Patent Document

CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of, and claims the benefit of, U.S. application Ser. No. 12/570,188, filed Sep. 30, 2009, currently pending. 
     
    
     TECHNICAL FIELD 
       [0002]    This description relates to absorbent devices, particularly to devices for absorbing urine discharge resulting from male urinary incontinence. 
       BACKGROUND 
       [0003]    Urinary incontinence may be caused by a variety of factors. It can occur, in varying degrees, in infants not yet toilet trained, young children suffering from nocturnal enuresis (bed wetting), men who have undergone a prostatectomy (surgical removal of the prostate) or other urinary tract surgeries, such as a cystectomy (surgical removal of the bladder), in diabetics with nerve damage, and in those who have had a stroke or spinal cord injury or who suffer from Parkinson&#39;s disease or multiple sclerosis. Aging is also a leading cause of incontinence. Other causes include loss of control from such actions as coughing, sneezing, and lifting, and an abnormal and overwhelming urge to urinate caused, for example, by various bladder conditions such as exposure to radiation therapy. Finally, those who are handicapped or otherwise medically compromised may have problems with incontinence. Urinary incontinence can be more than an inconvenience and an embarrassment, it can cause discomfort from being in wet or damp clothing as well as genital itching or a rash or infection caused by contact with discharged urine. 
         [0004]    Conventional absorbent devices to help manage urinary incontinence include those which are positioned beneath undergarments and next to the genitals. Discharged urine is retained within an absorbent layer while a moisture barrier layer is interposed between the retained urine and the undergarments and other clothing. In this way, discharged urine is retained and not allowed to leak onto, or otherwise soil, clothing. In addition, the anxiety and potential embarrassment of being seen with soiled clothing is avoided. The used absorbent device is then later disposed of at an appropriate time. Such devices include diapers, which enclose the genitals, perineum, and buttocks, and pads, which enclose only the genital region. 
         [0005]    While such absorbent devices may be effective in absorbing urine and preventing soiled clothing, a bulky or protruding appearance may call attention to the problem, the genitals may be allowed to come into contact with discharged urine and may become too warm, with resultant discomfort and the chance of rash or infection, and, the device may cause further discomfort by not remaining in place while allowing the wearer to move about freely and engage in normal daily activities. 
         [0006]    Thus, there is a need for a urinary incontinence device that is not only effective, but that fits the genital anatomy comfortably, particularly the male genital anatomy, allows sufficient freedom of movement to permit normal daily activities, may be worn discretely, and that helps the genitals from becoming too warm and helps prevent the genitals from coming into contact with discharged urine. 
       SUMMARY 
       [0007]    Devices of the present invention help prevent soiling of clothing with discharged urine, provide comfort to the genitalia particularly the male genitalia, allow sufficient freedom of movement to permit normal daily activities, and help separate the genitalia from discharged urine, thus providing a more natural feel. In one embodiment, a male urinary incontinence device includes a body which has a shell which forms a cavity adapted to hold male genitalia. Disposed within the cavity is an absorbent suitable for absorbing and storing discharged urine. A moisture barrier adjacent the body and placed between the absorbent and the clothing of the wearer to help prevent soiling of the clothing. A liquid-permeable liner is attached to the body so as to provide a gap between the liner and the absorbent. This hammock-like effect creates an air space and holds the male genitalia away from the discharged urine stored in the absorbent. When necessary, the device is removed and discarded. 
         [0008]    In one embodiment, the shell is formed from a flexible, semi-rigid shell. The body may further include a flexible, non-rigid crest extending from the shell at the top of the device and may further include a flexible, non-rigid tongue extending from the shell at the bottom of the device. In a further embodiment, the crest extends between about 15 percent and about 20 percent of the length of the body. In a further embodiment, the crest extends between about 2-5 cm from the shell. In a further embodiment, the tongue extends between about 25 percent and about 30 percent of the length of the body. In a further embodiment, the tongue extends from the shell about 4 cm. In a further embodiment, the overall length of the body is between about 16 cm and about 20 cm. In a further embodiment, the tongue forms an angle of between about 30 degrees and about 50 degrees. 
         [0009]    In one embodiment, the device forms a length external angle of between about 70 degrees and about 100 degrees. In a further embodiment, the device forms a width internal angle of between about 85 degrees and about 105 degrees. 
         [0010]    Additional objects, features, and advantages of the invention will become apparent to those skilled in the relevant art upon consideration of the following detailed description of preferred embodiments exemplifying the best mode of carrying out the invention as presently perceived. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         [0011]    The accompanying drawings, which are incorporated in, and constitute a part of, this specification, illustrate several embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention. For purposes of illustration, drawings may not be to scale. 
           [0012]      FIG. 1  is a perspective view of a male urinary incontinence device according to an embodiment of the present invention. 
