EP1157719A1 - Intravaginal probe for perineal auto-rehabilitation - Google Patents

Abstract

The probe consists of a passive element (1) of pre-specified weight comprising a rounded end introduction part (2). This is extended by a cylindrical part (3) defining a main body whose dimensions correspond to the ring formed by the perineal muscular system. The cylindrical part is extended by a truncated part (4) which enables the control of the resistance to the weight of the whole of the element to be obtained. The truncated part is extended by a second truncated part (5) which is widened in an opposite direction to the first truncated part. This defines a central concave revolution zone (6). This zone is extended by an outer part forming a ring enabling the manual gripping of the element and avoiding its migration into the vagina.

Description

The present invention relates to an intravaginal probe perineal self-rehabilitation.

The aim of such re-education is to remedy various causes of urinary incontinence, preventively in the postpartum period, or curative alone or in addition to medical or surgical treatment.

• prise de conscience,
• apprentissage de la qualité de la contraction musculaire,
• musculation,
• réentraínement à l'effort.

Among the different techniques used in this area, manual rehabilitation concerns, in addition to the anus-lifting muscles, the bulbo-cancellous muscles. Its principle comes from the exercises recommended by Mr. Kegel in 1948. Such re-education adapts to the results of a starting muscle test. It includes the following classic and successive phases:

• awareness,
• learning the quality of muscle contraction,
• bodybuilding,
• effort training.

Different studies have shown the effectiveness of rehabilitation manual as a rehabilitation technique proper. She seems suitable for the management of stress urinary incontinence because it acts on strengthening the pelvic floor. Intravaginal labor gives good results in all of the judgment criteria.

This technique can be effectively relayed by self-maintenance exercises, provided you have adequate equipment.

Until now, only vaginal cones were available. These act by reproducing an endocavitary gravity requiring theoretically the patient to lock her perineal muscular system. In fact, if their use improves the strength of the muscle floor pelvic, it does not allow an objective measurement of its strength. Analysis of the literature makes it possible to express reservations about the effectiveness of this type of material.

On the other hand, the vaginal cones have the advantage of being used in rehabilitation, therefore in self-maintenance, before or after rehabilitation traditional and in women refusing or unavailable to practice this last.

The international patent application WO-98 48 904 describes a vaginal weight designed to be introduced into the vagina for the purpose of put to the test and examine the striated muscle fiber of the structure perineal. This weight has the distinction of having a distributed mass asymmetrically and comprising a heavy element or a plurality heavy elements distributed internally, the center of gravity of the element or the overall center of gravity of the various heavy elements within the vaginal weight being located below the center of gravity of said weight when the latter does not contain the heavy element (s).

Nevertheless, and as already mentioned above, such a device does not allow an objective measurement of the floor strength pelvic muscle.

• une partie d'extrémité d'introduction arrondie, prolongée par,
• une partie cylindrique définissant un corps principal, dont les dimensions correspondent sensiblement à l'anneau formé par le système musculaire périnéal, et qui se prolonge par,
• une première partie sensiblement tronconique, permettant d'obtenir le contrôle de la résistance au poids de l'ensemble de l'élément, et qui se prolonge par,
• une seconde partie sensiblement tronconique, évasée dans une direction opposée à ladite première partie tronconique, définissant avec celle-ci une zone centrale concave de révolution, et qui se prolonge par,
• une partie externe formant un anneau permettant une préhension manuelle de l'élément, et évitant la migration de ce dernier dans le vagin.

In order to obtain such a result, and with the aim of overcoming the drawbacks of known systems, the invention relates to an intravaginal probe for perineal self-education, characterized in that it is constituted by an element of passive revolution and of predetermined weight, comprising:

• a rounded introduction end part, extended by,
• a cylindrical part defining a main body, the dimensions of which correspond substantially to the ring formed by the perineal muscular system, and which is extended by,
• a first substantially frustoconical part, making it possible to obtain control of the resistance to weight of the whole of the element, and which is extended by,
• a second substantially frustoconical part, flared in a direction opposite to said first frustoconical part, defining therewith a concave central zone of revolution, and which is extended by,
• an external part forming a ring allowing manual gripping of the element, and preventing migration of the latter into the vagina.

The present invention also relates to the characteristics which will emerge during the description which follows, and which should be considered in isolation or in all their technical combinations possible.

• la figure 1 est une vue en plan de la sonde intra-vaginale d'auto-rééducation périnéale selon l'invention,
• la figure 2 est une vue de dessus de l'extrémité externe de la sonde selon la figure 1.

This description, given by way of nonlimiting example, will make it easier to understand how the invention can be implemented, with reference to the accompanying drawings in which:

• FIG. 1 is a plan view of the intravaginal probe for perineal self-education according to the invention,
• FIG. 2 is a top view of the external end of the probe according to FIG. 1.

