CN115363643B

CN115363643B - Self-sampler and sampling method for omnibearing cast-off cells of male external genitalia

Info

Publication number: CN115363643B
Application number: CN202211321949.2A
Authority: CN
Inventors: 刘玉珍; 范应元
Original assignee: Weifang Medical University
Current assignee: Weifang Medical University
Priority date: 2022-10-27
Filing date: 2022-10-27
Publication date: 2023-03-24
Anticipated expiration: 2042-10-27
Also published as: CN115363643A

Abstract

The invention discloses a self-sampler for omnibearing desquamated cells of male external genitalia and a sampling method, belonging to the medical field, wherein the self-sampler is structurally a collecting bag made of soft plastic or latex; the self-sampler for the male external genitalia to remove cells in all directions comprises an opening part, a swelling part, a collecting bag body and a saccular structure; the mouth part, the expansion part, the collecting bag body and the saccular structure are integrated; the sampling method comprises the following steps: collecting exfoliated cells, transferring a specimen, and extracting and storing the specimen; the invention can overcome the defect of the existing sampling of the exfoliated cells of the male external genitalia, avoid the inconvenience and the embarrassment of medical personnel in sampling, comprehensively collect the exfoliated cells of the male external genitalia, reduce the false negative of results and improve the detection rate of HPV.

Description

Self-sampler and sampling method for omnibearing desquamated cells of male external genitalia

Technical Field

The invention relates to the field of medical treatment, in particular to a self-sampler for omnibearing desquamated cells of male external genitalia and a sampling method.

Background

The cervical cancer is the most common malignant tumor of women, and is the only tumor which can be diagnosed, treated and prevented in early stage by screening at present, the elimination of the cervical cancer is a very difficult task in China and even all over the world at present, and researches consider that persistent infection of high-risk Human Papilloma Virus (HPV) is a main pathogenic factor of the cervical cancer, so that the discovery and timely elimination of the HPV are important methods for preventing and eliminating the cervical cancer.

In women, collecting exfoliated cervical cells for cytology and HPV detection is the main method for screening cervical cancer and precancerous lesions thereof, and generally, a vaginal speculum is adopted to expose the cervix, then a cervical brush is used to scrape cells from the junction of squamous epithelium and columnar epithelium of the cervix, the cells are quickly soaked in a fixing solution for fixation, and then the cells are sent to a pathology department for examination.

Whether men need HPV examination has been a significant concern for both the doctor and the patient. HPV is transmitted mainly by sexual life, and theoretically, the probability of infection in women is very high in men due to sexual life contact conditions during HPV infection. After the female patient turns negative through treatment, the probability of reinfection is extremely high due to sexual life. Thus, from a physician's perspective, a male HPV examination is equally important.

The carcinogenic rate of HPV in men is far lower than that of women, the symptoms of most men infected with HPV are very slight, and most symptoms can be self-healed, so that the concealment of HPV in male population is very strong, the men usually see a doctor before the diagnosis under the advice of gynecologists after the diagnosis of HPV infection by partners, and the HPV detection of the domestic medical system at present is not specially carried out for the men, so that the report of the domestic HPV infection condition of men is rare, and the HPV infection of men does not cause enough attention. As most HPV detection exists only in gynecology or dermatology clinics in various hospitals, great inconvenience is brought to screening and elimination of early male infection. In fact, HPV infection has a great influence on both men and women. Firstly, the sexual life is influenced because the main transmission path of the virus is sexual transmission, once the virus is transmitted to a sexual partner through the sexual life, the injury to women is generally large, the injury comprises physical and psychological trauma, and even the emotion and family are influenced, although the invention of the condom greatly reduces the occurrence of sexually transmitted diseases, the condom can not ensure that the transmission of the diseases cannot be caused by the sexual intercourse with the condom; secondly, once the wart appears, the appearance is seriously influenced, and huge psychological stress is caused; thirdly, the male has symptoms of being bitter, stuffy, anxious and panic, and is not favorable for the improvement of the disease condition, causes the heart injury and seriously influences the normal life.

