EA041073B1 - REMOVING MENSTRUAL FLUID - Google Patents

Description

The present invention relates to the control of menstruation and, in particular, to a device that simplifies the daily planning for a woman during menstruation. In particular, the invention relates to a device that reduces the need for tampons, pads or synthetic hormones, while providing the user with predetermined periods without menstruation.

Prerequisites for the invention

The monthly hormonal cycle in women is accompanied by the release of fluid from the inner layer of the uterine wall (endometrium) through the vagina. The duration of menstrual bleeding is usually 2 to 7 days. The total volume of monthly menstruation is usually between 20 and 120 ml, with blood making up approximately half of the liquid and aqueous salts with tissue particles making up the other half. Menstruation usually occurs between the ages of 13 and 50, which is about half of a woman's life. Naturally, the fact that the average menstrual cycle has a duration of 28 days drew people's attention to the lunar cycle and astral connections. This phenomenon associated with female fertility served as an obstacle in the struggle of women to obtain equal status with men. The practice of controlling the menstrual cycle throughout history has included attempts to absorb fluids, wearing special clothing, throwing away soiled materials, laundry, isolating women, and more recently the use of feminine hygiene products or the suppression of menstruation through synthetic hormones.

The menstrual cycle is not only inconvenient and uncomfortable, but it is also often accompanied by emotional disturbances, which in some cases can be quite serious. In addition, existing means of controlling menstruation do not always solve these problems and sometimes even lead to serious complications. For example, the use of tampons can lead to toxic shock syndrome; the use of synthetic hormones is sometimes not recommended, and in some cases even contraindicated. Moreover, there is always the possibility of an unexpected occurrence or amount of discharge, which can have embarrassing and inconvenient consequences. Western society is making great efforts to remove any obstacles that could prevent women from maintaining equality and achieving equal status with men. Therefore, there is a need to provide new means of controlling menstruation during the menstrual cycle and preventing inconvenience.

In addition to the usual use of absorbent textiles, various devices have been proposed, some aimed at blocking vaginal discharge, others from the cervix, including intravaginal inflatables. Various drainage devices and collection means are known. Many devices, which are rather bulky, only passively transfer or collect liquids. Thus, the object of the present invention is to provide a device free from the disadvantages of known devices.

Since women currently occupy the most responsible positions, including in hospitals, senior management, high performance sports and even combat situations, it is necessary to ensure a period of time of at least several hours without menstruation, preferably six hours or more, without the need performing any actions not related to work tasks. Attempts have been made to aspirate fluid from the vagina or facilitate the drainage of fluid from the uterus. The object of the present invention is to provide a device that allows you to control the speed, duration and time of the onset of menstrual flow.

Another object of the present invention is to provide a system that allows a woman to more accurately plan her activities during the menstrual cycle and avoid uncomfortable and unpleasant moments.

Another object of the present invention is to provide a system to reduce the use of tampons and pads.

Yet another object of the present invention is to provide a system for collecting menstrual flow at predetermined times.

The present invention is directed to providing a system that provides predetermined periods of time without menses. The present invention is also directed to providing a device for collecting menstrual flow at predetermined times and providing the user with periods of time without menstrual flow.

Other objects and advantages of the present invention will be apparent from the description below.

The essence of the invention

The present invention provides a mother liquor aspiration device comprising: i) a vacuum pump;

ii) a suction tube having first and second ends and connected to the specified pump through the specified first end, and at least part of the tube defines a linear axis;

iii) a suction cup connected to said tube through said second end,

- 1 041073 having a width greater than the width of the specified tube and containing a hole for aspiration of the specified liquid, and the suction cup and the tube are made with the possibility of insertion into the human vagina;

iv) non-invasive means of opening the cervix;

v) a liquid trap connected between said pump and said suction tube to retain said liquid; and vi) a processor for controlling the operation of said pump and said non-invasive means of opening the cervix, as well as for storing software that determines the mode of operation of the device.

Said means for opening the cervix and said processor preferably comprise means for adjusting the vacuum to force the vacuum to be abruptly applied so that the vaginal and uterine fluid can be aspirated; the adjustment means preferably provide for vacuum fluctuations, for example by alternately connecting and disconnecting said pump with said suction cup at a frequency of 1 to 25 Hz, for example 1 to 15 or 4 to 15 Hz. The means for adjusting the vacuum may comprise a valve or a diaphragm pump, for example similar to breast pumps, or other suitable means. Said means of opening the cervix in a preferred embodiment of the invention contain a device that provides translational movement of the specified tube and the specified suction cup along the specified axis in both directions for a distance of up to 40 mm, up to 20 mm in each direction and containing a motor and a fastener for connecting the specified suction tube with the specified engine, and the specified suction cup is made of medical elastomer. Said means of opening the cervix in the device of the present invention, in another embodiment, comprises a device for vibrating the cervix during vacuum aspiration. Said means of adjusting the vacuum, providing a sharp application of vacuum, preferably provide vacuum oscillations in the form of square or sawtooth waves. In one embodiment, the device of the present invention includes a device that delivers acoustic waves to the cervix. Said means of opening the cervix may provide a combination of two or three of the following: vacuum oscillations, translational movement of the suction cup in contact with the cervix, and vibrations applied to the cervix. Said processor preferably also controls said engine. In one embodiment, the device of the present invention comprises one or more pressure sensors. Said processor preferably receives data from said sensors. Said suction cup is preferably made of medical grade elastomer and has a surface which is convex on the side of said suction tube. The suction cup and tube are smooth, without sharp or irritating elements. Said suction tube and said suction cup are made to fit against the cervix during aspiration of said fluid. The device preferably comprises means for cutting blood clots or tissue particles present in said mother liquor into smaller particles before passing said particles into said suction tube. The suction tube and the suction cup are made with the possibility of being introduced into the human vagina and adhering to the cervix during aspiration of the said liquid. Said translational movement causes said suction cup to move 20 mm towards the cervix and 20 mm away from the cervix, which results in displacement of said cervix. Said pump preferably provides a maximum vacuum pressure (negative pressure) of -150 to -800 mbar and a maximum positive pressure of 20 to 200 mbar.

The invention is directed to providing a device designed to remove uterine and vaginal fluid during menstruation, which leads to at least one of the following effects: providing the user with specified periods of time without menstrual flow, reducing the total volume of monthly menstrual flow, reducing the duration of menstrual bleeding, weakening menstrual cramps, lessening menstrual cramps, and less need for tampons and pads.

