Integrated cervical HPV (human papillomavirus) and cervical cytology self-sampling device

Abstract

The invention provides an integrated cervical HPV (human papillomavirus) and cervical cytology self-sampling device, and belongs to the field of medical instruments. The problems that most existing cervix uteri self-sampling devices are designed in a split mode, samplers and specimen protection liquid are packaged separately, the structure is complex, large-scale production is not facilitated, the sampling efficiency of sampling heads is low, and samples of the sampling heads are prone to being polluted are solved. The device comprises a sleeve, a central sampling tube and a balloon, the sleeve slidably sleeves the outer side of the central sampling tube, the central sampling tube is of a hollow structure, the front end of the central sampling tube is provided with a sampling head, the outer side of the central sampling tube is fixedly sleeved with a piston, the outer wall of the piston is in contact with the inner wall of the sleeve and is in sliding fit with the inner wall of the sleeve, and the outer wall of the piston is in sliding fit with the inner wall of the sleeve. The tail end of the central sampling tube is connected with a balloon, a plurality of through holes are formed in the side wall of the central sampling tube between the sampling head and the piston, and a sealing end cover is arranged at the front end of the sleeve. The self-sampling device is mainly used for self-sampling of cervical cancer screening.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and particularly relates to an integrated self-sampling device for cervical HPV virus and cervical cytology. Background Art

[0002] HPV (human papillomavirus) infection is a key factor in the occurrence of cervical cancer. More than 95% of cervical cancers are caused by HPV infection. The vast majority of HPV infections can resolve spontaneously, and only a few will persist, leading to the occurrence of cervical precancerous lesions and cervical cancer. The HPV test and TCT (ThinPrep cytology test) of cervical exfoliated cells are effective means for screening cervical precancerous lesions and cervical cancer, and are also the simplest, most economical, and convenient screening methods. Currently, the sampling of cervical exfoliated cells in hospitals, physical examination centers, or third-party testing centers all requires professional personnel such as gynecologists or nurses to operate. The main process of the operation is, in sequence, to fully expose the cervical os with a vaginal speculum, collect exfoliated cells with a cervical swab, and transfer the exfoliated cells to a preservation solution. However, this sampling method can easily make the examinee feel uncomfortable. Some examinees are nervous when facing medical staff or due to other factors, resulting in vaginal tension and are unable to tolerate the speculum to dilate the vagina and give up sampling. In addition, some examinees cannot go to professional places for screening due to remote locations or their own reasons. Therefore, there is an urgent need to develop a cervical self-sampling device, which can not only improve the accessibility of cervical cancer and precancerous lesion screening, increase the willingness for active screening, reduce the pain of the examinee and the wasted time such as queuing for medical treatment, but also optimize the allocation of medical resources. The existing cervical self-sampling devices still have the following problems: Most devices are designed as split-type, the sampler and the specimen preservation solution are separately packaged, and the user needs to transfer the specimen to the preservation solution after self-sampling, increasing the risk of contamination and the operation difficulty; in addition, when the examinee self-samples, it is impossible to confirm whether the sampling position is accurate, which easily leads to insufficient sampling or injury; although some cannula-type devices avoid the contamination of sampling by vaginal secretions, using a cotton swab head may result in insufficient sampling. In addition, the design of some devices is complex and not conducive to large-scale production. Chinese invention patent CN220917441U is a pressing-type HPV self-sampling device, which can be operated with one hand and has a simple design. However, if the sampling head cannot be retracted into the receiving cylinder after sampling, it is impossible to ensure that the sampling head is not contaminated by vaginal secretions when the sampler is withdrawn from the vagina. Summary of the Invention

[0003] In view of this, the present invention aims to provide an integrated self-sampling device for cervical HPV virus and cervical cytology to solve the problems that most of the existing cervical self-sampling devices are designed as split-type, the sampler and the specimen preservation solution are separately packaged, the user needs to transfer the specimen to the preservation solution after self-sampling, increasing the risk of contamination and the operation difficulty, the complex structure is not conducive to large-scale production, the sampling efficiency of the sampling head is low, and the sample of the sampling head is easily contaminated.

