EP0769931A1

EP0769931A1 - An assembly and method for prevention of urinary incontinence in humans

Info

Publication number: EP0769931A1
Application number: EP95926127A
Authority: EP
Inventors: John G. Simon; Michelle Maxfield-Bahr; Paul D. Mclaughlin; Leo C. Felice; Sharad Joshi
Original assignee: UroMed Corp
Current assignee: UroMed Corp
Priority date: 1994-06-29
Filing date: 1995-06-29
Publication date: 1997-05-02
Also published as: EP0769931A4; CA2193943A1; JPH10502269A; WO1996000542A1; AU2999195A

Abstract

This invention is an assembly for prevention of urinary incontinence, the assembly comprising an applicator (4), and an elastomer body (2). The applicator (4) is adapted to position the elastomer body (2) in the urethra of a human, includes a support portion (10) for retaining the elastomer body (2), and a manipulable portion (12) for positioning the elastomer body (2) in the urethra. A urethral plug assembly (300) having an anchoring member (307) defining an aperture (309), and having adhesive (311) thereon, wherein the adhesive (311) anchors the anchoring member (307) to tissue surrounding the meatus urinary.

Description

AN ASSEMBLY AND METHOD FOR PREVENTION OF URINARY INCONTINENCE IN HUMANS

Background of the Invention

(1) Field of the Invention

This invention relates to foam or elastomer occlusion devices and is directed more particularly to a disposable body of foam or elastomer material, an applicator for positioning and depositing the body of material in the urethra of a human, and a method for preventing unwanted discharge of urine.

(2) Description of the Prior Art

Urinary stress incontinence is defined as the involuntary loss of urine when the pressure within the bladder exceeds the urethral closure pressure required for maintaining closure. While the problem of urinary incontinence occurs in men and women, it is an affliction especially common in women of child bearing age and beyond.

There are in existence many methods used to address the problem of incontinence. Bladder neck suspension surgery, wherein the neck of the bladder is reduced by suspending the bladder, is one way to treat incontinence, especially in younger patients. However, there are numerous risks associated with such surgery, notwithstanding the expense. For some patients, surgery is not recommended for medical or other reasons, and for those with mild incontinence, surgery is not an appropriate solution. As an alternative to surgical correction, devices have been developed to address the problem of urinary incontinence. Many of these devices require surgery for implantation, and of these surgically implanted devices, there are two distinct types: non-manipulable devices and manipulable devices. One such non-manipulable device, described in United States Patent No. 4,019,499, is a capsule filled with a variable amount of fluid. The capsule is surgically implanted between supporting tissue and the urethra to exert an occluding force thereon. A similar, non-manipulable capsule implant is described in United States Patent No. 3,789,828. This device has ties extending therefrom to aid in fiber ingrowth, thus providing mechanical stability to the capsule. One problem associated with this device is the risk of fluid leakage. In addition to problems with leakage, the device is difficult for the physician to implant and requires a period of recovery and adjustment on the part of the patient. Also, severe tissue damage may result from the unnatural method in which such devices regulate incontinence.

Other surgically implanted devices exist which are manipulable. These devices provide the wearer with the ability to selectively control the operation of the device via manually operable elements implanted in the tissue surrounding the urethra. United States Patent No. 4,428,365, and United States Patent No. 4,846,784 each disclose an indwelling device having an inflatable chamber with an attached tubing and an inflation bulb. The wearer may manually adjust the pressure exhibited by the inflatable member on the urethra, simply by squeezing the tissue encasing the bulb. These devices, however, often produce thickening and scarring of surrounding tissue, making their usefulness questionable. And as with non-manipulable devices, they are cumbersome to surgically implant. Additional adverse effects associated with surgically implanted indwelling devices, whether non- manipulable or manipulable in nature, are encrustation, irritation and infection.

There are also known in the art certain indwelling devices that do not require surgical implantation. These devices are inserted by a physician through the urethral orifice and allow the wearer to void either past or through the device. An example of such a device is disclosed in United States Patent No. 4,850,963 in which a physician inserts a bolus of ferromagnetic material through the urethra and into the bladder. The bolus rests at the juncture of the bladder and urethra and is moved for bladder evacuation, by the relative positioning of a magnet across the body of the wearer. However, the bolus may become lodged in an area beyond the reaches of the magnetic force exhibited by the magnet, making the device inoperative. Another example of this type of indwelling device is the pre-stressed capsule disclosed in United states Patent No. 4,457,299. The capsule is inserted by a physician within the lower interior of the urethra and is set at a pre-stressed pressure slightly above involuntary pressure. When the urine pressure exceeds the pre-set pressure of the capsule, the capsule deforms allowing urine to flow around the device. This device, however, has no feature to prevent migration of the device into the bladder. In United States Patent No. 4,553,533 there is shown a prosthetic urethral sphincter valve which is placed in the urethra and anchored in the bladder. The patient increases his bladder pressure by means of a valsalva maneuver, and holds this pressure while the valve activates. Urine may then pass through the valve with the valve later returning to its closed position. This device is very complicated, expensive, difficult to manufacture and uncomfortable. Another physician-inserted device is disclosed in United States Patent No. 3,797,478. This device has an expandable collar which is inflated after insertion, by an injection of fluid therein. When it is desired to remove the device, the inflated collar is ruptured or serrated, thus expelling the fluid into the wearer's body. Notwithstanding the cumbrous use of this device, there is a risk of infection associated with the release of injection fluid upon removal. Similarly, United States Patent No. 3,841,304 discloses a plug which is inserted by a physician into the urethra and subsequently inflated to block the flow of urine. This device may be left in the body for extended periods. After insertion, the device merely requires repositioning in the urethra to permit bladder evacuation. Such a device leaves the wearer susceptible to infection, as bacteria may be introduced into the urethra during repositioning, or during indwelling time. Also, serious complications can occur upon removal, when a separate wire must be inserted therein. These devices, being indwelling, are often cumbersome to the wearer and often cause numerous complications such as encrustation, irritation and infection. Also known in the art are devices capable of being inserted by the wearer into the urethra. Such devices are removed for voiding, and then reintroduced into the urethra upon completion of bladder evacuation. An example of such a device is the solid-type urethral plug, described by Nielsen, Kurt K. et al., in "The Urethral Plug: A New Treatment Modality for Genuine Urinary Stress Incontinence in Women," J. Urology, vol. 44, p. 1100 (1990). This device consists of one or two solid spheres located along a soft shaft, and a thin, soft plate located at the end of the shaft. One sphere is located upstream of the maximum urethral closing pressure point, corresponding to the location of the sphincter. In the two sphere embodiment, the second sphere is located with its midpoint at the bladder neck, and is used to assist in reducing urinary flow and pressure transmission to the urethra so that the sphincter can operate. When the patient wants to evacuate the bladder, the plug is removed, evacuation occurs, and a fresh plug is inserted. One problem associated with this device is that the patient must have three urethral closure pressure profiles performed as well as other examinations, before the device is made for the wearer. Additional problems associated with this device include placement difficulties, lack of sealing capabilities associated therewith, and inadequate anchoring and, consequently, inadequate retention by the plate at the meatus, thereby allowing for migration of the device into the bladder or expulsion out of the body. In addition, there may be discomfort associated with insertion and removal, due to the size profile and rigidity of the spheres, which maintain a constant diameter during insertion and removal. Another "remove-to-void" device is disclosed in United States Patent No. 5,090,424, which comprises a conformable urethral plug. The body of the plug forms a cavity which is in fluid communication with another cavity via a check-valve. Thus, fluid may be pumped into the cavity within the urethra to provide a custom fit. This device, like many others relying on liquids or gels for expansion, relies heavily on a fluid- tight valve in order to maintain retention. Should valve failure occur, evacuation would immediately follow. There is also a chance of fluid leakage into the body of the wearer should rupture of the plug occur.

There are also known in the art certain external devices that do not require insertion into the urethra. Urine absorbing pads have been developed to collect and absorb urine as it flows out of the body. Such pads have difficulty retaining a stationary position and often lack effectiveness in preventing leakage. An example of an external device in which such problems have been addressed is the urine absorbing pad disclosed in U.S. Patent No. 5,074,855. This device employs adhesive to secure a pad to the vestibule such that urine is absorbed as it is expelled from the body. However, there are many disadvantages associated with such a device. Urine build-up in the urethra creating an uncomfortable sensation for the wearer is one such disadvantage. Additionally, due to the structure and function of such a device, there is nothing to increase urethral resistance to urine flow. Moreover, as such a pad is designed only to be worn externally, it is subject to migration in the course of one's daily movement and activities, even with the use of adhesive given the friction associated with undergarments contacting the pad. Migration, as such, increases the likelihood of accidents and leakage. Although this pad attempts to seal and absorb urine at the meatus, the meatus is not physically blocked; thus the wearer is susceptible to discomfort and leakage. This device, given its structure and composition, would not be effective internally due to the differing physiological conditions present in the urethra, bladder neck or bladder, where internal conditions such as temperature gradients and moisture levels exist.

