A new concept for Biofeedback & Electrostimulation in Uro-Gynaecology using a specially designed probe : PERISIZE
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1 1 PELVIC FLOOR REHABILITATION A new concept for Biofeedback & Electrostimulation in Uro-Gynaecology using a specially designed probe : PERISIZE First - some reminders about the female pelvic floor The inferior part of the abdominal cavity is covered by the pelvic floor in which the striated sphincter is integral. The constituent muscles are comprised mainly of type 1 fibres. The pelvic and uro-genital diaphragms are important The urogenital diaphragm is principally comprised of the deep and superficial transverse perineal muscles, completed by the perineal transverse ligament. It closes the urogenital opening. [Fig. 3] The pelvic diaphragm is essentially formed by the levator of the anus and the ischio-coccygeus muscles. It participates in countering the pressure exercised by the abdomen and assists in supporting weight of the pelvic viscera. Fig. 3 Pelvic diaphragm and uro-genital diaphragm A = anus ; BS = bulbo-spongiosus m. ; C = coccyx ; CV = vulval constrictor m.; E = levator ani m. ; IC = ischiocavernosus m. ; NFCP = fibrous nucleus of the perineum ; TS = transversus m. ; U = uterus ; V = vagina Where are the levator ani muscles? They are situated in the deep part of the perineal musculature and they stretch from the pubis to the coccyx and to the sacrum. These muscles, which all are recruited simultaneously, are controlled by the cortex. The distensions of the female pelvic diaphragm ends in a descent of the internal genital organs. Tears of the levator ani can be caused by labour resulting in lesions of the pelvic diaphragm.
2 2 The different planes of the pelvic floor muscles SUPERFICIAL : 5 muscles : Bulbo-spongeous (ex bulbo-cavernosus), Ischio-cavernosis, Superficial transversus, Vulval constrictor, Anal sphincter MEDIAL : Two muscles of the urogenital diaphragm : Deep transversus & Urethral sphincter DEEP : The pelvic diaphragm with 2 muscle groups : - the levator ani in 2 distinct groups: - the ilio-coccygeus muscle sphincter with the iliac fascia and the ischial fascia - the levator fascia with the puborectal & le pubo-coccygeus fascia - the ischio-coccygeus muscle What function do the levator ani muscles have and what is the visceral mechanism? The pelvic floor creates lines of force which oppose the natural tendencies of the viscera to form a hernia across the weakness of the perineal zone : the urogenital slit. This tendency is countered by Levator ani muscles and the superficial perineal muscles. The perineal support on the one hand, and the multi-directional suspension on the other hand, provide a precarious equilibrium with the multiplicity of methods of fixation and the almost constant movement of the pelvic viscera. With pushing, the vagina displaces itself downwards and the walls close together. They become a rigid segment resting on the central fibrous nucleus of the pelvic floor. The uterus displaces itself towards the coccygeus area, the neck always remaining above the horizontal plane across the summit of the coccygeus. With straining, the urethral-vaginal tube moves around the urogenital slit by moving down and back. The tightening of Levator ani causes the central fibrous nucleus of the pelvic floor to firm up, closes the urogenital slit and neutralises the pull on the neck by exercising a countering force in the opposite direction to the genital displacement. The body of the uterus rests on the bladder and is supported from below by the vagina. A deficit in the musculature leads to the suppression of natural physiological mechanisms : * the perineal corner disappears ; * the vagina and the vulva start to gape ; * the bladder becomes awkwardly positioned. An anterior colpocele becomes a cystocele then a rectocele.
3 3 The damage caused to different muscles during labour. We know that labour and delivery are the major causes of damage to the perineum. We will not go into the reasons here. One must remember that all of the deep and some of the superficial musculature are subject to damage depending in varying degrees on their suppleness, ability to stretch, elasticity, their anatomical shape and manner of insertion : An ischio-coccygeus muscle does not react like a pubo-rectalis, in the sling in the plane of the levators. This brings us to consider the best methods for functional examination and on the therapeutic strategies we should employ. Assessment only of the pubo-rectalis and pubo-coccygeus muscles seems to us to be insufficient. One should also assess the adjacent ilio-coccygeus and ischio-coccygeus planes. This assessment is difficult and requires the sensory- motor participation of the patient. This means that the result will depend on the intra-vaginal perception, with regard to the imagination as well as the anatomy of this internal zone. One may postulate that biofeedback from - or stimulation of - the whole zone containing the levator musculature without «details» may resolve only part of the problem. One should reactivate, restructure, sollicit the deepest parts which are not solicited by a general stimulation or an overall contraction. Stimulation & biofeedback results depend on the position of the electrodes. A probe with lateral bars like Periform probe (Mobilis ex-neen) permits only bilateral work on all the levator ani muscles but does not allow targeted treatment for asymmetry and does not allow posterior or anterior treatment stimulation or biofeedback. This probe does not allow too to stimulate or register each side right or left - of the levator ani. A classical probe with circular rings allows only bilateral work on all the levator ani muscles and does not allow targeted treatment for asymmetry but provides too upside stimulation which not recommended. We set out to design a probe without these limitations? How can muscles be more precisely stimulated or their EMG biofeedback read by PERISIZE?
