EP0219410A1 - Monometric probe for rehabilitating urinal or anal incontinence patients, and apparatus for active exercizing using the same - Google Patents

Abstract

The invention relates especially to a manometric probe for rehabilitating and, in particular, the active exercising, of urinal or anal incontinence patients, and is intended to be inserted into a body cavity (anus or vagina) in order to interact functionally with the sphincter muscle blocks to be rehabilitated. This probe comprises an elastically deformable elongated tubular sleeve (7) encased by rigid anterior (4) and posterior (5) distal parts, the sleeve (7) having a transverse dimension smaller than the transverse dimension of the distal parts, the sleeve defining, with the distal parts, a chamber (8) which possesses an orifice (9) for communication with an external medium which is intended, in the functional position of the probe, to be filled with a fluid forming a pressure-transmission medium, the probe being, in the functional position of the probe, disposed in the body cavity so that the elastically deformable sleeve is in close contact with the muscle blocks to be rehabilitated. The length of the elastic sleeve (7) is 20 to 30 mm for an anal probe and 45 and 55 mm for a vaginal probe. <IMAGE>

Description

The invention relates to a manometric probe usable for the rehabilitation of urinary or anal incontinence patients and intended to be introduced into a body cavity (anus or vagina) to functionally cooperate with the muscle masses to be reeducated, comprising a tubular sleeve elongated in an elastically material deformable supported at its two ends by anterior and posterior distal parts made of a rigid or relatively rigid material, said sleeve defining with the distal parts a chamber which has an orifice for communication with an external medium and which is intended, in position functional, to be filled with a fluid constituting a pressure transmission medium, the probe being, in the functional position, arranged in the body cavity so that the elastically deformable sleeve is in close contact with the muscle masses to be reeducated. The probe concerned by the invention is, in its most general definition, more particularly usable for active rehabilitation, but a particularly economical arrangement of this probe makes it usable for passive rehabilitation. In addition, the invention relates to an active rehabilitation device using the probe of the invention.

One of the causes of urinary or faecal incontinence resides in an insufficient musculation of the sphincter apparatus, respectively urinary or anal, which is opposed to the involuntary flows respectively of urine or faeces. To combat urinary or fecal incontinence of this type, an active mass re-education can be used. sphincter muscle designed to strengthen the muscles so that the sphincter apparatus can regain its effectiveness. This active rehabilitation consists of appropriate gymnastics of the sphincter muscle mass which, until now, has been carried out under direct medical supervision (for example in a hospital environment), possibly with the help of relatively complex manipulation devices.

According to patent application G.B. 666 348, there is already known a probe of the aforementioned kind intended to allow re-education of the sphincter muscle masses. However, this known probe is very ill-suited to the physiology of the human being, and in particular the length of the elastically deformable sleeve is excessive having regard to the average extent of the sphincter muscles of the human being. As a result, during use of this probe placed in the functional position, the areas of the elastic sleeve which extend beyond the sphincter muscles and which are not in abutment against them tend to swell. excessively by constituting one or two annular beads whose size varies as a function of the internal pressure, and therefore of the muscular efforts exerted by the patient. This results in an alteration of the pressure variation undergone by the compressed fluid in the chamber delimited by the sleeve, hence great uncertainty in the results of the measurements thus carried out. In addition, the size of the excess zone (s) of the elastic sleeve depends on the axial positioning of the probe in the natural duct (anus or vagina) and the reproducibility of the pressure measurements of the compressed fluid, which make it possible to follow the rehabilitation, s 'finds it greatly affected.

The invention therefore essentially aims to remedy the drawbacks of this known probe, and to offer an improved probe that gives better satisfaction; the invention also aims to provide simple means to implement and inexpensive, developed around this improved probe, allowing active rehabilitation can be performed by the patient alone at home.

For these purposes, a first aspect of the invention relates to a pressure probe which is characterized in that the length of the elastic sleeve is between approximately 20 and 30 mm in the case of a probe for anal use and between approximately 45 and 55 mm in the case of a vaginal probe.

Preferably, in the case of a probe intended for anal use, the tubular sleeve has a diameter of between approximately 9 and 15 mm in the undeformed state and the useful volume inside the sleeve is between approximately 3 and 7 cm³.

