WO1996039096A1

WO1996039096A1 - Rolling incontinence plug

Info

Publication number: WO1996039096A1
Application number: PCT/US1996/008309
Authority: WO
Inventors: Dezso K. Levius; Arnold W. Thornton; David W. Anderson
Original assignee: Iotek, Inc.
Priority date: 1995-06-05
Filing date: 1996-06-03
Publication date: 1996-12-12
Also published as: AU5965196A

Abstract

A rolling incontinence plug (10) includes a sealing member (22) having an axial hole. An elongated stem (12) is disposed within the hole of the sealing member. A longitudinal force is applied to the elongated stem (12) to longitudinal advance the stem (12). When such longitudinal force is applied, the stem (12) imparts a force on the sealing member (22) surface defining the axial hole. The sealing member (22) engages a urethral wall and rolls along the urethral wall while the force is being applied to the stem (12). The force is applied until the plug (10) is fully inserted into the urethral and an anchoring member (50) prevents further insertion of the plug (10).

Description

ROLLING INCONTINENCE PLUG

Background of the Invention

Field of the Invention This invention pertains to an incontinence control device. More particularly, this invention pertains to a female incontinence plug for rolling insertion into the urethra.

Description of the Prior Art

The inability to deter the flow of urine from the bladder is a common phenomenon in women, particularly older women. Such inability to contain urine or other fluids is termed "incontinence". The urethra is the passage through which the bladder is normally emptied during urination. The urethra is surrounded by a muscle or sphincter (urethral wall) that voluntarily holds the urethra closed when normal individuals are not urinating. Patients suffering from incontinence experience a disruption in both their professional and recreational activities. Further, incontinence is detrimental to the self-esteem of the afflicted patients. One method of treating incontinence is to use a device that obstructs the urethra such that it prevents the uncontrollable flow of fluid from the bladder through the urethra.

Incontinence plugs for insertion into the urethra are known in the prior art. Examples of such devices include those shown in U.S. Patent Nos. 5,090,424 and 5,080,006 and commonly assigned U.S. patent application Serial No. 08/328,331 filed October 24, 1994, and entitled "INCONTINENCE DEVICE" by inventors Robert E. Buuck and Dezso K. Levius. The '331 application utilizes a sleeve for initial insertion into the urethra. The incontinence plug is then passed through the sleeve such that the distal end of the plug does not come in contact with the entrance to the urethra. By not contacting the entrance to the urethra, the plug will not transport pathogens or bacteria from the urethral entrance or meatus to the bladder.

For a female incontinence device to be effective and to be used by a large number of patients, the design should accomplish several objectives. The device should restore continence to an acceptable level in a majority of patients for whom it may be prescribed. The incontinence device must be used with a minimum of complications. The incontinence device should be insertable into the urethra by the patient with a minimum of physical and social discomfort. Also, the incontinence device must be designed in such a manner and with materials acceptable to the Food and Drug Administration, so that the device can be produced, packaged and sterilized at low cost.

Most prior art involve devices that are pushed along the inside of the urethra, thereby rubbing against the urethral wall until fully inserted. The rubbing along the urethral wall by the incontinence device as it is being pushed through the urethra can cause trauma to the vessel. Further, pushing an incontinence device through the urethra can result in bacteria or other pathogens being transported from the urethral entrance along the urethra and toward or into the bladder. While the aforementioned devices advance treatment of incontinence, incontinence devices that produce less trauma to the urethra are needed and desired by patients using such devices. In addition, incontinence devices are needed that reduce the bacteria and other pathogens transported into the bladder during insertion of the devices. It is an object of the present invention to provide an improved design of an incontinence plug that substantially reduces trauma and minimizes transportation of bacteria and other pathogens into the bladder. Summary of the Invention

In accordance with one aspect of the invention, a rolling incontinence plug is provided. The plug includes a sealing member as previously described. The sealing member is shaped like an inverted tube and is filled with a deformable substance to permit rolling of the sealing member. The sealing member has an attached anchor member for anchoring the plug between the patient's vestibule and labia minora. An elongated stem is disposed within the axial hole of the sealing member. A proximal end of the stem is attached to a flange for providing limited insertion of the incontinence plug into the urethra. The flange has an adhesive layer on one side for securing the flange to the anchor member. According to another aspect of the present invention as previously described, a rolling incontinence plug is provided wherein a lower portion of the elongated stem tapers outwardly creating an enlarged diameter in the lower portion of the stem. The enlarged portion of the stem is configured to mold the sealing member against the urethral wall in order to more securely seal the urethra. The stem can also be configured such that the enlarged portion of the stem molds the sealing member partially within the bladder and partially against the urethral wall in order to prevent leakage from the bladder through the urethra.

According to yet another aspect of the present invention as first described, sleeve members protruding from the flange along side of the stem are provided. The sleeve members are configured to mold the shape of the sealing member in order to provide a more effective seal or to increase the pressure of the seal in the urethra.

