WO2024046295A1 - 一种检测装置 - Google Patents

一种检测装置 Download PDF

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Publication number
WO2024046295A1
WO2024046295A1 PCT/CN2023/115406 CN2023115406W WO2024046295A1 WO 2024046295 A1 WO2024046295 A1 WO 2024046295A1 CN 2023115406 W CN2023115406 W CN 2023115406W WO 2024046295 A1 WO2024046295 A1 WO 2024046295A1
Authority
WO
WIPO (PCT)
Prior art keywords
wedge
shaped structure
sample collector
sample
detection device
Prior art date
Application number
PCT/CN2023/115406
Other languages
English (en)
French (fr)
Inventor
蔡政君
商涛
唐林勇
Original Assignee
利多(香港)有限公司
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from CN202211091536.XA external-priority patent/CN117665275A/zh
Priority claimed from CN202211314003.3A external-priority patent/CN117929737A/zh
Application filed by 利多(香港)有限公司 filed Critical 利多(香港)有限公司
Publication of WO2024046295A1 publication Critical patent/WO2024046295A1/zh

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Classifications

    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/577—Immunoassay; Biospecific binding assay; Materials therefor involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q

Definitions

  • the present invention relates to the technical field of rapid medical detection, and in particular, to a portable detection device and sample collector.
  • the carrier of traditional disposable disposable rapid testing products is basically in the form of test strips or test boxes.
  • the test strips of test products using lateral flow generally include a bottom card, which runs from upstream to downstream.
  • Adhering to each other in sequence are sample pads, marker binding pads (also referred to as marker pads, usually using glass fiber as the carrier), test pads (usually using NC membrane as the carrier) and absorbent pads (usually using absorbent materials such as filter paper ), using the principle of immunochromatography to transfer samples on test paper and obtain test results.
  • the labeling pad includes labels that can bind to the analyte, such as latex, colloidal gold, fluorescent microspheres, etc. labeled with antigens or antibodies.
  • the test pad is generally equipped with detection lines and quality control lines.
  • markers can be captured and collect or not captured on the test line. Based on the signal of the marker, such as a color signal or a fluorescence signal, the presence or concentration of the analyte is determined.
  • the quality control line can be used to determine whether the test paper is effective or to position the instrument when reading the test results.
  • the detection test paper is placed between the upper cover and the lower plate.
  • the upper cover is provided with a sampling hole on the sample pad corresponding to the detection test paper, and the upper cover is provided with an observation window on the test pad corresponding to the detection test paper.
  • Disposable rapid detection and diagnostic products that use body fluids such as urine, blood or other human tissue fluids to detect diseases or other physical conditions have been commonly used around the world. Their application sites can be in laboratories operated by professionals, or in laboratories operated by professionals. It can be operated by non-professionals at home, school, shopping malls, road checkpoints, customs and other places.
  • the internal space of the receiving cavity can accommodate the absorbent material on the sampling rod and place it inside, and the liquid sample will be squeezed by squeezing. onto the sample pad.
  • the sampling hole of Chinese patent CN201010164579.7 is provided with a channel, which allows the sampling head to pass through, squeeze out the liquid sample, and transfer the sample to the sample pad through the drainage member.
  • the sample cannot reach the sample pad, increasing the risk of insufficient sample volume; the sampling rod may also fall out of the sampling hole or channel after loosening and contaminate the surrounding environment; The sample channel is sampled by the sampling rod during sample addition. Clogging, the liquid sample cannot be transferred to the test paper below in time and is transported away, but accumulates in the sample addition area.
  • the squeezed out liquid sample may be squeezed by the sampling rod and overflow or splash out of the sample addition area, or even splash into the operator's body, causing danger to the operator.
  • the existing sampling rod needs to exert a large force when squeezing the sampling component, and the stroke of the sampling rod is also large, which can easily cause a large impact on the extruded liquid sample, and the extruded liquid
  • the sample may be squeezed by the sampling rod and overflow or splash out of the sampling area, or even splash onto the operator's body, causing danger to the operator.
  • the invention provides a detection device, which includes a sample collector and a detection box.
  • the purpose of the invention is to solve the problem that the liquid sample collected by the sample collector is not easily squeezed out fully, and to prevent the liquid sample from being squeezed out during the extrusion process. Splash technical issues.
  • the present invention provides the following technical solutions.
  • the invention provides a detection device, which includes a sample collector and a detection box.
  • the detection box is used to store detection test strips.
  • the sample collector includes a sampling head, a handle and a connection part between the sampling head and the handle.
  • the detection box includes a Sample hole and buckle. When the sample collector is placed into the test box, the connecting part of the sample collector is clamped in the buckle of the test box.
  • the connecting part of the sample collector includes a wedge-shaped structure that is wide at the top and narrow at the bottom. The wedge-shaped structure is located at the tight fit between the connecting part of the sample collector and the buckle.
  • the detection device includes a sample collector and a detection box.
  • the detection box is provided with detection test paper.
  • the sample collector includes a sampling head, a handle and a connection part between the sampling head and the handle.
  • the detection box includes a adding Sample hole, enclosure and buckle.
  • the enclosure encloses the sampling hole and forms a storage cavity.
  • the connection part of the sample collector includes a wedge-shaped structure with a wide top and a narrow bottom.
  • the buckle of the detection box includes a pair of inverted The hooks of the pair of hooks face each other inwards. After placing the sampling head of the sample collector into the storage cavity of the test box, the wedge-shaped structure of the sample collector squeezes the buckle downward, causing the pair to turn upside down. The hook opens outward. After the wedge-shaped structure passes through the hook tip, the hook rebounds and hooks the wedge-shaped structure. The sample extruded from the sampling head enters the test paper through the sampling hole.
  • the wedge-shaped structure includes at least one inclined surface or arc surface, which guides the hook to open outward when the wedge-shaped structure presses the buckle downward.
  • At least the lower shape of the cross-section of the wedge-shaped structure includes: an inverted trapezoid, an inverted triangle, a combination of an inverted trapezoid and a rectangle, a semicircle or an approximate semicircle.
  • the cross-section of the wedge-shaped structure is an inverted "convex" shape.
  • the width of the bottom of the wedge-shaped structure is smaller than the distance between two hook tips of the hook.
  • the width of the bottom of the wedge-shaped structure is less than half of the width of its top.
  • the detection box includes a second buckle, which locks the sampling head of the sample collector after the sampling head of the sample collector is placed in the storage cavity of the detection device.
  • the second buckle is arranged in the storage cavity of the detection device.
  • the end of the second buckle is provided with a bump
  • the sampling head of the sample collector is provided with a recess.
  • the invention also provides a sample collector, which includes a sampling head, a handle and a connecting portion between the sampling head and the handle.
  • the connecting portion of the sample collector includes a wedge-shaped structure that is wide at the top and narrow at the bottom.
  • the wedge-shaped structure includes at least one inclined surface or arc surface.
  • At least the lower shape of the cross-section of the wedge-shaped structure includes: an inverted trapezoid, an inverted triangle, a combination of an inverted trapezoid and a rectangle, a semicircle or an approximate semicircle.
  • the cross-section of the wedge-shaped structure is an inverted "convex" shape.
  • the width of the bottom of the wedge-shaped structure is less than half of the width of its top.
  • the detection device of the present invention is provided with a wedge-shaped structure that is wide at the top and narrow at the bottom at the connection portion of the sample collector.
  • the wedge-shaped structure also includes a pair of inclined or arc surfaces with guiding functions, thereby making the wedge-shaped structure easier to Through the pair of hooks on the detection box, the squeezing force exerted on the sample collector is reduced.
  • the bottom size of the wedge-shaped structure is smaller than the distance between the hook tips of a pair of hooks on the detection box that cooperates with the wedge-shaped structure. Therefore, the bottom of the wedge-shaped structure enters the pair of hooks without being blocked.
  • the present invention can effectively reduce the liquid sample from splashing out of the detection device during the detection process, prevent the liquid sample from contaminating the environment around the detection, avoid the liquid sample from splashing on the operator's body, and reduce the risk of physical harm to the operator.
  • the detection device engages with the wedge-shaped structure through the hook, so that the sample collector is held on the detection box, the sampling pad can be fully squeezed, and the sample is fully squeezed out, avoiding the problem of insufficient sample volume causing detection failure. , and avoid the sampling rod falling out of the sampling hole or sampling channel and contaminating the surrounding environment.
  • Figure 1 is a schematic diagram of the initial use state of the detection device of the present invention, that is, when the sample collector has just been inserted into the detection box.
  • Figure 2 is a schematic diagram of the sample collector of the detection device of the present invention when it is fully inserted into the detection box.
  • Figure 3 is an exploded perspective view of the detection device of the present invention.
  • Figure 4 is a schematic diagram of a test strip in the form of lateral cross flow.
  • Figure 5 is a perspective view of the sample collector.
