting part 30 from the connecting end 270, and at the same time, the connecting part 30 is resisted on the connecting end by setting the stopper structure 380
  • the inlet 312 of 270 restricts the connection part 30 from continuing to enter the connection end 270, and through the cooperation of the engaging structure 370 and the stopper structure 380, the displacement of the connection part 30 along the axial direction of the detection chamber 210 can be restricted, so that the connection part 30 can be fixed on the connection end 270. end 270.
  • a reinforcing rib 390 may also be provided on the connecting portion 30, and the reinforcing rib 390 is disposed in the area where the stop structure 380 meets the outer surface of the connecting portion 30, and the reinforcing rib 390 is used to strengthen the stop structure 380 and the connecting portion 30. The strength of the connecting portion 30.
  • the sample collected by the sample collection device 1 can be obtained from a collection object (for example, a person to be tested). Taking fingertip blood collection as an example, the fingertip is punctured with a lancing device, so that the core 110 can directly suck blood from the fingertip at any angle. Due to the strong hydrophilicity of the core body 110 , even if the amount of blood sampled by fingertip blood collection is small, it can be continuously absorbed into the core body 110 . In some embodiments, after the core 110 absorbs the blood sample, the blood sample can be stored in the core 110. Since the core 110 has a strong hydrophilicity and water-locking ability, the blood sample is retained after entering the core 110.
  • the blood collection volume of the sample collection device 1 can be as high as 60 microliters to 70 microliters.
  • Fig. 6 is a schematic structural diagram of a buffer pre-storage unit 40 according to some embodiments of the present application.
  • the sample collection device 1 further includes a buffer pre-storage part 40
  • the buffer pre-storage part 40 includes a buffer 410 , a pre-storage chamber 420 and a sealing sheet 430
  • the buffer 410 is used to seal the core 110
  • the stored sample provides power to flow to the detection cavity 210
  • the buffer 410 is stored in the pre-storage cavity 420
  • the sealing sheet 430 seals the pre-storage cavity 420 to store the buffer 410 .
  • the buffer 410 may include but not limited to solutions such as phosphate buffer, organic acid buffer, borate buffer, etc.
  • the buffer 410 meets the requirement of mixing and slow-release of the sample, and at the same time, the buffer in the sample The components have little interference, are not easy to produce chemical precipitation, and do not affect the pH of the sample and other indicators.
  • the embodiment of this specification does not limit the selection of the buffer 410 .
  • the pre-storage cavity 420 may be disposed at the bottom of the buffer pre-storage portion 40 for storing the buffer 410 .
  • the sealing sheet 430 is sealed on the top of the pre-storage chamber 420, and is configured with the pre-storage chamber 420 as a closed storage space, so that when the buffer agent pre-storage part 40 is placed in any orientation, the buffer agent 410 will not flow out of the pre-storage chamber 420.
  • the sealing sheet 430 can be made of a material that can be broken when subjected to a certain pressure (for example, 100 MPa), so that after the collection part 10 is inserted into the buffer pre-storage part 40, the sealing sheet 430 can be pierced and the buffer 410 can be absorbed.
  • the sealing sheet 430 can be selected from a material that is not easy to break, but the connection strength between the sealing sheet 430 and the top of the pre-storage chamber 420 is weak, and it is easy to contact with the top of the pre-storage chamber 420 when subjected to a certain pressure (for example, 100MPa). separate, so that the sealing sheet 430 is pressed into the pre-storage cavity 420 , so that the collection part 10 can absorb the buffer 410 .
  • the buffer pre-storage part 40 further includes a guide cavity connected to the pre-storage cavity 420 , and the collection part 10 can slide into the pre-storage cavity 420 along the guide cavity.
  • the guide cavity can accommodate a part of the detection part 20 , and then the guide cavity can fit at least part of the outer wall of the detection part 20 .
  • a guiding groove or a guiding protrusion may be provided on the inner wall of the guiding cavity for guiding the collecting part 10 .
  • the sealing sheet 430 is disposed between the pre-storage chamber 420 and the guide chamber.
  • the collecting part 10 is separated from the buffer pre-storage part 40, and the core 110 and the connection part 30 can enter the buffer pre-storage part 40 through the guide cavity.
  • the core body 110 and the connection part 30 are guided to the sealed
  • the collection part 10 can be pressed down continuously to make the sealing sheet 430 invalid, and the core body 110 enters the pre-storage cavity 420 and absorbs the buffer 410 .
  • the collection part 10 can be temporarily stored in the buffer pre-storage part 40 to facilitate matching packaging. At this time, the collection part 10 is only inserted into the guide cavity and does not continue to exert pressure on the sealing sheet 430 .
  • the sample collection device 1 further includes a protective cap, the protective cap is formed in a cylindrical shape with an open end and a closed end, the collection part 10 is inserted into the protective cap from the open end, and the protective cap can completely cover the collection part 10 .
  • the open end of the protective cap can be detachably engaged with the outer surface of the detection part 20 .
  • the open end of the protective cap can be detachably engaged with the stopper structure 380 of the collection part 10 .
  • the outer wall of the protective cap forms a limiting protrusion
  • the inner wall of the guiding cavity forms a limiting groove adapted to the limiting protrusion.
  • the collection part 10 collects the sample
  • insert the buffer pre-storage part 40 and make the collection part 10 puncture the sealing sheet 430, so that the collection end 310 of the collection part 10 is inserted into the buffer 410, because the core body 110 inserts
  • the space in the pre-storage part 40 is reduced, so that the buffer agent 410 flows from the gap 111 of the core body 110 to the detection cavity 210 , thereby flushing the sample from the core body 110 into the detection cavity 210 .
  • Fig. 7 is a schematic flowchart of a sample collection method according to some embodiments of the present application.
  • a sample collection method may include a process 700 .
  • the process 700 can be performed by inspectors, and includes the following steps:
  • Step 710 contact the sample through the collection end of the connection part of the sample collection device, so that the core absorbs and stores the sample.
  • connection part 30 of the sample collection device 1 has a hollow structure
  • the core body 110 can be disposed in the hollow structure
  • the core body 110 is hydrophilic.
  • the inspector can directly touch the sample to be collected through the collection end 310 of the connection part 30, so that the core body 110 exposed at the notch 311 of the collection end 310 contacts the sample, so that the core body 110 can be rotated at any angle. Aspirate the sample directly. In some embodiments, after the core 110 absorbs the sample, the sample can be stored in the core 110 due to the hydrophilicity of the core 110 .
  • connection part 30 and the detection part 20 can be placed separately before use, and before using the sample collection device 1 for sampling, the connection part 30 needs to be assembled to the detection part 20, that is
  • the sample collection method further includes: connecting the connection part 30 and the detection part 20 .
  • the testing personnel can insert the fitting end 320 of the connecting part 30 into the connecting end 270 of the testing cavity 210, so that the engaging structure 370 of the connecting part 30 is engaged with the limiting structure in the testing cavity 210, so that the The connection part 30 is connected to the detection part 20 .
  • the detection element 220 and the detection part 20 can be placed separately before use. Before using the sample collection device 1 for sampling, the detection personnel can select the corresponding detection element 220 according to the item to be detected, and then the detection The element 220 is assembled into the detection part 20 , that is, the sample collection method further includes: putting the detection element 220 into the detection cavity 210 ; and using the cover 240 to cover the detection cavity 210 .
