Female urinary incontinence device

[57] ABSTRACT

A female urinary incontinence device including a pessary-like support, a deformable loop extending outward from the support and a flexible container removably secured to and opening through the loop. The deformable loop is adapted to encircle the urethral orifice of a wearer to hold the container in a desired position when the pessary-like support is received and retained within the vagina.

Claims, 4 Drawing Figures

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PATENTEDMAY 91972

3.661.155

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3,661,155

FEMALE URINARY INCONTINENCE DEVICE

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to a urine receptacle for women.

2. Prior Art

Female urinary devices adapted to be worn by the patient and having a urinary receptacle with or without a drain are known. Such devices are intended to eliminate the need for catheterizing or diapering female patients who are incontinent, due for example to paralysis, senility, or other causes. Known devices of this type are secured in place in various ways, including external straps or vaginally insertable portions that resiliently clasp the body. These devices require frequent cleaning or complete disposal after use, with accompanying bother or expense, and risk displacement when the patient moves or is moved. Furthermore, devices for this purpose must readily accommodate the anatomical differences that exist among individuals, especially in the specific location of the urethral orifice. The failure of known devices to satisfactorily fulfill the existing needs is evidenced by the generally continued practice of catheterizing incontinent bed-ridden patients. A need exists for a compact, easily constructed, economical, device that can be reliably retained in place, that is comfortable to wear and easy to clean, that accommodates the significant variations among individuals in the specific location of the urethral orifice, and that preferably includes a low-cost, disposable, receiver that is readily removed from and replaced on a supporting portion of the device.

SUMMARY OF THE INVENTION

Devices embodying the present invention include a vaginal pessary-like support portion, a formable loop portion extending therefrom and adapted to encircle the urethral orifice of the wearer, and a urinary receiver portion extending from the loop portion. The pessary-like support portion and the loop portion are selected of a size to fit the particular wearer, with the loop portion being of a shape and of a sufficient size to accommodate a wide variation in the actual location of the urethral orifice and to in part extend into the vaginal introitus. In addition, the loop portion is constructed to be variably positioned and to be conformed to a shape that follows the contour of the body to assure a close fit of the receiver portion about the urethral orifice, inside the labia minora. In the preferred embodiment, the pessary-like support portion is a resilient ring that is easily inserted and that expands after insertion to securely, reliably and comfortably retain the loop portion and receiver portion in place. The receiver portion may suitably be a tubular plastic or rubber member with an upper urine-receiving opening. In the preferred embodiment, the receiver is a receptacle or container and can include a closable discharge orifice for convenience in emptying. Alternatively, the receiver portion may be a part of or connected directly to a drain, with little or no capacity for urine storage. The upper portion of the receiver, defining the opening, is preferably constructed to facilitate the temporary attachment and removal of the receiver-receptacle to the loop portion.

The present device is readily fabricated from available items, for example, a spring ring of the type used in diaphragms and coated with latex is especially suitable as the support, the loop can be formed of malleable wire with a plastic covering, and the receiver portion can be made from thin rubber or plastic film, such as polyethylene. The ring and loop are easily cleaned and can be reused. The receiver portion can be conveniently and inexpensively replaced, thereby eliminating the need for cleaning and minimizing any risk of infection or objectionable odor. In use, the device ensures separation of the periurethral area of urinary collection from the perianal area, and prevents wetting of the skin of the perineum, buttocks and thighs. If the receiver portion is in the form of or includes a receptacle, it can be worn during the day and can be emptied easily and conveniently when filled. When a larger storage capacity is required, such as during the night, the receiver-receptacle, if provided with a discharge orifice, can be connected to a conventional leg bag or to a bed bag without detaching or removing the device itself. If not provided with a discharge orifice, or if a patient is completely bed-ridden, a receiver without storage capacity and constructed primarily for connection to a drain and drainage bag can be used.

The above and other features and advantages of this invention will become more apparent from the detailed description that follows, when considered in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of a sagittal section of a human female pelvis showing a urinary incontinence device embodying the present invention in place;

FIG. 2 is a perspective view of a preferred embodiment of the incontinence device of the present invention with a receptacle portion disassociated from a supporting portion;

FIG. 3 is a partial perspective view similar to FIG. 2, showing the receptacle portion attached to the supporting portion; and

FIG. 4 is a partial perspective view of another embodiment of the present invention.