  • Figure 6 is a schematic three-dimensional view of the assembled detection box of the present invention.
  • FIG. 7 is a top view of the detection box of FIG. 6 .
  • FIG. 8 is a cross-sectional view along the A-A direction of FIG. 7 .
  • FIG. 9 is a cross-sectional view along the B-B direction of FIG. 7 .
  • FIG. 10 is a top view of FIG. 2 .
  • FIG. 11 is a partial enlarged schematic diagram of the circle “A” in FIG. 5 .
  • Figure 12 is a schematic cross-sectional view showing the beginning of inserting the sample collector into the detection cartridge.
  • Figure 13 is a schematic cross-sectional view of the process of inserting the sample collector into the detection cartridge.
  • Figure 14 is a schematic cross-sectional view of the sample collector fully inserted into the detection cartridge.
  • Fig. 15 is a partial enlarged schematic diagram of the circle "B" in Fig. 14.
  • FIG. 16 is a cross-sectional view along the C-C direction of FIG. 11 .
  • Figures 17-23 are schematic diagrams of the modified design of Figure 16.
  • FIGs 24-26 are diagrams showing the process of inserting the connecting part into the buckle according to the design scheme shown in Figure 23.
  • Figures 27-29 are diagrams showing the process of inserting the connecting part into the buckle according to the design scheme shown in Figure 16.
  • Figure 30 is a partial enlarged schematic diagram of the circle "C" in Figure 24.
  • Figure 31 is a partial enlarged schematic diagram of the circle "D" in Figure 27.
  • Figure 32 is a comparative schematic diagram after overlapping the two solutions shown in Figure 24 and Figure 27 (the dotted line is the solution in Figure 24, and the solid line is the solution in Figure 27).
  • lower part includes the “bottom” of a component and that portion extending upwards a suitable distance from the “bottom” of the component.
  • the detection device shown in Figures 1 to 9 includes a detection box 300 and a sample collector 200 used in conjunction with the detection box.
  • the detection box includes an upper cover 1, a lower plate 2 and a detection test paper 100.
  • the detection test paper 100 is located between the upper cover and the lower plate of the detection box.
  • the upper cover 1 and the lower plate 2 are engaged with each other and the detection test strip 100 is installed in the detection box 300 .
  • the detection test paper 100 is a lateral cross-flow detection test paper, including a bottom card 101.
  • the sample pad 102, the marker binding pad 103, the test pad 104 and the water-absorbent pad 105 are adhered to each other in sequence from upstream to downstream (ie, the direction of liquid sample transmission).
  • the detection test paper 100 may also be a vertical flow detection test paper or other forms of detection test paper that are well known to those skilled in the art.
  • the sample collector 200 shown in FIG. 5 includes a handle 201, a connecting part 202 and a sampling head 203.
  • the connecting part 202 is between the handle 201 and the sampling head 203.
  • the sampling head 203 includes a sampling pad 204, and the sampling pad 204 is fixed to the sampling head 203 by buckling or pasting.
  • the sampling pad 204 can be made of absorbent tampons, sponges, absorbent fibers or porous polymer materials, or other absorbent materials known in the art, such as polyvinyl alcohol.
  • the sampling head 203 can also be provided with a transparent indicator area 205, which is located above the sampling pad 204.
  • the indicator test paper is stored in the indicator area 205.
  • the handle 201 can be designed into a flat configuration with a certain curvature to facilitate the operator to hold it, and the connecting portion 202 is designed into a thin neck shape.
  • the upper cover 1 of the detection box 300 is provided with a sampling hole 3 and an observation window 4.
  • the sampling hole 3 is located above the sample pad 102 for detecting the test paper, and the observation window 4 is located above the test pad 104 for detecting the test paper.
  • An enclosure 5 is provided around the sampling hole 3 .
  • the enclosure 5 can be erected on the upper surface of the upper cover to enclose the sampling hole 3 and form a storage cavity 6; the enclosure 5 can also sink downward from the upper surface of the upper cover toward the detection box.
  • the sampling hole 3 is enclosed and a receiving cavity 6 is formed.
  • the enclosure 5 may also have a part standing on the upper surface of the upper cover 1 and a part extending toward the inside of the detection box to enclose the sampling hole 3 and form a storage cavity 6 .
  • the enclosure 5 is generally a wall structure, with a storage cavity 6 inside.
  • the enclosure 5 includes a front enclosure 51 , a rear enclosure 52 and two side enclosures 53 .
  • the front enclosure 51 is located in the direction of the top of the sample collector
  • the rear enclosure 52 is located in the direction of the connecting portion 202 of the sample collector.
  • the area in the storage cavity 6 near the front enclosure 51 may be called the front end of the storage cavity
  • the area in the storage cavity near the rear enclosure 52 may be called the rear end of the storage cavity 6 .
  • the bottom of the storage chamber 6 includes a bottom plate 7 , and the sampling hole 3 is provided on the bottom plate 7 .
  • the sampling head 203 When the sampling head 203 is completely inserted into the storage cavity 6, the bottom of the sampling pad 204 abuts the bottom plate 7, and the sampling head 203 presses the sampling pad 204 downward, thereby squeezing the liquid sample out of the sampling pad 204.
  • the extruded liquid sample enters the sample pad 102 of the detection test paper through the sampling hole 3, and then the detection starts.
  • the bottom plate 7 can be part of the top plate of the upper cover, and the enclosure 5 is formed by a circle raised upward by the top plate of the upper cover at an appropriate height, and the cavity in the circle forms the storage cavity 6 .
  • the bottom plate 7 can be provided with a plurality of sampling holes 3 above the test paper sample pad 102. For example, two sampling holes are provided at intervals. On the one hand, the extruded sample can be quickly introduced onto the sample pad 102 of the test paper. , on the other hand, the strength of the bottom plate 7 is maintained so that it is not easily deformed during the extrusion process.
  • three guide grooves 8 are provided at the connection between the bottom plate 7 and the rear enclosure 52.
  • the guide grooves 8 penetrate the bottom plate 7. Therefore, the guide grooves 8 are connected with the inside of the detection box, so that The squeezed liquid sample is introduced into the detection box or onto the sample pad 102 of the detection test paper, and is absorbed by the sample pad 102 of the detection test paper.
  • a leakage hole 16 is opened at the lower part of the rear enclosure 52 of the storage cavity 6.
  • the leakage hole 16 penetrates the bottom plate 7.
  • the leakage hole 16 is connected with the inside of the detection box to allow the flow to the rear.
  • the liquid sample at the enclosure 52 can enter the interior of the detection box 300 through the leak hole 16 .
  • the guide groove 8 on the bottom plate corresponds to the leak hole 16 on the lower edge of the rear enclosure 52 , and the guide groove 8 extends to the leak hole 16 in the lower part of the rear enclosure 52 . More specifically, the guide groove 8 located on the bottom plate is connected to the leak hole 16 located on the rear enclosure, forming a right-angle opening or an "L"-shaped opening. Such a design can further increase the flux of liquid samples flowing into the detection box and prevent more liquid samples from being retained in the storage chamber 6 during the process of squeezing the sample collector, causing the liquid samples to splash out of the storage cavity 6 .
  • the rear end of the detection box storage cavity 6 is provided with a guide groove 8 on the bottom plate 7 , a drain hole 16 is provided at the lower part of the rear enclosure 52 , and a lateral opening is provided at the lower part of the side enclosure 53 .
  • the drain hole 24 and the guide groove 8 extend toward the drain hole 16 and the lateral drain hole 24 respectively, and intersect with the drain hole 16 and the lateral drain hole 24.
  • the drain hole 16 and the lateral drain hole 24 Therefore, an opening composed of the guide groove 8 , the leakage hole 16 and the lateral leakage hole 24 is formed at the two corners at the rear of the storage cavity 6 to drain the liquid accumulated at the rear of the storage cavity 6 sample.
  • FIG. 15 is a schematic diagram illustrating the distribution of the extruded liquid sample 500 (shown by the densely distributed small dots in FIG. 15 ) after the sample collector 200 is completely inserted into the detection cartridge 300 .
  • the opening size and height of the leakage hole 16, the distance between the leakage hole 16 and the bottom plate 7 (for example, the leakage hole can penetrate the bottom plate, or it can not penetrate the bottom plate above the bottom plate), and the number of leakage holes, etc. It can be adjusted according to factors such as the sampling volume of the sample collector, the capacity of the storage cavity, and the injection speed of the sampling hole.
  • the upper cover 1 is also provided with a fastening device for the sample collector.
  • the fastening device and the upper cover 1 are integrally formed of plastic.
  • the fastening device includes a buckle 10 .
  • the buckle 10 is formed on the top plate of the upper cover 1 and is located near or beside the storage cavity 6 ; more preferably, the buckle 10 is located near or beside the rear fence 52 .
  • the buckle 10 can also be located at other suitable positions as long as it can realize the function of the present invention. Therefore, the position of the buckle 10 should not limit the scope of the technical solution claimed by the present invention.