The current HPV detection sampling process for men in a medical system has the following defects: (1) no special sampling instrument: the cast-off cell sampler is designed aiming at the female physiological structure and cannot be suitable for males, so a brush or a cotton swab is often used for taking urethral secretion for inspection; (2) multipoint sampling cannot be performed: male HPV is mainly distributed in the urethral orifice, coronary sulcus and genital root, and sampling can only be done at the urethral orifice by using a cotton swab; (3) insufficient sampling quantity: the male genitalia is dry and has special shape, which can not ensure that enough exfoliated cells can be obtained, and the conditions of order rejection or false negative can occur because the detectable cell amount is insufficient and the report can not be normally sent. Therefore, it is difficult to detect HPV from the male genital tract, and the positive rate of HPV detection is low for men, who have less reliability than for women. And different parts are sampled, the detection rate is very different, for example, the HPV positive rate of penis sampling is about 50%, the HPV positive rate of glans penis sampling is about 30%, the HPV positive rate of urethra sampling is about 10%, the HPV positive rate of sperm sampling is only about 5%, and the HPV positive rate of multipoint sampling is more than 65%.

Chinese patent CN112674803A discloses a male genital HPV virus partition sampler, which comprises a sampling main body, wherein a main inner cavity is arranged in the sampling main body, an annular sprayer is matched in the main inner cavity, three limiting ribs are arranged on the outer side of the annular sprayer and positioned in limiting sliding grooves in the inner wall of the main inner cavity, a side inner cavity is arranged on the side surface of the main inner cavity, a connecting thread hard tube is arranged in the side inner cavity, the bottom of the connecting thread hard tube is butted with the annular hard tube, an adjusting nut is limited at the top of the side inner cavity and meshed with the connecting thread hard tube, the top of the connecting thread hard tube is butted with a pressurizing flusher through a connecting hose, and the bottom of the sampling main body is butted with a centrifugal tube; this patent compares traditional brush and wipes the method, greatly reduced the wound, improved the travelling comfort, but has following shortcoming: the annular flushing can not flush the concrete parts of the urethral orifice, the penis, the foreskin or the scrotum and the like, so that the zonal sampling can not be completed; the high-pressure washing only plays a role in moistening, and cells are difficult to wash down from the surface of the genitals; the shape of the device is not suitable for the shape of male genitals, and the scrotum and the root of the penis cannot be washed; the maximum capacity of a centrifuge tube on the market is 100mL at present, the centrifugal effect is possibly poor due to overlarge capacity, and the all-round high-pressure washing of male external genitalia is difficult to finish by 100mL of liquid; the device can not be used for one time, and has the problem of cross infection; the device is complex to operate and cannot perform self-sampling; the device is complex to manufacture, expensive and difficult to popularize and use in clinic; collection of high-pressure washing liquid for male external genitalia was completed only, and exfoliated cells were not separated and stored using a preservation liquid.

Disclosure of Invention

Aiming at the defects in the prior art, the invention provides the self-sampler and the sampling method for the omnibearing cast-off cells of the male external genitalia, which can overcome the defect of sampling the cast-off cells of the existing male external genitalia, avoid the inconvenience and embarrassment of medical staff in sampling, comprehensively collect the cast-off cells of the male external genitalia, reduce the false negative of results and improve the detection rate of HPV.

In order to solve the technical problems, the technical scheme adopted by the invention is as follows:

an automatic sampler for the omnibearing shed cells of male external genitalia has a structure of a collecting bag made of soft plastic or latex;

the self-sampler for the male external genitalia to remove cells in all directions comprises a mouth part, a swelling part, a collecting bag body and a saccular structure.

