NL8303923A - EXTERNAL URINATING EQUIPMENT FOR WOMEN. - Google Patents

Description

η * VO 5246

Title: Female external urinator

The invention relates to the field of human urinators or devices designed to be held in place outside the human body, and more particularly to the field of urinators, which are particularly designed to be used in principle of being gently held in place outside the female body. The device has proven effective when used by a patient who is in an upright, seated or generally supine position.

10 Certain paralyzed legs, paralyzed in all four limbs, inability to control and other female patients often require assistance in relieving urine from the urinary bladder.

The female urinary industry manufactures a variety of devices designed to provide different degrees of assistance for such patients. One difficulty faced by the female urinary industry is the manufacture of a device that is easy to wear and does not leak during use. This means, in principle, that the device must not only be able to be secured to the female body by commercially available fasteners and to be able to be held snugly in place by such fasteners, but also means that the device is effective and, by the way, must provide a non-sealing seal after application to the female body. (or outer surface of the body). In addition, the device must be non-adhesive, non-pinching, non-irritating, flexible, resilient, bacteria-free, sterile, and generally somewhat smooth and soft to the touch.

Much of the prior art is not concerned with the question of leaching, associated with the body engagement of a particular urinator on the female body, so that most of the prior art in the field of female urinators does not describes leak-proof urinator. The key to the leak-proof feature of a female urinary device is how it engages the female body.

Many of the difficulties associated with a female ureter 35 making sealing engagement with the female.

8303923 -2-fc * body, flow naturally from the special nature of the external female genitalia, which naturally surround the mouth of the urethra.

Medical records teach that the woman's external genitalia are formed by the labia, the labia majora and labia, the clitoris, the urethra, and the mouth of the sheath, and describes the term "external pubic parts" to describe all these parts. include. In addition, the "forecourt", as used in connection with the female body, is medically described as being in a triangular smooth region between the clitoris and the entrance to the sheath, and bounded on either side by the labia minora. Finally, medical practice teaches that the urethra (also referred to as the urethral outlet) is located at a posterior (or bottom) portion of the forecourt about an inch below the tickler near the edge of the sheath, and that the urinary tract 15 is surrounded by an excellent elevation of a mucous membrane.

It is an object of the invention to provide a female urinator capable of making a leak-proof sealing engagement with the female body when the patient is in a standing, sitting or generally reclined position.

Accordingly, a general object of the invention is to provide a system to control inability in women without the use of permanent cathedrals, diapers, etc.

This is accomplished by providing a urination device which can engage sealingly with the female body, which engagement is improved by a vacuum or negative pressure condition.

More specifically, it is an object that a weak vacuum state for such a device be somewhat constant and easily maintained at the area where the device contacts and surrounds the court fabric.

A further object is to provide a system comprising a discharge tube of a predetermined height and a valve which can achieve a vacuum state by maintaining a liquid column of a preselected and relatively constant height.

A further object is to provide a valve, which is generally unaffected by air or other gas during operation, which enters the 8303923-4 valve through the valve outlet.

. A related object is to provide such a valve, provided with a valve body, which can receive a water-repellent, filtered vent port which diffuses air or a smaller gas through it.

Yet another general object is to provide an appliance, a valve and a collection system which, when used together, cooperate to allow for a particularly useful result.

A particular object, therefore, is firstly to provide a device which can engage sealingly with certain woman's forecourt tissues, which engagement is enhanced by predetermined vacuum conditions, and secondly to provide a valve which provides the device of the predetermined desired vacuum state.

Although a wide variety of known valve shapes can be used, the illustrative preferred embodiments consist of hinge valves, which require a predetermined pressure to drive the device, and are in a normally closed position. In one embodiment, two filtered vent ports are provided which contain a water-repellent filter that allows diffusion of gas through them, but not of liquids. In a preferred system, which includes a 20 cm vertical length of tubing between the device and the check valve, the following pressure / vacuum sequence occurs when the device is in place. During the flow of urine, a (positive) pressure of 490-980 25 Pa is present in the portion of the system above the valve. When the flow ceases, this pressure immediately drops to a negative value, resulting in a vacuum height of 1.94-3.92 kPa. The upstream, water-repellent filter vent in the valve then allows air to enter the system until equilibrium is reached. In the described embodiment, this is a vacuum of about 784-980 Pa. The system remains at this height to ensure that no leakage occurs between the device and the forecourt tissue until urine flows freely through the device again causing an increase in pressure in the system to a positive value of 490-980 Pa, and the cycle is repeated. Use of a second filter vent port on the downstream side of valve 8303923

«I

-4- permits diffusion of a gas pressure scour into the collection bag and thus eliminates any adverse effect such pressures may have on the valve. Excessive pressure build-up in the bag causes the valve to remain in a closed position and thus prevents the addition of additional fluid into the bag or causes the development of a large pressure or liquid column on the inlet side of the valve, causing leakage around the unit.

According to the purposes, a female ureter is provided configured to seal the female body externally. The female urinator can be used to collect a patient's urine in a semi-continuous or even a continuous manner. Furthermore, the device can be used by the woman to collect urine when the patient is in an upright or standing position, a generally supine position or a sitting position.

The unit seals when gently held in place. The device first makes a sealing engagement with the mucous membrane that surrounds the urinary tract, and secondly with the court. In order to provide such a two-part sealing engagement, the device 20 is provided with a pair of raised sealing surfaces. A gentle pressure applied to a back or bottom of the device, which is opposite a urine receptacle cavity, causes one of the two raised sealing surfaces and a raised portion of the device to work together to clearly protrude into the urine-absorbing cavity of forcing the device of tissue surrounding the urethra, after which a stream of urine coming out of the urethra is directed into this cavity.

The sealing engagement of the device is additionally improved by the nature of the general front shape and surface geometry of the sealing surfaces, which are designed to be in principle adapted to the angle and body surfaces of the female body's court.

More specifically, the device seals the forecourt and separates the urethral mouth from the sheath mouth. Body engagement with the forecourt includes a series of sealing engagements between the labia minora, the mouth protrusion 8303323 * *. -5- between the mouth of the sheath and the mouth of the urethra and certain other tissues, which are located close to the clitoris but slightly away from it towards the mouth of the urethra.

In a second embodiment, rather than an oval or egg-shaped exterior shape, it is a pair of generally ellipse-shaped ridges provided with a more gentle slope between opposite ends of the major axis of the device. This has been established experimentally by use in a variety of female patients to determine an almost general shape for the adult female body.

The second embodiment may also be used as part of a system, wherein the device is initially applied by applying a gentle pressure to the back of the device with the hand or preferably by using underpants with an inner opening in the center of the crotch. When using a preferred embodiment of the device, it turned out to be desirable to provide a non-return valve between the urine receiver and the drain. As urine flows out of the device through the connecting tube 20 and the valve in the urine receiver, a vacuum is generated at the sealing surfaces of the device caused by the venturi action of the urine flow. The vacuum height achieved is a function of the length and diameter of the connecting tube, and the height of the device relative to the urine receiver and valve. The development of such a vacuum condition for the device at the body engaging areas with the woman improves sealing on the forecourt tissues.

This vacancy effect can be cumulative during subsequent urine drainage and can reach a height that may cause discomfort to the wearer. As a solution to this difficulty, the valve member may be provided with one or more vent ports using water-repellent filtering means which provide vent to allow ambient pressures to reach the interior of the system and to the vacuum height experienced by the user to decrease.

In summary, the second embodiment of the device is a one-piece, external female urine collection device that can be placed in the folds of the lips of the user to contact the forecourt tissue surrounding the urethra. and to be held soft and stabilized by mechanical means, but enhanced by a slight vacuum condition. The device consists of a generally elliptical and open cup-shaped portion, and has a generally centered bore opening to allow urine to flow freely through the portion and bore of the device. The top surface of the device includes a generally elliptical and inwardly closed, looped horned surface, and a substantially continuous curved spine extending upwardly therefrom. Portions of the top surface of the device, which are spaced from the horned surface opposite the curved back, and the curved back define dual upper portions of a cavity in the portion. These bipartite upper portions form an adjacent pair of sealing surfaces that extend substantially continuously along the exterior. outline of the device. The inner surface is further spaced from the outer surface relative to the cavity. From a rear of the part eh in one piece therewith and in communication with the bore opening and the cavity, a stem or cylindrical flange extends downward. The shape of the stem is adapted to prevent obstruction of fluid flow through the bore opening by forming a thin-walled chamber and a lower thick-walled section at the end of the chamber opposite the device, and arranged to be connected to the piece tube, which leads to the valve. The heavier section and the flexible thin-walled chamber are arranged to prevent the difficulty of kinking and to prevent impediment of fluid flow through the bore opening.