  • the buckle 10 includes a pair of inverted hooks 14 extending upward from the top plate of the upper cover 1 to a suitable height (the hooks 14 should have appropriate elasticity), and the hook tips 15 of the pair of hooks (such as (shown in Figure 30) face each other inwards.
  • the connecting portion 202 of the sample collector 200 includes an upper width and a lower Narrow wedge-shaped structure 202a (shown in Figures 5 and 11). Please refer to Figures 12-14 and Figures 27-29. After the sampling head 203 of the sample collector is placed into the storage cavity 6 of the detection box, the position of the lower part of the wedge-shaped structure 202a of the sample collector corresponds to the buckle. 10.
  • the wedge-shaped structure 202a presses the buckle 10 downward, and the wedge-shaped structure 202a or the inclined surface 202b or the arc surface 202c of the wedge-shaped structure 202a opens the upper part of the pair of hooks 14, even if the pair is inverted.
  • the upper part of the hook 14 produces appropriate elastic deformation, causing the upper part of the hook 14 to expand outward, thereby enlarging the gap between the pair of hook tips 15, so that the wedge-shaped structure 202a passes through the pair of hook tips 15, and then, The pair of hooks 14 rebound, and the pair of hook tips 15 hook the wedge-shaped structure 202a to keep the sampling head 203 in the storage cavity 6 and continue to squeeze out the liquid sample in the sampling pad 204.
  • the top of the pair of inverted hooks 14 is provided with an inclined surface 15a that guides the wedge-shaped structure 202a to squeeze the hook tips 15 (as shown in Figure 30), thereby further reducing the resistance of the wedge-shaped structure 202a passing through the pair of hook tips 15. That is to say, the force exerted on the handle 201 of the sample collector is reduced, thereby reducing the impact on the extruded liquid sample and preventing the liquid sample from splashing out of the storage cavity 6 .
  • the wedge-shaped structure 202a includes at least one inclined surface 202b (preferably a pair of inclined surfaces 202b), or as shown in Figures 21 and 22, the wedge-shaped structure 202a includes at least one arc surface 202c (preferably a pair of inclined surfaces 202b). Including a pair of arcuate surfaces 202c), when the wedge-shaped structure 202a squeezes the hook 14 downward, the inclined surface 202b or the arcuate surface 202c guides the upper part of the hook 14 to expand outward, that is, the inclined surface 202b or the arcuate surface 202c squeezes the hook 14 outward.
  • Figures 16 to 22 respectively illustrate several specific structures of the wedge-shaped structure 202a.
  • the cross-section of the wedge-shaped structure 202a is generally wide at the top and narrow at the bottom, thereby facilitating the wedge-shaped structure to be inserted into the hook 14 .
  • the shape of the entire cross-section of the wedge-shaped structure 202a or the shape of the lower part of the cross-section of the wedge-shaped structure 202a includes: an inverted trapezoid or an isosceles trapezoid (as shown in Figure 16), an inverted triangle or an isosceles triangle.
  • the cross-section of the wedge-shaped structure 202a is an inverted "convex" shape.
  • the cross-section of the wedge-shaped structure 202a can also be regarded as an approximately inverted “convex” shape.
  • the connecting portion 202 does not include a wedge-shaped structure, and its cross-section is rectangular, including square and rectangular.
  • 24 to 26 demonstrate the process of inserting the connecting portion 202 into a pair of hooks 14 when the connecting portion 202 does not include a wedge-shaped structure, that is, when its cross-section is rectangular (the embodiment shown in FIG. 23 ).
  • 27-29 demonstrate the process of inserting the wedge-shaped structure 202a into a pair of hooks 14 when the connecting part 202 includes a wedge-shaped structure 202a. Comparing the two, it is obvious that the solution in which the connecting part includes the wedge-shaped structure 202a is better than the solution in which the connecting part does not include the wedge-shaped structure. Further detailed analysis will be done below.
  • the width dimension d3 of its cross-section must be larger than the pair of hook tips 15 Otherwise, when the connecting portion 202 enters below the pair of hook tips 15, the pair of hook tips 15 will not be able to hook the connecting portion 202. As shown in FIG. 30 , when the cross-section of the connecting part 202 is rectangular (that is, the connecting part 202 does not include a wedge-shaped structure, and its upper and lower parts have the same size), the width dimension d3 of its cross-section must be larger than the pair of hook tips 15 Otherwise, when the connecting portion 202 enters below the pair of hook tips 15, the pair of hook tips 15 will not be able to hook the connecting portion 202. As shown in FIG.
  • the connecting portion 202 includes a wedge-shaped structure 202 a
  • the top dimension d3 of the wedge-shaped structure 202 a is greater than the distance d2 between the pair of hook tips 15
  • the bottom dimension d1 of the wedge-shaped structure 202 a is smaller than the distance d2 between the pair of hook tips 15 .
  • the distance between them is d2.
  • the pair of inclined surfaces 202b or arcuate surfaces 202c of the wedge-shaped structure 202a play a guiding role in the process, greatly reducing the squeezing force that needs to be applied to the handle 201 of the sample collector, thereby reducing the wedge-shaped structure of the sample collector.
  • 202a becomes easier to enter the buckle 10, and when the sampling head 203 squeezes out the liquid sample collected by the sampling pad 204, the impact on the squeezed out liquid sample is reduced, thereby reducing the splash of the liquid sample, and then it is easy to This method effectively overcomes the shortcomings of the existing technology and the technical solution shown in Figure 23.
  • the width d1 of the bottom 202d of the wedge-shaped structure is less than half of the width d3 of its top 202e.
  • the relationship between the width d1 of the bottom 202d of the wedge-shaped structure, the distance d2 between the pair of hook tips 15 when the hook is not squeezed, and the width d3 of the top 202e of the wedge-shaped structure is: d1 is smaller than d2, and d2 is smaller than d3.
  • the present invention designs the connecting portion 202 of the sample collector to include a wedge-shaped structure 202a, which not only facilitates the connecting portion 202 to be squeezed and passed through the pair of hook tips 15, but also ensures that the connecting portion 202 is vertically aligned.
  • the size is large enough to ensure that the connecting part 202 has sufficient strength and rigidity, so that the connecting part 202 is not easily deformed or broken during the extrusion process.
  • the pair of hooks 14 engage with the wedge-shaped structure 202a, so that the sample collector 200 is held on the detection box 300, the sampling pad 204 is fully squeezed, and the sample is fully squeezed out.
  • the detection box 300 also includes a second buckle 9. After placing the sampling head 203 of the sample collector into the storage cavity 6 of the detection device Finally, the second buckle 9 blocks the front end of the sampling head 203 of the sample collector.
  • the second buckles 9 and 10 are respectively located at both ends or the periphery of both ends of the sampling head 203 of the sample collector. This design is more conducive to exerting appropriate pressure on the sampling head 203 and is more conducive to quickly collecting the sample. The liquid sample collected by head 203 is squeezed out without causing liquid splash. As shown in Figures 12-14, during the extrusion process, the second The buckle 9 hooks the front end of the sampling head 203.
  • the sample collector 200 uses the contact point between the second buckle 9 and the sampling head 203 as a fulcrum to realize lever movement until the wedge-shaped structure 202a of the connecting portion 202 of the sample collector is squeezed. And passes through a pair of hook tips 15 and remains below the pair of hook tips 15 . The liquid sample in the sampling head 203 is fully squeezed out (as shown in Figure 15).
  • the second buckle 9 is provided in the storage cavity 6 of the detection device.
  • the end of the second buckle 9 is provided with a bump 91 (as shown in Figure 8), and the sampling head 203 of the sample collector is provided with a recess 206 (as shown in Figure 1 ), when the sampling head 203 of the sample collector is placed into the storage cavity 6 of the detection box, the second buckling bump 91 snaps into the recess 206 of the sampling head of the sample collector, thereby hooking the sample The top of head 203.
  • the buckle 10 is provided behind the rear enclosure 52 .
  • the gap between the pair of hooks 14 of the buckle 10 is a latching groove 13, and the latching groove 13 is on the same axis as the rear enclosure groove 12.
  • the pair of hooks 14 engage with the wedge-shaped structure 202a, so that the wedge-shaped structure 202a is restricted in the slot 13, so that the sample collector 200 is held on the detection box 300, the sampling pad 204 is fully squeezed, and the sample is fully squeezed. Press it out.
  • the sampling head 203 of the sample collector placed in the storage cavity 6 uses the second buckle 9 as a fulcrum to press down the sampling pad 204, so that the sampling pad 204 is squeezed by the bottom plate 7 and extruded. Liquid sample within sampling pad 204.
