RU2779089C2 - Device for taking smear from upper part of vagina and pap smear - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: device for taking a smear from the upper part of the vagina and a pap smear, containing a tip, includes an outer cylinder; a head separated into parts in a longitudinal direction in front of the outer cylinder, having an inner side of the head, made flat and thinner for simplification of head output, and an end side curved and thicker for control; the first ring in the end part of the outer cylinder; a spiral end for integration of the outer cylinder, piston lids, and a tip holder. Two, the second and the third, rings connect the spiral end to the piston lid for provision of movement of an inner cylinder. The first inner cylinder is installed with the possibility of free movement inside the outer cylinder. The piston lid engages with the soral end. The fourth ring has a protrusion of 1 mm in the end part for blocking the movement of the first inner cylinder. The first spring is between the second and the fifth ring. The second inner cylinder is closed from the front inside the first inner cylinder, and it has the first hole for head input in a center. The fifth ring rests on the spring. There is a hole in the center for input of the tip holder to the end part of the spiral. The second spring is located in the second inner cylinder. A reverse stroke cylinder serves for pressure transmission to the device for taking a smear from the upper part of the vagina and a pap smear. A square-shaped hole serves for the connection of the reverse stroke cylinder to a spiral on the front side, a circle is for simplification of pushing by a thumb the rear part of the reverse stroke cylinder. A cone prevents reverse retraction of the piston lid. The hole combines the piston lid with the reverse stroke cylinder. A twisted spiral has a square shape inside the reverse stroke cylinder. The sixth ring is located between the spiral and the tip holder. The seventh ring is intended for fixation of the tip holder.

EFFECT: provision of a possibility of self-application of a device.

6 cl, 12 dwg

Description

The field of technology to which the invention belongs

This invention relates to a device for taking a swab from the upper part of the vagina and a Pap smear, providing convenience for both women themselves and doctors when taking samples of cells or fluids (materials) of the cervix from the vagina for testing for the presence of human papillomavirus (HPV) , as well as bacposeva and sensitivity determination.

Prior Art

The cervix is the area where the uterus and vagina meet and includes the lower part of the uterus in the female reproductive system. Looking at the cervix from the vagina, it is shaped like a hemisphere at the end of the vagina. The cervix is the narrow cervical region of the uterus that opens into the vagina. It has a very strong muscular structure. It is also very tightly closed and can only open during childbirth. The cervix also helps prevent infections from entering the uterus and serves as an important barrier.

Human papillomavirus (HPV) is one of the most common sexually transmitted infections. HPV is found on the penis in men and on the bulb, vulva, and cervix in women. When HPV enters the body, it invades the cells and is called recurrent genital warts (warts). Their symptoms are warts on the hands and feet, the respiratory tract, and the genital area. There are hundreds of different subgroups of this virus known to exist, and some of these groups cause cervical cancer. HPV infection is the most common and occurs at any age. A person exposed to HPV infection does not become immune to the virus. There are two reasons why the body cannot acquire immunity:

• The body is not able to effectively respond to infection, and therefore the human immune system is not able to provide long-term protection. The human body may again face the risk of infection for the same type of HPV.

• The HPV virus or particles belonging to the virus do not mix with the blood and reside in the cell. Therefore, the body does not “remember” the virus and immunity is not formed.

Cervical cancer becomes a disease with a significantly higher probability of recovery when it is detected at the stage of a pathological precancerous change or at the earliest stage of cancer. Early diagnosis and treatment of this disease is very important. The incubation period for cervical cancer is very long. The period from the appearance of pathological precancerous changes, which are precursors of cancer in cells, to the formation of cancer varies from 5 to 10 years and in some cases even more.

