NO834178L - WOMEN COLLECTION DEVICE FOR WOMEN - Google Patents

Description

This invention relates to an area of human urine collection devices which are adapted to be held in place without

for the female genitalia; and more particularly this invention relates to an area of urine collection devices which are specially adapted to be easily held in place outside the female genital organ. The device has been found to be effective when used by a person who is in an upright, sitting or generally lying position.

Some paraplegic, quadriplegic, incontinent and other female persons often need assistance when emptying the bladder of urine. The female urine collection device industry produces a variety of devices to provide varying degrees of assistance to such individuals. One problem facing the female urine collection device industry is the production of a device that is easy to use and does not leak during use. This mainly means that the device must not only be able to be attached to the female genital organ, by means of commercially available fastening devices, and also be held tightly in place by such fastening devices, but it also means that the device must provide an efficient and otherwise non-leaking attachment when applied to the female genitalia (or external surface of the body). In addition, these devices must be non-binding, non-pinching, non-irritating, absorbent, elastic, sterile, aseptic, and mainly to some extent smooth and soft to the touch.

Many of the prior art have not addressed the leakage problem associated with the body fit of a particular urine collection device to the female organ; and therefore many of the prior designs of female urine collection devices have avoided requiring a leak-free urine collection device. The key to the leak-free property of any female urine collection device is the manner in which such a device is attached to the female organ.

Many of the difficulties associated with a female urine collection device that is supposed to make a tight connection to the female organ naturally arise from the special design of the external female genitalia which of course surrounds the urethral opening. Reference to figure 8 is made here to illustrate the connection of the device with generally recognized female

body surfaces.

Medical authorities teach us that the external genital organs in the female are the mons veneris, the labia majora and minora, the clitoris, the meatus urinarius, and the vaginal opening; and further defines the term "vulva" or "pudendum" to include all these parts. In addition, "vestibule" as used in connection with the female organ is medically defined to be located in a triangular-shaped, smooth area between the clitoris and the entrance of the vagina and limited on either side by the labia minora.

Finally, medical authorities teach us that the meatus urinarius (also referred to as the opening of the urethra) lies on a posterior (or lower) part of the vestibule, about an inch below the clitoris, near the border of the vagina, and that the meatus urinarius is surrounded of a prominent elevation of a mucous membrane (also referred to as mucosa).

It is an object of the present invention to provide a female urine collection device which can make a leak-free connection to the female organ while the person is in a standing, sitting or generally lying position.

The following is a main object of this invention to provide a system capable of treating incontinence in women without the use of internal catheters, diapers, etc. This is achieved by providing an improved urine collection device adapted to be tightly coupled with the female organ, being a such connectivity is enhanced by a vacuum or negative pressure condition.

A more specific goal is that a weak vacuum condition for such an improved device should be to some extent constant and easily maintainable in the area where the device is in contact with and surrounds the vestibular tissue.

A more specific object is to provide a system which includes a drain pipe of predetermined height and a valve adapted to provide a vacuum condition by maintaining a column of liquid having a preselected and relatively invariable height.

A further aim is to provide a valve which is generally unaffected during use by air and other gases entering the valve via the valve outlet.

A related object is to provide such a valve having a valve body adapted to receive a hydrophobic filtering drain valve which will allow air and other gases to diffuse therethrough.

Yet another main object of this invention is to provide an improved device, a valve and collecting system which, when used together, cooperates to achieve a particular useful result.

Accordingly, it is a more specific object firstly to provide an improved device capable of connecting tight connection, such connection being improved by predetermined vacuum conditions with special vestibular tissues in the woman and secondly to provide a new valve which provides the improved device with the predetermined desired vacuum conditions.

While a variety of known valve shapes can be used, the preferred illustrative designs are flap valves which require a predetermined pressure for the device to operate and which are normally in the closed position. In an illustrative version, there are two filtering drain valves that include a hydrophobic filter that allows diffusion of gas through it but not liquids. In a preferred system that includes a 20 cm vertical pipe between the device and the anti-backflow valve, the following pressure/vacuum sequence occurs when the female device is in place. During the urine flow, there is a 5 to 10 cm water pressure (positive) in the part of the system above the valve. When the flow stops, this pressure instantly drops to a negative value, resulting in a vacuum level of 30 - 40 cm of water. The hydrophobic upstream filter drain in the valve then allows air to enter the system until equilibrium is reached. In the device described, this is about 8 - 10 cm of water with a vacuum. The system remains at this level, thereby ensuring that it does not

becomes some leakage between the device and the vestibular tissue until the urine again flows freely through the device and causes a pressure increase in the system to a positive value of 5 - 10

cm of water, and this cycle is repeated. The use of a second filter drain valve on the downstream side of the valve allows the diffusion of any gas pressure that builds up inside the collection bag, thereby removing any detrimental effect such pressure may have on the valve. An excess pressure building up inside the bag could cause the valve to remain in a closed position thereby preventing the supply of additional fluid into the bag, or alternatively the development of a large pressure or column of fluid inside the valve which could result in

leakage around the device.

These and other objects of the present invention will become clear by reading the detailed description and by referring to the accompanying drawings.

Brief extract of the present invention.

According to the objectives of the present invention are

described here is a female urine collection device adapted for a tight external connection to the female organ. The female urine collection device of the present invention can be used to collect urine from a person in a semi-continuous or even a continuous manner. Furthermore, the present invention can be used by a female person to collect urine while the person is in an upright or standing position, a generally lying position or a sitting position.

The device connects tightly when carefully held in place. The device firstly makes a tight connection to the mucous membrane that surrounds the meatus urinarius, and secondly makes a tight connection to the vestibulum. To create such a double tight connection, the device is equipped with a pair of elevated connection surfaces. A gentle pressure against the back or underside of the device located opposite a urine-receiving space causes one of the two elevated mating surfaces and an elevated portion of the device to cooperate in forcing tissue surrounding the meatus urinarius to protrude markedly into the urine-receiving space of the device, thereby directing a stream of urine sent from the urethral opening into this space. The tight connection of the device is further enhanced by the general external shape and surface geometry of the connecting surfaces, which are adapted to substantially match the angle and body surfaces of the vestibulum of the female organ.

More precisely, the device connects tightly to the vestibulum and isolates the urethral opening from the vaginal opening. Bodily connection with the vestibulum includes a series of tight connections between the labia minora, the projection in the passageway between the vaginal opening and the urethral opening and other tissues located near the clitoris,

but which is slightly away from the clitoris in the direction of the urethral opening.

In another version of the invention, instead of an ovoid or egg-shaped outer design, the second version relates to a pair of generally elliptically shaped chambers which have a weaker slope between opposite ends of the main axis of the device. This has been determined through empirical application in a number of female subjects to obtain a semi-universal design for adult female organs.