  • the upper end of the second buckle 9 is provided with a bump 91 (as shown in Figure 8), and the top end of the sample collector is provided with a recess 206 (such as As shown in Figure 5), when the sampling head 203 of the sample collector is inserted into the storage cavity 6, the top end of the sampling head 203 is placed below the second buckle 9, and the bump 91 of the second buckle 9 is engaged with the sample. into the recess 206 of the collector (as shown in FIG. 1 ), then rotate using the buckle as a fulcrum, and press down the handle 201 of the sample collector so that the sampling pad 204 is squeezed by the bottom plate 7 .
  • the fulcrum cooperation method between the second buckle 9 and the sampling head 203 can also be in other forms, such as but not limited to the following methods.
  • the upper end of the second buckle 9 is set as a concave portion, and the top end of the sampling head includes a groove with the concave portion. Matching bumps.
  • an opening is opened in the second buckle 9 and a protrusion is provided at the top of the sampling head 203. The protrusion can be inserted into the opening to form a pressing fulcrum.
  • the second buckle 9 preferably has a certain degree of elasticity.
  • the second buckle 9 is provided in the storage cavity 6 and close to the front end of the storage cavity.
  • the second buckle 9 can be provided on the inner wall of the front enclosure 51 .
  • the second buckle 9 is disposed on the bottom plate area between the sampling hole 3 and the front wall 51 , and there is a gap between the second buckle 9 and the front wall 51 .
  • a certain interval space 11 (as shown in Figure 7). The spacing space 11 leaves a retreat space for the second buckle 9 .
  • the front end of the sampling head presses against the arm 92 of the second buckle 9 (such as 8), the clamping arm 92 elastically tilts into the separation space 11 after being pressed, until the protrusion 91 of the second buckle is engaged in the recess 206 of the sampling head, and the clamping arm 92 elastically returns to its original position.
  • the separation space 11 can also play a buffering role.
  • the second buckle 9 is provided on the inner wall of the front enclosure, the top end of the sampling head 203 inserted into the storage cavity 6 is very close to the front enclosure 51.
  • the liquid squeezed out from the sampling pad 204 When the sample volume is larger than the gap between the top of the sampling head 203 and the front fence 51, and this part of the liquid sample does not have time to flow into the detection box, the liquid sample located in the gap between the top of the sampling head 203 and the front fence 51 will It may be squeezed out of the enclosure 5, so the interval space 11 is provided to increase the temporary storage space of the liquid sample, which is equivalent to a buffer zone.
  • a groove 12 for receiving the connecting portion 202 of the sample collector is also opened on the rear enclosure 52 .
  • the connecting portion 202 of the collector can be embedded in the groove 12 of the rear enclosure, so that the sampling pad 204 of the sample collector 200 can be completely pressed flat against the bottom plate. 7, so that every position of the sampling pad 204 is fully squeezed.
  • SARS-CoV-2 portable novel coronavirus
  • the new coronavirus (SARS-CoV-2) detection test paper 100 includes a bottom card 101. On the bottom card 101, a sample pad 102, a marker binding pad 103, and Test pad 104 and absorbent pad 105.
  • the marker binding pad 103 is coated with an anti-novel coronavirus (anti-SARS-CoV-2) antibody-latex marker, and the detection line (T line) of the test pad is coated with an anti-SARS-CoV-2 antibody.
  • the control line (C line) was coated with goat anti-mouse IgG.
  • the sample collector 200 is packaged in a sealed bag and combined with the prepared detection box to form a complete detection device.
  • the sampling pad 204 of the sample collector 200 will absorb water and swell when it comes into contact with saliva.
  • SARS-CoV-2 portable novel coronavirus
  • sample collector 200 Take out the sample collector 200 from the sealed bag, put the sample collector into the tester's mouth, and draw saliva to a prescribed sample amount. If there is an indicator test paper, you can judge whether enough has been collected based on the discoloration of the indicator test paper. If there is no indicator paper, you can judge whether enough has been collected based on the expansion of the sampling pad.
  • the second buckle 9 in the storage cavity is in contact with the sampling head.
  • the recess 206 at the front end is engaged, and the sample collector 200 is pressed downwards with the second buckle 9 as the fulcrum.
  • the connecting part 202 of the collector is embedded in the groove 12 of the rear enclosure.
  • the liquid sample squeezed out from the collector sampling pad passes through the sampling hole 3 and reaches the sample pad 102 of the test paper. Then, the liquid sample reaches the water-absorbent pad 105 via the sample pad 102, the marker binding pad 103, and the test pad 104. If the test pad only shows color at the C line, it means the sample is negative. If both the C line and T line show color, it means the sample is positive and further nucleic acid analysis is required. If no color appears on the C line, then Indicates that this test is invalid.
  • Drug test strips 100 are also known as drug of abuse test strips.
  • a "drug of abuse” (DOA) is a drug used for non-medical purposes (usually for psychedelic effects). Abuse of this drug can lead to physical and mental harm and (in some cases) dependence, addiction, and even death.
  • DOA examples include cocaine, amphetamines (e.g., black beauties, white bennies, amphetamine tablets, dextroamphetamines, dexies, beans), methamphetamines (crank, methamphetamine, crystal, speed), methamphetamines (e.g., crank, methamphetamine, crystal, speed), Bitutes (stable Roche Pharmaceuticals, Nutley, New Jersey), sedatives (i.e.
  • lysergic acid diethylamide LSD
  • sedatives downers, goofballs, barbs, blue devils, yellow jackets, ludes
  • TCA tricyclic antidepressants
  • PCP phencyclidine
  • THC tetrahydrocannabinol
  • pot, dope, hash, weed, etc. opiates (such as Morphine, opium, cocaine, heroin, oxycodone).
  • This embodiment takes a portable amphetamine (urine) colloidal gold detection device as an example.
  • the portable amphetamine (urine) colloidal gold detection device includes detection test strips, detection boxes and sample collectors.
  • the test paper is a portable amphetamine (urine) colloidal gold test paper and includes a bottom card. On the bottom card, a sample pad, a marker binding pad, a test pad and an absorbent pad are adhered to each other in sequence from upstream to downstream.
  • the principle is that monoclonal antibodies compete for binding of amphetamine conjugates to amphetamines that may be present in urine.
  • the label binding pad contains anti-amphetamine monoclonal antibodies (colloidal gold antibodies) labeled with colloidal gold, and the test pad T line contains amphetamine conjugates.
  • the sample collector enters the tester's urine, and then squeezes the urine sample on the collector into the test box.
  • the urine sample then chromatographs upward on the test paper under the capillary effect. If the concentration of amphetamine in the urine sample is less than 1000ng/ml, the colloidal gold antibody cannot fully bind to the amphetamine. In this way, the colloidal gold antibody will be bound to the amphetamine conjugate fixed on the test pad during the chromatography process, and a purple-red strip will appear on the T line. If the concentration of amphetamine in the urine sample is higher than 1000ng/ml, the colloidal gold antibody will all combine with amphetamine, so it will not react with amphetamine in the T-line area due to competitive reaction.
  • the conjugate binds without the appearance of a purple-red band.
  • negative urine samples will appear as a purple-red band on the T line due to the lack of antibody-antigen competition reaction. Regardless of whether amphetamine is present in the urine sample, a purple-red band will appear at line C of the quality control line.
  • the purple-red strip appearing in the quality control area (C) is the standard to determine whether there is enough urine sample and whether the chromatography process is normal. It also serves as the internal control standard of the reagent.
  • One detection device is used in multiple drug abuse detection embodiments, and multiple test paper storage slots are provided on the lower plate of the detection box for placing detection test papers for different detection items.
  • test paper in this embodiment uses time-resolved immunofluorescence detection based on phosphorescent luminescence technology as an example.
  • Test strips are used to detect IgG antibodies produced after infection by pathogenic microorganisms.
  • the detection mode is an indirect method.
  • the preparation method of the test paper includes: labeling the anti-human immunoglobulin IgG antibody with a phosphorescent material and fixing it on the label conjugate pad; fixing the pathogenic microbial antigen to be analyzed on the detection line of the test pad, and fixing the IgG on the test line Pad quality control online.
  • the detection device of the present invention can be used in detection fields such as disease diagnosis, drunk driving testing, drug use analysis, hormone analysis, etc., to meet the requirements of rapid sampling and rapid detection.
  • the types of samples that can be detected by the detection device of the present invention can be urine, saliva, blood, sample lysate, etc.

