Gynecological self-test device and test liquid formula

Abstract

The invention discloses a gynecological self-test device and a detection liquid formula, the gynecological self-test device comprises a sampling unit, the sampling unit comprises a sampling swab, the sampling swab extends into the deep part of a to-be-tested part for sampling, the detection unit is internally provided with detection liquid, and the sampling swab after sampling is put into the detection liquid; and after the color of the swab to be sampled is changed, the swab is compared with the color on the colorimetric card to judge corresponding information. The formula of the detection liquid at least comprises 0.01%-5% of folic acid, 0.01%-5% of methylene blue, 66%-99% of dimethyl sulfoxide, 0.1%-15% of vitamin C, 1%-10% of glacial acetic acid and 0.5%-10% of glucose. Sampling and detection can be completed by the aid of a patient or relatives, professional equipment is not needed, the examination cost is effectively saved, examination can be completed within three minutes, the examination time is effectively shortened, the operation process is simpler and more convenient, and the method is more suitable for patients with slight symptoms or symptoms which cannot be perceived by themselves.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a gynecological self-testing device and a test liquid formula. Background Art

[0002] Gynecological diseases such as HPV virus infection, cytological screening, examination and post-review of tumors and lesions generally require multiple complex processes according to the examination type, and patients need to go to specialized medical examination institutions to complete them. Various instruments and reagents are required, and their diagnosis is generally achieved through morphological technology, which requires a high level of technical skills and experience from the diagnostic personnel.

[0003] For some people who only suspect that they have gynecological diseases, the existing technology lacks corresponding medical equipment to assist in self-examination, and they often need to go to the corresponding medical department to use machines for examination. Although the examination results are relatively accurate, it is inconvenient to use and has low efficiency. Summary of the invention

[0004] The purpose of the present invention is to solve the above problems and provide a gynecological self-testing device and a test liquid formula.

[0005] In order to achieve the above-mentioned purpose, the present invention specifically adopts the following technical solutions:

[0006] A gynecological self-testing device, comprising:

[0007] A sampling unit, wherein the sampling unit comprises a sampling swab, and when in use, the sampling swab is inserted into the part to be tested, and the sampling swab is inserted into the depth of the part to be tested again for sampling by controlling the rotation of the rotating sleeve at the end of the sampling unit;

[0008] Color chart;

[0009] The detection unit is provided with a detection liquid, the sampling swab after sampling is placed in the detection liquid, and the color of the sampling swab is compared with the color on the colorimetric card after the color changes to determine the corresponding information.

[0010] Optionally, the sampling unit includes a sampling catheter, a protective sleeve, a threaded sleeve, a rotating sleeve, a telescopic rod and a cotton swab head.

[0011] Optionally, the sampling unit includes a sampling guide sleeve, the sampling guide sleeve includes a guide sleeve cone head, the interior of the guide sleeve cone head is a hollow guide sleeve tube body, the end of the guide sleeve tube body is a connecting threaded part, the end of the connecting threaded part is provided with a locking slot band, and the end of the guide sleeve tube body is provided with a handle that tends to expand outward.

[0012] Optionally, a hollow threaded sleeve is provided at the end of the sampling guide sleeve, and the threaded sleeve is spirally connected to the connecting threaded portion.

[0013] Optionally, the threaded sleeve includes a sleeve body, an external threaded portion is arranged on the outside of the sleeve body, an internal threaded portion is arranged on the inside of the sleeve body, a locking boss is arranged at the end of the external threaded portion, and a segmented clamping ring is arranged at the end of the internal threaded portion.

[0014] Optionally, the rotating sleeve is arranged inside the threaded sleeve, and the rotating sleeve includes a rotating handle arranged at its end, a limiting step is fixedly arranged at one end of the rotating handle, an assembly groove is provided on the sleeve body 2 of the rotating sleeve away from the limiting step, the assembly groove is connected to the sliding groove, limiting grooves are provided at both ends of the sliding groove, and a connecting slot is provided between the sleeve body 2 and the limiting step.

[0015] Optionally, the telescopic rod includes a telescopic sliding column at the end, a guide column is fixed to the outside of the circumference of the telescopic sliding column, a rod body is fixed in the axial direction of the telescopic sliding column, a guide limit ring is provided on the rod body, a buffer reducing cone is fixed to the distal end of the rod body, and a cotton tooth is fixed to the end of the buffer reducing cone away from the rod body.

[0016] Optionally, a cotton swab head is fixed to the head end of the cotton-wrap teeth, the cotton swab head is wound with absorbent cotton, has a length of 10-30m, a maximum diameter of 5-15mm, and a sampling area of ​​the cotton swab head is spindle-shaped.

