WO2016159578A1 - Sample collection and division device for examining biological sample - Google Patents

Abstract

The present invention relates to a sample division device and, more specifically, to a sample division device comprising: a chamber perforated in a predetermined longitudinal direction, and having a first hollow part having an opening portion at one end thereof; a housing having one end thereof connected to the chamber, and having a second hollow part of which both ends are open and communicating with the first hollow part in the chamber; and a buffer tube having a filling space such that a predetermined solution is filled therein, and having an opening at one end thereof, and of which the side at which the opening is formed is connected and fixed to the other end of the housing, wherein the chamber includes: a sample part provided at the other end of the first hollow part, and capable of collecting a predetermined sample or discharging fluid inside the first hollow part; and an extending protrusion part provided in the first hollow part and extended in the longitudinal direction of the first hollow part, the buffer tube has a sealing membrane for sealing the opening such that the predetermined solution is filled in the filling space, the housing is connected to the chamber such that the position thereof is changed with respect to the chamber, and when the housing is displaced to approach the chamber, the sealing membrane is pierced by the extending protrusion part such that the solution is discharged to the outside through the sample part.

Description

Sampling and dispensing device for biological sample inspection

The present invention relates to a sampling, preparation or dispensing device, and more particularly to a device that can be used in in vitro diagnostic equipment.

Various chemical or biochemical assays for the determination of biological indicators associated with a particular disease, general state of health, or infection are generally performed through multi-step chemical reactions and physical manipulations using a variety of reagents and instruments. For example, when detecting a specific chemical contained in a sample such as blood or a biochemical such as a protein, the sample is taken, and the sample is placed in a predetermined container and reacted with one or more reagents, and then It requires several steps of physical manipulation to dispense the reacted sample.

For example, in order to perform a lateral flow immunoassay, a sample to be analyzed (for example, blood), a detection antibody labeled with a fluorescent substance, and a solution containing red blood cell fusion reagents when whole blood is used ( Reagent) is mixed at a quantitative ratio and reacted. This is then loaded onto, for example, a sample pad of a lateral flow assay device or cartridge comprising a membrane and a sample pad to which an antibody to an analyte in the blood is immobilized. It must be loaded for accurate and reproducible analysis.

Therefore, it is important to obtain accurate and reproducible results by measuring and using the correct volume for each of the above-mentioned steps. In this process, pipettes are usually used to measure the volume, but the exact amount is collected at every step due to the variability of the instrument itself, the variation of the users, that is, the variation between users, and the time and space between the same users. It is not possible to load, there is a disadvantage in that the operation is inconvenient in terms of method and takes a long time to prepare a sample. Therefore, in order to secure the accuracy of the test results, an apparatus and method for consistently and accurately performing sampling and loading are required.

[Preceding technical literature]

[Patent Documents]

Republic of Korea Patent Publication No. 2003-0078615

SUMMARY OF THE INVENTION The present invention has been made to solve the above-described problems, and provides an apparatus and method for detecting or analyzing a chemical or biological reaction for sampling or sampling, and for loading and separating a reactant, which are reproducible and accurate. I would like to.

Sample dispensing apparatus according to an embodiment of the present invention, the chamber is formed through a first hollow penetrating in a predetermined length direction having an opening at one side end; A housing having both sides open and having a second hollow communicating with the first hollow in the chamber, the one end being connected to the chamber; And a buffer tube having an opening at one side end and a side having the opening connected to the other side end of the housing and having a filling space for filling a predetermined solution, wherein the chamber is provided with the other side end of the first hollow. And a sample portion provided in the first hollow to collect a predetermined sample or to discharge the fluid in the first hollow, and an extension protrusion provided in the first hollow and extending in the longitudinal direction of the first hollow, The tube has a sealing membrane for sealing the opening so that a predetermined solution is filled in the filling space, and the housing is connected to the chamber to be positioned relative to the chamber, the housing being displaced so that the housing is moved to the chamber. As the sealing membrane is approached by the extension protrusion, the solution is discharged to the outside through the sample portion. It is.

In one embodiment, the housing has a configuration in which one side end is inserted into the first hollow of the chamber so that the housing is inserted into the first hollow and varies in position.

In another embodiment, the outer diameter of one side end of the housing corresponds to the inner diameter of the first hollow of the chamber so that the housing is inserted into and fitted into the first hollow of the chamber.

In another embodiment, the other end of the housing is provided with a locking protrusion extending a predetermined width in the outer diameter direction to be fixed when the housing is inserted into the first hollow.

In another embodiment, the fixing ring is inserted into the second hollow of the housing; further comprising, the housing, the inner diameter protrusion is provided in the other side end position and protrudes by a predetermined width in the inner diameter direction of the second hollow The buffer tube may include an outer diameter protrusion protruding in an outer diameter direction on one side of the opening, and the fixing ring may be positioned to be supported between the inner diameter protrusion and the fixing ring. It is fitted in the second hollow has a configuration that the buffer tube is fixed to the housing.

In another embodiment, the inner diameter protrusion has a plurality of vent holes penetrating in a direction in which the second hollow penetrates and spaced apart from each other in a circumferential direction, and the fixing ring has at least one portion of the second hollow. It is configured to be smaller than the inner diameter is configured to have a gap spaced apart from the inner circumferential surface of the second hollow by a predetermined interval, so that the air inside the housing can be discharged to the outside through the vent hole and the gap.

In another embodiment, the chamber has a predetermined bottom surface provided at the other side end where the sample portion is located, the sample portion is configured to protrude from the bottom surface, the bottom surface, the outer direction toward the center from the peripheral portion It is inclined so as to protrude, and the sample portion is located in the center of the bottom surface.

In another embodiment, the plurality of extension protrusions may be arranged to be spaced apart from each other by a predetermined distance, wherein each of the extension protrusions protrudes from the bottom surface, and an area between each of the extension protrusions is connected to the bottom surface. Has a configuration.

In another embodiment, the extension protrusion is configured to extend longer outward beyond the opening of the first hollow.

In another aspect, the present invention also provides a method for testing a biological sample using the apparatus of the present invention, the method comprising providing a biological sample; Contacting the sample part of the device with the biological sample and introducing the biological sample into the sample part by the contact; and driving the device to pierce the sealing membrane by the extension protrusion and thereby to pass the solution through the sample. Moving to the space of the housing and the chamber, in the process of mixing the biological sample and the solution, wherein the mixed solution is discharged to the outside through the sample part.

Sample dispensing apparatus according to another embodiment of the present invention, the chamber portion having a double pipe structure extending in the vertical direction; An upper cap having a double pipe structure extending in a vertical direction and disposed above the chamber part, and filled with a predetermined solution therein; And a sample collection unit disposed below the chamber unit and having a pipeline through which a predetermined sample may be collected or a solution may be discharged. The chamber part may include a cylindrical outer circumference having a first hollow having a predetermined inner diameter having an upper circumference and having an upper circumference formed therein, and disposed in the first hollow spaced apart from the outer circumferential portion at a predetermined interval in a radial direction. A cylindrical line portion having a discharge line extending in the longitudinal direction and penetrating in the vertical direction therein, an inner insertion groove made up of a space between the outer circumference portion and the line portion, and connecting the lower portion of the outer circumference portion and the line portion to each other And a lower connecting portion, wherein the upper cap includes a cap portion having a second hollow having a predetermined inner diameter having an outer circumference and having a lower end therein, and disposed in the second hollow spaced apart from the cap portion in a radial direction by a predetermined distance. A tube portion having a solution filling space extending in the longitudinal direction with the cap portion and having a lower end opened therein, the cap portion and the An outer insertion groove formed by a space between the tube parts, a cap cover connecting the cap part to the upper end of the tube part and sealing the upper end of the tube part, and a lower end of the tube part to seal the lower portion of the solution filling space And a sealing cover composed of a thin film of the upper cap, wherein the upper cap is connected to the chamber portion so as to be positioned in a vertical direction with respect to the chamber portion, wherein the line portion is disposed below the tube portion, and the upper cap is disposed. The sealing cover is drilled by the line part as it descends so that the solution passes through the discharge line and is discharged to the outside through the pipe of the sample collection part.

In one embodiment, the lower end of the upper cap is connected to the upper end of the chamber portion, wherein the outer circumference of the chamber portion is inserted into the lower end of the outer insertion groove of the upper cap and is inserted between the cap portion and the tube portion, The outer cap is inserted into the outer insertion groove while the upper cap is moved downward, and the line portion is configured to be inserted into the solution filling space of the tube portion.

Preferably, a first locking protrusion protruding by a predetermined width in the outer diameter direction is provided outside the upper end of the outer circumferential part, and a second locking protrusion protruding by a predetermined width in the inner diameter direction is provided inside the lower end of the cap part. The first locking protrusion and the second locking protrusion are engaged with each other when the lower end of the upper cap part and the upper end of the chamber part are engaged with each other, so that the upper end of the outer circumferential part has a predetermined deterrent force between the cap part and the tube part. The lower end of the cap portion and the upper end of the chamber portion are fitted to be fixed to the position connected to each other.

