WO2021150145A1

WO2021150145A1 - Portable female urination device

Info

Publication number: WO2021150145A1
Application number: PCT/RU2021/000022
Authority: WO
Inventors: Светлана Алексеевна ЛЕБЕДЕВА
Original assignee: Светлана Алексеевна ЛЕБЕДЕВА
Priority date: 2020-01-23
Filing date: 2021-01-21
Publication date: 2021-07-29

Abstract

The invention relates to medical technology and is used for female urination in conditions that are not conducive to urinating in the natural body position. The claimed device comprises a funnel having a cup (2) with an elongated recessed shape, a transverse rounded lip (3) along the edge of the cup (2), and a spout (4) arranged at the lip end and adjoining the bottom of the cup (2), said spout being configured for connection by means of a first tube (5) to an inlet opening of a diaphragm pump (12) that forms part of a hardware portion of the device. An outlet opening of the diaphragm pump (12) is connected by a second tube (5) to a container (7) for collecting urine. The elongated cavity of the cup (2) corresponds in volume to the labia minora, and the length of said cavity is one-quarter shorter than the length of the labia minora, the rear part of the cup (2) tapers, and the transverse rounded lip (3) is arranged on the front part of the cup such as to be perpendicular or slightly inclined by 1-3 degrees to the edges of the cup (2). The hardware portion comprises the diaphragm pump (12) for pumping urine, a pump control module (14), a control circuit board (13) with a microcontroller, a variable resistor connected to said control circuit board and having a knob (8), a storage battery (16) equipped with a booster circuit board (15), and an on/off button (9).

Description

PORTABLE URINAL DIVERSION FOR WOMEN

Technology area

The invention relates to medical technology, namely to sanitation and hygiene equipment, and is used to drain urine from women in various conditions that do not represent the ability to do so in the natural position of the body.

State of the art

Many devices are known for female urination in extreme conditions.

Since the 1920s, several dozen urine-diverting funnels and tubes have been patented, allowing women to urinate while standing - now they are produced under the brands Pibella, SheWee, Pstyle, Whiz Freedom, LadyP, Hopkins, etc. These tubes and funnels are made of solid plastic or silicone and allow urine to flow forward. However, a common problem with this solution is the lack of tightness when in contact with the body, which leads to leaks during use.

In a hospital setting or in case of urinary incontinence in patients in medical practice, urinals are used - reservoirs for collecting and taking urine for analysis. Distinguish between bedside urine bags ("duck" with a neck like "willow leaf", "medical vessel"), wearable leg urine bags and gel urine bags like diapers. The former are intended for patients arriving in a supine state, but who are able to lift the pelvis to use the drainage container (Buyers Guide to Bolster and Urinal Selection, https://www.365med.ru/%D1%8D%D0%BD%D1%86%D0%B8%D0%BA% D0% BB% D0% BE% D0% BF% D0% B 5% D0% B4% D0% B 8% D 1% 8F /% D0%

BF% D0% BE% D0% B4% D0% BA% D0% BB% D0% B0% D0% B4% D0% BD% D 1% 8 B% D0% B 5 -% D 1% 81% D 1% 83% D0% B4% D0 ^o / oBD% D0 ^o / oB0-% D0% B8-

% D0% BF% D0% B 8% D 1% 81% D 1% 81% D 1% 83% D0% B0% D 1% 80% D 1% 8 B)

In the second case, wearable urine bags are combined with urological catheters - a tube that is inserted into the bladder through the urethra to drain urine from the bladder. This method of urinary diversion is used in sedentary patients or in case of urinary incontinence. The duration of this method is usually limited to a few days, or is associated with rather time-consuming tactics of replacing the catheter (Bladder catheterization, https://empendium.com/ru/chapter/B33 LU.24.13.). The use of gel bags is non-invasive and may not require active movement of the patient's pelvis, however, the amount of fluid absorbed is usually limited to 750 ml, which leads to frequent and energy-intensive replacement.