  • the testing personnel can insert the adsorption section 221 of the detection element 220 into the slot of the bracket 250 in the detection chamber 210 , and insert the connection section 223 of the detection element 220 into the slot of the cover 240 . Then, the inspector can put the bracket 250 into the detection cavity 210 and place the bracket 250 close to the collection part 10 . Finally, the inspector covers the inspection cavity 210 with the cover 240 .
  • Step 720 insert the connection part into the buffer pre-storage part of the sample collection device, and insert the core into the buffer in the buffer pre-storage part.
  • the collection part 10 is inserted into the buffer pre-storage part 40 of the sample collection device 1, and the guide cavity of the buffer pre-storage part 40 guides the collection part 10 so that the collection part 10 moves toward the pre-storage cavity 420 until The collecting part 10 reaches the position of the sealing sheet 430 .
  • the collection part 10 continues to move toward the pre-storage cavity 420 and exerts pressure on the sealing sheet 430 , the sealing sheet 430 fails under the pressure, so that the collection part 10 can enter the pre-storage cavity 420 .
  • Step 730 flushing the sample from the core into the detection part of the sample collection device through the buffer to obtain a detection result.
  • the buffer 410 is stored in the pre-storage chamber 420 , and the collection end 310 of the collection part 10 can be immersed in the buffer 410 .
  • the space in the pre-storage part 40 is reduced, so that the buffer 410 flows from the gap 111 of the core body 110 to the detection chamber 210, thereby flushing the sample from the core body 110 into the detection chamber 210.
  • the sample is quickly washed into the detection cavity 210 of the detection part 20 by the buffer agent 410 from the second channel 340, and slowly flows to the detection element 220 in the detection cavity 210 under the buffering effect of the buffer unit 260, After passing through the adsorption section 221 of the detection element 220 , it reaches the detection section 222 .
  • the detection section 222 detects the components or indicators of the sample and obtains the detection results.
  • the possible beneficial effects of the embodiments of the present application include but are not limited to: (1)
  • the collection part includes a core body, which has hydrophilicity, and the hydrophilicity of the core body can increase the amount of sample drawn to meet the requirements of the detection part. detection requirements, and the absorption speed of the core body is fast, which improves the collection speed; not only that, using the hydrophilicity of the core body, after the core body absorbs the sample, the sample is stored on the core body with strong stability and is less affected by gravity, not only It can prevent the sample from backflow, and also allows the collection part to absorb the sample at any angle in space, making the sample collection operation easier and more random; (2) There are gaps inside the fiber bundle structure for the sample to pass through, which can increase the hydrophilic area of the core and make the sample more convenient.
  • the fiber bundle structure has adsorption properties to the red blood cells in the sample. During the collection process, the red blood cells remain in the fiber bundle structure, and the serum continues to flow into the detection chamber for detection, avoiding the influence of red blood cells on the detection Results;