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Abstract

一种检测装置，包括样本收集器（200）和检测盒（300），检测盒（300）用于存放检测试纸（100），样本收集器（200）包括取样头（203）、手柄（201）和介于取样头（203）与手柄（201）之间的连接部（202），检测盒（300）包括加样孔（3）和卡扣（10），当样本收集器（200）放入检测盒（300）内，样本收集器（200）的连接部（202）卡紧在检测盒（300）的卡扣（10）中，样本收集器（200）之连接部（202）包括有上宽下窄的楔形结构（202a），楔形结构（202a）位于样本收集器（200）连接部（202）与卡扣（10）卡紧配合处。采用样本收集器（200）连接部（202）的楔形结构（202a）使连接部（202）更容易通过检测盒（300）卡扣（10），从而减小了施加到样本收集器（200）上的挤压力，进而减少了样本收集器（200）对已经挤压出来的液体样本的冲击，从而有效地降低了液体样本的飞溅，避免飞溅的样本污染操作人员和环境。

Description

一种检测装置 技术领域
本发明涉及快速医学检测的技术领域，尤其涉及一种便携式的检测装置和样本收集器。
背景技术
传统的一次性抛弃式快速检测产品的载体基本是检测试纸或检测盒的形式，例如采用侧向横流(Lateral flow)方式的检测产品的检测试纸一般包括底卡，在底卡上从上游到下游依次相互叠加的粘附有样本垫、标记物结合垫(又可简称标记垫，通常采用玻纤作为载体)、测试垫(通常采用NC膜作为载体)和吸水垫(通常采用滤纸等吸水性材料)，利用免疫层析原理实现样本在试纸上的传递并获得检测结果。标记垫上包括能与被分析物结合的标记物，例如标记了抗原或抗体的乳胶、胶体金、荧光微球等。测试垫上一般设有检测线和质控线。随着样本在试纸上的流动，标记物会在检测线上被捕获并聚集或不被捕获。根据标记物的信号，例如颜色信号或荧光信号，判断被分析物是否存在或其浓度。质控线可用于判断试纸是否有效或用于仪器读取检测结果时的定位等作用。检测盒是将检测试纸放置在上盖和下板之间，上盖对应检测试纸的样本垫之上开设有加样孔，上盖对应检测试纸的测试垫之上开设有观察窗。
利用尿液、血液或人体其他组织液等体液对疾病或其他身体状况进行检测的一次性抛弃式快速检测诊断产品已在全世界普遍使用，其应用场所可以是在由专业人员操作的实验室，也可以在家中、学校、商场、道路卡口、海关等场所由非专业人员自行操作。
这类传统的检测产品仅仅是单纯的试纸条或检测盒，当用取样棒取样检测时，需要在采完样之后将取样棒放入收集瓶中，取样棒上的样品挤压至收集瓶后将样本滴加至样本垫或加样孔中，如美国专利申请US20040237674A1的图7和图8所示，这样的加样操作比较繁琐。中国专利CN200420110153.3和中国专利CN201010164579.7分别对检测盒进行了改进，简化了加样操作步骤。中国专利CN200420110153.3检测盒的加样孔凸出于检测盒的上盖形成一接纳腔，接纳腔的内部空间可容纳取样棒上的吸水材料置于其内，经挤压将液体样本挤压至样本垫上。中国专利CN201010164579.7的加样孔设有通道，该通道允许采样头通过，经挤压将液体样本挤出并经引流件将样本传递至样本垫上。这两件中国专利存在以下一些问题，例如：使用者需要一直按住取样棒保持挤压状态至液体样本挤压完全，若中途松开，取样棒失去挤压力后留存在取样棒上的液体样本就不能到达样本垫，增加了加样量不足的风险；也可能在松开后取样棒从加样孔或加样通道中掉出而污染周围环境；设置在上盖的加样孔或加样通道在加样时被取样棒 堵塞，液体样本不能被及时传送到下方的试纸上而输送走，而是积累在加样区，被挤出的液体样本可能会被取样棒挤压而溢出或飞溅出加样区，甚至飞溅到操作者的身体上，给操作者造成危险。此外，现有的取样棒在挤压取样部件时所需要施加的作用力较大，取样棒的行程也较大，很容易对已经挤出的液体样本造成较大的冲击，被挤出的液体样本可能会被取样棒挤压而溢出或飞溅出加样区，甚至飞溅到操作者的身体上，给操作者造成危险。
因此，如何提供一种检测装置，以实现快速检测，并且又能避免加样过程中有样本飞溅出加样区，是目前本领域技术人员急需解决的技术问题。
发明内容
本发明提供一种检测装置，该检测装置包括样本收集器和检测盒，本发明的目的在于解决样本收集器收集的液体样本不容易被充分的挤压出来，以及防止在挤压过程中液体样本飞溅的技术问题。
为了达到这个目的，本发明提供了如下技术方案。
本发明提供了一种检测装置，包括样本收集器和检测盒，检测盒用于存放检测试纸，样本收集器包括取样头、手柄和介于取样头与手柄之间的连接部，检测盒包括加样孔和卡扣，当样本收集器放入检测盒内，样本收集器的连接部卡紧在检测盒的卡扣中，样本收集器之连接部包括有上宽下窄的楔形结构，所述楔形结构位于样本收集器连接部与卡扣卡紧配合处。
更为具体的，所述检测装置包括样本收集器和检测盒，检测盒内设有检测试纸，样本收集器包括取样头、手柄和介于取样头与手柄之间的连接部，检测盒包括加样孔、围挡和卡扣，围挡将加样孔围合在其内并形成收纳腔，样本收集器之连接部包括有上宽下窄的楔形结构，检测盒的卡扣包括一对倒置的卡钩，该对卡钩的钩尖朝内彼此相对，在将样本收集器的取样头放入检测盒的收纳腔后，样本收集器的楔形结构向下挤压卡扣，使这对倒置的卡钩向外张开，楔形结构通过钩尖后，卡钩回弹并钩住楔形结构，从取样头挤压出来的样本经加样孔进入检测试纸。
进一步的，所述楔形结构包括至少一个斜面或者弧面，在楔形结构向下挤压卡扣时，该斜面或者弧面引导卡钩向外张开。
进一步的，至少所述楔形结构横截面的下部形状包括：倒置的梯形、倒置的三角形、倒置的梯形和矩形的组合、半圆形或者近似半圆形。
进一步的，所述楔形结构的横截面为倒置的“凸”字形。
进一步的，所述楔形结构底部的宽度小于卡钩之两个钩尖之间的间距。
进一步的，所述楔形结构底部的宽度小于其顶部宽度的二分之一。
进一步的，检测盒包括第二卡扣，在将样本收集器的取样头放入检测装置的收纳腔后，该第二卡扣卡住样本收集器的取样头。
进一步的，所述第二卡扣设置在检测装置的收纳腔内。
进一步的，所述第二卡扣的末端设有凸块，样本收集器的取样头设有凹部，当将样本收集器的取样头放入检测盒的收纳腔内后，所述第二卡扣的凸块扣合在样本收集器的取样头的凹部内。
本发明还提供了一种样本收集器，包括取样头、手柄和介于取样头与手柄之间的连接部，样本收集器之连接部包括有上宽下窄的楔形结构。
进一步的，所述楔形结构包括至少一个斜面或者弧面。
进一步的，至少所述楔形结构横截面的下部形状包括：倒置的梯形、倒置的三角形、倒置的梯形和矩形的组合、半圆形或者近似半圆形。
进一步的，所述楔形结构的横截面为倒置的“凸”字形。
进一步的，所述楔形结构底部的宽度小于其顶部宽度的二分之一。
有益效果
本发明所述检测装置在其样本收集器的连接部设置上宽下窄的楔形结构，优选地，该楔形结构还包括一对具有导引作用的斜面或者弧面，从而使该楔形结构更加容易通过检测盒上的这对卡钩，从而减小了施加到样本收集器上的挤压力。此外，该楔形结构的底部尺寸小于检测盒上与该楔形结构配合的一对卡钩之钩尖之间的间距，因此，该楔形结构的底部在未受到阻挡的情况下就进入到了这对卡钩之钩尖的下面，因此在挤压过程中，缩短了楔形结构沿着检测盒上的卡钩的滑移距离，进而有效地减少了样本收集器对已经挤压出来的液体样本的冲击，从而有效地降低了液体样本的飞溅。因此，本发明在检测过程中能够有效地减少液体样本飞溅出检测装置，避免液体样本污染检测周围的环境，避免液体样本飞溅到操作者的身体上，降低了对操作者的身体危害风险。并且，检测装置通过卡钩与楔形结构卡合，使样本收集器被保持在检测盒上，取样垫能够被充分挤压，样本被充分挤压出来，避免了加样量不足导致检测失败的问题，以及避免了取样棒从加样孔或加样通道中掉出而污染周围环境。
附图说明
图1是本发明之检测装置的初始使用状态示意图，即样本收集器刚插入检测盒时的示意图。
图2是本发明之检测装置的样本收集器完全插入检测盒时的示意图。
图3是本发明之检测装置的立体分解示意图。
图4是侧向横流形式的检测试纸的示意图。