The closest device to the claimed invention is the utility model of V.N. Nikiforov. (RU 150112 Ш, published on January 27, 2015). The solution proposed by Nikiforov is a composite device with a guiding chamber with a branch pipe, attached to the pelvic region of a woman with the help of special underpants, tubes leading from her, and a container for collecting urine, attached to the leg. The similarity of the claimed invention and V.N. Nikiforov is to use a guide chamber with a branch pipe and a remote design for collecting biological fluid with an antireflux valve.

However, in all of the above solutions there are limitations that are solved in the proposed invention. In particular, the proposed invention solves the following problems:

1.Leakage (which occurs when using silicone funnels or funnels leaning against the groin or labia);

2. urination without active movement of the pelvis in recumbent and seated patients;

3. there is no invasiveness of the urological catheter (which means that this method is more gentle and does not lead to possible infectious complications and damage to the urethra).

Disclosure of the essence of the invention

The technical problem is solved by a device for the mechanical diversion of urine in women, containing a urine diverting funnel with a tube, a tube and a container for collecting urine, while the urine diverting funnel has an elongated, recessed bowl, the length of which corresponds to ³ L of the length of the woman's labia minora, a transverse rounded protrusion along the edge bowls for the provision of moderate lateral pressure on the labia minora, and the branch pipe is located on the side of the protrusion, is mated with the bottom of the bowl and is configured to be connected by means of the first tube to the inlet of the membrane pump, which is part of the hardware part of the device, and the container for collecting urine is made with an opportunity connection by means of a second tube to the outlet of the diaphragm pump.

In a preferred embodiment, the hardware includes a miniature diaphragm pump for pumping urine including in the vertical direction, a pump control module, a control board with a microcontroller, a variable resistor connected to it, a battery equipped with a step-up board, and an on / off button.

At the same time, the body of the hardware part has fasteners for collapsible fixation of a container for collecting urine on it.

In addition, the body of the hardware part has attachments in the form of carabiners for fixing on clothes or medical rehabilitation structures.

The body of the apparatus complex also has a compartment for storing the urine diverting funnel.

The technical problem is also solved by a urine diverting funnel, which has an elongated, recessed bowl, the length of which corresponds to ³ lengths of the labia minora of a woman, a transverse rounded protrusion along the edge of the cup to exert moderate lateral pressure on the labia minora, and a branch pipe on the side of the protrusion, mated with the bottom of the bowl and designed to connect the funnel to the urine diversion tube.

In a preferred embodiment, the elongated cavity of the bowl of the urinary funnel is commensurate in volume with the labia minora of a woman, and the length of the elongated cavity of the bowl is ¹ L shorter than their length, the back of the bowl is made tapering, and the transverse the rounded protrusion on the front of the bowl is perpendicular or with a slight incline of 1-3 degrees to the edges of the bowl.

In this case, the elongated cavity of the bowl of the urinary funnel is commensurate in volume with the labia minora of a woman, and the length of the elongated cavity of the bowl is shorter than their length, the back of the bowl is made tapering, and the transverse rounded protrusion on the front of the bowl is perpendicular or with a slight slope of 1- 3 degrees to the edges of the bowl.

Preferably, the urine diversion funnel is made of polypropylene.

The tube of the urine diverting funnel in working condition is connected either with a short (about 13 cm) or with a long (about 40-50 cm) silicone tube, depending on the position of the woman's body in space and the need to use the hardware of the device with a membrane pump for mechanical pumping of fluid ...

The technical problem is solved by several innovations of the claimed invention.

1. None of the known designs of funnels and necks of urine bags uses an area that exerts lateral pressure on the labia minora in the clitoris. This innovation allows directing the external opening of the urethra forward, along the cavity of the funnel bowl, thereby directing the urine stream directly to the outlet opening of the funnel pipe. This not only prevents splashing, but also eliminates the need for subsequent use of absorbent wipes. 2. The small size of the claimed design of the funnel allows it to be used in conditions that do not imply the ability to remove items of underwear or change the position of the body - lying, sitting on a flat surface, standing (in bedridden patients, women in wheelchairs, women leading an active lifestyle and etc.).