[0004] To achieve the above object, the present invention adopts the following technical solutions: An integrated self-sampling device for cervical HPV virus and cervical cytology, which includes a sleeve, a central sampling tube and a balloon. The sleeve is slidably sleeved outside the central sampling tube. The central sampling tube is a hollow structure. A sampling head is provided at the front end of the central sampling tube. A piston is fixedly sleeved outside the central sampling tube. The outer wall of the piston contacts and slidably cooperates with the inner wall of the sleeve. A balloon is connected to the tail end of the central sampling tube. A plurality of through holes are provided on the side wall of the central sampling tube between the sampling head and the piston. A sealing end cap is provided at the front end of the sleeve.

[0005] Furthermore, a connecting pipe is provided at the tail end of the central sampling tube. The central sampling tube and the balloon are communicated through the connecting pipe.

[0006] Furthermore, a cell protection solution is provided inside the balloon.

[0007] Furthermore, a stop clamp is provided on the connecting pipe.

[0008] Furthermore, the sampling head includes a brush disc. A plurality of brush hairs are evenly provided at the front end of the brush disc. The tail end of the brush disc is connected to the central sampling tube.

[0009] Furthermore, the sealing end cap and the bottom of the sleeve are connected by threads.

[0010] Furthermore, a handle is provided on the outer wall at the tail end of the sleeve.

[0011] Furthermore, a holding end is provided on the outer wall at the tail end of the central sampling tube.

[0012] Furthermore, a plurality of fins are evenly spaced circumferentially on the side wall of the central sampling tube between the piston and the holding end.

[0013] Furthermore, the materials of the balloon and the connecting pipe are both rubber materials.

[0014] Compared with the prior art, the beneficial effects of the present invention are:

[0015] 1. The present invention provides an integrated self-sampling device for cervical HPV virus and cervical cytology. By pushing and rotating the central sampling tube, the sampling head collects the sample. After the sample collection is completed, the central sampling tube is pulled to retract the sampling head into the sleeve, ensuring that the sampling head is not contaminated by vaginal secretions during the process of withdrawing the device from the vagina;

[0016] 2. In the present invention, the sampler and the balloon containing the specimen preservation solution are integrally designed. After the sample collection of the device is completed and withdrawn from the vagina, the sampling head is sealed with a sealing end cap. At this time, the sampling head is in the closed chamber of the tube sleeve. The stopcock is opened, and the central sampling tube is pulled again. Under the action of the pressure difference, the preservation solution in the balloon flows through the connecting tube and the through hole on the central sampling tube in sequence and into the chamber where the sampling head is located in the inlet sleeve. After all the preservation solution enters the chamber, the stopcock is closed to protect the sampled specimen, effectively reducing sample contamination or loss during the transfer process;

[0017] 3. The present invention adopts a disc-shaped sampling head. Compared with a cotton swab-shaped sampling head, the sampling area is increased, and the sampling efficiency can be significantly improved, which is especially beneficial for TCT detection;

[0018] 4. The present invention is a disposable sampling device, which avoids the safety hazards caused by repeated use from the source;

[0019] 5. The structure of the present invention is simple and the cost is low, which is conducive to large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation to the present invention. In the drawings:

[0021] Figure 1 is a schematic diagram of the overall structure of an integrated cervical HPV virus and cervical cytology self-sampling device according to the present invention;

[0022] Figure 2 is a schematic diagram of a partial structure of an integrated cervical HPV virus and cervical cytology self-sampling device according to the present invention;

[0023] Figure 3 is a schematic diagram of the structure of the sleeve and the sealing end cap in an integrated cervical HPV virus and cervical cytology self-sampling device according to the present invention;

[0024] Figure 4 is an enlarged view of the structure at the sampling head of an integrated cervical HPV virus and cervical cytology self-sampling device according to the present invention;

[0025] Figure 5 is a schematic diagram of the structure of an integrated cervical HPV virus and cervical cytology self-sampling device according to the present invention when the sleeve is transparent;

[0026] 1 - Sleeve, 2 - Central sampling tube, 3 - Balloon, 4 - Sampling head, 5 - Piston, 6 - Through hole, 7 - Sealing end cap, 8 - Connecting tube, 9 - Stopcock, 10 - Brush disc, 11 - Brush, 12 - Handle, 13 - Gripping end, 14 - Rib. Detailed implementation mode

[0027] The following will clearly and completely elaborate on the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings in the embodiments of the present invention. It should be noted that, without conflict, the embodiments and features in the embodiments of the present invention can be combined with each other. The described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments.

