EP4358908A1

EP4358908A1 - External device for urinary diversion

Info

Publication number: EP4358908A1
Application number: EP22822914.2A
Authority: EP
Inventors: Volker Lang
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-11-29
Filing date: 2022-11-28
Publication date: 2024-05-01
Also published as: WO2023094643A1

Abstract

The invention relates to an external device for urinary diversion for men, consisting of a condom catheter (18) and a holding device, the holding device consisting of a sheet-like curved element (1) and a round or elliptical ring (4) that is connected to the sheet-like element at an obtuse angle.

Description

External device for urinary diversion

The invention relates to an external device for urinary drainage for men consisting of a urinal condom and a holding device.

Unfortunately, urinary incontinence is also a widespread ailment in men. It is particularly common in old people due to a slackening of the sphincter muscle, after a stroke, in Parkinson's and Alzheimer's diseases, surgical interventions on the prostate and paraplegia in accident victims, to name just a few important examples. If at all possible, external urinary drainage methods with as few complications as possible, such as urinal condoms or urinary pads, should be given preference over invasive methods such as bladder or urethral catheters with their high infection and complication rates.

In the case of urinary incontinence in men, if there are no physiological or medical contraindications, the urinal condom is a very safe, simple and helpful method for external, hygienic drainage of the urine into a collection bag. phone The urinal condoms that are available today in different and optimized fitting sizes are primarily made of latex, synthetic plastic elastomer and silicone and are provided with a uniform adhesive layer that is rolled up directly on the skin of the penis and glued by pressing on it. The problem here is that adhesives are tolerated quite differently, especially with sensitive skin. Therefore, uncoated urinal condoms are also offered, which can be individually adapted and fixed to the skin with various adhesives or adhesive strips. However, all of these urinal condoms available on the market today are only designed for single use and continuous application times of 12 to a maximum of 48 hours.

Despite short application times, local problems such as premature detachment from the skin, urinary leakage and, above all, skin inflammation, fungal and bacterial colonization can occur. The non-physiological stress on the skin of the penis with urine and the necessary frequent changing of the urinal condoms always mean additional stress on the skin with an increased risk of inflammation, especially due to the detachment of the adhesive. In addition, there are significant costs.

Urinary condoms of the type described above are known, for example, from EP 1491170B1.

The object of the present invention is now to create an external device for urinary drainage for men consisting of a urinal condom for single and multiple use for external urinary drainage that does not require any adhesives to be fixed to the penis and can nevertheless be attached securely and tightly.

According to the invention, this object is achieved by an external device for urine diversion corresponding to the features of claim 1. For this purpose, the urinal condom is held by a holding device, which consists of a sheet-shaped arched element and a round or elliptically shaped ring, which is connected to the sheet-shaped element at an obtuse angle. By providing this device according to the invention, an external urinary drainage system can be created which meets the following requirements:

1 .The secure mechanical fixation on the penis without urine leakage, continuously over several days and intermittently over weeks and months, with high skin tolerance and without the use of skin adhesives;

2. Easy application and removal of the external urinary diversion device with minimal trauma to the penis and skin, e.g. removal of glue, a necessary shave of pubic hair or maceration by urine;

3. Prevention of urinary reflux into the urethra or urinary bladder;

4. simple bacteriological and hygienic control options and,

5. If possible, a reduction in maintenance and costs compared to the use of single-use items that are common today.

Advantageous configurations of the external device for urinary drainage for men result from the dependent claims that follow the main claim.

A holding device according to the invention for fixing a urinal condom in an external device for urinary drainage for men results from claims 12-14.

The external device according to the invention for urinary drainage for men is explained in more detail below with reference to exemplary embodiments illustrated in the figures. Show it:

FIG. 1: a perspective view of an embodiment of the holding device for a urinal condom from above, from the side and from the front; FIG. 2: a perspective view corresponding to FIG. 1 from the front, tilted forward and up,

Figure 3: an embodiment of the holding device according to the invention in perspective from the front, above and tilted to the right,

FIG. 4: an embodiment of the holding device according to the invention in perspective from the front, above, slightly tilted forward,

FIG. 5: perspective view from above of the stretched penis and the glans with the holding device with the prepuce pulled back, covered by the urinal condom and with the urinal condom wall partially unrolled;

FIG. 6: in perspective from the left, from the side, the stretched penis and the glans with the holding device with the prepuce pulled back covered by the urinal condom and the partially unrolled urinal condom wall;

FIG. 7: in perspective, from the front left and from the side, an auxiliary application device with an adhesive-free urinal condom;

FIG. 8: a further embodiment of the holding device according to the invention from the front left and from above;

FIG. 9: a third embodiment of the urinal condom holding device in perspective from the front left and above; and

FIG. 10: a fourth embodiment of the holding device in perspective from the top left, tilted forward.