In view of the above problems associated with the prior art, an easily manipulable, "remove-to-void", indwelling urethral plug assembly having enhanced retention and sealing capabilities and further having a guide member for ease of locating and inserting the assembly, would be desirable to those afflicted with urinary incontinence.

Summary of the Invention

An object of the invention is, therefore, to provide an assembly for the prevention of urinary incontinence in humans, the assembly being expandable to block the urethra.

A further object is to provide such an assembly having an appropriately expandable body for effecting blockage of urine, and also having an applicator by which the body may be properly positioned within the urethra.

A still further object of the invention is to provide a method for preventing an unwanted discharge of urine, utilizing the aforesaid assembly.

With the above and other objects in view, as will hereinafter appear, a feature of the present invention is the provision of an assembly for prevention of urinary incontinence in humans, the assembly including an applicator for positioning a foam or elastomer body in a urethra of a female or male. The applicator comprises a support portion for retaining the foam or elastomer body, and a manipulable portion for disengaging the foam body from at least a portion of the applicator. The assembly further includes the foam or elastomer body which comprises a discrete body of foam or elastomer material mounted on the applicator support portion.

In accordance with a further feature of the invention, there is provided an assembly for prevention of urinary incontinence in humans, the assembly including an applicator for positioning a foam body in a urethra of a female or male. The applicator comprises a support portion for retaining the foam or elastomer body, the support portion comprising a tubular shell open at a first end and having a second end closed but slit so as to be adapted to open in response to pressure thereupon internally of the shell, and a manipulable portion comprising a plunger in part disposed in the shell open first end, the plunger being engageable with the foam body at a first end of the plunger and having a head at a second end thereof. The assembly further includes the foam or elastomer body which comprises a discrete elongated body of foam or elastomer material mounted in the shell. The applicator plunger is moveable in the shell to force the foam or elastomer body through the shell second end to disengage the foam or elastomer body from the applicator shell.

In accordance with a further feature of the invention, there is provided an assembly for prevention of urinary incontinence in humans, the assembly including an applicator for positioning a foam or elastomer body in a urethra of a female or male. The - applicator comprises a support portion for retaining the foam or elastomer body, the support portion comprising a tubular shell - open at a first end and having a closed second end expandable in balloon-like fashion, and a manipulable portion comprising a plunger in part disposed in the shell open first end, the plunger being engageable with the foam or elastomer body at a first end of the plunger and having a head at a second end thereof. The assembly further includes the foam or elastomer body which comprises a body of foam or elastomer material disposed in the shell and removed from the shell closed end. The applicator plunger is moveable in the shell to force the foam or elastomer body through the shell into the shell closed second end to expand the shell second end in the aforesaid balloon-like fashion.

In accordance with a still further feature of the invention, there is provided an assembly for prevention of urinary incontinence in humans, the assembly including an applicator for positioning a foam or elastomer body in a urethra of a female or male. The applicator comprises a support portion for retaining the foam or elastomer body, the support portion comprising an elongated projection, and a manipulable portion comprising a grip portion fixed to the projection. The assembly further includes the foam or elastomer body which comprises a discrete body of foam or elastomer material having a bore therein adapted to receive the applicator support portion projection, the foam or elastomer body being disposed on and extended over substantially the length of the projection. The projection is removable from the foam or elastomer body to disengage the foam or elastomer body from the applicator.

In accordance with a still further feature of the invention, there is provided a urethral plug assembly comprising an anchoring member defining an aperture and having adhesive or other sealing means thereon, wherein the adhesive or other sealing means secures and seals the anchoring member against and to the tissues surrounding the meatus urinarius. The aperture in the anchoring member can accommodate and hold a urethral plug (or other device such as a catheter) in the urethra, thereby forming a tight seal with the urethra, bladder neck or bladder wall to block the flow of urine.

The plug may comprise a foam or elastomer body which is of a sufficient diameter to allow occlusion of the urethra to prevent incontinence. It may comprise a simple shaft-like member. Alternatively, the plug may comprise a member which has the ability to change its shape. One such plug assembly may comprise a member having a body defining a lumen for accepting fluid from an external syringe, and delivering the fluid to a fluidly inflatable balloon. The fluid may be a liquid or gel, or air. Such a plug is to be inserted while the balloon is in a non-inflated position. Following insertion, fluid can be introduced into the lumen via a syringe, from where it travels through a valve to inflate and distend the balloon. The urethra, bladder neck or bladder of the wearer is thereby occluded.

Another type of plug assembly may comprise a mechanically expandable body and cooperating inner member, lying in coaxial engagement and possessing a contracted diameter for insertion and removal through the orifice of the urethra, and a larger, expanded diameter for blocking the flow of urine in the urethra, bladder neck or bladder. A larger diameter is achieved by mechanical deployment of the inner member resulting in a change in the shape of the body. This change in shape causes the external surface to expand, which seals the plug assembly to the urethral, bladder neck or bladder wall.

Alternatively, the plug may comprise a condition-responsive expandable member having the ability to possess an expanded condition when exposed to a physiological state, such as body temperature, moisture, or pH. The adaptation of the condition- responsive plug to the expanded condition occurs automatically without actuation of the plug by the wearer.

In each of the above plug assemblies, the portion of the plug assembly that functions to block the flow of urine is the plug itself, and the portion of the plug assembly that serves to anchor the plug in place at the meatus urinarius is the anchoring member. The anchoring member and a tab associated with the distal end of the plug engage one another at the meatus urinarius such that the plug assembly is prevented from migrating into the bladder. For bladder evacuation, only the plug portion is removed - the anchoring member remains in place at the meatus. Removal of the plug is accomplished by pulling a string or activating other withdrawal means such as the tab emanating from the distal portion of the plug.

In the preferred embodiment of the invention, an adhesive layer lies on the proximal surface of the anchoring member so as to secure and seal the anchoring member against the tissues surrounding the meatus urinarius. The anchoring member is able to accommodate and secure any one of the above-described plugs at the urinary meatus. This feature and its advantages will be better appreciated from the detailed description that follows.

In accordance with a still further feature of the invention, there is provided a method for preventing an unwanted discharge of urine, comprising the steps of providing an applicator with an expandable body fixed thereto in a non-expanded condition, manipulating the applicator to insert the body into a urethra and to separate the applicator from the body, to permit the body to expand in the urethra, and drawing the body in expanded condition from the urethra by pulling an appendage extending from the body and exteriorly of the urethra, when discharge of urine is desired.

The above and other features of the invention, including various novel details of construction and combinations of parts, will now be more particularly described with reference to the accompanying drawings and pointed out in the claims. It will be understood that the particular devices and methods embodying the invention are shown by way of illustration only and not as limitations of the invention. The principles and features of this invention may be employed in various and numerous embodiments without departing from the scope of the invention.

Brief Description of the Drawings

Reference is made to the accompanying drawings in which are shown illustrative embodiments of the invention from which its novel features and advantages will be apparent.

In the drawings:

FIG. 1 is an elevational view of one form of assembly illustrative of an embodiment of the invention;

FIG. 2 is a sectional view of the assembly of FIG. 1;

FIG. 3 is an exploded sectional view, showing a foam or elastomer body portion separated from the applicator portion of the assembly of FIGS. 1 and 2;

FIG. 4 is a diagrammatic illustration of the positioning of the assembly of FIGS. 1-3 for insertion of the foam or elastomer body in a female urethra;

FIG. 5 is a diagrammatic illustration of the insertion of the foam or elastomer body of FIGS. 1-3 in the female urethra;

FIG. 6 is a diagrammatic illustration of the removal of the foam or elastomer body of FIG. 5 from the urethra;

FIG. 7 is similar to FIG. 5, but illustrates insertion of the body of FIGS. 1-3 in the urethra of a male;

FIG. 8 is an elevational view, similar to FIG. 1, of another form of assembly illustrative of an alternative embodiment of the invention; FIG. 9 is a sectional view, similar to FIG. 2, of the embodiment shown in FIG. 8;

FIG. 10 is an elevational view of another form of assembly illustrative of an alternative embodiment of the invention;

FIG. 11 is a sectional view, similar to that shown in FIG. 3, of an alternative embodiment of elastomer body;

FIG. 12 is an elevational view of another form of assembly illustrative of an alternative embodiment of the invention;

FIG. 13 is a sectional view of the assembly of FIG. 12;

FIG. 14 is an exploded sectional view of the assembly of FIGS. 12 and 13, showing a foam or elastomer body portion moved to an operative position;

