RU2352260C2 - Sampling device - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns medicine for independent sampling from body cavity, for example, assays of neck of uterus. The device contains a rigid plastic tube at least 1 cm in diameter which is rounded off on the forward side and has additional apertures in diameter less than 5 mm. As a result, during introduction of the device by the user, the device for sampling can be moved into uterus neck precisely. Besides, the device for sampling is surrounded with vaginal cavity, and it is possible to prevent leakage of the washing liquid, and, hence, it is possible to use rather small quantity of the washing liquid, with reception of, at the same time, assays with high concentration of cervical cells.

EFFECT: method of sampling, the complete set for sampling and the device for sampling in the collecting are opened.

19 cl, 6 dwg, 1 ex

Description

The present invention relates to a device for sampling in accordance with the introductory part of paragraph 1.

A sampling device of this type is used, inter alia, for sampling, for example, from body cavities, and in particular from the cervix. To counteract the disastrous effects of cervical cancer, screening programs have been developed throughout which women undergo extensive screening. The usual way is to get a cervical smear (Pap smear). However, the mentioned sample should be taken by trained medical personnel. Many of the women examined find the mentioned procedure unpleasant, and, in addition, visiting an appropriate medical institution is associated with inconvenience. EP 0947164 A1 proposes a design that allows trained doctors, such as gynecologists, to take a sample of the endometrium from the uterine cavity (detection of endometrial cancer). Said device comprises an injection type design with a plunger-cylinder. Instead of a needle, there is a tube that should be inserted into the uterine cavity. A tube of this type has a diameter of about 3 mm and is relatively flexible. Sample openings are provided on the front side and sides of the tube.

If the device of this type for sampling is correctly positioned, then, as it turned out, it makes it possible to obtain good results when taking endometrial tissue. A device of this type for sampling is not suitable for collecting cervical cells (when detecting cervical cancer or precancerous diseases). The design of the tube does not allow women to independently use this device to take samples from the cervix or endometrium. When introduced into the vaginal cavity, the conduction of the tube is not controlled, and it is impossible to determine whether the end of the tube is correctly placed.

US Pat. No. 3,777,743 discloses an endometrial sampling device comprising a rigid hollow tube having a plurality of side sampling openings. The rigid tube has an external diameter of about 0.07 inches (1 inch = 2.54 cm) so that a sample can be taken from the walls of the cavity (endometrium). Although such a tube is controlled better due to its considerable stiffness, accurate placement is only possible when performed by a qualified doctor after opening the vaginal dilator to access the cervix due to its size. A device of this type for sampling is also suitable only for sampling the endometrium from the uterine cavity and is not suitable for collecting cervical cells, as described in the present description.

US 5045058 discloses a disinfecting device comprising a phallic form of solid soap containing an antiseptic contained in a storage container, which may also function as a syringe for rinsing in the vaginal cavity. The device allows flushing when filled with liquid. The device is not suitable for taking fluid from a body cavity, such as a vaginal cavity. The device is difficult to manipulate when it is used for self-flushing because of the need to perform many steps (i.e. assembling different parts, filling the device with liquid) and the lack of grip on the device to accurately position the top of the device.

Until recently, almost no successful results have been obtained regarding women taking, inter alia, a sample from the cervix or a smear from the cervix, despite the fact that the desire to obtain a device of this type has been stated many times in modern technology.

The present invention is the creation of an improved device for sampling, which can be used by women on their own and gives a reliable sample.

In the aforementioned sampling device, the aforementioned task is achieved using the features of paragraph 1.

The considerable thickness of the sampling tube to be introduced, compared to prior art devices (from about 1 cm and preferably 2 cm), makes it easier for the user to feel by touch. The rounded end, firstly, pushes adjacent parts of the cavity and, secondly, means that contact with the edge of the cavity is painless. Since the tube is rigid, i.e. not flexible, then the user can accurately manipulate it. The use of a substantially cylindrical tube means that when the latter is inserted into an empty cavity with a blind end, for example, a vaginal cavity, the wall of which is formed by muscle tissue, between this wall and the tube, i.e. in this case, with the vaginal cavity, a tight abutment is created, and the abutment is created in the deepest part, where the cervix is located, from which a sample should be taken. Due to the relatively large diameter, positioning at this blind end is also optimized. The user can accurately sense the end of the tube without pain. The length of the tube is at least about 15 cm. The tube preferably contains one part, but may contain a larger number of parts.

