WO1990008561A1

WO1990008561A1 - Urinary channeling device

Info

Publication number: WO1990008561A1
Application number: PCT/US1990/000395
Authority: WO
Inventors: Bridget Rawlinson; Maurice Williams
Original assignee: Rawlinson, Brian; Sasson, Jean, P.; Kennedy, Robert, B.
Priority date: 1989-01-27
Filing date: 1990-01-19
Publication date: 1990-08-09
Also published as: EP0411085A1; EP0411085A4; JPH04500471A

Abstract

A urinary channeling device (10) for in vivo use by incontinent human females has a body of a size and shape that generally matches that of the natural body cavity located between the urethral orifice of labia majora. The body (11) is formed with a hole therethrough to which a tube (20) is mounted.

Description

URINARY CHANNELING DEVICE

TECHNICAL FIELD This invention relates to devices for use in channeling urine from the urethral orifice of incontinent human females to urine collection containers.

BACKGROUND OF THE INVENTION Many human females are chronically incontinent in that they lack good urinary control. This is a not uncommon condition with the aged and permanently paralyzed. In other cases females may normally be able to exercise urinary control, but because they are temporarily bed-ridden they cannot assume a posture to be able to urinate properly into a urine collection device. A similar situation exists with new born infant females whose urinary output cannot be properly measured by medical personnel unless all of their urine is collected. Currently this is done by weighing their wet diapers. This, however, is inaccurate and unavailable as a collection technique where urine specimens are to be examined.

Since internal catheters cannot be well used except for acute incontinency, external catheters or urinary channeling devices have been devised for female use. Exemplary of such are those shown in U.S. patent numbers 2,556,102, 3,995,329, 4,484,917 and 4,681,572. These too, however, have mostly been devised for momentary use. Generally they are designed to distend the entire vulva or perineum and thereby form a leak-free seal with it. The discomfort generated is simply tolerated momentarily. Thus, they are ineffective for long term usage as on infants or on those who are chronically incontinent.

Recently, as shown in U.S. patent 4,496,355, a female urine collection device has been devised to reduce the discomfort associated with its use so that is might be usable on a long term basis. This device is smaller than the other devices and is designed so as not to cover the vagina. It has saddle-like contours with a hump to provide a double seal with body tissues. In use the urethral meatus is bulged into the device and a portion of the device set to protrude out of the folds of the labia majora. Though the level of discomfort is reduced, substantial pressure must remain exerted upon the vulva. Thus, its users are constantly aware of its presence. Moreover, a harness must be warn about the abdomen to create sufficient pressure to hold the device in its position covering the urethral orifice without shifting and creating leakage.

Accordingly, it is seen that a need still remains for a urinary channeling device for in vivo use by incontinent females that performs well with minimal leakage and yet which generates so little pressure on the ambient body tissues as to be capable of being worn comfortably for extended time periods. It is to the provision of such that the present invention is primarily directed.

SUMMARY OF THE INVENTION In a preferred form of the invention, a urinary channeling device is provided for in vivo use by incontinent human females who have a body cavity of natural anatomical size and shape, known as the vestibule, which is located between the urethral meatus that surrounds the urethral orifice and labia majora. The device has a body of a size and shape which generally matches that of the vestibule. This configuration enables it to reside securely and generally leak-free within the body cavity without exerting , substantial pressure upon the tissues that bound the cavity. The device body is formed with a hole through which urine may pass to a collection device.

In another preferred form of the invention a urinary channeling device is provided for in vivo use by incontinent human females. The device comprises a body having a generally flat or slightly convex front wall that has a generally oval periphery from which side walls convergently extend about a body cavity to a rear rim about the cavity. The body has a hole therein that extends from the front wall to the cavity.

BRIEF DESCRIPTION OF THE DRAWING

Fig. 1 is a perspective view of a preferred form of a urinary channeling device embodying principles of the invention in a preferred form.

Fig. 2 is a side view, in cross section, of the device illustrated in Fig. 1.

Fig. 3 is an internal side anatomical drawing of a portion of a human female which shows the device of Fig. 1 mounted in place for use.

Fig. 4 is an external front anatomical drawing of the female crotch with a tube shown protruding out of the body from the device.

Fig. 5 is an anatomical drawing of the human female vulva or perineum with the labia majora folds shown spread apart to reveal underlying body organs and tissues. Fig. 6 is an enlarged view showing how the device is held in place by surrounding body tissues.