A smear test is done to monitor for HPV infection against cervical cancer. The purpose of this test is the early diagnosis of cervical cancer and pathological precancerous changes. The pap smear test is also known as Pap test, Pap test, cervical smear test, cervical smear, and cervical cytology. This test is performed as part of a standard medical examination, as it can save a person's life. The HPV test involves taking samples of vaginal secretions using a device similar to cotton gemma. The removable swab is then placed in a special container and sent to the microbiological laboratory for a more thorough analysis. The laboratory assistant is trying to create an artificial environment suitable for the reproduction of bacteria. Thus, culture and susceptibility simply refer to the testing process used to identify bacteria in a sample and which antibiotics should be used to remove them. This method is commonly used in microbiology when testing a variety of samples, such as a variety of bodily secretions, including urine samples, for "bacteria and susceptibility testing". The obstetrician sends a sample taken directly from the fluid for microbiological analysis. The vaginal secret is stained and examined under a microscope.

The current Pap smear technique uses a sampling device that can only be used by a doctor during a general gynecological examination of patients. For smear analysis, cells removed during a gynecological examination from the cervix into the vagina are collected using an Eyre spatula or cytological brushes. In addition, a smear is taken from the cervix using a cytological brush. In the current technique, since the device used to collect the specimen needs to reach the transition zone, namely the area where the squamous epithelium covers the outer portion of the cervix and the columnar (cylindrical) cells cover the cervical canal, the rod-shaped sampling device it's hard to do it. In addition, when the user is using the device, if he/she fails to place the device correctly in the transition zone and if he/she inserts the device into a very deep area in the body cavity when he/she tries to place the device, a professional should be consulted, for example, doctor for general care, as this can cause injury. In the current technique, the Pap smear analysis done by the doctor in this way is very laborious and time consuming. In addition, women do not have sufficient access to medical facilities or facilities to enable them to have regular Pap smears.

In the current technique, when a sample taken from the cervix is removed and placed on the plate, there is a possibility that it will be touched by a doctor or there will be contact with any other object. In addition, so that the collected sample does not dry out and the cell forms are not damaged, the sample must be sent to the laboratory. With the present invention, an automatic upper vaginal and Pap smear device that can be used by a physician is brought into the laboratory environment without the risk of touching any foreign object. It is designed for automatic use (self use) or use by a physician and for rapid cell collection. In particular, the Pap smear test is used to take a vaginal smear for bacteriological culture and determine sensitivity, as well as for the early diagnosis and prevention of cervical tumors.

The present invention ensures that the patient herself can apply this test, or the doctor can apply this test, and in this case it is not necessary to completely sterilize the external genitalia and specifically use a piece of cotton, and for this reason it is a user-friendly device. The fact that the device is lubricated cleanly facilitates insertion of the device. Due to the correct insertion indicator of this invention, namely, the device for taking a swab from the upper part of the vagina and the Pap smear, the user can understand that it touches the necessary tissues.

The present invention, namely the upper vaginal and Pap smear device, overcomes the shortcomings of the prior art and provides new solutions to the problems of the prior art.

The structural details and features of the invention and all its advantages will be better understood by the written explanation below with reference to the relevant figures. Therefore, figures and description should be considered together.

Figures to help explain the invention

Fig. 1a: External view of the automatic device for taking a swab from the upper part of the vagina and a Pap smear with a cotton swab tip.

Fig. 1b: External view of the protective cover of the automatic upper vaginal and Pap smear device with a cotton swab tip.

Fig. 1c: External view of the cotton swab of the automatic upper vaginal and Pap smear.

Fig. 2a: Closed side view of the upper vaginal swab and Pap smear device with a cotton swab tip used by a physician.

Fig. 2b: Side view of the open state of the upper vaginal swab and Pap smear device with a cotton swab tip used by a physician.

Fig. 3a: Closed side view of the automatic upper vaginal and Pap smear device with a cotton swab tip.

Fig. 3b: Side view of the open state of the automatic upper vaginal and Pap smear device with a cotton swab tip.

Fig. Figure 4: Top view of an exploded view of the upper vaginal swab and Pap smear device with a cotton swab tip used by a physician.

Fig. Figure 5: Top view of an exploded state of the automatic upper vaginal and Pap smear with cotton swab tip.