The present invention provides a method for aspirating mother liquor, comprising

i) providing a suction cup made of a medical polymer and a suction tube, the first end of which is connected to a vacuum pump, and the second end is connected to said suction cup, wherein at least a portion of the tube defines a linear axis, and the suction cup contains an opening for aspiration of said liquid;

ii) providing a non-invasive means of opening the cervix, selected from (a) means for adjusting the vacuum, connecting and disconnecting the specified vacuum pump from the specified sucker with a frequency of from 1 to 15 Hz, providing fluctuations in the vacuum in the specified sucker, (b) a device that allows translational moving said suction cup along said axis in both directions to push and retract said sucker within a total distance of up to 40 mm, (c) a device that vibrates the cervix during vacuum aspiration, or

- 2 041073 (d) combinations of these agents;

iii) inserting the suction cup into the vagina so that the suction cup rests against the cervix;

iv) activating said means of opening the cervix, said vacuum oscillations preferably having a frequency of 1 to 15 Hz, said translational device displacing the cervix by 20 mm in each direction with a frequency of up to 5 Hz, for example with a frequency up to 2 Hz, and the specified device provides vibration of the cervix with a frequency of up to 300 Hz, for example, in the range from 25 to 300 Hz, and this device, if necessary, delivers acoustic waves; And

v) extraction of uterine and vaginal fluid from the vagina.

These actions result in at least one of the following effects: providing the user with specified periods without menstruation, reducing the total amount of monthly menstrual flow, reducing the duration of menstrual bleeding, easing menstrual cramps, easing menstrual pain, and reducing the need for tampons and pads.

The invention is directed to providing a system for removing uterine and vaginal fluid and containing a cup suction cup connected to a vacuum source and intended for insertion into the vagina near the cervix; and non-invasive means of opening the cervix, selected from (a) means for adjusting the vacuum, connecting and disconnecting the specified vacuum source from the specified sucker with a frequency of 1 to 15 Hz with the formation of vacuum oscillations in the specified sucker, (b) a device that allows the translational movement of the specified a tube and said suction cup along said axis in both directions, with possible periodic pushing and retracting of the sucker in directions away from and towards the cervix, (c) a device for vibrating the cervix during vacuum aspiration, or (d) a combination thereof;

moreover, the system allows a woman during her period to plan her activities and avoid uncomfortable and awkward moments, perhaps even without the use of tampons and pads; and the system can also provide a predetermined amount of time for a woman without menstruation.

The main purpose of the invention is to improve the quality of life; however, the device of the invention is also useful in the management and treatment of menstrual irregularities, including menorrhagia (excessive bleeding) and dysmenorrhea (pain and cramps).

The device, method and system of the present invention is directed to reducing the inconvenience and discomfort associated with the normal menstrual cycle, as well as menstrual disorders, with a concomitant reduction or elimination of the need for the use of tampons, pads and synthetic hormones to suppress menstruation, and to provide for women the ability to plan their activities during the menstrual cycle by providing a given period of time without menstruation.

Brief description of the drawings

The above and other characteristics and advantages of the invention will become more apparent when considering the following examples, with reference to the accompanying drawings.

In FIG. 1 shows a device according to one embodiment of the invention, namely the portion of the invention for insertion into the vagina (100), referred to in the following description as the tube and applicator assembly:

1A) the front of the semi-flexible tube (2) and the folded suction cup (4A) are covered with a plastic applicator (1) and the back of the tube (2) is open (in the following description, this configuration is referred to as the folded configuration);

1B) pulling the applicator (1) back (away from the body) opens and exposes the cervical suction cup (4B) (in the following description, this configuration is called the deployed configuration);

1C) the cervical tube and suction cup are shown without the applicator, which is intended to be removed by the user;

1D) a tube splitter, attached by the user to the rear end of the tube (5), separates it into two tubes: one tube is connected to the vacuum container/trapper (7) and the other to the vacuum release channel (6).

In FIG. 2 shows the tube and applicator assembly after removal of the applicator (100) with the suction cup (4B in Fig. 1) deployed in three views:

2A) front view;

2B) side view in cross section (along the line A-A) showing a double lumen tube (2) consisting of a vacuum lumen (22) and a vacuum lumen (21), a tube separator (5) consisting of a lumen (52) for vacuum and lumen (51) for vacuum release and separation

- 3 041073 tubes into two parts (6 and 7 according to Fig. 1); also shown is one of the four straps (41) designed to hold the suction cup in a fully open position, and the inner lip, designed to seal with the cervix (42) of the uterus;

2C) another cross-sectional view (along the line B-B) illustrating the division of the tube into two lumens (21 and 22).

In FIG. 3 shows the tube and applicator assembly after removal of the applicator (100 in FIGS. 1C and 1D), as well as the push and pull motor (200) covered by the body, in the detached (3A) and attached (3B) positions to the tube (2) ; also shown is a motor handle allowing the user to position the device (8) and a cable connecting the motor to the power supply (9).

In FIG. 4 shows the tube and applicator assembly (100) (after removal of the applicator) moving back and forth along the motor (200). Three positions are shown:

4A) the knot is in its most anterior position (i.e., the deepest position within the body), indicated as +20 mm;

4B) the node is in its home position, denoted 0, in which the typical length of the open portion of the tube (introduced into the vagina) is 70 mm (adjustable to suit the user's anatomy);

4C) the assembly is in its rearmost position, indicated as -20 mm;

In FIG. 5 is a partial sectional view of the engine housing (10) of FIG. 4. Parts of the rotor (12) and stator (11) of the linear motor are shown, as well as the carriage (201) moving forward and backward.

In FIG. 6 shows another view of the tube and applicator assembly (100) (after the applicator has been removed) and the push and pull motor (200) (covered by the body) attached to each other.

In FIG. 7 is a partial sectional view of the engine housing of FIG. 6. Parts of the rotor (12) and stator (11) of the linear motor are shown, as well as the carriage (201) moving forward and backward.

In FIG. 8 shows the tube and applicator assembly (100) (after removal of the applicator) and motor (200) of FIG. 7 without motor housing and disassembled parts. The screws (14) and grips (13) that allow the motor to be attached to the tube are shown in the exploded views.

In FIG. 9 shows another view of the carriage (201) complete with linear motor (11 and 12) and grips (13).

In FIG. 10 shows the carriage (201) identical to that of FIG. 9, with a cutout showing a color sensor (15) and an infrared flow sensor consisting of a sender (16) and a receiver (3).

In FIG. 11 shows the pump unit (300). Shown are vacuum pump (309), accumulator (311), vacuum valve (304), container/trap (310), vacuum tube connector (301), vacuum release connector (302), container pressure sensor (306), and accumulator pressure sensor (307).

