FR2757070A1 - Muscular contraction detection and selective stimulation intra-cavitary probe - Google Patents

Abstract

The probe includes a body (2) with cylindrical shape and housing a chamber (3) delimited by elastic walls (4). The chamber wall surface presents a number of electrical conductors (5). A fluid (7) is inserted into the chamber through a conduit (8). The conduit is connected to a fluid reservoir (9) outside the probe. The chamber is connected to a transducer which senses changes in the fluid pressure inside the chamber.

Description

 The invention relates to an intracavital physiological probe.

 The invention relates to a probe more particularly intended to allow the selective detection of muscle contractions and selective muscle stimulation in the vesico-sphincter apparatus.

 It is known that the normal behavior of the vesico-sphincter apparatus is an inhibition of the contractions of the bladder when the bladder is full and, in this case, an activation of the contraction of the striated sphincter of the urethra.

 When the behavior is abnormal, there is incontinence.

In the field of rehabilitation of urinary and anal functions, it has long been known:
-KEGEL AH Eafly genital relaxation: new technique of diagnosis and non surgical treatment. Obst 8 Gyn, 1956, 545-550,
-KEGEL AH Physiologic treatment of poor tome and function of genital muscles and urinary stress incontinence, West.J.Surg 1949, 57, 527.535,
-KEGEL AH Progressive resistance exercise in functional restoration of the perineal muscles Am.J Obst Gyn. 1958, 56, 238-248, to use pressure-sensitive probes to detect intracorporeal muscle contractions with a view to translating them into information that can be viewed, in particular by means of a suitable device such as a manometer, and to use å probes electrodes to stimulate the intracorporeal sphincters and muscles.

 From the point of view of recording muscle contractions, this visualization of contractions by the patient generally allows awareness and localization of contractions which can induce the recovery of a proprioceptive perception.

 To collect the desired contraction information, an attempt is made to detect contractions of the perineal mass using a pressure sensitive probe.

 Indeed, the perineum or pelvic floor is the crossroads of the muscles of the small pelvis and any contraction detected at this level generally reflects a contraction of muscles located in the urinary or anal tract.

 Conventionally, the physiological probes which make it possible to collect information reflecting the contractions of the bladder or the striated sphincter of the urethra by vaginal or anal route are (FR-A-1,466,248) constituted by a rigid cylindrical body surrounded by a chamber with a flexible wall which can, by injection of a fluid, expand radially around said body to apply it tightly against the wall of the natural conduit into which the probe has previously been introduced.

 The evoked injection of a fluid for pressurizing the chamber is carried out by the proximal end of the probe via a pipe connected to a source of pressurized fluid and a deflection of which is connected to a manometric type means.

Thus, any variation and the volume of the flexible chamber induces a variation in the nominal pressure of the fluid, which variation can be detected and displayed.
However, all probes of the peripheral chamber type are criticized for being sensitive to all the contractions of the muscle masses surrounding the duct in which this probe is engaged, whereas it would be desirable to collect only the perineal contractions.

 Indeed, with the known probes, abdominal and diaphragmatic contractions are also detected which disturbs the examination.

 A result which the invention aims to obtain is a probe which allows the collection of information of contractions in a determined direction and by this visualization of the information effectively allowing the patient to obtain the desired retro-control, ie simultaneously Pressure- EMG, either by stimulating with SEF, with a pressure collection of induced contraction.

From a musculo-sphincter stimulation point:
it has been known for a long time:
-CALDWELL KPS The electrical control of sphincter incompetence.

Lancet, 1963,2,174, -FALL, SUNDIN "AHLSTR M, CARLSSON, ERLANDSON Electrical stimulation in a careffuly tested and efficient form of treatment. Proceedings of VIII Int;
Conf. of Physical Medicine and Rehabilitation. 1980, - SUNDIN, CARLSSON, KOCK; Detrusor inhibition induced from mechanical stimulation of the anal region and from electrical stimulation of pudendal nerve afferents.

Invest. Urol. 1977,11,374,
to use stimulation probes fitted with bipolar type electrodes, connected by a flexible cord to electronic equipment, making it possible to adjust the shape, duration, frequency, intensity of the stimulus.

