MXPA99005254A

MXPA99005254A - Female incontinence device

Info

Publication number: MXPA99005254A
Application number: MXPA/A/1999/005254A
Authority: MX
Inventors: A Dann Jeffrey
Original assignee: A Dann Jeffrey; Gloth David A
Priority date: 1996-12-12
Filing date: 1999-06-07
Publication date: 2000-06-01

Abstract

This invention is a device (10) for alleviating female urinary incontinence comprising a resilient and at least partially deformable device body (12) having a distal tip portion (18), a flange (24), and an intermediate frusta-conical portion (22) extending outwardly from the tip portion (8) to the flange (24). In use, upper wall portions of the intermediate frusta-conical portion (22) adjacent to the tip portion (18) are moved toward abutting relation to form a first vacuum region within the tip portion (18) and a second vacuum region within the frusta-conical portion (22). The meatus of the user is disposed in the second vacuum region and is advantageously prevented from entering the first region by the upper wall portions of the intermediate frusta-conical portion. With this arrangement, the meatus is disposed in a"tent"region (i.e., the second vacuum region) which has a broad base, an apex, and is prevented from entering the first vacuum region which has a narrower entrance that could detrimentally entrap meatal tissue.

Description

DEVICE OF INCONTINENCE FEMEN? NO FIELD OF INVENTION This invention is generally related to a device for alleviating female urinary incontinence and specifically, with a device that maintains the closure of the external orifice of the urethra to relieve female urinary incontinence without causing discomfort or tissue damage. of the meatus.

ANT ^ CLEDLENTS OF THE INVENTION Female urinary incontinence is a common problem throughout the world. Urinary incontinence may result from sustained damage during birth, loss of urinary sphincter function, neurological disorders, trauma to the urethra and bladder neck, and failed surgical repairs. A variety of devices have been suggested to alleviate female urinary incontinence, including catheters, urethral plugs, Urethra collection devices, artificial intraurethral valves, vaginal scales and inflatable implantable prostheses. In general, these devices have been associated with problems of leakage, discomfort, inconvenience of use and urinary infection, Aderitás, several of the devices are considered invasive and require surgical intervention for their placement.

LIABILITY COMPENDIUM According to the invention, a device for alleviating female urinary incontinence includes a device body having a remote pupa portion, a flange and an intermediate truncated cone portion extending outwardly from the tip portion. . the eyelash. The device material is elastic and at least partially deformable. In use, the upper wall portions of the intermediate truncated cone portion adjacent to the tip portion are moved in abutment relationship to form a first vacuum region within the tip portion and a second region of, vacuum within the intermediate truncated cone portion. The meatus of the user is disposed in the second region and prevented from entering the first region by the upper wall portions of the intermediate truncated cone portion. Both the flange co or the truncated cone portion have body contact surfaces that, e? so, they make contact with the meatal tissue. More particularly, at least a portion of the truncated cpno side walls are disposed with the meatus and serve to substantially close the meatus. The vacuum environment within the first and second regions keeps the device in a secure seal with the meatus. The first and second vacuum regions can be separated by a closure formed by the top of the truncated cone wall upper portions. Alternatively, there may be a small space between the first and second vacuum regions. Advantageously, however, any space is too small to allow the meatal tissue to enter the first vacuum region thereby preventing the tissue from being pinched or herniated in another manner in the joint between the regions. For this purpose, preferably, the side walls < The truncated cone portion has a length equal to or greater than half the internal diameter of the flange. With this arrangement, a "tent" effect is created whereby the meatus is disposed in a store region (ie, the second tier 1 and empty) that has a broad base, or entrance adjacent to the tab and a Apex Significantly, the meatal tissue is prevented from entering the first region of vacuum that has a narrower entry through the apex of the tent region, thus preventing meatal discomfort or tissue entrapment at the entrance to the tissue. First Vacuum Region A method for alleviating female urinary incontinence without causing discomfort or mealjal damage is also described The method includes the steps of deforming a device body having a distal tip portion, a flange and a truncated cone portion intermediate that extends outward from the, tip portion to the flange, moving the upper wall portions of the adjacent truncated intermediate cone portion of the tip portion toward abutment relationship to form a first vacuum region within the tip portion and a second vacuum region within the intermediate truncated cone portion in which the user's meatus is disposed. The upper truncated cone wall portions advantageously prevent the meatal tissue from entering the first vacuum region. The method also includes the step of removing the device from the user's body to allow evacuation.3LIGHT DESCRIPTION OF THE DRAWINGS The previous features of this invention, as well as the invention itself, can be understood more fully from the following detailed description of the drawings in which: Figure 1 is a perspective view of a female incontinence device according to the invention, Figure 2 is a cross-sectional side view of the device of Figure 1, Figure 3 is a cross-sectional side view of the device. of Figure 1, placed on a meatus of a user, but not in use, since there is no vacuum environment, Figure 4 is a bottom view of the device as shown in Figure 3; cross-sectional side view of the device of Figure 1 in use; Figure t is a bottom view of the device as shown in Figure 5; Figure 7 is a cross-sectional side view of a female incontinence device in accordance with with an additional embodiment of the invention, and Figure 8 is a cross-sectional side view of the device of Figure 7 in use.