Fig. 6a: Closed side view of the upper vaginal and brush tip Pap smear device used by a physician.

Fig. 6b: Side view of the open state of the upper vaginal and brush-tip Pap smear device used by a clinician.

Fig. 7a: Closed side view of an automatic upper vaginal and brush-tip Pap smear.

Fig. 7b: Side view of the open state of the automatic upper vaginal and brush-tipped Pap smear.

Fig. 7c: Side view of the brush head of the automatic upper vaginal and Pap smear.

Fig. Figure 8: Top view of an exploded view of the upper vaginal and brush-tip Pap smear device used by a physician.

Fig. 9: Top view of an exploded state of an automatic upper vaginal and brush tip Pap smear device.

Fig. 10a: External view of the upper vaginal and brush-tipped Pap smear device used by a physician.

Fig. 10b: External view of the protective cover of the upper vaginal and brush-tipped Pap smear device used by the clinician.

Fig. 10c: External view of the brush tip of the upper vaginal and Pap smear device used by a physician.

Fig. 11a: External view of the upper vaginal and Pap smear device with a cotton swab tip used by a physician.

Fig. 11b: External view of the protective cover of the upper vaginal and Pap smear device with a cotton swab tip used by a physician.

Fig. 11c: External view of the cotton swab of the upper vaginal and Pap smear used by the doctor.

Fig. 12a: External view of the automatic upper vaginal and Pap smear device with brush tip.

Fig. 12b: External view of the protective cover of the automatic upper vaginal and brush-tipped Pap smear.

Fig. 12c: External view of the brush head of the automatic upper vaginal and Pap smear.

Reference numbers to help explain the invention

1. Outer cylinder

2. head

3. Inner side

4. End side

5. Ring 1

6. Spiral end

7. Ring 2a

8. Inner cylinder 1

9. Piston cover

10. Cylinder

11. Protective cover

12. Tip

13. Outer end face

14. Inner end face

15. Flexible tube

16. Medical tube

17. Spring 1

18. Reverse cylinder 1

19. a. Line 1

19b. Line 2

20. Ring 3

21. Ring 26

22. Spring 2

23. Inner cylinder 2

24. Ring 4

25. Hole 1

26. Handpiece holder

27. Spring 3

28. Reverse cylinder 2

29. Hole 2

30. Circle 1

31. Spiral

32. Ring 5

33. Ring 6

34. Head rod 1

35. Cotton swab

36. Empty space

37. Indicator of the correctness of the introduction

38. Cone

39. Circle 2

40. Rubber gasket

41. Back

42. Small cylinder 1

43. Wing

44. Small cone

45. Small cylinder 2

46. Rod head 2

47. Brush

48. Ring 7

49. Brush bristles

50. Sharp edge

51. Hole 3

Description of the invention

The present invention is characterized by the following components of an upper vaginal and Pap swab device that can be used by women alone or by physicians, allowing human papillomavirus (HPV) Pap smear and upper vaginal culture and susceptibility testing: external cylinder (1), head (2), inner side (3), end side (4), ring 1 (5), spiral end (6), ring 2a (7), inner cylinder 1 (8), piston cover ( 9), cylinder (10), protective cover (11), tip (12), outer end (13), inner end (14), flexible tube (15), medical tube (16), spring 1 (17) , return cylinder 1 (18), line 1 (19.a), line 2 (19.b), ring 3 (20), ring 2b (21), spring 2 (22), inner cylinder 2 (23), ring 4 (24), hole 1 (25), tip holder (26), spring 3 (27), return cylinder 2 (28), hole 2 (29), circle 1 (30), coil (31), ring 5 (32), ring 6 (33), head stem 1 (34), cotton swab (35), empty space (36), correct insertion indicator (37), cone (38), circle 2 (39), Rubber Gasket (40) Rear (41), Small Cylinder 1 (42), Wing (43), Small Cone (44), Small Cylinder 2 (45), Head Shaft 2 (46), Brush (47 ), ring 7 (48), brush bristles (49), sharp edge (50) and hole 3 (51).