图5是样本收集器的立体示意图。
图6是本发明之检测盒组装后的立体示意图。
图7是图6检测盒的俯视图。
图8是图7沿A-A方向的剖面图。
图9是图7沿B-B方向的剖面图。
图10是图2的俯视图。
图11是图5之圆圈“A”内的局部放大示意图。
图12是开始将样本收集器插入检测盒的剖面示意图。
图13是将样本收集器插入检测盒的过程剖面示意图。
图14是将样本收集器完全插入检测盒的剖面示意图。
图15是图14中的圆圈“B”内的局部放大示意图。
图16是图11沿C-C方向的剖视图。
图17-图23是图16的变更设计示意图。
图24-图26为图23所示的设计方案，将连接部插入卡扣的过程演示图。
图27-图29为图16所示的设计方案，将连接部插入卡扣的过程演示图。
图30为图24中的圆圈“C”内的局部放大示意图。
图31为图27中的圆圈“D”内的局部放大示意图。
图32为将图24和图27所示的两种方案重叠在一起后的对比示意图(虚线为图24的方案，实线为图27的方案)。
具体实施方式
本专利说明书中的“下部”包括某部件的“底部”和从该部件的“底部”向上延伸适当距离的那一部分。
如图1至图9所示的检测装置，包括检测盒300和与检测盒配合使用的样本收集器200。检测盒包括上盖1、下板2和检测试纸100，检测试纸100位于检测盒的上盖和下板之间。在一种实施例中，上盖1和下板2相互扣合并且将检测试纸100安装在检测盒300内。
如图4所示，检测试纸100为侧向横流形式的检测试纸，包括底卡101，在底卡 101上从上游到下游(即液体样本传输方向)依次相互叠加粘附有样本垫102、标记物结合垫103、测试垫104和吸水垫105。检测试纸100还可以是本领域技术人员所熟知的垂直流形式的检测试纸或其他形式的检测试纸。
如图5所示的样本收集器200包括手柄201、连接部202和取样头203，连接部202介于手柄201和取样头203之间。取样头203包括有取样垫204，取样垫204以卡扣或者粘贴等方式固定到取样头203上。取样垫204可以采用吸水棉条、海绵、吸水纤维或多孔高分子材料等，或本领域所知的其他吸水材料，例如聚乙烯醇等。取样头203还可设置一个透明的指示区205，该指示区位于取样垫204之上，在指示区205内存放有指示试纸，当取样垫204吸饱液体样本后，液体样本会接触到指示试纸，使指示试纸从第一种颜色变为第二种颜色，操作者可以根据指示试纸的变色情况判断样本是否收集足够了。手柄201可设计成具有一定弧度的扁平状构型以便于操作者拿捏，连接部202设计为细颈状。
如图6所示，检测盒300的上盖1设置有进样孔3和观察窗4，进样孔3位于检测试纸的样本垫102的上方，观察窗4位于检测试纸的测试垫104的上方。在进样孔3的周围区域设有围挡5。围挡5可以以竖立于上盖上表面的方式将进样孔3围合在其内并形成收纳腔6；围挡5也可以以下沉的方式从上盖上表面往下并向检测盒内延伸的方式将进样孔3围合在其内并形成收纳腔6。围挡5还可以既有一部分竖立于上盖1的上表面，也有一部分向检测盒内部延伸的方式将进样孔3围合在其内并形成收纳腔6。围挡5大致为围墙结构，其内为收纳腔6。围挡5包括前围挡51、后围挡52和两个侧围挡53。当样本收集器200的取样头203插入到收纳腔6内，前围挡51位于样本收集器的顶端方向，后围挡52位于样本收集器的连接部202方向。收纳腔6内位于前围挡51附近的区域可被称为收纳腔的前端，收纳腔内位于后围挡52附近的区域可被称为收纳腔6的后端。
收纳腔6的底部包括底板7，进样孔3设于底板7上。当将取样头203完全插入到收纳腔6内后，取样垫204的底部抵靠在底板7上，取样头203向下挤压取样垫204，从而将液体样本从取样垫204中挤压出来，被挤出的液体样本经由进样孔3进入到检测试纸的样本垫102上，然后开始检测。在一个实施例中，底板7可以是上盖顶板的一部分，而围挡5则由上盖顶板向上凸起适当高度围成一圈，圈内的空腔则形成收纳腔6。底板7在检测试纸样本垫102的上方可以设置多个进样孔3，例如间隔设置了两个进样孔，一方面可以较快地将挤压出来的样本引入到检测试纸的样本垫102上，另一方面保持底板7的强度，使其在挤压过程中不易变形。
在一个实施例中，在底板7和后围挡52的连接处设置了三个导流槽8，该导流槽8贯穿底板7，因此，导流槽8与检测盒内部相连通，从而可以将挤压出来的液体样本引入到检测盒内或检测试纸的样本垫102上，被检测试纸的样本垫102吸收。
在另一个实施例中，在收纳腔6的后围挡52的下部开设了泄流孔16，所述泄流孔16贯穿底板7，泄流孔16与检测盒内部相连通，使流动至后围挡52处的液体样本能通过泄流孔16进入检测盒300的内部。
在又一个实施例中，底板上的导流槽8与后围挡52下边沿的泄流孔16对应，导流槽8一直延伸到后围挡下部的泄流孔16处。更为具体的，位于底板上的导流槽8和位于后围挡上的泄流孔16相连接，形成直角型的开口或“L”型的开口。这样的设计可进一步加大液体样本流入检测盒内的通量，避免在挤压样本收集器的过程中有较多的液体样本滞留在收纳腔6内，导致液体样本飞溅出收纳腔6。
在再一个实施例中，检测盒收纳腔6后端在底板7上开设了导流槽8，在后围挡52的下部开设了泄流孔16，在侧围挡53的下部开设了侧向泄流孔24，导流槽8分别向泄流孔16和侧向泄流孔24延伸，并与泄流孔16和侧向泄流孔24相交，泄流孔16和侧向泄流孔24连接，因此，在收纳腔6后部的两个角落，形成了由导流槽8、泄流孔16和侧向泄流孔24共同组成的开口，以引流聚集在收纳腔6后部的液体样本。
图12、图13和图14演示了将样本收集器200插入到检测盒300的过程。图15示意了在样本收集器200完全插入到检测盒300后，被挤出的液体样本500(图15中的密布分布的小点所示)的分布示意图。
泄流孔16的开口大小和高度，泄流孔16与底板7之间的距离(例如泄流孔可以贯穿了底板，也可以在底板之上未贯穿底板)，以及泄流孔的数量等均可以根据样本收集器的采样量多少、收纳腔的容量、进样孔的进样速度等因素进行调整。
如图1和图2所示，上盖1上还设有样本收集器的扣紧装置。优选地，该扣紧装置与上盖1一起由塑料一体成型而成。该扣紧装置包括卡扣10。优选地，卡扣10形成于上盖1的顶板，并且位于收纳腔6的附近或者旁侧；更优选地，卡扣10位于后围档52的附近或者旁侧。卡扣10也可以位于其他合适的位置，只要其能够实现本发明的功能即可，因此，卡扣10的位置不应当限制本发明所要求保护的技术方案的范围。在一个优选的方案中，卡扣10包括由上盖1的顶板向上延伸适当高度的一对倒置的卡钩14(卡钩14应当具有适当的弹性)，该对卡钩的钩尖15(如图30所示)朝内彼此相对。对应地，样本收集器200之连接部202包括有上宽下 窄的楔形结构202a(如图5和图11所示)。请参阅图12-图14和图27-图29所示，在将样本收集器的取样头203放入检测盒的收纳腔6后，样本收集器的楔形结构202a的下部的位置对应于卡扣10。当向手柄施加适量的向下压力时，楔形结构202a向下挤压卡扣10，楔形结构202a或者楔形结构202a的斜面202b或者弧面202c撑开这对卡钩14的上部，即使这对倒置的卡钩14的上部产生适当的弹性变形，使卡钩14的上部向外扩张，进而使这对钩尖15之间的间隙变大，从而使楔形结构202a通过这对钩尖15，然后，该对卡钩14回弹，这对钩尖15钩住楔形结构202a，使取样头203保持在收纳腔6内，持续将取样垫204内的液体样本挤压出来。优选地，这对倒置的卡钩14的顶部设置有引导楔形结构202a挤压钩尖15的斜面15a(如图30所示)，从而进一步减小楔形结构202a通过这对钩尖15的阻力，也就是减小了施加在样本收集器之手柄201上的作用力，因而减少了对挤压出来的液体样本的冲击，避免了液体样本飞溅出收纳腔6。
如图16-图18和图20所示，楔形结构202a包括至少一个斜面202b(优选包括一对斜面202b)，或者如图21和图22所示，楔形结构202a包括至少一个弧面202c(优选包括一对弧面202c)，在楔形结构202a向下挤压卡钩14时，该斜面202b或者弧面202c引导卡钩14的上部向外扩张，即斜面202b或者弧面202c向外挤压那对钩尖15或者钩尖的斜面15a，推动卡钩14的上部向外扩张，使这对钩尖15之间的间隙变大，从而使楔形结构202a更容易通过这对钩尖15，然后卡钩14的上部弹性回弹，使这对钩尖15钩住楔形结构202a的顶部。
