EP0625890A1 - Device for correcting slight urinary incontinence in women - Google Patents

Device for correcting slight urinary incontinence in women

Info

Publication number
EP0625890A1
EP0625890A1 EP94901998A EP94901998A EP0625890A1 EP 0625890 A1 EP0625890 A1 EP 0625890A1 EP 94901998 A EP94901998 A EP 94901998A EP 94901998 A EP94901998 A EP 94901998A EP 0625890 A1 EP0625890 A1 EP 0625890A1
Authority
EP
European Patent Office
Prior art keywords
removable body
urinary incontinence
large end
bladder
removable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP94901998A
Other languages
German (de)
French (fr)
Inventor
Jean-Francois Chanez
Lionel Gigant
Bertrand Pauletto
Richard Worm
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
OSCAR INTERNATIONAL Sarl
Original Assignee
OSCAR INTERNATIONAL Sarl CHANEZ JEAN-FRANCOIS
OSCAR INTERNATIONAL Sarl
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by OSCAR INTERNATIONAL Sarl CHANEZ JEAN-FRANCOIS, OSCAR INTERNATIONAL Sarl filed Critical OSCAR INTERNATIONAL Sarl CHANEZ JEAN-FRANCOIS
Publication of EP0625890A1 publication Critical patent/EP0625890A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/005—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra with pressure applied to urethra by an element placed in the vagina

Definitions

  • the present invention relates to a device intended to remedy light urinary incontinence in women.
  • This incontinence is essentially characterized by a leakage of urine in a jet which occurs during sudden efforts accompanied by an abdominal overpressure; this can be caused by coughing, laughing, sneezing or even a sudden change in position. This is a real handicap which progressively worsens and manifests itself frequently in active or sporting life (running, brisk walking, tennis, golf ).
  • urethrovesical junction is thus outside the confines of abdominal pressures and the tightness of the bladder can no longer always be guaranteed.
  • the object of the invention is to remedy this drawback by proposing an alternative to the above-mentioned treatment, in particular to women who do not wish to undergo a surgical intervention or whose discomfort is insufficient to justify such an intervention.
  • the invention provides a device for remedying 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 the urethra through the anterior vaginal wall. and to oppose the ptosis of the bladder neck.
  • this device is characterized in that it is constituted by a removable body devoid of sharp angles made of a non-adherent material inert from the chemical and biological point of view and not likely to create problems of allergy, this removable body, the presence of which does not prevent urination, being capable of being easily put in place by the user in her vaginal cavity and of being extracted therefrom if necessary.
  • the removable body is an ovoid body and has a small end by which the user can introduce it into her vagina and a large end by which she can extract it.
  • Such a device can easily be put in place by the user, in a manner largely similar to periodic tampons, when there is a risk of leakage situation: bronchitis, chronic cough, running, tennis, golf ... II It is essential to choose, for the ovoid body, dimensions allowing it to oppose the mechanism of descent of the bladder during efforts and therefore urinary leakage, but, without causing untimely ascent of the urethra, so to allow easy urination without removing the device which can thus be kept in place for several hours, in particular for an entire day of eight hours.
  • the large end of the ovoid body with at least one flexible wire projecting towards the outside, largely similar to the cord worn by the periodic tampons; such a wire, which must be very flexible and not "prick" so as not to risk damaging 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 , a bead facilitating its handling during extraction.
  • the ovoid body is hollow and is provided at its large end with a central orifice suitable for gripping by a finger and allowing easy removal.
  • the presence of the ovoid body does not prevent urination when it is put in place.
  • the central orifice provided at the large end, cooperates with an orifice located at the small end.
  • the removable body cannot cause a traumatic injury and therefore, in addition to its rounded shape, that it is made of a non-adherent material and perfectly inert from a chemical point of view as biologically and not likely to cause allergy problems when in contact with human tissue.
  • the removable body is made of a biocompatible plastic material.
  • HDPE high density polyethylene
  • PVC polyvinyl chloride
  • PA - polyamides
  • PUR - polyurethane
  • PTFE polytetrafluoroethylene
  • fluorinated resins have already been the subject of numerous biomedical applications (bone, vascular prostheses and catheters) and have always made it possible to meet the requirements specific to this particular field.
  • odor absorbing substances in particular ammoniacal substances such as the odors generated by urinary incontinence.
  • zeolites incorporated in the plastic material at concentrations comprised within a range of 0.1 and 5% by weight.
  • these zeolites mention may be made, by way of example, of sodium aluminosilicate. The presence of such an additive allows a significant improvement in the comfort of the user.
  • the irregularities of the removable body can advantageously be constituted by a series of grooves and / or peripheral annular ribs situated at the level of the large end.
  • the removable body is provided with essentially parallel longitudinal slots. The role of these slots, which are, if necessary, perpendicular to the grooves and / or to the peripheral annular ribs, is to give the device an elasticity such as to facilitate its positioning and its maintenance.
  • FIG. 2 is a perspective view of a device corresponding to the invention
  • FIG. 3a is a longitudinal section of the device shown in FIG. 2
  • FIG. 3b is a section of the device shown in FIG. 3a, along the axis III-III,
  • FIG. 4 is an anatomical diagram showing the device of Figure 2 once placed in the vagina of a user.
  • the figure represents, on the one hand, the uterus
  • FIG. 1b is a similar diagram representing a state of ptosis following a relaxation of the pelvic muscles.
  • the bladder neck is outside the enclosure of the pressures of the abdomen and the tightness of the bladder VE does not can no longer be guaranteed in the case of risky situations (cough, sneeze, sport ).
  • the object of the device according to the invention is to correct this situation, and to bring the urethra UR and the bladder VE back to normal position at the uretrovesical junction.
  • the device consists of a hollow body 1 of ovoid shape made of a biocompatible plastic material as described above and comprising, on the one hand, a small end 2 through which the user can introduce it manually into its vaginal cavity VA and push it under the bladder VE in the position shown in FIG. 4, and on the other hand, a large end 3 by which it can extract it.
  • the hollow ovoid body 1 is, for this purpose, provided at its large end 3, with a central orifice 4 suitable for gripping by a finger and allowing easy removal according to arrow II ( Figure 4).
  • the orifice 4 cooperates, moreover, with an orifice 5 situated at the level of the small end 2 of the body 1 so as to allow the flow of physiological secretions when the device is placed in the vaginal cavity VA, as shown in Figure 4.
  • 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 been found to correspond to the anatomy of the majority of users and therefore capable of guaranteeing their comfort while allowing easy urination without removing the device.
  • the ovoid body 1 is provided with a series of peripheral annular ribs / grooves 6 located at the large end 3 and whose role is to define irregularities such as to facilitate the maintenance of the device in the position shown in Figure 4, after its establishment.
  • these grooves / ribs 6 cooperate with essentially parallel longitudinal slots 7 which extend perpendicular to the grooves / ribs 6 and make it possible to give the ovoid body 1 an elasticity such as to facilitate its positioning and its hold in the position shown in Figure 4.