The components of the upper vaginal swab and cotton swab-tipped Pap test device (35) of the present invention used by a physician have the following composition:

• Outer cylinder (1) with a diameter of 1.6 to 2.4 cm and a length of 10 to 14 cm,

• Head (2) divided longitudinally in front of the outer cylinder (1) and opening in the shape of a rose,

• The inner side (3) of the head (2) is flat and thin for easier head exit, while the end side (4) is curved and thick for control,

• Ring 1 (5) with a thickness of 1 to 1.2 cm in the end part of the outer cylinder (1),

• Spiral end (6) allowing integration of outer cylinder (1) and piston cover (9),

• Ring 2a (7) and ring 2b (21), connecting the spiral end (6) to the piston cover (9) and ensuring the movement of the inner cylinder 1 (8),

• Inner cylinder 1 (8), freely moving inside the outer cylinder (1),

• Piston cap (9), which engages with the helical end (6),

• Ring 3 (20) with a protrusion of 1 mm at the end, which prevents the inner cylinder 1(8) from moving further,

• Spring 2 (22), which is located between ring 2a (7) and ring 4 (24),

• Inner cylinder 2 (23), closed at the front inside inner cylinder 1 (8), yet having a head entry hole in the center,

• Ring 4 (24) resting on the spring 2 (22) in the edge of the inner cylinder 2 (23),

• Hole 1 (25) in the center, allowing the tip holder (26) to enter the end of the spiral (31),

• Tip holder (26) with an open end, allowing the insertion of a cotton swab (35),

• Spring 3 (27) located in inner cylinder 2 (23),

• Reverse Cylinder 2 (28) to transfer doctor pressure to the upper vaginal and Pap smear device,

• Hole 2 (29) is square, allowing the connection of the return cylinder 2 (28) with the spiral (31) on the front side,

• Circle 1 (30) to make it easier to push the back of the reverse cylinder 2 (28) with your thumb,

• A cone (38) preventing the piston cover (9) from moving back

• Hole 3 (51) connecting the piston cover (9) to the return cylinder 2 (28),

• Twisted helix (31) shaped square inside return cylinder 2 (28),

• Ring 5 (32) between the helix (31) and the tip holder (26),

• Ring 6 (33) for fixing the handpiece holder (26),

• Head shaft 1 (34) in the form of a toothpick,

• Cotton swab (35) on the end of the stem of head 1 (34),

• An empty space (36) to control that the sample is taken by moving the head shaft 1 (34) while applying pressure to the handpiece holder (26) of the upper vaginal and Pap swab,

• Correct insertion indicator (37) to check that the sample has been taken after the red line on the device disappears when the device touches the edge of the tissue while pushing it to the empty space (36) after pressure is applied to the swab device from upper vagina and Pap smear.

The components of the automatic upper vaginal and Pap smear device with cotton swab tip (35) and brush tip (47) according to the present invention have the following composition:

• A cylinder (10) integrated with an external cylinder (1) in an automatic patient-operated upper vaginal and Pap smear device,

• Wheel 2 (39) instead of wheel 1 (30) otherwise installed at the end of the return cylinder 2 (28),

• Rubber gasket (40) integrated with wheel 2 (39),

• The rear part (41), located at the end of the cylinder (10),

• Small cylinder 1 (42) passing through the center of the back (41),

• A flexible tube (15) that provides appropriate movement between the cylinder (10) and the medical tube (16) 25 to 40 cm long, connected to the small cylinder 1 (42),

• A medical tube (16) connected to a flexible tube (15) similar to the medical injector used for injections,

• Spring 1 (17) to allow rotational return of the upper vaginal and Pap smear device to its original position after pressure is applied by the patient inside the medical tube (16),

• Reverse cylinder 1 (18), which ensures the application of pressure by the patient;

• Line 1 (19.a) and line 2 (19.b), serving to check that the procedure was performed correctly when the patient applied pressure to the return cylinder 1 (18), located on the medical tube (16) and indicating start and end of applied pressure.