• une partie d'extrémité d'introduction arrondie 2, prolongée par,
• une partie cylindrique 3 définissant un corps principal, dont les dimensions correspondent sensiblement à l'anneau formé par le système musculaire périnéal, et qui se prolonge par :
     - une première partie sensiblement troncônique 4 permettant d'obtenir le contrôle de la résistance au poids de l'ensemble de l'élément 1 et qui se prolonge par :
  • une seconde partie sensiblement tronconique 5, évasée dans une direction opposée à ladite première partie tronconique 4, définissant avec celle-ci une zone centrale concave de révolution 6, et qui se prolonge par,
  • une partie externe formant un anneau 7 permettant une préhension manuelle de l'élément 1, et évitant la migration de ce dernier dans le vagin.

The probe, illustrated overall in FIG. 1, consists of an element 1 of passive revolution and of determined weight comprising:

• a rounded introduction end part 2, extended by,
• a cylindrical part 3 defining a main body, the dimensions of which correspond substantially to the ring formed by the perineal muscular system, and which is extended by:
  a first substantially frusto-conical part 4 making it possible to obtain control of the resistance to weight of the assembly of the element 1 and which is extended by:
  • a second substantially frustoconical part 5, flared in a direction opposite to said first frustoconical part 4, defining therewith a concave central zone of revolution 6, and which is extended by,
  • an external part forming a ring 7 allowing manual gripping of the element 1, and avoiding the migration of the latter into the vagina.

The dimensions of the endocavity part correspond to medium anatomical readings, allowing the probe to be used by all the women.

According to an advantageous embodiment, the introduction part 2 is in the form of a warhead, the end of which is made with a radius R ₁ , in particular between 8 and 15 mm and with a length L ₂ of approximately 13 mm. It extends towards the cylindrical part 3 which has a diameter D ₁ of approximately 30 mm and a length L ₁ of approximately 35 mm.

As regards said first frusto-conical part 4, it has a large base B whose diameter corresponds to the diameter D ₁ of the cylindrical part 3 from which it originates. Its small base b is approximately 10 mm in particular.

Said small base b coincides with the small base b 'of the second frustoconical part 5, coming from said first part 4. The large base B' of said second frustoconical part 5 has a diameter D ₂ of approximately 30 mm in particular.

The first frustoconical part 4 is of a height L ₃ of approximately 20 mm, in particular, while the second frustoconical part 5 is of a height L ₅ of approximately 10 mm, in particular.

Said frustoconical parts 4 and 5 define the concave central zone 6, which has, as far as it is concerned, a height L ₄ of approximately 10 mm, in particular, and a radius of curvature R ₄ , of the order of 12 mm, especially..

In fact, the double truncated cone of revolution, constituted by said parts 4 and 5, in the form of a diabolo, is therefore of a total height of 40 mm, in particular.

As regards the ring 7 forming the external part, this has a diameter D ₂ of approximately 30 mm, in particular, merging with the large base B 'of said second frustoconical part 5, of which it is issue. It has a thickness L ₆ of approximately 5 mm, in particular.

As will be seen in FIG. 1, all the angular areas of junction of the different parts are rounded along a radius R ₃ so as to allow easy introduction without apprehension or risk of injury.

This ring 7 allows, not only as already mentioned a manual gripping of the element, further avoiding its migration in the vagina, but also, it facilitates the introduction and extraction of the probe. In addition, its low thickness allows a user to work in underwear.

In addition, and what is very important, this same ring 7 avoids especially the stop of the probe on the bony promontory, which would harm its efficiency.

According to another characteristic of the invention, the element 1 has a weight of, in particular, between 350 and 500 grams. Function of weight is an essential element of the probe which in association with the part tapered outlet 4, stretching, in particular, over 20 mm in length, allows to obtain weight resistance control.

This probe being passive, without any external energy, the weight resistance control is performed only by the patient, this which constitutes the perineal self-rehabilitation sought.

According to another characteristic of the invention, the ring 7 forming the external part includes a system for fixing to a counterweight allowing to increase the work.

In fact, this peculiarity is interesting when the work is performed or controlled by a therapist who has a pull tab with tip, either a small suction cup or a magnetic tip to come attach to the outer face of the ring, in order to measure the forces and progress.

Advantageously, the probe is made of metal treated against oxidation and perfectly smooth. For this purpose, it could be, for example, drawn and chromed or stainless steel or titanium, at least in area.

This is to ensure a sterile environment and a ease of cleaning. The surface of the probe has no edges and is perfectly smooth, which favors its introduction without addition of lubricant and explains its comfort of maintenance.

The weight of the probe may surprise when weighed in the hand. In reality, the perineal muscles form a muscular hammock extremely solid, so the weight of the probe is perfectly suited to muscle resistance.