In FIG. 12 shows another view of the pumping unit (300) of FIG. 11. Shown are the vacuum pump (309), accumulator (311), exhaust valve (305), vacuum tube connector (301), vacuum connector (302), container pressure sensor (306), accumulator pressure sensor (307), and pressure sensor (308) when the vacuum is removed.

In FIG. 13 shows other views of the pump unit (300):

13A is a plan view showing the vacuum pump (309), accumulator (311), container/trap (310), vacuum tube connector (301), and vacuum connector (302);

13B) is a side sectional view (along the line C-C) showing the container/trapper (310), accumulator (311), vacuum tube connector (301), vacuum connector (302), vacuum pressure sensor (306). container, a battery pressure sensor (307) and a load sensor (312) used to measure the mass of the container/catcher.

In FIG. 14 is a cross-sectional view of a woman's body showing the rectum (405), bladder (401), vagina (406), urethra (409), labia minora (408), labia majora (407), and uterus, including myometrium (402), endometrium (403) and cervix (404). The tube (2) and the applicator (1) (parts of the device intended for insertion into the vagina (100) in a folded configuration, Fig. 1A) are shown outside the body.

In FIG. 15 is a cross-sectional view of the body of the woman of FIG. 14 showing the tube and applicator assembly in a collapsed configuration (FIG. 1A) inserted into the vagina and approaching the cervix (404).

In FIG. 16 shows the tube and applicator assembly approaching the cervix after retracting the applicator (1) along the tube (2) with the corresponding exposure and opening of the suction cup (4B) of FIG. 1B (expanded configuration). The suction cup fits and seals against the cervix (404) of the uterus.

In FIG. 17 shows the tube and applicator assembly (100) in a position where the suction cup rests against the cervix (as shown in FIG. 16) after removal of the applicator (1) (as shown in FIG. 1D). The tube separator (5) is attached to the tube (2) in this position.

In FIG. 18 shows the tube and applicator assembly (100) in a position where the applicator is removed and

- 4 041073 the suction cup is adjacent to the cervix (as shown in Fig. 17), and the motor (200) controlling pushing and retracting is also shown, covered with a housing and attached to the tube (as shown in Fig. 3B).

In FIG. 19 is a partial sectional view of the tube and applicator assembly (100) and motor (200) covered by the housing of FIG. 18.

In FIG. 20 shows a laboratory prototype device (500) according to one embodiment of the invention being tested on laboratory models of the uterus (504) and vagina (509). The unit is controlled by a processor-controller and data recorder (501), which controls the moving motor assembly (508) and the pressure fluctuation valve assembly (507); the latter is located on the transfer carriage (506) and moves the tube (505) adjacent by means of a suction cup (not shown) to the cervix of the uterine model (504). Also shown is a uterine pressure sensor (503) and a menses accumulator (502) for simulating an internal uterine pressure of about 50 mbar.

In FIG. 21 shows an example of time synchronization of intermittently applied vacuum (bottom) with cervical displacement (top), with the x-axis showing time (relative units) and the y-axis showing displacement or pressure in relative units; one cycle of movement and several cycles of vacuum oscillations are shown (21A); four examples of oscillatory waves with a sudden application of high impulse pressure (601) vacuum are shown, including square wave, sawtooth wave and modified sawtooth waves (21B).

Implementation of the invention

It has been found that menstrual fluid can be effectively removed from the vagina and uterus to shorten the duration of menstrual bleeding and provide a period of time without discharge, including aspiration of vaginal fluid while applying periodic vacuum oscillations and movements of the cervix.

In one embodiment of the system of the present invention, fluid is withdrawn from the uterus by means of a device whose end aspirating cup may be adjacent to the cervix. The device removes menstrual flow primarily from the uterus, but it can also take fluid outside the uterus and inside the vagina, especially when the suction cup is moved away from the cervix by a motor. The device for extracting menstrual flow consists of a vacuum pump, a vacuum accumulator, two high-speed switching valves to provide exposure to the cervix of alternating atmospheric and vacuum pressure, a container (trapper) for collecting menstrual flow, tubes, a linear motor enclosed in a protective housing, which also performs the function of a mounting surface relative to the vagina, a rigid and flexible tube with two lumens, an asymmetric suction cup attached to a rigid flexible tube adjacent to the cervix and moving in the axial direction with pushing into the fornix of the cervix and retracting from the cervix. The device may also contain multiple sensors, including pressure sensors on the accumulator, container, and suction cup. The device, especially during laboratory testing, but also in practical use, may include an IR sensor for indicating the flow of menstrual fluid, a scale for weighing the container, and a spectral sensor for analyzing the color of the extracted menstrual flow.

The extraction of menstrual flow according to the present invention provides at least one of the following effects: providing the user with specified periods of time without menstruation, reducing the total amount of monthly menstrual flow, reducing the duration of menstrual bleeding, easing menstrual cramps, easing menstrual pain, and reducing the need for tampons and pads .

In general, the invention is directed to the effective removal of menstrual fluid from the vagina and uterus in order to reduce the duration of menstrual bleeding and provide a period without menstruation, including aspiration of vaginal and uterine fluid while applying periodic vacuum fluctuations and preventing collapse (closure) of the cervix by using means opening of the cervix. Usually, during menstruation, there is positive pressure (~50 mbar) inside the uterus, and atmospheric pressure outside the vagina; under these conditions, there is a slow flow of menstrual flow through the cervix, which prevents its collapse. The cervical tissue has some structural strength to keep it open. The cervix passes into the vagina in such a way that when the vacuum pressure outside the cervix exceeds a certain threshold value, the channel can close; increased vacuum pressure and lack of fluid passing through the channel can cause narrowing or complete closure of the channel. Without wishing to be bound by any particular theory, the Applicant believes that the mechanism may involve physical separation of the closed cervical walls by application of vibrations, or may include an increase in intrauterine pressure leading to cervical dilatation. The cervical canal, through which menstrual fluid exits during menstruation, may periodically close (due to the collapse/pinching mechanism) when vacuum pressure is applied to the external os of the cervix. Applicants suggest that closure depends on the strength and frequency of applied pressure, as well as on the anatomy of the neck.