In another embodiment, the first locking protrusion is formed of a circular protrusion extending around the upper outer circumference of the outer circumference, and the second locking protrusion is protruded by a predetermined width in the inner diameter direction of the cap and is circumferentially formed. And a plurality of upper protrusions extending with a predetermined length and spaced apart from each other by a predetermined interval, spaced apart from the upper protrusion by a predetermined interval in a vertical direction, and protruding a predetermined width in an inner diameter direction of the cap portion, And a plurality of lower protrusions extending and spaced apart from each other by a predetermined interval, and when the lower end of the upper cap portion and the upper end of the chamber portion are coupled, the upper protrusion is positioned on the upper portion of the first locking protrusion, Is positioned below the first locking protrusion to fix the cap and the chamber.

In another embodiment, the upper protrusion and the lower protrusion are alternately disposed in the circumferential direction of the inner circumferential surface of the cap portion.

In another embodiment, the outer periphery of the lower end of the tube portion is provided with a friction protrusion protruding a predetermined width in the outer diameter direction and extending in the circumferential direction and in close contact with the inner circumferential surface of the upper end of the outer periphery.

In another embodiment, the height of the line portion is lower than the height of the outer circumference portion, so that when the upper end of the outer circumference portion and the lower end of the cap portion are connected to each other, the sealing cover and the line portion are spaced apart from each other in the vertical direction, and the upper cap is predetermined. When the distance is lowered, the line part penetrates the sealing cover, and the solution in the solution filling space is discharged through the discharge line.

In another embodiment, the outer diameter and the cross-sectional shape of the line portion correspond to the inner diameter and the cross-sectional shape of the solution filling space, so that when the upper cap is lowered, the line portion is inserted into the solution filling space after the sealing portion covers the sealing cover. Thus, the solution in the solution filling space is discharged through the discharge line without flowing out.

In another embodiment, the discharge line has a funnel shape at the top and has an extension that extends upwards in the inner diameter.

In another embodiment, the line portion has a ripping portion to tear the sealing cover at the top, wherein the ripping portion is provided at the top of the discharge line and at least one horizontal beam traversing the discharge line in the radial direction, and the horizontal It is composed of a protruding blade provided on the upper end of the beam to protrude upward.

In another embodiment, the chamber portion, the bottom portion of the line portion further includes a depression formed in the upward direction, wherein the depression, the first hemispherical dome is located in the top and has a hemispherical shape, and the An inner diameter of the interpolation recessed region is positioned below the first hemispherical dome and has a cylindrical interpolation depression region having an inner diameter larger than the diameter of the hemispherical dome, wherein the sample collection portion is located at the top and inserted into the interpolation depression region. An interpolation portion having a cylindrical shape having an outer diameter corresponding to the lower portion; a sampling tip having a tubular shape located at a lower portion to collect a sample; and formed on an upper surface of the interpolation portion and having a hemispherical shape and recessed downward; And a second hemispherical dome forming a spherical space.

In another embodiment, an internal thread portion is formed on an inner circumferential surface of the interpolation recessed area, and an external thread portion corresponding to the female thread portion is formed on an outer circumferential surface of the internal insert portion.

In another embodiment, the sample dispensing apparatus according to an embodiment of the present invention, the predetermined reagent solution is dried and placed in the spherical space formed by the first hemispherical dome and the second hemispherical dome are disposed, Drying reagents that dissolve and mix with the solution when the solution is discharged; It includes more.

Sample dispensing apparatus according to an embodiment of the present invention may further include a sample adapter, the sample adapter, the lower end of the chamber portion of the sample dispensing apparatus is inserted into the chamber portion having a predetermined space therein An incline holder and an incline positioned on a bottom surface of the chamber insert holder and configured to extend in one direction so that the discharged sample and solution are guided in one direction; And a cartridge inserting portion into which a cartridge used for analyzing a sample is inserted.

According to the present invention, the sampling and mixing and loading with the desired solution can be made accurately and simply. That is, for example, when using a lateral flow analysis based on an immune response, an accurate sampling of a sample or a sample, mixing with a predetermined solution, and an accurate loading on a lateral flow analysis device are required. The same predetermined tool is required, which is not suitable for accurate inspection unless the experienced user. However, when using the device according to the invention it is possible to simply take a sample through a sampling unit provided in the device, it can be reacted by mixing with a predetermined amount of solution contained in the device, the reaction solution is sampled Because it is loaded into the cartridge used in the lateral flow device and the like accurately and quantitatively through the wealth, the whole inspection can be made very simple without complicated operation.

1a to 1c is a view showing the structure of a sampling and dispensing apparatus according to an embodiment of the present invention.

2 is an exploded view showing the structure of a sample dispensing apparatus according to an embodiment of the present invention.

3 is a view showing a state in which a housing is inserted into a chamber in a sample dispensing apparatus according to an embodiment of the present invention.

Figure 4 is an exploded view showing the coupling structure of the housing, the buffer tube and the fixing ring of the sample dispensing apparatus according to an embodiment of the present invention.

5 is a view showing the formation of the air discharge region by the coupling structure of the housing and the fixed ring of the sample dispensing apparatus according to an embodiment of the present invention.

6 is a diagram showing a step-by-step inspection using a sample dispensing apparatus according to an embodiment of the present invention.

7 is a view showing the external appearance of the sample dispensing apparatus according to another embodiment of the present invention.

8 is an exploded view of the sample dispensing apparatus of FIG. 7.

9 is an exploded cross-sectional view of the sample dispensing apparatus of FIG. 7.

10 is a cross-sectional view of the sample dispensing apparatus of FIG. 7.

11 is a cross-sectional view of the sample dispensing apparatus of FIG. 7 including a drying reagent.

12 is a cross-sectional view of the sample dispensing apparatus of FIG. 7.

13 shows the adapter and the sample dispensing device and cartridge of FIG. 7 inserted therein.

14 is a view showing the internal structure of the adapter and the cartridge inserted thereto.

15A and 15B are cross-sectional views of the adapter and a longitudinal cross section of FIG. 14, respectively.

Advantages and features of the present invention and methods for achieving them will be apparent with reference to the embodiments described below in detail with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be embodied in various forms, and only the present embodiments allow the present invention to be sufficiently disclosed, and those skilled in the art to which the present invention pertains. It is provided to fully inform the person having the scope of the invention, which is defined only by the scope of the claims. Like reference numerals refer to like elements throughout.

The spatially relative terms "bottom", "top", "side", etc., may be used to easily describe the correlation of one member or component with another member or component as shown in the figures. Can be. Spatially relative terms are to be understood as including terms in different directions of the member in use or operation in addition to the directions shown in the figures. For example, when flipping the member shown in the figure, the member described as the "top" of another member may be placed at the "bottom" of the other member. Thus, the exemplary term “top” may include both directions below and above. The member can also be oriented in other directions, so that spatially relative terms can be interpreted according to the orientation.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In this specification, the singular also includes the plural unless specifically stated otherwise in the phrase. As used herein, “comprises” and / or “comprising” refers to the presence of one or more other components, steps, actions and / or members. Or does not exclude additions.

Unless otherwise defined, all terms (including technical and scientific terms) used in the present specification may be used in a sense that can be commonly understood by those skilled in the art. In addition, the terms defined in the commonly used dictionaries are not ideally or excessively interpreted unless they are specifically defined clearly.

In the drawings, the thickness or size of each part is exaggerated, omitted, or schematically illustrated for convenience and clarity of description. In addition, the size and area of each component does not necessarily reflect the actual size or area.

In addition, the direction mentioned in the process of demonstrating the structure of this invention in an Example is based on what was described in drawing. In the description of the structure constituting the present invention in the specification, if the reference point and the positional relationship with respect to the direction is not clearly mentioned, reference is made to related drawings.

1A to 1C are views showing the structure of the sample dispensing apparatus 1 according to an embodiment of the present invention, and FIG. 2 is an exploded view showing the structure of the sample dispensing apparatus 1 according to an embodiment of the present invention. 3 is a view showing a state in which the housing 200 is inserted into the chamber 100 in the sample dispensing apparatus 1 according to an embodiment of the present invention.

Sample dispensing apparatus (1) according to an embodiment of the present invention, the chamber 100 is formed through the first hollow (110) having an opening 112 at one side end penetrating in a predetermined length direction; A housing 200 having both sides open and having a second hollow 210 in communication with the first hollow 110 in the chamber 100, and one side of which is connected to the chamber 100; And a buffer tube 300 having an opening at one side end and a side having the opening connected to the other side end of the housing 200 and having a filling space 310 to fill a predetermined solution 312. , The chamber 100 is provided at the other side end of the first hollow 110, the sample portion 120 to collect a predetermined sample or to discharge the fluid in the first hollow 110, and the It is provided in the first hollow 110 and has an extending protrusion 130 extending in the longitudinal direction of the first hollow 110, the buffer tube 300, a predetermined solution in the filling space (310) ( And a sealing film 320 for sealing the opening to fill the 312, and the housing 200 is connected to the chamber 100 to be positioned relative to the chamber 100, wherein the housing 200 is As the housing 200 approaches the chamber 100 by displacing, the sealing film 320 is opened. Ttulryeoseo the solution 312 by the protrusion 130 has a configuration that through the treatment section 120 is discharged to the outside.

The chamber 100 may be configured, for example, in a cylindrical shape having a predetermined cylindrical shape or a predetermined polygonal shape. Preferably, it may be cylindrical as shown in the drawings, but is not necessarily limited thereto.