In addition to being generally elliptical in shape, the open cup-shaped portion has a gently sloping surface geometry which allows the device to be snugly secured against the court fabric without excessive pressure, which tightening sealing application is enhanced by slight vacuum condition, placed on the cavity of the device.

The invention is further elucidated with reference to the drawing, in which: 8303923 * f -7-

Fig. 1 is a spatial view from above of a portion of a pair of sealing surfaces located around the cavity at the urine receiving end of the device,

Fig. 2 is a spatial view similar to FIG. 1, with the device rotated about 180 ° about the longitudinal axis,

Fig. 3 is a plan view of the urine-receiving cavity of the device, illustrating the basically ovoid nature of the sealing surfaces,

Fig. 4 is a sectional view taken on the line IV-IV in FIG. 2, FIG. 4A is a sectional view similar to FIG. 4 with the discharge channel bent and placed in a position substantially different from 90 ° from that shown in FIG. 4 to illustrate the anti-kinking efficiency,

Fig. 4B is a sectional view taken on the line IV3-IVB in FIG. 4A, FIG. 5 is a spatial view of the device operatively connected to a fluid reservoir and used in conjunction with a preferred embodiment of a commercially available body securing and collection device,

Fig. 6 is a front view of the device of FIG. 5, FIG. 7 is a rear view of the device of FIG. 5,

Fig. 8 is a view of the external female genitalia showing the areas of the front engagement of the sealing surfaces of the device with the female body, FIG. 9 is a vertical mid-section of the female pelvic region showing approximately the placement and body engagement of the device when the patient is in an upright, generally supine or sitting position,

Fig. 10 is a ruined view of another preferred embodiment of the device, FIG. 11 is a side view of the device of FIG. 10,

Fig. 12 is a top view of the device of FIG. 10,

Fig. 13 is a section on line XIIII-XIII in FIG. 12,

Fig. 14 is an asm fig. 13 is equal cross-section, in which the prevention of kinking is illustrated, fig. 15 is a sectional view of a molded connection (8303923 *,.

-8- device with insert for attaching a piece of drain pipe to the appliance,

Fig. 16 is a sectional view of another embodiment of the device of FIG. 15, FIG. 17 is a sectional view of yet another embodiment of the device of FIG. 15,

Fig. 18 is a side view, partly in section, of the entire assembly using the device,

Fig. 19 is a side view of a valve and filter mechanism used in the system of FIG. 18,

Fig. 20 is a sectional view taken on the line XX-XX in FIG. 19,

Fig. 21 is a plan view of the hinge valve used in the system of FIG. 18,

Fig. 22 is a partial sectional view of a second embodiment of the valve of the system of FIG. 18, and

Fig. 23 is an exploded section taken along line XXIII-XXIII in FIG. 22.

In Fig. 1, the device 10 is shown in spatial form, and consists of a receptacle 12 and a hollow stem 14. The receptacle 12 contains a cavity 16. The cavity 16 has an entrance opening 18, which in principle is a vertical extension of the cavity. Is 16.

The cavity 16 is in principle oriented radially about a longitudinal axis 10, the receptacle 12 having a generally ovoid or ovoid outer circumference, and a generally elliptical or oval inner section, both of which are perpendicular to the longitudinal axis 20.

The opening 18 is provided with two generally elliptical sealing surfaces 22, 24, generally convex in cross section. Each sealing surface protrudes from the receptacle 12 in a saddle-shaped manner according to the direction of the longitudinal axis 20. Each sealing surface is in side elevation provided with two ridges located between two peaks (tops), each peak near a corresponding end from the major axis of the receptacle 12.

The first (or inner), substantially continuous sealing surface 22 includes a first or front peak 26, which can seally engage the female body in a first position just below the 9303923. This first site is generally located between the clitoral and the urethral outlet, and usually near the clitoral but some distance therefrom toward the urethral outlet. The inner sealing surface 22 also includes a second or posterior spike (or "bump") 28 which can sealingly engage the female body in a second location located between the urethral opening and the sheath outlet. The inner sealing surface 22 includes a first pair of spaced opposite side or connecting ridges 30, 32, which ridges can engage sealingly with the underside or inner surfaces of the two labia minora and an opposing pair of first elliptical regions.

The second (or outer) sealing surface 24 is in principle arranged along the outer circumference of the first sealing surface 22. The surface contours of the outer sealing surface 24 smoothly merge into the first sealing surface 22 at the first peak 26. The second sealing surface 24 is also provided with a second pair of ridges 34, 36, which can similarly engage sealingly with the two labia minora along an opposing pair of second elliptical or oval regions. In addition to smooth transition of the surface 24 into the peak 26, each second elliptical or oval region, both radially and axially, is slightly displaced from its associated neighboring first elliptical region, as shown in FIGS. 1 and 2.

The outer sealing surface 24 is provided with another peak 38, which can engage with the female body in a third place, which is located between the second place and the mouth of the sheath.

The surface geometry of the receptacle 12 is such that the inner sealing surface 22 generally protrudes and farther away from the main portion of the receptacle 12 than the outer sealing surface 24. This protrudes in a saddle fashion and along the direction of the longitudinal axis 20.

The surface contours of the inner sealing surface 22 and 35 and the outer sealing surface 24 are bent outwardly convexly, the curvature positively pointing away from the cavity 16. In addition, the inner sealing surface 22 smoothly merges into the cavity 16 to thereby provide the opening 18.

The inner sealing surface 22 and the outer sealing surface 5 24 each have a wall sufficiently thick that the inner sealing surface 22 and the outer sealing surface 24 each retain their shape and do not deform when the urinator 10 is held in place against the female body by a light pressure, generally applied along a rear or underside of the receptacle holder 12 opposite the cavity 16. The inner and outer sealing surfaces 22, 24 of the appliance 10 each allow the appliance 10 to have a has sealing engagement with the tissue surrounding the urinary tract. The surface curvature, the saddle-shaped contours and the elliptical cross-section of the two sealing surfaces 22, 24 of the device, 15 and more particularly the raised "bump" or peak 28 of the inner sealing surface 22, cooperate with the outer sealing surface 24 for providing a slight bulge of the urethral projection into the cavity 16 of the device 10 to thereby direct the flow of urine into the cavity 16 of the receptacle.

20 The dual sealing surfaces serve two purposes. Firstly, a urine sample to be used for analysis is not contaminated by sheath secretion, and secondly normal menstruation can be separately provided by the usual use of commercially available menstrual devices without handling of waste fluid.

Figures 1-3 illustrate the surface geometry of the inner and outer sealing surfaces 22, 24 of the device 10, with Figures 8 and 9 showing how the device 10 makes a sealing engagement with the female body.

The hollow stem 14, shown in Figures 1, 2 and 4, is oriented radially about the longitudinal axis 20, and in one piece with a portion of the rear or bottom of the receptacle 12 facing the cavity 16. The hollow stem 14 communicates with the cavity 16 and provides the cavity 16 of an outlet 40. Basically, looking down along the longitudinal axis 10 and into the cavity 16, the inner diameter of the hollow stem 14 is 8303923, s -11- circular in principle. The hollow stem 14 has a somewhat equal wall thickness, and an outer diameter, which gradually decreases slightly from the receptacle 12 to the outside.

The hollow stem 14 has a sufficient wall thickness and is made of a sufficiently resilient material, so that "kinking", which otherwise impedes the flow of urine from the cavity 16, does not occur, since the hollow stem 14 is provided with a kinking countermeasure, consisting of a hollow transition portion 42 (containing an outer corner 42a, a horizontal flange 42b and an inner corner 42c) and a hollow collar 44 for reducing the possibility of kinking.

A drain (for the cavity 16) is in one piece with the back or bottom of the receptacle 12 opposite the cavity 16, and includes the hollow stem 14, the hollow transition portion 42 and the hollow collar 44. As shown in FIG. the hollow stem 14 in one piece with the hollow transition parts 42a, b and c, and the hollow transition parts 42 in one piece with the hollow collar 44, which is also one piece with the rear or bottom of the receptacle 12 opposite the cavity 16.