- 5 041073 uterus and mechanical properties of cervical tissue. Closure can be the result of three independent mechanisms:

a) the cervical canal may not be open in a relaxed state (i.e., in the absence of external forces), but may periodically become pinched; this mechanism can be observed on images obtained with MRI and ultrasound of the uterus;

b) the application of vacuum to the lips of the cervix leads to their retraction from the body of the uterus, which causes stretching of the cervix; this process leads to axial (i.e. along the axis of the cervical canal) elongation and transverse (i.e. in a plane perpendicular to the cervical canal) narrowing of the cervix, which in turn leads to a narrowing of the cervical canal;

c) the application of vacuum pressure to the cervical canal in the absence (or insufficient amount) of fluid passing through it (for example, due to a blockage that has arisen near the internal os of the cervix), leads to increased pressure on the walls of the cervical canal (according to Bernoulli's law).

This increased pressure and lack of fluid flowing through the channel causes narrowing and finally complete closure of the channel as a result of collapse / pinching.

The device of the present invention is particularly effective due to the application of vacuum without closing the cervix. In a preferred embodiment, the implementation of the mechanical movement of the cervix is used in combination with vacuum oscillations, in another embodiment, high frequency and high amplitude vacuum oscillations are used. For example, by applying an extremely rapid high amplitude vacuum, in which the oscillations are in the form of a square or sawtooth wave, with a rapid increase in vacuum and a slow release of vacuum, aspiration is provided until the cervix is possibly closed. If the vacuum is applied for longer periods of time with a gradual increase in vacuum strength, the cervix may collapse and a further increase in suction pressure may not be effective. A preferred method of preventing cervical closure is to cause the cervix to oscillate by said mechanical movement, for example by pushing and pulling the cervix with a suction cup. Another method involves applying vibrations to the cervix during vacuum aspiration. Vibration can help dilate a collapsed cervix or prevent it from closing easily. Vibration can also stiffen the viscoelastic tissue of the cervix, which prevents closure, or change the viscosity of the uterine fluid to facilitate its flow.

Thus, in a preferred embodiment, the present invention provides an apparatus comprising at least a vacuum pump, a suction tube with a suction cup, a liquid trap, a processor, and cervical dilatation means applying vacuum pressure and preventing cervical closure. These means can prevent closure of the cervix by applying extremely rapid vacuum pressure (high impact or high frequency), applying an axial force to the cervix (pushing, pulling), and/or applying vibration to the cervix. The device of the present invention preferably comprises at least one of rectangular or sawtooth pressure oscillations, translational axial movement/force and vibrations; in one implementation, the device contains at least two of these options. In one embodiment, acoustic waves may be used in the device.

One of the important features of the device and method of the present invention is their non-invasive nature: the cervical canal is not crossed, and the design of the device excludes such a crossing or passage into the cervical canal.

Thus, the present invention provides a system comprising means for adjusting the vacuum to provide pressure fluctuations, preferably with a rapid pressure start, for example from 0 to -700 mbar, for example, including square waves, in combination with a movement of the cervix up to 20 mm in both directions and/or in combination with mechanical vibrations. The vacuum oscillations may have a frequency of 1 to 25 Hz, such as 1 to 15 Hz, such as 2 to 15 Hz, such as 4 to 15 Hz. The frequency of the linear movement may be from 1 to 6 Hz, for example from 2 to 5 Hz. Mechanical vibrations applied to the cervix may have a frequency of 25 to 300 Hz, such as 40 to 100 Hz. Vibrations can have non-zero axial and non-zero transverse components. Acoustic vibrations, including sound or ultrasound, can be used using energy outputs known from massage devices used on the human body.

One of the most important features of the system and device of the present invention is the simultaneous execution of the following actions:

(a) mechanical translation up to 20 mm forward and up to 20 mm back from the initial fit position; and (b) application of vacuum pressure pulses having pressure values from about 0 to -600 mbar with a frequency up to 15 Hz.

In a preferred embodiment of the invention, the translational movement is synchronized with the pressure pulses. Additional features of the invention include a color sensor, continuous

- 6 041073 seamlessly tracking the color of menstruation, providing indications of the progress of the extraction process and the health status of the user.

Another aspect of the invention includes a flow sensor. This configuration allows the system, together with the controller, to learn the user and change important parameters of the device, including vacuum pressure amplitude, vacuum pressure frequency, forward and reverse movement, movement frequency, and synchronization between vacuum fluctuations and displacement oscillations. The system can also adjust the time intervals within an individual regimen optimized for the patient. Specific parameters characterizing the user may be obtained prior to using the device from an expert or doctor, including a gynecologist, or through a questionnaire filled out by the user; parameters include surgical history, vaginal delivery and caesarean section, fibroids, other significant history, and other information that may affect optimal regimen.

Another feature of the system according to the present invention is the optional inclusion of the preparation phase in the mode before the main extraction phase; the preparation phase may provide, for example, a lower frequency or a weaker vacuum compared to the main phase. The phase structure is adapted to the requirements of a particular user.

In one embodiment of the invention, a fluid aspiration device, comprising a suction tube with an end suction cup, configured to independently apply vacuum pulses and move forward and backward along its axis, removes uterine and vaginal fluid by simultaneously applying pressure pulses and mechanical movements in accordance with a given mode. Said vacuum and/or air pressure pulses preferably vibrate adjacent tissues, including the cervix, and facilitate the flow of said fluids. In some embodiments, said regimen may include a cleansing cycle during or after fluid withdrawal, as well as a vibration mechanism for pain relief.

The invention is directed to providing a device and system for removing uterine fluid containing blood, water, electrolytes, mucus, plasma, cells and tissue particles, wherein the fluid is withdrawn and aspirated from the vagina by means of a vacuum source. Said uterine fluid may contain coagulated blood clots. The system and device comprise at least

i) vacuum pump or other vacuum source;

ii) a suction tube having first and second ends and connected to the specified pump through the specified first end, and at least part of the tube defines a linear axis;

iii) a suction cup connected to said tube by said second end having a width greater than that of said tube, the suction cup typically having a smaller opening attached to the tube and a wider opening to aspirate said liquid;

iv) a vacuum valve or similar instrument for connecting and disconnecting said pump alternately from said suction cup or for providing vacuum oscillations at a frequency of 1 to 15 Hz;

moreover, the pressure amplitude can be from -150 to -800 mbar (corresponding to a vacuum from 150 to 800 mbar), for example from -300 to -700 mbar, for example from -400 to -600 mbar; the actual pressure difference between the minimum and maximum negative pressure within one period of oscillation may be from 5 to 600 mbar, for example from 30 to 300 mbar;

v) a device for translational movement of said tube and said suction cup along said axis in both directions for up to 40 mm, typically including movement from the initial position by 5-20 mm in each direction; moreover, the device usually contains a motor and a fastener for connecting the suction tube with the specified engine;

vi) one or more pressure sensors, for example, to measure pressure downstream of the pump or in a collection container (container/trapper), upstream of the suction cup, or at some other point in the device;

vii) a liquid trap connected between said pump and said suction tube to contain said liquid, preferably made of washable or disposable plastic; and viii) a data logger or microprocessor receiving data from said sensors, controlling the operation of said pump, said valve or other means of adjusting the vacuum and said motor, and containing software that determines the mode of operation of the device.