The second edition of the improved device is also used as part of a system where the device is first applied by using a weak pressure against the back of the device either manually or preferably by using panties that have an opening centrally located in the crotch. When using one of the preferred versions of the improved device, it has been found desirable, between the urine container and the drainage channel of the improved device, to connect anti-backflow valves. As the urine flows from the device through the connecting tube and valve into the urine container, a vacuum develops at the connecting surfaces of the device, which is caused by the venturi effect of the urine flow. The vacuum level achieved is a function of the length of the connecting tube, its diameter and the relative height of the device in relation to the urine container and the valve. The development of such a vacuum condition for the device at the bodily areas for connection with the woman increases the connection to the vestibular tissues.

This vacuum effect can become cumulative during subsequent discharges of urine and can reach a level that can cause discomfort to the wearer. To solve this problem, each valve part can be equipped with one or more drain valves using hydrophobic filter methods which ensure that a valve allows the ambient pressure to reach the inside of the system and to reduce the vacuum level felt by the user.

Briefly, the second embodiment of the improved device of the present invention is a one-piece external female urine collection device adapted to be placed between the labial folds of the wearer, to be in contact with the vestibular tissue around the meatus, and to be held carefully fixed and stabilized by mechanical means but enhanced by a weak vacuum condition. The device includes a generally elliptical and open cup-shaped part, and has a generally centrally positioned hole so that urine can flow freely through the part and the hole in the device. The upper surface of the device includes a generally elliptical and inwardly directed, proximally curved, tapered surface and a continuous curved crest extending upwardly therefrom. Portions of the upper surface of the device located some distance from the cup-like surface on the opposite side of the curved edge and the curved edge delimits dual upper portions of a cavity within the part. Such double upper parts form a continuous pair of connecting surfaces which extend continuously around the outer circumference of the device. The inner surface is further up, away from the room, relative to the outer surface. Hanging from a back side of the part and continuous with it and communicating with the hole and space is a stem or cylindrical projecting edge. The design of such a stem is adapted to prevent mixing of liquid flow through the opening by forming a thin-walled chamber and a lower thick-walled portion at the end of the chamber opposite the device and adapted to be connected to the pipe leading to the valve. Such larger compartments and flexible thin-walled chambers are adapted to avoid the problem of curling and to prevent admixture of liquid flow through the opening.

In addition to being generally elliptical in shape, the open cup-shaped portion has a gently sloping surface geometry that allows the device to be tightly secured to the above-described vestibular tissue without excessive pressure and with such snug adherence being enhanced by a weak vacuum condition applied to the facility cave.

Brief description of the drawings.

Figure 1 is an overview picture looking down on part of a

pair of connecting surfaces located around the space at the urine-receiving end of the device; Figure 2 is another overview view of the device, which again looks down on the connection surfaces as in Figure 1 but with the device rotated approximately 180° around a central axis;

Figure 3 is a top-down view of the urine-receiving room

of the device, illustrating the predominantly egg-shaped nature of the connection surfaces;

Figure 4 is a side sectional view of the female device taken along line 4-4 of Figure 2, illustrating an anti-curling feature of a drain channel adapted to allow urine to flow freely out of the chamber, even after that the drain channel is located away from the central axis by as much as 90°;

Figure 4A is a side sectional view of the female device as in Figure 4 except that the drain channel is bent and offset in a position 90° from that shown in Figure 4 to more clearly illustrate the effectiveness of the anti-crease property; Figure 4B is a sectional view of the end of the device shown in Figure 4A when rotated 90° along its drain channel axis to illustrate the available opening through the anti-crease feature; Figure 5 is an overview illustration of the device functionally connected to a liquid reservoir and used in connection with a preferred form of a commercially available bodily safety and collection device; Figure 6 is a surface illustration of the preferred form of the body safety device seen from the front; Figure 7 is an overview illustration of the preferred form of the bodily safety device viewed from behind as the safety device connects to the female organ; Figure 8 is an illustration of the female external genitalia showing areas of frontal engagement of the engagement surfaces of the device with the female organ; Figure 9 is a vertical median section of the female hip area illustrating the approximate orientation and bodily connection of the device while the person is in either an upright, a generally lying or a sitting position. Figure 10 is an overview view of a preferred version of the improved female urine collection device according to the present invention; Figure 11 shows a side view of the device shown in Figure 10; Figure 12 is a picture of the device in Figure 10 seen from above;

Figure 13 shows a raised side section taken along the line 13-13

in Figure 12 and showing one way of attaching the collecting tube to the female device;

Figure 14 is an elevated side section of the device shown in Figure 13 and illustrates the anti-crease property of the present invention; Figure 15 is another modification of the present invention showing the use of an added molded connector useful for attaching the drain pipe to the female device; Figure 16 is a further version of ways to connect the drain pipe to the female device; Figure 17 is yet another version of further ways of connecting the discharge channel to the female element; Figure 18 is an elevated side view in partial section of the system employing the female collection device of the present invention; Figure 19 is an elevated side view of a valve and filter mechanism used in the system shown in Figure 18;

Figure 20 is an elevated side section taken along line 20 - 20

of Figure 19;

Figure 21 is a plan view of the flap valve used in the filter valve shown in Figure 20; Figure 22 is an elevated view of another form of valve, in partial section, of the type which may be used in the system shown in Figure 18; and Figure 23 is an uncovered side section taken along line 23 - 23 of the valve shown in Figure 22.

In all the drawings, like numbers refer to like parts.

Detailed description of the preferred edition.

Turning now to figure 1, device 10 is shown in perspective and includes a container 12 and a hollow stem 14. The container 12 contains a space 16. The space 16 has an entrance opening 18 which is essentially a vertical extension of room 16.

Room 16 is mainly radially oriented about a central axis 10; and the container 12 has a generally ovoid or egg-shaped outer circumference and a generally elliptical or oval-like inner cross-section, both of which are oriented perpendicular to the central axis 20.

Opening 18 is provided with two elliptical connecting surfaces 22, 24 which are convex in cross-section. Each connection surface protrudes from the container 12 in a saddle-like manner along the direction of the central axis 20. Each connection surface, viewed from the side, is provided with two edges located between two tips (or peaks), and each tip is located close to a

respectively end of the main axis of the container 12.

The first (or inner) continuous connecting surface 22 is provided with a first or frontal tip 26 which is adapted to engage closely with the female organ at a first point just below the clitoris. Such a first point is generally located between the clitoris and the urethral opening and is usually located close to the clitoris but a short distance from the clitoris in the direction of the urethral opening. The inner mating surface 22 is also provided with a second or posterior tip (or "hump") 28 adapted to closely engage the female organ at another point located between the urethral opening and the vaginal opening. The inner connecting surface 22

is provided with a first pair of spaced opposed lateral or connecting chambers 30, 32 which are adapted to closely engage with the underside or inner surfaces of the two labia minora along an opposite pair of first elliptical areas.

The second (or outer) connection surface 24 is located substantially along the outer circumference of the first connection surface 22. The surface contours of the outer connection surface 24 merge into the first connection surface 22 at the first peak 26. The second connection surface 24 is also provided with another pair of chambers 34, 36 similarly adapted to closely couple the two labia minora along an opposite pair of other elliptical or oval regions. Except for the transition of surface 24 in apex 26, each respective second elliptical or oval region is spaced slightly apart, both radially and axially, from its adjacent first elliptical region, as illustrated in Figures 1 and 2.

