Abstract:
A feminine care device for collecting urine including a reservoir defining a recess for receiving urine. The reservoir has a rim and flange configured for periurethral sealing and adhesion to the labia minora, respectively. A tab depends from the reservoir for engagement and adhesion to the anterior vaginal wall. A drain for selectively draining urine from the reservoir is provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application claims priority to U.S. Provisional Patent Application No. 60/177,921, filed Jan. 25, 2000, which is incorporated herein by reference in its entirety. 
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The subject disclosure relates to devices for aiding female urinary incontinence, and more particularly to an improved female urine collection device which comfortably and discretely conforms to the female body and protects against leakage.  
           [0004]    2. Background of the Related Art  
           [0005]    Approximately eleven million women in America experience involuntary leakage of urine. Such a condition erodes their quality of life because medical, emotional and social problems often accompany incontinence. Skin rashes, urinary tract infections, sleep disturbances, restricted social interactions, reduced sexual activity, loss of self-esteem and depression are only a few of the typical symptoms associated with incontinence.  
           [0006]    For many women, the condition is a consequence of aging and approximately half of the women in nursing homes are incontinent in varying degrees. Further, hospitalized patients, such as those in traction or who are otherwise bedridden must empty their bladder at bedside. Moreover, circumstances may simply make a restroom break inconvenient such as when working in outer space. To accommodate such conditions, it is desirable to provide a device which can comfortably and reliably collect, retain and empty, or channel urine so as to prevent embarrassing and untimely leakage.  
           [0007]    Several devices have been developed to perform this function. For example, U.S. Pat. No. 3,528,423 to Lee discloses a female incontinence device having an intravaginal stabilizer bar with projections for holding a face plate in place. The face plate has grooves to conform to the major and minor labia, respectively. The face plate further defines an outlet for allowing urine to collect in a reservoir. A drain tube may terminate in a plug or connect to a suitable receptacle. Buttons on the face plate provide anchors for a harness to secure the device to the patient&#39;s body.  
           [0008]    A further example includes U.S. Pat. No. 5,370,637 to Brodeur, which discloses a female urination aid to facilitate urination by females in a substantially upright position. A base defines an oval center opening which fits around a patient&#39;s vulva. The opening has upper contours and a seal to engage the labia. Finger pads on the base provide an area for the patient to apply pressure to effectuate proper engagement of the seal. An absorbent pad disposed at the bottom of the base can be used as a germicidal and deodorizing wipe. A collapsible fluid guide extends from the base and terminates at an outlet to take urine away from the patient. The fluid guide has an inner liner surrounded by an accordion boot.  
           [0009]    Still further, U.S. Pat. No. 4,986,823 to Anderson et al. discloses a device for directing a flow of urine from a female. The device includes a body having a collector surrounding the urethral meatus and a pair of limbs extending internally of the vagina through the vaginal orifice. A collection tube is connected to the collector to communicate the urine into a reservoir. Further, the collector includes torsion members to provide a spring force to separate the limbs. An applicator holds the limbs together for easy insertion.  
           [0010]    U.S. Pat. No. 5,336,208 to Rosenbluth et al. discloses a first embodiment having a disposable urinary incontinence pad with a base that has an adhesive layer for providing a fluid tight seal and occlusion against the urethral meatus and increasing retention against the vestibule of the vulva. Lateral edges of the base and an anterior end of the pad are tucked under the labia minora to enhance retention. Moreover, the adhesive layer can be extended onto the labia-engaging surface to further enhance the stability of the device. A handle in the form of a ring or loop of string facilitates removal. A second embodiment has a short protuberance to be received at least partially within the urethral meatus. A third embodiment has a flexible bladder filled with gel. The bladder conforms to the anatomical structure of the external female genitalia, filling the interlabial space, and sealing against the urethral meatus with the aid of an adhesive.  
