SE459469B - URIN COLLECTION FOR WOMEN - Google Patents

Description

459 469 10 15 20 25 30 35 2 against generally recognizable female body surfaces.

Medical authorities teach us that the external genitalia of the female human body are the mons veneris, labia majora and minora, the clitoris, the urethral orifice and the vaginal opening; and further, the term "vulva" or "pudendum" is defined as encompassing all of these parts. used in conjunction with the female body shape medically as lying within a triangular, "forecourt" defined smooth area between the clitoris and the vaginal opening as well as on either side bounded by the labia minora.

Finally, medical authorities teach that the meatus urinarius (also called the urethral orifice) is located at a posterior (or lower) part of the anus, about 25 mm below the clitoris, near the edge of the vagina, and that the meatus urinarius is surrounded by a marked elevation of a mucosa (also called mucosa).

An object of the present invention is to create a urine collecting device for women, which can abut leak-free and tight against the female body while occupying a standing, sitting or extended position.

Accordingly, a general object of the present invention is to provide a system which can handle female incontinences without the use of insertional catheters, diapers or the like. This is achieved by the provision of an improved urinator, which is arranged to be applied sealingly to the woman's exterior, which application is supported by a vacuum or negative pressure condition.

A more specific object is to ensure that a gentle vacuum condition for such an improved device can be maintained almost constantly and permanently in the area where the device abuts and surrounds the anterior tissue.

A more specific object is to provide a system which comprises an outlet pipe of a predetermined height and a valve which is arranged to provide a vacuum condition by maintaining a liquid column of a predetermined and fairly constant height. Yet another object is to provide a valve which is in operation substantially unaffected by air or other gas entering the valve through the valve outlet. 10 15 20 25 30 35 'place. A related object is the provision of such a valve with a valve body, which is arranged to accept a hydrophobic, filtered aeration port, which allows air or other gas to diffuse through it.

Another general object of the present invention has been to provide an improved urine collection device, a valve and a collection system which, in use, cooperate together to allow the achievement of a particularly good result.

Accordingly, a more precise object of the invention has been, firstly, to provide an improved device which is tightly employable against a certain forearm tissue in the woman, the application being supported by predetermined vacuum conditions, and secondly to provide a new one. type of valve, which gives the improved device the desired predetermined vacuum state. Although a number of known valve shapes can be used, the preferred illustrative embodiments are valve type valves which require a predetermined pressure for the operation of the device and which normally assume a closed position. In a preferred embodiment, two filter-provided aeration ports are used, which comprise a hydrophobic filter, which allows diffusion of gas but not of liquids through it. In a preferred system, which has approx. 20 cm. pipeline between the device and the non-return valve, the following pressure / vacuum sequence occurs, when the device is on During the urine flow there is a 5 - 10 cm fluid pressure (positive) in the part of the system, which is located above the valve. When flows stop, this pressure immediately drops to a negative value, resulting in a vacuum level of 30 - 40 cm liquid column. The upstream hydrophobic, filtering aeration in the valve then allows air to enter the system until equilibrium is reached. In the described system, this means a vacuum of approx. 8-10 cm liquid column. The system remains at this level and thereby ensures that no leakage occurs between the device and the courtyard tissue, until urine flows freely through the device again and causes a 459 469 10 15 20 25 30 35 '35 and seals secondarily to the court. 4 increase the pressure in the system to a positive value of 5-10 cm liquid column and the process is repeated. The use of a filtering aeration port on the downstream side of the valve allows diffusion of any gas pressure that has built up in the collection bag and thus eliminates any harmful effect that such pressure can have on the valve. An impermissibly high pressure, which builds up in the bag, could cause the valve to remain in the closed position and thereby prevent further urine from being introduced into the bag, or alternatively the build-up of a large column of liquid on the inlet side of the valve, which could lead to leakage around the device.

The just stated and other objects of the present invention will become apparent upon reading the detailed description and upon study of the accompanying drawings.

Summary of the invention.

In accordance with the objects of the present invention, a urinal for women is described herein, which is arranged to abut externally against the female body shape. The urinator for women of the present invention can be used to collect urine semi-continuously or even continuously.

Furthermore, the device according to the invention can be used by the woman for collecting urine while she is in a standing, lying or sitting position.

Seal the device when it is carefully held in place. The device first abuts sealingly against the mucous membrane around the urethral orifice. To achieve such a double sealing operation, the device has been provided with a pair of raised sealing surfaces. A gentle pressure applied to the back or underside of the device, located in the middle of a urine receiving cavity, causes one of the two raised sealing surfaces and a raised portion of the device to cooperate to force tissue around the urethral opening to markedly penetrate the device's urine receiving cavity. can direct a stream of urine emanating from the urethral opening into this cavity. The sealing abutment of the device is further supported due to the general shape and surface geometry of the sealing surfaces, which have been adapted to substantially correspond to the angle and body surfaces of the forecourt.

More specifically, the device abuts sealingly against the anterior court and isolates the urethral opening from the vaginal opening. The abutment of the device to the anterior court includes a series of sealing abutments between the labia minora, the fleshy portion between the vaginal opening and the urethral opening and certain other tissues located near the clitoris but at some distance from the clitoris towards the urethral opening.

Instead of the ovoid or egg-shaped shape, a second embodiment of the invention has a pair of substantially elliptically shaped axes with a smaller inclination between opposite ends of the major axis of the device. This has been achieved through an empirical adaptation to a number of women in order to establish a semi-universal form for adult women.