• en position couchée, le poids de la sonde est nul,
• en position assise, c'est-à-dire environ à 90 °, le poids de la sonde est divisé par deux,
• en position debout, et uniquement dans cette position, la sonde exerce son poids vers le bas, et il faut verrouiller le périnée pour qu'elle reste en place.

In addition, this weight varies according to the position of the patient and is therefore perfectly suited to exercise training. Indeed :

• in the supine position, the weight of the probe is zero,
• in a seated position, i.e. around 90 °, the weight of the probe is halved,
• in the standing position, and only in this position, the probe exerts its weight downwards, and the perineum must be locked so that it remains in place.

This instantaneous reduction or increase in the weight of the probe, depending on the position, allows more muscular rehabilitation fast.

The exercises described below follow this progression. implementation of the probe of the present invention can be carried out from the next way.

A review is carried out at the start, then after ten days of exercise with visual satisfaction scale.

1) FIRST WEEK:

1.1) Premier jour : « proprioception »

a) - contraction 1s - repos 3 s. Répéter dix fois sans chercher à serrer au maximum mais en contrôlant scrupuleusement l'absence de participation des fessiers, des abdominaux et de la bascule du bassin. Puis,

b) - repos complet pendant 20s. Puis recommencer l'exerce a) puis b) pendant un total de cinq minutes. Effectuer cet exercice matin et soir.

1.2) Deuxième jour : « fibres musculaires rapides »

a) - contraction 3s - repos 9s. Répéter dix fois en cherchant à serrer au maximum la sonde et en contrôlant toujours scrupuleusement l'absence de participation des fessiers, des abdominaux et de la bascule du bassin.

b) - repos complet pendant 30 s. Puis recommencer l'exercice a) puis b) pendant un total de cinq minutes. Effectuer cet exercice matin et soir.

1.3) Troisième jour : « fibres musculaires lentes »

a) - contraction 6s - repos 6s. Répéter dix fois sans chercher à serrer à 50 % du maximum et en contrôlant toujours scrupuleusement l'absence de participation des fessiers, des abdominaux et de la bascule du bassin.

b) - repos complet pendant 30s. Puis recommencer a) puis b) pendant un total de cinq minutes. Effectuer cet exercice matin et soir.

1.4) Continuer les exercices matin et soir en alternant les exercices « fibres rapides » et « fibres lentes » jusqu'à la fin de la première semaine, c'est-à-dire :

• exercices « fibres rapides » les jours pairs, 2, 4, 6,
• exercices « fibres lentes » les jours impairs 3, 5, 7.

Work in the lying position, legs stretched out, well relaxed, introduce the probe into the vagina. Market the exercises by placing one hand on the abs and the other on the side of the glutes to control their non participation. Maintaining the perineal contraction is done by counting high to avoid blockage in apnea.

1.1) First day: "proprioception"

a) - contraction 1s - rest 3 s. Repeat ten times without trying to tighten as much as possible but by scrupulously controlling the absence of participation of the glutes, the abdominals and the tilt of the pelvis. Then,

b) - complete rest for 20s. Then repeat exercise a) then b) for a total of five minutes. Perform this exercise morning and evening.

1.2) Second day: "fast muscle fibers"

a) - contraction 3s - rest 9s. Repeat ten times, trying to tighten the probe as much as possible and always scrupulously checking the absence of involvement of the glutes, abdominals and pelvic tilt.

b) - complete rest for 30 s. Then repeat exercise a) then b) for a total of five minutes. Perform this exercise morning and evening.

1.3) Third day: "slow muscle fibers"

a) - contraction 6s - rest 6s. Repeat ten times without trying to tighten to 50% of the maximum and always scrupulously checking the absence of participation of the glutes, the abdominals and the tilt of the pelvis.

b) - complete rest for 30s. Then repeat a) then b) for a total of five minutes. Perform this exercise morning and evening.

1.4) Continue the exercises morning and evening alternating the "fast fibers" and "slow fibers" exercises until the end of the first week, that is to say:

• “fast fiber” exercises on even days, 2, 4, 6,
• "slow fiber" exercises on odd days 3, 5, 7.

2) SECOND WEEK :

Work in a seated, relaxed position, supported back, legs one hand on the abdominals and the other on the side buttocks to control their non participation. Maintaining the perineal contraction is accomplished by counting out loud to avoid freediving blockage.

2.1) First, second and third day :

Repeat the same exercises and the same chronology as the first three days but in a seated position.

The sitting position allows you to vary the weight of the probe and program the intensity of the exercise. The modification of the seat angle between 0 ° and 90 ° allows the weight to be varied, therefore the effectiveness of the device. The easiest position is the one approaches 0 °, the most difficult is 90 °, because the perineal contraction is necessary to overcome the weight of the probe.

