Patent Publication Number: US-2006015082-A1

Title: Male urinary incontinence apparatus

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
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     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
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     COPYRIGHT NOTICE  
      A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyrights.  
     BACKGROUND OF THE INVENTION  
      1. Field of the Invention  
      The present invention relates to incontinence, and more particularly, to an apparatus for use by males suffering from incontinence problems.  
      2. Description of the Background Art  
      Incontinence is a growing problem, particularly in adult males ages 60 and older. Approximately two million males in the United States suffer moderate to severe incontinence. Common causes for this condition include an enlarged prostate, prostate cancer, pelvic trauma, spinal cord injury, and medication side effects. Over $15 billion is spent annually on incontinence related care.  
      There are many male urinary incontinence management devices on the market ranging from the intrusive urinary tract catheters, to diapers. Neither of these devices, however, offer safe, comfortable, and non-traumatic control or management of male urinary incontinence. The use of urinary tract catheters is often problematic due to their intrusive nature and resulting occurrence of urinary tract infections. On the other hand, the use of diaper-type devices often causes skin irritation and rashes. In addition, diaper-type devices are not effective in maintaining an accurate measure of a patient&#39;s fluid intake and output.  
      The present invention addresses the limitations of certain prior art devices used for managing male incontinence. Specifically, the invention provides a wearable external device that is both effective and easy to use, and which will remain generally unnoticed underneath the clothing of the wearer without creating a feeling of self-consciousness. While not a cure for male urinary incontinence, the invention is intended to allow for a better quality of life with less skin irritation and fewer problems as compared to present, commercially available and accepted incontinent devices.  
     BRIEF SUMMARY OF THE INVENTION  
      The present invention addresses and overcomes the limitations and disadvantages in the art by providing an apparatus for use in covering relation with the male penis to manage incontinence. The apparatus includes a generally tubular sheath adapted to be worn in covering relation over the user&#39;s penis. The sheath includes a tapered end or tip adapted for connection to a tube to facilitate fluid communication between the sheath interior and a urine collection bag that is preferably secured to the lower portion of the user&#39;s leg, or other drainage system such as a Foley catheter drainage bag. The sheath is preferably fabricated from a soft, rubber-like material, and preferably in a double wall configuration wherein inner and outer layers combine to form an interstitial space. The interstitial space may be filled with a liquid or gel substance for increased comfort. In an alternate embodiment, however, the sheath may be fabricated from a single layer of suitable material, such as silicone of latex. A significant aspect of the present invention relates to securing the sheath by a suitable fastening system. More particularly, a waist-strap or belt-like structure is disclosed as a securing means. The waist-strap securing means eliminates the risk of dislodgement of the sheath from the penis (hence incontinence).  
      Accordingly, it is an object of the present invention to provide an improved apparatus for controlling male incontinence.  
      Another object of the present invention is to provide an apparatus for controlling male incontinence that is comfortable and easy to use.  
      Still these and other objects will become apparent with reference to the detailed description below and the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS  
       FIG. 1  is front perspective view of an incontinence apparatus and strap according to the present invention;  
       FIG. 2  is a rear perspective view thereof;  
       FIG. 3  is rear perspective view thereof without the strap;  
       FIG. 4  is a side view thereof;  
       FIG. 5  is a perspective view of an alternate embodiment;  
       FIG. 6  is a partially sectioned view thereof;  
       FIG. 7  is a side perspective view of an alternate embodiment incontinence apparatus having an alternate securing means;  
       FIG. 8  is a rear perspective view thereof;  
       FIG. 9  is a side perspective view of yet another alternate embodiment; and  
       FIG. 10  is perspective view of yet another embodiment. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
      With reference now to the drawings  FIGS. 1-4  depict a preferred embodiment of an incontinence management apparatus, generally referenced as  10 , for use in covering relation with the male penis to manage incontinence. Incontinence management apparatus  10  includes a generally tubular sheath  12  adapted for fitting in covering relation over the user&#39;s penis (not shown). Sheath  12  preferably includes an first/proximal end  14  defining an opening, and a second/distal end  16  defining a tapered tip adapted for connection to a tube (not shown) to facilitate fluid communication between the sheath interior and a urine collection bag, such as a Foley catheter drainage bag or drainage system (not shown) secured to the lower portion of the user&#39;s leg as is customary in the art of incontinence management. Sheath  12  is preferably fabricated from a soft, rubber-like material, such as silicone or latex, however, any suitable material is considered within the scope of the invention. In an alternate embodiment, sheath first proximal end portion  14  may comprise a fabric body and the second distal end  16  may comprise a soft rubber-like material. In other embodiments, sheath  12  may be fabricated from a soft, rubber-like material wherein the proximal end includes a fabric liner. Sheath  12  further includes a pair of projecting flaps, referenced as  18 , each of which define an aperture  19 . Projecting flaps  18  function as mounting structures for connection of a strap  20 . The use of projecting flaps is considered significant as the flaps place the strap connection points in spaced relation from the user&#39;s penis and further allow for movement of the straps to conform to the user&#39;s movement thereby maximizing comfort. Strap  20  is preferably elastic or soft fabric such as spandex, and secures sheath  12  to the user&#39;s body, in covering relation with the user&#39;s penis, by wrapping around the user&#39;s waist.  