The second embodiment is also used as part of a system in which the device is initially applied by applying a gentle pressure to the back of the device, the antigen manually or preferably using underpants with a central opening in the crotch. When using a preferred embodiment of the improved device, it has been found desirable to connect a non-return valve device between the urine collector and the outlet channel of the device. As urine flows from the device through the connecting pipe and the valve to the urine collector, a vacuum arises at the sealing surfaces of the device, which arises as a result of the venturi effect of the urine flow. The vacuum level provided is a function of the length of the connecting line, its diameter and the relative height of the device in relation to the urine collector and the valve. The emergence of such a vacuum condition of the device at the surfaces of the abutment against the female body supports the seal against the tissues of the courtyard.

The vacuum effect can accumulate during the following urination and can reach a level that causes discomfort. To solve this problem, the valve can be provided with one or more vent ports with hydrophobic filter means, which provide venting that allows ambient pressure to reach the interior of the system and to reduce the vacuum level experienced by the user.

In summary, the second embodiment of the improved device of the present invention is a one-piece, female-designed external urine collection device which is arranged to be located within the user's pubic fold to contact the anterior tissue around the urethral opening and to be kept gentle and stable. by mechanical means, supported by a gentle vacuum condition.

The device consists of a substantially elliptical and open cup-shaped element and has a rally located bore, which opens in such a way that the center can flow freely through the organ and the bore. The upper side of the device comprises a substantially elliptical and inwardly directed, like a closed loop, nose-shaped surface and a substantially continuous, arcuate ridge, which projects upwards therefrom.

Parts of the upper surface of the device, which are located at a distance from the nose-shaped surface, opposite the arcuate ridge, and the arcuate ridge delimit double upper parts of a cavity within the device. These double upper parts form a pair of adjacent sealing surfaces, which extend substantially continuously around the outer circumference of the device. The inner surface is located further up, away from the cavity, relative to the outer surface. Projecting downwards from a rear side of the device and made in one piece with the same and in connection with the opening of the bore and the cavity, there is a shaft or a cylindrical flange.

The shape of this shaft is adapted to connect disturbance of liquid flow through the opening of the bore by forming a thin-walled chamber and a lower, thicker wall part at the end of the chamber opposite the means and arranged to be connected to the pipe leading to the valve.

This heavier section and flexible, thin-walled chambers are arranged to avoid kinking problems and to prevent disturbance of the flow through the opening of the bore.

In addition to being substantially elliptical in shape, the open cup-shaped member has a slightly inclined surface geometry which allows the device to be tightly attached to the above-described courtyard tissue without impermissibly high pressure, this carefully sealing application being supported by a careful 35 459 469 vacuum condition applied to the cavity of the device.

Brief description of the drawings.

Fig. 1 is a perspective view seen downwards towards a part of a pair of sealing surfaces, which are located around the cavity at the urine receiving end of the device; Fig. 2 is a second perspective view of the device, again seen downwards towards the sealing surfaces as in Fig. 1 but with the device rotated about 1800 about a central axis; Fig. 3 is a plan view from above towards the urine receiving cavity of the device, showing the substantially egg-shaped design of the sealing surfaces; Fig. 4 shows a cross-section through the urine collection device for women, taken along line 4-4 of Fig. 2 and illustrating the anti-kinking feature of the outlet duct, which allows free discharge of the urine from the cavity, even after the outlet duct has been moved as much as 900 from it. central axis; Fig. 4A shows a cross section similar to that in fig. 4, except that the outlet channel has been pivoted and is located in a position substantially 900 from the position in Fig. 4 to further illustrate the effect of the anti-kinking feature; Fig. 4A is a sectional view but rotated 90 ° to illustrate the opening; Fig. 4B shows the device in Fig. Fig. 5 is a perspective view showing the device operatively connected to a liquid container and used in connection with a preferred embodiment of a commercially available fastening and collecting device; Fig. 6 is a front view of a device for attachment to the body; Fig. 7 is a rear view of the preferred embodiment of the device for attachment to the body, the device having adapted to the shape of the body; Fig. 8 shows the external genitalia, showing the areas of surface abutment between the sealing surfaces of the urine collection device and the woman's body; Fig. 9 shows a vertical middle section of the female pelvic area, showing the approximate orientation and abutment of the device, while the woman assumes an upright, substantially extended lying or sitting position; Fig. 10 is a perspective view of a preferred embodiment of the improved urinal for women made according to the invention; Fig. 11 is a side view of the device of Fig. 10; Fig. 12 is a top plan view of the device of Fig. 1; Fig. 13 is a sectional side view taken along line 13-13 of Fig. 12 showing a device for connecting the manifold to the female device; Pig. 14 is a sectional side view of the device in fig. the anti-kink feature is displayed; 13, wherein Pig. 15 shows a further modification according to the invention, which shows the use of connecting means pressed with inserts, which is useful for the connection of the outlet line to the female urine collecting device; Fig. 16 shows another modification for the connection of the outlet line to the device; Fig. 17 shows a further modification of a connecting means for the connection of the outlet line to the urine collecting device; Fig. 18 is a side view, partly in section, of the system utilizing the urine collector of the present invention; Fig. 19 is a side view of the valve and filter mechanism used in the system of Fig. 18; Fig. 20 is a sectional view taken along line 20-20 of Fig. 19; Fig. 21 is a plan view of the flap valve used in the filter valve of Fig. 20; Fig. 22 is a plan view of a second embodiment of the valve, partly in section, of the system of Fig. 18; of a type useful in Pig. 23 is an exploded side sectional view taken along line 23-23 of the valve of FIG.

In the drawings, like reference numerals refer to like parts.

Detailed Description of the Preferred Embodiment

Referring now to Fig. 1, this means 10 10 15 20 25 30 35 459 469 9 is shown in perspective and the means is shown to consist of a container 12 and a hollow shaft 14. The container 12 contains a cavity 16. constitutes a vertical extension of the cavity 16.