[0017] Optionally, the detection unit includes a bottle body, a bottle cap is provided at the bottle mouth of the bottle body, the bottle cap and the bottle body are sealed by a sealing gasket, and the bottle body contains the detection liquid.

[0018] A test liquid formulation of a gynecological self-testing device as described in any one of the above items, comprising, by mass percentage, at least:

[0019] Folic acid: 0.01%-5%, methylene blue: 0.01%-5%, dimethyl sulfoxide: 66%-99%, vitamin C: 0.1%-15%, glacial acetic acid: 1%-10%, glucose: 0.5%-10%.

[0020] The beneficial effects of the present disclosure are as follows:

[0021] The present invention sets a sampling unit, and the length of the sampling head can be adjusted by rotating the handle, and the lesion can be directly reached without a cervical dilator. Then the sampling head is placed in the detection unit, and the sampling head is soaked in the detection liquid (i.e., dyeing reagent) therein. After a certain period of time, the inspection and diagnosis can be achieved by observing the color change of the sampling head. Compared with the existing technology, the patient or relatives can help complete the sampling and detection, and no professional equipment is required, which effectively saves the inspection cost. The inspection can be completed within three minutes, which effectively reduces the inspection time. The operation process is simpler and more convenient, and it is more suitable for patients with mild symptoms or who cannot perceive the symptoms themselves.

[0022] In order to more clearly illustrate the structural features and functions of the present invention, the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a structural schematic diagram of the gynecological self-testing device of the present invention;

[0024] Figure 2 It is a structural schematic diagram of the sampling guide sleeve in the present invention;

[0025] Figure 3 It is a structural schematic diagram of the threaded sleeve in the present invention;

[0026] Figure 4 It is a structural schematic diagram of the rotating sleeve in the present invention;

[0027] Figure 5 It is a structural schematic diagram of the telescopic rod in the present invention;

[0028] Figure 6 It is a structural schematic diagram of the detection unit in the present invention;

[0029] Figure 7 It is a schematic diagram of the sampling swab in the present invention extending into the detection unit for detection;

[0030] Figure 8 It is a schematic diagram of the colorimetric card in the present invention.

[0031] Reference numerals: 1, sampling guide sleeve; 101, guide sleeve cone head; 102, guide sleeve body; 103, connecting threaded portion; 104, locking slot belt; 105, handle; 2, protective sleeve; 3, threaded sleeve; 301, external threaded portion; 302, locking boss; 303, sleeve body 1; 304, internal threaded portion; 305, segmented clamping ring; 4, rotating sleeve; 401, assembly notch; 402, sliding groove; 403, Connecting slot; 404, rotating handle; 405, limiting step; 406, sleeve body II; 407, limiting slot; 5, telescopic rod; 501, cotton teeth; 502, buffer reducing cone; 503, guide limiting ring; 504, rod body; 505, guide column; 506, telescopic sliding column; 6, cotton swab head; 701, bottle cap; 702, sealing gasket; 703, bottle body; 704, dyeing solution; 8, colorimetric card. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the embodiments of the present invention more clear, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0033] A gynecological self-testing device provided by the disclosed embodiment solves the problem that when one wants to check whether one has gynecological diseases, one needs to go to the hospital for examination using professional instruments. This method is suitable for cases where one feels the condition is relatively serious. When one feels that the symptoms are very mild, or cannot accurately perceive whether one has the corresponding symptoms, it will be time-consuming to go to the hospital for examination. At the same time, a cervical dilator (i.e. duckbill forceps) is generally used during a gynecological examination. The use process is relatively painful, which will cause unnecessary pain to patients who cannot accurately judge whether they have gynecological diseases and whose symptoms are very mild.

[0034] The technical idea of ​​the present disclosure is that by setting a sampling unit, the length of the sampling head can be adjusted by rotating the handle 404, and the lesion can be directly reached without a cervical dilator, and then the sampling head is placed in the detection unit, and the sampling head is soaked in the detection liquid (i.e., the dyeing reagent) therein. After a certain period of time, the inspection and diagnosis can be achieved by observing the color change of the sampling head. Compared with the prior art, the present disclosure can be completed by the patient or relatives to help complete the sampling and detection, without the need for professional equipment, effectively saving the inspection cost, and the inspection can be completed within three minutes, effectively reducing the inspection time. The operation process is simpler and more convenient, and is more suitable for patients with mild symptoms or who cannot perceive the symptoms themselves.