In a preferred embodiment, the system and apparatus of the present invention comprise means for cutting said blood clots or tissue particles into smaller particles, preferably before entering said suction tube; in some embodiments, the means comprise a rotating cutting element or network of thin cutting wires, wherein said aspirated mother liquor travels through said rotating element or said network of wires and larger clumps or clumps are thus separated into smaller particles.

- 7 041073

Said rotating element may comprise a rotating disk with a shutter provided with a cutting edge. Said network of wires may comprise a strong flexible metal or polymeric material.

Said rotating disk with a front thin edge can cut, mix and homogenize the menstrual flow and ensure its free passage through the rest of the channels. The disk can rotate approximately 1-10 times per second. The disc can also control valve impulses. In a preferred embodiment, said suction cup and said suction tube are disposable. The underlying pressure inside a person's uterus during menstruation can be approximately 50 mbar between contractions. Thus, it may be necessary to use a slight positive pressure to equalize this pressure and ensure equal pressure on both sides in the cervix. In one embodiment of the invention, the application of a negative pressure may be followed by the application of a lower positive pressure, eg 10 to 200 mbar, eg 40 to 150 mbar. In another preferred embodiment, said suction cup and said tube form a single disposable plastic block. Said suction cup is made of medical plastic and contains a surface made convex on the side of said suction tube. The suction cup and tube are smooth with no sharp or irritating elements. The suction tube and the suction cup are designed to be introduced into the human vagina and adhere to the cervix during the aspiration of said liquid. Said translational movement typically causes said suction cup to move up to about 10 or about 20 mm, eg up to 15 mm in each direction, which results in displacement of said cervix by a similar distance. In some embodiments, said pump provides a maximum vacuum pressure (suction pressure or vacuum) of -200 to -800 mbar, said valve generates pressure oscillations of 4 to 10 Hz, and said cervical displacement is up to 15 mm. The operating parameters may be adjustable by the user and they may be optimized by the device, possibly in accordance with the recommendations of experts.

The invention is directed to providing a device designed to control menstruation by removing uterine fluid during menstruation, which leads to at least one of the following effects: providing the user with specified periods of time without menstruation, reducing the total volume of monthly menstrual bleeding, reducing the duration of menstrual bleeding , relieve menstrual cramps and menstrual pain, and reduce the need for tampons and pads.

Thus, the present invention provides a method for aspirating mother liquor, comprising the steps of providing a suction cup made of medical plastic and comprising a convex surface, the suction cup being connected to a vacuum source through said convex surface;

providing a vacuum valve or other means of providing partial vacuum oscillations in said suction cup at a frequency of 1 to 15 Hz, preferably 3 to 12 Hz, such as 4 to 10 Hz, such as 5 to 9 Hz;

providing a device pushing and pulling said suction cup up to 20 mm in each direction;

inserting said sucker into the vagina, ensuring that it adheres to the cervix;

activating said vacuum fluctuations and simultaneously activating said device, which results in displacement of the cervix up to 20 mm, preferably at a frequency of up to 2.5 Hz; and extraction of uterine fluid from the vagina;

moreover, the above method allows to provide at least one of the following effects: providing the user with specified intervals of time without menstruation, reducing the total amount of monthly menstrual flow, reducing the duration of menstrual bleeding, reducing menstrual cramps, reducing menstrual pain, and reducing the need for tampons and pads.

In one preferred embodiment, in at least some operating cycles, the suction cup is attached by said vacuum pressure to the cervix and moves the surrounding tissue distally (away from the uterus), followed by breaking the vacuum and releasing the tissue; this process improves the efficiency of liquid recovery. The vacuum in the suction cup can be interrupted by a vacuum relief valve placed near or on said convex surface.

Unlike other known means of controlling menstruation, the present method and apparatus prevents the outflow of menstrual fluid at predetermined future time intervals to provide certain periods of time without menstruation. The method is safe and easy to use by any instructed user, even without expert supervision. The device of the present invention creates a vacuum pressure and axial movements in a range that is safe for human tissues, which is confirmed by careful analysis and reliable modeling on

- 8 041073 uterus models.

The system and method of the present invention allows a woman to more accurately plan her activities during the menstrual cycle and avoid uncomfortable and unpleasant moments. The system and device of the present invention helps to reduce the use of tampons and pads. The system of the present invention provides for the collection of menstrual flow at predetermined points in time. The present invention provides predetermined periods without menses for women.

The present invention is further described and illustrated in the following examples.

Examples

Extraction of menses by applying oscillating vacuum pressure and pushing and retracting the cervix - an experimental simulation.

Materials.

Details and materials in the device and models.

Hollow uterine models made of thermoplastic elastomer (TPE) with properties similar to those of human tissue (504 in Fig. 20);

plugs for closing the opening of the uterus (cervical pharynx) and filling channels;

model of the vagina (509 in Fig. 20);

an empty water bottle connected to a plastic tube (502 in Fig. 20) to apply hydrostatic pressure through the standpipe;

water;

blood simulator (blood);

mucus simulant (wet and dried) to simulate tissue agglomerates of the sloughed endometrial layer (endometrial sloughing);

10 ml syringe (syringe);

digital scales (scales);

a prototype device used to extract menstrual flow (blood and endometrial shedding layer) from the uterus;

a vacuum pump connected to the suction tube (505 in Fig. 20);

vacuum pressure control valve;

a suction cup connected to a suction tube;

a rotary vacuum pressure swing valve (507 in FIG. 20) driven by a motor;

a mechanism that allows axial movement of the suction cup (506 in Fig. 20) relative to the cervix and is driven by a motor (508 in Fig. 20);

two pressure sensors to measure the pressure in the container and in the suction tube near the suction cup; and a data logger (501 in FIG. 20).

Example 1. Model comparison.

Several models were prepared in the following way. According to FIG. 20 is a TPE uterine model comprising a cavity, an opening (cervix) placed in the vaginal model, a filling channel through which the model tubes are inserted for filling with blood or water, and another channel (used to measure pressure, for example). The uterine model was mounted on a stand with a clamp in such a way that the uterine body was perpendicular to the ground. Plugs were installed to close the cervical os and the pressure measurement channel. Scales were placed directly under the stand. An empty bowl was placed under the uterus to ensure the collection of water. The tube connected to the bottle was introduced into said filling port. The pressure column was filled with a given amount (600 g) of water. The plug covering the cervical os has been removed. The flow of water through the pharynx into the cup was ensured with the accompanying continuous measurement of the mass of drained water until the uterus was empty, which made it possible to characterize various models. Some models have also been used to extract simulated menstrual fluid from the uterus as described below.