3. None of the known solutions involves active mechanical removal of liquid biological material (urine). The claimed solution allows for the diversion of urine through a tube, which is also in an upright position.

4. The use of a diaphragm pump solves the problem of "idling", allowing without inconvenience to keep the device turned on in the absence of urination.

5. The proposed method of collecting urine allows researchers and doctors to make a volume count and further clinical analysis of liquid biological material in vitro, since the collected fluid does not include vaginal discharge.

6. Due to the fact that the technology is non-invasive, it makes possible multiple use without possible complications and constant discomfort for women.

Brief Description of Drawings

Figure 1 shows the urine diverting funnel in projections from above, from the side (in section) and from the front. The numbers indicate:

1. Walls of the bowl of the urinary funnel 2. Bowl of the urinary funnel

3. The transverse protrusion of the urinary funnel

4. Small funnel tube with a small funnel

Figure 2 shows how to use the proposed device. FIG. 2 (a) shows the use of the proposed funnel complete with a short tube for comfortable urination in a standing position. FIG. 2 (6) shows a complete set of the proposed device consisting of a urine diverting funnel, two silicone tubes (long and short), hardware, including a membrane pump, related components, and containers for collecting urine. It also depicts the use of the second option by a woman in a standing position and the placement of fingers to hold the funnel while urinating.

The numbers indicate:

2. Bowl of the urinary funnel

5. Silicone tube / tubes for urine diversion

6. Hardware

7. Container for collecting urine

8. Knob variable resistor

9. On / Off Button

10. Storage compartment for urine diversion funnel

11. Hooks for fixing the hardware on clothing or rehabilitation structures

Fig. 3 shows the claimed device.

The numbers indicate:

2. Bowl of the urinary funnel

5. Silicone tubes for urine diversion 7. Container for collecting urine

8. Knob variable resistor

9. On / Off Button

12. Diaphragm pump

13. Control board with microcontroller

14. Pump control module

15. Raising Fee

16. Battery

Figure 4 shows the principle of placement and the effect of using the funnel of the claimed invention. FIG. 4 (a) schematically shows the internal and external organs of the pelvis of a woman in lateral projection, FIG. 4 (6) - placement of the funnel relative to them.

The numbers indicate:

2. Bowl of the urinary funnel

3. The transverse protrusion of the urinary funnel

4. Branch pipe of the urine diverting funnel

5. Silicone tube for urine diversion

17. The vestibule of the vagina (vestibulum vaginae)

18. Small labia (labia minora pudendi)

19. The outlet of the urethra (ostium urethrae externum)

20. Large labia (labia majora pudendi)

21. Uterus (uterus)

22. Bladder (vesica urinaria)

Implementation of the invention

The proposed device is a functional unity of two improved parts of the structure: 1) elongated a urine-diverting funnel with a transverse protrusion; and 2) an apparatus with a diaphragm pump.

The idea of a hard plastic urine-diverting funnel resting directly on the labium minor pudenda was realized in the form of a tube by the brands Pibella and SheeWee. The hardness of the plastic and the limited plane of the girth of the external genital organs of a woman allows for more accurate removal of liquid biological material, but this result requires training, which ultimately ensures comfortable urination in an exclusively standing position.

The urinary funnel is an elongated, recessed bowl 2 with a rounded transverse protrusion 3, located perpendicularly or with a slight slope of 1-3 degrees to the edges of the bowl 2 and with a pipe 4 under it, whose opening goes in the same direction with the bottom of the bowl 2 of the urinary funnel, - at the front end, and tapering upward and laterally opposite the rear end (see figure 1).

The urinary funnels will be presented in a size range differing in the length of the bowl 2 of the funnel, its depth and the height of the transverse protrusion. In general, the volume of the urinary funnel corresponds to the volume of the labia minora (labium minor pudenda), and its length is% of the length of the labia minora.