For the purpose of describing the drain, the inner diameter of the hollow stem 14 gradually decreases slightly as the main body of the receptacle 12 exits 20, leaving the wall thickness of the hollow stem 14 substantially the same. As part of the measure of the anti-kinking drain, the hollow stem 14 has a greater wall thickness than the hollow transition portions 42a, 42b and 42c, which themselves have a greater wall thickness than the hollow collar 44.

The hollow nature of the stem 14, the transition portion 42 and the collar 44 allows connection between the cavity 16 and the outlet 40. The relatively thin-walled hollow collar basically eliminates the adverse effects caused by kinking when the drain is in use is bent. As can be seen in Figures 4A and 4B, the discharge channel 30 can be bent upward through 90 ° from the longitudinal axis 20, maintaining a substantially complete flow from the outlet 40.

The progressively reduced thickness of the various elements as they rise axially from the stem 14 through the transition portion 42 into the hollow collar 44 allows the collar 44 to fold inward on one side to form at least an elliptical opening 8 t Q 7- $ 9 λ

J V V ^ v Ih U

ie a slightly flattened end to the stem 14, where it is attached to the transition portions 42, and opens into the rest of the interior of the collar 44, This is most clearly seen in the fig.

4A and 4B, and even ensures an open drain, when the stem 14 0 5 has been moved over substantially 90 from the usual position when the patient moves from an upright or reclined position into a sitting position.

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

When a slight pressure is applied in a direction substantially parallel to the longitudinal axis 20 along the back or bottom of the receptacle 12, the inner and outer sealing surfaces 22 and 24 and more particularly the hump 28 cooperate to effectively separating, i.e. sealing separately, through the inner and outer sealing surfaces 22, 24, and providing the cavity 16 of the receptacle 12 with a pair of sealing engagements with the female body. A sealing engagement is generally made around the mouth of the urethra. These dual sealing surfaces 22, 24 not only ensure a tight seal with minimal pressure, but also stabilize the device 10 against up and down or sideways movement.

The device 10 is made of a suitable soft rubber, rubber-like or plastic composition.

The device 10 may be held in place against the female body by any commercially available device designed to seal the device. For example, the device 10 can be held in place with a belt or belt device. The described embodiment, shown in Fig. 5, shows such an arrangement, consisting of a belt 46, four belts 48, 50, 52 and 54 and a cushion 56.

The belt 46 may circumferentially fit around the patient's waist and is made of a suitable resilient material for 8303323? -13- remaining essentially in place when pulled down by the action of the belts. The preferred belt is a commercially available type made from an assembly of fabric and elastic. The preferred belt is provided with a commercially available closure member 47 to fit a number of waist sizes.

The four belts 48, 50, 52, and 54 are also made of a suitable resilient material, so that the pad 56 is forced to exert a slight pressure on the back or bottom of the receptacle 12 opposite the cavity 16 when the strap - and girdle direction is worn by a patient in a standing, sitting or otherwise generally supine position. In the preferred embodiment, each belt consists of a fabric section and an elastic section. Each fabric portion is attached to the belt 46, and each elastic portion to the pad 56, as shown in Figures 5, 6 and 7.

This manner of attachment causes the pad 56 to conform to the rear or bottom of the receptacle 12 opposite the cavity 16 to thereby accomplish the previously described sealing engagements. In the preferred embodiment, the two lower (or outer) belts 48, 54 run as shown. in Figures 6 and 7, on either side of the rectum following the buttock fold, and are then attached to the belt 46. In this embodiment, the lower belts 48, 54 are attached to the belt 46 at the hipbone or at the ilium protrusion of the pelvis front-above. As shown in Figs. 6 and 7, the top (or inner) belts 50, 52, which are attached adjacent to the belt 46, are located at locations adjacent the associated lower belts 48, 54. In the preferred embodiment, the inner and outer belts in addition to being resilient and therefore stretchable, are also adjustable in length.

The pillow 56 is made of a suitably soft and pliable material. In the preferred embodiment, the side of the pad facing the female body is made of a soft felt-like material, the back of the pad facing away from the female body being reinforced with fiber. The preferred pad is slightly disc-shaped and slightly larger in cross-section than the cross-section of the rear or underside of the receptacle 12 opposite the cavity 16, 8303223-14, so that light pressure can generally be applied to the entire rear or bottom of the receptacle. receptacle 12 opposite the cavity 16. The belts 48, 50, 52 and 54 are usually attached to the outer circumference of the pad 56 in a manner that allows the pad 56 to make a significant surface contact with the back or bottom of the receptacle 12 opposite the cavity 16.

The pad 56 has a hole 58 located approximately in the center thereof. In the preferred embodiment, when the device 10 is brought into sealing body engagement with the female body, the hollow collar 44 protrudes through the hole 58 and away from the patient's body. As used in this preferred embodiment, the device 10 is connected by a suitable connector 60 (such as a connector) to a length of tube 62 of suitable diameter and flexibility. The piece of tube 62 is reconnected to fluid supply container 64, provided with a suitable connecting means 66 and clamping means 68. During the day, the fluid supply container 64 may be a leg bag, and a draining bag at night. A portion of the length of tube 62 is usually taped to the patient's thigh above the knee.

Since this portion of the tube 62 piece is taped to the leg, the hollow stem 14 resists kinking at the back or bottom of the receptacle 12 opposite the cavity 16, When the hollow stem 14 is bent away from the longitudinal axis 20 , first deforms the hollow collar 44, then the hollow transition portion 42, and finally the hollow stem 14. The relatively large inner diameter of the hollow collar 44 (compared to that of the hollow stem 14) allows significant displacement of the drain from the longitudinal axis 20 while maintaining a free flow of urine from the cavity 16. The hollow stem 14 can be bent about 90 ° from the longitudinal axis 20, with urine flowing into the cavity 16 flowing further out of the cavity 16 through the outlet 40 to the piece of pipe 62.

The hole 58 in the pad 56 is slightly larger than the hollow collar 44 to allow for this bending or this freedom of movement of the drain or piece of tube 62 without kinking or clamping 35 or both.

3303923 • * -15-

In this embodiment, the manufacture of the device has been carried out using commercially available injection molding agents. Usually urinators of rubber, rubbery material or plastic are made by dipping treatment, it being very difficult to control the wall thicknesses. The wall thicknesses of the collar, the hollow transition portion and the hollow stem of the present device can be controlled critically by a commercially available injection molding treatment. In the preferred embodiment, the device is made of a suitable thermoplastic rubber polymer or of a medical grade elastomer (such as a liquid silicone rubber).

An illustrative, second preferred embodiment of the device will now be discussed with reference to Figs. 10-14.

This device 130 is a one piece, external female urinary collection device, which can be placed in the user's lip folds, (generally along the inner surfaces or bottom sides thereof) and in contact with the forecourt tissue surrounding the corridor. determines the opening of the urethra. The device 130 includes a generally elliptical and open, cup-shaped portion 132 with a tapered upper chamber 134, which terminates at the narrow end in a generally center-bored opening 20 for urine to flow through the portion 132 and the device 130. The top surface geometry of the device 132 includes a generally elliptical and inwardly horned surface 138 in the form of a closed loop, and a substantially continuous curved back 140 extending therefrom extends above.

Portions of the top surface of the device 130, spaced from the horned surface 138 opposite the curved back 140, are referred to as the surface 142, and define and form an adjacent pair of sealing surfaces 140, 142. The inner surface 140 relative to the outer surface 142 is further upward from the cavity 134.

Extending substantially perpendicularly downwardly from a rear (generally indicated by the reference numeral 144, see Figs. 11 and 13) of the part 132, and in one piece there is a relatively thin-walled cylindrical flange or tubular part 146 which communicates with the bore opening 136 and the cavity 134 provides a drain channel. The flange 146 is oriented about the centerline 148 (see Fig. 13). Further details of the cylindrical flange or tube 146 are set forth below.

The sealing surfaces 140, 142 and the part 132 are oriented about a centerline 150, which is substantially parallel to the centerline 148, and may be displaced therefrom by the distance D (Fig. 13). Viewed from above, the projections of the sealing surfaces 140, 142 of the device 130 (Fig. 12) are generally elliptical. As can be seen, Ie, the device 130 has a major centerline A passing through centerlines 148 and 150, and a minor centerline B which is laterally oriented with respect to centerline 148, but perpendicular to the major centerline A ( Fig. 12).

These two axes A and B form a plane which is substantially perpendicular to the axis 148. Referring to Fig. 11, it can also be seen that the lateral projection of the device 130 is also generally elliptical in a second plane, that the centerline 148 contains or is substantially parallel thereto, a semi-minor centerline C being vertically oriented, as is the centerline 148.

