DE2742298A1 - DEVICE FOR MALE INCONTINENCE PATIENTS - Google Patents

Description

TlEDTKE * BüHLING "KlNNE - Patents wanted:

Dipl.-Ing. H. Tiedtke Dipl.-Chem. G. Bühling Dipl.-Ing. R. Kinne Dipl.-Ing. P. Grupe

Bavarlaring 4, Postfach 20 24 (8000 MQnchen 2

Tel .: (0 89) 53 96 53

Telex: 5-24845 tipat

cable: Germaniapatent Munich

September 20, 1977

B 8461

case J.13541

Incom Medicals Limited Manchester, England

Device for male incontinence patients

The invention relates to a device for male incontinence patients. The invention also relates to a method of manufacturing an embodiment of the device.

There are approximately three million incontinence patients in the British Isles, 75% of whom are male. That The main problem for these patients is a lack of muscle control and a lack of control over the muscles Sphincter, which controls the flow of urine from the bladder. This can be a permanent or a temporary state, the

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usually occurs in adult or elderly male patients. Because the urine is not like normal body function can be stored in the bladder, it emerges through the tenis immediately after its formation. This brings the Patient embarrassed and causing considerable difficulty for caregivers in a bedridden patient, as bed linen, mattresses and the like have to be changed frequently.

There have been a number of devices for overcoming these problems for many years. The first is an inner one Catheterization, in which an inner catheter is passed down the urethra into the bladder, which is connected to a urine collection container or drain container is connected. This can be used for short-term patients such as post-operative or distress conditions may be useful, however, long-term internal catheterization causes pain, infection can be of the bladder and seriously reduces the patient's mobility. The catheterization is therefore normally to be considered in a completely bedridden patient and then only for a short period of time.

A second commonly used method is the use of a sheath or a sleeve that is in the

, ς form of complete equipment made of heavy rubber or similar material is made. Equipment of this type usually consists of a large-sized envelope that fits most patients regardless of height. Usually this equipment is made by means of a complicated one Arrangement of straps or straps kept in a position, which are very cumbersome and their filing takes several minutes requires. This equipment or device is provided with its own bag, also made of rubber and therefore heavy and uncomfortable; the equipment may make it necessary to wear special undergarments to ensure that they

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remains in the correct position. A major factor against using this equipment or apparatus is: that a reflux of urine along the skin surface of the The penis can leak, causing infection and causing severe and painful rashes that continue through the Urine become irritated. The large size of this equipment also makes it less safe and worse is adaptable to individual patients.

Another solution developed in recent years is the use of a detachable cover similar to a condom with a urine outlet at the end. This outlet is also normally connected to a urinary bag or container. The main disadvantage of this device lies in the fact that, despite its light weight, a reflux v ^ n urine along the skin surface is possible. The device is susceptible to rupture and rupture through which urine can leak. A trinot tape, plastic tape or some such means is usually necessary to hold them in place, or a strip of adhesive plaster is used for this purpose. Again, long-term patients often suffer from skin infections and rashes. The main disadvantage of tape attachment is that it creates an obstruction in the supply of blood to the penis, resulting in pressure necrosis and disruption of the surface blood supply. This can be very risky. Further, this device has a problem of size in that it is practically impossible to make the device fit all patients although it is made in small, medium and large sizes.

The invention is based on the object of creating a device for male incontinence patients which avoids the disadvantages mentioned above.

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This object is achieved according to the invention in that the device for male incontinence patients has a sheath which fits over the penis and which has an outlet for emptying the urine into a container, the envelope having an inflated or inflatable flexible collar or Ring that presses against the penis, preventing urine leakage and holding the device in place is supported in their position.

In this way it is possible to create complicated tapes or Carrying straps, holding or tensioning straps, plastic straps or Adhesive plaster strips to make the known ones unnecessary Devices are used. It will be understood that because of the flexibility and inflatable waistband of the

Pressure required to hold the device in place, is exercised uniformly over a substantial area of the penis, thus improving comfort and unnecessary obstruction to blood circulation is avoided.

Furthermore, the inflatable waistband forms an effective seal that prevents leakage and unnecessary urine Prevents contact with the skin. It is also advantageous that the devices according to the invention are particularly light and can be applied and removed quickly, without such a heavy burden on the patient as some of the existing ones Devices need to be formed and made available in only one size suitable for all patients is.

The collar is advantageously formed by a flexible insert or cover part, which has an inner wall of the Shell is connected so that an inflatable annular chamber is formed between the shell and the flexible insert part. That The flexible insert preferably extends over a substantial part of the length of the sleeve to allow pressure to be applied

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any point is minimized and the area of skin that is available for contact with is reduced the urine is exposed. All parts of the envelope can be flexible and are preferably made flexible; the insert or the insert is, however, preferably more flexible than the adjoining part of the casing, so that this is ensured becomes that the covenant is inflated more inward than outward.

The device preferably has an inlet conduit through which air or other fluid enters the inflatable Fret can be pressed. This line can advantageously be equipped with a one-way valve. Attaching a However, inlet conduit is not essential. For example, it would be possible to inflate the covenant that through the wall air is introduced through the sheath using an injection cannula. In this case the wall would be off to produce a rubber or similar material that is sufficiently elastic that after removal of the Cannula to seal the remaining hole. In another embodiment the device according to the invention, it is possible to keep the federal government partially inflated at all times. In this If it is necessary to provide some device to reduce and increase the size of the inner cavity of the collar, to increase or decrease the pressure when attaching or removing the device.