The mouth part, the expansion part, the collecting bag body and the saccular structure are integrated;

the inflatable part is a cavity protruding downwards and communicated with the cavity of the collecting bag body, the front end of the inflatable part and the front end of the collecting bag body jointly form an opening, the rear end of the collecting bag body is connected with the bag-shaped structure, and the diameter of the bag-shaped structure is gradually reduced from front to back.

The diameter of the mouth part is 8-10cm, the length of the collecting bag body is 15cm, the diameter of the collecting bag body is 5-7cm, the distance from the upper side of the collecting bag body to the lowest side of the expansion part is 10cm, the length of the expansion part is 8cm, the length of the sac-like structure is 2cm, and the minimum diameter of the sac-like structure is 1cm;

the mouth part is tightened by an elastic rubber band and is used for wrapping the scrotum and the root of the penis; the collecting bag body is used for wrapping the penis; the capsular structure is used to cut or tear the liquid in the bag.

A method for sampling the whole-direction cast-off cells of male external genitalia includes: collecting exfoliated cells, transferring a specimen, and extracting and storing the specimen.

Collecting the exfoliated cells, namely opening a collecting bag from a rubber band at the opening of the collecting bag, unscrewing a cover of a centrifugal tube filled with 100mL of flushing liquid, pouring 100mL of flushing liquid into the collecting bag, sleeving all external genitalia into the collecting bag, and slowly pulling the rubber band at the opening of the collecting bag to the position above the scrotum and in front of the root of the penis to fully scrub and wash the urethral orifice, the coronary sulcus, the inside and outside of the foreskin, the scrotum and the root of the penis;

the washing solution is one of sterilized PBS or physiological saline.

And transferring the specimen, recycling the liquid in the collection bag into the original 100mL centrifuge tube through the saccular structure, screwing the cover, and sending the liquid to a clinical laboratory as soon as possible.

And extracting and storing the sample, centrifuging the liquid in a 100mL centrifugal tube by using a centrifugal machine, discarding supernatant, adding cell preservation liquid into the bottom sediment which is exfoliated cells, blowing and beating the exfoliated cells into single cell suspension by using a pipette, then putting the single cell suspension into a special sample storage bottle, and sending the single cell suspension to a hospital with detection capability or a third-party medical laboratory for detection.

Compared with the prior art, the invention has the beneficial effects that:

(1) The sampling method for the omnibearing cast-off cells of the male external genitalia can comprehensively collect the cast-off cells of the male external genitalia, and greatly reduces missed diagnosis caused in the cell sampling process;

(2) The sampling method of the omnibearing cast-off cells of the male external genitalia adopts the sterilized PBS or the normal saline in the collection bag to fully wash the genitalia, and has no wound and discomfort to patients;

(3) According to the sampling method for the omnibearing desquamated cells of the male external genitalia, the patient can sample by himself, and the embarrassment caused by the fact that medical staff draw materials can be fully overcome;

(4) The sampling method for the omnibearing cast-off cells of the male external genitalia is convenient to operate, simple and practical;

(5) The sampling method of the omnibearing cast-off cells of the male external genitalia has high detection rate, and the HPV positive detection rate can reach more than 95 percent;

(6) The self-sampler for the omnibearing cast-off cells of the male external genitalia can realize disposable use and prevent cross infection;

(7) The self-sampler for the omnibearing cast-off cells of the male external genitalia has the advantages of simple manufacture, low price, convenience and applicability.

Drawings

FIG. 1 is a schematic view of the construction of a autosampler for total exfoliation of cells from male external genitalia;

wherein the content of the first and second substances,

1. a mouth; 2. an expanded part; 3. a collection bag body; 4. a bladder-like structure.

Detailed Description

In order to more clearly understand the technical features, objects, and effects of the present invention, specific embodiments of the present invention will now be described.