图16-图22分别示意了楔形结构202a的几种具体结构。总体上，楔形结构202a的横截面大致为上部宽下部窄的结构，从而方便楔形结构插入卡钩14。具体地说，在一些方案中，楔形结构202a的整个横截面的形状或者楔形结构横截面的下部形状包括：倒置的梯形或者等腰梯形(如图16所示)、倒置的三角形或者等腰三角形(如图17和图18所示)、倒置的梯形和矩形的组合(如图20所示)、半圆形(如图21所示)或者近似半圆形(如图22所示)。在图19所示的实施例中，楔形结构202a的横截面为倒置的“凸”字形。在图20所示的实施例中，也可以将楔形结构202a的横截面视为近似倒置的“凸”字形。在图23所示的实施例中，连接部202不包括楔形结构，其横截面为矩形，包括正方形和长方形。
图24-图26演示了连接部202不包括楔形结构，即其横截面为矩形时(如图23所示的实施例)，将连接部202插入一对卡钩14的过程。图27-图29演示了当连接部202包括楔形结构202a时，楔形结构202a插入一对卡钩14的过程。将两者对比，显然，连接部包括有楔形结构202a的方案要优于连接部不包括有楔形结构的方案。下面将作进一步的详细分析。
如图30所示，当连接部202的横截面为矩形(即，连接部202不包括楔形结构，其上部和下部的尺寸相同)时，其横截面的宽度尺寸d3必须大于一对钩尖15之间的间距d2，否则，当连接部202进入到这对钩尖15的下面后，这对钩尖15将无法钩住连接部202。如图31所示，当连接部202包括楔形结构202a时，楔形结构202a的顶部尺寸d3大于一对钩尖15之间的间距d2，并且楔形结构202a的底部尺寸d1小于一对钩尖15之间的间距d2。以图16所示的楔形结构202a的具体结构为例，当楔形结构202a向下挤压通过一对钩尖15时，楔形结构202a的底部202d在无挤压状态率先通过一对钩尖15，直到楔形结构202a的一对斜面202b(或者如图21和图22所示的弧面202c)挤压这对钩尖15或者这对钩尖的斜面15a。请参阅图32所示，相对于连接部202的横截面为矩形的设计方案，楔形结构的设计方案在楔形结构202a在无挤压状态时就已经多下降了高度“h”，也就是说，楔形结构202a在挤压通过这对钩尖15的过程中，其下降的行程比连接部202的横截面为矩形的设计方案少了“h”。此外，楔形结构202a的一对斜面202b或者弧面202c在该过程中具有引导作用，大大减小了所需要施加在样本收集器之手柄201上的挤压力，从而使样本收集器的楔形结构202a进入卡扣10内变得更加容易，并且在取样头203挤出取样垫204所收集的液体样本时，减少了对已挤出的液体样本的冲击，从而减少了液体样本的飞溅，进而很好地克服了现有技术和图23所示的技术方案所存在的缺陷。
如图31所示，在一个优选的方案中，楔形结构底部202d的宽度d1小于其顶部202e宽度d3的二分之一。楔形结构的底部202d的宽度d1、在卡钩未被挤压时那对钩尖15之间的间距d2和楔形结构的顶部202e宽度d3之间的关系是：d1小于d2，d2小于d3。
本发明将样本收集器之连接部202设计成包括有楔形结构202a的方案，既有利于使连接部202更容易地挤压并且通过一对钩尖15，又能够确保连接部202在垂直方向的尺寸足够大，进而保证连接部202具有足够的强度和刚性，从而在挤压的过程中，连接部202不容易变形或者断裂。这对卡钩14与楔形结构202a卡合，实现样本收集器200被保持在检测盒300上，取样垫204被充分挤压，样本被充分挤压出来。
请参阅图1、图2、图6-图8和图12-图14所示，检测盒300还包括第二卡扣9，在将样本收集器的取样头203放入检测装置的收纳腔6后，该第二卡扣9卡住样本收集器的取样头203的前端。优选地，第二卡扣9与卡扣10分别位于样本收集器之取样头203的两端或者两端的外围，如此设计更加有助于对取样头203施加合适的压力，更加有利于快速将取样头203收集的液体样本挤压出来并且不产生液体飞溅。如图12-图14所示，在挤压的过程中，第二 卡扣9钩住取样头203的前端，样本收集器200以第二卡扣9与取样头203的碰触部位为支点，实现杠杆运动，直到样本收集器的连接部202之楔形结构202a挤压并且通过一对钩尖15，并且保持在该对钩尖15之下。取样头203内的液体样本被充分挤压出来(如图15所示)。
优选地，第二卡扣9设置在检测装置的收纳腔6内。
为了进一步提高第二卡扣9的卡扣效果，第二卡扣9的末端设有凸块91(如图8所示)，样本收集器的取样头203设有凹部206(如图1所示)，当将样本收集器的取样头203放入检测盒的收纳腔6内后，所述第二卡扣的凸块91扣合在样本收集器的取样头的凹部206内，从而钩住取样头203的顶端。
如图6所示，卡扣10设置在后围挡52的后面。在卡扣10的一对卡钩14之间的空隙为卡槽13，卡槽13与后围挡凹槽12在同一轴线上。当样本收集器200将取样头上的取样垫204完全挤压在底板7上后，样本收集器的连接部202卡入卡扣10内并被限制在卡槽13内，在操作者松开样本收集器的手柄201后，取样垫204仍保持在被挤压的状态。这对卡钩14与楔形结构202a配合卡合，使楔形结构202a被限制在卡槽13内，实现样本收集器200被保持在检测盒300上，取样垫204被充分挤压，样本被充分挤压出来。
请参阅图1和图2，放在收纳腔6内的样本收集器的取样头203以第二卡扣9为支点，下压取样垫204，使取样垫204受到底板7的挤压，挤出取样垫204内的液体样本。如图1和图2，以及图5至图9所示的实例中，第二卡扣9的上端设有凸块91(如图8所示)，样本收集器的顶端设有凹部206(如图5所示)，当样本收集器的取样头203插入收纳腔6内时，取样头203的顶端被放在第二卡扣9的下方，第二卡扣9的凸块91扣合在样本收集器的凹部206内(如图1所示)，然后以该扣合处为支点进行转动，下压样本收集器手柄201，使取样垫204受到底板7的挤压。第二卡扣9和取样头203之间形成支点配合方式还可以是其他形式，例如但不限于以下所列方式，例如第二卡扣9的上端设为凹部，取样头的顶端包括与该凹部配合的凸块。或者，在第二卡扣9上开设一个开孔，在取样头203的顶端设一个凸起，所述凸起可插入所述开孔，形成下压支点。这些变更设计方案未图示。
第二卡扣9最好具有一定的弹性。第二卡扣9设于收纳腔6内并且靠近收纳腔前端的位置处。例如第二卡扣9可以设置在前围挡51的内壁上。又例如在图7所示的实施例中，第二卡扣9设置在进样孔3与前围挡51之间的底板区域上，并且第二卡扣9与前围挡51之间留有一定的间隔空间11(如图7所示)。该间隔空间11给第二卡扣9留出了一个后撤空间。具体体现在，当将取样头203插入至收纳腔6内时，取样头的前端顶在第二卡扣9的卡臂92上(如 图8所示)，卡臂92受压后向间隔空间11内发生弹性倾斜，直至第二卡扣的凸块91扣合在取样头的凹部206内，卡臂92弹性恢复至原位。
在第二卡扣9与前围挡51之间设置间隔空间11的实施例中，该间隔空间11还可起到缓冲的作用。在采用第二卡扣9设置在前围挡的内壁上的方案中，插入收纳腔6内的取样头203的顶端与前围挡51靠得非常近，若从取样垫204挤压出来的液体样本量大于取样头203的顶端与前围挡51之间的间隙，且这部分液体样本又来不及流入检测盒内时，位于取样头203顶端与前围挡51之间的间隙内的液体样本就可能会被挤压出围挡5，因此设置的间隔空间11加大了液体样本的暂存空间，相当于一个缓冲区。
如图1、图2和图6所示，在后围挡52上还开了一个用于接纳样本收集器的连接部202的凹槽12。当样本收集器200以第二卡扣9为支点向下压时，收集器的连接部202可以嵌入后围挡的凹槽12内，使得样本收集器200的取样垫204能完全平压在底板7上，让取样垫204每一个位置都得到充分挤压。
实施例1便携式新型冠状病毒检测装置的制备
以制备便携式新型冠状病毒(SARS-CoV-2)检测装置为例。