Abstract

Dispositif pour remédier aux incontinences urinaires légères chez la femme destiné à être introduit dans la cavité vaginale (VA) et maintenu sous la vessie (VE) de façon à soutenir cette dernière ainsi que l'urètre (UR) au travers de la paroi vaginale antérieure et à s'opposer à la ptôse du col vésical, dispositif caractérisé en ce qu'il est constitué par un corps amovible (1) dépourvu d'angles vifs réalisé en un matériau non-adhérent inerte du point de vue chimique et biologique et non susceptible de créer des problèmes d'allergie, ce corps amovible (1) dont la présence n'empêche pas la miction étant susceptible d'être mis en place facilement par l'utilisatrice dans sa cavité vaginale (VA) et d'en être extrait en cas de besoin.Device for remedying mild urinary incontinence in women intended to be introduced into the vaginal cavity (VA) and held under the bladder (VE) so as to support the latter as well as the urethra (UR) through the anterior vaginal wall and to oppose ptosis of the bladder neck, device characterized in that it consists of a removable body (1) devoid of sharp angles made of a non-adherent material which is inert from the chemical and biological point of view and not capable of creating allergy problems, this removable body (1) whose presence does not prevent urination being capable of being easily put in place by the user in her vaginal cavity (VA) and of being extracted therefrom if needed.