In a further aspect of the present invention, a rolling incontinence plug allowing the selective release of fluid from the bladder is disclosed. The plug includes a sealing member as previously described. An elongated hollow stem is disposed within the axial hole of the sealing member. A distal end of the stem is open allowing fluid to pass through the hollow stem. At a proximal end of the stem a blocking plug or valve is used to seal the stem and prevent leakage of any fluid. The blocking plug can be removed and re-inserted by the patient at any time for selective release of fluid from the bladder.

In yet a further aspect of the present invention previously described, the hollow elongated stem can be sealed at the proximal end by a variety of methods. For example, the proximal end of the stem can extend beyond the flange and can be sealed by kinking or otherwise clamping the extension for selective operation by the patient to release fluid from the bladder. In yet another aspect of the present invention previously described as allowing selective release of fluids from the bladder, a rolling incontinence plug is provided having an inlet port and an outlet port in the stem for receiving and releasing fluids, respectively, from the bladder. The stem has a rounded closed tip at a distal end to aid in insertion. The plug is configured such that the sealing member normally blocks either the inlet port or the outlet port when the plug is in its fully inserted position. The patient can selectively release the fluid by moving the stem such that the sealing member blocks neither the inlet port nor the outlet port, thereby allowing fluid to flow freely therethrough. In one variation of this embodiment, the tip of the stem could be open, serving as the inlet port.

Finally, with respect to all of the above mentioned embodiments, another aspect of the invention includes a sealing member substantially torroidal in shape and having an axial hole through which an elongated stem is disposed. The sealing member is not attached to an anchor member or flange, but rather, freely rolls along the stem. The stem has an enlarged distal end to retain the sealing member on the stem and has a flange attached to a proximal end to limit insertion into the urethra.

While the present invention is described in association with particular shapes of an elongated stem, the invention is not limited in the type of shape that will provide an effective seal when used in conjunction with a sealing member. In addition, while the invention is described as using a deformable substance within the sealing member, the invention is not limited to the type of deformable material contained within the sealing member. For example, the sealing member can be made of a suitably deformable solid material. While the invention is described as using an anchor member to anchor the plug, any configuration that allows for limited insertion and secured placement of the plug can be used, such as, for example, a flange having an adhesive layer. Further, while several embodiments describe the stem as being attached to a flange with adhesive to limit insertion, the stem could alternatively be attached to an anchor member similar to that described with reference to the sealing member. Finally, although the invention is described as being used within a urethra to prevent uncontrollable flow of fluid from the bladder, it will be apparent that the invention could be utilized in other passageways such as a rectum or a vagina to prevent the uncontrollable flow of fluid or other substances. These and other features of the invention will become apparent to those skilled in the art upon more detailed description of the preferred embodiments of the invention.

Brief Description of the Drawings

Fig. 1 is a diagrammatic cross-sectional side view of a preferred embodiment of a rolling incontinence plug in its fully inserted position within a urethra;

Figs. 2A through 2D are diagrammatic top-sectional views of various embodiments of an anchor member as shown in cross-sectional view in Fig. 1 abutting a vestibule and a urethral entrance;

Fig. 3 is a diagrammatic bottom view of the anchor member of Fig. 2A, having a bottom sectional view of the incontinence plug of Fig. 1, installed in the external genitalia of a human female;

Fig. 4 is a split cross-sectional side view of a rolling incontinence plug showing the left side of the plug in its fully inserted position and the right side of the plug in an initial insertion position;

Fig. 5 is a split step-by-step cross-sectional side view of the rolling incontinence plug shown in Fig. 4 being inserted into a urethra;

Fig. 6 is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position within a urethra;

Fig. 7A is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position in a urethra where a portion of the incontinence plug is shaped to mold the plug into sealing engagement with a bladder neck and a urethral wall; Fig. 7B is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug shown in Fig. 7A in its fully inserted position where a portion of the incontinence plug is shaped to mold the incontinence plug into sealing engagement with the urethral wall;

Fig. 8 is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position in a urethra where the incontinence plug utilizes sleeve members to mold the incontinence plug into sealing engagement with a bladder neck and a urethral wall; Fig. 9 is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position within a urethra where the incontinence plug allows selective depletion of fluid using an inlet port and an outlet port in the plug;

Fig. 10 is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug, similar to that of Fig. 9 where the plug allows selective depletion of fluid, having an open passageway with a removable blocking plug;

Fig. 11 is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug, similar to that of Fig. 9 where the plug allows selective depletion of fluid, showing a plug extension kinked or otherwise clamped to allow selective depletion of fluid;

Fig. 12 is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug according to the present invention in its fully inserted position, within a urethra;

Fig. 13A is a diagrammatic cross-sectional view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position in a urethra where a portion of the incontinence plug is shaped to mold the plug into sealing engagement with a bladder neck and a urethral wall;

Fig. 13B is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug shown in Fig. 13A where a portion of the incontinence plug is shaped to mold the plug into sealing engagement with the urethral wall;