The difference between the proposed funnel is the presence of a transverse rounded protrusion 3, running perpendicularly or with a slight slope of 1-3 degrees to the edges of bowl 2, which is slightly pressed into the labia minora 18 (Fig. 4), just below the head of the clitoris (glans clitoridis), directing the outlet 19 of the urethra (ostium urethrae externum) forward, towards the urinary nozzle 4. Bowl shape 2 funnel allows without long training to correctly position the funnel on the labia minora 18, and a special protrusion 3 guarantees no leakage, as it contributes to an additional specified direction of urine flow.

The dimensions of the bowl of the funnel were chosen so that it tightly covered the labia of 18 women (labium minor pudenda) on the sides and with the posterior end fit snugly against the vestibule of the 17 vagina (yestibulum vaginae).

The urine diversion pipe 4 has a small socket at the end and is connected in a collapsible way with a silicone tube 5, the wall thickness of which is 2 mm, the inner diameter is not more than 6 mm and not less than 4 mm.

The material for bowl 2 is polypropylene or another hard plastic with similar properties.

The configuration of the funnel allows the use of both a short (about 13 cm) and a long (about 40-50 cm) silicone tube 5. In the first case, this allows a woman to urinate in a standing position without taking off her underwear and without using absorbent wipes. ... In the second case, the long silicone tube 5 is connected to the inlet of the diaphragm pump 12, which, using the hardware, removes the liquid biological material (urine) through the outlet through the second silicone tube 5 (a short tube from the first use case can be used) into the container 7 for collection with a volume of 0.3-0, 5 l, equipped with a check valve (see fig. 2).

The second functional element of the structure is a hardware part with a diaphragm pump 12, which also includes a control board 13 with a microcontroller, a motor control module 14, variable a resistor with a handle 8, a step-up board 15, a battery 16 and an on / off button 9 (Fig. 3). Diaphragm pumps with similar characteristics are used in aquaristics and in dispensers, for pumping water or machine oil and other liquid (including chemically aggressive) media. Miniature diaphragm pumps are distinguished by their small size, ease of use and the ability to work with liquids of different densities and different chemical compositions.

In the claimed invention, a diaphragm pump 12 with a voltage in the range of 5-8 V and a suction rate of 1.5-3 l / min is controlled by the pump control module 14 and is regulated by turning the knob 8 of a variable resistor connected to the control board 13 with a microprocessor and is powered from a battery 16 with a capacity of 2200 mAh and a voltage of 3.7 A, equipped with a step-up board 15 and a micro-USB module. Such a constructive solution has high autonomy and safety, low weight (no more than 250 g) and size (10x8 cm).

Changing the suction speed allows you to use the claimed device in a standing position, sitting on a flat surface, lying or lying on your side, avoiding leakage.

The body of the hardware part is collapsible on the side with the upper part of the container 7 for collecting urine with a volume of 0.5 liters and has hooks-carabiners for fixing the body of the hardware part with the container 7 for collection on clothes or medical structures - wheelchairs or beds on which a person is placed ... This solution allows, after turning on the pump 12, to use only one hand to hold the funnel in the proper position (see figure 2).

The container 7 for collecting urine is equipped with a check valve that prevents spilling of liquid when horizontal position of the device. It is important to note that, in the connected form, the case with the hardware is located under the upper part of the container 7 for collection, which in the horizontal position of the device gives its additional angle of inclination, at which liquid accumulates in the lower part of the container 7.

The housing of the hardware is also equipped with a storage compartment for the urine diversion funnel and a long silicone tube connecting it to the hardware.

For individual use as a sterilization process, it is allowed to rinse the device with running water or a cold disinfectant solution and then running water when it is switched on.

In a hospital setting, it is allowed to replace the urine diverting funnel and long tube after changing the user of the device, or sterilize the device using cold disinfectant solutions followed by rinsing with running water.

Testing of the proposed invention was carried out with two research methods - without connecting the hardware (passively, using a short silicone tube) and with connecting the hardware.