Another problem with another known device is that a relatively large amount of flushing fluid (typically 15-50 ml) is required to ensure that the desired flushing result is achieved since the fluid flows back directly along the hose during flushing. In addition, there is no certainty that the sample will contain enough cells to obtain a useful measurement result. To determine how accurately the tube was inserted, it is possible only after analysis in the laboratory.

The design in accordance with the present invention provides the possibility of both the introduction of the washing fluid, and sampling. Since it is possible to penetrate very accurately to the cervix or other designated place of sampling, and the abutment is created in the manner described above, a very small amount of flushing fluid (saline) can be dispensed with. For example, when taking a sample of the cervix, this amount is 5 cubic meters. see. This is three times less than previously used, therefore, as a result, the effect that solutions of this type could have on the medium in the cavity is very limited. The use of a small volume of liquid additionally increases the comfort of the procedure for the user. In addition, sampling itself can be performed with a higher degree of reliability in terms of the result achieved. In the end, a smaller amount of flushing fluid means that it is possible to obtain a higher concentration of the sample. Since the sample actually enters the protected environment of the inner area of the tube, the risk of sample damage is significantly limited compared to standard methods for taking a smear from the cervix. Therefore, in principle, a smaller sample may be sufficient. Naturally, measures must be taken to protect cells immediately after sampling. It turned out that the above method of sampling is more comfortable for women. After the sample is drawn in, rarely any moisture remains behind, and as a result, there is no unpleasant backflow after taking the sample. In addition, the risk of damage to delicate tissue is significantly limited. In the end, the shape of the sampling tube, combined with the presence of several separate small openings, means that the risk of damage, such as the walls of the uterus and vaginal cavity, is minimized. This is in stark contrast to other designs that were offered in the prior art.

In accordance with one aspect of the invention, the sampling device itself is provided with a sample holding means. However, in the present case, transferring the sample to an additional container that is filled with a preservative is preferred. Since a preservative of this type is often physiologically incompatible with the human body, measures should be taken to prevent the introduction of a preservative of this type into the body. The use of a separate container gives the best guarantee in this regard. Obviously, special designs can be created in the sampling device to thereby effectively prevent the entry of a preservative into the human body. If the sampling device has a cylinder design with a plunger, then all kinds of locking means in combination with spring structures can be provided for the aforementioned purpose.

Although the device for sampling is described above with regard to sampling from the vaginal cavity, it should be understood that this device is also suitable, if appropriate, after a suitable modification, for sampling from other cavities. This device can also be used to introduce liquids into other cavities in the manner described above.

The rounding at the insertion end is structurally designed so that the sampling device can be inserted by the user painlessly and easily, unlike the flexible tube or sampling brushes that are currently used to take cells from the cervix for examination. The rounded insertion end has such a shape and size that there is practically no risk of damage to the vaginal tissue or cervix.

The rounding at the insertion end of the tube is preferably structurally designed so that the plane of the central sampling hole extends perpendicular to the center line of the sampling device.

Separate small openings may be located near the insertion end to ensure optimum flushing. These holes preferably have a diameter of less than 5 mm, and in particular about 2 mm. In addition, due to the presence of these small holes, the risk of uncontrolled vacuum-induced forces is minimized. This is due to the fact that after the device is inserted into the cavity, not all openings will be closed due to contact with the cavity wall, and, therefore, an uncontrolled force caused by vacuum will not be created. Designing said openings in the form of one-way openings in accordance with a preferred embodiment of the invention, i.e. so that the material can only exit through them, makes it possible to centrally provide a sufficient aspiration effect in relation to the cells that it requires to be sampled. The above can be realized by creating a valve-type structure. However, the diameter of the hole can be selected so small that, during the suction stroke, the holes will be blocked by suction of the fabric. This type of aspiration can be achieved, for example, by pulling the plunger in the cylinder. The return movement of this type after the introduction of the flushing fluid can be performed either by hand or with the help of a spring when releasing the gripper or something similar. Additional control of the low pressure applied by the device in accordance with the invention can be achieved if the return movement of the plunger is limited, for example, by the presence of a stop means limiting its stroke length.