           [0011]    Also, U.S. Pat. No. 4,484,917 to Blackmon discloses a female external catheter formed from a main body having an inlet for receiving urine. An adhesive layer, surrounding the inlet, secures the inlet about the urethral meatus. A stabilizer provides a rigid backing for the adhesive layer. An outlet tube channels urine into a collection bag. U.S. Pat. No. 4,822,347 to MacDougall discloses a female incontinence device with a tubular sheath integral with a funnel and a urine conduit. A pad of adhesive material secures an entry portion around the urethral meatus. The sheath is a highly stretchable latex rubber in order to absorb the energy created by urine surges and, thus, prevent stress upon the adhesive seal. The conduit leads to a leg bag or urine collection vessel.  
           [0012]    Notwithstanding the above teachings, there is a need for an improved female urinary incontinence device. Typically, prior art devices are ill-suited for their intended use due to discomfort and potential for leakage, particularly for ambulatory patients. In light of the foregoing, a need exists for a female urinary incontinence device which is comfortable and secure for bedridden and ambulatory patients.  
         SUMMARY OF THE DISCLOSURE  
         [0013]    The subject disclosure is directed to a device to accommodate female urinary incontinence. The device includes a reservoir defining a recess for receiving urine. The reservoir has a rim configured to adhere the device to the periurethral surface and secure its position. A securement tab depends from the device for engagement in the vaginal opening to further secure the position and orientation of the device. Means for selectively draining the reservoir are also provided. Such means preferably includes a selectively actuable check valve. In another embodiment, an adhesive flange depends from the rim for engaging the labia minora. In use, an adhesive coating is applied to the tab and a string is attached to the tab. The tab has a plurality of hinges to allow the tab to conform to the vaginal opening.  
           [0014]    The method for collecting female urine includes the step of providing a collection device having a securing portion with a rim defining an inlet and configured to surround a urethra and engage a labia. A tab is adjacent to the rim and configured for insertion into a vaginal opening to secure a position of the securing portion. The method further includes the steps of applying an adhesive to the rim, adhering the rim to the periurethral surface to create a seal therewith and inserting the tab into the vaginal opening. 
       
    
    
       [0015]    These and other unique features of the system disclosed herein will become more readily apparent from the following description and the accompanying drawings.  
       BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]    So that those having ordinary skill in the art to which the disclosed device appertains will more readily understand how to make and use the same, reference may be had to the drawings wherein:  
         [0017]    [0017]FIG. 1 is a front perspective view of a first urinary incontinence device constructed in accordance with a preferred embodiment of the subject disclosure;  
         [0018]    [0018]FIG. 2 is a rear perspective view of the urinary incontinence device of FIG. 1;  
         [0019]    [0019]FIG. 3 is a side-elevational view of the urinary incontinence device of FIG. 1 during insertion of the securement tab into the vaginal opening of a patient;  
         [0020]    [0020]FIG. 4 is a side-elevational view of the urinary incontinence device of FIG. 1 fully disposed in an operational position on a patient;  
         [0021]    [0021]FIG. 5 is a side-elevational view of the urinary incontinence device as in FIG. 4 with the reservoir shown in partial cross-section as urine is drained therefrom;  
         [0022]    [0022]FIG. 6 is a perspective view of a second urinary incontinence device constructed in accordance with a preferred embodiment of the subject disclosure;  
         [0023]    [0023]FIG. 7 is a side-elevational view of the urinary incontinence device of FIG. 6 in an operational position on a patient;  
         [0024]    [0024]FIG. 8 is a partial cross-sectional view of the urinary incontinence device of FIG. 6 in an operational position on a patient as urine is received in the reservoir; and  
         [0025]    [0025]FIG. 9 is an illustration of a urine collection system constructed in accordance with a preferred embodiment of the subject disclosure. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0026]    The subject disclosure relates to an improved system for capturing the urine of women. The system is particularly applicable to women who are incontinent or bed-ridden, although the system may be utilized in many circumstances in which insertion of a catheter into the urethra is contra-indicated for medical reasons or such as during a long journey when a bathroom is unavailable, as would be readily appreciated by those skilled in the art.  
         [0027]    The present disclosure overcomes many problems of the prior art associated with female urinary aids. The advantages, and other features of the system disclosed herein, will become more readily apparent to those having ordinary skill in the art from the following detailed description of certain preferred embodiments of the invention taken in conjunction with the figures which set forth representative embodiments of the present disclosure.  