In the chamber 100, a first hollow 110 having an opening 112 is formed by penetrating in a predetermined length direction and having one side end opened. Here, the length direction means a direction in which the first hollow 110 is formed and penetrated as shown in the drawing. One side end of the chamber 100 is provided with the opening 112 so that the first hollow 110 is opened to expose the internal space.

The sample part 120 is provided at the other side end of the chamber 100. The other side end is a position opposite to one side end at which the opening 112 is provided, and both ends are defined as one side end and the other side end in the longitudinal direction through which the hollow penetrates. The sample part 120 is a member for introducing a sample such as blood into the device 1 according to the present invention through the surface tension, etc., may be configured in a predetermined tube shape, the shape is not limited. As an example, as shown in FIG. 1A, it may be composed of a fine thin tube having a small inner diameter, or may be configured in a ring shape having a predetermined inner diameter as shown in FIG. 1B. On the other hand, as shown in Figure 1c, the fine tube portion consisting of a predetermined fine tube may have a configuration of being fitted into the circular tube. On the other hand, at this time, the micro-tubular part may protrude outward and at the same time, may protrude a predetermined length in the inward direction of the chamber 100 to allow the quantification of the sample to be introduced. On the other hand, the specific configuration is not limited, and the sample unit 120 having various shapes and lengths may be provided. The sample part 120 is in communication with the first hollow 110. Accordingly, a predetermined liquid sample may be collected or discharged through a capillary phenomenon caused by surface tension. In addition, the fluid in the first hollow 110 may be discharged to the outside through the sample unit 120 as it communicates with the first hollow 110. According to such a configuration, the chamber 100 may be said to be essentially open at both ends, but for the sake of easy explanation, the opening part 112 is provided at one end and the sample part or the sampling part is provided at the other end. It will be described that 120 is provided.

Specifically, the chamber 100 has a predetermined bottom surface 140 provided at the other side end at which the sample part 120 is located, and the sample part 120 at the bottom surface 140. It can be said that is configured to protrude. The bottom surface 140 is a portion that partially seals the other side end, and is not necessarily limited to the term “bottom”. The bottom surface 140 is provided, and the sample part 120 protrudes from the bottom surface 140, so that the chamber 100 is provided with an open part 112 at one side end and a sample part at the other end. 120 may be provided.

On the other hand, preferably, the bottom surface 140 may be inclined to protrude outward from the peripheral portion toward the center, and may have a configuration in which the sample part 120 is positioned at the center of the bottom surface 140. . That is, as shown in the figure, the bottom surface 140 is composed of an inclined surface having a predetermined inclination angle θ so that the central portion protrudes outward and the sample portion 120 is disposed in the central portion, thereby having a funnel shape as a whole. have. Accordingly, the fluid in the first hollow 110 of the chamber 100 can be easily discharged to the outside through the sample unit 120.

An extension protrusion 130 is provided in the first hollow 110 of the chamber 100. The extension protrusions 130 are provided in the first hollow 110, but do not necessarily need to be all located in the first hollow 110, and protrude outward in the first hollow 110 as shown in the drawing. And it may be configured to extend a predetermined length longer to the outside beyond the opening 112.

On the other hand, preferably, the plurality of extension protrusions 130 are arranged a plurality of spaced apart from each other, each of the extension protrusions 130 protrudes from the bottom surface 140, the respective extension protrusions The area between the 130 has a configuration connected to the bottom surface 140.

That is, the extension protrusion 130 has a configuration extending from the inner surface of the bottom surface 140, which is the other end of the chamber 100 in the direction of the opening portion 112, a plurality of protruding, The extension protrusions 130 may be spaced apart from each other at a predetermined interval. In this case, an area between each of the extension protrusions 130 is connected to the bottom surface 140 and extends to the sample part 120, so that the fluid does not interfere with the flow of the fluid inside the chamber 100. It may be easily discharged to the sample unit 120.

The housing 200 is open so that both ends thereof have a second hollow 210 communicating with the first hollow 110 in the chamber 100, and one side end thereof is connected to the chamber 100. The housing 200 has a second hollow 210 that is open at both ends, and is connected to the chamber 100, so that the second hollow 210 and the first hollow 110 communicate with each other. One side end of the) has a configuration connected to the opening 112 of the chamber 100. Here, the communication means that the spaces of the first hollow 110 and the second hollow 210 are connected to each other to move the fluid.

The housing 200 is connected to the chamber 100, but is connected to be variable in position with respect to the chamber 100. That is, the housing 200 may be moved relative to the chamber 100 from a position connected to the chamber 100 by being displaced relative to the chamber 100. Here, since it is a relative displacement, it can be described that the chamber 100 is variably connected with respect to the housing 200 in another aspect. In addition, the proximity does not necessarily mean moving from a spaced position to a close position, but may be understood to be displaced so as to be closer to each other in a position in which a state of being connected and abutted is closer to each other to enlarge the size of the overlapped portion. have.

At this time, Preferably, the housing 200, one side end is inserted into the first hollow 110 of the chamber 100, the housing 200 is inserted into the first hollow 110 to change the position It may have a connection structure connected to the chamber 100 to. That is, as shown in Figure 1, by inserting a portion of one side end of the housing 200 through the opening 112 of the first hollow 110 of the chamber 100, the housing 200 And the chamber 100 may be connected to each other, and the second hollow 210 of the housing 200 and the first hollow 110 of the chamber 100 may communicate with each other. In addition, as the depth into which the housing 200 is inserted may vary, the housing 200 may have a configuration in which the position of the housing 200 is variable. That is, one side end of the housing 200 is inserted into the chamber 100 to connect the housing 200 and the chamber 100 to each other, and the housing 200 is pressed into the chamber 100 to insert more deeply. By doing so, the position change between the chamber 100 and the housing 200 can be made.

On the other hand, preferably, the outer diameter of one side end of the housing 200 corresponds to the inner diameter of the first hollow 110 of the chamber 100 so that the housing 200 is the first of the chamber 100. It may have a configuration that is inserted into the hollow 110. That is, the housing 200 is inserted into the opening 112 of the chamber 100, and the outer diameter of the housing 200 and the inner diameter of the first hollow 110 of the chamber 100 correspond to each other. The housing 200 may be fitted into the chamber 100. Accordingly, the housing 200 and the chamber 100 may have a structure such as a cylinder and a piston. At this time, the corresponding to each other may be understood to have a very similar size to each other, and not limited to exactly the same, there may be a difference. Of course, the forms must also correspond to each other.

Preferably, the other end of the housing 200, the engaging protrusion 230 is provided to extend a predetermined width in the outer diameter direction to be fixed when the housing 200 is inserted into the first hollow 110. . That is, a predetermined locking protrusion 230 is provided at the other end of the housing 200 to protrude a predetermined width in the outer diameter direction to prevent the housing 200 from being completely inserted into the chamber 100 and buried. do. When the housing 200 is deeply inserted into the first hollow 110, a predetermined distance is inserted to contact the locking protrusion 230 so that the housing 200 is not inserted anymore, thereby overinserting and embedding the housing 200. Can be prevented.

The buffer tube 300 is a member for containing a predetermined solution 312. The buffer tube 300 has a filling space 310 to fill a predetermined solution 312, an opening is provided at one side end to open the filling space 310, and the side at which the opening is provided is the housing ( It is connected to the other end of the 200 and fixed. Here, the other side end of the housing 200 means an opposite end when one side end of the housing 200 is connected to the chamber 100.

The buffer tube 300 is provided with a predetermined sealing film 320 for sealing the opening so as to maintain a predetermined solution 312 in the filling space 310. The sealing film 320 seals the filling space 310 so that the solution 312 contained in the filling space 310 does not unnecessarily flow out, and preferably the solution 312 is filled in the filling space 310. After soaking, the sealing film 320 may be disposed in the opening through a process of attaching or bonding to maintain the solution 312 in the filling space 310. On the other hand, the sealing film 320 has a relatively thin film structure and has a configuration that is appropriately broken by the extension protrusion 130 as described below, for example, may be made of an aluminum thin film, a vinyl thin film, and the like, but is not limited thereto.

In addition, by providing an air discharge area composed of a gap between the vent hole and the fixing ring, the air in the housing, the buffer tube and the chamber can be easily discharged, and the sample and the solution can easily flow down.

The operation of the sampling and dispensing device 1 of the present invention will be described below.

Referring to the drawings, the buffer tube 300 is connected to the upper end of the housing 200, the chamber 100 is connected to the lower end of the housing 200, and the extension protrusions in the chamber 100 ( 130 may extend upward to approach or contact the sealing membrane 320 provided under the buffer tube 300. In this case, as described above, the housing 200 and the buffer tube 300 are fixedly connected to each other, and the housing 200 is variably connected to the chamber 100. As the housing 200 is displaced closer to the chamber 100, the buffer tube 300 also approaches the housing 200, and as shown in FIG. 3, the extension protrusion 130 is connected to the buffer tube (see FIG. 3). The sealing film 320 in the lower portion is drilled. Therefore, the solution 312 in the buffer tube 300 flows down and may be discharged through the sample part 120.