  • the detection element includes an adsorption section and a detection section arranged in sequence, and the adsorption section is used to absorb red blood cells in the sample, so that a small amount of red blood cells entering the detection chamber are retained in the adsorption section. Through the cooperation of the core body and the adsorption section, the detection accuracy of the detection element can be improved; (5) each of the multiple detection pieces detects one or more different detection contents, and multiple detections can be obtained with one sample.
  • the sample collection device also includes a protective cap, which can completely cover the collection part and prevent the protective cap from contacting the sealing sheet, thereby preventing the sealing sheet from failing.
  • a protective cap which can completely cover the collection part and prevent the protective cap from contacting the sealing sheet, thereby preventing the sealing sheet from failing.

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Abstract

本申请实施例公开了一种样本采集装置及样本采集方法。该样本采集装置包括：采集部、检测部以及连接所述采集部与所述检测部的连接部；所述采集部包括芯体，所述连接部包括中空结构，所述芯体的至少部分设置于所述中空结构中；所述芯体具有亲水性。本申请的样本采集装置通过在采集部设置亲水性强的芯体，芯体具有极大的亲水表面，由芯体吸取样本，可以提高采集的样本量和效率，并且芯体对样本具有维持作用，使采集角度不受限制。

Description

一种样本采集装置及样本采集方法
交叉引用
本申请要求2022年01月13日提交的申请号为202210036630.9的专利申请的优先权，其内容通过引用结合于此。
技术领域
本申请涉及医疗器械领域，特别涉及一种样本采集装置及样本采集方法。
背景技术
在对样本进行采集和检测的领域，对于诸如血液、唾液等液体状的样本而言，常规的样本采集装置主要利用虹吸效应来将生物样本吸取到其内部，这种样本采集装置的采集量较小、采集角度受限制，导致检测精度低，操作不方便等。因此，需要提出一种采集量大、采集角度不受限制的样本采集装置。
发明内容
本说明书实施例之一提供一种样本采集装置，样本采集装置包括：采集部、检测部以及连接所述采集部与所述检测部的连接部；所述采集部包括芯体，所述连接部包括中空结构，所述芯体的至少部分设置于所述中空结构中；所述芯体具有亲水性。
在一些实施例中，所述芯体包括具有亲水性的纤维束结构，所述纤维束结构内部具有供样本通过的空隙。
在一些实施例中，所述纤维束结构对样本中的红细胞具有吸附性。
在一些实施例中，所述连接部包括采集端，所述采集端远离所述检测部；所述采集端具有缺口，所述芯体的部分表面从所述缺口中露出。
在一些实施例中，所述中空结构设置有第一通道和第二通道，所述第一通道和所述第二通道相互连通且贯穿所述连接部；所述第一通道的内径大于所述第二通道的内径。
在一些实施例中，所述芯体设置于所述第一通道内，所述芯体的外径大于所述第二通道的内径。
在一些实施例中，所述第一通道的内壁上设置有至少一个支撑结构，所述支撑结构凸出于所述第一通道的内壁；所述多个支撑结构与所述芯体的周侧抵接。
在一些实施例中，所述检测部包括检测腔，所述芯体的所述空隙与所述检测腔通过所述中空结构连通。
在一些实施例中，所述检测部包括设置于所述检测腔内的检测元件。
在一些实施例中，所述检测元件包括依次设置的吸附段和检测段；所述吸附段用于吸附样本中的红细胞；所述检测段用于检测样本。
在一些实施例中，所述检测元件包括沿所述检测腔的径向分布的多个检测件，所述多个检测件中的每一个的检测内容不同。
在一些实施例中，所述检测腔远离所述连接部的一端设置有操作口，所述检测元件从所述操作口放入和/或取出所述检测腔；所述操作口设置有封盖，所述封盖与所述操作口可拆卸连接。
在一些实施例中，所述检测部包括支架，用于支撑所述检测元件；所述支架与所述检测腔的内壁连接。
在一些实施例中，所述检测部包括设置于所述连接部与所述检测腔之间的缓冲单元，所述缓冲单元用于降低样本流向所述检测腔的流动速度。
在一些实施例中，所述检测部包括与所述连接部连接的连接端，所述连接端设置有限位结构；所述连接部包括卡合结构，所述卡合结构与所述限位结构卡接，限制所述采集部与所述检测部相互分离。
在一些实施例中，所述连接部包括止挡结构，所述止挡结构环绕设置于所述连接部的周侧并沿所述连接部的径向延伸，所述止挡结构的直径大于所述连接端的内径。
在一些实施例中，所述样本采集装置还包括缓冲剂预存部，所述缓冲剂预存部包括缓冲剂、 预存腔和密封片；所述缓冲剂存储于所述预存腔中，所述密封片密封所述预存腔。
在一些实施例中，所述缓冲剂预存部还包括连接所述预存腔的引导腔，所述密封片设置于所述预存腔和所述引导腔之间。
在一些实施例中，所述采集部与所述缓冲剂预存部分离设置，所述采集部通过所述引导腔进入所述缓冲剂预存部。
本说明书实施例之一提供一种样本采集方法，所述方法包括：通过样本采集装置的连接部的采集端接触样本，使芯体吸取并存储所述样本；其中，所述芯体设置于所述连接部内部，所述芯体具有亲水性；将所述连接部插入所述样本采集装置的缓冲剂预存部，使所述芯体插入所述缓冲剂预存部内的缓冲剂中；通过所述缓冲剂将所述样本从所述芯体冲入所述样本采集装置的检测部，获得检测结果。
在一些实施例中，所述方法还包括：连接所述连接部和所述检测部。
在一些实施例中，所述方法还包括：将检测元件放入所述检测部的检测腔；使用封盖盖合所述检测腔。
附图说明
本申请将以示例性实施例的方式进一步说明，这些示例性实施例将通过附图进行详细描述。这些实施例并非限制性的，在这些实施例中，相同的编号表示相同的结构，其中：
图1A是根据本申请一些实施例所示的样本采集装置的正视图；
图1B是根据本申请一些实施例所示的样本采集装置的侧视图；
图2是根据本申请一些实施例所示的芯体的横截面图；
图3是根据本申请一些实施例所示的采集部和连接部的结构示意图；
图4是根据本申请一些实施例所示的连接部的剖视图；
图5A是根据本申请一些实施例所示的样本采集装置的结构示意图；
图5B是根据本申请一些实施例所示的样本采集装置的另一视角的结构示意图；
图6是根据本申请一些实施例所示的缓冲剂预存部的结构示意图；
图7是根据本申请一些实施例所示的样本采集方法的流程示意图。
具体实施方式
