NZ258594A - Urinary incontinence device; removable body with tapered shape device - Google Patents

Description

New Zealand No. International No. 258594 TO BE ENTERED AFTER ACCEPTANCE AND PUBLICATION Priority dates: "I | 1 2 International fifing date: 1 \ \ 3. \ Classification: \PC<o'. RfalFS|H-8: (^(e,\FaJoo,l Abiuailoo Publication date: 2 6 NOV 1996 Journal No.: 11410 NEW ZEALAND PATENTS ACT 1953 COMPLETE SPECIFICATION Title of invention: Device for correcting slight urinary incontinence in women.

Name, address and nationality of applicant(s) as in internatioaai application form: Jean-Francois CHANEZ, of 1, avenue Auguste Renoir, Le Galion, 78260 Marly-Le-Roi, France, Lionel GIGANT, of 585 D, villa La Passerelle, Chemin de Villebruc, 06560 Valbonne, France, Bertrand PAULETTO, of 228, chemin des Basses-Ribes, 06130 Grasse, France, Richard WORM, of 375, Chemin de Piechel, 06740 Chateauneuf-de-Grasse, France, all are of French citizenship.

A 258594 Tt>e, present invention relates to a device designed to remedy minor urinary incontinence in women.

It is estimated that the pathology of urinary incontinence affects more than one million female subjects in France, and many of these are young, active women who have difficulty in holding back their urination sufficiently often that it is a problem in their daily life.

This incontinence is essentially characterized by the passing of urine in a spurt which occurs during sudden effort accompanied by abdominal hyperpressure, which can be caused by a cough, a laugh, a sneeze or even a sudden change in position. This involves a real handicap which gets progressively worse and is frequently manifested in active or athletic life (running, rapid walking, tennis, golf, etc...).

Among the different mechanisms incriminated in these phenomena, the most frequently encountered corresponds to a ptosis, that is, a prolapse of the bladder at the level of the bladder neck following a slackening of the muscles of the pelvic diaphragm; the urethrovesical junction is thus outside the area of abdominal 20 pressure and the competence of the bladder can no longer always be guaranteed.

^ Besides the wearing of disposable napkins, the treatment of this stress incontinence consists in attempting to reeducate the perineal muscles, that is, a strengthening of the muscular floor which supports the bladder and closes the urethra; unfortunately, 25 this kind of reeducation often gives only disappointing results.

Up to now, if this reeducation fails, the only treatment has consisted of a surgical operation realizing a suspension of the anterior vaginal, wall, often tied down to the retropubic ligaments. This involves, however, a "serious" treatment and for this 30 reason it is reserved to cases of major problems.

The objective of the invention is to remedy this disadvantage by proposing an alternative to the above-mentioned treatment, especially for women who do not wish to submit to a surgical operation or in whom the problem is not sufficient to justify 35 this type of operation.

For this reason, the invention proposes a device designed to remedy minor urinary incontinence in women, intended to be introduced in the vaginal cavity and 1 258594 maintained under the bladder in order to support the latter as well as urethra through the anterior vaginal wall and to counteract the ptosis of the neck of bladder.

According to the present invention this device is characterised in that it is formed of a removable body having no sharp angles, and an exterior including a non-adherent biocompatible material, which is chemically and biologically inert and not allergenic, wherein the removable body which does not prevent micturition, includes a small end and a large end, the small end being oriented to be first introduced in to the vaginal cavity when the device is to be used and the large end being oriented to assist in manual extraction of the removable body from the vaginal cavity.

According to another feature of this invention, the removable body is an ovoid shaped body.

Such a device may be easily placed by the user in a manner largely similar to the menstrual tampons when appears a condition involving threat of loss such as bronchitis, chronic cough, running a race, tennis, golf....

It is essential to choose for the ovoidal shaped body, dimensions which will allow to counter act to the mechanism of ptosis of the bladder, during efforts and then to loss of urines but without causing untimely climbing of urethra, in order to allow easy urinations without the need to remove the device which may thus be hold in position for several hours, namely for a whole day of eight hours.

It has been possible, as an exemple, to obtain particularly satisfactory results with an ovoidal, shaped body having a total lenght of about 40 to 50 mm and a diameter of the order of 25 to 35 mm. These dimensions are obviously in any manner considered as limitating the invention.