FIGS.15-17 are diagrammatic illustrations of, respectively, the positioning of the assembly of FIGS. 12 and 13, the placement of a portion of the assembly in the urethra, and removal of that portion of the assembly from the urethra of a female;

FIG. 18 is similar to FIG. 16, but shows placement and operation of the embodiment of FIGS. 12-14 in the urethra of a male;

FIG. 19 is an exploded sectional view, similar to FIG. 14, but showing an alternative embodiment;

FIG. 20 is an exploded sectional view, similar to that shown in FIG. 14, of an alternative embodiment of applicator support portion;

FIG. 21 is a sectional view of an alternative embodiment of assembly, similar to that shown in FIG. 20;

FIG. 22 is an enlarged sectional view of a portion of the assembly of FIG. 21; FIG. 23 is an elevational view of another form of assembly illustrative of another alternative embodiment of the invention;

FIG. 24 is a sectional view of the assembly of FIG. 23;

FIG. 25 is an exploded view of the assembly of FIGS. 23 and 24, showing a foam or elastomer body portion in section separated from an applicator portion, shown in elevation;

FIGS.26-28 are diagrammatic illustrations of, respectively, the positioning of the assembly in a female urethra, the placement of the foam or elastomer body in the urethra, and the removal of the foam body from the urethra;

FIG. 29 is a diagrammatic illustration of the insertion of the foam or elastomeric body of FIGS. 23-25 in a male urethra;

FIG. 30 is an exploded view of another alternative embodiment of the invention;

FIG. 31 is a side elevational view of a body portion and anchoring portion of the assembly of FIG. 30 after engagement;

FIG. 32 is a sectional view of an anchoring member portion of the assembly of FIG. 30;

FIG. 33 is a diagrammatic illustration of the positioning of the assembly of FIG. 30;

FIG. 34 is a sectional view of another alternative embodiment of the invention showing a balloon portion in a deflated state;

FIG. 35 is a sectional view similar to FIG. 34, showing the balloon portion in an inflated state;

FIG. 3€ is a sectional view of another alternative embodiment, having an expandable portion in a contracted state; FIG. 37 is similar to FIG. 36, but shows the expandable portion in an expanded state;

FIG. 38 is a side elevational view of another alternative embodiment, having an expandable portion in an elongated state;

FIG. 39 is a side elevational view, similar to FIG. 38, but showing the expandable portion in an expanded state;

FIG. 40 is a cross sectional view taken along line A-A of the body portion of each of the urethral plug assemblies; and

FIG. 41 is a cross sectional view taken along line A-A of the body portion of each of the urethral plug assemblies, and showing an alternative embodiment of the body portion.

Description of the Preferred Embodiments Referring to FIGS. 1 and 2, it will be seen that an illustrative embodiment of the invention includes a foam or elastomer body 2 and an applicator 4 for positioning and depositing the foam or elastomer body 2 in the urethra of a human.

The foam or elastomer body 2 comprises a body of foam or elastomer material, such as closed or open cell polyurethane, polyethylene, latex, silicone, Kraton, foamed Kraton, cellulose, and the like, which is expandable upon release from a confined area. While the body 2 may be of any of such materials, it will be referred to hereinafter as "elastomer body". The elastomer body 2 is provided with an enlarged base portion 6 (FIG. 3) . An appendage, such -as a string 8, is fixed to the elastomer body base portion 6 and extends therefrom. The appendage may, alternatively, be a tab or extension (not shown) of the elastomer body 2.

The applicator 4 includes a support portion 10 for supporting the elastomer body 2 prior to use, and a manipulable portion 12 for moving the elastomer body 2 from its supported position to an operative position within the urethra.

The support portion 10 comprises a tubular shell 14 open at a first end 16 and having a second end 18 substantially closed but adapted to open in response to pressure thereupon internally of said shell. As shown in FIG. 1, the shell second end 18 may be formed as a closed end and provided with slits 20 which permit the shell second end 18 to open when the elastomer body 2 is pressed thereagainst, as will be further described herein below. The shell 14 is adapted to retain the elastomer body 2, as may be seen in FIG. 2. The shell 14 is provided with a collar 22 extending radially outwardly from the shell proximate, but removed from, the shell second end 18.

The manipulable portion 12 comprises a plunger 24 in part disposed in the shell open first end 16. The plunger 24 is engageable with the elastomer body 2 at a first end 26 of the plunger. The plunger 24 is provided with a head 28 at a second end 30 thereof. The plunger first end 26 is open and in communication with a chamber 32 for releasably retaining the string 8.

The applicator plunger 12 is moveable in the shell 14, as by operator hand pressure on the plunger head 28, to force the elastomer body 2 through the shell second end 18 (FIG. 5) , to disengage the elastomer body 2 from the shell, as shown in FIG. 3.

In use (FIGS. 4 and 7) , the operator grasps the applicator shell 14, and inserts the shell second end 18 in the urethra. The collar 22 of the shell 14 prevents excessive entry of the device into the urethra (FIGS. 4 and 7) . The operator places a finger on the plunger head 28 and presses the plunger 24 into the shell 14 (FIGS. 5 and 7) to move the elastomer body 2. The pressure of the elastomer body 2 against the second end 18 of the shell forces open the slits 20 in the second end 18 to permit egress of the elastomer body, which thereupon expands to fill the urethra. Upon removal of the applicator 4 from the urethra, the elastomer body 2 remains in operative position in the urethra (FIG. 6) . The expanded base portion 6 of the elastomer body 2 serves as a meatal plate and prevents movement of the elastomer body towards the bladder. When it is desired to remove the elastomer body 2 from the urethra, the operator grasps the string 8 (FIG. 6) and pulls the elastomer body therefrom. Both the applicator 4 and the elastomer body 2 may be disposed of through ordinary trash disposal means.

Referring to FIGS. 8 and 9, it will be seen that an alternative embodiment of the assembly of FIGS. 1 - 3 includes an open second end 18' . Otherwise, the structure and operation of the embodiment shown in FIGS. 8 and 9 are substantially the same as the structure and operation of the embodiment shown in FIGS. 1 - 3. In FIG. 10, there is shown an alternative embodiment of tubular shell 14 having a frusto-conically shaped nozzle portion 14' having the open end 18' at the small end thereof.

In FIG. 11, there is shown an alternative embodiment of elastomer body 2' having an enlarged distal end 40. Otherwise, the structure and operation of the body 2' is substantially the same as the structure and operation of the body 2 shown in FIG. 3.

Referring to FIGS. 12 and 13, it will be seen that another illustrative embodiment of the invention includes an elastomer body 102 and an applicator 104 for positioning and depositing the elastomer body in the urethra.

The elastomer body 102 comprises a mass of foam or elastomer material which is readily compressible upon application of pressure thereto and is expandable upon release of pressure, or release from a confined space. Suitable materials have been found to be the aforementioned polyurethane, polyethylene, latex, silicone, Kraton, foamed Kraton, cellulose, and the like. The elastomer body 102 has fixed thereto and extending therefrom an appendage, such as string 108 (FIGS. 13 and 14) .

The applicator 104 includes a support portion 110 for supporting the elastomer body 102 prior to use, and during use, and a manipulable portion 112 for moving the body 102 to an operative position.

The support portion 110 comprises a tubular shell 114 open at a first end 116 thereof and having a second end 118 closed and expandable in balloon-like fashion (FIG. 14) in response to pressure thereupon internally of the shell. The shell 114 is adapted to support and retain the elastomer body 102 prior to use, as may be seen in FIG. 13. The shell 114 is provided with a collar 122 extending radially outwardly from the shell at the shell first end 116. The shell preferably is of a thermoplastic elastomeric, or semi-rigid foam, material, which is sufficiently rigid to support the body 102 in a barrel portion 120 of the shell 114, but sufficiently expandable to permit the required expansion at the second end 118 thereof. To facilitate expansion, the second end 118 of the shell 114 may be provided with folds 123 (FIG. 13) disposed internally of the shell. Alternatively, the second end 118 may be a discrete end component 150 (FIG. 19) of a second material attached to the tubular shell 114. The second material may be provided with physical properties to permit the required expansion.

The manipulable portion 112 comprises a plunger 124 in part disposed in the shell open first end 116. The plunger 124 is engageable with the body 102 at a first end 126 of the plunger. The plunger 124 is provided with a head 128 at a second end 130 thereof. The plunger first end 126 is open and in communication with a chamber 132 for releasably retaining the string 108.

The applicator plunger 124 is moveable in the shell 114, as by operator hand pressure on the plunger head 128, to force the body 102 through the shell barrel portion 120 into the shell expandable second end 118. Continued movement of the plunger 124 compresses the body 102 axially, while release of the body from the barrel portion 120, in combination with the axial compression of the body, causes radial expansion of the body 102 to expand the shell second end 118 balloon-like, as shown in FIG. 14, so as to obstruct the urethra and/or bladder neck. Axial movement of the plunger 124 in the shell 114 is limited by a stop ring 134 engageable with the shell collar 122.