这里将详细地对示例性实施例或实施方式进行说明，其示例表示在附图中。下面的描述涉及附图时，除非另有表示，不同附图中的相同数字表示相同或相似的要素。以下示例性实施例中所描述的实施方式并不代表与本申请相一致的所有实施方式。相反，它们仅是与如所附权利要求书中所详述的、本申请的一些方面相一致的装置和方法的例子。
在本申请使用的术语是仅仅出于描述特定实施例的目的，而非旨在限制本申请。在本申请和所附权利要求书中所使用的单数形式的“一种”、“所述”和“该”也旨在包括多数形式，除非上下文清楚地表示其他含义。
应当理解，本申请说明书以及权利要求书中使用的“第一”“第二”以及类似的词语并不表示任何顺序、数量或者重要性，而只是用来区分不同的组成部分。同样，“一个”或者“一”等类似词语也不表示数量限制，而是表示存在至少一个。除非另行指出，“前部”、“后部”、“下部”和/或“上部”等类似词语只是为了便于说明，而并非限于一个位置或者一种空间定向。“包括”或者“包含”等类似词语意指出现在“包括”或者“包含”前面的元件或者物件涵盖出现在“包括”或者“包含”后面列举的元件或者物件及其等同，并不排除其他元件或者物件。
本申请一个或多个实施例的样本采集装置可以用于采集各种生物样本或化学样本，包括但不限于血液、唾液、尿液、化学溶液、酶溶液、毒品溶液等液体状的样本。该样本采集装置还可以对采集的样本进行检测，从而为疾病诊断、免疫检测、毒品检查等提供参考依据。在本说明书的实施例中，样本采集装置的示例性应用场景可以为采集和检测血液，该血液可以来源于采血管或血袋中的储备血液，也可以来源于由采血针直接获取的人体血液，如指尖采血等。
在一些实施例中，样本采集装置可以是设置有虹吸管的采集装置，利用虹吸管的虹吸效应来吸取样本，使样本转移至检测腔进行检测。采用这种样本采集装置进行采集时，由于虹吸管引力有限，因此采集的样本量小、采集的效率低，并且由于样本会受到重力影响，通常需要采用水平放置或小角度(例如0°～10°之间)放置虹吸管的方式采集来提高样本采集量，导致采集的角度有限，操作不方便。本说明书一个或多个实施例的样本采集装置通过在采集部设置亲水性强的芯体，由芯 体吸取样本，可以提高采集的样本量和效率，并且芯体对样本具有维持作用，使采集角度也不受限制。
应当理解的是，本申请的样本采集装置的应用场景仅仅是本申请的一些示例或实施例，对于本领域的普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图将本申请应用于其它类似情景。
图1A是根据本申请一些实施例所示的样本采集装置1的正视图。图1B是根据本申请一些实施例所示的样本采集装置1的侧视图。
参见图1A和图1B，本说明书实施例提供一种样本采集装置1，该样本采集装置1包括采集部10、检测部20以及连接所述采集部10与所述检测部20的连接部30。采集部10可以用于采集样本，样本可以是例如血液、唾液、尿液、化学溶液、酶溶液等的采集对象。检测部20可以用于检测样本的各种指标。在一些实施例中，指标可以包括但不限于医学指标、生物学指标或化学指标等。例如，样本可以是血液，检测部20可以检测血液样本中诸如血清脂质、微量元素、抗生素等成分、病毒抗体以及酸碱度等指标。又例如，样本可以是唾液，检测部20可以检测唾液样本中的酶、多糖、酒精、病毒抗体等指标。
在一些实施例中，采集部10包括芯体110，连接部30包括中空结构，芯体110的至少部分设置于连接部30的中空结构中，即连接部30的中空结构能够容纳并固定芯体110，其中，芯体110的至少部分可以是指芯体110的全部或者芯体110的其中一部分。在一些实施例中，芯体110的全部设置于连接部30的中空结构中。在一些实施例中，芯体110的一部分设置于连接部30的中空结构中，芯体110的另一部分露出于连接部30的中空结构之外。在一些实施例中，芯体110可以用于吸取样本。在一些实施例中，芯体110也可以用于存储样本。有关采集部10的更详细的内容请参见图3和图4及其相关描述。
在一些实施例中，芯体110具有亲水性，亲水性可以是指能够吸引水分子的性质。具有亲水性的芯体110对水分子具有极大的液体表面张力，使水分子能够被吸取并保持在芯体110上，通俗来讲就是芯体110容易被样本中的水分润湿的性质。在一些实施例中，芯体110具有亲水性可以包括芯体110外表面具有亲水性，还可以包括芯体110的内部具有亲水性。在一些实施例中，芯体110的亲水性可以通过特殊的工艺处理获得。在一些实施例中，芯体110的亲水性也可以通过材料本身的性质获得。在一些实施例中，芯体110的亲水性也可以通过对芯体110的内部结构进行设计来获得。利用芯体110的亲水性，可以增强芯体110对水分子的吸引力，水分子会在该吸引力的作用下从芯体110湿润的区域快速扩散到干燥的区域，表现为样本逐渐浸湿芯体110的过程。芯体110的亲水性可以增大吸取的样本量，以满足检测部20的检测需求，并且，芯体110对水分子的吸引力可以增大吸取水分子的速度，提高样本采集速度；不仅如此，利用芯体110的亲水性，芯体110吸取样本后，样本存储在芯体110上的稳定性强，受重力影响小，不仅可以防止样本回流，还允许采集部10以空间任意角度吸取样本，使样本采集操作更简单随意。有关芯体110的更详细的内容请参见图2及其相关描述。
在一些实施例中，检测部20通过连接部30与采集部10连接。在一些实施例中，连接部30可以与检测部20可拆卸地连接，连接方式包括但不限于卡接、螺纹连接、过盈配合等。在一些实施例中，连接部30可以与检测部20不可拆卸地连接，连接方式包括但不限于一体成型、胶粘连接等。在一些实施例中，检测部20可以包括在检测样本时容纳样本的检测腔210，有关检测部20及检测腔210的更详细的内容请参见图5A和图5B及其相关描述。
图2是根据本申请一些实施例所示的芯体110的横截面图。其中，图2中的纤维束结构的排布和空隙111排布仅作为参考，图2并不限制纤维束结构的纤维束排布方式和密度。
参见图2，在一些实施例中，芯体110包括具有亲水性的纤维束结构，该纤维束结构可以是由大量单根纤维112相互黏合而固结成束状的结构。纤维束结构的材料选择可以选择生物相容性好、不易破坏样本中的组织细胞的材料，例如聚酯纤维、涤纶、医用棉等，这种材料能够减轻芯体110材料对样本的破坏，提高被吸取样本的稳定性，由于材料的生物相容性好，可以避免组织细胞的细胞膜破裂使组织细胞内的物质影响检测结果。在一些实施例中，纤维束结构可以经过化学方法或物理方法的处理，以增强其生物相容性等性质，例如，经过处理后的纤维束结构内的几乎所有纤维112可以沿芯体110的轴向方向延伸，再例如，经过处理后的纤维束结构可以具有等密度的横截面，等等。
在一些实施例中，芯体110可以经过改性处理而获得亲水性。在一些实施例中，改性处理是指在保持芯体110或芯体110的材料原有性能的前提下，赋予芯体110新的性能，如亲水性等。 在一些实施例中，芯体110的单根纤维112可以经过表面处理或横截面处理来获得亲水性，例如在单根纤维112表面加工微小凹凸，再例如将单根纤维112的横截面处理成L型或C型，这些处理方式可以增加单根纤维112的表面积，从而提高亲水性。在一些实施例中，亲水性可以包括对水分子的吸引力。在一些实施例中，芯体110中可以增加不同数量和种类的亲水性基团来增强对水分子的吸引力，从而获得亲水性，例如，在纤维112的表面或结构内添加氨基、羟基、羧基、酰胺基等亲水性基团成分，从而增加其亲水性。在一些实施例中，亲水性还可以包括对水分子的维持能力，也称为锁水能力。在一些实施例中，芯体110的材料中可以同时加入亲水性基团和疏水性基团，并形成交联型网格状高分子结构。由于亲水性基团对水分子的水合作用，可以提高芯体110对水分子的吸引力，而疏水性基团可以使进入网格内部的水分子由于极性作用而失去活动性，从而使水分子被维持在芯体110的材料内部，提高芯体110的锁水能力。通过设置具有交联型网格状高分子结构的亲水材料，可以使芯体110的吸水能力达到自身重量的百倍以上，极大地提高芯体110的对水的吸引力和锁水能力。