The holding device shown in Figure 1 consists of a sheet-like shaped pipe segment 1 with its convex back 2 and a concave inner side 3, which on both sides at the lower ends with a wide ring 4 under Forming an angle of about 120 ° on thinned material bridges 5, which act as a hinge, are connected. Ring 4 is still divided at the front. The left ring half 6 has a bore in which a closure cord 8 is fixed. The right ring half 9 shows the cord end 10 pulled through the bore 12.

In FIG. 2 one can see the concave inner surface 3 and the thinned material bridges 5 on both sides, the right ring half 9 and the left ring half 6 of the ring 4, which are rounded at their ends. A gap 11 is formed between these ends. Furthermore, the closure cord 18 fixed in the bore 7 and pulled through the hole 12 is shown with its end piece 10 .

In FIG. 3, as illustrated by the direction of the arrows 13 and 14, the two ring halves 6 and 9 are folded apart manually due to their possibility of movement by the parts 5 acting as hinges on both sides. A long closure strap 15 forming a kind of gate is provided here. Arrow 16 shows how the glans penis can be pushed into the ring 4 . After positioning the penis in the area, the ring can be adjusted to the outer contour of the penis by tightening the locking strap. Here, according to FIG. 4, it is shown how the two ring halves 6 and 9 are connected to one another via the fastening strap 15 up to a narrow gap 11.

FIG. 5 shows how the holding device is arranged on the extended penis and glans. The urinal condom 18 with an outlet nozzle 19 with a partially unrolled wall 20 that forms a sealing bead and connects the urinal condom holding device with its two ring halves 6 and 9 by the fastening strap 15 is clearly visible. The glans penis 21 with its urethral opening 22 is inserted into the urinary condom in such a way that a buffer area 23 is also formed. The body of the penis 2 and the Sulcus Coronarius Glandis 27 are exposed through the retracted foreskin 24 . The ring halves 6 and 9 and the bead 20 of the urinal condom are snapped in there. In FIG. 6 one can see the convex side 2 of the leaf-shaped curved element 1, under which the frenulum preputii 26 comes to lie on the non-visible concave surface 3 of the element. Clearly shown is the right ring half 6 of the retaining device and the bead 20 snapped into the sulcus coronarius gland 27 and onto the shaft of the penis 25.

In FIG. 7 one sees the partially unrolled, non-adhesive urinal condom with its bead 20 which is placed under tension on a wide, cylindrical, thin auxiliary ring 28 which has a larger diameter than the urinal condom. The insertion funnel 29 formed and the inlet 30 to the outlet connection 27 are clearly visible.

In the holding device shown in FIG. 8, the ring parts 6 and 9 form an elliptical cutout 32 on the inside. Also clearly shown is a movable locking clip 33 which can engage in a slot 34 in order to close the ring. All parts are made here, for example by injection molding, from a soft elastomer, preferably silicone

In the further embodiment according to FIG. 9, the ring parts 6 and 9 of the holding device 4 have a thin, approximately 10 mm raised edge 35, 36 which is arcuate. Furthermore, a bracket 33 with an associated slot 34 is designed as a closure. For an even better hold and increased tightness, the ring 4 can also be provided on the outside with a strip-shaped pressure-sensitive adhesive layer with a protective film. Here, too, all parts are produced from a soft elastomer, preferably silicone, for example by injection molding

In FIG. 10, the aforementioned embodiments are advantageously combined. The embodiment of the holding device shown in FIG. 10 is produced from a soft elastomer, preferably silicone, for example by injection molding. Here it is clear that a spherically indented floor 37 is formed by four segments, a, b, c and d, which as such are divided and thus do not form a completely closed floor. The respective segments are hereby movably connected in the region of the edge of the ring, designated 38 here. In addition, a thin-walled edge 39 that is raised by about 10 mm, for example, is provided, which in its rear part is continuously connected to the sheet-like element 3 on both sides (cf. reference number 40). To apply the holding device, it is applied under tension to the ring 28 of the application aid in such a way that the four segments a, b, c, d of the base lie folded up on the ring and part 39 above them. In this position, the urinal condom The holding device is brought over the glans and there, after anatomically correct positioning, is manually pushed off the ring 28 and snapped into the Sulcus Coronarius Glandis.

The application and function of the external urinary diversion device with the holding device for urinary condoms for adhesive-free, urine-tight long-term fixation is described below.

As shown above, the external urinary diversion device consists of two parts - on the one hand the holding device for urinal condoms and on the other hand the application aid with adhesive-free urinal condom.

