CN220542941U - Infertility detection device - Google Patents

Abstract

The utility model discloses an infertility detection device, which comprises a box body, wherein a sample adding hole and a sample groove are formed in the box body, and the sample groove is connected with a plurality of sample flow channels with controllable on-off; the locking assembly is connected to the opening end of the sample flow channel and comprises a movable plectrum which is arranged on the inner side of the opening end of the sample flow channel; a first stopper and a second stopper disposed on opposite sides of the sample flow path and held inside the sample flow path; the pulling piece is abutted or released from being abutted with the first limiting block and the second limiting block by moving to different positions, so that the sample flow channel is allowed to be switched between opening and closing. Through setting up the sample runner that can switch between locking state and open state, can fix the test paper to corresponding sample groove, make the sample solution can be absorbed by the test paper smoothly to avoid not installing the sample groove of test paper and produce the condition of sample outflow.

Description

Infertility detection device

Technical Field

The utility model relates to the field of medical equipment, in particular to a infertility detection device.

Background

Infertility is a global health problem affecting millions of childbearing people worldwide. According to the investigation and statistics of the world health organization, six people worldwide experience infertility in their lives, which is a condition that a couple fails to become pregnant naturally in one year under normal sexual life. The main reasons include abnormal number and quality of sperm or ovum, oviduct obstruction, and abnormal endometrium secretion. Infertility can be classified into male infertility and female infertility, and some infertility is caused by both factors of couples. In recent years, attention has been paid to the use of antigen-antibody reaction or the like for detecting the onset of some diseases, pregnancy, blood glucose levels, etc., and an immediate detection reagent (Point of Care Test: POCT) has been developed. The reagents have the advantages of quick identification effect, simple operation, low price and the like. Because of these characteristics, POCT agents are widely used in diagnosis stages of light symptoms, routine examinations, etc., and will also become an important diagnostic tool in future home care.

The prior art CN206684171U discloses a kit for the detection of sterile antibodies. Comprises a box body and a box cover connected with the box body, wherein the box body is internally provided with an infertility antigen membrane strip, a reaction tank, an enzyme conjugate reagent bottle, a sample diluent reagent bottle, a chromogenic substrate reagent bottle and a concentrated washing liquid reagent bottle; the sterile antigen membrane strip is provided with a detection area and a quality control area, wherein the detection areas are respectively provided with a detection line for coating sperm antigens, a detection line for coating endometrial antigens, a detection line for coating zona pellucida antigens, a detection line for coating ovarian antigens, a detection line for coating human chorionic gonadotrophin antigens, a detection line for coating trophoblast antigens, a detection line for coating cardiolipin antigens and a detection line for coating beta 2 glycoprotein antigens. The method can realize semi-quantitative detection of specific IgG antibodies or IgA antibodies or IgM antibodies of infertility-related antigens such as sperms, endometrium, zona pellucida, ovaries, human chorionic gonadotrophin, trophoblasts, cardiolipin, beta 2 glycoprotein 1 and the like in human serum, and achieves the effects of combined detection of eight infertility, comprehensive detection, rapid detection and easy automation.

However, existing infertility detection devices still suffer from at least one or more of the following problems: however, the infertility detection kit in the prior art generally adopts a disposable mode. The test paper for sample detection in the kit belongs to semi-quantitative products, can semi-quantitatively determine the change condition of female urine LH in a menstrual cycle, and requires continuous and uninterrupted test for a period of time, and is generally maintained for 5-10 days, so as to help doctors to know the follicular development, assist diagnosis of the infertility-related syndromes such as LUFS, PCOS and the like. In practice, the test paper shows the color shade to judge the result in each test, the kit itself is used as a carrier without loss, if the test paper is discarded together with the kit after each test, the cost is meaningless lost especially for the same inspector, and a large number of discarded kits are easy to cause environmental pollution if being improperly processed.

Furthermore, there are differences in one aspect due to understanding to those skilled in the art; on the other hand, as the inventors studied numerous documents and patents while the present utility model was made, the text is not limited to details and contents of all that are listed, but it is by no means the present utility model does not have these prior art features, the present utility model has all the prior art features, and the applicant remains in the background art to which the rights of the related prior art are added.

Disclosure of Invention

Aiming at the defects of the prior art, the utility model provides an infertility detection device, which aims at solving at least one or more technical problems existing in the prior art.