The cavity 16 has an inlet opening 18, which substantially the cavity 16 is substantially radially oriented about a central axis 20 and the container 12 has a substantially ovoid or ovoid outer circumference and a substantially elliptical or oval-like inner cross section, both of which are oriented perpendicular to the central axis 20. the opening 18 is provided with two substantially elliptical sealing surfaces 22,24, which are substantially convex in section. Each sealing surface projects from the container 12 in a saddle-like shape in the direction of the central axis 20. each sealing surface has in side view two axes lying between two tops (or tips) and each top is located at each end of the major axis of the container 12.

The first (or inner) substantially continuous sealing surface 22 has a first or anterior tip 26, which is designed to sealingly abut the woman's body at a first point immediately below the clitoris. This first point is generally located between the clitoris and the urethral opening and is usually located near the clitoris but slightly offset from it in the direction of the urethral opening. The inner sealing surface 22 is also provided with a second or rear top (or "hump") 28, which is arranged to abut against the body at a second point between the urethral opening and the vaginal opening. The inner sealing surface 22 is provided with a first pair of spaced apart side strips or connecting strips 30,32, which are arranged to abut against the underside or inside of the two inner labia along a pair of opposite first elliptical areas.

The second (or outer) sealing surface 24 is located substantially along the outer periphery of the first sealing surface 22. The surface contours of the outer sealing surface 24 merge into the first sealing surface 22 at a first top 26. The second sealing surface 245 also has a second pair of axes 34,36, which are similarly arranged to abut sealingly against the two inner labia along a pair of of each other 459 '10 15 20 25 30 35 sealing against the tissue around the urethral opening. Opposite other elliptical or oval regions. Except for the transition of the surface 24 into the apex 26, each second elliptical or oval region is slightly offset, both radially and axially, from the adjacent first elliptical region, as shown in Figs. 1 and 2.

The outer sealing surface 24 has a second top 38, which is arranged to abut sealingly against the body at a third point between the second point and the vaginal opening.

The surface geometry of the container 12 is such that the inner sealing surface 22 generally projects outwardly and further away from the main body of the container 12 than does the outer sealing surface 24. This projection runs in a saddle-like shape and along the direction of the central axis 20.

The surface contours of the inner sealing surface 22 and the outer sealing surface 24 are convexly curved in the outward direction, the curvature being positively directed away from the cavity 16. The inner 22 sealing surface also merges smoothly into the cavity 16 and thereby forms the opening 18.

The inner sealing surface 22 and the outer sealing surface 24 have a sufficient wall thickness for each of the inner sealing surface 22 and the outer sealing surface 24 to retain its shape and not be deformed when the ureter 10 is held in place against the body with a gentle pressure generally exerted along the container. The inner and outer sealing surfaces 22,24 of the device 10 allow the ureter 10 to be applied. The surface curvature, the saddle-like contours and the elliptical cross-section of the two sealing surfaces and more specifically the raised hump or top 28 on the inner sealing surface 22 cooperates with the outer sealing surface 24 to give a slight outward bulge of fleshy portions (meatus urinarial) into the cavity 16 of the device 10, thereby causing the urine jets to be directed into the cavity 16.

The double sealing surfaces serve two purposes. Firstly, if a urine sample is to be used for analysis, it will not be contaminated by vaginal secretions and secondly, the normal menstrual cycle can be taken care of separately during ordinary use of commercially available menstrual dressings. without disturbing urine management.

Figs. 1, 2 and 3 show the surface geometry of the inner and outer sealing surfaces 22,24 of the device 10; and Figs. 8 and 9 show how the device 10 sealingly abuts the body.

The hollow shaft 14, Figs. 1, 2 and 4, is radially oriented about the central axis 20 and is formed integrally with a portion of the back or bottom of the container 12. The hollow shaft 14 communicates with the cavity 16 and provides the cavity 16 an outlet 40§ Seen generally downwards along the central axis 20 and into the cavity 16, the inner diameter of the hollow shaft 14 is The hollow shaft 14 has a fairly constant wall thickness and has in the direction away from the cavity side, opposite the cavity 16. substantially circular . progressive slightly decreasing outer diameter.

The hollow shaft 14 has a sufficient wall thickness and consists of a sufficiently elastic material that kinks, which would normally interfere with the flow of urine out of the cavity 16, do not occur, since the hollow shaft 14 has a anti-kinking feature in that it includes a hollow transition zone 42 ( which includes outer corners 42a, a horizontal flange 4S2b and inner corners 42c) and a hollow collar 44 to reduce the likelihood of kinks.

An outlet channel (for the cavity 16) is integral with the back or underside of the container 12, opposite the cavity 16, and includes the hollow shaft 14, the hollow transition zone 42 and the hollow collar 44. As shown in Fig. 4, the hollow shaft 14 integral with the hollow transition zones 42 a, b and c; and the hollow transition zones 42 are integral with the hollow collar 44, which is also integral with the back or underside of the container 12, opposite the cavity 16.

To describe the outlet channel, it should be mentioned that the inner diameter of the hollow shaft 14 decreases somewhat progressively on the way outwards and away from the main part of the container 12, while the wall thickness of the hollow shaft 14 remains substantially constant. As part of the kink-preventing feature of the outlet channel, the hollow shaft 14 has a greater wall thickness than the hollow transition zones 42a, 42b and 42c, which themselves have a greater wall thickness than the hollow collar 44.

