Urine retention and collection devices for incontinent women

Surgery – Means and methods for collecting body fluids or waste material – Receptacle attached to or inserted within body to receive...

Reexamination Certificate

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C604S544000

Reexamination Certificate

active

06592560

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
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.
2. Background of the Related Art
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.
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.
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's body.
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'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.
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.
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.
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.
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
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.
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.
These and other unique features of the system disclosed herein will become more readily apparent from the following description and the accompanying drawings.


REFERENCES:
patent: 3528423 (1970-09-01), Lee
patent: 3683914 (1972-08-01), Crowley
patent: 4246901 (1981-01-01), Michaud
patent: 4296745 (1981-10-01), Raymond
patent: 4484917 (1984-11-01), Blackmon
patent: 4795449 (1989-01-01), Schneider et al.
patent: 4822347 (1989-04-01), MacDougall
patent: 4846819 (1989-07-01), Welch
patent: 4889533 (1989-12-01), Beecher
patent: 4904248 (1990-02-01), Vaillancourt
patent: 4986823 (1991-01-01), Anderson et al.
patent: 5049144 (1991-09-01), Payton
patent: 5147301 (1992-09-01), Ruvio
patent: 5336208 (1994-08-01), Rosenbluth et al.
patent: 5370637 (1994-12-01), Brodeur
patent: 22 08 810 (1973-08-01), None
patent: 24 47 642 (1976-01-01), None
patent: 1 479 675 (1967-05-01), None
patent: 2 126 902 (1984-04-01), None
patent: 2 129 686 (1984-05-01), None
patent: 97/28767 (1997-08-01), None
patent: 00/00116 (2000-01-01), None

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