In use (FIGS. 15 and 18) , the operator grasps the applicator plunger 124 and inserts the shell second end 118 into the urethra. The collar 122 of the shell 114 prevents excessive entry of the device into the urethra. The operator places a finger on the plunger head 128 and presses the plunger 124 into the shell 114 until the plunger stop ring 134 engages the shell collar 122 (FIG. 16) . The pressure of the foam body 102 against the second end 118 of the shell 114 forces the shell folds 123 to fill and expand to a ball-like configuration and obstruct the urethra. The plunger 124 is then withdrawn from the shell 114 to leave the shell and foam body 102 in the urethra. At this point, the shell 114 ceases being, in function, an applicator, and becomes in combination with the foam body, a urethral plug 136 disposed in the urethra. The shell collar 122 serves as a meatal plate and prevents movement of the plug 136 into the bladder.

To remove the urethral plug 136 from the urethra, the operator pulls on the string 108 (FIG. 17) which moves the foam body from the shell second end 118 into the shell barrel portion 120, whereupon the shell second end 118 collapses to permit withdrawal of the plug 136 from the urethra.

All components of the alternative embodiment may be disposed of as ordinary trash.

In FIG. 20, there is shown an alternative embodiment in which the second end 118' of the tubular shell 114 is open and the elastomer body 102 is incompletely expelled from the shell, such that a major portion 160 of the elastomer body 102 is pushed out of the open end 118' of the shell 114 and expands to fill the urethra, while a minor portion 162 of the body 102 remains in the shell 114. As in the embodiment illustrated in FIGS. 12-14, the body 102 and shell 114, once in operative position, act in cooperation with each other as a urethral plug. Pulling on the string 8 removes the plug 102, 114 from the urethra.

In FIG. 21, there is shown a further alternative embodiment, similar to that shown in FIG. 20, but in which the plunger 124' is locked in the shell 114' with the elastomer body 102 held in the second end 118' of the shell 114' and expanded in a balloon¬ like fashion, and in part exposed through an opening 152 in the shell second end 118'. In this embodiment, the entire assembly becomes a urethral plug, as shown in FIG. 21. To facilitate locking of the plunger 124' in the shell 114', the plunger and shell may be provided with cooperating detents 170 and recesses 172 (FIG. 22) which interlock in a snap-fit manner to secure the plunger 124' and shell 114' together.

Referring to FIGS. 23 and 24, it will be seen that still another illustrative embodiment of the invention includes an elastomer body 202 and an applicator 204 for positioning and depositing the body in the urethra. The elastomer body 202 comprises a body of foam or elastomer material, such as polyurethane, polyethylene, latex, silicone, Kraton, foamed Kraton, cellulose, and the like, which is expandable and which may be stretched over an elongated support 210 (FIG. 24) . The body 202 is provided with an expanded base portion 206. An appendage, such as a string 208, is fixed to the body base portion 206 and extends therefrom. The body 202 is further provided with a central bore 209 therein (FIG. 25) .

The applicator 204 includes a support portion 210 for supporting the elastomer body 202 prior to use, and a manipulable portion 212 for moving the body 202 into operative position within the urethra.

The support portion 210 comprises an elongated projection 214 for disposition in the elastomer body central bore 209, and the manipulable portion 212 comprises a grip portion 224 fixed to the projection 214. The grip portion 224 is open at a first end 226 thereof and is provided with a chamber 232 (FIG. 24) in communication with the open end 226 for releasably retaining the string 208.

As shown in FIG. 24, the projection 214 may extend from a closed second end 230 of the grip portion 224, centrally thereof, and through the open first end 226, with the string 208 coiled around the projection 214 or otherwise disposed in the grip portion chamber 232.

In use (FIG. 26) , the operator grasps the applicator grip portion 224 and inserts the projection 214, with the elastomer body 202 extended thereover (FIG. 24) , into the urethra. The elastomer body expanded base portion 206 prevents excessive entry of the device into the urethra (FIG. 26) . The operator actuates the grip portion 224 of the applicator 204 (FIGS. 27 and 29) to remove the applicator from the foam body 202, leaving the foam body in its expanded condition in the urethra. Such actuation may be by rotating, squeezing or pulling the grip portion 224. As the applicator 204 disengages from the body 202, the string 208 disengages from the applicator. The expanded base portion 206 of the body 202 serves as a meatal plate and prevents migration of the body into the bladder.

When it is desired to remove the body 202 from the urethra, the operator merely grasps the string 208 and pulls the body from the urethra.

As in the case of the other embodiments, the components of this alternative embodiment may be disposed of through normal trash disposal means.

Referring to FIG. 30, shown is a plug assembly 300, having a foam or elastomer body 302 sized to allow occlusion of the urethra following insertion. The plug assembly includes an applicator 304 for easy and comfortable insertion of the body 302 into the urethra of the wearer. An enlarged base portion 306 is disposed at a distal end of the body 302 and is a flanged type member. The base portion 306 may be either contiguous with the body 302 or, alternatively, may comprise a separate attachment to the body 302 of the plug assembly 300. The plug assembly 300 further comprises an anchoring member 307 disposed proximal to the base portion 306 and defining an aperture 309. Like the base portion 306, the anchoring member 307 may be either integral with the body 302, as shown in FIG. 31, or may comprise a separate component to be used in conjunction with the urethral plug assembly, as shown in FIG. 30. Anchoring member 307 is adapted to receive and securely hold the body 302 of the plug assembly 300 in the urethra, thereby enabling the body 302 to form a tight seal with the urethral wall to block the flow of urine. Upon insertion of the urethral plug assembly 300 by the wearer, the body 302 is introduced into the urethra until the base portion 306 contacts the tissues surrounding the meatus urinarius. The body 302 is comprised of a material, preferably an elastomer or foam material such as closed or open cell polyurethane, polyethylene, latex, silicone, Kraton, foamed Kraton, cellulose, and the like, which material is capable of compression to a smaller diameter as the body 302 passes into the urethra. Upon insertion, the urethral wall conforms to the shape of the body 302 of the plug assembly 300. The anchoring member 307, shown in FIG. 32, is preferably circular in shape and defines the aperture 309, which is of suitable size to accommodate and secure the body 302. The anchoring member 307 anchors the plug assembly 300 at the meatus urinarius. To carry out this function of anchoring, there is a layer of water-soluble adhesive 311 on the proximal surface of the anchoring member 307. Adhesives suitable for use in the invention include both natural and synthetic materials. Preferred adhesives include, but are not limited to, hydrogel adhesives, polyvinylether-based adhesives, acrylic-based adhesives and natural gum rubber adhesives. Other biocompatible adhesive materials known in the art may also be used.

The adhesive layer 311 anchors the anchoring member 307 at the meatus urinarius, thereby ensuring a firm and secure placement of the plug assembly 300 following insertion. The anchoring member 307 is of a thickness sufficient to prevent migration of the urethral plug assembly 300 into the urethra of the wearer, preferably in the range from about 0.03 inches to about 0.25 inches. The preferred range of thickness of the anchoring member 307 enables the plug assembly 300 to be worn comfortably by the wearer.

FIG. 33 shows the plug assembly 300 following insertion into the urethra by the wearer. As can be seen, the foam or elastomer body 302 is inserted into the urethra until the anchoring member 307 contacts and adheres to the meatus urinarius. The wearer then squeezes the applicator 304 to effect release of the plug assembly 300 from the applicator 304. Contact by the anchoring member 307 with the meatal tissues prevents the body 302 from further entering the urethra. The body 302 is locked into place in the anchoring member 307 by the seating therein of a smaller diameter portion 313 (FIGS. 30 and 31) of the body 302, which portion 313 is sized to achieve a snap-fit with the aperture 309 of the anchoring member 307. The base portion 306, emanating from the smaller diameter portion 313, is preferentially circular in shape and has a diameter larger than the diameter of the aperture 309 to further enhance such locking as it abuts the bottom of the anchoring member 307. This ensures that the body 302 is inserted to the proper depth of the urethra, while providing an additional means of retaining the plug assembly 300 in proper position and preventing migration of the plug assembly proximally beyond its proper place. The base portion 306 is of a thickness similar to that of the anchoring member 307, with a preferred range of from about 0.03 inches to about 0.25 inches. Materials suitably -comprising the base portion 306 include, but are not limited to, foam, elastomer, and plastic materials. More preferable materials include, but are not limited to, polyurethanes, polyethylenes and silicone.

An appendage, such as a string 308, secured in the body portion 302 of the plug assembly 300, passes through a slit in the base portion 306 and extends from the wearer's body for removal of the plug assembly 300 when bladder evacuation is desired. The appendage may, alternatively, be a tab or extension (not shown) of the body 302. A simple, continuous tug on the string 308 serves to unseat the base portion 306 from the aperture 309 in the anchoring member 307. The body 302 is then easily removed from the urethra.