Description

" Dispositif destiné à remédier aux incontinences urinaires légères chez la femme ""Device intended to remedy light urinary incontinence in women"
La présente invention concerne un dispositif destiné à remédier aux incontinences urinaires légères chez la femme.The present invention relates to a device intended to remedy light urinary incontinence in women.
On estime que la pathologie des incontinences urinaires touche en France plus d'un million de sujets du sexe féminin, et nombreuses sont les femmes jeunes et actives qui ont des difficultés à se retenir d'uriner suffisamment souvent pour que cela les gêne dans leur vie quotidienne.It is estimated that the pathology of urinary incontinence affects more than a million female subjects in France, and many young and active women find it difficult to refrain from urinating often enough to interfere with their lives. daily.
Cette incontinence se caractérise essentiellement par une fuite d'urine en jet qui survient lors d'efforts brusques s 'accompagnant d'une hyperpression abdominale ; celle-ci peut être provoquée par une toux, un rire, un éternuement ou même un changement brusque de position. Il s'agit là d'un handicap réel qui s'aggrave progressivement et se manifeste fréquemment dans la vie active ou sportive (course, marche rapide, tennis, golf ... ).This incontinence is essentially characterized by a leakage of urine in a jet which occurs during sudden efforts accompanied by an abdominal overpressure; this can be caused by coughing, laughing, sneezing or even a sudden change in position. This is a real handicap which progressively worsens and manifests itself frequently in active or sporting life (running, brisk walking, tennis, golf ...).
Parmi les différents mécanismes incriminés dans ces phénomènes, le plus fréquemment rencontré correspond à une ptôse, c'est-à-dire à une descente de la vessie au niveau du col vésical consécutive à un relâchement des muscles du diaphragme pelvien : la jonction urètrovésicale se trouve ainsi hors de l'enceinte des pressions de l'abdomen et l'étanchéité de la vessie ne peut plus toujours être garantie.Among the various mechanisms incriminated in these phenomena, the most frequently encountered corresponds to a ptosis, that is to say a descent of the bladder at the level of the bladder neck following a relaxation of the muscles of the pelvic diaphragm: urethrovesical junction is thus outside the confines of abdominal pressures and the tightness of the bladder can no longer always be guaranteed.
Outre le port de garnitures jetables, le traitement de ces incontinences d'effort consiste à tenter une rééducation des muscles périnéaux, c'est-à- dire un renforcement du plancher musculaire qui soutien la vessie et ferme l'urètre ; une telle rééducation ne donne malheureusement souvent que des résultats décevants.In addition to wearing disposable pads, the treatment of these stress incontinence consists in trying to rehabilitate the perineal muscles, that is to say a strengthening of the muscular floor which supports the bladder and closes the urethra; such re-education unfortunately often only gives disappointing results.
Jusqu'à présent, en cas d'échec de cette rééducation, le seul traitement consistait en une intervention chirurgicale réalisant une suspension de la paroi vaginale antérieure souvent amarrée aux ligaments rétropubiens. Il s'agit cependant là d'un traitement "lourd" pour cette raison réservé aux cas de gêne majeure.Until now, if this rehabilitation failed, the only treatment consisted of a surgical intervention carrying out a suspension of the anterior vaginal wall often moored to the retropubic ligaments. This is however a "heavy" treatment for this reason reserved for cases of major discomfort.
L'objet de l'invention est de remédier à cet inconvénient en proposant une alternative au traitement susmentionné, en particulier aux femmes qui ne souhaitent pas subir une intervention chirurgicale ou dont la gêne est insuffisante pour justifier une telle intervention.The object of the invention is to remedy this drawback by proposing an alternative to the above-mentioned treatment, in particular to women who do not wish to undergo a surgical intervention or whose discomfort is insufficient to justify such an intervention.
A cet effet, l'invention propose un dispositif pour remédier aux incontinences urinaires légères chez la femme destiné à être introduit dans la cavité vaginale et maintenu sous la vessie de façon à soutenir cette dernière ainsi que l'urètre au travers de la paroi vaginale antérieure et à s'opposer à la ptôse du col vésical.To this end, the invention provides a device for remedying 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 the urethra through the anterior vaginal wall. and to oppose the ptosis of the bladder neck.