The hollow design of the shaft 14, the transition zone 42 and the collar 44 allows communication between the cavity 16 and the outlet 40. The rather thin-walled hollow collar substantially eliminates the otherwise harmful effects which would be caused by kinks when the outlet channel is bent during use. As shown in Figs. 4a and 4b, the outlet channel can be bent up to 900 from the central axis 20 while maintaining substantially full flow from the outlet 40. The progressively decreasing thickness of the various elements seen axially upwards from the shaft 14 through the transition zone 42 to the hollow collar 44 allows an inward compression of the collar 44 on one side thereof to form at least one elliptical opening, i.e. a slightly flattened end on the shaft 14, where it is attached to the transition zone 42, which opens towards the rest of the interior of the collar 44.

This is most clearly shown in Figs. 4A and 4B and ensures an open outlet channel even when the shaft has been pivoted substantially 900 from its normal position, when the patient moves from a standing position or an extended lying position to a sitting position. Like the hollow shaft 14, each of the hollow transition zone 42 and the hollow collar 44 has a substantially circular cross-sectional shape. The outer diameter of the hollow collar 44 'is markedly larger than the outer diameter of the hollow transition zone 42, which in itself is slightly larger than the outer diameter of the hollow shaft 14.

When a gentle pressure is applied in a direction substantially parallel to the central axis along the back or bottom of the container 12, the inner and outer sealing surfaces 22 and 24 and more specifically the hump 28 will cooperate to effectively insulate and separately seal and provide voids to the container 12. 16 a pair of sealing abutments against the body. A sealing abutment is generally provided around the urethral opening. These double sealing surfaces 22,24 not only ensure a tight closure with a minimum of pressure but also stabilize the ureter 10 against upward and downward movement or to the sides.

The urine collector 10 is made of a suitable soft rubber material, a rubber-like material or plastic.

The urine collection device 10 can be held in place against the female body by any of a number of commercially available devices which are designed to hold the collection device in sealing abutment against the body. The device 10 can, for example, be held in place by means of a strap or belt device. The described embodiment, shown in Fig. 5, comprises just such an arrangement, consisting of a belt 46, four straps 48, 50, 52 and 54 and a pad 56.

The belt 46 is arranged to fit around the waist and is made of a suitable elastic material so that it remains substantially in place when pulled down by the straps. The preferred belt is a commercially available type made from a combination of fabric and elastomeric material. The preferred belt has been fitted with a commercially available locking device 47 ("VELCRO"), so that it can be adapted to a variety of waist sizes.

The four straps 48, 50, 52 and 54 are likewise made of a suitable elastic material, so that the pad 56 will exert a gentle pressure against the back or bottom of the container 12, opposite the cavity 16, when the belt and strap arrangement is carried by someone who is in a standing, sitting or otherwise substantially extended position.

In the preferred embodiment, each of the bands consists of a tissue part and an elastic part. Each fabric portion is attached to the belt 46 and each elastic portion is attached to the pad 56, as shown in Figures 5, 6 and 7. This method of attachment causes the pad 56 to conform to the back or bottom of the container 12, opposite the cavity. 16, whereby the above-described sealing bearings are provided. In the preferred embodiment, the two lower (or outer) straps 48, 54 of Figs. 6 and 7 are shown as walking on either side of the rectum, after which they follow the seat fold and are then attached to the belt 46. In this embodiment, these lower ligaments 48, 54 are attached to the ligament 46 either at the iliac bone or at the spinal iliac anterior superior. Figs. 6 and 7 also show upper (or inner) straps 50, 52, which have been attached to the belt 46 in positions near the respective lower straps 48, 54. In the preferred embodiment, these inner and outer straps are adjustable in length, in addition to that they are elastic and therefore can be stretched.

The pad S6 consists of a suitable soft and malleable material. In the preferred embodiment, the side of the pad facing the body is made of a soft, felt-like material, while the back of the pad, from the body, is fiber reinforced. The preferred pad is slightly disc-like in shape and slightly larger in cross-section than the cross-section of the back or bottom of the container 12, opposite the cavity 16, so that a gentle pressure can be applied over the entire back or bottom of the container 12, opposite the cavity 16. The straps 48, 50, S2 and 54 are usually attached to the outer periphery of the pad 56 in a manner that allows the pad 56 to have substantial surface contact with the back or bottom of the container 12, opposite the cavity 16.

The pad 56 is provided with an approximately centrally located hole 58. When the urine collector 16 has been brought into sealing contact with the body, in the preferred embodiment the hollow collar 44 will project through the hole 58 and in the direction away from the body. When used in this preferred embodiment, the collector '10 is connected by means of a suitable connector 60 (such as a coupling) to a pipeline piece 62 of suitable diameter and suitable flexibility. The pipeline piece 62 is in turn connected to a liquid container 64, which is provided with suitable connecting means 66 and clamping means 68. During the day the liquid container 64 may consist of a leg bag and at night it may consist of a drainage bag. Part of the pipeline 62 is normally taped to the thigh, above the knee.

When the pipeline piece 62 is taped to the leg, the hollow shaft 14 counteracts kinking at the back or underside of the container 12, opposite the cavity 16. When the hollow shaft 14 bends from the central shaft 20, it deforms 10 15 20 25 30 35 459 469 15 first the hollow collar 44 and then the hollow transition zone 42 and finally the hollow shaft 14.

The rather large diameter of the thin-walled hollow collar 44 (as opposed to the smaller diameter of the hollow shaft 14) allows a strong displacement of the outlet channel from the central shaft 20 while still maintaining the free outflow from the cavity 16. The hollow shaft 14 can be bent approximately 900 °. from the central shaft 20, and urine flowing into the cavity 16 may still continue to flow out of the cavity 16 through the outlet 40 to the pipeline piece 60. The hole 58 in the pad 56 is slightly larger than the hollow collar 44 to allow such bending or freedom of movement of the drainage channel or pipeline piece 62 without kinks or stops.