Tests have shown that the device in accordance with the present invention allows sampling simply and reliably. Users in 98.5% of cases classified the procedure as easy for independent execution when using written instructions (manuals). Users experienced less traumatic sensations, and the quality of diagnostic indicators significantly improved compared with the prior art, which significantly increased the value of subsequent laboratory findings.

It should be understood that referral to the laboratory may take place in any case that is known to the prior art. If a separate container is used, it can be mailed after clogging. The data provided by the sampler may be attached to this type of container. It has been found that a small amount of sample is sufficient to obtain a representative result. In practice, 1 ml is enough.

In the case of designs in which the sample remains in the sampling device, the sampling device can be sent back by mail or delivered to the place of issue or any other place.

In order to provide an even more accurate sampling, in accordance with a preferred embodiment, a part that extends outward, such as an inflatable part, may be located near the input end of the sampling device. After the introduction of the device for sampling, this part can be pumped so that the body cavity is additionally tightly closed, which eliminates the small risk of backflow of some amount of washing-up liquid. The above method can be applied, inter alia, to:

cytological examination of the cervix;

determination of HPV (human papillomavirus DNA) in cervical cells;

detection of Chlamydia (chlamydia) (sexually transmitted disease);

definitions of gonorrhea (sexually transmitted disease);

fertilization (partner sperm, donor sperm);

therapeutic washing.

The invention also relates to an assembly of a sampling device in which said fluid-containing agent is filled with a washing solution, in particular physiological saline.

The invention also relates to a kit containing the above-described sampling device, as well as a sealed container for holding said sample, said container being separate from said sampling device.

The invention relates to a method for sampling from a body cavity, for example, samples from the cervix, which consists in introducing a sampling tube into the entrance to the cavity, moving the tube in the cavity until it contacts the blind end of the cavity, and taking a sample by aspirating the material at the end of the sampling the tube through an opening in it, wherein after the introduction of the said sampling tube and before sampling, a washing solution is released with pressure from the said sampling tube into the body cavity. In particular, the washing solution is discharged with pressure from the chamber inside said tube and said sample is introduced into said chamber. According to a further preferred embodiment, after sampling, a container is provided and the contents of the sampling tube are transferred to a container, which is then sealed and transported. A container can be provided with a preservative.

The following is a detailed description of the invention in its exemplary embodiments, illustrated in the drawings, in which:

Figure 1 is a cross section of a first embodiment of a sampling device in accordance with the invention;

Figure 2 is a front view of the sampling device shown in figure 1;

Figure 3 - part of a second sampling device in accordance with the invention in a first position;

Figure 4 - image presented in figure 3, but in the second (sampling) position;

5 is a schematic illustration of a further embodiment of the invention; and

6 is a further embodiment of the invention.

Figure 1 shows a device for sampling in accordance with the invention. This device comprises a plunger 2, which is located in the cylinder 4. The plunger 2 can be moved with a handle 3, which is preferably made of plastic. Near the insertion end, the cylinder 4 is provided with a sampling hole 6 and a plurality of spray holes 7 (see also FIG. 2). The insertion end is designated 8 and has a rounded design. The rounding is smooth and such that the front surface near the sampling hole 6 is substantially perpendicular to the center line 9. It should be understood that the sampling device in accordance with the present invention may have other roundings. However, all of them should be such that during the introduction into the body cavity they could easily repel any obstacles, and the user could get an accurate sense of the position of the device without injuries.

The length of the cylinder is indicated by the letter L and preferably greater than 15 cm, in particular approximately 16 cm. The diameter is indicated by the letter d and is preferably at least about 1 cm.