The anchoring member 307 remains adhered to the tissue at the meatus urinarius and is not effected by removal of the body portion 302 of the plug assembly 300. Following bladder evacuation, a fresh plug (or other device such as an intermittent urinary catheter) may then be inserted into the urethra, using the anchoring member 307 as a guide to easily locate the meatus. The fresh plug would consist solely of the body portion 302 of the plug assembly 300; a fresh anchoring member 307 would not be necessary since the original anchoring member 307 remains adhered in place to the tissue surrounding the meatus. Alternatively, should the wearer choose not to insert a fresh plug (or other device) after voiding, the wearer simply removes the anchoring member 307 by moistening the anchoring member with appropriate release agents, as for example, water. The seal with the body tissue at the meatus urinarius is thus broken, and the anchoring member is easily disengaged. The wearer then disposes of the entire urethral plug assembly 300, including the anchoring member 307, through ordinary trash disposal means.

As previously noted, the operation of the urethral plug assembly 300 is such that upon insertion, the urethral walls conform to the shape of the body 302, thereby anchoring the body 302 of the urethral plug assembly 300 in the urethra. To further secure the body 302 in the urethra, the anchoring member 307, via the adhesive layer 311 on its proximal surface, forms a tight seal with the tissue surrounding the meatus urinarius. The anchoring member 307 thus ensures that the plug assembly 300 is tightly secured at the meatus urinarius and that the body 302 will not slip from its position in the urethra. A continuous blockage of urine results. The adhesive layer 311, although shown in the drawings to be continuous over the proximal surface of the anchoring member 307, may be discontinuous, depending on the degree of adhesion desired.

An alternative embodiment of the invention is shown in FIGS. 34 and 35, wherein the urethral plug assembly comprises a fluidly expandable member. Such a urethral plug assembly is fully described in U.S. Patent No. 5,090,424 and U.S. Serial No. 07/746,364 filed August 16, 1991 (now abandoned) , refiled as U.S. Serial No. 08/103,812 filed August 6, 1993, the teachings of which are herein incorporated by reference. Referring to the drawings, FIG. 34 shows a fluidly expandable urethral plug assembly 400 in a deflated state. The plug assembly 400 has a body 402 with an enlarged base portion 406 on its distal end, and an expandable balloon 416 at its proximal end. The body 402 is preferably formed of a biocompatible thermoplastic elastomer material, and the balloon 416 is also preferably formed of a biocompatible thermoplastic elastomer, such as that sold under the trademark KRATON. However, any biocompatible material may be used for each of the aforementioned elements, as the invention is not to be limited to those named above. As in the embodiment of FIG. 30, an anchoring member 407 defining an aperture 408 is disposed adjacent the base portion 406 and is adapted to receive and hold the body 402. The wall of the body 402 is relatively constant in outer diameter, allowing the device to be easily inserted into the urethra. The body 402 has a smaller diameter portion 413 sized to achieve a snap-fit upon insertion of the body 402 into the aperture 408 of the anchoring member 407. The body 402 is thereby locked into place in the anchoring member 407 by the seating therein of the smaller diameter portion 413 of the body 402. The base portion 406, similar to the embodiment of FIG. 30, emanates from the smaller diameter portion 413 and has a diameter larger than the diameter of the aperture 408 to further enhance such locking as it abuts the bottom of the anchoring member 407.

The internal portion of body 402 of the plug assembly 400 defines a lumen 409, a first cavity 411, and a valve seat 414. The fluid responsible for inflating the balloon 416 is introduced from an external delivery device 418, such as a syringe, adapted to be inserted into the first cavity 411. The fluid can be any fluid capable of being pumped from the delivery device 418 with sufficient force to displace a ball 415 resting against valve seat 414. The anchoring member 407, like the anchoring member 307 previously discussed in the above embodiment, is adapted to receive and hold the urethral plug assembly 400 at the meatus urinarius to assist the wearer in locating the meatus urinarius for proper insertion of the plug assembly 400. Upon proper insertion, the smaller diameter portion 413 of the body 402 forms a snap-fit in the aperture 408 of the anchoring member 407, thereby securing the urethral plug assembly 400 at the meatus urinarius. A layer of adhesive 410 on the proximal surface of the anchoring member 407 allows for tight sealing of the anchoring member 407 to the tissue surrounding the meatus urinarius, thereby enhancing the security of the urethral plug assembly in the urethra.

In FIG. 35, there is shown the urethral plug assembly 400 after fluid has been pumped into the balloon 416, such that the plug assembly 400 is in an inflated state. Inflation is carried out by inserting the delivery device 418 into the plug assembly 400 so that it lies within the first cavity 411. Fluid is then expelled from the delivery device 418 for travel through the first cavity 411 to the valve seat 414, whereby the force of the fluid pushes the ball 415 off the valve seat 414, thereby providing a continuous flow path from the first cavity 411 to the lumen 409. The fluid continues to travel out of an opening 420 of the lumen 409, whereupon it inflates the balloon 416. When balloon 416 is inflated, the injection of fluid from the delivery device 418 may be terminated and the delivery device 418 removed. At this point, the ball 415 falls back against valve seat 414 to occlude a valve seat opening 412, thus closing the opening 412 against fluid entry or exit. The fluid contained in the balloon 416 therefore functions to maintain the plug assembly 400 in its inflated state for urine blockage. When bladder evacuation is desired, the wearer deflates the balloon 416 by simply pulling on a cord 417 attached to the ball 415, causing the ball 415 to dislodge and pass from the valve seat opening 412 toward the distal end of the plug assembly 400. Although such action results in the expulsion of fluid from the balloon 416, the plug assembly 400 remains anchored at the meatus urinarius by the engagement of the base portion 406 with the anchoring member 407. Accordingly, the urethral plug assembly 400 continues to block the flow of urine while the wearer removes the body portion 402, now of reduced diameter. Removal is accomplished by a continuous tug on the string 417, which serves to unseat the base portion 406 from the aperture 408. The body 402 is then withdrawn from the urethra by pulling on the base portion 406. A fresh plug (or other device such as an intermittent catheter) may be inserted into the urethra of the wearer, with the anchoring member 407 serving as a guide to easily locate the meatus. Alternatively, the anchoring member 407 may be removed by moistening with water or other appropriate release agents. As in the embodiment of FIG. 30, if no fresh plug (or other device) is to be inserted, the anchoring member 407 is simply removed by moistening it with water or other appropriate release agents, thereby dislodging the anchoring member from the tissue surrounding the meatus.

In FIGS. 36 and 37 another embodiment of the invention is shown, wherein the urethral plug assembly comprises a mechanically expandable member. Such a urethral plug assembly is fully described in U.S. Serial No. 08/062,592 filed May 17, 1993, the teachings of which are herein incorporated by reference. FIG. 36 shows an expandable plug assembly 500 having a body 502 comprised of a hollow, cylindrical tube which is sized to be easily inserted through the orifice of the urethra. The body 502 is made from a biocompatible material having characteristics of compressibility. Attached on the periphery thereof, either by thermal bonding, laminating or other means, is a balloon 509, which is adapted to rest against the body 502. At the distal end of the tube is an enlarged base portion 504. As in the embodiments of FIG. 30 and FIGS. 34 and 35, an anchoring member 506 defining an aperture 508 is disposed above the base portion 504 and is adapted to receive and hold the body 502. The body 502 has a smaller diameter portion 503 sized to achieve a snap-fit upon insertion of the body 502 into the aperture 508 of the anchoring member 506. The body 502 is thereby locked into place in the anchoring member 506 by the seating therein of the smaller diameter portion 503 of the body 502. The base portion 504, similar to the embodiments of FIG. 30 and FIGS. 34 and 35, emanates from the smaller diameter portion 503 and has a diameter larger than the diameter of the aperture 508 to further enhance such locking as it abuts the bottom of the anchoring member 506. The anchoring member 506, adapted to receive and secure the urethral plug assembly 500 at the meatus urinarius, assists the wearer in locating the meatus urinarius for proper insertion of the plug assembly 500. Upon insertion, the smaller diameter portion 503 of the body 502 forms a snap-fit in the aperture 508 of the anchoring member 506, thereby securing the urethral plug assembly 500 at the meatus urinarius. A layer of adhesive 510 on the proximal surface of the anchoring member 506 allows for sealing of the anchoring member to the tissue surrounding the meatus urinarius, thereby enhancing the security of the urethral plug assembly in the urethra.