The outer engagement surface 24 is provided with another peak 38 which is adapted to engage tightly with the female organ at a third point located between the second point and the vaginal opening.

The surface geometry of container 12 is such that the inner connection surface 22 generally protrudes further away from the main body of container 12 than the outer connection surface 24 does. Such a projection is saddle-like and along the direction of the central axis 20.

The surface contours of the inner connection surface 22 and the outer connection surface 24 are convexly curved in an outward direction, the curvature being directed positively away from space 16. In addition, the inner connection surface 22 gradually transitions into space 16, thereby providing opening 18.

The inner connection surface 22 and the outer connection surface 24 each have a wall that is sufficiently thick that the inner connection surface 22 and the outer connection surface 24 each maintain their shape and are not deformed when the urine collection device 10 is held in place against the female organ by slight pressure mainly applied along a back or underside of container 12 opposite chamber 16. The inner and outer connecting surfaces 22, 24 of device 10 allow each device 10 to make a tight connection with the tissue surrounding the meatus urinarius. The surface curvature, saddle-like contours and elliptical cross-sections of the two mating surfaces of device 22, 24 and more precisely, the raised "hump" or peak 28 of the inner mating surface 22 cooperate with the outer mating surface 24 to create a slight bulge of channel (urine channel) projections into space 16 of device 10 and thereby cause the flow of urine to be directed into container space 16.

The dual connection surfaces serve two purposes. For

firstly, if a urine sample is to be used in analysis, it will not be contaminated by vaginal discharge; and secondly, the normal menstrual cycle can be provided separately through the usual use of commercially available monthly agents, without interfering with the handling of waste fluid.

Figures 1, 2 and 3 illustrate the surface geometry of the inner and outer connection surfaces 22, 24 of device 10; and figures 8 and 9 illustrate how device 10 makes a tight connection with the female organ.

The hollow trunk 14 shown in figures 1, 2 and 4 is radially oriented around the central axis 20 and is connected to a part of the back or underside of the container 12 opposite the room 16. The hollow trunk 14 communicates with the room 16 and equips the room 16 with an outlet 40. Looking mainly down along central axis 10 and into space 16, the inner diameter of hollow stem 14 is substantially circular. The hollow stem 14 has a somewhat constant wall thickness and has an outer diameter that gradually decreases,

to a small extent, as it moves outwards from container 12.

The hollow channel 14 has a sufficient wall thickness and is made of a sufficiently resilient material so that "curling", which would normally interfere with the flow of urine out of space 16, does not occur since the hollow stem 14 is provided with an "anti-curling" property which includes a hollow transition portion 42 (which includes outside corner 42a, horizontal edge 42b and inside corner 42c) and a hollow collar 44, to reduce the likelihood of curling.

A drain channel (for compartment 16) is connected to the back or underside of container 12 opposite compartment 16 and includes the hollow stem 14, the hollow transition part 42 and the hollow collar 44. As illustrated in Figure 4, the hollow stem 14 is connected to the hollow transition parts 42a, b, and c; and the hollow transitional parts 42 connect with the hollow collar 44 which also connects with the back or underside of container 12 opposite room 16.

For the purpose of describing the drain channel, the inner diameter of the hollow stem 14 decreases gradually, slightly, as it moves outward and away from the main body of container 12, while the wall thickness of the hollow stem 14 remains constant. As part of the anti-curl property of the drain channel, it has a hollow stem 14

a greater wall thickness than the hollow transition parts 42a, 42b, and 42c which themselves have a greater wall thickness than the hollow collar 44.

The hollow nature of stem 14, transition portion 42 and collar 44 allows connection between chamber 16 and outlet 40. The relatively thin-walled hollow collar essentially eliminates the detrimental effect caused by curling when the drain channel is bent in use. As can be seen in Figures 4a and 4b, the drain channel can be bent up to 90° away from the central axis 20, and full flow from outlet 40 is maintained.

The increasingly reduced thickness of the various elements passing axially upwards from stem 14 through transition portion 42 into hollow collar 44 allows an inward collapsing of collar 44 on one side thereof to form at least an elliptically shaped opening, i.e. a somewhat flattened end towards stem 14 where it is attached to transition part 42 which opens into the remaining interior of collar 44. This can best be seen in Figures 4A and 4B and ensures an open drainage channel even when stem 14 is moved 90 ° away from their normal position when the patient moves from a standing or lying position to a sitting position.

Like the hollow stem 14, the hollow transition part 42 and the hollow collar 44 each have a substantially circular cross-section. The outer diameter of the hollow collar 44 is significantly larger than the outer diameter of the hollow transition part 42, which itself is slightly larger than the outer diameter of the hollow stem 14.

When slight pressure is applied in a direction generally parallel to the central axis 20 along the rear or underside of the container 12, the inner and outer mating surfaces 22 and 24, and more specifically, the hump 28, cooperate to cause the inner and outer mating surfaces 22, 24 effectively insulates, connects separately and supplies compartment 16 of container 12 with a pair of tight connections with the female organ. A tight connection is mainly made around the urethral opening. These double connection surfaces 22, 24 not only ensure a tight connection with minimum pressure, but also stabilize device 10 against movement up and down or sideways.

Device 10 is manufactured from a suitable soft rubber, a rubber-like or plastic material.

Device 10 may be held in place against the female organ by any of a variety of commercially available aids designed to bring the device into tight engagement with the body. For example, device 10 can be held in place with a strap or belt device. The described edition, illustrated in figure 5, shows just such a device which includes a belt 46, four straps 48, 50, 52 and 54, and a pillow 56.

The belt 46 is adapted to fit around the hip of the person and is fabricated from suitable elastic material so that it will remain in place when pulled downward under the action of the straps. The preferred belt is a commercially available type made of fabric and elastic. The preferred belt is equipped with a commercially available closure device 47 ("VELCRO") to accommodate many different hip sizes.

The four straps 48, 50, 52 and 54 are also made of a suitable elastic material so that the pad 56 causes the application of a slight pressure against the back or underside of the container 12 opposite the compartment 16 when the belt and strap assembly is worn by a person who is in a standing, sitting or otherwise generally lying position. In the preferred version, each strap consists of a fabric part and an elastic part. Each fabric part is attached to the belt 46 and each elastic part to the pad 56 as illustrated in Figures 5, 6 and 7. This method of attachment causes the pad 56 to form to the back or underside of the container 1.2 opposite the compartment 16, thereby producing the above-described tight connections. In the preferred version, the lower (or outer) straps 48, 54 are illustrated in Figures 6 and 7, running on either side of the rectum, following the gluteal fold and then being attached to the belt 46. In this version, these lower straps 48, 54 attached to the belt 46 either at the hip bone or at the spina iliaca ante-rior superior of the pelvic bone. Also illustrated in Figures 6 and 7 are upper (or inner) straps 50, 52 which have been attached close together to the belt 46 at locations close to the respective lower straps 48, 54. In the preferred embodiment, in addition to being elastic and therefore stretchable, these inner and outer straps are adjustable in length, as well.

