Abstract:
The present invention relates to a device and method for managing uncontrolled urine release in females. The device is flexible and is worn externally on the vaginal area. This external device may further be attached to a urine collector, such as a bladder bag, and may be worn by a female person while standing, walking, sitting, or laying down. This external urine drainage device is comfortable and easy to use, avoids soiling of the laundry when worn correctly, runs a low risk of causing urinary infections or skin irritations, and is easily washable and re-usable.

Description:
FIELD OF THE INVENTION  
         [0001]    The invention concerns a device for the drainage of uncontrolled urine release in females.  
         BACKGROUND OF THE INVENTION  
         [0002]    Lack of urinary control (incontinence) is an ailment which affects a large number of adults in varying degrees. Solutions to managing uncontrolled urination, however, are limited. For some people, certain prescription medications assist in bodily control of urine release. In cases where medications do not work, are impracticable, or are only partially successful at controlling urine release, either a catheter is inserted into the bladder to drain the urine into a collection receptacle, or the incontinent person is diapered.  
           [0003]    Both catheter use and diapering have disadvantages. The insertion and removal of a catheter requires skill and is most commonly performed by a medical practitioner, requiring a person to remain in a hospital, nursing home, or other managed care setting. Catheters have to be removed and replaced approximately every five days resulting in high costs for people who rely on permanent assistance with urine drainage. Catheters are uncomfortable and the continuous insertion and removal of catheters irritates the urethra and may cause strictures and abscesses to form. Furthermore, catheters run a risk of causing urinary tract and bladder infections. Such infections are dangerous and can even become life threatening in an aging or feeble person.  
           [0004]    Diapers, on the other hand, require changing approximately seven times per day also resulting in high costs. Many diapers can be seen through clothing, are bulky and uncomfortable for the wearer, and have the potential for leakage thereby soiling the wearer&#39;s clothing. Furthermore, because urine is alkaline, continuous contact between the delicate skin of the genital area and a urine soaked diaper leads to various rashes, skin maceration, and in extreme cases, formation of ulcers.  
           [0005]    A need, therefore, exists for a new option for managing uncontrolled urine release which is inexpensive, runs a low risk of causing infections or skin irritations, and is comfortable for a person to use.  
         SUMMARY OF THE INVENTION  
         [0006]    A device for the drainage of urine release in incontinent females is disclosed. The device comprises a hollow body, a drainage spout, a rim, and a fastening body, wherein the device is worn externally of the female&#39;s body. A method for using this device is also disclosed.  
           [0007]    The hollow body of the device may comprise a floor section, two side walls, a front wall, and a rear wall, wherein the two side walls, the front wall, and the rear wall are integrally connected with the floor section. The fastening body of the device may comprise a flange such that the rim is shaped to encompass the female&#39;s vaginal area and the flange protrudes outwardly from the rim. The fastening body of the device may further comprise a flap attached to the front wall, and a flap attached to the rear wall, each flap having a distal end comprising a fastening element. Methods for using any of these devices are also disclosed.  
           [0008]    An advantage of the of the present invention is that it provides an external urine drainage device for females which is comfortable and easy to use, avoids soiling of laundry when applied correctly, runs a low risk of causing urinary infections or skin irritation, provides the wearer with a large range of mobility, and is re-usable.  
           [0009]    The urine drainage device for females of the present invention is made from a flexible material in the shape of a hollow body. The hollow body comprises a drainage spout at its distal end and a rim designed to encompass the vagina at its proximal end. The device further comprises a fastening body at its proximal end to connect the device to a holder, such as a hip belt, the waist line of a pair of pants, skirt, tights, underwear, or any other object which will hold the device appropriately in place when worn by a patient. Alternatively, the fastening body may be designed so that it functions as a holder on its own.  
           [0010]    When the device is worn, the device is guided between the thighs to mold it against the pelvic bone and to encompass the vagina, and the fastening body is attached to a holder or is worn directly by the wearer. The drainage spout is connected to a bladder bag or other appropriate urine collector either directly or through a flexible tube. Once the device is on the wearer, it can be worn not only while bedridden, but also while standing, walking, or sitting.  
           [0011]    The urine drainage device of the present invention is both environmentally friendly and re-usable. It can be washed on a daily basis in warm to hot water either by hand or in a washing machine. Simple washing with or without a mild soap or detergent prevents the formation of biological or crystalline deposits on the device and helps reduce the risk of infection and/or skin irritation.  
