Patent Publication Number: US-2013237964-A1

Title: Non-invasive urine directional device, urine collection system, and kit

Description:
TECHNICAL FIELD 
     This invention generally relates to a non-invasive urine directional device, urine collection system, and kit useful for physically active females and males. 
     BACKGROUND 
     Incontinence and over-active bladders often present a challenge to men and women who want to remain active. Further, some physical and work activities are performed where restroom facilities are not readily available. For example, physical activities such as hunting, endurance competitive sports, cold-weather outdoor sports, and the like, can present challenges that make urine elimination inconvenient, particularly for women. Work settings, such as the military service, may also not be conducive to a typical means of urine elimination. Women, in particular, often purposely dehydrate themselves to avoid the need to urinate in these situations, which can present health issues such as urinary tract infections and dehydration. 
     Although many urinary collection devices exist, the devices are generally not designed for physically activity users. Often, the devices are invasive, complex and uncomfortable. Invasive devices may place the user at a heightened risk for urinary infections. Further, the complexity of invasive design increases the cost of manufacture. Disposable diapers, incontinence pads or undergarments with absorbent features provide alternatives to the complex devices but present other undesirable issues because there is typically no means to convey the urine away from the user. Further, the disposable aspect of this group of devices is not environmentally friendly as reuse is prohibited. 
     There remains a need to provide men and women with comfortable, non-invasive urine collection devices that permit physical activity. This disclosure describes an improvement over these prior art technologies. 
     SUMMARY 
     In one embodiment, in accordance with the principles of the present disclosure, a urine directional device is provided. The urine directional device includes a form-fitting undergarment; a non-invasive receiving body; and a drainage element. The form-fitting undergarment has a pant shape with a first defined leg portion, a second defined leg portion, and an open crotch portion. The first defined leg portion and the second defined leg portion are configured to extend to at least an upper thigh region of a user&#39;s legs. The non-invasive receiving body is configured to receive and direct a urine flow away from a user&#39;s body. The receiving body has an open-top proximal end that tapers to an open outlet at a distal end. The proximal end of the receiving body is fastened to the open crotch portion of the form-fitting undergarment around a circumference of the open crotch portion. The distal end of the receiving body is fastened to the drainage element. The drainage element is in fluid communication with the receiving body and configured to extend a urine flow away from the user&#39;s body. The form-fitting undergarment holds the non-invasive receiving body snugly to permit the user to participate in physical activity. Another advantage of the device is that it is reusable. 
     In accordance with the principles of the present disclosure, another embodiment provides a non-invasive urine directional device having a band rather than a form-fitting undergarment to which a receiving body and drainage element is fastened. The band is configured with a non-invasive receiving body having a funnel shape that tapers from an open top at a proximal end to an open outlet at a distal end. The band includes at least a front strap and a back strap. The front strap has a proximal end and a distal end, the proximal end of the front strap fastened to a front portion of the band and a front connector portion located on a front section of the receiving body. The back strap has an inverted Y-shaped configuration with a single proximal portion that divides into a first distal end and a second distal end. The single proximal portion of the back strap is fastened to a back portion of the band. The first distal end is fastened to a first back connector portion located on a back section of the receiving body. The second distal end is fastened to a second back connector portion located on the back section of the receiving body. The drainage element is configured to extend a urine flow away from a user&#39;s body with an open outlet of the receiving body fastened to the drainage element. The drainage element is in fluid communication with the receiving body. The band holds the non-invasive receiving body in place when disposed upon a user, and the device is reusable. 
     In another embodiment, in accordance with the principles of the present disclosure, a non-invasive urine collection system is provided. The system comprises a urine directional device; and urine disposal assembly. The urine directional device includes a form-fitting undergarment or a band; a non-invasive receiving body; and a drainage element. The urine disposal assembly includes a urine collection bag in fluid communication with the receiving body and drainage element of the urine directional device. A fastener is configured to detachably connect the drainage element of the urine directional device to the urine disposal assembly. 