Fig. 14A is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position in a urethra where the incontinence plug utilizes sleeve members to mold the incontinence plug into sealing engagement with the bladder neck and a urethral wall;

Fig. 14B is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug shown in Fig. 14A, utilizing alternatively shaped sleeve members to mold the incontinence plug into sealing engagement with the bladder neck and the urethral wall;

Fig. 15 is a diagrammatic cross-sectional side view of an alternative embodiment of a rolling incontinence plug according to the present invention in its fully inserted position within a urethra where the incontinence plug allows selective depletion of fluids, using an inlet port and an outlet port in the plug; Fig. 16 is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug, similar to that of Fig. 15 where the plug allows selective depletion of fluids, showing an open passageway with a removable blocking plug; Fig. 17 is a diagrammatic cross-sectional side view of an alternative embodiment of the rolling incontinence plug, similar to that of Fig. 15 where the plug allows selective depletion of fluids, showing a plug extension kinked or otherwise clamped to allow selective depletion of fluid; and

Fig. 18 is a diagrammatic cross-sectional side view of a preferred embodiment of a rolling incontinence plug in its fully inserted position within a urethra being naturally deformed by sphincter muscles surrounding the urethra.

Detailed Description of the Preferred Embodiment

With reference now to the various drawing figures in which identical elements are numbered identically throughout, a description of the preferred embodiments of the present invention will now be provided.

Referring to Fig. 1, a preferred embodiment of a rolling incontinence plug 10 is shown in a diagrammatic cross-sectional side view. The plug 10 has an elongated, substantially cylindrical, hollow stem 12 with a radially extending flange 14 at a proximal end. The flange 14 preferably has an adhesive layer 16 covering an upper side of the flange 14. In this preferred embodiment, a distal end of the stem 12 is rounded and closed. The stem 12 is positioned inside an axial hole defined by opposing surfaces 21 of an exterior surface 24 of a sealing member 22. The sealing member 22 is substantially shaped like an inverted tube and the exterior surface 24 sealably engages a urethral wall 6. In this preferred embodiment, the sealing member 22 is fixedly attached to the stem 12 at inverted tube ends 25 and 26. The inverted tube ends 25 and 26 are attached by any suitable method, such as bonding, along the outer circumference of the stem 12 where the inverted tube ends 25 and 26 contact the stem 12. The sealing member 22 has an interior hollow area 23 that is filled with a deformable substance. In the preferred embodiment, the deformable substance used is saline. It will be apparent to those in the art that any deformable, non-toxic substance could be used. The exterior surface 24 of the sealing member 22 is secured to an anchor member 50 in the preferred embodiment. When the plug 10 is fully inserted, the anchor member 50 is anchored between a vestibule 5 and a pair of labia minora 3.1 and 3.2 of the patient and the flange 14 is secured to the anchor member 50 by the adhesive layer 16. It will be obvious to those skilled in the art that the flange 14 could be secured to the anchor member 50 by other means, such as, for example, a snapping mechanism between the flange 14 and the anchor member 50. In addition, as will be apparent to those skilled in the art, the flange 14 itself could be an anchor member of the same or similar configuration as described with reference to the embodiments of the anchor member 50. Various embodiments of the anchor member 50 are shown in Figs. 2A-2D. In the preferred embodiment, the anchor member 50 has a flexible outer peripheral member 52 with an exterior surface 54. The peripheral member 52 is substantially in the shape of a tubular ring which preferably can be made of deformable rubber. However, any other material having like characteristics can be utilized. Further, it will be apparent that the rubber peripheral member 52 can be solid or hollow with the hollow embodiment being filled with air or with a deformable material or fluid. The exterior surface 54 of the peripheral member 52 has an inner area 53 defining an inner circumference of the peripheral member 52. As will be apparent to those in the art, and as shown in Figs. 2A-2D, the exterior surface 24 of the sealing member 22 can be connected to the flexible peripheral member 52 in a variety of ways. In Fig. 2A, two pliable connecting ribs 56 and 58 attach to both the exterior surface 24 of the sealing member 22 and the exterior surface 54 of the peripheral member 52. In the preferred embodiment shown in Fig. 2A, the ribs 56 and 58 attach to the exterior surface 54 at points 60 and 62, respectively, along the inner area 53 of the peripheral member 52. Fig. 2B is an alternative embodiment of Fig. 2A wherein the peripheral member 52 is connected to the sealing member 22 by only one pliable connecting rib 56. In Fig. 2C, the sealing member 22 is affixed directly to the exterior surface 54 of the peripheral member 52 at point 64 along the inner area 53 of the peripheral member 52. Finally, Fig. 2D shows a substantially planar, connecting body 66, surrounding and attached to the sealing member exterior surface 24, such that the sealing member 22 extends axially through the connecting body 66. The connecting body 66 extends radially outwardly from the sealing member 22 and attaches to the peripheral member exterior surface 54 along the entire inner circumference defined by the inner area 53 of the peripheral member 52. The connecting ribs 56 and 58 and the connecting body 66 are thin and pliable, and can be formed of the same material as the peripheral member 52, although reduced in thickness. Upon a description of the operation, it will be apparent to those in the art that the overriding criteria for any connecting rib or body between the sealing member 22 and the peripheral member 52, are pliability and reduced material.