In order to achieve the above object, the present utility model provides an infertility detection device, comprising a box body, a sample inlet and a sample groove, wherein the sample groove is configured with a sample inlet and is in fluid connection with the sample inlet, and the sample groove is connected with a plurality of independent sample flow channels with controllable on-off; a plurality of operable locking assemblies connected to an open end of said sample flow path, comprising: a movable plectrum arranged at the inner side of the opening end of the sample flow channel; a first stopper and a second stopper disposed on opposite sides of the sample flow path and held inside the sample flow path; the poking piece is abutted or released from being abutted with the first limiting block and the second limiting block by moving to different positions, so that the sample runner is allowed to be switched between opening and closing.

Preferably, the locking assembly further comprises a self-locking switch that switches between a first operating position and a second operating position and a connector mechanically connected to the self-locking switch; wherein one end of the poking piece is rotationally connected to the connecting piece; when the self-locking switch is in the first working position, the poking piece is abutted against the first limiting block and the second limiting block, and when the self-locking switch is in the second working position, the self-locking switch drives the connecting piece to move, and the poking piece is enabled to rotate around the connecting piece, so that the abutment of the poking piece against the first limiting block and the second limiting block is relieved.

Preferably, the detection device further comprises one or more sleeves disposed on the upper surface of the cartridge body away from the sample application hole, wherein the sleeves are configured to be raised in the height direction of the cartridge body.

Preferably, the test device further comprises a test paper, the test paper comprises a socket section, a detection section and a tail section which are sequentially arranged along the flowing direction of the sample, wherein the detection section comprises a porous membrane layer and an absorption layer which are sequentially arranged along the flowing direction of the sample, a test line capable of capturing specific analytes in the sample is formed on the porous membrane layer, and a control line can be formed in an upstream or downstream area of the test line.

Preferably, the absorbent layer is configured to partially overlap the porous membrane layer in the test paper stacking direction.

Preferably, the socket segments are configured in a shape in which the width gradually increases in the direction of flow of the specimen.

Preferably, the end of the tail section remote from the sample introduction is configured in the form of an inward recess adapted to the contact surface with the stem.

Preferably, the loop and the tail section of the corresponding test paper are configured to be marked with indication matching information.

Preferably, the box further comprises a box cover, and the box cover is rotatably connected to the box body.

Preferably, the cover is configured with at least one viewing window corresponding to the test line and the viewing line.

The beneficial technical effects of the utility model are as follows:

1. through test paper socket joint to the sample tank and with the tail joint section configuration of test paper for having the inwards sunken form that suits with the loop column, thereby make the test paper can be connected to the installation of loop column more firmly and realize the test paper, make the installation and the dismantlement of test paper become simple and feasible to detection device body can realize repeatedly used through the mode of replacement test paper, when reducing use cost, also realized the reduction of environmental pollution pressure.

2. The tail connection section of each set of columns and the corresponding test paper is configured into the form of indication matched information, so that a user can conveniently and correctly obtain the detected index and the corresponding result by observing and reading the indication matched information, the test paper is prevented from being mounted in a sample groove with unmatched test indexes, failure of the detection process and/or errors of the detection result are avoided, and misguidance to the user is avoided.

3. Through setting up the sample runner that can switch between locking state and open state, can fix the test paper to corresponding sample groove, make the sample solution can be absorbed by the test paper smoothly to avoid not installing the sample groove of test paper and produce the condition of sample outflow.

4. The sample adding hole is not directly connected with the test paper, but the sample solution is pre-distributed through the sample groove, and the distributed sample solution can be respectively migrated in each test paper, so that the aim of simultaneously detecting a plurality of indexes is fulfilled.

Drawings

FIG. 1 is a schematic view of an apparatus development structure of an infertility detection apparatus according to an embodiment of the present utility model;

fig. 2 is a schematic diagram showing a closed state structure of a sterility-detecting device according to an embodiment of the present utility model;

FIG. 3 is a detailed schematic diagram of the structural relationship between a locking assembly of an infertility detection device and a sample trench in a locked state according to an embodiment of the utility model;

FIG. 4 is a detailed schematic diagram of the structural relationship between the locking assembly of the sterility testing device, the sample tank and the test paper in the receiving state;

fig. 5 is a schematic diagram of a test paper structure of a sterility testing device according to an embodiment of the present utility model.

List of reference numerals

100: a case body; 101: a sample adding hole; 102: a sample tank;

102a: a sample flow channel; 103: a sleeve column; 200: test paper;

201: a socket segment; 202: a detection section; 202a: a porous membrane layer;

202b: an absorption layer; 203: tail joint section; 300: a locking assembly;

301: a pulling piece; 302: a first limiting block; 303: a second limiting block;

304: a self-locking switch; 305: a connecting piece; 400: a box cover;

401: an observation window; 500: a rotating shaft.