2.2) Continue the exercises in the sitting position morning and evening , alternating the "fast fiber" and "slow fiber" exercises until the end of the week, that is to say:

• “fast fiber” exercises on even days 2, 4, 6,
• "slow fiber" exercises on odd days 3, 5, 7.

3) THIRD WEEK :

Work in a standing position, probe in place in the vagina. The hand positioning and counting out loud are no longer useful because the patient now knows how to control herself and avoid gestures parasites.

The shape of the probe allows it to be used with underwear so during usual household activity by example.

3.1) First day: "learning how to lock with short efforts" probe in place.

a) - perineal contraction - 1 cough with perineal support, standing position legs in normal position - rest 10s. Repeat ten times exercise.

b) - complete rest for 30 s.

c) - perineal contraction - 5 successive coughs with maintenance perineal, standing position legs in normal position - rest 20s. Repeat the exercise ten times.

d) - complete rest for 30 s.

e) - perineal contraction - 1 cough with perineal support, standing position legs apart - rest 10 s. Repeat ten times exercise.

f) - complete rest for 30 s.

g) - perineal contraction - 5 successive coughs with maintenance perineal, standing position legs apart - rest 20 s. Repeat ten times exercise.

3.2) Perform this exercise morning and evening for seven days. 4) FOURTH WEEK :

a) - contraction périnéale - 1 accroupissement avec maintien périnéal - repos 10 s. Répéter dix fois l'exercice.

b) - repos complet pendant 30 s.
   Effectuer l'exercice a) puis b) pendant un total de 10 minutes. Puis :

c) - contraction périnéale - 3 accroupissements successifs avec maintien périnéal - repos 20 s. Répéter dix fois l'exercice.

" Learning the locking with prolonged efforts " probe in place.

a) - perineal contraction - 1 squatting with perineal support - rest 10 s. Repeat the exercise ten times.

b) - complete rest for 30 s.
Perform exercise a) then b) for a total of 10 minutes. Then:

c) - perineal contraction - 3 successive squats with perineal support - rest 20 s. Repeat the exercise ten times.

Perform this exercise morning and evening.

5) TWENTY-NINTH DAY:

" Initial test ": maintaining the probe by having a usual activity for half an hour.

6) THIRTIETH DAY:

" Final test ": maintaining the probe by having a usual activity for half an hour. At this stage, the exercises can be carried out by cleaning, washing the dishes, passing the vacuum cleaner ... The probe, blocked by the perineum, remains in place while climbing the stairs, in a squatting position ...

The goal is reached at the end of rehabilitation, which aims to obtain effortless perineal blockage in the standing position. A rehabilitated perineum and effective contracts automatically when standing during exercise, which allows the disappearance of urinary leaks.

Claims (8)

Intravaginal probe for perineal self-rehabilitation, characterized in that it consists of an element (1) of passive revolution and of predetermined weight, comprising: a rounded introduction end part (2), extended by, a cylindrical part (3) defining a main body, the dimensions of which correspond substantially to the ring formed by the perineal muscular system, and which is extended by, a first substantially frustoconical part (4), making it possible to obtain control of the resistance to weight of the whole of the element (1), and which is extended by, a second substantially frustoconical part (5), flared in a direction opposite to said first frustoconical part (4), defining therewith a concave central zone of revolution (6), and which is extended by, an external part forming a ring allowing manual gripping of the element (1), and avoiding the migration of the latter into the vagina. Intravaginal probe according to claim 1, in which the insertion part (2) is in the form of a warhead, the end of which is produced with a radius R ₁ of between 8 and 15 mm. Intravaginal probe according to claim 1, in which the cylindrical part (3) has a diameter D ₁ of approximately 30 mm and a length L ₁ of approximately 35 mm. Intravaginal probe according to claim 1, in which said first frustoconical part (4) has a large base B whose diameter corresponds to that D ₁ of the cylindrical part (3) from which it comes, a height L ₃ of approximately 10 mm, and a small base b of approximately 10 mm, coinciding with the small base b 'of said second frustoconical part (5), the large base B' of which has a diameter D ₂ of approximately 30 mm also , said frustoconical parts 4, 5 defining said concave central zone (6) with a height L ₄ of approximately 10 mm. Intravaginal probe according to claim 1, in which the ring (7) forming the external part has a diameter D ₂ , of approximately 30 mm, merging with the large base B 'of said second frustoconical part (5 ), and with a thickness L ₆ of approximately 5 mm. Intravaginal probe according to any one of Claims 1 to 5, in which the element (1) has a weight included between 350 and 500 grams. Intravaginal probe according to any one of Claims 1 to 6, in which the element (1) is made of treated metal against oxidation and perfectly smooth. Intravaginal probe according to any one of Claims 1 to 7, in which the ring (7) forming the external part has a counterweight attachment system to increase the job.

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