Abstract:
The female urine collection device includes a formable ring and a collection receptacle. In one embodiment, the receptacle is an external catheter with a flexible neck that passes through and folds back over the ring. In another embodiment, the ring and collection receptacle are integrally formed. In all embodiments, the ring may be placed against the tissue around the urethral meatus to form a seal with the neck, permitting voiding into and through the collection receptacle. The ring may be manually held in place against the tissue around the urethral meatus to form a good seal. A protruding tip or probe may be included and inserted slightly into the vaginal opening or entrance to assure proper placement of the ring. In such embodiments, the ring may be integrally formed with the probe. An adjustable, inflatable pessary anchor may also be provided to help secure the collection receptacle adjacent the genital tissue.

Description:
This is a Continuation in Part of application Ser. No. 08/988,254 filed on Dec. 10, 1997. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention is generally related to non-invasive fluid collection apparatus and is specifically directed to a female urine collection device adapted for use in confined environments such as fighter jet cockpits or weightless environments in space and/or for use with invalid or semi-invalid patients. 
     2. Discussion of the Prior Art 
     Collection of urine in weightless environments has long been a problem on extended space flights. The problem is particularly complicated for female astronauts. Over the last twenty years, a number of devices have been designed and tested, but to date, all have been rejected because of discomfort in use, leakage and health risks, drawbacks that are particularly unsuitable for extended space flight. In addition, such devices are typically difficult to secure in place, which further aggravates the above mentioned drawbacks. Examples of devices which have proven to be unacceptable are manufactured by Hollister, Inc., Sherwood Medical Company and Rochester Medical. ITW Diamed Division also offered a Misstique External Urinary Collection System at one time. A product sold under the name FemFit has also been tested. The FemFit was rejected because of discomfort. While the Hollister and Misstique devices were more comfortable, they are semipermanent devices which must be fitted internally on the astronaut for the duration of the flight. 
     More recently, devices have been developed which include a rabbit ear type construction to be inserted into the vagina, with a cup placed over the urinary meatus, to be worn during the entire flight. This prior art device has been found to be undesirable because it is difficult to insert, is often painful to wear, and often leaks due to the collapsible tendency of the cup. In 1989, Merz, et al received U.S. Pat. No. 4,889,532, entitled: FEMALE URINARY INCONTINENCE DEVICE WITH A FORWARDLY-DIRECTED DISCHARGE PASSAGE AND SUPPORT SURFACE PORTIONS. The device is designed to be used primarily while seated, and incorporated a large pad attached to a periurinary meatus cup with a vaginally receptive urine deflective extension. In a weightless environment, the deflective extension actually drives urine into the vagina, causing discomfort, leakage and possible infection. The device is particularly ill-suited for extended space flight use. In a normal gravitational environment, leakage is a serious problem, since fluids tend to collect on the pad and then spill once the pad is removed. However, under weightless conditions, even a slight leak, which may be tolerable in a normal environment, is completely unacceptable. Furthermore, while a number of devices, such as belts and undergarments, have been utilized in attempts to secure these urine collection cups in place, nothing in the prior art has heretofore been found to be acceptable. 
     Although the above mentioned problems are most acute with respect to space flight, similar problems have been observed in urine collection devices utilized in other environments, such as hospitals or nursing homes, where such devices may be utilized for persons unable to function normally without assistance. 
     SUMMARY OF THE INVENTION 
     The subject invention is directed to a urine collection device for use by female astronauts while in a weightless environment. The device is also ideally suited for use in cases where a female patient is confined to a recumbent position. The device of the present invention permits collection of urine, either for disposal or for collection of specimens and samples, without leakage using a non-invasive procedure. 