Referring again to FIG. 36, enclosed within the cylindrical tube is a support rod 511, which may be a hollow or a solid member. The support rod 511 has a bulb 512 at one end thereof, abutting the proximal end of the tube. The bulb 512 functions to hold the support rod 511 within the tube. The support rod 511 has a string 514 attached at its end opposite the bulb 512, which extends through the body 502 and beyond the base portion 504, thus ensuring that the wearer will always be able to reach the string 514. On the string 514 there is preferably formed a knot 516. Although the knot 516 has been used advantageously, the attachment of any member having a diameter greater than the ball retention socket 518 in the base portion 504 suffices. The support rod 511 is formed of a biocompatible material; the body 502 is preferably formed of a biocompatible thermoplastic material; and the balloon 509 is preferably formed of a biocompatible thermoplastic elastomer, such as that sold under the trademark KRATON. However, any biocompatible material may be used for each of the aforementioned elements, as the invention is not to be limited to those named above.

The operation of the plug assembly 500 is described with reference to FIG. 37. A user inserts the plug assembly 500 while it is in a contracted configuration. As discussed in the previous embodiments, the plug assembly 500 is inserted into the urethra until the anchoring member 506 abuts the meatus urinarius and the adhesive layer 510 forms a seal with the tissue surrounding the meatus urinarius. The plug assembly 500 is further gently pressed until the smaller diameter portion 503 forms a snap-fit in the aperture 508 and the base portion 504 abuts the anchoring member 506, thereby locking the plug assembly 500 in place. At this point, the plug assembly 500 may be deployed by the wearer, whereupon it achieves an expanded configuration. To deploy, the wearer pulls on the string 514 depending from the support rod 511. By pulling on the string 514, a downward force is exerted on the string 514 in the vertical direction, forcing the support rod 511 to slide downwardly in the body 502 and exert a compressive force against the proximal end of the outer body 502. The body 502 thus expands outwardly in the horizontal direction, causing the balloon 509 to expand until the balloon forms a seal with the wall of the urethra, bladder neck or bladder. The wearer then secures the string 514 by sliding it through a slit in the ball retention socket 518 located in the base portion 504. This causes the knot 516 to act as a stop, as the knot rests within the socket 518, thereby preventing the body 502 from returning to its contracted state. The expansion of the body 502 serves to block the flow of urine as the balloon 509 forms a seal with the urethral, bladder neck or bladder wall. The placement of the plug assembly 500 is further retained in this position-by the anchoring of the plug assembly 500 at the meatus, effectuated by the adhesion of anchoring member 506 to the tissues surrounding the meatus.

The plug assembly 500, in its expanded form, functions to block the flow of urine from the wearer. When the wearer wishes to remove the plug assembly 500, a simple tug on the string 514 in a direction away from the socket 518 causes the knot 516 to be released therefrom, thus causing the body 502 to retract. The body 502 thereby returns to its original diameter prior to insertion, making plug removal a comfortable task. Thus, the body 502 and the balloon 509 cooperatively provide an expandable housing and the plug assembly 500 includes a means for mechanically expanding the housing and selectively returning the housing to its non-expanded condition. A continuous downward pulling of the string 514 unseats the base portion 504 from the aperture 508. A simple tug on base portion 504 removes the body 502 and bladder evacuation can occur. A fresh plug (or other device such as an intermittent catheter) may be inserted into the urethra of the wearer, with the anchoring member 506 serving as a guide to quickly and easily locate the meatus. Alternatively, the anchoring member 506 may be removed by moistening with water or other appropriate release agents.

In FIGS. 38 and 39 a further embodiment of the invention is shown wherein the urethral plug assembly comprises an automatically expandable member, the expansion being achieved without user actuation. Such a urethral plug assembly is fully described in U.S. Serial No. 08/088,469 filed July 7, 1993, the teachings of which are herein incorporated by reference. Referring now to FIG. 38, a plug assembly 600 is shown, which is preferably formed of a biocompatible thermoplastic material. In a preferred embodiment, the plug assembly includes a body 602 of known polyurethane-based polymer, which provides the plug assembly 600 with shape memory. The unique characteristic of the plastic polymer is its automatically triggered shape memory, which allows the body 602, constructed of the shape memory polymer, to be inserted into the urethra in a relatively compressed and elongated state, and regain a useful shape in response to a selected transition temperature, typically body temperature. The shape memory material, however, may alternatively comprise a hydrophilic material (not shown) capable of expanding in response to moisture or pH gradations. Similar to the above embodiments, the body 602 terminates in a base portion 604. An anchoring member 606 defining an aperture 608 is disposed adjacent to the base portion 604 and is adapted to receive and hold the body 602. The body 602 has a smaller diameter portion 603 sized to achieve a snap-fit upon insertion of the body 602 into the aperture 608 of the anchoring member 606. The body 602 is thereby locked into place in the anchoring member 606 by the seating therein of the smaller diameter portion 603 of the body 602. The base portion 604, similar to the embodiments of FIGS. 30, 34 and 36, emanates from the smaller diameter portion 603 and has a diameter larger than the diameter of the aperture 608 to further enhance such locking as it abuts the bottom of the anchoring member 606. The base portion 604, similar to base portions 306, 406 and 504 previously discussed, is of a diameter greater than the diameter of the aperture 608 in the anchoring member 606. The anchoring member 606, adapted to receive and hold the urethral plug assembly 600 at the meatus urinarius, assists the wearer in locating the meatus urinarius for proper insertion of the plug assembly 600. Upon proper insertion, the smaller diameter portion 603 of the body 602 forms a snap-fit in the aperture 608 of the anchoring member 606, thereby securing the urethral plug assembly 600 at the meatus urinarius. A layer of adhesive 610 on the proximal surface of the anchoring member 606 allows for sealing of the anchoring member 606 to the tissue surrounding the meatus urinarius, thereby enhancing the security of the urethral plug assembly 600 in the urethra.

For purposes of illustration only, the ability of the plug assembly 600 to expand in response to changes in temperature, will be discussed. When the urethral plug shown in FIG. 38 is subjected to a transition temperature, the relatively rigid body 602 of the plug assembly 600 changes to a second condition in which it is flexible and easily deformable. The body 602 is then pliable and, remembering its original mold shape, able to expand significantly in diameter to conform to the shape of the wearer's urethra. The expansion results in the formation of a tight seal between the body 602 and the urethra, bladder neck or bladder wall. The plug assembly 600 is further retained in this position by the anchoring of the plug assembly 600 at the meatus, with such anchoring facilitated by the adhesion of the anchoring member 606 to the tissue surrounding the meatus urinarius. Thus, the .plug assembly 600 is retained in the urethra to block the flow of urine. In accordance with the above discussion, the operation of the plug is discussed with reference to FIG. 39. The user inserts the urethral plug assembly 600 into the urethra while it is in its compressed and elongated state. The plug assembly 600 is inserted until the anchoring member 606 abuts the meatus urinarius and the adhesive layer 610 forms a seal with the tissues surrounding the meatus urinarius. The plug assembly 600 is further inserted until the smaller diameter portion 603 forms a snap-fit in the aperture 608 and the base portion 604 abuts the anchoring member 606, thereby locking the plug assembly 600 in place. The body 602 of the plug assembly 600, lying in the urethra, is exposed to the heightened temperature of the human body. The temperature increase causes the shape memory polymer comprising the body 602 to automatically expand outwardly and achieve a protrusion to conform to the size and shape of the wearer's urethra. The shape memory polymer is able to freely adapt and conform to its environment, the urethra, as it is only capable of expanding and conforming to the environment into which it is placed.

As urine accumulates in the bladder, pressure from the accumulating urine builds until the bladder is sufficiently full to exert a downward force on the urine in the bladder neck and urethra. The downward force in turn bears down on the proximal portion of the expanded body 602, furthering the diametrical expansion of the proximal portion of the body 602. The expanded body 602 provides a tight seal with the wall of the urethra, bladder neck or bladder to retain the body 602 in the wearer. When the wearer wishes to remove the body 602, for example, to void, a continuous tug on string 614 will cause the rubbery, diametrically expanded body 602 to elongate. The body 602 is thereby returned to a smaller diameter. A continuous downward pulling of the string 614 removes the body 602 from the urethra and bladder evacuation can occur. A fresh plug may be inserted, or alternatively, the anchoring member 606 may be removed by moistening with water. The ease with which the shape memory polymer plug allows removal prevents discomfort potentially associated with plug removal.

In FIG. 40, there is shown a cross sectional view of the urethral plug assembly along line A-A of the preferred embodiments set forth above. Body 702 is representative of elements 302, 402, 502, and 602 of the aforementioned plug assemblies, and as shown, is of a constant diameter. FIG. 41 shows an alternative embodiment of the urethral plug assembly, along line A-A. As shown in FIG. 41, the diameter of the body 802 is not constant, but variant, as shown by the radiused grooves 804 extending longitudinally along the diameter of the body. The radiused grooves 804 provide increased surface area contact which improves the coaptive interaction of the body 802 with the urethra. Such enhances the sealing ability of the plug, and means a better fit for the wearer.