Cushion 56 is made of a suitable soft and flexible material.

In the preferred version, the side of the pad facing the female organ is made of a soft, felt-like material; while the back of the pad, which is directed away from the female organ, is fiber reinforced. The preferred pad is somewhat discus-like in shape and larger in cross-section than the cross-section of the rear or underside of container 12 opposite compartment 16, so that a slight pressure can be applied generally across the entire rear or underside of container 12 opposite compartment 16. The straps 48, 50, 52 and 54 are optionally attached to the outer circumference of pad 56 in a manner that allows pad 56 to make surface contact with the rear or underside of container 12 opposite compartment 16.

Pad 56 has a hole 58 located approximately centrally. In the preferred version, when the device 10 is brought into close bodily connection with the female organ, the hollow collar 44 will protrude outwards through the hole 58 and away from the body of the person. As used in this preferred embodiment, device 10 is connected by means of a suitable connecting device 60 (such as a union) to a piece of pipe 62 having suitable diameter and suitable resilience. The pipe piece 62 is then connected to a liquid reservoir 64, the liquid reservoir 64 having suitable connection devices 66 and clamping devices 68. During the day, the liquid reservoir 64 can be a bag worn on the leg, and at night it can be a drainage bag. A part of the tube piece 62 is normally attached with tape to the person's thigh above the knee.

As the portion of the tube 62 is attached with tape to the leg, the hollow stem 14 resists curling on the back or underside of the container 12 opposite the compartment 16. As the hollow stem 14 is bent away from the central axis 20, the hollow collar 44 first becomes, then the hollow transfer part 42, then finally the hollow stem 14 deformed. The relatively large, thin, inner diameter of the hollow collar 44 (in contrast to the diameter of the hollow stem 14) allows significant displacement of the drainage channel from the central axis 20, while maintaining free flow of urine out of chamber 16. The hollow stem 14 can be bent approximately 90° away from the central axis 20; and urine flowing into chamber 16 will continue to flow out of chamber 16 through outlet 40 into tube 62.

Hole 58 in pad 56 is sufficiently larger than hollow collar 44 to allow such bending or freedom of movement of the drain channel or pipe piece 62 without curling or clogging or both.

In this edition, the device is fabricated using commercially available injection molding materials. Normally, rubber, rubber-like or plastic urine collection devices are made using a dipping process; and it is very difficult to control wall thicknesses. In the present invention, the control of wall thicknesses of the collar, the hollow transfer part and the hollow stem can be critically controlled by a commercially available injection molding process. In the preferred embodiment, the device is either made from a suitable thermoplastic rubber polymer or an elastomer of medical grade (such as a liquid silicone rubber).

Referring again to the drawings and Figures 10-14, another illustrative, preferred embodiment of the improved device will now be discussed.

Device 130 is a one-piece external female urine collection device adapted to be placed between the labial folds of the wearer (primarily along the inner surfaces or undersides thereof) and adapted to be in contact with the vestibular tissue surrounding the meatus defining the urethral opening. . Device 130 includes a generally elliptical and open cup-shaped portion 132 with a tapered upper chamber 134 terminating at its narrow end in a centrally located opening 136 to allow urine to flow through portion 132 and device 130. The upper surface geometry of device 132 includes a substantially elliptical and inwardly directed, closely curved, tapered surface 138 and a continuous curved edge 140 extending upwardly therefrom. Portions of the upper surface of device 130 that are away from the tapered surface 138 opposite the curved edge 140 are designated as surface 142, limit and form a close pair of connecting surfaces 140, 142. The inner surface 140 is located further up, away from space 134, relative to the outer surface 142.

Hanging down perpendicularly from a rear side (referred to generally by reference No. 144; see Figures 11 and 13) of portion 132 and continuous therewith is a relatively thin-walled, cylindrical, projecting edge or tubular portion 146 which communicates with opening 136 and furnishes space 134 with a drainage channel. Edge 146 is oriented around axis 148 (see Figure 13). Further details on

the cylindrical rim or tube 146 will be presented later.

The connection surfaces 140, 142 and part 132 are oriented

around an axis 150 which is parallel to axis 148 and which is located from this at the distance D (figure 13). As viewed from above on device 130 (Figure 12), the projections of the connection surfaces 140, 142 are substantially elliptical. Device 130 is seen to have a major axis "A" passing through axes 148 and 150 and a minor axis "B" which is oriented laterally to axis 148 but perpendicular to major axis "A" (Figure 12). Both of these axes "A" and "B" form a plane perpendicular to axis 148. Further, referring to Figure 11, it will be seen that the lateral projection of device 130 is also substantially elliptical along another plane that either contains or is parallel to axis 148 with a semi-minor axis "C" oriented vertically, as axis 148 is.

Mainly in the plane formed by the axes "A", "B" (figure 12) or in a plane (not shown) mainly parallel to this which is perpendicularly placed in relation to axis 150 is an origin (arbitrarily presented in figure 12) for a first radius of curvature R1, which generally describes the elliptical outer bounding edge of device 130. A second radius of curvature R2 having a different origin located in a position generally as described above for the first origin, generally describes the location of the tapered surface 138 which separate the adjacent connecting surfaces 140, 142. Within the plane formed by the axes "A",

"C" (figure 11) and from an origin located on axis 150, on the outside of device 130 (figure 13), a third radius of curvature R3 describes the gently sloping surface geometry (of device 130) at the entrance to room 134 where device 130 mainly makes connection with the vestibulum and the labial folds in the female. As best seen in Figure 13, the end surfaces of device 130 are defined by origin points that fall on axis "A" where radius R5 defines the outer geometry of the end of device 130 while radius R4 defines the tapered surface 1 38.

Vacuum bonding of the improved device 130 with the female can be mainly achieved when the following values are maintained. As it now refers to figures 11 and 12, length 160 along axis "A" spans from approx. 4.01 to approx. 4.78 cm. Length 160 is preferably approx. 4.39 cm. Width 162 taken along axis "B" ranges from approx. 2.62 to approx. 3.12 cm. Width 162 is preferably approx. 2.87 cm. The nominal projection height "C" ranges from approx. 0.94 to approx. 1.19 cm. "C" is preferably approx. 1.07 cm. The advance displacement ratio defined by distance "D" ranges from approx. 0.178 to approx. 0.218 cm. "D" is preferably approx. 0.198 cm. R1 ranges from approx. 3.81 to approx. 4.57 cm. R1 is preferably approx. 4.19 cm. R2 ranges from approx. 2.48 to approx. 2.98 cm. R2 is preferably approx. 2.73 cm. R3 ranges from approx. 2.32 to approx. 2.83 cm. R3 is preferably approx. 2.58 cm. R4 ranges from approx. 1.00 to 1.22 cm. R4 is preferably approx. 1.11 cm. R5 ranges from approx. 1.143 to approx. 1.397 cm. R5 is preferably approx. 1.27 cm. R6 ranges from approx. 3.77 to approx. 4.61 cm. R6 is preferably approx. 4.1 91 cm.

