Vaginal secretion closed sampling detection device and use method thereof

Abstract

The invention discloses a vaginal secretion closed sampling and detecting device and a using method thereof, and relates to the technical field of medical instruments.The vaginal secretion closed sampling and detecting device comprises a closed sterile tube, a sampling element, a detecting element and a display element, the sampling element is used for sampling vaginal secretion, the detecting element is arranged at the sampling end of the sampling element, and the display element is arranged on the closed sterile tube; the sampling element is arranged in the closed sterile tube, the sampling end of the sampling element can extend into the closed sterile tube, the sampling element is detachably connected with the closed sterile tube, a closed cavity can be formed in the closed sterile tube, and the detection element is used for reacting with vaginal secretion and developing. And the display element is used for comparing with the color developed by the detection element so as to determine the pH range of the vaginal secretion. The device can realize integration of sampling, detection and observation, is convenient to operate, and improves the detection accuracy.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a closed-loop sampling and testing device for vaginal secretions and its method of use. Background Technology

[0002] The pH value of vaginal secretions is a key indicator for assessing the vaginal microecological environment and diagnosing diseases such as bacterial vaginosis.

[0003] Currently, in clinical practice, sterile cotton swabs are typically used for sampling, and the samples are directly applied to specialized pH test strips for colorimetric analysis. However, this method has the following significant drawbacks: First, exposure of samples to air can cause liquid evaporation, drying, and potential oxidation, resulting in a significant pH shift during delayed detection, such as an increase from less than 4.5 to greater than 4.5, leading to false positive results and seriously affecting diagnostic accuracy. Secondly, the operation is complicated and poses a risk of secondary pollution.

[0004] It is evident that existing gynecological sampling swabs and transport tubes primarily focus on aseptic sample collection, preservation of microbial activity, or nucleic acid stability. They lack an integrated device that can combine sampling and detection, trigger pH color development immediately after sampling, maintain stable color development results over a long period, and facilitate closed observation. Summary of the Invention

[0005] The purpose of this invention is to provide a closed-loop sampling and testing device for vaginal secretions and its usage method, so as to solve the problems existing in the prior art, realize the integration of sampling, testing and observation, and be easy to operate and improve the accuracy of testing.

[0006] To achieve the above objectives, the present invention provides the following solution: This invention provides a closed-loop sampling and detection device for vaginal secretions, comprising a closed sterile tube, a sampling element, a detection element, and a display element. The sampling element is used to sample vaginal secretions. The detection element is disposed at the sampling end of the sampling element, and the sampling end of the sampling element can extend into the closed sterile tube. The sampling element and the closed sterile tube are detachably connected, and a sealed chamber can be formed inside the closed sterile tube. The detection element reacts with the vaginal secretions and develops a color. The display element is used to compare the color development with that of the detection element to determine the pH range of the vaginal secretions.

[0007] Preferably, the closed sterile tube includes a tube body and a tube cap, one end of the tube body is open, and the tube cap is detachably connected to the opening of the tube body.

[0008] Preferably, the sampling element includes a cotton swab rod and a cotton head, the cotton head is fixed to one end of the cotton swab rod and is the sampling end of the sampling element, the other end of the cotton swab rod is connected to the tube cap, and the detection element is located on the cotton head.

[0009] Preferably, an observation window is formed at the end of the tube body away from the tube cap, and when the cotton swab rod drives the cotton head to extend into the tube body, the position of the cotton head corresponds to the observation window; the display element is fixed on the tube body and is positioned close to the observation window.

[0010] Preferably, the detection element is a pH colorimetric material, which is immobilized on the cotton head.

[0011] Preferably, the pH colorimetric material is a composite pH indicator, which includes bromocresol green and methyl red.

[0012] Preferably, the display element is a standard colorimetric reference card.

[0013] Preferably, the inner wall of the sealed sterile tube is coated with a non-reactive moisturizing agent coating, which does not contact the detection element, or the non-reactive moisturizing agent coating does not interfere with color development after contacting the detection element.

[0014] Preferably, the non-reactive moisturizing agent coating comprises at least one of glycerin, propylene glycol, polyethylene glycol or sorbitol as the main component, and at least one of hydroxypropyl methylcellulose, sodium carboxymethyl cellulose or polyvinyl alcohol as the film-forming agent, and the thickness of the non-reactive moisturizing agent coating is 10 micrometers to 100 micrometers.