在一些实施例中，参见图2，芯体110经过改性处理后，不仅其表面具有很高的亲水性，同时纤维束结构中的每根纤维112都具有亲水性，从而使得整个芯体110的总亲水表面面积得到增加。其中，总亲水表面面积可以是所有单根纤维112表面积的总和，从而提高芯体110对水的吸引力。在一些实施例中，纤维束结构内部具有供样本通过的空隙111，空隙111可以是由纤维112和纤维112之间的间隙组成，样本从该空隙111移动。纤维束结构内部的空隙111可以增加芯体110的亲水面积，使样本更容易被吸取到芯体110上。在一些实施例中，由于芯体110对水分子具有较强的吸引力和锁水能力，芯体110能够吸取样本并将样本存储于芯体110的空隙111中，这些样本在芯体110的亲水性的作用下能够克服重力保持在芯体110内。在一些实施例中，芯体110可吸取并存储的样本体积可以高达60微升至70微升。
在一些实施例中，在纤维束结构中，空隙111与纤维束结构的体积比可以根据需求设置在不同的范围内，以获得不同的效果。示例地，空隙111与纤维束结构的体积比可以在1％-10％范围内，例如空隙111与纤维束结构的体积比可以为3％、6％、7％、8％或9％等。
在一些实施例中，空隙111与纤维束结构的体积比相对较低，例如，空隙111与纤维束结构的体积比在1％-5％范围内，说明芯体110中的纤维束结构较为密实(即纤维112与纤维112之间的间隙较小)，会对在芯体110上流动的样本产生适当的阻力，减缓样本通过空隙111的流速，从而对样本起到缓冲作用。并且，对于空隙111与纤维束结构的体积比相对于较低的芯体110，其将样本维持在内部的性能相对较强，可以避免样本回流。
在一些实施例中，空隙111与纤维束结构的体积比相对较高，例如，空隙111与纤维束结构的体积比在5％-10％范围内，说明芯体110中的纤维束结构较为稀疏(即纤维112与纤维112之间的间隙较大)，则样本在芯体110上流动的阻力小，可以提高芯体110吸取样本的速度，使样本能快速到达检测腔210，提高检测效率。
本公开实施例中的空隙111与纤维束结构的体积比不宜过高也不宜过低。若该空隙111与纤维束结构的体积比过低，则对样本产生的流动阻力过大，可能会降低采集效率，并对样本中的检测成分(如血液样本中的血浆)造成阻碍，甚至破坏样本中的组织细胞。若该空隙111与纤维束结构的体积比过高，则芯体110的总亲水表面面积会降低过多，从而降低芯体110的吸取样本的量。优选的，空隙111与纤维束结构的体积比在5％-6％范围内。
在另一些实施例中，空隙111与纤维束结构的体积比也可以是其他范围或任意设置，本说明书对此不做限制。
在一些实施例中，某些样本中的有色成分可能会干扰检测结果，因此，纤维束结构可以处理成具有吸附样本中有色成分或非检测成分的性能。这里以血液样本为例，血液样本中的红细胞可能会影响检测结果，因此，纤维束结构对样本中的红细胞具有吸附性，在采集过程中，红细胞保留在纤维束结构中，血清继续流动至检测腔210中进行检测。
在一些实施例中，芯体110可以经过改性处理而获得吸附红细胞的性质。例如，芯体110的纤维112素结构内可以添加能够吸附红细胞的血凝素等基团，这样红细胞可以与血凝素等基团结合而留在芯体110内。
在一些实施例中，空隙111与纤维束的体积比可以在5％-10％范围内，使芯体110具有较佳的吸附红细胞的性质。空隙111与纤维束的体积比不宜过高也不宜过低。若该空隙111与纤维束的体积比过高，说明芯体110中纤维112量较少，空隙111较大，则血凝素等基团的量也相应较少，会降低对红细胞的吸附量。并且，纤维112与纤维112之间的空隙111较大，容易导致红细胞在与 血凝素等基团尚未完全结合时就被冲刷到检测部20，降低芯体110对红细胞的过滤效果。若该空隙111与纤维束的体积比过低，说明芯体110中纤维112量较多，空隙111较小，红细胞容易堵塞空隙111影响芯体110吸取样本的速度，并且红细胞进入芯体110的间隙中容易受到挤压破坏，导致红细胞内的物质被冲刷到检测部20，影响检测结果。
图3是根据本申请一些实施例所示的采集部10和连接部30的结构示意图；图4是根据本申请一些实施例所示的连接部30的剖视图。
在一些实施例中，参见图3，连接部30可以构造为中空的柱状结构，即连接部30可以包括中空结构，中空结构可以包括但不限于圆柱状、棱柱状等形状。在一些实施例中，连接部30包括采集端310和装配端320，采集端310远离检测部20，可以是连接采集部10的一端；装配端320可以是与检测部20连接的一端。
在一些实施例中，采集端310具有缺口311，芯体110的部分表面从缺口311中露出，从而增大芯体110露出采集端310之外的面积。当采集样本时，通过该设置可以增加芯体110与样本的接触面积，提高样本的采集效率。采集端310的除了缺口311之外的部分可以为芯体110提供支撑，防止芯体110变形影响采集效果。在一些实施例中，采集端310的缺口311的正投影(指沿正视于缺口方向的投影)可以是弧形、三角形等形状，缺口311的数量可以是N个，N为自然数。
在一些实施例中，参见图4，连接部30的中空结构可以包括第一通道330和第二通道340，第一通道330和第二通道340相互连通且贯穿连接部30，使连接部30上形成允许样本流入的入口312和允许样本流出的出口321。在一些实施例中，连接部30的入口312位于采集端310，连接部30的出口321位于装配端320。在一些实施例中，第一通道330可以靠近采集端310，第一通道330的一端形成连接部30的入口312，另一端连通第二通道340；第二通道340可以靠近装配端320，第二通道340的一端形成连接部30的出口321，另一端连通第一通道330。在一些实施例中，第一通道330可以用于安装芯体110，第二通道340可以作为导流的空心通道。在一些实施例中，第一通道330和第二通道340的轴线可以是直线型、曲线型等。
在一些实施例中，第一通道330的内径大于第二通道340的内径。第一通道330的内径更大，可以容纳更大截面的芯体110，有助于提高采集样本的速率。第二通道340的的内径更小，更容易产生毛细现象，使样本在毛细作用下从芯体110朝向出口321流动。
在一些实施例中，芯体110设置于第一通道330内，芯体110的外径大于第二通道340的内径。这样，由于第一通道330的内径大于第二通道340的内径，则在第一通道330和第二通道340连接处形成台阶350，芯体110的端部能够抵接在该台阶350上，以限制芯体110朝向第二通道340的位移。
在一些实施例中，第一通道330的内壁上设置有至少一个支撑结构360，支撑结构360凸出于第一通道330的内壁，支撑结构360用于支撑和限位芯体110。在一些实施例中，支撑结构360凸出于第一通道330的内壁的凸出高度小于台阶350凸出于第一通道330的内壁的高度，以容纳内径大于第二通道340的芯体110。
在一些实施例中，支撑结构360可以构造为长条凸起，例如长条凸起可以沿第一通道330的轴向延伸，或者长条凸起可以相对于第一通道330的侧壁倾斜延伸。在一些实施例中，支撑结构360可以构造为间隔排列的多个凸点。在一些实施例中，支撑结构360可以构造为环状凸起，例如环状凸起可以是沿圆周方向延伸的封闭圆环，或者环状凸起可以是沿第一通道330的内壁螺旋延伸的螺旋环。应当注意的是，本公开实施例对支撑结构360的构型不构成对本说明书实施例的限制，其构型可以为长条凸起、凸点、环状凸起或其它任意凸起形状的一种或几种组合。
在一些实施例中，支撑结构360为多个，多个支撑结构360与芯体110的周侧抵接。在一些实施例中，支撑结构360的排布方式使得芯体110的周侧能够与第一通道330的内壁形成间隙，例如，四个长条凸起沿圆周方向等间隔布置等。芯体110与第一通道330的内壁形成间隙，可以减小芯体110与内壁的接触面积，从而减小芯体110在装配到第一通道330的过程中的摩擦阻力，使芯体110更容易插入第一通道330。并且，芯体110与第一通道330的内壁形成间隙，可以避免样本进入后造成粘连堵塞。并且，芯体110在吸收样本后会稍微膨胀变形，芯体110与第一通道330的内壁之间间隙为芯体110的膨胀提供了变形空间。