The proximate engagement surfaces 140, 142 which are continuous and provide dual proximate engagement surfaces around the entire circumference of device 130 allow device 130 to be tightly engaged and make continuous contact with the woman by connecting to the inner portions of the labial folds and the remaining of the above-mentioned vestibular tissue.

As reference is now made more specifically to the cylindrical, tube-like edge 146 which is best seen in figures 13 and 14, edge 146 is a thin-walled part sorne has a wall thickness that spans approx. 0.635 to approx. 0.889 cm and preferably approx. 0.7874 cm in length of the thin-walled portion, as measured from the back 144 of portion 132, being only slightly greater than the inner diameter of rim 146. A thick-walled extension 152 includes a central opening 154 and a lower, opposing hole 156 capable of receiving a length of tube 158 having an inner hole similar to the hole of orifice 154 whereby a free, unrestricted flow into the tube is permitted. Tube 158 is secured in the opposite hole 156 using suitable methods known in the art such as adhesive or heat sealing.

As can best be seen in figure 14, deflection of edge 146 results

in a slight closure of the inner diameter thereof by a bending of one side and stretching of the other side without closing the hole, thereby allowing a free, unimpeded passage of the urine through the inside of the rim 146, the thickened portion 152 and tube 158 to a suitable collection device. This anti-crease property can be readily accommodated and fabricated within a female urine collection device of the type described above.

Referring now to Figures 15 - 17, additional versions of connecting parts are shown, and where like parts are designated by like numbers with the addition of the suffixes a, b and c. In Figure 15, the flexible edge 146a includes a thickened part 152a which has a centrally located opening 154a and a tubular connecting portion 170 with an enlarged edge 172 molded into the thickened portion 152a. The tubular connector 170 includes at its free, exposed end a plurality of step-like ledges 174 of the type well known in the manufacturing art to extend and provide a closed receiving passage to the interior of tube 158a which has been extended thereabove. Connection part 170 has a central hole, not shown, of the same diameter as hole 154a to provide unobstructed flow of urine from the female device, not shown.

Another version of connecting parts describes the thin-walled edge 146b, in incomplete section, and in which the terminal ends 176, initially coaxial with this, are bent inward to form an inwardly directed edge 178 attached to tube 158b by adhesive or heat- sealing methods, shown in Figure 16.

Figure 17 is yet another version where the thin-walled edge 146c, shown in incomplete section, is provided with an inwardly directed edge 180 and a downwardly directed cylindrical edge 182. The inwardly directed edge 180 has a central hole adapted to receive tube 158c, while the downwardly directed edge 182 forms a chamber or pocket between itself and tube 158c to receive a sealing ring 184 of either adhesive or other known O-ring types of connection and retention mechanisms.

The anti-crease property in each of the last three editions shown

in Figures 15, 16 and 17 all function in the same manner as that shown in Figure 14, namely a thin-walled edge terminated by a thick-walled rigid portion which will orient the bending and stretching in the thin-walled portion 146a, b and c without curling or completely to shut off the flow of urine through it.

Reference is now made to figures 18 - 23 and in particular figure 18 in which the system of the present invention is generally described. device 130 is preferably connected to a urine collection vessel or a urine collection bag 190 (figure 18). The urine collector 190 is usually a closed and basically flat plastic bag or bag of the type well known in production. Device 130 can initially be secured to the desired vestibular tissue of the woman as described above, by using an easy securing and compression method such as a pair of briefs 192 (where only the crotch is shown in section) which has a centrally located opening to receive the downwardly extending portions 146 and 152. Preferably, a mini pad 194 having an adhesive layer 196 as a fuse to the briefs 194 serves to stabilize the collection container 130 and to hold it in the predetermined desired location. This is accomplished by applying a weak vacuum condition to chamber 134 of device 130. A known method of applying such a vacuum condition to chamber 134 is by maintaining a pre-selected pressure of liquid (such as urine) in device 130. In order to to accommodate this, the anti-backflow valve of the present invention is preferably connected between device 130 and container 190 to control the pressure of urine and vacuum. The novel valve 200 includes a valve structure 202 which defines a valve inlet 204 and a valve outlet 206 and includes a flap type valve 208. A preferred form of flap valve 208 includes a flap 210 integral through a neck piece 212 with a circular collar 214, see Figure 20 and 21. As best seen in Figure 20, valve inlet 104 includes an annular, axially extended, rounded collar 220 which serves as a seat against which flap 210 can rest in a normally closed relationship while on the outside of this another collar 222 is directed axially and which ends in the same plane as collar 220

and diametrically outward from this a ledge 224. Valve outlet 206 includes an opposed hole forming ledge 226 and an axially extending edge 228. Valve inlet 203 and valve outlet 206

with their coaxial arrangement causes edge 222 and shoulder 226 to engage collar 214 in a tightly coupled connection. Such a connection can be achieved either by tying it with a commercially available adhesive or alternatively by heat sealing the two plastic parts together. By maintaining the axial extent of the edges 222 and 228, to accommodate the thickness of flap valve 208, a normally closed, positive seat occurs between flap 210 and the axially directed edge 220, which serves as a seat for flap 210. As the urine flows downward, a predetermined urine pressure is established within tube 158 and acts against valve 210 causing it, upon the creation of such pressure, to deflect laterally to an open position in a known manner.

Flap 210 engages, covers and bonds tightly to seat formed at rim 220 thereby maintaining an outlet pressure or a cylinder of urine (or other fluid) in tubular portion 230 of valve inlet 204 (fluid not shown). Flap type valve 208 is made of a suitable commercially available elastic material which allows the output pressure or liquid cylinder to assume a predetermined value. The preferred flap type valve is made from an approx. 0.13 m thick polyester film. The neck piece 212 and collar 214 cooperate in bending flap 210 towards seat 230 and thereby preventing such liquid from flowing out of tube 230 via flap outlet 206.

As the liquid cylinder increases in height, the weight of the liquid in pipe 230 gradually increases to the point where valve 210 is forced away from the seat 220. Whereupon the height of the liquid cylinder rapidly decreases in pipe 230 and pipe 158 as the liquid flows past valve 210. Most of this liquid usually immediately flows out of valve outlet 206, preferentially filling container 190 connected thereto. The height of the liquid in pipe 230 is quickly reduced to a point where flap 210 can again support the weight of liquid in pipe 230. Whereupon flap 210 again moves upwards towards seat 220 through the bending effect of neck piece 212 and closes to seat 220.

It has been noticed, however, that the passage of urine through device 130 and tube 158 and valve 200 through a venturi-like effect develops an output vacuum condition which at device 130 acts against the body of the woman, and as the woman empties additional urine into space 134 of the improved device 130, a marked feeling of increasing discomfort is felt (over time) by the vestibular tissue until the improved device 130 has been placed. It has been observed, indirectly, that as urine is emptied into compartment 134 by the improved device 130, this urine entrains some of the air and some other gases initially present in compartment 134. Such entrainment empties compartment 134 of an output amount or quantity of air or other gases and serves to increase, over a period of time, the vacuum sensation.