Referring to Fig. 3, a diagrammatic bottom view of the anchor member 50, shown in Fig. 2A, is shown installed in the external genitalia of a human female. Fig. 3 shows one side of the anchor member 50 covered by one of the pair of labia minora 3.1, as indicated by the dashed-line representation of the peripheral member 52. The opposing side of the anchor member is shown with the other of the pair of labia minora 3.2 cut away, as indicated by the dashed-line representation of the labia minora 3.2. In the preferred embodiment, the anchor member 50 is configured to conform to the vestibule 5, while being naturally anchored against the vestibule 5 by the labia minora 3.1 and 3.2.

As shown in Fig. 1, the sealing member 22 is inserted into a passageway referred to as a urethra 4. The urethra 4 is defined by the aforementioned urethral wall 6. One end of the urethra 4 connects to a bladder 2. The opposite end of the urethra is a urethral entrance 8 through which the rolling incontinence plug 10 is initially inserted.

Fig. 4 shows a split cross-sectional view of the preferred embodiment of the rolling incontinence plug

10, shown in diagrammatic form in Fig. 1, with the right side of the plug 10 being only partially inserted into the urethra 4 and the left side of the plug being fully inserted into the urethra 4 and the bladder 2. As shown in the partially inserted view (on the right) , the distal end of the stem 12 is positioned within the axial hole of the sealing member 22 prior to insertion. Operation Fig. 5 shows a split cross-sectional view of the step-by-step insertion from right to left of the rolling incontinence plug 10, shown in diagrammatic form in Fig. 1, into the urethra 4. For ease of readability, only the first step shown in Fig. 5 is numbered, it being apparent that each successive step would have the same reference numbering. The plug 10 can be initially inserted via an insertion applicator (not shown) or by gripping the peripheral member 52 of the anchor member 50 and pushing a distal tip of the sealing member 22 into the urethral entrance 8. Force applied to opposing edges of the peripheral member 52 will cause the anchor member 50 to bend into a substantially oval shape. The anchor member 50 is sufficiently flexible to allow easy placement between the vestibule 5 and the labia minora 3.1 and 3.2. Once the plug 10 is initially inserted into the urethra 4 and the anchor member 50 is placed between the vestibule 5 and the labia minora 3.1 and 3.2, the force is released and the anchor member 50 is naturally anchored between the labia minora 3.1 and 3.2 and the vestibule 5, conforming to the shape of the vestibule 5 in response to the pressure applied by the labia minora 3.1 and 3.2. As the patient moves, the anchor member 50 conforms to the changes in pressure from the labia minora 3.1 and 3.2, without producing any thick, buckled material or discomfort to the patient.

Upon initial insertion of the plug 10 into the urethra 4, as shown on the far right side of Fig. 5, a longitudinal force is applied to the stem 12 to advance the stem 12 through the urethra 4 toward the bladder 2. As the stem 12 is advanced, the stem attachments to the inverted tube ends 25 and 26 force the sealing member 22 to roll along the urethral wall 6. Prior to insertion, a stiffening rod 27 (shown in Fig. 5) can be placed through the hollow stem 12 to provide sufficient stiffness to the stem 12 to permit the longitudinal force to advance the stem 12 through the sealing member 22, thereby causing the sealing member 22 to roll along the urethral wall 6. It will be apparent to those skilled in the art that the inverted tube ends 25 and 26 must be attached to the stem 12 at a location that allows the sealing member 22 to continue rolling along the urethral wall 6 until the plug 10 is fully inserted with the flange 14 being in communication with the anchor member 50. Once the flange 14 has advanced to communication with the anchor member 50, the stem 12 has fully advanced into the bladder 2 and the sealing member 22 has rolled to the neck of the bladder 2. The adhesive layer 16 on the flange 14 secures the flange 14 to the anchor member 50, thereby securing the plug 10 in its fully inserted position. The far left step shown in Fig. 5 shows a split view of the rolling incontinence plug 10 in its fully inserted position.

While the anchor member 50 is used to secure the plug 10 and restrict further insertion into the urethra 4, it is expected that most patients will have a natural, internal anchor as shown in Fig. 18. Although incontinence is caused when sphincter muscles 7 relax and no longer automatically close the urethra, some amount of pressure by the sphincter muscles 7 may still occur. As shown in Fig. 18, even a small amount of pressure by the sphincter muscles 7 will cause inward curvature of the plug 10 at sphincter pressure point 9. The inward curvature will cause a distal end 19 and a proximal end 20 of the sealing member 22 to naturally expand. Such deformation of the plug 10 will create a natural internal anchor for the plug 10 at the expanded distal and proximal ends 19 and 20 respectively, of the plug 10. The expanded distal end 19 will prevent involuntary dislodging of the plug 10. The expanded proximal end 20 will restrict involuntary insertion of the plug 10 into the urethra.