At this time, a predetermined sample, for example, a sample of a liquid such as blood, plasma, or serum through the sample unit 120 is first collected in such a manner as to flow into the sample unit through the tension, and then operated the housing 200 By breaking the seal of the tube, proper mixing between the sample and the solution 312 can be achieved. On the other hand, since the solution 312 in the buffer tube 300 can fill the quantitative amount through a predetermined supply device in the filling process, mixing between the quantitative solution 312 and the sample can be easily achieved.

4 is an exploded view showing the coupling structure of the housing 200, the buffer tube 300 and the retaining ring 400 of the sample dispensing apparatus 1 according to an embodiment of the present invention, Figure 5 is an embodiment of the present invention It is a figure which shows formation of the air discharge area | region V by the coupling structure of the housing | casing 200 and the fixed ring 400 of the sample dispensing apparatus 1 which concerns on an example.

According to one preferred embodiment, the buffer tube 300 and the housing 200 may have a more specific connection structure as follows.

Preferably, further comprising a fixing ring 400 inserted into the second hollow 210 of the housing 200, the housing 200 is provided in the other side end position and the second hollow 210 An inner diameter protrusion 220 protruding by a predetermined width in an inner diameter direction of the buffer tube 300, and the buffer tube 300 includes an outer diameter protrusion 330 protruding in an outer diameter direction on one side of the opening. The fixing ring 400 is fitted into the second hollow 210 of the housing 200 so that the outer diameter protrusion 330 is positioned and supported between the protrusion 220 and the fixing ring 400 to fix the buffer tube. 300 may have a configuration that is fixed to the housing 200.

The fixing ring 400 is a ring-shaped member in which a predetermined through portion 410 is provided inside, and here, the ring form generally refers to a form having a through portion 410 inside, and is necessarily a circular ring. It is not limited to, it is sufficient to have a form that is inserted into the second hollow 210 of the housing 200 to be coupled.

The housing 200 is provided at another side end position and has an inner diameter protrusion 220 protruding by a predetermined width in the inner diameter direction of the second hollow 210. That is, an inner diameter protrusion 220 protruding a predetermined width in an inner diameter direction may be provided at an inner circumferential surface portion at the other side end of the housing 200, and in other words, the second hollow portion of the other side end portion of the housing 200 may be provided. The inner diameter of the 210 may be smaller than that of other portions, and thus may have a predetermined step. Here, the other side means the opposite position of the position connected to the chamber 100 as described above. Meanwhile, the inner diameter protrusion 220 may have a predetermined ring shape, but the present invention is not limited thereto, and one or more protrusions protruding in the inner diameter direction may be spaced apart from each other. .

The buffer tube 300 has an outer diameter protrusion 330 protruding in an outer diameter direction on one side where the opening is formed. The outer diameter protrusion 330 is provided on the outer peripheral portion of the side in which the opening is formed, and is configured to protrude in the outer diameter direction. The outer diameter protrusion 330 may be configured in a ring-like shape as a whole, but is not limited thereto, and may have a shape in which structures such as a plurality of protrusions protruding in the outer diameter direction are spaced apart from each other.

The outer diameter protrusion 330 of the buffer tube 300 and the inner diameter protrusion 220 of the housing 200 are in contact with each other and fixed in position. That is, as shown in the figure, the buffer tube 300 is inserted into the second hollow 210 of the housing 200 so that the buffer tube 300 penetrates through the other end of the housing 200. While passing, the outer diameter protrusion 330 and the inner diameter protrusion 220 may be in contact with each other to have a configuration that is fixed. Accordingly, the outer diameter protrusion 330 and the inner diameter protrusion 220 may be in contact with each other, and may have a suitable structure to achieve appropriate support. That is, as described above, but may be preferably formed in a ring shape to abut the whole, it may be composed of a structure such as each projection.

In addition, at this time, the inner diameter of the second hollow 210 by the inner diameter protrusion 220, the outer diameter of the buffer tube 300 by the outer diameter protrusion 330, and the outer diameter of the buffer tube 300 are illustrated with each other. It may have a structure suitable to have a bonding structure such as. That is, the outer diameter of the other portion of the buffer tube 300 except for the outer diameter protrusion 330 is the inner diameter protrusion 220 is suitable to penetrate the other side of the housing 200 in which the inner diameter protrusion 220 is formed. It has an outer diameter smaller than the inner diameter of the formed portion, the outer diameter of the portion in which the outer diameter protrusion 330 is formed should be configured to be larger than the inner diameter of the portion in which the inner diameter protrusion 220 is formed. Of course, the outer diameter of the portion where the outer diameter protrusion 330 is formed should be smaller than the inner diameter of the other portion of the second hollow 210 of the housing 200.

The fixing ring 400 is fitted into the second hollow 210 of the housing 200, and the fitting is fixed such that the outer diameter protrusion 330 is located between the inner diameter protrusion 220 and the fixing ring 400. do. That is, the fixing ring 400 is connected to the housing 200 in a state where the outer diameter protrusion 330 and the inner diameter protrusion 220 are brought into contact with each other by penetrating the buffer tube 300 in the housing 200. By inserting and fixing in the second hollow 210, the outer diameter protrusion 330 is positioned between the inner diameter protrusion 220 and the fixing ring 400. In this case, the fixing ring 400 has an outer diameter corresponding to the inner diameter of the second hollow 210 of the housing 200, so that the fixing ring 400 has the second hollow 210 of the housing 200. It is firmly fitted into the inside, and thus the fixing between the housing 200 and the buffer tube 300 can be made firm. Therefore, by pressing the upper end of the buffer tube 300 to move the buffer tube 300 and the housing 200 with respect to the chamber 100 to the breakage of the above-described sealing film 320 and thus the solution 312 of Emissions can be carried out.

On the other hand, preferably, the inner diameter protrusion 220 has a plurality of vent holes 222 arranged in a plurality of spaced apart from each other in the circumferential direction and penetrates in a direction through which the second hollow 210 passes. 400, at least one portion is configured to be smaller than the inner diameter of the second hollow 210, and at least one portion is configured to have a gap spaced apart from the inner circumferential surface of the second hollow 210 by a predetermined interval. Internal air may be discharged to the outside through the vent hole 222 and the gap.

The inner diameter protrusion 220 has a vent hole 222 penetrating in a direction in which the second hollow 210 penetrates. Accordingly, as shown in the figure, the inner diameter protrusion 220 is configured to have a predetermined hole penetrating in the vertical direction. The vent holes 222 may be provided in plural, and may be arranged to be spaced apart from each other in the circumferential direction.

The fixing ring 400 has a shape and an outer diameter corresponding to the inner diameter of the second hollow 210 as a whole, wherein at least one portion is spaced apart from the inner circumferential surface of the second hollow 210 by a predetermined interval to form a gap. Has Accordingly, for example, the housing 200 is formed in a cylindrical shape, the second hollow 210 is formed in a circular shape, and the outer shape of the fixing ring 400 is also circular, and at least an outer portion of the fixing ring 400 is formed. One portion may have a predetermined recessed portion 420 recessed inwardly. Accordingly, an outer side of the fixing ring 400 contacts the inner circumferential surface of the second hollow 210 such that the fixing ring 400 is fixedly coupled to the second hollow 210 of the housing 200, and at least one portion of the fixing ring 400 is fixed. 2 A predetermined gap may be formed to be spaced apart from the inner circumferential surface of the hollow 210 by a predetermined interval. For example, the outer diameter m of the fixing ring 400 is similar to the inner diameter l of the second hollow 210 of the housing 200, but the outer diameter n of a part of the second hollow 210 of the housing 200 is different. It may have a configuration smaller than the inner diameter l.

Preferably, the gap formed between the fixing ring 400 and the inner circumferential surface of the second hollow 210 may overlap the vent hole 222 formed in the inner diameter protrusion 220. That is, the fixing ring 400 is fixed so that the recess 420 formed in the fixing ring 400 is positioned at the position where the vent hole 222 is formed, such that the vent hole 222 and the gap are mutually fixed. Overlapping the inner space of the housing 200 is connected to the outside may be a gas exchange.

With such a configuration, when the fixing ring 400 is coupled in the second hollow 210 of the housing 200, the gap between the second hollow 210 and the fixing ring 400 and The vent holes 222 provided in the inner diameter protrusion 220 may overlap each other to form an air discharge region V. Accordingly, the air in the housing 200 and the chamber 100 can be easily discharged to the outside through the air discharge area (V). That is, when the housing 200 and the buffer tube 300 are dropped and inserted into the chamber 100, excessive force is required for the drop or it is difficult to drop if the air inside cannot be discharged to the outside.

However, according to the present invention, as the air discharge area V is provided as described above, since the air inside the housing 200 can be easily discharged to the outside, the housing 200 and the buffer tube 300 fall down. Can be made easily. In addition, when the solution 312 in the buffer tube 300 is discharged after the housing 200 and the buffer tube 300 fall, and the solution of the solution 312 and the sample is discharged through the sample unit 120. Even when the air is discharged inside the housing 200 through the air discharge area (V) can be easily discharged.