4 4 The probe designed provides several options dependent on the choice of electrodes to provide stimulation or EMG readings from the musculature in general or targeted treatment. The PERISIZE is a probe with four hemispherical electrodes in 45 downward position. By positioning the probe and by selecting electrodes, one can treat asymmetry, an anterior zone, or a medial zone. For biofeedback any free electrode can be used as a earth-reference. Targeted biofeedback or stimulation of the pelvic floor muscles... Specifically, by selecting electrodes, the PERISIZE permits o stimulation and biofeedback of the whole of the levator ani elevator branch o stimulation and biofeedback of the ilio-coccygeous sphincteric branch permits o a targeted lateral stimulation and biofeedback for asymmetry o a targeted biofeedback with an earth-reference incorporated o a targeted antalgic stimulation of the scar for dyspareunia permits o a sit down stimulation and biofeedback control o an upside biofeedback control while coughing, bending or jumping How to use the new probe Procubitus or classical laid down Electrical Stimulation Using a 2 channels stimulator one may use 4 electrodes at the same time, e.g. 1, 2 on a side and 3, 4 on the other. If using 1 channel stimulator one may connect the 4th plugs into an adaptor plugged in 2. So one may connect 1, 2 on the red and 3, 4, on the black connector. One may use to only 2 electrodes plugging 2 pins (on the right and on the left) like 1 or 2 and 3 or 4. Bilateral stimulation : symetric pelvic floor plugging R & L 4 electrodes One stimulate the whole pelvic floor as with a Periform. But as each electrode has a surface of 471 mm2 (total for 4 electrode mm2), one stimulate a much more muscle area than with a Periform electrode. The stimulation has more efficiency and is more targeted. PFM insufficiency (50Hz) Urethral sphincteric insufficiency (35 & 50 Hz) Urge incontinence (5, 10 & 20 Hz)
5 5 PFM reinforcement (100Hz) Unilateral Stimulation : asymmetric pelvic floor plugging R or L One select on what side the muscle is weak 1, 2, or 3, 4. Unilateral PFM insufficiency (50 Hz) Unilateral PFM hypo tonicity (10Hz) Unilateral PF antalgy (4 Hz then 80 Hz) Stimulation by muscular zone : proprioceptivity 2 channels - R & L Even one selects 1, 3, and 2, 4, and the stimulation will be front and rear, even one crosses 1, 4 & 2, 3. One may too have a frequency modulation on each couple of electrodes. Proprioceptivity front &/or rear or crossed by frequency modulation (5, 10, 20, 35 & 50 Hz) EMG BIOFEEDBACK registering Bilateral BFB : symmetric PF plugging R & L One registers the whole PFM even on 1 channel (1, 3 & 2, 4 ) even on 2 (4 electrodes 1, 2 or 3, 4 ). Using a 2 channels one may control the difference between the right and the left side. Lateral PFM insufficiency PFM targeted Reinforcement High conscientiousness Control of the asymmetry recuperation Standing up position blocking control (reflex and voluntary) Unilateral BFB : symmetric PF plugging R & L One selects the side where the weakness is found and one plugs 1, 2, or 3, 4. One may control the muscle function improvement realised by session by session. One side PFM insufficiency One side Reinforcement One side control of muscle improvement Sitting down position EMG BIOFEEDBACK registering Two sides BFB : symmetric PF- plugging R & L One registers the whole PFM even on 1 channel (1, 3 & 2, 4 ) even on 2 (4 electrodes 1, 2 & 3, 4 ). Using a 2 channels one may control the difference between the right and the left side. Rear & front PF activity
6 6 Rear & front PF improvement Standing up position blocking control (reflex and voluntary) Standing up position EMG BIOFEEDBACK registering BFB bilatéral : périnée symétrique - branchement D & G One registers the whole PFM even on 1 channel (1, 3 & 2, 4 ) even on 2 (4 electrodes 1, 2 & 3, 4 ). Possible Indications : Two side PF activity when moving Standing up position blocking control (reflex and voluntary) One have to do almost 2 measurements : the first with the only PFM reflex contraction, and the second with a voluntary contraction. Then one have to compare the both results. The 2 nd measurement must have almost 20% more than the 1st to conclude that the patient is able to block the PFM with efficacy. Other advantages and interests of the PERISIZE 13 gr and 4 hemispheric electrodes. The first interest is the lightness of this new concept of probe. Its interest resides in its high and new technology which is radically different from the other manufactured probes. Thanks to a patented process it is possible to produce a light probe (13 gr. ) presenting electrodes which are not made of metal but made of metallized alloy, lighter than all injected probes. In another hand these probes haven t any soldering inside, to avoid any rupture in the electric conduction, and reducing the ohmic impedance. The second interest is the electric conductivity, the comfort of stimulation and a better registering. Indeed the traditional probe electrodes are made of steel ( chromium & nickel presenting allergic risk ) having a metal thickness in m/m. We have patented a system of medical alimentary metallization which allows to have only a metal thickness in microns (µ). This led to a better electric conduction, much higher than that produced by the steel electrodes. It should be known that the proper resistivity of the metal ring in contact with a mucosa membrane will condition the comfort of stimulation. The vaginal mucosa membrane has an ohmic resistivity which varies from 300 to 450 ohms. If the electrode has a too important resistivity (steel electrodes, soldering, wires) it may sometimes occur uncomfortable sensitivity, whereas if the resistivity is
7 7 close to zero (technique of metallization) comfort is exceptional. BFB is much better and sensitive. The third interest is the non allergic electrodes. Finally last advantage, and not the least, is the allergy to the components. The steel rings are likely to cause allergies because the presence of nickel and chromium in steel. In the PERISIZE metallization technique there is neither chromium, nor nickel... nor latex, only one alloy with gold, which is a natural metal. The only condition is to keep these probes distant from any product containing sulphur The forth interest is. the price. As the technique is less expensive, price will be lower too even for a so advanced probe. All probes are plugged in pigtail pins 2 m/m female. Conclusion Classical probes provide a contraction or receive biofeedback readings of the pelvic floor musculature without regard to the different contractile properties of each muscle. They are not well suited to those who wish to evaluate and treat the specific pelvic floor fascia which carpet the pelvic floor in a targeted way. The PERISIZE provide a range of options to satisfy most requirements.
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