In this embodiment, the urine collection device has been manufactured using § commercially available molding equipment. Normally, urination accessories are made of rubber, rubber-like material or plastic by dipping, making it very difficult to regulate the wall thickness. In the manufacture of the urine collector of the present invention, the control of the wall thickness of the collar, the hollow transition zone and the hollow shaft can be controlled very precisely using commercially available die casting equipment. In the preferred embodiment, the collecting device is made of either a suitable thermoplastic rubber polymer or an elastomer suitable for medical use (such as a liquid silicone rubber grade).

Referring now to Figs. 10-14 of the drawings, a preferred second embodiment of the urine collection device will now be described.

The urine collecting device 130 in Fig. 10 consists of a one-piece designed, for female, external use, urine collecting device, which is arranged to be placed in the pubic folds (generally along their insides or undersides) and arranged to lie in contact with the courtyard tissue around the fleshy party, which delimits the urethral opening. The collecting means 130 comprises a substantially elliptical and open 459 469 10 15 shell shell-shaped member 132 with a tapered upper chamber 134, which at its narrower end terminates with a substantially centrally located opening 136, so that urine can flow through the member 132 and the collecting means 130. The upper surface geometry of the member 132 comprises a substantially elliptical and inwardly directed, closed, pointed surface 138 and a substantially continuously curved axis 140, which extends upwardly therefrom. Portions of the upper side of the collector 130, which are spaced from the pointed surface 138, opposite the curved axis 140, have been designated 142 and form a pair of adjacent sealing surfaces 140,142. The inner surface 140 is located further upward, away from the cavity 134 relative to the outer surface 142. A rather thin-walled cylindrical flange or tubular member 146 extends downwardly substantially perpendicularly from a rear side (generally designated 144 in Fig. 11 and 13) on the member 132 and in one piece therewith, which tubular element communicates with the opening 136 and thus forms an outlet channel for the cavity 134.

The flange 146 is oriented about the axis 148 (see Fig. 13).

Further details of the tubular member 146 will be described in the following.

The sealing surfaces 140, 142 and the member 132 are oriented about an axis 150, which is substantially parallel to the axis 148 and is offset a distance D (Fig. 13) therefrom.

Seen from the top of the collector 130 (Fig. 12), the projections of the sealing surfaces 140,142 are substantially elliptical.

The collecting device 130 is shown having a major axis "A" passing through the axis lines 148 and 150 and a minor axis "B" which is located laterally relative to the axis line 148 but perpendicular to the major axis "A" (Fig. 12). .

Both of these axes "A" and "B" form a plane, substantially perpendicular to the axis line 148. of Fig. 11. Referring to 11, it further appears that the side projection of the collector is also substantially elliptical in a second plane, which either contains or is substantially parallel to the axis 148 with a semi-small axis "C" vertically similar to the axis 148. oriented Generally in the plane containing the axes "A", "B" (fig. 10 15 20 '25 30 35 459 469 17 12) or in a plane (not shown) substantially parallel thereto, which is perpendicular to the axis 150, there is an origin point (helpfully denoted B in Fig. 12) for a first radius of curvature R1, which generally indicates the elliptical outer border of the collector. A second radius of curvature R2 having a second origin point, located in a position generally as described above for the first origin point, generally indicates the position of the pointed surface 138, which separates the adjacent sealing surfaces 140,142. containing the axes "A", "C" (fig. 11) and from an origin point on the shaft 150 outside the collecting device 130 (Fig. 13), a third radius of curvature R3 describes the slightly inclined surface geometry (of the collecting device 130) at the entrance to the cavity 134, where the collecting device generally abuts the forecourt and pubic folds. As best shown in Fig. 13, the end faces of the collecting device 130 are defined by origin points on the axis "A", the radius R5 defining the outer end surface of the collecting device 130 while the radius R4 defines the pointed surface 138.

A vacuum closure of the improved collection device 130 is generally achievable if the following values are maintained: Referring to Figures 11 and 12, the length 160 along the axis "A" should amount to approx. 4.01 to 4.78 cm.

The length 160 is preferably about 4.39 cm. The width 162 along the axis "B" amounts to about 2.62 to 3.12 cm and is preferably about 2.87 cm. The nominal projection height "C" is from about 0.94 cm to about 1.19 'cm and preferably about 1.07 cm. The displacement ratio, defined as the distance "D", is from about 0.178 to about 0.218 cm, preferably 0.198 cm. R 1 ranges from about 3.81 cm to about 4.57 cm, preferably 4.19 cm. R 2 ranges from about 2.48 cm to about 2.98 cm and is preferably about 2.73 cm. R 3 ranges from about 2.32 to about 2.83 cm and is preferably about 2.58 cm. R 4 is from about 1.00 to 1.22 cm and is preferably about 1.11 cm. RS ranges from about 1.143 to about 1.397 cm and is preferably about 1.27 cm. R6 extends from 3.77 to about 4.61 cm and is preferably about 4.191 cm.

The adjacent sealing surfaces 140, 142, which are continuous and form double adjacent sealing surfaces around the entire periphery of the collector 130, allow the collector 130 to seal and abut the female body while abutting the inner portions of the labia and the labia. the aforementioned anterior tissue.

Referring now specifically to the cylindrical tubular flange 146 most clearly shown in Figures 13 and 14, the flange 146 is a thin-walled member having a wall thickness in the range of from about 0.635 mm to or about 0.889 mm, preferably about 0.778 mm. , the length of the thin-walled part, measured from the back 144 of the member 132 being only slightly larger than the inner diameter of the flange 146. A thick-walled extension 152 includes a central opening 154 and a lower bore 156, which can receive a pipe section 158 having an inner diameter substantially equal to the opening 154, so that free and unthrottled flow to the pipe section is allowed. The pipe piece 158 is fixed in the bore 156 in a suitably known manner, such as by means of adhesive or by heat sealing. As shown in Fig. 14, bending the flange 146 results in a moderate constriction of the inner diameter by bending one side and stretching the other side, without closing the opening, thereby allowing a free flow of urine. through the interior of the flange 146, the thickened portion 152 and the pipeline 158 to a suitable collection container.