           [0012]    Other advantages and embodiments of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention. 
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0013]    The design of the urine drainage device is explained in detail by drawings, showing:  
         [0014]    [0014]FIG. 1 A urine drainage device of the present invention as seen from a perspective from below.  
         [0015]    [0015]FIG. 2 A urine drainage device of the present invention as seen from a perspective from above.  
         [0016]    [0016]FIG. 3 A urine drainage device of the present invention as seen from a lateral perspective.  
         [0017]    [0017]FIG. 4 A cross-section view A-A of FIG. 1, respectively FIG. 2.  
         [0018]    [0018]FIG. 5 The detail from FIG. 3 marked by circle B. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0019]    As embodied and broadly described herein, the present invention is directed to a novel system for managing uncontrolled urination (incontinence) in females. The present invention is particularly directed to washable and re-usable external devices which can be comfortably worn by female subjects and which avoid soiling of laundry, run a low risk of causing urinary infections or skin irritation and allow a female subject to remain mobile while wearing the device.  
         [0020]    As depicted in FIGS.  1 - 5 , the urine drainage device of the present invention comprises a hollow body  10 . The hollow body  10  is preferably elongated and may be any appropriate shape to fit comfortably and securely around the vaginal area. The hollow body  10  may be made of any appropriate material which allows it to be comfortably worn by a female patient. Hollow body  10  is preferably made of a flexible, durable, and washable material such as, but not limited to, silicone-based materials, rubber or plastic.  
         [0021]    In a preferred embodiment, hollow body  10  is shaped like a small bathtub, having a rounded off floor section  11  with a slightly larger, rounded off front wall  15  and a slightly smaller, rounded-off rear wall  16  opposite, connected by side walls  13  and  14  which are molded and rounded off into the floor section  11 . Further in a preferred embodiment, side walls  13  and  14  converge slightly toward the smaller rear wall  16 .  
         [0022]    The device of the present invention further comprises a drainage spout  12 . The drainage spout  12  may be located anywhere toward the distal end of the device where drainage of urine through drainage spout  12  is facilitated. Preferably, drainage spout  12  is located on the lowest point of hollow body  10 . In a preferred embodiment, there is a funnel-shaped opening at the transition of smaller rear wall  16  forming a drain ending to which the drain spout  12  is attached. When the device is worn, its floor surface is thus tilted toward the drain which guarantees the complete emptying of the drainage device.  
         [0023]    The urine drainage device of the present invention further comprises a rim  17  which is attached to hollow body  10  and is shaped to encompass the vagina. In one embodiment, hollow body  10  is molded at its top to form the rim  17 . In a preferred embodiment, front and rear walls  15  and  16  and the two side walls  13  and  14 , end at the same level in a rim  17 .  
         [0024]    The rim may be specifically designed to connect with an opening in specifically adapted tights or underwear which may be worn together with the device. In a preferred embodiment, below the rim  17  on the outside of the side walls  13  and  14  extends a support  19  to fit the outline of an opening in specifically designed tights or underwear.  
         [0025]    The device further comprises at least one fastening body attached to the rim  17 . The at least one fastening body may be any type of system of elastics bands, cloths, underwear shaped attachments, or any fastening system which holds the urine drainage device in place during wear. In one embodiment, the rim  17  extends into a lateral, outward-facing flange which forms part of the at least one fastening body. The flange may be molded from the same material as hollow body  10 . The flange preferably covers the entire circumference of the rim and is designed to provide a seal against both thighs when worm. The flange is preferably designed to provide a watertight seal for the urine drainage device.  
         [0026]    In a further embodiment, a flange may be split by basically vertical incisions towards the rim  17  into separate flange elements  28 . The flange elements  28  may cover the entire circumference of the rim  17  with the exception of the centers of the front and rear walls  15  and  16 . The flange elements  28  provide an improved molding to the skin and body shape of the wearer beneath the crotch curvature while avoiding overlap between segments which could cause some discomfort. In a preferred embodiment, each flange element comprises a plurality of holes  29 . The holes reduce skin contact while simultaneously improving adhesion and permitting ventilation.  
         [0027]    Further in a preferred embodiment, flaps  20  and  22  are molded onto hollow body  10  and separated by incisions  27  from their neighboring flange elements  28 . As depicted in FIG. 3, band-shaped flap  20  is flexibly molded to shape itself comfortably to the pelvic bone  30 . Flap  20  may protrude up from rim  17  to elevate the hollow body  10  above the skin. Being thus elevated reduces skin irritation by avoiding urine contamination in the region of the vaginal dam.  