According to the present invention, the sampling and mixing and dispensing with the predetermined solution 312 can be made accurately and simply. That is, for example, in the case of a lateral flow immunoassay, a solution 312 containing a sample sample to be analyzed (analyte in blood), a detection antibody combined with a fluorescent substance, and a substance added to dissolve red blood cells is prepared. Quantitative reactions (typically 50 uL-150 Ll) can be dispensed into the sample pad of the cartridge 4 (where the antibody of the analyte is immobilized on the NC membrane) and a reproducible and accurate lateral flow immunoassay is performed. can do.

According to the present invention, a sample, for example, a biological sample is simply collected by the surface tension through the sample unit 120 provided in the chamber 100, and the solution 312 is quantitatively supplied through the buffer tube 300, Sampling of the sample and quantitative mixing of the solution 312 is made simple, and the solution mixed with the sample and the solution 312 is loaded accurately and quantitatively through the sample unit 120, so the overall inspection is very simple without complicated operation. But it can be done accurately.

6 is a diagram showing the inspection step by step using the sample dispensing apparatus 1 according to an embodiment of the present invention.

When the user inserts the sample dispensing device 1 into the reader as shown in (b) and presses it as shown in (c) in the state where the sample is taken as shown in FIG. 6 (a), the protruding structure (6) is sealed. As shown in (d), the detection solution 3 is moved into the chamber 100 in which the sample part 120 is provided. At this time, the surface tension of the sample is larger than the gravity of the solution 312, and the solution does not flow downward. When the solution 312 increases and the gravity increases, the sample and the solution 312 are passed through the sample part 120. ) The mixed solution flows down until the surface tension and gravity become equal. At this time, if there is an air vacuum, it is prevented from flowing down, and thus, as described above, an air discharge area V formed of a gap between the vent hole 222 and the fixing ring 400 is provided, whereby the sample and the solution 312 are mixed. It can flow down easily. This flowing down solution is loaded onto the sample inlet of the cartridge 4.

In this respect, the present application is a method for testing a biological sample using the apparatus according to the present invention, the method comprising the steps of providing a biological sample; Contacting the sample portion of the device with the biological sample and introducing the biological sample into the sample portion by the contacting; And driving the device to penetrate the sealing membrane by the extension protrusions, thereby moving the solution into the space of the housing and chamber, and mixing the biological sample and the solution in the process. The solution includes the step of discharging to the outside through the sample portion.

7 to 12 show a sample dispensing apparatus 2 according to another embodiment of the present invention. Here, FIGS. 7-12 have shown the external shape of the sample dispensing apparatus 2, the separation drawing, the cross-sectional drawing, and some cross-sectional drawing which can grasp | ascertain the internal structure, respectively.

7 to 12, the sample dispensing apparatus 2 according to an embodiment of the present invention, the chamber portion 500 having a double pipe structure extending in the vertical direction, has a double pipe structure extending in the vertical direction and the chamber An upper cap 600 disposed above the portion 500 and filled with a predetermined solution therein, and a conduit 702 disposed below the chamber 500 to collect a predetermined sample or discharge the solution. It is configured to include a sampling unit 700 having a).

First, the chamber part 500 is demonstrated.

The chamber 500 includes an outer circumferential portion 510, a line portion 520, an inner insertion groove 530, a lower connecting portion 540, and a recessed portion 560.

The outer circumferential portion 510 has a cylindrical shape to form an outer circumference of the chamber 500 and has a first hollow 512 having a predetermined inner diameter having an upper end opened therein.

A first locking protrusion 514 is provided at an outer side of the upper end of the outer circumferential portion 510 to protrude by a predetermined width in the outer diameter direction. In this case, the first locking protrusion 514 is configured of a circular protrusion extending around the top outer circumference of the outer peripheral portion 510.

On the other hand, the lower outer side of the outer peripheral portion 510, a connection groove 516 consisting of a plurality of irregularities can be formed to be connected to a predetermined external device. The connection groove 516 may be connected to a connection protrusion 912 formed in the chamber part holder 910 of the sample adapter 3 to be described later.

The line part 520 is disposed in the first hollow 512. Specifically, the line part 520 is disposed in the first hollow 512 to be spaced apart from the outer circumferential part 510 by a predetermined interval in a radial direction and extends along the length direction with the outer circumferential part 510. Therefore, the chamber part 500 has a double tube structure by the outer peripheral part 510 and the line part 520. Preferably, the height of the line portion 520 is configured to be lower than the height of the outer peripheral portion 510.

The discharge line 522 penetrated in the vertical direction is formed in the line part 520. The discharge line 522 may be configured as a predetermined passage so that a predetermined solution may be discharged downward through the discharge line 522 as described below.

At this time, the upper end of the discharge line 522 is formed in a funnel shape may be formed expansion portion 524 is extended as the inner diameter increases in the upward direction.

In addition, the upper end of the line unit 520 may be provided with a ripping unit 550 to tear the sealing cover 640 to be described later. The ripping unit 550 may be provided at an upper end of the discharge line 522 and provided at an upper end of the horizontal beam 552 and one or more horizontal beams 552 crossing the discharge line 522 in a radial direction. It may be composed of a protruding blade portion 554 protruding in the direction. That is, the ripping unit 550 may have a configuration in which it is easy to tear the sealing cover 640 in contact with the sealing cover 640 to be laterally projected sharply upward.

The inner insertion groove 530 is a space formed by a space between the outer peripheral portion 510 and the line portion 520. That is, the inner insertion groove 530 is a cylindrical space having a predetermined width and depth formed as the outer circumferential portion 510 and the line portion 520 are spaced apart by a predetermined distance in the radial direction, and the first hollow 512. Forms part of the.

The lower connection part 540 connects the outer circumferential part 510 and the lower end of the line part 520 to each other. Accordingly, the lower connection portion 540 may have a ring shape as a whole, and form a bottom surface of the inner insertion groove 530. In the description that the height of the line part 520 is lower than the height of the outer circumference part 510, the height may refer to the height from the lower connection part 540.

The depression 560 is configured as a depression space formed by recessing a lower portion of the line portion 520 with a predetermined depth and volume in an upward direction.

The depression 560 includes an upper first hemispherical dome 562 and an lower interpolation depression area 564.

The first hemispherical dome 562 has a hemispherical shape and is composed of a predetermined hemispherical space recessed upward. On the other hand, the hemispherical shape is not necessarily limited to the exact hemispherical shape, it is composed of a predetermined three-dimensional space and sufficient.

The interpolation recessed area 564 is positioned below the first hemispherical dome 562 and has a cylindrical shape having an inner diameter larger than the diameter of the first hemispherical dome 562. Meanwhile, a female screw portion 566 may be formed on the inner circumferential surface of the interpolation recessed region 564.

Hereinafter, the upper cap 600 will be described.

The upper cap 600 may include a cap portion 610, a tube portion 620, an outer insertion groove 630, a cap cover 660, and a sealing cover 640.

The cap 610 constitutes an outer circumference of the upper cap 600, and has a second hollow 612 of a predetermined inner diameter having an open lower end therein. On the other hand, the outer circumferential surface of the cap portion 610 may be formed with a predetermined gripping portion made of irregularities to facilitate the user's gripping. In addition, the outer peripheral surface of the lower end portion outside the cap portion 610 may be provided with a predetermined side plate portion 614 whose outer diameter is extended to the outside.

Inside the lower end of the cap 610, a second locking protrusion 650 protruding by a predetermined width in the inner diameter direction is provided. In this case, the second locking protrusion 650 includes a plurality of upper protrusions 652 and a plurality of lower protrusions 654.

The upper protrusion 652 is formed of a protrusion which protrudes by a predetermined width in the inner diameter direction of the cap part 610, extends with a predetermined length in the circumferential direction, and is spaced apart from each other by a predetermined interval. In addition, the lower protrusion 654 is disposed below the upper protrusion 652 at predetermined intervals and spaced apart in a vertical direction, protrudes by a predetermined width in the inner diameter direction of the cap 610, and has a predetermined length in the circumferential direction. And a plurality of protrusions extending and spaced apart from each other by a predetermined interval.

In this case, preferably, the upper protrusion 652 and the lower protrusion 654 are alternately disposed in the circumferential direction of the inner circumferential surface of the cap portion 610. That is, the upper protrusion 652 and the lower protrusion 654 may be alternately arranged in the circumferential direction.

The tube portion 620 is disposed in the second hollow 612 of the cap portion 610. Specifically, the tube portion 620 is disposed in the second hollow 612 spaced apart from the cap portion 610 by a predetermined interval in the radial direction and extends in the longitudinal direction with the cap portion 610. Therefore, the upper cap 600 has a double pipe structure by the cap portion 610 and the tube portion 620.

In the tube portion 620, a solution or buffer filling space 622 having a predetermined volume and having an open bottom is formed. The solution filling space 622 may be filled with a predetermined liquid solution, such as a buffer, required for the reaction.

Meanwhile, a predetermined friction protrusion 624 protrudes in the outer diameter direction and extends in the circumferential direction at the outer circumference of the lower end of the tube part 620.

The outer insertion groove 630 is a space composed of a spaced space between the cap portion 610 and the tube portion 620. That is, the outer insertion groove 630 is a cylindrical interspace having a predetermined width and depth formed as the cap part 610 and the tube part 620 are spaced apart by a predetermined distance in the radial direction, and the second hollow 612. Forms part of the.