Figs. 15-17 show further embodiments of connecting means, equal parts having been provided with the same reference numerals with the addition of the suffixes a, b and c.

In Fig. 15, the flexible flange 146a includes a thickened portion 152a with a central bore 154a and a pipe connection 170 with an enlarged flange 172 is molded into the thickened portion 152a. The pipe connection 170 has at its outer end a plurality of step-shaped ledges 174 of a per se known type for widening and sealingly receiving the pipeline l58a, which has been applied to the connection during some expansion. The connection 170 has a central bore, not shown, substantially equal to the diameter of the bore 154a to allow an unstriped flow of urine from the collector (not shown).

In a second embodiment, the end 176 of the thin-walled flange 146b, which is originally coaxial with the flange, is bent inwardly to form an inwardly directed flange 178, which is attached to the pipeline 158b by adhesive or by heat sealing, Fig. 16. In the embodiment in Figs. 17, the thin-walled flange 146c is provided with an inwardly directed flange 180 and a downwardly directed cylindrical flange 182. The inwardly directed flange 180 has a central bore arranged to receive the pipeline 158c while the downwardly directed flange 182 forms a chamber or pocket therebetween. and the conduit 158c for receiving a sealing ring 184, either of adhesive or in the form of an O-ring with retainers.

The kink-preventing features of each of the last described three embodiments of Figs. 15, 16 and 17 all function in the same manner as shown in Fig. 14 in that they comprise a thin-walled flange terminating in a thick-walled stiffer portion. which orients the elevation and stretch to the thin-walled portion 146a, b and c, without kinking or total shut-off of the urine flow through the flange.

Reference is now made to Figs. 18-23 and especially Fig. 18, where the system of the present invention is shown generally. In a urine collection vessel or a urine collection passage 190 (Fig. 18). and from the beginning flat plastic bag of itself The collecting device 130 can be attached from the beginning The collection bag 190 usually consists of a closed well-known type. at the woman's courtyard tissue as mentioned above using gently acting holding and pressure applicators, such as a pair of underpants 192 (of which only the crotch portion is shown in section) with a central opening for the downwardly projecting portions 146 and 152. a small pad 194 with a adhesive layer 196 for attachment to the underpants 192 to stabilize the collection device 130 and hold it in the predetermined, desired position. Preferably, the collection device 130 is preferably connected to the 459 469 10 15 20 25 30 35 20 position. This is assisted by providing a gentle vacuum condition in the cavity 134 of the collector 130. One way to provide a vacuum in the cavity 134 is to provide a predetermined liquid column (such as of urine) below the collector 130. To achieve this, the check valve is preferably connected between the collector 130 and the pad 190 to control the liquid column and thus the size of the negative pressure.

The new valve 200 comprises a valve structure 202, which has a valve inlet 204 and a valve outlet 206 and contains a flap valve 208. A preferred embodiment of a flap valve 208 has a valve flap 210, which during mediation of a neck 212 is made in one piece with a around walking collar 214, Figs. 20 and 21.

As most clearly shown in Fig. 20, the valve inlet 204 comprises an annular, axially directed flange 220 formed with a rounded edge, which serves as a seat, against which the valve flap 210 can be mounted in a normally closed position, while outside it there is a second flange 222, which is axially directed and terminates in the same plane as the flange 220, and diametrically outside the same a shoulder 224. The valve outlet 206 includes a bore forming a shoulder 226 and an axially extending flange 228. The valve inlet 204 and the valve outlet 206 with their coaxial arrangements cause the flange 222 and the shoulder 226 to grip the collar 214 in a tightly closing position. The closure can be achieved either by means of a commercially available adhesive or alternatively by heat sealing the two plastic parts against each other. By increasing the axial dimensions of the flanges 222 and 228 so that the thickness of the flap valve 208 is assumed between them, a normally closed abutment occurs between the valve flap 210 and the axially directed flange 220, which serves as a seat for the valve flap 210. When urine flows downward, a predetermined urine column is provided in the pipeline. 158 and acts against the valve flap 210, so that it is actuated to the open position in a manner known per se.

The flap 210 abuts and substantially covers and seals against the seat formed by the flange 220 and thereby maintains an initial column of urine (or other liquid) in the tubular portion 230 of the valve inlet. (the liquid is not displayed). The flap valve 208 is made of a suitable, commercially available elastic material which allows the initial fluid column to assume a predetermined value. The preferred valve-type valve is made of an approximately 0.13 mm thick polyester film. The neck 212 and the collar 214 cooperate to actuate the flap 210 against the seat 230 to thereby prevent this liquid from flowing out of the tube 230 through the valve outlet 206.

As the liquid column increases in height, the weight of the liquid in the tube 230 gradually increases to a point where the flap 210 is actuated away from the seat 220. The liquid column in the tube 230 and the tube 158 while the liquid Hereafter rapidly decreases the height of flows past the valve flap 210. Most of this liquid flows usually directly out of the valve outlet 206 and eventually fills the bag 190, which is connected to the pipeline. to a point where the flap 210 can again carry the weight of Then the flap 210 moves again The height of the liquid in the tube 230 rapidly decreases the liquid in the tube 230. upwards towards the seat 220, namely under the influence of the neck 212, and seals against the seat 220.