The external urinary diversion device is now attached to the stretched penis and glans as follows (however, attachment to the penis is not possible if the foreskin is narrowed). After choosing a tight-fitting size of the non-adhesive urinal condom with application aid and the appropriate holding device, the foreskin (prepuce) is carefully pulled back as far as possible and the glans penis and the urinal condom holding device are put on. For this purpose, the glans and penis are inserted into the manually opened ring halves 6 and 9 (see Figures 3 and 4) of the holding device until the inside 3 of part 1 extends over the frenulum preputii, its root and the recessed area 26 (see Figure 6). lies. Now the two ring halves 6 and 9 are joined manually with the help of the closure strap 15 to form the ring 4 which, if correctly positioned, will lie in the sulcus coronarius glandis 27 and on the body of the penis 25 (see Figure 6). The protruding closure strap is now cut off. Now the non-adhesive urinal condom can be applied with the auxiliary device. To do this, the insertion funnel 30 of the urinal condom is pressed manually onto the tip of the glans and the urinal condom with the auxiliary device is pushed forward onto the glans body 21 and over the special urinal condom holding device and finally the ring 20, which is under tension, is manually pushed off and used as a holding and sealing ring snapped into the sulcus coronarius glandis 27 on the body of the penis 25. Thereafter, the foreskin 24 can be easily advanced over the ring 20 and urinary condom.

If the urinal condom needs to be changed after a few days for hygienic reasons, this can be done very easily. After the foreskin has been pulled back as far as possible, the retaining sealing ring 20 is now slightly lifted from its base and separated, for example with scissors, with an unobstructed view. After that, the urinal condom can be easily pulled off.

The fixture may stay in place for weeks, especially if it has an antibacterial coating such as silver. If the holding device has to be removed for medical reasons, for example in the case of an allergy or a bacterial, local inflammation, this can be done in a simple manner. The closure of ring 4, for example a cord, strap and the like, can be opened by cutting it with scissors. Thereafter, the semi-circular parts 6 and 9 of the ring 4 can be pulled apart. It is even easier with a closure using a folding bracket. After ring opening, the holding device can be easily pulled off the glans penis.

The external male urinary diversion device according to the invention has the following advantages:

1 . no stress on the skin of the penis due to direct urine contact: a. by enclosing the glans penis in a urine-tight manner with the urethral opening opening directly into the outlet funnel of the urinary condom of the external urinary diversion device. b. with the help of the holding device optimally adapted to the glans with protection for the glans penis, not only tightly and tightly enclosing, glueless urinal condom, but also through its partially unrolled wall formed into an elastic sealing ring and holding ring in cooperation with the ring of the holding device as an abutment. No skin glue required for mechanical, leak-free fixation. There is no stress on the skin of the penis when the adhesive connection is loosened (mechanically or by chemical solvents, when shaving off hair and when changing external urinary drainage devices). Automatic, springy-elastic adjustment to the changed diameter of the penis, e.g. during a nocturnal erection. Minimization of bacteriological-hygienic problems: a. by avoiding injuries to the skin of the penis, for example when changing the external urinary diversion device, when shaving off hair and, above all, maceration of the skin as a result of exposure to urine; b. by no restrictions on daily intimate hygiene. Manual easy change of the urinal condoms and the holding device. With good hygiene, it is only necessary to change the fixture after days or even weeks, especially when using a fixture with an antibacterial silver coating on the surface. With very high mechanical loads in everyday life, special forms of the holding device with adhesive coating and protective film from the holding ring are possible.

Claims

Claims External male urinary diversion device consisting of a urinal condom and a holding device, characterized in that the holding device consists of a sheet-shaped curved element and a round or elliptical-shaped ring which is connected at an obtuse angle to the sheet-shaped element. Device according to Claim 1, characterized in that the round or elliptical ring is connected to the sheet-shaped arched element via a hinge-like thin, resilient bridge. Device according to Claim 1 or 2, characterized in that the obtuse angle is 110° - 130°, preferably approximately 120°. Device according to one of Claims 1 to 3, characterized in that the round or elliptically shaped ring is divided and can be closed via a closure element connecting the two parts of the ring. Device according to Claim 4, characterized in that the closure element consists of straps, cords or clips. Device according to one of the preceding claims, characterized in that the round or elliptical ring has lateral raised edges. Device according to one of the preceding claims, characterized in that the round or elliptical ring has a number of segments which can be easily folded upwards from their basic position and form an almost spherically pressed-in base in their non-deflected position. Device according to one of the preceding claims, characterized in that the urinal condom has an outlet nozzle and a rollable wall. Device according to one of the preceding claims, further characterized by an auxiliary device for applying the urinal condom consisting of a cylindrical, thin-walled ring onto which the urinal condom can be applied in such a way that its partially unrolled wall is applied to the ring as an elastic annular bead under tension. Device according to the preceding claim, characterized in that the circular or elliptical ring is made of elastic plastic. po device according to one of the preceding claims, characterized in that the holding device is made of an elastomer, preferably silicone, by injection molding. Holding device for fixing a urinal condom in a device according to any one of the preceding claims, characterized in that it consists of a sheet-shaped arched element and a round or elliptical-shaped ring which is connected at an obtuse angle to the sheet-shaped element. Holding device according to Claim 12, characterized in that the surface has an antibacterial coating. Holding device according to Claim 13, characterized in that the antibacterial coating consists of vapor-deposited or galvanically applied silver.