Selon l'invention, ce dispositif est caractérisé en ce qu'il est constitué par un corps amovible dépourvu d'angles vifs réalisé en un matériau non-adhérent inerte du point de vue chimique et biologique et non susceptible de créer des problèmes d'allergie, ce corps amovible dont la présence n'empêche pas la miction étant susceptible d'être mis en place facilement par l'utilisatrice dans sa cavité vaginale et d'en être extrait en cas de besoin. Selon une autre caractéristique de l'invention, le corps amovible est un corps de forme ovoïde et comporte une petite extrémité par laquelle l'utilisatrice peut l'introduire dans son vagin et une grosse extrémité par laquelle elle peut l'extraire. Un tel dispositif peut facilement être mis en place par l'utilisatrice, d'une manière largement similaire aux tampons périodiques, quand se présente une situation à risque de fuite : bronchite, toux chronique, course à pied, tennis, golf ... II est essentiel de choisir, pour le corps ovoïde, des dimensions lui permettant de s'opposer au mécanisme de descente de la vessie lors des efforts et donc à la fuite urinaire, mais, sans provoquer d'ascension intempestive de l'urètre, de façon à permettre des mictions aisées sans ôter l'appareil qui peut ainsi être maintenu en place pendant plusieurs heures, notamment pendant une journée entière de huit heures.According to the invention, this device is characterized in that it is constituted by a removable body devoid of sharp angles made of a non-adherent material inert from the chemical and biological point of view and not likely to create problems of allergy, this removable body, the presence of which does not prevent urination, being capable of being easily put in place by the user in her vaginal cavity and of being extracted therefrom if necessary. According to another characteristic of the invention, the removable body is an ovoid body and has a small end by which the user can introduce it into her vagina and a large end by which she can extract it. Such a device can easily be put in place by the user, in a manner largely similar to periodic tampons, when there is a risk of leakage situation: bronchitis, chronic cough, running, tennis, golf ... II It is essential to choose, for the ovoid body, dimensions allowing it to oppose the mechanism of descent of the bladder during efforts and therefore urinary leakage, but, without causing untimely ascent of the urethra, so to allow easy urination without removing the device which can thus be kept in place for several hours, in particular for an entire day of eight hours.
On a, à titre d'exemple, pu obtenir des résultats particulièrement satisfaisants avec un corps ovoïde ayant une longueur totale de l'ordre de 40 à 50 mm et un diamètre de l'ordre de 25 à 35 mm. Ces dimensions ne peuvent, bien entendu, en aucune façon être considérées comme étant limitatives de l'invention.It has been possible, for example, to obtain particularly satisfactory results with an ovoid body having a total length of the order of 40 to 50 mm and a diameter of the order of 25 to 35 mm. These dimensions cannot, of course, in any way be considered as limiting the invention.
Il est également essentiel de permettre à l'utilisatrice d'extraire le dispositif facilement et rapidement en cas de besoin ; il est, à cet effet, concevable de munir la grosse extrémité du corps ovoïde d'au moins un fil souple faisant saillie vers l'extérieur, largement similaire au cordon que porte les tampons périodiques ; un tel fil, qui doit être très souple et ne pas "piquer" pour ne pas risquer de léser les tissus vaginaux de l'utilisatrice, peut avoir une longueur de l'ordre de 7 à 8 cm et être muni, à son extrémité libre, d'un bourrelet facilitant sa prise en main lors de l'extraction.It is also essential to allow the user to extract the device quickly and easily when needed; to this end, it is conceivable to provide the large end of the ovoid body with at least one flexible wire projecting towards the outside, largely similar to the cord worn by the periodic tampons; such a wire, which must be very flexible and not "prick" so as not to risk damaging 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 , a bead facilitating its handling during extraction.
Toutefois, selon une caractéristique préférentielle de l'invention, le corps ovoïde est creux et est muni au niveau de sa grosse extrémité d'un orifice central adapté à la préhension par un doigt et permettant un enlèvement aisé.However, according to a preferred characteristic of the invention, the ovoid body is hollow and is provided at its large end with a central orifice suitable for gripping by a finger and allowing easy removal.
Comme il a déjà été indiqué, il est essentiel, conformément à l'invention, que la présence du corps ovoïde n'empêche pas la miction lorsqu'il est mis en place.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 put in place.
Selon une autre caractéristique de l'invention, l'orifice central, prévu au niveau de la grosse extrémité, coopère avec un orifice situé au niveau de la petite extrémité.According to another characteristic of the invention, the central orifice, provided at the large end, cooperates with an orifice located at the small end.
La présence de ce second orifice permet l'écoulement des sécrétions physiologiques.The presence of this second orifice allows the flow of physiological secretions.
Pour pouvoir donner satisfaction, il est, bien entendu nécessaire que le corps amovible ne puisse pas occasionner de blessure traumatique et donc, outre sa forme arrondie, qu'il soit réalisé en un matériau non adhérent et parfaitement inerte tant que point de vue chimique que du point de vue biologique et non susceptible de créer des problèmes d'allergie lorsqu'il se trouve en contact avec les tissus humains.To be able to give satisfaction, it is of course necessary that the removable body cannot cause a traumatic injury and therefore, in addition to its rounded shape, that it is made of a non-adherent material and perfectly inert from a chemical point of view as biologically and not likely to cause allergy problems when in contact with human tissue.
Conformément à une caractéristique préférentielle de l'invention, le corps amovible est constitué d'un matériau plastique biocompatible.According to a preferred characteristic of the invention, the removable body is made of a biocompatible plastic material.