Preferably also, in the case of a probe intended for vaginal use, the tubular sleeve has a diameter of between approximately 15 and 25 mm in the undeformed state and the useful volume inside the sleeve is between approximately 15 and 25 cm³.

A probe according to the invention is particularly advantageous for satisfying the requirements of an active rehabilitation insofar as, because of its shape, it adapts perfectly in the body cavity into which it is introduced and is well retained therein without risk of untimely expulsion under the action of the constraints to which she is subjected during this rehabilitation; this adaptation to the walls of the body cavity also results in a perfect and total transmission of the muscular effort of the probe, which makes it possible to measure both exact and reliable this muscular effort.

Finally, because of its good cooperation with the walls of the body cavity in which it is introduced, the probe according to the invention can receive at least two electrodes made of an electrically good conductive material which are fixed on the external surface of the elastically deformal sleeve. A probe thus arranged, associated with a device with controlled electrical discharges, may be particularly advantageous for implementing passive reeducation of urinary or faecal incontinence.

Still within the framework of the active rehabilitation envisaged above, it is interesting to make the most of the precise information provided by the probe. To this end, a second aspect of the invention relates to an apparatus which includes a pressure probe such as that defined above, connected by a conduit to a pressure sensor, means for introducing a pressurized fluid into the probe and its connection conduit, means for processing the output signal from the pressure sensor, display means receiving said signal to display the true pressure exerted on the probe and detected by the pressure sensor, and calibration means making it possible to set the display zero according to the pressure of the fluid introduced into the probe.

In an embodiment of this device which is particularly advantageous for its compactness, its low cost and the accuracy of the display, the pressure sensor provides an electrical output signal, the signal processing means are electronic means and the means for 'display includes a ramp of light displays corresponding respectively to preset pressure thresholds.

Finally, to facilitate the patient's work, the device of the invention may also include signaling means, in particular visual and / or audible, possibly adjustable, indicating the times of work and rest times. Thus the patient effortlessly has all the parameters useful for his rehabilitation.

• - la figure 1 est un vue schématique d'un appa­reil conforme à l'invention, la sonde manométrique étant représentée en coupe longitudinale diamétrale ;
• - la figure 2 est un schéma bloc simplifié de l'agencement électronique de l'appareil de la figure 1 ; et
• la figure 3 est une vue schématique de côté d'une sonde conforme à l'invention, agencée en vue de la mise en oeuvre d'une rééducation passive des inconti­nents urinaires ou anaux.

The invention will be better understood on reading the following detailed description of a preferred embodiment given solely by way of illustrative example, without any limiting character. In this description, reference is made to the appended drawings in which:

• - Figure 1 is a schematic view of an apparatus according to the invention, the pressure probe being shown in diametral longitudinal section;
• - Figure 2 is a simplified block diagram of the electronic arrangement of the apparatus of Figure 1; and
• Figure 3 is a schematic side view of a probe according to the invention, arranged for the implementation of a passive rehabilitation of urinary or anal incontinence.

Referring first to Figure 1, a pressure probe 1 according to the invention is shown in diametrical longitudinal section. This probe includes a support member 2 having a central region or core 3 of relatively reduced diameter supporting an anterior end portion 4 and a posterior end portion 5 having diameters relatively larger than that of the core 3. The support member is made of a rigid or semi-rigid material suitable for ensuring the desired function. It can be produced in one-piece form, as shown, or else be made up by assembling three parts corresponding to the three parts indicated above, the core then being able to be produced by a tubular element.

On the support 2 is threaded from the front a cap 6, made of latex or any other elastically deformable material having the property of adopting exactly the same shape and the same dimensions after deformation. The cap 6 covers the front end part 4 of the support and is tightly connected to the rear end part 5 of the support. Of course, other arrangements are possible, the essential being that a tubular sleeve 7 made of an elastically deformable material (preferably latex) extends between the posterior and anterior end portions of the support to form a chamber 8 capable of be filled with a fluid, preferably a gas, and advantageously air. In the configuration shown, the chamber 8 is annular around the core 3.

