MXPA98009687A - An intra-vaginal device - Google Patents

Abstract

An intra-vaginal device (30) to aid in controlling urinary incontinence. The device (30) has a base (31) from which there projects a rear part (34). The rear part (34) engages the posterior vaginal wall and rests on the pelvic floor and projects towards the cervix. The base (31) has a convex surface (33) which engages the anterior vaginal wall to support the vaginal wall and the urethra therebehind.

Description

INTRAVAGINE DEVICE TECHNICAL FIELD The present invention relates to intravaginal devices to help control urinary incontinence.

BACKGROUND OF THE INVENTION In U.S. Patent No. 4,139,006 an intravaginal device for controlling urinary incontinence in female patients is disclosed. The device is slightly arched to have portions, anterior and posterior, of attachment to the vaginal wall, slightly raised and with a smaller central opening. The anterior portion has a pair of projections generally within the plane of the device that engages the vaginal wall to apply pressure to the urethra to close it. U.S. Patent Nos. 5, 036,867 and 4,920,986 also disclose intravaginal devices to help control urinary incontinence. However, these devices are arched in the opposite direction to the anterior device and attach to the anterior vaginal wall to be nested in the neck of the bladder. The urethra does not close. U.S. Patent No. 4,920,986 discloses a modification of the two devices P1757 / 98MX, but once again, the device nests to the neck of the bladder.

OBJECT OF THE INVENTION An object of the present invention is to at least partially correct the hypermobility and increase the support of the urethra.

SUMMARY OF THE INVENTION An intravaginal device is disclosed herein to help control urinary incontinence, the device comprising: a base extending between the anterior vaginal wall and the posterior vaginal wall of a patient, in order to apply pressure to the The base itself has a convex forward surface for attaching the vaginal wall anterior to the support and elevating the anterior vaginal wall and the urethra without occluding the urethra, and a rear portion for attaching the posterior vaginal wall, and a rear portion extending from the rear, so that in use it extends from the same towards the neck or cervix and is supported on the pelvic floor in order to distribute the applied pressure to the posterior wall.

P1757 / 98MX BRIEF DESCRIPTION OF THE DRAWINGS OR FIGURES A preferred form of the invention will now be described by way of example with reference to the accompanying drawings, in which: Figure 1 is a schematic perspective view of an intravaginal device that helps control urinary incontinence; Figure 2 is a schematic top plan view of the device of Figure 1; Figure 3 is a schematic end elevation of the device of Figure 1; Figure 4 is a lateral schematic elevation of the device of Figure 1; Figure 5 is a schematic perspective view of a modified form of the device of Figure 1; Figure 6 is a schematic top plan view of the device of Figure 5; Figure 7 is a schematic end elevation of the device of Figure 5; Figure 8 is a lateral schematic elevation of the device of Figure 5; Figure 9 is a schematic perspective view of another device to help control urinary incontinence; P1757 / 98HX Figure 10 is a schematic side elevational view of the device of Figure 9; Figure 11 is a schematic top plan view of the device of Figure 9; Figure 12 is a schematic end elevation of the device of Figure 9; Figure 13 is a schematic perspective view of a modified form of the device of Figure 9; Figure 14 is a schematic side elevation of the device of Figure 13; Figure 15 is a schematic top plan view of the device of Figure 13; Figure 16 is a schematic end elevation of the device of Figure 13; Figure 17 is a cross-sectional, abdominal, sagittal view of a female patient illustrating the normal physiology of the bladder and urethra; Figure 18 is a cross-sectional, abdominal, sagittal view of an incontinent female patient with the neck of the bladder in a lowered position; and Figure 19 is a cross-sectional, abdominal, sagittal view of the female patient of Figure 18 showing the device of Figures 13 to 16 in place.