The cap cover 660 connects the upper end of the cap part 610 and the tube part 620 and seals the upper end of the tube part 620. Accordingly, the cap cover 660 has a circular plate shape as a whole. Preferably, a predetermined through hole 662 penetrating in the vertical direction may be formed at an outer portion of the cap cover 660. The through hole 662 may communicate with the outer insertion groove 630.

The sealing cover 640 is a member such as a predetermined thin film provided at the lower end of the tube portion 620. The sealing cover 640 may be formed of a predetermined waterproof material to seal the lower portion of the solution filling space 622 and to prevent the solution filled in the solution filling space 622 from flowing out. Therefore, the solution filling space 622 may be sealed by an upper cap cover 660 and a lower sealing cover 640 in a state where the solution is filled. The sealing cover 640 seals the filling space 622 so that the solution contained in the filling space 622 unnecessarily flows out, preferably, after the solution is contained in the filling space 622, a predetermined attachment, The sealing cover 640 may be disposed below the sealing cover 640 through a bonding process to maintain the solution filled in the filling space 622. On the other hand, the sealing cover 640 has a relatively thin thickness, as described below has a configuration that is broken by the ripping portion 550 on the line portion 520 and may be made of, for example, aluminum thin film, vinyl thin film, and the like. It is not limited to this.

Hereinafter, the sample collection unit 700 will be described.

The sample collection unit 700 may include a conduit 702, an insertion part 710, a sampling tip 720, and a second hemispherical dome 730.

The pipe 702 is made of a pipe having a predetermined inner diameter penetrating the sample collecting part 700 in the vertical direction. The inner diameter of the conduit 702 may be the same as the whole, or as shown in the figure, the lower part may be narrower than the upper part, and as described below, the conduit 702 has a capillary tube inside the collecting tip 720. It is comprised in a shape, and a sample can be taken by a capillary phenomenon.

The interpolation portion 710 is a member having a predetermined cylindrical shape and is a portion located above the sample collection portion 700. Preferably, the interpolation portion 710 has an outer diameter corresponding to the inner diameter of the interpolation depression region 564 so as to be inserted into the interpolation depression region 564, the interpolation depression region 564 on the outer circumferential surface of the interpolation portion 710. A male screw portion 712 may be formed to correspond to the female screw portion 566 formed in FIG.

As described above, the sampling tip 720 is positioned below the sample collection part 700 and has a capillary tube formed therein to collect a sample, and the capillary tube extends with the conduit 702. The sampling tip 720 may allow a liquid sample, such as blood, to flow into the conduit 702 of the collecting tip 720, that is, the capillary, through surface tension, and the like, but have a narrow tubular shape, but the specific shape thereof is not limited thereto.

It is possible to control the amount of the liquid sample to be collected by adjusting the volume of the pipe, for example, the capillary tube formed inside the sampling tip 720. The volume of the capillary is possible through the adjustment of the diameter and / or length in a range that does not inhibit the capillary phenomenon.

The second hemispherical dome 730 is formed on the upper surface of the interpolation portion 710 and is composed of a hemispherical space recessed downward. On the other hand, the hemispherical shape is not necessarily limited to the exact hemispherical shape, it is composed of a predetermined three-dimensional space and sufficient.

In one embodiment according to the present invention, the sampling unit 700 may be detachably attached to the chamber unit 500, which is advantageous to collect the sample in various amounts according to the type of material and / or analyte to be analyzed. Can be used. That is, the amount of sample required may vary depending on the analyte, the type of biological sample, or the sensitivity of the analytical method. Therefore, according to the amount of sample required for the test, as described above, various kinds of collecting part 700 having a collecting tip formed with a capillary tube of various volumes, and the kind of the test substance and / or biological sample of interest and / or Alternatively, it can be replaced with an appropriate collection part according to the inspection method.

Hereinafter, a coupling relationship between the chamber part 500, the upper cap 600, and the sample collecting part 700 will be described.

First, the coupling structure of the upper cap 600 and the chamber 500 will be described.

The upper cap 600 is disposed above the chamber part 500, and a lower end of the upper cap 600 is connected to an upper end of the chamber part 500, and is upward and downward with respect to the chamber part 500. It is connected to the chamber 500 to vary the position.

More specifically, the lower end of the upper cap 600 is connected to the upper end of the chamber 500, the outer peripheral portion 510 of the chamber 500 is the outer insertion groove of the upper cap 600 Is inserted into the lower end of the 630, it is fitted between the cap portion 610 and the tube portion 620.

At this time, the first locking protrusion 514 and the second locking protrusion 650 are engaged with each other, so that an upper end of the outer circumferential portion 510 has a predetermined deterrent force between the cap portion 610 and the tube portion 620. Fitted with Therefore, the lower end of the cap portion 610 and the upper end of the chamber portion 500 is fixed to the position connected to each other.

In more detail, when the lower end of the upper cap 600 and the upper end of the chamber part 500 are combined, the upper protrusion 652 formed on the lower inner circumferential surface of the cap part 610 is the chamber part 500. The upper protrusion of the first locking protrusion 514 formed on the outer circumferential surface of the, the lower protrusion 654 is located below the first locking protrusion 514. Accordingly, the first locking protrusion 514 has a coupling structure fitted between the upper protrusion 652 and the lower protrusion 654 so that the cap portion 610 and the chamber portion 500 are fixed to each other. . In other words, when there is no external force, the coupling structure as described above is maintained.

In this case, the line part 520 is located under the tube part 620. In more detail, the line part 520 is positioned directly below the solution filling space 622 of the tube part 620.

At this time, as described above, the height of the line portion 520 is lower than the height of the outer peripheral portion 510, when the upper end of the chamber portion 500 and the lower end of the upper cap 600 is fitted and the sealing The cover 640 and the line part 520 are spaced apart from each other in the vertical direction without affecting each other, and the solution in the solution filling part maintains the filled state in the solution filling space 622.

Next, the coupling structure of the sample collection part 700 and the chamber part 500 is demonstrated.

The sample collection part 700 is connected to the lower part of the chamber part 500. Specifically, the interpolation portion 710 on the upper portion of the sample collection portion 700 is inserted into the interpolation depression region 564 formed under the line portion 520 of the chamber portion 500. In this case, as described above, the interpolation portion 710 and the interpolation depression region 564 may be screwed by having the male screw portion 712 and the female screw portion 566, respectively.

When the sampling unit 700 and the chamber unit 500 are coupled as described above, the first hemispherical dome 562 and the second hemispherical dome 730 together form a spherical space. In this case, the spherical space does not necessarily mean a perfect spherical shape as described above. In addition, the discharge line 522 formed in the line portion 520 of the chamber portion 500 and the conduit 702 formed in the sample collection portion 700 may be connected to each other to form one discharge passage.

Hereinafter, the operation and use of the sample dispensing apparatus 2 according to the present embodiment will be described.

As described above, in a state in which the chamber part 500 and the upper cap 600 are coupled, when the external force is applied, the upper cap 600 may move downward. That is, when a force for pressing down the upper cap 600 is applied, the deterrent force between the first locking protrusion 514 and the second locking protrusion 650 is overcome and the upper cap 600 moves downward. do.

As the upper cap 600 descends, the outer circumferential portion 510 is inserted into the outer insertion groove 630. In this case, as described above, a through hole is preferably formed in the cap cover 660, so that the air in the outer insertion groove 630 may easily escape.

In this case, while the upper cap 600 is lowered, the tube part 620 is close to the line part 520, and when the upper cap 600 is further lowered, the ripping provided at the upper end of the line part 520. The part 550 tears the sealing cover 640. Therefore, the solution filled in the solution filling space 622 is discharged downward. The solution is discharged downward through the discharge line 522 formed in the line unit 520 and the conduit 702 formed in the sample collection unit 700.

In this case, preferably, the outer diameter and the cross-sectional shape of the line part 520 may correspond to the inner diameter and the cross-sectional shape of the solution filling space 622. That is, for example, when the line part 520 is configured as a cylindrical solid having a predetermined outer diameter, the solution filling space 622 may also be configured as a cylindrical space having the same inner diameter. Therefore, when the upper cap 600 is lowered, the line part 520 is inserted into the solution filling space 622 after opening the sealing cover 640, so that there is no gap, the solution filling space ( The solution in 622 does not flow out to the outside and moves along the discharge line 522 to be discharged through the sampling unit 700. In this process, capillary phenomenon is induced by surface tension inside the sampling tip 720. It is discharged by mixing with a sample such as blood collected through a fine thin tube.

In such embodiments, sample inspection or analysis can be performed with very simplified structures and fewer components. That is, since the tube part 620 in which the solution is filled is integrally formed in the upper cap 600 disposed above the chamber part 500, the number of parts may be reduced. In addition, by selectively separating and connecting the upper cap 600 to the chamber 500, it is possible to simply select the solution used for the inspection. In addition, since the solution can be discharged by simply pressing the upper cap 600, the inspection can be easily performed. In addition, the sampling unit 700 is detachable, in order to meet the change in the amount of sample required for sample inspection or analysis, to prepare a sampling unit 700 having a sampling tip 720 of various volumes, It can be used properly according to the volume, which maximizes convenience.

On the other hand, Figure 11 is a view showing a form that further includes a reagent 800 dried in this embodiment.

