OA10072A - Device for remedying mild urinary incontinence in women - Google Patents

Abstract

A device for correcting slight urinary incontinence in women. The device is designed to be inserted into the vaginal canal (VA) and held under the bladder (VE) in order to support the latter along with the urethra (UR) through the anterior vaginal wall, and counter ptosis of the bladder neck. The device consists of a removable body (1) with rounded edges made of a non-adhesive, non-allergenic, and chemically and biologically inert material. Said body (1) does not prevent micturition and can easily be inserted in and withdrawn from the vaginal canal (VA) as required by the user.

Description

1 10072 "Device intended to remedy the incontinences urinary light expensive woman"

The present invention relates to a device intended to remedy mild urinary incontinence in women.

It is estimated that the pathology of incontinence in France affects more than one million female subjects, and many young and active women have difficulty in restraining themselves from being urinated often enough to make it difficult for them in their daily lives.

This incontinence is essentially characterized by a leak of jet urine that occurs during sudden exertions accompanied by abdominal hyperpressure; it can be caused by a cough, a laugh, a sneeze or even a sudden change of position. This is a real disability that gradually worsens and semanifests frequently in the active or sporting life (running, brisk walking, tennis, golf ...).

Among the various mechanisms incriminated in these phenomena, the most frequently encountered corresponds to a ptosis, that is to say to a descent of the bladder at the level of the bladder neck following a relaxation of the pelvic diaphragm muscles. FR93 / 01206 2 urethroesical junction is thus outside the pressure of the abdomen and the tightness of the bladder can not always be guaranteed.

In addition to wearing disposable toppings, treatment of these incontinence of effort consists of retraining the perineal muscles, that is to say, a strengthening of the muscular floor which supports the bladder and closes the urethra; such reeducation unfortunately unfortunately only gives disappointing results.

Until now, in the event of failure of this education, the only treatment consisted of a surgical intervention performing a suspension of the anterior vaginal wall often moored to the retropubic ligaments. However, this is a "heavy" treatment for this reason reserved for major cases. The object of the invention is to overcome this disadvantage by proposing an alternative to the treatmentsusmentionné, particularly to women who do not want to undergo surgery or inconvenience is insufficient to justify such intervention. To this end, the invention provides a device for treating mild urinary incontinence in women intended to be introduced into the vaginal cavity and maintained under the bladder so as to support the latter as well as urethra through the anterior vaginal wall and to to oppose to laptose of the vesical neck.

According to the invention, this device is characterized in that it consists of a removable body devoid of sharp angles made of a material-adherent inert from the chemical and biological point of view and not likely to create problems. 3 allergy, this removable body whose presenceencêencês not prevent urination being likely to be put place easily by the user in its vaginal cavity and to be extracted when needed.

According to another feature of the invention, the removable body is a formovoid body and has a small end by which the user can introduce it into her vagina and a large end by which it can extract it.

Such a device can easily be put in place by the user, in a way similar to the periodic buffers, when a situation at risk of leakage occurs: bronchitis, coughing, running, tennis, golf ...

It is essential to choose, for the body, dimensions allowing him to oppose the mechanism of descent of the bladder during the efforts and thus urinary leakage, but without causing inadvertent ascension of the urethra, so as to allow urination easy without removing the device that can be kept in place for several hours, especially for a whole day of eight hours.

By way of example, it has been possible to obtain particularly satisfactory results with a body-like substance having a total length of about 40 to 50 mm and a diameter of about 25 to 35 mm. These dimensions can not, of course, in any way be considered as limiting the invention.

It is also essential to allow the user to retrieve the device easily and quickly when needed; for this purpose, it is conceivable to provide the large end of the ovoid body with at least one flexible wire protruding towards the outside, which is largely similar to the cord worn by the periodic buffers; such a thread, which must be very flexible and not "sting" so as not to risk deleting the vaginal tissues of the user, may have a length of the order of 7 to 8 cm and be provided, at its free end, with a bead making it easy to grip during extraction.