Between the flap 210 and the improved device 130, the inlet portion 204 of the valve structure 200 includes a first valve 240 through which air and other gases are allowed to pass so that an output vacuum condition acting on space 134 from the improved device 130 can be maintained.

Such a valve includes a hydrophobic filter or membrane 242 that covers valve 240 and allows the inflow or outflow of gases but, due to its hydrophobic nature, prevents the passage of liquids such as urine. Within the tubular portion 230, the liquid height is well above valve 240 and it is the hydrophobic filter 242 that prevents liquid from leaking out of the tubular portion 230. Filter membrane 242 has a pore size such that most gases are allowed to diffuse through, but such that urine or other liquids are not allowed to appreciably or substantially diffuse through. When the pore size varies from approx. 3 ym to approx. 15 ym (a preferred pore size variation), no diffusion of urine has been noted.

The illustrated version of the system which includes the improved device 130 with its outlet edge 146, 152 is connected by a piece of hollow and flexible plastic pipe 158 of suitable length and is generally used to connect the device 130 to the valve 200 according to the present invention . In most devices, a length of approx. 20.22 cm is preferred for tube 158. During the urine flow, a water pressure (positive) of 5 - 10 cm is present in the part of the system above the valve. When the outflow of urine stops, this pressure immediately drops to a negative value, which results in a vacuum level of 30 - 40 cm of water. The upstream hydrophobic filter drain 240 in valve 200 then allows air to enter the system until a semi-equilibrium condition is reached. In the device described, this is about 8 - 10 cm of water with a vacuum. The system remains at this level, ensuring tight connection of device 130 with the vestibular tissue until urine again flows and causes a pressure rise in the system to a positive value of 5 - 10 cm of water, and this cycle is repeated. The equilibrium vacuum level is determined in part by the length of the pipe and the vertical distance that the device is located above the valve. The top connection part of the valve (above the upstream outlet) generally has an inside diameter of from approx. 0.44 cm to approx. 0.71 cm with a preferred optimum internal diameter of approx. 0.508 cm to achieve the pressure/vacuum sequence described above.

It should be noted that as the woman empties urine into chamber 134 of the improved device 130, and as urine flows down through tube 158 and through valve 200, it has been observed that tiny bubbles can be seen in the urine cylinder. Such bubbles first appear on the liquid side of the semi-permeable membrane 242, have been seen to pass through the drain opening 240 and into the urine in the tube part 230 of the valve 200. When the drain opening 240 was not present on the tube part 230, such bubbles were not observed .

Furthermore, it has been observed that the height of the liquid column

in valve 200 and tube 158 in addition to being affected by the bending action of neck piece 212 of flap type valve 208, is a surface tension phenomenon of the particular fluid. For example, when the tube 154. specifically used is a commercially available extruded latex having a nominal inner diameter (I.D.) of 5/16 inch (nominally about 0.794 cm), the height of the female urine in valve 200 and tube 158 observed to extend to mainly approx. 7.62 to approx. 10.16 cm above drain inlet 240. One such special type of pipe available commercially is held to an I.D. tolerance of 1/64 inch (about 0.40 cm). Yet for a nominal pipe I.D. of 3/8 inch (nominally approx. 0.953 cm) it was observed that inside such a pipe 158 and in pipe part 230 of valve 200 above drain inlet 240 no such height or cylinder of urine could be maintained. The urine cylinder in pipe 158 extended upward from flapper-type valve 208 only up to drain opening 240. Furthermore, for a nominal pipe I.D. of 1/4 inch (nominally approx. 0.635 cm) was

it was noticed that the bubbles (observed in the urine) could not move up into the tube part 230 or the valve 200. The experiment with the nominal 5/16 tube I.D. was repeated, and a copious amount of commercially available soap solution was added to the urine cylinder; and the height of urine in tube 230 and tube 158 was observed to be markedly less than that noted above. For pipe 158, the preferred nominal I.D. 5/16 inch. The preferred I.D. at inlet end part 204 of valve 200 is approx. 0.508 cm.

Pipe 158 is preferably translucent, while valve 200 is preferably made of a suitable and clear plastic, and is preferably transparent.

Another suitable length of flexible plastic tubing 198 connects outlet end portion 206 of valve 200 to a suitable inlet connection 188 on urine collector 190. As urine flows downward through outlet valve portion 206 of valve 200 and fills collector 190, air and other gas are entrained after each separation from again, begins to collect in the collector 190 and eventually moves out of the collector 190 and up into the outlet pipe 198 where it can interfere with the action of the valve type valve 208.

Accordingly, outlet portion 206 of valve 200 preferably includes another outlet opening 244 to allow gases in outlet pipe 198 to pass through the wall of valve structure 200. This valve outlet opening 244 also includes and is covered by a hydrophobic filter membrane 246 which forms a liquid seal thereon. The second membrane 244 is preferably of the same material and has the same pore dimension as the first membrane 242. It should be mentioned that both of these membranes can either be cast in during the fabrication of the inlet part 204 and outlet part 206 of the valve 200 or alternatively can be made as part of a closure cap (not shown) which would be inserted into the valve ports 240 and 244. It will be appreciated that the downstream hydrophobic filter drain 244 allows air to escape from the collection/leg bag 190 thus allowing a higher liquid level before a back pressure which would impair proper action of the system, is developed, i.e. entrained air which serves to act against flap 210 and cause it to remain in a closed position, resulting in an undesirable fluid pressure within tube 158 and possibly leakage of fluid from collection unit 130.

Although not shown, it has been found that a valve having a simple downstream drain valve, i.e. drain valve 244 with a hydrophobic filter membrane 246, will act in a manner sufficient to withdraw air and other gases from the bag, and due to the intrusive nature of flap valve 208 will allow sufficient ambient air to enter the system to partially relieve the vacuum condition where device 130 is in contact with the vestibular and labial tissue. Such an edition would be identical to that described earlier with valve 200, but excluding the upper drain valve 240 and its associated hydrophobic filter 242.

The first version valve and filter (shown in Figures 19 - 21) described above is just one example of an "in-line" valve and filter that can be used. Another version of such a filter valve can be seen in figures 22 and 23. Where the first valve part, namely inlet part 204 and outlet part 206 can be cast in a simple, complete form with minimal side effects for valves 240 and 244, the second version needs of Figures 22 and 23 somewhat greater equipment costs due to the amount of parts involved. This version of valve 300 includes a main part 302 which has

an inlet end 304 shaped to fit the interior of pipe 158, and an outlet opening 306 entering a deflected or angled seat 308. A flapper valve 310 of a design completely identical to the previously described valve 208 includes a flapper 312 which connects itself to the seat 308 and cover opening 306, a hinge 314 and an enclosing part 316. A side opening 320 forms a chamber in part 302 which includes the seat 308, is covered by a covering part 322 which has a collar 324 which is used when connecting the peripheral portion 316 of valve 310 to maintain it in tight engagement with seat 308, but allow freedom of movement of flap 312 to open and provide drainage through opening 306. The main portion includes an outlet opening 330, adapted to

could be connected to drain pipe 198 which connects to collection part 190.