DESCRIPTION OF A PREFERRED EMBODIMENT

A female urinary incontinence device embodying the present invention is indicated generally at 10 and is shown in place in the sagittal section diagram of a female pelvis depicted in FIG. 1. The device 10 includes a supporting portion 12 and a receiver portion 14. The supporting portion 12 is constructed to be at least partially received within the vagina and serves to support and secure the receiver portion to the wearer in proper position adjacent the urethra, as shown in FIG. 1. The receiver portion 14 is in the form of a flexible container adapted to be removably secured to the supporting portion in contact with the wearer around the urethral orifice, inside the labia minora, and serves to receive and collect urine. Alternatively, as shown in FIG. 4, a receiver portion 14' can be constructed without storage capacity, primarily for connection to a drain or conduit.

As best shown in FIG. 2, the supporting portion 12 includes a vaginal pessary-like support 16 and an attached loop 18. In the preferred embodiment shown, the pessary-like support is in the form of a vaginal spring pessary, more particularly a spring diaphragm ring 19 or the like, typically circular, and covered with a latex coating 20 to reduce irritation to the wearer. As an alternative, malleable or otherwise formable material can be used for the ring and be formed to the particular shape required for the individual. The attached loop 18 is somewhat smaller than the ring 16 and extends outwardly from the ring. The loop 18 is constructed to conform or to be conformed to the contour of the body about the urethral orifice and to that end is, in the preferred embodiment, made of a malleable or plastic material, i.e., a material capable of being molded or shaped without breaking or returning to its original shape, including material that may require the application of heat or other softening agent to facilitate shaping. As shown, the loop 18 is a malleable copper wire 21, with a tubular protective plastic covering 23 or alternatively a latex coating or other suitable padding over its surface and is secured to the ring by its end portions 18α, 18i&gt;, which are spaced slightly apart, bent tightly over the ring, and recessed with respect to the latex coating 20 to avoid causing discomfort. Other known techniques for securing the support 16 and loop 18 may be used, depending upon the material from which the parts are made, to satisfactorily connect the two parts. It would be appreciated that where the ring 16 is not resilient, a one-piece construction can be utilized and could, for example, be of plastic or the like. In use, the exact shape of the loop must vary somewhat for different individuals and the malleable or plastic material should be individually adjusted to follow the contour

3,661,155 of the patient’s body about the urethral orifice. In a typical adjusted position, as shown in FIGS. 1 and 2, the ring 16 is substantially planar and loop 18 is elongated and curved longitudinally to extend first downward and outward from the ring 16 in the orientation of FIGS. 1 and 2 and then extends across the plane of the ring so as to follow the adjacent contour of the body of the wearer. In its general extent, the loop 18 is somewhat angularly related to the plane of the ring in a typical adjustment, as shown. The loop is substantially larger than the urethral orifice and extends into the vaginal introitus or opening, as illustrated in FIG. 1, and the ends 18α, 18b are spaced apart on the ring 16 to provide a large opening to the receiverreceptacle portion 14, all of which features serve to accommodate the significant variations that exist in the location of the urethral orifice among different individuals and to assure that the receptacle is properly positioned regardless of such variations. Typically, the ring 16 will be of a diameter between 35 to 100 millimeters and the loop will be of a length between 30 and 70 millimeters with a corresponding width at the point of maximum separation of 15 to 40 millimeters, respectively, and of 5 to 10 millimeters, respectively, where connected to the ring. The loop proportions remain about the same for various sizes and the largest loops are typically used with the largest rings, although not necessary.

The combination receiver and receptacle portion 14 includes a disposable, flexible bag 22 of thin plastic or rubber, or the like. In the preferred embodiment shown, the bag 22 is elongated, generally tubular in form and completely open at one end 22α, which is the upper end as worn and as shown in the orientation of the drawings. The lower end 22b optionally includes an orifice 24 in which case a piece of tubing 26 projecting through the orifice is also provided. A fluid-tight seal is provided between the bag and tubing piece, which can be accomplished with a heat seal, an adhesive, or by applying a band that tightly encircles a part of the bag about the tube. Alternatively, the tube portion can be formed integrally with the bag. The tube can be occluded by a plug, clamp or band (not shown) so that the bag retains any urine that may be voided by the wearer, or can be connected to a standard drainage bag.