However, according to a preferred feature of the invention, the ovoid body is notched and is provided at its large end with a central orifice adapted to grip by a finger and allowing easy removal.

As already indicated, it is essential, in accordance with the invention, that the presence of the ovoid body does not prevent urination when it is in place.

According to another feature of the invention, the central orifice, provided at the large end, cooperates with an orifice located at the level of the small end.

The presence of this second orifice allows the flow of physiological secretions.

In order to be able to give satisfaction, it is, of course, necessary that the removable body can not cause traumatic injury and, therefore, that it has a rounded shape, that it is made of an adherent material and perfectly inert as far as chemical point of view only from the point of view biological and nonsusceptible to create allergy problems when it comes into contact with human tissues.

According to a preferred feature of the invention, the removable body is made of a biocompatible plastic material. By way of nonlimiting example, it is possible to use: 1 0072 PCT / FR93 / 01206 5 - high density polyethylene (HDPE), - polypropylene (PP), - polyvinyl chloride (PVC) and its derivatives, - the polyamides (PA), - polyurethane (PUR), - silicones (Si) - fluorinated resins including polytetrafluoroethylene (PTFE).

It should be noted that fluorinated resins have already been the subject of many biomedical applications (bone prostheses, vascular and etcathetrons) and have always made it possible to satisfy the requirements specific to this particular field.

In accordance with the invention, it is also advantageous to incorporate in the material constituting the removable body, as an additive, odor absorbing substances including ammoniacal such as odor generated by urinary incontinence.

In a nonlimiting manner, it is possible, for this purpose, to mention the zeolites incorporated in the plastic material at concentrations ranging from 0.1 to 5% by weight. Among these zeolites, mention may be made, for example, of sodium aluminosilicate.

The presence of such an additive allows a significant improvement in the comfort of the user.

Regardless of the above, it is essential to ensure that the removable body remains well maintained in position in the vagina after it is put in place and is not likely to be automatically removed by the action of an effort by the user. inadvertent sliding; For this purpose, it is advantageous to provide its surface with irregularities whose range must be chosen so as to guarantee the comfort of the user who must not perceive the presence of the device after placement. By way of example, the irregularities of the removable body may advantageously be constituted by a series of grooves and / or peripheral annular ribs situated at the level of the large end.

According to another feature of the invention, the removable body is provided with substantially parallel longitudinal slots. The role of these slits, which are, where appropriate, perpendicular to the grooves and / or peripheral annular ribs, is to give the device aelasticity of a nature to facilitate its establishment and maintenance.

The characteristics of the device which is the subject of the invention will be described in more detail with reference to the accompanying drawings, in which: FIGS. 1a and 1b are anatomical diagrams explaining the essential mechanism of the stress incontinence, FIG. 1a is a perspective view of a device corresponding to the invention; FIG. 3a is a longitudinal section of the device represented in FIG. 2; FIG. 3b is a sectional view of the device shown in FIG. Figure 4 is an anatomical diagram showing the device of Figure 2 when placed in the vagina of a user.

Figure la represents, on the one hand, uterusUT and vagina VA and, secondly, the bladder VE and UR ureter in the normal position.

Figure 1b is a similar diagram a state of ptosis consecutive to one of the pelvic muscles. On this diagram, a clearing of the organs at the level of the urethroesical junction represented by the arrow I is distinguished. In this position, the vesral neck is outside the chamber of the pressures of the abdomen and the sealing of the VE bladder can no longer be guaranteed in the case of risk situations (coughing, sneezing, sport ...).

The device according to the invention has the object of correcting this situation, and of bringing back the urethra UR and the bladder VE in the normal position to the level of the ureterovesical junction.

According to FIGS. 2, 3a and 3b, the device is constituted by a hollow body 1 of ovoid shape made of a biocompatible plastics material as described above and comprising, on the one hand, a small end 2 through which the user can manually introduce it in its vaginal cavity VA and push it under the VE bladder in the position shown in Figure 4, and secondly, a large end 3 through which it can extract it.