As previously discussed, the anchoring member comprising the aforementioned urethral plug assemblies is available as a separate component. Such application is desirable when the wearer wishes to replace the anchoring member device itself. Once the device is removed from the meatal tissues, by means of moistening with water or other suitable release agents, a fresh device may be placed upon the tissue surrounding the meatus. In addition to serving as a guide for inserting the urethral plug assemblies disclosed in FIGS. 30, 34, 36 and 38, the anchoring member is also contemplated as a guide for easy insertion and accurate placement of other types of urinary devices, such as intermittent catheters and indwelling catheters for bladder infusion and drainage, and diagnostic instruments.

The anchoring member, whether utilized separately or as an integral component of the aforementioned urethral plug assemblies, may be comprised of plastics, foams, elastomers and/or metals. Preferred materials for the anchoring member include polyurethanes and polyethylenes. In one preferred embodiment the anchoring member is comprised of a magnetized material, most preferably, a magnetic-filled plastic. Upon adhesion to the tissue surrounding the meatus, the magnetized anchoring member serves as a "homing" device for medical devices requiring insertion into the urethra, such as urethral plugs, catheters, and diagnostic tools. The medical device to be inserted may be equipped with sensing means by which it locates the anchoring member. Alternatively, the medical device to be inserted may simply be attracted to the anchoring member by magnetic flux.

Another embodiment of the anchoring member includes providing the anchoring member in various colors, whereby the wearer or health care professional can quickly identify its location and, therefore, the location of the urethra of the wearer for easy insertion or removal of the medical device. Additionally, the anchoring member may comprise a distinctive surface configuration by which the wearer or health care professional is tactically guided to the location of the anchoring member. The medical device is then easily inserted into, or removed from, the urethra of the wearer.

The occlusion devices described above, as with any "remove- to-void" device, may have potential for contact between the voided urine of the wearer and the anchoring member surrounding the meatus urinarius. As such, there exists the potential for infections involving bacteria in the urine and/or the superficial regions of the urethral and bladder tissues. To avoid such problems, or to treat such problems, the present invention further provides for means which are capable of delivering a variety of antibiotics or other therapeutic compounds to the infected urinary tract. Such means are fully disclosed in U.S. Serial No. 07/636,285 and U.S. Serial No. 07/746,364, the teachings of which are incorporated herein by reference. Furthermore, the anchoring member provides for means to guard against infections. A variety of antibiotics and other therapeutic compounds may comprise a mixture with the adhesive, which mixture is placed on the proximal surface of the anchoring member. Alternatively, a variety of antibiotics and other therapeutic compounds may comprise a coating on the adhesive of the anchoring member.

Thus, there are presented alternative embodiments of assemblies for preventing urinary incontinence in females and males. The assemblies presented herein prevent loss of urine which can occur during physical exertion, sometimes as little as laughing, coughing, sneezing, or the like. It is intended that the plug assemblies of the alternative embodiments, including the applicators where applicable, be sterile and individually wrapped, with several assemblies packaged in a box.

It is to be understood that the present invention is by no means limited to the particular constructions herein disclosed and/or shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.

Having thus described our invention, what we claim as new and desire to secure by Letters Patent of the United States is:

Claims

1. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in the urethra of a human, said applicator comprising a support portion for retaining said elastomer body, and a manipulable portion for disengaging at least a portion of said body from at least a portion of said applicator, said body comprising a discrete body of foam or elastomer material mounted on said applicator support portion.

2. The assembly in accordance with claim 1, further comprising collar means extending radially outwardly from said applicator.

3. The assembly in accordance with claim 1 wherein said manipulable portion of said applicator is operative to disengage said body and said applicator support portion from said applicator manipulable portion.

4. The assembly in accordance with claim 1 wherein said applicator support portion comprises a tubular shell open at a first end and having a second end substantially closed but adapted to open to permit said foam body to pass therethrough, and said applicator manipulable portion comprises a plunger disposed in said shell first end, engageable with said foam body, and adapted to push said foam body through said shell second end.

5. The assembly in accordance with claim 4 wherein said applicator support portion is provided with slits at said second end to permit said second end to open for said passage of said body therethrough.

6. The assembly in accordance with claim 1 wherein said applicator support portion comprises a tubular shell open at a first end and having a second end closed and expandable in balloon-like fashion, and said applicator manipulable portion comprises a plunger disposed in said first end, engageable with said foam body, and adapted to push said foam body into said shell first end to expand said shell first end in said balloon-like fashion.

7. The assembly in accordance with claim 1 wherein said applicator support portion comprises an elongated projection, said applicator manipulable portion comprises a grip

portion fixed to said support portion, and said elastomer body has a bore centrally thereof in which is disposed said elongated projection, said body being extended over said elongated projection.

8. The assembly in accordance with claim 1 wherein said body is provided with an enlarged base portion at one end thereof.

9. The assembly in accordance with claim 1, further comprising a string fixed to said body and extending therefrom.

10. The assembly in accordance with claim 8, further comprising an appendage fixed to said foam body base portion and extending therefrom.

11. The assembly in accordance with claim 9 wherein said applicator plunger first end is open and said plunger has therein a chamber in communication with said plunger open first end for releasably housing said string.

12. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in a urethra of a human, said applicator comprising a support portion for retaining said body, said support portion comprising a tubular shell open at a first end and having a second end substantially closed but adapted to open in response to pressure thereupon internally of said shell, and a manipulable portion comprising a plunger in part disposed in said shell open first end, said plunger being engageable with said body at a first end of said plunger, said body comprising a discrete elongated body of foam or elastomer material mounted in said shell, said applicator plunger being moveable in said shell to force said body through said shell second end to disengage said body from said applicator.

13. The assembly in accordance with claim 12, further including a collar extending radially outwardly from said shell proximate but removed from said shell second end.

14. The assembly in accordance with claim 12 wherein said shell second end is slit so as to be adapted to open in response to pressure thereupon internally of said shell.

15. The assembly in accordance with claim 12 wherein said body is provided with an enlarged distal end.

16. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in a urethra of a human, said applicator comprising a support portion for retaining said body, said support portion comprising a tubular shell open at first and second ends, and a manipulable portion comprising a plunger in part disposed in said shell open first end, said plunger being engageable with said body at a first end of said plunger, said body comprising a discrete elongated body of foam or elastomer material mounted in said shell, said applicator plunger being moveable in said shell to force said body through said shell second end to disengage said body from said applicator.

17. The assembly in accordance with claim 16 wherein said tubular shell is provided with a collar portion proximate said shell second end and extending radially outwardly therefrom.

18. The assembly in accordance with claim 17, wherein a portion of said tubular shell is of frusto-conical configuration at said second end and said collar is disposed at the base of the frusto-conical portion.

19. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in a urethra of a human, said applicator comprising a support portion for retaining said body, said support portion comprising a tubular shell open at a first end and having a closed second end expandable in balloon-like fashion, and a manipulable portion comprising a plunger in part disposed in said shell open first end, said plunger being engageable with said body at a first end of said plunger, said body comprising a body of foam or elastomer material disposed in said shell and removed from said shell closed end, said applicator plunger being moveable in said shell to force said body through said shell into said shell closed second end to expand said shell second end in said balloon¬ like fashion.

20. The assembly in accordance with claim 19, further comprising an appendage fixed to and extending from said body.

21. The assembly in accordance with claim 19, further comprising a collar extending radially outwardly from said shell at a first end of said shell.

22. The assembly in accordance with claim 21, further comprising a stop ring extending radially outwardly from said plunger and engageable with said shell collar.

23. The assembly in accordance with claim 20 wherein said appendage comprises a string and wherein said first end of said plunger is open.and in communication with a chamber in said plunger for releasably housing said string.

24. The assembly in accordance with claim 19 wherein said body is an elongated body disposed in a barrel portion of said shell and is compressible axially by said plunger and expandable radially upon reaching said shell second end to assume an expanded configuration within said shell expandable second end.

25. The assembly in accordance with claim 24 wherein said applicator manipulable portion is operable to place said applicator support portion in said urethra, and is moveable within said support portion to move said body into said shell second end, to expand said body to retain said applicator support portion and said body in said urethra, and to withdraw said applicator manipulable portion from said applicator support portion, to leave said applicator support portion, with said body therein, in said urethra.

26. The assembly in accordance with claim 19 wherein said plunger is provided with a head at a second end of said plunger.

27. The assembly in accordance with claim 19, wherein said expandable closed second end comprises a discrete component joined to said tubular shell, said component having greater facility for expansion under internal pressure than said tubular shell.

28. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in a urethra of a human, said applicator comprising a support portion for retaining said body, said support portion comprising an elongated projection, and a manipulable portion comprising a grip portion fixed to said support portion, said body comprising a body of foam or elastomer material, said body having a bore therein adapted to receive said applicator support portion projection, said body being disposed on said projection, said applicator being removable from said body to disengage said body from said applicator.