In this version there is a drain outlet 332 on the upstream side of valve 310 which includes a cap with opening 334, capable of receiving a hydrophobic filter 336 which has the same function as the filters in the previous version. Similarly, a downstream drain valve 340 is covered by a vented hood 342 which carries a similar hydrophobic filter membrane 344. The mechanism of action of this valve is exactly the same as the first edition when used in

the system shown in Figure 18.

It may be made clear that flapper type valves 200 and 300 are only two versions of valves adapted to allow fluid to flow in only one direction as required by the present invention. Variations in applications of flap valves of this type are well known in the manufacturing art, however the application of such a valve having a drain valve with a hydrophobic filter in the surroundings shown here is not known to exist in the prior art. A system of the described type provides an easy-to-use mechanical means of initially attaching to the vestibular mucosa of the female anatomy and ensures, after the first urinary void, continuous connection with such vestibular and labial tissues by maintaining the vacuum condition. The harmful effects of the vacuum are mainly overcome by the hydrophobic filtering drain valves which reduce discomfort for the patient but ensure a sufficient vacuum condition for connection purposes. The system is cheap to manufacture and can be reused through general cleanliness practices and known techniques. The female collecting device may be injection molded from Kraton<0> material manufactured by Shell Oil Company; polyethylene; as well as other injection moldable, soft, rubber-like materials that are comfortable to the female organ. The valve parts can be injection molded of suitable plastic materials of a wide variety known on the market and insensitive to urine.

Although particular sizes have been proposed as collection devices applicable to the "normal adult woman", it should be noted that smaller devices can be used by petite women and that devices having the same proportional dimensions,

but which have a smaller length and width than the sizes presented, are being developed for use by non-virgin women, i.e. teenagers who suffer from incontinence.

What has been illustrated and described herein is a new system and improved female urine collection device.

While the valve and device of the present invention

has been illustrated and described with reference to several preferred editions, the preferred invention is not surrendered thereto. On the other hand, alternatives, changes or transformations may become visible to those who are knowledgeable in the production technique

by reading the preceding descriptions. Accordingly, such alternatives, changes and modifications must be considered to form part of the present invention insofar as they fall within the spirit and scope of the appended claims.

Claims (16)