Example 2 Uterine Emptying Model.

Simulated sloughed endometrial secretions designed to mimic menstruation (referred to as menstruation) were prepared containing artificial mucus (moist particles of sloughed endometrium) and artificially dried mucus particles (dried particles of sloughed endometrium 10x5x5 mm). The suction cup connected to the suction tube was designed to wrap around the cervix. A rotary valve (507 in Fig. 20) controlled fluctuations in the vacuum pressure generated by the vacuum pump; the valve had two working configurations: one for attaching the suction cup to the vacuum source and one for detaching it. In some embodiments, the suction cup is provided with a vacuum release valve. Plugs were inserted into the cervical os and the pressure channel to seal them. Particles of dried reject

- 9 041073 endometrium (simulated) with a total weight of ~3.5 g were introduced through the filling channel into the uterine cavity. The weight of the filled uterus was measured, and the weight of the desiccated sloughed endometrium contained in the uterine cavity was calculated as the difference between the current reading and the data recorded before the filling of the uterus, in order to achieve any value from 3.25 to 3.75 g. The syringe was flushed and filled with -3.5 g of moist particles of rejected endometrium, which were introduced through the filling channel into the uterine cavity. The weight of the filled uterus was measured, and the weight of the rejected endometrium (dried and wet) contained in the uterine cavity was calculated as the difference between the current readings and the data recorded before filling the uterus, with the goal of reaching any value from 6.75 to 7.25 d. The sloughed endometrium was compacted towards the pharynx by centrifugal force. The plug covering the cervical os has been removed. The uterus was placed on the simulator of the vagina according to Fig. 20 in such a way that the throat was directed 30° below the horizon.

The flow rate of particles of rejected endometrium through the cervical os was measured in several versions of the model (a)-(c) as follows.

(a) Vacuum + outflow under uterine pressure.

Measured the flow rate of menstrual flow through the cervical os under the influence of gravity, simulated baseline pressure of the uterus and vacuum pressure. Vacuum suction was measured by means of digital pressure transducers (sampling rate: 2 Hz) attached to the suction container and to the suction tube close to the suction cup. An empty plastic tube connected to an empty bottle was introduced into the filling channel. The bottle (502 in FIG. 20) was filled with dummy blood to create a ~50 cm high blood column (to simulate an intrauterine pressure of ~5 kPa=50 mbar). The suction cup was installed in such a way that it was adjacent to the cervix, as a result of which these elements were connected to each other without the application of a compressive force. Vacuum pressure was applied to the cervix by means of a vacuum pump by turning the adjustment valve to its maximum position. The magnitude and frequency of the vacuum pressure was set in accordance with the required mode. An example of a vacuum pressure profile (oscillatory wave) generated by a vacuum pump and a rotary valve in the vicinity of a suction cup is shown in FIG. 21B for pressure fluctuations of 1.1 Hz, despite the fact that frequencies of 6.2 and 11.8 Hz were mainly used. The pressure values measured for several pressure fluctuations are given in table. 1.

Table 1

Peak values of the vacuum pressure applied to the pharynx of the cervix

Applied Vacuum Pressure Profile Peak rated value vacuum pump pressure [mbar] Pressure fluctuation frequency [Hz] Permanent 450-500 0 vibrational 420-470 6.2 vibrational 390-440 11.8

Measurements were continued until the entire volume of the simulated rejected endometrium passed through the cervical os or for 30 minutes (whichever comes first). The time points at which the rejection of the endometrium was removed were determined visually.

(b) Vacuum + abduction + outflow under uterine pressure.

The rate of flow of menstrual flow through the cervical os under the influence of attractive forces, simulated uterine base pressure, vacuum suction, and gentle cervical abduction was studied. All pressure profiles listed in Table 1 were used. 1, and the cervix and sucker were not permanently fully connected to each other; using the device, running movements were performed (with a distance of 15 mm and a frequency of 1.1 or 2.5 Hz). When the suction cup is retracted from the cervix with the application of vacuum pressure, the cervix is retracted distally with the suction cup, and sometimes there is a sudden loss of vacuum when the suction cup is removed from the cervix (which creates an excitation effect similar to that of a rubber plunger, in which the cervix is repeatedly retracted with an increase in vacuum pressure and is released when the vacuum is removed).

(c) Vacuum + abduction + thrust + outflow under uterine pressure.

The flow rate of menstrual flow through the cervical os was measured under the action of attractive forces, simulated uterine base pressure, vacuum suction, and a combination of alternating soft abduction and pushing of the cervix. Since the lead and push was used

- 10041073 one engine is called, the indicated actions were always used with the same frequency. The engine provided the possibility of a full stroke of 30 mm, divided into retraction and push of 15/15 mm.

All tests were performed until complete emptying of the rejected endometrium or within 30 minutes (whichever comes first). After successful completion of the test (all sloughed endometrium is deflated, as indicated by removal of the sloughed endometrium blocking the os and free flow of blood through the pharynx) or unsuccessful completion (after 30 min, the sloughed endometrium is still blocking the os), uterine mass was measured and the amount of deflated of rejected endometrium as the difference between the current readings and the data obtained just before the start of the extraction. The procedure was repeated three times, once for each of the three uterine models, according to the vacuum pump pressure and stroke combinations shown in Table 1. 2.

table 2

Detailed information on vacuum pressure applied to the cervical os and on abduction and/or thrusting of the cervix

Profile Push/pull frequency [Hz] applied vacuum pressure Pressure fluctuation frequency [Hz] Push [mm] Lead [mm] 1a Permanent - No No - 1b vibrational 6.2 No No - 1s vibrational 11.8 No No - 2a Permanent - No 15 1.1 2b vibrational 6.2 No 15 1.1 2s vibrational 11.8 No 15 1.1 2d Permanent - No 15 2.5 2nd vibrational 6.2 No 15 2.5 2f vibrational 11.8 No 15 2.5 Behind Permanent - 15 15 1.1 3b vibrational 6.2 15 15 1.1 Zs vibrational 11.8 15 15 1.1 3d Permanent - 15 15 2.5 Ze vibrational 6.2 15 15 2.5 3f vibrational 11.8 15 15 2.5

Evaluation of the obtained results.