However, it has been found that the passage of urine through the collection device 130 and the tube 158 and the valve 200 through a venturi-like effect develops an initial vacuum state which is applied through the device 130 to the body, and as additional urine is delivered to the cavity 134 in the collection device 130 a marked sensation of increasing discomfort (over time) in the anterior tissue against which the collection device has been applied. It has been indirectly noted that as urine is discharged into the cavity 134 of the device 130, this urine will enclose some of the air and certain other gases which are initially present in the cavity 134.

This encloses the cavity 134 on a certain initial amount or volume of air or other gas and serves to increase the vacuum feeling over time.

Between the flap 210 and the device 130, the inlet part 204 of the valve structure 200 is provided with a first vent opening 240, through which air and certain other gases are allowed to pass, so that an initial vacuum, which has been applied, is applied. the housing 130 of the donet 130 can be maintained.

The vent is provided with a hydrophobic filter or membrane 242, which covers the vent and allows the ingress or expulsion of gases but due to its hydrophobic nature prevents the passage of liquids, such as urine. In the tubular portion 230, the height of the liquid is generally well above the vent opening 240 and it is the hydrophobic filter 242 which prevents the liquid from leaking out of the tubular portion 230. The filter membrane 242 has a pore size such that most of the gas is allowed to diffuse by the same, but at the same time such, -that urine or other liquids are not allowed to diffuse to a appreciable extent. As the pore size ranges from about 3 microns to about 15 microns (a preferred pore size range), no diffusion of urine has been noticed.

The illustrated embodiment of the system, including the collection device 130 with its outlet flanges 146, 152 connected to a piece of hollow and flexible plastic hose 158 of suitable length, is commonly used to connect the device 130 to the valve 200 of the present invention.

In most applications, a length of about 20 cm is preferred for the hose 158. During the urine flow, a (positive) pressure of 5-10 cm of water column arises in the part of the system located above the valve. When urine release ceases, this pressure immediately drops to a negative value, resulting in a vacuum level of 30-40 cm of fluid column.

The upstream vent 240 with the hydrophobic filter then allows air to enter the system, until a semi-equilibrium state is reached. In the arrangement described, this means a negative pressure of approximately 8-10 cm of liquid column.

The system remains at this level, which ensures tight abutment of the collection device 130 against the courtyard tissue, until the urinary flow continues and causes an increase in the pressure in the system to a positive value of 5-10 cm of fluid column and the process is repeated. The equilibrium vacuum level is determined in part by the length of the hose and the vertical distance of the collector above the valve. The upper connecting member of the valve (above the vent opening upstream) 10 15 20 25 30 35 459 469 23 generally has an inner diameter of from about 4.44 mm to about 7.11 mm with a preferred optimal inner diameter of about 5.08 mm for achieving the pressure / vacuum sequence described above.

It should be noted that when urine is discharged to the cavity of the collection device 130 and when urine flows down the hose 158 and through the valve 200, small bubbles may appear in the urine column. Such bubbles first appear at the liquid side of the semipermeable membrane 242 and have been observed to pass through the vent opening 240 and inwardly into the urine of the tubular portion 230 of the valve 200. were found on the tubular portion 230 any such If not the vent port 240 bubbles would not be observed.

It has further been observed that the height of the liquid column in the valve 200 and the hose 158, in addition to being caused by the action from the neck 212 of the flap valve 208, includes a surface tension phenomenon of the liquid in question. For example, when the hose 154 used is a special commercially available sprayed latex hose having a nominal inner diameter of about 0.794 cm, the female urine column valve 200 was noted and in the tube 158 generally extended 7.5 to 10.0 cm above the vent opening 240.

Such a commercially available hose has an inner diameter tolerance of about 0.4 mm. For a nominal hose inner diameter of about 0.953 cm, it was noted that no such urine column could be maintained in the hose 158 and in the tubular portion 230 of the valve 200, above the valve inlet 240. in the hose 158 extended upwardly from the flap valve 208. At a nominal hose inner diameter of about 0.635 cm, it was only generally noted up to the vent opening 240 that the bubbles observed in the urine could not move upward in the tubular member 230 or in the valve 200.

The experiment with a nominal hose inner diameter of about 0.794 cm was repeated and a considerable amount of commercially available soap solution was added to the urine column, the height of the urine in the tube 230 and the hose 158 being noted to be considerably lower than stated above. For the hose 158, the preferred nominal inner diameter is about 0.794 cm. The preferred inner diameter at the inlet end 204 of the valve 200 is approximately 0.508 cm.

The hose 158 is preferably substantially transparent while the valve 200 is preferably made of a suitable and clear plastic material and is preferably transparent.

A second piece of a flexible plastic hose 198 connects the outlet end portion 206 of the valve 200 to a suitable inlet connection 188 on the urine collector 190. As the urine flows downward through the outlet portion 206 of the valve 200 and fills the urine collector 190, entrapped air and other gases gradually separate and begin to collect. in the urine collector 190 and can eventually be taken out of the urine collector and ascend through the outlet hose 198 and interfere with the function of the flap valve 208.