When the plug 10 is removed, the flange 14 is severed from the anchor member 50 and the stem 12 is pulled out of the bladder 2 and the urethra 4, which causes the sealing member 22 to roll down the urethral wall 6 toward the urethral entrance 8. Both the insertion and removal of the rolling incontinence plug 10 shown in Fig. 5 utilize the friction between the exterior surface 24 of the sealing member 22 and the urethral wall 6 to aid the rolling action of the sealing member 22 along the urethral wall 6. The rolling action of the sealing member 22 along the urethral wall 6 reduces trauma, which is often caused by rubbing against the urethral wall 6. In addition, the rolling action reduces the pathogens and bacteria transported through the urethra 4 because the sealing member 22 does not slide through the urethra 4.

Al ternative Embodiments

Figs. 1 and 6 through 18, are not drawn to scale. Rather, these figures are diagrammatically drawn for ease of reference. For example, the stem referenced as 12 in Figs. 1, 6-11, and 18, and referenced as 112 in Figs. 12-17, may be sized to be twice the length of the urethra to aid in pre-insertion of the device.

Referring to Fig. 6, an alternative embodiment of the preferred rolling incontinence plug 10 of Fig. 1 is shown. The plug 10 in Fig. 6 has one modification to the plug 10 shown in Fig. 1. The plug 10 in Fig. 6 utilizes a flange 28 attached to the sealing member 22, rather than the preferred anchor member 50 shown in Figs. 1-3. The flange 28 has an adhesive layer 29 covering an upper side of the flange 28 for securing the flange 28 against the vestibule 5. Although the alternative embodiments hereinafter described are shown using a flange 28 attached to the sealing member 22, it will be apparent that each alternative embodiment could utilize an anchor member attached to the sealing member 22 as described with reference to Figs. 1 through 3. Figs. 7A and 7B show alternative embodiments for the present invention providing various configurations of the stem 12 to create a leak-proof seal between the sealing member 22 and the urethral wall 6 and the bladder 2. Fig. 7A shows a fully inserted plug 10 where the stem 12 tapers outwardly and downwardly toward the flange 14. The diameter of the tapered portion of the stem 12 is greater than the diameter of the distal end of the stem 12. The tapering begins at a location 30 between the proximal and the distal end of the stem 12 such that when the plug 10 is fully inserted, the sealing member 22 is sealably pressed against a portion of the urethral wall 6 and is partially pressed into the bladder 2.

Fig. 7B is a slight modification of the embodiment shown in Fig. 7A. The stem 12 in Fig. 7B begins tapering at a location 30' between the distal end and the proximal end such that when the plug 10 is fully inserted, the sealing member 22 is sealably pressed against the urethral wall 6 and is entirely within the urethra 4.

Fig. 8 shows an alternative embodiment of the present invention using sleeve members 32.1 and 32.2 to sealably press the sealing member 22 against the urethral wall 6 and into the bladder 2, thereby preventing leakage of fluid from the bladder 2. Fig. 8 shows sleeve members 32.1 and 32.2 extending upwardly from the flange 14 along the outer border of the stem

12. The distal ends of the sleeve members 32.1 and 32.2 taper outwardly (toward the sealing member 22 when the plug 10 is inserted) and downwardly toward the flange 14. This embodiment presses the sealing member 22 against the urethral wall 6 and into the bladder 2. The sleeve members 32.1 and 32.2 communicate such that combined, they surround the stem 12. As will be obvious to those skilled in the art, the sleeve members could comprise various configurations . Like the embodiment shown in Fig. 7B, the sleeve members could be configured to press the sealing member 22 into the urethral wall 6 entirely within the urethra 4 and not extending into the bladder 2. It will be further apparent to those in the art that the sleeve members may either partially or entirely surround the stem 12. As will also be obvious to those in the art, the sleeve members could comprise two or more sleeve members as shown and described, or only one sleeve member that entirely or partially surrounds the stem 12.

Fig. 9 shows an alternative embodiment of the present invention offering the patient the added feature of selectively releasing fluid from the bladder 2 without removing the plug 10. The plug 10 is configured substantially the same as the embodiment shown in Fig. 6. However, the stem 12 must be hollow and has an inlet port 34 near the distal end and an outlet port 36 near the proximal end. The inlet port 34 receives fluid from the bladder 2 and the outlet port 36 releases the fluid received in the inlet port 34. The plug 10 is configured such that when fully inserted as shown in Fig. 10, the sealing member 22 is positioned around the hollow stem 12 to block the outlet port 36. The patient can selectively release fluid by moving the stem 12 and thereby rolling the sealing member 22 to a position whereby the sealing member 22 does not block the inlet port 34 or the outlet port 36. This allows fluid to flow through the inlet port 34 and out of the outlet port 36. Once the fluid depletion is complete, the patient simply advances the hollow stem 12 back into its fully inserted position, causing the sealing member 22 to roll back into the position of blocking the outlet port 36 of the stem 12. It will be obvious to those skilled in the art that the plug 10 could also be configured such that the sealing member 22 blocks the inlet port 34 while in the fully inserted position. Movement of the stem 12 would roll the sealing member 22 and thereby allow the inlet port to receive fluid from the bladder 2 which would then be released through the outlet port 36. It will also be obvious to those skilled in the art that, rather than utilizing an inlet port as shown in Fig. 9, the distal end of the stem 12 could be open, allowing fluid from the bladder 2 to flow through the stem 12.