One result which the invention aims to obtain is a probe which allows electrostimulation in a determined direction allowing the patient to obtain stimulation with regard to the urethral sphincter or the perineal musculature.
The invention will be clearly understood on reading the description below made by way of nonlimiting example with reference to the attached drawing which schematically represents:
FIG. 1: a view in longitudinal section of the probe according to the invention,
- Figure 2: a section along l-ll of Figure 1
Referring to the drawing, we can see a physiological probe 1 made up of a body 2 which is substantially rigid and generally cylindrical.

 As shown in the drawing, the body carries at least one chamber 3 delimited by an elastic wall 4, on the surface of which are fixed electrical conductive bundles 5 by means within the reach of ordinary skill in the art, expandable radially to the cylindrical surface of the body 6 in particular under the effect of the pressure developed by a fluid 7 introduced into said chamber via a pipe 8, moreover at least momentarily connected to a source 9 of fluid under pressure, in particular external to the probe.

As it appears, the chamber 3 extends over a fraction of the length of the probe and this fraction is located at a predetermined distance from at least one of its ends 10,11
As it also appears, the chamber 3 is at least indirectly connected to a means 12 for detecting variations in the pressure of the fluid it contains.

According to an essential characteristic of the invention, instead of extending over the entire periphery of the body of the probe, the chamber 3 extends over a sector S bordering its periphery so that å, in the expanded position, constitute a protuberance 13 3 such as a lateral bulb which gives the probe 1 an asymmetrical shape
Preferably, the body of the probe is approximately one hundred and thirty millimeters in length and approximately twenty five millimeters in diameter.

 Preferably, the body has a hardness of at least eight shorts.

 The chamber extends over a length of about thirty millimeters, the nearest edge of which is located at a distance of approximately thirty millimeters from the distal end 10 of the body.

 The chamber extends over a sector S of the periphery of the cylindrical body comprised between two planes bounded by the longitudinal axis of the cylindrical body and forming between them a dihedral angle measuring between twenty and one hundred and eighty degrees and preferably an angle of one hundred forty degrees.

 In the drawings, in order to facilitate understanding, the proportions have not been respected, just as the thickness of the wall 4 has been notably exaggerated.

The angular extent limited to the periphery of the cylindrical body of the probe of the deformable chamber allows, by judicious orientation of said probe around its longitudinal axis in a natural conduit and or by adjusting the nominal pressure of expansion of the chamber to collect information on contractions or the absence of contraction of localized muscles and or to stimulate these localized muscles -
For example, in a vaginal situation, the expandable chamber of the probe can be oriented so as to be deformed in the posterior vaginal cavity and to marry this cavity. The probe can also be oriented to collect contractions and or stimulate muscle bundles from one of the left or right homoQateral muscle groups of the pubo-rectal muscles -
It should be noted that the deformable chamber allows precise and close contact with the perineal muscle masses regardless of the conformity of the mucosa of the natural conduit used (yawning, prolapse, atresia ...) -
In summary, avoiding (as with all the other probes) the parasitic recording of the work of the abdominals, and the diaphragm, one obtains on a display screen (not shown) a trace of the pure perineal contractions increased or not by the signal of the electro-stimulation
If the patient presents a reversal of perineal control (pushing force during a voluntary restraint command), the tracing is zero and straight or increased by the signal of electro-stimulation.

 In a (preferred) embodiment, the rigid body 2 is tightly covered with a sheath 14 of elastic material impermeable to the fluid used to expand the chamber and the wall 4 which constitutes this sheath is tightly anchored to the cylindrical face 6 of the body of the probe 1 with the exception of the sector of this face 15 in which the chamber must be formed and where this sheath constitutes the deformable wall 4 of said chamber.

 Conventionally, the means 12 for detecting pressure variations in the chamber 3 consists of a transducer of pressure actions into electrical signals.

In a (preferred) embodiment, this transducer is located in the body of the probe so as to collect unaltered information
Indeed, when the transducer is outside the probe and connected to the expandable chamber by a pipe, the transmission of information is significantly altered due to the pressure drop induced by the length of the pipe.

 Obviously, the wires and "or the lines which are connected to the probe are tightly sealed and preferably by removable means.

 These means within the reach of ordinary skill in the art have not been shown.