     The preferred embodiment of the invention utilizes a malleable ring, preferably of a formable metal or rubber, that can be formed or manipulated to fit by the user or the care provider. A collection receptacle is attached to the ring. In one preferred embodiment, the receptacle is an external catheter and resembles a collapsible bag or cup with an elongated, reduced neck portion secured to the ring. In another embodiment, the receptacle is a cup integrally formed with the ring. In use, the ring is held on the palm side of the hand with the receptacle extending through the gap between the index and forefingers, such that the receptacle and any attached fluid capture bag are located on the back side of the hand. With the bag away from the body, the ring is placed against the tissue around the urethral meatus in a position such that it is in communication with the urinary meatus opening completely surrounding it. The ring is shaped to permit a good fit. The ring is held in position by the two fingers, with the palm of the hand toward and against the genital region and the fingers positioned to point in a posterior direction. The seal is formed by pressing the ring into the tissue around the urinary meatus. This achieves a good seal in the anterior portion of the tissue around the urethral meatus because of the firmness of the tissue in that area. If necessary, a good seal may be assured in the posterior portion of the ring by pressing the lower part of the ring slightly inside the vaginal opening or entrance and against the anterior wall thereof. When properly positioned, the ring should fit between the bones of the pelvis. The user then voids through the ring and into the receptacle which is in fluid communication via a tube with a urine capture device such as a bag or vacuum system. The receptacle may be sealed at the tube by clamping. In some applications, particularly in a weightless environment, the receptacle may be squeezed by the fingers prior to clamping to assure that all of the voided urine is forced into the bag. 
     Where desired, a probe may be provided on the lower portion of the ring to assure proper positioning of the ring relative to the urinary meatus and the vagina. This is particularly useful when a care giver is using the device with an invalid patient. In one embodiment, such probe may be integrally formed with the ring. In another embodiment, such probe may be integrally formed with the ring and the receptacle. 
     The device is particularly well suited for use in a weightless environment where gravity cannot be used to assist in the flow of the voided liquid. All of the void is directed into the neck of the receptacle which can be squeezed, as necessary, to assure all of the liquid is driven into a capture bag attached to the device. The device virtually eliminates leakage since it forms a good seal around the urinary meatus opening in a unique and non-invasive manner. 
     It is, therefore, an object and feature of the invention to provide a convenient, easy to use device for collecting voided liquids in a weightless environment by a female astronaut. 
     It is also an important object and feature of the invention to provide a urine collection device which may be used by patients while in either a standing, sitting or recumbent position for collection of specimens or for disposal. 
     It is another object and feature of the invention to provide a female urine collection device that permits collection of the voided liquid in a non-invasive procedure. 
     It is a further object and feature of the subject invention to provide a urine collection device which is easy to use and may be utilized with minimum training either by the user or by a care giver. 
     It is an additional object and feature of the invention to provide a female urine collection device that is of simple design and is inexpensive to manufacture, permitting mass manufacture of the units in a disposable configuration. 
     Other objects and features of the invention will be readily apparent from the drawings and following detailed description. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of the urine collection device of the subject invention. 
     FIG. 2 is an exploded view of the device of FIG.  1 . 
     FIG. 3 is an enlarged fragmentary sectional view taken generally along line  3 — 3  of FIG.  1 . 
     FIG. 4 is a cross-sectional view taken along line  4 — 4  of FIG.  3 . 
     FIG. 5 is a cross-sectional view taken along line  5 — 5  of FIG.  3 . 
     FIG. 6 is a perspective view of the preferred embodiment of the subject invention with the probe device removed. 
     FIG. 7 is an enlarged fragmentary sectional view corresponding generally to FIG.  3  and taken along the line  7 — 7  of FIG.  6 . 
     FIG. 8 is a planar view of the malleable ring component of the subject invention, formed to provide a custom fit, with the original ring shape shown in phantom. 
     FIG. 9 is an edge view of the ring shown in FIG. 8, also shaped to provide a custom fit, with the original ring shape shown in phantom. 
     FIG. 10 is a perspective view of an embodiment of the invention in which the ring, receptacle and probe are integrally formed and attached to a pessary anchor. 
     FIG. 11 is a perspective view of another embodiment of the invention in which the ring, receptacle and probe are integrally formed. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The preferred embodiments of the invention comprise three distinctive configurations that combine a ring with a urine collection receptacle. In one configuration, as shown in FIGS. 1-5, the urine collection device includes a receptacle or periurethral cup  9  having a sleeve  18  and a probe  12  adapted to be placed in the vaginal opening in order to assure proper orientation. This is particularly suited for applications where a care giver is using the device on a patient. Another configuration shown in FIGS. 6 and 7 eliminates the probe and may be used where the probe is not acceptable or desirable. In another configuration shown in the embodiments of FIGS. 10 and 11, the cup is integrally formed with the probe. In any of these configurations, a ring may be used to (i) form a flange or enlarged lip to permit a person to easily and securely hold the urine collection device in place and (ii) form a seal between the device and the tissue around the urethral meatus. The ring may also be used to secure an external catheter to the periurethral cup in configurations incorporating such. FIGS. 8 and 9 illustrate one configuration for the ring. 