[0035] refer to Figure 1 and Figure 8A gynecological self-testing device includes a sampling unit, and the sampling unit includes a sampling swab. When in use, the sampling swab is first extended to the part to be tested. By controlling the rotation of the rotating sleeve 4 at the end of the sampling unit, the sampling swab can be extended again to extend to the lesion position of the part to be tested for sampling. When in use, the length of the sampling swab can be flexibly adjusted to sample lesions of different depths, which is more flexible and convenient to use. At the same time, when sampling, if the exact depth or position of the lesion is not clearly known, the length of the sampling swab can also be adjusted to sample positions of different depths to improve the accuracy of sampling.

[0036] The self-testing device also includes a detection unit, in which a detection liquid is contained. The sampling swab after sampling is placed in the detection liquid, and the color of the sample area attached to the sampling swab is observed after waiting for a period of time.

[0037] The sample swab after color change is compared with the colorimetric card 8, and the diagnosis result is obtained by observing whether the color of the sample swab is closest to any one of the five colors in the colorimetric card 8. Optionally, the five colors in the colorimetric card 8 include light brown, light green, green, blue-black, dark green and black.

[0038] The colorimetric card 8 is a paper printout, which specifically lists the various colors required for diagnostic comparison and their meanings in the following table:

[0039] color Inflammation and HPV infection Lesions Negative Light brown No inflammation or HPV infection No lesions Weak positive Light green, green Suspected inflammation or HPV infection Positive Blue-black, black-green, green Suspected lesions

[0040] refer to Figure 2 The sampling unit includes a sampling guide sleeve 1, which is a hollow tube for accommodating a sampling swab. The edge of the head end of the sampling guide sleeve 1 is chamfered to reduce the resistance that may be generated when it is inserted into the part to be tested and the damage to the surrounding tissue. The sampling guide sleeve 1 includes a guide sleeve cone head 101, and the interior of the guide sleeve cone head 101 is a hollow guide sleeve body 102, in which the sampling swab and other related parts are placed. At the end of the guide sleeve body 102 is a connecting threaded portion 103, which is arranged on the inner wall of the guide sleeve body 102. At the end of the connecting threaded portion 103, a locking card slot band 104 is arranged, and the threaded sleeve 3 sleeved therein can be connected through the connecting threaded portion 103 and the locking card slot band 104. A handle 105 with a tendency to expand outward is arranged on the outside of the end of the guide sleeve body 102, which is more convenient during operation. The handle 105 can also be in other shapes, which are not limited here.

[0041] Optionally, the guide sleeve cone head 101 , the connecting threaded portion 103 , the locking slot band 104 and the handle 105 constituting the sampling guide sleeve 1 are all injection molded from a plastic material at one time.

[0042] refer to Figure 1The sampling unit further includes a protective sleeve 2, which is a hollow tube with one end closed. When in use, the protective sleeve 2 is sleeved on the outside of the guide sleeve cone 101 of the sampling guide sleeve 1 to isolate the internal sampling swab from dust and provide certain protection. Optionally, the protective sleeve 2 is made of soft plastic injection molding.

[0043] refer to Figure 3 The sampling unit also includes a threaded sleeve 3, which is connected to the connecting threaded portion 103 at the end of the sampling guide sleeve 1. The threaded sleeve 3 includes a sleeve body 303, an external threaded portion 301 is arranged on the outside of the sleeve body 303, and an internal threaded portion 304 is arranged on the inner wall of the sleeve body 303. The length of the external threaded portion 301 is one quarter of the length of the entire sleeve body 303, and the length of the internal threaded portion 304 is consistent with the length of the sleeve body 303, that is, it covers the entire inner wall of the sleeve body 303. Optionally, a locking boss 302 is arranged at the end of the external threaded portion 301. By setting the locking boss 302, when the threaded sleeve 3 is connected to the sampling guide sleeve 1, the fixed position of the threaded sleeve 3 can be limited.

[0044] refer to Figure 4 The inner wall of the threaded sleeve 3 is connected to the rotating sleeve 4. The rotating sleeve 4 includes a rotating handle 404 arranged at its end. A limiting step 405 is fixedly arranged at one end of the rotating handle 404. The rotating sleeve 4 is provided with an assembly groove 401 on the sleeve body 2 406 away from the limiting step 405. The assembly groove 401 is connected to the sliding groove 402. Limiting grooves 407 are provided at both ends of the sliding groove 402, and a connecting slot 403 is provided between the sleeve body 2 406 and the limiting step 405.