     In another embodiment, a kit is provided. The kit comprises a reusable urine directional device configured to extend a urine flow away from a user&#39;s body; a urine disposal assembly; and a reusable wash bag configured to hold the urine directional device during a cleansing process. The kit provides an environmentally friendly alternative to disposable urine collection systems. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present disclosure will become more readily apparent from the specific description accompanied by the following drawings, in which: 
         FIG. 1  is a front perspective view of a urine directional device in accordance with the principles of the present disclosure; 
         FIG. 2  is a top plan view of a component of the urine directional device shown in  FIG. 1 ; 
         FIG. 3  is a side plan view of a component of the urine directional device of  FIG. 1 ; 
         FIG. 4  is a front perspective view of the urine directional device disposed upon a user; 
         FIG. 5  is a front perspective view of a urine collection system; 
         FIG. 6  is a front perspective view of the urine collection system disposed upon a user; 
         FIG. 7  is a front perspective view of a urine directional device in accordance with the principles of the disclosure; and 
         FIG. 8  is a front perspective view of a kit in accordance with the principles of the disclosure. 
     
    
    
     Like reference numerals indicate similar parts throughout the figures. 
     DETAILED DESCRIPTION 
     The present disclosure can be understood more readily by reference to the following detailed description of the disclosure taken in connection with the accompanying drawing  FIGS. 1-8 , which form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure. Also, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges can be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. It is also understood that all spatial references, such as, for example, horizontal, vertical, top, upper, lower, bottom, left and right, distal and proximal, are for illustrative purposes only and can be varied within the scope of the disclosure. For example, the references “upper” and “lower” are relative and used only in the context to the other, and are not necessarily “superior” and “inferior”. 
       FIG. 1  illustrates a urine directional device  10  in accordance with an embodiment of the invention. As shown in  FIG. 1 , a form-fitting undergarment  11  has a pant shape with a first leg portion  12   a  and a second leg portion  12   b  and an open crotch portion  13 . An open top of a receiving body  14  is fitted around a circumference of the open crotch portion  13 . As shown in  FIGS. 2 and 3 , the receiving body  14  can include an optional outer ridge  15  around the circumference of the open top of the receiving body  14 . The circumference of the open top of the receiving body  14  is fastened to the circumference of the open crotch portion  13  with a fastening means  16  to form a gap-free seal between the form-fitting undergarment  11  and the receiving body  14 . The receiving body  14  is configured to be held snugly in place within the form-fitting undergarment  11  to permit physical activity of the user. 
     The receiving body  14  is a hollow, molded piece configured to direct a urine flow away from a user. In one embodiment, the receiving body  14  is in the form of an open funnel, with the proximal end  17  configured to fit the contours of the female anatomic pelvic structures such that the receiving body  14  is non-invasive and sufficient in proportion to impart the urine directional device  10  substantially leakage proof capabilities during the voiding of urine. In another embodiment, the receiving body  14  is configured to fit the male anatomy such that the fit is non-invasive and sufficient in proportion to impart the urine directional device  10  with leakage proof capabilities during the voiding of urine. As shown in  FIGS. 1-3 , the proximal end  17  of the receiving body  14  tapers to an open outlet  18  at a distal end of the receiving body. The open outlet  18  is positioned approximately in a center of the receiving body  14  to guide the urine flow away from the user into a drainage element  19 , as shown in  FIG. 2 . 
     The form-fitting undergarment  11  is manufactured or assembled as a one-piece garment made from a form-fitting material, preferably a 360-degree stretch fabric, capable of moving with the user&#39;s body through all ranges of motion. The form-fitting undergarment  11  can be manufactured in different sizes to fit the user comfortably and accommodate physical activity. The form-fitting material contributes to snugly keeping the receiving body  14  in functional placement upon fastening the form-fitting undergarment  11  to the receiving body  14 . Materials that can be used for the form-fitting undergarment  11  include nylon, LYCRA®, spandex and other shaper fabrics that conform to the user&#39;s body. One such material comprises nylon and spandex, preferably about 90% nylon and 10% spandex. The form-fitting undergarment  11  can include construction elements such as a waistband and trim to provide additional durability to the urine directional device  10 . 
     As shown in  FIG. 1 , each leg portion  12   a,    12   b  of the form-fitting undergarment extends to at least an upper thigh region of the user&#39;s legs. Depending upon the user&#39;s preference each leg portion  12   a,    12   b  can also be constructed to extend to a mid-thigh region, a knee region, or an ankle region. Each leg portion  12   a,    12   b  is configured to pull the receiving body  14  into an extended open position when the user adopts a widened stance with legs positioned apart during a urine void such that all of a urine flow is directed into the receiving body  14 . For cold weather, outdoor physical activity, such as cross-country skiing, dog sledding, and the like, longer leg portions provide an additional benefit of an extra layer of warmth. 