In the plane formed by the center lines A, B (Fig. 12) or in a plane (not shown), generally parallel thereto, which is perpendicular to the center line 150, an origin is generally present ( arbitrarily depicted in Fig. 12) for a first radius of curvature R1, generally describing the elliptical outer edge boundary of the device 130. A second radius of curvature R2, having a second origin, located substantially in the same location as described above for the first origin, generally describes the location of the horned surface 138, which separates the adjacent sealing surfaces 140, 142. In the plane formed by the centerlines A, C (fig. 11) and from an origin located on the centerline 150 outside the device 130 (fig. 13), a third radius of curvature R3 describes the gently sloping surface geometry ( from the device 130) at the entrance to the cavity 134, where the device 130 generally contacts the woman's court and lip folds. As can be seen most clearly in Fig. 13, the end surfaces of the device 130 are defined by origins, which are on the axis A, where the radius R5 determines the outer end geometry of the device 130, and the radius R4 8303923 ♦ -17 determines the horned surface 138.

Vacuum sealing of the device 130 to the woman can generally be achieved if the following values are maintained. Referring now to Figs. 11 and 12, the length 60 along the axis A is between 4.01 and 4.78 cm. The length 160 is preferably about 4.39 cm. The width 162 along the center line B is between 2.62 and 3.12 cm. The width 162 is preferably about 2.87 cm. The nominal projection height C is between 0.94 and 1.19 cm. C is preferably about 1.07 cm. The offset relationship, determined by the distance D, is between 0.178 and 0.218 cm. D is preferably about 0.198 cm. R1 is between 3.81 and 4.57 cm. R1 is preferably about 4.19 cm. R2 is between 2.48 and 2.98 cm. R2 is preferably about 2.73 cm. R3 is between 2.32 and 2.83 cm. R3 is preferably about 2.58 cm. R4 is between 1.00 and 1.22 cm. R4 is preferably about 1.11 cm. R5 is between 1,143 and 1,397 cm. R5 is preferably about 1.27 cm. R6 is between 3.77 and 4.61 cm. R6 is preferably 4.191 cm.

The adjacent sealing surfaces 140, 142, which are continuous and provide two adjacent sealing surfaces along the entire periphery of the device 130, allow the device 130 to have sealing and continuous contact with the woman through engagement with the interior portions. of the lip folds and the rest of the aforementioned forecourt fabric.

Referring more particularly to Figures 13 and 14, the cylindrical tubular flange 146 is a thin-walled portion with a wall thickness between 0.0635 and 0.0889 cm, and preferably about 0.0787 cm, the length of the thin-walled portion, measured from the rear 144 of the portion 132, is only slightly larger than the inner diameter of the flange 146. A thick-walled extension 152 includes a center opening 154 and a lower counterbore 156, which can receive a length of tube 158, provided with an inner bore which is substantially the same as the bore of the opening 154, allowing free unobstructed flow in the pipe section.

The length of tube 158 is secured in the counterbore 156 by suitable means known in the art, such as an adhesive, or by heat welding.

As can be seen most clearly in Fig. 14, the bending of the flange 146 results in a slight closing due to its inner diameter by bending one side and stretching the other side without closing the bore, and thus allowing an unobstructed passage of urine through the interior of, the flange 146, the thickener portion 152 and the length of tube 158 to a suitable trap. This anti-kinking measure can be easily incorporated and made in one piece in the above-described embodiment of the female urine receiver.

Referring now to Figs. 15-17, additional embodiments of the connector are shown. In Fig. 15, the flexible flange 146a includes a thickened portion 152a having a center bore 154a, and a pipe connector 170 with an enlarged flange 172, formed as an insert in the thickened portion 152a. The pipe connector 170 includes, at the free end, a plurality of stepped shoulders 174 of the type well known in the art to expand and provide a sealed receptacle and passage to the interior of the pipe 158a expanded thereover. The connector 170 has a center bore, not shown, which is substantially equal to the diameter of the bore 154a to provide an unobstructed flow of urine from the female device (not shown).

A second embodiment of the connector comprises a thin-walled flange 146b, a portion of which is "shown in section," and wherein the ends 176, which are initially co-axial thereto, are bent inwardly to form an inwardly directional flange 178, affixed to the piece of tube 158b by adhesive or heat welding, shown in Fig. 16.

Fig. 17 shows yet another embodiment, wherein a thin-walled flange 146c, a portion of which is shown in section, includes an inwardly facing flange 180 and a downwardly facing cylindrical flange 182. The inwardly facing flange 180 has a center bore for receiving the length of tube 158c, the downwardly flange 182 forming a chamber or receiving cavity with the length of tube 158c for receiving a sealing ring 184 of an adhesive and other known O-rings sealing and retaining mechanism ..

The anti-kinking measure in each of the last three embodiments shown in Figures 15, 16 and 17 operates in the same manner as that shown in Figure 14, that is, a thin-walled flange terminating in a thick-walled rigid portion, the bending and stretching directs into the thin-walled portion 146a, b and c without kinking or completely occluding the flow of urine therethrough.

The present system is shown in FIGS. 18-23 and in particular FIG. 18. The device 130 is preferably connected to a urine collection vessel or urine collection bag 190 (Fig. 18). The urine receiver 190 is usually a sealed and initially flat plastic bag or pouch of a type well known in the art. The device 130 may initially be secured to the woman's desired forecourt fabric, as set forth above, by applying a light fastener and pressure means, such as a pair of underpants 192 (of which only the cross is shown in section), which has a central aperture for receiving the downwardly extending portion 146 and 152. Preferably, a mini pad 194, provided with an adhesive layer 196 for affixing to the underpants 194, serves to stabilize the catcher 130 and secure it to the keep the predetermined desired location thereof.

This is complemented by placing a slight vacuum state on the cavity 134 of the device 130. A known method of placing such a vacuum state on the cavity 134 is by maintaining a preselected liquid column (such as urine) under the device. 130.

To accomplish this, the check valve is preferably disposed between the device 130 and the receiver 190 to control the urinary column and the vacuum. The valve 200 includes a valve construction 202, which defines a valve inlet 204 and a valve outlet 206 and encloses a hinge valve 208. A preferred embodiment of the hinge valve 208 includes a flap 210, which is one-piece neck 212 with a circular circumferential collar 214, see FIGS. 20 and 21. As seen most clearly in FIG. 20, valve inlet 104 includes an annular, axially extending, rounded edge flange 220, which serves as a seat against which flap 210 extends. can place in a usually closed bandage, on the outside of which there is a second flange 222, which is axially oriented and terminates in the same plane as the flange 220, and diametrically outwardly thereof relative to a shoulder 224. The valve outlet 206 includes a counterbore, which forms a shoulder 226, and an axially extending flange 228. The valve inlet 204 and the valve outlet 206, by their co-axial arrangement, fill the flange 222 and the shoulder 226, the collar 214 apply under a tight sealing dressing. This sealing can be accomplished by bonding with a commercially available adhesive or also by heat sealing the two plastic portions together. By maintaining the axial size of the flanges 222 and 228 to match the thickness of the hinge valve 208, a normally closed positive seating occurs between the flap 210 and the axially oriented flange 220, serving as the seat for the blow 210. When urine flows downward, a predetermined urine column is established in the length of tube 158, which acts against the blow 210 and pushes it to an open position in a known manner after the creation of this column .

The flap 210 engages, substantially covers and seals against the seat formed by the flange 220, thereby maintaining a first urinary column (or other fluid column) in the tubular portion 230 of the valve inlet 204 (the fluid is not shown ). The hinge valve 15 208 is made of a commercially available, suitable flexible material that allows the first liquid column to assume a predetermined value. The preferred hinge valve is made of a polyester film with a thickness of about 0.13 mm. The neck 212 and the collar 214 cooperate to press the flap 210 against the seat 230 thus preventing the liquid from leaving the valve outlet 206 flows out of the piece of tube 230.

As the column of liquid increases in height, the weight of the liquid in the length of tube 230 eventually increases to the point where the flap 210 is lifted off the seat 220. Thereafter, the height of the liquid column in the tube 230 and the length of tube 258 decreases rapidly as the liquid flows past the flap 210. Most of this fluid usually flows out immediately from the valve outlet 206, preferably filling the associated trap 190. The height of the fluid in the tube 230 is rapidly reduced to a point where the blow 210 regains the weight of the liquid in the tube 230. Then, the flap 210 moves up again against the seat 220 by the compression action of the neck 212, and seals the seat 220.