         [0028]    Referring to FIG. 1, there is shown urinary incontinence device constructed in accordance with a preferred embodiment of the subject disclosure and designated generally by reference numeral  100 . In general, the device  100  includes a securing portion  110  to sealingly engage a patient, a carriage  130  for storing urine and a drain tube  140 . In operation, the patient is ambulatory yet micturation is captured for subsequent release. The device  100  is secured in place as easily as a tampon and remains hidden under the patient&#39;s clothing in a manner superior to diapers and pads. The drain tube  140  allows the patient to selectively empty the reservoir body.  
         [0029]    With continuing reference to FIG. 1, the securing portion  110  includes an elongated tab  112  which serves to secure the device  100  in place. The tab  112  is sized and shaped for insertion into the vaginal opening  180  of the patient. Preferably, the tab  112  is constructed of nylon, styrene, flexible polyvinyl plastic or the like. Hinges  114  integral with the tab  112  create flexibility which helps the tab  112  conform to the patient&#39;s anatomy. In one embodiment, the upstanding tab  112  is coated with a bio-compatible adhesive to secure placement of the tab  112  and therefore the device  100  in place. The bio-compatible adhesive preferably does not alter the bacteria flora balance of the vaginal track. A string  116  in combination with the hinges  114  facilitates easy removal of the tab  112  from the vaginal opening  180 . In one embodiment, the adhesive on the tab  112  is pressure sensitive and contains a hydrophilic resin. Further, the coating weight of the adhesive on the tab  112  should be set to maximize wet adhesion and wet shear resistance. In another embodiment, a water soluble adhesive based upon polyvinylmethyl ether may be used. In yet another embodiment, the tab  112  has a plurality of protuberances (not shown) to engage the vaginal rugae and help secure the tab  112  in place.  
         [0030]    The securing portion  110  also includes a rim  118  sized and configured to sealingly engage the labia minora of the patient (see FIG. 4). The rim  118  defines an inlet  120  which surrounds the urethra of the patient. Preferably, the tab  112  is disposed adjacent the rim  118  and projects at approximately a 45-50 degree angle so that it corresponds with that of the typical vaginal axis. Preferably, the rim  118  is composed of a malleable material, such as rubber, so that it readily conforms to the anatomy of the patient. It is envisioned that in order to effectively seal around the urethra, the rim  118  is coated with a bio-compatible adhesive appropriate to the corresponding contact area with the patient. In one embodiment, the adhesive of the rim  118  swells and becomes sticky upon contact with moisture. Further, the rim  118  may have a groove (not shown) which is filled with adhesive. In a preferred embodiment, the groove has a depth of 0.0015 to 0.0020 inches.  
         [0031]    The securing portion  110  also includes a flange  122  surrounding the rim  118 . The flange  122  engages the labia minora to help secure the rim  118  in place on the patient. Preferably, the flange  122  is constructed of nylon, styrene, flexible polyvinyl plastic or the like. In one embodiment, a sticky adhesive is hot melt onto the flange  122  to create the securement of the flange  122  to the labia minora. In another embodiment, the flange  122  is provided with double-sided tape. In still another embodiment, the flange  122  is provided with adhesive by a vacuum transfer process. The adhesive should be bio-compatible with respect to the contact area. Further, the adhesive may contain a moisture absorbent component such as carboxy methyl cellulose to enhance adhesion. In yet embodiment, no flange is required.  
         [0032]    Still referring to FIG. 1, the carriage  130  depends from the rim  118  of the securing portion  110  to collect urine as it evacuates the patient. Preferably, the carriage  130  is sized and configured for free movement of the patient and concealment under traditional clothing. When empty as shown, the carriage  130  compresses to maximize comfort and minimize obtrusiveness. It is envisioned that the top surface  132  of the carriage  130  is a flexible polyvinyl plastic in order to provide shape and support. In one embodiment, a plurality of channels  134  in the top surface  132  of the carriage  130  provide additional structural support. A plurality of bellows portion  136  depends from the top surface  132  of carriage  130  to allow for expansion as urine collects therein. The bellows portion  136  is preferably elastomeric in construction.  