Detailed Description

The present utility model will be described in detail with reference to the accompanying drawings.

In the description of the present utility model, it should be noted that terms such as "upper," "lower," "left," "right," and the like are based on the orientation or positional relationship shown in the drawings, and are merely for convenience and to simplify the description, rather than to indicate or imply that the apparatus or element must have a particular orientation, be constructed and operate in a particular orientation. The terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. The positional relationship terms used in the drawings are merely for illustration, and are not to be construed as limiting the present technology.

The present utility model provides an infertility detection device as shown in fig. 1 to 4, comprising: a cartridge 100 configured with a well 101 and a sample well 102 in fluid connection with the well 101, the well 102 being connected to a plurality of independent on-off controllable sample flow channels 102a; the detection device further includes a plurality of locking assemblies 300 operable, the locking assemblies 300 being connected to the open ends of the sample flow channels 102a, the locking assemblies 300 comprising: a movable dial 301 disposed inside the open end of the sample flow path 102a, and a first stopper 302 and a second stopper 303 disposed on opposite sides of the sample flow path 102a and held inside the sample flow path 102a; wherein, the pulling piece 301 is abutted against or released from the first limiting block 302 and the second limiting block 303 by moving to different positions, so as to allow the sample flow channel 102a to be switched between opening and closing.

According to a preferred embodiment, the locking assembly 300 is configured to switch between the locked and the unlocked state by configuring the latching switch 304 as a push-on switch. Specifically, the main structure of the self-locking switch 304 includes a button, a spring, and a snap member. When the locking assembly 300 is in the locked state, the spring is in the original length, and the connecting piece 305 is pushed by the spring to tightly press the pulling piece 301, the first limiting block 302 and the second limiting block 303; when the locking assembly 300 is to be switched to the open state, the button is pressed, the spring is forced to be in a compressed state by the change of the height of the button relative to the sample flow channel 102a, and is maintained in the compressed state by the buckling member, the compressed state spring no longer applies pressure to the connecting piece, and the pulling piece 301 rotates around the connecting piece 305, so that the locking assembly 300 is switched to the open state.

According to a preferred embodiment, the shape of the paddle 301 is adapted to the sample flow path 102 a.

According to a preferred embodiment, as shown in fig. 1, the detection device further comprises one or more sleeves 103 arranged on the upper surface of the cartridge 100 at the end facing away from the loading well 101. The socket 103 is configured to protrude in the height direction of the case 100. Further, the sleeve 103 may be cylindrical, elliptic cylindrical or cubic in shape in view of easy processing and low cost.

According to a preferred embodiment, the test strip 200 is used for rapid detection and display of the corresponding results, and as shown in fig. 5, the test strip 200 includes a socket section 201, a detection section 202 and a tail section 203 which are sequentially arranged along the flow direction of the sample; the detection section 202 includes a porous membrane layer 202a and an absorption layer 202b sequentially arranged in the sample flow direction. Further, a test line is formed on the porous membrane layer 202a that captures a specific analyte in the sample. Specifically, to detect an analyte in a sample, a specific ligand (which may be the same substance as the analyte, or an analog that induces a competing reaction with the analyte) is immobilized on the porous membrane layer 202a to form a test line to selectively capture the desired analyte.

According to a preferred embodiment, the absorbent layer 202b is configured to partially overlap the porous membrane layer 202a in the stacking direction of the test strip 200, and functions to provide a driving force for the liquid sample to flow in the structure of the test strip 200.

According to a preferred embodiment, a control line may be formed in the region upstream or downstream of the test line for detecting and generating an indication of whether the sample successfully generated target migration in the structure of the strip 200, and the generation of the indication is only related to whether the sample has generated target migration, and not to the concentration of the target in the sample.

According to a preferred embodiment, the porous membrane layer 202a and the absorbent layer 202b may be made of nitrocellulose membrane (Nitrocellulose membrane), glass fiber membrane (Glass fiber membrane), polyethersulfone membrane (Polyethersulfone membrane), nylon membrane (Nylon film), or the like.

According to a preferred embodiment, as shown in fig. 5, the socket section 201 is configured in a shape in which the width gradually increases in the direction of the flow of the sample, and the function of this configuration is to: the test paper 200 can accurately absorb the sample liquid, and the contact area of the test paper 200 and the sample liquid is increased, so that the detection accuracy is improved. In addition, such a shape of gradually increasing width in the direction of sample flow may also help the test strip 200 to be inserted more easily into a designated slot of the test device to ensure proper performance of the operation process. Further, the shape of socket segment 201 may be isosceles trapezoid, isosceles triangle, diamond, or other possible geometric shapes. In particular, the above-mentioned symmetrical shape of the socket segment 201 can make the flow path of the sample liquid in the test paper 200 approximately equal, so that the time for the sample liquid to reach the porous membrane layer 202a is substantially consistent, and the accuracy of the detection result is ensured.