The entire device, with the possible exception of the one-way valve, is preferably made of a single part molded from elastically deformable material such as soft rubber. This enables the production of a hygienic one and easy to sterilize device by means of a simple manufacturing process.

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In an advantageous manufacturing process, one brings liquid rubber, or gum milk on a suitably shaped mandrel and leaves it to form a first rubber layer set or harden. A non-stick or repellent material is then placed around the mandrel over the first layer applied in an area in which the inflatable waistband is to be formed. After attaching a suitable molding A second layer of the liquid gum or gum milk is applied in a position for the configuration of the inlet line. After the entire device has set, it can be pulled off the mandrel.

The invention is explained in more detail using an exemplary embodiment with reference to the drawing.

The device shown is made of soft rubber and has a sheath 1 which has an opening at one end through which the penis is inserted. The other end has an outlet conduit 3 which, in use, connects to a tube leading to a urinary container (not shown) that can be carried by the patient, or if so is bedridden, can stand freely.

A flexible tubular insert or collar 4 approximately 2.5 cm in length extends over a substantial part Part, namely almost half of the length of the shell and is connected at its edges to the inner wall of the shell, that an annular space or an annular chamber 5 is formed between the shell and the collar. This annular Chamber 5 for inflating or inflating the covenant can be via an air inlet line 6, which receives a one-way valve 7, be filled with air.

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The one-way valve 7 has a plastic housing 8 which has an inlet 9 and an outlet 10 and in which a valve member is contained in the form of a ball 11, which by means of a Spring 12 is pressed against a valve seat 13. Outer ribs 14 ensure that the valve does not come out of the inlet pipe slips out.

All parts with the exception of the one-way valve 7 are molded in one piece from soft rubber. It can be seen that the part of the envelope adjoining the insert or the collar 4 is relatively thick. This is necessary to ensure that the inflatable waistband is inflated inward rather than outward.

To attach the device to a patient, the penis is inserted through the opening 2. The mouth of a 5 ml injection syringe (not shown) is then inserted into the valve inlet 9 and pushes the ball off the valve seat 13. The mouth of the syringe seals against the sides ^there d inlet 9 so that the syringe is pressed into the annular air chamber 5 upon pressing of the piston. The collar formed by the insert 4 is inflated in this way and holds the device in place while at the same time forming an effective seal against leakage of urine and preventing unnecessary contact of the urine with the skin. Then the syringe can be removed, after which the valve organ seals against the valve seat 13 and prevents the escape of air. The urine outlet line 3 is connected to a pipe which leads to a container. For outpatients, this can be a leg bag, which is a plastic bag usually strapped to the patient's thigh with soft rubber bands. In the case of a bedridden patient, the container can be a collecting container attached to the bed.

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To put down the device, the syringe is used in a similar manner to draw off the air, whereby the Bund is emptied.

It can be seen that the device shown can be used in different ways without deviating from the principle of the invention can be modified. For example, all parts with the exception of the insert or the collar 4 can be made of solid material be made. Furthermore, instead of molding all rubber parts in one piece, the collar 4 and the inlet duct 6 manufactured separately and then glued in place. Alternatively, instead of using rubber, any soft plastic material with similar properties be used. However, the device shown has proven to be particularly advantageous, is durable and light and can be used repeatedly after cleaning, for example with boiling water. Since the annular air chamber 5 in the inflatable waistband is completely segregated from the interior of the envelope, it does not need to be cleaned. By the length of the waistband of about 2.5 cm will reduce the point pressure, while the rubber has good frictional resistance results, by which the removal of the device is prevented. The device eliminates the need to use bands, special ones Underpants or a harness. The device can be put down in seconds. The device can easily be used by the patient be filed if necessary. A major advantage of the device is that the inflatable waistband is efficient prevents the reflux of urine, thus reducing the risk of infection and irritation.

With the invention, a device for male urinary incontinence patients .ι the type is created that has a shell which fits over the penis and which has an outlet for the drainage of urine into a receptacle. The shell will held in place within the envelope by means of an inflatable collar. When inflated, the waistband expands

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inward and serves to hold the device in place and prevent urine leakage.

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Claims (9)

Claims Apparatus for male incontinence patient, characterized by a sheath (1) which fits over the penis and an outlet conduit (3) for discharging urine into a container _for said sheath an inflated or anfblasbaren flexible collar (4) which presses against the penis, preventing urine leakage and holding the device in place. 2. Apparatus according to claim 1, characterized in that the collar is formed from a flexible insert (4), which is connected to a wall inside of the shell (1), an inflatable ring-shaped between the shell and the insert Chamber (5) is formed. VI / 13 809812/0981 £ β 2 ^ 42298 3. Apparatus according to claim 2, characterized in that the annular chamber (5) has a substantial Part of the length of the sheath (1) extends. 4. Apparatus according to claim 2 or 3, characterized in that the flexible insert (4) is more flexible than the adjacent part of the wall of the shell (1). 5. Device according to one of the preceding claims, ^ O characterized by an inlet line (6) for inflation of the federal government (4). 6. Device according to one of the preceding claims, characterized by a one-way valve (7) through which the Bund (4) is inflatable. 7. Device according to one of the preceding claims, characterized in that it is made in one piece from flexible material is made.
20th 8. Device according to one of the preceding claims, characterized in that it. Made of elastically deformable Material is made. ■> 9. A method for producing the device according to claim 2, characterized in that setting material is applied to a mandrel to form a first layer, that non-adhesive material is applied to the material around the mandrel at a portion where the annular chamber is to be formed , and that another layer of the setting material is applied over the mandrel. 809812/0981