         [0033]    A drain tube  140  depends from carriage  130  for allowing the patient to release urine collected therein. The drain tube  140  has a manual release valve  142  to allow selective opening of the drain tube  140  by the patient. Alternatively, the drain tube  140  terminates with a check valve that opens and closes with the use of a pull tab (not shown). In yet another embodiment, the drain tube  140  terminates in a collection bag (not shown). In still another embodiment, the drain tube  140  includes an internal pinch valve.  
         [0034]    It is also envisioned that the drain tube  140  allows cleansing and medicating of the vaginal area without removal of the device  100 . For cleansing, the patient would introduce a cleaning solution such as water into the carriage  130  by way of the drain tube  140 . For medicating, the patient would introduce by way of the drain tube  140  a therapeutic solution. The therapeutic solution would be varied according to the condition of the patient such as an anti-inflammatory agent, an antibiotic, a fungicide or the like.  
         [0035]    Referring to FIG. 2, the string  116  is preferably attached to a distal end  124  of the upstanding tab  112  to facilitate easy removal of the device  100  by minimizing the effort required to remove the tab  112 . In one embodiment, the top surface  132  of the carriage  130  contains a leak proof air vent  126 . The air vent  126  allows efficient emptying of the carriage  130  without creating a vacuum effect therein.  
         [0036]    It should be recognized that although “patient” is used throughout the specification to refer to a woman utilizing the subject system, the patient may be ambulatory and other than minor urinary incontinence perfectly healthy. For simplicity, the subject application describes a patient inserting and removing the subject invention, however, it is also envisioned that a caregiver may insert, empty and remove the device  100 . Preferably, the patient uses their hands to insert the device  100 .  
         [0037]    Referring to FIG. 3, to apply the device  100 , a patient inserts the tab  112  into the vaginal opening along the direction indicated by arrow  170 . If the adhesives are coated with silicone coated release paper (not shown), the patient removes the silicone coated release paper or similar non-sticking packaging in preparation for use of the device  100 .  
         [0038]    Referring to FIG. 4, during application the patient fully engages the tab  112  within the vaginal opening to locate the rim  118  around the urethra. The device  100  is secured in place sufficiently to withstand greater than 100 mmHg output pressure of the urethral sphincter and contain up to 400 ml of micturation. As a result, when the bladder evacuates through the urethra, the urine passes through the inlet  120  in the direction indicated by arrows  172  into the carriage  130 .  
         [0039]    It is envisioned that the tab  112  can be held in place due to the pressure from the wall of the vaginal opening. When the tab  112  is coated with a pressure sensitive adhesive, the pressure from the wall of the vaginal opening will create additional adhesive tension. Similarly, if the tab  112  has protuberances (not shown) provided thereon, the pressure from the wall of the vaginal opening will create additional structural tension with the protuberances.  
         [0040]    Still referring to FIG. 4, when pressure is applied on the rim  118 , it conforms to the surface of the labia minora. Preferably, an adhesive on the rim  118  swells and becomes sticky to create a periurethral leak-proof seal. As the flange  122  engages the labia minora, the rim  118  is further affixed about the urethra. Preferably, the flange  122  is pressed into place to engage an adhesive thereon in contact with the labia minora.  
         [0041]    The forward portion of the carriage  130  and the drain tube  140  can be flexed to rest against the patient&#39;s lower abdomen. Thus, the obtrusiveness of the device  100  is minimized. As the carriage  130  collects urine, the plurality of bellows portion  136  expands outwardly in the direction indicated by arrow  174 . When the carriage  130  is full of urine, the urine may splash undesirably while a patient moves. Further, the splashing may cause partial leakage about the rim  118 . Under such circumstances, it is envisioned that a reticulated polyurethane foam (not shown) in the carriage  130  will absorb the urine to prevent sloshing and the associated undesirable effects and will add only minimal weight.  