The drying reagent 800 is, for example, a predetermined reagent present in the dried form for the reaction of a biological sample with a specific analyte. The drying reagent 800 may be placed and disposed in the spherical space formed by the first hemispherical dome 562 and the second hemispherical dome 730 described above. For example, when the sampling part 700 is coupled to the chamber part 500, the drying reagent 800 is combined into the second hemispherical dome 730 in a state including the drying reagent 800. ) Can be placed.

As such, the drying reagent 800 is located in the spherical space, so that the drying reagent 800 can be dissolved when the solution in the solution filling portion moves along the discharge line, and the dissolved drying reagent 800 is mixed with the solution. The mixture may be discharged to the outside while being mixed with the sample of the sampling tip 720. Therefore, a variety of solutions and samples can be mixed with each other for easy operation.

FIG. 13 shows a sample inspection device including a sample dispensing device 2 and a cartridge 4 connected to an adapter 3 according to a second embodiment of the invention, and FIG. 14 shows a sample adapter 3 and Fig. 15 shows the internal structure of the inserted cartridge, and Fig. 15 shows a cross section of the adapter and the adapter and the cartridge 4 inserted therein.

The sample dispensing device 2 according to the invention can be used with the adapter 3.

In one embodiment the sample dispensing device 2 according to the invention can be manufactured and used separately from the adapter 3.

In another embodiment the sample dispensing device 2 according to the invention can be manufactured and used integrally with the adapter 3.

At this time, the adapter 3 is configured to include an insert holder 910, the inclined line 920, and the cartridge inserting portion 940 to which the sample dispensing apparatus 2 is inserted and fixed.

The insertion holder 910 is configured as a cylindrical portion having a predetermined space so that the lower end of the chamber portion 500 of the sample dispensing apparatus 2 is inserted into and fitted into the insertion holder 910. In this case, a plurality of predetermined connection protrusions 912 are provided on the inner circumferential surface of the insertion holder 910 so as to be coupled to the connection grooves 516 formed on the outer side of the lower end of the outer peripheral portion 510 of the chamber part 500. Can be. Thus, the sample dispensing device 2 can be inserted into the insertion holder 910 and fixed in position.

The inclined line 920 is provided on the bottom surface of the insertion holder 910. The inclined line 920 extends in one direction and has an inclination having a predetermined inclination angle so that the sample and the solution discharged from the sample dispensing apparatus 2 are guided in one direction while being mixed along the inclined surface, and thus the predetermined cartridge 4 Is loaded.

As shown in FIG. 15, the solution and the sample discharged from the sample dispensing apparatus 2 are moved along the inclined line 920 as shown by arrow K and loaded into the sample pad of the predetermined cartridge 4 located on the side.

The adapter 3 facilitates loading of the sample connected to the sample pad of the cartridge connected thereto, as well as a space for holding a predetermined volume of the mixture discharged from the sample dispensing device to facilitate loading of the sample into the sample pad. For example, after collecting a sample such as blood through the sample collection unit 700, the sample dispensing apparatus is mounted on the adapter 3, and the upper cap 600 is pressed, and then the ripping unit 550 is used. The sealing cover 640 is gripped and the buffer solution filled in the tube part 620 is discharged to move along the discharge line 522, and the first hemispherical dome of the depression 560 formed at the bottom of the discharge line and While passing through the sample collection unit 700 through a space formed by two hemispherical domes, it is mixed with a sample such as blood contained in the sample collection unit and discharged. When the formed space includes a dried reagent, the dried reagent is also dissolved in the discharge process and discharged together. The adapter has a warp line 920 for better mixing of the biological solution such as buffer solution, if desired dry reagent and blood. The mixture is further mixed as it travels along the oblique line 920 and loaded well mixed into the sample pad of the cartridge to obtain more reproducible results.

In this aspect, the sample dispensing device 2 is enclosed in the adapter 3 such that the distal end of the sample collection part 700 is located along the inclined plane of the inclined line included in the adapter 3, in particular away from the sample pad of the inclined line. It is preferable to be located in the upper part located in the side.

The inspection using the sample dispensing apparatus 2 according to an embodiment of the present application will be described step by step. Basically, after taking a sample using a sampling tip as shown in FIG. 6 (a), the sample is collected in the adapter 3 if necessary, and the adapter is collected in the cartridge 4, but the order is not limited thereto. After the cartridge is first inserted, the sample dispensing device may be filled.

When the sample is collected using the sample dispenser 2 in the same manner as in FIG. 6A, the sample dispenser 2 is inserted into the adapter, if necessary, and the upper cap portion is pressed into the ripping unit 550. The sealing cover 640 is opened, and the solution of the solution filling space 622 moves along the discharge line 522 into the chamber 500 in which the sampling unit 700 is provided. At this time, the sample does not flow down due to the surface tension, but as the solution flows down, it is mixed with the sample and the solution of the sampling tip according to its gravity. The extension protrusion 130 of the sample dispensing apparatus 1 is formed in a circular shape instead of spaced apart, so that pressure is formed by being in close contact with the upper cap 600, so that the solution is not discharged from the inside of the chamber 500. Only through 522. In addition, the sampling unit 700 is detachable, and if the volume of the sampling tip is manufactured and used differently, the sampling unit 700 having an appropriate volume according to the material to be analyzed or tested, the type of reaction and / or the type of the sample. Can be replaced. In addition, if additional reagents other than those contained in the solution are needed, they may be placed in a dry form in the space formed by the first hemispherical dome and the second hemispherical dome, which are mixed with the discharge of the solution and ultimately It is mixed with the sample of the collecting tip.

In this respect, the present application is a method for testing a biological sample using the apparatus 2 according to the present invention as described above, the method comprising the steps of providing a biological sample such as blood; Contacting a sampling tip formed in the sampling section of the device with the biological sample and introducing the biological sample into the sampling tip by the contacting; And driving the upper cap downward by applying an external force to the cap portion, wherein the sealing cover is opened by the ripping portion, through which the solution contained in the solution filling space of the cap portion is contained in the chamber portion. It moves along the discharge line and in the process is discharged to the outside while the biological sample and the solution are mixed. The method according to the invention further comprises the step of mounting the device to an adapter after the step of introducing the biological sample into the sampling tip, the device being engaged with the adapter through the bottom of the chamber portion, the adapter being It is inserted into a cartridge containing an analysis device such as lateral flow, and the discharged mixture is loaded at a predetermined site in the cartridge.

The method according to the present invention is carried out in vitro and may be carried out in a biological, for example, mammalian, for example, human-derived sample, for example, in a sample comprising blood, saliva, urine, etc., including whole blood, plasma, serum, and the like. It can be conveniently used to determine the presence or amount of specific components required to provide the information necessary for detection or diagnosis.

Although the preferred embodiments have been illustrated and described above, the invention is not limited to the specific embodiments described above, and does not depart from the gist of the invention as claimed in the claims. Various modifications can be made by the person having the above, and these modifications should not be understood as being separate from the technical spirit of the present invention.

Claims (27)

1. A chamber having a first hollow penetrating in a predetermined length direction and having an opening at one side end thereof;

   A housing having both sides open and having a second hollow communicating with the first hollow in the chamber, the one end being connected to the chamber;

   And a buffer tube having an opening at one side end and a side at which the opening is provided connected to the other side end of the housing and having a filling space to fill a predetermined solution.

   The chamber is

   A sample part provided at the other end of the first hollow and collecting a predetermined sample or allowing the solution in the first hollow to be discharged; and

   An extension protrusion provided in the first hollow and extending in the longitudinal direction of the first hollow;

   The buffer tube,

   And a sealing membrane for sealing the opening to fill a predetermined solution in the filling space.

   The housing is connected to the chamber to vary in position relative to the chamber,

   And the sealing membrane is drilled by the extension protrusion as the housing is displaced so that the housing approaches the chamber, and the solution is discharged to the outside through the sample part.
2. The method according to claim 1 or 2,

   The housing,

   One end is inserted into the first hollow of the chamber,

   And a sample dispensing device connected to said chamber such that said housing is inserted into said first hollow and varies in position.
3. The method of claim 2,

   The outer diameter of one side end of the housing,

   And a housing corresponding to the inner diameter of the first hollow of the chamber such that the housing is inserted into and fitted into the first hollow of the chamber.
4. The method of claim 2,

   At the other end of the housing,

   A sample dispensing device provided with a locking protrusion extending in a predetermined width in an outer diameter direction to fix a position when the housing is inserted into the first hollow.
5. The method according to any one of claims 1 to 4,

   And a fixing ring inserted into the second hollow of the housing.