[0045] Optionally, the sliding groove 402 is opened on the surface of the second sleeve body 406 and is arranged along the axial direction of the second sleeve body 406, and the limiting grooves 407 are arranged at both ends of the sliding groove 402, and the directions of the two limiting grooves 407 are opposite.

[0046] refer to Figure 5 The sampling unit further comprises a telescopic rod 5, the telescopic rod 5 comprises a telescopic sliding column 506 at the end, a guide column 505 is fixed to the outer circumference of the telescopic sliding column 506, a rod body 504 is fixed to the axial direction of the telescopic sliding column 506, a guide stop ring 503 is arranged on the rod body 504, a buffer reducer 502 is fixed to the distal end of the rod body 504, a cotton tooth 501 is fixed to the end of the buffer reducer 502 away from the rod body 504, wherein the guide column 505 is connected to the sliding groove 402 and the stop groove 407. Optionally, the telescopic tube axially passes through the rotating sleeve 4 and the threaded sleeve 3, and extends into the interior of the sampling guide sleeve 1.

[0047] Optionally, the buffer reducer cone 502 is a conical structure, and a hollow structure is opened on the conical structure, so that the buffer reducer cone 502 has a certain supporting capacity in the axial direction and also has better bending performance, which can reduce the probability of breakage during sampling.

[0048] A cotton swab head 6, i.e., a sampling swab, is fixed to the head of the cotton-wound teeth 501. Optionally, the cotton swab head 6 is wound with absorbent cotton, has a length of 10-30 mm, a maximum diameter of 5-15 mm, and a sampling area in the shape of a spindle.

[0049] Working principle: The protective sleeve 2 is installed on the outer wall of the guide sleeve tube body 102 of the sampling guide sleeve 1, and the outer threaded portion 301 of the threaded sleeve 3 is screwed into the bottom of the connecting threaded portion 103 of the sampling guide sleeve 1 until the locking boss 302 of the threaded sleeve 3 is locked with the locking card slot band 104 of the sampling guide sleeve 1 to prevent rotation. The sleeve body of the rotating sleeve 4 is inserted into the inner wall of the threaded sleeve 3 of the threaded sleeve 3, and the segmented collar 305 of the threaded sleeve 3 is embedded in the limiting groove 407 of the rotating sleeve 4. The telescopic sliding column 506 of the telescopic rod 5 is located in the sleeve body of the rotating sleeve 4. The inner wall, its guide column 505 passes through the sliding groove 402 of the rotating sleeve 4 and is inserted into the groove of the inner threaded portion 304 of the sleeve of the threaded sleeve 3. The buffer reducing cone 502 and the guide limit ring 503 of the telescopic rod 5 are located in the guide sleeve body 102 of the sampling guide sleeve 1; the rotating handle 404 of the rotating sleeve 4 is rotated, and its sliding groove 402 drives the guide column 505 of the telescopic rod 5 to move along the inner threaded portion 304 of the sleeve of the threaded sleeve 3, thereby driving the telescopic rod 5 to slide in the guide sleeve body 102 of the sampling guide sleeve 1 to realize the extension and retraction of the cotton swab head 6.

[0050] When sampling, after removing the protective cover 2, hold the handle 105 of the sampling guide sleeve 1 with one hand, insert it into the part to be tested by the guide sleeve cone head 101 shown in the figure, rotate the rotating handle 404 of the rotating sleeve 4 clockwise, and the cotton swab head 6 extends to the part to be tested. According to the sampling requirements, continue to rotate the rotating handle 404 of the rotating sleeve 4 to complete the sampling process.

[0051] refer to Figure 6 The detection unit includes a bottle body 703, a bottle cap 701 is provided at the bottle mouth of the bottle body 703, the bottle cap 701 and the bottle body 703 are sealed by a sealing gasket 702, and the bottle body 703 contains the detection liquid, wherein the detection liquid is a folate receptor molecule-mediated cell double staining liquid 704.

[0052] Optionally, the bottle cap 701 is made of plastic injection molding, and its outer ring is provided with an anti-skid stripe structure to make it easier to open the bottle cap 701, and an anti-skid thread groove is provided on the inner wall. Optionally, the sealing gasket 702 is made of Teflon material to achieve sealing and prevent corrosion.

[0053] Optionally, the bottle body 703 is blown from brown glass, and the outer ring of the bottle mouth is threaded to facilitate cooperation with the bottle cap 701 to achieve sealing.

[0054] The present disclosure provides a formula of a detection liquid, which, by mass percentage, at least comprises:

[0055] Folic acid: 0.01%-5%, methylene blue: 0.01%-5%, dimethyl sulfoxide: 66%-99%, vitamin C: 0.1%-15%, glacial acetic acid: 1%-10%, glucose: 0.5%-10%.