Accordingly, the outlet portion 206 of the valve 200 is preferably provided with an aeration opening 244 to allow gas in the outlet hose 198 to pass through the wall of the valve 200. This valve vent 244 is also provided with and is covered by a hydrophobic filter membrane 246, which forms a liquid seal at this location. The second membrane 244 preferably consists of the same material as the first membrane 242 and has the same pore size as this. It should be mentioned that both of these membranes can either be insert-pressed during the manufacture of the inlet part 204 and the outlet part 206 to the valve 200 or alternatively be designed as part of a closing lid (not shown), which is inserted in the two ports 240 and 244. It will be appreciated that the hydrophobic filter vents 244 allow air to be discharged from the collection / bone bag 190 and thus allow a higher liquid level before a back pressure arises which impairs the proper functioning of the system, i.e. the entrapped air acts against the valve flap 210, so that this remains in the closed position, resulting in an impermissibly high column of liquid in the hose 158 and possibly a leakage of liquid from the urine collector 130. Although not shown, it has been found that a valve with a single downstream vent port, i.e. the vent port 244 with the hydrophobic filter membrane 246, works satisfactorily for the emission of air and other gases from the bag one, and due to the non-positive nature of the flap valve 10 15 20 25 30 35 'while the non-positive nature of the valve flap 312 459 469 25 208, a sufficient amount of ambient air is allowed to enter the system to partially cancel the vacuum state when the collecting device 130 abuts against the anterior and labial tissues. Such a construction would be identical to that described above with reference to the valve 200 but with the upper vent port 240 and its filter diaphragm 242 omitted.

The first embodiment of valve and filter (shown in Figs. 19-21), which has been described above, is only an example of valve and filter "in line", which can be used.

A second embodiment of such a filter provided with a filter is shown in Figs. 22 and 23. While the first valve, namely the inlet part 204 and the outlet part 206 can be pressed in a simple smooth shape with minimal side effect for the ports 240 and 244, the second embodiment according to Figs. 22 and 23 slightly higher tool cost due to the variety of details included. This embodiment of the valve 300 includes a main body 302 having an inlet end 304 which is suitably shaped to open towards the interior of the hose 158 and an outlet opening 306 which opens through an inclined seat 308. ' A flap valve 308 of substantially the same design as the flap valve 208 includes a valve flap 310 which abuts the seat 308 and covers the opening 306, a hinge 314 and an enclosing ring 316. The opening 320 forms in the body 302 a chamber which includes the seat 308 and is covered by a lid 322 with a flange 324 for engaging the edge ring 316 of the flap 310 to hold A side allowable to move freely to open and allow outflow through the opening 306. The main body has an outlet opening 330, which is designed to open against the outlet hose 198, which leads to the collection bag 190.

In this embodiment there is an aeration opening 332 on the upstream side of the valve 310, which port has a lid 334 provided with a heel, that one can insert a hyatophobic 1 filter 336, which fulfills the same function as the filters in the above ¿Similarly, a downstream located vent port 340 covered by a lid 342 with a similar hydrophobic membrane 344. described embodiments.

The function of this valve is substantially the same as that of the first described valve, when used in a system thereof in FIG. 18 showed the battle.

It will be appreciated that the flap valves 200 and 300 are only two embodiments of valves which are arranged to allow liquid flow in only one direction, as required by the present invention. Variations and modifications of flap valves of this kind are generally well known in the literature, but the use of such a valve with an aeration opening with a hydrophobic filter therein in the environment shown and described herein is not known in the literature. A system of the type described provides a gently acting mechanical aid for initial engagement with the anterior tissue and, after an initial urination, ensures a continuous sealing abutment against the anterior and labial tissues by maintaining the vacuum condition. The adverse effects of the vacuum condition are avoided by the aeration ports provided with hydrophobic filters, which reduce the feeling of discomfort but ensure a sufficient vacuum for the seal to be maintained. The system is economical to manufacture and reusable using general cleanliness and known techniques. The urine collection device can be sprayed by "Kraton" (registered trademark), manufactured by Shell Oil Company, of polyethylene and also by other spray-pressable, soft, rubber-like materials, which can feel comfortable.The valve elements can be sprayed by a variety of widely differing, against Although specific sizes have been specified for a urine collection device that can be used by the "normal adult woman", it is recognized that smaller sizes can be used by smaller women and that collection devices that have the same general proportions. but less length and width than the stated sizes develop for not yet adult women, ie teenagers, who suffer from incontinence.

Modifications and detailed changes can be made within the scope of the inventive concept.

Claims (5)

459 469 27 Patent claims A one-piece urine collection device for women, arranged to be placed inside the pubic folds and in contact with the anterior tissue around the urethral opening, characterized in that the device consists of a substantially ovoid-shaped, open cup-shaped container (12) with a cavity (16) and a cavity (16). substantially centrally located opening (18), which opens through the member and defines a vertical axis (20) through the member, the upper periphery of the member having a generally convex curved outside and a substantially continuous curved axis extending upwardly therefrom for defining the upper portions of the cavity of the member, the upper periphery and axis generally defining a pair of adjacent sealing surfaces (22, 24) and the member having a substantially elliptical cross-section in a plane perpendicular to the vertical axis (20). , and the sealing surface (22, 24) has a concave surface along the minor axis of the elliptical cross-section and the inner surface (22) of said adjacent surfaces is generally located further upwards in relation to an outer surface of these sealing surfaces for sealing and continuous contact and abutment against the labia and the anterior tissue. Urine collection device according to claim 1, characterized in that it is provided with an outlet channel (14), which merges with said member at its rear side and extends outwardly therefrom and communicates with the opening (18), and means for preventing the outlet channel from forming kinks. Collector according to claim 2, characterized in that the outlet of the drain channel includes a chamber (44), a transition part (42) and a hollow shaft (14), all of which communicate with the cavity (16) and together form the means for preventing kinking. Collector according to Claim 3, characterized in that the chamber (44) has a larger diameter than in transition, characterized in that the wall thicknesses of the chamber (44), the part (42), which in turn have a larger diameter than the shaft (14). Urine collection device according to claim 4, the transition part (42) and the shaft (14) are inversely proportional to the diameters, the wall thickness of the chamber being less than the wall thickness of the transition part, which in turn is less than the wall thickness of the shaft, so that Angular movements of the shaft (14) of up to 90 ° from the normal position cause a partial deflection of the chamber wall and the transition part but maintain an open bore in the shaft in connection with the chamber and the cavity.