 Also, the transducer can be poisoned in the body of the probe and be attached thereto sealingly and dismountably.

 According to the invention, on the one hand, the probe is provided with at least two electrical conductive bundles 5 which are flush with the external surface 15 of the probe and are arranged in the sector of the deformable chamber on the elastic wall and at least indirectly connected to an electrically conductive two-wire line.

 The electrical conductor bundles are two or four in number, arranged either circularly or semi-circularly in the sector delimited by the deformable chamber, or longitudinally in the sector delimited by the deformable chamber on the elastic wall.

In one (preferred) embodiment, is added to these two or four electrically conductive bundles a so-called reference electrode or electrically conductive earth 16, placed in a circular or semi-circular manner or in the form of a patch on the elastic wall of the expandable chamber, allowing electromiographic recording using two electrically conductive beams
The two-wire line 17 allows the connection of the probe to an electrostimulation device 18.

 The shape of the probe again allows a very precise and selective positioning of the electrodes on a part of the body cavity which the probes with electric rings (circular stimulation) or the inflatable probes whose design allows stimulation is not possible. look at the bladder wall of the vagina, or next to the perineal wall of the vagina.

 With the probe of the invention, the electrodes can be placed precisely opposite a homolateral group as well as opposite the bladder and the external striated sphincter as well as the perineum.

 The probe of the invention therefore makes it possible to reconcile electro-stimulation and pressure feedback of the same anatomical area.

 It therefore makes it possible to combine the results of the two treatments by achieving, by electrical stimulation, a choke effect on the voluntary contraction of the perineum and the external or urethral striated sphincter and recording by the sensor of the voluntary perineal or sphincter or urethral contraction added to the electrotherapeutic stimuli.

 The probe of the invention therefore makes it possible to reconcile a double feedback check by pressure and by Blectromyographic route.

 It allows to combine the results of two treatments by performing a simultaneous recording of the voluntary contraction of the perineum on two channels with increased precision of the results in real time.

Claims (4)

 1. Physiological probe (1) comprising a body (2) substantially rigid and generally cylindrical which carries at least one chamber (3) delimited by an elastic wall (4),  on which are fixed electrical conductor bundles (5), radially expandable to the cylindrical surface (6) of the body, in particular under the effect of the pressure developed by a fluid (7) introduced into said chamber via a pipe (8) by elsewhere at least temporarily connected to a source (9) of pressurized fluid, in particular external to the probe,  which expandable chamber on the one hand extends over a fraction of the length of the probe and at a predetermined distance from at least one of its ends (10,11) and, on the other hand, is at least indirectly connected to a means (12) for detecting variations in the pressure of the fluid it contains,  this probe being CHARACTERIZED in that, instead of extending over the entire periphery of the body of the probe, the chamber (3) extends over a sector (S) limited from its periphery so that, in the expanded position, constitute a protuberance (I 3) such as a lateral bulb which gives an asymmetrical shape to the probe (1).  2. Probe according to claim 1 characterized in that the rigid body (2) is closely covered with a sheath (14) of elastic material impermeable to the fluid used to expand the chamber and the wall (4) which constitutes this sheath is tightly anchor to the body (2) of the probe (1) with the exception of the sector of this face (I (15) in which the chamber must be formed and where this sheath constitutes the deformable wall (4) of said chamber.  3. Probe according to any one of claims 1 and 2 characterized in that on the one hand, it is provided with at least two electrical conductive bundles (5) which are flush with the external surface (15) of the probe in a sector substantially identical in which the deformable chamber is located and mounted either in a semi-circular, or circular, or in longitudinal and of a reference or earth electrical conductor beam (16) which is flush with the external surface (15) of the probe in a substantially identical sector in which the deformable chamber is located and mounted either in a circular, or in a semi-circular, or in a pellet, and on the other hand these electrical conductive bundles (5 and 16) are at least indirectly connected to a line (17 ) electrically conductive two-wire.  4. Probe according to any one of claims I to 3 characterized in that the chamber extends over a sector (S) of the periphery of the cylindrical body comprised between two half-planes limited by the longitudinal axis of the cylindrical body and forming between them a death angle measuring between twenty and one hundred and eighty degrees and preferably an angle of one hundred and forty degrees.