在一些实施例中，连接部30可以选用透明材料制成，例如透明塑料、玻璃等，以便于观察第一通道330内的芯体110的情况，例如观察样本浸润芯体110的程度、芯体110的膨胀变形情况等。在一些实施例中，连接部30可以选用非透明材料制成，例如非透明塑料、金属材料等。
图5A是根据本申请一些实施例所示的样本采集装置1的结构示意图；图5B是根据本申 请一些实施例所示的样本采集装置1的另一视角的结构示意图。
在一些实施例中，检测部20包括检测腔210，芯体110的空隙111与检测腔210通过连接部30的中空结构连通。这样，样本被芯体110吸取到连接部30的中空结构内之后，能够从中空结构进入检测腔210。
在一些实施例中，检测部20还包括设置于检测腔210内的检测元件220。检测腔210可以是能够容纳检测元件220的中空腔体。在一些实施例中，检测腔210可以为检测元件220提供密封的环境，以防止外界环境中的物质污染样本和检测元件220，影响检测结果，例如，防止外界湿度、细菌、污物等物质进入检测腔210，保证检测准确性。在一些实施例中，检测部20可以包括壳体230，壳体230限定出检测部20的检测腔210。在一些实施例中，壳体230的形状可以包括但不限于圆柱筒状、棱柱筒状、或不规则筒状等。在一些实施例中，壳体230可以由透明材料制成，方便观察检测元件220的检测结果。在一些实施例中，检测腔210可以与连接部30的中空结构(例如，连接部30的出口321)连通，使得芯体110的空隙111通过连接部30的中空结构与检测腔210连通，实现样本从采集部10向检测部20输送。
在一些实施例中，检测腔210远离连接部30的一端设置有操作口，检测元件220从操作口放入和/或取出检测腔210。在一些实施例中，操作口设置有封盖240，封盖240与操作口可拆卸连接，该可拆卸地连接方式包括但不限于螺纹连接、卡扣连接等连接方式，以打开或封闭操作口。在一些实施例中，封盖240位于检测腔210内部的表面可以设置插槽，插槽用于固定和安装检测元件220。
在一些实施例中，检测元件220可以是用于检测样本并显示检测结果的元件。例如，在血液样本检测中，检测元件220上设置能够与血液样本进行生物学或化学反应的生物酶，当血液样本到达检测元件220上之后，生物酶与血液样本反应而显示出颜色信号，检测人员可以根据该颜色信号来判断血液样本中是否存在检测物质。
在一些实施例中，检测元件220包括沿检测腔210的轴线方向依次设置的吸附段221和检测段222。在一些实施例中，吸附段221位于靠近连接部30的一端，连接部30内的芯体110采集样本后，样本内的大部分非检测成分或有色成分留滞在芯体110中，但依然可能有少量非检测成分或有色成分到达检测腔210，吸附段221能够再次吸附该非检测成分或有色成分。例如，对于血液样本，血液中的红细胞会干扰检测元件220的颜色显示，因此芯体110被设置为能够吸附并留滞住大量红细胞，吸附段221也可以用于吸附样本中的红细胞，使得即使有少量红细胞进入检测腔210也能被留滞在吸附段221。通过芯体110和吸附段221的配合，可以极大限度的避免样本中的非检测成分或有色成分进入检测段222，从而提高检测元件220的检测精度。
在一些实施例中，检测段222用于检测样本。在一些实施例中，检测段222设置有能够与样本发生反应的物质，例如化学试剂、反应酶等物质，这些物质可以覆盖检测段222整个区域或局部区域，本公开对此不作限制。在一些实施例中，检测元件可以分别用于检测血清脂质、微量元素、抗生素、酸碱度等，本说明书实施例对此不作限制。
在一些实施例中，检测元件可以包括多个(两个或两个以上)检测件，检测件可以检测样本的一项或多项检测内容并显示检测结果。在一些实施例中，检测件可以沿检测腔210的轴线方向设置。在一些实施例中，当需要检测样本的一项检测内容时，检测腔210内可以设置一个检测件。在检测件上可以设置一个指示符，该指示符由能够与样本发生反应的物质组成，该指示符可以形成为线状、二维图形、文字、数字等符号，本说明书实施例对此不作限制。在一些实施例中，检测件的指示符可以是指示线，不同指示线在遇到样本内的不同成分后能够显示出不同的颜色，以获得检测结果。
在一些实施例中，当需要检测样本的多项(两项或两项以上)检测内容时，检测腔210内可以设置一个检测件。在检测件上可以设置多个指示符，每个指示符可以检测不同的检测内容，则使用一份样本和一个检测件就可以获得多个检测结果，提高检测的效率。在一些实施例中，检测件的指示线数量可以是1至3条指示线。
在一些实施例中，当需要检测样本的多项检测内容时，检测腔210内还可以设置多个检测件。在一些实施例中，检测元件220包括沿检测腔210的径向分布的多个检测件，检测件径向分布在检测腔210内，彼此之间不重叠遮挡，便于观察检测件上的检测结果。在一些实施例中，在垂直于检测腔210的轴线的截面上，多个检测件中的每一个检测件可以自检测腔210的周侧延伸至检测腔210的轴线位置。例如，当检测件为三个时，三个检测件可以沿检测腔210的径向呈三等分分布，在垂直于检测腔210的轴线的截面上，每个检测件自检测腔210的周侧的三等分位置延伸至检测腔 210的轴线位置。在一些实施例中，多个检测件中的每一个的检测内容不同，例如，每一个检测件上设置一个指示符，每个检测件用于检测样本的一项检测内容，再例如，每一个检测件上设置多个指示符，每个检测件用于检测样本的多项检测内容，这样能够利用有限的检测件检测尽可能多的检测内容，提高检测效率。
在一些实施例中，检测元件220还包括连接段223，连接段223的一端与检测段222连接，连接段223的另一端延伸至检测腔210远离连接部30的一端。在一些实施例中，连接段223的一端与检测段222连接，另一端可以插设在封盖240的插槽中。在一些实施例中，检测元件220也可以不包括连接段223，检测元件220的吸附段221可以通过下面描述的支架250固定，检测段222通过吸附段221支撑在检测腔210内。
在一些实施例中，检测元件220的吸附段221、检测段222和连接段223可以一体成型。在一些实施例中，吸附段221和连接段223的厚度或硬度可以适当增加，以提供更大的支撑力，便于吸附段221和连接段223固定在检测腔210内。
在一些实施例中，检测部20包括支架250，用于支撑检测元件220。在一些实施例中，支架250上可以设置卡槽，检测元件220的吸附段221可以穿插在该卡槽中。在一些实施例中，支架250与检测腔210的内壁连接，这样能保持支架250的稳定性，当样本采集装置1以不同方位放置时，支架250保持在检测腔210内不会晃动。在一些实施例中，支架250可以沿检测腔210的轴线方向与检测腔210的内壁连接。
在一些实施例中，支架250可以是空心柱体，支架250的一端设置卡槽，另一端设置开口，检测元件220的吸附段221从卡槽插入支架250的内部，并且延伸到开口处。在一些实施例中，支架250上可以开设观察窗251，通过观察窗251可以观察样本在吸附段221的吸附效果。
在一些实施例中，检测部20包括与检测腔210连接的缓冲单元260，缓冲单元260用于降低样本的流动速度。当样本被芯体110采集后，可以通过缓冲剂410将样本冲刷到检测腔210，在冲刷力的作用下样本流向检测腔210的速度较快，缓冲单元260可以减缓样本流向缓冲腔的速度，防止样本从连接部30的第二通道340冲出后溅射到检测腔210。关于缓冲剂410的更多说明可以参见图6的描述。在一些实施例中，缓冲单元260可以构造为柱状的缓冲垫，缓冲单元260可以设置在连接部30和支架250之间。在一些实施例中，缓冲单元260可以由纤维束、聚酯纤维112、棉等材料制成。在另一些实施例中，检测部20也可以不设置缓冲单元260，而是通过设置芯体110中空隙111与纤维束结构的体积比，使得芯体110本身即可实现缓冲样本的效果。空隙111与纤维束结构的体积比的具体设置方式可以参见本说明书其它地方的描述，此处不在赘述。
在一些实施例中，当检测部20内设置有缓冲单元260时，支架250沿检测腔210的轴线方向可以延伸至缓冲单元260远离连接部30的一端。在一些实施例中，支架250沿检测腔210的轴线方向在检测腔210内的延伸长度也可以任意设置，本说明书实施例对此不作限制。