P1757 / 98MX DETAILED DESCRIPTION OF THE PREFERRED MODALITY The following modalities are modifications and / or improvements of the devices described in the International Application No. PCT / US97 / 00186. In Figures 1 to 8 of the accompanying drawings, two intra-vaginal devices 30 are schematically illustrated to help control urinary incontinence. The devices 30 each include a base 31 'having an arched forward portion 32 with a convex forward surface 33 that engages the anterior wall to support and elevate the anterior vaginal wall and the urethra behind the wall vaginal. In that regard, you should appreciate that the devices 30 do not close the urethra. The base 31 is, in general, of toroidal configuration and provides a rear part 34 and a central opening 35. Extending in a generally normal manner (ie at a slight inclination) with respect to the base 30 and from the rear 34, is found a rear portion 36 that is also generally of toroidal configuration and has a central opening 37. The base 30 and the rear portion 36 define an included slightly obtuse angle during use, the rear portion 36 engages the posterior vaginal wall and is supported down the pelvic floor and P1757 / 98MX is generally projected towards the neck or cervix from base 31. Base 31 extends between the posterior and anterior vaginal walls to apply support pressure thereto. The pressure applied to the posterior vaginal wall is distributed over the rear portion 36. Preferably, the device 30 is formed of a resilient plastic material. The above preferred embodiments, described with reference to Figures 1 and 8, are particularly suitable for use by women with incontinence and prolapse with a poor pelvic floor. With reference to the preferred embodiments of Figures 5 to 8, it should be noted that the surface 33 is not only convex as a result of consisting of a curve extending around the center of the opening 35 (as best seen in Figure 7) , but can also be convex in a plane generally perpendicular to it, as best seen in cross section of Figure 8.? The base 31 has a length 48 of between 35 millimeters and 55 millimeters, preferably within the range of 40 millimeters to 50 millimeters. The base 33 should also have a depth 49 of 1 to 3 centimeters, preferably 1.5 to 2.5 centimeters. In addition, the base P17? 7/98 X 33 should have a thickness of 50 of 3 to 6 millimeters, preferably of 4 to 5 millimeters. In Figures 9 to 16 of the accompanying drawings intravaginal devices 40 are schematically illustrated to help control urinary incontinence. Each device 40 has a base 41 provided with a front arched portion 42. The portion 42 has a convex surface 43 which applies pressure to the anterior vaginal wall to support the vaginal wall and the urethra behind it. The base 31 is of toroidal configuration and has a central opening 45. Projecting generally generally from the base 41 is a rear portion 46 which is generally of an "oval" configuration. That is, it has elongated sides that end with an upper arched portion. The rear portion 46 has a central slot 47. Again, the base 41 is slightly inclined toward the rear portion 46. The base 41 extends between the anterior and posterior vaginal walls to apply pressure thereto. The pressure applied to the posterior vaginal wall is distributed over the back portion 46. The back portion 46 projects to the cervix or neck and is supported by the pelvic floor. The device of Figures 9 to 16 is suitable P1757 / 98MX for young women with prolapse and urinary incontinence. Preferably, it is formed of an absorbent material so that it can also act as a buffer. It should be appreciated that in the embodiment of Figures 13 to 16, the surface 43 is not only convex as a result of consisting of a curve extending around the center of the opening 35 (as seen in Figure 15), but it can also be convex in a plane generally perpendicular to it, as best seen in Figure 14. The base 41 has a length 48 of between 35 millimeters and 55 millimeters, preferably in the range of 40 millimeters to 50 millimeters. The base 43 should also have a depth 49 of 1 to 3 centimeters, preferably 1.5 to 2.5 centimeters. In addition, the base 43 should have a thickness of 50 of 3 to 6 millimeters, preferably of 4 to 5 millimeters. The rear surface 44 is also provided with an elongated portion 51 which is formed by the shaping of the rear surface 44 so as to be convex when viewed in lateral elevation (as best seen in Figure 14). The rear surface 44, which engages the posterior posterior vaginal wall is also arcuate so that it is convex in a plane normal to the rear portion 46.