         [0028]    In a preferred embodiment, flap  22  protrudes from the smaller rear wall  16 , as seen in FIGS. 4 and 5, and consists of an upward-pointing first section  24  which goes over into a second section  25 , consisting of a three-walled tunnel profile, whose open side faces drain spout  12 . The first section  24  is formed by and incorporates the body-facing wall of the tunnel profile in section  25 . As depicted in FIG. 3, section  24  of flap  22  takes a sealing position against the vaginal dam  34  of the wearer while the second section  25  with its tunnel profile fits into anal crevice  32 . The shape of a tunnel profile results in a good fit in the anal crevice. Flaps  20  and  22  are preferably made of the same material as hollow body  10 , and comprise at least one fastening element  21  at their far ends. The at least one fastening element  21  may be any system of snaps, buttons, hook and loop fastening material (such as VELCRO), or any other appropriate system or combination thereof  
         [0029]    The vulva  31  as shown shaded in FIG. 3 is situated inside hollow body  10 , whose floor section  11  is slightly tilted toward drain spout  12  situated at its lowest point when hollow body  10  is positioned on the wearer by flaps  20  and  22 . In a preferred embodiment, at the larger front wall  15  where band-shaped flap  20  protrudes on the side of the pelvic bone, there is a centrally positioned ventilation opening  18  slightly below support  19  to ventilate the interior of hollow body  10 . The distance of opening  18  to the support rim  19  is calculated to avoid both contact against pelvic bone  30  which would prevent its proper functioning when the urine drainage device is worn, and urine leakage through the height of opening&#39;s position. This opening  18  allows damp air to escape thereby reducing the risk of skin rashes, and improves the draining of urine into the drainage spout by relieving and vacuum formation within hollow tube  10 .  
         [0030]    The urine drainage device may be put on by a wearer by attaching the fastening body to some type of holder, like a belt, pant or skirt waistline, or any other appropriate object which facilitates holding the device in place. If the fastening body of the urine drainage device is designed to incorporate its own holder, the device may simply by put on and then adjusted to ensure a proper seal with the vagina.  
         [0031]    In a preferred embodiment, the urine drainage device is attached to a hip belt by at least one fastening element  21  on each of flaps  20  and  22 . The hip belt may be put on the wearer at the height of the 3rd or 4th loin vertebrae. The urine drainage device is held between the wearer&#39;s legs by the band-shaped flap  20  and guided on the side of the pelvic bone fastened to the hip belt by fastening device  21  of flap  20 . The flange elements  28  position themselves as drawn shaded as Position  28  in FIG. 4 to lie next to each other with a sealing function against the skin  33 . The upward facing first section  24  of the tunnel-shaped flap  22  facing the vaginal dam lies in a sealing capacity between neighboring flange elements  28  against the vaginal dam  34 , while the second section  25  with the tunnel-shaped profile extends into anal crevice  32  and, being flexible, adapts its shape to the width of the anal crevice.  
         [0032]    Band-shaped flap  20  rests against pelvic bone  30 , while the vulva  31  with the urine exit is situated inside the space of hollow body  10 , whose rim forms a seal against the skin. This way, urine released into the hollow body  10  can drain easily through the drainage spout  12 .  
         [0033]    The urine drainage device of the present invention may be attached, via the drainage spout  12 , to a urine collector, such as a bladder bag, preferably worn on the leg. Drainage spout  12  may be attached directly to a urine collector or it may be attached through a flexible tube.  
         [0034]    The measurements of the urine drainage device correspond to the average measurements of the corresponding body area of the wearer. Larger or smaller sizes can be produced for which fastening elements  21  can easily be lengthened or shortened as required. The urine drainage device can be molded in one piece (i.e., integrally molded) from the same flexible material, preferably silicone-containing materials. Silicone is a very flexible and elastic material, very skin-friendly, unaffected by contact with body fluids, and easily and completely cleaned by hot water.  
         [0035]    Other embodiments and uses of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. The specification and examples should be considered exemplary only with the true scope and spirit of the invention indicated by the following claims. As will be easily understood by those of ordinary skill in the art, variations and modifications of each of the disclosed embodiments can be easily made within the scope of this invention as defined by the following claims.