在一些实施例中，检测部20包括与连接部30连接的连接端270，连接端270设置有限位结构，限位结构用于限制连接部30脱出检测腔210的位移。在一些实施例中，限位结构可以设置与连接段223的内壁上。在一些实施例中，连接部30包括卡合结构370，卡合结构370与限位结构卡接，从而限制采集部10与检测部20相互分离。
在一些实施例中，限位结构可以是限位台阶(图中未示出)，卡合结构370可以是倒钩，该倒钩具有一定的弹性变形能力，连接部30插入检测腔210的过程中，倒钩被沿径向压缩，当倒钩穿过限位台阶后，在弹性恢复力的作用下沿径向展开，并卡接在限位台阶上，从而限制连接部30脱离检测腔210。
在一些实施例中，检测腔210的连接端270的内径可以小于检测腔210其他部分的内径，以形成配合卡合结构370的限位台阶，并且使连接端270与采集部10配合更紧密。检测腔210其他部分的内径大于连接端270的内径，可以增加检测腔210的容积，便于容纳检测元件220。
在一些实施例中，连接部30包括止挡结构380，止挡结构380的直径大于连接端270的内径，当连接部30插接在连接端270时，止挡结构380抵接在连接端270的入口312外侧形成止挡，阻止连接部30继续进入连接端270的位移。在一些实施例中，连接部30包括止挡结构380，止挡结构380环绕设置于连接部30的周侧并沿连接部30的径向延伸，止挡结构380可以是凸出于连接部30的环形凸缘，或者可以是凸块等。
在一些实施例中，连接部30通过设置卡合结构370卡接在连接端270的限位结构上，限制连接部30脱离连接端270，同时连接部30通过设置止挡结构380抵挡在连接端270的入口312，限制连接部30继续进入连接端270，则通过卡合结构370和止挡结构380的配合，可以限制连接部 30沿检测腔210轴线方向的位移，使连接部30固定在连接端270。
在一些实施例中，连接部30上还可以设置加强筋390，该加强筋390设置在止挡结构380与连接部30的外表面交接的区域，该加强筋390用于加强止挡结构380和连接部30的强度。
在一些实施例中，样本采集装置1所采集的样本可以从采集对象(例如，受检测的人员)获取。以指尖釆血为例，用采血器刺破指尖，使芯体110以任一角度直接吸取指尖血液即可。由于芯体110的亲水性较强，即使指尖采血的血液样本量较少，也能够不断被吸取到芯体110内。在一些实施例中，当芯体110吸取血液样本后，血液样本可以存储在芯体110中，由于芯体110具有极强的亲水性和锁水能力，血液样本进入芯体110后被保持在芯体110中，不会因受到重力而流出芯体110。在一些实施例中，当样本采集装置1被应用于指尖采血时，由于芯体110的亲水性，样本采集装置1的采血量可以高达60微升～70微升。
图6是根据本申请一些实施例所示的缓冲剂预存部40的结构示意图。
在一些实施例中，参见图6，样本采集装置1还包括缓冲剂预存部40，缓冲剂预存部40包括缓冲剂410、预存腔420和密封片430，缓冲剂410用于为芯体110上存储的样本提供流动到检测腔210的动力，缓冲剂410存储于预存腔420中，密封片430密封预存腔420，以存储缓冲剂410。
在一些实施例中，缓冲剂410可以包括但不限于磷酸盐缓冲液、有机酸缓冲液、硼酸盐缓冲液等溶液，缓冲剂410满足对样本进行混合缓释的需求，同时对样本中的成分干扰小、不易产生化学沉淀以及不影响样本的酸碱度等指标。本说明书实施例对缓冲剂410的选用不作限制。
在一些实施例中，预存腔420可以设置在缓冲剂预存部40的底部，用于存放缓冲剂410。在一些实施例中，密封片430封挡在预存腔420的顶部，并且与预存腔420构造为封闭的存储空间，使缓冲剂预存部40以任意方位放置时，缓冲剂410不会流出预存腔420。在一些实施例中，密封片430可以选用在受到一定压强(例如，100MPa)时可破裂的材料，使采集部10插入缓冲剂预存部40后能够刺破密封片430，并吸收缓冲剂410。在一些实施例中，密封片430可以选用不容易破裂的材料，但密封片430与预存腔420的顶部的连接强度较弱，在受到一定压强(例如，100MPa)时容易与预存腔420的顶部分离，使密封片430被压入预存腔420内，使采集部10能够吸收缓冲剂410。
在一些实施例中，缓冲剂预存部40还包括连接预存腔420的引导腔，采集部10可以沿引导腔滑动进入预存腔420。在一些实施例中，采集部10完全插入缓冲剂预存部40时，引导腔能够容纳检测部20的一部分，则引导腔可以与检测部20的至少部分外壁贴合。在一些实施例中，引导腔的内壁上可以设置引导槽或引导凸起，用于引导采集部10。在一些实施例中，密封片430设置于预存腔420和引导腔之间。
在一些实施例中，采集部10与缓冲剂预存部40分离设置，芯体110和连接部30可以通过引导腔进入缓冲剂预存部40，当芯体110和连接部30被引导腔引导至密封片430处时，可以继续下压采集部10使密封片430失效，芯体110进入预存腔420并吸收缓冲剂410。
在一些实施例中，采集部10可以暂存在缓冲剂预存部40以方便配套封装，此时采集部10仅插设在引导腔中，并不继续对密封片430施加压力。
在一些实施例中，样本采集装置1还包括保护帽，保护帽形成为具有开口端和封闭端的筒状，采集部10从开口端插入保护帽，保护帽能够将采集部10完全包覆。在一些实施例中，保护帽的开口端可以与检测部20的外表面可拆卸地卡接。在一些实施例中，保护帽的开口端可以与采集部10的止挡结构380可拆卸地卡接。
在一些实施例中，保护帽的外壁形成有限位凸起，引导腔的内壁形成有与该限位凸起适配的限位槽，采集部10插入保护帽之后，保护帽可以插入引导腔，此时限位凸起和限位槽配合，用于限制保护帽插入引导腔的插入深度，防止保护帽接触到密封片430，从而防止密封片430失效。
在一些实施例中，采集部10采集样本后，插入缓冲剂预存部40，并使采集部10刺破密封片430，使采集部10的采集端310插入缓冲剂410中，由于芯体110插入预存部40的过程中，预存部40内的空间减小，使缓冲剂410从芯体110的空隙111中向检测腔210流动，从而将样本从芯体110冲入检测腔210。
图7是根据本申请一些实施例所示的样本采集方法的流程示意图。
参见图7，在一些实施例中，样本采集方法可以包括流程700。在一些实施例中，流程700可以由检测人员执行，并且包括以下步骤：
步骤710，通过样本采集装置的连接部的采集端接触样本，使芯体吸取并存储所述样本。
在一些实施例中，样本采集装置1的连接部30内有中空结构，芯体110可以设置在中空 结构内，芯体110具有亲水性。关于样本采集装置1、连接部30以及芯体110的具体结构可以参见本说明书其他地方的描述，此处不再赘述。
在一些实施例中，检测人员可以直接通过连接部30的采集端310接触待采集的样本，使露出于采集端310的缺口311的芯体110与样本接触，从而使芯体110以任一角度直接吸取样本。在一些实施例中，芯体110吸取样本后，由于芯体110的亲水性，样本可以存储于芯体110中。
在一些实施例中，为了便于封装和运输，连接部30和检测部20在使用前可以是分离放置的，在使用样本采集装置1进行采样前，需要将连接部30组装到检测部20，即样本采集方法还包括：连接连接部30和检测部20。
在一些实施例中，检测人员可以将连接部30的装配端320插入到检测腔210的连接端270，使连接部30的卡合结构370卡接在检测腔210内的限位结构，从而将连接部30连接到检测部20。
在一些实施例中，检测元件220和检测部20在使用前可以是分离放置的，在使用样本采集装置1进行采样前，检测人员可以根据需要检测的项目选择对应的检测元件220，然后将检测元件220组装到检测部20的内部，即样本采集方法还包括：将检测元件220放入检测腔210；使用封盖240盖合检测腔210。