It is also essential to allow the user to take out the device easily and quickly, in case of need. It may be conceivable for this purpose, to provide at the large end of the ovoidal, shaped body at least one flexible thread protruding towards the exterior, largely similar to the cord weared by the menstrual tampons.

Such a thread which has to be very flexible and not "prick" so as not to risk to damage the vaginal tissues of the user, may have a lenght of the order of 7 to 8 cm and to be provided at its free end with a beading that facilitates its being grasped by the hand during the removal. | N2. PATENT v ■ 4 2RR'i94 However according to a preferred feature of this invention, the ovoidal shaped body is hollow and is provided ai the level of the large end with a central opening fitted for the prehension with one finger and which allows an easy removal.

As it has been already mentioned, it is essential according to this invention, that the presence of the body does not prohibit urination when it is positioned.

According to another feature of this invention, the small end and the central opening foreseen at the level of the large end, cooperates with another opening located at the level of the small end.

The presence of this second opening allow the discharge of physiological secretions. In order to give satisfaction it is, of course, necessary that the removable body cannnot cause any traumatic wound and this, besides its rounded shape, being made in a non-adhering and perfectly chemically and biologically inert material which is incapable to create any allergy problem when it is in contact with human tissues.

According to a preferred feature of this invention, the removable body is made of a biocompatible plastic material.

As a non limitative example, it may advantageously be used : - high density polyethylene (PEHD) - polypropylene (PP) - Vinyl polychloride (PVC) and its derivatives - polyamides (PA) - polyurethan (PUR) - silicones (Si) - fluorinated resins among which polytetrafluoroethylene (PTFE) It is to be noted that the fluorinated resins have already been the subject of numerous biomedical applications (bone prosthesis, cardiovascular prosthesis, and catheters) and have continuously permitted the requirements specific to this particular area, to be satisfied.

According to this invention it is moreover advantageous to incorporate to the material which constitutes the removable body as an additive, some substances N.Z. PATENT G: 2 3 OCT 1996 ( RECEIVE i.. which are able to absorb the odours, namely the ammoniacal odours, such as those generated by the urinary incontinence.

In a rion limitative manner it may be cited for this purpose the zeolites introduced in this plastic matarial at concentrations extending within a range from 0.1 to 5% by weight. Among the zeolites, it may be as an example be cited sodium aluminosilicate.

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

Independently of the aforesaid, it is essential to guarantee that the removable body remain well held in position in the vagina, after it is put in place so that there is no risk of it being spontaneously removed due to the effect of an exertion by the user as a result of an untimely slippage; for this reason, it is advantageous to provide its surface with irregularities the geometry of which should be chosen so as to guarantee the comfort of the user who should not perceive the presence of the device after it is put in place.

As an example the iregularities of the removable body may advantageously formed by series of grooves and/or peripheral annular ribs located at the level of the large end.

According to another feature of this invention the removable body is provided with longitudinal slits which are substantially parallel. The role played by these slits which are optionally perpendicular to the grooves and/or to the peripheral annular ribs, is to confer to the device a flexibility of nature, to make easy its positionning and its holding.

The features of the device which constitutes the subject matter of this invention will be describes with more details by reference to the annexed drawings in which : • Figure 1a and 1b are anatomical diagrams making clear the essential mechanism of urinary stress incontinence • Figure 2 is a perspective view of a device corresponding to the invention • Figure 3a is a longitudinal section of the device shown in figure 2 • Figure 3b is a section of the device shown in figure 3a along the axis Ill-Ill • Figure 4 is an anatomical diagram showing the device from figure 2 once it is . placed in the vagina of a user Figure 1a shows, on one hand, the uterus UT and the vagina VA and, on the other, the bladder VS and the urethra UR in normal position.

Figure 1b is a similar diagram showing a state of ptosis following a slackening of the pelvic muscles. On this plan it is clearly distinguished a prolapse of the organs with respect to the urethro-vesical junction represented by the arow I. In this position, the neck of the bladder is outside the area of abdominal pressures and the competence of the bladder VE, can no longer be guaranteed in risky situations (cough, sneeze, sports, etc).

The device in accordance with the invention has as its objective to correct this situation and to bring the urethra UR and the bladder VE into the normal position at the level of the urethrovesical junction.