Finally, an orifice 9 is provided for communicating the chamber 8 with an external environment. In the simple embodiment shown in FIG. 1, a channel 10 is drilled axially in the rear terminal part 5 of the support 2 and opens at 9 into the chamber 8.

In the channel 10 is fitted a thin and flexible tube 11 connected to a housing 12 containing the command and control electronics which will be described later.

Finally, the tube 11 is provided with a bypass constituted by a thin tube 13 terminated by a connection sleeve 14 provided with an isolation valve 15. This connection sleeve can receive any suitable end piece from a suitable fluid source (for example compressed air tank or bulb) intended for injecting a determined quantity of the pressurized fluid into the fluid circuit, including into chamber 8.

FIG. 2 schematically illustrates the electronics associated with the probe 1 and contained, inter alia, in the housing 12.

At the end of the tube 10 is fixed a pressure sensor 16 which outputs an electrical signal representative of the pressure of the fluid in the tube 12. After shaping and processing of the electrical signal by a circuit 17, the electrical signal representative of the pressure is applied to a display device 18 which, advantageously, comprises a threshold circuit 19 controlling a ramp of light displays 20 (for example light-emitting diodes or displays liquid crystal).

A zero adjustment circuit 21, for example connected to circuit 18, makes it possible to adjust the zero on the display 18 as a function of the pressure at rest in the tube 11.

In Figure 1, there is shown the housing 12 provided with its ramp of light emitting diodes 20 and a button 22 for acting on the circuit 21 for zero adjustment.

While retaining the same general conformation, the manometric probe 1 is produced with a different dimensioning according to the body cavity in which it must be engaged.

In the case of a probe for anal use for adults, the elastic sleeve 7 has a useful length (deformation length) of between 20 and 30 mm, typically around 25 mm and its diameter is around 9 to 15 mm. , typically about 12 mm. Given the presence of the rigid or semi-rigid core 3, the volume of the chamber 8 is approximately 3 to 7 cm³, typically 5 cm³. The diameter of the distal ends is approximately 80 mm and the length of the probe is approximately 80 mm.

For a vaginal probe, the elastic sleeve 7 has a useful length of between 45 and 55 mm, typically about 50 mm, and its diameter is about 15 to 25 mm, typically about 20 mm. The volume of the chamber 8 is about 15 to 25 cm³, typically about 20 cm³. The diameter of the distal ends is approximately 26 mm. The length of the probe is approximately 125 to 130 mm.

The operation is carried out as follows.

The appropriate probe 1 is introduced into the body cavity so that the elastic sleeve 7 is at the height of the sphincter muscle mass to be rehabilitated. Pressurized air is introduced through the nozzle 14 (tap 15 open); in a typical example the pressure in the chamber 8 is of the order of 2.10⁴ Pa. The valve 15 is then closed. In any case, this inflation pressure must be adapted as a function of the characteristics of the material constituting the sleeve 7.

Under the action of this pressure, the latex sleeve 7 is swollen and closely follows the shape of the wall of the body cavity. A calibration of the device and then carried out, using button 22, to light the first diode marked 0.

From this moment, any deformation of the body cavity due to a contraction of the sphincter musculature is faithfully followed by the latex sleeve 7 and this results in an instantaneous and faithful pressure increase in the chamber 8. This pressure variation is immediately displayed by the lighting of the diode corresponding to the pressure exerted by the patient. As soon as this effort is released, the air pressure returns to its initial value and the 0 LED lights up again.

In principle, the exercise is performed with a muscle contraction time (working time) equal to half the muscle relaxation time (rest time) and the working time is generally around 10 s, but can , at the end of rehabilitation, be increased to a longer duration (20 s, even 30 s).

To facilitate the patient's work, the housing 12 also incorporates different circuits (the design of which remains conventional) displaying the working times and rest. A flip-flop electronic circuit (not shown) controls two light-emitting diodes:
- a light-emitting diode marked T on the housing (for example of green color) remains lit during all the duration of the working time (for example (10 s); its lighting is accompanied by an audible signal emitted by a vibrator 23 controlled by the same scale circuit;
- at the end of the working time, the diode T goes out, and the circuit lights up another diode marked R on the housing (for example of red color) which remains lit throughout the duration of the rest time (for example 20 s).