Table below. 3, which shows the results of tests conducted for all combinations of magnitudes and frequencies of pressure, leads and pushes disclosed in table. 2.

- 11 041073

Table 3

Summary of the test results described in table. 2

Number of repetitions Test score Mass fraction (%) of the rejected endometrium, deflated during the study 1a 3 0, 0, 0 3%, 6%, 11% (average: 7%) 1b 3 0, 0, 0 21%, 13%, 15% (average: 17%) 1s 3 0, 1, 0 16%, 100%, 12% (average: 42%) 2a 3 0, 0, 0 4%, 7%, 11% (average: 7%) 2b 3 1, 0.5, 0 100%, 100%, 7% (average: 68%) 2s 3 0, 0, 0 23%, 5%, 61% (average: 30%) 2d 3 0, 0, 0 17%, 18%, 24% (average: 19%) 2nd 3 1, 1, oh 100%, 100%, 56% (average: 85%) 2f 3 0, 1, 0 18%, 100%, 25% (average: 48%) Behind 3 0, 0, 0.5 16%, 14%, 100% (average: 42%) 3b 3 0, 1, 0 40%, 100%, 60% (average: 67%) Zs 3 0, 0, 0 27%, 40%, 20% (average: 29%) 3d 3 oh 1 oh 41%, 100%, 0% (average: 47%) Ze 3 o, 0, 1 73%, 54%, 100% (average: 75%) 3f 3 0, 0, 0.5 17%, 21%, 100% (average: 45%)

The test is rated 1 point if all fluid is drained after 5 minutes or less, 0.5 points if all fluid is drained after 6-30 minutes, and 0 points if fluid is not drained after 30 minutes.

It appears that the application of fluctuations in vacuum pressure to the cervix as a whole was more effective in removing menstrual flow compared to the application of continuous pressure. When using only pressure oscillations from the vacuum pump (namely, without the use of retraction and/or pushing), a higher frequency of oscillation leads to better performance. When combining abduction (or abduction simultaneously with pushing) with vacuum pressure oscillations, a lower frequency of pressure oscillations turned out to be more effective. The effect of abduction with vacuum (continuous or fluctuating) did little to remove menses from the uterus. The frequency of derivation did not have a noticeable effect on the operation of the device. Combined with vacuum pressure, abduction and pushing helped to remove menstrual fluid from the uterus, but no more than abduction alone. The high frequency of pushing and pulling resulted in better device performance.

It can be concluded that fluctuations in vacuum pressure have a better effect than continuous pressure, with more efficient extraction achieved while using cervical displacement.

Example 3

Another experiment simulating the suction of menstrual fluid from the uterus by applying vacuum pressure to the cervical os was carried out as follows. The TPE uterine model was filled with 8.00 to 8.25 g of artificial mucus simulating menstrual flow (endometrium sloughed off, in this case only wet) and mounted on the vaginal model. The uterus was then connected via one of the filling channels to a bottle filled with a blood simulant to create an intrauterine pressure of 50 mbar. Vacuum pressure (of various strengths and frequencies; see Table 4) was applied to the orifice of the model (cervical os) to drain intrauterine menses through a flexible plastic cup connected to the suction container of the pump. Pressure sensors connected to the data logger continuously measured (at a sampling rate of 2 Hz) the pressure in the suction container, as well as the pressure generated inside the uterus or in the suction tube in close proximity to the cervix. The nominal vacuum pressure applied by the pump was continuous or oscillating (with a frequency of 5 or 9 Hz) reaching the maximum value allowed by the system (420-500 mbar) or lower value (300-400 mbar) (Table 4). Pump pressure was intermittently combined with axial movement of the suction cup toward and/or away from the cervix to compress or retract it; retraction of the suction cup from the cervix by applying vacuum pressure caused the cervix to be pulled distally along with the suction cup and sometimes resulted in a sudden loss of vacuum when the suction cup was detached from the cervix. Lead and push were applied for each of two frequencies (1.1 and 2.5 Hz) and each of three

- 12 041073 distances (10, 15 and 20 mm on each side) (Table 4). A total of 34 combinations of distances and frequencies of vacuum pressure and retraction/push were applied in five test blocks (Table 4). Each of these tests was repeated three times. Each trial was assigned a score from 0 to 1, depending on the time it took for the menstrual flow to descend through the suction cup: 1 - success after <3 min, 0.5 - success after <15 min, 0.25 - success after <30 min, 0 - failure after >30 min. For each combination of pressure and travel distance, an average score was calculated after three trials. The results are shown in table. 4.

Table 4

Model test results

Pressure profile Peak pressure value [mbar] I hesitate Frequency pushing pressure frequency [Hz] Push [mm] Lead [mm] /retracted AND I [Hz] Average NI score 1 oscillatory 420-500 5 No No - 0.33 2 oscillatory 420-500 9 No No - 0.33 3 oscillatory 420-500 5 15 15 1.1 0.75 4 oscillatory 420-500 9 15 15 1.1 1.00 5 oscillatory 420-500 5 15 15 2.5 1.00 6 oscillatory 420-500 9 15 15 2.5 1.00 7 Standing HH oh 420-500 - 15 15 1.1 0.67 8 Standing HH oh 420-500 - 15 15 2.5 1.00 1 oscillatory 300-400 5 No No - 0.33 2 oscillatory 300-400 9 No No - 0.00 3 oscillatory 300-400 5 15 15 1.1 1.00

- 13 041073

Swinger

th 300-400 9 15 15 1.1 0.50 5 oscillatory 300-400 5 15 15 2.5 1.00 6 oscillatory 300-400 9 15 15 2.5 0.33 7 Standing HH oh 300-400 - 15 15 1.1 0.42 8 Standing HH oh 300-400 - 15 15 2.5 0.33 3 oscillatory 420-500 5 10 10 1.1 0.58 4 oscillatory 420-500 9 10 10 1.1 0.67 5 oscillatory 420-500 5 10 10 2.5 0.83 6 oscillatory 420-500 9 10 10 2.5 0.67 7 Standing HH oh 420-500 - 10 10 1.1 0.17 8 Standing HH oh 420-500 - 10 10 2.5 0.00 3 oscillatory 420-500 5 10 20 1.1 1.00 4 oscillatory 420-500 9 10 20 1.1 1.00 5 oscillatory 420-500 5 10 20 2.5 0.67 6 oscillatory 420-500 9 10 20 2.5 1.00 7 Standing HH oh 420-500 - 10 20 1.1 0.33 8 Standing HH oh 420-500 - 10 20 2.5 0.33 3 oscillatory 420-500 5 No 20 1.1 1.00 4 oscillatory 420-500 9 No 20 1.1 0.83 5 oscillatory 420-500 5 No 20 2.5 1.00 6 oscillatory 420-500 9 No 20 2.5 1.00 7 Standing HH oh 420-500 - No 20 1.1 0.67 8 Standing HH oh 420-500 - No 20 2.5 0.67

Increasing the vacuum pressure generally resulted in more successful extraction of menses. Pressure fluctuations also resulted in more successful descent of menses compared to continuous pressure. Cervical abduction and thrust generally resulted in more successful descent of menstrual fluid, with 15 mm abduction and thrust being more successful than 10 mm abduction and thrust.