DETAILED DESCRIPTION Referring now in detail to the drawings, Fig. 5 shows the human female vulva with its covering lips or folds, known as the labia majora, shown spread apart to reveal underlying organs and tissue. The labia minora is seen to surround a sub-cavity known as the vestibule. The bottom of the vestibule is formed by the urethral meatus which surrounds the urethral orifice. The vagina is also located within the bounds of the labia minora but below the vestibule. Herein the side walls of the vestibule are deemed to extend to the labia majora in defining its shape and size, although there is an unwalled area immediately beneath the labia majora since the vestibule is a sub-cavity. A very small portion of the labia minora may be present here as a wall fragment that substantially coextends from the lips of the natural vestibule.

With reference now to Figs. 1 and 2, a urinary channeling device 10 is seen to have a body 11 of a size and shape that generally matches that of the vestibule, as it has been just defined. The body is of a two-piece construction having a relatively hard core 13 jacketed by a relatively soft outer shell 14. The core is of a relatively hard plastic. The core is dipped in molten latex which, after setting, forms a relatively soft outer shell. The body 11 has a front wall 16 whose outer surface is generally flat, though slightly convex to rest smoothly on the labia majora, and whose periphery 16' is generally ovally shaped. Continuous side walls 17 extend rearwardly from the front wall about a cavity 18 to a rear rim 19 of the cavity. Though not readily apparent in these figures, the side walls do converge slightly as they extend towards the rim to match the size and shape of the vestibule side walls. The front wall 16 is formed with a hole which extends to the body cavity 18. A short, fairly rigid plastic tube 20 is press fitted tightly into this hole.

For use the folds of the labia majora are spread and the area cleansed. The channeling device is then placed in the vestibule with its more pointed end located upwardmost adjacent the clitoris and with the open body cavity 18 and rim 19 facing the urethral orifice. Upon release of the labia majora it folds over the front wall 16 about the tube 20, as shown in Fig. 4. An unshown, long, flexible drain tube may then be telescopically mounted to the end of the rigid tube 20. The drain tube terminates in a conventional urine collection bag. When the user is ambulatory the drain tube terminates in a flexible collection bag that is strapped onto a leg.

Urine channeling devices of the type just described have been found to work well on both ambulatory and bed ridden females without discomfort, shifting or significant leakage. The device is held snuggly in place by the side walls of the vestibule and possibly also by very small portions of the labia minora, by the urethral meatus, and by the labia majora. For adults the body preferably has an overall outside length of 35 mm and a maximum outside width of 21 mm. The inside of the rim 19 preferably measures 21 by 12 mm maximum. For infants the I.D. of the rim preferably measures 7.5 mm maximum by 12 mm long. For children 5 to 12 years old the I.D. of the cavity is preferably 11 mm maximum wide by 13 mm long. If necessary a peri-pad formed with a hole and belt may also be worn with the tube 20 projecting through a hole formed in the pad. This is usually not necessary except in cases where the user is quite old. The presence of its cavity 18 has been found to reduce the chance of the device from being dislodged upon the impact of a stream of urine since the force of such is dispersed.

It thus is seen that a urinal channeling device is now provided which is of relatively simple and economic construction and which can be effectively used without discomfort on either long or short term bases. It should, of course, be understood that the just described embodiment merely illustrates principles of the invention in a preferred form and that many modifications may be made to it without departure from the spirit and scope of the invention as set forth in the following claims.

Claims

1. A urinary channeling device for in vivo use by incontinent human females who have a body cavity of natural anatomical size and shape known as the vestibule located between the urethral meatus that surrounds the urethral orifice and labia majora and with the device having a body of a size and shape generally the same as said natural body cavity size and shape thereby adapted to reside securely within the body cavity without exerting substantial pressure upon the cavity bounding tissues, and wherein said device body is formed with a hole therethrough through which urine may pass.

2. The urinary channeling device of claim 1 wherein said hole has a relatively large urine entry portion and a relatively small urine exit portion.

3. The urinary channeling device of claim 2 wherein said hole entry portion is bounded by generally ovally shaped body side walls.

4. The urinary channeling device of claim 3 wherein said hole exit portion is bounded by generally cylindrically shaped body side walls.

5. The urinary channeling device of claim 3 further comprising a tube having one end mounted in said body hole exit portion.

6. The urinary channeling device of claim 1 wherein said device body comprises a relatively hard plastic inner core jacketed by a relatively soft plastic outer shell.

7. A urinary channeling device for in vivo use by incontinent human females and which comprises a body having a generally flat front wall with a generally ovally shaped periphery from which side walls convergently extend about a body cavity to a rear surface rim about the cavity, and wherein said body has a hole therein that extends from said front wall to said body cavity.

8. The urinary channeling device of claim 7 further comprising a tube that projects from said body front wall in fluid communication with said hole.

9. The urinary channeling device of claim 7 wherein the periphery of said rear rim is generally ovally shaped.

10. The urinary channeling device of claim 7 wherein said body has a relatively hard inner core and a relatively soft outer shell.