DETAILED DESCRIPTION OF THE INVENTION Referring to Figures 1 and 2, a female urinary incontinence device 10 includes - £, a device body 12 having a tip portion 18, remote from the wearer's body, a flange 24 and an intermediate truncated cone portion 22 extending outwardly from the tip portion to the flange. The device body 12 defines an interior chamber 16 extending from the curved outer end wall 27 of the tip portion 18 to the flange 24 < A body contact portion 20 of the device includes a crank contact surface 2 of the flange 24 and a body contact surface 29 of the intermediate truncated cone portion 22. In use, the body contacting surface 26 of the flange 24 makes contact with the tissue surrounding the wearer's Xa urethra face and the body contacting surface 29 of the intermediate truncated cone portion 22 makes contact and gently compresses the meatus. A medi.o ambiente *? The vacuum formed inside the chamber 16 during the application of the device serves to keep the device 10 in secure sealed engagement with the user, as will be described. Portion 18 may collect a small amount of urine, even though this usually occurs. When evacuation is necessary) the user easily removes the device 10. The tip portion 18 has a substantially hemispherical sub-configuration with laterally vertical lateral walls 19 centered about a central longitudinal axis of the diagonal and the wall 27 of external end curve that serves as a clamping period to facilitate the application and removal of the device. In an alternative embodiment, the outer end wall 27 of the tip portion 18 is flat. The tip portion 18 must be at least partially deformable and, more particularly, compressible in order to produce at least a partial vacuum in the chamber 16 sufficient to seal the device 10 to the user's body by or differential in air pressure between the air inside the chamber and atmospheric air pressure. Specifically, an air and fluid seal is formed between the body and the user and the device. In use, when a portion of the side walls 25 of the truncated cone portion 22 are disposed in contact with the tissue 3.2 meatal (Figure 5). From this maternity, truncated-ring portion 22 provides closure to the user's meatus. Significantly, the truncated cone portion 22 is designed in such a way as to avoid causing discomfort or damage to the meatal tissue, as will become apparent. The contraction surface 26 of the tab 24 forms a continuous ring around the meatus and improves the seal of the device to the wearer's body. More particularly, the flange 24 facilitate the proper placement of the device in the body of the female user in the urethral prism. If desired, the fixation of the device to the wearer's body can be improved by the use of an adhesive material disposed on the contact surface 26 of cuetp? of the flange 24 and the body contact surface 29 of the truncated cone portion 22. Alternatively, can u be used? Non-adhesive seal material to improve the seal between the device and the wearer's body. Even though the exact dimensions of the device 10 can vary without abandoning the spirit of the invention, in general the dimensions of the device are dictated by the typical female anatomy. In particular, the internal diameter of the flange (labeled A) is generally between approximately 1.0 -r-2.5 centimeters and, preferably, approximately 2.0 centimeters. The internal diameter of the substantially hemispherical tip portion 18 (labeled B) may also vary, but in the preferred embodiment it is of the Order of 9.5 millimeters. The length of the side walls 25 of the intermediate truncated cpno portion 22 (labeled D) is preferably equal to or greater than half the internal diameter A of the flange 24. In this manner, in the preferred embodiment in which the diameter The inside of the flange 24 is approximately 2.0 centimeters, the length D of the truncated cone side walls 25 is preferably at least 1.0 centimeter. The angle 15 between the side walls 25, the intermediate truncated cone portion 22 and the flange 24 is obtuse. Generally, the angle 15 is selected to allow the length D of the truncated cone side walls 25 to be equal to or exceed half the internal diameter A of the flange. In the above preferred embodiment, the angle 15 is between approximately 110 and 120 degrees. Typically, the female urinary incontinence device 10 is of unit construction. Alternatively, however, the portions of the device 10 can be constructed separately and subsequently joined. The device 10 is comprised of any elastic material and at least partially deformable, suitable for application to the human body in the manner described below. In the preferred embodiment, the device is comprised of silicone approved by FDA or a thermoplastic elastomer, even when Urethane, latex or material can be used. Referring also to Figures 3-6, the application of the device 10 to the user's body will be described. The method 32 of the user will be closed by gentle compression of the surrounding area. The meatus closure is maintained by two vacuum regions formed within the device body chamber 16 during application of the device, as will become apparent. The device 10 is formed by gently pressing together the tip portion 18 and the top wall portions 23 of the truncated cone side walls 25 (ie, the upper truncated cone sidewall portions 23) adjacent the tip portion 18. . By tightening the portions 18 and 23, the truncated cone side wall portions 2 " move, or gently push inwardly toward the stopper relationship. This deformation of the device body 12 reduces the volume of air in the chamber 16 and thus creates at least a partial vacuum environment within the chamber. More