         [0042]    Referring to FIG. 5, to empty the carriage  130 , the patient positions the drain tube  140  over a toilet and opens or removes the valve  142  to allow the urine to exit out of the drain tube  140  in the direction indicated by arrow  176 . The patient may be lying down, sitting or standing to evacuate the carriage  130 . As urine exits, air enters air vent  126  in the direction indicated by arrow  178  and the plurality of bellows portion  136  compresses in the direction indicated by arrow  180 . When evacuation of the carriage  130  is complete, the drain tube  140  is again blocked by the valve  142  and the patient can once again return to normal activity. It is envisioned that the patient may apply the device  100  and wear it for extended periods while evacuating the carriage  130  multiple times as may be required. When removal of the device  100  is desired, the patient can grasp the string  116  and remove the tab  112  from the vaginal opening. If the rim  118  and flange  122  are provided with adhesives, they can be manually peeled away from the periurethral surface and the labia minora, respectively.  
         [0043]    Referring to FIG. 6, another device constructed in accordance with the subject disclosure is illustrated and designated generally by reference numeral  200 . In general, device  200  includes a securing portion  210  to sealingly engage a patient, a reservoir body  210  for storing urine and a drain (not shown). In operation, the patient is ambulatory, the device  200  remains hidden and the patient can selectively empty the reservoir body.  
         [0044]    The securing portion  210  includes an elongated tab  212  which serves to secure the device  200  in place. Preferably, the hinges  214  create flexibility which helps the tab  212  conform to the patient&#39;s anatomy. The upstanding tab  212  is coated with a bio-compatible adhesive to further secure placement of the tab  212  and therefore the device  200  in place.  
         [0045]    The securing portion  210  also includes a rim  218  sized and configured to sealingly engage the periurethral surface of the patient. The rim  218  defines an inlet  220  which surrounds the urethra of the patient. It is envisioned that in order to effectively seal around the urethra, the rim  218  is malleable and coated with an adhesive. In one embodiment, the adhesive of the rim  218  swells and becomes sticky upon contact with moisture.  
         [0046]    The securing portion  210  also includes a flange  222  surrounding the rim  218 . The flange  222  engages the labia minora to help secure the rim  218  in place periurethrally on the patient. Preferably, a sticky adhesive is hot melt or vacuum transferred onto the flange  222  to create the securement of the flange  222  to the labia minora. In another embodiment, the flange  222  is provided with double-sided tape.  
         [0047]    Referring now to FIG. 7, the reservoir body includes a diaphragm  230  depending from the rim  218  to collect urine as it evacuates the patient. Preferably, the diaphragm  230  is sized and configured to be contained within the flange  222  when empty. Further, the diaphragm  230  is preferably elastomeric in construction to provide additional expansion and absorption of the energy of evacuating urine. The diaphragm  230  defines a drain  240  for allowing the patent to release urine collected therein. The drain  240  is an opening at the lowest part of the diaphragm  230 . Release  244  allows the patient to manually open the drain  240 .  
         [0048]    In use, the patient fully engages the tab  212  within the vaginal opening to locate the rim  218  around the urethra. It is envisioned that the tab  212  is held in place due to the pressure from the wall of the vaginal opening and adhesive tension. As a result, when the bladder evacuates through the urethra, the urine passes into the diaphragm  230 . The diaphragm  230  defines a plurality of bellows  236  to allow for expansion as urine collects therein.  
         [0049]    When pressure is applied on the rim  218 , the rim  218  conforms to the periurethral surface. Preferably, an adhesive on the rim  218  swells and becomes sticky to create a periurethral leak-proof seal. As the flange  222  engages the labia minora, the rim  218  is further affixed about the urethra. Preferably, the flange  222  is pressed into place to engage an adhesive thereon. The drain  240  extends away from the patient at the lowest point of the diaphragm  230 . The drain  240  is normally blocked with a one-way valve (not shown) or an end plug  242  which is attached to a release  244 .  
         [0050]    Referring now to FIG. 8, when the device  200  is in place on a patient, the rim  218  surrounds the urethra exit point. As a result, when the bladder evacuates through the urethra, the urine passes into the diaphragm  230 . As the diaphragm  230  collects urine, the plurality of bellows  236  expand downward. Preferably, the diaphragm  230  is constructed of elastomeric material to allow further expansion. When the diaphragm  230  is full of urine, the patient may empty the diaphragm  230  from the drain  240 . Preferably, the drain  240  extends from the low point of the diaphragm  230  to facilitate complete evacuation of the diaphragm  230 . It is envisioned that the patient will empty the device  200  into the toilet. Alternatively, the patient may empty the device  200  into a receptacle for subsequent disposal. To open the drain  240 , the end plug  242  is removed by pulling the release  244 .  
