ITPV940009A1 - VAGINAL / ANAL PROBE FOR INCONTINENCE THERAPY BY ELECTROSTIMULATION AND / OR BIOFEEDBACK PRESSOR OR ELECTROMYOGRAPHIC - Google Patents

Description

Description of industrial invention entitled:

"VAGINAL / ANAL PROBE FOR THE THERAPY OF INCONTINENCE BY ELECTROSTIMULATION AND / OR BIOFEEDBACK AT THE PRESSURE OR ELECTROMYOGRAPHIC",

Summary:

This is a vaginal / anal probe for use in various cases of urinary / fecal incontinence. Consisting of a durable body, which determines the interconnection with a stimulation / biofeedback equipment, and of a disposable body (in the vagina or anus) in suitably metallized plastic material. The durable body can contain the electronic section for the transformation of the pressure exerted by the vaginal walls into an electrical signal, or for the preamplification of the electromyographic signal generated by the contracting pelvic floor muscles.

The disposable insertable body is made up of various plastic parts coupled together, some of which are metallized to become conductive. The electrical contacts between the durable body and the disposable insertable body are achieved by means of two balls and a metal stem.

State of the art:

Re-education of incontinence, especially female stress urinary incontinence, begins to have a good spread and excellent chances of success, thanks also to the overcoming of some "taboos" by the patient and the externalization of the problem to the specialist. A method, not very common in Italy, but well known in other countries such as France, England and the United States, consists in the vaginal or anal electro-stimulation of certain muscle groups.

Another method, called "biofeedback", provides instead the patient's awareness of the muscular phenomena responsible for continence, and the achievement of voluntary control of these phenomena. In other words, the level of contraction of certain muscles that affect the vaginal walls and the anus is detected, transformed into a light or sound signal and submitted to the patient who, in this way can appreciate even the slightest changes in the degree of muscle contraction control yourself.

The current probes, mainly of French or American fabrication, are made of plastic material but the electrodes, in charge of contact with the anatomical parts concerned, are normally made of metal.

Obviously, the first requirement that is encountered in the "routine" practice of instrumental perineal rehabilitation, to avoid the contagion of diseases from one patient to another and in any case to ensure a minimum of hygiene, is the sterilization of the probes or, alternatively, the use of single-patient probes (preferably single-use). The plastic / metal solution used up to now is certainly functional, however it involves a significant cost of the probe itself, which can hardly be considered "single-use" and is therefore "sterilized" every time.

Sterilization is normally carried out by immersing the probe in a special disinfectant liquid, but the operation takes a few hours, therefore the need arises to have several probes in order to treat more patients.

Furthermore, the probe, even if sterilized, induces in the patient a legitimate doubt about its cleanliness. After all, after a few sessions and as many sterilizations, the appearance of a "used" vaginal probe is certainly no longer that of a new one.

There are currently separate probes for the detection of perineal contraction and for perineal stimulation.

The vaginal probes for detecting the level of perineal contraction known up to now normally consist of a pre-inflated pressure-sensitive chamber, connected to the detection instrument by means of a small tube.

Description:

The probe, which is the subject of the present patent application, consists of two distinct parts which are joined at the time of therapy; for simplicity I have called you two parts as DURABLE BODY (as it can be used for all therapies) and INSERTABLE BODY (single-use, can be "thrown" after the session). The electrical connection between the two parts is ensured by two small spheres, which, housed in the durable body, ensure contact with the rear metallized area of the insertable body and by a metal rod which determines contact with the front metallized area of the insertable part. The electrical stimulation of the appropriate anatomical parts (vaginal walls or anus), as required by the therapeutic protocol, takes place between the posterior metallized electrode and the anterion metallized electrode (as regards the vaginal insertable body), while in the anal electrode they will be directly the two metallized areas of the stem to constitute the electrical stimulation surfaces

- The DURABLE BODY, consisting of a plastic or rubber container and a metal stem, can contain f) pressure transducer, which transforms the force into an electric signal, as well as the relative electronic circuits for conditioning this signal. This expedient allows to obtain a better sensitivity of the probe, since there is no connection pipe between the probe and the pressure transducer. The transformation of the pressure into an electrical signal takes place directly in the durable body, and the connection between the probe and the equipment does not take place by means of a tube but rather by means of an electric cable.