It can be concluded that pressure fluctuations are important for the extraction of menses; however, their use above 5 Hz may not be useful. A higher amplitude of pressure fluctuations leads to a positive effect. Application of abduction (plunger effect)

Claims (17)

affects the efficiency and effectiveness of menstrual flow extraction with or without pushing. Increasing the frequency of movement (displacement of the cervix) may not be helpful. Although the present invention has been described using some specific examples, many modifications and variations are possible. Therefore, it is to be understood that the invention is not intended to be limited in any way other than by the scope of the accompanying claims. CLAIM 1. A device for aspiration of the uterine fluid, containing i) vacuum pump (309); ii) a suction tube (2) having first and second ends connected to said pump via said first end, at least part of the tube defining a linear axis; iii) a suction cup (4B) connected to said tube through said second end, having a width greater than that of said tube and containing an opening for aspiration of said liquid, the suction cup and tube being insertable into a human vagina; iv) non-invasive means of opening the cervix; v) a liquid trap (310) connected between said pump and said suction tube to retain said liquid; and vi) a processor (501) for controlling the operation of said pump and said non-invasive means of opening the cervix, as well as for storing software that determines the mode of operation of the device. 2. The device of claim 1, wherein said cervical opening means and said processor comprise vacuum adjusting means to apply vacuum rapidly to allow aspiration of vaginal and uterine fluid. 3. A device according to any one of claims 1, 2, in which said means of opening the cervix contain a device that allows translational movement of the specified tube and the specified sucker along the specified axis in both directions for a distance of up to 40 mm and containing a motor and a fastener for connection the specified suction tube with the specified motor. 4. A device according to any one of claims 1 to 3, wherein said means for opening the cervix comprise a device for vibrating the cervix during vacuum aspiration. 5. An apparatus according to any one of claims 1 to 4, wherein said processor and said non-invasive means of opening the cervix provide a sudden application of vacuum, repeated in the form of square or sawtooth waves. 6. A device according to any one of claims 1 to 5, wherein said means for opening the cervix comprise a device that delivers acoustic waves to the cervix. 7. The device according to any one of claims 1 to 6, containing one or more pressure sensors. 8. An apparatus according to any one of claims 1-7, wherein said processor receives data from said sensors. 9. Device according to any one of claims 1 to 8, wherein said suction cup is made of a medical grade elastomer and comprises a surface formed convex on the side of said suction tube. 10. A device according to any one of claims 1 to 9, wherein said suction tube and said suction cup are adapted to fit against the cervix during aspiration of said fluid. 11. An apparatus according to any one of claims 1 to 10, further comprising means for cutting blood clots or tissue particles present in said mother liquor into smaller particles before passing said particles into said suction tube. 12. A device according to any one of claims 3 to 11, wherein said translational movement causes said suction cup to move up to 20 mm in each direction, resulting in displacement of said cervix. 13. An apparatus according to any one of claims 1 to 12, wherein said pump provides a maximum negative pressure of -150 to -750 mbar and a maximum positive pressure of 10 to 200 mbar. 14. The device according to any one of claims 1 to 13 for use in removing uterine and vaginal fluid during menstruation, which leads to at least one of the following effects: providing the user with specified periods of time without menstrual flow, reducing the total amount of monthly menstrual flow, reduce the duration of menstrual bleeding, relieve menstrual cramps, relieve menstrual pain, and reduce the need for tampons and pads. 15. The apparatus of claim 1, wherein said pump alternately generates a negative pressure and a weaker negative pressure, or atmospheric pressure, or positive pressure. 16. The method of aspiration of the uterine fluid, including - 15 041073 i) providing a suction cup (4B) made of medical plastic and containing a convex surface, the suction cup being connected to a suction tube having a first end connected to a vacuum pump and a second end connected to said suction cup, wherein at least a portion of the tube defines a linear axis, and the suction cup contains an opening for aspiration of said liquid, and a means for cutting blood clots or tissue particles present in said mother liquor into smaller particles before passing said particles into said suction tube; ii) providing a non-invasive means of opening the cervix, selected from (a) means for adjusting the vacuum, connecting and disconnecting the specified vacuum pump from the specified sucker with a frequency of from 1 to 15 Hz, providing fluctuations in the vacuum in the specified sucker, (b) a device that allows translational moving said suction cup along said axis in both directions, (c) a device for vibrating the cervix during vacuum aspiration, or (d) a combination of said means; iii) inserting the suction cup into the vagina so that the suction cup rests against the cervix; iv) activating said cervical dilatation means, said vacuum oscillations having a frequency of 1 to 15 Hz, said translational device displacing the cervix by 20 mm in each direction at a frequency of up to 5 Hz; and/or the specified device provides vibration of the cervix with a frequency of up to 300 Hz; And v) extraction of uterine and vaginal fluid from the vagina; which results in at least one of the following effects: providing the user with predetermined periods without menstruation, reducing the total amount of monthly menstrual flow, reducing the duration of menstrual bleeding, easing menstrual cramps and menstrual pain, and reducing the need for tampons and pads. 17. A system for removing uterine and vaginal fluid, containing i) a suction cup (4B) connected to a vacuum source (309) and inserted into the vagina close to the cervix; and ii) non-invasive means of opening the cervix, selected from (a) means for adjusting the vacuum, connecting and disconnecting the specified source of vacuum from the specified suction cup with a frequency of 1 to 15 Hz, providing fluctuations in the vacuum in the specified sucker, (b) a device that allows translational moving said tube and said suction cup along said axis in both directions, (c) a device for vibrating the cervix during vacuum aspiration, or (d) a combination of said means; wherein the system aims to reduce the inconvenience and discomfort associated with the normal menstrual cycle and menstrual irregularities, with the possible elimination of the need for the use of tampons or pads or synthetic hormones to suppress menstruation, and to enable the woman to plan her activities during the menstrual cycle by providing specified periods of time without menstrual flow. -