           [0013]      FIG. 2  is a cross-sectional view taken generally along the plane of the line  2 - 2  in  FIG. 1  and illustrating an embodiment of the present invention. 
           [0014]      FIG. 3  is a cross-sectional view taken generally along the plane of the line  3 - 3  in  FIG. 1  and illustrating an embodiment of the present invention. 
           [0015]      FIG. 4  is a view of an interior side of a male urinary incontinence device according to an embodiment of the present invention. 
           [0016]      FIG. 5  is a cross-sectional side view of an embodiment of the present invention illustrated in  FIGS. 1 and 2  and including a representation of the male anatomy while the device is in use. 
           [0017]      FIG. 6  is a view of an interior side of a male urinary incontinence device according to an embodiment of the present invention. 
           [0018]      FIG. 7  is a cross-sectional view taken generally along the plane of the line  7 - 7  in  FIG. 6  and illustrating an embodiment of the present invention. 
           [0019]      FIG. 8  is a top elevation view of a male urinary incontinence device according to an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    In one embodiment, shown in  FIG. 1 , a male incontinence device  10  includes a body  11  and a first liquid-permeable liner  24 . The device  10  has a top  13  which, when worn, points generally toward the navel of the wearer, and a bottom  15  which, when worn, points generally toward the perineum of the wearer. The device  10  further has an external side  17  which, when worn, faces away from the wearer, and an interior side  19  which, when worn, faces the wearer and, particularly, the genitalia  38  of the wearer. See,  FIG. 5 . 
         [0021]    The body  11  forms a cavity  36  (see, also,  FIGS. 2 ,  3 ,  5 , and  7 ) adapted to hold human male genitalia  38  and includes a shell  14  and may further include a crest  26  at the top  13  and may further include a tongue  28  at the bottom  15 . Note that the neither the crest  26  nor the tongue  28  are shown in  FIGS. 5 and 7 . Especially when the shell  14  is comprised of flexible, semi-rigid material as described below, the device  10  is easily moved to the side while being worn to facilitate normal male urination. The device  10  also includes at least one moisture barrier  12 ,  16  adapted to prevent moisture, and specifically urine, from wetting the clothes of the wearer. 
         [0022]    As best seen in  FIGS. 2 ,  3 , and  7 , but also in  FIG. 5 , the first liquid-permeable liner  24  cooperates with the body  11 , and particularly the shell  14  to create a gap D G  and a chamber  32 . This effect is aided by securing the first liquid-permeable liner  24 , having an area sufficient to prevent its total collapse into the body  11 . Thus, the first liquid-permeable liner  24  is sufficiently suspended to create the gap D G  and the chamber  32  and acts to hold the male genitalia  38  separated from discharged urine stored in one or more absorbent  18 ,  20 . In this configuration, the first liquid-permeable liner  24  also provides needed support to the male genitalia  38 . The gap D G  and the chamber  32  also create an opportunity for air to circulate about the genitals  38  for a further drying effect. While the first liquid-permeable liner  24  may be secured about the periphery  34  of the body  11 , the first liquid-permeable liner  24  may also be secured inboard of the periphery  34 . 
         [0023]    As shown in  FIGS. 2 and 3 , the device  10  forms a length external angle α and, as shown in  FIG. 8 , a width internal angle θ. The length external angle α is that angle formed by the intersection of extending a tangent from the top  13  of the device  10  and from the bottom  15  of the device  10 . The width internal angle θ is that angle formed between an apex 40 of the external side  17  of the device  10  and edges  42  at the widest point W D  of the device  10 . 
         [0024]    The length external angle α cooperates with the width external angle θ to accommodate human male genitalia  38  ( FIG. 5 ) and to minimize the characteristic visible “bulge” indicative of men wearing an incontinence device. The length external angle α is between about 70 deg. and about 100 deg. The width internal angle θ is between about 85 deg. and about 105 deg. Proportionally, the width internal angle θ is between about 85 percent and 150 percent of the length external angle α. 
         [0025]    As shown in  FIGS. 2 and 3 , the crest  26  extends from the shell  14  and generally comprises soft, flexible material. The crest  26  forms a comfortable seal at the abdomen of the wearer and can provide additional absorbent protection. Also shown in  FIGS. 2 and 3 , the tongue  28  extends from the shell  14  and also generally comprises soft, flexible material. The tongue  28  forms a comfortable seal beneath the scrotum and in the perineum. Additionally, the tongue  28  may provide further absorbent protection. The tongue  28  forms an angle β of between about 30 deg. and 50 deg. Both the crest  26  and the tongue  28  provide a comfortable transition from the device  10  to the human body. 
         [0026]    In an embodiment, the periphery  34  of the device  10  comprises soft, flexible material for comfort and to help seal the device  10  against the body of the wearer. 
         [0027]    As shown in  FIGS. 2-4  and in Table 1, below, the device  10  has an overall length L D , a width at the widest part W D , a depth at the apex 40 of D A , a tongue length L T , and a crest length L C . Proportionally, the width W D  is between about 50 percent and about 55 percent of the overall length L D . As will be appreciated by those skilled in the relevant art, the indicated sizes are exemplary only, and smaller, larger, and other intermediate sizes are possible without departing from the spirit of the invention. 
         [0028]    Table 1, below, lists representative dimensions for four different sized devices  10 . All dimensions are in centimeters (cm). 
         [0000]    
       