         [0051]    Referring now to FIG. 9, there is disclosed a urine collection system constructed in accordance with the subject disclosure and designated generally by reference numeral  300 . The system  300  includes a securing portion  310  to sealingly engage a patient, a collection portion for storing urine and an irrigation portion for cleansing the vaginal area. In operation, the securing portion  310  engages the patient to capture micturation in a bag  330  of the irrigation portion for subsequent release. The irrigation portion allows the patient to cleanse and medicate the vaginal area of the patient.  
         [0052]    The securing portion  310  includes a tab  312  which serves to secure the system  300  in place. The tab  312  is sized and shaped for insertion into the vaginal opening of the patient. Preferably, the tab  312  is coated with an adhesive to secure the tab  312  within the vaginal opening. The tab  312  does not have a string and is removed by grasping. In another embodiment, a string is fixed on a distal end of the tab  312  to facilitate removal from the vaginal opening.  
         [0053]    The securing portion  310  also includes a rim  318  sized and configured to sealingly engage the periurethral surface of the patient. The rim  318  defines an inlet which surrounds the urethra of the patient. Preferably, the rim  318  is coated with a bio-compatible adhesive appropriate to the corresponding contact area with the patient. The securing portion  310  also includes a flange  322  surrounding the rim  318 . The flange  322  engages the labia minora to help secure the rim  318  in place on the patient. Preferably, the flange  322  is coated with a bio-compatible adhesive to enhance engagement with the patient.  
         [0054]    With continuing reference to FIG. 9, the collection portion includes a syphon portion  340 , shown partially in phantom lines, depending from the rim  318  of the securing portion  310  to collect urine as it evacuates the patient. The syphon portion  340  terminates in a tube for irrigation  342  and a tube for urine collection  344 . In another embodiment, the syphon portion  340  is funnel-shaped. Preferably, the irrigation tube  342  terminates with a one-way check valve  346  to prevent fluid from entering the irrigation tube  342 . A conduit  348  connects to the irrigation tube  342  for delivering topical medical and irrigation solutions. The conduit  348  has a female Luer end  350  to facilitate the introduction of solutions into the conduit  348  through the one-way check valve  346  and into the syphon portion  340  for receiving a cleansing or medicating solution. It is envisioned that the irrigation portion may be adapted for use with each of the urinary incontinence devices disclosed herein. Once in the syphon portion  340 , fluids will wash over the vaginal area within the inlet of the rim  318 .  
         [0055]    The urine collection tube  344  allows the urine and fluid collected in syphon portion  340  to pass into a flexible tube  352 . In another embodiment, the urine collection tube  344  has a leak-proof air vent which allows air into the system  300  but prevents urine from leaking. The flexible tube  352  is reticulated and allows routing in a convenient manner. The flexible tube  352  empties into the bag  330 . The bag  330  has a check valve  354  at its entry to prevent backflow. Alternatively, the urine collection tube  344  may include a pinch valve or squeeze valve to allow bi-directional flow unless manually closed. Such a configuration allows solutions introduced via irrigation portion to be maintained with the syphon portion  340  to more thoroughly wash the vaginal area.  
         [0056]    The bag  330  has straps  356  to fasten to the lower leg of the patient. When full, the patient removes the straps  356 , detaches the bag  330  from the reticulated tube  352 , empties the bag  330  and reattaches the bag  330  to the reticulated tube  352  and restraps the bag  330  on their lower leg. In another embodiment for bedridden patients, the bag  330  mounts on a bed frame or adjacent structure. It is envisioned that when the irrigation tube  342  is used, the cleansing and medicinal solutions are collected in the bag  330  for disposal.  
         [0057]    While the disclosure has been described with respect to preferred embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made thereto without departing from the spirit or scope as defined by the appended claims.