The proposed device for sampling operates as follows:

In the initial position shown in figure 1, the space 5 for the plunger is filled with saline. If you should take a sample from the cervical cavity, then the device is injected using a capture of 10 cylinder. Since the cylinder 4 is made in the form of a rigid plastic tube, it is possible to perform highly sensitive and accurate positioning. The user can accurately move the rounded end 8 to a close position to the cervix. The rounded end 8 allows the user to accurately determine contact with the cervix. At the moment, the handle 3 of the plunger should be moved to the grip 10 of the cylinder to push out the washing liquid 5. Then the handle 3 of the plunger should be moved back relative to the grip 10 of the cylinder. This movement may be relatively short. In accordance with a preferred embodiment, at most about 5 cubic meters are added. cm saline, and this amount is enough to take a sample of about 1 cubic meter. see Return movement may be limited by locking and / or locking means (such as shown in FIGS. 3, 4 and 6). After the sample is taken, it can be transferred to a separate container, which is filled with a liquid retainer. It is also possible to use structures in which the sample is stored in a protected form in the volume of space 5. This can be achieved, for example, by screwing on an auxiliary device that contains a liquid retainer. A suitable design makes it possible to move the plunger up and down only once to ensure that there is no inadvertent aspiration of the liquid and then its return to the user's body.

Figures 3 and 4 show an additional embodiment of the invention and, in particular, only one lower end of this embodiment. This embodiment is generally indicated at 11. The plunger tube or cylinder is indicated at (a) at 14, while the plunger itself comprises a plunger rod 12 and an end 13 of the plunger. This end 13 of the plunger moves up and down in a separate capsule 19, which, in turn, is provided at its end with a central outlet 16 and flush holes 17. In this case, the volume 15 is also filled with saline. A flexible ring 20 is located between the capsule 19 and the plunger tube 14.

During the insertion movement, the capsule 19 will be pressed against the plunger tube 14. Since the plunger rod 12 is not actuated, the pressure in the chamber 21 will not change. After the introduction is made in a suitable way, the physiological saline solution is discharged with pressure from the space 15. This is achieved by moving the plunger rod 12.

In contrast to the design described above, this design has a sleeve 22 that is connected to the plunger rod and can be biased into the chamber 21. This sleeve is driven by the capture of the plunger. Bringing it into action causes a decrease in volume in the chamber 21 and inflating the flexible part 20, as shown in Fig.4. As a result, effective closure of the corresponding cavity is possible.

Figure 5 shows an additional embodiment of the present invention. This embodiment is generally indicated by 31 and comprises a plunger 32 and a handle 33. The plunger 32 moves in a cylinder 34, which is provided with a ribbed structure 41 that can be gripped by hand. In front of the plunger is a compartment 35 with fluid.

In contrast to the above-described embodiment, the tube in the sampling device 31 consists of two parts. In addition to the above-described cylindrical part 34, in this embodiment there is also a tubular part 40, which can be connected to it. This part has the same outer diameter as the cylinder 34. Inside there is a passage 45 of a small diameter, and near the free end 38, as in the above embodiment, there are openings 36 and 37, while the openings 37 serve to discharge the washing liquid. The tubes 34 and 40 are connected using any connecting part that is known in the art, in this case a screw threaded connection, which is generally indicated by 39. It should be understood that it is also possible to use a bayonet, clamp, snap and similar connections instead of a screw threaded connection 39 of this type. The slotted design of the sampling device in accordance with the embodiment shown in FIG. 5 allows a simple method for sterilizing parts 34 and 40, so that it is easier to take into account storage requirements and shelf life of the irrigation fluid.

Figure 6 shows an additional embodiment of the invention. The sampling device is indicated at 41 and comprises a tube 44 having an insertion end 48 with a central sampling hole 47 and side holes 46. These holes are closed by a sealing strip 50 having a gripping tab 51 for tearing off the strip 50. The plunger 42 can be moved with the handle 43. B the position shown in Fig.6, the end 53 of the plunger is in an idle state. The cylinder 44 comprises an upper part 54 having a relatively large diameter and a lower part 55 having a small diameter. Part with a small diameter is made with a size to install the end of the 53 plunger with a tight pair. The upper part 54 is configured to install both the plunger 42 and the spring 56 located around the plunger. On one side, this spring rests on a ledge 57 and on the other side, on a protrusion 58 at the top of the plunger 42. This protrusion also acts as a stop for the end cover 59 of the tube 44. In the position shown in FIG. 6, a volume 60 is formed under the end of the plunger 53, which preferably contains saline solution, the exact volume of which is known.