         
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                   
                 TABLE 1 
               
               
                   
                   
               
               
                   
                 Size 
                 L D   
                 W D   
                 D A   
                 L T   
                 L C   
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Small (cm) 
                 16.5 
                 9 
                 5 
                 5 
                 3.5 
               
               
                   
                 Medium (cm) 
                 17.5 
                 9.5 
                 5.5 
                 5 
                 3.5 
               
               
                   
                 Large (cm) 
                 19 
                 9.5 
                 6.0 
                 5 
                 3.5 
               
               
                   
                 Extra-Large (cm) 
                 19.5 
                 10 
                 6.0 
                 5 
                 3.5 
               
               
                   
                   
               
             
          
         
       
     
         [0029]    Thus, as Table 1 above shows, the width at the widest point W D  is between about 9 cm and 10 cm, the ratio of the width W D  to overall length L D  (W D /L D ) is between about 45 percent and about 65 percent, the depth of the device at the apex 40 D A  is between about 5 cm and about 6 cm, and the ratio of the depth of the device at the apex 40 D A  to a long axis L D  is between about 25 percent and about 40 percent. 
         [0030]    In one embodiment, the shell  14  is flexible and semi-rigid and may be molded from a sheet or batt of fibers by placing the fiber sheet of batt between dies and, with the application of heat and pressure, molded into the desired shape. The shell  14  may also be resilient and attempt to return to its original shape when distorting forces are removed. Conventional examples include materials used to make particle masks so manufactured using natural fibers, such as wool and cotton, and synthetic materials, such as nylon, acrylonitrile, polyethylene, polyester, or polypropylene fibers. These fibers are often mixed with chemical resins, such as polyolefinic resins The nominal thickness of the shell  14  is about 2 mm. As will be appreciated by those skilled in the relevant art, various foams and other plastics may also be employed in making the shell  14 . The shell  14  is flexible with the pressures due to normal activities while being worn. At the same time, the shell  14  is resistant to flattening out against the genitalia  38 . The latter may be aided in part, for example, by molding into the shell  14 , elongated ridges to improve shape retention as may be seen in conventional dust masks. An exemplary shell  14  that has been used successfully uses the material of the 8000 series N95 Particle Mask from 3M, St. Paul, Minn. Other, non-limiting, examples include those found in U.S. Pat. Nos. 4,384,577 to Huber et al. and 3,220,409 to Liloia et al. 
         [0031]    In a further embodiment, the shell  14  comprises rigid material, plastic, for example. In such an embodiment, the shell  14  can provide further strength to help keep the body  11  from collapsing around the genitalia  38 , in the case of penile, testicular, or scrotal surgery, for example. 
         [0032]    The first liquid-permeable liner  24  is in contact with the genitalia  38  and serves to allow discharged urine to pass through freely and to keep the genitalia separated from the discharged urine. Preferably, the first liquid-permeable liner  24  is compliant, soft to the touch, and nonirritating. In addition, the first liquid-permeable liner  24  is non-absorbent and preferably formed from rapidly drying material which wicks away moisture quickly. Typically, the liner  24  is a netting material, woven or non-woven, comprised of, for example, polyester, nylon, polypropylene, rayon, or cotton. Other materials include apertured hydrophobic formed film. Exemplary, but non-limiting, formed films include those described in U.S. Pat. Nos. 4,324,246 to Mullane et al. and 4,342,314 to Radel et al. Other, non-limiting, liner materials include that described in U.S. Pat. No. 5,705,249 to Takai et al. 