particularly, as the upper truncated cone side wall portions 23 are brought into abutment relationship, a first vacuum region 21 is formed within the tip portion 18 and a second debris vacuum region 42 of the portion 22 of truncated cone, as shown in Figure 5. The vacuum regions 21, 42 formed in this manner cause the device to be held in securely sealed engagement with the wearer's body. The meatal tissue 32 is disposed within the second vacuum region 42 defined by the truncated cone portion 22, with the body contact surface 29 of the truncated cone portion 2/2 making contact with the metal tissue. Significantly, the upper truncated cone side walls 23 moved inward prevent the meatal tissue 32 from extending into the first vacuum region 21. In this way, the discomfort and / or damage caused by other means by pinching the tissue at the relatively narrow entry to the first region is avoided. The deformation of the body 12 of the device can form a seal between the vacuum regions 21 and 42 as opposed to the truncated cone side wall portions 23 which abut at the apex 36, as shown in Figure 5. Alternatively, a small space between these opposite upper truncated cone-shaped brass wall portions 23 may remain, but said space being too small to undesirably trap the meatal tissue. Note that even in cases where a small space remains between the opposite upper truncated cone side wall portions 23, two vacuum regions 21, 42 are still formed, with said regions being in communication through said space. The deformed device is placed on the meatus 32 and released, thereby allowing the device body 12 to expand to its original shape. This restoration deformation causes at least partial vacuum to be provided in Regions 21 and 42 whereby the external atmospheric pressure pushes a. the body contact surface 26 of the flange 24 and the body contact surface 29 of the truncated cone portion 22 against the meatal tissue 32. When the deformed device is placed on the meatus 32, the intermediate truncated cone portion 22 moves downward towards the meatus 32, thereby increasing the already obtuse g between the truncated cone side walls and the flange 24. The length D of the truncated cone side walls 25 ensures that, as the device body 12 deforms, the upper truncated cone side wall portions 23 are put together in close stop relation, thus forming the first region 21 of vacuum and second region 42 of vacuum. Manifested differently, the length D of the truncated cone side walls 25 is selected to prevent the walls 25 from being coplanar on the flange (ie, to prevent flattening of the truncated cone side walls). that said disposition could cause the meatal tissue to be trapped within the relatively narrow entrance, or base of the distant tip portion 18 and, therefore, cause pinching of the meatus, with the present device 10, an effect of The tent, by which the meatal tissue 32 is disposed in a "tent" region (ie, the second region 42 of vacuum) having a relatively broad base, or substantial entrance and height or position from the meatus. Advantageously, the meatal fabric 32 is prevented from entering the first region 21 from a gap having a narrower base, or entrance, by a "apex" 36 of the tent in the upper truncated cone side wall portions 23- The entrance of the second vacuum region 4 has the same diameter as that diameter ad? internal tab, which is wide relative to the d-i-meter B of the "tip" portion 18. Usually, since the meatal tissue 32 is notThe mobile and distensible is also prevented from entering the first vacuum region 21 due to the substantial height or distance of the tent apex 36 from the meatus created by the length of the truncated cpno side walls. Generally, the device 10 is brought into contact with the wearer's body already in its deformed state as shown in Figure 5. However, the device can be brought into contact with the wearer's body prior to surgery. deformation (ie, before the formation of vacuum regions 21 and 42), as shown in Figure 3. In this case, once the device is placed over the meatus 32 > the device body 12 is formed in the manner described above. The device 10 is separated by the user to allow evacuation when necessary. Specifically, the device can be pulled directly from the skin or, preferably, the device body 12 is slightly depressed in order to reduce the pressure difference. It will be noted that the configuration of the various portions of the device, such as the flange 24 and the tip portion 18, can be modified without abandoning the spirit of the invention. As an example, an alternative mode 10 'differs from the device 10 of FIGS. 1-6 in that the intermediate truncated side cone walls 25' intersect? the tip portion 18 * • of the principle of the externally curved-end wall 27-Manifested differently, the vertical side walls 19 of the dot portion 18 (Figure 2) are removed so that the device 10 'is substantially conical in configuration, as shown ep. Figure 7. When the device 10 'is in use, as shown in Figure 8, the size of the vacuum cavity 42' is increased and the size of the vacuum cavity 21 'is decreased, compared to the regions 42 and 21 in the embodiment of Figures 1-6, respectively, The above discussion of dimensions A, B and D in the device 10 also pertains to the dimensions A ', B' and D 'of the device 10', having described the preferred embodiments of the invention, it will now become apparent to one skilled in the art that other embodiments incorporating their concepts may be used. It is considered, therefore, that these modalities should not be limited to the disctite modalities but rather should be limited only by the spirit and scope of the appended claims.