To use this device, the user tears off the strip 50 by capturing the tongue 51. Then, the device is inserted into the corresponding cavity. The depth of introduction of the device is precisely determined by stopping further introduction when a sensation of resistance appears upon reaching the deepest part of the corresponding cavity. Alternatively, the user can accurately determine how deep the device is inserted, according to the marks on the outside of the tube 44. After the correct insertion, the action is carried out with the handle 43 to move the plunger 42 in a downward direction to release physiological saline from the volume 60 with a pressure. After reaching the lower point, the plunger 42 simply release the handle 43 of the plunger, then thanks to the spring 56, the end 53 of the plunger makes a return movement for a given stroke length, and, as a result, a given sample volume is taken.

It should be understood that bringing to the end position of the end 53 of the plunger, as well as the return movement of the plunger, can be realized in any other way.

A specialist in the art, after reading the foregoing, will immediately come to other options that are obvious and are within the scope of the claims of the attached claims.

Example 1

A study was conducted to test the device in accordance with the present invention for reliability and the ability to independently perform sampling of cervical cells in 110 women at home in order to detect HPV, when compared with the classic Pap smear. All of these women received a device for self-sampling at home, including written instructions. The same women visited the clinic to take a Pap smear by a doctor.

The results of HPV on materials taken by women using the device of the present invention at home and prepared by a doctor using the classical method of taking a Pap smear were comparable.

In addition, 98.5% of users of the device in accordance with the present invention classified the procedure as easy to do on their own using written instructions.

Claims (19)

1. A device for sampling from a body cavity, for example, from the cervix, including tubular means configured to be inserted into said cavity, the insertion end of which is rounded to form a central sampling opening, storage means connected to said tubular means, and vacuum means connected to said storage means and / or tubular means, characterized in that said tubular means comprises a rigid tube having a diameter of at least 1 cm, wherein akruglennom insertion end is disposed a plurality of additional holes having a diameter less than 5 mm. 2. The device according to claim 1, characterized in that it contains a fluid-containing medium and pumping means for discharging with a pressure of liquid from said liquid-containing medium to the input end of said tube. 3. The device according to claim 1 or 2, characterized in that the additional holes are located near said sampling hole. 4. The device according to claim 2, characterized in that the said means of evacuation contains said pump hole. 5. The device according to claim 1, characterized in that said storage means comprises said liquid-containing means. 6. The device according to claim 5, characterized in that the said liquid-containing medium has a volume of less than 10 cm ³ . 7. The device according to claim 1, characterized in that the said means of evacuation contains a plunger and a cylinder. 8. The device according to claim 7, characterized in that said tube contains said cylinder. 9. The device according to claim 3, characterized in that it contains means for sealing said holes. 10. The device according to claim 1, characterized in that said evacuation means comprises a plunger in said tubular means and a stop means for restricting the movement of said plunger relative to the tubular means. 11. The device according to claim 10, characterized in that it contains means for clamping said plunger. 12. A device assembly for sampling from a body cavity, comprising a sampling device according to any one of claims 1, 7 or 8, wherein the sampling device further comprises a fluid holding means and pump means for discharging a fluid pressure from said containing liquid means for introducing the end of said tube, wherein said liquid containing medium is filled with a washing solution. 13. The device according to item 12, in which the said washing solution contains saline. 14. A kit for sampling from a body cavity, comprising a device according to one of the preceding paragraphs and a sealed container for containing said sample, said container being separate from said device. 15. The method of sampling from the body cavity, for example, from the cervix, which consists in introducing the device according to claims 1-11 into the entrance to the cavity, moving it in the cavity until it contacts the deaf end of the cavity, and taking a sample by aspiration of the material at the end of the said device, through the hole in the tubular means, after the introduction of the said device and before sampling, a washing solution with pressure is released from the said device into the said body cavity. 16. The method according to clause 15, wherein said washing solution is discharged with pressure from the chamber inside said device, and said sample is introduced into said chamber. 17. The method according to p. 15 or 16, characterized in that the said wash solution contains saline. 18. The method according to p. 15, characterized in that after sampling the contents of the device are transferred to a container, which is then sealed and transported. 19. The method according to p, characterized in that the said container contains a preservative.

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