     With specific reference to FIGS. 1,  2 ,  10  and  11 , the probe component  12  includes a probe end  14  with a radiused tip and formed to define a cupped channel  16 . The probe end  14  terminates in an enlarged, generally cylindrical, open ended deformably resilient sleeve  18  around which a ring may be positioned. Depending on the particular configuration and use of ring, the sleeve and probe and ring may be made of unitary construction such as is shown in FIGS. 10 and 11 (see ring  50 ), or as shown in FIGS. 1 and 2, may be made of assembled discrete components (see ring  38 ). 
     Turning to the exemplary embodiment of FIGS. 1 and 2, the sleeve is ribbed as at  20  and  22  to permit the sleeve to seat against the inner surface of the ring. In the illustrated embodiment, the external catheter component comprises a collapsible bag  24 , a neck component  30  and a coupler  26  having a reduced portion  28  adapted for receiving a reduced connector end  32  of the neck component  30 . The enlarged or expanded portion  34  of the neck component is a tubular member made of a flexible material so that it can be rolled as shown at  36 . The outer diameter of the neck  34  is approximately the same as the diameter of the ring  38 . When assembling the device, the rolled portion  36  is placed through the ring  38  and folded back over the ring at fold  40  (see FIG.  3 ). The resilient sleeve can then be compressed or otherwise deformed and inserted into the ring such that the assembled ring and neck are placed over ribs  20  and  22  on sleeve  18 , where they are friction held in assembled relationship by the restoration force of sleeve  18  as it presses out against ring  38 . When assembled in this manner, ring  38  can serve three functions. First, the diameter of a cross-section of the ring is large enough to function as a flange or lip against which a person can apply pressure to hold the periurethral cup against the tissue around the urethral meatus. Second, having a large diameter also permits the ring to be securely pressed into the soft tissue posterior to the urethral meatus to form a tight seal with the body to the extent the ring is used to form a seal with the body. Third, the ring serves as a rigid surface against which sleeve  18  can press under its radial restoration force to secure and seal the neck component of the external catheter between the ring and the sleeve. More specifically, the sleeve  18  is made of a resilient, slightly flexible material such as, by way of example, a synthetic rubber of the like, and can be formed to fit the shaped ring  38  (see FIGS.  4  and  5 ). In use, the probe tip  14  is inserted slightly into the vaginal opening to position the opening in the sleeve  18  and the ring  38  in alignment with the urinary meatus opening. The index and forefingers are used to apply axial pressure to the ring such that the ring is held firmly against the tissue around the urethral meatus by the index and forefingers with the neck  32  extending through the fingers and the bag positioned on the back side of the hand. 
     In this embodiment, while the enlarged portion of the neck is very flexible, the smaller portion will be more firm so that it does not collapse during use. The ribs or ridges on the sleeve are optional and other methods of securing the ring and neck to the assembly may be utilized, as will be known to those who are skilled in the art. 