A selector 24 can be provided for choosing between two or more working time durations (for example 10 s and 30 s as shown on the housing 12 of FIG. 1).

Electric power is supplied by cells or batteries (not shown), the connection of which is effected using an ON-OFF switch 25.

Although the manometric probe according to the invention was designed essentially for active rehabilitation, it is however likely to find an interesting application in passive rehabilitation with a simple and inexpensive adaptation.

3 shows, in side external view, a pressure probe 1 'for passive rehabilitation, the elements identical to those of the probe 1 of Figure 1 being designated by the same reference numerals.

Compared to probe 1, probe 1 'is distinguished by the presence of two (or more than two) electrodes 26, made of an electrically conductive material, fixed on the outside surface of the sleeve 7. Two electric wires 27, penetrating through the channel 10, provide the link between the electrodes 26 and an electrical excitation apparatus (not shown). When pressurized air is introduced into the chamber 8 via the conduit 11, the sleeve 7 closely follows the shape of the body cavity and intimately applies the electrodes 26 against the mucous membranes lining said cavity, thus ensuring good contact electric required for the transmission to the muscular mass of the electric impulses delivered by the electric excitation device.

As goes without saying and as it already follows from the above, the invention is in no way limited to those of its modes of application and embodiments which have been more particularly envisaged; on the contrary, it embraces all its variants.

Claims (8)

1. Manometric probe usable for rehabilitation, in particular active rehabilitation, of urinary or anal incontinence patients, and intended to be introduced into a body cavity (anus or vagina) to cooperate functionally with the muscle masses to be rehabilitated, comprising a tubular sleeve elongated (7) of an elastically deformable material supported at its two ends by anterior (4) and posterior (5) distal parts made of a rigid or relatively rigid material, said sleeve defining with the distal parts a chamber (8) which has an orifice (9) for communication with an external medium and which is intended, in the functional position, to be filled with a fluid constituting a pressure transmission medium, the probe being, in the functional position, disposed in the body cavity in such a way that the elastically deformable sleeve is in close contact with the muscle masses to be rehabilitated,
characterized in that the length of the elastic sleeve (7) is between approximately 20 to 30 mm in the case of a probe for anal use and between approximately 45 and 55 mm in the case of a probe for vaginal use. 2. Probe according to claim 1, intended for anal use, characterized in that the tubular sleeve (7) has a diameter of between approximately 9 and 15 mm in the undeformed state and in that the useful volume at the inside of the sleeve is between approximately 3 and 7 cm³. 3. Probe according to claim 1, intended for vaginal use, characterized in that the tubular sleeve (7) has a diameter of between approximately 15 and 25 mm in the undeformed state and in that the volume useful for inside of the sleeve is between approximately 15 and 25 cm³. 4. Probe according to any one of claims 1 to 3, characterized in that the opening (9) of the chamber is formed in the core (3) of the support (2). 5. Probe (1 ') according to any one of claims 1 to 4, intended for the passive rehabilitation of urinary or anal incontinent patients, characterized in that on the external surface of the elastically deformable sleeve (7) are fixed at least two electrodes (26) of electrically conductive material. 6. Apparatus for the active rehabilitation of urinary or anal incontinence patients, characterized in that it comprises a manometric probe (1) according to any one of claims 1 to 4 connected by a conduit (11) to a pressure sensor ( 16), means (13, 14, 15) for introducing a pressurized fluid into the probe (1) and its connection duct (11), means (17) for processing the output signal from the pressure sensor (16 ), display means (20) receiving said signal to display the true pressure exerted on the probe (1) and detected by the pressure sensor (16), and calibration means (21, 22) for adjusting the zero of the display as a function of the pressure of the fluid introduced into the probe. 7. Apparatus according to claim 6, characterized in that the pressure sensor (16) provides an electrical output signal, in that the means (17) for processing the signal are electronic means and in that the means for display (20) comprise a ramp of light displays corresponding respectively to preset pressure thresholds. 8. Apparatus according to claim 6 or 7, characterized in that it further comprises means (23, T, R) for signaling, in particular visual and / or audible, possibly adjustable (at 24), indicating the working times and rest times.

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