     As illustrated in  FIG. 2 , a vertical y axis length of the receiving body  14  is longer than a horizontal x axis width of the receiving body  14 , with the vertical length y fitted into the open crotch portion  13  of the form-fitting undergarment  11  from the front to the back, and the horizontal length x fitted into the open crotch portion  13  of the form-fitting undergarment  11  from side to side. For a female user, the vertical y axis of the receiving body  14  extends out to a length ranging from about 15 cm to about 25 cm, with approximately 21 cm representing the length of the receiving body  14  for an average sized female user. For a female user, the horizontal x axis of the receiving body  14  generally extends out to a width of from about 5 cm to about 15 cm, with approximately 6 cm representing the width of the receiving body  14  for the average sized female user. For a male user, the vertical y axis of the receiving body  14  extends out to a length ranging from about 15 cm to about 25 cm, with approximately 16 cm representing an average length of the receiving body  14 . For a male user, the horizontal x axis of the receiving body  14  generally extends out to a width of about from about 10 cm to about 25 cm, with approximately 15 cm representing an average width of the receiving body  14 . For an average sized male user, a diameter of the circumference of the open top of the receiving body  14  is approximately 31 cm. 
     The receiving body  14  is constructed from a material that is comfortable and of sufficient rigidity to provide structure to secure the receiving body  14  in place during different ranges of motion. Materials used for the receiving body  14  can be selected from any number of flexible, waterproof, and/or hydrophobic materials compatible to human skin. Examples of appropriate materials include silicon based materials; FDA approved medical grade polyurethane; and the like. The thickness of the material selected depends upon the user&#39;s needs, taking into account, for example, the duration of each wearing, cost constraints, reuse expectations, considerations relating to the fit of outer clothing, and the like. In one embodiment, the material for the receiving body  14  has a thickness ranging from 0.05 to 0.25 cm, more preferably 0.1 to 0.3 cm. FDA approved medical grade polyurethane that can be used for the receiving body  14  has an approximate thickness of 0.15 cm. 
     The receiving body  14  is configured to be substantially undetectable when disposed underneath outer clothing. The receiving body  14  is proportionally sized in accordance with the size of the user, thus contributing to the receiving body  14  being inconspicuous underneath outer clothing. That is, a user fitting into a small form-fitting undergarment  11  will preferably have a correspondingly small receiving body  14  assembled into the form-fitting undergarment  11 . For female users, the receiving body proximal end  17  is configured such that external female genitalia are generally not in direct contact with the receiving body  14 . This non-invasive configuration can decrease the problem of vaginitis and also makes the directional device  10  substantially leak proof. 
     As illustrated in  FIG. 3 , the receiving body  14  is molded in a boat-like shape, with a height h of the receiving body  14  extending from the proximal end  17  to the open outlet  18  at the distal end. For an average sized female, the height h of the receiving body is approximately 10 cm. 
     As shown in  FIGS. 1-6 , a fastener  16  is used to fasten the form-fitting undergarment  11  to the receiving body  14 . Any number of fastening mechanisms can be used, including zippers, adhesives, stitching, and the like. In one embodiment, the open crotch region  13  is permanently affixed to the receiving body  14  with the outer edge  15  placed inside the form-fitting undergarment  11  such that the presence of the receiving body  14  is more inconspicuous when covered with clothing. In one embodiment, at least one seam is used as the fastener  16  to permanently fasten the receiving body  14  and form-fitting undergarment  11  around the circumference of the proximal end  17  of the receiving body  14  to form one piece that can be easily cleaned, thus promoting reuse. 
     The drainage element  19  is configured to provide an unobstructed flow path for the urine to drain away from the user&#39;s body. As shown in  FIG. 1 , the drainage element  19  is a tube. The receiving body  14  and the drainage element  19  can be manufactured as separate molded pieces and thereafter fastened or connected. Alternatively, the receiving body  14  and drainage element  19  can be manufactured as a single molded unit. Generally, materials used for the drainage element  19  should be flexible yet of a sufficient rigidity such that the drainage element  19  will not collapse during physical activity and movement of the user. To impart different structural components, the drainage element  19  can be constructed from more than one material. Preferred materials for the drainage element  19  include silicone based materials, FDA approved medical grade polyurethane, and the like. For ease of manufacture, the same material used for the receiving body  14  can also be used for the drainage element  19 . In one embodiment, the material for the receiving body  14  has a thickness ranging from 0.05 to 0.25 cm, more preferably 0.1 to 0.3 cm, most preferably about 0.15 cm. 
