LV11000B - Device designed to remedy minor urinary incontinence in women - Google Patents

Abstract

This device is intended for use in treatment to normalize minimal incontinence of urine in women. The device is put into the vagina canal (VA) and is placed under the urinary bladder (VE), to support the urinary bladder along the urethra (UR) through the front vagina wall and to counteract the glissade of the neck of the urinary bladder (ptosis). This device consists of a movable body with rounded sides. It is formed from a hypo-allergenic material that does not stick and is chemically and biologically inert. This device does not disturb urination and is easy to insert and to remove from the vagina canal (VA) when desired.<IMAGE>

Description

LV 11000

DEVICE DESIGNED TO REMEDY MINOR URINARY INCONTINENCE

IN WOM£N

The present invention relates to a device designed to remedy minor urmary mcontmence in women.

It is estimated that the pathology of urinary incontinence affects more than one miliion 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, vvhich can be caused by a cough, a laugh, a sneeze or even a sudden change in position. This involves a real handicap vvhich gets progressively vvorse and is frequently manifested in active or athletic life (running, rapid vvalking, 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 Ievel of the bladder neck follovving a slackening of the muscles of the pelvic diaphragm; the urethrovesical junction is thus outside the area of abdominal pressure and the competence of the bladder can no longer always be guaranteed.

Besides the vvearing 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 vvhich supports the bladder and closes the urethra; unfortunately, this kind of reeducation often gives only disappointing results.

Up to novv, if this reeducation fails, the only treatment has consisted of a surgical operation realizing a suspension of the anterior vaginai, wall, often tied down to the retropubic ligaments. This involves, hovvever, a &quot;serbus&quot; treatment and for this 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 vvomen who do not wish to submit to a surgical operation or in whom the problem is not sufficient to justify this type of operation.

For this reason, the invention proposes a device designed to remedy minor urinary incontinence in vvomen, intended to be introduced in the vaginai cavity and 2 maintained under the bladder in order to support the latter as well as urethra through the anterior vaginai wall and to counteract the ptosis of the neck of bladder.

According to the present invention this device is charactensed in that it is formed of a removable body which is free of Sharp angles, mad in a chemically and biologicially inert non adhesive material and vvhich is not susceptible to create any allergy problem, this removable body the presence of vvhich does not mhibit urination, being susceptible to be easily placed by the user in her vaginai cavity and to be removed in case of need.

According to another feature of this invention, the removable body is an ovoid shaped body vvhich involves a small end by vvhich the user may introduce it in her vaginai cavity and a large end through vvhich she can remove it.

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

It is essential to choose for the ovoidal shaped body, dimensions vvhich vvill allovv to counter act to the mechanism of ptosis of the bladder, during efforts and then to loss of urines but vvithout causing untimely climbing of urethra, in order to allovv easy urinations vvithout the need to remove the device vvhich may thus be hold in position for several hours, namely for a vvhole 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 allovv 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 tovvards the exterior, largely similar to the cord vveared by the menstrual tampons.

Such a thread vvhich has to be very flexible and not &quot;prick&quot; so as not to risk to damage the vaginai tissues of the user, may have a lenght of the order of 7 to 8 cm and to be provided at its free end vvith a beading that facilitates its being grasped by the hand during the removal. - 3 - LV 11000

Hovvever according to a preferred feature of this invention, the ovoidal shaped body is hollovv and is provided at the Ievel of the large end with a Central opening fitted for the prehension with one finger and which allovvs an easy removal.

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

According to another feature of this invention, the Central opening foreseen at the Ievel of the large end, cooperates with another opening located at the Ievel of the small end.

The presence of this second opening allovv the discharge of physiological secretions. In order to give satisfaction it is, of course, necessary that the removable body cannnot cause any traumatic vvound and this, besides its rounded shape, being made in a non-adhering and perfectly chemically and biologically inert material vvhich 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 vvhich polytetrafluoroethylene (PTFE)

It is to be noted that the fluorinated resins have already been the subjet 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 vvhich constitutes the removable body as an additive, some substances 4 vvhich are able to absorb the odours, namely the ammoniacal odours, such as those generated by the urinary incontinence. !n a non 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 vveight. Among the zeolites, it may be as an example be cited sodium alummosilicate.

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 vvhich 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 Ievel of the large end.

According to another feature of this invention the removable body is provided with longitudinal slits vvhich are substantially parallel. The role played by these slits vvhich 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 vvhich constitutes the subject matter of this invention vvill be describes vvith more details by reference to the annexed dravvings in vvhich : • Figurē 1a and 1b are anatomical diagrams making clear the essential mechamsm of urinary stress incontinence • Figurē 2 is a perspective view of a device corresponding to the invention • Figurē 3a is a longitudinal section of the device shovvn in figurē 2 • Figurē 3b is a section of the device shovvn in figurē 3a along the axis lll-lll - 5 - LV 11000 • Figurē 4 is an anatomical diagram shovving the device from figurē 2 once it is piaced in the vagina of a user

Figurē 1a shovvs, on one hand, the uterus UT and the vagina VA and, on the other, the bladder VS and the urethra UR in normai position.

Figurē 1b is a similar diagram shovving a State of ptosis follovving a slackening of the pelvic muscles. On this plān it is clearly distinguished a prolapse of the orgāns 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 normai position at the Ievel of the urethrovesical junction.

According to figurēs 2, 3a and 3b, the device is constituted of a hollovv 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 vvhich the user may introduce it manually in her vaginai cavity (VA) and push it under the bladder (VE) in the position shovvn in figurē 4 and on the other side a large end (3) by vvhich she can extract it.