It has been noted, however, that the passage of urine through the device 130 and the piece of tube 158 and the valve 200, through a venturi action, develops a first vacuum condition which is applied by the device 130 to the woman's body. wherein, when the woman discharges additional urine into the cavity 134 of the device 130, a clear sense of increased discomfort is felt (with time) at the forecourt tissue to which the device 130 is applied. Indirectly, it has been observed that when urine is discharged into the cavity 134 of the device 130, it entrains some of the air and certain other gases initially present in the cavity 134. This entrapment deprives the cavity 134 of a first amount of air or other gas, and serves to enhance the vacuum feel over time.

Between the flap 210 and the device 130, the inlet portion 204 of the valve assembly 200 includes a first vent 240 through which air and certain other gases can pass, so that a first vacuum condition applied to the cavity 134 of the device 130 can be enforced.

Such a vent contains a water-repellent filter or membrane 242, which covers the vent 240 and allows the inflow or outflow of gases, but due to the water-repellent nature prevents passage of liquids, such as urine. In the tubular section 230, the height of the liquid is usually marked above the vent 240, with the water-repellent filter 242 preventing liquid from leaking out from the tubular section 230. The filter membrane 242 has a pore size such that most of the gas can diffuse through it, but urine or other liquids cannot detect or clearly diffuse through it. When the pore size is between 3 and 15 µm (a preferred pore size range), no diffusion of urine is noted.

The illustrated embodiment of the system, which includes the device 130 with the outlet flange 146, 152 connected to a length of hollow and flexible plastic tube 158 of suitable length, is commonly used to connect the device 130 to the valve 200. in most applications, a length of about 20 cm for the piece of pipe 158 is preferred. During the flow of urine, a (positive) pressure of 490-980 Pa is present in the portion of the system above the valve. When the discharge of the urine flow ceases, this pressure immediately drops to a negative value, resulting in a vacuum height of 2.94-3.92 kPa.

fe? V v v o £ *%, »t -22-

The upstream, water-repellent filter vent 240 in the valve 200 then allows air to enter the system until approximately equilibrium is reached. In the described embodiment, this is a vacuum of about 784-980 Pa. The system remains at this height to ensure tight engagement of the device 130 with the forecourt tissue until the urine flows again to cause an increase in pressure in the system to a positive value of 490-980 Pa, after which the cycle is repeated. The equilibrium vacuum height is determined in part by the length of the tube and the vertical distance of the device 10 above the valve. The upper connector in the valve (above the upstream vent) generally has an inner diameter ranging from 0.445 to 0.711 cm, with an optimum preferred inner diameter being about 0.508 cm for achieving the above pressure / vacuum sequence.

It should be noted that when the woman discharges urine into the cavity 134 of the device 130, and urine flows down the length of the tube 158 and through the valve 200, small bubbles have been observed to be seen in the urine column. . These bubbles first appear on the liquid side of the semi-permeable membrane 242, observed to pass through the vent 240 and into the urine in the tubular portion 230 of the valve 200. Without the vent 240 in the tubular portion 230, no bubbles are observed.

It has further been observed that the height of the liquid column in the valve 200 and the length of the tube 158 except for the compression action on the neck 212 of the hinge valve 208 is caused by the surface tension of the particular liquid. For example, when the piece of tube 154 used is more particularly of a commercially available extruded latex with a nominal inner diameter of about 0.794 cm, it has been observed that the height of the urine in the valve 200 and the piece of tube 158 generally extends between 7.62 and 10.16 cm above the vent inlet 240. Such a commercially available piece of pipe is maintained at an allowable clearance of the inner diameter of about 0.40 cm. Still, for a nominal inner diameter of the tubing length of about 0.953 cm, it has been observed that such a urinal height 35 or column cannot become in the tubing section 158 and tubular portion 230 3303923 t-23- of the valve 200 above the vent inlet 240. enforced. The urethra in the section of tube 158 then extends upwardly from hinge valve 208 only to generally vent vent 240. For a nominal inner diameter of about 0.635 cm for the 5 piece of tube, it has further been noted that the bubbles (observed in the urine) do not move up into the tubular portion 230 or valve 200.

The test with the nominal inner diameter of the tube piece of about 0.794 cm was repeated, and a significant amount of a commercially available soap solution was added to the urine column, after which the urine height in the tube 230 and the tube 158 remained significantly lower than previously noted. For the piece of tube 158, the preferred nominal inner diameter is 0.794 cm. The preferred inner diameter at the inlet end portion 204 of the valve 200 is about 0.508 cm.

The piece of tube 158 is preferably substantially translucent, with the valve 200 preferably being made of a suitable and clear plastic and preferably transparent.

A second length of flexible plastic tubing 198 of appropriate length connects the outlet end portion 206 of the valve 200 with a suitable inlet connection 188 to the urine receiver 190. When urine flows down 20 through the outlet valve portion 206 of the valve 200 and the receiver 190 entrains, entrained air and other possibly entrained gas begins to accumulate in the trap 190, which air is eventually displaced from the trap 190 and up into the outlet tube section 198 where it may interfere with operation of the hinge valve 208.

Accordingly, the outlet portion 206 of the valve 200 preferably includes a second vent 244 to allow the gas in the exhaust tube 198 to pass through the wall of the valve structure 200. This valve vent 244 also includes and is covered by a water-repellent filter membrane 246, which forms a liquid seal there.

The second membrane 244 is preferably of the same fabric and the same pore size as the first membrane 242. It should be noted that the two membranes may be formed as an insert during the manufacture of the inlet portion 204 and the outlet portion 206 of the valve 200 or may be formed as part of a closure cap (not shown-35) which is inserted into the valve ports 240 and 244. Obviously, a 5 nt cs? t

V W w w 4 J

-24τ that the downstream, water-repellent filter vent 244 allows air to escape from the catcher / leg bag 190, thereby allowing for greater fluid height before developing a back pressure, which penalizes proper operation of the system, ie entrained 5 air serves to act against the flap 210 to keep it in a closed position, resulting in an undesired liquid column in the length of tube 158 and a possible leakage of liquid from the receiver unit 130.

Although not shown, a valve with a single downstream vent port, that is, the vent port 244 with a water-repellent filter membrane 246, has been found to be effective in removing air and other gases from the bag, and resulting from the The non-positive nature of the hinge valve 208 allows sufficient ambient air to enter the system to partially cancel the vacuum state where the device 130 engages the fore and lip fabric. Such an embodiment is similar to the previously described embodiment with the valve 200, but omitting the upper vent port 240 and the associated water-repellent filter 242.

The first embodiment of the valve and filter (shown in Fig. 19-21), as described above, is only an example of an inline valve and filter, which can be used. A second embodiment of such a valve equipped with filters can be seen in Figs. 22 and 23. While the first valve part, namely the inlet part 204 and the outlet part 206, can be formed in a simple starting form with a minimal lateral operation for the gates 240 and 244, the second embodiment of Figures 22 and 23 requires somewhat greater investment in tools due to the greater number of parts included. This embodiment of the valve 300 includes a main body 302, including an inlet end 304, 30 appropriately shaped for engaging the interior of the length of tube 158, and an outlet opening 306, which extends into an inclined or beveled seat 308 . A hinge valve 310 with a design substantially similar to that of the previously described valve 208 includes a flap 312 which engages the seat 308 and covers the opening 306, a hinge 314, and a surrounding body 316. A side opening 320, which forms a chamber in the body 302, which contains the seat 308, is closed by a cover member 322, provided with a flange means 324 for engaging the circumferential body portion 316 of the valve 310 to engage it securely. with the seat 308 but allowing a movement of the flap 312 to open and providing a vent through the opening 306. The main body includes an outlet opening 330 adapted to engage the discharge tube 198 connected to the catcher 190,

In this embodiment, upstream of valve 310, a vent port 332 is provided, which includes an apertured cap 334 that can receive a water-repellent filter 336 serving the same purpose as the filters in the previous embodiment. Similarly, a downstream vent port 340 is covered by a ported cap 342, which bears a similar water-repellent filter membrane 344. The operation of this valve is substantially the same as the first embodiment when used in the system shown in Fig. 18.