     The drainage element  19  includes a hollow tubing that permits fluid communication between the receiving body  14  and the drainage element  19 . The drainage element  19  is configured with a length sufficient to guide through a distal end  20  of the drainage element  19  away from the user&#39;s body. Preferably, the drainage element  19  is configured to have a length of at least  15  cm. For an average sized female to extend the drainage element to mid-thigh, the length of the drainage element  19  will be approximately 21 cm when measuring from the open outlet  18  of the distal end of the receiving body  14  to the distal end  20  of the drainage element  19  (or approximately 31 cm when measuring from the proximal end  17  of the receiving body  14  to the distal end  20  of the drainage element). The drainage element  19  can be detachably connected to the receiving body  14  such that the user can alternate between different lengths of the drainage element  19  if desired by the user. Alternatively, the drainage element  19  can be permanently affixed to the open outlet  18  of the receiving body  14  using an adhesive, other bonding mechanism or substance, or molding. As shown in  FIG. 4 , for extreme weather conditions or in certain work conditions, the extension of the drainage element  19  to the user&#39;s ankle eliminates the need to remove outer clothing during urine elimination. This is particularly useful for women who have multiple layers of clothing in adverse conditions. For the drainage element  19  configured to extend to the ankle, the length of the drainage element  19  is approximately 90 cm for the average female height. One or more supports can be used to strap or otherwise secure the drainage element  19  to the user&#39;s leg or otherwise attach or affix to the user&#39;s clothing, if desired by the user. When the directional device  10  is disposed upon a user, as shown in  FIG. 4 , the user adopts an upright position during urine elimination to avoid leakage. 
     In  FIG. 5 , a urine collection system  21  is shown where the urine directional device  10  further comprises a urine disposal assembly  22 . The urine disposal assembly  22  includes a urine collection bag  42  that is in fluid communication with the receiving body  14  and the drainage element  19  of the urine directional device  10 . The distal end  20  of the drainage element  19  is configured for a detachable connection with the urine disposal assembly  22  using a fastener  43 . Any suitable fastener mechanism may be used, including a clamp, a flange, a clip, a snap retaining ring, a tie strap, and the like. As shown in  FIG. 5 , the fastener  43  is a flange having a series of circular ridges. The drainage element  19  is detached from the urine collection bag  42  whenever the user wishes to empty, clean or dispose of the urine collection bag  42 . The receiving body  14 , drainage element  19 , and urine collection bag  42  are all in fluid communication in the urine collection system  21 . 
     As illustrated in  FIG. 5 , the fastener  43  is connected to the one-way valve  44  to prevent back-flow from the urine collection bag  42 . The urine collection bag  42  is configured with the urine reservoir  48  inside the urine collection bag  42 . A system of one or more support elements  50  can be affixed to the urine collection bag  42  through a system of one or more recesses  51  including holes or other such perforations that are outside of the reservoir  48  as shown in  FIG. 5 . As shown in  FIG. 6 , the one or more support element(s)  50  can be extended around the circumference of the user&#39;s leg and held together with a mating attachment mechanism  52  such as VELCRO® fastening tabs. The urine collection bag  42  can be configured with a drainage piece  54  including a drain port or valve configured with an open and closed position such that the user can empty the urine collection bag  42  after use. Alternatively, the urine collection bag  42  can be disposable and thus require no drainage piece. 
     As illustrated in  FIG. 5 , the urine collection bag  42  receives and stores urine collected from the receiving body  14  as drained through the drainage element  19 . Any waterproof material compatible with skin can be used for constructing the urine collection bag  42 . The size of the urine collection bag  42  is of sufficient proportion to accommodate typical voiding quantities, with different sizes possible depending upon the duration of time that the urine collection system  22  is in use and the degree of physical activity exerted by the user. The bag  42  preferably holds at least 250 ml volume and can be configured for volumes up to 1000 ml or 1500 ml and beyond to extend the time of usage. The shape of the urine collection bag  42  can be selected from any number of commercially available urine bags or specifically configured for the user&#39;s needs where the shape can be contoured, straight, wide, slim and long, and the like. In one embodiment, the urine collection bag is transparent to permit the user to observe the level of fluid in the bag reservoir  48 . Commercially available urine collection bags  42  include Freedom leg bags by Coloplast-Mentor (Minneapolis, Minn.). The urine collection bag  42  can be located on any desired region of the leg, including the user&#39;s upper thigh, lower thigh, calf, or ankle, on the side, back or front region of the leg. 