P1757 / 98MX The two modalities described above are directed to problems of urinary incontinence previously mitigated by procedures of bandaging or fixation of the urethra. In the two embodiments described above, surfaces 33 and 43 apply pressure to the anterior vaginal wall adjacent to the urethra, in order to support and elevate the anterior vaginal wall and the urethra positioned behind it. This support and elevation is preed without occluding the urethra. In the two modalities described above, dimensions 48 and 49 are arranged so that the force applied to the anterior vaginal wall is distributed to the extent that the urethra is not occluded but simply elevated and supported. Figure 17 illustrates the normal anatomy of the urinary system of a female patient. Figure 13 shows the pubic symphysis 60, the bladder 62 and the neck of the bladder 64, the urethra 66, the pelvic floor 68, the vagina 70 with the anterior vaginal wall 72 and the posterior vaginal wall 74 and the uterus 76 Above the pelvic floor 68 is the abdominal cavity 78 and the vaginal cavity 80 lies below the pelvic floor. It is important to note in Figure 17 the position of the neck of the bladder 64. The bladder 62 is positioned so that the neck 64 of the bladder is positioned above the pelvic floor 68. The upper portion 84 of P1757 / 98MX the urethra 66 lies within the abdominal cavity 78 and the lower portion 86 of the urethra lies within the vaginal cavity 80. As a consequence of the upper portion 84 of the urethra 66 that lies within the abdominal cavity 78, when exerts dynamic abdominal pressure, for example by exercise or by coughing, abdominal pressure is exerted not only on the bladder 62 but also on the upper portion 84 of the urethra 66. This transient pressure on the upper portion 84 of the urethra 66 balances the pressure exerted on the bladder 62 and thus helps to avoid leakage of urine despite the increased transient pressure in the bladder. In Figure 18, the neck of the bladder 64 has descended to a location at or below the pelvic floor 68. The entire urethra 66 lies within the vaginal cavity 80. In this condition, when a dynamic abdominal pressure is exerted due to the upper portion 84 of the urethra 66 that no longer lies within the abdominal cavity 78, no pressure is exerted on the urethra 66 to deflect the greatest transient pressure in the bladder. As a result, -orina will leak when a dynamic abdominal pressure is exerted, a condition known as urinary tension incontinence. It will be appreciated that the condition illustrated in Figure 18 can be either a static condition, P1757 / 98 X example when there is a cystocele condition, or a dynamic condition, which exists only in response to increased abdominal pressure. In a patient suffering from the latter condition, the normal position of the neck of the bladder 64 in the abe of increased abdominal pressure may be similar to that shown in Figure 18. However, due to inadequate support, under greater abdominal pressure the neck from bladder 64 will descend momentarily to a location in and below the pelvic floor 68, preing the urine leakage consequences described above. Figure 19 shows the device 40 installed to correct the improper position of the urethra 66. While the figures show the use of the device 40, it should be understood that the device 30 is installed and operates in the same general manner as the device 40. rear portion 46 of device 40 rests on posterior vaginal wall 74. The length and configuration of rear portion 46 of the device prevents it from rotating or moving within vagina 70. The lower end of device 40 rests on the pelvic floor 68. When the device 40 is installed in this position, the convex front surface 43 of the base 41 of the device displaces the anterior vaginal wall 72 forward and upwardly to P1757 / 98MX support the urethra 66. This support hypermobile urethra stabilizes a manner that the upper portion 84 of the urethra 66 is retained within the abdominal cavity 78. Consequently, when a dynamic abdominal pressure, a portion of the abdominal pressure is exerted it is applied against the upper portion 84 of the urethra 66, which provides additional force to deflect the transient pressure increases of the bladder. In most adult patients, it has been found that the device 40 in which the base 41 has a length 48 (see Figure 14) of 35 to 55 millimeters, and more usually of 40 to 50 millimeters, will elevate to the anterior wall 72 of the vagina 70 sufficiently to support the urethra 66 in the desired position. However, it will be appreciated that the length 48 of the device 40 that is needed to achieve this result will depend on the physiology of the particular patient, so that devices having a height greater than 55 millimeters or less than 35 millimeters may be necessary. to elevate the anterior vaginal wall 72 to support the urethra 66 in the proper position without occluding it. While the upper portion 84 of the urethra 66 is supported above the anterior segment of the pelvic floor 68 in an intra-abdominal retropubic position, continence should be achieved, thereby correcting the hypermobility and increasing P1757 / 98MX the support of the urethra. As will be appreciated, the purposes of devices 40 and 30 are to support the urethra 66 without occluding it. Because exerting a force at a single point along the length of the urethra 66 tends to have an occlusive effect, it is desired to disperse the support along a stretch of the urethra. As the length of the urethra 66 of an adult female tends to be about 3 centimeters, an effective depth 49 (Figure 14) for the convex front end 43 of the base 41 of the device 40 has turned out to be approximately 2.5 centimeters. However, it will be appreciated that a device 30, 40 having a leading edge 43 with a depth as small as 1 centimeter, can produce acceptable results as long as the effecrum of the supporting edge is to elevate the urethra to an intra-operative position. abdominal retropubic, without occluding it.

P1757 / 98MX

Claims (10)

1. NOVELTY OF THE INVENTION Having described the present invention, it is considered as a novelty and, therefore, the content of the following CLAIMS is claimed as property: 1. An intravaginal device to help control urinary incontinence, the device comprises: base that extends between the anterior vaginal wall and the posterior vaginal wall of a patient, in order to apply pressure to them, the base has a convex front surface to attach the vaginal wall anterior to the support and elevate the anterior vaginal wall and the urethra, and a back to attach the posterior vaginal wall; and a rear portion extending from the rear, so that, in use, it extends therefrom to the cervix or neck and is supported on the pelvic floor in order to distribute the applied pressure to the posterior wall. The device according to claim 1, wherein the base is generally of toroidal configuration in order to have a central opening. 3. The device according to claim 1 or 2, wherein the rear portion is inclined toward the P1757 / 98MX base in order to define an included obtuse angle, slightly greater than 90 ° C. The device according to claims 1, 2 or 3, wherein the front convex surface is arched both within the plane of the base and in a plane generally perpendicular to the base. The device according to claims 1 to 4, wherein the rear part is generally of toroidal configuration and has a central opening. The device according to claims 1 to 4, wherein the rear portion has elongated sides extending from the base, the sides extending towards an arcuate end. The device according to claim 6 wherein the rear portion has a surface for coupling the posterior vaginal wall, the surface is arched so as to be convex in the plane normal to the rear portion. The device according to claims 6 or 7, wherein the rear portion has an enlarged portion projecting towards the posterior vaginal wall. The device according to claim 4, wherein the rear portion has a central slot. 10. The device according to claims 1 to 5, formed of resilient plastic material. P1757 / 98MX 11. The device according to claims 1 to 5, formed of an absorbent material in order to act as a tampon. 12. An intravaginal device to help control urinary incontinence, the device is essentially as described above in relation to Figures 1 to 4, 5 to 8, 9 to 12 or 13 to 16. P1757 / 98MX