It is understood that the hinge valves 200 and 300 are only two embodiments of valves capable of flowing fluid in only one direction 20 as required by the invention. Changes in hinge valve embodiments of this type are well known in the art, but not the use of such a valve having a vent port with a water-repellent filter therein in the environment described herein. The disclosed system provides a soft mechanical means for initially engaging the forecourt mucosa of the female body, and ensures a continuous seal with these forecourt and lip tissues after maintenance of the vacuum condition after an initial discharge of urine. The adverse effects of the vacuum have generally been eliminated by the water-repellent, filter-vented ports which reduce the patient's discomfort but ensure an adequate vacuum condition for sealing purposes. The system can be manufactured inexpensively and can be reused by observing general cleanliness and known techniques. The female receiving device can be made of polyethylene by injection molding, as well as others at the 8 3 i; 3 9 2 3 -26- use injection molding, soft rubber-like materials, which are comfortable for the female body. The valve elements can be injection molded from suitable plastic materials of a wide variety known in the market, and inert to urine.

Although certain dimensions have been set forth for the receptacle, which can be used for a "normal adult woman", it should be understood that narrower units can be used for small and slender women, with apparatus having the same general characteristics, but having a length and width smaller than the stated dimensions have been developed for use for immature women, ie teenagers suffering from uncontrollability.

What is depicted and described here is a new system and an improved urinator for women. While the valve and device have been shown and described in a number of preferred embodiments, the invention is not limited thereto. On the contrary, alternatives, changes or modifications may become apparent to those skilled in the art after reading the foregoing description. These alternatives, changes and modifications are therefore to be considered part of the invention insofar as they are within the scope and scope of the appended claims.

8303923

Claims (31)