A titre d'exemple non limitatif, on peut avantageusement utiliser : - le polyéthylène haute densité (PEHD),By way of nonlimiting example, one can advantageously use: - high density polyethylene (HDPE),
- le polypropylène (PP),- polypropylene (PP),
- le polychlorure de vinyle (PVC) et ses dérivés,- polyvinyl chloride (PVC) and its derivatives,
- les polyamides (PA) , - le polyuréthanne (PUR),- polyamides (PA), - polyurethane (PUR),
- les silicones (Si)- silicones (Si)
- les résines fluorées dont le polytétrafluoréthylène (PTFE) .- fluorinated resins including polytetrafluoroethylene (PTFE).
Il est, à noter que les résines fluorées ont déjà fait l'objet de nombreuses applications biomédicales (prothèses osseuses, vasculaires et cathéters) et ont toujours permis de satisfaire aux exigences propres à ce domaine particulier.It should be noted that fluorinated resins have already been the subject of numerous biomedical applications (bone, vascular prostheses and catheters) and have always made it possible to meet the requirements specific to this particular field.
Conformément à l'invention, il est en outre avantageux d'incorporer au matériau constitutif du corps amovible, à titre d'additif, des substances absorbantes d'odeur notamment ammoniacales telles que les odeurs générées par l'incontinence urinaire.According to the invention, it is also advantageous to incorporate into the constituent material of the removable body, as an additive, odor absorbing substances, in particular ammoniacal substances such as the odors generated by urinary incontinence.
De façon non limitative, on peut, à cet effet, citer les zéolithes incorporés dans le matériau plastique à des concentrations comprises dans une fourchette de 0,1 et 5 % en poids. Parmi ces zéolithes, on peut, à titre d'exemple, mentionner l'aluminosilicate de sodium. La présence d'un tel additif permet une amélioration sensible du confort de l'utilisatrice.Without limitation, mention may be made, for this purpose, of the zeolites incorporated in the plastic material at concentrations comprised within a range of 0.1 and 5% by weight. Among these zeolites, mention may be made, by way of example, of sodium aluminosilicate. The presence of such an additive allows a significant improvement in the comfort of the user.
Indépendamment de ce qui précède, il est essentiel de garantir que le corps amovible reste bien maintenu en position dans le vagin après sa mise en place et ne risque pas de s'extraire automatiquement sous l'action d'un effort de l'utilisatrice par suite d'un glissement intempestif ; à cet effet, il est avantageux de munir sa surface d'irrégularités dont la géométrie doit être choisie de manière à garantir le confort de l'utilisatrice qui ne doit pas percevoir la présence du dispositif après mise en place.Independently of the above, it is essential to guarantee that the removable body remains well maintained in position in the vagina after its installation and does not risk being extracted automatically under the action of an effort of the user by following an untimely slip; for this purpose, it is advantageous to provide its surface with irregularities whose geometry must be chosen so as to guarantee the comfort of the user who should not perceive the presence of the device after installation.
A titre d'exemple, les irrégularités du corps amovible peuvent avantageusement être constituées par une série de rainures et/ou de nervures annulaires périphériques situées au niveau de la grosse extrémité. Selon une autre caractéristique de l'invention, le corps amovible est muni de fentes longitudinales essentiellement parallèles. Le rôle de ces fentes, qui sont, le cas échéant, perpendiculaires aux rainures et/ou aux nervures annulaires périphériques, est de conférer au dispositif une élasticité de nature à faciliter sa mise en place et son maintien. Les caractéristiques du dispositif qui fait l'objet de l'invention seront décrites plus en détail en se référant aux dessins annexes dans lesquels :By way of example, the irregularities of the removable body can advantageously be constituted by a series of grooves and / or peripheral annular ribs situated at the level of the large end. According to another characteristic of the invention, the removable body is provided with essentially parallel longitudinal slots. The role of these slots, which are, if necessary, perpendicular to the grooves and / or to the peripheral annular ribs, is to give the device an elasticity such as to facilitate its positioning and its 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:
- les figures la et lb sont des schémas anatomiques explicitant le mécanisme essentiel de l'incontinence urinaire d'effort,- Figures la and lb are anatomical diagrams explaining the essential mechanism of stress urinary incontinence,
- la figure 2 est une vue en perspective d'un dispositif correspondant à l'invention,FIG. 2 is a perspective view of a device corresponding to the invention,
- la figure 3a est une coupe longitudinale du dispositif représenté sur la figure 2, - la figure 3b est une coupe du dispositif représenté sur la figure 3a, selon l'axe III-III,FIG. 3a is a longitudinal section of the device shown in FIG. 2, FIG. 3b is a section of the device shown in FIG. 3a, along the axis III-III,
- la figure 4 est un schéma anatomique représentant le dispositif de la figure 2 une fois mis en place dans le vagin d'une utilisatrice. La figure la représente, d'une part, l'utérus- Figure 4 is an anatomical diagram showing the device of Figure 2 once placed in the vagina of a user. The figure represents, on the one hand, the uterus