[0015] The present invention also provides a method of using the vaginal secretion closed sampling and detection device based on any one of the above technical solutions, comprising the following steps: S1. The closed-type vaginal secretion sampling and testing device is sterilized; S2. Remove the sampling element and the detection element through a sealed sterile tube; S3. Insert the sampling end of the sampling element into the patient's vagina and bring it into contact with the secretions, so that the secretions wet the detection element at the sampling end and trigger the color reaction of the detection element; S4. Place the sampling element and detection element containing the secretions back into the closed sterile tube and immediately seal the closed sterile tube; S5. Observe the color of the detection element from the outside of the self-sealing sterile tube, and compare the observed color with the standard colorimetric colorimeter of the display element to determine the pH range of vaginal secretions.

[0016] The present invention achieves the following technical effects compared to the prior art: The present invention provides a closed-loop sampling and testing device for vaginal secretions and its method of use, comprising a closed sterile tube, a sampling element, a detection element, and a display element. The sampling element is used to sample vaginal secretions, and the detection element is disposed at the sampling end of the sampling element. After sampling, the detection element immediately develops a color. The sampling end of the sampling element can extend into the closed sterile tube, and the sampling element and the closed sterile tube are detachably connected. A sealed chamber can be formed inside the closed sterile tube, thereby sealing the sampling element and the detection element within the sealed chamber. This effectively prevents pH drift caused by sample drying, making the test results closer to the actual values ​​in the body, and greatly improving the screening for bacterial vaginosis. The accuracy of the test is high. Meanwhile, the anti-drying design and sealed environment ensure that the colorimetric results remain stable for several hours, allowing for safe sample transport and solving the problem of delayed detection. The detection element reacts with vaginal secretions and develops color, while the display element compares the colorimetric results with those of the detection element to determine the pH range of the vaginal secretions. This allows the closed-loop vaginal secretion sampling and detection device of this invention to integrate sampling, colorimetric development, and observation, eliminating the need for sample transfer and additional reagents. It achieves a simple "one-insert-one-cap-one-view" operation, improving detection efficiency, and is particularly suitable for primary healthcare and bedside testing. Furthermore, its simple overall structure, based on mature consumable technology, facilitates large-scale production and has high market promotion value. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the closed-loop sampling and detection device for vaginal secretions in Example 1; Figure 2 This is a schematic diagram of the sampling element and detection element in Example 1; In the diagram: 1-tube body, 2-tube cap, 3-cotton swab rod, 4-cotton head, 5-detection element, 6-display element, 7-non-reactive moisturizing agent coating, 8-observation window. Detailed Implementation

[0019] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] The purpose of this invention is to provide a closed-loop sampling and testing device for vaginal secretions and its usage method, so as to solve the problems existing in the prior art, realize the integration of sampling, testing and observation, and be easy to operate and improve the accuracy of testing.

[0021] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0022] Example 1 like Figures 1-2 As shown, this embodiment provides a closed-loop sampling and testing device for vaginal secretions, including a closed sterile tube, a sampling element, a detection element 5, and a display element 6. The sampling element is used to sample vaginal secretions. The detection element 5 is disposed at the sampling end of the sampling element, and then the detection element 5 performs immediate color development after sampling. The sampling end of the sampling element can extend into the closed sterile tube. The sampling element and the closed sterile tube can be detachably connected, and a sealed chamber can be formed inside the closed sterile tube, thereby sealing the sampling element and the detection element 5 in the sealed chamber. This effectively prevents pH drift caused by sample drying, making the test results closer to the true value in vivo, and greatly improving the screening of bacterial vaginosis. The accuracy of the test is ensured, and the anti-drying design and sealed environment allow the color development results to remain stable for several hours, allowing for safe sample transport and solving the problem of delayed detection. The detection element 5 is used to react with vaginal secretions and develop color, and the display element 6 is used to compare with the color development of the detection element 5 to determine the pH range of the vaginal secretions. Thus, the vaginal secretion closed sampling and detection device of this invention integrates sampling, color development, and observation, eliminating the need for sample transfer and additional reagents. It achieves simple operation of "one insertion, one cap, and one look," improving detection efficiency. It is especially suitable for primary healthcare and bedside testing. At the same time, the overall structure is simple and based on mature consumable technology, making it easy to mass-produce and giving it high market promotion value.

[0023] Specifically, the closed sterile tube includes a tube body 1 and a tube cap 2. One end of the tube body 1 is open, and the tube cap 2 is detachably connected to the opening of the tube body 1, thereby enabling the removal of the sampling element and the sealing after sampling. The connection between the tube body 1 and the tube cap 2 is preferably a threaded connection.