[0056] The preparation method of the detection solution, i.e., the staining solution 704, is to first dissolve methylene blue in dimethyl sulfoxide, and then successively add folic acid, vitamin C, glacial acetic acid, etc. after the dissolution.

[0057] The principle of staining is as follows: folate receptor molecules are highly expressed in tumor cells, and are expressed in inflammatory cells or HPV virus antigens, while normal cells have less or almost no expression. When the antibody methylene blue molecules enter the cells through the cell membrane, they specifically bind to the antigens in the cells under the action of multiple physical and chemical forces such as electrostatic attraction and hydrogen bonding, and form a visible gradient color complex on the cell surface. The gradient color change of the complex is highly consistent and compliant with the patient's condition, so the degree of inflammation or HPV virus infection and abnormal lesions can be judged.

[0058] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A gynecological self-testing device, characterized in that: include: A sampling unit, wherein the sampling unit comprises a sampling swab, and when in use, the sampling swab is inserted into the part to be tested, and the sampling swab is inserted into the depth of the part to be tested again for sampling by controlling the rotation of the rotating sleeve at the end of the sampling unit; Color chart; The detection unit is provided with a detection liquid, the sampling swab after sampling is placed in the detection liquid, and the color of the sampling swab is compared with the color on the colorimetric card after the color changes to determine the corresponding information.

2. The gynecological self-testing device according to claim 1, characterized in that: The sampling unit comprises a sampling conduit, a protective sleeve, a threaded sleeve, a rotating sleeve, a telescopic rod and a cotton swab head.

3. The gynecological self-testing device according to claim 2, characterized in that: The sampling unit includes a sampling guide sleeve, which includes a guide sleeve cone head. The interior of the guide sleeve cone head is a hollow guide sleeve tube body. The end of the guide sleeve tube body is a connecting threaded portion. The end of the connecting threaded portion is provided with a locking slot band. The end of the guide sleeve tube body is provided with a handle that tends to expand outward.

4. The gynecological self-testing device according to claim 3, characterized in that: The end of the sampling guide sleeve is provided with a hollow threaded sleeve, and the threaded sleeve is spirally connected to the connecting threaded portion.

5. The gynecological self-testing device according to claim 3, characterized in that: The threaded sleeve comprises a sleeve body, an external threaded portion is arranged on the outside of the sleeve body, an internal threaded portion is arranged on the inside of the sleeve body, a locking boss is arranged at the end of the external threaded portion, and a segmented clamping ring is arranged at the end of the internal threaded portion.

6. The gynecological self-testing device according to claim 4, characterized in that: The rotating sleeve is arranged inside the threaded sleeve, and the rotating sleeve includes a rotating handle arranged at its end, and a limiting step is fixedly arranged at one end of the rotating handle. An assembly notch is provided on the sleeve body 2 of the rotating sleeve away from the limiting step, and the assembly notch is connected to the sliding groove. Limiting grooves are provided at both ends of the sliding groove, and a connecting slot is provided between the sleeve body 2 and the limiting step.

7. The gynecological self-testing device according to claim 2, characterized in that: The telescopic rod includes a telescopic sliding column at the end, a guide column is fixed to the outer circumference of the telescopic sliding column, a rod body is fixed in the axial direction of the telescopic sliding column, a guide limiting ring is arranged on the rod body, a buffer reducing cone is fixed to the far end of the rod body, and a cotton winding tooth is fixed to the end of the buffer reducing cone away from the rod body.

8. The gynecological self-testing device according to claim 7, characterized in that: A cotton swab head is fixed to the head end of the cotton-wound teeth. The cotton swab head is wound with absorbent cotton and has a length of 10-30m and a maximum diameter of 5-15mm. The sampling area of ​​the cotton swab head is in the shape of a spindle.

9. The gynecological self-testing device according to claim 1, characterized in that: The detection unit comprises a bottle body, a bottle cap is arranged at the bottle mouth of the bottle body, the bottle cap and the bottle body are sealed by a sealing gasket, and the detection liquid is contained in the bottle body.

10. A test liquid formulation for a gynecological self-testing device according to any one of claims 1 to 9, characterized in that: Calculated by mass percentage, at least including: Folic acid: 0.01%-5%, methylene blue: 0.01%-5%, dimethyl sulfoxide: 66%-99%, vitamin C: 0.1%-15%, glacial acetic acid: 1%-10%, glucose: 0.5%-10%.

Images