         [0033]    A first absorbent  18  provides collection and storage of discharged urine and is formed of material adapted to absorb and retain human urine. Successful materials include processed wood pulp and super-absorbent polymers found in conventional disposable diapers and feminine hygiene products, such as polyacrylate/polyacrylamide copolymers, ethylene maleic anhydride copolymer, cross-lined carboxy-methyl-cellulose, polyvinyl alcohol copolymers, cross-linked polyethylene oxide, and starch grafted copolymer of polyacrylonitrile. 
         [0034]    Turning now to  FIGS. 2 and 4 , a second absorbent  20  may be included to provide additional absorbent capacity. As shown in  FIG. 4 , the second absorbent may be limited to a central portion of the device  10  where the majority of the discharged urine would collect. Accordingly, the second absorbent  20  may provide a higher absorbent density so that additional urine can be effectively absorbed and stored. 
         [0035]    Exemplary absorbent materials that have been used successfully include those of Always® Ultra Thin™ pads (Procter &amp; Gamble, Cincinnati, Ohio). See, for example, U.S. Pat. Nos. 4,950,264 to Osborn, III; 5,520,875 to Wnuk et al.; and 6,601,705 to Molina et al. For other, non-limiting, absorbent materials, see, also, U.S. Pat. Nos. 5,075,344 to Johnson; 3,926,891 to Gross et al.; and 4,293,609 to Erickson. 
         [0036]    In a further embodiment, a second liquid-permeable liner  22  may be provided adjacent the absorbent  18 ,  20 . The second liquid-permeable liner  22  may comprise any suitable material for enclosing the absorbent  18 ,  20 . Exemplary materials include apertured hydrophobic formed films discussed above as well as woven and non-woven materials. 
         [0037]    Turning again to  FIGS. 2 ,  3 , and  7 , in a further embodiment, a first moisture barrier  12  is provided on the external side  17  of the device  10 . A sheet of thin plastic of the type commonly found in conventional incontinence devices and feminine pads have been used successfully. 
         [0038]    In a further embodiment, shown in  FIGS. 2 and 3 , a second moisture barrier  16  is provided adjacent to the absorbent  18 . As with the first moisture barrier  12 , the second moisture barrier  16  of the type of thin plastic sheet commonly used in conventional incontinence devices and feminine pads have been used successfully. 
         [0039]    Turning now to  FIG. 3 , an embodiment of a male urinary incontinence device  10  is shown which includes a shell  14 , a moisture barrier  16 , an absorbent  18 , and a second liquid-permeable liner  22 . The embodiment shown in  FIG. 3  does not include a moisture barrier  12  on the external side of the device  10  and includes just one absorbent  18 . The first liquid-permeable liner  24  provides support for the genitalia  38  and helps separate the genitalia  38  from urine stored in the absorbent  18 . The shell  14  provides shape for the body  11  and helps to prevent the device  10  from collapsing around the genitalia  38 . Finally, the moisture barrier  16 , placed between the absorbent  18  and the clothing of the wearer to help protect the clothing from becoming soiled. 
         [0040]    Turning now to  FIGS. 6 and 7 , an embodiment of a male urinary incontinence device  10  is shown which includes neither a crest  26  nor a tongue  28 . 
       EXPERIMENTAL RESULTS 
       [0041]    In a series of tests, a size small device  10  was used and held in a position similar to that which it would be in when worn and water streamed from a syringe-type delivery apparatus with a slit to mimic the action of urine being excreted from a male penis. In two tests, the absorbent from an Always® Regular feminine hygiene pad absorbed 70 ml before reaching saturation. In one test, the absorbent from an Always® Overnight feminine hygiene pad absorbed 120 ml before reaching saturation. 
         [0042]    While certain preferred embodiments of the present invention have been disclosed in detail, it is to be understood that various modifications may be adopted without departing from the spirit of the invention of scope of the following claims.

Technology Category: 1