[0028] See Figures 1-5 To illustrate this embodiment, an integrated self-sampling device for cervical HPV virus and cervical cytology includes a sleeve 1, a central sampling tube 2, and a balloon 3. The sleeve 1 is slidably sleeved outside the central sampling tube 2. The central sampling tube 2 is a hollow structure. A sampling head 4 is provided at the front end of the central sampling tube 2. A piston 5 is fixedly sleeved outside the central sampling tube 2. The outer wall of the piston 5 contacts and slidably cooperates with the inner wall of the sleeve 1. A balloon 3 is connected to the tail end of the central sampling tube 2. A cell protection solution is provided inside the balloon 3. A plurality of through holes 6 are formed in the side wall of the central sampling tube 2 between the sampling head 4 and the piston 5. A sealing end cap 7 is provided at the front end of the sleeve 1. In this embodiment, the sampling head 4 collects the sample by pushing and rotating the central sampling tube 2. After the sample collection is completed, the central sampling tube 2 is pulled to retract the sampling head 4 into the sleeve 1, ensuring that the sampling head is not contaminated by vaginal secretions during the process of withdrawing the device from the vagina.

[0029] In this embodiment, a connecting pipe 8 is provided at the tail end of the central sampling tube 2. The central sampling tube 2 and the balloon 3 are connected through the connecting pipe 8.

[0030] In this embodiment, a stop clamp 9 is provided on the connecting pipe 8. The stop clamp 9 is used to control the on-off of the connecting pipe 8.

[0031] In this embodiment, the sampling device and the balloon 3 containing the specimen protection solution are integrally designed. After the sample collection is completed and the device is withdrawn from the vagina, the sampling head 4 is sealed with the sealing end cap 7. At this time, the sampling head 4 is in the sealed chamber of the tube sleeve 1. The stop clamp 8 is opened, and the central sampling tube 2 is pulled again. The protection solution in the balloon 3 flows into the chamber where the sampling head 4 is located in the sleeve 1 through the connecting pipe 8 and the through holes 6 on the central sampling tube 2 under the action of the pressure difference. After all the protection solution enters the chamber, the stop clamp 9 is closed to protect the sampled sample, effectively reducing sample contamination or loss during the transfer process.

[0032] In this embodiment, the sampling head 4 includes a bristle disk 10. A plurality of bristles 11 are evenly arranged at the front end of the bristle disk 10. The tail end of the bristle disk 10 is connected to the central sampling tube 2. Compared with the cotton swab sampling head, the sampling area of the sampling head 4 in this embodiment is increased, and the sampling efficiency can be significantly improved, which is especially beneficial for TCT detection.

[0033] In this embodiment, the overall shape of the bristles 11 on the sampling head 4 can be adaptively adjusted according to actual needs. The plurality of bristles 11 on the sampling head 4 can also be designed and combined into a sampling head 4 with an overall hemispherical structure, thereby improving the comfort of the device during sampling.

[0034] In this embodiment, the sealing end cap 7 and the bottom of the sleeve 1 are connected by threads.

[0035] In this embodiment, a handle 12 is provided on the outer wall of the tail end of the sleeve 1. The handle 12 is used for hand-held fixation and pushing and pulling of the sleeve 1.

[0036] In this embodiment, a holding end 13 is provided on the outer wall of the tail end of the central sampling tube 2. The holding end 13 is used for hand-held pushing and pulling of the central sampling tube 2.

[0037] In this embodiment, a plurality of ribs 14 are evenly arranged at intervals along the circumferential direction on the side wall of the central sampling tube 2 between the piston 5 and the holding end 13. The arrangement of the ribs 14 increases the strength of the central sampling tube 2 and prevents the central sampling tube 2 from being damaged due to excessive force during pushing and pulling.

[0038] In this embodiment, both the balloon 3 and the connecting tube 8 are made of rubber material. The materials of the balloon 3 and the connecting tube 8 in this embodiment can be adaptively adjusted according to actual needs.