UT et le vagin VA et, d'autre part, la vessie VE et l'urètre UR en position normale.UT and the vagina VA and, on the other hand, the bladder VE and the urethra UR in normal position.
La figure lb est un schéma similaire représentant un état de ptôse consécutif à un relâchement des muscles pelviens. On distingue * clairement sur ce schéma une descente des organes au niveau de la jonction uretrovesicale représentée par la flèche I. Dans cette position, le col vésical se trouve hors de l'enceinte des pressions de l'abdomen et l'étanchéité de la vessie VE ne peut plus être garantie dans le cas de situations à risque (toux, éternuement, sport ... ) .FIG. 1b is a similar diagram representing a state of ptosis following a relaxation of the pelvic muscles. We distinguish * clearly on this diagram a descent of the organs at the level of the uretrovesical junction represented by the arrow I. In this position, the bladder neck is outside the enclosure of the pressures of the abdomen and the tightness of the bladder VE does not can no longer be guaranteed in the case of risky situations (cough, sneeze, sport ...).
Le dispositif conforme à l'invention a pour objet de corriger cette situation, et de ramener l'urètre UR et la vessie VE en position normale au niveau de la jonction uretrovesicale.The object of the device according to the invention is to correct this situation, and to bring the urethra UR and the bladder VE back to normal position at the uretrovesical junction.
Selon les figures 2, 3a et 3b, le dispositif est constitué par un corps creux 1 de forme ovoïde réalisé en un matériau plastique biocompatible tel que décrit ci-dessus et comportant, d'une part, une petite extrémité 2 par laquelle l'utilisatrice peut l'introduire manuellement dans sa cavité vaginale VA et le pousser sous la vessie VE dans la position représentée sur la figure 4, et d'autre part, une grosse extrémité 3 par laquelle elle peut l'extraire.According to Figures 2, 3a and 3b, the device consists of a hollow body 1 of ovoid shape made of a biocompatible plastic material as described above and comprising, on the one hand, a small end 2 through which the user can introduce it manually into its vaginal cavity VA and push it under the bladder VE in the position shown in FIG. 4, and on the other hand, a large end 3 by which it can extract it.
Le corps ovoïde creux 1 est, à cet effet, muni au niveau de sa grosse extrémité 3, d'un orifice central 4 adapté à la préhension par un doigt et permettant un enlèvement aisé selon la flèche II (figure 4) .The hollow ovoid body 1 is, for this purpose, provided at its large end 3, with a central orifice 4 suitable for gripping by a finger and allowing easy removal according to arrow II (Figure 4).
L'orifice 4 coopère, par ailleurs, avec un orifice 5 situé au niveau de la petite extrémité 2 du corps 1 de façon à permettre l'écoulement des sécrétions physiologiques lorsque le dispositif est mis en place dans la cavité vaginale VA, comme représenté sur la figure 4.The orifice 4 cooperates, moreover, with an orifice 5 situated at the level of the small end 2 of the body 1 so as to allow the flow of physiological secretions when the device is placed in the vaginal cavity VA, as shown in Figure 4.
Il est clair que, dans cette position, le corps ovoïde 1 oppose de par son propre volume une résistance schématisée par la flèche IV à la descente de la jonction uretrovesicale telle que représentée sur la figure lb et concourt par suite au maintien de l'urètre UR et de la vessie VE dans la position normale représentée sur la figure la.It is clear that, in this position, the ovoid body 1 opposes by its own volume a resistance shown schematically by arrow IV to the descent of the uretrovesical junction as shown on FIG. 1b and contributes as a result of maintaining the urethra UR and the bladder VE in the normal position shown in FIG.
Selon la figure 3a, le corps amovible 1 a une longueur L de l'ordre de 40 à 50 mm et une largeur 1 de l'ordre de 25 à 35 mm ; ces dimensions se sont, en effet, avérées correspondre à l'anatomie de la majorité des utilisatrices et donc, propre à garantir leur confort tout en permettant des mictions aisées sans ôter le dispositif.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 been found to correspond to the anatomy of the majority of users and therefore capable of guaranteeing their comfort while allowing easy urination without removing the device.
Selon les figures 2 et 3a, le corps ovoïde 1 est muni d'une série de nervures/rainures annulaires périphériques 6 situées au niveau de la grosse extrémité 3 et dont le rôle est de définir des irrégularités de nature à faciliter le maintien du dispositif dans la position représentée sur la figure 4, après sa mise en place.According to Figures 2 and 3a, the ovoid body 1 is provided with a series of peripheral annular ribs / grooves 6 located at the large end 3 and whose role is to define irregularities such as to facilitate the maintenance of the device in the position shown in Figure 4, after its establishment.
Selon les figures 2 et 3b, ces rainures/ nervures 6 coopèrent avec des fentes longitudinales 7 essentiellement parallèles qui s'étendent perpendiculairement aux rainures/nervures 6 et permettent de conférer au corps ovoïde 1 une élasticité de nature à faciliter sa mise en place et son maintien dans la position représentée sur la figure 4. According to FIGS. 2 and 3b, these grooves / ribs 6 cooperate with essentially parallel longitudinal slots 7 which extend perpendicular to the grooves / ribs 6 and make it possible to give the ovoid body 1 an elasticity such as to facilitate its positioning and its hold in the position shown in Figure 4.