   The housing,

   An inner diameter protrusion provided at the other side end position and protruding by a predetermined width in the inner diameter direction of the second hollow;

   The buffer tube,

   An outer diameter protrusion protruding in an outer diameter direction on one side where the opening is formed,

   And the buffer ring is fixed in the second hollow of the housing so that the outer diameter protrusion is positioned and supported between the inner diameter protrusion and the fixing ring so that the buffer tube is fixed to the housing.
6. The method of claim 5,

   The inner diameter protrusion,

   A vent hole penetrating in a direction in which the second hollow penetrates and spaced from each other in a circumferential direction and arranged in plurality;

   The fixing ring,

   At least one portion is configured to be smaller than the inner diameter of the second hollow and at least one portion is configured to have a gap spaced apart from the inner peripheral surface of the second hollow by a predetermined interval,

   Sample dispensing apparatus in which the air inside the housing can be discharged to the outside through the vent hole and the gap.
7. The method according to any one of claims 1 to 6,

   The chamber is

   Has a predetermined bottom surface provided on the other side end where the sample portion is located, and is configured to protrude the sample portion from the bottom surface,

   The bottom surface is,

   From the periphery to the center it slopes outwards,

   The sample dispensing apparatus is located in the center of the bottom surface.
8. The method of claim 7, wherein

   The extension protrusion,

   A plurality of arranged spaced apart from each other by a predetermined interval,

   Each of the extension protrusions protrudes from the bottom surface,

   And a region between each of the extension protrusions is connected to the bottom surface.
9. The method according to any one of claims 1 to 8,

   The extension protrusion,

   A sample dispensing device configured to extend longer beyond the opening of the first hollow.
10. A method of testing a biological sample using the apparatus according to any one of claims 1 to 9, wherein the method

    Providing a biological sample;

    Contacting the sample portion of the device with the biological sample and introducing the biological sample into the sample portion by the contacting; And,

    Driving the device to pierce the sealing membrane by the elongated protrusion and thereby to move the solution into the space of the housing and chamber, in the process of mixing the biological sample with the solution, wherein the mixed solution Is discharged to the outside through the sample portion.
11. A chamber part having a double pipe structure extending in a vertical direction;

    An upper cap having a double pipe structure extending in a vertical direction and disposed above the chamber part, and filled with a predetermined solution therein;

    A sample collection unit disposed below the chamber unit and having a pipeline through which a predetermined sample may be collected or a solution may be discharged; Including;

    The chamber part,

    A cylindrical outer periphery constituting the outer periphery and having a first hollow of a predetermined inner diameter having an upper end opened therein,

    A cylindrical line part disposed in the first hollow spaced apart from the outer circumferential part in a radial direction and extending in the longitudinal direction with the outer circumferential part, and having a discharge line penetrating in the vertical direction therein;

    An inner insertion groove formed of a spaced space between the outer peripheral portion and the line portion, and

    It includes a lower connecting portion for connecting the lower portion of the outer peripheral portion and the line portion,

    The upper cap is

    A cap part having a second hollow having a predetermined inner diameter constituting an outer periphery and having a lower end opened therein;

    A tube portion disposed in the second hollow spaced apart from the cap portion in a radial direction and extending along the cap portion in a length direction and having a solution filling space having an open lower end therein;

    An outer insertion groove formed of a spaced space between the cap and the tube,

    A cap cover connecting an upper end of the cap part and the tube part to seal an upper end of the tube part;

    It is provided at the bottom of the tube portion to seal the lower portion of the solution filling space and comprises a sealing cover composed of a predetermined thin film,

    The upper cap is connected to the chamber portion to be positioned in a vertical direction with respect to the chamber portion, the line portion is disposed below the tube portion,

    And the sealing cover is opened by the line part as the upper cap is lowered so that the solution passes through the discharge line and is discharged to the outside through a pipe of the sample collecting part.
12. The method of claim 11,

    The lower end of the upper cap is connected to the upper end of the chamber portion,

    The outer circumferential portion of the chamber portion is inserted into a lower end of the outer insertion groove of the upper cap to be fitted between the cap portion and the tube portion,

    And the outer circumference portion is inserted into the outer insertion groove while the upper cap moves downward by an external force, and the line portion is configured to be inserted into the solution filling space of the tube portion.
13. The method according to claim 11 or 12,

    On the outside of the upper end of the outer peripheral portion,

    A first locking protrusion protruding by a predetermined width in the outer diameter direction is provided,

    Inside the lower end of the cap portion,

    A second locking protrusion protruding by a predetermined width in the inner diameter direction is provided,

    When the lower end of the upper cap and the upper end of the chamber portion are engaged, the first locking protrusion and the second locking protrusion are engaged with each other, so that the upper end of the outer circumference portion is inserted with a predetermined deterrent force between the cap portion and the tube portion. Sample dispensing apparatus is configured to be fixed in the position in which the lower end of the cap and the top of the chamber is connected to each other.
14. The method of claim 13,

    The first locking protrusion,

    Consists of a circular protrusion extending around the outer periphery of the outer peripheral portion,

    The second locking protrusion,

    A plurality of upper protrusions protruding by a predetermined width in an inner diameter direction of the cap part and extending in a circumferential direction and spaced apart from each other by a predetermined interval;

    A plurality of lower protrusions disposed to be spaced apart from each other in a vertical direction by the upper protrusion, protruding by a predetermined width in an inner diameter direction of the cap part, extending with a predetermined length in a circumferential direction, and spaced apart from each other by a predetermined interval,

    When the lower end of the upper cap portion and the upper end of the chamber portion are coupled, the upper protrusion is positioned above the first locking protrusion, and the lower protrusion is positioned below the first locking protrusion, so that the cap portion and the chamber portion are located. Position set sample dispensing device.
15. The method of claim 14,

    And the upper protrusion and the lower protrusion are alternately arranged in the circumferential direction of the inner circumferential surface of the cap portion.
16. The method according to any one of claims 11 to 15,

    Around the outer bottom of the tube portion,

    A sample dispensing apparatus including a friction protrusion protruding a predetermined width in the outer diameter direction and extending in the circumferential direction and in close contact with an inner circumferential surface of an upper end of the outer circumferential portion.
17. The method according to any one of claims 11 to 15,

    The height of the line portion is lower than the height of the outer peripheral portion,

    When the upper end of the outer peripheral portion and the lower end of the cap portion is connected to each other, the sealing cover and the line portion are spaced apart from each other in the vertical direction,

    And the line portion penetrates the sealing cover when the upper cap is lowered by a predetermined distance so that the solution in the solution filling space is discharged through the discharge line.
18. The method according to any one of claims 11 to 15,

    The outer diameter and cross-sectional shape of the line portion correspond to the inner diameter and cross-sectional shape of the solution filling space,

    And the line portion is inserted into the solution filling space after the upper cap is lowered so that the solution in the solution filling space is discharged through the discharge line without flowing out.
19. The method according to any one of claims 11 to 15,

    The discharge line,

    Sample dispensing device having a funnel shape at the top and having an extended portion extending inwardly upward.
20. The method according to any one of claims 11 to 15,

    The line portion,

    Has a ripping portion to tear the sealing cover at the top,

    The ripping unit,

    And at least one horizontal beam provided at an upper end of the discharge line to traverse the discharge line in a radial direction, and a protruding blade provided at an upper end of the horizontal beam to protrude upward.
21. The method according to any one of claims 11 to 15,

    The chamber part,

    Further including a depression formed by recessing the lower portion of the line portion in an upward direction,

    The depression,

    A first hemispherical dome located in an upper portion and having a hemispherical shape and recessed in an upward direction; and

    A cylindrical interpolation recessed area located below the first hemispherical dome and having an inner diameter greater than the diameter of the hemispherical dome,

    The sample collection unit,

    An interpolation portion positioned in an upper portion and having a cylindrical shape having an outer diameter corresponding to an inner diameter of the interpolation depression region so as to be inserted into the interpolation depression region;

    A sampling tip which is located at the bottom and has a thin tubular shape to collect a sample,

    And a second hemispherical dome formed on an upper surface of the interpolation portion and having a hemispherical shape and recessed downward to form a spherical space together with the first hemispherical dome.
22. The method of claim 21,

    A female thread portion is formed on the inner circumferential surface of the interpolation depression region,

    Sample dispensing apparatus is formed on the outer circumferential surface of the interpolation portion formed with a male screw portion corresponding to the female screw portion.
23. The method of claim 21 or 22,

    And a predetermined dry reagent is placed in the spherical space formed by the first hemispherical dome and the second hemispherical dome together and is dissolved and mixed with the solution when the solution is discharged. Sample dispensing device.
24. The sample dispensing device according to any one of claims 11 to 23 further comprises an adapter;

    The adapter,

    A lower end of the chamber part of the sample dispensing device is inserted into the chamber and has a predetermined space therein;

    A ramp formed on the bottom surface of the chamber insert holder and configured to extend in one direction so that the discharged sample and solution are guided in one direction; And

    Sample dispensing apparatus comprising a; cartridge insert used to analyze the sample.
25. The method of claim 24,

    Wherein said adapter is formed separately or integrally with said sample dispenser.
26. A method of testing a biological sample using the apparatus according to any one of claims 11 to 25, wherein the method

    Providing a biological sample;

    Contacting a sampling tip formed in the sampling section of the device with the biological sample and introducing the biological sample into the sampling tip by the contacting; And

    And applying an external force to the cap part to drive the upper cap downward.

    The sealing cover is opened by the ripping part, and the solution included in the solution filling space of the cap part moves along the discharge line of the chamber part, and is discharged to the outside while the biological sample and the solution are mixed in the process. How.
27. The method of claim 26,

    After the step of introducing the biological sample to the sampling tip, further comprising mounting the device to an adapter, wherein the device is engaged with the adapter through the bottom of the chamber portion.

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