[0024] The sampling element includes a cotton swab rod 3 and a cotton head 4. The cotton head 4 is fixed to one end of the cotton swab rod 3 and serves as the sampling end of the sampling element. The other end of the cotton swab rod 3 is connected to the tube cap 2, which facilitates the removal and placement of the cotton swab rod 3 into the closed sterile tube. The detection element 5 is located on the cotton head 4, ensuring that when the cotton head 4 samples the patient's vaginal secretions, the detection element 5 can contact the secretions and produce a color reaction.

[0025] The cotton head 4 is preferably made of medical absorbent cotton.

[0026] The tube body 1 has an observation window 8 at the end away from the tube cap 2. The observation window 8 is made of transparent material, so that the internal state of the tube body 1 can be observed. When the cotton swab rod 3 drives the cotton head 4 into the tube body 1, the position of the cotton head 4 corresponds to the observation window 8, so that the color of the cotton head 4 can be directly observed through the observation window 8. This allows the user to read the pH value instantly and accurately through the observation window 8 in a closed state. The display element 6 is fixed on the tube body 1 and is set close to the observation window 8. By bringing the display element 6 close to the cotton head 4, the color of the cotton head 4 can be compared with the color display element, and the comparison accuracy can be improved.

[0027] The tube body 1 is preferably made of polypropylene material, and its tail section of about 1.5 cm is made of transparent PET material, forming an observation window 8. The tube cap 2 has a built-in silicone sealing ring, which can form a highly sealed sterile inner cavity after being screwed tightly with the open end of the tube body 1.

[0028] As a preferred embodiment, the observation window 8 can also be directly opened on the bottom surface of the tube body 1, and the display element 6 can be set close to the observation window 8. Those skilled in the art can make adaptive adjustments to the specific positions of the observation window 8 and the color display element according to actual needs.

[0029] The detection element 5 is a pH colorimetric material that is sensitive to the pH value of vaginal secretions. The pH colorimetric material is fixed on the cotton head 4. When the vaginal secretions are sampled through the cotton head 4, a colorimetric reaction will occur immediately when the pH colorimetric material comes into contact with the secretions, making it easy to know the pH value of the vaginal secretions.

[0030] In a preferred embodiment, the pH colorimetric material is a composite pH indicator. This composite pH indicator exhibits a continuous and visually distinguishable color gradient within a pH range of 3.0-7.0 (preferably 4.0-5.5). The composite pH indicator comprises bromocresol green and methyl red, and is firmly bonded to the fibers of the cotton head 4 through impregnation, embedding, or coating processes. After being immobilized in the cotton head 4, it remains active even after sterilization by ethylene oxide or gamma irradiation. In this embodiment, the cotton head 4 is impregnated in an ethanol solution containing 0.04% bromocresol green and 0.02% methyl red, followed by drying and curing at 50°C. This allows the pH colorimetric material to be firmly immobilized in the cotton head 4, and the color of the pH colorimetric material changes from yellow to blue-green near pH 4.5, exhibiting a clear gradient.

[0031] Display element 6 is a standard colorimetric reference card.

[0032] The inner wall of the sealed sterile tube is coated with a non-reactive humectant coating 7 to prevent drying. The non-reactive humectant coating 7 does not contact the detection element 5, or, if the non-reactive humectant coating 7 comes into contact with the detection element 5, it does not interfere with color development.

[0033] The non-reactive moisturizing coating 7 contains at least one of glycerin, propylene glycol, polyethylene glycol or sorbitol as the main component, and at least one of hydroxypropyl methylcellulose, sodium carboxymethyl cellulose or polyvinyl alcohol as the film-forming agent. The non-reactive moisturizing coating 7 is preferably a solid or gel-like film formed on the inner wall or inner bottom surface of a closed sterile tube. The thickness of the non-reactive moisturizing coating 7 is 10 micrometers to 100 micrometers, preferably 10 micrometers to 50 micrometers.

[0034] As a preferred embodiment, the non-reactive humectant coating 7 is formed by coating and drying 80wt% glycerin and 5wt% hydroxypropyl methylcellulose, with the balance being water. It can maintain a high humidity environment inside the closed sterile tube, and because it is non-flowing, it will not come into direct contact with the cotton head 4.

[0035] In this embodiment, the bottom of the inner wall of the tube 1 is preferably sprayed with a trace amount of medical-grade glycerin as an inert moisturizer, and the outer wall of the tube 1 near the observation window 8 is printed with a standard color chart containing standard color blocks of pH 4.0, pH 4.5 and pH 5.5 as a display element 6.