Claims

R E V E N D I C A T I O N S 1°) Dispositif pour remédier aux inconti¬ nences urinaires légères chez la femme destiné à être introduit dans la cavité vaginale (VA) et maintenu sous la vessie (VE) de façon à soutenir cette dernière ainsi que l'urètre (UR) au travers de la paroi vaginale antérieure et à s'opposer à la ptôse du col vésical, dispositif caractérisé en ce qu'il est constitué par un corps amovible (1) dépourvu d'angles vifs réalisé en un matériau non-adhérent inerte du point de vue chimique et biologique et non susceptible de créer des problèmes d'allergie, ce corps amovible (1) dont la présence n'empêche pas la miction étant susceptible d'être mis en place facilement par l'utilisatrice dans sa cavité vaginale (VA) et d'en être extrait en cas de besoin.CLAIMS 1) Device to remedy slight urinary incontinence in women intended to be introduced into the vaginal cavity (VA) and held under the bladder (VE) so as to support the latter as well as the urethra (UR) at across the anterior vaginal wall and to oppose the ptosis of the bladder neck, device characterized in that it consists of a removable body (1) devoid of sharp angles made of a non-adherent material inert to the point of chemical and biological view and not likely to create allergy problems, this removable body (1) whose presence does not prevent urination being capable of being easily put in place by the user in her vaginal cavity (VA) and to be extracted if necessary.
2°) Dispositif selon la revendication 1, caractérisé en ce que le corps amovible (1) est un corps de forme ovoïde et comporte une petite extrémité (2) par laquelle l'utilisatrice peut l'introduire dans son vagin (VA) et une grosse extrémité (3) par laquelle elle peut l'extraire.2 °) Device according to claim 1, characterized in that the removable body (1) is an ovoid body and has a small end (2) through which the user can introduce it into her vagina (VA) and a large end (3) by which it can extract it.
3°) Dispositif selon la revendication 2, caractérisé en ce que le corps ovoïde (1) est creux et est muni, au niveau de sa grosse extrémité (3), d'un orifice central (4) adapté à la préhension par un doigt et permettant un enlèvement aisé.3 °) Device according to claim 2, characterized in that the ovoid body (1) is hollow and is provided, at its large end (3), with a central orifice (4) suitable for gripping by a finger and allowing easy removal.
4°) Dispositif selon la revendication 3, caractérisé en ce que l'orifice central (4) prévu au niveau de la grosse extrémité (3) coopère avec un orifice (5) situé au niveau de la petite extrémité (2) de façon à permettre l'écoulement des sécrétions physiologiques lorsque le dispositif est mis en place.4 °) Device according to claim 3, characterized in that the central orifice (4) provided at the large end (3) cooperates with an orifice (5) located at the small end (2) so as to allow the flow of physiological secretions when the device is put in place.
5°) Dispositif selon l'une quelconque des revendications 1 à 4, caractérisé en ce que le corps amovible (1) est en un matériau plastique biocompatible choisi dans le groupe formé par le polyéthylène haute densité, le polypropylene, le polychlorure de vinyle et ses dérivés, les polyamides, le polyuréthanne, les silicones et les résines fluorées dont le polytétrafuoréthylène.5 °) Device according to any one of claims 1 to 4, characterized in that the removable body (1) is made of a biocompatible plastic material chosen from the group formed by high density polyethylene, polypropylene, polyvinyl chloride and its derivatives, polyamides, polyurethane, silicones and fluorinated resins including polytetrafuoroethylene.
6°) Dispositif selon la revendication 5, caractérisé en ce que le matériau plastique constitutif du corps amovible renferme un additif de nature à absorber les odeurs ammoniacales générées par l'incontinence urinaire.6 °) Device according to claim 5, characterized in that the plastic material constituting the removable body contains an additive capable of absorbing ammonia odors generated by urinary incontinence.
7e) Dispositif selon la revendication 6, caractérisé en ce que l'additif de nature à absorber les odeurs ammoniacales est constitué par un zéolithe mis en oeuvre à une concentration pondérale comprise entre 0,1 et 5 %.7 e ) Device according to claim 6, characterized in that the additive capable of absorbing ammoniacal odors consists of a zeolite used at a weight concentration between 0.1 and 5%.
8e) Dispositif selon l'une quelconque des revendications 1 à 7, caractérisé en ce que le corps amovible (1) comporte, sur sa surface, des irrégularités de nature à garantir son maintien après mise en place.8 e ) Device according to any one of claims 1 to 7, characterized in that the removable body (1) comprises, on its surface, irregularities such as to guarantee its maintenance after installation.
9e) Dispositif selon la revendication 8, caractérisé en ce que les irrégularités du corps amovible sont constituées par une série de rainures et/ou de nervures annulaires périphériques (6) situées au niveau de la grosse extrémité (3).9 e ) Device according to claim 8, characterized in that the irregularities of the removable body are constituted by a series of grooves and / or peripheral annular ribs (6) located at the large end (3).
10°) Dispositif selon l'une quelconque des revendications 1 à 9, caractérisé en ce que le corps amovible est muni de fentes longitudinales (7) essentiellement parallèles permettant de conférer au dispositif une élasticité de nature à faciliter sa mise en place et son maintien. 10 °) Device according to any one of claims 1 to 9, characterized in that the removable body is provided with longitudinal slots (7) essentially parallel to give the device an elasticity such as to facilitate its establishment and its maintenance .
EP94901998A 1992-12-07 1993-12-07 Device for correcting slight urinary incontinence in women Withdrawn EP0625890A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9214708 1992-12-07
FR9214708A FR2698781B1 (en) 1992-12-07 1992-12-07 Device intended to remedy light urinary incontinence in women.
PCT/FR1993/001206 WO1994013223A1 (en) 1992-12-07 1993-12-07 Device for correcting slight urinary incontinence in women