In the first case, the tests showed a high degree of comfort of use and a complete absence of leaks (no more than 1 ml per one act of urination), which makes it possible to use this method without the use of absorbent wipes. The tests were carried out in a standing position, the funnel was pressed against the labia minora with the index and middle fingers of one hand (see Fig. 2). In the second case, the tests were carried out in the supine position; lying on the side with the upper leg bent and raised; while sitting on a flat surface (chair). The funnel was also pressed against the labia minora with the index and middle fingers of one hand. In all cases, during the first 2-3 tests, urination was difficult due to psychological barriers. Nevertheless, the method of urination when using the device showed efficiency and the absence of leaks (no more than 2 ml per one act of urination), which later (after 3-4 tests) led to a weakening of previous stereotypes and made urination psychologically comfortable even in unfamiliar conditions. This result shows that the use of the claimed invention requires a habit, but the opportunities that it provides for some groups of women (disabled people with paralyzed lower limbs, bedridden patients, women in cars standing in traffic jams, etc.) make it possible to talk about the effectiveness and practicality of the claimed solution ...

Claims

Claim

1. A device for mechanical drainage of urine in women, containing a urine diverting funnel with a tube, a tube and a container for collecting urine, characterized in that the urine diverting funnel has an elongated, recessed bowl, the length of which corresponds to% of the length of the woman's labia minora, a transverse rounded protrusion along the edge bowls for the provision of moderate lateral pressure on the labia minora, and the branch pipe is located on the side of the protrusion, is mated with the bottom of the bowl and is configured to be connected by means of the first tube to the inlet of the membrane pump, which is part of the hardware part of the device, and the container for collecting urine is made with the possibility of connection by means of a second tube with the outlet of the membrane pump.

2. The device according to claim 1, characterized in that the elongated cavity of the bowl of the urinary funnel is commensurate in volume with the labia minora of the woman, and the length of the elongated cavity of the bowl is shorter than their length, the back of the bowl is made tapering, and the transverse rounded protrusion on the front of the bowl located perpendicularly or with a slight slope of 1-3 degrees to the edges of the bowl.

3. The device according to claim 1, characterized in that the urine diverting funnel is made of polypropylene.

4. The device according to claim 1, characterized in that the branch pipe of the urine diverting funnel in working condition is connected to either a short or a long silicone tube, depending on the position of the woman's body in space and the need for use hardware part of the device with a diaphragm pump for mechanical pumping of liquid.

5. The device according to claim 1, characterized in that the hardware part includes a miniature diaphragm pump for pumping urine, including in the vertical direction, a pump control module, a control board with a microcontroller, a variable resistor connected to it, a battery equipped with a step-up board, and an on / off button.

6. The device according to claim 1, characterized in that the housing of the hardware part has fasteners for collapsible fixation of a container for collecting urine on it.

7. The device according to claim. 1, characterized in that the body of the hardware part has fasteners in the form of carabiners for fixing on clothing or medical rehabilitation structures.

8. The device according to claim. 1, characterized in that the body of the hardware complex has a compartment for storing the urine diverting funnel.

9. Urine diverting funnel, which has a bowl with a branch pipe, characterized in that the bowl has an elongated, recessed shape, the length of which corresponds to% of the length of the female labia minora, a transverse rounded protrusion along the edge of the bowl to exert moderate lateral pressure on the labia minora, and the branch pipe is located with the side of the protrusion, is mated with the bottom of the bowl and is designed to connect the funnel to the urine drainage tube.

10. Funnel according to claim 9, characterized in that the elongated cavity of the bowl of the urinary funnel is commensurate in volume with the labia minora of a woman, and the length of the elongated cavity of the bowl is ¹ A shorter than them length, the back of the bowl is made tapering, and the transverse rounded protrusion on the front of the bowl is perpendicular or with a slight slope of 1-3 degrees to the edges of the bowl.

11. Funnel according to claim 9, characterized in that the urine diverting funnel is made of polypropylene.

12. Funnel according to claim 9, characterized in that the branch pipe of the urine diverting funnel in working condition is connected either with a short (about 13 cm) or with a long (about 40-50 cm) silicone tube with a wall thickness of 2 mm, depending on the position of the woman's body in space and the need to use the hardware of a device with a diaphragm pump for mechanical pumping of fluid.