      As discussed above, sheath  12  is preferably fabricated from a soft, FDA approved silicon material, in a double walled tubular configuration adapted to be filled with a gel, water, or any other suitable substance. More particularly, sheath  12  is preferably fabricated as an open ended, generally tubular structure, having radially inner and outer sleeve members sealingly connected to form a double wall sheath defining an interior volume for receiving the user&#39;s penis. The inner and outer sleeve members are preferably sealed along common peripheral edges by heat sealing and/or ultrasonic welding. Once formed the double wall structure defines an internally enclosed interstitial space that may be filled with a liquid or gel substance for increased comfort. The combination of soft and pliable inner and outer sleeve members containing a liquid or gel substance results in an apparatus that may be comfortably worn over the user&#39;s penis.  
       FIGS. 5 and 6  depict an alternate embodiment male incontinence apparatus, referenced as  30 . Incontinence management apparatus  30  comprises a generally tubular sheath  32  adapted for fitting in covering relation over at least a portion of the user&#39;s penis (not shown). Sheath  32  preferably includes an first/proximal end  34  defining an opening, and a second/distal end  36  defining a tapered tip adapted for connection to a tube (not shown) to facilitate fluid communication between the sheath interior and a urine collection bag (not shown) that is preferably secured to the lower portion of the user&#39;s leg as is customary in the art of incontinence management. Sheath  32  further includes a strap  38 . Strap  38  is preferably elastic or soft fabric, and secures sheath  32  to the user&#39;s body, in covering relation with at least a portion of the user&#39;s penis, by wrapping around the user&#39;s waist. In alternate embodiments, strap  38  may comprise a soft fabric having a hook and loop fastening mechanism (e.g. Velcro®).  
      Sheath  32  is preferably fabricated from a soft, FDA approved silicone material, in a double walled tubular configuration adapted to be filled with a gel, water, or any other suitable substance. As noted herein above, the sheath may also incorporate fabric sections, however, the FDA approved silicone, or other rubberized material, is considered preferable for use at the distal end or tip. As best depicted in sectional view of  FIG. 6 , sheath  32  is preferably fabricated as an open ended, generally tubular structure, having an inner sleeve  33  and an outer sleeve  35  radially spaced from inner sleeve  33  to form an interstitial space. The inner and outer sleeves are preferably sealed along common peripheral edges by heat sealing and/or ultrasonic welding. Once formed the double wall structure defines an internally enclosed interstitial space that may be filled with a liquid or gel substance for increased comfort. The combination of soft and pliable inner and outer sleeve members containing a liquid or gel substance results in an apparatus that may be comfortably worn over the user&#39;s penis.  
       FIGS. 7-8  depict a male incontinence apparatus, referenced as  50 , having an alternate securing mechanism. More particularly, male incontinence apparatus  50  comprises a generally tubular sheath  52  adapted for fitting in covering relation over at least a portion of the user&#39;s penis (not shown). Similar to the embodiments previously disclosed herein, tubular sheath  52  includes an first/proximal end  54  defining an opening, and a second/distal end  56  defining a tapered tip adapted for connection to a tube (not shown) to facilitate fluid communication between the sheath interior and a urine collection bag (not shown) that is preferably secured to the lower portion of the user&#39;s leg, or Foley drainage bag, as is customary in the art of incontinence management. Sheath  52  further includes a circumferential strap  58  disposed at or in proximity to the first/proximal end  54  of sheath  52 . Circumferential strap  58  preferably includes a first end portion  58 A adapted with a locking member, and a second end portion  58 B adapted with projecting teeth. Circumferential strap  58  functions to secure apparatus  50  to the user by causing radially inward deformation of proximal end  54  upon tightened, releasable locking engagement of strap ends  58 A and  58 B.  
      Finally,  FIGS. 9 and 10  depict additional embodiments for an apparatus for managing incontinence in males.  FIG. 9  depicts such an apparatus, referenced as  60 , wherein the apparatus defines a plurality of apertures  62  in the double wall structure which function to provide ventilation for increased comfort. Apparatus  60  further includes a circumferential strap  64  for securing apparatus  60  to the user when in use. As best illustrated by  FIG. 9 , circumferential strap  64  may be slidably disposed along the length of the apparatus to allow for user positioning thereof, or may be fixed at any suitable location.  FIG. 10  depicts an embodiment of the apparatus, referenced as  70 . Apparatus  70  is similar in structure to the apparatus  60  depicted in  FIG. 9 , to the extent that apparatus  70  is depicted with apertures  72 . However, apparatus  70  is adapted with opposing radially projecting flaps  74  and is thus adapted for use with a strap to secure apparatus  70  to the user. Thus, a primary advantage of the present invention is to provide a male incontinence apparatus that is secured to the user by a waist-strap or belt that prevents the apparatus from being dislodged from the user&#39;s penis thereby effectively eliminating the risk of incontinence.  
      As should now be apparent, each of the various embodiments disclosed herein are suitable for use in the management of incontinence in males by placement of one of said apparatus over the male penis so as to be in substantial covering relation therewith and securing the apparatus using the provided securing structure. Once the apparatus is fitted on and secured to the user, the apparatus may be connected to a urine collection bag affixed to the user&#39;s leg by plastic tubing connected to the apparatus distal end such that discharged urine flows out of the distal end of the apparatus through the tubing and into collection bag.  
      The instant invention has been shown and described herein in what is considered to be the most practical and preferred embodiment. It is recognized, however, that departures may be made therefrom within the scope of the invention and that obvious structural and/or functional modifications will occur to a person skilled in the art.