2. Device as claimed in claim 1, characterized by a discharge channel in one piece with the part at a rear thereof, which channel extends from there and communicates with the bore opening, and by means for preventing the kinking of the discharge channel. soft and pliable device for sealingly engaging the female body at the forecourt surface tissue generally along the labia minora, a portion of this tissue located near the clitoris and another portion of this tissue located near the urethral outlet and is displaced to the sheath outlet for receiving urinary discharge from a patient, characterized by an open receptacle provided with a mouth defining a saddle for engagement with the woman in the forecourt tissue which saddle is provided with at least two generally adjacent surfaces with a generally outwardly convex curvature, of which The neighboring surfaces an inner generally 30 is disposed a little further up relative to an outer of the neighboring surfaces for making a sealing engagement with the woman along the forecourt fabric, which receptacle includes an outlet for discharging the discharge therefrom and by means for preventing the outlet from closing and obstructing the outlet therefrom. 3303323 -28- r - 4. One-piece, soft and pliable device for sealingly gripping the female body at the forecourt surface tissue generally along the folds of the labia minora, part of the tissue located near the clitoris, and another portion of this tissue located near the mouth of the urethra and displaced to the mouth of the sheath, for receiving urination from a patient, characterized by an open and generally oval receiving container, provided with a saddle-defining mouth, for engagement with the woman at the forecourt fabric, which saddle defines two generally adjacent surfaces, which are generally slightly further up relative to an outer thereof arranged to make sealing engagement with the woman along at least two generally different surface peripheral portions of the court fabric, the receptacle holding a tubular one piece therewith and provided with an outlet which may permit the discharge to be naturally discharged therefrom, and by means for preventing the tubing from kinking and obstructing the natural discharge therefrom . 5. Device according to any one of claims 2-4, characterized in that the drain outlet comprises a chamber, further a transition section and a hollow connecting stem, all of which communicate with the cavity and together form a means of preventing: kink Device according to claim 5, characterized in that the chamber has a larger diameter than the transition section, which has a larger diameter than the stem. Device according to claim 6, characterized in that the wall thickness of the chamber, of the transition portion and of the stem are inversely proportional to the diameters, the chamber wall being thinner than the transition portion, which is thinner than the stem causing angular movement from the stem to 90 from its usual position causes partial reversal of the chamber wall and the transition portion, but maintains an open bore in the stem in communication with the chamber and the cavity. 8. Uriner for externally sealingly engaging a female body, characterized by a receptacle provided with an 8303923. Opening and having a cavity, said cavity directed radially about a longitudinal axis, the receptacle having a substantially elliptical cross-section which is perpendicular to the longitudinal axis, said aperture having two sealing surfaces, each sealing surface 5 protrudes from the cavity in a saddle-shaped manner, each sealing surface is provided with two ridges, placed between two peaks, each place is placed near an associated end of the major axis of the receptacle, the first sealing surface is provided with a first peak for the sealingly engaging the female body in a first place, which first position is between the clitoral and the urethral outlet and near the clitoral but slightly displaced from the clitoral toward the urethral outlet, the first sealing surface is provided with a second peak for sealingly engaging the female body a second place, located between the mouth of the urethra and the mouth of the sheath, the first sealing surface includes a first pair of ridges for sealingly engaging the two labia minora along an opposing pair of first elliptical areas , each concerning first elliptical region is located near one of the two labia minora, the second sealing surface is placed substantially along the outer circumference of the first sealing surface and smoothly merges into the first sealing surface at the first peak, the second sealing surface is provided with a second pair of ridges for sealingly engaging the two labia minora along an opposing pair of second elliptical regions, each respective second elliptical region is spaced from an adjacent first elliptical region and from the longitudinal axis, the second sealing surface is provided with a third p For sealing engagement, the female body is in a third location, located between the second location and the sheath outlet, the first sealing surface protrudes further from the cavity than the second sealing surface, the first sealing surface and the second sealing surface convex are curved and the curvature is directed outward and away from the cavity, the first sealing surface and the second surface each have a wall 35 of sufficient thickness so that the first sealing surface and the second 8 3 ö 3 8 2 3 '' Sealing surfaces each maintain their respective shape and do not deform when the urinator is held against the female body by a slight pressure applied substantially along a bottom of the receptacle opposite the cavity, then, when a light pressure is applied along the bottom of the receptacle opposite the cavity, the first and second sealing surfaces cooperate for the Effectively separating the mouth of the sheath from the forecourt, separately sealing the urethra and the cavity of the receptacle provided with a pair of sealing engagements with the female body, namely first around the female body forecourt and second around the female body. urinary tract of the female body. 9. Urinating device for externally sealingly engaging a female body, characterized by a receptacle, provided with an opening and with a cavity, which cavity is oriented radially about a longitudinal axis, which receptacle has a substantially elliptical cross-section, which is perpendicular is oriented to the longitudinal axis, which opening is provided with two sealing surfaces, each sealing surface protruding from the cavity in a saddle-shaped manner, each sealing surface having two ridges, placed between two peaks, each peak placed near a corresponding end from the major axis of the receptacle, the first sealing surface includes a first spike for sealingly engaging the female body in a first place, which first position is between the clitoral and the urethral outlet and near the clitoral at a distance from the tickler in the direction of the outlet of the urethra, the first sealing surface is provided with a second peak, for sealingly engaging the female body in a second place, which is located between the mouth of the urethra and the mouth of the sheath, the first sealing surface is provided with a pair of ridges for sealingly engaging the two labia minora along an opposing pair of first elliptical regions, each associated first elliptical region is located adjacent one of the two labia minora, the second sealing surface is disposed substantially along the outer periphery of the first sealing surface and smoothly overflows into the first sealing surface at the first peak, the 8303923 Β ψ -31- second sealing surface includes a second pair of ridges for sealingly engaging the two labia minora along an opposing pair of second ellipsoidal areas, each respective second elliptical a little further we g is provided of an adjacent first elliptical region and of the longitudinal axis, the second sealing surface is provided with a third peak, for sealingly engaging the female body at a third location, which is located between the second location and the outlet of the sheath, the first sealing surface protrudes further from the cavity than the second sealing surface, the first sealing surface and the second sealing surface are bent convexly and the curvature is directed outward from the cavity, the first sealing surface and the second sealing surface each are provided with a wall sufficiently thick that the first sealing surface and the second sealing surface each maintain their respective shape and do not deform when the urinator is held against the female body by a slight pressure applied substantially along a bottom of the receptacle opposite the cavity, and by a hollow one-piece handle the bottom of the receptacle opposite the cavity, which hollow stem communicates with the cavity and the cavity front-20 of an outlet, then when a slight pressure is applied along the bottom of the receptacle opposite the cavity, the first and second sealing surfaces cooperate to effectively separate the front court from the sheath outlet, separately sealing the urethra and providing the receptacle cavity with a pair of sealing engagements with the female body, first around the front court of the female body and secondly around the urinary tract of the female body. Device according to claim 9, characterized in that the hollow stem is oriented radially around the longitudinal axis. Device according to claim 9 or 10, characterized in that the hollow stem has a circular cross-section and an inner diameter, which extends outwardly and away from the underside of the receptacle opposite the cavity. Device according to claim 11, characterized in that the hollow stem comprises a hollow transition part which forms one whole with it and also 8 '6 3 S 2 3 -32- with a hollow collar which forms one piece with the bottom of the receptacle opposite the cavity. 13. Device according to claim 12, characterized in that the hollow transition section and the hollow collar are each directed radially around the longitudinal axis. Device according to claim 12 or 13, characterized in that the hollow transition section and the hollow collar each have a circular cross-section, the inner diameter of the hollow collar being larger than that of the hollow transition section, the inner diameter of which is larger than that of the hollow stem, which has a greater wall thickness than the hollow transition portion, which has a greater wall thickness than the hollow collar. * 15. Device, characterized by a cushion, provided with a front to be directed towards the female body, which cushion is made of a soft and pliable fabric, and is provided with a number of stretchable belts, each attached to the outer edge circumference thereof. with a first end attached to the peripheral periphery of the pad, and with a second end attached to a belt, which fits around the waist of a female patient, the belt and each belt each having a length, sufficient to cause the front of the pad to exert a slight pressure on an area near the forecourt of the female body when the strap is worn around the waist in the usual manner, and through a urinator for externally sealing engagement of the female body, consisting of a receptacle, provided with an opening and with a cavity, which is oriented radially around 25 and longitudinal axis, which receptacle is provided n of a substantially elliptical cross-section, oriented perpendicular to the longitudinal axis, the opening having two sealing surfaces, each sealing surface protruding from the cavity in a saddle-shaped manner, each sealing surface having two ridges, placed between two peaks 30, each peak is located near an associated end of the major axis of the receptacle, the first sealing surface includes a first peak for sealingly engaging the female body at a first location located between the clitoral and the outlet of the the urethra and a short distance near the clitoris in the direction of the urethral outlet, the first sealing surface is provided with a second peak for sealingly engaging the female body in a second position, which located between the mouth of the urethra and the mouth of the sheath, the first cover surface is provided with and of a first pair of ridges for sealingly engaging the two small labia along an opposing pair of first elliptical regions, each respective first elliptical region being adjacent one of the two small labia, the second sealing surface substantially along the outer periphery of the first sealing surface is positioned and smoothly merges into the first sealing surface at the first peak, the second sealing surface includes a second pair of ridges for sealingly engaging the two labia minora along an opposing pair of second ellipsoidal areas, each respective second elliptical region is spaced from an adjacent first elliptical region and from the longitudinal axis, the second sealing surface includes a third peak for sealingly engaging the female body in a third location located between the second location and the mouth of the s chede, the first sealing surface protrudes further from the cavity than the second sealing surface, the first sealing surface and second sealing surface 20 are bent convexly and the curvature is directed outward from the cavity, the first sealing surface and the second sealing surface each include a wall, which is sufficiently thick that the first sealing surface and the second sealing surface each retain their respective shape and do not deform when the front of the pad holds the urinator 25 in place against the female body when a slight pressure is applied essentially to underside of the receptacle opposite the cavity, whereupon when a slight pressure is exerted by the pad against the underside of the receptacle opposite the cavity, the first and second sealing surfaces cooperate to effectively separate the front court from the mouth of the sheath , sealing the urinary tract separately and providing the cavity of the receptacle with a pair of sealing engagements with the female body, namely, first around the female body's forecourt, and secondly around the female body's urethra to thereby allow urine to flow freely from the urinary bladder to flow into the cavity without leakage of the urine from the receptacle. 