According to a preferred embodiment, as shown in fig. 5, the end of the tail section 203 remote from the sample introduction has an inwardly concave shape, and this inwardly concave shape is configured to fit against the contact surface of the stem 103, so that the test strip 200 can be firmly connected to the stem 103, avoiding failure of the test strip 200 due to unexpected displacement during the test.

According to a preferred embodiment, each sleeve column 103 and the tail section 203 of the corresponding test paper 200 are configured to be marked with indication matching information, and after a user installs the test paper 200 corresponding to different test indexes to the corresponding sample groove 102 and completes detection by observing or reading the indication matching information, the detected indexes and the corresponding results can be conveniently and correctly obtained through the indication information on the sleeve column 103, so that the fault of the detection process and/or the error of the detection result caused by installing the test paper 200 to the sample groove 102 with the unmatched test indexes are avoided, and misguidance is not generated for the user. Optionally, each set of posts 103 and the corresponding trailing section 203 are configured to have the same color. For example, the cartridge 103 and the corresponding test strip 200 for testing Follicle stimulating hormone (FSH, follicle-stimulating hormone) are each configured to be yellow, the cartridge 103 and the corresponding test strip 200 for testing Estradiol (E2, estradiol) are each configured to be green, the cartridge 103 and the corresponding test strip 200 for testing luteinizing hormone (LH, luteinizing hormone) are each configured to be purple, the cartridge 103 and the corresponding test strip 200 for testing Anti-mullerian hormone (AMH, anti-mullerian horone) are each configured to be gray, the cartridge 103 and the corresponding test strip 200 for testing Thyroid stimulating hormone (TSH, thyroid-stimulating hormone) are each configured to be orange, and the like.

According to a preferred embodiment, as shown in fig. 1 to 2, the detecting device further comprises a cover 400 for protecting the detecting device and isolating each detecting-related component from the external environment, and the cover 400 is pivotally connected to the case 100, and by this connection, the cover 400 can be rotatably connected to the case 100 in a manner that it can be opened and closed.

Further, the pivotal connection may be by way of a hinge 500.

According to a preferred embodiment, the box cover 400 includes an observation window 401 disposed inside its structure, the observation window 401 is disposed at a location corresponding to the test line and the observation line formed by the porous membrane layer 202a, and the shape and size of the observation window 401 are configured to be sufficient for a user to observe and judge the formation of the test line and the observation line. Preferably, the shape of the viewing window 401 may be rectangular, rounded rectangular, trapezoidal, circular, oval, etc.

According to a preferred embodiment, the viewing window 401 is made of a transparent material. The transparent material may be quartz, glass, organic glass (such as polymethyl methacrylate-PMMA, acrylic), polyimide, etc., and the above listed materials should have the following characteristics in addition to good transparency: the durability is good, so that the water tank can be used for multiple times; the chemical resistance is good, and the sample liquid cannot be corroded or chemical reaction is expected to occur; light leakage, reflection and refraction are prevented as much as possible to improve the accuracy of observation.

For ease of understanding, the working principle and method of use of the sterility testing device of the present utility model will be discussed. 1) The user installs each test strip 200 of the target into each corresponding sample slot 102 according to the indication information of each sleeve column 103 and the tail section 203, and the step of installing the test strip 200 comprises the following steps: the self-locking switch 304 in the locking state is switched to the on state, the pulling piece 301 correspondingly rotates to a preset angle around the connecting piece 305 (compared with the locking state, the rotation angle is smaller than 90 degrees), the sample flow channel 102a is opened, the socket section 201 is taken as the starting end, the test paper 200 is installed in a space formed by the pulling piece 301 and the lower wall surface of the sample flow channel 102a, after the extension degree of the socket section 201 reaches the preset degree, the self-locking switch 304 is switched to the locking state again, the pulling piece 301 is reset, the tail section 203 of the test paper 200 is fixed to the corresponding sleeve column 103, and for the sample groove 102 provided with the test paper 200, the pulling piece 301 has a fixing effect on the test paper 200 by applying pressure to the test paper 200; for the sample groove 102 where the test paper 200 is not mounted, the pulling piece 301 is tightly abutted against the first limiting block 302 and the second limiting block 303, so that the sample flow channel 102a is isolated from the external environment. Such a design may avoid outflow of sample fluid when some of the sample wells are not inserted into test strip 200.