The components of the automated patient-used and physician-used upper vaginal and brush-tip Pap smear device (47) of the present invention have the following composition:

• Wing (43), which provides a full cycle of rotation of the brush (47) at the end of the spiral (31),

• Small cone (44) to allow return cylinder 2 (28) to pass through hole 2 (29) in one direction,

• Small cylinder 2 (45), which ensures further movement of the brush (47) on the edge of the wing (43),

• Ring 7 (48), fixing the tip holder (26), closing the system, facilitating the sampling procedure and ensuring rotation in one direction,

• Head stem 2 (46) integrated with ring 7 (48),

• Brush (47) at the end of the shaft of head 2 (46),

• Longer spring 2 (22) located between ring 2a (7) and ring 4 (24) so that the brush (47) can make more turns,

• The longer spring 3 (27) located in the inner cylinder 2 (23) is even longer so that the brush (47) can make even more turns,

• Tip holder (26) with one end closed to allow it to pass onto the brush (47),

• Spiral and transversal bristles (49) with brushes (47),

• Sharp edge (50) of the bristles (49) of the brush (47) for easy removal of cells from the cervix.

The components of the automatic patient-used and clinician-used upper vaginal and Pap smear device with cotton swab tip (35) and brush tip (47) of the present invention have the following composition:

• Protective cover (11) mounted on the head (2) made of very thin soft material (latex) covering the head, slippery and 4 cm long,

• Curved outer end (13) and beveled inner end (14) in the tip (12) of the protective cover (11).

The invention can be used both automatically by the patient and by the doctor. The device provides the convenience of taking samples of cervical cells for the presence of human papillomavirus (HPV), culture and determination of sensitivity or fluids from the upper part of the vagina. The device uses the brush tip (47) to take cervical cell samples and the cotton swab (35) to take vaginal fluid samples.

This invention consists of a movable cylinder and springs, and thus, when pressure is applied, the head (2) of the device for taking a swab from the upper part of the vagina and the Pap smear opens and the cotton swab (35) or brush (47) takes a sample from the corresponding area and returns to the cylinder and closes. Thus, contact of samples with any surfaces is prevented. In order to easily take samples from the protruding cervix, the bristles (49) of the brush (47) have a long spiral shape with sharp edges and provide a full cycle of rotation.

The present invention easily reaches the required depth due to its lubricity, and the heads come out with a flexible protective cover (11), which is easily opened with a simple push. When the patient performs the procedure, the invention does not harm her, ensuring that the device for taking a swab from the upper part of the vagina and the Pap smear reaches the required depth thanks to line 1 (19.a) and line 2 (19.b) on the medical tube (16). When pressure is applied to the cotton swab (35), the red line on the correct insertion indicator (37) disappears. Thus, with the help of the correct insertion indicator (37), the control of sampling is ensured.

EFFECT: invention provides opening of the head (2) by transferring force to the outer cylinder (1) from the flexible tube (15) by means of manual pressure applied to the reverse cylinder 1 (18) in an automatic device for taking a smear from the upper part of the vagina and a Pap smear. The sample taken from the upper part of the vagina and cervix is delivered to the laboratory without coming into contact with any foreign surfaces.

Advantages of the invention:

• Does not cause pain or discomfort in the vaginal area,

• Due to the fact that the outer side of the head (2) of the device for taking a smear from the upper part of the vagina and Pap smear has a curved and wavy shape, when inserted into the vagina to the desired depth, pain does not occur,

• When the procedure in the upper vaginal and Pap smear device is completed, it does not need to be closed and closes automatically.

• When touching the desired tissues, the red line on the correct insertion indicator (37) disappears, allowing you to confirm the correct insertion.

• The upper vaginal and Pap smear device, positioned with one hand and guided with the other, provides control inside the vagina thanks to a flexible tube (15),

• The upper vaginal and Pap smear device is sterile thanks to the protective cover (11),

• The upper vaginal and Pap swab device ensures sufficient contact with the cervix due to the automatic rotation of the brush tip (47).