16. Device, characterized by a cushion, provided with a front to face the female body, which cushion is made of a soft and pliable fabric and is provided with a hole in the middle 5, in which a number of stretchable belts are attached to the outer edge circumference of the pillow, each stretchable belt includes a first end, which is attached to the outer edge circumference of the pillow, and includes a second end, which is attached to a belt, which can fit all around the waist of a female patient, the strap and each girdle individually have a length sufficient to apply a slight pressure through the front of the pad to an area near the forecourt of the female body when the belt is worn around the waist in a conventional manner, by a fluid reservoir for receiving and containing urine from the female patient, which fluid stock parent is provided with connecting means for operatively connecting the fluid reservoir to a first end of a tube, and by a urinating device for externally sealingly engaging the female body, which device consists of a receptacle provided with an opening and with a cavity, 20 which is oriented radially about a longitudinal axis, the receptacle having a substantially elliptical cross-section, which is perpendicular to the longitudinal axis, and of two sealing surfaces, each sealing surface protruding from the cavity in a saddle-shaped manner, each sealing surface having two ridges, positioned between two peaks, each peak is located near an associated end of the major axis of the receptacle, the first sealing surface includes a first peak for sealingly engaging the female body in a first location between the clitoris and the mouth of the urethra and zi ch located a short distance from the clitoris 30 toward the urethral outlet, the first sealing surface includes a second peak for sealingly engaging the female body at a second location, located between the urethral outlet and the mouth of the sheath, the first sealing surface includes a first pair of ridges for sealingly engaging the two labia minora along an opposite side 8303923; * -35- Next pair of elliptical regions, each respective first elliptical region is located near one of the two labia minora, the second sealing surface is located substantially along the outer circumference of the first sealing surface and smoothly merges into the first sealing surface at the first peak, the second sealing surface includes a second pair of ridges for sealingly engaging the two labia minora along an opposing pair of second elliptical regions, each respective second elliptical region being a short distance from an adjacent first elliptical region and from the longitudinal axis, the second sealing surface includes a third peak for sealingly engaging the female body at a third location located between the second location and the sheath outlet, the first sealing surface protruding further from the recess the second sealing surface, the first one off sealing surface and the second sealing surface are curved convexly and the curvature is directed outwardly away from the cavity, the first sealing surface and the second sealing surface are each provided with a wall sufficiently thick so that the first sealing surface and the second sealing surface each retained and not deform when the front of the pad holds the urinator in place against the female body when a slight pressure is applied substantially along a bottom of the receptacle opposite the cavity, and from a hollow stem, which extends from a is broken with the underside of the receptacle opposite the cavity, communicates with the cavity, and provides the cavity with an outlet operatively connected to a second end of the tube, when a slight pressure is applied through the cavity cushion against the bottom of the receptacle opposite the cavity, the first and second sealing surfaces cooperate v for effectively separating the front court from the mouth of the sheath, separately sealing the urinary passage 30 and providing the receptacle cavity with a pair of sealing engagements with the female body, namely, first around the front court of the sheath female body and secondly around the urethra of the female body to thereby allow urine to flow freely from the urinary bladder into the fluid reservoir without leakage of urine from the receptacle. 8303§23 -36- Device according to claim 16, characterized in that the hollow stem is oriented radially around the longitudinal axis. 18. Device according to claim 16 or 17, characterized in that the hollow stem has a circular cross-section and an inner diameter, which recesses outwardly from the bottom of the receptacle opposite the cavity. Device according to claim 15 or 18, characterized in that four stretchable belts are attached to the cushion. 20. Device as claimed in claim 18, characterized in that the hollow stem comprises a hollow transition part which forms a whole therewith and also with a hollow collar which is integral with the underside of the receptacle opposite the cavity. 21. Device according to claim 20, characterized in that the hollow transition part and the hollow collar are oriented radially around the longitudinal axis. The device according to claim 20 or 21, characterized in that the hollow transition portion and the hollow collar each have a circular cross-section, the inner diameter of the hollow collar being greater than that of the hollow transition portion, the inner diameter of which is greater than those of the hollow stem, the wall thickness of which is greater than that of the hollow transition section, which has a greater wall thickness than the hollow collar. 23. Device characterized by a urinally sealing device for externally sealing engagement of a female body, the device comprising a receptacle containing a cavity directed radially about a longitudinal axis, and by a drainage channel that prevents kinking and integrally formed with a rear of the receptacle opposite the cavity, the discharge channel consisting of a hollow stem, a hollow transition portion integral with it, and a hollow collar integral with the hollow transition portion, which hollow collar also integral with the underside of the receptacle opposite the cavity, the hollow stem communicating with the cavity and providing an outlet, the hollow stem, the hollow transition portion and the hollow collar each substantially in line with the direction of the longitudinal axis and each have a circular cross section, the inner diameter of the hollow collar is greater than that of the hollow The transitional section, the inner diameter of which is larger than that of the hollow stem, the inner diamond of which gradually decreases from the bottom of the receptacle opposite the cavity, the hollow stem has a greater wall thickness than the hollow transition portion, which is provided with a greater wall thickness than the hollow collar, after which when the hollow shaft has been displaced from the longitudinal axis to a value of approximately 90 °, the collar together with the transition section are reversed along a part of their walls, the hollow shaft opening out in the collar and the connection between the cavity and the outlet is maintained. 24. One-piece, external female urine receiver designed to be placed in the user's lip folds and in contact with the forecourt tissue surrounding the corridor defining the urethral mouth, and held in place by soft mechanical means, aided by a controlled vacuum, characterized by a generally elliptical and open cup-shaped part, provided with a generally central bore opening, an upper surface of the part having a generally elliptical and inwardly directed horns provided surface in the form of a closed loop, and a substantially continuous curved spine extending upwardly therefrom, surface portions of the upper surface which are flattened from the horned surface opposite the curved spine and surface portions of the curved back, define two-pronged upper portions, which form an adjacent pair of sealing surfaces, the interior of the adjacent surfaces is located further upwardly from the cavity relative to the exterior of the adjacent surfaces, passage means comprising a substantially hollow one-piece discharge channel with the portion at a rear thereof extending therefrom and in communicating with the bore opening, and means for preventing the substantial closure of the drain and thus obstructing the natural flow of urine from the portion for sealingly and continuously contacting and engaging the lip pleats and the court fabric. 25. One-piece, soft and pliable urinator for sealingly engaging the female body at the forecourt surface tissue underneath folding of the labia minora near the tickler and near the mouth of the urethra but shifted to the mouth of the 8303923-38 sheath, for picking up urine from a patient and to be held in place by a light vacuum, characterized by a generally ellipsoidal receptacle with an open mouth, which receptacle includes a bore opening, and a mouth in communication with the bore opening 5 engagement with the patient at the forecourt tissue, which mouth includes a generally elliptical and inwardly-horned, closed-loop surface in the form of a closed loop and a substantially continuous arched spine extending upwardly therefrom, whereby areas of the mouth spaced from the horned surface opposite the curved back, and surface portions of the curved bridge, define two adjacent surfaces with a generally outwardly convex curvature surrounding the mouth, the interior of the adjacent surfaces being further up from the bore opening relative to the outer of the adjacent surfaces, through means include a substantially hollow cylindrical portion, in one piece with the receptacle at a rear thereof, extending generally perpendicularly therefrom and communicating with the bore opening, and means preventing the cylindrical portion substantially closes and thus impedes the natural flow of urine from the receptacle 20 for sealing and continuous contact and engagement with the court fabric. 26. Female urinary collection system, characterized by a sealed urinary collection vessel, comprising a vessel inlet, by a flow control unit, containing a valve housing, which determines a liquid flow passage therethrough, a valve inlet and a valve outlet, and means for controlling a predetermined urine flow between the valve inlet and the valve outlet and through the housing, and to maintain a preselected vacuum condition, the valve inlet, which receptacle is in fluid communication with the flow control unit through the valve outlet, and the predetermined pressure condition provided, and by a one-piece, external, urine collection device for women to be placed in the lip folds of the user, in contact with the forecourt tissue surrounding the corridor, which defines the urethral mouth and to be held in place by a light vacuum, the device comprising a generally elliptical and open, cup-shaped part, provided with an in the generally centered bore opening, of which part an upper surface includes a generally elliptical and inwardly-horned closed-loop surface and a substantially continuous curved spine, which extending upwardly therefrom, surface portions of the top surface which are spaced from the horned surface opposite the curved back define two-prong upper portions of a cavity in the portion, said two-prong upper portions defining an adjacent pair of sealing surfaces , the interior of the adjacent surfaces is positioned further upward from the cavity, relative to the exterior of the adjacent surfaces, by passage means comprising a substantially hollow one-piece drain with the portion at a rear thereof, extending therefrom and communicating with the bore opening, which drain is connected to the valve pi outlet, the top surface of the portion being in contact and engagement with the forecourt tissue, the flow controller and the urine receiver cooperate for the preselected vacuum condition provided with the flow controller, whereby the urine receiver is in fluid communication with the device through the flow control unit and by means for preventing the substantial closure of the drain and thus obstructing the natural flow of urine from the device, for sealingly and continuously contacting and engaging the lip folds and the forecourt tissue and for generally continuous collection of urine in the collection vessel. 27. Female urinary collection system, characterized by a sealed urinary collection vessel, comprising a vessel inlet, by a flow control unit, which includes a valve housing, which defines a valve inlet and valve outlet and encloses a flow control element, by means for maintaining a predetermined flow of urine between the valve inlet and the valve outlet and through the flow control element and the housing, and by means for maintaining predetermined rates of diffusion of gas through at least two different parts of the housing, the inlet of the -trap vessel is connected to the valve outlet, and by a one-piece, soft and pliable urinator for sealingly engaging the female body at the forecourt surface tissue1 underneath folding of the 35 labia minora near the clitoris and near the mouth of the urine 8303023 -40- tube, but moved to the mouth of the sheath, to accommodate urination from a pat and to be held in place by light vacuum, which device includes a generally ellipsoidal receptacle with an open mouth, which receptacle includes a bore opening and a mouth in connection therewith for engagement with the patient at the forecourt fabric, the mouth of which has a generally elliptical and inwardly-horned closed-loop surface in the form of a closed loop and a substantially continuous curved spine extending therefrom, surface portions of the mouth which spaced from the horned surface opposite the curved back, and surface portions of the curved back define two adjacent surfaces with a generally outwardly convex curvature surrounding the mouth, further extending the interior of the adjacent surfaces is positioned upwardly from the bore aperture relative to the outermost 15 of the adjacent surfaces, by passage means, which form a substantially hollow one piece with the receptacle at a rear thereof, generally extending perpendicularly therefrom and communicating with the bore opening, which cylindrical portion is connected to the valve inlet, the mouth of the receptacle in contact and engages the forecourt tissue, the flow control unit and the urinator to cooperate in maintaining the predetermined flow of urine between the valve inlet and the valve outlet and by means for preventing substantially closing the cylindrical portion and the thus obstructing the natural flow of urine from the receptacle, sealingly and continuously contacting and engaging the forecourt tissue for generally uninterrupted collection of urine in the collection vessel, and maintaining the predetermined diffusion rates of the gas. 28. System according to claim 27, characterized in that the flow control element is a pressure-engageable valve means containing a flow control surface and a valve seat for controllably maintaining the flow of urine through the housing. System according to claim 27, characterized in that the flow control element is a check valve with a hinge element. System according to claim 29, characterized in that the means 83 0 3 S23 -41- for maintaining the predetermined flow of the urine, and the means for maintaining the predetermined diffusion rates, at least one semi- permeable, water-repellent membrane which is carried along the respective portions of the housing, the downstream of these portions of the housing now containing a vent hole through the housing and the membrane engaging with it so that urine does not leak therefrom, which membrane has a pore size such that the urine does not diffuse through it, but that gas can generally diffuse through it. System according to claim 30, characterized in that the membrane has a pore size of 3-15 µm. m. 32. System according to claim 30, characterized in that the vent hole and the water-repellent membrane are provided in a number of two, and are provided in the housing both upstream and downstream of the hinge valve. 33. Flow control unit, characterized by a valve body, which defines a valve inlet and a valve outlet and encloses a flow control element, by means for maintaining a predetermined flow of liquid between the inlet and the outlet and through the element and the housing, 20 and by means for maintaining predetermined diffusion rates of gas through at least two different parts of the housing. 34. A unit according to claim 33, characterized in that the flow control element is a pressure-engageable valve means comprising a flow control surface and a valve seat for controllably maintaining the flow of the liquid through the housing. Unit according to claim 33, characterized in that the flow control element is a check valve with a hinge element. 36. A unit according to claim 35, characterized in that the means for maintaining the predetermined flow of liquid and the means for maintaining the predetermined diffusion rates comprise at least two semi-permeable membranes along the portions of be worn in the housing, each of the parts of the housing having a hole through the housing, and the membranes engaging therewith such that fluid does not leak therefrom, which membranes are each pore-sized so that fluid does not diffuse therethrough 8303923 -42-, but gas can generally diffuse through it. The unit according to claim 36, characterized in that the membranes have a pore size of 3-15 µm when the liquid consists of human urine. 83 0 3 9 2 3