Example 1

A self-sampler for the omnibearing shedding cells of male external genitalia has a structure of a collecting bag made of soft plastic;

as shown in FIG. 1, the self-sampler for the whole orientation of exfoliated cells in male external genitalia comprises a mouth part 1, a swelling part 2, a collecting bag body 3 and a sac-like structure 4.

The mouth part 1, the expansion part 2, the collecting bag body 3 and the saccular structure 4 are integrated;

the inflatable part 2 is a cavity which protrudes downwards and is communicated with the cavity of the collection bag body 3, the front end of the inflatable part 2 and the front end of the collection bag body 3 jointly form an opening part 1, the rear end of the collection bag body 3 is connected with the saccular structure 4, and the diameter of the saccular structure 4 is gradually reduced from front to back;

the diameter of the mouth part 1 is 8cm, the length of the collection bag body 3 is 15cm, the diameter of the collection bag body 3 is 5cm, the distance from the upper side of the collection bag body 3 to the lowest side of the expansion part 2 is 10cm, the length of the expansion part 2 is 8cm, the length of the saccular structure 4 is 2cm, and the minimum diameter of the saccular structure 4 is 1cm;

the mouth part 1 is tightened by an elastic rubber band and is used for wrapping the scrotum and the root of the penis; the collecting bag body 3 is used for wrapping the penis; the capsular structure 4 is used to cut or tear open the liquid inside the removal pouch.

A sampling method of all-round cast-off cells of male external genitalia specifically comprises the following steps:

1. collecting the exfoliated cells: opening the collection bag from the rubber band at the opening of the collection bag, unscrewing the cover of a centrifuge tube filled with 100mL of sterilized PBS, pouring 100mL of sterilized PBS into the collection bag, sleeving all external genitalia into the collection bag, slowly pulling the rubber band at the opening of the collection bag to the position above the scrotum and in front of the root of the penis, and fully rubbing and washing the urethral orifice, the coronary sulcus, the inside and outside of the foreskin, the scrotum and the root of the penis.

2. Transferring the specimen: the liquid in the collection bag was recovered into the original 100mL centrifuge tube, the cap was tightened, and the tube was sent to the clinical laboratory as soon as possible.

3. Sample extraction and preservation: centrifuging the liquid in a 100mL centrifugal tube by using a centrifugal machine, discarding supernatant, taking bottom sediment as exfoliated cells, adding cell preservation solution, blowing and beating the cells into single cell suspension by using a pipette, then putting the cell suspension into a special sample preservation bottle, and sending the single cell suspension to a hospital with detection capability or a third-party medical laboratory for detection.

Example 2

as shown in FIG. 1, the self-sampler for the male external genitalia which can remove cells in all directions comprises an oral part 1, a swelling part 2, a collecting bag body 3 and a saccular structure 4.

the inflatable part 2 is a cavity protruding downwards and communicated with the cavity of the collecting bag body 3, the front end of the inflatable part 2 and the front end of the collecting bag body 3 jointly form an opening part 1, the rear end of the collecting bag body 3 is connected with the saccular structure 4, and the diameter of the saccular structure 4 is gradually reduced from front to back;

the diameter of the mouth part 1 is 9cm, the length of the collecting bag body 3 is 15cm, the diameter of the collecting bag body 3 is 6cm, the distance from the upper side of the collecting bag body 3 to the lowest side of the expansion part 2 is 10cm, the length of the expansion part 2 is 8cm, the length of the saccular structure 4 is 2cm, and the minimum diameter of the saccular structure 4 is 1cm;

2. Transferring the specimen: the liquid in the collection bag was recovered into the original 100mL centrifuge tube, the cap was tightened and sent to the clinical laboratory as soon as possible.

3. Sample extraction and preservation: centrifuging the liquid in a 100mL centrifugal tube by using a centrifugal machine, discarding supernatant, adding cell preservation liquid into the bottom sediment which is the exfoliated cells, blowing and beating the cell preservation liquid into single cell suspension by using a pipette, then putting the cell suspension into a special sample preservation bottle, and sending the single cell suspension to a hospital with detection capability or a third-party medical laboratory for detection.