The said device of each claim and all other features are accompanied by reference numbers, and these reference numbers are used to facilitate the understanding of the claims, and in no way limit the scope and scope of the present invention.

Thus, when describing the invention, it will be obvious that it can be varied in many ways. Such changes should not be construed as a departure from the spirit and scope of the invention, and all such modifications that will be apparent to those skilled in the art are intended to be included within the scope of the following claims.

Claims (36)

1. A device for taking a swab from the upper part of the vagina and a Pap smear, containing a tip (35), (47), characterized in that it includes: - outer cylinder (1); - a head (2) divided into parts in the longitudinal direction in front of the outer cylinder (1); having an inner side (3) of the head (2) made flat and thinner to facilitate the exit of the head, and an end side (4) curved and thicker for control; - the first ring (5) in the end part of the outer cylinder (1); - spiral end (6) for integrating the outer cylinder (1) and the piston cover (9); - two, second and third, rings (7), (21) connecting the spiral end (6) with the piston cover (9) to ensure the movement of the inner cylinder (8); - the first inner cylinder (8) installed with the possibility of free movement inside the outer cylinder (1); - a piston cover (9) engaging with the helical end (6); - the fourth ring 3 (20) having a protrusion of 1 mm in the end part to block the movement of the first inner cylinder (8); - the first spring (22), which is located between the second (7) and fifth (24) rings; - a second inner cylinder (23) closed from the front inside the first inner cylinder (8) and having a first opening for the entry of the head in the center; - the fifth ring (24) resting on the spring (22); - a hole (25) in the center for insertion of the tip holder (26) into the end part of the spiral (31); - tip holder (26); - a second spring (27) located in the second inner cylinder (23); - a return cylinder (28) for transmitting pressure to the device for taking a swab from the upper part of the vagina and a Pap smear; - a square hole (29) for connecting the return cylinder 2 (28) with the spiral (31) on the front side; - a circle (30) to facilitate pushing the back of the reverse cylinder (28) with your thumb; - a cone (38) that prevents the piston cover (9) from moving back; - a hole (51) to ensure the combination of the piston cover (9) with the return cylinder (28); - a twisted helix (31) having a square shape inside the return cylinder (28); - the sixth ring 5 (32) between the helix (31) and the tip holder (26); and - the seventh ring 6 (33) for fixing the handpiece holder (26). 2. The device according to claim 1, characterized in that the tip is made in the form of a cotton swab, and the device additionally includes: - head rod (34); - an empty space (36) to control sampling by moving the head shaft (34) while applying pressure to the tip holder (26) of the upper vaginal and Pap smear device; - correct insertion indicator (37) to check that the sample has been taken after the red line on the device disappears when the device touches the edge of the tissue in the process of pushing it to the empty space (36) after applying pressure to the device to take a swab from the upper part of the vagina and Pap smear. 3. The device according to claim. 1, characterized in that the tip is made in the form of a brush tip (47), including a brush placed at the end of the head rod (46) and provided with a spiral and transversal bristle (49) with a sharp edge (50) to facilitate extraction of cells from the cervix, and the device additionally contains: - a wing (43) configured to rotate the brush; - a small cone (44) for the passage of the return cylinder (28) through the square hole (29) in one direction; - a small cylinder (45) to ensure further movement of the brush along the edge of the wing (43); - a ring (48) fixing the tip holder (26) to facilitate the sampling procedure and ensure rotation in one direction; - the head stem (46) integrated with the eighth ring (48). 4. The device according to claim. 1, characterized in that the head contains a protective casing. 5. Device according to claim. 1, characterized in that the outer cylinder (1) has a diameter in the range from 1.6 to 2.4 cm and a length in the range from 10 to 14 cm; 6. The device according to claim 1, characterized in that the first ring (5) has a thickness of 1 to 1.2 cm.

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