[0036] Before use, the entire embodiment must undergo ethylene oxide sterilization or irradiation sterilization treatment.

[0037] This embodiment, through the above design, has a reasonable structure and mature manufacturing process, and can be manufactured on a large scale through existing medical device production lines. It solves a clear clinical need and has broad application prospects in the fields of gynecological disease diagnosis, health screening, and personal care.

[0038] Example 2 This embodiment provides a method for using the closed-loop sampling and detection device for vaginal secretions based on Embodiment 1, including the following steps: S1. The closed-type vaginal secretion sampling and testing device is sterilized; S2. Remove the sampling element and detection element 5 through a sealed sterile tube; S3. Insert the sampling end of the sampling element into the patient's vagina and contact it with the secretions, so that the secretions wet the detection element 5 at the sampling end and trigger the color reaction of the detection element 5. S4. Place the sampling element and detection element 5 containing the secretions back into the closed sterile tube, move the sampling end to the observation window 8 area, and immediately seal the closed sterile tube; S5. Hold the sealed sterile tube and observe the color of the detection element 5 from the outside of the sealed sterile tube. Compare the observed color with the standard colorimetric colorimeter of the display element 6 to determine the pH range of the vaginal secretions.

[0039] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A closed-loop sampling and detection device for vaginal secretions, characterized in that: The device includes a closed sterile tube, a sampling element, a detection element, and a display element. The sampling element is used to sample vaginal secretions. The detection element is disposed at the sampling end of the sampling element, and the sampling end of the sampling element can extend into the closed sterile tube. The sampling element and the closed sterile tube can be detachably connected, and a sealed chamber can be formed inside the closed sterile tube. The detection element is used to react with the vaginal secretions and develop a color. The display element is used to compare the color development of the detection element with the color development of the detection element to determine the pH range of the vaginal secretions.

2. The vaginal secretion closed sampling and detection device according to claim 1, characterized in that: The closed sterile tube includes a tube body and a tube cap, with one end of the tube body open and the tube cap detachably connected to the opening of the tube body.

3. The vaginal secretion closed sampling and detection device according to claim 2, characterized in that: The sampling element includes a cotton swab rod and a cotton head. The cotton head is fixed to one end of the cotton swab rod and serves as the sampling end of the sampling element. The other end of the cotton swab rod is connected to the tube cap, and the detection element is located on the cotton head.

4. The vaginal secretion closed sampling and detection device according to claim 3, characterized in that: The tube body has an observation window at the end away from the tube cap, and when the cotton swab rod drives the cotton head into the tube body, the position of the cotton head corresponds to the observation window; the display element is fixed on the tube body and is set close to the observation window.

5. The vaginal secretion closed sampling and detection device according to claim 3, characterized in that: The detection element is a pH colorimetric material, which is fixed on the cotton head.

6. The vaginal secretion closed sampling and detection device according to claim 5, characterized in that: The pH colorimetric material is a composite pH indicator, which includes bromocresol green and methyl red.

7. The vaginal secretion closed sampling and detection device according to claim 1, characterized in that: The display element is a standard colorimetric reference card.

8. The vaginal secretion closed sampling and detection device according to claim 1, characterized in that: The inner wall of the sealed sterile tube is coated with a non-reactive moisturizing agent coating. The non-reactive moisturizing agent coating does not contact the detection element, or the non-reactive moisturizing agent coating does not interfere with color development after contacting the detection element.

9. The vaginal secretion closed sampling and detection device according to claim 8, characterized in that: The non-reactive moisturizing agent coating comprises at least one of glycerin, propylene glycol, polyethylene glycol or sorbitol as the main component, and at least one of hydroxypropyl methylcellulose, sodium carboxymethyl cellulose or polyvinyl alcohol as the film-forming agent, and the thickness of the non-reactive moisturizing agent coating is 10 micrometers to 100 micrometers.

10. A method of using the vaginal secretion closed sampling and detection device according to any one of claims 1-9, characterized in that: Includes the following steps: S1. The closed-type vaginal secretion sampling and testing device is sterilized; S2. Remove the sampling element and the detection element through a sealed sterile tube; S3. Insert the sampling end of the sampling element into the patient's vagina and bring it into contact with the secretions, so that the secretions wet the detection element at the sampling end and trigger the color reaction of the detection element; S4. Place the sampling element and detection element containing the secretions back into the closed sterile tube and immediately seal the closed sterile tube; S5. Observe the color of the detection element from the outside of the self-sealing sterile tube, and compare the observed color with the standard colorimetric colorimeter of the display element to determine the pH range of vaginal secretions.

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