The hollow ovoid body 1 is, for this purpose, provided at its large end 3, a orificecentral 4 adapted to the gripping by a finger and allowing easy removal according to the arrow II (Figure 4). The orifice 4 cooperates, moreover, with an orifice 5 situated at the small end 2 of the body 1 in order to allow the flow of physiological secretions when the device is placed in the vaginal cavity VA, as shown in FIG. 4.

It is clear that, in this position, the ovoid body 1 opposes by its own volume a resistance shown schematically by the arrow IV at the descent of the urethrovesical junction as shown on 1 00 Z2 WO 94/13223 PCT / FR93 / 01206 8 Figure 1b and contributes to the maintenance of UR ureter and VE bladder in the normal positionrepresented in Figure la.

According to FIG. 3a, the removable body 1 has a length L of the order of 40 to 50 mm and a width 1 of the order of 25 to 35 mm; these dimensions have, in fact, proven to correspond to the anatomy of the majority of users and therefore, to ensure their comfort while allowing easy urination without removing the device.

According to FIGS. 2 and 3a, the ovoid body 1is provided with a series of peripheral annular ribs / grooves 6 situated at the level of the coarse end 3 and whose role is to define irregularities of a nature to facilitate the maintenance of the device in the position shown in Figure 4, after its introduction.

According to FIGS. 2 and 3b, these grooves / ribs 6 cooperate with substantially parallel longitudinal slots 7 which extend perpendicularly to the grooves / ribs 6 and allow the ovoid body 1 to be provided with an elasticity of a nature to facilitate its installation and maintenance. the position shown in Figure 4.

Claims (10)

1 * 0072 PCT / FR93 / 01206 CLAIMS 1 *) Device for remedying mild urinary incontinence-in women intended to be introduced into the vaginal cavity (VA) and maintained under the bladder (VE) so as to support the latter as well as the urethra (UR) through the vaginal lower wall and to oppose the ptosis of the bladder neck, characterized in that it consists of a removable body (1) devoid of sharp angles made of an inert non-adherent material of chemical and biological point of view and not likely to create allergy problems, this removable body (1) whose presenceencêenênhibé urination being likely to be put place easily by the user in its vaginal cavity (VA) and d ' to be extracted when needed. 2 ') Device according to claim 1, characterized in that the removable body (1) is an ovoid body and has a small end (2) by which the user can introduce it into her vagina (VA) and a big end (3) by which she can extract it. 3 ') Device according to claim 2, characterized in that the ovoid body (1) is hollow andis provided, at its large end (3), a central orifice (4) adapted for gripping by a finger to allow a easy removal. 4 ') Device according to claim 3, characterized in that the central orifice (4) provided at the level of the large end (3) cooperates with an orifice (5) located at the small end (2) to allow the flow ofphysiological secretions when the device is put in place. 5 ') Device according to any one of claims 1 to 4, characterized in that theamovable body (1) is a biocompatible plastic material WO 94/13223 10 15 20 10072 PCT / FR93 / 01206 10 selected from the group formed by the high density polyethylene, polypropylene, polyvinyl chloride and its derivatives, polyamides, polyurethane, lilicones and fluorinated resins including polytetrafluoroethylene. 6. Device according to claim 5, characterized in that the plastic material constituting the removable body contains an additive likely to absorb the ammoniacal odors generated by urinary incontinence. 7 *) Device according to claim 6, characterized in that the additive likely to absorb ammoniacal odors is constituted by a zeolite used at a concentration by weight of between 0.1 and 5%. 8 *) Device according to any one of the claims 1 to 7, characterized in that theamovable body (1) comprises, on its surface, uneirregularities likely to ensure its maintenance aftermount in place. 9 *) Device according to claim 8, characterized in that the irregularities of the bodyamovible are constituted by a series of groovesand / or peripheral annular ribs (6) located at the large end (3). 10 *) Device according to any one of claims 1 to 9, characterized in that theamovable body is provided with substantially parallel longitudinal slots (7) for imparting an elasticity device audispositif such as to facilitate its establishment and maintenance. 25