Publications (1)

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EP0625890A1 true EP0625890A1 (en) 1994-11-30

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EP94901998A Withdrawn EP0625890A1 (en) 1992-12-07 1993-12-07 Device for correcting slight urinary incontinence in women

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EP (1) EP0625890A1 (en)
JP (1) JPH07503885A (en)
AU (1) AU684733B2 (en)
BR (1) BR9305852A (en)
CA (1) CA2129530A1 (en)
CZ (1) CZ190594A3 (en)
FI (1) FI943658A (en)
FR (1) FR2698781B1 (en)
HU (1) HUT69456A (en)
NO (1) NO942937L (en)
NZ (1) NZ258594A (en)
OA (1) OA10072A (en)
SK (1) SK94494A3 (en)
WO (1) WO1994013223A1 (en)

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Also Published As

Publication number Publication date
FR2698781A1 (en) 1994-06-10
FR2698781B1 (en) 1995-04-07
OA10072A (en) 1996-10-14
NO942937L (en) 1994-09-23
HU9402520D0 (en) 1994-11-28
BR9305852A (en) 1997-02-18
CA2129530A1 (en) 1994-06-23
FI943658A0 (en) 1994-08-05
SK94494A3 (en) 1995-04-12
AU684733B2 (en) 1998-01-08
NZ258594A (en) 1996-11-26
CZ190594A3 (en) 1995-01-18
NO942937D0 (en) 1994-08-08
HUT69456A (en) 1995-09-28
FI943658A (en) 1994-10-05
JPH07503885A (en) 1995-04-27
WO1994013223A1 (en) 1994-06-23
AU5653394A (en) 1994-07-04

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