Example 3

An automatic sampler for the omnibearing shed cells of male external genitalia has a structure of a collecting bag made of latex;

The mouth part 1, the expansion part 2, the collection bag body 3 and the saccular structure 4 are integrated;

the diameter of the mouth part 1 is 10cm, the length of the collecting bag body 3 is 15cm, the diameter of the collecting bag body 3 is 7cm, the distance from the upper side of the collecting bag body 3 to the lowest side of the expansion part 2 is 10cm, the length of the expansion part 2 is 8cm, the length of the saccular structure 4 is 2cm, and the minimum diameter of the saccular structure 4 is 1cm;

A sampling method for omnidirectionally exfoliative cells of male external genitalia specifically comprises the following steps:

1. collecting the exfoliated cells: opening the collection bag from the rubber band at the opening of the collection bag, unscrewing the cover of a centrifuge tube filled with 100mL of sterilized PBS, pouring 100mL of physiological saline into the collection bag, sleeving all external genitalia into the collection bag, slowly pulling the rubber band at the opening of the collection bag to the position above the scrotum and in front of the root of the penis, and fully rubbing and washing the urethral orifice, the coronary sulcus, the inside and outside of the foreskin, the scrotum and the root of the penis.

All percentages used in the present invention are mass percentages unless otherwise indicated.

Finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments described above, or equivalents may be substituted for elements thereof. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A self-sampler for the omnibearing shedding cells of male external genitalia is characterized in that the self-sampler is a collecting bag made of soft plastic or latex;

the self-sampler for the omnibearing shedding of the cells of the male external genitalia comprises an opening part (1), an expansion part (2), a collecting bag body (3) and a saccular structure (4);

the mouth part (1), the expansion part (2), the collection bag body (3) and the saccular structure (4) are integrated;

the inflatable part (2) is a cavity which protrudes downwards and is communicated with the cavity of the collecting bag body (3), the front end of the inflatable part (2) and the front end of the collecting bag body (3) jointly form an opening part (1), the rear end of the collecting bag body (3) is connected with a bag-shaped structure (4), and the diameter of the bag-shaped structure (4) is gradually reduced from front to back;

the mouth part (1) is tightened by an elastic rubber band and is used for wrapping the scrotum and the root of the penis; the collecting bag body (3) is used for wrapping the penis; the saccular structure (4) is used for cutting or tearing off the liquid in the removal bag;

the diameter of the mouth part (1) is 8-10cm, the length of the collecting bag body (3) is 15cm, the diameter of the collecting bag body (3) is 5-7cm, the distance from the upper side of the collecting bag body (3) to the lowest side of the expansion part (2) is 10cm, the length of the expansion part (2) is 8cm, the length of the sac-shaped structure (4) is 2cm, and the minimum diameter of the sac-shaped structure (4) is 1cm.

2. A method for sampling whole exfoliated cells from male external genitalia using the autosampler of claim 1, comprising: collecting exfoliated cells, transferring a specimen, and extracting and storing the specimen;

collecting the exfoliated cells, namely opening a collecting bag from a rubber band at the opening of the collecting bag, unscrewing a cover of a centrifugal tube filled with 100mL of washing liquid, pouring 100mL of the washing liquid into the collecting bag, sleeving all external genitalia into the collecting bag, slowly pulling the rubber band at the opening of the collecting bag to the position above the scrotum and in front of the root of the penis, and fully rubbing and washing the urethral orifice, the coronary sulcus, the inside and outside of the foreskin, the scrotum and the root of the penis;

transferring the specimen, recycling the liquid in the collection bag into the original 100mL centrifuge tube through a sac-shaped structure, screwing down the cover, and sending the liquid to a clinical laboratory as soon as possible;

the washing solution is one of sterilized PBS or physiological saline;