Alternatively, the durable body can contain the amplification circuits for the EMG signal (electromyography), if it is desired to detect muscle contraction through muscle action potentials.

Where it is desired to use only the stimulation function of the probe, the durable body can also simply contain the connection between the cable coming from the stimulation device and the metal parts intended for contact with the metallized parts of the insertable body.

- 11 INSERTABLE BODY, composed of a certain number of parts in plastic material, obtained by injection molding, some of which are subsequently metallized to make them conductive on the surface.

By using different plastic parts it is possible to obtain at least 3 different types of insertable bodies:

> The DISPOSABLE INSERTABLE BODY FOR VAGINAL STIMULATION ONLY (see Table 2), which can also be used for electromlographic detection only, is composed of:

• Cannula, made of suitably metallized plastic, the metallization is divided into two parts (the rear zone, intended to receive electrical contact from the sphere of the durable body, and the front zone, intended to receive electrical contact from the metal stem of the durable body. )

• Rear metallized plastic electrode, in electrical contact with the rear metallized area of the cannula • Anterior metallized plastic electrode, in electrical contact with the anterior metallized area of the cannula, Core, serves only as a spacer but could be suitably metallized to extend the surface of the posterior and anterior electrodes, • Tip, serves to facilitate the introduction of the probe.

• Jacket, necessary to isolate the rear metallized area.

> The DISPOSABLE INSERTABLE BODY FOR STIMULATION AND / OR VAGINAL PRESSURE DETECTION (see Table 2) consists of:

• Cannula, in metallized plastic

• Rear electrode in metallized plastic

• Front electrode in metallized plastic

• Spacer core

• Elastic membrane

• Tip

Shirt.

> The DISPOSABLE INSERTABLE BODY FOR ANAL STIMULATION ONLY, also usable for the EMG detection of the muscle action potentials of the levator ani muscle (see Table 3), consists of:

Metallized plastic cannula

• Rear stop

• Front stop

Tip

• Shirt.

It should be noted that the plastic piece called cannula is the same for all three configurations of the insertable part.

the posterior and anterior metallized electrodes are the same for the two types of vaginal insertable bodies.

The shirts are the same for the two types of bodies that can be inserted by stimulation only. It follows a modular concept.

The union between the durable body and the appropriate insertable body constitutes the actual probe. Using 13 different types of insertable bodies, 3 types of probe are possible (see Table 1).

It is interesting to underline how in this type of probe (using the vaginal insertable body for stimulation and detection) it is possible to stimulate and detect pressure at the same time; In practice it becomes possible to provide stimulation to the patient and at the same time ask him to collaborate in the contraction, being able to visualize, at the same time, the work done by the patient himself.

Claims (5)

Claims; 1) Vaginal / anal probe for the therapy of incontinence by electrostimulation and / or pressure or electromyographic detection, characterized by a completely insertable plastic body where the contact areas (electrodes) are obtained by surface metallization of some plastic details. 2) Vaginal / anal probe for the incontent therapy by means of electrostimulation and / or pressure or electromyographic detection, according to claim 1 and characterized by insertable plastic parts of modular design. 3) Vaglnal / ana probe! And for the therapy of incontinence by electrostimulation and / or pressure or electromyographic detection, according to claims 1 and 2 and characterized by the possibility of stimulation and simultaneous detection of the level of perineal tension, by means of a translator internal pressure. 4) Vaginal / anal probe for the therapy of incontinence by electrostimulation and / or pressure or electromyographic detection, according to claims 1, 2, and 3 and characterized by insertable parts of particular type and shape. 5) Vaginal / anal probe for the therapy of incontinence by electrostimulation and / or pressure or electromyographic detection, according to claims 1, 2, 3, and 4, as described above, represented in the accompanying drawings and for the purposes set out above.