According to figures 2, 3a and 3b, the device is consented of a hollow body (1) made of ovoid shape, realized in a biocompatible plastic material such as above described and including on one side a small end (2) by which the user may introduce it manually in her vaginal cavity (VA) and push it under the bladder (VE) in the position shown in figure 4 and on the other side a large end (3) by which she can extract it.

The hollow ovoid-shaped body is for this purpose provided at the level of its large end (3) with a central opening (4), suitable for grasping with one finger and allowing an easy removal along the arow II.

Opening 4 cooperates, on the other side, with an opening (5) located at the level of the smali end (2) of the body (1) in order to allow the discharge of the physiological secretions when the device is put in place in the vaginal cavity (VA) as shown as in figure 4.

It is clear that in this position, the ovoid-shaped body (1) opposes by its own volume a resistance schematized by the arrow IV, to the prolapse of the urethro-vesical junction as depicted in figure 1b and consequently works to support the urethra (UR) and the bladder (IE) to remain in the normal position as shown in figure 1a.

According to figure 3a, the removable body 1 has a length (L) of the order of 40-50 rryri and_a width (L) of the order of 25-35 mm, these dimensions are recognized to correspond to the anatomy of the majority of users, and are thus appropriate to guarantee their comfort while allowing easy urination without removing the device.

According to figure 2 and 3a, the ovoid-shaped body (1) is provided with a serie of peripheral annular ribs/grooves (6) located at the level of the large end (3) and the role of which is to create some irregularities which make easier the holding of the device in the position shown on figure 4 after it is put in place.

According to figure 2 and 3b these grooves or ribs (6) cooperate with longitudinal slits (7) which extend essentially perpendicular to the grooves/slits (6) and allow thus to confer to the ovoid-shaped body (1) a flexibility of nature to make easy its placing and its holding in the position shown on figure 4. 258594

Claims (8)

WHAT WE CLAIM IS:

1. Device to remedy minor urinary incontinence in a woman, intended to be introduced into the vaginal cavity (VA) and held under the bladder (VE) so as to support the bladder and the urethra (UR) through an anterior vaginal wall and to oppose the ptosis of the neck of the bladder, comprising a removable body having no sharp angles, and an exterior including a non-adherent biocompatible material, which is chemically and biologically inert and not allergenic, wherein the removable body which does not prevent micturition, includes a smal 1 end and a large end, the small end being oriented to be first introduced in to the vaginal cavity when the device is to be used and the large end being oriented to assist in manual extraction of the removable body from the vaginal cavity.

2. The device as in claim 1, wherein the removable body has an ovoTd shape.

3. The device as claimed in claim 2 the removable body is hollow and wherein the large end of the remov; i body includes a central opening designed for gripping using a finger and to allow an easy manual removal of removable body from the vaginal cavity.

4. Device as claimed in claim 3, wherein the small end and the central opening foreseen at the level of the large end, cooperates with another opening located at the level of the small end so as to allow a flow of physiological secretions when the device is disposed within the vaginal cavity.

5. Device according to anyone of claims 1 to 4 wherein the exterior of the removable body comprise a biocompatible plastics material selected from the group consisting of high density polyethylene, polypropylene, polyvinyl chloride derivatives, polyamides, polyurethan, silicones, and polytetrafluoroethylene and fluorinated resins.

6. Device as claimed in claim 5 wherein the removable body includes an additive to absorb the ammonical odours generated by urinary incontinence.

7. Device as claimed in claim 6 wherein the additive is made of a zeolite, between 0,1 and 5% of the biocompatible plastics. N.2, PATENT OF'... ; 2 3 OCT 1996 receive:; • ' 75B59 O V 3

8. Device as in any one of claims 1 to 7 wherein the removable body has a surface including essentially parallel longitudinal slots to hold the device within the vaginal cavity. , ii n ukwrt*— By the authorised agents A J PARK ^SOl Per ♦ N.Z. PATL'i 0!T(CE \ 1 2 3 OCT m ► T. CUV-ID fc 25g53 ™ —fo — DESCRIPTIVE SUMMARY .■ . > • - DEVICE DESIGNED TO REMEDY MINOR URINARY INCONTINENCE IN WOMEN Device designed to remedy minor urinary incontinence in women, characterized by the fact that it is constituted of an essentially rigid removable body with no sharp angles, capable of being introduced manually into the vaginal cavity and held under the bladder so as to support the latter as well as the urethra through the anterior vaginal wall and to work against the ptosis of the bladder neck. Figure 4 f