The upper open end 22α of the bag is dimensioned to fit, when open, within the loop 18. That is, the periphery of the bag at the open end is approximately the same length as the periphery of the loop. As best shown in FIG. 3, the bag is removably connected to the loop with the upper end extending through the loop and an upper marginal portion 22m folded over the loop and over a portion of the ring 16 between the ends 18α, 18i&gt; of the loop, and back down about the upper part of the bag. This marginal portion is adhered to the outside surface of the bag, as with a strip of pressure sensitive adhesive tape 28. With this arrangement, the opening to the bag follows the contour of the loop, which in turn is formed to closely follow the contour of the wearer. As a result, the upper end of the bag is in substantially fluid-tight relation with the area directly surrounding the urethral orifice. Other means of securing the bag may be used. For example, pressure sensitive adhesive may be provided on the outer surface of the bag about the upper edge so that the edge, when folded over the loop, will adhere to the outside surface of the bag without tape. Alternatively, a permanently attached skirt may be provided on the loop and the bag may be adhesively affixed to the skirt, as by a continuous circumferential strip of tape.

Two flaps 30, 32 project laterally from the bag 22 in opposite directions approximately midway along the length of the bag for attaching a strap 34. A slot 35 in the flap 30 and a slot 36 in the flap 32 receive the strap 34, which is adapted to surround the leg of the wearer and secure the portion of the bag 22 that depends from the loop 18 in a relatively fixed position along the leg of the wearer. Preferably, the strap is of plastic material and a surface 34a that faces the leg of the wearer is coated or covered with a soft fabric or fluff for comfort. Most advantageously, the ends of the strap have interlocking fastening material 38, 39, such as Velcro or the like, on surfaces that oppose each other when the strap encircles the leg of the wearer to adjustably secure the bag against the leg.

In use, the formable loop 18 is first shaped to conform to the wearer and a bag 22 is attached by slipping the upper end 22α of the bag through the loop, folding the top marginal portion 22m over the loop and adhering it to the outside of the bag with adhesive, preferable pieces of pressure sensitive adhesive tape 28 at spaced locations about the periphery of the loop. The support portion 12, is selected of the appropriate size for the wearer. This support and the upper edge of the bag 22 along the loop 18 are lubricated with a surgical lubricating jelly, preferably one containing a mild antiseptic agent. The device is then grasped in the usual way for pessary insertion, with the loop and receptacle towards the wrist of the inserting hand, and inserted in the vagina like a cervical diaphragm, i.e., to a position where the posterior lip of the ring 16 rests against the superior, posterior wall of the vagina immediately posterior to the cervix uteri while the anterior lip rests on the anterior, inferior vaginal wall, just inside the vaginal orifice, as shown in FIG. 1. The loop 18, properly adjusted, fits snugly around the urethral orifice and inside the labia minora. This is not a watertight seal but, because the loop and the mouth of the bag 22 are considerably larger than the urethral orifice, there is no backflow of urine around the periurethral skin, provided that an initial gravity flow into the receptacle is provided by proper positioning. The device is removed as required for cleaning and the attachment of a fresh bag. The bag can be emptied through the tube 26 when required. For larger capacity, the tube 26 can be attached to a conventional leg bag or to a bed bag, without detaching or removing the device.

In the alternative embodiment shown in FIG. 4 the receiver portion 14' is funnel-like in shape with little or no storage capacity and terminates in a tube portion 27'. The receiver portion can be made of thin, flexible, rubber or plastic and can be attached to the loop 18 in the same manner as the receiver portion 14, and the tube portion 26' can be constructed in the same manner as the tube portion 26. As shown, however, a modified construction is contemplated in which the receiver portion 14' is of one-piece construction, is relatively stiff about an upper edge portion 40 to form the loop portion and is made of a material that is formable, i.e., capable of being molded, such as readily softenable plastic material. The tube portion 41 is secured in use to a drain tube 41 and separate receptacle.

From the above description it will be apparent that a reliable and relatively comfortable female urinary incontinence device has been provided, which is easily fabricated, which properly fits the wearer, which facilitates the use of disposable bags, which can be readily secured in place or removed, and which can be emptied without removal.

While a preferred embodiment of this invention has been described in detail, it will be apparent that modifications or alterations can be made therein without departing from the spirit and scope of the invention set forth in the appended claims.