The hollovv ovoid-shaped body is for this purpose provided at the Ievel of its large end (3) vvith a Central opening (4), suitable for grasping vvith one finger and allovving an easy removal along the arovv II.

Opening 4 cooperates, on the other side, vvith an opening (5) located at the Ievel of the small end (2) of the body (1) in order to allovv the discharge of the physiological secretions when the device is put in place in the vaginai cavity (VA) as shovvn as in figurē 4.

It is clear that in this position, the ovoid-shaped body (1) opposes by its own volume a resistance schematized by the arrovv IV, to the prolapse of the urethro-vesical junction as depicted in figurē 1b and consequently vvorks to support the urethra (UR) and the bladder (IE) to remain in the normai position as shovvn in figurē 1a. 6

According to figurē 3a, the removable body 1 has a length (L) of the order of 40-50 mm and a vvidth (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 vvhile allowing easy urination vvithout removing the device. 5

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

According to figurē 2 and 3b these grooves or ribs (6) cooperate with longitudinal slits (7) vvhich extend essentially perpendicular to the grooves/slits (6) and allovv 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 figurē 4. 15 LV 11000

- 7 -CLAIMS 1. Device to remedy minor urinary mcontinence in vvomen, designed to be 5 mtroduced into the vaginai cavity (VA) and held under the bladdsr (VE) so as to support the latter as well as the urethra (UR) through the anterior vaginai wall and to work against the ptosis of the neck of the bladder, a device charactenzed by the fact that it is constituted of an essentially rigid removable body (1, 10) with no Sharp angles, realized in a non-adherent material, inert chemically and io biologically and not capable of causing allergy problems, this removable body (1, 10), the presence of which does not prevent urination, being capable of bemg placed easily by the user in her vaginai cavity and of being removed from it as needed. 15 2. Device as in claim Γ, characterized by the fact that the removable body (1) is a body of ovoīd shape and which includes a small end (2) thereby the user may introduce the said body (1) in her vaginai cavity and a large end (3), thereby she can extract it. 2u 3. Device as in claim 2° characterized in that the ovoīdal body (1) is hollovv and is provided at the Ievel of its large end (3) with a Central opening (4) suitable for the gripping using a finger and allovving an easy removal. 4. Device as in claim 3°, characterized in that the Central opening (4) foreseen at 25 the Ievel of the large end (3), cooperates with as opening (5) located at the Ievel of the small end in order to allow the discharge of the flux of physiological secretions when the device is placed. 5. Device according to anyone of claims 1 to 4° characterized in that the removable 3o body (1) is made of biocompatible plastic material selected from the group consisting of high density polyethylene, polypropylene, polyvinyl chloride and its derivatives, polyamides, polyurethan, silicones, and fluorinated resins as polytetrafluoroethylene. 35 6. Device as in claim 5° characterized in that the plastic material vvhich constitutes the removable body contains an additive to be able to absorb the ammonical odours generated by the urinary incontinence. 3 7. Device as in claim 6° characterized in that the additive to be able to absorb the ammonical odours is made of a zeolithe, used at a vveight concentration between 0,1 and 5%. 8. Device as in any of claims 1 to 7° characterized by the fact that the removable body (1) has on its surface irregularities such as to secure its stay after it is put in place. 9. Device as in claim 8° characterized in that the irregularities of the removable body (1) are made of a serie of annular peripheral grooves or ribs (6) located at the Ievel of the large end (3). 10. Device according to anyone of claims 1 to 9° characterized by the fact that the removable body (1) is fitted with longitudinal slits (7) substantially parallel each to another, allowing to confer to the device a flexibility by nature to make easy its placial and its holding.

Claims (10)

A device for the normalization of unexplained urinary incontinence in women intended for administration to the vagina (VA) and for placement under the bladder (VE) so as to support the bladder and urethra (UR) through the front wall of the vagina and act against the bladder neck (ptosis), characterized in that the device consists of a rigid movable body (1, 10) with rounded edges, formed of a non-stick, chemically and biologically inert and non-allergenic material with a movable body (1, 10). , the presence of which does not interfere with urination, it is easy to put the user in the vagina and remove it if necessary. Device according to claim 1, characterized in that the movable body (1) is ovoid and has the thinnest end (2) through which the user can enter said body (1) into the vagina, and the thickest end (3) with whom she can pull it out. Device according to claim 2, characterized in that the egg body (1) has a dent and at the level of the thicker end (3) it has a central opening (4) adapted to be gripped and easily moved by the finger. Device according to Claim 3, characterized in that the central opening (4) provided at the level of the thicker end (3) is connected to an opening (5) disposed at the lower end of the device to allow the device to escape freely during insertion. physiological secretions. Device according to any one of Claims 1 to 4, characterized in that the movable body (1) is made of a biocompatible material selected from the group: high density polyethylene, polypropylene, polyvinyl chloride and its derivatives, polyamides, polyurethane , silicone and fluorinated resins such as polytetrafluoroethylene. Device according to claim 5, characterized in that the plastic of the mobile body contains an additive capable of absorbing ammonia odors caused by urinary incontinence. Device according to claim 6, characterized in that the additive capable of absorbing ammonia odor is zeolite having a weight concentration of 0.1 to 5%. Device according to any one of claims 1 to 7, characterized in that the movable body (1) has irregularities which ensure the device is held in the vagina. -2- Device according to claim 8, characterized in that the roughness of the movable body (1) is formed by a series of ring peripheral grooves or ribs (6) arranged at the level of the thicker end (3). Device according to one of Claims 1 to 9, characterized in that the movable body (1) is provided with longitudinal cuts (7) substantially parallel to one another, which allows the device to have a natural elasticity, making it easy to insert and hold it. . 2