1. A one-piece external female urine collection device adapted to be placed between the labial folds of the wearer and in contact with the vestibular tissue around the meatus which limits the urethral opening, said device including a generally ovoid and open cup-shaped portion having a space and a centrally located hole through said part, the upper circumference of said part having a convexly curved outer surface and a continuous, curved edge extending upwards therefrom and delimiting the upper parts of said space within said part, said upper circumference and edge limit a proximal pair of connecting surfaces, an inner one of the said proximal surfaces being located further up in relation to an outer one of the said surfaces, for close and continuous contact and connection with the labial folds and said vestibular tissue. 2. The urine collection device according to claim 1 which includes a drainage channel continuous with said part on the rear side thereof, extending therefrom and communicating with said opening; and ways to prevent said channel from folding. 3. A one-piece, soft and flexible device adapted for tight connection with the female organ by vestibular surface tissue generally along the labia minora, a portion of said tissue located near the clitoris and another portion of said tissue located near the opening of urethra and which is offset towards the opening of the vagina, for receiving urinary discharge from a human, comprising: an open mouth container having a mouth defining a saddle for connecting to the female at said vestibular tissue, the saddle having at least two generally adjacent surfaces with a generally outwardly directed convex curvature, with an inner one of said adjacent surfaces generally being placed slightly further upwards in relation to an outer one of said adjacent surfaces, to effect connection with the female along said vestibular tissue, the container including an outlet which will permit discharge therefrom, and means to prevent said outlet from closing and interfering with discharge therefrom. 4. A urine collection device adapted for external tight connection with a female organ, comprising (a) a container having an opening and containing a compartment, said compartment being oriented radially about a central axis, said container having an elliptical cross-section oriented perpendicular to said central axis, said opening having two connecting surfaces, each connecting surface projecting away from said space in a saddle-like manner, each connecting surface having two chambers located between two peaks, each peak being located near a respective end of the main axis of said container, the first connecting surface having a first tip adapted to closely connect to the female organ at the first point, the first point being located between the clitoris and the urethral opening and being close to the clitoris, but located a short distance from the clitoris in the direction of the urethral opening, said connection surface having another top adapted for tight connection with the female nal organ at another point located between the urethral opening and the vaginal opening, said first connecting surface having a pair of chambers adapted to tightly connect with the two labia minora along an opposing pair of first elliptical areas, each of the respective first elliptical areas being located in close proximity of one of the two labia minora, the second connecting surface being located along the outer periphery of said first connecting surface and merging into the first connecting surface at said first apex, the second connecting surface having another pair of chambers adapted for tight connection with the two labia minora along an opposite pair of other, elliptical areas, each of the respective other elliptical areas being located a short distance away from a nearby, first elliptical area, and from said central axis, the second connecting surface having a third top adapted for tight connection with the female organ at a third point localis pea between the said second point and the vaginal opening, the said first connection surface projecting further away from the said space than the said second connection surface, the said first connection surface and the said second connection surface being convexly curved and the curvature being directed outwards and away from said space, the first connecting surface and said second connecting surface each having a wall sufficiently thick that said first connecting surface and said second connecting surface each maintain their respective shape and are not deformed when said urine collection device is held firmly against the female organ by a weak pressure directed along an underside of said container opposite said space; and (b) a hollow stem which is continuous with said underside of said container opposite said space, the hollow stem communicating with said space and providing said space with an outlet; whereupon, when a slight pressure is applied along said underside of said container opposite said compartment, said first and said second connecting surfaces cooperate to effectively isolate the vestibulum from the vaginal opening, each separately connecting around urinary meatus; and providing said compartment of said container with a pair of tight connections with the female organ firstly around the vestibulum of the female organ and secondly around the meatus urinarius of the female organ. 5. The urine collection device according to claim 4, where said hollow stem is radially oriented around said central axis. 6. The urine collection device according to claim 4 or 5, where said hollow stem has a circular cross-section and an inner diameter that slopes outwards and away from said underside of said container opposite said space. 7. In combination with (a) a urine collection device adapted for external tight connection with a female organ, said device having a container containing a space, said space being radially oriented around a central axis; (b) non-folding drain channel connected to a rear side of said container opposite said compartment and including a hollow stem, a hollow transition part connected thereto and a hollow collar connected to said hollow transition part, said hollow collar also connects to said underside of said container opposite said space, said hollow stem communicating with said space and supplying said space with an outlet, said hollow stem, said hollow transition part, and said hollow collar each being aligned along the direction of said central axis and each has a circular cross-section, the inner diameter of said hollow collar being larger than the inner diameter of said hollow transition part, said inner diameter of said hollow transition part being larger than the inner diameter of said hollow stem, said inner diameter of said hollow stem decreases progressively as it leans away from said underside of said container opposite said space, as said hollow stem has a greater wall thickness than said hollow transition part, said hollow transition part having a greater wall thickness than said hollow collar; whereupon, when said hollow trunk is placed away from said central axis up to a value of approx. 90°, said collar together with said transition part will turn along part of its walls with the hollow trunk opening into said collar, and communication between said space and said outlet is maintained. 8. A one-piece, external, female urine collection device adapted to be placed between the labial folds of the wearer, adapted to be in contact with the vestibular tissue around the mea-tui°Sefining the urethral orifice, and adapted to be held in place by by means of convenient mechanical means and assisted by a controlled vacuum, said device comprising: an elliptical and open, cup-shaped part having a centrally located hole through said part, an upper surface of said part including an elliptical and inwardly curved near-curved , tapered surface and a continuous curved edge extending upwardly therefrom, surface portions of said upper surface located away from said tapered surface opposite said curved edge and surface portions of said curved edge bounding double upper portions forming an adjacent pair of connection surfaces, with the inner of the mentioned, nearby surfaces being located further up from the said space relatively to the outer of the adjacent surfaces, the passageway means including a hollow drainage channel which is connected to said part at the rear thereof, extends therefrom and communicates with said hole; and ways to prevent said drainage channel from closing and thereby disrupting the natural flow of urine from said part, for close and continuous contact and connection with the labial folds and said vestibular tissue. 9. A one-piece, soft and flexible urine collection device adapted to connect tightly to the female organ by vestibular surface tissue along the underfolds of the labia minora, near the clitoris and near the urethral opening, but positioned in the direction of the vaginal opening, adapted to receive urine discharge from a person and adapted to be held in place by a weak vacuum, said device comprising: a generally ellipsoidal open-mouth container including a hole through said device and said container and a mouth communicating with said opening to connect to said person at said vestibular tissue, said mouth including a generally elliptical and inwardly directed, near-curved, tapered surface and <V> a <ei> Hon?nuer, curved edge extending upwardly therefrom, surface portions of said mouth being placed away from said tapered surface opposite said curved edge, and as surface parts of said curved edge limit two adjacent e surfaces with outwardly directed, convex curvature, which surround said mouth, the inner of said nearby surfaces being placed further up from said opening relative to the outer of said nearby surfaces; the passage way means including a hollow cylindrical part which is connected to said container at the rear thereof, the latter normally extending therefrom and communicating with said opening; and ways to prevent said cylindrical part from closing and thereby disrupting the natural flow of urine from said container, for close and continuous contact and connection with said vestibular tissue. 10. A female urine collection system comprising a closed urine collection container having a container inlet; an inflow control unit including a valve housing containing passage means for fluid flow having a valve inlet and a valve outlet, and means for controlling a predetermined flow of urine between said valve inlet and said valve outlet and through said valve housing to maintain a preselected vacuum condition at said valve inlet, said collection container being in liquid communication with said inlet control unit via said valve outlet and providing said predetermined pressure condition; and a one-piece external female urine collection device adapted to be placed between the labial folds of the wearer, adapted to be in contact with the vestibular tissue around the meatus defining the urethral opening and adapted to be held in place by a weak vacuum, said device including a generally elliptical and open, cup-shaped portion having a centrally positioned opening through said portion, an upper surface of said portion including a generally elliptical and inwardly directed, near-curved, tapered surface and a continuous, curved edged extending upwardly therefrom, the surface portions of said upper surface which are located away from said tapered surface opposite said curved edge defining double upper portions of a space within said portion, said double upper portions forming a contiguous pair of connection surfaces, the inner of the mentioned, nearby surfaces being located further up from the mentioned room relative to the outer of the mentioned tea, nearby surfaces; the passageways including a "substantially hollow drain channel which is connected to said part at the rear thereof, extending therefrom and communicating with said hole, said drain channel being connected to said valve inlet, said upper surface of said part being in contact with and connects to said vestibular tissue, said inflow control unit and said urine collection device cooperating to give said inflow control unit the said, preselected vacuum state, said urine collection container thereby being in fluid communication with said device through said inflow control unit; and means for avoid that said drainage channel closes and thereby disrupts the natural flow of urine from said device, for close and continuous contact and connection with the labial folds and the said vestibular tissue, and for general uninterrupted collection of urine in said collection container. 11. A female urine collection system comprising; a closed urine collection container having a container inlet; an inlet control assembly which includes a valve housing limiting a valve inlet and a valve outlet and enclosing an inlet control element;. means for maintaining a predetermined flow of urine between said valve inlet and said valve outlet and through said flow control element and said valve housing; means for maintaining predetermined degrees of diffusion of gas through at least two different parts of said valve body; in that the inlet to said collection container is connected to said valve outlet; and a one-piece, soft and flexible urine collection device, adapted to closely connect to the female organ at the vestibular surface tissue along the underfolds of the labia minora, close to the clitoris, and close to the urethral opening, but located towards the vaginal opening, adapted to receive urine discharge from a person and adapted to be held in place by a weak vacuum, said device including an open mouth ellipsoidal container including an opening through said device and said container and a mouth communicating with said container to connect to said person by said vestibular tissue, said orifice including an elliptical and inwardly directed, near-curved, tapered being ten ig surface and a continuous curved edge extending therefrom, surface portions of said mouth being located away from said tapered surface opposite said curved edge and surface portions of said curved edge delimiting two adjacent surfaces of outwardly convex curvature surrounding said mouth, the inner of the said adjacent surfaces being located further up from said hole relative to the outer of the said adjacent surfaces; the passage devices include a tapered cylindrical part which is connected to said container at the rear thereof, extending normally from there and communicating with said opening, said cylindrical part being connected to said valve inlet, said mouth of said container being in contact with and connects to said vestibular tissue, said inflow control unit and said urine collection device cooperating to maintain said predetermined urine flow between said valve inlet and said valve outlet; and means for preventing said cylindrical portion from closing and thereby disrupting the natural flow of urine from said container, for close and continuous contact and connection with said vestibular tissue for uninterrupted urine collection in said collection container and for maintaining said predetermined rates of diffusion of said gas. 12. The urine collection system of claim 11 wherein said inflow control element is a side bendable, connectable valve device which includes an inflow control surface and a valve seat to controllably maintain flow of said urine through said valve housing. 13. The urine collection system of claim 11 wherein said inflow control element is a flap type control valve element. 14. The urine collection system of claim 13 wherein said means for maintaining a predetermined flow of said urine and said means for maintaining said predetermined degree of diffusion includes at least one semipermeable hydrophobic membrane respectively carried along said parts of said valve housing, being at least down- the flow part of said parts of said housing includes a respective drain hole through said housing and at least one of said membranes respectively connects with it so that said urine does not leak therefrom, at least one membrane having a pore dimension such that said urine not diffusing through, but allowing gas to diffuse through. 15. The urine collection system of claim 14 where said membranes have a pore dimension of approx. 3 to 15 ym. 16. The urine collection system of claim 14 where, as mentioned, at least one valve hole and hydrophobic membrane are two in number and are found in said valve part both on the upstream and downstream side of said flap valve.