2) The proper amount of sample is transferred to the sample adding hole 101, the liquid sample is distributed to each test paper 200 through the sample groove 102, and the box cover 400 is rotated to be buckled with the box body 100, so that the interference of the external environment to the detection result is avoided.

3) Based on the capillary principle, the sample gradually flows to the porous membrane layer 202a, and the test line and/or the control line are displayed, so that the user can judge the corresponding index according to the conditions of the test line and the control line displayed by the porous membrane layer 202a through the observation window 401.

4) After the test is finished, the box cover 400 is rotated to be far away from the box body 100, the self-locking switch is switched to be in an on state, each test paper 200 is taken down and discarded to a designated place, and the box body 100, the test paper 200, the locking assembly 300 and the box cover 400 are cleaned, disinfected and dried for the next detection.

It should be noted that the above-described embodiments are exemplary, and that a person skilled in the art, in light of the present disclosure, may devise various solutions that fall within the scope of the present disclosure and fall within the scope of the present disclosure. It should be understood by those skilled in the art that the present description and drawings are illustrative and not limiting to the claims. The scope of the utility model is defined by the claims and their equivalents. The description of the utility model encompasses multiple inventive concepts, such as "preferably," "according to a preferred embodiment," or "optionally," all means that the corresponding paragraph discloses a separate concept, and that the applicant reserves the right to filed a divisional application according to each inventive concept.

Claims (10)

1. An infertility detection device, comprising:

a cartridge (100) configured with a sample well (101) and a sample groove (102) in fluid connection with the sample well (101), wherein the sample groove (102) is connected with a plurality of independent on-off controllable sample flow channels (102 a);

a plurality of operable locking assemblies (300) connected to an open end of the sample flow channel (102 a), comprising:

a movable dial (301) disposed inside the open end of the sample flow path (102 a);

a first stopper (302) and a second stopper (303) which are disposed on opposite sides of the sample flow path (102 a) and are held inside the sample flow path (102 a); wherein,

the pulling piece (301) is abutted or released from the first limiting block (302) and the second limiting block (303) by moving to different positions, so that the sample flow channel (102 a) is allowed to be switched between opening and closing.

2. The detection device according to claim 1, wherein the locking assembly (300) further comprises a self-locking switch (304) that switches between a first operating position and a second operating position and a connection (305) mechanically connected to the self-locking switch (304); wherein,

one end of the poking piece (301) is rotatably connected to the connecting piece (305);

when the self-locking switch (304) is positioned at the first working position, the poking piece (301) is abutted against the first limiting block (302) and the second limiting block (303),

when the self-locking switch (304) is in the second working position, the self-locking switch (304) drives the connecting piece (305) to move, and the poking piece (301) rotates around the connecting piece (305), so that the poking piece (301) is released from abutting against the first limiting block (302) and the second limiting block (303).

3. The device according to claim 1, further comprising one or more cartridges (103) disposed on the upper surface of the cartridge (100) facing away from the loading well (101), wherein,

the sleeve (103) is configured to be convex in the height direction of the case (100).

4. The test device according to claim 3, further comprising a test strip (200), the test strip (200) comprising a socket section (201), a test section (202) and a tail section (203) arranged in this order in the direction of flow of the test sample, wherein,

the detection section (202) comprises a porous membrane layer (202 a) and an absorption layer (202 b) which are sequentially arranged along the flowing direction of the sample, wherein,

forming a test line for capturing a specific analyte in a sample in the porous membrane layer (202 a),

a control line is formed in a region upstream or downstream of the test line.

5. The detection apparatus according to claim 4, wherein the absorption layer (202 b) is configured in a form of partially overlapping the porous membrane layer (202 a) in a stacking direction of the test paper (200).

6. The device according to claim 4, wherein the socket section (201) is configured in a shape with a width gradually increasing in the direction of the sample flow.

7. The device according to claim 4, characterized in that the end of the tail section (203) remote from the sample introduction is configured in the form of an inward recess adapted to the contact surface with the stem (103).

8. The test device of claim 4, wherein the sleeve (103) and the trailing section (203) of the corresponding test strip (200) are configured to be identified with indication mating information.

9. The device of claim 4, further comprising a cap (400), the cap (400) being rotatably coupled to the housing (100).

10. The device according to claim 9, characterized in that the cover (400) is configured with at least one viewing window (401) corresponding to the test line and the viewing line.