在一些实施例中，检测人员可以将检测元件220的吸附段221插设在检测腔210内的支架250的卡槽中，将检测元件220的连接段223插设在封盖240的卡槽中。接着，检测人员可以将支架250放入检测腔210，使支架250靠近采集部10放置。最后，检测人员将封盖240盖合检测腔210。
步骤720，将所述连接部插入所述样本采集装置的缓冲剂预存部，使所述芯体插入所述缓冲剂预存部内的缓冲剂中。
在一些实施例中，将采集部10插入样本采集装置1的缓冲剂预存部40，缓冲剂预存部40的引导腔对采集部10进行引导，使采集部10朝向预存腔420的方向移动，直到采集部10到达密封片430的位置。
在一些实施例中，采集部10继续朝向预存腔420的方向移动，并对密封片430产生压力，密封片430在压力的作用下失效，使采集部10能够进入到预存腔420内。
步骤730，通过所述缓冲剂将所述样本从所述芯体冲入所述样本采集装置的检测部，获得检测结果。
在一些实施例中，预存腔420内存储有缓冲剂410，采集部10的采集端310可以浸没在缓冲剂410内。由于芯体110插入预存部40的过程中，预存部40内的空间减小，使缓冲剂410从芯体110的空隙111中向检测腔210流动，从而将样本从芯体110冲入检测腔210。在一些实施例中，样本被缓冲剂410从第二通道340快速冲入检测部20的检测腔210，并在缓冲单元260的缓冲作用下，缓慢流到检测腔210中的检测元件220上，经过检测元件220的吸附段221后到达检测段222。
在一些实施例中，检测段222对样本的成分或指标进行检测，并获得检测结果。
本申请实施例可能带来的有益效果包括但不限于：(1)采集部包括芯体，芯体具有亲水性，芯体的亲水性可以增大吸取的样本量，以满足检测部的检测需求，并且，芯体吸取速度快，提高采集速度；不仅如此，利用芯体的亲水性，芯体吸取样本后，样本存储在芯体上的稳定性较强，受重力影响小，不仅可以防止样本回流，还允许采集部以空间任意角度吸取样本，使样本采集操作更简单随意；(2)纤维束结构内部具有供样本通过的空隙，可以增加芯体的亲水面积，使样本更容易被吸取到芯体上；(3)纤维束结构对样本中的红细胞具有吸附性，在采集过程中，红细胞保留在纤维束结构中，血清继续流动至检测腔中进行检测，避免红细胞影响检测结果；(4)检测元件包括依次设置的吸附段和检测段，吸附段用于吸附样本中的红细胞，使少量进入检测腔的红细胞留滞在吸附段。通过芯体和吸附段的配合，可以提高检测元件的检测精度；(5)多个检测件中的每一个检测一项或多项不同的检测内容，则使用一份样本就可以获得多个检测结果，可以提高检测的效率；(6)样本采集装置还包括保护帽，保护帽能够将采集部完全包覆，防止保护帽接触到密封片，从而防止密封片失效。需要说明的是，不同实施例可能产生的有益效果不同，在不同的实施例里，可能产生的有益效果可以是以上任意一种或几种的组合，也可以是其他任何可能获得的有益效果。
上文已对基本概念做了描述，显然，对于本领域技术人员来说，上述详细披露仅仅作为示例，而并不构成对本申请的限定。虽然此处并没有明确说明，本领域技术人员可能会对本申请进行各种修改、改进和修正。该类修改、改进和修正在本申请中被建议，所以该类修改、改进、修正仍属于本申请示范实施例的精神和范围。
同时，本申请使用了特定词语来描述本申请的实施例。如“一个实施例”、“一实施例”、 和/或“一些实施例”意指与本申请至少一个实施例相关的某一特征、结构或特点。因此，应强调并注意的是，本说明书中在不同位置两次或多次提及的“一实施例”或“一个实施例”或“一个替代性实施例”并不一定是指同一实施例。此外，本申请的一个或多个实施例中的某些特征、结构或特点可以进行适当的组合。

Claims (22)

  1. 一种样本采集装置，其特征在于，包括：采集部、检测部以及连接所述采集部与所述检测部的连接部；
    所述采集部包括芯体，所述连接部包括中空结构，所述芯体的至少部分设置于所述中空结构中；所述芯体具有亲水性。
  2. 根据权利要求1所述的样本采集装置，其特征在于，所述芯体包括具有亲水性的纤维束结构，所述纤维束结构内部具有供样本通过的空隙。
  3. 根据权利要求2所述的样本采集装置，其特征在于，所述纤维束结构对样本中的红细胞具有吸附性。
  4. 根据权利要求1所述的样本采集装置，其特征在于，所述连接部包括采集端，所述采集端远离所述检测部；所述采集端具有缺口，所述芯体的部分表面从所述缺口中露出。
  5. 根据权利要求1所述的样本采集装置，其特征在于，所述中空结构设置有第一通道和第二通道，所述第一通道和所述第二通道相互连通且贯穿所述连接部；所述第一通道的内径大于所述第二通道的内径。
  6. 根据权利要求5所述的样本采集装置，其特征在于，所述芯体设置于所述第一通道内，所述芯体的外径大于所述第二通道的内径。
  7. 根据权利要求5所述的样本采集装置，其特征在于，所述第一通道的内壁上设置有至少一个支撑结构，所述支撑结构凸出于所述第一通道的内壁；所述多个支撑结构与所述芯体的周侧抵接。
  8. 根据权利要求2所述的样本采集装置，其特征在于，所述检测部包括检测腔，所述芯体的所述空隙与所述检测腔通过所述中空结构连通。
  9. 根据权利要求8所述的样本采集装置，其特征在于，所述检测部包括设置于所述检测腔内的检测元件。
  10. 根据权利要求9所述的样本采集装置，其特征在于，所述检测元件包括依次设置的吸附段和检测段；
    所述吸附段用于吸附样本中的红细胞；
    所述检测段用于检测样本。
  11. 根据权利要求9所述的样本采集装置，其特征在于，所述检测元件包括沿所述检测腔的径向分布的多个检测件，所述多个检测件中的每一个的检测内容不同。
  12. 根据权利要求9所述的样本采集装置，其特征在于，所述检测腔远离所述连接部的一端设置有操作口，所述检测元件从所述操作口放入和/或取出所述检测腔；所述操作口设置有封盖，所述封盖与所述操作口可拆卸连接。
  13. 根据权利要求10所述的样本采集装置，其特征在于，所述检测部包括支架，用于支撑所述检测元件；所述支架与所述检测腔的内壁连接。
  14. 根据权利要求8所述的样本采集装置，其特征在于，所述检测部包括设置于所述连接部与所述检测腔之间的缓冲单元，所述缓冲单元用于降低样本流向所述检测腔的流动速度。
  15. 根据权利要求1所述的样本采集装置，其特征在于，所述检测部包括与所述连接部连接的连接端，所述连接端设置有限位结构；
    所述连接部包括卡合结构，所述卡合结构与所述限位结构卡接，限制所述采集部与所述检测部相互分离。
  16. 根据权利要求15所述的样本采集装置，其特征在于，所述连接部包括止挡结构，所述止挡结构环绕设置于所述连接部的周侧并沿所述连接部的径向延伸，所述止挡结构的直径大于所述连接端的内径。
  17. 根据权利要求4所述的样本采集装置，其特征在于，所述样本采集装置还包括缓冲剂预存部，所述缓冲剂预存部包括缓冲剂、预存腔和密封片；
    所述缓冲剂存储于所述预存腔中，所述密封片密封所述预存腔。
  18. 根据权利要求17所述的样本采集装置，其特征在于，所述缓冲剂预存部还包括连接所述预存腔的引导腔，所述密封片设置于所述预存腔和所述引导腔之间。
  19. 根据权利要求18所述的样本采集装置，其特征在于，所述采集部与所述缓冲剂预存部分离设置，所述采集部通过所述引导腔进入所述缓冲剂预存部。
  20. 一种样本采集方法，其特征在于，包括：
    通过样本采集装置的连接部的采集端接触样本，使芯体吸取并存储所述样本；其中，所述芯体设置于所述连接部内部，所述芯体具有亲水性；
    将所述连接部插入所述样本采集装置的缓冲剂预存部，使所述芯体插入所述缓冲剂预存部内的缓冲剂中；
    通过所述缓冲剂将所述样本从所述芯体冲入所述样本采集装置的检测部，获得检测结果。
  21. 根据权利要求20所述的方法，其特征在于，所述方法还包括：连接所述连接部和所述检测部。
  22. 根据权利要求21所述的方法，其特征在于，所述方法还包括：
    将检测元件放入所述检测部的检测腔；
    使用封盖盖合所述检测腔。
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