[0039] In this embodiment, the sleeve 1 can be selected as a transparent or opaque sleeve according to actual needs. The structure of using the transparent sleeve 1 is as Figure 5 shown.

[0040] This embodiment is a disposable sampling device, which avoids the safety hazards caused by repeated use at the source.

[0041] This embodiment has a simple structure and low cost, which is beneficial to large-scale production.

[0042] The working principle of this embodiment is as follows: In the initial state of the device, the stop clamp 9 is in the closed state, the protective liquid in the balloon 3 is in the filled state, and the sampling head 4 is in the initial position, that is, the sampling head 4 is in the cannula 1. The user takes out the sampling device from the package, lubricates the sampler with physiological saline, removes the sealing end cap 7 at the front end of the cannula 1, and carefully and slowly inserts the sampler into the vagina by holding the sampler with one hand through the handle 12 until resistance is felt and it cannot be inserted further, indicating that the front end of the sampler has reached the cervical os. At this time, the sampler is slightly withdrawn by no more than 1 cm. With the other hand, carefully and slowly push the central sampling tube 2 through the holding end 13 until it cannot be pushed, indicating that the sampling head 4 has completely extended. Hold the cannula 1 with one hand and rotate the holding end 13 three to five turns in any direction with the other hand to complete the collection of the sample by the sampling head 4. After the sample collection is completed, retract the sampling head 4 into the cannula 1 by pulling the holding end 13, then withdraw the device from the vagina through the holding end 13. Then screw the sealing end cap 7 into the front end of the cannula 1. After tightening the sealing end cap 7, open the stop clamp 9, and pull the holding end 13 backward again. At this time, the pressure difference causes the protective liquid in the balloon 3 to flow into the chamber where the sampling head 4 is located in the cannula 1 through the communication tube 8 and the through hole 6 on the central sampling tube 2 in sequence. After all the protective liquid enters the chamber, close the stop clamp 9, and the sampling is completed. Then package the entire sampling device and send it to a professional institution for cervical cancer screening.

[0043] The embodiments of the present invention disclosed above are only used to help explain the present invention. The embodiments do not describe all the details in detail, nor do they limit the invention to the specific embodiments described. According to the content of this specification, many modifications and changes can be made. These embodiments are selected and specifically described in this specification to better explain the principle and practical application of the present invention, so that those skilled in the art in the relevant technical field can well understand and utilize the present invention.

Claims

1. An integrated cervical HPV virus and cervical cytology self-sampling device, characterized by: The invention comprises a sleeve (1), a central sampling tube (2) and a balloon (3). The sleeve (1) is slidably sleeved on the outer side of the central sampling tube (2). The central sampling tube (2) is a hollow structure. A sampling head (4) is arranged at the front end of the central sampling tube (2). A piston (5) is fixedly sleeved on the outer side of the central sampling tube (2). The outer wall of the piston (5) contacts and slidably fits with the inner wall of the sleeve (1). The tail end of the central sampling tube (2) is connected with the balloon (3). A plurality of through holes (6) are provided on the side wall of the central sampling tube (2) between the sampling head (4) and the piston (5). A sealing end cover (7) is arranged at the front end of the sleeve (1).

2. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: A connecting tube (8) is provided at the tail end of the central sampling tube (2), and the central sampling tube (2) and the balloon (3) are connected via the connecting tube (8).

3. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: Furthermore, a cell protection liquid is provided in the balloon (3).

4. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 2, characterized in that: The connecting pipe (8) is provided with a flow-stop clamp (9).

5. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: The sampling head (4) comprises a bristle disc (10), a front end of which is evenly provided with a plurality of bristles (11), and a rear end of the bristle disc (10) is connected to a central sampling tube (2).

6. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: The sealing end cover (7) is connected to the bottom of the sleeve (1) via threads.

7. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: A handle (12) is provided on the outer wall of the rear end of the sleeve (1).

8. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: A gripping end (13) is provided on the outer wall of the rear end of the central sampling tube (2).

9. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 8, characterized in that: A plurality of fins (14) are evenly spaced along the circumferential direction on the side wall of the central sampling tube (2) between the piston (5) and the gripping end (13).

10. The integrated cervical HPV virus and cervical cytology self-sampling device according to claim 1, characterized in that: The balloon (3) and the connecting tube (8) are both made of rubber.

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