29. The assembly in accordance with claim 28, further comprising an appendage fixed to and extending from said body.

30. The assembly in accordance with claim 28, further comprising an expanded base portion on a distal end of said body and extending radially outwardly from said distal end of said body.

31. The assembly in accordance with claim 30, further comprising a string fixed to and extending from said base portion of said body.

32. The assembly in accordance with claim 31 wherein said applicator grip portion is provided with an opening at an end thereof from which extends said projection, and is provided with a chamber in communication with said opening for receiving and releasably retaining said string extending from said body.

33. The assembly in accordance with claim 28 wherein said body is extended over said applicator projection.

34. The assembly in accordance with claim 33 wherein said body is extended over substantially the length of said applicator projection.

35. The assembly in accordance with claim 32 wherein said applicator grip portion is provided with a closed end and said projection extends from said closed end centrally through said chamber and said opening.

36. An assembly for prevention of urinary incontinence in humans, said assembly comprising an applicator for positioning an elastomer body in a urethra of a human, said applicator comprising a support portion for retaining said body, said support portion comprising a tubular shell open ,at first and second ends thereof, and a manipulable portion comprising a plunger in part disposed in said shell open first end, said plunger being engageable with said body at a first end of said plunger, said body comprising a body of foam or elastomer material disposed in said shell and removed from said shell second end, and said applicator plunger being moveable in said shell to force said body through said shell and in part through said second end, to permit expansion of a first portion of said body forced through said second end, said shell second end retaining a second portion of said body in said applicator support portion.

37. The assembly in accordance with claim 36, further comprising means for locking said plunger in said support portion.

38. A method for preventing an unwanted discharge of urine, comprising the steps of: providing an applicator with an expandable body fixed thereto in a non-expanded condition; manipulating said applicator to insert said body into a urethra and to separate said applicator from -said body, to permit said body to expand in said urethra; and drawing said body in expanded condition from said urethra by pulling an appendage extending from said body and exteriorly of said urethra when discharge of urine is desired.

39. The method in accordance with claim 38 wherein said applicator comprises a shell and a plunger, with said body disposed in said shell, and said manipulation of said applicator to insert said body in said urethra comprises positioning an end of said shell in said urethra and moving said plunger in said shell to expel said body from said shell and into said urethra, and said manipulation of said applicator to separate said applicator from said body comprises withdrawal of said applicator from said urethra.

40. The method in accordance with claim 38 wherein said applicator comprises a plunger, and said body comprises an expandable mass disposed in a shell having an expandable end, and said manipulation of said applicator to insert said body in said urethra comprises positioning said plunger to move said shell into said urethra and moving said plunger in said shell to move said mass in said shell to said expandable end of said shell to permit expansion of said mass and said shell expandable end, and said manipulation of said applicator to separate said applicator from said body comprises withdrawal of said plunger from said shell.

41. The method in accordance with claim 38 wherein said applicator comprises a plunger, and said body comprises an expandable mass disposed in a shell having an open end, and said manipulation of said applicator to insert said body in said urethra comprises positioning said plunger to move said shell into said urethra and moving said plunger in said shell to move said mass in said shell to a position in which a portion of said mass extends beyond said shell open end to permit expansion of said portion of said mass, and said manipulation of said applicator to separate said applicator from said body comprises withdrawal of said plunger from said shell.

42. The method in accordance with claim 38 wherein said applicator comprises a grip portion and an elongated projection extending from said grip portion with said expandable body being stretched over said elongated projection, and said manipulation of said applicator to insert said body into said urethra comprises positioning said body in said urethra by manipulation of said grip portion of said applicator, and said manipulation of said applicator to separate said applicator from said body comprises withdrawal of said elongated projection from said body, to permit said body to expand in said urethra.

43. A device for controlling urinary incontinence comprising: a member defining an aperture therein, said member adapted to be anchored to the meatus urinarius of a human; and a means for blocking the flow of urine sized to be received in said aperture, said means for blocking being removably inserted through said aperture and into said meatus urinarius to block the flow of urine therefrom, said member adapted to be retained on said meatus urinarius while said means for blocking is being removed, and a fresh means for blocking is being inserted.

44. The device according to claim 43, including means for anchoring said member, said anchoring means comprising adhesive.

45. The device according to claim 44 wherein said adhesive is selected from the group consisting of hydrogel adhesive, polyvinylether-based adhesive, acrylic-based adhesive, and natural gum rubber adhesive.

46. The device according to claim 43 wherein said member is circular.

47. The device according to claim 43 wherein said member comprises a magnetic material, and said magnetic material is adapted to attract a medical or diagnostic device thereto.

4_ _The device.according to claim 47 wherein said magnetic material is selected from the group consisting of a plastic and a metal.

49. The device according to claim 43 wherein said member has a thickness sufficient to prevent migration into the urethra of said human.

50. The device according to claim 49 wherein said thickness is from about 0.03 inches to about 0.25 inches.

51. The device according to claim 43 wherein said means for blocking the flow of urine further comprises an extension emanating therefrom, said extension adapted to be grasped by a user for removal.

52. The device according to claim 51 wherein said extension is selected from the group consisting of a tab and a string.

53. The device according to claim 43 wherein said means for blocking the flow of urine comprises a biocompatible material selected from the group consisting of foam, elastomer, and a combination of foam and elastomer.

54. The device according to claim 43 wherein said means for blocking the flow of urine comprises a fluidly expandable member.

55. The device according to claim 43 wherein said means for blocking the flow .of urine comprises a mechanically expandable member.

56. The device according to claim 43 wherein said means for blocking the flow of urine comprises an automatically expandable member.

57. The device according to claim 54 wherein said means for blocking the flow of urine comprises means for transmitting fluid to said fluidly expandable member.

58. The device according to claim 55 wherein said means for blocking the flow of urine comprises an actuating member having means for imparting a mechanical force to said mechanically expandable member, thereby causing said member to expand.

59. The device according to claim 56 wherein said automatically expandable member comprises a shape memory polymer.

60. The device according to claim 43 wherein said means for blocking the flow of urine further includes a body having radiused grooves on the periphery of said body.

61. A device for guiding an instrument into the urethra of a human comprising: a member defining an aperture therein, said member having means for anchoring said member to the meatus urinarius of said human, said member adapted to be retained on said meatus urinarius while said instrument is being inserted through said aperture and into said urethra of said human, and removed from said urethra of said human.

62. The device according to claim 61 wherein said means for anchoring said member comprises adhesive.

63. The device according to claim 62 wherein said adhesive is selected from the group consisting of hydrogel adhesive, polyvinylether-based adhesive, acrylic-based adhesive, and natural gum rubber adhesive.

64. The device according to claim 61 wherein said member is circular.

65. The device according to claim 61 wherein said member has a thickness sufficient to prevent migration into the urethra of said human.

66. The device according to claim 65 wherein said thickness is from about 0.03 inches to about 0.25 inches.

67. The device according to claim 61 wherein said member comprises a magnetic material, said magnetic material being adapted to attract or guide a medical or diagnostic device thereto.

68. The device according to claim 67 wherein said magnetic material is selected from the group consisting of a plastic and a metal.

69. The device according to claim 61 wherein said member further comprises colors for user recognition.

70. The device according to claim 61 wherein said member further comprises a surface configuration, said surface configuration providing a tactile guide for a user to insert an instrument into, or remove an instrument from, the user's body.

71. A method of using a urethral plug assembly for controlling urinary incontinence comprising: providing a urethral plug having an anchoring member defining an aperture adapted to receive and hold said plug, said anchoring member having adhesive thereon; inserting said urethral plug into the urethra of a human such that said anchoring member abuts the meatus urinarius of said human; securing said anchoring member against said meatus urinarius; and retaining said urethral plug in position in said urethra without movement or slippage of said plug from said position until bladder evacuation is desired.

72. The method of using a urethral plug according to claim 71, further comprising sealing said anchoring member to the meatus urinarius.

73. The method of using a urethral plug according to claim 71, wherein said urethral plug comprises an expandable urethral plug.

74. The method of using a urethral plug according to claim 73, further comprising expanding said urethral plug to occlude the urethra.

75. The method of using a urethral plug according to claim 71, further comprising removing said urethral plug to evacuate the bladder.

76. The method of using a urethral plug according to claim

75, further comprising retaining said anchoring member on the tissues surrounding the meatus urinarius of said human following removal of said urethral plug.

77. The method of using a urethral plug according to claim

76, further comprising inserting a fresh plug, said fresh plug adhering to said anchoring member to further secure said fresh plug in position in the body of said human.

78. The method of using a urethral plug according to claim 71, further comprising adding a therapeutic compound to said adhesive.