Claims

CLAIMS A device for alleviating female urinary incontinence comprising:. an elastic and when partially deformable device body having a distal tip portion, a flange and an intermediate truncated cone portion extending outward from the tip portion to the flange, wherein, in use, the body of The device is shaped so that the wall portions of the intermediate truncated onus portion adjacent to the tip portion move in abutting relationship to form a first region within the tip portion and a second region within the portion of the tip. or intermediate truncation, and wherein the client's meatus is disposed in the second region and prevents it from entering the first region through the wall portions of the intermediate truncated cone portion,
2. The device described in the claim 1, where the deformation of the device body causes a vacuum environment to form in the first and second rows whereby a surface c ^ e makes contact with the body of the flange and a surface which makes contact with the body of the intermediate truncated pono portion are kept in contact with the client's meatus.
3. The device described in claim 1, wherein the first and second regions are separated by a closure formed by the stop of the wall portions of the intermediate truncated cone portion.
4 - The device described in claim 1, wherein the device body further comprises a holding portion to facilitate the application and removal of the device.
5 - The device described in claim 1, wherein the flange has an inner diameter and the intermediate truncated cone portion has side walls having a length equal to or greater than half the inner diameter of the flange.
6, r- U device for relieving female urinary incontinence, which comprises: an elastic device body and a least partially deformable body having a distal tip portion, a flange and an intermediate truncated cone portion that extends upwards from the tip portion of the eyelash. wherein, in use, the truncated Coho portion is deformed to form a broad base tent region having an apex in a portion end region? truncated intermediate cone adjacent to the tip portion, the tent region being disposed on the wearer's meatus, and wherein the user is prevented from extending beyond the apex of the tent region toward the portion on end.
7. The device described in claim 6, wherein the deformation of the device body causes a vacuum environment to form in the tent region and the tip portion by means of the dual a surface that makes contact with the body of the device. the flange and a surface that contacts the body of the intermediate truncated cone portion are kept in contact with the client's meatus.
8. The device described in claim 6, wherein the tent region and the tip portion are separated by a pierre formed by the apex.
9. The device described in claim 6, wherein the device body further comprises a gripping portion to facilitate the application and removal of the device.
10. The device described in claim 6, wherein the flange has an inner diameter and the intermediate truncated cone portion has side walls which have a length equal to or greater than half the inner diameter of the flange.
11. The device described in claim 6, wherein the intermediate truncated cone portion has side walls having a selected length to prevent the truncated cone portion from coplacing with the flange.
12. -r A method to relieve urinary incontinence of a female user, which comprises the steps of: deforming a device body having a distal tip portion, a flange and an inner truncated cone portion extending outwardly from the tip portion to the flange, moving the wall portions of the intermediate truncated cone portion adjacent to the tip portion in abutment relationship to form a first region within the tip portion and a second region within the intermediate truncated cone portion in which the user's meatus is disposed, in where the meatus of the wearer is prevented from entering the first region by the wall portions of the intermediate truncated cone portion; and removing the device body from the user's meatus to allow for evacuation,
13. The method of claim 12, p of the deformation step causes a vacuum environment to form in the first and second regions, by which a surface that contacts the body of the flange and a surface that makes contact with the body of the intermediate truncated cone portion are kept in contact with the wearer's duck.
14, - LE the method described in claim 12, wherein the deformation step includes the a or separating the first and second regions by means of a form-forming butt seal of the wall portions of the intermediate truncated conp portion.
15. The method described in claim 12, in dohde the flange has an inner diameter and the method further comprises the step of forming the device body so that the intermediate truncated cone portion has side walls having a length equal to or greater than half the internal diameter of the flange. L SUMMARY OF THE INVENTION A device for alleviating female urinary incontinence comprising an elastic and at least partially deformable device body having a distal tip portion, a flange and an intermediate truncated cone portion extending outwardly from the tip portion to the flange . In use, the upper p "net portions of the intermediate truncated cone portion adjacent to the tip portion are moved toward the abutment to form a first vacuum region within the tip portion-and a second vacuum region within. of the truncated cone portion. The meatus of the user is disposed in the second region of Vacuum and advantageously prevented from entering the first region by the portions d? upper wall of the intermediate truncated cone portion, Cpn this disposition, the meatus is arranged in a region of rtienda ". {ie, the second vacuum region) that has a broad base and an apex and is prevented from entering to the first vacuum region that has a narrower entrance and could detrimentally trap the meatus tissue.The vacuum regions keep the device in securely sealed engagement with the meatus tissue.