Fig. 10 is an alternative embodiment of the present invention utilizing the added feature of selective release of fluid from the bladder 2 as described with reference to Fig. 9. In the embodiment shown in Fig. 10, the stem 12 is hollow. The flange 14 has an opening 38 where the hollow stem 12 is attached. A blocking plug or valve 40 is inserted into the flange opening 38 to prevent fluid from escaping from the hollow stem 12. The blocking plug 40 as shown in Fig. 10 has a rounded handle 46 for pulling the blocking plug 40 out of the hollow stem 12. The distal end of the hollow stem 12 is not closed as shown in previous embodiments. Rather, the distal end is open allowing fluid from the bladder 2 to freely flow into the hollow stem 12. The distal end has rounded edges 44, to aid in the insertion of the plug 10. Obviously, the distal end could be closed and the stem could have an inlet port on the side of the stem 12, rather than an open distal end, for receiving bladder fluid. As will be apparent to those skilled in the art, the blocking plug 40 can assume various configurations.

Fig. 11 is another embodiment of the present invention providing for the selective release of fluid from the bladder 2. In the embodiment shown in Fig. 11, the stem 12 is hollow. The flange 14 has an opening 38 where the hollow stem 12 is attached to the flange 14. A hollow stem extension 42 is connected to the flange opening 38 and extends beyond the flange 14. The stem extension 42 is made of deformable material that can be kinked to prevent leakage of fluid from the hollow stem 12. The patient can selectively un-kink the stem extension to release fluid from the bladder 2 and then kink the stem extension 42 again to prevent leakage. As will be apparent to those skilled in the art, other clamping devices that restrict fluid flow can be utilized with the stem extension 42 to prevent leakage. Figs. 12 through 17 show alternative embodiments of the embodiments described above. The significant difference resides in the configuration of the sealing member 22. Referring to Fig. 12, a rolling incontinence plug 110 is shown having an elongated substantially cylindrical, hollow stem 112 with a radially extending flange 114 at a proximal end. The flange 114 has an adhesive layer 116 covering an upper side of the flange 114 for securing the plug 110 to the vestibule 5. At a distal end of the stem 112, a hemispherical dome 118 having a radially extended bottom surface 120 is attached to the stem 112 to prevent the sealing member 122 from rolling off the end of the stem 122. The stem 112 is disposed within an axial hole defined by opposing surfaces 121 of an exterior surface 124 of a sealing member 122. The sealing member 122 is substantially torroidal in shape and the diameter of the hole in the sealing member 122 is sized to frictionally engage the stem 112 positioned therethrough. The sealing member

122, shown as a solid in Figs. 12-17, can be hollow and filled with a deformable substance. The exterior surface 124 of the sealing member 122 is made of a material that can frictionally engage the urethral wall 6. Attachment points 131.1 and 131.2 represent optional attachments for the embodiments of Figs. 12-17 between the sealing member 122 and the stem 112.

Figs. 13A and 13B show alternative embodiments of the invention as described with reference to Fig. 12, with various configurations of the stem 112 to create a leak-proof seal between the sealing member 122 and the urethral wall 6 and the bladder 2. Fig. 13A shows a fully inserted plug 110 where the stem 112 tapers outwardly and downwardly toward the flange 114. The diameter of the tapered portion of the stem 112 is greater than the diameter of the distal end of the stem 112. The tapering begins at a location 130 between the proximal and the distal end of the stem 112 such that when the plug 110 is fully inserted, the sealing member 122 is sealably pressed against a portion of the urethral wall 6 and is partially pressed into the bladder 2. Fig. 13B is a slight modification of the embodiment shown in Fig. 13A in that the stem 112 begins tapering at a location 130' between the distal end and the proximal end such that when the plug 110 is fully inserted, the sealing member 122 is sealably pressed against the urethral wall 6 and is entirely within the urethra 4.

Fig. 14A shows an alternative embodiment of the invention as described with reference to Fig. 12 using sleeve members 132.1 and 132.2 to sealably press the sealing member 122 against the urethral wall 6 and into the bladder 2, thereby preventing leakage of fluid from the bladder. Fig. 14A shows sleeve members 132.1 and 132.2 extending upwardly from the flange 114 along the outer border of the stem 112. The distal ends of the sleeve members 132.1 and 132.2 taper outwardly (toward the^"urethral wall 6 when the plug 110 is inserted) and downwardly toward the flange 11 . This embodiment presses the -sealing member 122 against the urethral wall 6 and into the bladder 2. The sleeve members 132.1 and 132.2 communicate such that combined, they surround the stem 112.