     An embodiment more preferable for use in a weightless environment is shown in FIGS. 6 and 7. As there shown, the bag  24 , coupler  26  and reduced portion  28 , and the neck assembly  30  are the same as in the embodiment of FIGS. 1-5. The enlarged or expanded portion  34  of the neck is passed through the ring  38  (see FIG. 7) and folded over the ring  38  at fold  40 . The outer end of the expanded portion may be rolled as in FIGS. 1-5 or unrolled as in FIGS. 6-7. The length of the fold  40  as shown in FIG. 7 is not a critical part of the invention as long as it is sufficient to eliminate any leakage between the sleeve and the neck. In this second embodiment, ring  38  serves only two functions. First, the diameter of a cross-section of the ring is large enough to function as a flange or lip against which a person can apply pressure to hold the periurethral cup against the tissue around the urethral meatus. Second, this large diameter also permits the ring to be securely pressed into the genital tissue to form a tight seal with the body. In use, the ring is positioned in the palm of the hand, with the neck between the index and forefingers, with the bag on the back side of the hand. The ring is placed firmly against the genital tissue and surrounding the urinary meatus. As better shown in FIGS. 8 and 9, the ring  38  may be formed to provide a good fit, with the posterior end  42  bent slightly toward and, if necessary, slightly into the vaginal opening. The peripheral shape of the ring may be adjusted, as shown in FIG. 8, to fit. It is desirable that the ring fit between the pelvic bones for best results. Again, in this embodiment, while the enlarged portion of the neck is very flexible, the smaller portion will be more firm so that it does not collapse during use. 
     In the embodiment shown in FIGS. 10 and 11, periurethral cup  9  and probe  12  are integrally formed with a ring  50 . Again, probe  12  includes a probe end  14  with a radiused tip and formed to define a cupped channel  16 . The probe end  14  terminates in an enlarged, generally cylindrical, open ended deformably resilient sleeve  18  which forms a part of cup  9 . In FIG. 10, ring  50  borders the opening formed by the intersection of the open end of sleeve  18  and the open portion of channel  16 . In FIG. 11, ring  50  borders the open end of sleeve  18  while probe  12  extends therefrom. 
     In the embodiment of FIG. 10, periurethral cup  9  is also provided with a pessary anchoring device  52  used to secure cup  9  adjacent the tissue around the urethral meatus. Specifically, anchoring device  50  comprises an inflatable balloon  54  in fluid communication with an air bulb  56  by way of a tube  58 . An air bulb  56  may be used to inflate balloon  54 . A valve  60  may be provided to control release of air from balloon  54 . Of course, those skilled in the art will understand that balloon  54  may have any suitable shape and various methods and structures for inflating and deflating balloon  54  may be used without departing from the invention. In one embodiment, cup  9  is attached to anchoring device  50  by way of an apertured shoulder  62  integrally formed as part of cup  9 . Shoulder  62  is provided with an aperture  64  to permit cup  9  to be slidingly mounted on air tube  58 . Although not necessary to the general anchoring function of anchoring device  50 , balloon  54  may also be provided with one or more drainage apertures  55 . 
     In use, balloon  54  is inserted into the vaginal cavity and inflated until comfortably seated within said cavity. Cup  9  may be slidingly moved along tube  58  until cup  9  is properly positioned against the genital tissue around the urethral meatus. One desirable feature of such an anchor is the ability to adjust the system for different size persons. Specifically, the inflation size of balloon  54  can be adjusted to fit different size vaginal cavities, while the position of cup  9  along flexible tube  58  may be adjusted relative to balloon  54  to accommodate different body shapes and sizes. If balloon  54  is provided with one or more apertures  55 , such apertures permit drainage of bodily secretions from the vaginal cavity, such that the anchoring device may be left inserted for extended periods of time without posing infection or other health risks to the user. 
     In all of the preferred embodiments, the sleeve is preferably formed of a firm but flexible material such as silicone. The neck of the external catheter is preferably formed of a thin, flexible material such as latex. Of course, it will be understood that other materials may be substituted. The ring is preferably a formable material, such as deformable metal for strength or rubber for flexibility. In one embodiment, a deformable metal ring is molded inside of softer rubber, enhancing both the strength of the ring and the ability to seal against the tissue around the urethral meatus. Such an arrangement can be used in any of the above-described embodiments. In integrally formed embodiments, the individual components may be formed of the same material, such as flexible rubber or similar material. Preferably, all materials are inert such that prolonged contact with the user will not cause any type of allergic, infectious, or similar negative reaction by the user. 
     The neck, sleeve and ring are an assembled device, which may be adapted to be connected to any of a variety of tubes, bags, or other urine capture devices. For example, in FIGS. 10 and 11, tube  72  is provided to attach the invention to a urine collection bag  74 . Alternatively, collection bag  74  could be replaced by a vacuum system (not shown) or other fluid/waste collection system. Those skilled in the art will understand that other urine capture devices may be used without departing from the invention.