如图4所示，新型冠状病毒(SARS-CoV-2)检测试纸100包括底卡101，在底卡101上从上游到下游依次相互叠加的粘附有样本垫102、标记物结合垫103、测试垫104和吸水垫105。其中标记物结合垫103上包被有抗新型冠状病毒(抗SARS-CoV-2)抗体-乳胶标记物，在测试垫的检测线(T线)包被有抗SARS-CoV-2抗体，质控线(C线)包被有羊抗鼠IgG。
将制备好的新型冠状病毒(SARS-CoV-2)检测试纸装入检测盒300中，使检测盒的上盖1的进样孔3位于检测试纸的样本垫102上方，观察窗4位于检测试纸的测试垫104上方。
将样本收集器200封装于密封袋中，与制备好的检测盒组成完整的检测装置。样本收集器200的取样垫204接触到唾液后会吸水膨胀。
实施例2检测装置的使用
以使用便携式新型冠状病毒(SARS-CoV-2)检测装置为例。
从密封袋中取出样本收集器200，将样本收集器放入测试者的口腔内吸取唾液至规定的样本量。若有指示试纸，可以根据指示试纸的变色情况判断是否已收集足量。若没有指示试纸，可以根据取样垫的膨胀程度判断是否已收集足量。
将已收集足量的取样头203插入至检测盒的收纳腔6内，收纳腔内的第二卡扣9与取样头 前端的凹部206扣合，样本收集器200以第二卡扣9为支点向下压，收集器的连接部202嵌入后围挡的凹槽12内，当取样头的取样垫204被完全平压在底板7上后，连接部202卡入卡扣10内并被限制在卡槽13内，此时操作者可以松开收集器，取样垫204可一直保持在被挤压状态。
从收集器取样垫上挤压出来的液体样本通过进样孔3到达检测试纸的样本垫102。然后，液体样本经由样本垫102、标记物结合垫103、测试垫104到达吸水垫105。若测试垫的只在C线位置显示颜色，则表明样本为阴性，若C线和T线位置均显示出颜色，则表明样本为阳性，需进一步进行核酸分析，若C线没有出现颜色，则表明本次检测无效。实施例3便携式毒品检测装置和使用
毒品检测试纸100又称为滥用药物检测试纸，“滥用药物”(DOA)是一种用于非医疗目的(通常用于迷幻效果)的药物。这种药物的滥用可能导致身体和精神伤害以及(在一些情况下的)依赖性、成瘾、甚至死亡。DOA的实例包括可卡因、苯丙胺类(例如black beauties、white bennies、安非他命药片、右旋苯丙胺类药物、dexies、beans)、甲基苯丙胺类(crank、甲基安菲他命、crystal、speed)、巴比妥类(安定Roche Pharmaceuticals,Nutley,New Jersey)、镇静药类(即安眠药)、麦角酸酰二乙胺(LSD)、镇静剂(downers、goofballs、barbs、blue devils、yellow jackets、ludes)、三环类抗抑郁药(TCA,例如丙咪嗪、阿密曲替林和多虑平)、苯环己哌啶(PCP)、四氢大麻酚(THC,pot,dope,hash,weed等)、和鸦片剂(例如吗啡、鸦片、可卡因、海洛因、oxycodone)。
本实施例以便携式安非他命(尿液)胶体金法检测装置为例。
便携式安非他命(尿液)胶体金法检测装置包括检测试纸、检测盒和样本收集器。其中检测试纸为便携式安非他命(尿液)胶体金法检测试纸包括底卡，在底卡上从上游到下游依次相互叠加的粘附有样本垫、标记物结合垫、测试垫和吸水垫。通过单克隆抗体竞争结合安非他命偶联物和尿液中可能含有的安非他命的原理。标记物结合垫包含有被胶体金标记的抗安非他命单克隆抗体(胶体金抗体)，测试垫T线包含有安非他命偶联物。
测试时，样本收集器进入测试者的尿液中，然后将收集器上的尿液样本挤压入检测盒内，尿样随之在毛细效应下在检测试纸向上层析。如安非他命在尿样中浓度低于1000ng/ml时，胶体金抗体不能与安非他命全部结合。这样，胶体金抗体在层析过程中会被固定在测试垫上的安非他命偶联物结合，在T线上会出现一条紫红色条带。如果安非他命在尿样中浓度高于1000ng/ml时，胶体金抗体与安非他命全部结合，从而在T线区内因为竞争反应不会与安非他 命偶联物结合而不出现紫红色条带。阴性尿样在检测过程中由于缺少抗体抗原竞争反应，将会在T线出现紫红色条带。无论安非他命是否存在于尿样中，一条紫红色条带都会出现在质控线C线处。质控区(C)内所显现的紫红色条带是判定是否有足够尿样，层析过程是否正常的标准，同时也作为试剂的内控标准。
将一个检测装置用于多项滥用药物检测实施例中，在检测盒的下板上设置多个试纸存放槽，用于放置不同检测项的检测试纸。
实施例4便携式免疫荧光分析(FIA)检测装置和使用
本实施例检测试纸是以基于磷光发光技术的时间分辨免疫荧光检测为例。
检测试纸是用于检测病原体微生物感染后产生的IgG抗体，检测模式是间接法模式。检测试纸的制备方法包括：将磷光材料标记抗人免疫球蛋白IgG抗体，并将其固定在标记物结合物垫上；将要分析的病原体微生物抗原固定在测试垫的检测线上，将IgG固定在测试垫的质控线上。
检测时，将收集器上的液体样本挤压入检测盒内，然后拔出收集器，将装有本例所述检测试纸的检测盒插入荧光分析仪中，通过检测试纸T线和C线的磷光信号强度值，分析出检测结果。当检测线和质控线同时都产生磷光信号，为阳性反应结果，说明样本中含有目标待测物；当检测线没有产生磷光信号而质控线产生磷光信号，是为阴性反应结果，说明样本中不含有目标待测物。
采用本发明所述检测装置可用于疾病诊断、酒驾测试、吸食毒品情况、激素情况分析等检测领域，满足快速取样快速检测的要求。本发明所述检测装置可检测的样本类型可以是尿液、唾液、血液、样本裂解液等。

Claims (15)

  1. 一种检测装置，包括样本收集器和检测盒，检测盒用于存放检测试纸，其特征在于：样本收集器包括取样头、手柄和介于取样头与手柄之间的连接部，检测盒包括加样孔和卡扣，当样本收集器放入检测盒内，样本收集器的连接部卡紧在检测盒的卡扣中，样本收集器之连接部包括有上宽下窄的楔形结构，所述楔形结构位于样本收集器连接部与卡扣卡紧配合处。
  2. 根据权利要求1所述的检测装置，其特征在于，检测盒的卡扣包括一对倒置的卡钩，该对卡钩的钩尖朝内彼此相对，在将样本收集器的取样头放入检测盒的收纳腔后，样本收集器的楔形结构向下挤压卡扣，使这对倒置的卡钩向外张开，楔形结构通过钩尖后，卡钩回弹并钩住楔形结构。
  3. 根据权利要求2所述的检测装置，其特征在于，所述楔形结构包括至少一个斜面或者弧面，在楔形结构向下挤压卡扣时，该斜面或者弧面引导卡钩向外张开。
  4. 根据权利要求1所述的检测装置，其特征在于，至少所述楔形结构横截面的下部形状包括：倒置的梯形、倒置的三角形、倒置的梯形和矩形的组合、半圆形或者近似半圆形。
  5. 根据权利要求1所述的检测装置，其特征在于，所述楔形结构的横截面为倒置的“凸”字形。
  6. 根据权利要求2所述的检测装置，其特征在于，所述楔形结构底部的宽度小于卡钩之两个钩尖之间的间距。
  7. 根据权利要求6所述的检测装置，其特征在于，所述楔形结构底部的宽度小于其顶部宽度的二分之一。
  8. 根据权利要求1所述的检测装置，其特征在于，检测盒包括第二卡扣，在将样本收集器的取样头放入检测装置的收纳腔后，该第二卡扣卡住样本收集器的取样头。
  9. 根据权利要求8所述的检测装置，其特征在于，所述第二卡扣设置在检测装置的收纳腔内。
  10. 根据权利要求9所述的检测装置，其特征在于，所述第二卡扣的末端设有凸块，样本收集器的取样头设有凹部，当将样本收集器的取样头放入检测盒的收纳腔内后，所述第二卡扣的凸块扣合在样本收集器的取样头的凹部内。
  11. 一种样本收集器，包括取样头、手柄和介于取样头与手柄之间的连接部，其特征在于，样本收集器之连接部包括有上宽下窄的楔形结构。
  12. 根据权利要求11所述的检测装置，其特征在于，所述楔形结构包括至少一个斜面或者弧面。
  13. 根据权利要求11所述的检测装置，其特征在于，至少所述楔形结构横截面的下部形状包括： 倒置的梯形、倒置的三角形、倒置的梯形和矩形的组合、半圆形或者近似半圆形。
  14. 根据权利要求11所述的检测装置，其特征在于，所述楔形结构的横截面为倒置的“凸”字形。
  15. 根据权利要求11所述的检测装置，其特征在于，所述楔形结构底部的宽度小于其顶部宽度的二分之一。
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