Fig. 14B shows an alternative shape of sleeve members 132.1 and 132.2 shown in Fig. 14A. Sleeve members 132.1' and 132.2' extend upwardly from the flange 114 spaced from and around the stem 112. Distal ends of the sleeve members 132.1' and 132.2' taper inwardly toward the stem 112 and downwardly toward the flange 114. When fully inserted as shown in Fig. 14B, the sleeve members 132.1' and 132.2' extend along the urethral wall 6 and press the sealing member 122 into the stem 112 and the bladder 2. The various configurations of sleeve members described with reference to Fig. 8 are also applicable to the sleeve members utilized in Figs. 14A and 14B.

Fig. 15 shows an alternative embodiment of the incontinence plug 110 described with reference to Fig. 12. The plug 110 in Fig. 15 offers the patient the added feature of selectively releasing fluid from the bladder 2 without removing the plug 110. The plug 110 is configured substantially the same as the embodiment shown in Fig. 12. However, the stem 112 must be hollow and has an inlet port 134 near the distal end and an outlet port 136 near the proximal end. The inlet port 134 receives fluid from the bladder 2 and the outlet port 136 releases the fluid received in the inlet port 134. The plug 110 is configured such that when fully inserted as shown in Fig. 15, the sealing member 122 is positioned around the hollow stem 112 to block the outlet port 136. The patient can selectively release fluid by moving the stem 112 and thereby rolling the sealing member 122 such that the sealing member 122 does not block the inlet port 134 or the outlet port 136. This allows fluid to flow out of the outlet port 136. Once the fluid depletion is complete, the patient simply advances the hollow stem 112 into its fully inserted position, causing the sealing member 122 to roll back into the position of blocking the outlet port 136 of the stem 112. It will be obvious to those skilled in the art that the plug 110 could also be configured to allow the sealing member 122 to block the inlet port 134 during a fully inserted position. Movement of the stem 112 would move the sealing member 122 and thereby allow the inlet port 134 to receive fluid from the bladder 2 which would then be released through the outlet port 136.

Fig. 16 is an alternative embodiment of the invention in Fig. 12 utilizing the added feature of selective release of fluid from the bladder 2. In the embodiment shown in Fig. 16, the stem 12 is hollow. The flange 114 has an opening 138 where the hollow stem 112 is attached. A blocking plug or valve 140 is inserted into the flange opening 138 to prevent fluid from escaping from the hollow stem 112. The distal end of the hollow stem 112 does not have a dome as shown in previous embodiments. Rather, the distal end is open allowing fluid from the bladder 2 to freely flow into the hollow stem 112. However, the distal end has rounded outwardly extending edges 144, to secure the sealing member 122 on the stem 112. The blocking plug 140 shown in Fig. 16, and its variations, are the same as those described with reference to Fig. 9.

Fig. 17 is another embodiment of the invention described in Fig. 16, providing for the selective release of fluid from the bladder 2. In the embodiment shown in Fig. 17, the stem 112 is hollow. The flange 114 has an opening 138 where the hollow stem 112 is attached to the flange 114. A hollow stem extension 142 is connected to the flange opening 138 and extends beyond the flange 114. The stem extension 142 is made of deformable material that can be kinked to prevent leakage of fluid from the hollow stem 112. The patient can selectively un-kink the stem extension to release fluid from the bladder 2 and then kink the stem extension 142 again to prevent leakage from the hollow stem 112. As will be apparent to those skilled in the art, other clamping devices that restrict fluid flow can be utilized with the stem extension 142 to prevent leakage.

With each of the embodiments of the rolling incontinence plug shown and described above, a plug that rolls along the urethral wall in order to reduce trauma and reduce the transportation of pathogens is provided. In addition, the rolling action of the sealing member minimizes discomfort to the patient . Although the invention has been described with reference to the plugs 10 and 110 being used inside a urethra, those skilled in the art will know that the plug can also be effectively utilized in other passageways such as a rectum or vagina to restrict the flow of fluid or other substance. While the invention has been disclosed with preferred embodiments for the purpose of illustration, it will be appreciated that modifications and equivalents of the disclosed concepts may be apparent to those skilled in the art having the benefit of the teachings of the present invention. It is intended that the scope of the present invention not be limited by the specific embodiments shown above but shall include such modifications and equivalents.

Claims

What is claimed is:

1. A plug for treating incontinence by inserting said plug into a urethra defined by a urethral wall and having a urethral entrance, said plug comprising: a. a sealing member having an exterior surface including opposing surfaces defining a hole formed axially therethrough, b. a stem with a proximal end and a distal end, said stem extending through the hole of said sealing member and being configured to movably engage said opposing surfaces, and c. a stop secured to the proximal end for restricting insertion of said plug into the urethra.