     As illustrated in  FIG. 6 , the urine collection bag  42  can be placed inconspicuously on the user&#39;s leg such that an outer garment covers the urine collection system  21 . The urine collection bag  42  can optionally include a portion with a comfort backing, such as a soft fabric affixed to the urine collection bag  42 . The comfort backing may be laminated, glued, stitched, or otherwise attached to or manufactured as a part of the urine collection bag  42 . In one embodiment, the portion of the urine collection bag  42  having the comfort backing includes the back region resting against the user&#39;s leg, with the front region of the urine collection bag  42  comprising a transparent material to show an amount of urine present in the bag reservoir  48  at any given time. 
     As shown in  FIG. 6 , when disposed upon a user, the urine collection system  21  is configured to provide the user with a hand&#39;s free portable and inconspicuous means of urine elimination which can be of particular benefit to women. The optimal position for a user of the urine collection system  21  is an upright stance. 
       FIG. 7  illustrates a non-invasive urine directional device  100  that includes a band  101  configured with a non-invasive receiving body  114 ; and a drainage element  119 . The band  101  replaces the form-fitting undergarment  11  shown in the configuration of  FIG. 1  as the support for holding the receiving body  114  in place when disposed on the user. As shown in  FIG. 7 , the receiving body  114  has an open top with at least three connection portions  105   a,    105   b,    105   c.  The receiving body  114  is configured to have a front section and a back section. The band  101  is made of an elastic material or other stretchable material, with sizing in a small, medium, large, and so on. The band  101  includes at least a front strap  102  and a back strap  103 . The front strap  102  has a proximal end and a distal end. The proximal end of the front strap  102  is fastened to a front portion of the band  101 . The distal end of the front strap  102  is fastened to a front connection portion  105   a  located on the front section of the receiving body  114 . The back strap  103  has an inverted Y-shaped configuration with a single proximal portion  103   a  that is fastened to a back portion of the band  101 . The single proximal portion  103   a  of the back strap  103  divides into a first distal end  103   b  and a second distal end  103   c.  The first distal end  103   b  is fastened to a first back connector portion  105   b  located on the back section of the receiving body  114 . The second distal end  103   b  is fastened to a second back connector portion  105   c  located on the back section of the receiving body  114 . The front strap  102  and the back strap  103  can be detachably fastened to the band  101  or permanently fastened to the band  101 . Similarly, the front strap  102  and the back strap  103  can be detachably fastened to the receiving body  114  or permanently fastened to the receiving body  114 . For the detachable embodiments, the straps  102 ,  103  can be mattingly fastened using hooks, snaps, VELCRO® strips and the like. A proximal end  117  of the receiving body  114  tapers in a funnel shape to an open outlet  118  at a distal end of the receiving body  114 . The receiving body  114  is configured to fit the male anatomy or the female anatomy in a manner sufficient to prevent any leakage of urine during use. Materials and dimensions of the receiving body  114  are the same as described for the receiving body  14  shown in  FIG. 1 . A drainage element  119  is fastened to the open outlet  118  of the receiving body  114  or molded as a single, congruent piece with receiving body  114 . The drainage element  119  is in fluid communication with the receiving body  114 , with the drainage element  119  configured to extend a urine flow away from a user&#39;s body. The distal end  120  of the drainage element  119  provides an outlet for the urine. 
     The urine directional device  100  shown in  FIG. 7  is configured such that the user can void in a sitting position in addition to a standing position. This sitting position is particularly useful for a male user as the device  100  provides an alternative to invasive catheters. In one configuration in accordance with the principles of the disclosure, the urine directional device  100 , as shown in  FIG. 7 , is configured to be utilized when a user is in a sitting position, raising one leg slightly during a voiding to further ensure against leakage. 
     In accordance with the principles of the disclosure, a kit  760  is also provided. As shown in  FIG. 8 , the kit  760  includes the reusable urine directional device  700  ( 10 ,  100 ) and configured to extend a urine flow away from a user&#39;s body; the urine disposal assembly  722  ( 22 ); and a reusable wash bag  775 . The reusable wash bag  775  is configured to hold at least the urine directional device  700  ( 10 ,  100 ) during a cleansing process. The reusable wash bag  775  can be made from any number of fabrics or materials including a washable net fabric with a zipper  776  or other type of closure. Optionally, the kit can be assembled to include only the reusable wash bag  775  and the urine directional device  700 . 
     It will be understood that various modifications can be made to embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplification of the various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.