2. A plug according to claim 1 wherein said sealing member is substantially shaped like an inverted tube.

3. A plug according to claim 1 further comprising an anchor including a peripheral member having an exterior surface, said exterior surface connected to said sealing member for anchoring said plug at the urethral entrance.

4. A plug according to claim 3 further comprising an adhesive layer on said stop for adhering said stop to said anchor.

5. A plug according to claim 1 wherein a portion of the exterior surface of said sealing member sealably contacts the urethra wall and rolls along the urethral wall toward the bladder in response to said stem axially advancing and imparting a force on said opposing surfaces of said sealing member causing said opposing surfaces to roll relative to a longitudinal axis of said stem.

6. A plug according to claim 1 wherein said stem further comprises attachment means for attaching said stem to the opposing surfaces of said sealing member at a location permitting continued advancement of said plug to a desired position in the urethra, said continued advancement including continuous rolling of said sealing member along the urethral wall until the desired position is reached.

7. A plug according to claim 1 further comprising at least one sleeve member configured to extend axially from said stop and sized to deform said sealing member in the urethra into sealing engagement with the urethral wall.

8. A plug for treating incontinence by inserting said plug into a urethra defined by a urethral wall and having a urethral entrance, said plug comprising: a. a sealing member having an outer membrane defining an interior, and having flowable mass disposed within said interior, said membrane movable in response to a force acting on said membrane for said membrane to roll relative to a longitudinal axis of said sealing member and with opposing surfaces of said membrane defining a hole axially extending through said sealing member, b. advancing means for imparting a force on said membrane to urge said membrane to roll relative to said axis when said sealing member is inserted within a urethra and with said membrane abutting said urethral wall, and c. a stop for limiting insertion of said plug into the urethra.

9. A plug according to claim 8 wherein said sealing member is substantially shaped like an inverted tube.

10. A plug according to claim 8 wherein said advancing means is a stem inserted within said hole, said stem further comprising attachment means for attaching said stem to said opposing surfaces and said membrane frictionally engaging said urethral wall to cause said membrane to roll in response to axial movement of said stem.

11. A plug according to claim 10, further comprising conduit means for permitting controlled fluid flow through said hole.

12. A plug according to claim 11 wherein said conduit means includes a fluid passage through said stem.

13. A plug according to claim 12 wherein said conduit means further includes a blocking member configured to be removably inserted into said fluid passage at a proximal end of said stem and having a removal means for selectively removing said blocking member from said fluid passage for releasing fluid.

14. A plug according to claim 12 wherein said conduit means further includes an extended portion of a proximal end of said stem with said extended portion deformable to a flow-restricted state.

15. A plug according to claim 12 wherein said stem further comprises a. an inlet port for receiving fluid into said fluid passage, and b. an outlet port for releasing fluid from said fluid passage.

16. A plug according to claim 15 wherein said sealing member is configured to removably block one of said inlet port and said outlet port when said plug is fully inserted into the urethra.

17. A plug according to claim 12 wherein said conduit means further includes a seal removably securable at a proximal end of said stem for controlling the release of fluid from said stem.

18. A plug according to claim 10 wherein said stem is shaped to deform said sealing member in the urethra into sealing engagement with the urethral entrance.

19. A plug according to claim 8 further comprising an anchor including a peripheral member having an exterior surface, said exterior surface connected to said sealing member for anchoring said plug at the urethral entrance.

20. A plug according to claim 19 further comprising a securing means for removably securing said stop in a fully inserted position.

21. A plug according to claim 20 wherein said securing means is an adhesive layer on said stop for adhering said stop to said anchor.

22. A plug according to claim 8 further comprising a flange connected to said sealing member and extending radially therefrom, said flange including an adhesive layer on one side for adhering said flange to the urethral entrance.

23. A plug for treating incontinence by inserting said plug into a urethra defined by a urethral wall and having a urethral entrance, said plug comprising: a. a sealing member having an outer membrane defining an interior, and having flowable mass disposed within said interior, said membrane movable in response to a force acting on said membrane for said membrane to roll relative to a longitudinal axis of said sealing member and with opposing surfaces of said membrane defining a hole axially extending through said sealing member, said membrane sized to permit said membrane to expand at a distal end and a proximal end of said membrane in response to pressure by a sphincter muscle between said distal end and said proximal end; b. advancing means for imparting a force on said membrane to urge said membrane to roll relative to said axis when said sealing member is inserted within a urethra and with said membrane abutting said urethral wall; and c. a stop for limiting insertion of said plug into the urethra.

24. A plug according to claim 23 wherein said expanded distal end of said membrane is sized to anchor said plug within the urethra, preventing involuntary removal of said plug from the urethra.

25. A plug according to claim 23 wherein said expanded proximal end of said membrane is sized to anchor said plug within the urethra, restricting involuntary insertion of said plug into the urethra.